U.S. patent application number 12/872730 was filed with the patent office on 2011-03-17 for patient monitoring, diagnosis, and/or therapy systems and methods.
Invention is credited to Jesse W. Hartley, John D. Hatlestad, Kent Lee, Quan Ni, Krzysztof Z. Siejko, Jeffrey E. Stahmann, Qingsheng Zhu.
Application Number | 20110061647 12/872730 |
Document ID | / |
Family ID | 41050495 |
Filed Date | 2011-03-17 |
United States Patent
Application |
20110061647 |
Kind Code |
A1 |
Stahmann; Jeffrey E. ; et
al. |
March 17, 2011 |
Patient Monitoring, Diagnosis, And/Or Therapy Systems and
Methods
Abstract
Systems and methods involve an implantable device configured to
perform at least one cardiac-related function, a patient-external
respiratory therapy device, and a communication channel configured
to facilitate communication between the implantable device and the
respiratory therapy device. The implantable and respiratory therapy
devices operate cooperatively via the communication channel to
provide one or more of patient monitoring, diagnosis, and therapy.
The communication channel may be configured to facilitate
communication between an external processing system and at least
one of the implantable device and the respiratory therapy device.
The processing system is communicatively coupled to at least one of
the implantable and respiratory therapy devices via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
Inventors: |
Stahmann; Jeffrey E.;
(Ramsey, MN) ; Lee; Kent; (Shoreview, MN) ;
Hartley; Jesse W.; (White Bear Lake, MN) ; Ni;
Quan; (Shoreview, MN) ; Hatlestad; John D.;
(Maplewood, MN) ; Zhu; Qingsheng; (Wexford,
PA) ; Siejko; Krzysztof Z.; (Maple Grove,
MN) |
Family ID: |
41050495 |
Appl. No.: |
12/872730 |
Filed: |
August 31, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10943721 |
Sep 17, 2004 |
7787946 |
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12872730 |
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60504229 |
Sep 18, 2003 |
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Current U.S.
Class: |
128/202.16 |
Current CPC
Class: |
A61B 5/0031 20130101;
A61B 5/103 20130101; A61M 2016/0042 20130101; A61B 5/053 20130101;
A61B 5/389 20210101; A61B 5/6891 20130101; A61M 2205/3306 20130101;
A61M 2205/52 20130101; A61B 7/00 20130101; A61B 5/285 20210101;
A61M 16/10 20130101; G16H 20/40 20180101; A61B 5/1116 20130101;
A61B 5/14539 20130101; A61M 16/026 20170801; A61M 2016/0036
20130101; A61M 2230/65 20130101; A61N 1/365 20130101; A61B 5/02405
20130101; A61B 5/0836 20130101; A61B 5/145 20130101; A61B 5/4818
20130101; A61B 5/4519 20130101; A61M 2230/63 20130101; A61B 5/0215
20130101; A61B 5/6814 20130101; A61M 2230/50 20130101; A61N 1/3601
20130101; A61M 2230/04 20130101; A61M 2230/432 20130101; A61M
2230/435 20130101; A61B 5/02055 20130101; A61M 2202/0208 20130101;
A61M 2205/3303 20130101; A61B 5/6823 20130101; A61B 5/686 20130101;
A61M 2230/202 20130101; A61M 2230/205 20130101; A61N 1/36557
20130101; A61B 5/6828 20130101; A61B 2562/0219 20130101; A61M
16/0666 20130101; A61B 5/287 20210101; A61M 16/0051 20130101; A61M
2205/3592 20130101; A61M 2016/0039 20130101; A61M 2230/60 20130101;
A61B 5/14542 20130101; A61M 2205/3561 20130101; A61M 2016/0021
20130101; A61M 2230/10 20130101; A61N 1/36592 20130101; A61N 1/37
20130101; A61B 5/398 20210101; A61B 5/0809 20130101; G16H 20/30
20180101; G16H 50/20 20180101; A61B 5/4035 20130101; A61N 1/3627
20130101; A61B 5/363 20210101; A61N 1/36514 20130101; A61M
2205/3375 20130101; A61B 5/087 20130101; A61B 5/369 20210101; A61M
2230/30 20130101; A61N 1/36535 20130101; A61N 1/36578 20130101;
A61N 1/36585 20130101; A61B 5/7275 20130101; A61B 5/113
20130101 |
Class at
Publication: |
128/202.16 |
International
Class: |
A61M 16/00 20060101
A61M016/00 |
Claims
1. A system, comprising: an implantable device configured to
perform at least one cardiac-related function; a patient-external
respiratory therapy device; and a communication channel configured
to facilitate communication between the implantable device and the
respiratory therapy device, the implantable and respiratory therapy
devices operating cooperatively via the communication channel to
provide one or more of patient monitoring, diagnosis, and therapy.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/943,721, filed on Sep. 17, 2004, which
claims the benefit of Provisional Patent Application Ser. No.
60/504,229, filed on Sep. 18, 2003, to which Applicant claims
priority under 35 U.S.C. .sctn.120 and 35 U.S.C. .sctn.119(e),
respectively, and which are incorporated herein by reference in
their entireties.
FIELD OF THE INVENTION
[0002] The invention relates to systems and methods providing
patient monitoring, diagnosis and/or therapy.
BACKGROUND OF THE INVENTION
[0003] The human body functions through a number of interdependent
physiological systems controlled through various mechanical,
electrical, and chemical processes. The metabolic state of the body
is constantly changing. For example, as exercise level increases,
the body consumes more oxygen and gives off more carbon dioxide.
The cardiac and pulmonary systems maintain appropriate blood gas
levels by making adjustments that bring more oxygen into the system
and dispel more carbon dioxide. The cardiovascular system
transports blood gases to and from the body tissues. The
respiration system, through the breathing mechanism, performs the
function of exchanging these gases with the external environment.
Together, the cardiac and respiration systems form a larger
anatomical and functional unit denoted the cardiopulmonary
system.
[0004] Various disorders may affect the cardiovascular,
respiratory, and other physiological systems. For example, heart
failure (HF) is a clinical syndrome that impacts a number of
physiological processes. Heart failure is an abnormality of cardiac
function that causes cardiac output to fall below a level adequate
to meet the metabolic demand of peripheral tissues. Heart failure
is usually referred to as congestive heart failure (CHF) due to the
accompanying venous and pulmonary congestion. Congestive heart
failure may have a variety of underlying causes, including ischemic
heart disease (coronary artery disease), hypertension (high blood
pressure), and diabetes, among others.
[0005] There are a number of diseases and disorders that primarily
affect respiration, but also impact other physiological systems.
Emphysema and chronic bronchitis are grouped together and are known
as chronic obstructive pulmonary disease (COPD). Pulmonary system
disease also includes tuberculosis, sarcoidosis, lung cancer,
occupation-related lung disease, bacterial and viral infections,
and other conditions.
[0006] Chronic obstructive pulmonary disease generally develops
over many years, typically from exposure to cigarette smoke,
pollution, or other irritants. Over time, the elasticity of the
lung tissue is lost, and the lungs become distended, unable to
expand and contract normally. As the disease progresses, breathing
becomes labored, and the patient grows progressively weaker.
[0007] Disordered breathing is a respiratory system disorder that
affects a significant percentage of patients between 30 and 60
years. Disordered breathing, including apnea and hypopnea, may be
caused, for example, by an obstructed airway, or by derangement of
the signals from the brain controlling respiration. Sleep
disordered breathing is particularly prevalent and is associated
with excessive daytime sleepiness, systemic hypertension, increased
risk of stroke, angina and myocardial infarction. Disordered
breathing can be particularly serious for patients concurrently
suffering from cardiovascular deficiencies.
[0008] Various types of disordered respiration have been
identified, including, apnea (interrupted breathing), hypopnea
(shallow breathing), tachypnea (rapid breathing), hyperpnea (heavy
breathing), and dyspnea (labored breathing). Combinations of the
respiratory cycles described above may be observed, including, for
example, periodic breathing and Cheyne-Stokes respiration (CSR).
Cheyne-Stokes respiration is particularly prevalent among heart
failure patients, and may contribute to the progression of heart
failure.
[0009] There are a number of cardiovascular system disorders that
have secondary effects with respect to other physiological systems.
When functioning properly, the human heart maintains its own
intrinsic rhythm, and is capable of pumping an adequate amount of
blood throughout the body's circulatory system. However, some
people have abnormal cardiac rhythms, referred to as cardiac
arrhythmias, that cause a decrease in cardiac output.
[0010] Bradycardia is a condition that involves a heart beat that
is abnormally slow, causing insufficient blood supply to the body's
tissues. Tachyarrhythmia occurs when the patient's cardiac rhythm
is too fast. The excessively rapid cardiac contractions result in
diminished blood circulation because the heart has insufficient
time to fill with blood before contracting to expel the blood.
Ventricular fibrillation is a particularly dangerous form of
tachyarrhythmia, and may result in death within minutes if the
heart's normal rhythm is not restored.
[0011] Because of the complex interactions between the
cardiovascular, pulmonary and other systems, effective approaches
to monitoring, diagnosis, and treatment of various disorders is
needed. The present invention fulfills these and other needs, and
addresses other deficiencies of prior art implementations and
techniques.
SUMMARY OF THE INVENTION
[0012] The present invention is directed to systems and methods for
monitoring, diagnosing, and/or treating a patient. Various
embodiments of the invention are directed to systems and method
configured to monitor, diagnose, and/or provide patient therapy
using one or more individual medical procedures. Each of the
individual medical procedures provide a particular monitoring,
diagnosis or therapeutic function or set of functions. Each
individual medical procedure may be implemented as a stand-alone
system. Two or more of the individual medical procedures may be
used in combination to provide more comprehensive patient
monitoring, diagnosis and/or therapy. One or more functions of two
or more individual medical procedures may be used in combination to
enhance patient monitoring, diagnosis and/or therapy.
[0013] Various embodiments of the invention are directed to systems
and methods configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures. Coordinated medical
procedures may involve cooperative operation of two or more of the
individual processes. Coordinated medical procedures may also
involve cooperative operation of one or more functions of two or
more of the individual processes.
[0014] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0015] According to various embodiments of the invention, a system
may be implemented to include an implantable device configured to
perform at least one cardiac-related function and a
patient-external respiratory therapy device. A communication
channel may be configured to facilitate communication between the
implantable device and the respiratory therapy device. The
implantable and respiratory therapy devices may be configured to
operate cooperatively via the communication channel to provide one
or more of patient monitoring, diagnosis, and therapy. The
communication channel may be configured to facilitate
uni-directional or bi-directional communication between the
implantable device and the respiratory therapy device.
[0016] In one configuration, each of the implantable and
respiratory therapy devices provides at least two of patient
monitoring, diagnosis, and therapy. In another configuration, each
of the implantable and respiratory therapy devices provides each of
patient monitoring, diagnosis, and therapy.
[0017] The respiratory therapy device may be configured to
coordinate one or more of initiation, modification, and termination
of a function of the implantable device. The implantable device may
be configured to coordinate one or more of initiation,
modification, and termination of a function of the respiratory
therapy device.
[0018] One or both of the implantable and respiratory therapy
devices may comprise one or more sensors configured to detect one
or more conditions affecting the patient. The implantable and
respiratory therapy devices may be configured to provide one or
more of the patient monitoring, diagnosis and therapy based at
least in part on the one or more detected conditions.
[0019] The system may further include a drug delivery device. The
drug delivery device may be controllable by one or both of the
implantable and respiratory therapy devices.
[0020] The respiratory therapy device may comprises a positive
airway pressure device. The respiratory therapy device may comprise
a gas therapy device. The implantable device may comprise a cardiac
rhythm management device.
[0021] In accordance with another embodiment, a system includes an
implantable device configured to perform at least one
cardiac-related function, a patient-external respiratory therapy
device, a processing system external of the implantable and
respiratory therapy devices, and a communication channel configured
to facilitate communication between the processing system and at
least one of the implantable device and the respiratory therapy
device. The processing system may be communicatively coupled to the
at least one of the implantable and respiratory therapy devices via
the communication channel to provide one or more of patient
monitoring, diagnosis, and therapy.
[0022] The communication channel may be configured to facilitate
communication between the implantable device and the respiratory
therapy device. The communication channel may be configured to
facilitate uni-directional, bi-directional, or a combination of
uni- and bi-directional communication between the processing system
and one or both of the implantable and respiratory therapy
devices.
[0023] The processing system may be configured to manage
patient-related information. For example, the processing system may
be implemented as a server-based patient information management
system. The processing system may be configured to coordinate one
or more of initiation, modification, and termination of a therapy
deliverable by one or both of the implantable and respiratory
therapy devices. The processing system may be configured to
coordinate one or more of initiation, modification, and termination
of a diagnostic procedure performed by one or both of the
implantable and respiratory therapy devices.
[0024] The processing system may be configured to coordinate one or
more of initiation, modification, and termination of a monitoring
procedure performed by one or both of the implantable and
respiratory therapy devices. One or both of the implantable and
respiratory therapy devices may be configured to coordinate a
function of the processing system. The processing system may be
configured to remotely interrogate one or both of the implantable
and respiratory therapy devices.
[0025] According to other embodiments, methods may involve
providing a first set of medical procedures associated with a
patient-external respiratory therapy device and providing a second
set of medical procedures associated with an implantable device,
the implantable device configured to perform at least one
cardiac-related function. Methods may further involve coordinating,
via communication between the implantable and respiratory therapy
devices, one or more processes of the first and second sets of
medical procedures, wherein the first and second sets of medical
procedures involve at least one of patient monitoring, diagnosis,
and therapy.
[0026] In accordance with other embodiments, method may involve
providing a first set of medical procedures associated with a
patient-external respiratory therapy device, and providing a second
set of medical procedures associated with an implantable device,
the implantable device configured to perform at least one
cardiac-related function. Methods may further involve coordinating
one or more processes of the first and second sets of medical
procedures using a patient-external processing system, wherein the
first and second sets of medical procedures involve at least one of
patient monitoring, diagnosis, and therapy.
[0027] The above summary of the present invention is not intended
to describe each embodiment or every implementation of the present
invention. Advantages and attainments, together with a more
complete understanding of the invention, will become apparent and
appreciated by referring to the following detailed description and
claims taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1A is block diagram of a system for providing
coordinated monitoring, diagnosis and therapy in accordance with
embodiments of the invention;
[0029] FIGS. 1B-1D illustrate various medical procedures that may
be implemented by a coordinated medical system in accordance with
embodiments of the invention.
[0030] FIGS. 2A-2B are block diagrams of a coordinated system
including a respiratory therapy device and an implantable
device;
[0031] FIG. 3 is a block diagram of a respiratory therapy system
that may be utilized in a coordinated system in accordance with
embodiments of the invention;
[0032] FIG. 4A is a partial view of an implantable device that may
be utilized in a coordinated system in accordance with embodiments
of the invention;
[0033] FIG. 4B illustrates a normal respiration pattern as
represented by a transthoracic impedance sensor signal;
[0034] FIG. 5A is a view of a transthoracic cardiac sensing and/or
stimulation device as implanted in a patient in accordance with an
embodiment of the present invention;
[0035] FIG. 5B is a block diagram illustrating various components
of a transthoracic cardiac sensing and/or stimulation device in
accordance with an embodiment of the present invention;
[0036] FIGS. 5C-5E are diagrams illustrating various components of
a transthoracic cardiac sensing and/or stimulation device located
in accordance with embodiments of the invention;
[0037] FIGS. 5F-5H are diagrams illustrating electrode subsystem
placement relative to a heart in accordance with embodiments of the
invention;
[0038] FIG. 6 illustrates respiration intervals used for disordered
breathing detection according to embodiments of the invention;
[0039] FIG. 7 illustrates respiration intervals used in detection
of sleep apnea and severe sleep apnea according to embodiments of
the invention;
[0040] FIGS. 8A-B are graphs of respiration patterns that may be
detected according to embodiments of the invention;
[0041] FIG. 9 is a flow chart illustrating a method of apnea and
hypopnea detection according to embodiments of the invention;
[0042] FIG. 10 is a graph illustrating a breathing interval
according to embodiments of the invention;
[0043] FIG. 11 is a graph illustrating a hypopnea detection
approach in accordance with embodiments of the invention;
[0044] FIGS. 12-13 are charts illustrating nomenclature for
individual disordered breathing events and combinations of
disordered breathing events that can be addressed in accordance
with embodiments of the invention, respectively;
[0045] FIGS. 14A-14E are graphs illustrating disordered breathing
events comprising a mixture of apnea and hypopnea respiration
cycles;
[0046] FIG. 14F is a graph illustrating a periodic breathing
respiration pattern that may be detected according to embodiments
of the invention;
[0047] FIG. 14G is a graph illustrating a Cheyne-Stokes respiration
pattern that may be detected according to embodiments of the
invention;
[0048] FIG. 15 is a flowchart of a method for detecting disordered
breathing in accordance with an embodiment of the invention;
[0049] FIG. 16A is a flowchart of a method of classifying a
disordered breathing event in accordance with embodiments of the
invention;
[0050] FIG. 16B is a block diagram of disordered breathing
classification circuitry that may be implemented in accordance with
embodiments of the invention;
[0051] FIGS. 16C and 16D provide graphs of accelerometer signals
representing chest wall motion for central and obstructive
disordered breathing, respectively in accordance with embodiments
of the invention;
[0052] FIGS. 16E and 16F are flowcharts of a method for classifying
disordered breathing events as central, obstructive or mixed events
in accordance with embodiments of the invention;
[0053] FIG. 16G is a flowchart illustrating a method for triggering
disordered breathing therapy based on a prediction of disordered
breathing according to embodiments of the invention;
[0054] FIG. 17 is a block diagram of a disordered breathing therapy
system including disordered breathing prediction functionality in
accordance with embodiments of the invention;
[0055] FIG. 18 is a diagram conceptually illustrating how
conditions affecting the patient may be used in predicting
disordered breathing in accordance with embodiments of the
invention;
[0056] FIG. 19 is a diagram conceptually illustrating the operation
of a disordered breathing prediction engine in accordance with
embodiments of the invention;
[0057] FIG. 20 is a flowchart illustrating a method for
establishing and updating the prediction criteria library according
to embodiments of the invention;
[0058] FIG. 21 is a flowchart illustrating a method of adapting a
disordered breathing therapy according to embodiments of the
invention;
[0059] FIG. 22 is a flowchart illustrating a method of adapting a
disordered breathing therapy taking into account both therapy
effectiveness and therapy impact in accordance with embodiments of
the invention;
[0060] FIG. 23 illustrates a patient instrumented with a sleep
quality monitor according to embodiments of the invention;
[0061] FIG. 24 is a block diagram of a sleep detector that may be
used in connection with a therapy system for disordered breathing
in accordance with embodiments of the invention;
[0062] FIG. 25 is a flowchart illustrating a method of detecting
sleep according to embodiments of the invention;
[0063] FIG. 26 is a flowchart illustrating a method for detecting
sleep using accelerometer and minute ventilation signals according
to embodiments of the invention;
[0064] FIGS. 27 and 28 are graphs illustrating a patient's activity
and heart rate, respectively;
[0065] FIG. 29 is a graph of the patient's minute ventilation
signal;
[0066] FIG. 30 illustrates adjustment of the activity sleep
threshold in accordance with embodiments of the invention;
[0067] FIG. 31 are graphs of autonomic arousal responses which may
be utilized by the disordered breathing therapy system in
accordance with embodiments of the invention;
[0068] FIG. 32 depicts a flow diagram illustrating various optional
processes that may be implemented in connection with arousal
detection according to embodiments of the invention;
[0069] FIG. 33 is a block diagram of a cardiac rhythm management
(CRM) system suitable for implementing an arousal detection
methodology in accordance with embodiments of the present
invention.
[0070] FIG. 34 is a block diagram of a medical system including a
cardiac device that may be used to characterize patient respiration
in accordance with embodiments of the invention;
[0071] FIG. 35A illustrates a marked respiration waveform in
accordance with embodiments of the invention;
[0072] FIG. 35B illustrates a marked respiration waveform including
respiration and ECG graphs in accordance with embodiments of the
invention;
[0073] FIGS. 36A-36B are flowcharts of methods for acquiring and
organizing information as event log entries in accordance with
embodiments of the invention;
[0074] FIG. 37 is a block diagram of a respiratory logbook system
in accordance with embodiments of the invention;
[0075] FIG. 38 illustrates an exemplary depiction of a user
interface display that may be used with a respiratory logbook
system in accordance with embodiments of the invention;
[0076] FIG. 39A provides a timing diagram illustrating the
acquisition of respiration logbook information for a detected event
affecting respiration in accordance with embodiments of the
invention;
[0077] FIG. 39B provides a timing diagram illustrating the
acquisition of respiratory logbook information for a predicted
event affecting respiration in accordance with embodiments of the
invention;
[0078] FIG. 40 is a block diagram of a sleep logbook system in
accordance with embodiments of the invention;
[0079] FIG. 41 illustrates an exemplary depiction of a user
interface display that may be used with a sleep logbook system in
accordance with embodiments of the invention;
[0080] FIGS. 42A and 42B are block diagrams of implantable systems
implementing snoring detection and therapy features in accordance
with embodiments of the present invention;
[0081] FIGS. 42C and 42D are block diagrams illustrating
embodiments of the present invention with a snore detector in a
patient-external configuration;
[0082] FIG. 43 is a flow chart of a method for posture detection in
accordance with embodiments of the invention;
[0083] FIG. 44 is a graph representative of accelerometer signals
associated with a patient moving from a standing to supine or
supine to standing position;
[0084] FIGS. 45A-45D are block diagrams illustrating medical
systems with posture detection functionality in accordance with
embodiments of the invention;
[0085] FIG. 46 is a flow chart of uses for posture detection in
accordance with the invention;
[0086] FIGS. 47A and 47B are flowcharts of methods involving the
use of electrodes coupled to an external respiratory therapy device
in accordance with embodiments of the invention;
[0087] FIGS. 48A-48D are block diagrams of external respiratory
therapy devices having one or more electrodes mechanically coupled
to the respiratory therapy mask assembly and used in connection
with generating electrocardiogram (ECG) signals in accordance with
embodiments of the invention;
[0088] FIGS. 48E-48F are block diagrams of external respiratory
therapy devices having one or more electrodes communicatively
coupled to the respiratory therapy device controller and used in
connection with generating ECG signals in accordance with
embodiments of the invention;
[0089] FIGS. 48G-48J are block diagrams of external respiratory
therapy devices having one or more electrodes mechanically coupled
to the respiratory therapy mask assembly and used in connection
with detecting cardiac events in accordance with embodiments of the
invention;
[0090] FIGS. 48K-48L are block diagrams of external respiratory
therapy devices having one or more electrodes communicatively
coupled to the respiratory therapy device controller and used in
connection with detection of cardiac events in accordance with
embodiments of the invention;
[0091] FIGS. 48M-48N are block diagrams of an external respiratory
therapy device having cardiac electrodes communicatively coupled to
an implantable medical device in accordance with embodiments of the
invention;
[0092] FIG. 49A is a block diagram of an external respiratory
therapy device including one or more electrodes mechanically
coupled to the respiratory therapy mask assembly and a respiratory
therapy controller incorporating an ECG signal processor in
accordance with embodiments of the invention;
[0093] FIG. 49B is a block diagram of an external respiratory
therapy device including one or more electrodes mechanically
coupled to the respiratory therapy mask assembly and a respiratory
therapy controller incorporating cardiac event detector in
accordance with embodiments of the invention;
[0094] FIG. 50 is a process flow diagram illustrating various
optional processes that may be implemented using one or more
electrodes coupled to an external respiratory therapy device;
[0095] FIG. 51 is a block diagram of a patient-external respiratory
therapy device that may be used to provide breathing therapy
monitored by an implantable device in accordance with embodiments
of the invention;
[0096] FIGS. 52A-52E are flowcharts illustrating methods of
implantably monitoring an externally delivered breathing therapy in
accordance with embodiments of the invention;
[0097] FIG. 52F is a graph of respiratory pressure with respect to
time illustrating a respiratory pressure notch observable when a
patient is using a breathing therapy device;
[0098] FIG. 53 is a block diagram of an implantable medical device
including a cardiac therapy pulse generator that may be used to
monitor patient conditions in accordance with embodiments of the
invention;
[0099] FIGS. 54A-54F are flowcharts illustrating methods that
involve implantably monitoring patient conditions to develop
feedback control information for sleep disordered breathing therapy
in accordance with embodiments of the invention;
[0100] FIG. 55A is a block diagram of a system used to provide
measurement of one or more parameters influenced by disordered
breathing for diagnosis and therapy in accordance with embodiments
of the invention;
[0101] FIG. 55B is a block diagram of a system used to provide
measurement of expired gases for diagnosis and therapy in
accordance with embodiments of the invention;
[0102] FIG. 56 is a block diagram illustrating a system for
diagnosis and/or therapy using measurement of expired gases in
accordance with embodiments of the invention;
[0103] FIG. 57 is a block diagram illustrating a system for
diagnosis and/or therapy using measurement of blood gases/blood pH
in accordance with further embodiments of the invention;
[0104] FIG. 58 is a block diagram illustrating a system for
diagnosis and/or therapy using measurement of blood gases/blood pH
in accordance with embodiments of the invention;
[0105] FIG. 59 is a flow chart illustrating a method of diagnosis
and/or therapy in accordance with embodiments of the invention;
[0106] FIG. 60A is a flowchart of a method of diagnosing pulmonary
diseases and disorders in accordance with embodiments of the
invention;
[0107] FIGS. 60B-60D are graphs of normal, obstructive and
restrictive respiratory patterns, respectively, in accordance with
embodiments of the invention;
[0108] FIGS. 61A-61D are block diagrams of a pulmonary disease
assessment system in accordance with embodiments of the
invention;
[0109] FIGS. 62A-62N are charts illustrating relationships between
pulmonary or cardiac diseases, symptoms and/or physiological
changes caused by the pulmonary diseases, and conditions used to
detect the symptoms and/or physiological changes in accordance with
embodiments of the invention;
[0110] FIG. 63A is a block diagram of a system that may be used to
assess a pulmonary disease in accordance with embodiments of the
invention;
[0111] FIGS. 63B-63K are criteria sets for assessing a presence of
various non-rhythm pulmonary diseases in accordance with
embodiments of the invention; and
[0112] FIGS. 64A-64B are flowcharts illustrating methods of
assessing a presence of a non-rhythm pulmonary disease in
accordance with embodiments of the invention.
[0113] FIG. 65 is a block diagram of an implantable medical device
including a cardiac therapy pulse generator that may be utilized in
a system delivering coordinated disordered breathing therapy in
accordance with embodiments of the invention;
[0114] FIGS. 66A-66B are flowcharts illustrating methods that
involve controlling and coordinating cardiac therapy and
respiratory therapy in order to coordinate sleep disordered
breathing therapy in accordance with embodiments of the
invention;
[0115] FIG. 67 is a block diagram of a medical system 100 that
includes components useful in implementing detection and/or
assessment of non-rhythm pulmonary diseases and controlling drug
therapy in accordance with embodiments of the invention;
[0116] FIGS. 68A-68D are block diagrams systems that may be used
for control of drug therapy in accordance with embodiments of the
invention;
[0117] FIG. 69 is a flowchart illustrating a method of determining
a presence of a non-rhythm pulmonary disease and delivering therapy
in accordance with embodiments of the invention;
[0118] FIG. 70 is a flowchart illustrating a method of assessing a
presence of a non-rhythm pulmonary disease and delivering drug
therapy in accordance with embodiments of the invention;
[0119] FIGS. 71A and 71B are block diagrams of medical systems that
may be used to implement therapy control based on cardiopulmonary
status assessment in accordance with embodiments of the
invention;
[0120] FIG. 72 illustrates a medical system including an external
respiratory device and an implantable device that may be used to
assess the patient's cardiopulmonary status and control the
delivery of therapy in accordance with embodiments of the
invention;
[0121] FIG. 73 is a flowchart illustrating a method of determining
a presence of a non-rhythm pulmonary disease and delivering therapy
in accordance with embodiments of the invention;
[0122] FIG. 74 is a flowchart illustrating a method of assessing a
presence of a non-rhythm pulmonary disease and delivering drug
therapy in accordance with embodiments of the invention;
[0123] FIG. 75 is a block diagram of a system that provides and
adjusts a gas therapy by cooperation between internal and external
medical devices in accordance with embodiments of the present
invention;
[0124] FIG. 76 is a block diagram illustrating a system for
modulating a patient-external therapy device in combination with a
patient-internal device incorporating therapy control in accordance
with embodiments of the present invention;
[0125] FIG. 77A is a block diagram illustrating a system for
modulating a patient-external therapy device with a sensor in a
respiratory mask in combination with a patient-internal device
incorporating therapy control in accordance with embodiments of the
present invention;
[0126] FIG. 77B is a block diagram illustrating a system for
modulating a patient-external therapy device incorporating therapy
control in combination with a patient-internal device configured to
transmit information to the external device in accordance with
embodiments of the present invention;
[0127] FIG. 78 is a flow chart illustrating a method of gas therapy
control based on signals transmitted from a patient-internal device
in accordance with embodiments of the present invention;
[0128] FIG. 79 is a block diagram of an implantable medical device
that may be utilized in connection with a medical disease/disorder
detection and/or monitoring system in accordance with embodiments
of the invention;
[0129] FIG. 80 is a flowchart of a method of detecting the presence
of medical disorders in accordance with embodiments of the
inventions;
[0130] FIG. 81 is a flowchart illustrating a method of assessing a
presence of a medical disease in accordance with embodiments of the
invention;
[0131] FIG. 82 is a graph illustrating the variation of heart rate
and blood pressure with respiration cycles;
[0132] FIGS. 83A-83C are block diagrams illustrating systems that
may be used to modulate intrathoracic pressure based on cardiac
cycle phase in accordance with embodiments of the invention;
[0133] FIGS. 84A and 84B are block diagrams illustrating systems
that may be used to modulate cardiac pacing based on respiration in
accordance with embodiments of the invention;
[0134] FIGS. 85A and 85B are flowcharts of methods of modulating
airway pressure based on cardiac cycle phase in accordance with
embodiments of the invention;
[0135] FIG. 85C is a flowchart of a method for controlling cardiac
pacing based on respiration in accordance with embodiments of the
invention;
[0136] FIG. 86 illustrates modulation of therapy pressure during
various cardiac cycles in accordance with embodiments of the
invention;
[0137] FIGS. 87A, 87B, and 87C are block diagrams of systems
providing diurnal data collection to aid nocturnal therapy and
diagnosis of sleep disorders in accordance with embodiments of the
invention;
[0138] FIG. 88 is a flow chart illustrating of method of moderating
sleep therapy using data acquired during non-sleep in accordance
with embodiments of the present invention;
[0139] FIG. 89 is a pictorial diagram of a carotid pulse waveform,
a phonocardiogram (PCG) waveform, an electrocardiogram (ECG)
waveform, and a filtered transthoracic impedance signal for two
consecutive heartbeats;
[0140] FIG. 90A is a flow chart illustrating a method of
controlling a medical process using brain state information in
accordance with embodiments of the invention;
[0141] FIGS. 90B-90D are block diagrams of systems implementing
control of medical processes using brain activity information in
accordance with embodiments of the invention;
[0142] FIG. 91 is a flow chart illustrating a brain state algorithm
based on signals from an EEG sensor in accordance with embodiments
of the invention;
[0143] FIGS. 92-94 are block diagrams of systems implementing
diagnosis of sleep-related disorders using EMG and sleep disordered
breathing information in accordance with embodiments of the
invention;
[0144] FIG. 95 is a flow chart illustrating an EMG based algorithm
in accordance with embodiments of the invention;
[0145] FIGS. 96 and 97A-97B are block diagrams of systems
implementing diagnosis of medical conditions using muscle movement
information in accordance with embodiments of the invention;
[0146] FIGS. 98A-98D are diagrams illustrating various
configurations of sensors coupled to an implanted medical device in
accordance with embodiments of the invention; and
[0147] FIG. 99 is a flow chart illustrating an EMG based algorithm
in accordance with embodiments of the invention.
[0148] FIGS. 100 and 101 are block diagrams illustrating a
controller configured to receive one or more inputs for modifying
the rate at which cardiac pacing for disordered breathing is
delivered in accordance with embodiments of the invention;
[0149] FIGS. 102-104 are signal flow diagrams illustrating pacing
rate adjustment in accordance with embodiments of the
invention;
[0150] FIG. 105 is a block diagram illustrating a controller that
includes several different inputs to modify the rate at which
pacing or other therapy is delivered based on disordered breathing
detection in accordance with embodiments of the invention;
[0151] FIGS. 106 and 107 are graphs illustrating modification of a
pacing rate in accordance with embodiments of the invention;
[0152] FIG. 108 is a graph illustrating a method of using at least
one of coefficients a and b as a function of one or more previous
cardiac intervals in accordance with embodiments of the
invention;
[0153] FIGS. 109A and 109B are flowcharts depicting methods of
classifying sleep stages according to embodiments of the
invention;
[0154] FIG. 110 illustrates a block diagram of a system suitable
for implementing a sleep stage classification method according to
embodiments of the invention;
[0155] FIG. 111 presents a block diagram illustrating sleep stage
discrimination circuitry configured according to embodiments of the
invention;
[0156] FIGS. 112 and 113 are flowcharts illustrating methods of
performing sleep stage classification in accordance with
embodiments of the invention;
[0157] FIG. 114 is a process flow diagram illustrating a process
for using sleep stage classification in cooperation with therapy
delivery and testing in accordance with embodiments of the
invention;
[0158] FIG. 115 illustrates a medical system that may be used to
perform sleep stage informed therapy in accordance with embodiments
of the invention; and
[0159] FIGS. 116A-116D illustrate various configurations of a
muscle atonia sensor mechanically coupled to an implanted medical
device in accordance with embodiments of the invention.
[0160] While the invention is amenable to various modifications and
alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in detail below. It
is to be understood, however, that the intention is not to limit
the invention to the particular embodiments described. On the
contrary, the invention is intended to cover all modifications,
equivalents, and alternatives falling within the scope of the
invention as defined by the appended claims.
DESCRIPTION OF VARIOUS EMBODIMENTS
[0161] In the following description of the illustrated embodiments,
references are made to the accompanying drawings which form a part
hereof, and in which are shown by way of illustration, various
embodiments by which the invention may be practiced. It is to be
understood that other embodiments may be utilized, and structural
and functional changes may be made without departing from the scope
of the present invention.
[0162] Methods, devices, and systems implementing a coordinated
approach to patient monitoring, diagnosis, and/or therapy in
accordance with the present invention may incorporate one or more
of the features, structures, methods, or combinations thereof
described herein below. For example, a medical system may be
implemented to include one or more of the features and/or processes
described below. It is intended that such a method, device, or
system need not include all of the features and functions described
herein, but may be implemented to include one or more selected
features and functions that provide useful structures and/or
functionality.
[0163] Disorders and diseases affecting the interdependent
physiological systems of the human body may be more effectively
diagnosed and treated using a coordinated approach. Various
embodiments of the invention are implemented using medical systems
employing one or a number of patient-external and/or
patient-internal medical devices. Medical devices may communicate
or otherwise operate in concert or in a stand-alone manner to
provide more comprehensive patient monitoring, diagnosis, and
therapy. As referenced herein, the term "condition," denotes an
attribute that may be sensed and/or measured based on a signal
generated by a sensor or other input device of a respiratory
therapy device or another medical device. The terms "symptom" and
"physiological change" refer to a manifestation of a medical
disease or disorder. Symptoms and/or physiological changes may be
detectable based on a sensed presence of one or more physiological
conditions and/or measured values associated with the one or more
sensed physiological conditions. The terms "disease" and/or
"disorder" are used to refer to a medical dysfunction that is
characterizable by a collection of symptoms or physiological
changes.
[0164] FIG. 1A is a block diagram of a medical system 100 that may
be used to implement coordinated patient monitoring, diagnosis,
and/or therapy in accordance with embodiments of the invention. The
medical system 100 may include, for example, one or more
patient-internal medical devices 110 and one or more
patient-external medical devices 120. Each of the patient-internal
110 and patient-external 120 medical devices may include one or
more of a patient monitoring unit 112, 153, a diagnostics unit 114,
154, and/or a therapy unit 116, 155.
[0165] The patient-internal medical device 110 is typically a fully
or partially implantable device that performs monitoring,
diagnosis, and/or therapy functions. The patient-external medical
device 120 performs monitoring, diagnosis and/or therapy functions
external to the patient (i.e., not invasively implanted within the
patient's body). The patient-external medical device 120 may be
positioned on the patient, near the patient, or in any location
external to the patient. It is understood that a portion of a
patient-external medical device 120 may be positioned within an
orifice of the body, such as the nasal cavity or mouth, yet can be
considered external to the patient (e.g., mouth pieces/appliances,
tubes/appliances for nostrils, or temperature sensors positioned in
the ear canal). The patient-internal and patient-external medical
devices 110, 120 may be coupled to one or more sensors 141, 142,
145, 146, patient input devices 143, 147 and/or other information
acquisition devices 144, 148. The sensors 141, 142, 145, 146,
patient input devices 144, 147, and/or other information
acquisition devices 144, 148 may be employed to detect conditions
relevant to the monitoring, diagnostic, and/or therapeutic
functions of the patient-internal and patient-external medical
devices 110, 120.
[0166] The medical devices 110, 120 may each be coupled to one or
more patient-internal sensors 141, 145 that are fully or partially
implantable within the patient. The medical devices 110, 120 may
also be coupled to patient-external sensors positioned on, near, or
in a remote location with respect to the patient. The
patient-internal and patient-external sensors are used to sense
conditions, such as physiological or environmental conditions, that
affect the patient.
[0167] The patient-internal sensors 141 may be coupled to the
patient-internal medical device 110 through internal leads. In one
example, an internal endocardial lead system used to couple cardiac
electrodes to an implantable pacemaker or other cardiac rhythm
management device. One or more patient-internal sensors 141 may be
equipped with transceiver circuitry to support wireless
communications between the one or more patient-internal sensors 141
and the patient-internal medical device 110 and/or the
patient-external medical device 120.
[0168] The patient-external sensors 142 may be coupled to the
patient-internal medical device 110 and/or the patient-external
medical device 120 through leads or through wireless connections.
Patient-external sensors 142 preferably communicate with the
patient-internal medical device 110 wirelessly. Patient-external
sensors 146 may be coupled to the patient-external medical device
120 through leads or through a wireless link.
[0169] The medical devices 110, 120 may be coupled to one or more
patient-input devices 143, 147. The patient-input devices are used
to allow the patient to manually transfer information to the
medical devices 110, 120. The patient input devices 143, 147 may be
particularly useful for inputting information concerning patient
perceptions, such as how well the patient feels, and information
such as patient smoking, drug use, or other activities that are not
automatically sensed or detected by the medical devices 110,
120.
[0170] The medical devices 110, 120 may be connected to one or more
information systems 144, 148, for example, a database that stores
information useful in connection with the monitoring, diagnostic,
or therapy functions of the medical devices 110, 120. For example,
one or more of the medical devices 110, 120 may be coupled through
a network to a information system server that provides information
about environmental conditions affecting the patient, e.g., the
pollution index for the patient's location.
[0171] In one embodiment, the patient-internal medical device 110
and the patient-external medical device 120 may communicate through
a wireless link between the medical devices 110, 120. For example,
the patient-internal and patient-external devices 110, 120 may be
coupled through a short-range radio link, such as Bluetooth or a
proprietary wireless link. The communications link may facilitate
uni-directional or bi-directional communication between the
patient-internal 110 and patient-external 120 medical devices or
particular units of medical devices 110, 120. Data and/or control
signals may be transmitted between the patient-internal 110 and
patient-external 120 medical devices to coordinate the functions of
the medical devices 110, 120.
[0172] In another embodiment of the invention, the patient-internal
and patient-external medical devices 110, 120 may be used within
the structure of an advanced patient management system. Advanced
patient management systems involve a system of medical devices that
are accessible through various communications technologies. For
example, patient data may be downloaded from one or more of the
medical devices periodically or on command, and stored at a patient
information server. The physician and/or the patient may
communicate with the medical devices and the patient information
server, for example, to acquire patient data or to initiate,
terminate or modify therapy.
[0173] In the implementation illustrated in FIG. 1A, the
patient-internal medical device 110 and the patient-external
medical device 120 may be coupled through a wireless or wired
communications link to a patient information server that is part of
an advanced patient management system 170. The APM patient
information server 170 may be used to download and store data
collected by the patient-internal and patient-external medical
devices 110, 120. Systems and methods involving advanced patient
management techniques are further described in U.S. Pat. Nos.
6,336,903, 6,312,378, 6,270,457, and 6,398,728, hereby incorporated
herein by reference.
[0174] Various embodiments described herein may be used in
connection with advanced patient management. Methods, structures,
and/or techniques described herein relating to advanced patient
management, such as those involving remote patient/device
monitoring, diagnosis, therapy, or other advanced patient
management related methodologies, may incorporate features of one
or more of the following references: U.S. Pat. Nos. 6,221,011;
6,277,072; 6,280,380; 6,358,203; 6,368,284; and 6,440,066 each
hereby incorporated herein by reference.
[0175] The data stored on the APM patient information server 170
may be accessible by the patient and the patient's physician
through terminals 150, e.g., remote computers located in the
patient's home or the physician's office. The APM patient
information server 170 may be used to communicate to one or more of
the patient-internal and patient-external medical devices 110, 120
to effect remote control of the monitoring, diagnosis, and/or
therapy functions of the medical devices 110, 120.
[0176] In one scenario, the patient's physician may access patient
data transmitted from the medical devices 110, 120 to the APM
patient information server 170. After evaluation of the patient
data, the patient's physician may communicate with one or more of
the patient-internal or patient-external devices 110, 120 through
the APM system 170 to initiate, terminate, or modify the
monitoring, diagnostic, and/or therapy functions of the
patient-internal and/or patient-external medical systems 110,
120.
[0177] The patient-internal and patient-external medical devices
110, 120 may not communicate directly, but may communicate
indirectly through the APM system 170. In this embodiment, the APM
system 170 may operate as an intermediary between two or more of
the medical devices 110, 120. For example, data and/or control
information may be transferred from one of the medical devices 110,
120 to the APM system 170. The APM system 170 may transfer the data
and/or control information to another of the medical devices 110,
120.
[0178] In one scenario, the APM system may communicate directly
with the patient-internal and/or patient-external medical devices
110, 120. The advanced patient management (APM) information server
170 may be used to download and store data collected by the
patient-internal and patient-external medical devices 110, 120.
[0179] FIGS. 1B-1D illustrate various medical procedures that may
be implemented by a coordinated medical system in accordance with
embodiments of the invention. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0180] Other aspects of the invention are directed to methods and
systems configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures.
[0181] Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0182] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0183] Embodiments of the invention involve individual systems for
performing the various medical procedures 180. Each of the
procedures 180 may be implemented as a stand alone system or in
combination with other individual medical procedures or systems
180, such as those described in FIGS. 1B-1D.
[0184] Other embodiments of the invention involve systems for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilize one or more of the medical procedures 180. The
coordinated system may include, for example, an implantable cardiac
device 181 and a patient-external respiratory therapy device 184.
The system may further include an external processor 183 providing
a coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 184 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[0185] As indicated in FIG. 1A, one or both of the devices 110, 120
of the medical system 100 may include a monitoring unit 112, 153, a
diagnostics unit 114, 154, and a therapy unit 116, 155. Each of
these units 112, 114, 116, 153, 154, 155 may be used alone or in
cooperation with other components of the medical system 100 to
implement the various medical procedures 180.
[0186] Monitoring circuitry 112, 153 of one or both devices 110,
120 may include detection and/or monitoring functionality that may
be employed to implement one or more processes of the medical
procedures 180 indicated in FIG. 1B-1D involving monitoring and/or
detection. For example, monitoring circuitry 112, 153 may be used
in connection with on or more of sleep detection 54, sleep quality
monitoring 58, sleep stage detection 60, marked respiratory
waveform generation 105, medical event/respiratory event logbook
generation 106, sleep logbook generation 184, monitoring of
respiratory therapy 122, posture detection 131, cardiac event
detection via the respiratory therapy device 133 snoring detection
139, and autonomic arousal detection 106.
[0187] Diagnosis circuitry incorporated in one or both devices 110,
120 may be used to implement processes of the one or more of the
medical procedures 180 indicated in FIGS. 1B-1D that involve
assessing a presence of diseases or disorders. For example, one or
both diagnosis units 114, 153 maybe used in connection with one or
more of pulmonary disease detection 136, disordered breathing
detection 54, central and obstructive disordered breathing
detection 124, detection of movement disorders 141, disease
detection based on use of diurnal data 129, use of electromyogram
for disease diagnosis 127, diagnosis based on blood chemistry/blood
gas 130, and disease detection by synergistic use of respiratory
therapy and cardiac devices 126.
[0188] Therapy delivery of therapy control circuitry incorporated
in one or both devices 110, 120 may be used to implement processes
of the one or more of the medical procedures 180 indicated in FIGS.
1B-1D that involve delivery or control of therapy For example, one
or both therapy units 116, 155 maybe used in connection with one or
more of adaptive cardiac therapy for disordered breathing 59,
overdrive pacing for disordered breathing 128, therapy based on
prediction of disordered breathing 103, respiratory therapy based
on feedback from an implanted monitor 123, modification of therapy
using detected cardiopulmonary conditions 137, automatic activation
of therapy based on brain waves 132, modulation of external gas
therapy 135, disordered breathing therapy using a combination of
cardiac and respiratory therapies 138, modulation of respiration
therapy based on cardiac cycle phase 141, modulation of cardiac
pacing based on respiration cycle 197.
[0189] The block diagrams of FIGS. 2A and 2B provide examples of a
coordinated monitoring, diagnosis and/or therapeutic system 200 in
accordance with embodiments of the invention. Referring to FIG. 2A,
the system 200 employs medical device 210 that may be fully or
partially implantable. The medical device 210 performs at least one
cardiac function. The implantable cardiac device 210 may be coupled
to an array of data acquisition devices 212, including
patient-internal sensors, patient-external sensors, patient input
devices, and/or other information systems for sensing, detecting
and/or measuring conditions or parameters affecting the patient and
useful for the monitoring, diagnostic, and/or therapeutic functions
of the coordinated system 200.
[0190] The system 200 employs a respiratory therapy device 220. The
respiratory therapy device may be positioned on the patient, near
the patient, or in any location external to the patient. It is
understood that a portion of a respiratory therapy device 220 may
be positioned within an orifice of the body, such as the nasal
cavity or mouth, yet can be considered external to the patient
(e.g., mouth pieces/appliances, tubes/appliances for nostrils, or
temperature sensors positioned in the ear canal). The respiratory
therapy device 220 may be coupled to an array of data acquisition
devices 222, including patient-internal sensors, patient-external
sensors, patient input devices, and/or other information systems
for sensing, detecting and/or measuring conditions or parameters
affecting the patient and useful for the monitoring, diagnostic,
and/or therapeutic functions of the coordinated system 200.
[0191] Patient conditions or parameters may include both
physiological and non-physiological contextual conditions affecting
the patient. Physiological conditions may include a broad category
of conditions associated with the internal functioning of the
patient's physiological systems, including the cardiovascular,
respiratory, nervous, muscle and other systems. Examples of
physiological conditions include blood chemistry, patient posture,
patient activity, respiration quality, sleep quality, among
others.
[0192] Contextual conditions generally encompass non-physiological,
patient-external or background conditions. Contextual conditions
may be broadly defined to include, for example, present
environmental conditions, such as patient location, ambient
temperature, humidity, air pollution index. Contextual conditions
may also include historical/background conditions relating to the
patient, including the patient's normal sleep time and the
patient's medical history, for example.
[0193] Table 1 provides a representative set of patient conditions
that may be used in connection with a coordinated approach to
patient monitoring, diagnostics, and/or therapy in accordance with
embodiments of the invention. Table 1 also provides illustrative
sensing methods that may be employed to sense the conditions. It
will be appreciated that patient conditions and detection methods
other than those listed in Table 1 may be used in connection with
patient monitoring, diagnosis, and/or therapy and are considered to
be within the scope of the invention.
TABLE-US-00001 TABLE 1 Sensor type or Detection Condition Type
Condition method Physiological Cardiovascular Heart rate EGM, ECG
System Heart rate variability QT interval Ventricular filling
pressure Intracardiac pressure sensor Blood pressure Blood pressure
sensor Respiratory System Snoring Accelerometer Microphone
Respiration pattern Transthoracic impedance (Tidal volume Minute
sensor (AC) ventilation Respiratory rate) Patency of upper airway
Intrathoracic impedance sensor Pulmonary congestion Transthoracic
impedance sensor (DC) Nervous System Sympathetic nerve activity
Muscle sympathetic nerve Activity sensor Brain activity EEG Blood
Chemistry CO2 saturation Blood analysis O2 saturation Blood alcohol
content Adrenalin Brain Natriuretic Peptide (BNP) C-Reactive
Protein Drug/Medication/Tobacco use Muscle System Muscle atonia EMG
Eye movement EOG Patient activity Accelerometer, MV, etc. Limb
movements Accelerometer, EMG Jaw movements Accelerometer, EMG
Posture Multi-axis accelerometer Contextual/ Environmental Ambient
temperature Thermometer Non- Humidity Hygrometer Physiological
Pollution Air quality website Time Clock Barometric pressure
Barometer Ambient noise Microphone Ambient light Photodetector
Altitude Altimeter Location GPS, proximity sensor Proximity to bed
Proximity to bed sensor Historical/Background Historical sleep time
Patient input, previously detected sleep onset times Medical
history Patient input Age Recent exercise Weight Gender Body mass
index Neck size Emotional state Psychological history Daytime
sleepiness Patient perception of sleep quality Drug, alcohol,
nicotine use
[0194] One or both of the medical devices 210, 220 of FIG. 2A may
include a monitoring unit, as previously described in connection
with FIG. 1A, that processes signals from one or more of the
sensors or other data acquisition devices. The monitoring unit may
include processes to detect the occurrence of various events,
including, for example, normal and/or abnormal physiological system
events or condition, cardiovascular system events, a respiratory
system events, muscle system events, nervous system event, and/or a
sleep-related events. Other types of events may also be detected.
For example, detection of a cardiovascular system event may involve
detection of detect abnormal or unusual events of the
cardiovascular system such as ventricular tachycardia or
fibrillation. The detection of a cardiovascular system event may
alternatively involve detection of normal cardiac beats or other
events or conditions associated with the usual functioning of the
heart.
[0195] Respiratory event detection may involve events or conditions
associated with various respiratory system disorders, such as a
disordered breathing event or a pulmonary congestion condition.
Respiratory system event/condition detection may also be used to
detect the inspiratory and expiratory phases of normal respiration
cycles, for example.
[0196] Muscle system event/condition detection may involve
detection of abnormal limb movements, such as those associated with
periodic limb movement disorder (PLMD), for example. Muscle system
event/condition detection may further be used to detect normal or
abnormal conditions, such as normal muscle atonia associated with
REM sleep or abnormal muscle tone of the upper airway associated
with obstructive sleep apnea events. The muscle system
event/condition detection may also be used, for example, to detect
the level of patient activity. Patient activity information may be
useful, for example, in assessing the overall activity level of the
patient, or determining if the patient is asleep.
[0197] Detection of nervous system events may comprise, for
example, detection arousals for sleep, or detection of brain wave
activity events. Sleep-related events such as sleep onset, sleep
offset, sleep stages, arousals from sleep sleep disordered
breathing events, and nocturnal movements may be monitored in
connecting with sleep quality assessment.
[0198] Information related to parameter or conditions affecting the
patient may be stored in memory. The stored data may be transmitted
to another component of the medical devices 210, 220 or to a
separate device for storage, further processing, trending, analysis
and/or display, for example. In one scenario, the stored data can
be downloaded to a separate device periodically or on command. The
stored data may be presented to the patient's health care
professional on a real-time basis, or as a long-term, e.g., month
long or year long, trend of daily measurements.
[0199] One or both of the devices 210, 220 may include the
capability of assessing disease presence and/or diagnosing various
diseases or disorders. The diagnostics capability of the medical
devices 210, 220 may rely on information acquired and stored in
memory over a period of time. Diagnostics or assessments of disease
presence may involve evaluation of events or conditions detected by
the monitoring/detection components of the devices 210, 220.
[0200] One or both medical devices 210, 220 may include the ability
to deliver or control the delivery of therapy to a patient. In the
example provided in FIG. 2A, the cardiac device 210 may deliver
cardiac electrical stimulation therapy using a cardiac pulse
generator and electrical stimulation electrodes.
[0201] The respiratory therapy device 220 may delivery any of a
variety of respiration therapies, including, for example,
continuous positive airway pressure (CPAP), bi-level positive
airway pressure (bi-PAP), proportional positive airway pressure
(PPAP), auto-titrating positive airway pressure, ventilation, gas,
pharmacological agent, or oxygen therapies, among others.
[0202] One of the devices 210, 220 may partially or fully control
the therapy delivered by the other device 220, 210. For example,
the cardiac device 210 may control or aid in the control of therapy
delivered by the respiratory device 220. The respiratory device 220
may control or aid in the control of therapy delivered by the
cardiac device 210.
[0203] One or both of the medical devices 210, 220 may fully or
partially control other therapy delivery devices or receive input
from other sensors. For example, one or both of the medical devices
210, 220 may be used to control a drug therapy device, such as a
drug pump, a controllable nebulizer, and/or electrically activated
drug patch. In a further example, one or both of the medical
devices 210, 220 may be used to control a nerve stimulation or
muscle stimulation therapy device, such as a hypoglossal or phrenic
nerve stimulation device.
[0204] In one implementation, illustrated in FIG. 2A, the medical
system 200 includes a uni-directional or bidirectional
communications channel 241 between the medical devices 210, 220.
The communications channel 241 facilitates the cooperation between
the medical devices 210, 220. The communications channel 241 may be
implemented as a wireless link between the cardiac device 210 and
the respiratory therapy device 220. The wireless communication
channel 241 coupling the medical devices 210, 220 may utilize a
variety of wireless protocols, including, for example, Bluetooth,
IEEE 802.11, and/or a proprietary wireless protocol.
[0205] In another implementation, illustrated in FIG. 2B, the
medical system 201 includes an external processor 230. The external
processor 230 may comprise, for example, an advanced patient
management system, as previously described. The external processor
230 may acquire patient conditions or parameters 232, store patient
information, provide monitoring and/or diagnostic functionality
231, control therapy 231 delivered by the cardiac and/or
respiratory devices 210, 220 and/or other therapy devices.
[0206] The external processor may be coupled to one or both of the
cardiac and respiratory devices 210, 220 through wireless or wired
communications channels 243, 242. In one implementation, the
cardiac and respiratory devices 210, 220 may not communicate
directly, but may communicate indirectly via the external processor
230.
[0207] FIG. 3 illustrates a respiratory therapy device 300 in
accordance with embodiments of the invention. Respiratory therapy,
such as gas therapy, oxygen therapy, CO2 therapy, positive airway
pressure therapy, or other therapies provided to a patient through
the pulmonary system, may mitigate a patient's suffering from a
number of respiratory disorders. Some lung diseases, such as
emphysema, sarcoidosis, and chronic obstructive pulmonary disorder,
reduce lung function to the extent that supplemental oxygen is
needed to continue normal bodily functions. For many patients with
end stage lung disease, oxygen therapy allows the patients to get
the oxygen they need, helps them be more active, and may also
prevent or treat heart failure. All types of respiratory therapy
devices are referred to generically herein as xPAP devices.
[0208] The respiratory therapy device 300 may include, for example,
any of the positive airway pressure devices, including CPAP,
bi-level positive airway pressure (bi-PAP), proportional positive
airway pressure (PPAP), and/or autotitration positive airway
pressure devices, for example. Continuous positive airway pressure
(CPAP) devices deliver a set air pressure to the patient. The
pressure level for the individual patient may be determined during
a titration study. Such a study may take place in a sleep lab, and
involves determination of the optimum airway pressure by a sleep
physician or other professional. The CPAP device pressure control
is set to the determined level. When the patient uses the CPAP
device, a substantially constant airway pressure level is
maintained by the device.
[0209] Autotitration PAP devices are similar to CPAP devices,
however, the pressure controller for autotitration devices
automatically determines the air pressure for the patient. Instead
of maintaining a constant pressure, the autotitration PAP device
evaluates sensor signals and the changing needs of the patient to
deliver a variable positive airway pressure. Autotitration PAP and
CPAP are often used to treat sleep disordered breathing, for
example.
[0210] Bi-level positive airway pressure (bi-PAP) devices provide
two levels of positive airway pressure. A higher pressure is
maintained while the patient inhales. The device switches to a
lower pressure during expiration. Bi-PAP devices are used to treat
a variety of respiratory dysfunctions, including chronic
obstructive pulmonary disease (COPD), respiratory insufficiency,
and ALS or Lou Gehrig's disease, among others.
[0211] Respiratory therapy may be provided by a servo ventilation
device. Servo ventilation devices provide airway pressure dependent
on the respiration cycle stage. A servo ventilation device provides
positive pressure on inhalation and negative pressure on
exhalation.
[0212] The respiration therapy control unit 340, illustrated in
this example as a positive airway device, includes a flow generator
342 that pulls in air through a filter. The flow generator 342 is
controlled by the pressure control circuitry 344 to deliver an
appropriate air pressure to the patient. Air flows through tubing
346 coupled to the respiratory device 300 and is delivered to the
patient's airway through a mask 348. In one example, the mask 348
may be a nasal mask covering only the patient's nose. In another
example, the mask 348 covers the patient's nose and mouth.
[0213] The respiratory device 300 includes a communications unit
380 for communicating with one or more separate devices, including
patient-external and/or patient-internal monitoring, diagnostic
and/or therapeutic devices.
[0214] The respiratory therapy device 300 may receive information
from one or more data acquisition devices 350, e.g., sensors,
patient input devices, and/or other information systems. The
acquired information may be used to implement one or more
monitoring, diagnostic and/or therapeutic functions 360 of the
respiratory therapy device 300. In one example, a monitoring
processor 360 may be used to store information related to one or
more physiological or nonphysiological parameters acquired over a
period of time. In another example, a diagnostics unit may assess
the presence of a disease or disorder based on information acquired
through use of the data acquisition devices and/or received via the
communications channel 370 from a separate device. In yet a further
example, therapy delivered by the respiratory therapy device 300
may be controlled by a therapy processor 360. Alternatively or
additionally, the therapy processor 360 may control therapy
delivered by remote device coupled to the respiratory therapy
device 300 via the communications channel 370.
[0215] FIG. 4A is a partial view of an implantable cardiac device
that may include circuitry for implementing coordinated monitoring,
diagnosis and/or therapy in accordance with embodiments of the
invention. In this example, the implantable device comprises a
cardiac rhythm management device (CRM) 400 including an implantable
electrical stimulation generator 405 electrically and physically
coupled to an intracardiac lead system 410. Portions of the
intracardiac lead system 410 are inserted into the patient's heart
490. The intracardiac lead system 410 includes one or more
electrodes configured to sense electrical cardiac activity of the
heart, deliver electrical stimulation to the heart, sense the
patient's transthoracic impedance, and/or sense other physiological
parameters, e.g. cardiac chamber pressure or temperature. Portions
of the housing 401 of the pulse generator 405 may optionally serve
as a can electrode.
[0216] Communications circuitry is disposed within the housing 401
for facilitating communication between the electrical stimulation
generator 405 and remote devices having wireless communication
functionality, such as a portable or bed-side communication
station, patient-carried/worn communication station, or external
programmer, for example. The wireless communications circuitry can
also facilitate unidirectional or bidirectional communication with
one or more implanted, external, cutaneous, or subcutaneous
physiologic or non-physiologic sensors, patient-input devices
and/or other information systems.
[0217] The housing 401 of the electrical stimulation generator 405
may optionally incorporate various sensors, including, for example,
a motion sensor that may be programmed to sense various conditions.
For example, the motion sensor may be optionally configured to
sense snoring, patient activity level, and/or chest wall movements
associated with respiratory effort, for example. In one example
implementation, the motion detector may be implemented as an
accelerometer positioned in or on the housing 401 of the electrical
stimulation generator 405. If the motion sensor is implemented as
an accelerometer, the motion sensor may also provide respiratory
information, e.g. rales, coughing, and cardiac information, e.g.
S1-S4 heart sounds, murmurs, and/or other acoustic information.
[0218] The lead system 410 of the CRM 400 may incorporate one or
more electrodes used to sense transthoracic impedance.
Transthoracic impedance sensing may be used to acquire the
patient's respiration waveform, or other respiration-related
information. Transthoracic impedance may be sensed using one or
more intracardiac electrodes 441, 442, 451-455, 463 positioned in
one or more chambers of the heart 490. The intracardiac electrodes
441, 442, 451-455, 463 may be coupled to impedance drive/sense
circuitry positioned within the housing of the electrical
stimulation generator 405.
[0219] In one implementation, impedance drive/sense circuitry
disposed within the housing 401 generates a current that flows
through the tissue between an impedance drive electrode 451 and a
can electrode on the housing 401 of the electrical stimulation
generator 405. The voltage at an impedance sense electrode 452
relative to the can electrode changes as the patient's
transthoracic impedance changes. The voltage signal developed
between the impedance sense electrode 452 and the can electrode is
detected by the impedance sense circuitry disposed within the
housing 401 of the electrical stimulation generator 405. Other
locations and/or combinations of impedance sense and drive
electrodes are also possible.
[0220] The voltage signal developed at the impedance sense
electrode 452, illustrated in FIG. 4A, is proportional to the
patient's transthoracic impedance and represents the patient's
respiration waveform. The transthoracic impedance increases during
respiratory inspiration and decreases during respiratory
expiration. The peak-to-peak transition of the transthoracic
impedance is proportional to the amount of air moved in one breath,
denoted the tidal volume. The amount of air moved per minute is
denoted the minute ventilation. A normal "at rest" respiration
pattern, e.g., during non-REM sleep, includes regular, rhythmic
inspiration--expiration cycles without substantial interruptions,
as indicated in FIG. 4B.
[0221] Returning to FIG. 4A, the lead system 410 may include one or
more cardiac pace/sense electrodes 451-455 positioned in, on, or
about one or more heart chambers for sensing electrical signals
from the patient's heart 490 and/or delivering pacing pulses to the
heart 490. The intracardiac sense/pace electrodes 451-455, such as
those illustrated in FIG. 4A, may be used to sense and/or pace one
or more chambers of the heart, including the left ventricle, the
right ventricle, the left atrium and/or the right atrium. The lead
system 410 may include one or more defibrillation electrodes 441,
442 for delivering defibrillation/cardioversion shocks to the heart
490.
[0222] As described above, the housing 401 of the electrical
stimulation generator 405 may include circuitry for detecting
cardiac arrhythmias and/or for controlling pacing and/or
defibrillation therapy in the form of electrical stimulation pulses
or shocks delivered to the heart through the lead system 410. Also
disposed within the housing 401 may be various communications
circuitry and monitoring, diagnostic, and/or therapy control
circuitry that may be used to effect coordinated monitoring,
diagnosis and/or therapy in accordance with embodiments of the
invention.
[0223] In accordance with another embodiment, an implantable
transthoracic cardiac sensing and/or stimulation (ITCS) device may
be implemented to detect/monitor normal and abnormal cardiac and/or
respiratory activity, and may be configured to deliver an
appropriate therapy in response to abnormal activity or conditions.
An ITCS device 500 of the present invention may be configured for
monitoring, diagnosing, and/or treating cardiac and disordered
breathing events/conditions. An ITCS device 500 is typically
implemented to sense activity of both the cardiac system and the
respiratory system. Using appropriate sensors, the ITCS device 500
may be implemented to detect and monitor a variety of disordered
breathing conditions, including sleep and non-sleep related
disordered breathing conditions. An ITCS device 500 may further be
implemented to detect sleep, and may further be implemented to
detect stages of patient sleep. An ITCS device 500 so implemented
may be configured to perform a variety of sensing, monitoring,
diagnosing, and/or therapy control/coordination functions,
including those described herein and in the references respectively
incorporated herein.
[0224] In particular configurations, the ITCS device may perform
functions traditionally performed by cardiac rhythm management
devices, such as providing various cardiac monitoring, pacing
and/or cardioversion/defibrillation functions. Exemplary pacemaker
circuitry, structures and functionality, aspects of which can be
incorporated in an ITCS device of a type that may benefit from
multi-parameter sensing configurations, are disclosed in commonly
owned U.S. Pat. Nos. 4,562,841; 5,284,136; 5,376,476; 5,036,849;
5,540,727; 5,836,987; 6,044,298; and 6,055,454, which are hereby
incorporated herein by reference in their respective entireties. It
is understood that ITCS device configurations can provide for
non-physiologic pacing support in addition to, or to the exclusion
of, bradycardia and/or anti-tachycardia pacing therapies. Exemplary
cardiac monitoring circuitry, structures and functionality, aspects
of which can be incorporated in an ITCS of the present invention,
are disclosed in commonly owned U.S. Pat. Nos. 5,313,953;
5,388,578; and 5,411,031, which are hereby incorporated herein by
reference in their respective entireties.
[0225] An ITCS device can incorporate circuitry, structures and
functionality of the subcutaneous implantable medical devices
disclosed in commonly owned U.S. Pat. Nos. 5,203,348; 5,230,337;
5,360,442; 5,366,496; 5,397,342; 5,391,200; 5,545,202; 5,603,732;
and 5,916,243 and commonly owned U.S. Patent Application No.
60/462,272, filed Apr. 11, 2003; U.S. Publication Nos.
2004/0230229; 2004/0230230; 2005/0004615; U.S. Pat. No. 7,570,997;
and U.S. Publication No. 2004/0215240, all of which are
incorporated herein by reference.
[0226] FIG. 5A is a block diagram illustrating various components
of an ITCS device 500 that provides for disordered breathing
detection and/or treatment in accordance with embodiments of the
present invention. In general terms, cardiac activity and
disordered breathing (e.g., sleep disordered breathing and wakeful
disordered breathing) may be detected, monitored, and/or treated
with use of an ITCS device 500, such as the one shown in FIG. 5A.
An ITCS device 500 may be implanted under the skin in the chest
region of a patient. The ITCS device 500 may, for example, be
implanted subcutaneously such that all or selected elements of the
device are positioned on the patient's front, back, side, or other
body locations suitable for sensing cardiac activity and delivering
cardiac stimulation therapy. It is understood that elements of the
ITCS device 500 may be located at several different body locations,
such as in the chest, abdominal, or subclavian region with
electrode elements respectively positioned at different regions
near, around, or on the heart.
[0227] The primary housing (e.g., the active or non-active can) 502
of the ITCS device 500, for example, may be configured for
positioning outside of the rib cage at an intercostal or subcostal
location, within the abdomen, or in the upper chest region (e.g.,
subclavian location, such as above the third rib). In one
implementation, one or more electrodes may be located on the
primary housing 502 and/or at other locations (e.g., electrode 504)
about, but not in direct contact with the heart, great vessels or
coronary vasculature. A pulse generator and a cardiac stimulation
controller are disposed in the primary housing 502. The cardiac
stimulator controller determines and coordinates appropriate
cardiac and/or respiratory therapy to be delivered to a patient,
and the pulse generator produces the appropriate energy waveforms
associated with a selected therapy. Also disposed in the primary
housing 502 is a cardiac activity detector configured to detect
normal and abnormal (e.g., arrhythmic) cardiac activity.
[0228] In a further implementation, one or more subcutaneous
electrode subsystems or electrode arrays 504 may be used to sense
cardiac activity and deliver cardiac stimulation energy in an ITCS
device 500 configuration employing an active can or a configuration
employing a non-active can. Electrodes (e.g., electrode 504) may be
situated at anterior and/or posterior locations relative to the
heart.
[0229] The ITCS device 500 depicted in FIG. 5A may be configured in
a manner described herein or may have other configurations. An ITCS
device 500 of the present invention may be implemented to include
one or more of cardiac and/or respiratory detection/monitoring
circuitry (e.g., for cardiac activity, breathing patterns such as
from transthoracic impedance signals, heart sounds, blood
gas/chemistry such as oxygen saturation and/or pH), cardiac and
respiratory diagnostics circuitry, and cardiac and respiratory
therapy circuitry. An ITCS device 500 of the present invention may
be implemented to provide for upgradeability in terms of
functionality and/or configuration. For example, an ITCS device 500
may be implemented as an upgradeable or reconfigurable
cardiac/respiratory monitor or stimulation device.
[0230] An ITCS device 500 in accordance with embodiments of the
present invention provides for patient breathing monitoring and
disordered breathing detection and/or prediction. Such embodiments
may further provide treatment for detected or predicted disordered
breathing events or conditions, as determined by a therapy
controller or in response to an externally generated command signal
(such as received from an advanced patient management system or
programmer). Detection and treatment of disordered breathing and/or
respiratory conditions may be facilitated by use of an ITCS device
500 having appropriate sensing/detection/therapy delivery
capabilities, or by cooperative use of an ITCS device 500 and an
external programmer or an advanced patient management system via a
communications interface.
[0231] With continued reference to FIG. 5A, the ITCS device 500
includes a housing 502 within which various cardiac and respiratory
sensing, detection, processing, and energy delivery circuitry may
be housed. Communications circuitry is disposed within the housing
502 for facilitating communication between the ITCS device 500 and
an external communication device, such as a portable or bed-side
communication station, patient-carried/worn communication station,
or external programmer, for example. The communications circuitry
may also facilitate unidirectional or bidirectional communication
with one or more external, cutaneous, or subcutaneous physiologic
or non-physiologic sensors. The housing 502 is typically configured
to include one or more electrodes (e.g., can electrode and/or
indifferent electrode). Although the housing 502 is typically
configured as an active can, it is appreciated that a non-active
can configuration may be implemented, in which case at least two
electrodes spaced apart from the housing 502 are employed.
[0232] In the configuration shown in FIG. 5A, a subcutaneous
electrode 504 may be positioned under the skin in the chest region
and situated distal from the housing 502. The subcutaneous and, if
applicable, housing electrode(s) may be positioned about the heart
at various locations and orientations, such as at various anterior
and/or posterior locations relative to the heart. The subcutaneous
electrode 504 is coupled to circuitry within the housing 502 via a
lead assembly 506. One or more conductors (e.g., coils or cables)
are provided within the lead assembly 506 and electrically couple
the subcutaneous electrode 504 with circuitry in the housing 502.
One or more sense, sense/pace or defibrillation electrodes may be
situated on the elongated structure of the electrode support, the
housing 502, and/or the distal electrode assembly (shown as
subcutaneous electrode 504 in the configuration shown in FIG.
5A).
[0233] In one configuration, the lead assembly 506 is generally
flexible and has a construction similar to conventional
implantable, medical electrical leads (e.g., defibrillation leads
or combined defibrillation/pacing leads). In another configuration,
the lead assembly 506 is constructed to be somewhat flexible, yet
has an elastic, spring, or mechanical memory that retains a desired
configuration after being shaped or manipulated by a clinician. For
example, the lead assembly 506 may incorporate a gooseneck or braid
system that may be distorted under manual force to take on a
desired shape. In this manner, the lead assembly 506 may be
shape-fit to accommodate the unique anatomical configuration of a
given patient, and generally retains a customized shape after
implantation. Shaping of the lead assembly 506 according to this
configuration may occur prior to, and during, ITCS device 500
implantation.
[0234] In accordance with a further configuration, the lead
assembly 506 includes an electrode support assembly, such as an
elongated structure that positionally stabilizes the subcutaneous
electrode 504 with respect to the housing 502. In this
configuration, the rigidity of the elongated structure maintains a
desired spacing between the subcutaneous electrode 504 and the
housing 502, and a desired orientation of the subcutaneous
electrode 104/housing 502 relative to the patient's heart. The
elongated structure may be formed from a structural plastic,
composite or metallic material, and includes, or is covered by, a
biocompatible material. Appropriate electrical isolation between
the housing 502 and subcutaneous electrode 504 is provided in cases
where the elongated structure is formed from an electrically
conductive material, such as metal.
[0235] In one configuration, the electrode support assembly and the
housing 502 define a unitary structure (e.g., a single
housing/unit). The electronic components and electrode
conductors/connectors are disposed within or on the unitary ITCS
device 500 housing/electrode support assembly. At least two
electrodes are supported on the unitary structure near opposing
ends of the housing/electrode support assembly. The unitary
structure may have an arcuate or angled shape, for example.
[0236] According to another configuration, the electrode support
assembly defines a physically separable unit relative to the
housing 502. The electrode support assembly includes mechanical and
electrical couplings that facilitate mating engagement with
corresponding mechanical and electrical couplings of the housing
502. For example, a header block arrangement may be configured to
include both electrical and mechanical couplings that provide for
mechanical and electrical connections between the electrode support
assembly and housing 502. The header block arrangement may be
provided on the housing 502 or the electrode support assembly.
Alternatively, a mechanical/electrical coupler may be used to
establish mechanical and electrical connections between the
electrode support assembly and housing 502. In such a
configuration, a variety of different electrode support assemblies
of varying shapes, sizes, and electrode configurations may be made
available for physically and electrically connecting to a standard
ITCS device 500 housing 502.
[0237] It is noted that the electrodes and the lead assembly 506
may be configured to assume a variety of shapes. For example, the
lead assembly 506 may have a wedge, chevron, flattened oval, or a
ribbon shape, and the subcutaneous electrode 504 may include a
number of spaced electrodes, such as an array or band of
electrodes. Moreover, two or more subcutaneous electrodes 504 may
be mounted to multiple electrode support assemblies 506 to achieve
a desired spaced relationship amongst subcutaneous electrodes
504.
[0238] FIG. 5B is a block diagram depicting various components of
an ITCS device 500 in accordance with one configuration. According
to this configuration, the ITCS device 500 incorporates a
processor-based control system 505 which includes a micro-processor
526 coupled to appropriate memory (volatile and non-volatile) 509,
it being understood that any logic-based control architecture may
be used. The control system 505 is coupled to circuitry and
components to sense, detect, and analyze electrical signals
produced by the heart and deliver electrical stimulation energy to
the heart under predetermined conditions to treat cardiac
arrhythmias. In certain configurations, the control system 505 and
associated components also provide pacing therapy to the heart. The
electrical energy delivered by the ITCS device 500 may be in the
form of low energy pacing pulses, non-excitatory energy (e.g.,
sub-threshold stimulation energy) or high-energy pulses for
cardioversion or defibrillation.
[0239] Cardiac signals are sensed using the subcutaneous
electrode(s) 514 and the can or indifferent electrode 507 provided
on the ITCS device 500 housing. Cardiac signals may also be sensed
using only the subcutaneous electrodes 514, such as in a non-active
can configuration. As such, unipolar, bipolar, or combined
unipolar/bipolar electrode configurations as well as multi-element
electrodes and combinations of noise canceling and standard
electrodes may be employed. The sensed cardiac signals are received
by sensing circuitry 524, which includes sense amplification
circuitry and may also include filtering circuitry and an
analog-to-digital (A/D) converter. The sensed cardiac signals
processed by the sensing circuitry 524 may be received by noise
reduction circuitry 503, which may further reduce noise before
signals are sent to the detection circuitry 522.
[0240] Noise reduction circuitry 503 may also be incorporated after
sensing circuitry 522 in cases where high power or computationally
intensive noise reduction algorithms are required. The noise
reduction circuitry 503, by way of amplifiers used to perform
operations with the electrode signals, may also perform the
function of the sensing circuitry 524. Combining the functions of
sensing circuitry 524 and noise reduction circuitry 503 may be
useful to minimize the necessary componentry and lower the power
requirements of the system.
[0241] In the illustrative configuration shown in FIG. 5B, the
detection circuitry 522 is coupled to, or otherwise incorporates,
noise reduction circuitry 503. The noise reduction circuitry 503
operates to improve the signal-to-noise ratio (SNR) of sensed
cardiac signals by removing noise content of the sensed cardiac
signals introduced from various sources. Typical types of
transthoracic cardiac signal noise includes electrical noise and
noise produced from skeletal muscles, for example.
[0242] Detection circuitry 522 typically includes a signal
processor that coordinates analysis of the sensed cardiac signals
and/or other sensor inputs to detect cardiac arrhythmias, such as,
in particular, tachyarrhythmia. Rate based and/or morphological
discrimination algorithms may be implemented by the signal
processor of the detection circuitry 522 to detect and verify the
presence and severity of an arrhythmic episode.
[0243] The detection circuitry 522 communicates cardiac signal
information to the control system 505. Memory circuitry 509 of the
control system 505 contains parameters for operating in various
sensing, defibrillation, and, if applicable, pacing modes, and
stores data indicative of cardiac signals received by the detection
circuitry 522. The memory circuitry 509 may also be configured to
store historical ECG and therapy data, which may be used for
various purposes and transmitted to an external receiving device as
needed or desired.
[0244] In certain configurations, the ITCS device 500 may include
diagnostics circuitry 510. The diagnostics circuitry 510 typically
receives input signals from the detection circuitry 522 and the
sensing circuitry 524. The diagnostics circuitry 510 provides
diagnostics data to the control system 505, it being understood
that the control system 505 may incorporate all or part of the
diagnostics circuitry 510 or its functionality. The control system
505 may store and use information provided by the diagnostics
circuitry 510 for a variety of diagnostics purposes. This
diagnostic information may be stored, for example, subsequent to a
triggering event or at predetermined intervals, and may include
system diagnostics, such as power source status, therapy delivery
history, and/or patient diagnostics. The diagnostic information may
take the form of electrical signals or other sensor data acquired
immediately prior to therapy delivery.
[0245] According to a configuration that provides cardioversion and
defibrillation therapies, the control system 505 processes cardiac
signal data received from the detection circuitry 522 and initiates
appropriate tachyarrhythmia therapies to terminate cardiac
arrhythmic episodes and return the heart to normal sinus rhythm.
The control system 505 is coupled to shock therapy circuitry 516.
The shock therapy circuitry 516 is coupled to the subcutaneous
electrode(s) 514 and the can or indifferent electrode 507 of the
ITCS device 500 housing. Upon command, the shock therapy circuitry
516 delivers cardioversion and defibrillation stimulation energy to
the heart in accordance with a selected cardioversion or
defibrillation therapy. In a less sophisticated configuration, the
shock therapy circuitry 516 is controlled to deliver defibrillation
therapies, in contrast to a configuration that provides for
delivery of both cardioversion and defibrillation therapies.
[0246] In accordance with another configuration, an ITCS device 500
may incorporate a cardiac pacing capability in addition to
cardioversion and/or defibrillation capabilities. As is shown in
dotted lines in FIG. 5B, the ITCS device 500 may include pacing
therapy circuitry 530, which is coupled to the control system 505
and the subcutaneous and can/indifferent electrodes 514, 507. Upon
command, the pacing therapy circuitry delivers pacing pulses to the
heart in accordance with a selected pacing therapy. Control
signals, developed in accordance with a pacing regimen by pacemaker
circuitry within the control system 505, are initiated and
transmitted to the pacing therapy circuitry 530 where pacing pulses
are generated. A pacing regimen may be modified by the control
system 505.
[0247] A number of cardiac pacing therapies may be useful in a
transthoracic cardiac monitoring and/or stimulation device. Such
cardiac pacing therapies may be delivered via the pacing therapy
circuitry 530 as shown in FIG. 5B. Alternatively, cardiac pacing
therapies may be delivered via the shock therapy circuitry 516,
which effectively obviates the need for separate pacemaker
circuitry.
[0248] The ITCS device 500 shown in FIG. 5B is configured to
receive signals from one or more physiologic and/or non-physiologic
sensors. Depending on the type of sensor employed, signals
generated by the sensors may be communicated to transducer
circuitry coupled directly to the detection circuitry 522 or
indirectly via the sensing circuitry 524. It is noted that certain
sensors may transmit sense data to the control system 505 without
processing by the detection circuitry 522.
[0249] Non-electrophysiological cardiac sensors 561 may be coupled
directly to the detection circuitry 522 or indirectly via the
sensing circuitry 524. Non-electrophysiological cardiac sensors 561
sense cardiac activity that is non-electrophysiological in nature.
Examples of non-electrophysiological cardiac sensors 561 include
blood oxygen sensors, transthoracic impedance sensors, blood volume
sensors, acoustic sensors and/or pressure transducers, and
accelerometers. Signals from these sensors are developed based on
cardiac activity, but are not derived directly from
electrophysiological sources (e.g., R-waves or P-waves). A
non-electrophysiological cardiac sensor 561, as is illustrated in
FIG. 5B, may be connected to one or more of the sensing circuitry
524, detection circuitry 522 (connection not shown for clarity),
and the control system 505.
[0250] Communications circuitry 518 is coupled to the
microprocessor 526 of the control system 505. The communications
circuitry 518 allows the ITCS device 500 to communicate with one or
more receiving devices or systems situated external to the ITCS
device 500. By way of example, the ITCS device 500 may communicate
with a patient-worn, portable or bedside communication system via
the communications circuitry 518. In one configuration, one or more
physiologic or non-physiologic sensors (subcutaneous, cutaneous, or
external of patient) may be equipped with a short-range wireless
communication interface, such as an interface conforming to a known
communications standard, such as Bluetooth or IEEE 802 standards.
Data acquired by such sensors may be communicated to the ITCS
device 500 via the communications circuitry 518. It is noted that
physiologic or non-physiologic sensors equipped with wireless
transmitters or transceivers may communicate with a receiving
system external of the patient.
[0251] The communications circuitry 518 may allow the ITCS device
500 to communicate with an external programmer. In one
configuration, the communications circuitry 518 and the programmer
unit (not shown) use a wire loop antenna and a radio frequency
telemetric link, as is known in the art, to receive and transmit
signals and data between the programmer unit and communications
circuitry 518. In this manner, programming commands and data are
transferred between the ITCS device 500 and the programmer unit
during and after implant. Using a programmer, a physician is able
to set or modify various parameters used by the ITCS device 500.
For example, a physician may set or modify parameters affecting
sensing, detection, pacing, and defibrillation functions of the
ITCS device 500, including pacing and cardioversion/defibrillation
therapy modes.
[0252] Typically, the ITCS device 500 is encased and hermetically
sealed in a housing suitable for implanting in a human body as is
known in the art. Power to the ITCS device 500 is supplied by an
electrochemical power source 520 housed within the ITCS device 500.
In one configuration, the power source 520 includes a rechargeable
battery. According to this configuration, charging circuitry is
coupled to the power source 520 to facilitate repeated non-invasive
charging of the power source 520. The communications circuitry 518,
or separate receiver circuitry, is configured to receive RF energy
transmitted by an external RF energy transmitter. The ITCS device
500 may, in addition to a rechargeable power source, include a
non-rechargeable battery. It is understood that a rechargeable
power source need not be used, in which case a long-life
non-rechargeable battery is employed.
[0253] The components, functionality, and structural configurations
depicted in FIGS. 5A-5E are intended to provide an understanding of
various features and combination of features that may be
incorporated in an ITCS device 500. It is understood that a wide
variety of ITCS and other implantable cardiac monitoring and/or
stimulation device configurations are contemplated, ranging from
relatively sophisticated to relatively simple designs. As such,
particular ITCS or cardiac monitoring and/or stimulation device
configurations may include particular features as described herein,
while other such device configurations may exclude particular
features described herein.
[0254] In accordance with embodiments of the invention, an ITCS
device 500 may be implemented to include a subcutaneous electrode
system that provides for one or both of cardiac sensing and
arrhythmia therapy delivery. According to one approach, an ITCS
device 500 may be implemented as a chronically implantable system
that performs monitoring, diagnostic and/or therapeutic functions.
The ITCS device 500 may automatically detect and treat cardiac
arrhythmias.
[0255] In one configuration, an ITCS device 500 includes a pulse
generator and one or more electrodes that are implanted
subcutaneously in the chest region of the body, such as in the
anterior thoracic region of the body. The ITCS device 500 may be
used to provide atrial and/or ventricular therapy for bradycardia
and tachycardia arrhythmias. Tachyarrhythmia therapy may include
cardioversion, defibrillation and anti-tachycardia pacing (ATP),
for example, to treat atrial or ventricular tachycardia or
fibrillation. Bradycardia therapy may include temporary post-shock
pacing for bradycardia or asystole.
[0256] In one configuration, an ITCS device 500 according to one
approach may utilize conventional pulse generator and subcutaneous
electrode implant techniques. The pulse generator device and
electrodes may be chronically implanted subcutaneously. Such an
ITCS may be used to automatically detect and treat arrhythmias
similarly to conventional implantable systems. In another
configuration, the ITCS device 500 may include a unitary structure
(e.g., a single housing/unit). The electronic components and
electrode conductors/connectors are disposed within or on the
unitary ITCS device 500 housing/electrode support assembly.
[0257] The ITCS device 500 contains the electronics and may be
similar to a conventional implantable defibrillator. High voltage
shock therapy may be delivered between two or more electrodes, one
of which may be the pulse generator housing (e.g., can), placed
subcutaneously in the thoracic region of the body.
[0258] Additionally or alternatively, the ITCS device 500 may also
provide lower energy electrical stimulation for bradycardia
therapy. The ITCS device 500 may provide brady pacing similarly to
a conventional pacemaker. The ITCS device 500 may provide temporary
post-shock pacing for bradycardia or asystole. Sensing and/or
pacing may be accomplished using sense/pace electrodes positioned
on an electrode subsystem also incorporating shock electrodes, or
by separate electrodes implanted subcutaneously.
[0259] The ITCS device 500 may detect a variety of physiological
signals that may be used in connection with various diagnostic,
therapeutic or monitoring implementations in accordance with the
present invention. For example, the ITCS device 500 may include
sensors or circuitry for detecting pulse pressure signals, blood
oxygen level, heart sounds, cardiac acceleration, and other
non-electrophysiological signals related to cardiac activity. In
one embodiment, the ITCS device 500 senses intrathoracic impedance,
from which various respiratory parameters may be derived,
including, for example, respiratory tidal volume and minute
ventilation. Sensors and associated circuitry may be incorporated
in connection with an ITCS device 500 for detecting one or more
body movement or body position related signals. For example,
accelerometers and GPS devices may be employed to detect patient
activity, patient location, body orientation, or torso
position.
[0260] The ITCS device 500 may be used within the structure of an
APM system. APM systems may allow physicians to remotely and
automatically monitor cardiac and respiratory functions, as well as
other patient conditions. In one example, implantable cardiac
rhythm management systems, such as cardiac pacemakers,
defibrillators, and resynchronization devices, may be equipped with
various telecommunications and information technologies that enable
real-time data collection, diagnosis, and treatment of the patient.
Various embodiments described herein may be used in connection with
advanced patient management.
[0261] An ITCS device 500 according to one approach provides an
easy to implant therapeutic, diagnostic or monitoring system. The
ITCS system may be implanted without the need for intravenous or
intrathoracic access, providing a simpler, less invasive implant
procedure and minimizing lead and surgical complications. In
addition, this system would have advantages for use in patients for
whom transvenous lead systems cause complications. Such
complications include, but are not limited to, surgical
complications, infection, insufficient vessel patency,
complications associated with the presence of artificial valves,
and limitations in pediatric patients due to patient growth, among
others. An ITCS system according to this approach is distinct from
conventional approaches in that it may be configured to include a
combination of two or more electrode subsystems that are implanted
subcutaneously in the anterior thorax.
[0262] In one ITCS system configuration, as is illustrated in FIG.
5C, electrode subsystems of the ITCS system include a first
electrode subsystem, including a can electrode 533, and a second
electrode subsystem 535 that may include at least one coil
electrode, for example. The second electrode subsystem 535 may
include a number of electrodes used for sensing and/or electrical
stimulation. In various configurations, the second electrode
subsystem 535 may include a single electrode or a combination of
electrodes. The single electrode or combination of electrodes
including the second electrode subsystem 535 may include coil
electrodes, tip electrodes, ring electrodes, multi-element coils,
spiral coils, spiral coils mounted on non-conductive backing, and
screen patch electrodes, for example. A suitable non-conductive
backing material is silicone rubber, for example.
[0263] The can electrode 533 is located on the housing 531 that
encloses the ITCS device 500 electronics. In one embodiment, the
can electrode 533 includes the entirety of the external surface of
housing 531. In other embodiments, various portions of the housing
531 may be electrically isolated from the can electrode 533 or from
tissue. For example, the active area of the can electrode 533 may
include all or a portion of either the anterior or posterior
surface of the housing 531 to direct current flow in a manner
advantageous for cardiac sensing and/or stimulation.
[0264] The housing 531 may resemble that of a conventional
implantable ICD, is approximately 20-100 cc in volume, with a
thickness of 0.4 to 2 cm and with a surface area on each face of
approximately 30 to 100 cm.sup.2. As previously discussed, portions
of the housing may be electrically isolated from tissue to
optimally direct current flow. For example, portions of the housing
531 may be covered with a non-conductive, or otherwise electrically
resistive, material to direct current flow. Suitable non-conductive
material coatings include those formed from silicone rubber,
polyurethane, or parylene, for example.
[0265] FIG. 5C illustrates the housing 531 and can electrode 533
placed subcutaneously, superior to the heart 540 in the left
pectoral region, which is a location commonly used for conventional
pacemaker and defibrillator implants. The second electrode
subsystem 535 may include a coil electrode mounted on the distal
end of a lead body 537, where the coil is approximately 3-15 French
in diameter and 5-12 cm in length. The coil electrode may have a
slight preformed curve along its length. The lead may be introduced
through the lumen of a subcutaneous sheath, through a common
tunneling implant technique, and the second electrode subsystem
535, e.g., including a coil electrode, may be placed
subcutaneously, deep to any subcutaneous fat and adjacent to the
underlying muscle layer.
[0266] In this configuration, the second electrode subsystem 535 is
located approximately parallel with the inferior aspect of the
right ventricle of the heart 540, just inferior to the right
ventricular free wall, with one end extending just past the apex of
the heart 540. For example, the tip of the electrode subsystem 535
may extend less than about 3 cm and may be about 1-2 cm left
lateral to the apex of the heart 540. This electrode arrangement
may be used to include a majority of ventricular tissue within a
volume defined between the housing 531 and the second electrode
subsystem 535. In one configuration, a majority of the ventricular
tissue is included within a volume associated with an area bounded
by lines drawn between the distal and proximal ends of the second
electrode subsystem 535 and the medial and lateral edges of the
left pectoral can electrode 533.
[0267] In one example arrangement, the volume including a majority
of ventricular tissue may be associated with a cross sectional area
bounded by lines drawn between the ends of the electrode subsystems
533, 535 or between active elements of the electrode subsystems
533, 535. In one implementation, the lines drawn between active
elements of the electrode subsystems 533, 535 may include a medial
edge and a lateral edge of the can electrode 533, and a proximal
end and a distal end of a coil electrode utilized within the second
electrode subsystem 535. Arranging the electrode subsystems so that
a majority of ventricular tissue is contained within a volume
defined between the active elements of the electrode subsystems
533, 535 provides an efficient position for defibrillation by
increasing the voltage gradient in the ventricles of the heart 540
for a given applied voltage between electrode subsystems 533,
535.
[0268] In a similar configuration, and as shown in FIG. 5D, the
housing 531 including the can electrode 533 is placed in the right
pectoral region. The second electrode subsystem 535 is located more
laterally, to again include a majority of the ventricular tissue in
a volume defined between the can electrode 533 and the second
electrode subsystem 535.
[0269] In a further configuration, and as shown in FIG. 5E, the
ITCS device housing 531 containing the electronics (i.e., the can)
is not used as an electrode. In this case, an electrode system
including two electrode subsystems 538, 539 coupled to the housing
531 may be implanted subcutaneously in the chest region of the
body, such as in the anterior thorax. The first and the second
electrode subsystems 538, 539 are placed in opposition with respect
to the ventricles of the heart 540, with the majority of the
ventricular tissue of the heart 540 included within a volume
defined between the electrode subsystems 538, 539. As illustrated
in FIG. 5E, the first electrode system 538 is located superior to
the heart 540 relative to a superior aspect of the heart 540, e.g.,
parallel to the left ventricular free wall. The second electrode
system 539 is located inferior to the heart 540 and positioned in
relation to an inferior aspect of the heart 540, e.g., parallel to
the right ventricular free wall.
[0270] In this configuration, the first and the second electrode
subsystems 538, 539 may include any combination of electrodes,
including or excluding the can electrode, used for sensing and/or
electrical stimulation. In various configurations, the electrode
subsystems 538, 539 may each be a single electrode or a combination
of electrodes. The electrode or electrodes including the first and
second electrode subsystems 538, 539 may include any combination of
one or more coil electrodes, tip electrodes, ring electrodes,
multi-element coils, spiral coils, spiral coils mounted on
non-conductive backing, and screen patch electrodes, for
example.
[0271] FIGS. 5F-5H provide additional detailed views of
subcutaneous electrode subsystem placement considered particularly
useful with ITCS devices incorporating disordered breathing
detection in accordance with embodiments of the present invention.
FIG. 5F illustrates first and second electrode subsystems
configured as a can electrode 562 and a coil electrode 564,
respectively. FIG. 5F illustrates the can electrode 562 located
superior to the heart 560 in the left pectoral region and the coil
electrode 564 located inferior to the heart 560, parallel to the
right ventricular free wall of the heart 560.
[0272] The can electrode 562 and the coil electrode 564 are located
so that the majority of ventricular tissue is included within a
volume defined between the can electrode 562 and the coil electrode
564. FIG. 5F illustrates a cross sectional area 565 formed by the
lines drawn between active elements of the can electrode 562 and
the coil electrode 564. Lines drawn between active areas of the
electrodes 562, 564, may be defined by a medial edge and a lateral
edge of the can electrode 562, and a proximal end and a distal end
of a coil electrode utilized as the second electrode subsystem 564.
The coil electrode 564 extends a predetermined distance beyond the
apex of the heart 560, e.g. less than about 3 cm.
[0273] A similar configuration is illustrated in FIG. 5G. In this
embodiment, the can electrode 562 is placed superior to the heart
560 in the right pectoral region. The coil electrode 564 is located
inferior to the heart. In one arrangement, the coil electrode is
located relative to an inferior aspect of the heart 560, for
example, the apex of the heart. The can electrode 562 and the coil
electrode 564 are positioned so that the majority of ventricular
tissue is included within a volume defined between the can
electrode 562 and the coil electrode 564.
[0274] FIG. 5G illustrates a cross sectional area 565 formed by the
lines drawn between active elements of the can electrode 562 and
the coil electrode 564. Lines drawn between active areas of the
electrodes 562, 564, may be defined by a medial edge and a lateral
edge of the can electrode 562, and a proximal end and a distal end
of a coil electrode utilized as the second electrode subsystem 564.
The coil electrode 564 extends a predetermined distance beyond the
apex of the heart 560, e.g. less than about 3 cm.
[0275] FIG. 5H illustrates a configuration wherein the pulse
generator housing 561 does not include an electrode. In this
implementation two electrode subsystems are positioned about the
heart so that a majority of ventricular tissue is included within a
volume defined between the electrode subsystems. According to this
embodiment, the first and second electrodes are configured as first
and second coil electrodes 568, 569.
[0276] The first coil electrode 568 is located superior to the
heart 560 and may be located relative to a superior aspect of the
heart, e.g., the left ventricular free wall. The second coil
electrode 569 is located inferior to the heart 560. The second
electrode 569 may be located in relation to an inferior aspect of
the heart 560. In one configuration, the second electrode 569 is
positioned parallel to the right ventricular free wall with a tip
of the electrode 569 extending less than about 3 cm beyond the apex
of the heart 560. As illustrated in FIG. 5H, the volume defined
between the electrodes may be defined by the cross sectional area
565 bounded by lines drawn between active areas of the electrodes
568, 569.
[0277] Disordered Breathing Detection
[0278] According to various embodiments of the invention, detection
of disordered breathing events may be used in connection with
providing coordinated monitoring, diagnosis and/or therapy. In one
embodiment, detection and assessment of disordered breathing is
used to adapt (initiate, modify and/or terminate) therapy delivery.
In another embodiment, disordered breathing events detected during
and/or after therapy delivery may be used to assess the
effectiveness of the disordered breathing therapy. In various
implementations, some of which are described below, episodes of
disordered breathing may be detected and classified by analyzing
the patient's respiration patterns and/or other conditions
associated with disordered breathing. Systems and methods directed
to disordered breathing detection may be implemented to include
selected features, functions, and/or structures described in
commonly owned, co-pending U.S. Pat. No. 7,252,640, which is hereby
incorporated herein by reference.
[0279] In accordance with one embodiment of the invention, the
cardiac electrical therapy for disordered breathing may be adapted
based on detected episodes of disordered breathing. In one
scenario, one or more episodes of disordered breathing are detected
and the cardiac electrical therapy is initiated or increased to
treat the detected episodes. Adaptation of the therapy may
continue, enabling the system to deliver a therapeutically
appropriate therapy throughout the disordered breathing episode or
episodes. If the system determines that the disordered breathing
has mitigated or ceased, then the therapy may be reduced or
terminated. Therapy may continue after the disordered breathing
episode has stopped to prevent future occurrences of disordered
breathing.
[0280] Table 1 provides a representative set of conditions
affecting the patient that may be used to monitor and/or diagnose
disordered breathing and/or to adapt a disordered breathing
therapy. Table 1 also provides example sensing methods that may be
employed to sense the conditions.
[0281] Detection of disordered breathing may involve detecting one
or more conditions indicative of disordered breathing listed in
Table 1. The patient conditions listed in Table 1 may be employed
in a multi-sensor approach to detect and confirm episodes of
disordered breathing. For example, the accuracy of a preliminary
disordered breathing detection may be enhanced by verifying the
patient is asleep, in bed, inactive, lying down, or that the
present environmental conditions are associated with disordered
breathing in the patient.
[0282] Table 2 provides examples of how a representative subset of
the physiological and non-physiological conditions listed in Table
1 may be used in connection with disordered breathing
detection.
TABLE-US-00002 TABLE 2 Condition Examples of how condition may be
used in Type Condition disordered breathing detection Physiological
Heart rate Decrease in heart rate may indicate disordered breathing
episode. Decrease in heart rate may indicate the patient is asleep.
Heart rate variability Disordered breathing causes heart rate
variability to decrease. Changes in HRV associated with sleep
disordered breathing may be observed while the patient is awake or
asleep Ventricular filling May be used to identify/predict
pulmonary pressure congestion associated with respiratory
disturbance. Blood pressure Swings in on-line blood pressure
measures are associated with apnea. Disordered breathing generally
increases blood pressure variability - these changes may be
observed while the patient is awake or asleep. Snoring Snoring is
associated with a higher incidence of obstructive sleep apnea and
may be used to detect disordered breathing. Respiration Respiration
patterns including, e.g., respiration rate, pattern/rate may be
used to detect disordered breathing episodes. Respiration patterns
may be used to determine the type of disordered breathing.
Respiration patterns may be used to detect that the patient is
asleep. Patency of upper Patency of upper airway is related to
obstructive airway sleep apnea and may be used to detect episodes
of obstructive sleep apnea. Pulmonary Pulmonary congestion is
associated with congestion respiratory disturbances. Sympathetic
nerve End of apnea associated with a spike in SNA. activity Changes
in SNA observed while the patient is awake or asleep may be
associated with sleep disordered breathing CO2 Low CO2 levels
initiate central apnea. O2 O2 desaturation occurs during severe
apnea/hypopnea episodes. Blood alcohol content Alcohol tends to
increase incidence of snoring & obstructive apnea. Adrenalin
End of apnea associated with a spike in blood adrenaline. BNP A
marker of heart failure status, which is associated with
Cheyne-Stokes Respiration C-Reactive Protein A measure of
inflammation that may be related to apnea. Drug/Medication/Tobacco
These substances may affect the incidence of both use central &
obstructive apnea. Muscle atonia Muscle atonia may be used to
detect REM and non- REM sleep. Eye movement Eye movement may be
used to detect REM and non-REM sleep. Non- Temperature Ambient
temperature may be a condition physiological/ predisposing the
patient to episodes of disordered Contextual breathing and may be
useful in disordered breathing detection. Humidity Humidity may be
a condition predisposing the patient to episodes of disordered
breathing and may be useful in disordered breathing detection.
Pollution Pollution may be a condition predisposing the patient to
episodes of disordered breathing and may be useful in disordered
breathing detection. Posture Posture may be used to confirm or
determine the patient is asleep. Activity Patient activity may be
used in relation to sleep detection. Location Patient location may
used to determine if the patient is in bed as a part of sleep
detection.
[0283] Episodes of disordered breathing are associated with acute
and chronic physiological effects. Acute responses to disordered
breathing may include, for example, negative intrathoracic
pressure, hypoxia, arousal from sleep, and increases in blood
pressure and heart rate. During obstructive apnea episodes,
negative intrathoracic pressure may arise from an increased effort
to generate airflow. Attempted inspiration in the presence of an
occluded airway results in an abrupt reduction in intrathoracic
pressure. The repeated futile inspiratory efforts associated with
obstructive sleep apnea may trigger a series of secondary
responses, including mechanical, hemodynamic, chemical, neural, and
inflammatory responses.
[0284] Obstructive sleep apneas may be terminated by arousal from
sleep several seconds after the apneic peak, allowing the breathing
to resume. Coincident with arousal from sleep, surges in
sympathetic nerve activity, blood pressure, and heart rate may
occur. The adverse effects of obstructive apnea are not confined to
sleep. Waking conditions such as sympathetic nerve activity and
systemic blood pressure are increased. There may also be a
sustained reduction in vagal tone, causing reduction in total heart
rate variability during periods of wakefulness.
[0285] Central sleep apnea is generally caused by a failure of
respiratory control signals from the brain. Central sleep apnea is
a component of Cheyne-Stokes respiration (CSR), a respiration
pattern primarily observed in patients suffering from chronic heart
failure (CHF). Cheyne-Stokes respiration is a form of periodic
breathing in which central apneas and hypopneas alternate with
periods of hyperventilation causing a waxing-waning pattern of
tidal volume. In some CHF patients, obstructive sleep apnea and
central sleep apnea may coexist. In these patients, there may be a
gradual shift from predominantly obstructive apneas at the
beginning of the night to predominantly central apneas at the end
of the night.
[0286] Several mechanisms may be involved in central apneas
observed in patients suffering from chronic heart failure.
According to one mechanism, increased carbon dioxide sensitivity in
CHF patients triggers hyperventilation initiating a sleep apnea
episode. Breathing is regulated by a negative feedback system that
maintains the arterial partial pressure of carbon dioxide
(PaCO.sub.2) within limits. Changes in PaCO.sub.2 lead to changes
in ventilation wherein the greater the sensitivity to carbon
dioxide, the greater the ventilatory response.
[0287] In patients with cardiopulmonary disorders, an increase in
carbon dioxide sensitivity may minimize perturbations in
PaCO.sub.2, thus protecting them against the long-term consequences
of hypercapnia, an excess of carbon dioxide in the blood. This
protective mechanism may be advantageous while the patient is
awake, however, the increased sensitivity to carbon dioxide may
disrupt breathing during sleep.
[0288] During sleep, ventilation decreases and PaCO.sub.2 levels
increase. If the PaCO.sub.2 level decreases below level referred to
as the apneic threshold, ventilation ceases, central sleep apnea
ensues, and PaCO.sub.2 rises to previous levels.
[0289] In patients with increased sensitivity to carbon dioxide,
the negative-feedback system that controls breathing initiates a
large ventilatory response when PaCO.sub.2 rises. The resultant
hyperventilation, by driving the PaCO.sub.2 level below the apneic
threshold, results in central sleep apnea. As a result of the
apnea, the PaCO.sub.2 level rises again, leading to an increase in
ventilation. In this way, cycles of hyperventilation and central
apnea may recur throughout sleep.
[0290] The posture of CHF patients during sleep may also be
implicated in triggering apnea. When CHF patients lie down, the
prone posture may create central fluid accumulation and pulmonary
congestion causing the patient to reflexively hyperventilate.
Hyperventilation may initiate the cyclical pattern of
hyperventilation-apnea described above.
[0291] Arousals are not necessarily required in central sleep
apneas for the resumption of breathing at the termination of the
apneic event. In central apnea, the arousals follow the initiation
of breathing and may facilitate the development of oscillations in
ventilation by recurrently stimulating hyperventilation and
reducing PaCO.sub.2 below the apneic threshold. Once triggered, the
pattern of alternating hyperventilation and apnea is sustained by
the combination of increased respiratory drive, pulmonary
congestion, arousals, and apnea-induced hypoxia causing PaCO.sub.2
oscillations above and below the apneic threshold. Shifts in the
patient's state of consciousness, particularly with repeated
arousals, may further destabilize breathing.
[0292] With the transition from wakefulness to NREM sleep, the
waking neural drive to breathe is lost, and the threshold for a
ventilatory response to carbon dioxide is increased. Therefore, if
the patient's PaCO.sub.2 level during wakefulness is below this
higher sleeping threshold, the transition to NREM sleep may be
accompanied by a transient loss of respiratory drive resulting in a
central apnea. During the apnea, the PaCO.sub.2 rises until it
reaches the new higher threshold level and initiates breathing. If
sleep becomes firmly established, regular breathing resumes.
However, if an arousal should occur, the increased PaCO.sub.2 level
associated with sleep is now relatively too high for a state of
wakefulness and will stimulate hyperventilation. Thus, although
arousals terminate obstructive sleep apneas, arousals trigger the
respiratory oscillations associated with central apneas,
particularly Cheyne-Stokes respiration.
[0293] In addition to the acute responses to sleep disordered
breathing, such as those discussed above, sleep disordered
breathing is also associated with a number of secondary or chronic
responses, including, for example, chronic decrease in heart rate
variability (HRV) and blood pressure changes. Patients with central
sleep apnea may have higher urinary and circulating norepinephrine
concentrations and lower PaCO.sub.2 during both sleep and
wakefulness.
[0294] Acute responses to disordered breathing are associated with
physiological conditions that are modulated during an ongoing
disordered breathing event. Sensing conditions modulated by the
acute responses to disordered breathing may be used to detect a
disordered breathing event contemporaneously with the occurrence of
the disordered breathing event. Chronic responses to disordered
breathing may be modulated by an aggregation of disordered
breathing events that occur over time. Chronic responses to
disordered breathing may be used to determine if disordered
breathing events have occurred.
[0295] Both acute and chronic responses to disordered breathing may
be used to asses the efficacy and impact of disordered breathing
therapy. In one implementation, a first subset of patient
conditions may be used to detect disordered breathing, including
presently occurring events, and/or an aggregation of events
occurring over time. A second subset of patient conditions,
possibly overlapping the subset used for disordered breathing
detection, may be used to assess the disordered breathing therapy.
For example, according to one embodiment, the efficacy of the
therapy may be assessed and the therapy may be adapted to enhance
the efficacy based on the assessment. In another embodiment, the
therapy may be assessed to determine an impact of the therapy on
the patient. The therapy may be adapted to reduce therapy impact of
the therapy on the patient based on the assessment. In yet a
further embodiment, the therapy may be adapted both to enhance
therapy effectiveness and to reduce an impact of the therapy on the
patient. Other constraints may be utilized for therapy adaptation,
including, for example, preservation of useable device life, and/or
avoidance of interactions between disordered breathing therapy and
other therapies delivered to the patient.
[0296] Conditions used to assess therapy effectiveness may be
different from, or the same as, conditions used to assess an impact
of the therapy on the patient. Table 3 provides a representative
set of conditions that may be used for therapy assessment.
TABLE-US-00003 TABLE 3 Condition Therapy Impact Therapy Efficacy
Arousal-Based Sleep May be used to assess Fragmentation Measures
therapy impact during sleep. Restful sleep (Patient May be used to
assess reported) therapy impact during sleep. Discomfort (Patient
May be used to assess reported) therapy impact. Pacing algorithm
May be used to assess interaction therapy impact. Remaining useful
life of May be used to assess therapy device therapy impact.
Disturbed Breathing-Based May be used to analyze/assess Measures
efficacy of therapy to mitigate disordered breathing episodes.
Respiration quality (Patient May be used to analyze/assess
reported) efficacy of therapy to mitigate disordered breathing
episodes. Heart rate variability Disordered breathing causes heart
(HRV) rate variability to decrease. Therapy may be modified based
on changes in HRV Blood pressure Disordered breathing causes blood
pressure increase Sympathetic nerve activity Changes in sympathetic
nerve (SNA) activity are caused by disordered breathing. Therapy
may be adjusted based on the level of SNA Blood chemistry A number
of disordered breathing related changes may occur in a patient's
blood chemistry, including, e.g., higher norepinephrine levels, and
lower PaCO.sub.2
[0297] It is understood that the patient conditions that may be
used in connection with disordered breathing therapy, including
detection of disordered breathing and/or therapy assessment, for
example, are not limited to the representative sets listed in
Tables 1-3 or those described herein. Further, although
illustrative sensing methods for detecting the patient conditions
listed above are provided, it is understood that the patient
conditions may be detected using a wide variety of technologies.
The invention is not limited to the particular conditions or the
particular sensing technologies discussed herein in connection with
the illustrative embodiments.
[0298] In one embodiment, episodes of disordered breathing may be
detected by monitoring the respiratory waveform output of a
transthoracic impedance sensor. When the tidal volume (TV) of the
patient's respiration, as indicated by the transthoracic impedance
signal, falls below a hypopnea threshold, then a hypopnea event is
declared. For example, a hypopnea event may be declared if the
patient's tidal volume falls below about 50% of a recent average
tidal volume or other baseline tidal volume value. If the patient's
tidal volume falls further to an apnea threshold, e.g., about 10%
of the recent average tidal volume or other baseline value, an
apnea event is declared.
[0299] In another embodiment, detection of disordered breathing
involves defining and examining a number of respiratory cycle
intervals. FIG. 6 illustrates respiration intervals used for
disordered breathing detection according to an embodiment of the
invention. A respiration cycle is divided into an inspiration
period corresponding to the patient inhaling, an expiration period,
corresponding to the patient exhaling, and a non-breathing period
occurring between inhaling and exhaling. Respiration intervals are
established using inspiration 610 and expiration 620 thresholds.
The inspiration threshold 610 marks the beginning of an inspiration
period 630 and is determined by the transthoracic impedance signal
rising above the inspiration threshold 610. The inspiration period
630 ends when the transthoracic impedance signal is maximum 640. A
maximum transthoracic impedance signal 640 corresponds to both the
end of the inspiration interval 630 and the beginning of the
expiration interval 650. The expiration interval 650 continues
until the transthoracic impedance falls below an expiration
threshold 620. A non-breathing interval 660 starts from the end of
the expiration period 650 and continues until the beginning of the
next inspiration period 670.
[0300] Detection of sleep apnea and severe sleep apnea according to
embodiments of the invention is illustrated in FIG. 7. The
patient's respiration signals are monitored and the respiration
cycles are defined according to inspiration 730, expiration 750,
and non-breathing 760 intervals as described in connection with
FIG. 6. A condition of sleep apnea is detected when a non-breathing
period 760 exceeds a first predetermined interval 790, denoted the
sleep apnea interval. A condition of severe sleep apnea is detected
when the non-breathing period 760 exceeds a second predetermined
interval 795, denoted the severe sleep apnea interval. For example,
sleep apnea may be detected when the non-breathing interval exceeds
about 10 seconds, and severe sleep apnea may be detected when the
non-breathing interval exceeds about 20 seconds.
[0301] Hypopnea is a condition of disordered breathing
characterized by abnormally shallow breathing. FIGS. 8A-8B are
graphs of tidal volume derived from transthoracic impedance
measurements. The graphs compare the tidal volume of a normal
breathing cycle to the tidal volume of a hypopnea episode. FIG. 8A
illustrates normal respiration tidal volume and rate. As shown in
FIG. 8B, hypopnea involves a period of abnormally shallow
respiration.
[0302] According to an embodiment of the invention, hypopnea is
detected by comparing a patient's respiratory tidal volume to a
hypopnea tidal volume threshold. The tidal volume for each
respiration cycle is derived from transthoracic impedance
measurements acquired in the manner described above. The hypopnea
tidal volume threshold may be established using clinical results
providing a representative tidal volume and duration of hypopnea
events. In one configuration, hypopnea is detected when an average
of the patient's respiratory tidal volume taken over a selected
time interval falls below the hypopnea tidal volume threshold.
Furthermore, various combinations of hypopnea cycles, breath
intervals, and non-breathing intervals may be used to detect
hypopnea, where the non-breathing intervals are determined as
described above.
[0303] FIG. 9 is a flowchart illustrating a method of apnea and/or
hypopnea detection according to embodiments of the invention.
Various parameters are established 901 before analyzing the
patient's respiration for disordered breathing episodes, including,
for example, inspiration and expiration thresholds, sleep apnea
interval, severe sleep apnea interval, and hypopnea tidal volume
threshold.
[0304] The patient's transthoracic impedance is measured 905 as
described in more detail above. If the transthoracic impedance
exceeds 910 the inspiration threshold, the beginning of an
inspiration interval is detected 915. If the transthoracic
impedance remains below 910 the inspiration threshold, then the
impedance signal is checked 905 periodically until inspiration 915
occurs.
[0305] During the inspiration interval, the patient's transthoracic
impedance is monitored until a maximum value of the transthoracic
impedance is detected 920. Detection of the maximum value signals
an end of the inspiration period and a beginning of an expiration
period 935.
[0306] The expiration interval is characterized by decreasing
transthoracic impedance. When the transthoracic impedance falls 940
below the expiration threshold, a non-breathing interval is
detected 955.
[0307] If the transthoracic impedance does not exceed 960 the
inspiration threshold within a first predetermined interval 965,
denoted the sleep apnea interval, then a condition of sleep apnea
is detected 970. Severe sleep apnea is detected 980 if the
non-breathing period extends beyond a second predetermined interval
975, denoted the severe sleep apnea interval.
[0308] When the transthoracic impedance exceeds 960 the inspiration
threshold, the tidal volume from the peak-to-peak transthoracic
impedance is calculated, along with a moving average of past tidal
volumes 985. The peak-to-peak transthoracic impedance provides a
value proportional to the tidal volume of the respiration cycle.
This value is compared 990 to a hypopnea tidal volume threshold. If
the peak-to-peak transthoracic impedance is consistent with 990 the
hypopnea tidal volume threshold for a predetermined time 992, then
a hypopnea cycle is detected 995.
[0309] Additional sensors, such as motion sensors and/or posture
sensors, may be used to confirm or verify the detection of a sleep
apnea or hypopnea episode. The additional sensors may be employed
to prevent false or missed detections of sleep apnea/hypopnea due
to posture and/or motion related artifacts.
[0310] Another embodiment of the invention involves classifying
respiration patterns as disordered breathing episodes based on the
breath intervals and/or tidal volumes of one or more respiration
cycles within the respiration patterns. According to this
embodiment, the duration and tidal volumes associated with a
respiration pattern are compared to duration and tidal volume
thresholds. The respiration pattern is detected as a disordered
breathing episode based on the comparison.
[0311] According to principles of the invention, a breath interval
is established for each respiration cycle. A breath interval
represents the interval of time between successive breaths, as
illustrated in FIG. 10. A breath interval 1030 may be defined in a
variety of ways, for example, as the interval of time between
successive maxima 1010, 1020 of the impedance signal waveform.
[0312] Detection of disordered breathing, in accordance with
embodiments of the invention, involves the establishment of a
duration threshold and a tidal volume threshold. If a breath
interval exceeds the duration threshold, an apnea event is
detected. Detection of sleep apnea, in accordance with this
embodiment, is illustrated in the graph of FIG. 10. Apnea
represents a period of non-breathing. A breath interval 1030
exceeding a duration threshold 1040, comprises an apnea
episode.
[0313] Hypopnea may be detected using the duration threshold and
tidal volume threshold. A hypopnea event represents a period of
shallow breathing. Each respiration cycle in a hypopnea event is
characterized by a tidal volume less than the tidal volume
threshold. Further, the hypopnea event involves a period of shallow
breathing greater than the duration threshold.
[0314] A hypopnea detection approach, in accordance with
embodiments of the invention, is illustrated in FIG. 11. Shallow
breathing is detected when the tidal volume of one or more breaths
is below a tidal volume threshold 1110. If the shallow breathing
continues for an interval greater than a duration threshold 1120,
then the breathing pattern represented by the sequence of shallow
respiration cycles, is classified as a hypopnea event.
[0315] FIGS. 12 and 13 provide charts illustrating classification
of individual disordered breathing events and series of
periodically recurring disordered breathing events, respectively.
As illustrated in FIG. 12, individual disordered breathing events
may be grouped into apnea, hypopnea, tachypnea and other disordered
breathing events. Apnea events are characterized by an absence of
breathing. Intervals of reduced respiration are classified as
hypopnea events. Tachypnea events include intervals of rapid
respiration characterized by an elevated respiration rate.
[0316] As illustrated in FIG. 12, apnea and hypopnea events may be
further subdivided as either central events, related to central
nervous system dysfunction, or obstructive events, caused by upper
airway obstruction. A tachypnea event may be further classified as
a hyperpnea event, represented by hyperventilation, i.e., rapid
deep breathing. A tachypnea event may alternatively be classified
as rapid breathing, typically of prolonged duration.
[0317] FIG. 13 illustrates classification of combinations of
periodically recurring disordered breathing events. Periodic
breathing may be classified as obstructive, central or mixed.
Obstructive periodic breathing is characterized by cyclic
respiratory patterns with an obstructive apnea or hypopnea event in
each cycle. Central periodic breathing involves cyclic respiratory
patterns including a central apnea or hypopnea event in each cycle.
Periodic breathing, illustrated in FIG. 14F, may also be of mixed
origin. Mixed origin periodic breathing is characterized by cyclic
respiratory patterns having a mixture of obstructive and central
apnea events in each cycle. Cheyne-Stokes respiration, illustrated
in FIG. 14G, is a particular type of periodic breathing involving a
gradual waxing and waning of tidal volume and having a central
apnea and hyperpnea event in each cycle. Other manifestations of
periodic breathing are also possible. The various forms of
disordered breathing may be determined based on the characteristic
respiration patterns associated with particular types of disordered
breathing.
[0318] As illustrated in FIGS. 14A-E, a respiration pattern
detected as a disordered breathing episode may include only an
apnea respiration cycle 1410 (FIG. 14A), only hypopnea respiration
cycles 1450 (FIG. 14D), or a mixture of hypopnea and apnea
respiration cycles 1420 (FIG. 14B), 1430 (FIG. 14C), 1460 (FIG.
14E). A disordered breathing event 1420 may begin with an apnea
respiration cycle and end with one or more hypopnea cycles. In
another pattern, the disordered breathing event 1430 may begin with
hypopnea cycles and end with an apnea cycle. In yet another
pattern, a disordered breathing event 1460 may begin and end with
hypopnea cycles with an apnea cycle in between the hypopnea
cycles.
[0319] FIG. 15 is a flow graph of a method for detecting disordered
breathing in accordance with embodiments of the invention. The
method illustrated in FIG. 15 operates by classifying breathing
patterns using breath intervals in conjunction with tidal volume
and duration thresholds as previously described above. In this
example, a duration threshold and a tidal volume threshold are
established for determining both apnea and hypopnea breath
intervals. An apnea episode is detected if the breath interval
exceeds the duration threshold. A hypopnea episode is detected if
the tidal volume of successive breaths remains less than the tidal
volume threshold for a period in excess of the duration threshold.
Mixed apnea/hypopnea episodes may also occur. In these cases, the
period of disordered breathing is characterized by shallow breaths
or non-breathing intervals. During the mixed apnea/hypopnea
episodes, the tidal volume of each breath remains less than the
tidal volume threshold for a period exceeding the duration
threshold.
[0320] Transthoracic impedance is sensed and used to determine the
patient's respiration cycles. Each breath 1510 may be characterized
by a breath interval, the interval of time between two impedance
signal maxima, and a tidal volume (TV).
[0321] If a breath interval exceeds 1515 the duration threshold,
then the respiration pattern is consistent with an apnea event, and
an apnea event trigger is turned on 1520. If the tidal volume of
the breath interval exceeds 1525 the tidal volume threshold, then
the breathing pattern is characterized by two respiration cycles of
normal volume separated by a non-breathing interval. This pattern
represents a purely apneic disordered breathing event, and apnea is
detected 1530. Because the final breath of the breath interval was
normal, the apnea event trigger is turned off 1532, signaling the
end of the disordered breathing episode. However, if the tidal
volume of the breath interval does not exceed 1525 the tidal volume
threshold, the disordered breathing period is continuing and the
next breath is checked 1510.
[0322] If the breath interval does not exceed 1515 the duration
threshold, then the tidal volume of the breath is checked 1535. If
the tidal volume does not exceed 1535 the tidal volume threshold,
the breathing pattern is consistent with a hypopnea cycle and a
hypopnea event trigger is set on 1540. If the tidal volume exceeds
the tidal volume threshold, then the breath is normal.
[0323] If a period of disordered breathing is in progress,
detection of a normal breath signals the end of the disordered
breathing. If disordered breathing was previously detected 1545,
and if the disordered breathing event duration has not exceeded
1550 the duration threshold, and the current breath is normal, then
no disordered breathing event is detected 1555. If disordered
breathing was previously detected 1545, and if the disordered
breathing event duration has extended for a period of time
exceeding 1550 the duration threshold, and the current breath is
normal, then the disordered breathing trigger is turned off 1560.
In this situation, the duration of the disordered breathing episode
was of sufficient duration to be classified as a disordered
breathing episode. If an apnea event was previously triggered 1565,
then an apnea event is declared 1570. If a hypopnea was previously
triggered 1565, then a hypopnea event is declared 1575.
Central/Obstructive Disordered Breathing Discrimination
[0324] Aspects of the invention are directed to methods and systems
configured to monitor, diagnose, and/or provide patient therapy
using one or more individual medical procedures involving
discrimination between central and obstructive disordered
breathing. Each of the circles 180 illustrated in FIGS. 1B-1D
represents an individual medical procedure providing a specific
monitoring, diagnosis or therapeutic function or set of functions.
Each individual medical procedure may be implemented as a
stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0325] Other aspects of this invention involving discrimination
between central and obstructive disordered breathing are directed
methods and systems configured to monitor, diagnose, and/or provide
therapy using coordinated medical procedures. Coordinated medical
procedures may involve cooperative operation of two or more of the
individual processes 180. Coordinated medical procedures may also
involve cooperative operation of one or more functions of two or
more of the individual processes 180.
[0326] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0327] Embodiments of the invention involve an individual system
124 (FIG. 1C) for discriminating between central and obstructive
disordered breathing. The central/obstructive disordered breathing
discrimination system 124 may be implemented as a stand alone
system or in combination with other individual medical systems,
such as those described in FIGS. 1B-1D.
[0328] Embodiments of the invention are directed to methods and
systems for classifying the origin of disordered breathing events
and/or discriminating between disordered breathing origin types.
One embodiment of the invention involves a method for classifying
disordered breathing in a patient. The method includes detecting a
disordered breathing event and sensing motion associated with
respiratory effort during he disordered breathing event. The
disordered breathing event is classified based on the sensed
motion. At least one of detecting the disordered breathing event,
sensing the motion associated with respiratory effort, and
classifying the disordered breathing event are performed at least
in part implantably. Implantably performing an operation comprises
performing the operation using a device that is partially or fully
implantable within the patient's body.
[0329] In another embodiment of the invention, a disordered
breathing classification system includes a disordered breathing
detector configured to detect disordered breathing in a patient. A
motion sensor is configured to sense the patient's motion
associated with respiratory effort during the disordered breathing
event. A disordered breathing classification processor is coupled
to the motion sensor and the disordered breathing detector. The
disordered breathing classification processor is configured to
classify the disordered breathing event based on motion associated
with respiratory effort. At least one of the disordered breathing
detector, the motion sensor, and the disordered breathing
classification processor is at least in part implantable.
[0330] Another embodiment of the invention involves a system 185
for providing coordinated patient monitoring, diagnosis and/or
therapy that utilizes discrimination 124 of central and obstructive
disordered breathing. The coordinated system may include, for
example, an implantable cardiac device 181 and a patient-external
respiratory therapy device 184. The system 185 may further include
an external processor 183 providing a coordination function. A
communication channel couples the implantable device 181 and the
respiratory therapy device 184. The implantable 181 and respiratory
therapy devices 184 operate cooperatively via the communication
channel to provide one or more of patient monitoring, diagnosis,
and therapy.
[0331] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy further
includes a system 124 configured to discriminate between central
and obstructive disordered breathing. The disordered breathing
discrimination system 124 includes a disordered breathing detector
configured to detect a disordered breathing event and a motion
sensor configured to sense motion associated with respiratory
effort of a patient during the disordered breathing event. The
disordered breathing detector and the motion sensor are coupled to
a disordered breathing classification processor. The disordered
breathing classification processor is configured to classify the
disordered breathing event based on the respiratory effort motion.
At least one of the disordered breathing detector, the motion
sensor, and the disordered breathing classification processor is at
least in part implantable.
[0332] The implantable and respiratory therapy devices 181, 184 may
operate cooperatively based on discrimination 124 between central
and obstructive disordered breathing. For example, discrimination
124 between central and obstructive disordered breathing may allow
the implantable and respiratory therapy devices 181, 184 to operate
cooperatively to provide a first therapy to treat obstructive
disordered breathing and a second therapy to treat central
disordered breathing. Systems and methods directed to
discrimination of central and obstructive disordered breathing
events may be implemented to include selected features, functions,
and/or structures described in commonly owned, co-pending U.S. Pat.
No. 7,510,531, which is hereby incorporated herein by
reference.
[0333] According to various implementations, disordered breathing
events may be classified based on a patient's motion associated
with respiratory effort during the disordered breathing event. For
example, central apnea may be identified by insufficient
respiration for at least about 10 seconds with insufficient
respiratory effort. Obstructive apnea may be identified by
insufficient respiratory inspiration for at least about 10 seconds
accompanied by respiratory effort. Respiratory effort may be
detected by sensing patient motion associated with respiratory
effort during the disordered breathing event. The sensed motion may
comprise motion of the patient's chest, abdomen, diaphragm, and/or
other motion associated with respiratory effort.
[0334] Disordered breathing episodes may be classified as central
disordered breathing, obstructive disordered breathing, or a
combination of central and obstructive types. Various forms of
disordered breathing that may be classified with respect to origin
(central, obstructive, or mixed origin) may include, for example,
apnea, hypopnea, hyperpnea, tachypnea, periodic breathing,
Cheyne-Stokes respiration (CSR), and/or other forms of disordered
breathing.
[0335] FIG. 16A is a flowchart of a method of classifying a
disordered breathing event in accordance with embodiments of the
invention. The method involves detecting 1601 a disordered
breathing event and sensing 1602 motion associated with respiratory
effort during the disordered breathing event. Disordered breathing
may be detected based on the patient's respiration patterns, or by
other methods. Motion associated with respiratory effort may be
involve chest wall motion, abdominal motion and/or other motions
associated with respiratory effort. The disordered breathing event
may be classified 1603 as central, obstructive, or a mixture of
central and obstructive types based on the patient's movements
associated with respiratory effort during the disordered breathing
event.
[0336] In one scenario, the disordered breathing event may include
both central and obstructive types. The disordered breathing event
may be classified as a mixed central and obstructive disordered
breathing event if central disordered breathing is classified
during one portion of the disordered breathing event and
obstructive disordered breathing is classified during another
portion of the disordered breathing event.
[0337] FIG. 16B is a block diagram of disordered breathing
classification circuitry 1600 for classifying disordered breathing
in accordance with embodiments of the invention. The disordered
breathing classification circuitry 1600 illustrated in FIG. 16B
includes a disordered breathing classification processor 1651 that
receives signals from a disordered breathing event detector 1637
and a motion sensor 1661.
[0338] The disordered breathing event detector 1637 received
signals from at least one sensor 1635, e.g., a respiration sensor,
for detecting a physiological signal indicative of disordered
breathing. The disordered breathing event processor 1637 analyzes
the sensor signals and may determine that a disordered breathing
event is in progress based on the analysis.
[0339] In one implementation, the sensor 1635 generates a signal
modulated by patient respiration. Such a signal may be generated,
for example, by a transthoracic impedance sensor, an airflow meter,
or by other sensing methods. A disordered breathing event may be
detected based on the patient's breath intervals and/or tidal
volume as described more fully herein.
[0340] The motion sensor 1661 may be configured to sense chest wall
motion, abdominal motion, and/or other patient movement indicative
of respiratory effort. The motion sensor 1661 generates a signal
indicative of respiratory effort that is communicated to the
disordered breathing classification processor 1651.
[0341] The sensors 1635, 1661 may comprise any number of
patient-internal and/or patient-external sensors coupled through
leads or wirelessly to other components of the disordered breathing
classification circuitry 1600. In various embodiments, a signal
indicative of the patient's respiration may be acquired using an
implantable or patient-external transthoracic impedance sensor,
blood oxygen sensor, microphone, flow meter, or by other
patient-internal and/or patient-external sensing methods.
[0342] Sensing chest, abdominal, or other motion associated with
respiratory effort may be accomplished using a patient-internal or
patient-external sensing device. In one example, patient motion
associated with respiratory effort may be sensed using an implanted
or patient-external accelerometer. The accelerometer may be
incorporated as a component of an implanted medical device, such as
an implantable cardiac rhythm management system having
functionality for delivering cardiac electrical therapy for
disordered breathing.
[0343] In another example, motion associated with respiratory
effort may be detected based on changes in an electromyogram (EMG)
sensor signal. An EMG sensor may be positioned internally or
externally to detect electrical activity of a patient's
intercostal, pectoral and/or diaphragmatic muscles indicative of
motion. In yet another example, motion associated with respiratory
effort may be detected using a transthoracic impedance sensor. The
patient's transthoracic impedance is modulated as the chest wall
and/or abdomen moves during inspiratory attempts. Transthoracic
impedance may be sensed using intracardiac electrodes, subcutaneous
electrodes, or patient-external electrodes positioned at
appropriate locations in, on, or about the patient's thorax.
[0344] A disordered breathing event may be classified as a central,
obstructive or mixed type based on the based on the patient's
respiratory efforts during disordered breathing episodes. The
disordered breathing classification processor 1651 may discriminate
between central and obstructive disordered breathing events using
signals received from the motion sensor 1661 and the disordered
breathing detector 1641. If patient motion associated with
respiratory effort is of sufficient magnitude during disordered
breathing, then the disordered breathing classification processor
1651 may determine that the disordered breathing event is
obstructive in origin. If respiratory effort motion is insufficient
during the disordered breathing event, then the disordered
breathing classification processor 1651 may classify the disordered
breathing event as central in origin. If the respiratory effort
motion is sufficient during one portion of the disordered breathing
episode, but is insufficient during another portion, then the
disordered breathing classification processor 1651 may classify the
episode as a mixture of central and obstructive types.
[0345] In one configuration, the disordered breathing
classification circuitry 1600 may be fully patient-external. In
another configuration, some functions of the disordered breathing
classification circuitry may be implemented in an implantable
device and other functions may be implemented as a patient external
device. The implantable and the patient-external disordered
breathing classification system components may be coupled through
leads or a wireless communications link, such as through a Blue
Tooth or a proprietary wireless communication link.
[0346] In yet another configuration, the disordered breathing
classification circuitry 1600 may be fully implantable. Disordered
breathing classification circuitry 1600 may be incorporated, for
example, as a component of a cardiac device such as a pacemaker,
defibrillator, cardiac resynchronizer, implantable cardiac monitor,
or other implantable medical device.
[0347] Classification of the disordered breathing event in
accordance with the processes of the invention involves evaluating
chest wall motion or other motion associated with respiratory
effort. FIGS. 16C and 16D provide graphs of accelerometer signals
representing chest wall motion for central and obstructive
disordered breathing, respectively. As illustrated in FIG. 16C,
apnea is detected when the transthoracic impedance signal 1671
remains below an inspiration threshold 1672 for a period of time
greater than an apnea interval 1673, e.g., 10 seconds. In this
example, the apnea event is a central apnea event and the signal
1674 from an accelerometer sensing the patient's chest wall motion
also falls below a motion threshold 1675 during the period of
non-respiration. The lack of chest wall motion indicates that the
patient's breathing reflex is not being triggered by the central
nervous system, indicative of a central disordered breathing
event.
[0348] FIG. 16D illustrates the accelerometer signal and
transthoracic impedance signal for an obstructive apnea event.
Apnea is detected when the transthoracic impedance signal 1676
remains below an inspiration threshold 1677 for a period of time
greater than an apnea interval 1673. In this example, the apnea
event is an obstructive apnea event and the signal 1678 from an
accelerometer sensing the patient's chest wall motion rises above a
chest well motion threshold 1679 during the period of
non-respiration. The chest wall motion indicates that the patient's
breathing reflex is being triggered by the central nervous system,
indicative of an obstructive disordered breathing event.
[0349] FIG. 16E is a flowchart of a method for classifying
disordered breathing events as central, obstructive or mixed events
in accordance with embodiments of the invention. One or more
conditions associated with disordered breathing are sensed 1680.
For example, one or more of the conditions listed in Table 1 may be
sensed to detect that a disordered breathing event is occurring.
The patient's chest wall motion is sensed 1681 during the
disordered breathing event.
[0350] If disordered breathing is detected 1682, then the chest
wall motion signals are analyzed 1683 for obstructive/central
origin discrimination. A parameter, e.g., average amplitude or
frequency, of the signal produced by the motion sensor may be
compared to a threshold. If the chest wall motion signal is not
greater 1684 than a threshold, then the disordered breathing is
classified 1686 as central disordered breathing. If the chest wall
motion signal is greater than or equal to the threshold 1684 and
the chest wall motion is associated with respiratory effort 1685,
then the disordered breathing is classified 1687 as obstructive
disordered breathing. For example, if chest wall motion from the
accelerometer is synchronous with a reduced transthoracic impedance
during a disordered breathing episode, then the concurrence of
disordered breathing and chest wall motion indicates disordered
breathing that is obstructive in origin.
[0351] If the disordered breathing event continues 1688, then chest
wall motion continues to be sensed 1683. A second or subsequent
portion of the disordered breathing event may have a different
classification from the initial classification based on the
presence or lack of motion associated with respiratory effort.
[0352] The flowchart of FIG. 16F follows from FIG. 16E and
illustrates optional processes that may be implemented following
classification of the disordered breathing event. Disordered
breathing information may optionally be stored, transmitted,
displayed, and/or printed 1690. For example, disordered breathing
information may be stored over several weeks or months to enhance
diagnosis of disordered breathing or other conditions, or to
analyze disordered breathing trends and/or therapy
effectiveness.
[0353] Additionally, or alternatively, classification of the origin
of disordered breathing events may be used in connection with
providing 1691 a therapy to treat the disordered breathing. Therapy
for treating disordered breathing may involve cardiac electrical
therapy, among other therapies. In one scenario, a first therapy
regimen may be used to treat disordered breathing that is central
in origin. A second therapy regimen may be used to treat disordered
breathing that is obstructive in origin. The first and/or the
second therapies may be initiated after the origin of the
disordered breathing is determined.
[0354] Further, therapies other than disordered breathing therapy
may be initiated, modified, or terminated 1692 based on the
classification of disordered breathing. For example, as previously
discussed, disordered breathing in the form of Cheyne-Stokes
respiration is related to congestive heart failure and may be used
to monitor the progression of CHF. As previously discussed,
Cheyne-Stokes respiration is marked by periodic patterns of waxing
and waning respiration interrupted by periods of central apnea.
Characteristics of the disordered breathing experienced by the
patient, e.g., origin, duration, and severity, may be used to
initiate or adjust therapy, such as cardiac pacing therapy and/or
cardiac resynchronization therapy, delivered to the patient.
[0355] In various embodiments of the invention described herein,
discrimination between central and obstructive disordered breathing
is based on sensing chest wall motion using an implanted motion
sensor, e.g., an accelerometer. In other embodiments, a
patient-external motion detector, such as a patient-external
accelerometer, patient-external respiratory bands, transthoracic
impedance sensor, or a mercury switch, may be used alone or in
combination with other implanted or patient-external respiratory
sensors and detection algorithms for central/obstructive disordered
breathing classification.
[0356] In one example, a movement sensor, such as an accelerometer,
is mounted inside an implantable CRM device to sense chest wall
motions that are indicative of obstructive apnea. The output of the
movement sensor may be used in combination with other sensors (such
as trans-thoracic impedance) for classification of obstructive
apnea. Multi-sensor pulse generators are products in a unique
position to provide accurate long-term monitoring and prediction of
the progression of disease in patients with disordered breathing.
Discrimination between types of apnea events allows more accurate
diagnosis, monitoring, and/or treatment of abnormal respiration
patterns associated with CHF or sleep disordered breathing.
Monitoring with discrimination between types of apnea may enable
therapy improvements to counteract the effects of abnormal
respiratory patterns.
Disordered Breathing Prediction
[0357] Aspects of the invention that include prediction of
disordered breathing are directed to methods and systems configured
to monitor, diagnose, and/or provide patient therapy using one or
more individual medical procedures. Each of the circles 180
illustrated in FIGS. 1B-1D represents an individual medical
procedure providing a specific monitoring, diagnosis or therapeutic
function or set of functions. Each individual medical procedure may
be implemented as a stand-alone system. Two or more of the
individual medical procedures 180 may be used in combination to
provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy including prediction of
disordered breathing.
[0358] Other aspects of the invention are directed to methods and
systems configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures including disordered breathing
prediction. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0359] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0360] Embodiments of the invention involve an individual system 88
(FIG. 1D) for predicting disordered breathing. The disordered
breathing prediction system 88 may be implemented as a stand alone
system or in combination with other individual medical systems,
such as those described in FIGS. 1B-1D.
[0361] An embodiment of the invention involves an automated method
of predicting disordered breathing in a patient. One or more
conditions associated with disordered breathing are detected and
compared to one or more sets of disordered breathing prediction
criteria. Disordered breathing is predicted based on the
comparison. At least one of comparing the conditions to the
disordered breathing prediction criteria and predicting the
disordered breathing is performed at least in part implantably.
[0362] In others embodiment of the invention, a method for
predicting disordered breathing involves detecting one or more
conditions predisposing a patient to disordered breathing. The
predisposing conditions are compared to one or more sets of
disordered breathing prediction criteria. Disordered breathing is
predicted based on the comparison. At least one of comparing the
predisposing conditions to the one or more sets of disordered
breathing prediction criteria and predicting the disordered
breathing is performed at least in part implantably.
[0363] Yet another embodiment of the invention involves detecting
one or more precursor conditions associated with disordered
breathing. The precursor conditions are compared to one or more
sets of disordered breathing prediction criteria. Disordered
breathing is predicted based on the comparison. At least one of
comparing the precursor conditions to the one or more sets of
disordered breathing prediction criteria and predicting the
disordered breathing is performed at least in part implantably.
[0364] In a further embodiment of the invention, a medical device
includes a detector system and a prediction engine. The detector
system is configured to detect one or more conditions associated
with disordered breathing. The prediction engine is coupled to the
detector system and is configured to compare the one or more
detected conditions to one or more sets of disordered breathing
prediction criteria and to predict disordered breathing based on
the comparison. The prediction engine includes at least one
implantable component.
[0365] Another embodiment of the invention involves an automated
disordered breathing prediction system. The system includes means
for detecting one or more conditions associated with disordered
breathing, means for comparing the detected one or more conditions
to one or more sets of disordered breathing prediction criteria and
means for predicting disordered breathing based on the comparison.
At least one of the means for comparing and the means for
predicting includes an implantable component.
[0366] In yet another embodiment of the invention, an automated
system for predicting disordered breathing includes means for
detecting conditions predisposing the patient to disordered
breathing. The system further includes means for comparing the
predisposing conditions to one or more sets of disordered breathing
prediction criteria and means for predicting disordered breathing
based on the comparison. At least one of the means for comparing
the predisposing conditions to the one or more sets of prediction
criteria, and the means for predicting disordered breathing
includes an implantable component.
[0367] In yet a further embodiment of the invention, an automated
system for predicting disordered breathing includes means for
detecting precursor conditions associated with disordered
breathing. The system further includes means for comparing the
precursor conditions to one or more sets of disordered breathing
prediction criteria and means for predicting disordered breathing
based on the comparison. At least one of the means for comparing
the precursor conditions to the one or more sets of disordered
breathing prediction criteria and means for predicting disordered
breathing includes an implantable component.
[0368] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes prediction 88 of disordered breathing. The
coordinated system may include, for example, an implantable cardiac
device 181 and a patient-external respiratory therapy device 184.
The system may further include an external processor 183 providing
a coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 184 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[0369] According to one embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy further
includes a system 88 configured to predict disordered breathing.
The disordered breathing prediction system 88 includes a detector
system configured to detect conditions associated with disordered
breathing and a prediction engine coupled to the detector system.
The prediction engine is configured to compare the detected
conditions to one or more sets of prediction criteria and predict
the disordered breathing based on the comparison. The prediction
engine includes at least one implantable component.
[0370] The implantable and respiratory therapy devices 181, 184 may
operate cooperatively based on the predication 88 of disordered
breathing. For example, implantable and respiratory therapy devices
181, 184 to operate cooperatively to provide monitoring and/or
diagnosis based on the prediction of disordered breathing. In
another example, the implantable and respiratory therapy devices
181, 184 may provide a coordinated therapy to treat the predicted
disordered breathing. Systems and methods directed to prediction of
disordered breathing may be implemented to include selected
features, functions, and/or structures described in commonly owned,
co-pending U.S. Pat. No. 7,396,333, which is hereby incorporated
herein by reference. Systems and methods directed to therapy
triggered by prediction of disordered breathing may be implemented
to include selected features, functions, and/or structures
described in commonly owned, co-pending U.S. Pat. No. 7,680,537,
which is hereby incorporated herein by reference.
[0371] The flowchart of FIG. 16G illustrates a method for
triggering disordered breathing therapy based on a prediction of
disordered breathing according to various embodiments of the
invention. The method involves sensing 1630 one or more conditions
predictive of disordered breathing and predicting disordered
breathing 1640 based on the sensed conditions. Disordered breathing
may be predicted, for example, by comparing the detected conditions
to disordered breathing prediction criteria. A representative set
of conditions that may be used to predict disordered breathing are
listed in Table 1. The representative set of conditions listed in
Table 1 is not exhaustive, and conditions other than those listed
may be used to predict disordered breathing. If disordered
breathing is predicted, therapy is adapted 1650 to treat the
disordered breathing, e.g., reduce the severity of the disordered
breathing or prevent the disordered breathing from occurring. The
adapted therapy is delivered 1660 to the patient. One or more of
sensing the conditions affecting the patient, predicting the
disordered breathing based on the sensed conditions and delivering
the therapy to treat the disordered breathing is performed as least
in part implantably.
[0372] FIG. 17 illustrates a block diagram of a disordered
breathing therapy system configured in accordance with embodiments
of the invention and including disordered breathing prediction
functionality. The system may use patient-internal sensors 1710,
implanted within the body of the patient, to detect physiological
conditions. For example, the system may determine heart rate, heart
rate variability, respiration cycles, tidal volume, and/or other
physiological signals using an intracardiac electrocardiogram (EGM)
signal detector and transthoracic impedance sensor that are part of
an implanted cardiac rhythm management system such as a cardiac
pacemaker or defibrillator.
[0373] The system may use patient-external sensors 1720 to detect
physiological or non-physiological conditions. In one scenario,
whether the patient is snoring may be useful in predicting
disordered breathing. Snoring may be detected using an external
microphone or an implanted accelerometer, for example. In another
situation, temperature and humidity may be factors that exacerbate
the patient's disordered breathing. Signals from temperature and
humidity sensors may be used to aid in the prediction of disordered
breathing.
[0374] Additionally, the system may use information input 1730 by
the patient to inform the disordered breathing prediction system of
one or more patient conditions. In various embodiments, the
patient's medical history, self-described medication use, alcohol
or tobacco use, day-time sleepiness, or perceptions of sleep
quality over the past one or more sleep periods may be useful in
connection with the disordered breathing prediction.
[0375] Signals from one or more of the patient-internal sensors
1710, patient-external sensors 1720, and patient input devices 1730
may be coupled to a disordered breathing prediction engine 1740 for
prediction evaluation. In one implementation, the prediction engine
1740 may compare the patient conditions to one or more sets of
disordered breathing criteria and predict disordered breathing
based on the comparison. The prediction engine 1740 is coupled to a
therapy controller 1750. If disordered breathing is predicted, the
therapy controller 1750 delivers an appropriate therapy to the
patient to mitigate the disordered breathing.
[0376] In one example, the patient conditions may be sensed and
processed using implantable sensors 1710, and the prediction
analysis and therapy delivery may be performed by a
patient-external disordered breathing prediction engine 1740 and a
patient-external therapy controller 1750. Some or all of the
implantable sensors 1710 may have remote communication
capabilities, such as a wireless proprietary or a wireless
Bluetooth communications link. In this implementation, the wireless
communications link couples the implantable sensor or sensors 1710
to the patient-external disordered breathing prediction engine
1740. Electrical signals representing patient conditions are
produced by the implantable sensors 1710 and transmitted to the
patient-external disordered breathing prediction engine 1740.
[0377] In another example, an implantable therapy device may
incorporate a disordered breathing prediction engine 1740 and one
or more patient-external sensors 1720. Signals representing the
patient conditions may be transmitted from the patient-external
sensors to the implanted prediction engine 1740 over a wireless
communication link.
[0378] In a further example, the prediction engine may be a
patient-external device coupled wirelessly to the therapy
controller. Various combinations of wireless or wired connections
between the patient-internal sensors 1710, patient-external sensors
1720, patient input devices 1730, the prediction engine 1740, and
the therapy controller 1750 are possible.
[0379] The above examples provide a few of the many possible
configurations that may be used to provide disordered breathing
therapy based on the prediction of disordered breathing in
accordance with various embodiments of the invention. It is
understood that the components and functionality depicted in the
figures and described herein can be implemented in hardware,
software, or a combination of hardware and software. It is further
understood that the components and functionality depicted as
separate or discrete blocks/elements in the figures can be
implemented in combination with other components and functionality,
and that the depiction of such components and functionality in
individual or integral form is for purposes of clarity of
explanation, and not of limitation.
[0380] One subset of the detected patient conditions, such as the
representative conditions listed in Table 1, may represent
conditions that predispose the patient to disordered breathing.
Predisposing conditions may be statistically associated with an
onset of disordered breathing during the next few hours following
the detection of the conditions leading to the disordered breathing
prediction. Another subset of conditions may represent precursor
conditions used to predict an imminent onset of disordered
breathing that may occur within a time window measured in terms of
a few minutes or seconds. Detection of patient conditions
associated with disordered breathing and prediction of disordered
breathing based on predisposing or precursor conditions is
performed on real-time basis.
[0381] A subset of patient conditions may be used to verify or
otherwise inform the disordered breathing prediction. In one
example, information regarding sleep onset or sleep stage or state,
e.g., REM or non-REM sleep, may be employed in prediction of sleep
disordered breathing. A subset of the conditions listed in Table 1
may be used to detect whether the patient is asleep and to track
the various stages of sleep. Another subset of the conditions may
be employed to detect disordered breathing episodes, to classify
disordered breathing episodes. Table 4 below provides examples of
how some conditions listed in Table 1 may be used in disordered
breathing prediction.
TABLE-US-00004 TABLE 4 Examples of how condition is used in
Condition disordered breathing prediction Heart rate Decrease in
heart rate may indicate disordered breathing episode. Decrease in
heart rate may indicate the patient is asleep. Heart rate
variability May be used to determine sleep state and reduction in
heart rate variability is a chronic factor associated with
disordered breathing. Ventricular filling May be used to
identify/predict pulmonary congestion pressure associated with
respiratory disturbance. Blood pressure Swings in on-line blood
pressure measures are associated with apnea. Snoring Snoring is
associated with a higher incidence of obstructive sleep apnea and
may be used to detect disordered breathing. Respiration Respiration
patterns may be used to detect disordered signals/respiration
breathing episodes. patterns Respiration patterns may be used to
determine the type of disordered breathing. Respiration patterns
may be used to detect that the patient is asleep. Hyperventilation
may be used to predict disordered breathing. Previous episodes of
disordered breathing may be used to predict further episodes. One
form of disordered breathing may be used to predict another form of
disordered breathing Patency of upper airway Patency of upper
airway is related to obstructive sleep apnea and may be used to
detect episodes of obstructive sleep apnea. Pulmonary congestion
Pulmonary congestion is associated with respiratory disturbances.
Sympathetic nerve End of apnea associated with a spike in SNA
activity CO2 saturation Low CO2 levels initiate central apnea. O2
saturation O2 desaturation occurs during severe apnea/hypopnea
episodes. Blood alcohol content Alcohol tends to increase incidence
of snoring & obstructive apnea. Adrenalin End of apnea
associated with a spike in blood adrenaline. Brain Natriuretic
Peptide A marker of heart failure status, which is associated with
(BNP) Cheyne-Stokes Respiration C-Reactive Protein A measure of
inflammation that may be related to apnea. Drug/Medication/Tobacco
These substances may affect the likelihood of both central use
& obstructive apnea. Muscle atonia Muscle atonia may be used to
detect REM and non-REM sleep. Eye movement Eye movement may be used
to detect REM and non-REM sleep. Temperature Ambient temperature
may be a condition predisposing the patient to episodes of
disordered breathing. Humidity Humidity may be a condition
predisposing the patient to episodes of disordered breathing.
Pollution Pollution may be a condition predisposing the patient to
episodes of disordered breathing. Posture Posture may be used to
determine if the patient is asleep and may predispose the patient
to disordered breathing. Posture may be a condition predisposing
the patient to episodes of disordered breathing. Activity Patient
activity may be used in relation to sleep detection. Sleep stage
NREM sleep may be associated with a higher probability of DB
Location Patient location may used to determine if the patient is
in bed as a part of sleep detection.
[0382] FIG. 18 conceptually illustrates how patient conditions such
as those listed in Table 1 and/or 4 may be used in predicting
disordered breathing 1810 according to embodiments of the
invention. In one embodiment, the system tracks one or more of the
conditions listed in Table 1, Table 4, or both, to predict
disordered breathing. For example, over the course of a period of
time, e.g., at least a 16 hour window preceding and including the
patient's historical sleep time, the system may track one or more
conditions to determine the presence and/or level of each
particular condition.
[0383] In one implementation, the system tracks conditions that
have been determined to predispose 1820 the patient to an attack of
disordered breathing. Predisposing conditions represent patient
conditions statistically associated with an onset of disordered
breathing. The presence of one or more predisposing conditions may
indicate that disordered breathing is likely to occur within the
next time period, such as an eight hour period following the
disordered breathing prediction, or during the current sleep
period. For example, the predisposing conditions may include the
air pollution index of the patient's environment downloaded from an
air quality website, recent tobacco use reported by the patient,
the degree of the patient's pulmonary congestion detected by an
implanted transthoracic impedance sensor, as well as other
predisposing conditions detected patient-internally and/or
patient-externally.
[0384] Additionally, or alternatively, the system may use previous
episodes of disordered breathing to determine that the patient is
predisposed to further episodes of disordered breathing within
particular time period, such as during a sleep period. For example,
previous episodes of disordered breathing during a first interval
within the sleep period may be an indication that additional
episodes are likely to occur in a second and subsequent interval
within the same sleep period. In one example, the occurrence of a
first type of disordered breathing may be used to predict a second
type of disordered breathing. In another example, the periodicity
of disordered breathing may be used to predict future episodes of
disordered breathing.
[0385] The disordered breathing prediction engine may use the type,
duration, frequency, and/or severity of the previous disordered
breathing episodes to inform the disordered breathing prediction
analysis. Quantification of the severity, frequency, and duration
of disordered breathing may be accomplished using any of a number
of disturbed breathing measures, including, for example, percent
time in disordered breathing and the apnea/hypopnea index.
[0386] A further example of a condition predisposing a patient to
hypopnea or apnea is body posture. A supine posture is more likely
to result in obstruction of the upper airway and can be used to
predict episodes of obstructive hypopnea and apnea. Posture and/or
torso orientation sensing may be accomplished, for example, using
an implantable multiaxis accelerometer.
[0387] As previously discussed, sleep disordered breathing is a
prevalent form of disordered breathing. Thus, a patient may be more
likely to experience episodes of disordered breathing when the
patient is in bed sleeping. Thus, proximity to bed may be employed
as a predisposing condition to disordered breathing. The disordered
breathing therapy system may use a bed proximity sensor to detect
that the patient is in bed. Bed proximity may be detected by
placing a beacon transmitter on the patient's bed. Receiver
circuitry on or in the patient, for example, incorporated in the
patient's pacemaker, receives the beacon signal and determines that
the patient is in bed.
[0388] Conditions that predispose the patient to disordered
breathing 1820 are conditions that indicate the likelihood that one
or more episodes of disordered breathing will occur during the next
time period, such as over the course of the night or other sleep
period. Based on predisposing conditions 1820, an onset of
disordered breathing may be predicted 1812 to occur within a time
window that may include several hours, for example, eight
hours.
[0389] A second set of conditions, denoted herein as precursor
conditions 1830, may be used to predict 1814 an impending onset of
disordered breathing. Precursor conditions 1830 indicate that an
episode of disordered breathing is imminent and will occur within a
time window that may be measured in terms of minutes or seconds,
for example. In one implementation, precursor conditions 1830 may
be used to predict that an episode of disordered breathing will
occur within the next 1800 seconds, for example.
[0390] In one embodiment, precursor conditions 1830 indicative of
an impending onset of disordered breathing may include, for
example, pre-apnea or pre-hypopnea conditions. In one
implementation, changes in blood gas concentration, such as
CO.sub.2, may be causal to central apnea. Therefore, a precursor
condition of pre-apnea in a particular patient may be detected when
the patient's CO.sub.2 level, as measured, for example, by a
patient-external CO.sub.2 sensor, falls below a selected level,
indicating an impending onset of an apnea episode.
[0391] In another embodiment, a patient's heart rate variability
may be significantly altered before, during, and after episodes of
apnea. Heart rate variability may be used, for example, as a
precursor condition to predict an impending episode of disordered
breathing.
[0392] In yet another embodiment, a pre-apnea or pre-hypopnea
condition may be detected by analyzing the patient's respiration
patterns. Respiration cycles just prior to disordered breathing
event, e.g., an apnea or hypopnea event, may exhibit a
characteristic pattern. For example, an apnea event for many
patients is preceded by a period of hyperventilation with a number
of rapid, deep breaths. The pattern of hyperventilation may be
detected by analyzing patient's transthoracic impedance signal to
determine respiration rate and tidal volume.
[0393] Cheyne-Stokes respiration and some apnea/hypopnea episodes
may exhibit a crescendo--decrescendo respiration pattern. The
crescendo--decrescendo respiration pattern produces
hyperventilation during the crescendo stage and hypoventilation
during the decrescendo phase. Hyperventilation, secondary to
pulmonary congestion, drives arterial partial pressure of carbon
dioxide down. A decrease in arterial partial pressure of carbon
dioxide below an apnea level may be a causal mechanism for central
apnea. According to one embodiment of the invention, detection of
an impending onset of disordered breathing may be implemented by
detecting a series of increasing tidal volumes followed by a series
of decreasing tidal volumes.
[0394] For some patients, disordered breathing occurs at regular
intervals, allowing the periodicity of the disordered breathing
episodes to be used as a precursor condition. If disordered
breathing episodes of the patient occur at regular intervals, the
next episode of disordered breathing may be predicted based on the
time elapsed since the last episode was detected.
[0395] In addition, the occurrence of one form of disordered
breathing may be used to predict another form of disordered
breathing. For example, a patient may characteristically experience
one or more episodes of obstructive sleep apnea during the first
part of the night followed by central sleep apnea episodes during
the later part of the night. In another example, one or more
episodes of hypopnea may be used to predict future apnea
episodes.
[0396] Snoring is an additional example of a pre-apnea or
pre-hypopnea condition. In many, patient snoring, or more generally
any abnormal airflow in the upper airway, which may be detectable
via acoustic means, precedes more significant sleep disordered
breathing conditions such as hypopnea or apnea. Precursor
conditions 1830 may be analyzed individually, or in combination
with one or more predisposing conditions 1820, to predict the
impending onset of a disordered breathing episode.
[0397] The conditions and associated prediction criteria used for
disordered breathing prediction may be highly patient specific.
Conditions that are reliably predictors of disordered breathing in
one patient may not be effective for another patient. Therefore,
conditions used to predict disordered breathing and the respective
prediction criteria are preferably based on patient-specific
data.
[0398] A subset of patient conditions may be used to verify or
confirm a prediction of disordered breathing. For example, before
or after a prediction of disordered breathing is made, one or more
verification conditions 1840 may be checked to confirm the
prediction. The verification conditions, as well as the
physiological and contextual conditions used to predict disordered
breathing, may be highly patient specific.
[0399] In one example embodiment, a characteristic pattern of
respiration is a reliable predictor of disordered breathing in a
particular patient only when the patient is supine. If the
prediction is made while the patient not supine, normal variations
in respiration cycles in this particular patient may lead to an
erroneous prediction of disordered breathing. Thus, before
disordered breathing is predicted, a posture sensor signal is
checked to verify that the patient is supine. If the patient is
supine and the patient's respiration cycles are consistent with
criteria indicating that disordered breathing is likely, the
disordered breathing prediction is made.
[0400] In another example, the patient is known to suffer from
episodes of apnea during sleep. The patient's sleep apnea may be
predicted using a number of contextual and physiological
conditions. The prediction of sleep apnea may be made after
assessing that the patient's posture and location are consistent
with sleep. Before a prediction of sleep apnea is made, the system
confirms that the patient is lying down in bed by checking the
signal from an implantable posture sensor and a bed proximity
sensor.
[0401] The operation of a disordered breathing prediction engine
1900, according various to embodiments, is conceptually illustrated
in the block diagram of FIG. 19. Periodically, one or more patient
conditions are detected and compared to a library 1910 of
prediction criteria. The prediction criteria library 1910 may
incorporate one or more sets of prediction criteria 1911, 1912,
1913, 1914. Each of these sets of criteria may be compared to the
detected patient conditions. If the criteria of a prediction
criteria set 1911, 1912, 1913, 1914 are substantially consistent
with the patient conditions, a preliminary disordered breathing
prediction may be made.
[0402] In various embodiments, the prediction criteria sets 1911,
1912, 1913, 1914 represent one or more condition thresholds
associated with an onset of disordered breathing. In one example
embodiment, the level of one or more detected conditions may be
compared to the prediction criteria sets 1911, 1912 1913, 1914. If
the levels of the one or more conditions are substantially
consistent with the thresholds specified in a prediction criteria
set 1911, 1912, 1913, 1914, a preliminary prediction of disordered
breathing may be made.
[0403] The examples that follow are described in terms of a
condition being consistent with a prediction criteria when the
condition exceeds a prediction criteria threshold. However, it will
be understood that different threshold requirements may be defined
for different conditions. For example, one condition may be defined
to be consistent with a prediction criterion when the condition
exceeds a prediction criterion threshold. Another condition may be
defined to be consistent with a prediction criterion threshold when
the condition falls below the threshold. In yet another example, a
condition may be defined to be consistent with the prediction
criterion when the condition falls within a specified range of
values. Patient conditions may be compared to prediction criteria
based on the timing, rate of change, or maximum or minimum value of
the condition, for example.
[0404] In the example provided in FIG. 19, the prediction criteria
N 1914 involves two contextual conditions, C1 and C2, and two
physiological conditions, P1 and P2. In this particular example, if
conditions C1, C2, P1, and P2 exceed levels Level1, Level2, Level3,
and Level4, respectively, the patient may be likely to experience
disordered breathing during the night. Therefore, when conditions
C1, C2, and P1, P2 reach the levels specified in criteria N 1914,
preliminary prediction of disordered breathing is made. One or more
additional verification criteria 1920 may be used to confirm the
preliminary predication of disordered breathing.
[0405] In another embodiment of the invention, the relationships
between the detected conditions are analyzed to predict disordered
breathing. In this embodiment, the disordered breathing prediction
may be based on the existence and relative values associated with
two or more patient conditions. For example, if condition A is
present at a level of x, then condition B must also be present at a
level of f(x) before a disordered breathing prediction is made.
[0406] In yet another embodiment of the invention, the estimated
probability, P(C.sub.n), that disordered breathing will occur if a
particular condition level is detected may be expressed as a
function of the ratio of the number of times disordered breathing
occurred within a selected time interval following the detection of
the particular condition level to the total number of observed
occurrences of the condition level. The probability that disordered
breathing will occur, P(C.sub.n), is compared to a threshold
probability level to make the disordered breathing prediction.
Other methods of calculating the estimated probability are also
possible.
[0407] The prediction of disordered breathing may be based on the
convergence or divergence of a number of conditions occurring
within the same time period. In this situation, a composite
probability score may be computed as a combination of the
individual probabilities. In one embodiment, the probabilities are
combined by adding the condition probabilities after multiplying
each of the condition probabilities by a weighting factor. For
example, if the disordered breathing prediction is based on four
substantially simultaneous conditions, C.sub.1, C.sub.2, C.sub.3,
and C.sub.4, the total probability score PS.sub.T may be calculated
as:
PS.sub.T=A.times.P(C.sub.1)+B.times.P(C.sub.2)+C.times.P(C.sub.3)+D.time-
s.P(C.sub.4), [1]
[0408] where A, B, C, and D are scalar weighting factors that may
be used to estimate the relative importance of each of the
conditions C.sub.1, C.sub.2, C.sub.3, and C.sub.4. If the
probability score exceeds a selected prediction criteria threshold,
then disordered breathing is predicted.
[0409] Although the above process describes combining the estimated
probabilities for each condition by adding each of the estimated
probabilities, other methods are also possible. For example, a
detected patient condition may operate against a prediction of
disordered breathing. In this situation, the estimated probability,
P.sub.n(C.sub.n), that disordered breathing will not occur if a
particular condition level is detected may be expressed as a
function of the ratio of the number of times disordered breathing
did not occur within a selected time interval following the
detection of the particular condition level to the total number of
observed occurrences of the condition level. This value may be
subtracted from the total to determine the probability score.
Non-linear methods of combining the estimated probabilities to
arrive at a composite probability are also possible.
[0410] If the conditions affecting the patient are consistent with
a prediction of disordered breathing, the prediction may be
verified by comparing one or more verification conditions to
verification criteria. If the verification conditions are
consistent with the verification criteria, a prediction of
disordered breathing is made.
[0411] In the embodiments described above, predictions of
disordered breathing are based upon comparisons of one or more
patient conditions to sets of prediction criteria. The initial data
from which the initial prediction criteria sets are formed may be
derived from past observations taken from population data, or from
data collected from a particular patient. The initial prediction
criteria sets may then be modified as additional data are collected
from the patient.
[0412] In one embodiment, an estimated accuracy for the prediction
criteria is updated for every prediction event. The estimated
positive predictive value (PPV) for a prediction criteria set N may
be expressed as:
PPV N = TP TP + FP [ 2 ] ##EQU00001##
[0413] where TP (true positive) is the number of times the
prediction criteria set successfully predicted disordered
breathing, and FP (false positive) is the number of times the
prediction criteria erroneously predicted disordered breathing.
[0414] If the estimated accuracy of prediction criteria set N,
PPV.sub.N, falls below a predetermined level, for example, 0.7, the
prediction criteria set N may be modified. In one embodiment, a
possible prediction criteria set is formed, for example, by
modifying the threshold level of one or more of the conditions
represented by the original prediction criteria set N. In one
embodiment, each threshold in the original prediction criteria set
N is modified by an incremental value, to make the prediction
criteria set more accurate.
[0415] In another embodiment, conditions represented in the
original prediction criteria set N are compared to the conditions
that are present just prior to a disordered breathing occurrence to
determine how the modification for the possible prediction criteria
set should be implemented. For example, if the level of a
particular condition just prior to the occurrence shows a
relatively large variation just prior to the disordered breathing
episode, but the levels of other conditions remain constant, then
only the changing level may be modified in the possible prediction
criteria set.
[0416] Each time the possible prediction criteria set is satisfied,
no prediction of disordered breathing is made, however, the
accuracy of the possible prediction criteria set is updated, for
example, using an equation similar in form to Equation 2. If the
accuracy of the possible prediction criteria set reaches a selected
level, for example, 0.7, and the accuracy original prediction
criteria set N remains below 0.7, the possible prediction criteria
set may replace the original prediction criteria set N in the
prediction criteria library.
[0417] According to various embodiments, new prediction criteria
sets may be added to the prediction criteria library. In accordance
with these embodiments, if a disordered breathing episode occurs
without prediction, the levels of the detected patient conditions
prior to the disordered breathing episode are saved as a possible
prediction criteria set. Each time the possible prediction criteria
set is satisfied, no prediction of disordered breathing is made,
however, the accuracy of the possible prediction criteria set is
updated, for example, using an equation similar in form to Equation
2. If the accuracy of the possible prediction criteria set reaches
a selected level, for example, 0.7, the possible prediction
criteria set may be added to the prediction criteria library.
[0418] The system may also be adjusted to provide increasingly
sensitive disordered breathing prediction criteria sets, according
to various embodiments. The estimated sensitivity for a prediction
criteria set N may be expressed as:
Sensitivity N = TP TP + FN [ 3 ] ##EQU00002##
[0419] where TP (true positive) is the number of times the
prediction criteria successfully predicted disordered breathing,
and FN (false negative) is the number of times the prediction
criteria erroneously predicted that disordered breathing would not
occur.
[0420] In one embodiment, if the prediction criteria accuracy for
the prediction criteria set N becomes larger than a selected
number, for example, 0.9, then the threshold levels of one or more
of the conditions represented in the prediction criteria set N may
be adjusted to provide enhanced sensitivity.
[0421] In one example, the threshold level of each condition
represented in the prediction criteria set N is modified by an
incremental value, thus making the prediction criteria set N more
sensitive. In another embodiment, conditions represented in the
prediction criteria set N are compared to the conditions that are
present just prior to a disordered breathing occurrence to
determine how the modification of the prediction criteria set N
should be implemented. In yet another embodiment, a condition
threshold level that is modified is based upon the relative
importance of the condition in the overall prediction criteria. In
another example, if the level of a particular condition is changing
just prior to the occurrence of the disordered breathing episode,
but the levels of other conditions remain constant, only the
changing condition may be modified.
[0422] Following adjustment by any of the processes described
above, the adjusted prediction criteria set may be designated as a
possible prediction criteria set. Each time the possible prediction
criteria set is satisfied, no prediction of disordered breathing is
made, however, the accuracy of the possible prediction criteria set
is updated, for example, using Equation 2 or 3. If the accuracy of
a possible prediction criteria set reaches a selected level, for
example, 0.7, the possible prediction criteria set may be added to
the prediction criteria library.
[0423] The system may also be adjusted to provide improved
specificity or a negative predictive value (NPV) of disordered
breathing prediction criteria in a manner similar to the adaptive
method described previously. Calculation of specificity and NPV for
a prediction criteria N may be accomplished using equations 4 and 5
below.
Specificity N = TN TN + FP [ 4 ] NPV N = TN TN + FN [ 5 ]
##EQU00003##
[0424] where TN (true negative) is the number of times the
prediction criteria successfully predicted the absence of
disordered breathing, FP (false positive) is the number of times
the prediction criteria erroneously predicted disordered breathing
and FN (false negative) is the number of times the prediction
criteria erroneously predicted the absence of disordered
breathing.
[0425] The flowchart of FIG. 20 illustrates a method for
establishing and updating the prediction criteria library according
to embodiments of the invention. Previous observations of
disordered breathing may be assimilated from population data 2002
or from past observation of the specific patient 2004. One or more
prediction criteria sets are determined and organized in a
prediction criteria library 2006.
[0426] Conditions associated with disordered breathing are
periodically detected 2008 and compared to the prediction criteria
sets in the prediction criteria library. If the conditions are
consistent 2010 with any of the prediction criteria sets in the
library, then disordered breathing is predicted 2015. Within a
selected time window following the disordered breathing prediction,
the system determines if disordered breathing occurs 2020.
[0427] One illustrative approach to detecting disordered breathing
involves monitoring a respiratory waveform output, for example,
using a transthoracic impedance sensor. When the tidal volume (TV)
of the patient's respiration, as indicated by the transthoracic
impedance signal, falls below a hypopnea threshold, then a hypopnea
event is declared. For example, a hypopnea event may be declared if
the patient's tidal volume fall below about 50% of the recent
average tidal volume or other baseline tidal volume. When the
patient's tidal volume falls further to an apnea threshold, e.g.,
about 10% of the recent average tidal volume, an apnea event is
declared.
[0428] If disordered breathing occurs 2020, the prediction criteria
accuracy of the prediction criteria set used for the disordered
breathing prediction is updated 2025. If the updated prediction
criteria accuracy is greater 2030 than a selected number, then a
possible prediction criteria set is formed 2035. The possible
prediction criteria set may be formed, for example, by substituting
more sensitive condition levels when compared to the original
prediction criteria set.
[0429] If disordered breathing is not detected 2020 following the
prediction, then the prediction criteria set accuracy is updated
2040. If the prediction criteria set accuracy decreases 2045 below
a selected number, then a possible prediction criteria set 2050 is
formed. The possible prediction criteria set may be formed, for
example, by substituting more stringent condition levels to produce
a more accurate prediction.
[0430] If the detected patient conditions are not consistent 2010
with any of the prediction criteria sets in the prediction criteria
library, disordered breathing is not predicted. Within a time
window following the disordered breathing prediction, the system
determines if disordered breathing occurs 2055. If disordered
breathing occurs 2055, then the system checks to see if the patient
conditions are consistent 2060 with any of the possible prediction
criteria sets. If the patient conditions are not consistent 2060
with any of the possible prediction criteria sets, a possible
prediction criteria set is formed 2056.
[0431] If the patient conditions are consistent 2060 with a
possible criteria set, the possible prediction criteria set
accuracy is updated 2070. If the possible prediction criteria
accuracy increases beyond a selected number 2075, the possible
prediction criteria set is added 2080 to the prediction criteria
library.
[0432] Adaptation of Therapy
[0433] Aspects of the invention are directed to methods and systems
configured to monitor, diagnose, and/or provide patient therapy
using one or more individual medical procedures including
adaptation of therapy based on therapy effectiveness and/or other
factors. Each of the circles 180 illustrated in FIGS. 1B-1D
represents an individual medical procedure providing a specific
monitoring, diagnosis or therapeutic function or set of functions.
Each individual medical procedure may be implemented as a
stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0434] Other aspects of the invention that include adaptation of
therapy are directed to methods and systems configured to monitor,
diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0435] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0436] One embodiment of the invention involves an individual
system 59 (FIG. 1B) that is configured to adapt therapy based on
therapy effectiveness and/or other factors. Adaptation of therapy
may be implemented in a stand alone system or in a combination of
individual medical systems, such as those described in FIGS.
1B-1D.
[0437] Various embodiments of the invention involve methods and
systems for providing an adaptive therapy for disordered breathing.
In accordance with an embodiment of the invention, an automated
method for providing disordered breathing therapy involves
detecting disordered breathing and adapting a cardiac electrical
therapy to mitigate the disordered breathing. The adapted therapy
is delivered to the patient. At least one of detecting the
disordered breathing, adapting the therapy to mitigate the
disordered breathing, and delivering the therapy is performed at
least in part implantably.
[0438] In accordance with a further embodiment of the invention, an
automated method of providing disordered breathing therapy involves
detecting disordered breathing and delivering a cardiac electrical
therapy to mitigate the disordered breathing. The effectiveness of
the therapy is assessed and therapy is adapted to enhance therapy
efficacy. At least one of detecting the disordered breathing,
delivering the therapy, evaluating the therapy, and adapting the
therapy to enhance effectiveness, is performed at least in part
implantably.
[0439] In accordance with yet another embodiment of the invention,
an automated method for providing disordered breathing involves
detecting disordered breathing and adapting a cardiac electrical
therapy to mitigate the disordered breathing while adjusting an
impact of the therapy on the patient. At least one of detecting the
disordered breathing and adapting the therapy to mitigate the
disordered breathing is performed at least in part implantably.
[0440] Yet another embodiment of the invention includes an
automated medical device for providing disordered breathing
therapy. The medical device includes a detector system configured
to detect patient conditions. A disordered breathing detection
system is coupled to the detector system and is configured to
detect disordered breathing. A therapy control module is coupled to
the disordered breathing detector system and is configured to adapt
a cardiac electrical therapy to mitigate the disordered breathing.
A therapy delivery system, coupled to the therapy control module,
is configured to deliver the adapted therapy to the patient. At
least one of the detector system, the disordered breathing
detection system, the therapy control module, and the therapy
delivery system includes an implantable component.
[0441] A further embodiment of the invention involves a disordered
breathing therapy system. The system includes means for detecting
disordered breathing and means for adapting a cardiac electrical
therapy to mitigate the disordered breathing. The system further
includes means for delivering the adapted therapy to the patient.
At least one of the means for detecting disordered breathing, means
for adapting a therapy to mitigate the disordered breathing, and
means for delivering the adapted therapy includes an implantable
component.
[0442] Another embodiment of the invention involves a system for
providing therapy for disordered breathing. The system includes
means for detecting disordered breathing and means for delivering a
cardiac electrical therapy to the patient to mitigate the
disordered breathing. The system further includes means for
evaluating the effectiveness of the therapy and means for adapting
the therapy to enhance the effectiveness of the therapy. At least
one of the means for detecting the disordered breathing, the means
for delivering the disordered breathing, the means for evaluating
the effectiveness of the disordered breathing, and the means for
adapting the disordered breathing to enhance effectiveness includes
an implantable component.
[0443] Yet another embodiment of the invention includes means for
detecting disordered breathing in a patient and means for adapting
a cardiac electrical therapy to mitigate the disordered breathing
while adjusting an impact of the therapy on the patient. The
adapted therapy is delivered to the patient. At least one of the
means for detecting the disordered breathing, the means for
adapting a therapy to mitigate the disordered breathing, and the
means for delivering the adapted therapy to the patient includes an
implantable component.
[0444] Other embodiments of the invention are directed to methods
and systems for adjusting cardiac pacing rate for disordered
breathing therapy. Cardiac intervals between cardiac beats are
obtained. A first indicated pacing interval is determined based at
least on a cardiac interval duration and a previous value of the
first indicated pacing interval. Cardiac pacing to mitigate
disordered breathing is provided based on the first indicated
pacing interval.
[0445] Another embodiment of the invention involves a system for
delivering disordered breathing therapy including adaptive
adjustment of pacing rate. The system includes a sensing circuit
configured to sense cardiac beats. A controller is coupled to the
sensing circuit. The controller is configured to determine a first
indicated pacing interval based at least on a cardiac interval
duration and a previous value of the first indicated pacing
interval. A cardiac pacing circuit coupled to the controller is
configured to provide cardiac pacing to mitigate disordered
breathing based on the first indicated pacing interval.
[0446] Other embodiments of the invention involve a coordinated
system for providing adaptive therapy. The coordinated system may
include, for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy. Systems and methods directed to adaptive
therapy for disordered breathing may be implemented to include
selected features, functions, and/or structures described in
commonly owned, co-pending U.S. Pat. No. 7,720,541, which is hereby
incorporated herein by reference.
[0447] A disordered breathing therapy system may include a therapy
assessment processor for assessing various parameters of the
therapy. The therapy assessment processor may receive input from
one or more of the patient-internal sensors patient-external
sensors and/or other input devices capable of sensing conditions
affecting the patient. The therapy assessment processor may also
receive information from one or more of the cardiac arrhythmia
detector sleep quality monitor sleep detector and/or disordered
breathing detector/predictor. The therapy assessment processor may
use the information acquired from one or more of these sources to
adapt the therapy to achieve a therapeutic goal, for example, to
adapt the therapy to achieve a level of effectiveness.
[0448] In one implementation, a therapeutic goal may involve
terminating detected disordered breathing episodes and the
disordered breathing therapy may be adapted to achieve this goal.
Additionally, or alternatively, a therapeutic goal may involve
terminating a disordered breathing episode and preventing further
disordered breathing. In this example situation, the therapy
regimen may be adapted to provide a first therapy to terminate the
disordered breathing episode and provide a second preventative
therapy to reduce or eliminate further disordered breathing
episodes. The second preventative therapy may be adapted to reduce
episodes of disordered breathing below a predetermined disordered
breathing episode threshold. A disordered breathing episode
threshold may be expressed, for example, in terms of an
apnea/hypopnea index (AHI) or percent time in periodic breathing (%
PB).
[0449] FIG. 21 is a flowchart illustrating a method of adapting a
disordered breathing therapy according to embodiments of the
invention. The flowchart of FIG. 21 illustrates a method of
adapting disordered breathing therapy to achieve a desired level of
therapy efficacy. In this embodiment, a first set of conditions
associated with disordered breathing is detected 2110 and used to
determine if a disordered breathing episode is occurring. If
disordered breathing is detected 2120, disordered breathing therapy
is delivered 2130 to the patient to mitigate the disordered
breathing. In one embodiment, the therapy delivered to the patient
may include, for example, cardiac pacing at a rate in excess of an
intrinsic rate, or in excess of a normally programmed rate, such as
a normally programmed sleep rate.
[0450] Adapting the cardiac electrical therapy may also involve
modifying the electrical stimulation energy with or without an
increase in the pacing rate. Increased stimulation energy has been
shown to produce higher cardiac contractility, which may be
particularly beneficial for patients suffering from chronic heart
failure. Loss of cardiac contractility is thought to initiate and
drive the progression of heart failure, a disorder that is
intertwined with Cheyne-Stokes respiration.
[0451] Further, adapting a cardiac electrical therapy to mitigate
disordered breathing may involve adapting a therapy involving
non-excitatory electrical stimulation of one or more heart
chambers, e.g., the left and/or right ventricles, or other cardiac
sites. Non-excitatory electrical stimulation may be delivered
during absolute refractory periods of the cardiac tissue, for
example, to improve cardiac contractility. The non-excitatory
stimulation therapy may be used alone or in combination with the
pacing to provide a comprehensive therapy regimen for patients with
CHF and disordered breathing such as Cheyne-Stokes respiration.
[0452] In other embodiments, adapting the cardiac electrical
therapy to mitigate disordered breathing may involve initiating a
particular pacing regimen or switching from one pacing mode to
another pacing mode. In one example, the cardiac pacing regimen may
be switched from a dual-chamber pacing mode to a bi-ventricular or
other resynchronization mode. In other examples, the pacing mode
may be switched to a pacing mode that promotes atrial pacing, or
promotes consistent ventricular pacing. In yet another example, the
cardiac electrical therapy may involve initiating multi-site
electrical stimulation to the heart or changing from one electrical
stimulation site to another. The pacing mode may be switched from
single chamber to multiple chambers, or the reverse. For example, a
bi-ventricular mode may be switched to a left ventricular mode
only. Alternatively, a single chamber mode, e.g., LV or RV, may be
switched to a bi-ventricular mode. Other therapy regimens,
involving various pacing modes, pacing sites, or non-excitatory
electrical stimulations, are possible in connection with providing
cardiac electrical therapy for disordered breathing. The type of
cardiac electrical therapy beneficial to a patient is highly
patient specific and may be determined based on the responses of a
particular patient.
[0453] A second set of conditions associated with therapy
effectiveness is sensed 2140 and used to assess the effectiveness
of the therapy. The detected conditions used to assess the efficacy
of the therapy and adapt the therapy to mitigate disordered
breathing may represent one or more of the acute conditions
associated with disordered breathing, e.g., detected episodes of
interrupted breathing, hypoxia, arousals, negative intrathoracic
pressure, blood pressure, and heart rate or blood pressure
surges.
[0454] Additionally, or alternatively, the conditions used to
assess therapy efficacy and adapt the cardiac electrical therapy
may include one or more chronic conditions associated with
disordered breathing, including, for example, decreased heart rate
variability, increased blood pressure, chronic changes in
sympathetic nerve activity, and changes in blood chemistry, such as
increased levels of PaCO.sub.2 and norepinephrine levels, among
others.
[0455] In general, a therapeutic goal in the treatment of
disordered breathing is to provide the least aggressive therapy
that effectively mitigates, terminates or prevents the patient's
disordered breathing or achieves a particular therapeutic goal
associated with disordered breathing therapy. The disordered
breathing therapy regimen may be enhanced by increasing the
intensity or level of therapy to more effectively mitigate the
disordered breathing. Alternatively, the disordered breathing
therapy regimen may be enhanced by reducing the intensity or level
of therapy while maintaining a desired decrease in the severity or
frequency of disordered breathing episodes, thus reducing
undesirable side effects from the therapy and extending the device
lifetime.
[0456] If the therapy effectiveness is acceptable 2150, e.g.,
terminates or reduces the patient's disordered breathing or meets
some other desired goal, then the therapy may be adapted 2160 to
provide a less aggressive therapy, e.g., decreased pacing rate,
decreased pacing energy, or altered pacing mode, as described
above. If the therapy is not effective 2150, then the therapy may
be adapted 2170 to enhance therapy efficacy by providing a more
aggressive therapy, e.g., increased pacing rate, increased pacing
energy, or pacing mode switch.
[0457] In one embodiment, therapy may be determined to be
ineffective if disordered breathing continues unmitigated following
therapy delivery. In this situation, the therapy may be adapted to
provide a more aggressive therapy, for example, cardiac pacing at a
higher rate. In another embodiment, if the disordered breathing
decreases sufficiently in severity, or is otherwise sufficiently
mitigated, the therapy may be enhanced by adapting the therapy to
provide a less aggressive therapy, e.g., pacing at a lower rate or
a decreased energy level. As previously discussed, a less
aggressive therapy is preferable to reduce the risk of arousal, to
avoid unnecessary stress on the patient's heart, and to prolong
battery life, for example.
[0458] The flowchart of FIG. 22 illustrates a method of adapting a
disordered breathing therapy taking into account both therapy
effectiveness and therapy impact in accordance with embodiments of
the invention. In this example, a first set of conditions
indicative of disordered breathing are sensed 2210 and used to
determine if a disordered breathing episode is occurring. If
disordered breathing is detected 2220, therapy is delivered 2230 to
the patient to mitigate the disordered breathing.
[0459] A second set of conditions, possibly overlapping the first
set, are sensed 2240 and used to adapt the therapy. Based on the
second set of sensed conditions, therapy efficacy is assessed 2245.
If the therapy efficacy is not acceptable 2250, then the therapy
may be adapted 2260 to enhance therapy efficacy. If the therapy
efficacy is acceptable 2250, then the impact of the therapy on the
patient may be assessed 2270.
[0460] If the therapy impact on the patient is acceptable 2280, the
system continues to deliver the therapy. When the therapy regimen
is complete 2285, then therapy is terminated 2290.
[0461] If the therapy impact on the patient exceeds acceptable
limits, the therapy impact is not acceptable 2280, and the therapy
may be adapted 2260 to reduce the therapy impact. Various methods
of assessing the impact of the therapy and determining if the
therapy impact is acceptable are described herein.
[0462] The methods illustrated in the flow graphs of FIGS. 21 and
22 contemplate real-time monitoring of patient conditions allowing
the therapy system to dynamically adjust the therapy regimen to
accommodate the changing needs of the patient. In one
configuration, the therapy may be adjusted during the period that
therapy is delivered to the patient. In another configuration, the
therapy may be adapted between disordered breathing episodes or
from night-to-night based on assessment of the efficacy of therapy
delivered in connection with one or more previously detected
disordered breathing episodes.
[0463] Evaluation of the impact of disordered breathing therapy on
the patient preferably takes into consideration the impact of
disordered breathing therapy on the overall therapeutic goals for
the patient, including cardiac pacing therapy goals and disordered
breathing therapy goals. The disordered breathing therapy may
involve a variety of therapy regimens implemented to achieve
predetermined therapeutic goals. The effectiveness of the therapy,
or the degree to which the therapy meets one or more therapeutic
goals, may be assessed by detecting and analyzing episodes of
disordered breathing that occur during therapy delivery, or during
other periods, including periods of wakefulness.
[0464] For example, a therapeutic goal may involve terminating a
disordered breathing episode and the disordered breathing therapy
may be adapted to achieve this goal. Additionally, or
alternatively, a therapeutic goal may involve terminating a
disordered breathing episode and preventing further disordered
breathing. In this example situation, the therapy regimen may be
adapted to provide a first therapy to terminate the disordered
breathing episode and provide a second preventative therapy to
reduce or eliminate further disordered breathing episodes. The
second preventative therapy may be adapted to reduce episodes of
disordered breathing below a predetermined disordered breathing
episode threshold. A disordered breathing episode threshold may be
expressed, for example, in terms of an apnea/hypopnea index (AHI)
or percent time in periodic breathing (% PB).
Sleep Quality Monitoring
[0465] Aspects of the invention that include sleep quality
monitoring are directed to methods and systems configured to
monitor, diagnose, and/or provide patient therapy using one or more
individual medical procedures. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0466] Other aspects of the invention involving sleep quality
monitoring are directed to methods and systems configured to
monitor, diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0467] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0468] Embodiments of the invention involve an individual system 58
(FIG. 1D) for monitoring sleep quality. The sleep quality monitor
58 may be implemented as a stand alone system or in combination
with other individual medical systems, such as those described in
FIGS. 1B-1D.
[0469] Various embodiments of present invention involve methods and
systems for collecting sleep quality data and evaluating the sleep
quality of a patient. An embodiment of the invention involves a
method for collecting sleep quality data. The method includes
detecting physiological and non-physiological conditions associated
with the sleep quality of a patient and collecting sleep quality
data based on the detected conditions. Collecting the sleep quality
data may be performed at least in part implantably.
[0470] Another embodiment of the invention involves a method for
evaluating sleep quality. In accordance with this method, one or
more metrics associated with sleep are determined. One or more
metrics associated with events that disrupt sleep are determined. A
composite sleep quality metric is determined using the one or more
metrics associated with sleep and the one or more metrics
associated with events that disrupt sleep.
[0471] In yet another embodiment of the invention, a method for
evaluating sleep quality includes detecting physiological and
non-physiological conditions associated with the sleep quality of a
patient and collecting sleep quality data based on the detected
conditions. The sleep quality of the patient is evaluated using the
collected data. At least one of collecting the sleep quality data
and evaluating the sleep quality of the patient is performed at
least in part implantably.
[0472] Another embodiment of the invention involves a method for
evaluating sleep quality. One or more conditions associated with
sleep quality of a patient are detected during a period of
wakefulness. Sleep quality data is collected based on the detected
conditions. The patient's sleep quality is evaluated using the
collected sleep quality data. At least one of collecting the data
and evaluating the sleep quality is performed at least in part
implantably.
[0473] A further embodiment of the invention involves a medical
device including a detector system configured to detect
physiological and non-physiological conditions associated with
sleep quality and a data collection system for collecting sleep
quality data based on the detected conditions. The data collection
system includes an implantable component.
[0474] Yet another embodiment of the invention relates to a medical
device configured to evaluate sleep quality. The medical device
includes a detector system configured to detect physiological and
non-physiological conditions associated with the sleep quality of a
patient. A sleep quality processor, coupled to the detection
system, is configured to determine metrics based on the detected
conditions. The metrics include one or more metrics associated with
sleep, one or more metrics associated with events that disrupt
sleep, and at least one composite sleep quality metric based on the
one or more metrics associated with sleep and the one or more
metrics associated with events that disrupt sleep.
[0475] In another embodiment of the invention, a medical device for
assessing sleep quality includes a detector unit configured to
detect physiological and non-physiological conditions associated
with sleep quality and a sleep quality data collection unit
configured to collect sleep quality data based on the detected
conditions. A data analysis unit coupled to the data collection
unit evaluates sleep quality based on the collected sleep quality
data. At least one of the data collection unit and the data
analysis unit includes an implantable component.
[0476] A further embodiment of the invention involves a system for
collecting sleep quality data. The system includes means for
detecting physiological and non-physiological conditions associated
with sleep quality and means for collecting sleep quality data
based on the detected conditions. The means for collecting the
sleep quality data includes an implantable component.
[0477] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes sleep quality data. The coordinated system may
include, for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[0478] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
system 58 configured to collect and/or evaluate sleep quality data.
The sleep quality collection and/or evaluation system comprises a
detector system configured to detect physiological and
non-physiological conditions associated with sleep quality of a
patient. A data collection system is coupled to the detector system
and is configured to collect sleep quality data based on the
detected conditions. A data analysis system is coupled to the data
collection system and is configured to evaluate the sleep quality
using the collected sleep quality data, wherein at least one of the
data collection system and the data analysis system includes an
implantable component. The implantable device and the patient
external respiratory device are configured to work in cooperation
to collect and/or use the sleep quality data. Systems and methods
directed to sleep quality data collection and evaluation may be
implemented to include selected features, functions, and/or
structures described in commonly owned, co-pending U.S. Publication
No. 2005/0042589, which is hereby incorporated herein by
reference.
[0479] Superficially, sleep may viewed as a monolithic event that
is characterized by a period of unconsciousness. If examined in
greater detail, sleep periods may be described as involving a
series of events or stages. For example, sleep is typically divided
into various stages of sleep, including rapid eye movement (REM)
sleep and non-REM (NREM) sleep. Non-REM sleep may be further
subdivided into stage 1, stage 2 and stage 3 non-REM sleep, for
example.
[0480] In accordance with various embodiments of the invention,
conditions related to sleep quality, e.g., sleep fragmentation
and/or other arousal-based measures, patient-reported restful
sleep, and patient-reported discomfort during therapy delivered
during sleep, among other sleep quality factors, may be used to
assess the impact of the therapy on the patient. A therapy
assessment processor may assess therapy impact based on sleep
quality using information acquired by a sleep quality monitor. For
example, if a patient is receiving effective disordered breathing
therapy and has low sleep fragmentation, reports restful sleep with
no discomfort, the therapy effectiveness may be relatively high and
the adverse effects of the therapy on the patient may be relatively
low. If sleep fragmentation unrelated to disordered breathing
episodes is relatively high, or if the patient reports discomfort
or feeling tired after sleeping, these conditions may indicate that
the disordered breathing therapy is causing sleep disturbances
and/or other undesirable effects.
[0481] Because disordered breathing generally occurs during sleep,
it may be particularly important to assess sleep quality during
disordered breathing therapy delivery. It is undesirable to provide
therapy that eliminates the disordered breathing but increases
sleep fragmentation. In such a situation, the disordered breathing
therapy may exacerbate the adverse effects produced by the
respiratory disturbances. Thus, it may be preferable to assess the
impact of the therapy on the patient and adjust the therapy to
improve sleep quality. Sleep fragmentation and sleep disruptions
may also occur if disordered breathing therapy is ineffective and
disordered breathing occurs during sleep. Therefore, a therapy
impact assessment based on detected sleep quality and/or
patient-reported restful sleep may preferably take into account an
assessment of therapy effectiveness.
[0482] Sleep quality assessments depend upon acquiring
sleep-related data, including the patient's typical sleep patterns
and the physiological, environmental, contextual, emotional, and
other conditions affecting the patient during sleep. Diagnosis of
sleep disorders and assessment of sleep quality often involves the
use of a polysomnographic sleep study at a dedicated sleep
facility. However, such studies are costly, inconvenient to the
patient, and may not accurately represent the patient's typical
sleep behavior. In a polysomnographic sleep study, the patient is
instrumented for data acquisition and observed by trained
personnel. Sleep assessment in a laboratory setting presents a
number of obstacles in acquiring an accurate picture of a patient's
typical sleep patterns. For example, spending a night in a sleep
laboratory typically causes a patient to experience a condition
known as "first night syndrome," involving disrupted sleep during
the first few nights in an unfamiliar location. In addition,
sleeping while instrumented and observed may not result in a
realistic perspective of the patient's normal sleep patterns.
[0483] Further, polysomnographic sleep studies provide an
incomplete data set for the analysis of some sleep disorders,
including, for example, sleep disordered breathing. A number of
physiological conditions associated with sleep disordered breathing
are detectable during periods of wakefulness, e.g., decreased heart
rate variability, elevated sympathetic nerve activity,
norepinephrine concentration, and increased blood pressure
variability. Collection of data during periods of sleep and/or
during periods of wakefulness may provide a more complete picture
of the patient's sleep quality.
[0484] Various aspects of sleep quality, including number and
severity of arousals, sleep disordered breathing episodes,
nocturnal limb movements, and cardiac, respiratory, muscle, and
nervous system functioning may provide important information for
diagnosis and/or therapy delivery. An initial step to sleep quality
evaluation is an accurate and reliable method for discriminating
between periods of sleep and periods of wakefulness. Further,
acquiring data regarding the patient's sleep states or stages,
including sleep onset, termination, REM, and NREM sleep states, and
arousal events, including autonomic arousals may be used in
connection sleep quality assessment. For example, the most restful
sleep occurs during stages 3 and 4 non-REM sleep. One indicator of
sleep quality is the percentage of time a patient spends in these
sleep stages. Knowledge of the patient's sleep patterns may be used
to diagnose sleep disorders and/or adjust patient therapy,
including, e.g., cardiac or respiratory therapy. Trending
disordered breathing episodes, arousal episodes, and other sleep
quality aspects may be helpful in determining and maintaining
appropriate therapies for patients suffering from disorders ranging
from snoring to chronic heart failure.
[0485] The present invention involves methods and systems for
acquiring sleep quality data and using the sleep quality data to
assess the effectiveness and/or impact of disordered breathing
therapy delivered to the patient. Methods of the invention involve
sensing conditions associated with the sleep quality of the patient
including physiological and/or non-physiological conditions. Data
related to the patient's sleep quality is collected based on the
sensed conditions. Sensing for conditions affecting the patient and
related to sleep quality may occur during periods of wakefulness
and/or during periods of sleep. Sensing the conditions associated
with sleep quality and/or collecting the sleep quality data may be
performed using a device having a component that is at least in
part implantable.
[0486] A representative set of the conditions associated with sleep
quality is listed in Table 1. Patient conditions used to evaluate
sleep quality may include, for example, both physiological and
non-physiological (i.e., contextual) conditions.
[0487] Each of the conditions listed in Table 1 may serve a variety
of purposes in evaluating sleep quality. For example, a subset of
the conditions may be used to detect whether the patient is asleep
and to track the various stages of sleep and arousal incidents.
Another subset of the conditions may be used to detect disordered
breathing episodes. Yet another subset may be used to detect
abnormal limb movements. In one implementation, some or all of the
listed conditions may be collected over a relatively long period of
time and used to analyze long term sleep quality trends. Trending
may be used in connection with an overall assessment of sleep
quality and diagnosis and treatment of sleep-disordered breathing,
movement disorders, and/or other sleep disorders.
[0488] Table 5 provides examples of how some physiological and
non-physiological conditions may be used in connection with sleep
quality assessment.
TABLE-US-00005 TABLE 5 Condition Examples of how condition is used
in sleep quality Type Condition assessment Physiological Heart rate
Decrease in heart rate may indicate disordered breathing episode.
Decrease in heart rate may indicate the patient is asleep. Heart
rate variability May be used to determine sleep state. Changes in
heart rate variability, detected during periods of sleep or
wakefulness, may indicate that the patient suffers from sleep
disordered breathing. QT interval May be used to detect sleep
apnea. Ventricular filling May be used to identify/predict
pulmonary pressure congestion associated with respiratory
disturbance. Blood pressure Variation in blood pressure is
associated with apnea. Snoring Associated with a higher incidence
of obstructive sleep apnea and may be used to detect disordered
breathing. Respiration pattern May be used to detect disordered
breathing episodes. May be used to determine the type of disordered
breathing. May be used to detect sleep. Patency of upper Related to
obstructive sleep apnea and may be used airway to detect episodes
of obstructive sleep apnea. Pulmonary congestion Associated with
respiratory disturbances. Sympathetic nerve Apnea termination is
associated with a spike in activity (SNA) SNA. SNA activity may be
elevated during periods of wakefulness if the patient experiences
sleep disordered breathing. Electroencephalogram May be used to
determine sleep stages, including (EEG) REM and NREM sleep stages
CO2 saturation Low CO2 levels may indicate initiation of central
apnea. O2 saturation O2 desaturation occurs during severe
apnea/hypopnea episodes. Blood alcohol content Alcohol tends to
increase the incidence of snoring & obstructive apnea.
Adrenalin End of apnea associated with a spike in blood adrenaline.
Brain Natriuretic A marker of heart failure status, which is
associated Peptide (BNP) with Cheyne-Stokes Respiration. C-Reactive
Protein A measure of inflammation that may be related to apnea.
Drug/Medication/Tobacco These substances may affect incidence of
both use central & obstructive apnea. Muscle atonia Muscle
atonia may be used in connection with detection of REM and non-REM
sleep. Eye movement Eye movement may be used in connection with
detection of REM and non-REM sleep. Activity May be used to detect
sleep and patient well being. Limb movements May be used to detect
abnormal limb movements during sleep. Non- Ambient Temperature
Ambient temperature may predispose the patient to physiological
episodes of disordered breathing during sleep. Humidity Humidity
may predispose the patient to episodes of disordered breathing
during sleep. Pollution Pollution may predispose the patient to
episodes of disordered breathing during sleep. Posture Posture may
be used to determine if the patient is asleep. Posture may
predispose the patient to disordered breathing. Time Used to
establish historical sleep time. Ambient noise level Noise level
may affect sleep quality. Location Patient location may used to
determine if the patient is in bed as a part of sleep detection.
Altitude Altitude may predispose the patient to episodes of
disordered breathing and may affect sleep quality. Barometric
Pressure Barometric pressure may predispose the patient to episodes
of disordered breathing. Proximity to bed May be used to determine
if patient is in bed. Historical sleep time May be used in
connection with sleep detection. Medical history History of medical
disorders, e.g., CHF, that are associated with disordered breathing
such as Cheyne-Stokes respiration. Age Age is associated with
increased risk of disordered breathing, RLS and other sleep
disruptive disorders. Weight Associated with sleep disordered
breathing, e.g., Gender obstructive sleep apnea. Obesity Neck size
Patient reported drug, Patient drug, alcohol and nicotine use may
affect alcohol, nicotine use sleep quality. Psychological history
Psychological factors, e.g., clinical depression may be associated
with insomnia Emotional state Emotional state, e.g., stress,
anxiety, euphoria, may affect sleep quality. Daytime sleepiness May
be used to evaluate sleep quality. Patient perceptions of sleep
quality
[0489] FIG. 23 illustrates a patient 2310 instrumented with a sleep
quality monitor according to embodiments of the invention. The
sleep quality monitor 2320 collects sleep quality data from the
patient using a number of sensors 2311-2319. In one configuration,
the collected data is analyzed by a therapy assessment processor
that may be an integrated component of an implantable disordered
breathing therapy system. The collected sleep quality data may be
downloaded to a patient-external device 2330 for storage, analysis,
or display.
[0490] In the implementation illustrated in FIG. 23, the
implantable sleep quality monitor 2320 is coupled to a number of
sensors 2311-2319. In this example, the sensors include an EGM
sensor 2316 for detecting heart rate and heart rate variability
conditions. A transthoracic impedance sensor 2317 is used to detect
the respiration conditions of the patient, including, for example,
minute ventilation, respiration rate, and tidal volume. An activity
detector, e.g., accelerometer, 2315 may be used to detect patient
activity conditions. The sleep quality monitor 2320 senses patient
conditions including the patient's posture and location using a
posture sensor 2314 and a proximity to bed sensor 2313,
respectively. The sleep quality monitor 2320 senses the patient's
brain activity using EEG sensors 2311 and the patient's eye
movements using EOG sensors 2312. Jaw and limb movements are sensed
using accelerometers attached to the patient's jaw 2318 and legs
2319.
[0491] In this application, the sleep quality monitor 2320 is
configured to track the patient's heart rate, heart rate
variability, minute ventilation, respiration rate, tidal volume,
posture, proximity to bed, brain activity, eye movements, jaw
movements and leg movements. At periodic intervals, the sleep
quality monitor 2320 samples signals from the sensors and stores
data regarding the detected conditions in memory circuitry within
the sleep quality monitor 2320. The sleep quality monitor 2320 may
additionally access an external input unit 2330 to detect patient
reported conditions, for example, recent tobacco and medication use
by the patient. Further, the sleep quality data monitor 2320 may
monitor conditions using one or more external sensors. In the
illustrated example, a thermometer 2335 is coupled through the
external programmer 2330 and a pollution website 2340 is accessible
to the sleep quality monitor 2320 through the internet 2350.
[0492] The sleep quality monitor 2320 may operate to acquire data
during periods of both sleep and wakefulness. It may be beneficial,
for example, to track changes in particular conditions measured
during periods of wakefulness that are associated with sleep
disordered breathing. For example, some patients who suffer from
sleep apnea experience changes in heart rate variability, blood
pressure variability, and/or sympathetic nerve activity during
periods of wakefulness. Detection and analysis of the physiological
changes attributable to sleep disorders and measurable during the
time the patient is awake provides a more complete picture of sleep
quality.
[0493] In another example, the patient's sleep quality may be
evaluated by determining the patient's activity level while the
patient is awake. The activity level of the patient during the day
may provide important information regarding the patient's sleep
quality. For example, if the patient is very inactive during
periods of wakefulness, this may indicate that the patient's sleep
is of inadequate quality or duration. Such information may also be
used in connection with assessing the efficacy of a particular
sleep disorder therapy and/or adjusting the patient's sleep
disorder therapy. Patient activity information may be sensed for
example, for example, using an accelerometer and/or transthoracic
impedance sensor disposed within or on an implantable device.
Collection of patient activity information may be performed over a
period of time. Assessment of the patient activity data may
indicate changes in the patient's well-being as indicated by a drop
in activity level.
[0494] In another example, the patient's sleep quality may be
evaluated by determining the patient's activity level while the
patient is awake. The activity level of the patient during the day
may provide important information regarding the patient's sleep
quality. For example, if the patient is very inactive during
periods of wakefulness, this may indicate that the patient's sleep
is of inadequate quality or duration. Such information may also be
used in connection with assessing the efficacy of a particular
sleep disorder therapy and/or adjusting the patient's sleep
disorder therapy. Methods and systems for determining the patient's
activity level and generally assessing the well-being of a patient
are described in commonly owned U.S. Pat. No. 6,021,351 which is
incorporated herein by reference.
[0495] The sleep quality monitor 2320 may calculate one or more
sleep quality metrics quantifying the patient's sleep quality. A
representative set of the sleep quality metrics include, for
example, sleep efficiency, sleep fragmentation, number of arousals
per hour, denoted the arousal index (AI).
[0496] The sleep quality monitor 2320 may also compute one or more
metrics quantifying the patient's disordered breathing, such as the
apnea hypopnea index (AHI) providing the number of apneas and
hypopneas per hour, and the percent time in periodic breathing (%
PB).
[0497] Further, metrics associated with sleep movement disorders
may also be determined by the sleep quality monitor 2320. Such
metrics may include, for example, a general sleep movement disorder
index (MDI) representing the number of abnormal movements arising
from movement disorders such as restless leg syndrome, periodic
limb movement disorder and bruxism per hour. In addition, specific
indices may be calculated for each type of movement disorder, e.g.,
a bruxism index (BI) characterizing the number of jaw movements per
hour, a RLS index (RLSI) characterizing the number of restless leg
syndrome episodes per hour, and a PLM index (PLMI) characterizing
the number of periodic limb movements experienced by the patient
per hour.
[0498] In addition, percentage of sleep time during which the
patient experiences movement disorders (% MD) may be calculated.
Specific metrics relating to the percentage of time during which
the patient experiences bruxism (% B), restless leg syndrome (%
RLS), and periodic leg movement disorder (% PLMD) may also be
determined.
[0499] Further, sleep summary metrics may be computed, either
directly from the collected patient condition data, or by combining
the above-listed sleep quality and sleep disorder metrics. In one
embodiment, a composite sleep disordered respiration metric (SDRM)
may be computed by combining the apnea hypopnea index AHI and the
arousal index AI. The composite sleep disordered respiration metric
(SDRM) may be computed as a linear combination of the AHI and AI as
follows:
SDRM=c.sub.1*AHI+c.sub.2*AI [6]
[0500] where c.sub.1 and c.sub.2 are constants chosen to balance
the relative contributions of respiratory and arousal effects on
sleep disturbance. The AHI may be monitored by performing
disordered breathing detection based on transthoracic impedance
measurements as previously described. The AI may be estimated, for
example, by monitoring the patient activity, minute ventilation,
and posture sensors for body motion indicating sleep termination or
arousal. A more sensitive measure of arousal may be made using EEG
signals. In this implementation, the constant c.sub.2 may be
adjusted to reflect the increased sensitivity to arousal.
[0501] In another embodiment, an undisturbed respiration sleep time
(URST) or undisturbed respiration sleep efficiency (URSE) may be
computed based on the amount of time the patient spends asleep in
bed without respiratory disturbance.
[0502] The URST or URSE metrics may be determined using three
parameters: total time in bed (TIB), total time asleep (TA), and
combined sleep time duration in disturbed respiration (STDR). Time
in bed may be determined by a combination of posture sensing and
sensing the proximity of the patient to bed. The posture condition
of the patient may determined, for example, using an implantable
multiaxis accelerometer sensor.
[0503] The patient's total time in bed (TIB) may be determined
using a proximity to bed sensor. The proximity to bed sensor may
use a receiver in the sleep quality monitor 2320 for receiving
signals transmitted from a beacon 2370 located at the patient's bed
2360. If the proximity to bed receiver detects a signal of
sufficient strength from the proximity to bed beacon 2370, then the
receiver detects that the patient is in bed 2360.
[0504] Total time asleep (TA) may be determined using the sleep
detection method described in more detail above. The total sleep
time in disturbed respiration (STDR) may be determined, for
example, based on detection of sleep and disordered breathing using
the sleep and disordered breathing detection methods described
above.
[0505] The patient's undisturbed respiration sleep time (URST) is
calculated as:
URST=TA-STDR [7]
[0506] where TA=total time asleep and STDR=sleep time in disturbed
breathing.
[0507] The undisturbed respiration sleep efficiency (URSE) in
percent is calculated
URSE=100*URST/TIB [8]
[0508] where URST=undisturbed respiration sleep time and TIB=total
time in bed.
[0509] Similar metrics may be calculated for movement disorders
generally, or for specific movement disorders, e.g., RLS, PLMD, or
bruxism. For example, the composite RLS, PLMD, and bruxism metrics,
RLSM, PLMDM, and BM, respectively, may be calculated using
equations similar in form to equation 6 above:
RLSM=c.sub.1*RLSI+c.sub.2*AI [9]
[0510] where RLSI=number of restless leg movement syndrome episodes
per hour, AI=number of arousals per hour, and c.sub.1 and c.sub.2
are constants chosen to balance the relative contributions of
abnormal movement and arousal effects on sleep disturbance.
PLMDM=c.sub.1*PLMDI+c.sub.2*AI [10]
[0511] where PLMDI=number of periodic leg movement syndrome
episodes per hour, AI=number of arousals per hour, and c.sub.1 and
c.sub.2 are constants chosen to balance the relative contributions
of abnormal movement and arousal effects on sleep disturbance.
BM=c.sub.1*BMI+c.sub.2*AI [11]
[0512] where BMI=number of bruxism movement episodes per hour,
AI=number of arousals per hour, and c.sub.1 and c.sub.2 are
constants chosen to balance the relative contributions of abnormal
movement and arousal effects on sleep disturbance.
[0513] The patient's undisturbed movement sleep time (UMST) and
undisturbed movement sleep efficiency (UMSE) may be calculated for
each movement related disorder separately or in combination using
equations similar in form to equations 2 and 3, above.
[0514] In addition, a composite sleep disorder index SDI
quantifying the combined effect of both respiratory and movement
disorders may be computed by combining the apnea hypopnea index
(AHI), the movement disorder index (MDI), and the arousal index
(AI).
[0515] A sleep disturbance index (SDI) may be computed as a linear
combination of the AHI, and the combined disorder index DI.sub.C.
The combined disorder index may include both abnormal breathing and
movement components. For example, the sleep disturbance index SDI
is characterizable by the equation:
SDI=c.sub.4*DI.sub.C+c.sub.3*AI, [12]
[0516] where DI.sub.C is a combined disorder index of the form:
DI.sub.C=c.sub.41*DI.sub.1+c.sub.42*DI.sub.2 [13]
In equation 12, c.sub.4 and c.sub.3 are constants chosen to balance
the relative contributions of the combined disorder and arousal
effects, respectively. The disorder index, DI.sub.C, may be used to
characterize the effects of one or more sleep disorders, including,
e.g., disorders associated with disturbed respiration and/or
abnormal movements. The combined disorder index may represent only
one disorder index, or may be a linear combination of two or more
sleep disorder indices, e.g., the apnea/hypopnea index (AHI) and
the abnormal movement disorder index (MDI). The constants c.sub.41
and c.sub.42 may be used as weighting factors associated with
particular disorder indices.
[0517] The patient's undisturbed sleep time (UST) may be
calculated:
UST=TA-STSD [14]
[0518] where TA=total time asleep and STSD=sleep time spent in
sleep disorders.
[0519] The undisturbed sleep efficiency (USE) in percent may be
calculated:
USE=100*UST/TIB [15]
[0520] where UST=undisturbed sleep time and TIB=total time in
bed.
[0521] Sleep quality metrics, such as those described above, or
other metrics, may be acquired and analyzed using the sleep quality
data collection and analysis unit 2320. Sleep quality metrics, in
addition to raw or processed data based on physiological and
non-physiological conditions may determined periodically, e.g.,
daily, and stored or transmitted to another device. Such data can
be presented to the patient's health care professional on a
real-time basis, or as a long-term, e.g., month long or year long,
trend of daily measurements.
[0522] The health care professional may access the data during
clinic visits via programmer interrogation of the implanted device,
through occasional or periodic trans-telephonic device
interrogations, or through an automatic or "on-demand" basis in the
context of an advanced patient management system. The health care
professionals may use the sleep quality indicator trends alone or
in conjunction with other device-gathered or clinical data to
diagnose disorders and/or adjust the patient's device or medical
therapy as needed to improve the patient's quality of sleep.
[0523] Cardiac Pacing for Disordered Breathing
[0524] Aspects of the invention that include cardiac pacing for
disordered breathing are directed to methods and systems configured
to monitor, diagnose, and/or provide patient therapy using one or
more individual medical procedures. Each of the circles 180
illustrated in FIGS. 1B-1D represents an individual medical
procedure providing a specific monitoring, diagnosis or therapeutic
function or set of functions. Each individual medical procedure may
be implemented as a stand-alone system. Two or more of the
individual medical procedures 180 may be used in combination to
provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[0525] Other aspects of this invention involving cardiac pacing for
disordered breathing are directed to methods and systems configured
to monitor, diagnose, and/or provide therapy using coordinated
medical procedures. Coordinated medical procedures may involve
cooperative operation of two or more of the individual processes
180. Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0526] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0527] Embodiments of the invention involve an individual system
128 (FIG. 1C) for treating disordered breathing using cardiac
pacing. The system for treating disordered breathing using cardiac
pacing may be implemented as a stand alone system or in combination
with other individual medical systems, such as those described in
FIGS. 1B-1D.
[0528] Embodiments of the present invention are directed to systems
and methods for treating disordered breathing using cardiac pacing.
Various embodiments of present invention involve methods and
systems for providing disordered breathing therapy. One embodiment
of the invention provides a method for delivering disordered
breathing therapy. Cardiac intervals between cardiac beats are
obtained. A first indicated pacing interval is determined based at
least one cardiac interval duration and a previous value of the
first indicated pacing interval. Cardiac pacing to mitigate
disordered breathing is provided based on the first indicated
pacing interval.
[0529] Another embodiment of the invention involves a system for
delivering disordered breathing therapy. The system includes a
sensing circuit configured to sense cardiac beats. A controller is
coupled to the sensing circuit. The controller is configured to
determine a first indicated pacing interval based on at least one
cardiac interval duration and a previous value of the first
indicated pacing interval. A cardiac pacing circuit coupled to the
controller is configured to provide cardiac pacing to mitigate
disordered breathing based on the first indicated pacing
interval.
[0530] Another embodiment of this invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes cardiac pacing for disordered breathing. The
coordinated system may include, for example, an implantable cardiac
device 181 and a patient-external respiratory therapy device 184.
The system may further include an external processor 183 providing
a coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 183 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[0531] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
system 128 configured to deliver cardiac pacing for disordered
breathing. The disordered breathing therapy system 128 includes a
sensing circuit configured to sense cardiac beats. A controller is
coupled to the sensing circuit. The controller is configured to
determine a first indicated pacing interval based on at least one
cardiac interval duration and a previous value of the first
indicated pacing interval. A cardiac pacing circuit coupled to the
controller is configured to provide cardiac pacing to mitigate
disordered breathing based on the first indicated pacing interval.
Systems and methods directed to rate regularization of cardiac
pacing for disordered breathing therapy may be implemented to
include selected features, functions, and/or structures described
in commonly owned, co-pending U.S. Pat. No. 7,336,996, which is
hereby incorporated herein by reference.
[0532] In various implementations, disordered breathing therapy may
comprise overdrive pacing. Overdrive pacing comprises pacing one or
more heart chambers at a rate higher than an intrinsic rate. In
accordance with embodiments of the invention, therapy to mitigate
disordered breathing involves overdrive cardiac pacing of one or
more atria and/or one or more ventricles as treatment for
disordered breathing.
[0533] When operating in the overdrive pacing mode, a cardiac
rhythm management device may deliver pacing pulses at a pacing
preference (PP) rate that is a small amount above the intrinsic
heart rate. If intrinsic beats are detected, the PP rate may be
increased until it becomes slightly faster than the intrinsic heart
rate of the sensed beat. The PP rate may then be gradually
decreased to search for the intrinsic heart rate. After an
intrinsic beat is sensed, the PP rate may be increased until the
pacing rate is a small amount above the intrinsic heart rate.
[0534] In one implementation, a CRM device may be switched to
operate in the overdrive pacing mode upon detection or prediction
of disordered breathing. In another implementation, the CRM device
may be switched to operate in the overdrive pacing mode following a
determination that the patient is asleep. In yet another
implementation, characteristics of the disordered breathing are
used to develop an indicated pacing interval. The description that
follows involves atrial overdrive pacing in the AAI(R) or DDD(R)
modes. It will be appreciated that similar techniques may be
implemented to effect ventricular overdrive pacing in the VVI(R)
mode or overdrive pacing in a biventricular mode.
[0535] FIG. 100 is a block diagram illustrating a pacemaker
controller 10025 in accordance with embodiments of the invention.
The pacemaker controller 10025 uses signals from several different
inputs to modify the rate at which pacing or other therapy is
delivered. For example, Input #1 may provide information about
atrial heart rate, Input #2 may provide information about
ventricular heart rate, Input #3 may provide an accelerometer-based
indication of activity, and Input #4 may provide an impedance-based
indication of respiration, such as minute ventilation. Based on at
least one of these and/or other inputs, controller 10025 provides
an output indication of pacing rate as a control signal delivered
to a therapy delivery circuit, such as to one or more of an atrial
therapy delivery circuit and a ventricular therapy delivery
circuit.
[0536] Various methods and systems for implementing impedance
measurements in a cardiac rhythm management device are described in
commonly owned U.S. Pat. Nos. 6,463,326, 6,161,042, 6,076,015 which
are incorporated herein by reference.
[0537] Atrial and ventricular therapy delivery circuits issue
pacing pulses based on one or more such control signals received
from controller 10025. Control of the pacing rate may be performed
by controller 10025, either alone or in combination with peripheral
circuits or modules, using software, hardware, firmware, or any
combination of the like. The software embodiments provide
flexibility in how inputs are processed and may also provide the
opportunity to remotely upgrade the device software while still
implanted in the patient without having to perform surgery to
remove and/or replace the device.
[0538] In various embodiments, a CRM device provides cardiac pacing
therapy to treat disordered breathing. The CRM device obtains
intervals between successive sensed or evoked atrial beats. The CRM
device computes a new first indicated pacing interval based at
least in part on the duration of a cardiac interval and a previous
value of the first indicated pacing interval. In various
implementations, the cardiac interval duration used to compute the
new first indicated pacing interval may comprise a previous cardiac
interval duration or a most recent cardiac interval duration. The
CRM device provides pacing therapy delivered at a rate
corresponding to the inverse of the duration of the first indicated
pacing interval.
[0539] FIG. 101 is a block diagram illustrating one
conceptualization of portions of the controller 10025 used to
effect overdrive pacing for disordered breathing therapy in
accordance with embodiments of the invention. The description that
follows involves atrial overdrive pacing in the AAI(R) or DDD(R)
modes. It will be appreciated that similar techniques may be
implemented to effect ventricular overdrive pacing in the VVI(R)
mode or overdrive pacing in a biventricular mode.
[0540] At least one signal from an atrial sensing circuit is
received by atrial event module 501, which recognizes the
occurrence of atrial events included within the signal. Such events
are also referred to as "beats," "activations," "depolarizations,"
"P-waves," or "contractions." Atrial event module 10101 may detect
intrinsic events (also referred to as sensed events) from the
signal obtained from atrial sensing circuit. Atrial event module
10101 may also detect evoked events (resulting from a pace) either
from the signal obtained from atrial sensing circuit, or preferably
from an atrial pacing control signal obtained from pacing control
module 10105, which also triggers the delivery of a pacing stimulus
by atrial therapy circuit. Thus, atrial events include both
intrinsic/sensed events and evoked/paced events.
[0541] A time interval between successive atrial events, referred
to as an A-A interval, is recorded by a first timer, such as A-A
interval timer 10110. A filter 10115 computes a "first indicated
pacing interval," i.e., one indication of a desired time interval
between atrial events or, stated differently, a desired atrial
heart rate. The first indicated pacing interval is also referred to
as an atrial pacing preference (APP) indicated pacing interval. In
various embodiments, filter 10115 includes an averager, a weighted
averager, a median filter, an infinite impulse (IIR) filter, a
finite impulse response (FIR) filter, or any other analog or
digital signal processing circuit providing the desired signal
processing described more particularly below.
[0542] In one embodiment, filter 10115 computes a new value of the
first indicated pacing interval (also referred to as the
APP-indicated pacing interval) based on the duration of the most
recent A-A interval recorded by timer 10110 and on a previous value
of the first indicated pacing interval stored in first indicated
pacing interval register 10120. Register 10120 is then updated by
storing the newly computed first indicated pacing interval in
register 10120. Based on the first indicated pacing interval stored
in register 10120, pacing control module 10105 delivers control
signals to atrial therapy circuit for delivering therapy, such as
pacing stimuli, at the APP-indicated atrial heart rate
corresponding to the inverse of the duration of the first indicated
pacing interval.
[0543] FIG. 102 is a signal flow diagram illustrating one
embodiment of operating filter 10115. Upon the occurrence of a
sensed or evoked atrial beat, timer 10110 provides filter 10115
with the duration of the A-A interval concluded by that beat, which
is referred to as the most recent A-A interval (AA.sub.n). Filter
10115 also receives the previous value of the first indicated
pacing interval (T.sub.n-1) stored in register 10120. The most
recent A-A interval AA.sub.n and the previous value of the first
indicated pacing interval T.sub.n-1 are each scaled by respective
constants A and B, and then summed to obtain a new value of the
first indicated pacing interval (T.sub.n), which is stored in
register 10120 and provided to pacing control module 10105. In one
embodiment, the coefficients A and B are different values, and are
either programmable, variable, or constant.
[0544] If no atrial beat is sensed during the new first indicated
pacing interval T.sub.n, which is measured as the time from the
occurrence of the atrial beat concluding the most recent A-A
interval AA.sub.n, then pacing control module 10105 instructs
atrial therapy circuit to deliver an atrial pacing pulse upon the
expiration of the new first indicated pacing interval T.sub.n. In
one embodiment, operation of the filter is described by
T.sub.n=AAA.sub.n+BT.sub.n-1, where A and B are coefficients (also
referred to as "weights"), AA.sub.n is the most recent A-A interval
duration, and T.sub.n-1 is the previous value of the first
indicated pacing interval.
[0545] From these examples, it can be seen that the first indicated
pacing interval can be calculated using either a sensed or paced
terminating event and using either a sensed or paced initiating
event.
[0546] Initialization of filter 10115 includes seeding the filter
by storing, in register 10120, an initial interval value. In one
embodiment, register 10120 is initialized to an interval value
corresponding to a lower rate limit (LRL), i.e., a minimum rate at
which pacing pulses are delivered by device. Register 10120 could
alternatively be initialized with any other suitable value.
[0547] In one embodiment, operation of filter 10115 is based on
whether the beat concluding the most recent A-A interval AA.sub.n
is a sensed/intrinsic beat or a paced/evoked beat. In this
embodiment, the pacing control module 10105, which controls the
timing and delivery of pacing pulses, provides an input to filter
10115 that indicates whether the most recent A-A interval AA.sub.n
was concluded by an evoked beat initiated by a pacing stimulus
delivered by CRM device, or was concluded by an intrinsic beat
sensed by atrial sensing circuit.
[0548] In general terms, if the most recent A-A interval AA.sub.n
is concluded by a sensed/intrinsic beat, then filter 10115 provides
a new first indicated pacing interval T.sub.n that is adjusted from
the value of the previous first indicated pacing interval
T.sub.n-1. For example, the new first indicated pacing interval
T.sub.n may be decreased by an amount that is based at least
partially on the duration of the most recent A-A interval AA.sub.n
and on the duration of the previous value of the first indicated
pacing interval T.sub.n-1. If, however, the most recent A-A
interval AA.sub.n is concluded by a paced/evoked beat, then filter
10115 may provide a new first indicated pacing interval T.sub.n
that is increased from the value of the previous first indicated
pacing interval T.sub.n-1. For example, the new first indicated
pacing interval T.sub.n may be increased by an amount that is based
at least partially on the duration of the most recent A-A interval
AA.sub.n and on the duration of the previous value of the first
indicated pacing interval T.sub.n-1. If no atrial beat is sensed
during the new first indicated pacing interval T.sub.n, measured as
the time from the occurrence of the atrial beat concluding the most
recent A-A interval AA.sub.n, then pacing control module 10105 may
instruct the atrial therapy circuit to deliver an atrial pacing
pulse upon the expiration of the new first indicated pacing
interval T.sub.n.
[0549] FIG. 103 is a signal flow diagram illustrating another
conceptualization of operating filter 10115, with certain
differences from FIG. 102 more particularly described below. In
this embodiment, the pacing control module 10105, which controls
the timing and delivery of pacing pulses, provides an input to
filter 10115 that indicates whether the most recent A-A interval
AA.sub.n was concluded by an evoked beat initiated by a pacing
stimulus delivered by the CRM device, or was concluded by an
intrinsic beat sensed by a trial sensing circuit.
[0550] If the most recent A-A interval AA.sub.n was concluded by an
intrinsic beat, then the most recent A-A interval, AA.sub.n, and
the previous value of the first indicated pacing interval,
T.sub.n-1, are each scaled by respective constants A and B, and
then summed to obtain the new value of the first indicated pacing
interval T.sub.n, which is stored in register 10120 and provided to
pacing control module 10105. Alternatively, if the most recent A-A
interval AA.sub.n was concluded by an evoked/paced beat, then the
most recent A-A interval AA.sub.n and the previous value of the
first indicated pacing interval T.sub.n-1 are each scaled by
respective constants C and D, and then summed to obtain the new
value of the first indicated pacing interval T.sub.n, which is
stored in register 10120 and provided to pacing control module
10105. In one embodiment, the coefficients C and D are different
from each other, and are either programmable, variable, or
constant. In a further embodiment, the coefficient C is a different
value from the coefficient A, and/or the coefficient D is a
different value than the coefficient B, and these coefficients are
either programmable, variable, or constant. In another embodiment,
the coefficient D is the same value as the coefficient B.
[0551] In one embodiment, operation of filter 10115 is described by
T.sub.n=AAA.sub.n+BT.sub.n-1, if AA.sub.n is concluded by an
intrinsic beat, and is described by T.sub.n=CAA.sub.n+DT.sub.n-1,
if AA.sub.n is concluded by a paced beat, where A, B, C and D are
coefficients (also referred to as "weights"), AA.sub.n is the most
recent A-A interval duration, T.sub.n is the new value of the first
indicated pacing interval, and T.sub.n-1 is the previous value of
the first indicated pacing interval. If no atrial beat is sensed
during the new first indicated pacing interval T.sub.n, which is
measured as the time from the occurrence of the atrial beat
concluding the most recent A-A interval AA.sub.n, then pacing
control module 10105 instructs atrial therapy circuit to deliver an
atrial pacing pulse upon the expiration of the new first indicated
pacing interval T.sub.n.
[0552] Another approach to operating filter 10115 is illustrated in
the signal flow graph of FIG. 104. In this embodiment, the
coefficients A, B, C, and D can be more particularly described
using an intrinsic coefficient (a), a paced coefficient (b), and a
weighting coefficient (w). In one such embodiment, A=aw, B=(1-w),
C=bw, and D=(1-w). In one example, operation of the filter 10115 is
described by T.sub.n=awAA.sub.n+(1-w)T.sub.n-1, if AA.sub.n is
concluded by an intrinsic beat, otherwise is described by
T.sub.n=bwAA.sub.n+(1-w)T.sub.n-1, if AA.sub.n is concluded by a
paced beat.
[0553] If no atrial beat is sensed during the new first indicated
pacing interval T.sub.n, which is measured as the time from the
occurrence of the atrial beat concluding the most recent A-A
interval AA.sub.n, then pacing control module 10105 instructs
atrial therapy circuit to deliver an atrial pacing pulse upon the
expiration of the new first indicated pacing interval T.sub.n. In
one embodiment, the coefficients a and b are different from each
other, and are either programmable, variable, or constant.
[0554] The above-described parameters (e.g., A, B, C, D, a, b, w)
are stated in terms of time intervals (e.g., AA.sub.n, T.sub.n,
T.sub.n-1). However, an alternate system may produce results in
terms of rate, rather than time intervals, without departing from
the present method and apparatus. In one embodiment, weighting
coefficient w, intrinsic coefficient a, and paced coefficient b,
are variables. Different selections of w, a, and b, will result in
different operation of the present method and apparatus. For
example, as w increases the weighting effect of the most recent A-A
interval AA.sub.n increases and the weighting effect of the
previous first indicated pacing rate T.sub.n-1 decreases. In one
embodiment, w= 1/16=0.0625. In another embodiment, w= 1/32. Another
possible range for w is from w=1/2 to w= 1/1024. A further possible
range for w is from about 0 to about. 1. Other values of w, which
need not include division by powers of two, may be substituted
without departing from the present method and apparatus.
[0555] In one embodiment, intrinsic coefficient a, is selected to
be less than (or, alternatively, less than or equal to) 1.0. In one
example, the intrinsic coefficient a is selected to be lesser in
value than the pacing coefficient b. In one embodiment, a may be
about.0.6 and b may be about 1.5. In another embodiment, a=1.0 and
b=1.05. One possible range for a is from a=0.6 to a=1.0, and for b
is from b=1.05 to b=1.5. The coefficients may vary without
departing from the present method and apparatus.
[0556] In one embodiment, for a<1.0, filter 10115 provides a new
first indicated pacing interval T.sub.n that is at least slightly
shorter than the expected intrinsic A-A interval being measured by
timer 10115. Thus, filter 10115 operates to promote atrial pacing
by increasing the APP-indicated rate until it becomes slightly
faster than the intrinsic atrial rate. The APP-indicated rate is
then gradually decreased to search for the underlying intrinsic
atrial heart rate. After a sensed atrial beat, the APP filter 10115
again increases the APP indicated pacing rate until it becomes
faster than the intrinsic atrial rate by a small amount. As a
result, most atrial heart beats are paced, rather than sensed.
[0557] The overdrive pacing as described above, or as implemented
in connection with pacing one or more ventricles may be provided as
therapy for disordered breathing. Additionally, such pacing therapy
may be activated upon detection or prediction of disordered
breathing. For example, pacing may occur at a programmed rate until
a disordered breathing episode is detected. After detection of
disordered breathing, the CRM device may switch to overdrive pacing
to mitigate the disordered breathing.
[0558] In another example, the CRM may deliver pacing at a
programmed rate until patient conditions indicate that disordered
breathing is likely to occur. After disordered breathing is
predicted, the CRM may deliver overdrive pacing to prevent or
mitigate episodes of disordered breathing.
[0559] Although disordered breathing may occur while the patient is
awake, it is most likely to occur during sleep. In another example,
the CRM may be equipped with a sleep detection system. The CRM may
switch from pacing at a programmed rate to overdrive pacing when
the CRM detects that the patient is asleep or when the CRM detects
a particular sleep state, e.g., non-REM sleep.
[0560] FIG. 105 is a block diagram illustrating generally, by way
of example, but not by way of limitation, another conceptualization
of portions of controller 10025, with certain differences from FIG.
101 more particularly described below. In FIG. 105, controller
10025 receives from a disordered breathing therapy control circuit
a control signal indicating an overdrive pacing rate for disordered
breathing therapy. The signal may be based, for example, on the
severity, duration, frequency or type of disordered breathing
experienced by the patient, or by other factors, such as therapy
interaction and/or patient comfort. In one example, the control
signal may be based on a disordered breathing index, such as an
apnea/hypopnea index. The disordered breathing therapy pacing rate
is expressed in terms of a second indicated pacing interval stored
in register 3910.
[0561] Pacing control module 10105 delivers a control signal, which
directs atrial therapy circuit to deliver a pacing pulse, based on
either (or both) of the first or second indicated pacing intervals,
stored in registers 10120 and 3910, respectively. In one
embodiment, pacing control module 10105 includes a selection module
3915 that selects between the new first indicated pacing interval
T.sub.n and the second indicated pacing interval that is modulated
by disordered breathing conditions.
[0562] In one embodiment, selection module 10525 selects the
shorter of the first and second indicated pacing intervals as the
selected indicated pacing interval S.sub.n. If no atrial beat is
sensed during the selected indicated pacing interval S.sub.n, which
is measured as the time from the occurrence of the atrial beat
concluding the most recent A-A interval AA.sub.n, then pacing
control module 10105 instructs atrial therapy circuit to deliver an
atrial pacing pulse upon the expiration of the selected indicated
pacing interval S.sub.n.
[0563] In general terms, for this embodiment, the atrium is paced
at the higher of the disordered breathing therapy rate and the
APP-indicated rate. If, for example, the patient is experiencing no
disordered breathing or only mild disordered breathing, the
disordered breathing therapy rate is lower than the patient's
intrinsic rate, then atrial pacing pulses will be delivered at the
APP-indicated rate, which is typically slightly higher than the
patient's intrinsic atrial heart rate. But if, for example, the
patient is experiencing more significant disordered breathing, so
that the disordered breathing therapy rate is higher than the
APP-indicated rate, then pacing pulses generally will be delivered
at the disordered breathing therapy rate. In an alternative
embodiment, the pacing rate is determined by blending the
disordered breathing therapy rate and the APP-indicated rate,
rather than by selecting the higher of these two indicated rates
(i.e., the shorter of the first and second indicated pacing
intervals). In one such example, selection module 10525 applies
predetermined or other weights to the first and second indicated
pacing intervals to compute the selected pacing interval
S.sub.n.
[0564] FIG. 106 is a graph illustrating generally, by way of
example, but not by way of limitation, one embodiment of an
APP-indicated rate for successive atrial heart beats for one mode
of operating filter 10115. As discussed above, the APP-indicated
rate is simply the frequency, between atrial heart beats,
associated with the first indicated pacing interval. Stated
differently, the APP indicated rate is inversely related to the
duration of the first indicated pacing interval. If pacing is based
solely on the APP indicated rate, pacing control module 10105
directs atrial therapy circuit to issue a pacing pulse after the
time since the last atrial beat equals or exceeds the first
indicated pacing interval. However, as described above, in certain
embodiments, pacing control module 10105 directs atrial therapy
circuit to issue a pacing pulse based on factors other than the APP
indicated rate, for example, based on the severity of disordered
breathing experienced by the patient.
[0565] In the example illustrated in FIG. 106, a first paced atrial
beat, indicated by a "P" was issued upon expiration of the first
indicated pacing interval (i.e., the APP indicated pacing interval)
T.sub.0, as computed based on a previous atrial beat. In one
embodiment, the new APP indicated pacing interval T.sub.1 is
computed based on the duration of most recent A-A interval AA.sub.1
and a previous value of the APP indicated pacing interval T.sub.0,
as discussed above. In FIG. 106, the new APP indicated pacing
interval T.sub.1 corresponds to a lower rate limit (LRL) time
interval. In one embodiment, as illustrated in FIG. 106, the
allowable range of the APP indicated pacing interval is limited so
that the APP indicated pacing interval does not exceed the duration
of the LRL time interval, and so that the APP indicated pacing
interval is not shorter than the duration of an upper rate limit
(URL) time interval.
[0566] In the example of FIG. 106, the second atrial beat is also
paced upon expiration of the APP indicated pacing interval T.sub.1.
In one embodiment, the new APP indicated pacing interval T.sub.2 is
computed based on the duration of most recent A-A interval AA.sub.2
and a previous value of the APP indicated pacing interval, T.sub.1,
as discussed above. The first and second atrial beats are paced
beats because the APP indicated atrial heart rate is higher than
the underlying intrinsic atrial heart rate.
[0567] The third atrial beat is sensed well before expiration of
the APP indicated pacing interval T.sub.2, such that no pacing
pulse is issued. For the sensed third atrial beat, filter 10115
computes the new APP indicated pacing interval T.sub.3 as being
shorter in duration relative to the previous APP indicated pacing
interval T.sub.2.
[0568] The fourth, fifth, and sixth atrial beats are sensed before
expiration of the APP indicated pacing interval T.sub.3, T.sub.4,
and T.sub.5, respectively. For each of the sensed fourth, fifth,
and sixth atrial beats, filter 10115 computes a new APP indicated
pacing interval as being shorter in duration relative to the
previous APP indicated pacing interval.
[0569] At the time of the seventh atrial beat, the APP indicated
heart rate has increased above the underlying intrinsic atrial
heart rate, such that the seventh atrial beat is paced upon
expiration of the APP indicated pacing interval T.sub.6. Because
the seventh atrial beat is paced, rather than sensed, the new APP
indicated pacing interval T.sub.7 is computed as being longer than
the previous APP indicated pacing interval T.sub.6.
[0570] Similarly, the eighth and ninth atrial beats are each paced
upon expiration of the corresponding APP indicated pacing interval,
i.e., T.sub.7, and T.sub.8, respectively. Each APP indicated pacing
interval T.sub.7, and T.sub.8 is longer than the corresponding
previous APP indicated pacing interval, i.e., T.sub.6, and T.sub.7,
respectively. In this way, the APP indicated atrial heart rate is
gradually decreased to search for the underlying intrinsic atrial
heart rate.
[0571] At the time of the tenth atrial beat, the APP indicated
heart rate has been lowered sufficiently to allow the sensing of
the tenth atrial beat. The tenth atrial beat is sensed before
expiration of the APP indicated pacing interval T.sub.9, such that
no pacing pulse is issued. For the sensed tenth atrial beat, filter
10115 computes the new APP indicated pacing interval T.sub.10 as
being shorter in duration relative to the previous APP indicated
pacing interval T.sub.9.
[0572] The eleventh atrial beat is paced upon expiration of the APP
indicated pacing interval T.sub.10. For the paced eleventh atrial
beat, filter 10115 computes the new APP indicated pacing interval
T.sub.11 as being longer in duration relative to the previous APP
indicated pacing interval T.sub.10. Similarly, the twelfth and
thirteenth atrial beats are each paced upon expiration of the
corresponding APP indicated pacing interval, i.e., T.sub.11, and
T.sub.12, respectively. Each APP indicated pacing interval
T.sub.12, and T.sub.13 is longer than the corresponding previous
APP indicated pacing interval, i.e., T.sub.11, and T.sub.12,
respectively. In this way, the APP indicated atrial heart rate is
gradually decreased to find the underlying intrinsic atrial heart
rate.
[0573] The fourteenth atrial beat is sensed before expiration of
the APP indicated pacing interval T.sub.13, such that no pacing
pulse is issued. For the sensed fourteenth atrial beat, filter
10115 computes the new APP indicated pacing interval T.sub.14 as
being shorter in duration relative to the previous APP indicated
pacing interval T.sub.13.
[0574] The fifteenth atrial beat is paced upon expiration of the
APP indicated pacing interval T.sub.14. For the paced fifteenth
atrial beat, filter 10115 computes the new APP indicated pacing
interval T.sub.15 as being longer in duration relative to the
previous APP indicated pacing interval T.sub.14.
[0575] The intrinsic coefficient a of filter 10115 controls the
"attack slope" of the APP indicated heart rate as the APP indicated
heart rate increases because of sensed intrinsic beats. The paced
coefficient b of filter 10115 controls the "decay slope" of the APP
indicated heart rate as the APP indicated heart rate decreases
during periods of paced beats.
[0576] In one embodiment, in which a<1.0 and b>1.0,
decreasing the value of a further beneath 1.0 increases the attack
slope such that the APP indicated rate increases faster in response
to sensed intrinsic beats, while decreasing the value of b toward
1.0 decreases the decay slope such that the APP indicated rate
decreases more slowly during periods of paced beats. Conversely,
for a<1.0 and b>1.0, increasing the value of a toward 1.0
decreases the attack slope such that the APP indicated rate
increases more slowly in response to sensed intrinsic beats, while
increasing the value of b from 1.0 increases the decay slope such
that the APP indicated rate decreases more quickly during periods
of paced beats.
[0577] In one embodiment, for a<1.0 and b>1.0, decreasing
both a and b increases the APP indicated rate such that the APP
indicated rate is higher above the mean intrinsic rate. Because the
APP indicated rate is higher, variability in the intrinsic heart
rate is less likely to result in sensed events. On the other hand,
for a<1.0 and b>1.0, increasing both a and b decreases the
APP indicated rate such that it is closer to, the mean intrinsic
rate. Because the APP indicated rate is closer to the mean
intrinsic rate, the same degree of variability in the intrinsic
heart rate is more likely to result in sensed events. Thus, by
adjusting the coefficients of filter 10115, as discussed above, it
is possible to obtain more intrinsic beats than paced beats for a
particular degree of variability in the patient's heart rate.
[0578] In one embodiment, these coefficients are programmable by
the user, such as by using remote programmer. In another
embodiment, the user selects a desired performance parameter (e.g.,
desired degree of overdrive pacing, desired attack slope, desired
decay slope, etc.) from a corresponding range of possible values,
and CRM device automatically selects the appropriate combination of
coefficients of filter 10115 to provide a filter setting that
corresponds to the selected user-programmed performance parameter,
as illustrated generally by Table 6. Other levels of
programmability or different combinations of coefficients may also
be used.
TABLE-US-00006 TABLE 6 Example of Automatic Selection of Aspects of
Filter Setting Based on a User-Programmable Performance Parameter.
User-Programmable Performance Intrinsic Paced Parameter Coefficient
a Coefficient b 1 (Less Aggressive Attack/Decay) 1.0 1.05 2 0.9 1.2
3 0.8 1.3 4 0.7 1.4 5 (More Aggressive Attack/Decay) 0.6 1.5
[0579] FIG. 106 illustrates that sensed atrial beats increase the
APP indicated rate by an amount that is based on the sensed atrial
heart rate. Thus, for an abrupt and large increase in sensed atrial
rate, the APP indicated rate will increase faster than for a slower
and smaller increase in sensed atrial heart rate. However,
increases in the APP indicated rate do not depend solely on the
sensed atrial heart rate. Instead, such increases in the APP
indicated heart rate also depend on the previous value of the APP
indicated heart rate. This provides a smoothing function so that
the APP indicated heart rate is not overly sensitive to a single
extremely premature atrial beat, changes in the atrial rate are
more gradual, and the degree of such rate changes is programmably
adjustable, as described above. Moreover, in one embodiment, filter
10115 operates continuously to provide continuous rate adjustment
based on the APP indicated rate.
[0580] FIG. 107 is a graph illustrating generally, by way of
example, but not by way of limitation, one embodiment of selecting
between more than one indicated pacing interval. FIG. 107 is
similar to FIG. 106 in some respects, but FIG. 107 includes a
second indicated pacing interval. In one embodiment, the first
indicated pacing interval is the APP indicated pacing interval,
described above, and the second indicated pacing interval is a
disordered breathing therapy pacing interval, based on the
severity, frequency, duration, type, or other parameter of
disordered breathing experienced by the patient.
[0581] In one embodiment, a selected indicated pacing interval is
based on the shorter of the first and second indicated pacing
intervals. Stated differently, CRM device provides pacing pulses at
the higher indicated pacing rate. In the example illustrated in
FIG. 107, the first and second beats and the eighth through
fifteenth beats are paced at the disordered breathing therapy
indicated rate, because it is higher than the APP indicated atrial
rate and the intrinsic (sensed) atrial rate. The third, fourth,
fifth and sixth atrial beats are sensed intrinsic beats that are
sensed during the shorter of either of the APP and sensor indicated
pacing intervals. The seventh beat is paced at the APP indicated
rate, because it is higher than the disordered breathing therapy
indicated rate, and because no intrinsic beat is sensed during the
APP indicated interval T.sub.6. In this embodiment, the ranges of
both the sensor indicated rate and the APP indicated rate are
limited so that they do not extend to rates higher than the URL or
to rates lower than the LRL. In one embodiment, the above-described
equations for filter 10115 operate to increase the APP indicated
rate toward the disordered breathing therapy indicated rate when
the sensor indicated rate is greater than the APP indicated rate,
as illustrated by first through third and eighth through fifteenth
beats in FIG. 107. In an alternate embodiment, however,
T.sub.n=bwAA.sub.n+(1-w)T.sub.n-1, if AA.sub.n is concluded by a
APP indicated paced beat, and T.sub.n=T.sub.n-1 if AA.sub.n is
concluded by a disordered breathing therapy indicated paced beat,
thereby leaving the APP indicated rate unchanged for disordered
breathing therapy indicated paced beats. In one embodiment, the LRL
and the URL are programmable by the user, such as by using remote
programmer.
[0582] In one embodiment, filter 10115 includes variable
coefficients such as, for example, coefficients that are a function
of heart rate (or its corresponding time interval). In one example,
operation of the filter 10115 is described by
T.sub.n=awAA+(1-w)T.sub.n-1, if AA.sub.n is concluded by an
intrinsic beat, otherwise is described by
T.sub.n=bwAA.sub.n+(1-w)T.sub.n-1, if AA.sub.n is concluded by a
paced beat, where at least one of a and b are linear, piecewise
linear, or nonlinear functions of one or more previous A-A
intervals such as, for example, the most recent A-A interval,
AA.sub.n.
[0583] FIG. 108 is a graph illustrating generally, by way of
example, but not by way of limitation, one embodiment of using at
least one of coefficients a and b as a function of one or more
previous A-A intervals such as, for example, the most recent A-A
interval, AA.sub.n. In one such example, a is less than 1.0 when
AA.sub.n is at or near the lower rate limit (e.g., 1000 millisecond
interval or 60 beats/minute), and a is greater than 1.0 when
AA.sub.n is at or near the upper rate limit (e.g., 500 millisecond
interval or 120 beats/minute). For a constant b, using a smaller
value of a at lower rates will increase the pacing rate more
quickly for sensed events; using a larger value of a at higher
rates increases the pacing rate more slowly for sensed events. In
another example, b is close to 1.0 when AA.sub.n is at or near the
lower rate limit, and b is greater than 1.0 when AA.sub.n is at or
near the upper rate limit. For a constant a, using a smaller value
of b at lower rates will decrease the pacing rate more slowly for
paced events; using a larger value of b at higher rates decreases
pacing rate more quickly for paced events.
[0584] The above-described system provides, among other things, a
cardiac rhythm management system including an atrial pacing
preference (APP) filter for promoting atrial pacing. The APP filter
controls the timing of delivery of atrial pacing pulses. The atrial
pacing preference pacing may be initiated upon detection or
prediction of disordered breathing, for example, to provide
overdrive pacing to terminate or mitigate occurrences of disordered
breathing.
[0585] The atrial pacing pulses are delivered at a first indicated
pacing rate, i.e., the APP-indicated rate, that is typically at a
small amount above the intrinsic atrial heart rate. For sensed
beats, the APP indicated pacing rate is increased until it becomes
slightly faster than the intrinsic atrial heart rate. The
APP-indicated pacing rate is then gradually decreased to search for
the underlying intrinsic atrial heart rate. Then, after a sensed
atrial beat, the APP filter again increases the APP indicated
pacing rate until it becomes faster than the intrinsic atrial rate
by a small amount. As a result, most atrial heart beats are paced,
rather than sensed.
[0586] Although the preceding discussion contemplates providing
atrial overdrive pacing for disordered breathing therapy, similar
processes for providing ventricular overdrive pacing or
bi-ventricular overdrive pacing may be implemented. The pacing rate
may be adjusted based on characteristics of the disordered
breathing experienced by the patient. For example, the overdrive
pacing may be modulated by the type, severity, frequency, and/or
duration of the disordered breathing.
[0587] Further, the smoothed pacing rate may be limited. For
example, the pacing rate may be capped or limited before therapy is
delivered. In another implementation, the intrinsic input interval
may be limited to some predetermined value. The predetermined may
be set by the physician or may be determined from other variables.
By limiting the input intrinsic interval, the output pacing rate is
limited. Limiting the smoothed pacing rate may be useful in
managing atrial fibrillation or flutter, for example. Methods and
systems for providing rate regularization for atrial and
ventricular pacing that may be used to implement disordered
breathing therapy in accordance with embodiments of the present
invention are described in commonly owned U.S. Pat. Nos. 6,351,669,
6,353,759, and 6,285,907, which are incorporated herein by
reference.
Sleep Detection
[0588] Aspects of the invention that include sleep detection are
directed to methods and systems configured to monitor, diagnose,
and/or provide patient therapy using one or more individual medical
procedures. Each of the circles 180 illustrated in FIGS. 1B-1D
represents an individual medical procedure providing a specific
monitoring, diagnosis or therapeutic function or set of functions.
Each individual medical procedure may be implemented as a
stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0589] Other aspects of the invention that include sleep detection
are directed to methods and systems configured to monitor,
diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0590] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0591] Embodiments of the invention involve an individual system 64
(FIG. 1D) for detecting sleep. The sleep detection system 64 may be
implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[0592] In various embodiments of the invention, a device for
detecting sleep includes a first sensor for sensing a first
sleep-related signal and a second sensor for sensing a second
sleep-related signal, wherein the first and the second
sleep-related signals are indicative of sleep. A sleep detector
coupled to the first and the second sensors is configured to adjust
a sleep threshold associated with the first sleep-related signal
using the second sleep-related signal. The sleep detector detects a
sleep condition by comparing the first sleep-related signal with
the adjusted threshold. A component of one or more of the sleep
detector, first sensor, and second sensor is implantable.
[0593] In accordance with another embodiment of the present
invention, a method for sleep detection involves adjusting a sleep
threshold associated with a first sleep-related signal using a
second sleep-related signal. The first sleep-related signal is
compared to the adjusted threshold and sleep is detected based on
the comparison.
[0594] Yet another embodiment of the invention includes means for
adjusting a sleep threshold of a first sleep-related signal using a
second sleep-related signal, means for comparing the first
sleep-related signal to the adjusted threshold, and means for
detecting sleep based on the comparison.
[0595] In further embodiment of the invention, a method for
detecting sleep includes sensing a plurality of sleep-related
signals. A relationship is defined between at least two of the
sleep-related signals, the relationship associated with sleep
detection. Sleep is detected using the sleep-related signal
relationship. At least one of the sensing and detecting is
performed at least in part implantably.
[0596] Other embodiments of the invention involve a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes sleep detection. The coordinated system may include,
for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[0597] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
sleep detection unit 64. The sleep detection unit 64 includes a
first sensor configured to sense a first sleep-related signal and a
second sensor configured to sense a second sleep-related signal.
Sleep detection circuitry coupled to the first and the second
sensors is configured to adjust a sleep threshold associated with
the first sleep-related signal using the second sleep-related
signal, and to detect a sleep condition by comparing the first
sleep-related signal with the adjusted threshold, wherein one of
the first sensor, second sensor and sleep detector comprises an
implantable component, and wherein the implantable cardiac device
and the patient-external respiratory therapy device are configured
to operate cooperatively based on the detected sleep condition.
[0598] The implantable and respiratory therapy devices 181, 184 may
operate cooperatively based on sleep detection. For example, a
first therapy may be delivered by the patient-external respiratory
therapy system while the patient is asleep. A second therapy may be
delivered by the implantable cardiac device while the patient is
awake. Thus, the therapy burden may be shifted from one device to
another device based on the detection of sleep.
[0599] Various embodiments of the invention involve the use of
sleep information to adapt therapy for disordered breathing. A
disordered breathing therapy system, may include a sleep detector.
The sleep detector may include circuitry for detecting sleep onset
and offset, sleep stages, including REM and non-REM sleep stages,
and arousals from sleep, including autonomic arousals.
[0600] Collecting information related to sleep involves
discriminating between a state of sleep and a state of wakefulness.
One method of detecting sleep involves comparing one or more
detected physiological conditions to thresholds indicative of
sleep. When the detected conditions are consistent with thresholds
indicating sleep, then sleep onset is declared. For example,
decreased patient activity is a condition associated with sleep.
When the patient's activity falls below a predetermined threshold,
the system declares the onset of sleep. When the patient's activity
rises above the threshold, the system declares the end of sleep. In
a similar manner, a number of patient conditions, such as heart
rate, respiration rate, brain wave activity, etc., may be compared
individually or collectively compared to thresholds or other
indices to detect sleep.
[0601] A method for detecting sleep in accordance with embodiments
of the invention involves adjusting a sleep threshold associated
with a first patient condition using a second patient condition.
The first patient condition is compared to the adjusted threshold
to determine if the patient is asleep or awake.
[0602] FIG. 24 illustrates a sleep detector that may be used in
connection with a therapy system for disordered breathing. The
sleep detector 2436 uses a number of sensors 2401, 2402, 2403 to
sense sleep-related patient conditions. A representative set of
sleep-related conditions include, for example, patient activity,
patient location, posture, heart rate, QT interval, eye movement,
respiration rate, transthoracic impedance, tidal volume, minute
ventilation, brain activity, muscle tone, body temperature, time of
day, and blood oxygen level.
[0603] According to embodiments of the invention, a first
sleep-related condition detected using a sleep detection sensor
2401 is compared to a sleep threshold for detecting the onset and
termination of sleep. A second sleep-related condition, detected
using a threshold adjustment sensor 2402, is used to adjust the
sleep threshold. Although the example described herein involves one
sleep detection sensor 2401 and one threshold adjustment sensor
2402, any number of thresholds or other indices corresponding to a
number of sleep detection sensors may be used. Furthermore,
conditions detected using any number of adjustment sensors may be
used to adjust the thresholds or indices of a plurality of sleep
detection signals. Additional sleep-related signals derived from
one or more confirmation sensors 2403 may optionally be used to
confirm the onset or termination of the sleep condition.
[0604] Signals derived from the sensors 2401, 2402, 2403 are
received by interface circuitry 2431 that may include, for example,
amplifiers, signal processing circuitry, and/or A/D conversion
circuitry for processing each sensor signal. The interface
circuitry 2431 may further include sensor drive circuitry required
to activate the sensors 2401, 2402, 2403.
[0605] The sleep detector 2436 is configured to compare the level
of a first sleep-related condition detected using the sleep
detection sensor 2401 to a sleep threshold adjusted by a second
sleep-related condition detected using the threshold adjustment
sensor 2402. A determination of sleep onset or sleep termination
may be made by the sleep detector 2436 based on the comparison. The
onset or termination of sleep may optionally be confirmed using
patient conditions derived using a sleep confirmation sensor
2403.
[0606] FIG. 25 is a flowchart illustrating a method of detecting
sleep according to embodiments of the invention. A sleep threshold
associated with a first sleep-related patient condition is
established 2505. The sleep threshold may be determined from
clinical data of a sleep threshold acquired using a group of
subjects, for example. The sleep threshold may also be determined
using historical data taken from the particular patient for whom
the sleep condition is to be detected.
[0607] First and second sleep-related conditions are detected 2510,
2520. The first and the second sleep-related conditions may be
detected using sensors implanted in the patient, attached
externally to the patient or located remote from the patient, for
example. The first and the second sleep-related conditions may
include any condition associated with sleep and are not limited to
the representative sleep-related conditions listed above.
[0608] The sleep threshold established for the first sleep-related
condition is adjusted using the second sleep-related condition
2530. For example, if the second sleep-related condition indicates
a high level of activity that is incompatible with a sleep state,
the sleep threshold of the first sleep-related condition may be
adjusted downward to require sensing a decreased level of the first
sleep-related condition before a sleep condition is detected.
[0609] If the first sleep-related condition is consistent with
sleep according to the adjusted sleep threshold 2540, sleep is
detected 2550. If the first sleep-related condition is not
consistent with sleep using the adjusted sleep threshold sleep is
not detected 2560. After either sleep is detected or not detected,
the first and the second sleep-related conditions continue to be
detected 2510, 2520 and the threshold adjusted 2530 allowing
further evaluation of the sleep state.
[0610] The flow chart of FIG. 26 illustrates a method for detecting
sleep using accelerometer and minute ventilation (MV) signals
according to embodiments of the invention. In the method
illustrated in FIG. 26, an accelerometer and a minute ventilation
sensor are used to detect patient activity and patient respiration
conditions, respectively. A preliminary sleep threshold is
determined 2610 with respect to the patient activity condition
sensed by the accelerometer. The preliminary sleep threshold may be
determined from clinical data derived from a group of subjects or
from historical data taken from the patient over a period of
time.
[0611] The activity condition of the patient is monitored 2620
using an accelerometer that may be incorporated in an implantable
cardiac rhythm management system. Alternatively, the accelerometer
may be attached externally to the patient. The patient's MV
condition is monitored 2625, for example, using a transthoracic
impedance sensor. A transthoracic impedance sensor may be
implemented as a component of an implantable CRM device.
[0612] In this embodiment, the patient's activity represents the
sleep detection condition and is compared to the sleep threshold.
The patient's MV is used as the threshold adjustment condition to
adjust the sleep threshold. In addition, in this example, the
patient's heart rate is monitored 2630 and used to provide a sleep
confirmation condition.
[0613] The sleep threshold adjustment is accomplished using the
patient's MV condition to adjust the activity sleep threshold. If
the patient's MV condition is low relative to an expected MV level
associated with sleep, the activity sleep threshold is increased.
Similarly, if the patient's MV level is high relative to an
expected MV level associated with sleep, the activity sleep
threshold is decreased. Thus, when the patient's MV level is high,
less activity is required to make the determination that the
patient is sleeping. Conversely when the patient's MV level is
relatively low, a higher activity level may result in detection of
sleep. The use of two sleep-related conditions to determine the
patient's sleep state enhances the accuracy of sleep detection over
previous methods.
[0614] Various signal processing techniques may be employed to
process the raw sensor signals. For example, a moving average of a
plurality of samples of the sensor signals may be calculated.
Furthermore, the sensor signals may be amplified, filtered,
digitized or otherwise processed.
[0615] If the MV level is high 2635 relative to an expected MV
level associated with sleep, the activity sleep threshold is
decreased 2640. If the MV level is low 2635 relative to an expected
MV level associated with sleep, the activity sleep threshold is
increased 2645.
[0616] If the patient's activity level is less than or equal to the
adjusted sleep threshold 2650, and if the patient is currently not
in a sleep state 2665, then the patient's heart rate is checked
2680 to confirm that the patient is asleep. If the patient's heart
rate is compatible with sleep 2680, then sleep onset is determined
2690. If the patient's heart rate is incompatible with sleep, then
the patient's sleep-related conditions continue to be
monitored.
[0617] If the patient's activity level is less than or equal to the
adjusted sleep threshold 2650 and if the patient is currently in a
sleep state 2665, then a continuing sleep state is determined 2675
and the patient's sleep-related conditions continue to be monitored
for sleep termination to occur.
[0618] If the patient's activity level is greater than the adjusted
sleep threshold 2650 and the patient is not currently in a sleep
state 2660, then the patient's sleep-related conditions continue to
be monitored until sleep onset is detected 2690. If the activity
level is greater than the adjusted sleep threshold 2650 and the
patient is currently in a sleep state 2660, then sleep termination
is detected 2670.
[0619] The graphs of FIGS. 27-30 illustrate the adjustment of the
activity sleep threshold. The relationship between patient activity
and the accelerometer and MV signals is trended over a period of
time to determine relative signal levels associated with sleep.
[0620] The graph of FIG. 27 illustrates the patient's activity as
indicated by an accelerometer. The patient's heart rate (HR) and
sensor indicated heart rate (SIR) for the same period are shown in
the graph of FIG. 28. The accelerometer signal indicates a period
of sleep associated with a relatively low level of activity
beginning slightly before 23:00 and continuing through 6:00. The
patient's heart rate appropriately tracks the activity level
indicated by the accelerometer indicating a similar period of
decreased heart rate corresponding to sleep. The signal level of
the accelerometer during known periods of sleep may be used to
establish a threshold for sleep detection.
[0621] FIG. 29 is a graph of the patient's minute ventilation
signal over time. Historical data of averaged minute ventilation is
graphed to indicate variations over a 24 hour period. MV data is
shown for averages of 1 month to 8 months. The minute ventilation
data may be used to determine the minute ventilation signal level
associated with sleep. In this example, a composite minute
ventilation graph using the historical data presents a roughly
sinusoidal shape with the relatively low minute ventilation levels
occurring during the period approximately from hours 21:00 through
8:00. The decreased minute ventilation level is associated with
periods of sleep. The minute ventilation level associated with
sleep is used to implement sleep threshold adjustment.
[0622] FIG. 30 illustrates adjustment of the activity sleep
threshold using the MV data. The initial sleep threshold 3010 is
established using the baseline activity data acquired as discussed
above. If the patient's MV level is low relative to an expected MV
level associated with sleep, the activity sleep threshold is
increased 3020. If the patient's MV level is high relative to an
expected MV level associated with sleep, the activity sleep
threshold is decreased 3030. When the patient's MV level is high,
less activity detected by the accelerometer is required to make the
determination that the patient is sleeping. However, if the
patient's MV level is relatively low, a higher activity level may
result in detection of sleep. The use of two sleep-related signals
to establish and adjust a sleep threshold enhances the accuracy of
sleep detection over previous methods.
[0623] Additional sleep-related conditions may be sensed and used
to improve the sleep detection method described above. For example,
a posture sensor may be used to detect the posture of the patient
and used to confirm sleep. If the posture sensor signal indicates
an upright posture, then the posture sensor signal may be used to
override a determination of sleep using the sleep detection and
threshold adjustment conditions. Other conditions may also be used
in connection with sleep determination or confirmation, including
the representative set of sleep-related conditions indicated above.
In another example, a proximity to bed sensor may be used alone or
in combination with a posture sensor to detect that the patient is
in bed and is lying down.
[0624] A sleep detection system may detect sleep onset,
termination, arousals as well as the sleep stages, including REM
and non-REM sleep. REM sleep may be discriminated from NREM sleep,
for example, by examining one or more signals indicative of REM,
e.g., muscle atonia, rapid eye movements, or EEG signals. Various
conditions indicative of sleep state may be detected using sensors,
e.g., electroencephalogram (EEG), electrooculogram (EOG), or
electromyogram (EMG) sensors, coupled through wired or wireless
connections to the sleep detection circuitry. The sleep detection
circuitry may analyze the various patient conditions sensed by the
sensors to track the patient's sleep through various sleep states,
including REM and NREM stages.
Sleep Stage Detection
[0625] Aspects of the invention that include sleep stage detection
are directed to methods and systems configured to monitor,
diagnose, and/or provide patient therapy using one or more
individual medical procedures. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0626] Other aspects of the invention involving sleep stage
detection are directed to methods and systems configured to
monitor, diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0627] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0628] Embodiments of the invention involve an individual system
060 (FIG. 1D) for detection sleep stage. The sleep detector 60 may
be implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[0629] Various embodiments of the invention are directed to
classifying various sleep states. In one embodiment of the
invention, a method involves sensing sleep-related conditions and
using the detected sleep-related signals to classify one or more
sleep states of a patient. The sleep-related conditions include at
least one REM-modulated condition and at least one condition
associated with a sleep-wake status of the patient. Classifying the
one or more sleep states is performed at least in part
implantably.
[0630] Another embodiment of the invention involves sensing a
REM-modulated condition and using the REM-modulated condition to
classify one or more sleep states. Classifying the one or more
sleep states is performed at least in part implantably.
[0631] In a further embodiment of the invention, a medical system
includes a detector system, having a sensor configured to sense a
condition associated with REM sleep. The medical system further
includes a classification system coupled to the sensor system and
configured to classify one or more sleep states based on the
condition associated with REM sleep. The classification system
includes an implantable component.
[0632] In yet another embodiment of the invention, a medical system
involves means for detecting conditions related to sleep, including
a condition associated with a sleep-wake status of a patient and a
condition associated with REM sleep. The system further includes
means for classifying one or more sleep states based on the
detected conditions. The means for classifying includes an
implantable component.
[0633] In a further embodiment, a medical system includes means for
sensing a condition associated with REM sleep and means for
classifying a one or more sleep states based on the detected
condition associated with REM sleep. The means for classifying the
one or more sleep states includes an implantable component.
[0634] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes sleep stage classification 60. The coordinated system
may include, for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[0635] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy further
includes a system 60 configured to detect sleep stage. The sleep
stage system includes a detector system comprising a sensor
configured to detect a condition associated with REM sleep. A
classification system is coupled to the detector system and
configured to classify one or more sleep stages based on the one or
more sleep-related conditions. The classification system includes
an implantable component. The implantable cardiac device and the
patient-external respiratory device operate cooperatively based on
the sleep stage classification. Systems and methods directed to
sleep state classification may be implemented to include selected
features, functions, and/or structures described in commonly owned,
co-pending U.S. Publication No. 2005/0043652, which is hereby
incorporated herein by reference.
[0636] Sleep and its various states have been linked to an increase
in respiratory and cardiac disorders, particularly for patients
with cardiopulmonary disorders. For example, some epidemiologic
studies note a peak incidence of sudden cardiac death around 5 to 6
am. One explanation for this peak suggests an association between
the incidence of sudden death and episodes of rapid eye movement
(REM) sleep, morning wakening or arousal. The mechanism eliciting
fatal arrhythmia may be related to the intense phasic sympathetic
modulation of the cardiovascular system during the REM state or
morning wakening.
[0637] Non-REM sleep may also be linked to an increased likelihood
of cardiac arrhythmia. Some patients are predisposed to nocturnal
cardiac paroxysms associated with surges in vagal activity. Because
non-REM sleep is associated with conditions of "vagal dominance,"
characterized by lower heart rate and low-to-high frequency power
ratios, non-REM sleep may be implicated in these nocturnal
arrhythmias.
[0638] Sleep may also be associated with increased respiratory
disruptions. Variations in disease, medication, etiology, and
phenotype may all contribute to a patient's sleep state
propensities to cardiac or respiratory disorders. Sleep stage
classification may be used to provide more effective therapy,
better diagnostic information, and improved prognostic and
preventive therapy capabilities. Sleep stage classification in
concert with therapy may result in improved therapy management for
both cardiac and respiratory conditions, such as those described
above. Tracking physiological changes during sleep may also provide
a mechanism for improved diagnosis of sleep-related disorders.
[0639] Diagnostic testing or therapeutic device testing may be
advantageously performed during sleep or during particular sleep
stages. Diagnostic testing may involve, for example, assessing the
patient's autonomic integrity during sleep and the possible use of
REM episodes as a surrogate for stress testing. Performing
diagnostic procedures during sleep recognizes opportunities
afforded by sleep or particular sleep stages to routinely perturb
the cardiovascular system under controlled conditions to assess the
patient's autonomic response.
[0640] Therapeutic device testing, such as AVI search, capture
threshold, and cardiac template acquisition, may also be performed
during sleep. Sleep provides a period of time to perform such
therapeutic device tests while the patient's activity is low,
resulting in more effective and consistent testing conditions.
[0641] Various embodiments of the invention involve sensing a
physiological condition associated with REM sleep and using the REM
condition to classify the patient's sleep stages. REM-modulated
conditions represent a group of physiological conditions that
change during REM sleep and may be used to discern REM sleep from
non-REM periods. REM sleep, as indicated by its name, is
characterized by rapid bursts of eye movements, intense brain
activity, and a general state of atonia, or skeletal muscle
paralysis.
[0642] Various embodiments of the invention exploit the marked loss
of skeletal muscle tone during REM to produce a REM-modulated
signal. In this implementation, sensing a REM-modulated signal
involves sensing the patient's skeletal muscle tone. Other
REM-modulated signals may be used to detect REM sleep, including,
for example, eye movement and brain wave activity. A representative
set of sensors that may be used to sense REM-modulated signals
include, for example, electroencephalogram (EEG) electrodes for
detecting brain activity, electrooculogram (EOG) sensors for
detecting eye movement, sensors for detecting muscle atonia,
including electromyogram (EMG) sensors, strain gauge sensors,
piezoelectric sensors, mechanical force sensor, or other
transducers.
[0643] Sensing a condition associated with REM sleep may be used to
discern REM sleep periods from non-REM periods. Sleep stage
classification may be further enhanced by detecting a condition
associated with a sleep-wake status of the patient, the condition
associated with the sleep-wake status indicating whether the
patient is asleep or awake.
[0644] According to embodiments of the invention, a sleep stage
classification approach involves sensing sleep-related conditions,
including at least one condition modulated by the sleep-wake status
of the patient and a REM-modulated condition. The condition
modulated by the sleep-wake status of the patient represents a
condition that may be used to discriminate between periods of sleep
and periods of wakefulness or arousal. Discriminating between
periods of sleep and periods of wakefulness may be accomplished,
for example, by sensing patient activity. According to this
approach, if the patient's activity level is relatively low, e.g.,
below a sleep threshold, then the patient is determined to be
asleep. The level of patient activity may be detected using an
accelerometer, heart rate sensor, respiratory minute ventilation
(MV) sensor or other types of sensors, for example.
[0645] Information derived from the REM-modulated condition may be
used in combination with information related to the patient's
sleep-wake status. This technique may be used to determine, for
example, sleep onset and sleep offset, the duration and degree of
arousals from sleep, and to classify sleep stages including REM and
non-REM states.
[0646] In accordance with embodiments of the invention, a sleep
stage classification processor receives the outputs of the one or
more sensors configured to sense signals associated with the
sleep-related conditions. The sleep stage processor may perform
sleep stage classification on a real-time basis, or may process
previously acquired and stored sensor data in a batch mode to
retrospectively classify the sleep stages of one or more sleep
periods.
[0647] Sleep stage classification may involve an adaptive approach,
wherein the sleep stage processor learns the physiological
responses of a patient in various sleep stages. The learned
responses may be used to enhance the accuracy and/or sensitivity of
the sleep stage classification. Adaptive sleep stage classification
may involve monitoring the changes in one or more physiological
signals over a period of time and adjusting thresholds used for
determining sleep onset, sleep offset, and various sleep stages to
accommodate the drift or other changes in the sleep-related
signals.
[0648] In one configuration, one or more of the sensors used to
detect the sleep-related conditions, e.g., the REM-modulated
condition and/or the condition associated with the patient's
sleep-wake status, may be implantable, or may utilize an
implantable component. In another configuration, the sleep stage
processor may be partially or fully implantable. In other
configurations, both the sensors and the sleep stage processor may
be implantable or use implantable components.
[0649] As previously discussed, sleep stage classification may be
useful in coordinating sleep stage informed therapy delivery to
treat various disorders and to perform sleep stage informed testing
and monitoring. In one example implementation, cardiac therapy may
be triggered during particular sleep stages to reduce the
likelihood of cardiac arrhythmia during vulnerable sleep periods.
In a similar manner, sleep stage classification may be used to
trigger disordered breathing therapy to preclude or reduce episodes
of sleep-disordered breathing.
[0650] The flow graph of FIG. 109A depicts a method of classifying
sleep stages according to embodiments of the invention. A
REM-modulated condition e.g., brain activity, eye movement, and/or
muscle atonia, is detected 10910 and is used to classify 10920 the
patient's sleep stage. Using the detected REM-modulated condition,
the system may determine that the patient is in a REM sleep stage
or in a non-REM period, for example.
[0651] Another method for classification of sleep stages in
accordance with embodiments of the invention is illustrated in the
flow graph of FIG. 109B. The method involves detecting
sleep-related conditions including at least one REM-modulated
condition 10930 and at least one condition 10940 associated with a
sleep-wake status of the patient. Sleep stage classification is
performed 10950 based on the detected conditions.
[0652] A block diagram of a system 11000 suitable for implementing
a sleep stage classification method according to embodiments of the
invention is illustrated in FIG. 110. The sleep stage
classification system 11000 may include one or more sensors 11030
used to sense a physiological signal associated with the sleep-wake
status of the patient. In one example implementation, the
sleep-wake sensor 11030 may be responsive to patient activity. When
the patient's activity falls below a threshold, the patient is
considered to be asleep. When the patient's activity rises above
the activity threshold, the patient is considered to be awake.
Other methods of detecting whether the patient is asleep or awake
are also possible.
[0653] The system further includes a REM sensor 11020 sensitive to
a REM-modulated physiological condition. REM sleep detection may be
implemented by comparing the output of a skeletal muscle tone
sensor to a threshold, for example. When the REM sensor output
indicates loss of muscle tone consistent with a REM sleep
threshold, the patient is determined to be in REM sleep. The
sleep-wake sensor 11030 and the REM sensor 11020 may optionally be
used in cooperation with additional sensors employed to detect
additional sleep-related conditions. The additional sleep-related
conditions may be used to augment the accuracy, sensitivity, or
other functional capabilities, of the sleep stage classification
system 11000. For example, a patient posture or torso orientation
sensor may be used in combination with a patient activity sensor to
provide enhanced detection of the sleep-wake status of the patient.
If the patient's activity is low, as indicated by the output of a
patient activity sensor, and the patient is lying down, as
indicated by the output of a torso orientation sensor, then the
combination of the two conditions may allow for more accurate sleep
onset detection.
[0654] The REM sensor 11020, the sleep-wake status sensor 11030,
and any additional sensors are coupled to a sleep/sleep stage
detector 11010 that detects and processes the sensor outputs. The
sleep/sleep stage detector 11010 may use outputs from the
sleep-wake sensor 11930 and the REM sensor 11020 to determine if
the patient is awake or asleep, to determine the duration and
degree of arousals from sleep, to classify sleep stages including
REM and non-REM states, and to determine the duration of various
sleep stages, for example.
[0655] In one embodiment, one or both the REM sensor 11020 and the
sleep-wake sensor 11930 are positioned external to the patient and
the sleep/sleep stage detector 11010 is implantable or includes an
implantable component. In another embodiment, one or both the REM
sensor 11020 and the sleep-wake sensor 11030 are fully or partially
implantable and the sleep/sleep stage detector 11010 is positioned
externally to the patient. In yet another embodiment, the REM
sensor 11020, sleep-wake sensor 11030, and the sleep/sleep stage
detector 11010 all include implantable components or are fully
implantable.
[0656] Components of the sleep stage classification system 11000
may employ wireless communications. For examples, the REM sensor
11020 and sleep-wake sensor 11030 may be coupled to the sleep/sleep
stage detector 11010 using a wireless communications link. In one
example, some or all of the sensors 11020, 11030 use remote
communication capabilities, such as a wireless proprietary or a
wireless Bluetooth communications link.
[0657] The sleep/sleep stage detector 11010 may adaptively classify
sleep stages by learning patient responses in connection with
various sleep stages. In one example, the sleep/sleep stage
detector 11010 may perform sleep stage classification by comparing
sensor signal levels to predetermined thresholds. Initial
thresholds may be established using clinical data derived from a
group of individuals, or using patient-specific data. After initial
thresholds have been established, the sleep/sleep stage detector
11010 may update the thresholds to provide more sensitive and/or
more accurate sleep stage classification based on data acquired
from the patient over time. A sleep stage threshold may be updated
by a recent history of the sensor output level associated with a
particular sleep stage. This process may involve collecting data
over time to determine the sleep patterns of the patient and
adjusting the thresholds based on the sleep patterns. By this
process, initially established thresholds, e.g., sleep onset
threshold for an accelerometer output, or REM sleep threshold for
an EMG sensor output, may be modified as additional data is
acquired from the patient regarding the relationship between the
sensor output levels and patient's sleep stage.
[0658] FIG. 111 presents a block diagram illustrating sleep stage
discrimination circuitry 11100 utilizing a sleep stage
classification system implemented in accordance with embodiments of
the invention. Sleep stage discrimination circuitry 11100 may be
employed, for example, to perform sleep stage informed diagnostic
monitoring and/or diagnostic testing to assess the capabilities of
the patient's physiological systems. Such diagnostic monitoring or
testing may involve one or more physiological systems, including,
for example, the cardiac and respiratory systems. Additionally, or
alternatively, the sleep stage discrimination circuitry 11100 may
be used to provide sleep stage informed therapy to a patient, for
example, cardiac rhythm therapy, respiratory therapy, or other
types of therapy enhanced by sleep stage classification. Further,
the sleep stage discrimination circuitry 11100 may be used to
perform sleep stage informed therapeutic device testing. Uses of
the sleep stage discrimination circuitry 11100 may be purely or
predominantly diagnostic, purely or predominantly therapeutic, or
may include a combination of therapeutic and diagnostic
operations.
[0659] The sleep stage discrimination circuitry 11100 includes a
medical device 11101 coupled to a variety of sensors 11105, 11110,
11115. The sensors 11105, 11110, 11115 provide physiological
information used in connection with sleep stage classification and
the therapeutic and/or diagnostic operations performed by the
medical device 11101. The sleep stage sensors 11105 include a
sensor capable of detecting a REM-modulated condition, such as
skeletal muscle atonia. Additional sleep stage sensors, including
one or more sensors indicative of the sleep-wake status of the
patient, e.g., a patient activity sensor, may also be used.
[0660] The medical device 11101 may also be coupled to sensors
11110, 11115 configured to detect one or more aspects of the
patient's physiological systems, including, for example, the
cardiac and/or respiratory functions of a patient. In various
configurations, the medical system 11100 may monitor, test, or
provide therapy to the patient, including cardiac and/or
respiratory therapy. In one implementation, cardiac sensors 11115,
e.g., cardiac electrodes, may be used to sense the electrical
activity of the heart. The cardiac system sensors may comprise
patient-internal or patient-external cardiac electrodes
electrically coupled to the patient's heart tissue, for
example.
[0661] The medical device 11101 may be coupled to one or more
respiratory system sensors 11110 capable of detecting conditions
associated with the respiratory functions of the patient. In one
embodiment, the respiratory functions of the patient may be
monitored using a transthoracic impedance sensor. Transthoracic
impedance tracks the patient's respiratory effort, increasing upon
respiratory inspiration and decreasing upon respiratory expiration.
The transthoracic impedance signal may be used to determine the
patient's respiration tidal volume (TV), minute ventilation (MV),
and/or other respiratory parameters, for example. Sensors other
than, or in addition to, the cardiac and respiration system sensors
described herein may be used to detect cardiac and/or respiration
functions of the patient.
[0662] The sleep/sleep stage detector 11120 uses information from
the sleep stage sensors 11105 to determine the states of the
patient's sleep, including, for example, sleep onset, termination,
REM and non-REM states. Information generated by the sleep/sleep
stage detector 11120 may be used by other components of the medical
device 11101 to provide therapy, testing, and/or monitoring
coordinated with the patient's sleep stage.
[0663] Sleep stage information may be provided to a therapy module
11130 coupled to the sleep/sleep stage detector 11120. The therapy
module 11130 controls the delivery of sleep stage informed therapy
to the patient. For example, cardiac therapy may be coordinated
using sleep stage classification information to provide cardiac
arrhythmia therapy during REM or other proarrhythmic sleep periods.
Sleep stage classification may also be used, for example, in
connection with delivery of sleep informed therapy to preclude or
reduce episodes of disordered breathing while the patient is
asleep. Other types of therapy may also be enhanced using sleep
stage classification.
[0664] The sleep/sleep stage detector 11120 may be coupled to a
monitoring unit 11150 configured to collect and store historical
data acquired from the sleep stage sensors 11105, respiratory
system sensors 11110, the cardiac system sensors 11115, and/or
other components of the medical device 11101. The monitoring unit
11150 may track one or more patient conditions and provide data
used in the analysis of various physiological processes. The
monitoring module 11150 may collect data useful in assessing trends
of various physiological systems. Trending data may be used in
combination with sleep stage classification to identify gradual
changes in the patient's physiological conditions, especially those
altered by sleep, or by particular sleep stages.
[0665] A testing module 11140 may be implemented within the medical
device 11101 to control diagnostic tests and/or to control device
testing to maintain or improve the operation of the medical device
11101. Information from the sleep/sleep stage detector 11120 is
used by the testing module 11140 to ensure that diagnostic and/or
device testing appropriately coincides with a sleep or waking state
of the patient, or to a particular state of sleep.
[0666] Diagnostic testing may be employed to investigate the
functioning of one or more of the patient's physiological systems.
Diagnostic testing may include changing one or more parameters of
the patient's therapy, e.g., cardiac rhythm therapy, and assessing
the impact of the change on the patient. For example, the patient's
therapy regime may be altered during sleep, or during a particular
sleep stage, to determine the effect of the change on the
patient.
[0667] A diagnostic testing methodology may use sleep stage
classification to determine the general behavior of the patient's
physiological responses in connection with various sleep stages.
Such a process may involve determining the patient's intrinsic
responses to normal variations in physiologic processes. In
addition, the patient's evoked physiological responses to
device-based stimuli may also be determined.
[0668] In one implementation of sleep coordinated diagnostic
testing, non-REM sleep may present an opportunity to perform
automatic or physician activated diagnostic testing under
relatively controlled circumstances. The medical device 11101 may
perform diagnostic testing during non-REM sleep when the patient's
activity is low. In one configuration, the medical device 11101 may
modify or implement a particular cardiac pacing regimen during a
non-REM period to determine the effect of such modification on the
patient's cardiac system.
[0669] In addition to diagnostic testing, various device testing
procedures may preferably be conducted while the patient's activity
is low, such as during non-REM sleep. For example, a medical device
11101 providing cardiac rhythm management therapy may perform
device testing to improve or modify a pacing regimen during the
non-REM sleep state. In one implementation, a pacemaker may perform
tests during non-REM sleep to optimize a pacing escape interval,
such as the AV delay of a dual chamber or bi-ventricular device. In
another example, a pacemaker may adjust pacing energy levels based
on a capture threshold test performed during non-REM sleep. In yet
another embodiment, a cardiac rhythm management system may use
non-REM sleep as an opportune period of low patient activity to
acquire or update cardiac waveform morphological templates used to
identify various cardiac arrhythmias.
[0670] The flow graph of FIG. 112 illustrates a method of
performing sleep stage classification in accordance with
embodiments of the invention. The method involves detecting 11210
at least one REM-modulated signal, e.g., a signal modulated by
muscle atonia. If the REM-modulated signal is consistent 11220 with
a predetermined REM sleep threshold, then the system determines if
REM sleep onset has previously been declared 11230. If REM sleep
onset was not previously declared 11230, then the system declares
REM sleep onset 11250.
[0671] If the REM-modulated signal is not consistent 11220 with the
predetermined REM sleep threshold and REM sleep onset was
previously declared 11260, then REM sleep offset is declared 11270.
If the REM-modulated signal is not consistent 11220 with the REM
sleep threshold and REM onset was not previously declared 11260,
the system continues to sense 11210 the REM-modulated signal to
detect REM sleep onset.
[0672] The flow graph of FIG. 113 illustrates a method of using a
sleep-wake condition in combination with a REM-modulated condition
to classify sleep stages according to embodiments of the invention.
According to this implementation, the system determines sleep onset
and sleep offset by comparing a patient activity signal to a
threshold. Various methods of sleep onset and sleep offset
detection, for example, the methodologies described herein may be
used in connection with the sleep stage classification approaches
of the present invention.
[0673] The method illustrated in FIG. 113 involves determining REM
sleep onset and offset using a REM-modulated signal. REM sleep
periods may be classified as intervals between REM onset and
offset. Non-REM sleep periods may be classified as intervals
between sleep onset and offset that are not classified as REM
sleep.
[0674] A signal related to the activity level of the patient, e.g.,
accelerometer signal, is detected 11305 and compared 11310 to a
predetermined sleep threshold. If the patient's activity level is
consistent 11310 with the sleep threshold, and if sleep onset was
previously declared 11315, the system detects 11325 a REM-modulated
signal. If the patient's activity level is not consistent 11310
with a sleep threshold and if sleep onset was previously declared
11345, then sleep offset is declared 11350. If the patient's
activity level is consistent 11310 with the sleep threshold and if
sleep onset was not previously declared 11315, the system declares
sleep onset 11320 and senses 11325 the REM-modulated signal.
[0675] If the REM-modulated signal level is consistent 11330 with a
REM sleep threshold, and REM sleep onset 11335 was not previously
declared, then REM sleep onset is declared 11340. If the
REM-modulated signal level is not consistent 11330 with the REM
sleep threshold and REM onset was previously declared 11355, then
REM sleep offset is declared 11360.
[0676] Using the method illustrated in FIG. 113, sleep onset,
offset, REM, and non-REM sleep may be detected. Periods of REM
and/or non-REM sleep may be advantageously used in connection with
a number of diagnostic and therapeutic operations, as previously
discussed. FIG. 114 is a process flow diagram illustrating a
process for using sleep stage classification in cooperation with
therapy delivery and testing in accordance with embodiments of the
invention.
[0677] As presented in the process flow diagram of FIG. 114, the
system detects 11460 cardiac signals and analyzes 11450 the cardiac
signals on a beat-to-beat basis. Beat-to-beat cardiac signal
analysis 11450 may be used to perform arrhythmia detection 11465
based on rate and/or morphological analysis techniques, for
example. Depending on the type of arrhythmia detected, if any, an
appropriate therapy 11475 may be delivered to the heart. In one
implementation, bradycardia pacing therapy may be delivered to the
heart to maintain the patient's rhythm at a hemodynamically
sufficient rate. In other examples, a variety of tiered
tachyarrhythmia therapies, including, for example, anti-tachycardia
pacing, cardioversion, and/or defibrillation may be available to
treat detected cardiac tachyarrhythmias.
[0678] The illustrative system utilizes REM-modulated and
sleep/wake condition signals 11405 for sleep stage classification
11410. Sleep stage classification 11410 may be used in cooperation
with the beat-to-beat cardiac signal analysis 11450 to implement
sleep stage informed arrhythmia analysis 11455, thus augmenting the
delivery of cardiac arrhythmia therapy 11475. In one example,
bradycardia pacing therapy may be enhanced by the ability to switch
to a lower pacing rate when the patient is determined to be asleep.
Such a procedure may be advantageous, for example, both to increase
the device lifetime and to reduce stress on the heart. In a further
example, preventive arrhythmia therapy 11475 may be delivered
during sleep or based on prediction of future arrhythmic events,
e.g., upon detection of a pro-arrhythmic sleep stage 11465. In one
example, preventive arrhythmia therapy may be delivered to prevent
tachyarrhymias known to occur more frequently during REM sleep or
during arousal from sleep.
[0679] Sleep stage classification may also be used in connection
with therapy to terminate or prevent sleep-disordered breathing.
Various therapies may be implemented to treat sleep-disordered
breathing, including maintaining continuous positive air pressure
to prevent collapse of tissue into the respiratory passage,
electrical stimulation of nerves or muscles, and cardiac pacing
therapy, for example. Because disordered breathing is more likely
to occur when the patient is asleep, disordered breathing detection
or prediction 11432 may be augmented by employing sleep stage
informed respiratory analysis 11425 in accordance with embodiments
of the present invention.
[0680] Detection of disordered breathing may be accomplished by
detecting 11430 respiration signals representing the patient's
breathing cycles and analyzing each breath 11420. In one
implementation, disordered breathing, including, e.g., hypopnea and
apnea, may be detected 11432 by monitoring the respiratory waveform
output produced by a transthoracic impedance sensor.
[0681] When the tidal volume (TV) of the patient's respiration, as
indicated by the transthoracic impedance signal, falls below a
hypopnea threshold, then a hypopnea event is declared. For example,
a hypopnea event may be declared if the patient's tidal volume
falls below about 50% of a recent average tidal volume or other
baseline tidal volume value. If the patient's tidal volume falls
further to an apnea threshold, e.g., about 10% of the recent
average tidal volume or other baseline value, an apnea event is
declared.
[0682] Another method of detecting 11432 disordered breathing
involves analyzing the patient's respiratory patterns. According to
this method, the patient's respiratory cycle is divided into
several periods, including, inspiration, expiration, and
non-breathing periods. The inspiration, expiration, and
non-breathing respiratory periods are analyzed for patterns
consistent with various types of disordered breathing.
[0683] As described herein, sleep-disordered breathing may be
predicted based on a number of patient conditions that increase the
likelihood of disordered breathing. Conditions that predispose the
patient to disordered breathing include, for example, air
pollution, alcohol use, and pulmonary congestion, among other
conditions. In addition to predisposing conditions that make
disordered breathing more likely, various precursor conditions may
be used to determine that a disordered breathing episode is
imminent. For example, blood chemistry, hyperventilation, and the
regular periodicity of previous disordered breathing episodes may
be used to predict an imminent onset of disordered breathing. If
disordered breathing is detected or predicted 11432, an appropriate
therapy 11434 may be provided to terminate or prevent the
disordered breathing.
[0684] Sleep stage classification 11410 may also be used to
identify preferable periods of time for performing 11485 various
testing procedures, including, for example, diagnostic testing
and/or testing of therapeutic device parameters. In various
implementations, sleep stage informed diagnostic testing may allow
testing to assess the patient's autonomic integrity. Sleep stage
classification may further allow the use of REM episodes as a
surrogate for stress testing, and recognition of opportunities to
routinely perturb the cardiovascular system under controlled
conditions.
[0685] Sleep stage classification also provides an opportunity to
test one or more parameters of a therapeutic device while the
patient's activity is low. Such testing may involve, for example,
capture threshold testing for a cardiac pacing device and cardiac
signal morphology template acquisition to be used in connection
with cardiac arrhythmia detection. Thus, sleep stage classification
may be used to provide more effective therapy, better diagnostic
information, and improved prognostic and predictive
capabilities.
[0686] FIG. 115 illustrates a medical system that may be used to
perform sleep stage informed therapy in accordance with embodiments
of the invention. The block diagram of FIG. 115 shows the medical
system 11500 divided into functional blocks. It will be appreciated
by those skilled in the art that there exist many possible
configurations in which these functional blocks can be arranged and
implemented. The example depicted in FIG. 115 is one possible
functional arrangement.
[0687] FIG. 115 illustrates an implantable cardiac pulse generator
11501 enclosed in a housing 11590 and configured to provide therapy
for cardiac arrhythmia. Various cardiac electrical therapies,
including therapy for disordered breathing and cardiac rhythm
therapies, including bradycardia pacing, anti-tachycardia pacing,
defibrillation, and cardioversion, may be implemented in
cooperation with sleep stage classification in accordance with
embodiments of the invention.
[0688] Optionally, the medical device 11500 may also be configured
to detect respiratory disorders, e.g., sleep-disordered breathing,
and to provide therapy to mitigate the respiratory disorders.
Disordered breathing therapy, including cardiac pacing and/or other
types of disordered breathing therapy, such as continuous positive
air pressure (CPAP), nerve stimulation, muscle stimulation or other
therapy for treating disordered breathing, may be controlled or
provided by components of the cardiac pulse generator 11501.
[0689] Although FIG. 115 depicts a sleep stage classification
system implemented in a cardiac pulse generator 11501, it is
understood that configurations, features, and combinations of
features described in the disclosure may be implemented in a number
of medical devices. Sleep stage classification may be implemented
in connection with various diagnostic and therapeutic devices and
such embodiments and features are not limited to the particular
devices described herein.
[0690] Further, although various embodiments involve devices or
systems having an implantable control system and implantable
sensors, it is understood that therapy or diagnostic systems
utilizing the sleep stage classification methodologies of the
present invention may be configured so that the control system or
components of the control system are arranged externally to the
patient. The sensors and the control system, and in particular the
patient sleep stage classification system, may involve
patient-external components, patient-internal components or a
combination of patient-external and patient-internal
components.
[0691] In the embodiment illustrated in FIG. 115, the implantable
pulse generator 11501 includes circuitry for providing cardiac
rhythm therapy 11542 to treat various arrhythmic conditions.
Cardiac arrhythmia therapy is implemented by detecting electrical
signals produced by the heart, analyzing the signals for
arrhythmia, and providing an appropriate therapy to terminate or
reduce the arrhythmia. The pulse generator 11501 is coupled to a
cardiac lead system having sensing and therapy electrodes 11550,
11522 electrically coupled to the patient's heart. The cardiac lead
system sensing and therapy electrodes 11550, 11522 may include one
or more electrodes positioned in or around the heart as well as one
or more electrodes positioned on the housing 11590 or header of the
pulse generator 11501. In one arrangement, the electrodes used for
sensing are also used for therapy delivery. In another arrangement,
a set of therapy electrodes different from the sensing electrodes
is used.
[0692] Cardiac signals sensed by sensing electrodes 11550 of the
cardiac lead system are coupled to an arrhythmia analysis unit
11556 configured to identify cardiac arrhythmias. The arrhythmia
analysis unit 11556 may use information derived from a sleep stage
processor 11552 to provide sleep stage informed arrhythmia
detection. If cardiac arrhythmia is detected, the therapy unit
11542 may provide a number of therapies to treat the detected
arrhythmia.
[0693] The cardiac therapy may include pacing therapy controlled to
treat cardiac rhythms that are too slow. In this situation, the
therapy unit 11542 controls the delivery of periodic low energy
pacing pulses to one or more heart chambers through pacing
electrodes of the cardiac lead system 11550. The pacing pulses
ensure that the periodic contractions of the heart are maintained
at a hemodynamically sufficient rate.
[0694] The cardiac therapy may also include therapy to terminate
tachyarrhythmia, wherein the heart rhythm is too fast. The
arrhythmia analysis unit 11556 detects and treats episodes of
tachyarrhythmia, including tachycardia and/or fibrillation. The
arrhythmia analysis unit 11556 recognizes cardiac rhythms
consistent with various types of tachyarrhythmia. When
tachyarrhythmia is identified, the therapy unit 11522 may deliver
high energy electrical stimulation to the heart through
defibrillation electrodes of the cardiac lead system 11550 to
terminate the arrhythmia.
[0695] Implementation of an appropriate cardiac therapy may be
augmented using sleep stage classification determined by the sleep
stage processor 11552 in accordance with embodiments of the
invention. As previously discussed, sleep stage classification may
be used to determine an optimal arrhythmia therapy. In one example
implementation, cardiac therapy may be triggered by signals from
the sleep stage processor 11552 to prevent cardiac arrhythmia
during REM or other proarrhythmic sleep periods. In another
example, the lower rate limit of a bradycardia pacing regimen may
be modified when the sleep stage processor 11552 indicates that the
patient is asleep.
[0696] The sleep stage processor 11552 performs sleep stage
classification based on one or more sleep-related signals,
including at least one REM-modulated signal. In the illustrative
embodiment of FIG. 115, a muscle atonia sensor 11548, for example,
a EMG sensor, provides a REM-modulated signal to the sleep stage
processor 11552. Additionally, a signal responsive to the patient's
activity may be used in combination with the REM-modulated signal
to augment sleep stage classification. In the example
implementation illustrated in FIG. 115, the patient activity signal
is provided by an accelerometer 11546.
[0697] The medical device 11500 may optionally include components
for performing respiratory system analysis 11554. In one
embodiment, the patient's respiration patterns may be analyzed with
knowledge of the patient's sleep stage to determine an appropriate
therapy to mitigate detected episodes of disordered breathing or to
prevent the occurrence of sleep-disordered breathing.
[0698] A transthoracic impedance sensor 11544 may be implemented to
produce a signal representing the patient's respiration cycles. A
respiration analysis unit 11554 uses sleep stage information
provided by the sleep stage processor 11552 in analyzing the
patient's respiration patterns to detect episodes of
sleep-disordered breathing. Based on sleep stage classification,
respiration analysis, and, optionally, cardiac system analysis,
cardiac electrical stimulation therapy may be delivered to the
patient through the cardiac electrodes 11522 to mitigate or prevent
disordered breathing, including sleep apnea, hypopnea, or other
forms of disordered breathing. According to one embodiment,
preventive therapy for disordered breathing may be initiated if the
sleep stage classification processor indicates the patient is
asleep, or upon detection of a particular sleep stage.
[0699] FIGS. 116A-D illustrate various configurations of a muscle
atonia sensor mechanically coupled to an implanted medical device
11600, such as an implantable pacemaker or implantable
cardioverter/defibrillator in accordance with embodiments of the
invention. The implantable medical device 11600 may include a
housing 11620 enclosing the medical device circuitry and a header
11610 for coupling a lead system 11660 to the circuitry of the
medical device 11600.
[0700] A muscle atonia sensor may be implemented, for example,
using an electromyogram (EMG) electrode 11630 or force responsive
sensor 11640 positioned on the housing 11620 of the medical device
11600 as illustrated in FIGS. 116A and 116B, respectively. FIG.
116C illustrates a muscle atonia sensor 11650 positioned on the
header 11610 of the medical device 11600. Alternatively, a muscle
atonia sensor 11670, e.g., EMG electrode or strain gauge, may be
positioned on the lead system 5760 or may be coupled to the medical
device 11600 through a catheter or lead system 11660, as
illustrated in FIG. 116D.
Detection of Autonomic Arousal
[0701] Aspects of the invention that include autonomic arousal
detection are directed to methods and systems configured to
monitor, diagnose, and/or provide patient therapy using one or more
individual medical procedures. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0702] Other aspects of the invention involving automatic arousal
detection are directed to methods and systems configured to
monitor, diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0703] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0704] Embodiments of the invention involve an individual system
106 (FIG. 1C) configured to detect autonomic arousal events. The
autonomic arousal detector 106 may be implemented as a stand alone
system or in combination with other individual medical systems,
such as those described in FIGS. 1B-1D.
[0705] Various embodiments are directed to systems and methods for
detecting arousals of a patient during sleep. One embodiment of the
invention is directed to a method for acquiring sleep information
including autonomic arousal events. The method involves sensing one
or more physiological conditions modulated by a patient's autonomic
arousal response. Autonomic arousal events occurring during sleep
are detected based on the one or more sensed signals. At least one
of sensing the physiological signals and detecting the autonomic
arousal events is performed at least in part implantably.
[0706] Another embodiment of the invention is directed to a method
for acquiring sleep-related information. An arousal signal
modulated by changes in muscle tone associated with autonomic
arousal is sensed using a sensor disposed on an implantable therapy
device. Autonomic arousal events are detected based on the arousal
signal.
[0707] Yet a further embodiment of the invention involves a method
for detecting arousals from sleep. One or both of a signal
modulated by brainwave activity associated with an autonomic
arousal response and a signal modulated by changes in muscle tone
associated with the autonomic arousal response are generated.
Autonomic arousal events are detected, using an implantable device,
based on at least one of the brainwave signal and the muscle tone
signal.
[0708] Another embodiment of the invention involves a system for
detecting autonomic arousal events. The system includes an
implantable therapy device and one or more sensors mechanically
coupled to the implantable therapy device. The sensors are
configured to sense one or more physiological conditions modulated
by a patient's autonomic arousal response. An arousal detector is
coupled to the sensor and is configured to detect autonomic arousal
events based on the sensed physiological conditions.
[0709] In accordance with another embodiment of the invention, a
system detects autonomic arousal events occurring during sleep. The
system includes one or more sensors configured to sense one or more
physiological conditions associated with a patient's autonomic
arousal response. An implantable arousal detector is coupled to the
one or more sensors. The arousal detector is configured to detect
autonomic arousal events based on the one or more physiological
conditions.
[0710] One embodiment of the invention is directed to a medical
system detecting autonomic arousal events occurring during sleep.
The system includes one or more sensors configured to sense one or
more physiological conditions associated with a patient's autonomic
arousal response. The system also includes an implantable arousal
detector coupled to the one or more sensors. The arousal detector
is configured to detect autonomic arousal events based on the one
or more physiological conditions.
[0711] Other embodiments of the invention involve a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes autonomic arousal detection 106 The coordinated
system may include, for example, an implantable cardiac device 181
and a patient-external respiratory therapy device 184. The system
may further include an external processor 183 providing a
coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 184 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[0712] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes
an autonomic arousal detector 106 coupled to one or both of the
implantable device and the patient external respiratory device. The
autonomic arousal detector comprises one or more sensors configured
to sense one or more physiological conditions associated with a
patient's autonomic arousal response. The autonomic arousal
detector also includes an implantable arousal detector coupled to
the one or more sensors, the arousal detector configured to detect
autonomic arousal events based on the one or more physiological
conditions. The implantable device and the patient external
respiratory device are configured to operate cooperatively using
the detected autonomic arousal events.
[0713] The implantable and respiratory therapy devices 181, 184 may
operate cooperatively to detect autonomic arousal events. For
example, sensors of the respiratory therapy device may sense the
one or more physiological conditions associated with autonomic
arousal response. The sensed information may be transmitted to an
arousal detector disposed within a housing of the implantable
device. Systems and methods directed to autonomic arousal detection
may be implemented to include selected features, functions, and/or
structures described in commonly owned, co-pending U.S. Publication
No. 2005/0076908, which is hereby incorporated herein by
reference.
[0714] One indicator of sleep quality is the number of arousals
experienced during sleep. An arousal is an event that occurs during
sleep and may be identified based on changes in EEG signals during
non-REM sleep and changes in EEG and EMG signals during REM sleep.
Arousal events may or may not culminate in wakefulness. The patient
may experience an arousal event during sleep and never wake up.
[0715] In one implementation, arousal from sleep has been
identified, for example, based on a shift in the patient's EEG
signal to a higher frequency for a specified period of time during
non-REM sleep assuming sleep has been previously detected. Arousals
during REM sleep have been identified by the EEG arousal defined
above in addition to changes in an electromyogram (EMG) signal or
body movements. Arousals, as identified based on changes in EEG
signals, encompass activation of the patient's autonomic nervous
system.
[0716] Activation of the patient's autonomic nervous system during
sleep may be used to identify arousal events referred to herein as
an autonomic arousal event. Autonomic arousal events may be
identified by an autonomic arousal response involving transient
activation of the patient's autonomic nervous system. The autonomic
arousal response may or may not result in detectable changes to the
patient's EEG signal.
[0717] Autonomic arousal events comprise transient changes during
sleep that affect autonomic physiological parameters such as heart
rate, blood pressure, cardiac output, peripheral vasoconstriction,
sympathetic nerve traffic, and arteriole size, among other
conditions. For example, an autonomic arousal event may be detected
based on a change of about 4 mm Hg increase in systolic blood
pressure and/or about a 4 beat per minute increase in heart rate.
As previously mentioned, autonomic arousal events begin during
sleep and may or may not result in wakefulness. Thus, the patient
may experience a number of autonomic arousal events while asleep
without achieving a waking state. Nevertheless, these autonomic
arousal events disrupt the patient's sleep and degrade sleep
quality.
[0718] Information about the autonomic arousal events may be stored
in memory, and/or transmitted to a separate device for printing or
display. Information about the autonomic arousal events may be used
to diagnose sleep disorders and/or adjust patient therapy, such as
cardiac stimulation therapy, drug therapy, neural stimulation
therapy, and/or respiration therapy. Trending sleep information
including autonomic arousal events and correlating the sleep
information with sleep disorder events may be helpful in
determining and maintaining appropriate therapies for patients
suffering from a range of sleep disorders.
[0719] Many sleep disorder events, e.g., disordered breathing
events and movement disorder events, are followed by autonomic
arousal events. These autonomic arousals disrupt the normal sleep
pattern and may be involved in causing chronic hypertension. The
autonomic arousal response may be visible on signals generated by
electroencephalogram (EEG) sensors, electromyogram (EMG) sensors,
and/or other sensors sensitive to autonomic nervous system
changes.
[0720] In accordance with embodiments of the present invention,
information related to the patient's autonomic arousal response may
be collected and/or analyzed. The identification of autonomic
arousal events may be used for a variety of purposes, including
detecting and/or verifying sleep disorder events, trending the
number of arousals per night, and developing various indices such
as an arousal index and/or a composite index based on arousals and
sleep disorder events. The arousal information may be collected and
used in the evaluation of sleep and/or sleep disorders.
[0721] Frequent arousals are indicative of a number of medical
disorders, including sleep disorders such as sleep disordered
breathing. Frequent arousals of the sympathetic nervous system may
lead to chronic hypertension or other medical problems. The ability
to detect individual and/or aggregate arousals may be used in
diagnosing various medical disorders, including disordered
breathing. If the patient receives therapy to treat disordered
breathing, then the ability to count and trend arousals also
provides information regarding therapy efficacy. For example, if
arousals decline after therapy is delivered, then it may be assumed
that the therapy provides an effective treatment for the disordered
breathing. Further, detection of an arousal following delivery of
therapy may be used to provide feedback for therapy control.
[0722] Methodologies may involve using arousal information in
combination with disordered breathing information. For example, the
system may provide the capability of discriminating between
disordered breathing events that cause arousals and disordered
breathing events that do not cause arousals. The detection of
arousals may allow trending of arousals that occur during sleep.
The disordered breathing events that are followed by arousals are
considered to be the most disruptive, because repeated arousals
prevent the patient from receiving a restful sleep. Some patients
continue to experience disordered breathing events during an
aroused status. It may be desirable to ignore disordered breathing
events that occur during an aroused state. The ability to detect an
arousal and ignore subsequently detected disordered breathing
events during arousal may improve the accuracy of disordered
breathing indices, e.g., apnea/hypopnea index.
[0723] An arousal detection system may comprise, for example, a
sensor that generates a signal modulated by changes in muscle tone
associated with autonomic arousal. Such a signal may be generated,
for example, using an electromyogram sensor or a strain gauge
positioned in contact with or near skeletal muscle, such as the
pectoral muscle. The sensor may be disposed on an implantable
device such as an implantable cardiac rhythm management system,
e.g., a pacemaker, defibrillator, cardiac monitor, cardiac
resynchronizer, or the like.
[0724] Other sensors may be used in connection with arousal
detection in addition to or instead of the muscle tone sensor. For
example, an accelerometer may be employed to detect patient
movement correlated to arousal. An electrogram or other cardiac
sensor may be used to detect various cardiac parameters associated
with arousal. For example, heart rate increases upon arousal, the
AV delay decreases upon arousal, and heart rate variability is
modified by autonomic tone changes associated with arousal. Cardiac
output increases during arousal, as may be measured via an
impedance sensor. Blood pressure, measured, for example, by a
lead-based pressure gauge, is modulated by arousal and may be
utilized in arousal detection. Peripheral arterial tonography may
be used in arousal detection. Arteriole size, which may be measured
by photoplethysmography, decreases upon arousal due to sympathetic
nervous system activation. Sympathetic nerve traffic modulated by
arousal may be sensed using microelectrodes coupled to an
implantable device.
[0725] In accordance with one embodiment, an arousal detector
includes circuitry configured to detect changes in the patient's
nervous system. The changes may comprise sympathetic and/or
parasympathetic nervous system changes. The arousal detector may be
configured to detect the presence of individual arousal events, the
presence of aggregate arousals, or the presence of both individual
and aggregate arousals.
[0726] For example, in one implementation, the sensors may sense
conditions that are modulated contemporaneously with an arousal
event. In this implementation, the system may detect an individual
arousal event during or slightly after the occurrence of the
arousal event, for example. In another implementation, the sensors
may be sensitive to conditions that are modulated by the aggregate
effect of multiple arousal events that occur over a period of time.
In such an implementation, detection of individual arousals may or
may not occur. The sensors may detect changes in physiological
conditions that are caused by the occurrence of multiple arousals.
The changes in the physiological conditions are used by the arousal
detector to determine that multiple arousal events that have
occurred over a period of time. A representative set of conditions
indicative of the occurrence of multiple arousal events over a
period of time may include, heart rate variability, blood pressure,
AV-delay, arteriole size, sympathetic nerve activity, among others.
This list is not exhaustive and other conditions may be sensed by
the system to determine the occurrence of multiple arousal
events.
[0727] The arousal detection system ay include functionality for
evaluating the arousal information and/or determining values or
indices using the arousal information. For example, the arousal
detection system ay determine the number of arousals occurring
within a sleep period, or other specified time period. The therapy
assessment processor 260 may determine an arousal index (arousals
detected per unit time), an apnea/hypopnea index (apneas or
hypopneas detected per unit time), or other indices. Further, the
arousal detection system may evaluate the sleep disorder events to
determine if arousals are associated with the sleep disorder
events. For example, if an arousal is detected within a
predetermined time period after a sleep disorder event is detected,
the arousal may be associated with the sleep disorder event. Using
this process, arousals from sleep that are associated with sleep
disorder events can be discriminated from arousals from sleep that
are not associated with sleep disorder events.
[0728] In one application the number of arousals may be counted and
used to calculate an arousal index to quantify the number of
arousals experienced by the patient per unit time. Arousal
information may be used to determine a number of sleep quality
indices. The arousal information may be used in diagnosing and
treating a variety of disorders, including nocturnal sleep
disorders, such as sleep disordered breathing, and other
conditions. The ability to count and trend these arousals provides
diagnostic information regarding patient status with respect to the
disorders. For example, autonomic arousals are associated with
causing hypertension. A presence of hypertension may be determined
or predicted based on arousal information, such as a trend of
arousal events over time. Trending arousals may be used to improve
therapy used to treat sleep disorders.
[0729] Arousals fracture sleep staging, leading to disrupted sleep,
and as a consequence, daytime sleepiness. An arousal will bring a
patient out of REM sleep or deep sleep (stage 3-4), and bring them
temporarily to a waking state. As a consequence, the amount of REM
and deep sleep is limited, since the patient has to go back through
Stage 1-2 sleep before they enter REM or deep sleep.
[0730] In one configuration, arousal information may be used by a
therapy controller disposed within an implantable therapy device,
for initiating, terminating, or adjusting therapy. Alternatively,
the arousal information may be transmitted to the APM system or
other remote device for automatic or physician conducted analysis.
The APM system may transmit control signals to the implanted device
to initiate, terminate or modify therapy delivered by the implanted
device. For example, arousal feedback information may be used by an
APM system, an implantable cardiac device, to provide closed-loop
control of the therapy using arousal information feedback.
[0731] In one implementation, detection of arousals involves
evaluating signals generated by sensors for a characteristic
signature of autonomic arousal. Autonomic arousal responses, as
detected using EEG sensors and EMG sensors, are illustrated in the
graph of FIG. 31.
[0732] Referring now to FIG. 31, a sleep study sensor array output
is illustrated including an apnea event terminating in an arousal.
Arousal detection may be implemented using implantable sensors
capable of detecting changes in the sympathetic or parasympathetic
nervous system. These changes may be either short-term (i.e.,
changes associated with individual arousals) or long-term (i.e.,
aggregate effect of multiple arousals). A short-term effect of
arousal includes, for example, the activation of sympathetic nerve
activities. Sympathetic or parasympathetic changes, or the changes
of autonomic balance can be assessed, for example, by heart rate
variability (HRV), which can be detected using a device configured
to sense cardiac activity, changes in heart rate, and/or changes in
AV conduction.
[0733] In the graphs of FIG. 31, the abscissa of all the graphs is
the same time period during the sleep analysis of a patient. The
ordinate of each of the graphs is the signal amplitude of the
respective sensor. Traces 3181, 3182, 3183, and 3184 are the top,
second, third, and fourth traces respectively, plotted from sensors
adapted to produce electroencephalogram (EEG) signals. Evident in
all four traces, but particularly pointed out in traces 3181 and
3182 is a characteristic signature of an EEG signal indicative of
arousal 3194. A trace 3185 provides an electrocardiogram (EKG) of
the heart beats during the time period of the graph. A trace 3186
provides an electromyogram defining muscular movement during the
time period of the graph. Particularly evident in the trace 3186 is
a characteristic signature of an EMG signal indicative of arousal
3192.
[0734] Traces 3187, 3188, 3191, and 3189 illustrate various
parameters related to respiration. Trace 3187 is nasal pressure,
3188 is thoracic effort, 3191 is abdominal effort, and 3189 is the
sum of the thoracic and abdominal effort. Trace 3193 depicts the
blood oxygen saturation level of the patient. Pulmonary activity
may be sensed through the use of internal sensors, such as
impedance sensors and/or minute ventilation sensors described
further below.
[0735] In accordance with aspects of the present invention, arousal
detection may be used in connection with detection of sleep
disorders, such as disordered breathing. Sleep disordered breathing
may cause the patient to arouse from sleep frequently during a
sleep period. Thus arousals from sleep follow the sleep disorder
event. In one configuration, arousal detection may be used as a
surrogate for direct detection of the disordered condition. For
example, in systems that do not have a respiration sensor capable
of detecting disrupted respiration, arousal detection may be used
as a surrogate for detecting disrupted respiration. Information
from the arousal detector may be used to separate sleep disorder
events, e.g., apnea, hypopnea, followed by arousal versus those
terminated without arousal. The sleep disorder events that are
followed by arousal are considered to be the most disruptive, as
these arousals interrupt the normal course of sleep and prevent the
patient from receiving a full sleep cycle each night. Detecting
these types of sleep disorder events enhances the specificity of
sleep disorder event detection and guides diagnosis and/or
therapy.
[0736] The arousal information may be used to modify therapy for
sleep disorder events such as disordered breathing. In various
implementations, the arousal information and/or disordered
breathing information may be used to modify disordered breathing
therapy delivered to the patient.
[0737] For example, cardiac electrical therapy may be provided by
an implanted therapy device. Detection of disordered breathing may
be used to initiate the cardiac electrical therapy. Detection of
arousal, indicating the end of the disordered breathing event, may
be used to terminate the electrical stimulation therapy, for
example.
[0738] In another example, cardiac electrical therapy may be
provided, and the number of arousals monitored. If the cardiac
electrical therapy causes an excessive number of arousals, then the
cardiac electrical therapy may be adjusted or terminated.
[0739] In another example, an APM system may receive information
about sleep disorder events from the disordered breathing
detector/predictor 258 (FIG. 2) and/or arousal information from the
arousal detector. The information may be automatically evaluated by
the APM system, or may be evaluated by the patient's physician. The
APM system may be used to transmit control signals to an implanted
device to initiate, terminate or modify the therapy delivered to
the patient.
[0740] In various configurations, an EMG sensor may be positioned
on a housing or header of an implantable device, such as a cardiac
rhythm management device, or may be located on a catheter or lead
coupled to the cardiac rhythm management device. An EMG sensor
located on a device positioned in the pectoral region provides
access to skeletal muscle that may be exploited to detect
arousal.
[0741] FIG. 32 depicts a flow diagram illustrating various optional
processes that may be implemented in connection with arousal
detection according to embodiments of the invention. Detection of
sleep 3220 may be used to inform the arousal detection process 3210
and the sleep disorder event detection process 3240. Information
about sleep, sleep disorder events, and arousals from sleep are
monitored 3270. The information may be used to diagnose
sleep-related disorders and/or other disorders 3275, calculate
arousal and sleep disorder indices, develop trend information 3280,
correlate arousals with sleep disorder events 385, and/or adjust
therapy delivered to the patient 3290. Upon detection of a sleep
disorder event 3240, e.g., sleep disordered breathing, therapy to
mitigate the sleep disorder event may be initiated 3250. Arousal
detection 3210 signals the end of the sleep disorder event, and
therapy may be terminated 3260 following detection of arousal from
sleep.
[0742] FIG. 33 is a block diagram of an arousal detector that is
implemented in cooperation with a cardiac rhythm management (CRM)
system such as a pacemaker and/or cardioverter/defibrillator with
functionality to deliver cardiac electrical stimulation for
disordered breathing in accordance with an embodiment of the
invention. The system may be partially or completely
implantable.
[0743] Cardiac sense circuitry 3342, cardiac electrical stimulation
control and delivery circuitry 3350, disordered breathing detector
3320, arousal detector 3360, and sleep detector 3330 are arranged
within a housing that is hermetically sealed and suitable for
implanting within the patient, such as within the pectoral region
of the patient's chest. An accelerometer 3333 configured to detect
patient activity may also be incorporated within the housing. An
EMG sensor is implemented as an arousal sensor 3335 and is disposed
on the housing so that the EMG sensor 3335 is positioned in contact
with or near skeletal muscle, such as the pectoral muscle. An
intracardiac lead system includes cardiac electrodes 3341 for
electrically coupling to the patient's heart and one or more
transthoracic impedance electrodes 3342 for generating a
respiration signal.
[0744] The sleep detector 3330 uses the patient activity signal
generated by the accelerometer 3333 and the respiration signal
generated by the transthoracic impedance electrodes 3342 to
determine if the patient is asleep or awake.
[0745] The disordered breathing detector 3320 detects disordered
breathing events based on the patient's respiration patterns, as
described more fully above. The arousal detector 3360 compares the
EMG signal to a characteristic arousal signature and detects
arousal based on the comparison. Disordered breathing detection and
arousal detection may be enhanced using sleep/wake information
provided by the sleep detector 3330.
[0746] In one embodiment, the CRM provides cardiac electrical
stimulation the to one or more heart chambers as therapy for
disordered breathing. The cardiac electrical therapy control unit
3350 may utilize signals from the sleep detector 3330, disordered
breathing detector 3320, and arousal detector 3360 to initiate,
terminate, and/or adjust the cardiac electrical stimulation therapy
for disordered breathing. For example, the therapy control unit
3350 may initiate a process for treating disordered breathing
episodes when the sleep detector 3330 determines that the patient
is asleep.
[0747] In one scenario, the therapy control unit 3350 may initiate
cardiac electrical stimulation, e.g., cardiac overdrive pacing, to
treat disordered breathing upon detection of a disordered breathing
event during sleep. In another scenario, the therapy control unit
3350 may initiate cardiac electrical stimulation to treat
disordered breathing when sleep is detected. The therapy control
unit 3350 may adjust the cardiac electrical stimulation when a
disordered breathing event is detected during sleep. If an arousal
is detected, then the therapy control unit 3350 may terminate or
adjust the cardiac electrical stimulation therapy for disordered
breathing.
Marked Respiratory Waveform
[0748] Aspects of the invention that include generation of a marked
respiratory waveform are directed to methods and systems configured
to monitor, diagnose, and/or provide patient therapy using one or
more individual medical procedures. Each of the circles 180
illustrated in FIGS. 1B-1D represents an individual medical
procedure providing a specific monitoring, diagnosis or therapeutic
function or set of functions. Each individual medical procedure may
be implemented as a stand-alone system. Two or more of the
individual medical procedures 180 may be used in combination to
provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[0749] Other aspects of the invention that involve a marked
respiratory waveform are directed to methods and systems configured
to monitor, diagnose, and/or provide therapy using coordinated
medical procedures. Coordinated medical procedures may involve
cooperative operation of two or more of the individual processes
180. Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0750] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0751] Embodiments of the invention involve an individual system
105 (FIG. 1C) for generating a marked respiratory waveform. The
marked respiratory waveform system 105 may be implemented as a
stand alone system or in combination with other individual medical
systems, such as those described in FIGS. 1B-1D.
[0752] Various embodiments of the invention are directed to
characterizing respiration using a marked respiration waveform. In
accordance with one embodiment, a method for characterizing
respiration includes acquiring a respiration waveform. One of more
characteristics associated with the patient's respiration are
detected. A marked respiration waveform is generated using the
respiration waveform and one or more symbols indicating the one or
more characteristics associated with the patient respiration. At
least one of acquiring the respiration waveform, detecting the one
or more characteristics associated with the respiration, and
generating the marked respiration waveform is performed at least in
part implantably.
[0753] Another embodiment of the invention involves a system for
characterizing patient respiration. The system includes a
respiration waveform sensor configured to acquire a respiration
waveform. A respiration processor is configured to determine one or
more characteristics associated with the respiration. A waveform
generator is coupled to the respiration waveform sensor and the
respiration processor. The waveform generator is configured to
generate a marked respiration waveform comprising the respiration
waveform and symbols indicating the one or more characteristics
associated with the respiration. At least one of the respiration
waveform sensor, the respiration processor, and the waveform
generator includes an implantable component.
[0754] Other embodiments of the invention involve a system
providing coordinated patient monitoring, diagnosis and/or therapy
that generates and/or uses a marked respiration waveform. The
coordinated system may include, for example, an implantable cardiac
device 181 and a patient-external respiratory therapy device 184.
The system may further include an external processor 183 providing
a coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 184 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[0755] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
system for characterizing respiration using a marked respiration
waveform. The marked respiration waveform is coupled to at least
one of the implantable device and the patient external respiratory
device.
[0756] The marked respiration waveform system 105 includes a
respiration waveform sensor configured to acquire a respiration
waveform and a respiration processor configured to determine one or
more characteristics associated with the respiration. A waveform
generator is coupled to the respiration waveform sensor and the
respiration processor. The waveform generator is configured to
generate a marked respiration waveform comprising the respiration
waveform and symbols indicating the one or more characteristics
associated with the respiration. At least one of the respiration
waveform sensor, the respiration processor, and the waveform
generator comprises an implantable component. The implantable
device and the patient external respiratory device are configured
to operate cooperatively to generate or use the marked respiration
waveform. Systems and methods directed to patient respiration
characterization may be implemented to include selected features,
functions, and/or structures described in commonly owned,
co-pending U.S. Pat. No. 7,678,061, which is hereby incorporated
herein by reference.
[0757] FIG. 34 is a block diagram of a medical system 3400
including patient-external or fully or partially implantable a
medical device 3400 incorporating a marked respiration waveform
system in accordance with embodiments of the invention. The medical
device 3400 may optionally include a cardiac therapy circuit 3415
and a cardiac sense circuit 3420 coupled through a lead system to
cardiac electrodes 3425. The cardiac electrodes 3425, illustrated
in FIG. 34 may be used to electrically couple to the patient's
heart for sensing electrical cardiac signals and/or delivering
therapy to the heart in the form of electrical stimulation energy,
e.g., pacing pulses and/or defibrillation/cardioversion shocks as
more fully described herein.
[0758] The medical system 3400 incorporates a system for generating
marked respiration waveforms. In the embodiment illustrated in FIG.
34, respiration waveforms are acquired based on signals generated
by a respiration sensor 3445. In a preferred embodiment, the
respiration sensor comprises a transthoracic impedance sensor.
Other methods of acquiring a respiration waveform are also
possible. Such methods may include, for example, the use of
patient-external respiratory bands, respiration flowmeter
measurements, implantable or patient-external breath sound
detection, blood oxygen levels, and/or other processes.
[0759] Various respiration-related conditions affecting the patient
may be acquired using the cardiac electrodes 3425, sensors 3471,
patient input devices 3472 and/or other information systems 3473.
The sensors 3471 may comprise patient-internal and/or
patient-external sensors coupled through leads or wirelessly to the
respiration processor 3431. The patient input device 3472 allows
the patient to input information relevant to respiration
conditions. For example, the patient input device 3472 may be
particularly useful for inputting information concerning
patient-known information, such as information related to patient
smoking, drug use, or other activities or perceptions that are not
automatically sensed or detected.
[0760] The respiration processor 3431 may be coupled to other
information systems 3473, such as network-connected servers. The
respiration processor 3431 may access the information systems 3473
to acquire information about conditions that may affect patient
respiration. In one implementation, the respiration processor 3431
accesses the information systems 3473 to acquire information about
conditions correlated to, or otherwise associated with, an
increased or decreased incidence of disordered breathing in the
patient. For example, the respiration processor 3431 may access an
air quality website to acquire the ambient pollution index. In this
scenario, a particular level of pollution may be correlated to in
increased likelihood of disordered breathing.
[0761] Signals from the respiration sensor 3445 and/or signals
produced by one or more additional sensors or devices 3471, 3425,
3472, 3473, may be used by the respiration processor 3431 to detect
one or more characteristics related to patient respiration. The
respiration characteristics are used to generate a marked
respiration waveform.
[0762] In one embodiment, the respiration characteristics may
include parameters associated with the respiration waveform
morphology, such as peak inspiration, expiration slope, or
inspiration slope. The respiration characteristics may include a
variety of physiological and/or non-physiological conditions. For
example, the respiration characteristics may include parameters
derived from the respiration waveform, e.g., respiration rate,
tidal volume, minute ventilation, or breath intervals. Additionally
or alternatively, the respiration characteristics may include
symptoms and/or physiological conditions derived from the
respiration waveform, e.g., dyspnea, pulmonary congestion. The
respiration characteristics may include non-physiological,
contextual conditions such as pollution, ambient temperature,
and/or humidity. The respiration characteristics may also include
parameters characterizing disordered breathing, such as duration,
severity, frequency, and type of disordered breathing.
[0763] In another embodiment, the respiration characteristics may
include conditions associated with respiration, including, for
example, physiological conditions and/or contextual,
non-physiological conditions. Table 1 provides examples of patient
conditions that may be used in connection with generation of a
marked respiration waveform in accordance with embodiments of the
invention. Table 1 also provides illustrative sensing methods that
may be employed to sense the conditions. The list provided in Table
1 is not exhaustive and additional or different conditions may be
used.
[0764] Respiration-related conditions that may be used to generate
a marked respiration waveform may include, for example, both
physiological and non-physiological (contextual) conditions
affecting the patient. Physiological conditions may include a broad
category of conditions associated with the internal functioning of
the patient's physiological systems, including the cardiovascular,
respiratory, nervous, muscle and other systems. Examples of
physiological conditions include blood chemistry, patient posture,
patient activity, respiration patterns, blood pressure, among
others.
[0765] The respiration processor 3431 may optionally include a
disordered breathing processor 3436 for detecting disordered
breathing episodes, including, for example, episodes of central
and/or obstructive disordered breathing including apnea, hypopnea,
Cheyne-Stokes respiration, or other types of disordered breathing.
The disordered breathing processor 3436 may also determine various
characteristics of the disordered breathing episodes, such as the
severity, frequency, duration, and other characteristics of the
disordered breathing. The occurrences of disordered breathing
and/or disordered breathing characteristics may be indicated in the
marked respiration waveform.
[0766] The respiration waveform generator 3430 uses the acquired
respiration waveform, the respiration characteristics derived from
the respiration waveform, and/or the other conditions associated
with respiration to generate a marked respiration waveform. The
marked respiration waveform comprises the respiration waveform and
one or more symbols or other indicators associated with the
presence of various respiration waveform characteristics and/or
respiration-related conditions. As illustrated in FIG. 35A, the
symbols may be displayed at positions relative to the marked
respiration waveform to indicate the timing of the respiration
characteristics and/or conditions.
[0767] The medical system 3400 may acquire one or more additional
waveforms representative of physiological and/or non-physiological
conditions affecting the patient.
[0768] The marked respiration waveform may be displayed along with
the one or more additional waveforms. The additional waveforms may
be time aligned with the respiration waveform to facilitate
comparison, such as the ECG and respiration waveforms depicted in
FIG. 35B.
[0769] The medical system 3400 may include a memory circuit 3460
used to store information related to respiration waveforms,
including for example, information related to detected respiration
characteristics, respiration-related conditions and/or marked or
unmarked respiration waveform data. Stored information may be
transmitted by communication circuitry 3450 to a remote device
3455, such as a remote device programmer, a patient management
server, or other computing device through a wireless or wired
communications link.
[0770] As illustrated in FIG. 35A, the marked respiration waveform
3510 may comprise respiratory symbols positioned at locations
relative to the respiration waveform to indicate the time of
occurrence of respiration events, and the time of occurrence of
various respiration conditions and/or characteristics. In the
example depicted in FIG. 35A, the respiration waveform 3510 is
marked with minute ventilation symbols 3520 denoting peaks on the
waveform and apnea markers 3530, 3535 denoting when an apnea event
is detected 3530 and when the apnea event ends 3535. In addition,
other symbols indicating respiration characteristics and/or
disordered breathing characteristics described above may be used to
annotate the respiration waveform. The marked respiration waveform
information may be stored, transmitted, printed and/or displayed on
a display device to allow the patient's physician to view
respiratory disturbances and/or other characteristics. Generation
of a marked respiration waveform allows a clinician to view
respiration disturbances and to determine that respiration events
were properly detected. Further, the marked respiration waveform
may be used to guide diagnosis and therapy.
[0771] FIG. 35B provides an illustration of a marked respiration
waveform in accordance with embodiments of the invention including
respiration and electrocardiogram (ECG) graphs. The respiration
waveform and ECG graph, such as the one depicted in FIG. 35B, may
be produced, for example, by a medical device having a
transthoracic impedance sensor and intracardiac EGM electrodes.
[0772] As illustrated in FIG. 35B, the marked respiration waveform
may present one or more additional waveforms. The additional
waveforms may include, for example, waveforms depicting patient
activity, posture, blood gas, blood pressure, and/or other
waveforms. In FIG. 35B, an ECG is shown above respiratory waveform
3510. The ECG is time-aligned with respiration waveform 3510 and
can be marked with indicators corresponding to the occurrence of
breathing events, cardiac events, and/or other events. Displaying
marked respiration waveforms and other waveforms related to patient
conditions allows the patient's physician to verify, for example,
that a disordered breathing event was properly detected. This
confirmation may be used to enhance diagnosis and/or therapy.
Symbols indicating characteristics and/or conditions related to the
cardiovascular, respiratory and/or other physiological systems
provide further diagnostic information for physicians. For example,
annotated waveforms allow a physician to evaluate the impact of
respiration events on other physiological systems.
[0773] Medical Event Logbook
[0774] Aspects of the invention a medical event logbook are
directed to methods and systems configured to monitor, diagnose,
and/or provide patient therapy using one or more individual medical
procedures. Each of the circles 180 illustrated in FIGS. 1B-1D
represents an individual medical procedure providing a specific
monitoring, diagnosis or therapeutic function or set of functions.
Each individual medical procedure may be implemented as a
stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0775] Other aspects of the invention involving a medical event
logbook are directed to methods and systems configured to monitor,
diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0776] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0777] Embodiments of the invention involve an individual system
109 (FIG. 1C) for providing a medical event logbook. The medical
event logbook system 109 may be implemented as a stand alone system
or in combination with other individual medical systems, such as
those described in FIGS. 1B-1D.
[0778] Embodiments of the invention relate to acquiring and
organizing information related to medical events affecting the
patient into a logbook. One embodiment of the invention involves a
method for organizing medical information. The method involves
detecting or predicting a respiratory event of a patient.
Responsive to the detection or prediction of the respiratory event,
collection of medical information associated with the respiratory
event is initiated. The medical information is collected and
organized as a respiratory event log entry. At least one of
detecting or predicting the respiratory event, collecting the
medical information and organizing the medical information is
performed implantably.
[0779] In accordance with another embodiment of the invention, a
method for accessing medical information involves collecting
medical information associated with respiratory events. The
collection of medical information associated with respiratory
events includes initiating, responsive to the detection or
prediction of the respiratory event, collection of medical
information associated with each respiratory event. The medical
information is collected and organized a respiratory logbook. A
user interface is provided for accessing the respiratory logbook.
At least one of detecting or predicting the respiratory event,
collecting the medical information and organizing the medical
information is performed implantably.
[0780] Another embodiment of the invention involves a method for
organizing respiratory information associated with medical events.
Responsive to the detection and/or prediction of a medical event,
the system initiates collection of respiratory information
associated with the medical event. The respiratory information is
collected and organized as a medical event log entry. At least one
of detecting or predicting the medical event, collecting the
respiratory information and organizing the respiratory information
is performed implantably.
[0781] In accordance with a further embodiment of the invention, a
method for accessing respiratory information associated with
medical events of a patent involves collecting and organizing
respiratory information associated with medical events. Collection
of the respiratory information is implemented by initiating,
responsive to the detection or prediction of a medical event,
collection of respiratory information associated with each medical
event. The respiratory information is collected and organized in a
medical event logbook. A user interface provides access to the
medical event logbook. At least one of detecting or predicting the
medical event, collecting the respiratory information and
organizing the respiratory information is performed
implantably.
[0782] Yet another embodiment involves a method for organizing
medical event information. According to this method, a medical
event is predicted. The system collects information associated with
conditions affecting the patient prior to the occurrence of the
medical event. The medical event is detected, and the system
collects information during the medical event. The collected
information is organized as a medical event log entry. At least one
of detecting the medical event, predicting the medical event,
collecting the respiratory information and organizing the
respiratory information is performed implantably.
[0783] In accordance with another embodiment of the invention, a
medical event logbook system includes an event detector configured
to detect or predict a medical event. A data acquisition unit is
coupled to the event detector and is configured to collect,
responsive to the detection or prediction of the medical event,
respiratory information associated with the medical event. The
system also includes processor configured to organize the acquired
respiratory information as a medical event log entry. At least one
of the event detector, the data acquisition unit, and the processor
includes an implantable component. In accordance with a further
embodiment, a respiratory event logbook system includes an event
detector configured to detect or predict a respiratory event
affecting the patient. A data acquisition unit is coupled to the
event detector and is configured to collect medical information
associated with the respiratory event responsive to the detection
or prediction of the respiratory event. The system includes a
processor configured to organize the collected medical information
associated with the respiratory event as a respiratory event log
entry. At least one of the event detector, the data acquisition
unit, and the processor includes an implantable component.
[0784] Other embodiments of the invention involve a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that generates or utilizes a medical event logbook. The coordinated
system may include, for example, an implantable cardiac device 181
and a patient-external respiratory therapy device 184. The system
may further include an external processor 183 providing a
coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 184 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[0785] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
medical event logbook 109 coupled to at least one of the
implantable device and the patient external respiratory therapy
device. The medical event logbook is configured to acquire and
organize data related to medical events. The medical event logbook
includes an event detector configured to detect or predict a
medical event affecting the patient. A data acquisition unit is
coupled to the event detector. The data acquisition unit is
configured to collect respiratory information associated with the
medical event responsive to the detection or prediction of the
medical event. A processor, coupled to the data acquisition unit,
is configured to organize the collected respiratory information
associated with the medical event as a medical event log entry. The
implantable device and the patient external respiratory device are
configured to operate cooperatively to generate or utilize the
medical event logbook.
[0786] Other embodiments of the invention involve a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that generates or utilizes a respiratory event logbook. The
coordinated system may include, for example, an implantable cardiac
device 181 and a patient-external respiratory therapy device 184.
The system may further include an external processor 183 providing
a coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 184 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[0787] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
respiratory event logbook 109 coupled to at least one of the
implantable device and the patient external respiratory therapy
device. The respiratory event logbook is configured to acquire and
organize data related to medical events. The respiratory event
logbook includes an event detector configured to detect or predict
a respiratory event affecting the patient. A data acquisition unit
is coupled to the event detector. The data acquisition unit is
configured to collect medical information associated with the
respiratory event responsive to the detection or prediction of the
respiratory event. A processor, coupled to the data acquisition
unit, is configured to organize the collected medical information
associated with the respiratory event as a respiratory event log
entry. The implantable device and the patient external respiratory
device are configured to operate cooperatively to generate or
utilize the respiratory event logbook. The implantable and
respiratory therapy devices 181, 184 may operate cooperatively to
acquire, organize or use information associated with the
respiratory event logbook and/or the medical event logbook. Systems
and methods directed to a medical event logbook may be implemented
to include selected features, functions, and/or structures
described in commonly owned, co-pending U.S. Publication No.
2005/0080348, which is hereby incorporated herein by reference.
[0788] FIG. 36A is a flowchart illustrating a method of acquiring
and organizing respiratory information collected in response to a
medical event. The medical event may involve various types of
events affecting one or more of the respiratory system,
cardiovascular system, nervous system, muscle systems, and/or other
physiological systems or combinations of physiological systems of
the patient. The system implementing the method may be programmable
to detect or predict a particular type of event, for example, a
cardiac event, such as cardiac arrhythmia or an ectopic beat. The
system may collect information about one or more respiratory
parameters during, before and/or after the medical event.
[0789] In response to the detection or prediction 3612 of the
medical event, collection 3614 of respiratory information for the
medical event logbook entry is initiated. In some embodiments, the
respiratory information is collected 3616 during the event. In
other embodiments, the respiratory information is collected 3616
during the event and during a time period proximate to the event.
Information may be collected during the event, during a period of
time preceding the event, and/or during a period of time following
the event. In some embodiments, the information may be collected
prior to the prediction or detection of the event.
[0790] To facilitate collection of respiratory information
preceding the prediction or detection of the event, respiratory
conditions may be monitored, e.g., on a continuous or periodic
basis, and stored in a temporary buffer. Temporary storage is
required to provide information prior to the event prediction or
detection, e.g., onset data. The size of the temporary storage
buffer may vary according to the medical events for which onset
data is desired. Due to the varied nature of onset data
requirements and the reality of limited storage in the system, the
system may allow different onset data lengths and different
sampling rates for the temporarily stored data. In the preferred
embodiment the system would use a circular buffer to store the
temporary data such that the oldest data is replaced by the newest
data.
[0791] Once initiated, collection of respiratory information, which
may involve storage of the information in long term memory, may be
performed on a substantially continuous basis, or it may be
performed periodically. Long term storage of data acquired
periodically may be beneficial when the event is relatively
prolonged, such an in the case of a disease or disorder that may
linger for several days or weeks. The type of data collected, data
collection frequency, and/or data collection intervals may be
selectable by the user. Further, the system may be programmable to
use different data collection regimens under different conditions
over the course of the event. For example, the system may be
programmable to collect data more frequently during sleep or during
particular stages of the disease progression, for example. The
system may be programmed to collect data on a continuous basis
during some time intervals, and periodically during other time
intervals, for example.
[0792] Collecting information preceding the event facilitates
enhanced identification of conditions that may be used to detect or
predict the occurrence of future events. For example, acquiring
information preceding a medical event allows for the identification
and assessment of physiological conditions present immediately
before and leading up to the medical event. The identification of
precursor conditions for medical events may facilitate increased
sensitivity and/or accuracy in detecting or predicting occurrences
of the future events.
[0793] The acquired respiratory information is organized 3618 as a
medical event log entry. A medical event logbook may comprise a
number of entries, each entry corresponding to a separate medical
event. The medical events represented in the medical event logbook
may comprise, for example, cardiovascular system events, nervous
system events, respiratory system events, or any other medical
events affecting the patient. The event entries included in medical
event log may be organized according to various categories,
including for example, event type, event time/date, order of
occurrence of the event, therapy provided to treat the event, among
other categories. The selection of categories used to organize the
information may be programmable by the user. The organized
information may be stored in long term memory, displayed, printed,
and/or transmitted to a separate device. In one approach, the
medical event comprises a cardiac event. Respiratory information
collected before, during and/or after the cardiac event may be
stored as a log entry in a cardiac arrhythmia logbook, for
example.
[0794] In one embodiment of the invention, the collected
information for the events is optionally accessible 3620 through an
interactive user interface. Selection of events to the accessed may
involve a hierarchical selection menu, or other selection method,
for example. In one implementation, the user may select a log entry
from the menu by activating an input mechanism. Upon selection of
the log entry, the user interface may provide graphical or textual
depictions of the collected respiratory information associated with
the medical event.
[0795] FIG. 36B is a flow chart for an embodiment involving
collecting medical information associated with a respiratory event.
The respiratory event may be detected or predicted 3622. The event
may include any detectable or predictable respiratory event, such
as disordered breathing (apnea, hypopnea, tachypnea), coughing
and/or breathing irregularities associated with pulmonary diseases
and disorders such as asthma, pulmonary edema, chronic obstructive
pulmonary disease, and/or pleural effusion, among others.
[0796] In response to the detection or prediction 3622 of the
respiratory event, collection 3624 of medical information for the
respiratory event logbook entry is initiated. The medical
information may be collected 3624 during the event and/or during a
time period proximate to the event. Information may be collected
during the event, during a period of time preceding the event,
and/or during a period of time following the event. In some
embodiments, the information may be collected prior to the
prediction or detection of the respiratory event.
[0797] To facilitate collection of medical information preceding
the prediction or detection of the respiratory event, the medical
information may be monitored, e.g., on a continuous or periodic
basis, and stored in a temporary buffer. Temporary storage is
required to provide information prior to the event prediction or
detection, e.g., onset data. The duration of the temporary storage
may vary according to the respiratory events for which onset data
is desired. For example, temporary storage of about one minute may
be sufficient to understand onset conditions for an obstructive an
apnea event whereas temporary storage of about one day may be
required to understand onset conditions for an asthma event.
[0798] Due to the varied nature of onset data requirements and the
reality of limited storage in the system, the system may allow
different onset data lengths and different sampling rates for the
temporarily stored data. In a preferred embodiment, the system uses
a circular buffer to store the temporary data such that the oldest
data is replaced by the newest data.
[0799] Once initiated, collection of respiratory information, which
may involve storage of the information in long term memory, may be
performed on a substantially continuous basis, or it may be
performed during discrete intervals. Long term collection of data
on a periodic basis may be beneficial when the event is relatively
prolonged, such an in the case of a disease or disorder that may
linger for several days or weeks. Various collection parameters,
such as the type of data collected, data collection frequency,
and/or data collection intervals may be selectable by the user.
Further, the system may be programmable to use different data
collection regimens under different conditions over the course of
the event. For example, the system may be programmed to collect
data more frequently during sleep or during particular stages of
the disease progression, for example. The system may be programmed
to collect data on a substantially continuous basis during some
time intervals, and periodically during other time intervals, for
example.
[0800] Collecting medical information preceding the respiratory
event facilitates enhanced identification of conditions that may be
used to detect or predict the occurrence of future events. For
example, acquiring information preceding the event affecting
patient respiration allows for the identification and assessment of
physiological conditions present immediately before and leading up
to the event. In one scenario, the patient may experience a period
of hyperventilation prior to an apnea event. Collecting respiratory
information prior to the apnea event allows the identification of
hyperventilation as a precursor condition. The identification of
precursor conditions for apnea facilitate increased sensitivity
and/or accuracy in detecting or predicting future occurrences of
apnea.
[0801] Additionally, or alternatively, medical information
preceding the respiratory event may provide insight into conditions
that predispose the patient to certain respiratory events.
Acquiring information preceding the event may provide allow
identification of the triggering or causal factors of the event.
For example, an asthma attack may be induced by increased exercise
or a sudden change in ambient temperature, e.g., the patient moving
from a warmer location to a colder location. Collection of medical
information preceding the asthma attack allows the factors that
precipitate the respiratory event to be identified. Such
information may be used to enhance the detection and/or prediction
of future events.
[0802] Information collected following the event may be used to
assess the acute effects of the event. Episodes of disordered
breathing, for example, may be associated with acute physiological
effects, including negative intrathoracic pressure, hypoxia, and
arousal from sleep. Such effects may be detectable for a period of
time following the respiratory event.
[0803] For example, obstructive sleep apneas are typically
terminated by arousal from sleep that occurs several seconds after
the apneic peak, allowing the resumption of airflow. Coincident
with arousal from sleep, and continuing for some period of time
after termination of the event, surges in sympathetic nerve
activity, blood pressure, and heart rate occur.
[0804] During obstructive apnea events, the effort to generate
airflow increases. Attempted inspiration in the presence of an
occluded airway results in an abrupt reduction in intrathoracic
pressure. The repeated futile inspiratory efforts associated with
obstructive sleep apnea may trigger a series of secondary
responses, including mechanical, hemodynamic, chemical, neural, and
inflammatory responses. Collection of data following obstructive
sleep apnea events may be used to determine the presence and/or
severity of the secondary responses to obstructive apnea events.
The post-event information enhances the ability to evaluate the
impact of the secondary responses upon the patient.
[0805] As previously described, obstructive sleep apnea events are
typically terminated by arousal from sleep. However, arousals are
not usually required for the resumption of breathing in central
sleep apnea events. In the case of central apnea events, the
arousals follow the initiation of breathing. Arousals following
central apnea events may facilitate the development of oscillations
in ventilation by recurrently stimulating hyperventilation and
reducing PaCO.sub.2 below the apneic threshold. Once triggered, the
pattern of alternating hyperventilation and apnea may be sustained
by the combination of increased respiratory drive, pulmonary
congestion, arousals, and apnea-induced hypoxia causing PaCO.sub.2
oscillations above and below the apneic threshold. Shifts in the
patient's state of consciousness, particularly with repeated
arousals, may further destabilize breathing. Collecting information
during central apnea events and before and/or after the occurrence
of the events may allow identification of the oscillations
associated with central apnea.
[0806] The collected medical information, which may be stored in
long term memory, transmitted, printed and/or displayed is
organized as a respiratory logbook entry 3628. The medical
information may include various physiological and non-physiological
data. For example, respiratory system data, cardiovascular system
data, nervous system data, posture, activity, medical history data,
environmental data (temperature, altitude, air quality) and other
types of medical information may be organized as a respiratory
logbook entry. The respiratory logbook entry may be stored,
transmitted, printed and/or displayed.
[0807] A respiratory event logbook may comprise a number of
entries, each entry corresponding to a separate respiratory event.
The event entries included in medical event log may be organized
according to various categories, including for example, event type,
event time/date, order of occurrence of the event, therapy provided
to treat the event, among other categories. The selection of
categories used to organize the information may be programmable by
the user. The organized information may be stored in long term
memory, displayed, printed, and/or transmitted to a separate
device.
[0808] The collected information for the events may be optionally
accessible 3630 through an interactive user interface. The
interactive user interface may provide access to one or more log
entries through activation of a selection process, involving a
hierarchical selection menu, or other selection method, for
example. In one implementation, the user may select a log entry
from the menu by activating an input mechanism. Upon selection of
the log entry, the user interface may provide graphical or textual
depictions of the collected respiratory information associated with
the medical event.
[0809] Relating to both FIGS. 36A and 36B, the event information of
the logbook may be stored in long term memory using various storage
methodologies. For example, the logbook may utilize a flat file
system, hierarchical database, relational database, or distributed
database. Data for a group of events may be analyzed and/or
summarized in various formats. Graphical and/or textual summary
information may be displayed on the user interface and/or otherwise
communicated to the user. For example, histograms, trend graphs,
and/or other analytical tools or formats may be generated based on
the logbook event entries. A logbook display may have the ability
to display trends of the patient's apnea/hypopnea index, histograms
of number of apneas/hypopneas and/or obstructive/central events per
night, sleep stage diagram (shows the stage of sleep for each
night), heart rate trend during the night, oxygen saturation trend
during the night.
[0810] In various embodiments, collection of medical information
may be initiated responsive to prediction of a medical event. In
this scenario, information may be collected prior to the prediction
of the medical event, prior to the detection of the medical event,
during the event, and/or following the event.
[0811] FIG. 37 is a block diagram of a logbook system 3700 in
accordance with embodiments of the invention. The respiratory
logbook system 3700 implements an event-driven method of collecting
and organizing data related to events affecting patient
respiration.
[0812] Various patient conditions may be monitored through sensors
3722, patient input devices 3723, and/or information systems 3724.
Data associated with patient conditions may be stored in short term
memory 3740. One or more of the patient conditions may be used by
event detection circuitry 3736 to detect or predict the occurrence
of an event affecting respiration. Detection or prediction of an
event affecting respiration initiates the long term storage of
information associated with the event by the event information
processor 3732 into the long term memory 3760. For example, the
event information processor 3732 may collect information supplied
by one or more of the sensors 3722, patient input devices 3723, and
information systems 3724 before, during, and/or after the detection
and/or prediction of the event. The collected information
associated with each event is organized as a respiratory logbook
entry in the respiratory logbook. The respiratory logbook, or
portions thereof, may be stored in long term memory 3760,
transmitted to a remote device 3755, and/or displayed on a display
device 3770.
[0813] The embodiment illustrated in FIG. 37 includes a respiration
sensor 3745 that senses a physiological condition modulated by
patient respiration. In one embodiment, the respiration sensor may
comprise a transthoracic impedance sensor. Other methods of sensing
respiration are also possible. Such methods may include, for
example, the use of patient-external respiratory bands, respiration
flowmeter measurements, implantable or patient-external breath
sound detection, blood oxygen levels, and/or other processes. The
respiration sensor 3745 may be used, for example, to acquire a
respiration waveform before, during, and/or after an event
affecting the patient respiration. The respiration waveform may be
a component of the respiratory log entry for the event.
[0814] Information about various conditions affecting the patient
and associated with the event may be acquired using sensors 3722,
patient input devices 3723 and/or other information systems 3724.
The sensors 3722 may comprise patient-internal and/or
patient-external sensors coupled through leads or wirelessly to the
interface 3731 of the respiratory logbook system 3700. The sensors
may sense various physiological and/or non-physiological conditions
affecting patient respiration or other physiological systems. The
patient input device 3723 allows the patient to input information
relevant to conditions affecting the patient that may be useful in
generating a respiratory event log. For example, the patient input
device 3723 may be particularly useful for acquiring information
known to the patient, such as information related to patient
smoking, drug use, recent exercise level, and/or other patient
activities, perceptions and/or symptoms. The information provided
by the patient-input device may include patient-known information
relevant to the event affecting respiration that is not
automatically sensed or detected by the respiratory logbook system
3700.
[0815] The respiratory logbook system 3700 may also include one or
more information systems 3724 such as a remote computing device
and/or a network-based server. The event information processor 3732
may access the information systems 3724 to acquire information from
databases and/or other information sources stored on or generated
by the remote computing devices and/or servers. The information
acquired from the information system s 3724 may be recorded in the
respiratory logbook along with other information relevant to the
event affecting respiration. In one exemplary implementation, the
respiratory logbook system 3700 may access an internet connected
air quality server to collect data related to environmental
conditions, such as an ambient pollution index. In another
implementation, the respiratory logbook system 3700 may access the
patient's medical history through a patient information server.
[0816] The sensors 3722, patient input devices 3723, and
information systems 3724 are coupled to other components of the
respiratory logbook system 3700 through interface circuitry 3731.
The interface 3731 may include circuitry for energizing the sensors
3722 and/or for detecting and/or processing signals generated by
the sensors. The interface 3731 may include, for example, driver
circuitry, amplifiers, filters, sampling circuitry, and/or A/D
converter circuitry for conditioning the signals generated by the
sensors.
[0817] The interface 3731 may also include circuitry 3750 for
communicating with the patient input device 3723, information
systems 3724, a device programmer 3755, an APM system (not shown),
or other remote devices. Communication with the patient input
device 3723, information systems 3724 and/or a remote device
programmer 3755 and/or other remote devices may be implemented
using a wired connection or through a wireless communication link,
such as a Bluetooth or other wireless link. The communication
circuitry 3750 may also provide the capability to wirelessly
communicate with various sensors, including implantable,
subcutaneous, cutaneous, and/or non-implanted sensors.
[0818] The respiratory logbook system 3700 may optionally be
implemented as a component of a medical device that includes a
therapy system, such as a cardiac rhythm management system 3701.
The cardiac rhythm management system 3701 may include cardiac
electrodes 3725 electrically coupled to the patient's heart.
Cardiac signals sensed by cardiac sense circuitry 3720 may be used
in the detection and treatment of various anomalies of the heart
rhythm. Anomalous heart rhythms may include, for example, a rhythm
that is too slow (bradycardia), a heart rhythm that is too fast
(tachycardia), and/or a heart rhythm that involves insufficiently
synchronized contractions of the atria and/or ventricles, a symptom
of congestive heart failure.
[0819] If an arrhythmia is detected by the cardiac rhythm
management system, then a cardiac therapy circuit 3715 may deliver
cardiac therapy to the heart in the form of electrical stimulation
pulses, such as pacing and/or cardioversion/defibrillation pulses.
The cardiac signals and/or cardiac conditions, e.g., arrhythmia
conditions, derived or detected through the use of the cardiac
signals may be associated with an event affecting respiration. The
cardiac information associated with the event may be acquired and
organized by the respiratory logbook system 3700.
[0820] A user interface may be used to view and/or access the
respiratory logbook information. FIG. 38 illustrates an exemplary
depiction of a user interface display 3800. An area 3805 of the
display may be used to provide textual or graphical information
about respiratory events. As illustrated in FIG. 38, a menu 3810 of
respiratory events may be presented and may enable the user to
access additional information related to the respiratory event. The
menu 3810 may provide a summary of parameters associated with the
events contained in the respiratory logbook. As illustrated in FIG.
38, one or more summary parameter headings, such as episode number
3821, date/time 3822, type 3823, duration 3824, sleep stage 3825,
and/or environment 3826, among other parameter headings, may be
presented at the top of the menu 3810 or in another convenient
location. The summary parameter headings 3821-3826 may be
programmable, and additional or alternative parameter headings to
those depicted in FIG. 38 may be selected, for example.
[0821] The type parameter 3823 may contain abbreviations for
various respiratory events. For example AP-C and AP-O may
abbreviate central and obstructive apneas respectively, HP
abbreviates a hypopnea, CS abbreviates Cheyne-Stokes respiration
and RSB abbreviates rapid-shallow breathing.
[0822] The respiratory events displayed as menu items in the menu
3810 may be selected by a user according to episode number,
date/time, duration, type, number, or by other criteria. The menu
items may be selected for display based on various criteria ranges
and/or thresholds. For example, in the example screen illustrated
in FIG. 38, different groups of events selected as menu items may
be selected by activating the modify query button 3831. The modify
query button 3831 and other buttons illustrated on the display may
be voice activated, activated through touching the display screen,
or by operating a keyboard or pointing device, for example.
[0823] In one implementation, activation of the modify query button
3831 initiates a dialog session that allows the user to select
respiratory events to be presented in the menu according various
criteria such as by date/time, duration, type, number, or by other
criteria ranges or thresholds. In one example, the user may select
all apnea events to be presented as menu items. In another example,
the user may select all events that occurred between a first date
and a second date. In yet another example, the user may select all
events that occurred while the patient experienced certain
environmental conditions, e.g., ambient temperature range and/or
humidity range. In yet another example, the user may choose to
select all events of the respiratory logbook. The selection
criteria may be displayed in an episode query selection area 3832
of the display. The episode query selection area 3832 in the
depiction of a respiratory logbook display shown in FIG. 38
indicates that all episodes have been selected to be displayed as
menu items.
[0824] The menu 3810 allows the user to choose respiratory events
for which additional textual and/or graphical information is
displayed. The additional information provides more detailed
information about the selected events beyond the summary
information presented in the menu 3810. In the exemplary
illustration depicted in FIG. 38, the selections are indicated by
check marks 3807 beside the selected respiratory events. For
convenience, the display may include a select all button 3851
and/or a select none button 3852. Activation of the select all
button 3851 causes all events in the menu 3810 to be selected.
Activation of the select none button 3852 causes all events in the
menu 3810 to be deselected.
[0825] Following selection of one or more episodes in the menu,
activation of the detail button 3842 causes detailed textual
information associated with a selected event to be presented on the
display screen. The detail information may be displayed in the area
of the screen 3805 previously occupied by the menu 3810, for
example. The user may scroll back and forth through the textual
information for the one or more selected events using the prey
button 3841 and the next button 3843. The textual information may
be printed upon activation of the print button 3844, or may be
saved to a disk, or other storage medium, through activation of the
save to disk button 3855.
[0826] Graphical information associated with the selected events
may be displayed upon activation of the signals button 3862. In one
implementation, a respiration waveform acquired during, before
and/or after a selected event may be displayed in the area 3805 of
the display previously used for the menu 3810. Waveforms of other
parameters, e.g., cardiac rhythm, patient activity, may
additionally or alternatively be displayed. In one implementation,
a marked waveform may be displayed. For example, a marked
respiration waveform may include the respiration waveform acquired
before, during, and after the event, along with one or more symbols
aligned with the respiration waveform to indicate the occurrence of
one or more conditions. The symbol may provide a numerical value or
a textual description associated with the respiration
characteristic, e.g., average respiration rate, expiratory slope,
etc. In one example, various characteristics of disordered
breathing events including quantifiable characteristics, such as
episode duration, blood oxygen saturation, disordered breathing
type, and/or other detected characteristics may also be displayed
along with the respiration waveform. A user may scroll through the
waveforms associated with the selected events using the prey and
next buttons 3841, 3843.
[0827] FIG. 39A provides a timing diagram illustrating the
acquisition of respiratory logbook information for a detected event
affecting respiration in accordance with embodiments of the
invention. The respiratory logbook system senses and stores in a
temporary buffer a sliding scale window 3910 of one or more patient
conditions, such as those listed in Tables 1-3. The selection of
information that is sensed and stored may be programmable by the
physician. The selection of the information to be acquired may be
based on the patient's medical history. For example, if the patient
suffers from sleep apnea, or another form of disordered breathing,
the respiratory logbook would preferably be programmed to sense
conditions associated with disordered breathing. Conversely, if the
patient suffers from chronic obstructive pulmonary disorder, a
different set of conditions from those used for disordered
breathing could be sensed.
[0828] If an event affecting respiration is detected 3915, then
pre-event information 3930 acquired prior to the event is stored.
Information is collected and stored during 3940 the event. Upon
detection that the event has terminated 3945, post-event
information 3950 is collected and stored for a period of time after
the termination of the event. The event and post-event information
3940, 3950 may be acquired on a continuous basis, or the
information may be acquired during discrete intervals. After the
post-event information 3950 is collected, the acquired information
3930, 3940, 3950 is organized as a logbook entry. The respiratory
logbook system begins sensing for the next event.
[0829] FIG. 39B provides a timing diagram illustrating the
acquisition of respiratory logbook information for a predicted
event affecting respiration in accordance with embodiments of the
invention. The respiratory logbook system senses and stores in a
temporary buffer a sliding scale window 3910 of one or more patient
conditions, such as those listed in Tables 1-3. The conditions that
are sensed and stored are programmable and may be selected based on
the patient's medical history. For example, the information sensed
and stored may include information that has been effectively used
to predict the one or more types of events affecting the patient's
respiration. If an event affecting respiration is predicted 3912,
then pre-prediction information 3920 is acquired and stored. When
the event affecting respiration is detected 3915, then pre-event
information 3930 acquired prior to the event is stored. Information
3940 is collected and stored during the event. Upon detection that
the event has terminated 3945, information 3950 is collected and
stored for a period of time after the termination of the event. The
pre-event, event and post-event information 3930, 3940, 3950 may be
acquired on a continuous basis, or the information may be acquired
during discrete intervals. After the post-event information 3940 is
collected, the acquired information 3920, 3930, 3940, 3950 is
organized as a logbook entry. The respiratory logbook begins
sensing for the next event.
[0830] Sleep Logbook
[0831] Aspects of the invention that include a sleep logbook are
directed to methods and systems configured to monitor, diagnose,
and/or provide patient therapy using one or more individual medical
procedures. Each of the circles 180 illustrated in FIGS. 1B-1D
represents an individual medical procedure providing a specific
monitoring, diagnosis or therapeutic function or set of functions.
Each individual medical procedure may be implemented as a
stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0832] Other aspects of the invention involving a sleep logbook are
directed to methods and systems configured to monitor, diagnose,
and/or provide therapy using coordinated medical procedures.
Coordinated medical procedures may involve cooperative operation of
two or more of the individual processes 180. Coordinated medical
procedures may also involve cooperative operation of one or more
functions of two or more of the individual processes 180.
[0833] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0834] Embodiments of the invention involve an individual system
182 (FIG. 1C) for acquiring and organizing information related to
sleep in a logbook format. The sleep logbook system 182 may be
implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[0835] Embodiments of the invention are directed to methods and
systems for organizing information related to sleep and/or events
occurring during sleep. One embodiment of the invention involves an
automated method for collecting and organizing information
associated with sleep. The method includes detecting sleep and
acquiring information associated with sleep. The acquired
information is organized as a sleep logbook. At least one of
detecting sleep, acquiring the information associated with sleep,
and organizing the acquired information is performed at least in
part implantably.
[0836] Another embodiment involves a method for organizing
sleep-related information. The method includes acquiring
information associated with one or more sleep periods. The
information associated with the one or more sleep periods is
organized as a sleep logbook. A user interface is provided for
accessing the sleep logbook.
[0837] In another embodiment of the invention, a sleep logbook
system provides organized sleep information. The sleep logbook
includes a sleep detector configured to detect sleep. A data
acquisition unit acquires sleep information related to sleep. A
processor is coupled to the sleep detector and the data acquisition
unit. The processor organizes the acquired sleep information as a
sleep logbook entry. At least one of the sleep detector, the data
acquisition unit, and the processor includes an implantable
component.
[0838] Other embodiments of the invention involve a system for
providing coordinated patient monitoring, diagnosis and/or therapy
utilizing a sleep logbook 182. The coordinated system may include,
for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[0839] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy further
includes a sleep logbook system configured to collect and organize
information related to sleep. The sleep logbook system includes a
sleep detector configured to detect sleep. The sleep logbook system
also includes a data acquisition unit configured to acquire
information related to sleep. A processor is coupled to the sleep
detector and the data acquisition unit. The processor is configured
to organize the acquired sleep information as a sleep logbook
entry. The implantable and respiratory therapy devices 181, 184
work cooperatively to implement or use the sleep logbook. Systems
and methods directed to a sleep logbook may be implemented to
include selected features, functions, and/or structures described
in commonly owned, co-pending U.S. Pat. No. 7,572,225, which is
hereby incorporated herein by reference.
[0840] Sleep quality assessments depend upon acquiring
sleep-related data, including the patient's typical sleep patterns
and the physiological, environmental, contextual, emotional, and
other conditions affecting the patient during sleep. Diagnosis of
sleep disorders and assessment of sleep quality often involves the
use of a polysomnographic sleep study at a dedicated sleep
facility. However, such studies are costly, inconvenient to the
patient, and may not accurately represent the patient's typical
sleep behavior. In a polysomnographic sleep study, the patient is
instrumented for data acquisition and observed by trained
personnel. Sleep assessment in a laboratory setting presents a
number of obstacles in acquiring an accurate picture of a patient's
typical sleep patterns. For example, spending a night in a sleep
laboratory typically causes a patient to experience a condition
known as "first night syndrome," involving disrupted sleep during
the first few nights in an unfamiliar location. In addition,
sleeping while instrumented and observed may not result in a
realistic perspective of the patient's normal sleep patterns.
[0841] Further, polysomnographic sleep studies provide an
incomplete data set for the analysis of some sleep disorders,
including, for example, sleep disordered breathing. A number of
physiological conditions associated with sleep disordered breathing
are detectable during periods of wakefulness, e.g., decreased heart
rate variability, elevated sympathetic nerve activity,
norepinephrine concentration, and increased blood pressure
variability. Collection of data during periods of sleep and/or
during periods of wakefulness may provide a more complete picture
of the patient's sleep quality.
[0842] Various aspects of sleep quality, including the number and
severity of arousals, sleep disordered breathing episodes, and
nocturnal limb movements. Further, cardiac, respiratory, muscle,
and nervous system functioning may provide important information
for diagnosis and/or therapy delivery. An initial step to sleep
quality evaluation is an accurate and reliable method for
discriminating between periods of sleep and periods of wakefulness.
Further, acquiring data regarding the patient's sleep states or
stages, including sleep onset, termination, REM, and NREM sleep
states may be used in connection sleep quality assessment. For
example, the most restful sleep occurs during stages 3 and 4 NREM
sleep. One indicator of sleep quality is the percentage of time a
patient spends in these sleep stages. Knowledge of the patient's
sleep patterns may be used to diagnose sleep disorders and/or
adjust patient therapy, including, e.g., cardiac or respiratory
therapy. Trending disordered breathing episodes, arousal episodes,
and other sleep quality aspects may be helpful in determining and
maintaining appropriate therapies for patients suffering from
disorders ranging from snoring to congestive heart failure.
[0843] FIG. 40 is a block diagram of a sleep logbook system 4000 in
accordance with embodiments of the invention. In this exemplary
embodiment, the system includes sleep logbook functionality
provided along with a cardiac rhythm management. This embodiment is
particularly useful for patients benefiting from cardiac pacing
and/or defibrillation support through an implantable cardiac pulse
generator.
[0844] Various patient conditions associated with sleep may be
monitored through sensors 4010, 4022, patient input devices 4023,
and/or information systems 4024. One or more of the patient
conditions may be used by sleep detection circuitry 4036 to detect
the onset and/or offset of sleep. Detection of sleep onset
initiates the collection of information associated with the sleep
period by the data acquisition unit 4033 of a sleep logbook
processor 4032. For example, the data acquisition unit 4033 may
collect information supplied by one or more of the sensors 4010,
4022, patient input devices 4023, and information systems 4024
before, during, and/or after the sleep period. The collected
information associated with each sleep period is organized as a
sleep logbook entry in the sleep logbook. The sleep logbook, or
portions thereof, may be stored in memory 4060, transmitted to a
remote device 4055, and/or displayed on a display device 4070.
[0845] The embodiment illustrated in FIG. 40 may include, for
example, a respiration sensor that senses a physiological condition
modulated by patient respiration. In one embodiment, the
respiration sensor may comprise an implantable transthoracic
impedance sensor. Other methods of sensing respiration are also
possible. Such methods may include, for example, the use of
patient-external respiratory bands, respiration flowmeter
measurements, implantable or patient-external breath sound
detection, blood oxygen levels, and/or other processes. The
respiration sensor may acquire information used in the detection of
sleep onset and offset, as described in greater detail below.
Additionally or alternatively, respiration sensing may be used, for
example, to acquire a respiration waveform before, during, and/or
after an event affecting the patient respiration. The respiration
waveform may be a component of the sleep logbook entry.
[0846] Information about various conditions associated with and/or
occurring during sleep may be acquired using sensors 4010, 4022,
patient input devices 4023 and/or other information systems 4024.
The sensors may comprise patient-internal 4010 and/or
patient-external 4022 sensors coupled through leads or wirelessly
to the interface 4031 of the sleep logbook system 4000. The sensors
4010, 4022 may sense various physiological and/or non-physiological
conditions. The patient input device 4023 allows the patient to
input information relevant to conditions affecting the patient that
may be useful in generating a sleep log. For example, the patient
input device 4023 may be particularly useful for acquiring
information known to the patient, such as information related to
patient smoking, drug use, recent exercise level, and/or other
patient activities, symptoms, or perceptions, including patient
perceptions of daytime sleepiness and/or sleep quality. The
information provided by the patient-input device may include
patient-known information that is not automatically sensed or
detected by the sleep logbook system 4000.
[0847] The sleep logbook system 4000 may also include one or more
information systems 4024 such as a remote computing device and/or a
network-based server. The event information processor 4032 may
access the information systems 4024 to acquire information from
databases and/or other information sources stored on or generated
by the remote computing devices and/or servers. The information
acquired from the information systems 4024 may be recorded in the
sleep logbook along with other information relevant to the event
affecting sleep. In one exemplary implementation, the sleep logbook
system 4000 may access an internet connected air quality server to
collect data related to environmental conditions, such as an
ambient pollution index. In another implementation, the sleep
logbook system 4000 may access the patient's medical history
through a patient information server.
[0848] The sensors 4010, 4022, patient input devices 4023, and
information systems 4024 are coupled to other components of the
sleep logbook system 4000 through interface circuitry 4031. The
interface 4031 may include circuitry for energizing the sensors
4010, 4022 and/or for detecting and/or processing signals generated
by the sensors. The interface 4031 may include, for example, driver
circuitry, amplifiers, filters, sampling circuitry, and/or A/D
converter circuitry for conditioning the signals generated by the
sensors.
[0849] The interface 4031 may also include circuitry 4050 for
communicating with the patient input device 4023, information
systems 4024, a device programmer 4055, an APM system (not shown),
or other remote devices. Communication with the patient input
device 4023, information systems 4024 and/or a remote device
programmer 4055 and/or other remote devices may be implemented
using a wired connection or through a wireless communication link,
such as a Bluetooth or other proprietary wireless link. The
communication circuitry 4050 may also provide the capability to
wirelessly communicate with various sensors, including implantable,
subcutaneous, cutaneous, and/or external sensors.
[0850] The sleep logbook functionality may optionally be provided
in a medical device that includes a therapy system, such as an
implantable cardiac rhythm management system 4001. The cardiac
rhythm management system 4001 may include cardiac electrodes 4025
electrically coupled to the patient's heart. Cardiac signals sensed
by cardiac sense circuitry 4020 may be used in the detection and
treatment of various anomalies of the heart rhythm. Anomalous heart
rhythms may include, for example, a rhythm that is too slow
(bradycardia), a heart rhythm that is too fast (tachycardia),
and/or a heart rhythm that involves insufficiently synchronized
contractions of the atria and/or ventricles, a symptom of
congestive heart failure.
[0851] If an arrhythmia is detected by the cardiac rhythm
management system, then a cardiac therapy circuit 4015 may deliver
cardiac therapy to the heart in the form of electrical stimulation
pulses, such as pacing and/or cardioversion/defibrillation pulses.
The cardiac signals and/or cardiac conditions, e.g., arrhythmia
conditions, derived or detected through the use of the cardiac
signals may be associated with sleep. The cardiac information
associated with sleep may be acquired and organized by the sleep
logbook system 4000.
[0852] A user interface may be used to view and/or access the sleep
logbook information. FIG. 41 illustrates an exemplary depiction of
a user interface display 4100. An area 4105 of the display may be
used to provide textual or graphical information about sleep. As
illustrated in FIG. 41, a menu 4110 of sleep periods may be
presented and may enable the user to access additional information
related to the sleep periods and/or to sleep disorder events
occurring during the sleep periods. The menu 4110 may provide a
summary of parameters associated with sleep periods contained in
the sleep logbook. As illustrated in FIG. 41, one or more summary
parameter headings, such as sleep period 4121, onset date/time
4122, offset date/time 4123, apnea/hypopnea index (AHI) 4124,
uninterrupted sleep efficiency 4125, among other parameter
headings, may be presented at the top of the menu 4110 or in
another convenient location. The summary parameter headings
4121-4125 may be programmable, and additional or alternative
parameter headings to those depicted in FIG. 41 may be
selected.
[0853] The sleep periods displayed as menu items in the menu 4110
may be selected by a user according to episode number, date/time,
duration, or by other criteria such as by one or more sleep quality
indices. Additionally or alternatively, the menu items may reflect
one or more sleep disorder events, e.g., movement disorder events
and/or disordered breathing events. The menu items may be selected
for display based on various criteria ranges and/or thresholds. For
example, in the example screen illustrated in FIG. 41, different
groups of sleep periods selected as menu items may be selected by
activating the modify query button 4131. In an alternate scenario,
different groups of sleep disorder events selected as menu items
may be selected by activating the modify query button 4131. The
modify query button 4131 and other buttons illustrated on the
display may be voice activated, activated through touching the
display screen, or by operating a keyboard or pointing device, for
example.
[0854] In one implementation, activation of the modify query button
4131 initiates a dialog session that allows the user to select
sleep periods and/or sleep disorder events to be presented in the
menu according various criteria such as by date/time, duration,
type, sleep quality metrics, or by other criteria parameters. In
one example, the user may select all sleep periods having an
uninterrupted sleep efficiency (USE) metric below a threshold to be
presented as menu items. In another example, the user may select
all sleep periods between a first date and a second date. In yet
another example, the user may select all sleep disorder events of a
particular type that occurred while the patient experienced certain
environmental conditions, e.g., ambient temperature range and/or
humidity range. In yet another example, the user may choose to
select all sleep periods or all sleep disorder events represented
in the sleep logbook. The selection criteria may be displayed in an
episode query selection area 4132 of the display. The episode query
selection area 4132 in the depiction of a sleep logbook display
shown in FIG. 41 indicates that all sleep periods have been
selected to be displayed as menu items.
[0855] The menu 4110 allows the user to choose sleep periods for
which additional textual and/or graphical information is displayed.
The additional information provides more detailed information about
the selected periods beyond the summary information presented in
the menu 4110. In the exemplary illustration depicted in FIG. 41,
the selections are indicated by check marks 4107 beside the
selected sleep periods. For convenience, the display may include a
select all button 4151 and/or a select none button 4152. Activation
of the select all button 4151 causes all sleep periods in the menu
4110 to be selected. Activation of the select none button 4152
causes all sleep periods in the menu 4110 to be deselected.
[0856] Following selection of one or more sleep periods in the
menu, activation of the detail button 4142 causes detailed textual
information associated with a selected sleep period to be presented
on the display screen. The detail information may be displayed in
the area of the screen 4105 previously occupied by the menu 4110,
for example. The user may scroll back and forth through the textual
information for the one or more selected sleep periods using the
prey button 4141 and the next button 4143. The textual information
may be printed upon activation of the print button 4144, or may be
saved to a disk, or other storage medium, through activation of the
save to disk button 4155.
[0857] Graphical information associated with the selected sleep
periods may be displayed upon activation of the signals button
4162. In one implementation, a respiration waveform acquired during
all or a portion of a selected sleep period may be displayed in the
area 4105 of the display previously used for the menu 4110. In one
implementation, a respiration waveform may be acquired before,
during and/or after respiration events that occur during sleep.
Waveforms of other parameters, e.g., cardiac rhythm, patient
activity, may additionally or alternatively be displayed. In one
implementation, a marked waveform may be displayed. For example, a
marked respiration waveform may include the respiration waveform
along with one or more symbols aligned with the respiration
waveform to indicate the occurrence of one or more conditions. The
symbols may provide a numerical value or a textual description
associated with the respiration characteristic, e.g., average
respiration rate, expiratory slope, etc. In one example, various
characteristics of disordered breathing events including
quantifiable characteristics, such as episode duration, blood
oxygen saturation, disordered breathing type, and/or other detected
characteristics may also be displayed along with the respiration
waveform. A user may scroll through the waveforms associated with
the selected events using the prey and next buttons 4141, 4143.
[0858] Snoring Detection Systems and Methods
[0859] Aspects of the invention that include snoring detection are
directed to methods and systems configured to monitor, diagnose,
and/or provide patient therapy using one or more individual medical
procedures. Each of the circles 180 illustrated in FIGS. 42B-42D
represents an individual medical procedure providing a specific
monitoring, diagnosis or therapeutic function or set of functions.
Each individual medical procedure may be implemented as a
stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0860] Other aspects of the invention that include snoring
detection are directed to methods and systems configured to
monitor, diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0861] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of,
the medical procedures or devices implementing such medical
procedures. The transfer of information may implicate one of the
medical procedures, some of the medical procedures, or all of the
medical procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0862] Systems and methods may provide for snoring detection to
determine, predict, and/or verify the presence of sleep disordered
breathing. According to various embodiments, snoring sounds
generated by a patient are detected. The presence of sleep
disordered breathing is determined using the detected snoring
sounds. In other embodiments, snoring is detected from disturbances
in a respiration or airflow signal.
[0863] Snoring sounds or snoring-related respiration/airflow
disturbances may be detected internally of the patient or
externally of the patient. Determining presence of sleep disordered
breathing may be performed internally or externally of the patient.
Determining presence of sleep disordered breathing may include
computing a snoring index developed from the detected snoring.
Sleep apnea may be detected using the snoring index. Sleep apnea
may be verified using internal or external sensors. In one
approach, sleep disordered breathing is detected, such as by use of
a minute ventilation sensor, and presence of the sleep disordered
breathing may be confirmed using the detected snoring.
[0864] Embodiments of methods of detecting snoring in a patient
involve generating a signal modulated by snoring and detecting
snoring based on the generated signal, wherein at least one of
generating the signal and detecting snoring is performed using a
component disposed in or on a cardiac rhythm management device.
Modulating the signal by snoring and detecting snoring may be
performed implantably, such as by using a sensor disposed in or on
a pulse generator housing. The sensor may alternately or
additionally be disposed in or on a lead system coupled to a pulse
generator, in or on a header of a pulse generator, coupled to a
cardiac rhythm management system, mechanically coupled to an
external respiration therapy device, or disposed in or on a
respiratory mask. Detecting snoring may involve using circuitry
disposed in or on a cardiac rhythm management device, which may
further deliver a therapy to mitigate the detected snoring, and/or
detect sleep disordered breathing based on the detected snoring,
and/or deliver a therapy to treat the detected disordered
breathing.
[0865] According to other embodiments, systems may include a sensor
configured to sense snoring generated by a patient and a processor
coupled to the sensor. The processor algorithmically determines
presence of sleep disordered breathing using the sensed snoring.
The sensor may include one or more of an accelerometer, a
microphone, a pressure transducer, a subsonic sensor, a respiration
sensor, or a vibration or motion sensor. The sensor may be
implemented for patient-external sensing of the snoring or on or
within an implantable sensing device. The processor may be disposed
within an implantable medical device (e.g., CRM device). Systems
may further include a positive airway pressure (CPAP) device
communicatively coupled to one or both of the sensor and the
processor. Sleep disordered breathing may be verified using the
CPAP device.
[0866] Systems and methods that employ snoring detection 139 (FIG.
1D) may be implemented as a stand-alone system or in combination
with other individual medical systems, such as those described in
FIGS. 1B-1D. Various embodiments involve a system for providing
coordinated patient monitoring, diagnosis and/or therapy that
utilizes snoring detection 139. The coordinated system may include,
for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[0867] The implantable and respiratory therapy devices 181, 184 may
operate cooperatively based on detected snoring. For example,
detection of snoring and/or severity of snoring may allow the
implantable and respiratory therapy devices 181, 184 to operate
cooperatively to provide a therapy to treat patient snoring and/or
sleep apnea associated with the detected snoring. Systems and
methods directed to snoring detection may be implemented to include
selected features, functions, and/or structures described in
commonly owned, co-pending U.S. Pat. No. 7,532,934, which is hereby
incorporated herein by reference.
[0868] Embodiments are directed to one or more of sensing,
detection, and treatment of snoring using an at least partially
implantable device. Snoring information is useful in disordered
breathing detection, verification, and/or prediction, such as for
detecting or prediction of apnea events. Snoring detection is also
useful independent of disordered breathing, to treat the snoring
itself. Snoring may lead to insomnia, arousals from sleep, marital
discord, and wake-time sleepiness. Snoring detection in accordance
with the present invention may also be used to treat the snoring,
such as by modulating the pressure of a continuous positive airway
pressure (CPAP) device to reduce the snoring, for example.
[0869] An internal or external snore sensor, such as a vibration
sensor, respiration sensor, airflow sensor, accelerometer or
microphone, may be coupled to a patient-internal medical device
(PIMD), such as a cardiac rhythm management (CRM) device, or a
respiration therapy device. In some embodiments, the snore sensor
may be configured as a patient-external device, possibly mounted on
a respiratory mask, for example. Information from the snore sensor
is wirelessly transmitted to the PIMD device.
[0870] In other embodiments, the snore sensor may be associated
with an implanted device, such as an accelerometer positioned
within or on the housing of an PIMD device, or on the PIMD lead
system. A snore detector in the PIMD device may receive signals
from the patient-external and/or patient-internal snore sensor, and
may generate one or more snore indices, based on the frequency,
severity and/or other characteristics of snoring incidents, for
example. A snore index may be used, for example, to determine if a
patient is at risk for daytime fatigue and sleepiness due to
excessive nighttime snoring indicating sleep disordered
breathing.
[0871] In further embodiments, an airflow sensor may be associated
with an implanted device, such as a transthoracic impedance sensor
mounted on the lead system of a PIMD device. The snore detector in
the PIMD device may be configured to algorithmically detect snoring
using the transthoracic impedance signal, and may be configured to
generate one or more snoring indices. For example, airflow may be
measured, such as by use of transthoracic impedance or external
airflow sensing, and snoring may be determined using the airflow
measurement.
[0872] Detection of the snore severity, as measured by a severity
snore index, may be used to test for risk of vascular disease such
as hypertension. A snore index also may be used in connection with
disordered breathing detection and/or prediction. One or more snore
indices may be stored, trended, displayed and/or transmitted to
another device.
[0873] FIGS. 42A and 42B illustrate embodiments of the present
invention involving snoring detection using an implantable device.
The processes and systems exemplified by these embodiments may be
implemented alone or in combination with one or more processes and
systems exemplified by other embodiments described herein to
provide a coordinated approach to patient monitoring, diagnosis,
and/or therapy.
[0874] In various embodiments, a snore sensor may be implantable,
partially implantable, or patient-external. The snore sensor may be
coupled to detection circuitry directly, coupled through wiring,
and/or coupled wirelessly. The sensor may be incorporated into a
lead, such as a cardiac pacing lead.
[0875] In accordance with embodiments of the invention, illustrated
in FIGS. 42A and 42B, a snore sensor 4220 (FIG. 42A) and 4230 (FIG.
42B), such as an accelerometer or microphone, is coupled to a PIMD
device 4210 and used for snoring detection. In one embodiment (FIG.
42A), the snore sensor 4220 is a patient-external device, possibly
mounted on a CPAP mask housing, for example. Information from the
snore sensor 4220 is wirelessly transmitted to the PIMD device
4210.
[0876] In another embodiment (FIG. 42B), the snore sensor 4230 is
an implanted device, such as, for example, an accelerometer or a
transthoracic impedance sensor positioned within or on the housing
of the PIMD device 4210, or on a PIMD lead system (not shown). For
example, the low frequency sounds produced by snoring can be
detected using a PIMD accelerometer, such as an accelerometer used
in connection with rate adaptive pacing or posture sensing, for
example. By way of further example, disturbances in a transthoracic
impedance sensor signal indicative of snoring may be detected.
[0877] According to a further embodiment, the snore sensor
4220/4230 may be implemented as an airflow sensor configured to
sense airflow disturbances indicative of snoring. The snore sensor
4220/4230 may be implemented as an internal or an external airflow
sensor. For example, the snore sensor 4230 may be implemented as an
external airflow sensor, which may be provided on a CPAP mask, and
configured to sense patient snoring.
[0878] A snore detector 4240 in the PIMD device 4210 receives
signals from the patient-external snore sensor 4220 and/or
patient-internal snore sensor 4230, and may generate one or more
snore indices, based on the frequency, severity and/or other
characteristics of snoring incidents, for example. Snoring
detection in accordance with embodiments of the invention may be
used alone, or in combination with other sensors, to detect and/or
verify occurrences of disordered breathing. For example, detection
of periodic snorts may indicate an episode of obstructive sleep
apnea.
[0879] The snoring methodology described herein may be used in
cooperation with a multi-sensor system. Snore information may be
used in combination with information from other patient-internal
and/or patient-external sensors to confirm the detection of
disordered breathing. In accordance with the present invention, any
number or all of snoring sensor(s), snoring detector(s), disordered
breathing detector(s), and disordered breathing prediction
device(s) may be implantable, partially implantable, or
patient-external, as long as at least one element is at least
partially implantable. In one approach, an initial detection of a
disordered breathing episode may be made by an optional disordered
breathing detector 4250 based on respiration patterns detected
using a transthoracic impedance sensor. Snore information may be
used alone, or in combination with other sensor signals, to confirm
the initial detection of disordered breathing.
[0880] In another example, an initial detection of a disordered
breathing episode may be made by a CPAP device using a respiration
signal acquired from sensors on the CPAP mask. The CPAP device may
communicate with the PIMD device 4210 for confirmation of
disordered breathing. Based on snoring information obtained and
evaluated in the PIMD device 4210, the PIMD device 4210 may confirm
or refute the occurrence of disordered breathing and respond
accordingly, such as through a change of settings, alarm, or other
action.
[0881] In another implementation, detection of snoring may be used
to modulate CPAP pressure, allowing auto-titration of CPAP pressure
therapy through snoring detection. Detection of snoring may
indicate that the CPAP pressure is insufficient to open the
patient's airways. In accordance with an embodiment of the
invention, a CPAP mounted microphone may be used to detect snoring.
Based on detection of snoring, or based on snoring characteristics,
e.g., the snore index, CPAP pressure may be modulated. For example,
the snore index may be compared to a threshold. If the snore index
is beyond the threshold, the CPAP pressure may be increased. In
another example, CPAP therapy pressure may be adjusted as a
function of the snore index. In a further embodiment, optional
therapy circuitry 4251 may be used to provide therapy to, for
example, reduce snoring, correct disordered breathing, improve
patient hemodynamics, or other therapy.
[0882] FIGS. 42C and 42D illustrate embodiments of the present
invention with a snore detector 4221 in a patient-external
configuration 4223. The snore detector 4221 may be coupled to the
PIMD device 4210 wirelessly, for example. The snore sensor may be
an internal snore sensor 4230 (FIG. 42C) or a patient-external
snore sensor 4220 (FIG. 42D), such as of a type previously
described. Similarly to the snore detector 4221, the disordered
breathing detector 4250, and therapy circuitry 4251 may be
implemented in either or both of patient-external and internal
configurations, as well as cooperate with the PIMD device 4210 for
coordinated and/or combined therapy.
[0883] Posture Detection System
[0884] Aspects of the invention that include detection of patient
posture are directed to methods and systems configured to monitor,
diagnose, and/or provide patient therapy using one or more
individual medical procedures. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0885] Other aspects of the invention that involve posture
detection are directed to methods and systems configured to
monitor, diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[0886] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0887] One embodiment of the invention involves an individual
system 131 (FIG. 1D) for detecting patient posture. The posture
detection system 131 may be implemented as a stand alone system or
in combination with other individual medical systems, such as those
described in FIGS. 1B-1D.
[0888] Embodiments of the invention relate to detection of patient
posture. One embodiment of the invention involves a posture
detection system including an implantable cardiac device and a
patient-external respiratory therapy device. The implantable
cardiac device and the patient-external respiratory therapy device
are coupled by a communications channel configured to transfer at
least posture information between the implantable cardiac device
and a patient-external respiratory therapy device.
[0889] According to one aspect of the invention, the
patient-external respiratory therapy device includes components of
the posture detector. For example, the posture detector may be
positioned on the respiratory mask or the respiratory mask strap.
In another example, the posture detector may be positioned on the
patient's body and communicatively coupled to a control unit of the
respiratory therapy device through a lead. The patient-external
respiratory therapy device transmits posture information to the
implantable cardiac device.
[0890] According to another aspect of the invention, the
implantable cardiac device includes components of the posture
detector. The implantable cardiac device transmits posture
information to the patient-external respiratory therapy device.
[0891] Another embodiment of the invention involves a posture
detection method. The posture detection method includes detecting
posture using a sensor of a patient-external respiratory therapy
device or a sensor of an implantable cardiac device. The posture
information is transmitted between the patient-external respiratory
therapy device and the implantable cardiac device.
[0892] According to various aspects of the invention, the posture
information may be used to adjust therapy delivered to the patient.
The therapy adjusted may include a therapy delivered by the
implantable device, or by the external respiratory therapy device.
In one implementation, the implantable device delivers a cardiac
electrical stimulation therapy and the cardiac electrical
stimulation therapy is adjusted based on patient posture.
Alternatively, or additionally, therapy delivered by the
respiratory therapy device may be modified using the posture
information.
[0893] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
system 131 that utilizes patient posture detection. The coordinated
system includes, for example, an implantable cardiac device 181 and
a patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[0894] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
system 131 configured to detect patient posture. The posture
detection system 131 includes an implantable cardiac device, a
patient-external respiratory therapy device and a communications
channel between the implantable cardiac device and the a
patient-external respiratory therapy device. The communications
channel is configured to transfer information between the
implantable cardiac device and the patient-external therapy
respiratory device, where at least one of the implantable cardiac
device and the patient-external respiratory therapy device includes
one or more components of a posture detector. The communications
channel is configured to at least transfer posture information
between the implantable cardiac device and the patient-external
respiratory therapy device. Systems and methods directed to posture
detection may be implemented to include selected features,
functions, and/or structures described in commonly owned,
co-pending U.S. Pat. No. 7,664,546, which is hereby incorporated
herein by reference.
[0895] Posture detection may involve, for example, determining a
positional orientation of the patient's body or the positional
orientation of a portion of the patient's body, such as the
patient's torso. Posture detection includes discriminating between
a horizontal, recumbent or supine position and a vertical or
upright position, determining an inclination of a portion of the
patient's body, and or determining if the patient is lying on his
or her side, back, or front. Knowledge of patient posture may be
used by the implantable device to diagnose various patient
disorders and/or to adjust patient therapy, for example. A supine
posture is more likely to result in obstruction of the upper airway
and can be used to predict episodes of obstructive hypopnea and
apnea, for example.
[0896] Discriminating between a recumbent and an upright position
of the patient's body is useful in connection with determining if a
patient is asleep or awake. Patient posture can be used as an
indicator or verifier that a patient is sleeping. Diagnosis of
various conditions, e.g., sleep apnea, may be enhanced with
knowledge of the patient's sleep state. Thus, a patient may be
diagnosed as having sleep disordered breathing if breathing
interruptions occur while a patient is sleeping, as indicated by
patient posture during the disordered breathing episodes.
[0897] The position of the patient's body, such as the inclination
of the upper torso, may predispose the patient to various medical
disorders, including disorders affecting the respiratory,
cardiopulmonary, and/or cardiovascular systems. Information about
patient position may be evaluated with respect to the detection of
various disorders to determine if an association between patient
position and a particular disorder is present.
[0898] Knowledge of patient posture may enhance therapy delivery.
Therapy may be adjusted to provide a more appropriate therapy based
on whether the patient is asleep or awake. For example, a cardiac
pacing rate may be decreased from a waking rate to a lower sleeping
rate to account for the decreased hemodynamic need of the patient
during sleep.
[0899] Some patients suffer from a number of disorders that are
treated with multiple therapy devices. For example, a patient
suffering from cardiac and respiratory problems may receive therapy
from an implantable cardiac rhythm management system, e.g., a
bi-ventricular pacing device for synchronizing ventricular
contractions, and an external respiratory therapy device. Using
therapy devices in a coordinated manner provides opportunities for
enhanced monitoring, diagnosis and/or therapy delivery. Various
embodiments described herein are directed to a posture sensor
disposed on a respiratory therapy mask. Information related to
patient posture is transmitted to an implantable device, such as a
cardiac therapy device.
[0900] FIG. 43 is a flowchart of a method for determining patient
posture. At least one of a patient-external respiratory device and
an implantable device include 4310 a posture detector. The posture
detector, which may be positioned on a component of the respiratory
therapy device, within an implantable housing of the implantable
device, or in other locations, acquires 4320 patient posture
information. The posture information is transmitted 4330 to between
the patient-external respiratory device and the implantable
device.
[0901] In a one configuration, the posture detector is coupled by a
wire lead to the controller unit of the respiratory therapy device.
Communications circuitry positioned within the controller unit
wirelessly transmits the posture information, possibly along with
other relevant information, to the implantable device. In another
configuration, the circuitry for wirelessly transmitting the
posture information to the implantable device is disposed with the
posture sensor on the respiratory mask or mask strap, for
example.
[0902] In another configuration, the posture detector is disposed
within a housing of an implantable device. Communications circuitry
positioned within the implantable device housing wirelessly
transmits the posture information to the control unit of the
respiratory therapy device, possibly along with other relevant
information.
[0903] In yet another configuration, the posture information may be
relayed from one device to another device through a patient
information server, such as is used in an advanced patient
management system.
[0904] Posture sensing may employ various types of sensors,
including, for example, multiaxis accelerometers, inclination
sensors, magnetometers, mercury-type switches, or other sensing
methodologies. In one implementation, an accelerometer is used as a
posture sensor. FIG. 44 is a waveform signal generated by an
accelerometer that indicates patient posture. When a patient moves
from a supine position to an upright position, the accelerometer
produces fluctuating waveform signals. When a patient is supine and
moves to an upright standing position, a negative change in voltage
on the waveform occurs, e.g. from 0 Volts to -0.5 Volts. When a
patient is in the standing position and moves to a supine position,
a positive change in voltage on the waveform occurs, e.g. from 0
Volts to 0.25 Volts.
[0905] FIGS. 45A-45D are diagrams illustrating medical systems 4500
with posture detection functionality in accordance with embodiments
of the invention. The medical system 4500 includes a respiratory
therapy device 4510 communicatively coupled to a CRM system 4550.
Delivery of cardiac electrical stimulation therapy provided by the
CRM system 4550, e.g., bradycardia pacing, tachycardia pacing,
cardiac resynchronization pacing and/or
cardioversion/defibrillation, is controlled by a cardiac therapy
control unit 4555 disposed within the housing of the CRM
system.
[0906] The respiratory therapy device 4510 may comprise for
example, a positive airway pressure (CPAP) device, a nebulizer,
ventilator, or other type of respiration therapy device. For the
purposes of describing FIGS. 45A-45D, the respiratory therapy
device 4510 is considered to be a CPAP device. The CPAP device
includes a respiratory therapy control unit 4511, respiratory mask
4520, and tubing 4515 coupling the respiratory mask 4520 to the
control unit 4511. Respiratory therapy pressure is controlled by
circuitry 4526 within the control unit 4511. The respiratory
therapy control unit 4511 develops an airway pressure delivered to
the patient through the respiratory mask 4520 via tubing 4515.
Various methodologies and systems for implementing CPAP therapies
are described in U.S. Pat. Nos. 5,245,995 and 5,199,424, which are
incorporated herein by reference.
[0907] The respiratory mask 4520 is held in place over the
patient's nose and/or mouth using a strap 4521 or other type of
securing structure. In one embodiment, illustrated in FIG. 45A, a
posture detector 4525 is positioned on a component of the CPAP
device, preferably on the mask 4520 or mask strap 4521. With the
posture detector 4525 positioned on the mask 4520 or mask strap
4521, the sensor produces signals modulated by changes in the
position of the patient's torso and/or head. The posture detector
4525 is coupled to the respiratory therapy control unit 4510
through a lead extending from the mask assembly 4520, 4521.
[0908] In another embodiment, illustrated in FIG. 45B, one or more
posture detectors 4525 are positioned on or near the patient so
that changes in the patient's posture are detectable by an
accelerometer or other sensor used for sensing patient position.
The posture detectors 4525 may be positioned on or near the
patient's head, chest, abdomen, or other appropriate location of
the patient's body. The posture detector 4525 may be
communicatively coupled to the respiratory therapy unit 4510
through a wire lead or through a wireless communications link.
[0909] The respiratory therapy unit includes a signal processor
4531 for energizing the posture detector 4525 and/or receiving the
signals from the posture detector 4525. Compatible communications
units 4541, 4540 of the CPAP 4510 and CRM 4550 devices establish a
wireless communication channel between the CPAP device 4510 and the
CRM device 4550. Posture information is transmitted over the
wireless communications channel 4540, 4541 from the CPAP device
4510 to the CRM device 4550.
[0910] In a further embodiment, illustrated in FIG. 45C, a signal
processing circuitry 4531, including circuitry for wireless
communication is positioned along with the posture detector 4525 on
the respiratory mask 4520 or mask strap 4521. In one configuration,
the posture detector and processing circuitry 4525, 4531 are
configured to detect patient posture and wirelessly communicate
posture information to the implantable device 4550. Posture
information may also be transferred between the implantable device
4550 and the respiratory therapy device 4510. In another
configuration (not shown), the posture detector and associated
circuitry 4525, 4531 detect patient posture and wirelessly
communicate the posture information to the respiratory therapy
device 4510.
[0911] FIG. 45D illustrates another embodiment of a posture
detection system. In this embodiment, the implantable device 4550
includes the posture sensor 4525 and associated circuitry 4531. The
posture detector 4525 may comprise, for example, an accelerometer
or other sensor disposed within or on an implantable housing or
other component of the implantable device 4550. The posture
information may be transmitted form the implantable device 4550 to
the external respiratory therapy device 4510.
[0912] The CRM device 4550 may utilize the received posture
information for diagnostic or therapeutic purposes. For example, as
previously discussed, the CRM device 4550 may use the posture
information to detect or confirm sleep. The posture information may
also be used in connection with detecting or predicting disordered
breathing. Further posture information may be used by the CPAP
device 4510 or the CRM device 4550 to correlate patient posture,
e.g., particular patient positions or torso inclinations, to
episodes of disordered breathing. Correlation of patient posture to
detected disordered breathing episodes may be used to enhance
detection or prediction of subsequent episodes of disordered
breathing. Methods of detecting disordered breathing using a CPAP
device are described in previously incorporated U.S. Pat. Nos.
5,245,995 and 5,199,424.
[0913] Posture information may be used by the implantable cardiac
device 450 to initiate, modify or terminate a therapy delivered by
the CRM device to the patient. For example, based on the posture
information, the CRM device may decrease or increase a pacing rate,
switch from a uni-ventricular pacing mode to a bi-ventricular
pacing mode or the reverse, initiate, modify or terminate cardiac
electrical stimulation therapy for disordered breathing. The CPAP
device 4510 may also utilize the received posture information to
adjust the external respiratory therapy delivered by the CPAP
device 4510.
[0914] FIG. 46 is a process flow diagram illustrating various uses
for posture information in accordance with the present invention. A
posture sensor coupled to a respiratory therapy device generates
signals 4610 modulated by patient posture. The signals are
evaluated 4620 to determine various aspects of patient posture. For
example, evaluation of the posture sensor signals may provide
information about the patient position, such as whether the patient
is recumbent or upright, the inclination of the patient's torso,
whether the patient is lying on his or her back, left side, right
side, or front, and/or other posture or position-related
information.
[0915] The posture information is transmitted to an implantable
device, such as a pacemaker or other implantable cardiac device.
The posture information may be used to detect or verify sleep.
Additionally or alternatively, the posture information may be used,
to diagnose 4630 or predict various disorders of the patient, such
as disordered breathing, or for other purposes. The implantable CRM
device may use the posture information to adjust 4640 cardiac
electrical stimulation therapy delivered to the patient.
[0916] The posture information may also be used by the respiratory
therapy device. The respiratory therapy device may use the posture
information to detect or verify sleep, to diagnose 4650 or predict
episodes of disordered breathing. The posture information may be
used respiratory therapy device to modify 4660 the therapy
delivered by the respiratory therapy device.
[0917] The implantable device, respiratory therapy device, or both
may be coupled to an APM system. Posture information may be relayed
to the APM system. The APM system may store the posture
information, use 4670 the posture information to monitor the
patient, diagnose various disorders affecting the patient, and/or
to adjust patient therapy. The APM system may transmit the posture
information to a variety of other devices connected through the APM
system.
[0918] Cardiac Electrical Activity Detected Via Respiratory Therapy
Device
[0919] Aspects of the invention that include use of an external
respiratory therapy device to detect cardiac electrical activity
are directed to methods and systems configured to monitor,
diagnose, and/or provide patient therapy using one or more
individual medical procedures. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[0920] Other aspects of the invention involving cardiac detection
via a respiratory therapy device are directed to methods and
systems configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures. Coordinated medical
procedures may involve cooperative operation of two or more of the
individual processes 180. Coordinated medical procedures may also
involve cooperative operation of one or more functions of two or
more of the individual processes 180.
[0921] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0922] Embodiments of the invention involve an individual system
133 (FIG. 1C) for detecting cardiac electrical activity using a
respiratory therapy device. The cardiac electrical activity
detection system 133 via a respiratory therapy device may be
implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[0923] Various embodiments are directed to methods and systems for
detecting cardiac electrical activity using an external respiratory
therapy device. In accordance with one embodiment, a medical system
includes one or more cardiac electrodes configured to sense cardiac
electrical activity. The cardiac electrodes are coupled to an
external respiratory therapy device. The cardiac electrical
activity is used to generate an electrocardiogram (ECG) signal.
[0924] In accordance with another embodiment of the invention, a
system includes sensors coupled to an external respiratory therapy
device. The sensors are configured to sense electrical activity of
a heart. A cardiac event detector is coupled to the one or more
sensors and is configured to detect one or more cardiac events
based on the sensed cardiac electrical activity.
[0925] Another embodiment of the invention involves a method for
generating an electrocardiogram (ECG) signal. Cardiac electrical
activity is sensed using one or more cardiac electrodes coupled to
an external respiratory therapy device. The ECG signal is generated
based on the sensed cardiac electrical activity.
[0926] A further embodiment involves detecting cardiac events. The
method includes sensing cardiac electrical activity using one or
more cardiac electrodes coupled to an external respiratory therapy
device. The cardiac events are detected based on the sensed cardiac
electrical activity.
[0927] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes an external respiratory therapy system 133 to detect
cardiac electrical activity. The coordinated system includes, for
example, an implantable cardiac device 181 and a patient-external
respiratory therapy device 184. The system may further include an
external processor 183 providing a coordination function. A
communication channel couples the implantable device 181 and the
respiratory therapy device 184. The implantable 181 and respiratory
therapy devices 184 operate cooperatively via the communication
channel to provide one or more of patient monitoring, diagnosis,
and therapy.
[0928] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy further
includes a system 133 configured to detect electrical activity of a
heart using a respiratory therapy device. The cardiac electrical
activity detection system 133 includes one or more sensors coupled
to an external respiratory therapy device configured to sense
electrical activity of a heart and to generate a cardiac electrical
signal based on the sensed electrical activity. The system further
includes a cardiac event detector coupled to the one or more
sensors configured to detect one or more cardiac events based on
the sensed electrical activity. Systems and methods directed to
detection of cardiac activity using an external respiratory therapy
device may be implemented to include selected features, functions,
and/or structures described in commonly owned, co-pending U.S. Pat.
No. 7,364,547, which is hereby incorporated herein by
reference.
[0929] Treatment of respiratory disorders may involve the use of an
external respiratory therapy device. Respiratory therapy devices
may include a respiratory mask assembly that fits over the
patient's nose and/or face and directs a flow of gas to the
patient. The mask assembly is connected through a tube to a control
unit that controls the flow of air or other gas to the patient.
Sensors on the mask, in the control unit, or elsewhere may
facilitate control of the respiratory therapy delivered to the
patient.
[0930] External respiratory therapy devices are often used to treat
breathing disorders, such as sleep disordered breathing. Sleep
apnea is a common form of sleep disordered breathing and is
characterized by periods of interrupted breathing during sleep.
Apnea and other types of disordered breathing may be caused
blockage of the airway due to prolapse of soft tissue into the
throat (obstructive apnea) and/or by derangement of the central
nervous system signals controlling the breathing reflex. The
cessation of breathing may occur repeatedly during sleep, sometimes
hundreds of times a night and sometimes for a minute or longer.
Respiratory therapy for sleep disordered breathing typically
involves the use of an external respiratory device during the
night. The external respiratory therapy device delivers positive
airway pressure to the patient. The positive air pressure acts as a
pneumatic splint, keeping the patient's airway open and reducing
episodes of disordered breathing.
[0931] Patient's suffering from respiratory disorders may
concurrently experience cardiac dysfunction. Sleep apnea and
cardiac arrhythmia are common comorbidities. Further, Cheyne-Stokes
respiration is frequently observed in patients with congestive
heart failure. Cheyne-Stokes respiration in congestive heart
failure patients is associated with poor prognosis and may be used
to track the progression of the disease. Cardiac arrhythmias have
been associated with the hypoxia or autonomic arousal from sleep
disordered breathing.
[0932] Although cardiac conditions and respiratory disorders are
commonly found in combination, monitoring and/or treatment of the
disorders is generally accomplished using separate medical devices.
Respiratory disorders such as disordered breathing have
traditionally been treated using the above-described external
respiratory therapy devices. Monitoring cardiac conditions such as
cardiac arrhythmia may be accomplished using a patient worn or
carried monitor, for example, a Holter monitor, having electrodes
attached to the patient's chest for detecting cardiac electrical
activity. Cardiac conditions such as arrhythmia and congestive
heart failure may also be monitored and/or treated using an
implantable cardiac rhythm management (CRM) system.
[0933] The nightly use of an external respiratory therapy device by
the patient provides an opportunity to detect and/or diagnose
cardiac disorders in addition to respiration disorders. Embodiments
of the invention involve the use of cardiac sensors used in
cooperation with a respiratory therapy device to provide
coordinated patient monitoring, diagnosis and/or therapy. The
cardiac sensors sense cardiac electrical activity used to generate
an electrocardiogram signal. Further embodiments of the invention
involve detecting cardiac arrhythmia based on the sensed cardiac
electrical activity.
[0934] FIGS. 47A and 47B are flowcharts illustrating methods of
using a cardiac electrical activity sensor disposed on a
respiratory therapy device in accordance with embodiments of the
invention. One or more electrodes are disposed 4710, 4730 on a
respiratory therapy device in locations that facilitate sensing
cardiac electrical activity. The electrodes may be positioned on a
respiratory mask, mask strap, or in other locations of the
respiratory therapy device from which cardiac signals can be
sensed. In one embodiment, the sensed cardiac electrical activity
is used 4720 to generate an electrocardiogram (ECG) signal. In
another embodiment, the sensed cardiac electrical activity signal
is used 4740 to detect arrhythmia.
[0935] FIGS. 48A-48F illustrate various embodiments for sensing
cardiac activity and generating ECG signals using electrodes
coupled to an external respiratory therapy device. In some
embodiments, cardiac electrodes disposed on the mask of an external
respiratory device sense cardiac signals. Circuitry coupled to the
electrodes generates an ECG waveform. The ECG waveform generating
circuitry coupled to the electrodes may be disposed on the mask,
within the CPAP controller, or in another location.
[0936] In the illustrative examples presented herein, the external
respiratory therapy device is configured as a continuous positive
airway pressure (CPAP) device 4820 including a controller 4820,
tubing 4822, and respiratory mask apparatus 4824. Any type of
external respiratory therapy device other than CPAP can
alternatively be used, such as bi-level positive airway pressure
devices, auto titrating positive airway pressure devices,
nebulizers, respirators, ventilators, and other external
respiratory therapy devices. The CPAP controller 4820 develops a
positive air pressure that is delivered to the patient's airway
through tubing 4822 and mask assembly 4824. The positive airway
pressure provided by the respiratory therapy device 4800 acts as a
pneumatic splint keeping the patient's airway open and reducing the
severity and/or number of occurrences of disordered breathing due
to airway obstruction.
[0937] A typical CPAP device delivers air pressure through a nasal
mask worn by the patient. The application of continuous positive
airway pressure keeps the patient's throat open, reducing or
eliminating the obstruction causing apnea. Positive airway pressure
devices may be used to provide a variety of respiration therapies,
including, for example, continuous positive airway pressure (CPAP),
bi-level positive airway pressure (bi-level PAP), proportional
positive airway pressure (PPAP), auto-titrating positive airway
pressure, ventilation, gas or oxygen therapies. Some positive
airway pressure devices may also be configured to provide both
positive and negative pressure, such that negative pressure is
selectively used (and de-activated) when necessary, such as when
treating Cheyne-Stokes breathing, for example. The term CPAP will
be used herein as a generic term for any device using forms of
positive airway pressure (and negative pressure when necessary),
whether continuous or otherwise.
[0938] In some embodiments (FIGS. 48A-48D), the one or more cardiac
electrodes 4826 are mechanically coupled to the respiratory therapy
device 4800. The electrodes 4826 may be positioned on the mask
assembly 4824 of the external respiratory device 4800. For example,
electrodes 4826 may be positioned on the mask, mask strap, or other
appropriate location on the mask assembly in a location that
facilitates sensing cardiac electrical activity. The mask assembly
4824 serves to hold the electrodes 4826 in place while the external
respiration therapy is delivered to the patient.
[0939] In some configurations, the electrodes 4826 are coupled to
an ECG processor 4821 that uses the cardiac signals sensed by the
electrodes 4826 to generate an ECG waveform. The ECG processor 4821
may be disposed, for example, within or on the CPAP controller
unit. The electrodes 4826 may be coupled to the ECG processor 4821
through a wire lead 4860.
[0940] In some implementations, the ECG processor 4821 may be
positioned proximate the electrodes 4826, for example, on the
respiratory mask assembly. This configuration facilitates
generation of an ECG waveform that may be transmitted via a
wireless communications link 4870 to the CPAP controller 4820 or
other medical devices 4830.
[0941] The ECG waveform generated by the ECG processor 4821 may be
printed on a printing device, displayed on a display device 4831,
stored in memory, and/or analyzed by circuitry disposed within the
CPAP controller 4820 and/or the cooperating medical device
4830.
[0942] If the patient uses the external respiratory therapy device
regularly, for example each night, data acquisition via the
electrodes 4826 coupled to the external respiratory device 4800
allows a significant amount of information about the patient's
cardiac functioning to be collected during each sleep period. In
some implementations, the cooperating medical device 4830 may
comprise a patient-worn or patient-carried device. In other
implementations, the medical device 4830 may comprise an
implantable device, for example, an implantable monitor or
implantable therapy device.
[0943] In some embodiments (FIGS. 48C and 48D), the ECG processor
4821 may be disposed within the medical device 4830. The medical
device 4830 may additionally include circuitry for storing and/or
analyzing the ECG signals. Information about the ECG signals may be
downloaded from the medical device 4830 to an external device for
display, analysis, or storage, for example.
[0944] In one configuration, the electrodes 4826 may be
communicatively coupled to the external device 4830 through a wire
lead 4860. In another configuration, additional circuitry, e.g.,
amplifiers and/or transmitter circuitry, may be used to provide a
wireless link 4870 between the cardiac electrodes 4826 and the
device 4830.
[0945] In some embodiments (FIGS. 48E and 48F), one or more cardiac
electrodes 4826 may be positioned on the patient's chest, or
another location suitable for sensing cardiac electrical activity.
The cardiac electrodes may be communicatively coupled to the
external respiratory device 4800. For example, the sensors may be
communicatively coupled to the CPAP controller 4820 through a wire
lead 4860 (FIG. 48E). Alternatively, additional circuitry may be
situated proximate the electrodes to facilitate communication with
the CPAP controller 4820 through a wireless communications link
4870 (FIG. 48F).
[0946] FIGS. 48G-48L illustrate embodiments of the invention
involving cardiac event detection using one or more cardiac
electrodes 4826 coupled to an external respiratory therapy device
4800. In some embodiments (FIGS. 48G-48J), the electrodes 4826 are
mechanically coupled to the respiratory mask apparatus 4824. The
respiratory mask apparatus 4824 serves as a support for the
electrodes 4826 positioning the electrodes against the patient's
face to facilitate sensing cardiac electrical activity. The
electrodes 4826 are coupled to an external or implantable cardiac
event detector 4828 through wired 4860 or wireless 4870
connections. In some embodiments (FIGS. 48G and 48H), the cardiac
event detector 4828 is disposed within or on the CPAP controller
4820 housing. In other embodiments (FIGS. 48I and 48J), cardiac
event detector 4828 circuitry is separate from the CPAP controller
4820.
[0947] FIGS. 48K and 48L illustrate embodiments of the invention
wherein one or more cardiac electrodes 4826 are positioned on the
patient's chest or other location suitable for sensing cardiac
electrical activity. The electrodes are coupled to a cardiac event
detector 4828 of an external respiratory therapy device 4800. The
electrodes 4826 may be coupled to the cardiac event detector 4828
through a wire lead 4860 or through a wireless connection 4870.
[0948] The CPAP device 4820 may optionally include a respiratory
event detector 4829. In accordance with one implementation, the
respiratory event detector may be used to provide feedback for
therapy control. For example, CPAP therapy may be initiated or
adjusted based on the presence, absence, severity, frequency and/or
duration of disordered breathing events detected by the respiratory
event detector.
[0949] If a respiratory event detector is included, the respiratory
event detector and the cardiac event detector may be coupled to an
event processor 4880. The event processor 4880 may be used to
detect physiological events, including events affecting one or more
of the cardiac and pulmonary systems based on inputs from the
cardiac and respiratory event detectors. The cardiac event
detector, respiratory event detector and/or event processor may be
employed to detect various cardiac and/or respiratory dysfunctions,
including, for example, bradycardia, tachycardia, including atrial
tachyarrhythmia, ventricular tachyarrhythmia and ventricular
fibrillation, myocardial ischemia, and/or myocardial infarction.
The event processor may compare occurrences of respiratory and
cardiac events including one or more of the timing, severity, type,
and occurrence rate of the respiratory and cardiac events and
detect the physiological events based on these and/or other
factors.
[0950] The cardiac event detection circuitry illustrated, for
example, in FIGS. 48I and 48J may be implemented in a patient
carried or patient worn device, or in an implantable device such as
a cardiac defibrillator or pacemaker.
[0951] FIG. 48M illustrates an embodiment of the invention wherein
one or more cardiac electrodes 4826, and circuitry used to
establish a wireless communications link 4870, are disposed on the
CPAP mask assembly 4824. In FIG. 48M, signals sensed by the cardiac
electrodes are transmitted to an implantable device 4890, bypassing
the CPAP controller 4820.
[0952] The implantable device 4890 may comprise, for example, an
implantable therapy device, such as an implantable electrical
stimulation device or implantable drug pump. The implantable device
may comprise an implantable monitor. In one implementation, the
implantable device 4890 may comprise an implantable pacemaker,
defibrillator, cardioverter, cardiac resynchronizer, or other
cardiac therapy devices that receives the ECG signals. In another
implementation, the implantable device 4890 may comprise an
implantable loop recorder, such as a subcutaneous ECG recorder. The
implantable device may include a cardiac event detector that
analyzes the ECG signals to detect cardiac events including cardiac
arrhythmia, ischemia, and/or myocardial infarction.
[0953] FIG. 48N illustrates an embodiment wherein the cardiac
electrodes 4826 are coupled to the CPAP device 4820 through a wire
lead. Signals received by the CPAP device 4820 may be wirelessly
transmitted to the implantable device 4890 for storage, analysis or
for other purposes.
[0954] FIGS. 49A and 49B are block diagrams of a medical system
including an external respiratory therapy device that may be used
in connection with sensing cardiac electrical activity. FIG. 49A
illustrates an embodiment that are directed to generating an
electrocardiogram signal in accordance embodiments of the
invention. FIG. 49B illustrates an embodiment that uses the sensed
electrical cardiac activity to detect arrhythmia.
[0955] FIGS. 49A and 49B depict block diagrams of a CPAP device
4900 having cardiac sensing capabilities in accordance with the
present invention. The CPAP device includes a CPAP controller 4910,
tubing 4915, and mask assembly 4920. The CPAP controller unit may
include a respiratory event detector 4940 configured to detect
disordered breathing episodes, such as sleep apnea and/or hypopnea.
Detection of disordered breathing may be used to initiate or adjust
respiratory therapy delivered to the patient.
[0956] The CPAP controller unit 4910 includes flow generator 4912
that pulls in air through a filter. The flow generator 4912 is
controlled by the pressure control circuitry 4913 to deliver an
appropriate air pressure to the patient. Air flows through tubing
4915 coupled to the CPAP device 4910 and is delivered to the
patient's airway through the mask assembly 4920. The CPAP
controller 4910 may be coupled through communications circuitry
4960 to other computing devices 4950, such as a programmer or
patient management server to facilitate storage, evaluation and/or
display of the cardiac information.
[0957] In embodiments of the present invention, the mask apparatus
4920 may comprise a nasal mask covering only the patient's nose. In
other configurations the mask covers the patient's nose and mouth.
One or more cardiac electrodes may be coupled to the CPAP device
4900. For example, the one or more cardiac electrodes 4922, 4924
may be incorporated on the respiratory therapy mask 4920. However,
the one or more cardiac electrodes 4922, 4924 can be positioned in
another location of the respiratory therapy device that facilitates
acquisition of a cardiac signal and. For example, electrodes 4922
can be incorporated in a respiratory mask strap (not shown).
[0958] As illustrated in FIG. 49A, the cardiac electrodes 4922,
4924 are communicatively coupled to signal processing circuitry
4930 within the CPAP controller 4910. The cardiac activity
information is used to generate an electrocardiogram signal. The
ECG signal can be used by the CPAP control unit 4910 to control the
external respiratory therapy delivered to the patient. Additionally
or alternatively, the ECG signal can be stored in memory 4935, used
to generate an ECG display or printout, and/or evaluated for
diagnostic or therapeutic purposes.
[0959] FIG. 49B illustrates a block diagram of an embodiment of the
invention that involves detection of cardiac arrhythmia. In this
configuration, cardiac electrodes 4922, 4924 positioned on the
respiratory mask 4920, sense cardiac electrical activity. The
electrodes 4922, 4924 are coupled to an arrhythmia detector 4960
disposed within a housing of the respiratory therapy control unit
4910. The cardiac event detector 4960 uses the cardiac electrical
activity sensed by the electrodes 4922, 4924 to detect cardiac
events, such as bradycardia, ventricular tachyarrhythmia,
ventricular fibrillation, and/or other arrhythmic events. In one
implementation, the cardiac event detector 4960 may evaluate the
cardiac electrical activity to determine heart rate and detect
arrhythmia based on heart rate. In another implementation, the
arrhythmia detector 4960 may analyze the morphology of the cardiac
electrical activity signal and detect arrhythmia based on the
morphology of the cardiac electrical activity signal. Other methods
of arrhythmia detection are possible.
[0960] FIG. 50 illustrates various optional processes that may be
facilitated using cardiac electrodes coupled to a respiratory
therapy device. Cardiac electrical activity is sensed using
electrodes coupled to an external respiratory therapy device 5010.
According to one aspect of the invention, the sensed cardiac
activity may be used to detect arrhythmia 5020. If arrhythmia is
detected, an alarm may be generated 5022, such as an audible or
visual alarm. The alarm may include various tones or signals to
indicate more than one type of arrhythmic condition, for example.
In one implementation, the alarm may involve wireless communication
with a remote device, such as a cell phone or pager, for
example.
[0961] The sensed cardiac activity may be used to generate 5030 an
ECG signal. The ECG signal may be stored and/or transmitted 5032 to
a separate device. For example, the ECG signal may be transmitted
to a patient management server for further analysis. The ECG
waveform may be displayed 5034 on a display device or printed. The
ECG signal may be used to initiate cardiac therapy 5024 to treat an
arrhythmia.
[0962] Detected cardiac events and detected respiratory events may
also be analyzed to determine relationships between cardiac and
respiratory events. The results of this comparison may be
displayed, stored, transmitted or used to modify cardiac or
respiratory therapy.
[0963] Acquisition of ECG signals over a period of time may be used
to trend cardiac conditions and/or diagnose 5036 cardiac
dysfunction, for example. Further, the ECG signals may be evaluated
may be used to adjust 5038 the patient's therapy, such as the
external respiratory therapy delivered to the patient.
[0964] The ECG signal may be analyzed to detect morphological
characteristics and/or cardiac timing measurements indicative of
heart status including, for example, RR interval, PP interval, AV
interval, PR interval, QT interval and/or ST elevation. The ECG
signal may be used to determine statistics derived from heart
rates, such as heart rate variability and various cardiac timing
measurements, including RR timings and AV delay timing. Various
cardiac events and/or other indications of heart status may be
determined based on the ECG signal, including arrhythmia,
myocardial ischemia, and/or other events. These analyses may be
used to identify patient's cardiac condition and adjust
therapy.
[0965] Implantable Monitor for External Respiratory Therapy
[0966] Aspects of the invention that include implantably monitoring
external breathing therapy are directed to methods and systems
configured to monitor, diagnose, and/or provide patient therapy
using one or more individual medical procedures. Each of the
circles 180 illustrated in FIGS. 1B-1D represents an individual
medical procedure providing a specific monitoring, diagnosis or
therapeutic function or set of functions. Each individual medical
procedure may be implemented as a stand-alone system. Two or more
of the individual medical procedures 180 may be used in combination
to provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[0967] Other aspects of the invention involving implantable
monitoring of external respiratory therapy are directed to methods
and systems configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures. Coordinated medical
procedures may involve cooperative operation of two or more of the
individual processes 180. Coordinated medical procedures may also
involve cooperative operation of one or more functions of two or
more of the individual processes 180.
[0968] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[0969] One embodiment of the invention involves an individual
system 122 (FIG. 1C) for implantably monitoring external
respiratory therapy delivered to a patient. The respiratory therapy
monitoring system 122 may be implemented as a stand alone system or
in combination with other individual medical systems, such as those
described in FIGS. 1B-1D.
[0970] Embodiments of the invention are directed to methods and
systems for monitoring therapy delivered to a patient. An
embodiment of the invention involves a method for implantably
monitoring a patient-external respiration therapy delivered to the
patient. The method includes sensing one or more conditions
associated with patient-external breathing therapy. The
patient-external respiration therapy is monitored by an implantable
device based on the sensed conditions.
[0971] In accordance with another embodiment of the invention, a
medical system, includes a sensing system configured to sense
conditions associated with a patient-external breathing therapy.
The system also includes an implantable monitoring device, coupled
to the sensing system. The implantable monitoring device is
configured to monitor the patient-external breathing therapy based
on the one or more sensed conditions.
[0972] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes system 122 sensed conditions to monitor
patient-external breathing therapy. The coordinated system
includes, for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[0973] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
system 122 configured to monitor external breathing therapy based
on sensed conditions. The monitoring system 122 includes a sensing
system configured to sense conditions associated with a
patient-external breathing therapy and an implantable monitoring
device. The implantable monitoring device is coupled to the sensing
system and is configured to monitor the patient-external breathing
therapy based on the one or more sensed conditions. Systems and
methods directed to implantably monitoring external breathing
therapy may be implemented to include selected features, functions,
and/or structures described in commonly owned, co-pending U.S. Pat.
No. 7,468,040, which is hereby incorporated herein by
reference.
[0974] Breathing disorders may be more effectively monitored and/or
treated using a coordinated approach. Various embodiments of the
invention are implemented using medical systems employing two or
more patient-external and/or patient-internal medical devices. The
medical devices may communicate or otherwise operate in concert to
provide more comprehensive patient monitoring for external
breathing therapy.
[0975] A number of disorders are treated using external breathing
therapy devices. For example, rhythm related breathing disorders
such as sleep apnea, hypopnea may be treated with a positive airway
pressure device. Asthma may be treated with a nebulizer. Various
diseases affecting the pulmonary system may be treated with gas or
oxygen therapy. Embodiments of the invention are directed to
methods and systems utilizing an implantable device to monitor
parameters associated with an external breathing therapy delivered
to the patient. External breathing therapy may be delivered by
various types of patient-external respiratory therapy devices,
including, for example, nebulizers, respirators, ventilators,
external gas therapy devices and/or positive airway pressure
devices.
[0976] A typical continuous positive airway pressure (CPAP) device
delivers air pressure through a nasal mask worn by the patient. The
application of continuous positive airway pressure keeps the
patient's throat open, reducing or eliminating the obstruction
causing apnea. Positive airway pressure devices may be used to
provide a variety of respiration therapies, including, for example,
continuous positive airway pressure (CPAP), bi-level positive
airway pressure (bi-level PAP), proportional positive airway
pressure (PPAP), auto-titrating positive airway pressure,
ventilation, gas or oxygen therapies. Some positive airway pressure
devices may also be configured to provide both positive and
negative pressure, such that negative pressure is selectively used
(and de-activated) when necessary, such as when treating
Cheyne-Stokes breathing, for example.
[0977] The parameters monitored by the monitoring system may
include therapy effectiveness, impact of the therapy on the
patient, therapy usage, compliance with a prescribed usage and/or
therapy interactions, for example. In various embodiments described
herein, sensors coupled to the implantable monitoring device sense
conditions used to monitor therapy parameters. For example, the
sensed conditions may be used to evaluate the effectiveness of the
breathing therapy the impact of the therapy on the patient and/or
therapy interactions between the external breathing therapy and
other therapies delivered to the patient. The external breathing
therapy may be adjusted to enhance therapy effectiveness, to reduce
an impact of the therapy and/or to reduce therapy interactions. The
implantable device may monitor the patient's use of the external
breathing therapy and/or compliance with a prescribed usage of the
breathing therapy, for example.
[0978] The implantable device may transmit information about the
sensed conditions and/or the monitored parameters to the external
breathing therapy device. The information may be used by the
external breathing therapy device to automatically adjust the
breathing therapy delivered to the patient. The information may be
transmitted, either by the implantable device, or by the external
breathing therapy device, to a patient management system. Advanced
patient management (APM) systems involve a system of medical
devices that are accessible through various communications
technologies. Medical information may be transmitted to a remote
patient management server from the various medical devices. The
medical information may be analyzed and used to diagnose and/or
monitor disease progression, to determine appropriate therapies for
the patient, and/or for other medical purposes.
[0979] Information acquired by the monitoring device, including
information associated with the sensed conditions and/or the
parameters of the breathing therapy, may be evaluated to facilitate
diagnosis and/or therapy adjustment. The information transmitted to
the patient management system may be used for diagnostic purposes
related to the breathing disorder affecting the patient, for
example. The patient management system may adjust breathing therapy
delivery based on the information. In one implementation, the
patient management system transmits control signals to the
breathing therapy device to adjust the breathing therapy. Further,
the patient and/or the patient's physician may access the
information through the patient management system.
[0980] The block diagram of FIG. 51 illustrates an example of
medical system 5100 including a fully or partially implantable
device 5101 that may be used to monitor breathing therapy delivered
by an external device in accordance with embodiments of the
invention. The system 5100 employs a medical device 5101 that may
be coupled to an array of data acquisition devices, including
patient-internal sensors 5111, patient-external sensors 5112,
patient input devices 5113, and/or other information systems 5114
as described herein.
[0981] Conditions used to monitor parameters of the breathing
therapy may include both physiological and non-physiological
contextual conditions affecting the patient. Table 1 above provides
a representative set of patient conditions that may be used to
monitor breathing therapy in accordance with embodiments of the
invention. Table 1 also provides illustrative sensing methods that
may be employed to sense the conditions. It will be appreciated
that patient conditions and detection methods other than those
listed in Table 1 above may be used and are considered to be within
the scope of the invention.
[0982] The implantable device 5101 of FIG. 51 includes a monitoring
unit 5137 that processes signals received from the sensors, 5111,
5112, patient input devices 5113, and/or other information system
5114. The monitoring unit 5137 may include one or more a detection
units 5124, 5126, 5128 that detect the occurrence of various
physiological events. For example, the monitoring unit 5137 may
include one or more of a disordered breathing detector 5124, a
sleep detector 5128, and/or a therapy usage detector 5126. Other
event detection components may also be included in the monitoring
unit 5137. The monitoring unit 5137 may include circuitry used to
calculate various indices, such as AHI, % PB, arousals per unit
time, and/or other indices that can be used to evaluate therapy
efficacy, therapy impact and/or other parameters. The monitoring
unit 5137 may compare the patient's therapy usage to a prescribed
therapy to determine therapy compliance.
[0983] The disordered breathing detector 5124 may be coupled to a
respiration sensor, for example, and used to detect disordered
breathing events based on the inspiratory and expiratory phases of
the patient's respiration cycles, for example. The sleep detector
5128 may analyze various inputs from the patient-internal sensors
5111, patient-external sensors 5112, patient input devices 5113,
and/or other information systems 5114 to detect sleep-related
events, including, for example, sleep onset, sleep offset, sleep
stages, and arousals from sleep.
[0984] The therapy usage detector may detect the proximity of the
patient to the external breathing device, to determine therapy
usage. In another example, the therapy usage detector may analyze
the patient's respiration waveform to determine therapy usage.
[0985] The monitoring unit 5137 may operate in cooperation with a
memory 5136. The memory 5136 may store information derived from
signals produced by the patient-internal sensors 5111,
patient-external sensors 5112, patient input devices 5113, and/or
other information systems 5114. The memory 5136 may also store
information about detected events, e.g., sleep and disordered
breathing events, and/or information related to calculated indices
characterizing various events such as sleep and/or disordered
breathing events. The stored data, along with other information
related to the breathing therapy may be transmitted to another
component of the medical device 5101 or to a separate device 5140
for storage, further processing, trending, analysis, printing
and/or display, for example. In one scenario, the stored data can
be downloaded to a separate device periodically or on command. The
stored data may be presented to the patient's health care
professional on a real-time basis, or as a long-term, e.g., month
long or year long, trend of daily measurements.
[0986] The medical device 5101 may optionally include a therapy
unit. In various examples provided herein, the medical device 5101
is a cardiac device configured to deliver cardiac electrical
stimulation therapy using a cardiac pulse generator 5175 and
electrical stimulation electrodes 5152.
[0987] The medical device 5101 may further include a communications
unit 5106 that controls communications between the medical device
5101 and other devices or systems. For example, the communications
unit 5106 may be used to provide wireless or wired communications
links between the medical device 5101 and one or more of the
patient-internal sensors 5111, patient-external sensors 5112,
patient input devices 5113, and information systems 5114.
[0988] The communications unit 5106 may also facilitate
communications between the medical device 5101 and a remote device
5140 such as the patient-external breathing therapy device, a
programmer, and/or an APM system. The wireless connections coupling
the medical device 5101 to various other devices and systems may
utilize a variety of wireless protocols, including, for example,
Bluetooth, IEEE 802.11, and/or a proprietary wireless protocol.
[0989] Detecting the onset, termination, duration, stages, and
quality of sleep experienced by a patient may be employed in
connection with monitoring breathing therapy. Patients suffering
from sleep apnea, or other types of sleep disordered breathing, are
generally treated with breathing therapy only during periods of
sleep. Monitoring the sleep disordered breathing therapy may
involve determining when the patient is asleep and/or monitoring
arousals and/or various sleep stages.
[0990] In addition, monitoring patient sleep may be used to assess
an impact of breathing therapy on the patient. Therapy impact
information may be used to determine an appropriate breathing
therapy for the patient. The implantable monitoring device may
include a sleep detector 5128 for detecting when the patient is
asleep and the various stages of sleep. Various methods of sleep
detection implementable in an implanted device involve sensing one
or more conditions associated with sleep. The sleep-related
conditions may be compared to a threshold to determine if the
patient is asleep.
[0991] The sleep-related conditions may be derived from
patient-external or implantable sensors and analyzed by a sleep
detector located in the implantable monitoring device or by
circuitry within the APM communication unit (i.e., a supervisor
device that co-ordinates diagnostics between various sensors. In
one implementation proximity to bed, sleep detection may be
implemented in an implantable cardiac rhythm management system
configured as a pacemaker/defibrillator as an ITCS device.
[0992] Sleep detection may involve sensing one or more conditions
indicative of sleep. A representative set of sleep-related
conditions include body movement, heart rate, QT interval, eye
movement, respiration rate, transthoracic impedance, tidal volume,
minute ventilation, body posture, brain activity, cardiac activity,
muscle tone, body temperature, time of day, historical sleep times,
blood pressure, and blood gas concentration, proximity to bed, for
example.
[0993] Sleep may be detected by comparing levels of the one or more
sleep-related conditions to one or more sleep thresholds. For
example, sleep may be detected by based on the patient's heart
rate. When the patient's heart rate decreases below a sleep
threshold, the patient may be determined to be asleep. Sleep may
also be detected base on the patient's activity. If the patient's
activity decreases below a sleep threshold, then the patient may be
determined to be asleep. Another method of detecting sleep involves
monitoring the patient's minute ventilation. If the patient's
minute ventilation falls below a sleep threshold, then the patient
may be determined to be asleep.
[0994] Sleep may be detected by comparing multiple sleep-related
conditions to multiple thresholds. For example, the patient may be
determined to be asleep if the patient's activity, sensed by an
accelerometer, falls below an activity sleep threshold and the
patient's heart rate, sensed by cardiac electrodes, falls below a
heart rate sleep threshold.
[0995] Sleep may also be detected using one sleep-related condition
to modify the sleep threshold of another sleep-related condition. A
first sleep-related condition may be sensed. The level of the
sleep-related condition may be compared to a sleep threshold to
determine the onset and termination of sleep. A second
sleep-related condition may be used to adjust the sleep threshold.
Additional sleep-related conditions may optionally be sensed to
confirm the onset or termination of the sleep condition.
[0996] A sleep detector 5128 (FIG. 51) may be configured to compare
the levels of one or more sleep-related conditions to one or more
thresholds. In one implementation, the one sleep related condition
may be compared to a sleep threshold or other index to detect
sleep. In another implementation, multiple sleep-related conditions
may be compared to multiple thresholds or indices. In a further
implementation, one or more of the sleep-related conditions may be
used to adjust the sleep thresholds or indices. Furthermore, the
onset or termination of sleep may be confirmed using an additional
number of sleep-related conditions.
[0997] One or more sleep-related conditions may be sensed using
implantable sensors and/or patient-external sensors, for example.
In one embodiment, patient activity may be compared to a sleep
threshold to determine when the patient is asleep. A low level of
activity is indicative that the patient is sleeping. Patient
activity may be sensed, for example, using an accelerometer
positioned on or in the housing of an implantable cardiac device,
or in another convenient location. The accelerometer signal may be
correlated with activity level or workload.
[0998] A second sleep-related condition may be used to adjust the
sleep threshold. In one embodiment, the patient's minute
ventilation is used to adjust the sleep threshold. The patient's
respiration may be sensed using a transthoracic impedance sensor.
Transthoracic impedance may be used to derive various parameters
associated with respiration, including, for example, tidal volume
and/or minute ventilation. A transthoracic impedance sensor may be
integrated into an implantable cardiac device with intracardiac
electrodes, for example. Impedance driver circuitry generates a
current that flows through the blood between the impedance drive
electrode and a can electrode on the housing of the cardiac device.
The voltage at an impedance sense electrode relative to the can
electrode changes as the transthoracic impedance changes.
[0999] FIGS. 52A-E are flowcharts illustrating methods related to
implantably monitoring external breathing therapy in accordance
with various embodiments of the invention. As illustrated in the
flowchart of FIG. 52A, a method for monitoring external breathing
treatment involves sensing 5202 one or more conditions associated
with patient-external breathing therapy and implantably monitoring
5204 the patient-external breathing therapy based on the one or
more sensed conditions. The sensed conditions are used to monitor
one or more parameters of the patient-external breathing therapy,
such as the patient's compliance with the external breathing
therapy, the effectiveness of the external breathing therapy, the
impact of the external breathing therapy on the patient, and/or
other conditions.
[1000] The parameters monitored by the implantable device, and the
conditions sensed to monitor the breathing therapy parameters can
be programmable. The implantable device may acquire information
used to monitor the breathing therapy parameters continuously or
during selected periods of time. For example, if the patient
suffers from sleep disordered breathing, the implantable device may
acquire information associated with the breathing therapy after
detecting that the patient is asleep.
[1001] Information acquired by the implantable device based on the
sensed conditions may be stored, displayed, printed, trended and/or
transmitted from the implantable device to another device, such as
a patient-external device, implantable device, therapy device,
device programmer, and/or advanced patient management server.
Information associated with the monitored parameters, e.g., therapy
usage, may be stored, displayed, printed, trended, and/or
transmitted from the implantable device to another device
[1002] FIG. 52B is a flowchart illustrating a method for monitoring
the effectiveness of an externally delivered breathing therapy
using an implantable device. The patient's respiration is sensed
5206 and a respiration waveform is generated 5208. The sensed
respiration waveform is used by the implantable device to detect
5210 disordered breathing events. An apnea/hypopnea index (AHI) is
calculated 5212 based on the detected disordered breathing events.
The AHI is used to assess the effectiveness 5214 of the breathing
treatment. A lower AHI may indicate a more effective breathing
treatment than a relatively higher AHI, for example. The therapy
effectiveness information may be transmitted 5216 to the external
breathing therapy device and/or to an APM server. The therapy
effectiveness data may be used 5218 by the external breathing
therapy device, or by the APM device, for example, to adjust the
external breathing therapy. The therapy adjustment may be performed
automatically by the APM or by the external breathing therapy
device. The therapy adjustment may be performed manually by the
patient's physician based on the effectiveness information.
[1003] External breathing therapy may be inconvenient to use and
uncomfortable to the patient. As a result, the patient may limit
the use of the therapy. For example, if the use of the breathing
therapy interferes with the patient's ability to sleep, the patient
may stop using the breathing therapy, or may use the breathing
therapy infrequently. The patient may not keep track of how
frequently he or she uses the breathing therapy and may not be able
to accurately report breathing therapy compliance to the
physician.
[1004] FIG. 52C is a flowchart of a method for implantably
monitoring a patient's usage of the external breathing therapy. In
this example, usage of an external breathing therapy for sleep
disordered breathing is determined based on the patient's proximity
to the external breathing therapy device during sleep. As
illustrated in FIG. 52C, one or more conditions indicative of sleep
may be sensed 5222. The implantable device detects 5224 sleep based
on the sensed sleep-related conditions. The proximity of the
patient to the external breathing therapy device is sensed
5226.
[1005] The proximity of the patient to the external breathing
therapy device may be determined using a transmitter coupled to the
external breathing therapy device and a receiver in the implantable
monitoring device. If the patient is near the external breathing
therapy device, the receiver receives a signal broadcast by the
transmitter. The transmitter may be located on a bedside unit of
the external breathing therapy device, or on the respiratory mask
of the external breathing therapy device, for example.
[1006] The implantable device monitors 5228 the patient's usage of
external breathing therapy based on the proximity of the patient to
the external breathing therapy device during sleep. Other methods
of determining patient usage of the external breathing therapy
device may also be implemented. For example, the morphology of the
patient's respiration waveform during external breathing therapy
may be detectably different from the patient's respiration waveform
when therapy is not being delivered. The implantable device may
sense the patient's respiration and monitor usage of the external
breathing therapy device based on evaluation of the patient's
respiration waveform.
[1007] The implantable device may monitor patient compliance with
respect to a prescribed breathing therapy. The implantable device
may transmit information related to the patient compliance to an
external device, such as a patient management device accessible to
the patient and/or the patient's physician. The information may be
used to alert to the patient and/or to the patient's physician when
the patient's compliance with the prescribed breathing therapy
drops below a threshold level.
[1008] FIG. 52D is a flowchart of a method for implantably
monitoring patient compliance with a prescribed breathing therapy
in accordance with embodiments of the invention. Breathing therapy
is delivered to the patient using a patient external device. The
patient's use of externally delivered breathing therapy is
monitored 5240 using an implantable device.
[1009] In one implementation, the implantable device may monitor
patient use of the breathing therapy may by sensing the proximity
of the patient to the breathing therapy unit. According to this
approach, if the patient is within a selected proximity range of
the patient-external breathing therapy unit, then the patient is
assumed to be using the breathing therapy.
[1010] Another approach to monitoring patient compliance with
breathing therapy involves analyzing the respiratory waveform of
the patient. For example, the implantable device may sense the
transthoracic impedance of the patient to determine the patient's
respiratory waveform. The patient's use of the breathing therapy
may be determined by detecting features of the respiratory waveform
indicative of breathing therapy usage. In one scenario, use of the
breathing therapy may be determined by comparing the morphology of
a patient's respiratory waveform during therapy to the morphology
of the patient's respiratory waveform without therapy. The
patient's respiratory waveforms with and without therapy may be
compared to detect features that indicate usage. For example, the
patient may be determined to be using the breathing therapy if the
patient's respiratory waveform exhibits a pressure notch indicative
of flow controlled breathing therapy usage. FIG. 52F illustrates a
graph of respiratory pressure 5298 with respect to time. The notch
5299 on the pressure graph indicates that the patient is using the
breathing therapy device.
[1011] In another example, patient compliance with the prescribed
breathing therapy may be determined based on night to night changes
in therapy effectiveness. For example, if the therapy effectiveness
stays constant or changes slowly over the course of several nights,
it may be determined that the patient is using the breathing
therapy as prescribed. Usage of the therapy may be determined by
using a baseline of therapy effectiveness developed over several
nights. If the therapy effectiveness drops significantly from the
baseline, then the patient may have stopped using the therapy
device.
[1012] Returning to FIG. 52D, information related to the patient's
use of the breathing therapy may be collected and/or evaluated by
the implantable device, including, for example, the times the
patient used the breathing therapy, the duration of the usage, the
frequency of usage, and/or other information. The patient's
compliance with a prescribed breathing therapy may be determined
5242 by comparing the actual use to the prescribed use. In one
scenario, the compliance determination may be performed by the
implantable device. In another scenario, information related to the
patient use of the breathing therapy may be transmitted 5244 to a
remote device, such as the breathing therapy device or a patient
management device, where the analysis is performed. The patient
and/or the patient's physician may be alerted 5250 to the patient's
compliance with the breathing therapy. In one scenario, the patient
and/or the patient's physician may be alerted if the patient's
compliance decreases below a threshold value. The patient may be
reminded to use the breathing therapy. If patient compliance is
low, the physician and/or the patient may adjust the therapy to
increase breathing therapy compliance.
[1013] In accordance with one embodiment, the breathing therapy may
be implantably monitored for therapy effectiveness and impact to
the patient. The flowchart of FIG. 52E illustrates an example
method involving the use of a monitoring device configured as a
component of an implantable cardiac device to monitor breathing
therapy delivered by a continuous positive airway pressure (CPAP)
device. In this example, therapy for sleep disordered breathing is
delivered to the patient using a continuous positive airway
pressure (CPAP) device. The effectiveness of the breathing therapy
and the impact of the therapy on the patient are monitored by an
implantable cardiac device.
[1014] Sensors coupled to the implantable monitoring device sense
one or more patient conditions related to therapy effectiveness.
For example, the respiration of the patient may be sensed 5252 and
the monitoring device may detect 5254 disordered breathing episodes
based on the respiration signal. The monitoring device may monitor
therapy effectiveness by monitoring the severity, frequency and/or
duration of sleep disordered breathing episodes experienced by the
patient. In one implementation, the monitoring device may calculate
5256 an apnea/hypopnea index (AHI) and/or a percent time in
periodic breathing (% PB) indicative of the frequency of disordered
breathing episodes. The effectiveness of the CPAP therapy may be
monitored 5260 based on the calculated indices. If the AHI and/or %
PB are relatively low, the breathing therapy may be determined to
be effective.
[1015] A CPAP device typically includes a respiratory mask, e.g., a
nasal or facial mask, worn by the patient to facilitate delivery of
air or other gas to the patient's airway. The respiratory mask may
be inconvenient and/or uncomfortable for the patient to wear and
may keep the patient awake. Further, delivery of positive airway
pressure may disturb the patient, inhibit sleep, and/or cause the
patient to arouse frequently. Sleep disturbances may be more
frequent and/or severe if the CPAP therapy pressure is too high.
Information about these side effects of the breathing therapy may
be helpful in tailoring a therapy regimen for the patient. The
monitoring device may monitor the impact of the CPAP therapy on the
patient based on one or more sensed conditions indicative of the
impact of the therapy on the patient.
[1016] In one example, the one or more sensed conditions 5262
relate to sleep and may be used to detect 5264 sleep and/or
arousals from sleep. The monitoring unit implemented in an
implantable cardiac device may monitor 5266 the impact of the CPAP
therapy on the patient by monitoring the patient's sleep. For
example, the monitoring unit may monitor the total time the patient
spends sleeping, the number of arousals experienced by the patient
in one night, and/or the depth of the arousals. In one
implementation the cardiac device may calculate the number of
arousals experienced by the patient per hour (A/h).
[1017] The therapy effectiveness and impact information may be
transmitted 5268 to the CPAP device and/or an APM server. The
information may be used to automatically or manually adjust the
therapy delivered to the patient. For example, if the AHI is high,
the breathing therapy pressure may be adjusted upward to provide a
more effective therapy. If the patient experiences an arousal rate,
e.g., A/h, greater than a threshold without experiencing sleep
disordered breathing episodes, the therapy may be determined to be
too aggressive. The breathing therapy pressure may be adjusted
downward to provide a disordered breathing therapy that is more
comfortable to the patient and allows the patient to sleep with
fewer interruptions.
[1018] Feedback System for Sleep Disordered Breathing Therapy
[1019] Aspects of the invention that include disordered breathing
therapy feedback are directed to methods and systems configured to
monitor, diagnose, and/or provide patient therapy using one or more
individual medical procedures. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[1020] Other aspects of the invention involving a feedback system
for disordered breathing therapy are directed to methods and
systems configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures. Coordinated medical
procedures may involve cooperative operation of two or more of the
individual processes 180. Coordinated medical procedures may also
involve cooperative operation of one or more functions of two or
more of the individual processes 180.
[1021] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1022] One embodiment of the invention involves an individual
system 123 (FIG. 1B) for developing feedback using monitored
conditions for controlling sleep disordered breathing therapy. The
sleep disordered breathing therapy feedback system 123 may be
implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[1023] Various embodiments of present invention involve methods and
systems for developing and providing feedback information for sleep
disordered breathing therapy. In accordance with one embodiment, a
method of controlling sleep disordered breathing therapy includes
monitoring one or more patient conditions using a monitoring device
having circuitry disposed within an implantable housing. Feedback
information for controlling sleep disordered breathing therapy is
developed based on the one or more monitored conditions. The
feedback information is provided to a device delivering therapy to
treat sleep disordered breathing. The housing of the therapy device
is separate from the implantable housing of the monitoring
device.
[1024] In accordance with another embodiment of the invention, a
method of adjusting sleep disordered breathing therapy includes
monitoring one or more patient conditions using a monitoring device
having circuitry disposed within an implantable housing. Feedback
information for controlling sleep disordered breathing therapy is
developed based on the one or more monitored conditions. The
feedback information is provided to a device delivering therapy to
treat sleep disordered breathing. The housing of the therapy device
is separate from the implantable housing of the monitoring device.
The sleep disordered breathing therapy is adjusted using the
feedback information.
[1025] Yet another embodiment of the invention involves a medical
system for controlling sleep disordered breathing therapy. The
medical system includes a monitoring unit having components
disposed within an implantable housing. The monitoring unit is
configured to monitor one or more patient conditions. A processor
is coupled to the monitoring unit. The processor is configured to
provide feedback information related to sleep disordered breathing
therapy delivered to a patient based on the one or more monitored
conditions. Components of a therapy device delivering the
disordered breathing therapy are disposed within a therapy device
housing. The therapy device housing is separate from the
implantable housing of the monitoring device.
[1026] A further embodiment of the invention involves a medical
system for providing sleep disordered breathing therapy. The
medical system includes a monitoring unit having components
disposed within an implantable housing. The monitoring unit
configured to monitor one or more patient conditions. The system
also includes a therapy device having components disposed within a
housing that is separate from the implantable housing of the
monitoring device. The therapy device is configured to deliver
sleep disordered breathing therapy. A processor is coupled to the
monitoring unit and the therapy device. The processor is configured
to provide feedback information related to the sleep disordered
breathing therapy based on the one or more patient conditions.
[1027] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
system that utilizes feedback of sensed conditions for controlling
sleep disordered breathing therapy. The coordinated system
includes, for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[1028] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
system 123 configured to develop feedback based on sensed
conditions associated with disordered breathing therapy. The
disordered breathing therapy feedback system 123 includes a
monitoring unit having components disposed within an implantable
housing, the monitoring unit configured to monitor one or more
patient conditions, and a processor coupled to the monitoring unit.
The processor is configured to provide feedback information related
to sleep disordered breathing therapy delivered to a patient based
on the one or more monitored conditions, wherein components of a
therapy device delivering the disordered breathing therapy are
disposed within a therapy device housing and the therapy device
housing is separate from the implantable housing of the monitoring
device.
[1029] The implantable and respiratory therapy devices 181, 184 may
operate cooperatively based on system 123 feedback information from
delivered respiratory therapy. For example, system 123 feedback
information from delivered respiratory therapy may allow the
implantable and respiratory therapy devices 181, 184 to operate
cooperatively to adjust sleep disordered breathing therapy. Systems
and methods directed to feedback for sleep disordered breathing
therapy may be implemented to include selected features, functions,
and/or structures described in commonly owned, co-pending U.S. Pat.
No. 7,469,697, which is hereby incorporated herein by
reference.
[1030] Sleep disordered breathing disorders may be more effectively
monitored and/or treated using a coordinated approach. Various
embodiments of the invention are implemented using medical systems
employing two or more patient-external and/or patient-internal
medical devices. The medical devices may communicate or otherwise
operate in concert to provide more comprehensive patient monitoring
for disordered breathing.
[1031] Embodiments of the invention are directed to methods and
systems utilizing an implantable device to monitor conditions
associated with sleep disordered breathing. Feedback for
controlling sleep disordered breathing therapy is provided based on
the monitored conditions. Various types of therapy have been used
to treat sleep disordered breathing. Positive airway pressure
devices, e.g., continuous positive airway pressure (CPAP) devices
are among the most frequently used mechanical respiration therapy
devices employed for treating sleep disordered breathing. Sleep
disordered breathing has also been treated using muscle and/or
nerve stimulation therapy. For example, a treatment for obstructive
sleep apnea involves compensating for the decreased muscle activity
by electrical activation of the tongue muscles. The hypoglossal
(HG) nerve innervates the protrusor and retractor tongue muscles.
In one approach, an appropriately applied electrical stimulation to
the hypoglossal nerve, for example, may prevent backward movement
of the tongue, thus preventing the tongue from obstructing the
airway.
[1032] Central sleep apnea may also be treated by phrenic nerve
pacing, also referred to as diaphragmatic pacing. Phrenic nerve
pacing uses an electrode implanted in the chest to stimulate the
phrenic nerve. The phrenic nerve is generally known as the motor
nerve of the diaphragm. It runs through the thorax, along the
heart, and then to the diaphragm. Diaphragmatic pacing involves the
use of electronic stimulation of the phrenic nerve to control the
patient's diaphragm and induce a respiratory cycle. Pacing the
phrenic nerve may be accomplished by surgically placing a nerve
cuff on the phrenic nerve, and then delivering an electric
stimulus. The electric stimulus of the phrenic nerve then causes
the diaphragm to induce a respiratory cycle.
[1033] Recently, cardiac pacing therapy has been used as a therapy
for disordered breathing. Cardiac pacing therapy may be implemented
using an implanted electrical pulse generator coupled to
endocardiac leads inserted into one or more heart chambers. Cardiac
pacing for sleep disordered breathing treatment may include pacing
one or more heart chambers, and may involve pacing at a rate above
a lower rate limit during sleep and/or during episodes of
disordered breathing, for example.
[1034] Drug therapy may also be used to treat disordered breathing.
Drugs may be delivered to the patient through one or more
automatically controllable drug delivery devices, e.g., a drug
pump, a controllable nebulizer, or an electrically activated drug
patch, for example.
[1035] The block diagram of FIG. 53 illustrates an example of
medical system 5300 including a fully or partially implantable
device 5301 that may be used to monitor patient conditions and to
develop feedback information for a device delivering sleep
disordered breathing therapy in accordance with embodiments of the
invention. The medical device 5301 that may be coupled to an array
of data acquisition devices, including patient-internal sensors
5311, patient-external sensors 5312, patient input devices 5313,
and/or other information systems 5314 as described in more detail
above.
[1036] Patient conditions monitored by the implantable device may
include both physiological and non-physiological contextual
conditions affecting the patient. Table 1 above provides a
representative set of patient conditions that may be monitored by
the device 5301 in accordance with embodiments of the invention.
Table 1 also provides illustrative sensing methods that may be
employed to sense the conditions. It will be appreciated that
patient conditions and detection methods other than those listed in
Table 1 may be used and are considered to be within the scope of
the invention.
[1037] The implantable device 5301 of FIG. 53 includes monitoring
circuitry 5337 for processing signals received from the sensors,
5311, 5312, patient input devices 5313, and/or other information
system 5314. The monitoring circuitry 5337 may include one or more
a detection units 5324, 5326, 5328 that detect the occurrence of
various physiological events. For example, the circuitry 5327 may
include one or more of a disordered breathing detector 5324, a
sleep detector 5328, and/or a therapy usage detector 5326. Other
event detection components may also be included. The monitoring
circuitry 5327 may be used to calculate various indices, e.g., AHI,
% PB, and/or arousals per unit time, used for evaluating therapy
efficacy, and/or therapy impact. The monitoring circuitry 5327 may
compare the patient's therapy usage to a prescribed therapy to
determine therapy compliance. The monitoring circuitry 5327
communicates with a therapy feedback unit 5325 that develops
feedback information based on the monitored conditions, the
detected events, and/or the calculated indices.
[1038] In one exemplary implementation, the disordered breathing
detector 5324 may be coupled to a respiration sensor. The
disordered breathing detector 5324 may use the respiration signal
developed by the respiration sensor to detect disordered breathing
events based on the inspiratory and expiratory phases of the
patient's respiration cycles, for example. The sleep detector 5328
may analyze various inputs from the patient-internal sensors 5311,
patient-external sensors 5312, patient input devices 5313, other
information systems 5314 to detect sleep-related events, including,
for example, sleep onset, sleep offset, sleep stages, and arousals
from sleep.
[1039] The monitoring circuitry 5327 includes a memory 5336 for
storing information derived from signals produced by the
patient-internal sensors 5311, patient-external sensors 5312,
patient input devices 5313, and/or other information systems 5314.
The memory 5336 may also store information about detected events,
e.g., sleep and disordered breathing events, and/or information
related to calculated indices characterizing various events such as
sleep and/or disordered breathing events. The stored data may be
transferred to the feedback unit 5325 and used to develop feedback
information to control disordered breathing therapy. The stored
data may be retrieved by another component of the medical device
5301 for later use, or may be transmitted to a separate device 5340
for storage, further processing, trending, analysis and/or display,
for example. In one scenario, the stored data can be downloaded to
a separate device periodically or on command. The stored data may
be presented to the patient's health care professional on a
real-time basis, or as a long-term, e.g., month long or year long,
trend of daily measurements.
[1040] The medical device 5301 may optionally include a therapy
unit. In some examples described herein, the medical device 5301
comprises a cardiac therapy device configured to deliver cardiac
electrical stimulation therapy using a cardiac pulse generator 5375
and electrical stimulation electrodes 5352.
[1041] The medical device 5301 may further include a communications
unit 5306 that controls communications between the medical device
5301 and other devices or systems. For example, the communications
unit 5306 may be used to provide wireless or wired communications
links between the medical device 5301 and one or more of the
patient-internal sensors 5311, patient-external sensors 5312,
patient input devices 5313, and information systems 5314.
[1042] The communications unit 5306 may also facilitate
communications between the medical device 5301 and a remote device
5340 such as the sleep disordered breathing therapy device, a
programmer, and/or an APM system. The wireless connections coupling
the medical device 5301 to various other devices and systems may
utilize a variety of wireless protocols, including, for example,
Bluetooth, IEEE 802.11, and/or a proprietary wireless protocol.
[1043] Detecting the onset, termination, duration, stages, and
quality of sleep experienced by a patient may be employed in
connection with monitoring patient conditions and providing
feedback for sleep disordered breathing therapy. Patients suffering
from sleep apnea, or other types of sleep disordered breathing, may
be treated with for sleep disordered breathing only during periods
of sleep. Monitoring patient conditions and/or development of
feedback information may involve determining if the patient is
asleep and/or detecting various sleep-related processes, such as
arousals from sleep and/or REM or non-REM sleep stages.
[1044] In addition, patient sleep may be monitored and information
associated with patient sleep may be used to assess an impact of
breathing therapy on the patient. Therapy impact data may be used
to develop feedback information used to adjust the therapy. The
implantable monitoring device 5301 may include a sleep detector
5328 for detecting when the patient is asleep and various stages
and/or processes of sleep. Various methods of sleep detection
implementable in an implanted device involve sensing one or more
conditions indicative of sleep. The sleep-related conditions may be
compared to a threshold to determine if the patient is asleep.
[1045] The sleep-related conditions may be sensed or derived using
patient-external or implantable sensors and analyzed by a sleep
detector of the implantable monitoring device or by circuitry
within the APM communication unit (i.e., a supervisor device that
co-ordinates diagnostics between various sensors. For example,
sleep detection may be implemented in an implantable cardiac rhythm
management system configured as a pacemaker/defibrillator or an
ITCS device.
[1046] Sleep detection may involve sensing one or more conditions
indicative of sleep. A representative set of sleep-related
conditions include body movement, heart rate, QT interval, eye
movement, respiration rate, transthoracic impedance, tidal volume,
minute ventilation, body posture, brain activity, cardiac activity,
muscle tone, body temperature, time of day, historical sleep times,
blood pressure, and blood gas concentration, proximity to bed, for
example.
[1047] Sleep may be detected by comparing levels of the one or more
sleep-related conditions to one or more sleep thresholds. For
example, sleep may be detected by monitoring the patient's heart
rate. When the patient's heart rate decreases below a sleep
threshold, the patient may be determined to be asleep. Sleep may
also be detected by monitoring the patient's activity. If the
patient's activity decreases below a sleep threshold, then the
patient may be determined to be asleep. Another method of detecting
sleep involves monitoring the patient's minute ventilation. If the
patient's minute ventilation falls below a sleep threshold, then
the patient may be determined to be asleep.
[1048] Sleep may be detected by comparing multiple sleep-related
conditions to multiple thresholds. For example, the patient may be
determined to be asleep if the patient's activity, sensed by an
accelerometer, falls below an activity sleep threshold and the
patient's heart rate, sensed by cardiac electrodes, falls below a
heart rate sleep threshold.
[1049] Sleep may also be detected using one sleep-related condition
to modify the sleep threshold of another sleep-related condition. A
first sleep-related condition may be sensed. The level of the
sleep-related condition may be compared to a sleep threshold to
determine the onset and termination of sleep. A second
sleep-related condition may be used to adjust the sleep threshold.
Additional sleep-related conditions may optionally be sensed to
confirm the onset or termination of the sleep condition.
[1050] A sleep detector 5328 (FIG. 53) may be configured to compare
the levels of one or more sleep-related conditions to one or more
thresholds. In one implementation, the one sleep related condition
may be compared to a sleep threshold or other index to detect
sleep. In another implementation, multiple sleep-related conditions
may be compared to multiple thresholds or indices. In a further
implementation, one or more of the sleep-related conditions may be
used to adjust the sleep thresholds or indices. Furthermore, the
onset or termination of sleep may be confirmed using an additional
number of sleep-related conditions.
[1051] The sleep-related conditions may be sensed using implantable
sensors and/or patient-external sensors, for example. In one
embodiment, patient activity may be compared to a sleep threshold
to determine when the patient is asleep. A low level of activity is
indicative that the patient is sleeping. Patient activity may be
sensed, for example, using an accelerometer positioned on or in the
housing of an implantable cardiac device, or in another convenient
location. The accelerometer signal may be correlated with activity
level or workload.
[1052] A second sleep-related condition may be used to adjust the
sleep threshold. In one embodiment, the patient's minute
ventilation is used to adjust the sleep threshold. The patient's
respiration may be sensed using a transthoracic impedance sensor.
Transthoracic impedance may be used to derive various parameters
associated with respiration, including, for example, tidal volume
and/or minute ventilation. A transthoracic impedance sensor may be
integrated into an implantable cardiac device with intracardiac
electrodes, for example. Impedance driver circuitry generates a
current that flows through the blood between the impedance drive
electrode and a can electrode on the housing of the cardiac device.
The voltage at an impedance sense electrode relative to the can
electrode changes as the transthoracic impedance changes.
[1053] As illustrated in the flowchart of FIGS. 54A and 54B,
embodiments of the invention are directed to monitoring 5410 one or
more patient conditions using an implantable monitoring device.
Feedback information is developed 5412 based on the monitored
conditions. The feedback information is provided 5414 to a device
delivering therapy to treat sleep disordered breathing. The
monitoring device and the therapy device have separate housings.
Components of the monitoring device are disposed within an
implantable housing. The therapy device may comprise a housing that
is implantable or patient-external. The feedback information may be
used to adjust 5420 (FIG. 54B) the sleep disordered breathing
therapy. The feedback information may comprise control signals
indicating the sleep disordered breathing therapy should be
initiated, modified, or terminated.
[1054] In one implementation, the feedback control signals are
provided to the therapy device by the monitoring unit. Therapy
adjustment based on the feedback information is made automatically
by the therapy device. In other implementations, information
related to the monitored conditions is transmitted from the
monitoring device to a physician or medical decision network.
[1055] In one scenario, the medical decision network may develop
the feedback control signals and transmit the feedback control
signals to the therapy device. In another scenario, a physician may
determine the feedback adjustments to be made to the therapy and
may operate a programmer or other device to transfer the feedback
control information to the therapy device.
[1056] In various implementations, the implantable device may
monitor one or more patient conditions indicative of the severity
of sleep disordered breathing events, the effectiveness of the
sleep disordered breathing therapy, and/or the impact of the
therapy on the patient. The implantable device may monitor
conditions indicative of interactions between the sleep disordered
breathing therapy and other therapies delivered to the patient.
Based on the monitored conditions, feedback information is provided
to the therapy device. The feedback information may be used to
adjust the therapy to enhance therapy effectiveness, to reduce an
impact of the therapy, to avoid or reduce therapy interactions,
and/or to accomplish other therapeutic goals.
[1057] In one embodiment, the implantable device may develop the
feedback information and transmit the feedback information directly
to the sleep disordered breathing therapy device. The feedback
information may be used by the therapy device to automatically
adjust the therapy delivered to the patient. In another embodiment,
both the implantable monitoring device and the therapy device may
be communicatively coupled to a separate medical device, such as a
device programmer or patient management system.
[1058] In one approach, the implantable device may transmit
information about the sensed patient conditions to the separate
medical device. The separate medical device may develop the
feedback information. The feedback information and/or information
related to the monitored conditions may be printed, displayed
and/or stored. The feedback information may be used to manually or
automatically adjust the sleep disordered breathing therapy. For
example, the separate medical device may transmit the feedback
information to the therapy device. The feedback information may be
used by the therapy device to automatically adjust the sleep
disordered breathing therapy.
[1059] In another approach, the feedback information may be
developed by the monitoring device based on the sensed conditions.
The feedback information may be transmitted from the monitoring
device to the therapy device through the separate medical device.
The feedback information may be used by the therapy device to
automatically adjust the sleep disordered breathing therapy.
[1060] The flowchart of FIG. 54C illustrates a method of providing
feedback information in accordance with an embodiment of the
invention. The monitoring device senses 5430 one or more patient
conditions associated with sleep. Sleep is detected 5432 based on
the sleep-related conditions. The monitoring device senses 5434 one
or more conditions associated with disordered breathing during
sleep. One or more disordered breathing events occurring during
sleep are detected 5436. Characteristics of the sleep disordered
breathing events, such as, severity, frequency, and/or duration,
may be determined 5438. Determination of the one or more
characteristics of the sleep disordered breathing events may
involve calculation of one or more indices characterizing the
disordered breathing events. The indices may include, for example,
an apnea/hypopnea index (AHI) and/or a percent time in periodic
breathing (% PB), among other indices. Feedback information is
provided 5440 to a device delivering therapy for sleep disordered
breathing based on the one or more characteristics of the sleep
disordered breathing events.
[1061] Another embodiment of the invention is illustrated in the
flowchart of FIG. 54D. According to this method, one or more
patient conditions are sensed 5450 using the implantable monitoring
device. Information related to the patient conditions is
transmitted 5452 to an advanced patient management (APM)
system.
[1062] Feedback information based on the patient conditions is
developed 5454 using the APM system. The feedback information is
transmitted 5456 from the APM system to a therapy device delivering
therapy for sleep disordered breathing. The sleep disordered
breathing therapy is adjusted 5458 based on the feedback
information.
[1063] FIG. 54E is a flowchart illustrating a method for providing
sleep disordered breathing therapy feedback information based on an
effectiveness of the sleep disordered breathing therapy. The
patient's respiration is sensed 5460 and a respiration waveform is
generated 5462. The sensed respiration waveform is used to detect
5464 disordered breathing events. An apnea/hypopnea index (AHI) is
calculated 5466 based on the detected disordered breathing events.
The AHI is used to assess the effectiveness 5468 of the sleep
disordered breathing therapy. A lower AHI indicates more effective
breathing treatment than a relatively higher AHI, for example.
Feedback information is developed 5468 based on the disordered
breathing index. The feedback information is transmitted 5470 to
the therapy device. The therapy device uses the feedback
information to adjust 5472 the sleep disordered breathing
therapy.
[1064] In accordance with one embodiment, feedback for the sleep
breathing therapy may be based on therapy effectiveness and impact
to the patient. The flowchart of FIG. 54F illustrates an example
method that may involve the use of circuitry disposed within the
housing of an implantable cardiac rhythm management (CRM) device to
monitor breathing therapy delivered by an external breathing
therapy device. In one example, therapy for sleep disordered
breathing is delivered to the patient using a continuous positive
airway pressure (CPAP) device. The effectiveness of the breathing
therapy and the impact of the therapy on the patient are monitored
by an implantable CRM device.
[1065] Sensors coupled to monitoring circuitry disposed within the
cardiac device housing may sense one or more patient conditions
related to therapy effectiveness. For example, a condition
modulated by patient respiration may be sensed and a respiration
waveform signal generated 5474. Monitoring circuitry disposed
within the housing of the cardiac device may detect 5476 disordered
breathing episodes based on the respiration signal. The monitoring
circuitry may determine therapy effectiveness based on the
severity, frequency and/or duration of sleep disordered breathing
episodes experienced by the patient. In one implementation, the
monitoring circuitry disposed within the CRM may calculate 5478 an
apnea/hypopnea index (AHI) and/or a percent time in periodic
breathing (% PB) indicative of the frequency of disordered
breathing episodes. The effectiveness of the sleep disordered
breathing therapy is determined based on the sleep disordered
breathing index 5480. If the AHI and/or % PB are relatively low,
the breathing therapy may be determined to be effective. If the AHI
and/or % PB are relatively high, then the breathing therapy may be
determined to be ineffective.
[1066] A CPAP device typically includes a respiratory mask, e.g., a
nasal of facial mask, worn by the patient to facilitate delivery or
air or other gas to the patient's airway. The respiratory mask may
be inconvenient and/or uncomfortable for the patient to wear and
may keep the patient awake. Further, delivery of positive airway
pressure may inhibit sleep, or cause the patient to arouse
frequently. Information about these side effects of the breathing
therapy may be helpful in tailoring a therapy regimen for the
patient. The CRM may monitor one or more conditions indicative of
an impact of the CPAP therapy on the patient.
[1067] Impact of the CPAP therapy may be determined based on
information related to sleep quality. Sensors coupled to the
monitoring circuitry within the CRM are configured to sense 5482
one or more conditions related to sleep. The sleep related
conditions are used to detect 5484 sleep and/or arousals from
sleep. The monitoring circuitry within the CRM determines 5486 the
impact of the CPAP therapy on the patient by monitoring the
patient's sleep. For example, the monitoring circuitry may monitor
the total time the patient spends sleeping, the number of arousals
experienced by the patient in one night, the number of arousals
correlated to sleep disordered breathing events, and/or the depth
of the arousals. In various implementations the monitoring unit may
calculate various indices characterizing sleep and/or one or more
composite indices based on indices related to sleep and indices
related to sleep disordered breathing. In one example, the
monitoring unit calculates the number of arousals experienced by
the patient per hour (A/h).
[1068] Feedback information is developed 5488 based on the therapy
effectiveness and impact information. The feedback information may
be transmitted to the therapy device and used to automatically
adjust the therapy delivered to the patient. For example, if the
AHI is high, the breathing therapy pressure may be adjusted upward
to provide a more effective therapy. If the patient experiences an
arousal rate greater than a threshold without experiencing sleep
disordered breathing episodes, the therapy may be determined to be
too aggressive. The breathing therapy pressure may be adjusted
downward to provide a disordered breathing therapy that is more
comfortable to the patient and allows the patient to sleep
better.
[1069] Diagnosis and/or Therapy using Blood Chemistry/Expired Gas
Parameter Analysis
[1070] Aspects of the invention that include diagnosis and/or
therapy using blood chemistry/expired gas parameter analysis are
directed to methods and systems configured to monitor, diagnose,
and/or provide patient therapy using one or more individual medical
procedures. Each of the circles 180 illustrated in FIGS. 1B-1D
represents an individual medical procedure providing a specific
monitoring, diagnosis or therapeutic function or set of functions.
Each individual medical procedure may be implemented as a
stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[1071] Other aspects of the invention that include diagnosis and/or
therapy using blood chemistry/expired gas parameter analysis are
directed to methods and systems configured to monitor, diagnose,
and/or provide therapy using coordinated medical procedures.
Coordinated medical procedures may involve cooperative operation of
two or more of the individual processes 180. Coordinated medical
procedures may also involve cooperative operation of one or more
functions of two or more of the individual processes 180.
[1072] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1073] Embodiments of the invention may incorporate medical gas
therapy systems and methods, such as systems and methods for
diagnosis and/or therapy using measurement of expired gases and/or
blood gases. Embodiments may include systems and methods for
detecting and/or diagnosing disorders, such as disordered
breathing, a pulmonary disorder, and/or a cardiac disorder, and
providing therapy based on one or more conditions or parameters
influenced by such diseases/disorders, such as blood gas
concentrations, expired gas concentrations, or blood acid-base
balance (i.e., hydrogen ion concentration). Methods of providing
disordered breathing therapy may involve determining one or more
parameters influence by disordered breathing, which may include one
or more of blood gas concentration, expired respiratory gas
concentration, or blood hydrogen ion concentration, also known as
pH. Respiratory and cardiac therapies may be adjusted based on the
one or more detected parameters.
[1074] In certain embodiments, a disordered breathing therapy
method may involve sensing at least one of an expired respiratory
gas concentration, a blood gas concentration, or blood pH.
Respiratory and cardiac therapies may be adjusted based on one or
more of these parameters. In other embodiments, a medical system
includes a detector configured to detect blood gas concentration,
expire respiratory gas concentration, or hydrogen ion
concentration. The medical system further includes a therapy
delivery system. The therapy delivery system includes a respiratory
therapy delivery device configured to deliver respiratory therapy
to a patient and a cardiac therapy delivery device configured to
deliver cardiac therapy to the patient. A therapy controller is
coupled to the respiratory therapy delivery device and the cardiac
therapy delivery device and is configured to adjust respiratory and
cardiac therapies based on the detected blood gas concentration,
expired gas concentration, and/or blood pH.
[1075] Systems and methods that employ diagnosis and/or therapy
using blood chemistry/expired gas parameter analysis 130 (FIG. 1C)
may be implemented as a stand-alone system or in combination with
other individual medical systems, such as those described in FIGS.
1B-1D. Various embodiments involve a system for providing
coordinated patient monitoring, diagnosis and/or therapy that
utilizes diagnosis and/or therapy using blood chemistry/expired gas
parameter analysis 130. The coordinated system may include, for
example, an implantable cardiac device 181 and a patient-external
respiratory therapy device 184. The system may further include an
external processor 183 providing a coordination function. A
communication channel couples the implantable device 181 and the
respiratory therapy device 184. The implantable 181 and respiratory
therapy devices 184 operate cooperatively via the communication
channel to provide one or more of patient monitoring, diagnosis,
and therapy.
[1076] The implantable and respiratory therapy devices 181, 184
may, for example, operate cooperatively based on detected blood gas
concentration, expired gas concentration, and/or blood pH. For
example, detection of detected blood gas concentration, expired gas
concentration, and/or blood pH and/or deviation of same from
pre-established thresholds may allow the implantable and
respiratory therapy devices 181, 184 to operate cooperatively to
adjust one or both of respiratory and cardiac therapies. Systems
and methods directed to use of blood chemistry and/or expired gas
parameter analysis for diagnosis and/or therapy may be implemented
to include selected features, functions, and/or structures
described in commonly owned, co-pending U.S. Publication No.
2005/0065572, which is hereby incorporated herein by reference.
[1077] Many patients suffering from obstructive sleep apnea (OSA)
have intermittent oxygen desaturation associated with periods of
apnea or hypopnea. Oxygen saturation levels below 90% are
considered harmful. Usually, treatment is directed at correcting
the apnea, which may in turn prevent hypoxemia. Unfortunately, many
patients fail or are not candidates for nasal continuous positive
airway pressure (CPAP) or surgical correction of their OSA. For
these patients, oxygen administration for the correction of
OSA-related nocturnal hypoxemia may reduce symptoms of OSA. Oxygen
therapy has also been successfully used to treat central apneas as
well, including Cheyne-Stokes respiration (CSR). Systems of the
present invention may controls gas therapy using one or more
patient-internal sensors, one or more patient-external sensors,
and/or an implanted device.
[1078] Gas therapy, such as oxygen therapy, continuous positive
airway pressure therapy, or other therapies provided to a patient
through the pulmonary system, may mitigate a patient's suffering
from a number of respiratory disorders. Some lung diseases, such as
emphysema, sarcoidosis, and chronic obstructive pulmonary disorder,
reduce lung function to the extent that supplemental oxygen is
needed to continue normal bodily functions. For many patients with
end stage lung disease, oxygen therapy allows the patients to get
the oxygen they need, helps them be more active, and may also
prevent heart failure.
[1079] Gas therapy devices may be used to provide a variety of
respiration therapies, including, for example, providing
vasodilating agents, continuous positive airway pressure (CPAP),
bi-level positive airway pressure (bi-level PAP), proportional
positive airway pressure (PPAP), auto-titrating positive airway
pressure, ventilation, gas or oxygen therapies. All types of gas
therapy and positive airway pressure devices are referred to
generically herein as xPAP devices.
[1080] Expired gases or blood gases may be used to adjust cardiac
rhythm management (CRM) and/or xPAP therapies to provide more
effective treatment of disordered breathing, a pulmonary disorder,
and/or a cardiac disorder. The blood gas sensors may be implemented
using either a patient-internal sensor or a patient-external
sensor. Expired gases may be sensed using a patient-external sensor
positioned, for example, on the respiratory mask of the xPAP
device. The use of external sensors avoids the stability,
reliability, and power consumption problems associated with
implanted sensors. The use of implanted sensors resolves compliance
issues common to xPAP therapy. The gas concentration in the expired
air collected at the very end of expiration (just before inhalation
starts) is representative of the blood gas concentration. This
provides a non-invasive way of measuring blood gas
concentrations.
[1081] The blood hydrogen ion concentration (or pH) is related to
the relative amount of carbon dioxide and various chemical
buffering agents in the blood. The blood pH is therefore closely
influenced by respiration. The blood pH is related to the internal
respiratory control and is therefore an important indicator of
respiratory disorders, including apnea, COPD and others. An example
of a pH sensor suitable for implantation is described in U.S. Pat.
No. 4,312,734, which is hereby incorporated herein by reference. An
example of an oxygen sensor suitable for implantation is described
in U.S. Pat. No. 4,390,405, which is hereby incorporated herein by
reference.
[1082] Various diseases and disorders, e.g., sleep apnea, are
associated with various levels of expired respiratory gases and/or
blood gases. The detection of changes in expired gases, blood
gases, and/or blood pH may be used in connection with diagnosis of
a variety of diseases. Further, expired gas, blood gas
concentrations, and/or pH may be used to detect and/or predict
episodes of disordered breathing, a pulmonary disorder, and/or a
cardiac disorder. Further, detection of expired gas, blood gas
concentrations, and/or blood pH may be used to initiate, terminate,
or modify respiratory and cardiac therapy.
[1083] Embodiments of the invention are directed to systems and
methods that acquire and process blood chemistry information in an
implantable or partially implantable device. Information acquired
from blood gas or pH sensors, for example, may be used in
connection with patient monitoring, diagnosis, and therapy. An
implantable system may incorporate expired gas, blood gas, and/or
pH detection for various purposes, including disease diagnosis and
therapy control, among other functions. Systems may include one or
more or expired gas, blood gas, and/or pH sensors, which may be
implemented as one or more patient-internal and/or one or more
patient-external sensors.
[1084] The following discussion, with reference to FIGS. 55 through
59, describes embodiments of the invention involving measurement of
expired gases, blood gases or blood pH used for diagnosis and
therapy. The processes and systems exemplified by these embodiments
may be implemented alone or in combination with one or more
processes and systems exemplified by other embodiments described
herein (e.g., in FIGS. 1B-1D) to provide a coordinated approach to
patient monitoring, diagnosis, and/or therapy.
[1085] In accordance with embodiments of the invention, a system
controls gas therapy, such as oxygen therapy, using one or more
patient-internal sensors, one or more patient-external sensors,
and/or an implanted device. The gas therapy may be delivered to the
patient, and measurement of exhaled gas concentration may be
implemented using a respiratory mask, such as a CPAP mask, for
example. The one or more sensors may include, for example, a gas
saturation sensor or other implanted sensor for determining the
patient's blood gas saturation. The patient's blood gas saturation
may be determined externally, e.g., using pulse oximetry
techniques, and/or external sensors positioned on a respiratory
mask or nasal cannulae.
[1086] As is illustrated in FIG. 55A, a system 5500 may be
configured with one or more sensors 5510 that are configured to
sense one or more parameters influence by disordered breathing. The
sensors 5510 may be implemented as implantable sensors,
patient-external sensors, or both implantable and patient-external
sensors. A disordered breathing (DB) therapy controller 5550 may be
configured for implantable or patient-external operation. For
example, the DB therapy controller 5550 may be implemented as a
controller of an xPAP device 5530 or a controller of a cardiac
rhythm management device 5520. The DB therapy controller 5550
detects disordered breathing using sense information received from
the sensors 5500, and adjusts therapies deliverable by the xPAP and
CRM devices 5530, 5520 responsive to the sense information.
Adjustment of xPAP and CRM therapies includes, for example,
initiation, termination, or modification of such therapies.
[1087] In accordance with other embodiments, as illustrated in FIG.
55B, a system 5500 may be configured with a patient-external
expired gas sensor 5540 used to modify cardiac pacing therapy and
respiratory therapy for treating disordered breathing, a pulmonary
disorder, and/or a cardiac disorder. The expired gas sensor 5540
may be positioned in an appropriate location on the mask of an xPAP
device 5530. In the embodiment illustrated in FIG. 55B, the expired
gas sensor 5540 is coupled to the xPAP device 5530. Expired gas
concentration is measured at the end of expiration. A timing
element (not shown) may be used to coordinate operations with the
patient's respiration cycle to make the expired gas concentration
measurement at the end of expiration.
[1088] The xPAP device 5530 includes a DB therapy controller 5550.
The DB therapy controller 5550 detects expired gas, e.g., expired
oxygen, and compares concentration of the expired gas to a
predetermined threshold or range. When the gas concentration is
beyond the threshold or range, the DB therapy controller 5550 may
initiate, terminate, or modify a respiratory therapy provided by
the xPAP device 5530. Further, the DB therapy controller 5550 may
communicate with a CRM device 5520, e.g., through a wireless
communication link or other communications mechanism, to initiate,
terminate, or modify the electrical stimulation therapy provided by
the CRM device 5520.
[1089] In other embodiments, as illustrated in FIG. 56, a system
5600 includes the DB therapy controller 5550 located within the CRM
device 5520. The external expired gas sensor 5540 may wirelessly
transmit to the CRM device 5520 sensed signals associated with
expired gas concentration. The DB therapy controller 5550 compares
the concentration of the expired gas to a predetermined threshold
or range. When the gas concentration is beyond the threshold or
range, the DB therapy controller 5550 may initiate, terminate, or
modify an electrical stimulation therapy provided by the CRM device
5520. Further, the DB therapy controller 5550 may communicate with
the xPAP device 5530, e.g., through a wireless communication link
or other communications mechanism, to initiate, terminate, or
modify a respiratory therapy provided by the xPAP device 5530.
[1090] In accordance with yet other embodiments, as illustrated in
FIG. 57, a system 5700 includes an implanted blood sensor 5760 that
provides information used to modify cardiac pacing therapy and
respiratory therapy for disordered breathing, a pulmonary disorder,
and/or a cardiac disorder. The implanted blood sensor 5760 may
include one or both of a blood gas sensor or a blood pH sensor. For
example, the blood sensor 5760 may be configured to sense one or
more of blood oxygen concentration, blood carbon dioxide
concentration, or blood pH.
[1091] The blood sensor 5760 may be positioned, for example, on an
endocardiac lead implanted in a chamber of the patient's heart and
coupled to the CRM device 5520. The CRM device 5520 in this example
includes, or otherwise incorporates the functionality of, the DB
therapy controller 5550. The DB therapy controller 5550 may detect
blood gas concentration, e.g., blood oxygen and/or carbon dioxide
concentration, and compare concentration of the blood gas to a
predetermined threshold or range. When the blood gas concentration
is beyond the threshold or range, the DB therapy controller 5550
may initiate, terminate, or modify the electrical stimulation
therapy provided by the CRM device 5520. Further, the DB therapy
controller 5550 may communicate with the xPAP device 5530, e.g.,
through a wireless communication link or other communications
mechanism, to initiate, terminate, or modify the respiratory
therapy provided by the xPAP device 5530. An equivalent to the
above example could be implemented using a blood pH sensor or a
combination of blood gas and blood pH sensors.
[1092] In further embodiments, as illustrated in FIG. 58, a system
5800 includes the DB therapy controller 5550 within the xPAP device
5530. The blood sensor 5760 may wirelessly transmit to the xPAP
device 5530 sensed signals associated with blood gas concentration
and/or blood pH. The DB therapy controller 5550 compares the
concentration of the expired gas to a predetermined threshold or
range. When the gas concentration is beyond the threshold or range,
the DB therapy controller 5550 may initiate, terminate, or modify
the respiratory therapy provided by the xPAP device 5530. Further,
the DB therapy controller 5550 may communicate with the CRM device
5520, e.g., through a wireless communication link or other
communications mechanism, to initiate, terminate, or modify the
electrical stimulation therapy provided by the CRM device 5520. An
equivalent to the above example could be implemented using a blood
pH sensor or a combination of blood gas and blood pH sensors.
[1093] As is illustrated in the examples shown in FIGS. 55 through
58, many possible combinations of componentry and nesting or
combinations of componentry are possible in accordance with the
present invention. The specific configurations shown in FIGS. 55
through 58 are non-limiting examples of possible configurations of
systems in accordance with the present invention.
[1094] FIG. 59 is a flow chart illustrating a method 5900 of
therapy control based on signals from a patient-internal device in
accordance with embodiments of the invention. The method 5900 may
be useful for controlling systems using combined gas and cardiac
therapies, such as those illustrated with reference to FIGS. 55
through 58. For clarity of understanding, and not by way of
limitation, the sensing of blood oxygen level and/or blood pH will
be used as an example of one use of the method 5900. For example,
an equivalent embodiment could be implemented using blood carbon
dioxide level.
[1095] Block 5902 provides for the sensing of a blood chemistry
parameter, such as blood gas concentration (e.g., blood oxygen
level or blood carbon dioxide level) and/or blood pH. An analysis
5904 is made of the sensed blood gas concentration and/or blood pH.
For example, a blood oxygen and/or pH level may be compared to a
range of acceptable levels to detect whether the blood gas
concentration/pH is within an acceptable range, or whether some
disease/disorder is diagnosable. If blood oxygen/pH level is
acceptable and no disease/disorder is diagnosed at analysis 5904,
the blood gas/pH sensing continues at block 5902. Sensing may occur
continuously, intermittently, by-request, periodically, or as
otherwise desired.
[1096] If a disease/disorder is detected at analysis 5904, a
determination 5906 is made, relative to the detected
disease/disorder. For example, detecting a blood oxygen below a
lower threshold may suggest that more oxygen is needed by the
patient. A decision 5908 is made as to whether some modifications
and/or therapies are desired to increase the blood oxygen level.
For example, if a patient is receiving oxygen therapy and cardiac
pacing, the oxygen level administered to the patient may be
adjusted and the heart rate may be adjusted. In another embodiment,
if the patient is sleeping and wearing a CPAP device, the air
pressure may be increased and the heart rate may be increased. In a
further embodiment, the patient may be administered a vasodilating
agent, or have a level of vasodilating agent therapy modified along
with adjustment of the heart rate. Combined therapies may also be
performed, such as increasing gas pressure and adding a
vasodilating agent, or other desired therapy combination.
[1097] If no therapy change is desired, the presence of the
disease/disorder may be recorded and monitored, and/or an alert
signal may be generated responsive to the detection of the
disease/disorder, for example, before returning to the sense block
5902. If a therapy change is desired, the therapy is modified at a
block 5910 before again returning to the blood sense block 5902.
For example, if a patient is receiving oxygen therapy, the oxygen
level administered to the patient is increased, and the method 5900
may be performed again after an appropriate time to determine if
the change was effective, or whether other action is necessary.
[1098] Information about the patient's blood gas and/or pH levels
may be used to enhance sleep monitoring and/or diagnosis of a
variety of disorders. Detection of blood gas level and/or pH may be
used to diagnose disorders as well as trigger the sleep-time
therapy in a respiratory and cardiac device. Data acquired during
sleep may assist in diagnosing various sleep-related disorders. The
collected data may be stored, displayed, printed, or transmitted to
a separate device.
[1099] Pulmonary Disease Assessment System
[1100] Aspects of the invention are directed to methods and systems
configured to monitor, diagnose, and/or provide patient therapy
using one or more individual medical procedures including
assessment of pulmonary disease. Each of the circles 180
illustrated in FIGS. 1B-1D represents an individual medical
procedure providing a specific monitoring, diagnosis or therapeutic
function or set of functions. Each individual medical procedure may
be implemented as a stand-alone system. Two or more of the
individual medical procedures 180 may be used in combination to
provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[1101] Other aspects of the invention involving pulmonary disease
assessment are directed to methods and systems configured to
monitor, diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[1102] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1103] Embodiments of the invention involve an individual system
136 (FIG. 1D) for assessing a presence of a pulmonary disease. The
pulmonary disease assessment system 136 may be implemented as a
stand alone system or in combination with other individual medical
systems, such as those described in FIGS. 1B-1D.
[1104] Embodiments of the invention are directed to methods and
systems for assessing a presence of pulmonary disease. One
embodiment of the invention involves a method for assessing a
presence of a pulmonary disease other than a breathing rhythm
disorder. The method includes sensing one or more conditions
associated with the non-rhythm pulmonary disease using a
respiratory therapy device. The presence of the non-rhythm
pulmonary disease is assessed based on the one or more sensed
conditions.
[1105] According to various aspects of the invention, sensing the
one or more sensed conditions may include sensing one or more of
respiratory pressure, respiratory flow, and exhaled gas
concentration.
[1106] The presence of various types of non-rhythm pulmonary
diseases may be assessed, including, for example, obstructive
pulmonary diseases, restrictive pulmonary diseases, pulmonary
vasculature disorders, pleural disorders, and/or other pulmonary
diseases or disorders that are not breathing rhythm disorders.
[1107] According to another embodiment of the invention, a medical
system for assessing a non-rhythm pulmonary disease presence
includes a respiratory therapy device having a therapy unit and a
sensor system. The therapy unit is configured to deliver
respiration therapy to a patient. The sensor system is configured
to sense one or more conditions associated with a pulmonary disease
other than a breathing rhythm disorder. The system further includes
a diagnosis unit coupled to the sensor system. The diagnosis unit
is configured to assess a presence of the non-rhythm pulmonary
disease based on the one or more sensed conditions.
[1108] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
including non-rhythm pulmonary disease assessment. The coordinated
system includes, for example, an implantable cardiac device 181 and
a patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[1109] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy further
includes a pulmonary disease assessment system. The respiratory
therapy device includes a sensor system configured to sense one or
more conditions associated with a pulmonary disease other than a
breathing rhythm disorder. The system further includes a diagnosis
unit coupled to the sensor system and configured to assess a
presence of the non-rhythm pulmonary disease based on the one or
more sensed conditions, wherein the implantable device and the
patient external respiratory therapy device operate cooperatively
to implement the pulmonary disease assessment system. Systems and
methods directed to assessing pulmonary disease may be implemented
to include selected features, functions, and/or structures
described in commonly owned, co-pending U.S. Pat. No. 7,575,553,
which is hereby incorporated herein by reference.
[1110] Pulmonary disorders may be organized into broad categories
encompassing disorders of breathing rhythm and non-rhythm pulmonary
diseases and/or disorders. Breathing rhythm disorders include
various syndromes characterized by patterns of disordered breathing
that produce insufficient respiration, for example, sleep apnea,
hypopnea, and Cheyne-Stokes Respiration (CSR), among others.
Breathing rhythm disorders are not necessarily accompanied by
alteration of pulmonary structures.
[1111] Non-rhythm pulmonary diseases or disorders typically involve
physical changes to lung structures, such as loss of elasticity of
the lung tissue, obstruction of airways with mucus, limitation of
the expansion of the chest wall during inhalation, fibrous tissue
within the lung, excessive pressure in the pulmonary arteries,
and/or other characteristics. Pulmonary diseases or disorders that
are not rhythm-related are referred to herein as non-rhythm
pulmonary diseases and may include obstructive pulmonary diseases,
restrictive pulmonary diseases, infectious and non-infectious
pulmonary diseases, pulmonary vasculature disorders, and pleural
cavity disorders, for example.
[1112] Embodiments of the invention are directed to methods and
systems for assessing a presence of non-rhythm pulmonary diseases
using a sensor system coupled to a respiratory therapy device. If
the non-pulmonary disease is present based on the assessment, then
a diagnosis of the non-pulmonary disease may be made. A non-rhythm
pulmonary disease assessment system may be used to discriminate
between types of non-rhythm pulmonary diseases, e.g., between
obstructive pulmonary diseases and restrictive pulmonary diseases.
The assessment system may additionally or alternatively be used to
discriminate between non-rhythm pulmonary diseases of a particular
type, e.g., between asthma and emphysema, both of which are
pulmonary diseases of the obstructive type.
[1113] If the presence of a non-rhythm pulmonary disease is
detected, then the progression of the disease may be monitored.
Monitoring the progression of the non-rhythm pulmonary disease may
involve, for example, evaluating one or more physiological changes
or symptoms associated with the disease. Evaluating the
physiological changes or symptoms may be accomplished by
periodically sensing for conditions modulated by the symptoms or
physiological changes and storing information about the sensed
conditions. Monitoring disease progression may involve, for
example, monitoring the severity of the disease, disease onset,
changes during the course of the disease, regression, disease
offset, and/or other aspects of the disease.
[1114] Embodiments of the invention utilize the sensor system of a
patient-external respiratory therapy device to determine a presence
of a non-rhythm pulmonary disease. The respiratory therapy device
may comprise, for example, a gas therapy device, nebulizer,
ventilator, positive airway pressure device, or other type of
external respiration therapy device. In a preferred embodiment, the
respiratory therapy device comprises a positive airway pressure
device. Continuous positive airway pressure (CPAP) devices are
frequently used to treat sleep apnea and/or other breathing rhythm
disorders. A CPAP device may be used regularly during a patient's
sleep time to prevent or treat sleep disordered breathing events.
Use of a CPAP device for treatment of breathing rhythm disorders
facilitates detection of non-rhythm pulmonary diseases. The CPAP
device provides respiratory sensing functionality on a periodic
basis that may be employed to sense conditions indicative of
symptoms or physiological changes associated with non-rhythm
pulmonary disease.
[1115] FIG. 60 is a flowchart illustrating a method of assessing a
presence of a non-rhythm related pulmonary disease in accordance
with embodiments of the invention. The method involves using 6010 a
respiratory therapy device to sense conditions associated with the
non-rhythm related pulmonary disease and assessing 6020 a presence
of the non-rhythm pulmonary disease based on the sensed
conditions.
[1116] The respiratory therapy device may include one or more
sensors used to sense physiological conditions related to
non-rhythm pulmonary disease. The respiratory therapy device
sensors may include, for example, one or more ventilatory pressure
sensors, capable of sensing inspiratory pressure and/or expiratory
pressure, one or more ventilatory flow sensors, capable of sensing
inspiratory flow and/or expiratory flow, one or more ventilatory
gas sensors, capable of sensing exhaled CO2 and/or exhaled O2,
among other sensors.
[1117] One or more of the physiological conditions sensed by the
sensors of the respiratory therapy device may be measured and
compared to criteria associated with presence of a non-rhythm
pulmonary disorder. In some implementations, the one or more
physiological conditions may be trended over time and the trended
measurements compared to trend criteria. In some implementations,
the criteria depend on relationships between the various
measurements acquired using the sensors of the respiratory therapy
device.
[1118] The measurements collected using the respiratory therapy
device sensors may be stored in memory, along with sets of criteria
used for assessing the presence of various non-rhythm pulmonary
disorders. In one implementation, the memory storing the criteria
sets and a diagnostic processor are disposed within the housing of
the respiratory therapy device controller, for example. The
diagnostic processor compares the measured conditions to the
criteria sets in memory to assess the presence of various
non-rhythm pulmonary disorders.
[1119] In one implementation, the measurements acquired by the
respiratory therapy device may be transmitted to a remote device,
such as an advanced patient management system. Diagnostic circuitry
within the advanced patient management system may compare the
conditions measured by the respiratory therapy device to the
criteria sets stored in the APM system to assess the presence of
non-rhythm pulmonary disorders.
[1120] According to one aspect of the invention, pulmonary function
testing may be employed to detect physiological changes associated
with the presence of pulmonary disease. Pulmonary function tests
performed in a clinical setting may be used to evaluate lung
mechanics, gas exchange, pulmonary blood flow, and blood gases and
pH. They are used to evaluate patients in the diagnosis of
pulmonary disease, assessment of disease development, or evaluation
of the risk of pulmonary complications from surgery.
[1121] Pulmonary performance may be evaluated based on data
acquired by the respiratory therapy device during normal and forced
inspiration and expiration. From such data, pulmonary parameters
including tidal volume, minute ventilation, forced expiratory
volume, forced vital capacity, among other parameters may be
determined.
[1122] Pulmonary function testing is conventionally performed in a
clinical setting and measures values indicative of the ability of
the lungs to exchange oxygen and carbon dioxide. The total lung
capacity (TLC) is divided into four volumes. The tidal volume
(V.sub.T) is the volume inhaled or exhaled in normal quiet
breathing. The inspiratory reserve volume (IRV) is the maximum
volume that can be inhaled following a normal quiet inhalation. The
expiratory reserve volume (ERV) is the maximum volume that can be
exhaled following a normal quiet exhalation. The residual volume
(RV) is the volume remaining in the lungs following a maximal
exhalation. The vital capacity (VC) is the maximum volume that can
be exhaled following a maximal inhalation; VC=IRV+V.sub.T+ERV. The
inspiratory capacity (IC) is the maximum volume that can be inhaled
following a normal quiet exhalation; IC.dbd.IRV+V.sub.T. The
functional residual capacity (FRC) is the volume remaining in the
lungs following a normal quiet exhalation; FRC=ERV+RV.
[1123] The vital capacity and its components (V.sub.T, IRV, ERV,
IC) are typically measured using a spirometer, which is a device
that measures the volumes of air inhaled and exhaled. The FRC is
usually measured by the helium dilution method using a closed
spirometry system. A known amount of helium is introduced into the
system at the end of a normal quiet exhalation. When the helium
equilibrates throughout the volume of the system, which is equal to
the FRC plus the volume of the spirometer and tubing, the FRC is
determined from the helium concentration. This test may
underestimate the FRC of patients with emphysema. The FRC can be
determined quickly and more accurately by body plethysmography. The
residual volume and total lung capacity are determined from the
FRC.
[1124] In the forced vital capacity (FVC) maneuver, the patient
exhales as forcefully and rapidly as possible, beginning at maximal
exhalation. Several parameters are determined from the spirogram.
The FVC is the total volume of air exhaled during the maneuver; it
is normally equal to the vital capacity. The forced expiratory
volume (FEV) is the volume expired during a specified time period
from the beginning of the test. The times used are 0.5, 1, 2, and 3
seconds; corresponding parameters are FEV.sub.0.5, FEV.sub.1.0,
FEV.sub.2.0, and FEV.sub.3.0. The maximal expiratory flow rate
(MEFR) is the slope of the line connecting the points where 200 ml
and 1200 ml have been exhaled; it is also called FEF.sub.200-1200
(forced expiratory flow). The maximal midexpiratory flow rate
(MMFR, MMF) is the slope of the line connecting the points where 25
percent and 75 percent of the FVC have been exhaled; it is also
called FEF.sub.25-75%.
[1125] The Maximal Voluntary Ventilation (MVV) is the maximal
volume of air that can be breathed by the patient, expressed in
liters per minute; it was formerly called maximal breathing
capacity (MBC). The patient breathes as rapidly and deeply as
possible for 12 to 15 seconds and the volume exhaled is determined
by spirometry.
[1126] Various parameters related to pulmonary performance, some of
which may be measured using sensors of a respiratory therapy device
include, for example, tidal volume, minute ventilation, inspiratory
reserve volume, forced expiratory volume (FEV), residual volume,
and forced vital capacity (FVC), among other parameters. According
to one embodiment, testing of some pulmonary function parameters
may be performed using the ventilation pressure and ventilation
flow sensors of a CPAP device. The pulmonary function testing may
be used, for example, to discriminate between restrictive and
obstructive pulmonary disorders. Methods and systems for acquiring
and using pulmonary function testing information, aspects of which
may be utilized in connection with embodiments of the invention,
are described in commonly owned U.S. patent application Ser. No.
10/885,145, filed Jul. 6, 2004, which is incorporated herein by
reference.
[1127] Because the results of pulmonary function tests vary with
size and age, the normal values are calculated using prediction
equations or nomograms, which give the normal value for a specific
age, height, and sex. The prediction equations are derived using
linear regression on the data from a population of normal subjects.
The observed values are usually reported as a percentage of the
predicted value. Abnormal test results may show either an
obstructive or restrictive pattern. Sometimes, both patterns are
present.
[1128] The results of pulmonary function testing, along with other
measured physiological conditions, may be compared to initial or
baseline results to detect changes in the patient's pulmonary
status over time. The changes from baseline values may be used to
discern a presence of disease processes. Further, over time, a
database of information about relevant conditions and specific to
the patient is established. The information may be used to develop
sets of criteria specific to the patient and associated with the
presence of a particular pulmonary disease processes. Thus, in some
implementations, the system may learn to recognize the presence of
disease based on the history of symptoms and/or physiological
changes that occur in a particular patient.
[1129] FIG. 60B illustrates a normal respiratory pattern, having
normal FEV and FVC. FIG. 60C illustrates an obstructive pattern. An
obstructive pattern occurs when there is airway obstruction from
any cause, as in asthma, bronchitis, emphysema, or advanced
bronchiectasis; these conditions are grouped together in the
nonspecific term chronic obstructive pulmonary disease (COPD). In
this pattern, the residual volume is increased and the PV/TLC ratio
is markedly increased. Owing to increased airway resistance, the
flow rates are decreased. The FEV/FVC ratios, MMFR, and MEFR are
all decreased; FEV.sub.1.0/FVC is less than 75 percent.
[1130] FIG. 60D illustrates a restrictive pattern. A restrictive
pattern occurs when there is a loss of lung tissue or when lung
expansion is limited as a result of decreased compliance of the
lung or thorax or of muscular weakness. The conditions in which
this pattern can occur include pectus excavatum, myasthenia gravis,
diffuse idiopathic interstitial fibrosis, and space occupying
lesions (tumors, effusions). In this pattern, the vital capacity
and FVC are less than 80 percent of the predicted value, but the
FEV/FVC ratios are normal. The TLC is decreased and the RV/TLC
ratio is normal.
[1131] Embodiments of the invention utilize a patient-external
respiratory therapy device to perform periodic pulmonary function
testing. A CPAP or other external respiratory device may measure
ventalitory pressure, ventilatory airflow, and/or ventalitory gas
during periodic, e.g., nightly, therapy sessions. The ventalitory
pressure and/or airflow measurements may be used to measure FVC and
FEV during forced expiration. From these two parameters, FEV/FVC
can be derived to differentiate obstructive versus restrictive
respiratory patterns as shown in the FIGS. 60C and 60D. Other
measurements that are possible using the respiratory device sensors
include low forced expiratory flow (FEF), high functional residual
capacity (FRC), total lung capacity (TLC), and high residual volume
(RV).
[1132] In one embodiment, the patient may perform forced
expirations while connected to the external respiratory device.
During the forced expirations, circuitry in the external
respiratory device may collect measurements, including FEV and FVC
measurements.
[1133] In addition, the forced expiratory flow (FEF.sub.25-75%) may
be measured. The middle half by volume of the total expiration is
marked, and its duration is measured. The FEF.sub.25-75% is the
volume in liters divided by the time in seconds. In patients with
obstructive diseases, the FEF.sub.25-75% is generally greater than
their expected values.
[1134] Circuitry incorporated in the CPAP device may be used to
compare measured FVC, FEV and FEF.sub.25-75% values derived from
the pressure sensor and/or from the airflow sensor with predicted
values from normal subjects in accordance with various embodiments.
The comparison provides diagnostic information of lung mechanics.
Data acquired by the CPAP device may be transmitted from the CPAP
device to an advanced patient management (APM) system or other
remote device.
[1135] FIGS. 61A-61D are block diagrams of systems that may be used
for non-rhythm pulmonary disease assessment in accordance with
embodiments of the invention. FIG. 61A illustrates an external
respiratory therapy device 6110, e.g., a CPAP device, used to sense
conditions associated with a non-rhythm pulmonary disease. The
sensed conditions are evaluated by circuitry within the external
respiratory therapy device 6110 to assess a presence of the
non-rhythm pulmonary disease.
[1136] The respiratory therapy device 6110 is coupled to one or
more sensors 6135 configured to sense one or more conditions
modulated by physiological changes and/or symptoms of the
non-rhythm pulmonary disease. The sensors of the respiratory device
used to sense the conditions may include, for example, ventalitory
airflow, ventilatory pressure, ventilatory gas, and/or other
conditions modulated by symptoms of the non-rhythm pulmonary
disease.
[1137] A representative set of symptoms and/or physiological
changes associated with non-rhythm pulmonary diseases may involve
dyspnea (e.g., non-specific dyspnea, orthopnea, exertional dyspnea,
paroxysmal nocturnal dyspnea), abnormal concentrations of blood or
respiratory gases (e.g., cyanosis, hypoxemia, hypercapnea, low
pCO2, arterial acidosis, high alveolar--arterial pO2 differential),
pulmonary function dysfunction (e.g., low forced expiratory volume
(FEV), forced vital capacity (FVC), FEV/FVC, low forced expiratory
flow (FEF), high functional residual capacity (FRC), total lung
capacity (TLC), high residual volume (RV), high lung compliance,
slow exhalation, respiratory failure), other pulmonary conditions
(e.g., ventilation-perfusion mismatch), and cardiovascular
conditions (e.g., circulatory collapse).
[1138] Table 7 lists non-rhythm pulmonary disease symptoms or
physiological changes, conditions indicative of the symptoms or
physiological changes, and sensors of the respiratory therapy
device that may be used to sense the conditions.
TABLE-US-00007 TABLE 7 Symptom or Physiological Change Condition
Sensor Used Non-specific dyspnea Exhaled % CO2 CO2 sensor Orthopnea
Exhaled % O2 O2 sensor Exertional dyspnea Expiratory flow Flowmeter
Paroxysmal nocturnal dyspnea Inspiratory flow Flowmeter Cyanosis
Exhaled % O2 O2 sensor Hypoxemia High alveolar-arterial pCO2
differential Hypercapnea Exhaled % CO2 CO2 sensor Low pCO2 Arterial
acidosis Low FEV, FVC, FEV/FVC Expiratory flow Flowmeter Low FEF
Inspiratory flow Flowmeter High FRC, TLC Expiratory pressure
Pressure sensor High RV Inspiratory pressure Pressure sensor High
lung compliance Slow exhalation Respiratory Failure Exhaled % O2 O2
sensor Ventilation-perfusion mismatch Exhaled % CO2 CO2 sensor
Circulatory collapse
[1139] The one or more sensors 6135 are coupled to sensor signal
processor circuitry 6130 which may be configured to energize the
sensors and to receive and condition signals generated by the
sensors 6135. The sensor signal processor circuitry 6130 may
comprise, for example, sensor driver circuitry, filters, sampling
circuitry, and A/D converter circuitry. The sensor signals may be
averaged, filtered, or otherwise processed by the signal processor
circuitry 6130 prior to use by other components of the respiratory
therapy device 6110.
[1140] The respiratory therapy device 6110, illustrated in FIG. 61A
as a positive airway pressure (xPAP) device includes a respiration
therapy control unit 6120. The respiration therapy control unit
6120 comprises a flow generator 6121 that pulls in air through a
filter. The flow generator 6121 is controlled by the pressure
control circuitry 6122 to deliver an appropriate air pressure to
the patient. Air flows through tubing 6123 coupled to the xPAP
device 6110 and is delivered to the patient's airway through a mask
6124. In one example, the mask 6124 may be a nasal mask covering
only the patient's nose. In another example, the mask 6124 covers
the patient's nose and mouth. Other air delivery systems are also
possible.
[1141] Continuous positive airway pressure (CPAP) devices deliver a
set air pressure to the patient. The pressure level for the
individual patient may be determined during a titration study, for
example. Such a study may take place in a sleep lab, and involves
determination by a sleep physician or other professional of the
optimum airway pressure for the patient. The CPAP device pressure
control is set to the determined level. When the patient uses the
CPAP device, a substantially constant airway pressure level is
maintained by the device. The constant air pressure acts a
pneumatic splint to keep soft tissue in the patient's throat from
collapsing and obstructing the airway.
[1142] Autotitration PAP devices are similar to CPAP devices,
however, the pressure controller for autotitration devices
automatically determines the air pressure delivered to the patient.
Instead of maintaining a constant pressure, the autotitration PAP
device evaluates sensor signals and the changing needs of the
patient to deliver a variable positive airway pressure.
Autotitration PAP and CPAP are often used to treat sleep disordered
breathing, for example.
[1143] Bi-level positive airway pressure (bi-PAP) devices provide
two levels of positive airway pressure. A higher pressure is
maintained while the patient inhales. The device switches to a
lower pressure during expiration. Bi-PAP devices are used to treat
a variety of respiratory dysfunctions, including chronic
obstructive pulmonary disease (COPD), respiratory insufficiency,
and ALS or Lou Gehrig's disease, among others.
[1144] The xPAP device may include a memory 6150 that stores
criteria used in the assessment of pulmonary disease. The memory
may additionally or alternatively store information related to
measurements of the conditions sensed by the xPAP device.
[1145] In accordance with various embodiments of the invention, the
xPAP device 6110 may include a diagnostic unit 6160 that evaluates
patient conditions sensed by the sensors 6135 and assesses a
presence of a non-rhythm pulmonary disease. For example, the
diagnostic unit 6160 may compare the measured conditions to sets of
criteria indicative of non-rhythm pulmonary diseases. If the
measured conditions are consistent with a particular set of
criteria, the diagnostic unit may indicate that the non-rhythm
pulmonary disease associated with the particular criteria set is
present.
[1146] The xPAP device 6110 may include a communications unit 6140
for communicating with one or more separate devices 6170, such as a
device programmer or a cooperating patient-external or
patient-internal monitoring, diagnostic and/or therapeutic device.
Communication between cooperating devices allows the xPAP device
6110 to provide information to the cooperating device or devices or
to control therapy delivered by the cooperating devices, for
example. In one scenario, the xPAP device 6110 may transmit to a
cooperating therapy device information about the presence of a
non-rhythm pulmonary disease/disorder. The therapy device may
adjust therapy delivered by the device based on the presence of the
non-rhythm pulmonary disease/disorder. Additionally, or
alternatively, the xPAP device 6110 may adjust the respiration
therapy delivered to the patient based on the non-rhythm pulmonary
disease assessment.
[1147] In one implementation, a system for assessment of non-rhythm
pulmonary disorders may be used within the structure of an advanced
patient management system. In this implementation, an advanced
patient management system includes a remote computer system that
allows a physician to remotely monitor cardiac, respiratory, and
other patient functions. The advanced patient management system may
have the capability of assessing the presence of various non-rhythm
pulmonary diseases based on respiration measurements acquired by
the xPAP device 6110 and transmitted to the APM system.
[1148] As previously discussed, the xPAP device 6110 may include a
memory 6150 for storing data related to the non-rhythm pulmonary
disease. For example, the xPAP device 6110 may initiate collection
and storage of data hourly, nightly, weekly, or according to some
other time schedule that corresponds to the patient's usage times
of the respiratory therapy device. Typically an xPAP device is used
nightly for treatment of sleep apnea and/or other breathing rhythm
disorders. The xPAP device 6110 may collect data from the sensors
6135 during one or more periods of time that the device is used.
The presence of the non-rhythm pulmonary disease may be assessed
based on the collected data. Assessment of the presence of the
non-rhythm pulmonary disease may involve assessment of the severity
of the disease, disease onset, changes during the course of the
disease, regression, disease offset, and/or other aspects of the
disease.
[1149] In one implementation, the diagnosis unit 6160 is a
component of the respiratory therapy device 6110, as illustrated in
FIG. 61A. In another implementation, the diagnosis unit 6160 may be
configured as a component of a device 6170 separate from the
respiratory therapy device 6110. The latter implementation is
illustrated in the block diagram of FIG. 61B. In this
implementation, the respiratory therapy device 6110 may transmit
information about conditions sensed by the respiratory therapy
device 6110 to the diagnosis unit 6160 of a remotely located device
6170. The diagnosis unit 6160 assesses the non-rhythm pulmonary
disease presence based on the transmitted information.
[1150] The remote device 6170 may comprise a patient-external or
patient-internal medical device. The remote device 6170 may be
configured, for example, as a cardiac diagnostic and/or therapeutic
device. In one configuration, for example, the remote device may
comprise a cardiac rhythm management system, such as a pacemaker,
defibrillator, and/or cardiac resynchronizer.
[1151] The block diagrams of FIGS. 61C and 61D illustrate other
exemplary arrangements that may be used for pulmonary disease
assessment in accordance with embodiments of the invention. The
system illustrated in FIG. 61C includes a respiratory therapy
device 6110 and a medical device 6190 remote from the respiratory
therapy device 6110. In this example, both the respiratory therapy
device 6110 and the medical device 6190 are equipped with sensors
6135, 6136 for sensing conditions associated with symptoms of one
or more non-rhythm pulmonary diseases. For example, the respiratory
therapy device 6110 and the additional medical device 6190 may each
sense a subset of the conditions listed in Table 1. The respiratory
therapy device 6110 may transmit its sensed condition information
to the medical device 6190 over a wired or wireless communications
link. The medical device 6190 includes a diagnostic unit 6160
configured to assess a presence of one or more non-rhythm pulmonary
diseases. The diagnostic unit 6160 may assess the non-rhythm
pulmonary diseases, for example, by comparing sensed conditions to
one or more sets of criteria indicative of the non-rhythm pulmonary
diseases as previously described.
[1152] The block diagram of FIG. 61D illustrates a further
exemplary arrangement of a pulmonary disease assessment system. In
this example, the system includes a respiratory therapy device 6110
and an additional medical device 6190, e.g., a therapeutic or
monitoring device. The respiratory therapy device 6110 and the
additional medical device 6190 communicate with a diagnostic unit
6160, such as a diagnostic unit of an APM system. The respiratory
therapy device 6110 and the additional medical device 6190 are each
equipped with sensors 6135, 6136 for sensing conditions associated
with one or more non-rhythm pulmonary diseases. The respiratory
therapy device 6110 and the medical device 6190 may transmit sensed
condition information to the diagnostic unit 6160 through wireless
or wired communication links. The pulmonary disease diagnostic unit
6160 is configured to use the information transmitted by the
respiration therapy device 6110 and the medical device 6190 to
assess the presence of one or more non-rhythm pulmonary
diseases.
[1153] Assessment of conditions indicative of non-rhythm pulmonary
diseases/disorders may include assessing the patient's pulmonary
function as previously described. The charts provided in FIGS.
62A-62G illustrate conditions and sensors that may be used to
determine physiological changes associated with various non-rhythm
pulmonary diseases and disorders. The charts depicted in FIGS.
62A-62G illustrate relationships between various physiological
changes and/or disease symptoms associated with non-rhythm
pulmonary diseases. FIG. 62A lists representative sets of
non-rhythm pulmonary diseases that may be assessed in accordance
with embodiments of the invention. The representative set of
non-rhythm pulmonary diseases that may be assessed includes, for
example, obstructive pulmonary diseases (e.g., chronic bronchitis,
emphysema, asthma), restrictive pulmonary diseases (e.g.,
sarcoidosis, pulmonary fibrosis, pneumoconiosis), infections
pulmonary diseases (e.g., bronchitis, pneumonia, bronchiolitis,
tuberculosis, and bronchiectasis), pulmonary vasculature diseases
(e.g., pulmonary hypertension, pulmonary edema, pulmonary embolism,
atalectasis), and diseases of the pleural cavity (e.g., pleural
effusion, pneumothorax, and hemothorax).
[1154] The non-rhythm pulmonary diseases listed in FIG. 62A are
cross-referenced with the physiological changes and/or symptoms
associated with the non-rhythm pulmonary disease. The physiological
changes and/or symptoms are cross referenced with conditions
indicative of the physiological changes and/or symptoms. Sensors
used to sense the conditions indicative of the physiological
changes or symptoms are provided in FIG. 62A. Sensors of the
respiratory therapy device may include, for example, ventilation
gas, ventilation flow and/or ventilation pressure sensors, or other
sensors for example.
[1155] The left section 6202 of FIG. 62A illustrates various
conditions that may be sensed using sensors of a respiratory
therapy device (CPAP), a cardiac device (CRM), or an external
non-CPAP, non-CRM device. The top section 6201 lists various
conditions that may be sensed and information about sensors used to
sense the conditions. The center section 6204 of FIG. 62A provides
physiological changes and/or symptoms that may be evaluated using
the conditions listed in the left section 6202. The right section
6203 of FIG. 62A provides pulmonary diseases/disorders. The
presence of the pulmonary diseases/disorders of the right section
6203 may be assessed based on the physiological changes and/or
symptoms of the center section 6204.
[1156] For legibility, the left and right sections 6202, 6203 of
FIG. 62A are divided into six portions, FIGS. 62B-62G. FIG. 62B
represents the upper left portion 6210 of the left section 6202 of
FIG. 62A. FIG. 62C represents the upper right portion 6212 of the
left section 6202 of FIG. 62A. FIG. 62D represents the lower left
portion 614 of the left section 6202 of FIG. 3A. FIG. 3E represents
the lower right portion 6216 of the left section 6202 of FIG. 62A.
FIG. 62F represents the upper portion 6220 of the right section 603
of FIG. 62A. FIG. 62G represents the lower portion 6222 of the
right section 6203 of FIG. 62A. Relevant portions of the center
section 6204 and the top section 6201 of FIG. 62A appear in each of
the FIGS. 62B-62G for convenience.
[1157] An example of how FIGS. 62A-62N may be used follows.
Referring to FIGS. 62F and 62G, the restrictive pulmonary disorder
pneumoconiosis produces the physiological changes non-specific
dyspnea (FIG. 62F) and cough (FIG. 62G). Non-specific dyspnea (FIG.
62F) and cough (FIG. 62G) are indicated by marks in the column
denoted pneumoconiosis in FIGS. 3F and 3G, respectively.
Non-specific dyspnea may be detected based on one or more of the
conditions listed in the row for non-specific dyspnea illustrated
in FIGS. 62B and 62D. The conditions include duration of symptoms,
abnormal breathing/coughing, blood pO2, inspiratory flow,
expiratory flow, exhaled % CO2 and exhaled % O2, illustrated in
FIG. 62D. The conditions also include arterial/venous pO2, blood
pCO2, blood pO2, exhalation time, inspiration time, minute
ventilation, tidal volume, respiration rate, and/or respiration
sounds illustrated in FIG. 62B.
[1158] The presence of a disorder/disease, such as those listed in
FIGS. 62A-62G, may be assessed by based on physiological changes
and/or symptoms associated with the disorder/disease. The
physiological changes and/or symptoms may be detected using
conditions sensed by a sensor system of a respiratory therapy alone
or in combination with the sensor systems of other therapeutic or
diagnostic medical devices. If the sensed conditions indicate that
the physiological changes or symptoms of a disease or disorder are
consistent with a threshold level, the presence of the disease or
disorder may be determined.
[1159] In another example, assessment of disease presence may be
based on relative changes in one or more conditions indicative of
physiological changes or symptoms caused by the disease. For
example, assessment of a presence of a disease or disorder may be
accomplished by evaluating the changes in conditions indicative of
physiological changes or symptoms caused by the disease. The
changes in the one or more conditions may be compared to threshold
criteria. If changes in the conditions indicative of physiological
changes or symptoms caused by the disease are consistent with
threshold levels, a presence of the disease or disorder may be
determined.
[1160] In a further example, the threshold criteria may involve
relationships between the conditions indicative of physiological
changes or symptoms caused by the disease. The presence of a
disease may be assessed by evaluating relationships between
conditions indicative of physiological changes or symptoms caused
by the disease. For example, assessment of a disease may involve
the determination that levels or amounts of two or more conditions
have a certain relationship with one another. If relationships
between the conditions indicative of physiological changes or
symptoms caused by the disease are consistent with threshold
relationship criteria, the disease or disorder may be present.
[1161] In accordance with various embodiments of the invention, the
presence of a non-rhythm pulmonary disease, such as those listed in
FIGS. 62A-62G, may be assessed by evaluating conditions indicative
of the non-rhythm pulmonary disease sensed using a respiration
therapy device. In one example, the presence of a non-rhythm
pulmonary disease may be assessed by comparing conditions
indicative of physiological changes or symptoms caused by the
disease to threshold criteria. If the conditions indicative of
physiological changes or symptoms caused by the disease are
consistent with threshold levels, the system may determine that the
non-rhythm pulmonary disease or disorder is present.
[1162] In another example, assessment of disease presence may be
based on relative changes in one or more conditions indicative of
physiological changes or symptoms caused by the disease. For
example, diagnosis of a non-rhythm pulmonary disease may be
effected by evaluating the changes in conditions indicative of
physiological changes or symptoms caused by the disease. The
changes in the one or more conditions may be compared to threshold
criteria. If changes in the conditions indicative of physiological
changes or symptoms caused by the disease are consistent with
threshold levels, the non-rhythm pulmonary disease or disorder may
be present.
[1163] In a further example, the threshold criteria may involve
relationships between the conditions indicative of physiological
changes or symptoms caused by the disease. The presence of a
non-rhythm pulmonary disease may be assessed by evaluating
relationships between conditions indicative of physiological
changes or symptoms caused by the disease. For example, assessment
of a disease may involve the determination that levels or amounts
of two or more conditions have a certain relationship with one
another. If relationships between the conditions indicative of
physiological changes or symptoms caused by the disease are
consistent with threshold relationship criteria, the non-rhythm
pulmonary disease or disorder may be present.
[1164] FIG. 63A illustrates a system for assessing a presence of a
non-rhythm pulmonary disease/disorder in accordance with
embodiments of the invention. The system includes a diagnosis
processor 6320 that receives information from a sensing system of a
respiratory device 6321. The sensing system 6321 measures one or
more conditions associated with a non-rhythm pulmonary disease or
disorder. In some embodiments, the diagnosis processor may also
receive sensory information from another device 6322, such as a
cardiac therapy device.
[1165] The diagnosis processor 6320 accesses a criteria library
6310. The criteria library 6310 stores sets of criteria 6311-6314
respectively associated with various non-pulmonary
diseases/disorders. FIGS. 63B-63K illustrate criteria sets that may
be used to assess a presence of non-rhythm pulmonary disease in
accordance with embodiments of the invention. The exemplary
criteria sets may be used to assess the presence of chronic
bronchitis (FIG. 63B), emphysema (FIG. 63C), asthma (FIG. 63D),
pulmonary fibrosis (FIG. 63E), pulmonary hypertension (FIG. 63F),
pulmonary edema (FIG. 63G), pulmonary embolism (FIG. 63H),
atelectasis (FIG. 63I), and hemothorax (FIG. 63J). The charts of
FIGS. 63A-63J list physiological changes or symptoms associated
with the non-rhythm pulmonary disease in the left hand column,
conditions used to detect the particular physiological change or
symptom in the middle column, and the respiration therapy device
sensor used to sense the condition in the right hand column.
[1166] Using FIG. 63J as a representative example, the presence of
atelectasis may be assessed based on the symptoms non-specific
dyspnea, hypoxemia, and/or hypercapnia. Non-specific dyspnea may be
detected based on one or more of the following criteria: exhaled %
CO2, exhaled % O2, expiratory flow, and/or inspiratory flow. The
levels of one or more of these conditions may be compared to
threshold levels for assessment of atelectasis. Other symptoms
associated with atelectasis include hypoxemia, which may be
determined based on comparison of the patient's exhaled % O2 to a
threshold criterion, and hypercapnia, which may be determined based
on comparison of the patient's exhaled % CO2 to a threshold
criterion.
[1167] The criteria listed in FIGS. 63B-63J involve conditions that
may be detected using sensors of a respiratory therapy device, such
as a CPAP device. The non-rhythm pulmonary disease assessment
system described herein may use one or more additional sensors
and/or devices other than the respiratory therapy device to enhance
disease assessment, such as those indicated in FIGS. 62A-62G. In
one example, conditions detected using an external respiratory
therapy device, e.g., CPAP device, may be used along with
conditions detected using an implantable cardiac device, e.g.,
pacemaker or defibrillator to assess the presence of a non-rhythm
pulmonary disease. In another example, conditions detected using an
external respiratory therapy device, e.g., CPAP device, may be used
along with conditions detected using an additional external
device.
[1168] FIG. 63K illustrates an exemplary criteria set for assessing
a presence of tuberculosis. Tuberculosis may be assessed based on
conditions sensed using a respiratory therapy device in addition to
conditions sensed using other devices. FIG. 63K lists physiological
changes or symptoms associated with tuberculosis in the left hand
column, conditions used to assess a presence of tuberculosis in the
middle column, and the respiration therapy device sensor or other
device sensor used to sense the condition in the right hand
column.
[1169] FIG. 64A is a flowchart illustrating a method for assessing
a presence of a non-rhythm pulmonary disease/disorder in accordance
with embodiments of the invention. The processes of FIG. 64A may be
implemented using system components and criteria sets such as those
illustrated in FIGS. 63A-63K.
[1170] One or more conditions modulated by symptoms of a non-rhythm
pulmonary disease/disorder are measured 6410. The conditions may be
sensed by a sensing system of a respiratory therapy device, and
optionally, by a sensing system of another medical device, such as
a cardiac rhythm management device. A diagnosis processor receives
the measured conditions and accesses 6420 a criteria library. The
diagnostic unit compares 6430 the measured conditions with the one
or more criteria sets.
[1171] If the measured conditions are consistent 6440 with a
particular criteria set, the presence of the non-rhythm pulmonary
disease/disorder associated with the particular criteria set is
detected 6450. If the If the measured conditions are not consistent
6440 with a particular criteria set, the presence of the non-rhythm
pulmonary disease/disorder associated with the particular criteria
set is not detected 6460.
[1172] According to some embodiments, the system may monitor the
non-rhythm pulmonary disease/disorder. Monitoring the progression
of the disease/disorder may include periodically measuring the
conditions relevant to the disease/disorder and storing information
relevant to the disease/disorder. The periodically measured
conditions may be used to monitor the severity of the disease,
disease onset, symptoms or physiological changes during the course
of the disease, disease regression, disease offset, and/or other
aspects of the disease.
[1173] FIG. 64B is a flowchart illustrating a method of monitoring
a presence of a non-rhythm pulmonary disease in accordance with
embodiments of the invention. Criteria sets for assessment of the
non-rhythm pulmonary diseases are established 6462. A respiratory
therapy device such as a CPAP device is used 6464 to sense
conditions modulated by disease symptoms. The sensor information
may be gathered periodically 6466, e.g., nightly, and stored for
evaluation. If a presence of the disease was previously determined
6468, then the progression of the disease may be monitored 6470
based on the conditions used to determine a presence of the
disease, or other conditions.
[1174] If a presence of the disease was not previously determined
6468, then the levels of the sensed conditions are compared 6472 to
a set of criteria associated with the disease. If levels of the
conditions are consistent 6474 with the threshold levels, then the
presence of the disease is determined 6476. If levels of the
conditions are not consistent 6470 with the threshold levels, then
the system continues 6464 to sense conditions modulated by disease
symptoms.
[1175] Coordination of Respiratory and Cardiac Therapies for
Disordered Breathing
[1176] Aspects of the invention are directed to methods and systems
configured to provide coordinated respiratory and cardiac therapies
for disordered breathing using one or more individual medical
procedures. Each of the circles 180 illustrated in FIGS. 1B-1D
represents an individual medical procedure providing a specific
monitoring, diagnosis or therapeutic function or set of functions.
Each individual medical procedure may be implemented as a
stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[1177] Other aspects of the invention involving disordered
breathing therapy are directed to methods and systems configured to
monitor, diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[1178] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1179] Embodiments of the invention involve an individual system
138 (FIG. 1B) for coordinating disordered breathing therapy. The
coordinated disordered breathing therapy system 138 may be
implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[1180] Various embodiments of present invention involve methods and
systems for coordinating sleep disordered breathing therapies. In
accordance with one embodiment, a method for treating disordered
breathing includes controlling a patient-external respiratory
therapy delivered to a patient and controlling a cardiac therapy
delivered to the patient. The patient-external respiratory therapy
and the cardiac therapy are coordinated to treat the disordered
breathing.
[1181] In accordance with another embodiment of the invention, a
medical system includes a respiratory therapy controller configured
to control an external respiratory therapy delivered to a patient
and a cardiac therapy controller configured to deliver a cardiac
therapy to the patient. The system also includes a processor,
coupled to the respiratory therapy controller and the cardiac
therapy controller. The processor is configured to coordinate
delivery of the external respiratory therapy and the cardiac
therapy to treat disordered breathing.
[1182] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes coordination 138 of delivery of disordered breathing
therapy. The coordinated system may include, for example, an
implantable cardiac device 181 and a patient-external respiratory
therapy device 184. The system may further include an external
processor 183 providing a coordination function. A communication
channel couples the implantable device 181 and the respiratory
therapy device 184. The implantable 181 and respiratory therapy
devices 184 operate cooperatively via the communication channel to
provide one or more of patient monitoring, diagnosis, and
therapy.
[1183] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy further
includes a system 138 configured to coordinate delivery of
disordered breathing therapy. The disordered breathing delivery
coordination system 138 includes a respiratory therapy controller
configured to control an external respiratory therapy delivered to
a patient and a cardiac therapy controller configured to control a
cardiac therapy delivered to the patient. The system further
includes a processor coupled to the respiratory therapy controller
and the cardiac therapy controller for coordinating delivery of the
external respiratory therapy and the cardiac therapy in order to
treat the disordered breathing. Systems and methods directed to
coordinate use of respiratory and cardiac therapies for sleep
disordered breathing may be implemented to include selected
features, functions, and/or structures described in commonly owned,
co-pending U.S. Pat. No. 7,591,265, which is hereby incorporated
herein by reference.
[1184] Sleep disordered breathing may be more effectively monitored
and/or treated using a coordinated approach. Various embodiments of
the invention are implemented using medical systems employing two
or more patient-external and/or patient-internal medical devices.
The medical devices may communicate or otherwise operate in concert
to provide coordinated disordered breathing therapy.
[1185] Embodiments of the invention are directed to methods and
systems utilizing a plurality of therapies to treat sleep
disordered breathing. The therapies include, at least, an external
respiratory therapy and cardiac electrical stimulation therapy.
Other therapies may also be cooperatively utilized.
[1186] Delivery of the plurality of therapies may be coordinated to
achieve various therapeutic goals, e.g., to enhance overall therapy
efficacy, to reduce impact to the patient, to avoid therapy
interactions, among others. According to one example, coordination
of therapies may involve shifting the therapy burden from one type
of therapy to another type of therapy in response to events or
conditions. In one implementation, shifting the burden from one
type of therapy to another type of therapy may involve initiating
or increasing a first type of disordered breathing therapy and
terminating or decreasing a second type of disordered breathing
therapy. Another example of coordinating therapy may involve using
one type of therapy to treat one type of disordered breathing, and
using another type of therapy to treat another type of disordered
breathing.
[1187] Various types of therapies have been used to treat sleep
disordered breathing. Positive airway pressure devices, e.g.,
continuous positive airway pressure (CPAP) devices are among the
most frequently used mechanical respiration therapy devices
employed for treating sleep disordered breathing. Sleep disordered
breathing has also been treated using muscle and/or nerve
stimulation therapy. For example, a treatment for obstructive sleep
apnea involves electrical activation of the tongue muscles. The
hypoglossal (HG) nerve innervates the protrusor and retractor
tongue muscles. In one approach, an appropriately applied
electrical stimulation to the hypoglossal nerve, for example, may
prevent backward movement of the tongue, thus preventing the tongue
from obstructing the airway.
[1188] Central sleep apnea may also be treated by phrenic nerve
pacing, also referred to as diaphragmatic pacing. Phrenic nerve
pacing uses an electrode implanted in the chest to stimulate the
phrenic nerve. The phrenic nerve is generally known as the motor
nerve of the diaphragm. It runs through the thorax, along the
heart, and then to the diaphragm. Diaphragmatic pacing involves the
use of electronic stimulation of the phrenic nerve to control the
patient's diaphragm and induce a respiratory cycle. Pacing the
phrenic nerve may be accomplished by surgically placing a nerve
cuff on the phrenic nerve, and then delivering an electric
stimulus. The electric stimulus of the phrenic nerve then causes
the diaphragm to induce a respiratory cycle.
[1189] Recently, cardiac pacing therapy has been used as a therapy
for disordered breathing. Cardiac pacing therapy may be implemented
using an implanted electrical pulse generator coupled to
endocardiac leads inserted into one or more heart chambers. Cardiac
pacing for sleep disordered breathing treatment may include pacing
one or more heart chambers, and may involve pacing at a rate above
a lower rate limit during sleep and/or during episodes of
disordered breathing, for example. Other forms of cardiac pacing
such as cardiac resynchronization therapy, biventricular pacing can
be delivered to the patient to treat disordered breathing.
[1190] Another cardiac therapy that can be adapted to mitigate
disordered breathing involves non-excitatory stimulation therapy.
In one example, non-excitatory cardiac stimulation therapy involves
electrical stimulation of one or more heart chambers, e.g., the
left and/or right ventricles, or other cardiac sites, at an energy
level below a capture threshold. In another example, non-excitatory
cardiac stimulation therapy involves cardiac electrical stimulation
delivered to one or more heart chambers during absolute refractory
periods of the cardiac tissue. The non-excitatory stimulation may
improve cardiac contractility. The non-excitatory cardiac
stimulation therapy may be used alone or in combination with
cardiac pacing therapy to provide a comprehensive therapy regimen
for patients with CHF and disordered breathing such as
Cheyne-Stokes respiration.
[1191] Cardiac therapy has also been used to mitigate disordered
breathing using methods that involve overdrive cardiac pacing of
one or more atria or one or more ventricles.
[1192] Drug therapy may also be used to treat disordered breathing.
Drugs may be delivered to the patient through one or more
automatically controllable drug delivery devices, e.g., a drug
pump, a controllable nebulizer, or an electrically activated drug
patch, for example.
[1193] The block diagram of FIG. 65 illustrates an example of
system 6500 including a fully or partially implantable device 6501
that may be used to monitor patient conditions and to coordinate
sleep disordered breathing therapy in accordance with embodiments
of the invention. The medical device 6501 may be coupled to an
array of data acquisition devices, including patient-internal
sensors 6511, patient-external sensors 6512, patient input devices
6513, and/or other information systems 6514 as described in more
detail above. Patient conditions monitored by the implantable
device 6501 may include both physiological and non-physiological
contextual conditions affecting the patient such as those listed in
Table 1.
[1194] The implantable device 6501 of FIG. 65 includes a
coordination processor 6537 for processing signals received from
the sensors, 6511, 6512, patient input devices 6513, and/or other
information system 6514. The coordination processor 6537 may
include one or more a detection units 6524, 6526, 6528 that detect
the occurrence of various physiological events. For example, the
coordination processor 6537 may include one or more of a disordered
breathing detector 6524, a sleep detector 6528, and/or a therapy
usage detector 6526. Other event detection components may also be
included. The coordination processor 6537 may be used to calculate
various indices, e.g., AHI, % PB, and/or arousals per unit time,
used for evaluating therapy efficacy, and/or therapy impact. The
coordination processor 6537 may compare the patient's therapy usage
to a prescribed therapy to determine therapy compliance. The
coordination processor 6537 can develop control signals for
implementing a coordinated therapy based on the monitored
conditions, the detected events, and/or the calculated indices.
[1195] In one exemplary implementation, the disordered breathing
detector 6524 may be coupled to a respiration sensor. The
disordered breathing detector 6524 may use the respiration signal
developed by the respiration sensor to detect disordered breathing
events based on the inspiratory and expiratory phases of the
patient's respiration cycles, for example. The sleep detector 6528
may analyze various inputs from the patient-internal sensors 6511,
patient-external sensors 6512, patient input devices 6513, other
information systems 6514 to detect sleep-related events, including,
for example, sleep onset, sleep offset, sleep stages, and arousals
from sleep.
[1196] The coordination processor 6537 may include a memory 6536
for storing information derived from signals produced by the
patient-internal sensors 6511, patient-external sensors 6512,
patient input devices 6513, and/or other information systems 6514.
The memory 6536 may also store information about detected events,
e.g., sleep and disordered breathing events, and/or information
related to calculated indices characterizing various events such as
sleep and/or disordered breathing events. The stored data may be
used by coordination processor 6537 to develop a coordinated
disordered breathing therapy. The stored data may be retrieved by
another component of the medical device 6501 for later use, or may
be transmitted to a separate device 6540 for storage, further
processing, trending, analysis and/or display, for example. In one
scenario, the stored data can be downloaded to a separate device
periodically or on command. The stored data may be presented to the
patient's health care professional on a real-time basis, or as a
long-term, e.g., month long or year long, trend of daily
measurements.
[1197] In the particular embodiment illustrated in FIG. 65, the
medical device 6501 includes a cardiac therapy unit 6575. This
example, the medical device 6501 comprises a cardiac therapy device
6575 configured as a cardiac pulse generator to deliver cardiac
electrical stimulation therapy via electrical stimulation
electrodes 6552.
[1198] The medical device 6501 may further include a communications
unit 6506 that controls communications between the medical device
6501 and other devices or systems. For example, the communications
unit 6506 may be used to provide wireless or wired communications
links between the medical device 6501 and one or more of the
patient-internal sensors 6511, patient-external sensors 6512,
patient input devices 6513, and information systems 6514.
[1199] The communications unit 6506 may also facilitate
communications between the medical device 6501 and a remote device
6540 such as another sleep disordered breathing therapy device, a
programmer, and/or an APM system. The wireless connections coupling
the medical device 6501 to various other devices and systems may
utilize a variety of wireless protocols, including, for example,
Bluetooth, IEEE 802.11, and/or a proprietary wireless protocol.
[1200] Detecting the onset, termination, duration, stages, and
quality of sleep experienced by a patient may be employed in
connection with constructing a coordinated disordered breathing
therapy. Patients suffering from sleep apnea, or other types of
sleep disordered breathing, may be treated for sleep disordered
breathing only during periods of sleep. Coordinating disordered
breathing therapy may involve determining if the patient is asleep
and/or detecting various sleep-related processes, such as arousals
from sleep and/or REM or non-REM sleep stages.
[1201] In addition, information associated with patient sleep may
be used to assess an impact of breathing therapy on the patient.
Therapy impact data may be used to develop information to
coordinate and adjust the therapy. The implantable monitoring
device 6501 may include a sleep detector 6528 for detecting when
the patient is asleep and various stages and/or processes of sleep.
Various methods of sleep detection implementable in an implanted
device involve sensing one or more conditions indicative of sleep.
The sleep-related conditions may be compared to one or more
thresholds to determine if the patient is asleep.
[1202] The sleep-related conditions may be sensed or derived using
patient-external or implantable sensors and analyzed by a sleep
detector coupled to or incorporated in the implantable therapy
coordination device. For example, sleep detection may be
implemented in an implantable cardiac rhythm management system
configured as a pacemaker/defibrillator and incorporating a
coordination processor or an ITCS device.
[1203] As illustrated in the flowchart of FIG. 66A, embodiments of
the invention are directed to an automated method for controlling
disordered breathing therapy delivered to a patient. The method
involves controlling 6610 delivery of an external respiratory
therapy and controlling delivery 6620 of a cardiac therapy. The
external respiratory therapy and the cardiac therapy are
coordinated 6630 to treat disordered breathing.
[1204] In various implementations, one or more conditions affecting
the patient and associated with disordered breathing and/or
disordered breathing therapy may be sensed. The sensed conditions
may be used, for example, to detect and/or predict disordered
breathing episodes, determine a severity of disordered breathing,
detect sleep, assess sleep quality, evaluate an efficacy of the
therapy, evaluate an impact of the therapy on the patient,
determine therapy interactions, determine patient usage of the
therapies, among other factors. Coordination of the therapies may
be performed based on the sensed conditions. The therapies may be
adjusted to enhance therapy effectiveness, to reduce an impact of
the therapy, to avoid or reduce therapy interactions, and/or to
accomplish other therapeutic goals.
[1205] According to embodiments presented herein, a coordinating
processor unit is used to generate control signals used for
controlling disordered breathing therapies delivered to the
patient. In one embodiment, the coordinating unit may transmit
control signals directly to an external respiratory therapy device
and a cardiac therapy device. The control signals may be used by
the respective therapy devices to automatically adjust the therapy
delivered to the patient. In another embodiment, both the
coordinating unit and the therapy devices may be communicatively
coupled to a separate medical device, such as a device programmer
or patient management system. The coordinating unit may transmit
control information indirectly to the therapy devices through a
device programmer or patient management system.
[1206] In one embodiment of the invention, a sensor system may
sense one or more conditions related to disordered breathing.
Disordered breathing events may be detected based on the sensed
conditions. Characteristics of the disordered breathing events such
as severity, frequency, and/or duration, may be determined.
Determination of the one or more characteristics of the sleep
disordered breathing events may involve calculation of one or more
indices characterizing the disordered breathing events. The indices
may include, for example, an apnea/hypopnea index (AHI) and/or a
percent time in periodic breathing (% PB), among other indices. The
external respiratory therapy and the cardiac therapy maybe
coordinated based on the characteristics of the disordered
breathing events.
[1207] In accordance with an embodiment of the invention,
illustrated in the flowchart of FIG. 66B, coordination of
disordered breathing therapies, including an external respiratory
therapy and a cardiac electrical stimulation therapy, may be
implemented using circuitry disposed within the housing of an
implantable cardiac rhythm management (CRM) device. The therapies
delivered to the patient may be coordinated based on a variety of
factors, including therapy effectiveness and/or impact of the
therapy on the patient. In this embodiment, the external
respiratory therapy is delivered by a continuous positive airway
pressure (CPAP) device. The cardiac therapy comprises cardiac
electrical stimulation therapy for treating disordered breathing
delivered by the CRM device.
[1208] One or more sensors may be employed to sense conditions
related to disordered breathing and/or disordered breathing
therapy, including, for example, the effectiveness of the breathing
therapy and/or the impact of the therapy on the patient. The
sensors may be coupled to the CPAP device, the CRM device, or a
first set of sensors may be coupled to the CPAP device and a second
set coupled to the CRM device. The coordinating unit within the CRM
device receives the signals from the sensors, determines therapy
effectiveness and/or impact, and coordinates therapy delivered by
the CPAP and CRM devices.
[1209] In one example, a condition modulated by patient respiration
may be sensed 6674 and a respiration waveform signal generated.
Circuitry disposed within the housing of the CRM device may detect
6676 disordered breathing episodes based on the respiration signal.
The coordination unit may determine therapy effectiveness based on
the severity, frequency and/or duration of sleep disordered
breathing episodes experienced by the patient. In one
implementation, coordination circuitry disposed within the CRM
device may calculate 6678 an apnea/hypopnea index (AHI) indicative
of the frequency of disordered breathing episodes. The
effectiveness of the sleep disordered breathing therapy may be
determined 6680 based on the sleep disordered breathing index. If
the AHI is relatively low, the breathing therapy may be determined
to be effective. If the AHI is relatively high, then the breathing
therapy may be determined to be ineffective.
[1210] A CPAP device typically includes a respiratory mask, e.g., a
nasal of facial mask, worn by the patient to facilitate delivery or
air or other gas to the patient's airway. The respiratory mask may
be inconvenient and/or uncomfortable for the patient to wear and
may keep the patient awake. Further, delivery of positive airway
pressure may inhibit sleep, or cause the patient to arouse
frequently. Information about these side effects of the breathing
therapy may be helpful in coordinating a therapy regimen for the
patient.
[1211] Impact of the external breathing therapy and/or cardiac
electrical stimulation therapy may be determined based on the
patient's sleep quality. Sensors coupled to the coordination
processor within the CRM device are configured to sense 6682 one or
more conditions related to sleep. The sleep related conditions are
used to detect 6684 sleep and/or arousals from sleep. The
coordination processor within the CRM device determines 6686 the
impact of the therapies on the patient by monitoring the patient's
sleep. For example, the coordination processing may monitor the
total time the patient spends sleeping, the number of arousals
experienced by the patient in one night, the number of arousals
correlated to sleep disordered breathing events, the number of
arousals correlated to therapy delivery, and/or the depth of the
arousals. In various implementations the coordination processor may
calculate various indices characterizing sleep and/or one or more
composite indices based on indices related to sleep and indices
related to sleep disordered breathing. In one example, the
monitoring unit calculates the number of arousals experienced by
the patient per hour (A/h).
[1212] Therapy coordination may be accomplished 6688 based on the
therapy effectiveness and impact information. Control signals may
be transmitted from the coordinating processor unit to the therapy
units of the CRM and CPAP devices. One or both of the therapies
delivered by the CRM and CPAP devices may be adjusted to enhance
therapy effectiveness and/or reduce side effects.
[1213] In various examples, coordinated disordered breathing
therapy may involve adjusting the cardiac electrical stimulation
therapy for disordered breathing, adjusting the neurostimulation
therapy for disordered breathing and/or adjusting the external
respiration therapy for disordered breathing. According to this
scenario, a disordered breathing therapy coordination processor may
distribute the burden of disordered breathing therapy between one
or more therapy devices.
[1214] In one implementation, certain types of therapy may be used
for predetermined periods of time. For example, a predetermined
level of cardiac and/or nerve stimulation therapy may be used prior
to the patient falling asleep. The therapy burden may be shifted to
the external respiratory therapy device after sleep has been
detected. In one implementation, the therapy burden may be
distributed based on detected arousals. For example, if the
delivery of one type of therapy causes the patient to arouse from
sleep, the therapy burden may be shifted to other types of therapy
to enhance the patient's sleep quality. Alternatively, rather than
shifting to other types of therapy, therapy parameters of a
particular therapy may be adjusted to provide more restful sleep.
For example, an external respiratory therapy pressure may be
adjusted downward to provide a disordered breathing therapy that is
more comfortable to the patient and allows the patient to sleep
better. In one implementation, the respiratory therapy pressure may
be adjusted downward and the pacing rate may be adjusted upward to
maintain effectiveness of the therapy while reducing an impact on
the patient.
[1215] In another implementation, the therapy burden may be
distributed based on therapy efficacy. In one scenario, the therapy
controller may add therapies to the overall disordered breathing
therapy regimen to improve therapy efficacy. For example, if the
therapy coordination processor determines that disordered breathing
is occurring despite the use of one type of therapy, additional one
or more types of therapy may be added to the regimen in order to
treat disordered breathing.
[1216] In one scenario, the disordered breathing therapy burden may
be distributed based on device usage. For example, if the patient
does not use the external respiratory therapy device, then the
disordered breathing therapy coordination processor may signal a
CRM device and/or an external respiratory therapy device to
initiate or increase the level of therapy delivered by the CRM
device, the external respiratory therapy device, and/or other
therapy devices.
[1217] In one embodiment, the coordination processor may coordinate
the disordered breathing therapy to enhance therapy efficacy while
adjusting or avoiding a therapy impact. The coordination processor
may acquire information related to the sensed conditions and may
evaluate therapy efficacy and/or impact on the patient, i.e., side
effects of the therapy, based on the sensed conditions. The
coordination processor may modify the therapy delivered by one or
more therapy devices to enhance therapy efficacy while reducing or
avoiding side effects. The coordination processor may modify the
therapy to reduce interactions between the disordered breathing
therapy and other types of therapies delivered to the patient,
e.g., neurostimulation for anti-hypertensive therapy and/or cardiac
pacing for cardiac rhythm management. The coordination processor
may modify the therapy to reduce interactions between different
types of disordered breathing therapies, for example. The therapy
controller may modify a therapy to increase the useable lifetime of
an implantable device.
[1218] Pulmonary Disease Assessment with Drug Therapy Control
[1219] Aspects of the invention that include controlling a drug
therapy for treating a non-rhythm pulmonary disease are directed to
methods and systems configured to monitor, diagnose, and/or provide
patient therapy using one or more individual medical procedures.
Each of the circles 180 illustrated in FIGS. 1B-1D represents an
individual medical procedure providing a specific monitoring,
diagnosis or therapeutic function or set of functions. Each
individual medical procedure may be implemented as a stand-alone
system. Two or more of the individual medical procedures 180 may be
used in combination to provide more comprehensive patient
monitoring, diagnosis and/or therapy. One or more functions of two
or more individual medical procedures 180 may be used in
combination to enhance patient monitoring, diagnosis and/or
therapy.
[1220] Other aspects of the invention involving pulmonary disease
assessment and drug therapy are directed to methods and systems
configured to monitor, diagnose, and/or provide therapy using
coordinated medical procedures. Coordinated medical procedures may
involve cooperative operation of two or more of the individual
processes 180. Coordinated medical procedures may also involve
cooperative operation of one or more functions of two or more of
the individual processes 180.
[1221] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1222] Embodiments of the invention involve an individual system
134 (FIG. 1B) for controlling drug therapy to treat non-rhythm
pulmonary disease. The drug therapy control system 134 may be
implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[1223] Embodiments of the invention involve assessing a presence of
a pulmonary disease or disorder that is not a breathing rhythm
disorder and controlling the deliver of a drug therapy to treat the
pulmonary disease. According to one embodiment, a method for
controlling therapy for a non-rhythm related pulmonary disease
includes sensing one or more conditions associated with the
non-rhythm pulmonary disease using sensors of a patient-external
respiratory therapy device. A presence of the non-rhythm pulmonary
disease is assessed based on the one or more sensed conditions. A
control signal for controlling a drug therapy to treat the
non-rhythm pulmonary disease is generated based on the assessment
of the non-rhythm pulmonary disease.
[1224] According to one aspect, sensing the one or more conditions
associated with the non-rhythm pulmonary disease involves
performing a pulmonary function test using the sensors of the
respiratory therapy device. One or more pulmonary function
conditions are determined based on the pulmonary function test.
[1225] According to another aspect, the method includes comprising
delivering the drug therapy using the generated control signal. In
one embodiment, the drug therapy may be delivered using the
respiratory therapy device. In other embodiments, the drug therapy
may be delivered using a therapy device other than the respiratory
therapy device.
[1226] One or more additional conditions associated with the
non-rhythm pulmonary disease may be sensed using an implantable
device. The disease assessment may be based in part on the one or
more additional conditions.
[1227] Another embodiment of the invention involves a medical
system for controlling therapy to treat a non-breathing rhythm
related pulmonary disease. The system includes an external
respiratory therapy device. The external respiratory therapy device
includes a therapy unit configured to deliver respiration therapy
to a patient and a sensor system configured to sense one or more
conditions associated with a non-rhythm pulmonary disease. A
diagnosis unit is coupled to the sensor system and is configured to
assess a presence of the non-rhythm pulmonary disease based on the
one or more sensed conditions. A drug therapy controller is coupled
to the diagnosis unit. The drug therapy controller is configured to
control a drug therapy delivered to the patient to treat the
non-rhythm pulmonary disease.
[1228] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes a system 134 for controlling a drug therapy to treat
non-rhythm pulmonary disease. The coordinated system includes, for
example, an implantable cardiac device 181 and a patient-external
respiratory therapy device 184. The system may further include an
external processor 183 providing a coordination function. A
communication channel couples the implantable device 181 and the
respiratory therapy device 184. The implantable 181 and respiratory
therapy devices 184 operate cooperatively via the communication
channel to provide one or more of patient monitoring, diagnosis,
and therapy.
[1229] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
system 134 configured to control drug therapy to treat non-rhythm
pulmonary disease. The drug therapy control system 134 includes an
external respiratory therapy device with a therapy unit configured
to deliver respiration therapy to a patient and a sensor system
configured to sense one or more conditions associated with a
non-rhythm pulmonary disease. The system further includes a
diagnosis unit coupled to the sensor system configured to assess a
presence of the non-rhythm pulmonary disease based on one or more
sensed conditions. A drug therapy controller is coupled to the
diagnosis unit and is configured to control a drug therapy
delivered to the patient to treat the non-rhythm pulmonary
disease.
[1230] The implantable and respiratory therapy devices 181, 184 may
operate cooperatively based on system 134 control of drug therapy
delivered to a patient. For example, control of drug therapy to
treat non-rhythm pulmonary disease may allow the implantable and
respiratory therapy devices 181, 184 to operate cooperatively to
provide therapies for treating conditions associated with
non-rhythm pulmonary disease. Systems and methods directed to
assessing pulmonary disease with drug therapy control may be
implemented to include selected features, functions, and/or
structures described in commonly owned, co-pending U.S. Publication
No. 20050142070, which is hereby incorporated herein by
reference.
[1231] Pulmonary disorders may be organized into broad categories
encompassing disorders of breathing rhythm and non-rhythm pulmonary
diseases and/or disorders. Breathing rhythm disorders include
various syndromes characterized by patterns of disordered breathing
that produce insufficient respiration, for example, sleep apnea,
hypopnea, and Cheyne-Stokes Respiration (CSR), among others.
Breathing rhythm disorders are not necessarily accompanied by
alteration of pulmonary structures.
[1232] Non-rhythm pulmonary diseases or disorders typically involve
physical changes to lung structures, such as loss of elasticity of
the lung tissue, obstruction of airways with mucus, limitation of
the expansion of the chest wall during inhalation, fibrous tissue
within the lung, excessive pressure in the pulmonary arteries,
and/or other characteristics. Pulmonary diseases or disorders that
are not rhythm-related are referred to herein as non-rhythm
pulmonary diseases and may include various types, for example,
obstructive pulmonary diseases, restrictive pulmonary diseases,
infectious and non-infectious pulmonary diseases, pulmonary
vasculature disorders, and pleural cavity disorders.
[1233] Embodiments of the invention are directed to controlling a
drug therapy to treat a non-rhythm pulmonary disease. A presence of
a non-rhythm pulmonary disease is determined using a sensor system
coupled to a respiratory therapy device. If the non-pulmonary
disease is present based on the assessment, then a drug therapy to
treat the non-pulmonary disease may be delivered. In accordance
with embodiments of the invention, a non-rhythm pulmonary disease
assessment system may be used to discriminate between types of
non-rhythm pulmonary diseases, e.g., between obstructive pulmonary
diseases and restrictive pulmonary diseases. The non-rhythm
pulmonary disease assessment system may discriminate between
non-rhythm pulmonary diseases of a particular type, e.g., between
asthma and emphysema, both of which are pulmonary diseases of the
obstructive type. Discrimination between pulmonary diseases
afflicting the patient facilitates delivery of an effective drug
therapy, allowing the system to deliver an appropriate therapy for
the particular pulmonary disease detected.
[1234] If the presence of a non-rhythm pulmonary disease is
determined, then the progression of the disease may be monitored.
Monitoring the progression of the non-rhythm pulmonary disease may
involve, for example, periodically evaluating one or more
physiological changes or symptoms associated with the disease.
Evaluation of the one or more physiological changes or symptoms may
be accomplished by sensing conditions associated with the symptoms
or physiological changes. In a preferred embodiment, information
about the sensed conditions is stored and may be trended or
otherwise processed to facilitate disease detection.
[1235] Typically, a physiological sensor generates a signal
modulated by a physiological parameter. In some cases, a
physiological condition may be directly measured based on the
sensor signal. For example, a blood pressure measurement may
directly correlate to the signal generated by a calibrated blood
pressure sensor. In other cases, a condition measurement may be
derived from the sensor signal. For example, tidal volume is a
respiratory system condition that may be derived based on the
signal generated by a transthoracic impedance sensor. In another
example, heart rate is a cardiac system condition that may be
derived from a cardiac electrogram sensor.
[1236] Monitoring a disease may involve, for example, monitoring
the severity and/or other characteristics of the disease over time.
Monitoring the disease may involve detecting disease onset,
monitoring progression and/or regression of the disease and
detecting disease offset. Disease monitoring may involve monitoring
one or more conditions associated with the physiological changes
and/or symptoms of the disease.
[1237] In one implementation, the presence of the non-rhythm
pulmonary disease is assessed based on one or more patient
conditions indicative of symptoms or physiological changes
associated with the disease. The one or more conditions are sensed
using the sensing system of a patient-external respiratory therapy
device. In a preferred embodiment, the respiratory therapy device
comprises a positive airway pressure device.
[1238] Continuous positive airway pressure (CPAP) devices are
frequently used to treat sleep apnea and/or other breathing rhythm
disorders. A CPAP device may be used regularly during a patient's
sleep time to alleviate symptoms of breathing rhythm related
disorders. The sensors of the CPAP device, used nightly to treat
disordered breathing disorders, may be employed to detect and/or
assess non-rhythm pulmonary diseases. A drug therapy for the
non-rhythm pulmonary disease may be controlled based on the
assessment of the disease.
[1239] In another implementation, the presence of the non-rhythm
pulmonary disease may be detected and/or assessed based on
conditions sensed using sensors of a patient-external respiratory
therapy device in combination with additional conditions sensed
using sensors of an implantable device. The implantable device may
comprise, for example, an implantable cardiac device, such as a
pacemaker, defibrillator, cardioverter, cardiac monitor, and/or
cardiac resynchronizer.
[1240] FIG. 67 is a block diagram of a medical system 6700 that
includes components useful in implementing detection and/or
assessment of non-rhythm pulmonary diseases and controlling drug
therapy in accordance with embodiments of the invention. One or
more of the components identified in FIG. 67 may be used for
assessing pulmonary diseases and controlling delivery of drug
therapy.
[1241] For example, the medical system 6700 may be implemented to
include one or more of the features and/or processes described
herein. A system for assessing pulmonary diseases and controlling
delivery of drug therapy need not include all of the features and
functions described, but may be implemented to include one or more
selected features and functions that provide unique structures
and/or functionality.
[1242] FIG. 67 illustrates a patient internal device 6710 and a
patient external device 6720. Sensors and/or input devices
6741-6748 coupled to the patient-internal device and the
patient-external device may be used to sense patient conditions
indicative of symptoms of a pulmonary disease. In addition to the
sensing functions performed by the therapy devices 6710, 6720, the
devices 6710, 6720 may respectively include therapy units 6716,
6726 providing therapy for disorders other than the detected
pulmonary disease, e.g., cardiac therapy for cardiac rhythm
disorders and/or CPAP therapy for breathing rhythm disorders.
Either of the patient internal device 6710 and/or the patient
external device 6720 may include a drug therapy control unit 6750
configured to generate control signals deliverable to a drug
therapy device 6727. The drug therapy device provides drug therapy
to treat one or more non-rhythm pulmonary diseases. In some
embodiments, the components used to generate the drug therapy
control signal or signals may be included in both the patient
internal device and the patient external device. The patient
internal device 6710 and/or the patient external device 6720 may
generate control signals that initiate, modify, and/or terminate
drug therapy for the non-rhythm pulmonary disease.
[1243] The patient-internal device 6710 is typically a fully or
partially implantable device that includes circuitry for
implantably performing one or more of monitoring 6712, diagnosis
6714, and/or therapy control/delivery functions 6716, 6750. The
patient-external device 6720 includes circuitry for performing one
or more of monitoring, diagnosis and/or therapy control/delivery
functions patient-externally (i.e., not invasively implanted within
the patient's body). The patient-external medical device 6720 may
be positioned on the patient, near the patient, or in any location
external to the patient. It is understood that a portion of a
patient-external medical device 6720 may be positioned within an
orifice of the body, such as the nasal cavity or mouth, yet can be
considered external to the patient (e.g., mouth pieces/appliances,
tubes/appliances for nostrils, or temperature sensors positioned in
the ear canal).
[1244] Each of the patient-internal 6710 and patient-external 6720
devices may include a patient monitoring unit 6712, 6722. The
patient-internal and patient-external devices 6710, 6720 may be
coupled to one or more sensors 6741, 6742, 6745, 6746, patient
input devices 6743, 6747 and/or other information acquisition
devices 6744, 6748. The sensors 6741, 6742, 6745, 6746, patient
input devices 6744, 6747, and/or other information acquisition
devices 6744, 6748 may be employed to detect conditions relevant to
the monitoring, diagnostic, and/or therapeutic functions of the
patient-internal and patient-external medical devices 6710, 6720.
The sensors 6741, 6742, 6745, 6746, patient input devices 6744,
6747, and/or other information acquisition devices 6744, 6748 may
be used to detect conditions associated with pulmonary disease.
[1245] The medical devices 6710, 6720 may each be coupled to one or
more patient-internal sensors 6741, 6745 that are fully or
partially implantable within the patient. The medical devices 6710,
6720 may also be coupled to patient-external sensors 6742, 6746
positioned on, near, or in a remote location with respect to the
patient. The patient-internal and patient-external sensors are used
to sense conditions, such as physiological or environmental
conditions.
[1246] The patient-internal sensors 6741 may be coupled to the
patient-internal medical device 6710 through internal leads. In one
example, an internal endocardial lead system is used to couple
cardiac electrodes that sense cardiac electrical activity to an
implantable pacemaker or other cardiac rhythm management device. In
some applications, one or more patient-internal sensors 6741 may be
equipped with transceiver circuitry to support wireless
communications between the one or more patient-internal sensors
6741 and the patient-internal medical device 6710. Similarly,
patient internal sensors 6745 may be coupled to a patient-external
device 6720 through wireless communications links.
[1247] The patient-external sensors 6742, 6746 may be coupled to
the patient-internal medical device 6710 and/or the
patient-external medical device 6720 through leads or through
wireless connections. Patient-external sensors 6742 preferably
communicate with the patient-internal medical device 6710
wirelessly. Patient-external sensors 6746 may be coupled to the
patient-external medical device 6720 through leads or through a
wireless link.
[1248] The medical devices 6710, 6720 may be coupled to one or more
patient-input devices 6743, 6747. The patient-input devices are
used to allow the patient to manually transfer information to the
medical devices 6710, 6720. The patient input devices 6743, 6747
may be particularly useful for inputting information concerning
patient perceptions, such as how well the patient feels, and
information such as patient smoking, drug use, or other activities
that are not automatically sensed or detected by the medical
devices 6710, 6720.
[1249] The medical devices 6710, 6720 may be connected to one or
more information systems 6744, 6748, for example, a database that
stores information useful in connection with the monitoring,
diagnostic, or therapy functions of the medical devices 6710, 6720.
For example, one or more of the medical devices 6710, 6720 may be
coupled through a network to a information system server that
provides information about environmental conditions affecting the
patient, e.g., the pollution index for the patient's location.
[1250] The medical devices 6710, 6720 may incorporate therapy units
6716, 6726 for configured to control and deliver therapy to the
patient. The therapy units 6716, 6726 may be implemented to provide
therapy other than a drug therapy delivered to treat the pulmonary
disease. For example, in one embodiment, the patient-internal
device 6710 may comprise a cardiac rhythm management (CRM) system
configured to deliver cardiac pacing therapy to the patient. The
patient-external device 6720 may comprise a positive airway
pressure (xPAP) device configured to deliver a respiratory therapy
to treat a breathing rhythm disorder. One or both of the
patient-internal device 6710 and the patient-external device 6720
may include components that control delivery of a drug therapy to
treat the non-rhythm pulmonary disease.
[1251] The system 6700 further includes a diagnostics unit 6714
that is configured to detect and/or assess a presence of non-rhythm
pulmonary disease. In some embodiments, the diagnostics unit 6714
may be fully incorporated into the patient-external device 6720. In
other embodiments, the diagnostics unit 6714 may be fully
incorporated into the patient-internal device 6710. In yet other
embodiments, components of the diagnostics unit 6714 may be
incorporated into both the patient-internal and patient-external
devices 6710, 6720. In yet further embodiments, the diagnostics
unit may be located remotely from both the patient-internal medical
device 6710 and the patient-external medical device 6720. In one
scenario, the diagnostics processor may be implemented as a
component of an advanced patient management (APM) system 6730, for
example.
[1252] The monitoring units 6712, 6722 of the patient-internal and
patient external medical devices 6710, 6720 collect data based on
conditions sensed or detected through the use of the sensors 6741,
6742, 6745, 6746, patient input devices 6743, 6746, and/or
information systems 6744, 6748 coupled to the patient-internal and
patient-external devices 6710, 6720. The collected data is
transferred to a diagnostics unit 6714.
[1253] The diagnostics unit 6714 is configured to assess the
presence of the non-rhythm pulmonary disease based on the sensed
conditions. The diagnostics processor 6714 may also assess and/or
monitor the progression, of the medical disease or disorder.
Monitoring the progression of the disease may involve, for example,
periodically evaluating one or more conditions indicative of
physiological changes or symptoms of the disease. Monitoring
disease progression may involve, for example, monitoring the
severity of the disease, monitoring disease onset, progression,
regression and offset, and/or monitoring other aspects of the
disease.
[1254] A drug therapy controller 6750 may be configured as a
component of the patient-internal device 6710, the patient external
device 6720, a device remote from the patient-internal and patient
external devices 6710, 6720, or as a stand alone unit. In some
configurations, components of the drug therapy controller may be
housed in both the patient-internal and patient external devices
6710, 6720. Components of the drug therapy controller and the drug
therapy delivery unit may be disposed within a single housing.
[1255] The drug therapy controller 6750 generates a control signal
for controlling drug therapy delivered to the patient based on the
assessment of the non-rhythm pulmonary disease. The drug therapy
controller 6750 may generate a control signal to initiate drug
therapy if disease onset is detected or if one or more symptoms of
the disease are determined to reach a threshold limit, for example.
The control signal may indicate termination of the drug therapy if
one or more symptoms of the disease subside. Further, during the
course of the disease, the control signal may be adjusted based on
the assessment of the presence of the non-rhythm pulmonary disease
as indicated by sensed conditions indicative of disease
symptoms.
[1256] The control signal generated by the drug therapy controller
6750 is received by the drug therapy unit 6727. The drug therapy
unit 6727, which may comprise an implantable or patient-external
device, provides a drug therapy to treat the non-rhythm pulmonary
disease. Therapy delivered by the drug therapy unit 6727 is
controlled by the control signal generated by the drug therapy
controller 6750. In various embodiments, the drug therapy unit may
be implemented as an implantable or patient-external drug pump, a
gas therapy device, nebulizer, and/or an activatable drug
patch.
[1257] In various embodiments, the patient-internal device 6710,
the patient-external device 6720, drug controller 6750, drug
delivery unit 6727, and/or other devices depicted in FIG. 67 may
communicate through wireless links. For example, two or more
devices, such as the patient-internal and patient-external devices
6710, 6720, may be coupled through a short-range radio link, such
as Bluetooth or a proprietary wireless link. The wireless
communications link may facilitate uni-directional or
bi-directional communication between the patient-internal 6710 and
patient-external 6720 medical devices. In one implementation, data
and/or control signals may be transmitted between the
patient-internal 6710 and patient-external 6720 medical devices to
coordinate the functions of the medical devices 6710, 6720.
[1258] In an embodiment of the invention, the patient-internal and
patient-external medical devices 6710, 6720 may be used within the
structure of an advanced patient management system. Advanced
patient management systems involve a system of medical devices that
are accessible through various communications technologies. For
example, patient data may be downloaded from one or more of the
medical devices periodically or on command, and stored at a patient
information server. The physician and/or the patient may
communicate with the medical devices and the patient information
server, for example, to acquire patient data or to initiate,
terminate or modify therapy.
[1259] In the implementation illustrated in FIG. 67, the
patient-internal device 6710 and the patient-external device 6720
may be coupled through a wireless or wired communications link to a
patient information server that is part of an advanced patient
management (APM) system 6730. The APM patient information server
6730 may be used to download and store data collected by the
patient-internal and patient-external devices 6710, 6720.
[1260] The data stored on the APM patient information server 6730
may be accessible by the patient and the patient's physician
through terminals, e.g., remote computers located in the patient's
home or the physician's office. The APM patient information server
6730 may be used to communicate to one or more of the
patient-internal and patient-external medical devices 6710, 6720 to
effect remote control of the monitoring, diagnosis, and/or therapy
functions of the medical devices 6710, 6720.
[1261] In one scenario, the patient's physician may access patient
data transmitted from the medical devices 6710, 6720 to the APM
patient information server 6730. After evaluation of the patient
data, the patient's physician may communicate through one or more
of the patient-internal or patient-external devices 6710, 6720
through the APM system 6730 to initiate, terminate, or modify the
monitoring, diagnostic, and/or therapy functions of the
patient-internal and/or patient-external medical systems 6710,
6720.
[1262] The patient-internal and patient-external medical devices
6710, 6720 may not communicate directly, but may communicate
indirectly through the APM system 6730. In this embodiment, the APM
system 6730 may operate as an intermediary between two or more of
the medical devices 6710, 6720. For example, data and/or control
information may be transferred from one of the medical devices
6710, 6720 to the APM system 6730. The APM system 6730 may transfer
the data and/or control information to another of the medical
devices 6710, 6720.
[1263] FIGS. 68A-68D are block diagrams of systems that may be used
for non-rhythm pulmonary disease assessment with drug therapy
control in accordance with embodiments of the invention. FIG. 68A
illustrates an external respiratory therapy device 6810, e.g., a
CPAP device, used to sense conditions associated with a non-rhythm
pulmonary disease. The sensed conditions are evaluated by the
external respiratory therapy device to assess a presence of the
non-rhythm pulmonary disease.
[1264] The respiratory therapy device 6810 is coupled to one or
more sensors or other input devices 6835 configured to sense or
detect conditions indicative of physiological changes and/or
symptoms associated with the non-rhythm pulmonary disease. A
representative set of symptoms and/or physiological changes
associated with non-rhythm pulmonary diseases may include, for
example, dyspnea (e.g., non-specific dyspnea, orthopnea, exertional
dyspnea, paroxysmal nocturnal dyspnea), abnormal concentrations of
blood or respiratory gases (e.g., cyanosis, hypoxemia, hypercapnea,
low pCO2, arterial acidosis, high alveolar--arterial pO2
differential), respiratory sounds (e.g., wheezing, crackles,
rhonchi, fiction rub, attenuated breath sounds, snoring), pulmonary
function dysfunction (e.g., low forced expiratory volume (FEV),
forced vital capacity (FVC), FEV/FVC, low forced expiratory flow
(FEF), high functional residual capacity (FRC), total lung capacity
(TLC), high residual volume (RV), high lung compliance, slow
exhalation, tachypnea, shallow breathing, high minute ventilation,
respiratory failure, reduced diffusion capacity), other pulmonary
conditions (e.g., hemoptysis, cough, pleuritic chest pain, local
inflammation, excess mucous production, chest pain, respiratory
infection, as indicated by a slightly elevated white blood count,
pulmonary mucus, overinflated lungs, alveolar wall breakdown,
mucosal pulmonary edema, ventilation-perfusion mismatch,
subepithelial fibrosis (chronically), respiratory muscle fatigue,
high small airway resistance, hoarseness), cardiovascular
conditions (e.g., pulmonary hypertension, high pulmonary vascular
resistance, tachycardia, circulatory collapse, pulsus paradoxicus,
syncope, hypertension, S3 heart sounds, RV hypertrophy, systolic
murmur), and general systemic conditions (e.g., fever, weight loss,
weight gain, night sweats, peripheral edema, high hemoglobin,
fatigue, joint pain, hypersomnolence.
[1265] The sensors and/or other input devices 6835 are coupled to
signal processor circuitry 6830 which may be configured to energize
the sensors, to receive and condition signals generated by the
sensors, and/or to facilitate communication between the respiratory
therapy device 6810 and the sensors 6835. The signal processor
circuitry 6830 may comprise, for example, driver circuitry,
filters, sampling circuitry, A/D converter circuitry. The
sensor/input device signals may be averaged, filtered, or otherwise
processed by the signal processor circuitry 6830 prior to use by
other components of the respiratory therapy device 6810.
[1266] The respiratory therapy device 6810, illustrated in FIG. 68A
as a positive airway pressure (xPAP) device includes a therapy
control unit 6820. The therapy control unit 6820 comprises a flow
generator 6821 that pulls in air through a filter. The flow
generator 6821 is controlled by the pressure control circuitry 6822
to deliver an appropriate air pressure to the patient. Air flows
through tubing 6823 coupled to the xPAP device 6810 and is
delivered to the patient's airway through a mask 6824. In one
example, the mask 6824 may be a nasal mask covering only the
patient's nose. In another example, the mask 6824 covers the
patient's nose and mouth. Other air delivery systems are also
possible.
[1267] Continuous positive airway pressure (CPAP) devices deliver a
set air pressure to the patient. The pressure level for the
individual patient may be determined during a titration study, for
example. Such a study may take place in a sleep lab, and involves
determination by a sleep physician or other professional of the
optimum airway pressure for the patient. The CPAP device pressure
control is set to the determined level. When the patient uses the
CPAP device, a substantially constant airway pressure level is
maintained by the device. The constant air pressure acts a
pneumatic splint to keep soft tissue in the patient's throat from
collapsing and obstructing the airway.
[1268] Autotitration PAP devices are similar to CPAP devices,
however, the pressure controller for autotitration devices
automatically determines the air pressure delivered to the patient.
Instead of maintaining a constant pressure, the autotitration PAP
device evaluates sensor signals and the changing needs of the
patient to deliver a variable positive airway pressure.
Autotitration PAP and CPAP are often used to treat sleep disordered
breathing, for example.
[1269] Bi-level positive airway pressure (bi-PAP) devices provide
two levels of positive airway pressure. A higher pressure is
maintained while the patient inhales. The device switches to a
lower pressure during expiration. Bi-PAP devices are used to treat
a variety of respiratory dysfunctions, including chronic
obstructive pulmonary disease (COPD), respiratory insufficiency,
and ALS or Lou Gehrig's disease, among others.
[1270] Some positive airway pressure devices may also be configured
to provide both positive and negative pressure, such that negative
pressure is selectively used (and de-activated) when necessary,
such as when treating Cheyne-Stokes breathing, for example. The
term xPAP will be used herein as a generic term for any such
device, including devices using forms of positive airway pressure
(and negative pressure when necessary), whether continuous or
otherwise.
[1271] In accordance with various embodiments of the invention, the
xPAP device 6810 may include a diagnostic unit 6810. The diagnostic
unit 6810 evaluates patient conditions sensed or input directly by
the sensors/input devices 6835 or derived from the sensor signals
to assess a presence of a non-rhythm pulmonary disease.
[1272] In some embodiments, the therapy control unit 6820 of the
respiratory therapy unit 6810 includes circuitry for drug therapy
control 6823. The drug therapy controller 6823 generates a control
signal to initiate, terminate, or modify drug therapy based on the
assessment of the non-rhythm pulmonary disease. In one embodiment,
the drug therapy comprises a gas that is delivered to the patient
through the xPAP tubing 6823 and mask 6824. A gas therapy delivery
unit is incorporated within the xPAP device 6810. The drug therapy
controller 6823 generates a signal that controls and modulates the
release of a gas by the gas therapy delivery unit 6827.
[1273] The xPAP device 6810 may include a communications unit 6840
for communicating with one or more separate devices 6870, such as a
device programmer, APM system, and/or other patient-external or
patient-internal monitoring, diagnostic and/or therapeutic devices.
Communication between cooperating devices allows the xPAP device
6810 to provide or obtain information to/from the cooperating
devices or to control therapy delivered by the cooperating devices,
for example.
[1274] In one implementation, illustrated in FIG. 68B, one or both
of the diagnostics unit and the drug therapy controller may be
positioned remotely with respect to the patient-external
respiratory therapy device 6810. The xPAP device 6810 may include a
monitoring unit 6850 including a memory for storing data related to
the non-rhythm pulmonary disease or other data. In one scenario,
monitoring unit 6850 may sense the one or more patient conditions
and may store data related to the sensed conditions. The monitoring
unit may collect and store data hourly, nightly, weekly, randomly
or according to a time schedule that corresponds to the patient's
usage times of the respiratory therapy device 6810. Typically an
xPAP device is used nightly for treatment of sleep apnea and/or
other breathing rhythm disorders. The xPAP device 6810 may collect
data from the sensors/input devices 6835 during one or more periods
of time that the device is used. The presence of the non-rhythm
pulmonary disease may be assessed based on the collected data.
Assessment of the non-rhythm pulmonary disease may involve
assessment of the onset, progression, regression and/or offset of
the disease.
[1275] In the implementation illustrated in FIG. 68B, the
respiratory therapy device 6810 may transmit information about
conditions sensed by the respiratory therapy device 6810 to the
diagnosis unit 6860 of a remotely located device 6870. The
diagnosis unit 6860 assesses the non-rhythm pulmonary disease
presence based on the transmitted information. The drug therapy
controller develops a control signal for controlling drug therapy
delivery. The remotely located device 6870 transmits the control
signal to a drug delivery unit. In one embodiment, the drug
delivery unit may be activated to release a gas, e.g., albuterol,
into the airflow of the respiratory therapy device. In other
embodiments, other types of drug delivery methodologies, such as a
drug pump, an electrically activated drug patch, and/or other types
of drug delivery devices may be employed.
[1276] The remote device 6870 may comprise a patient-external or
patient-internal medical device. The remote device 6870 may be
configured, for example, as a cardiac diagnostic and/or therapeutic
device. In one configuration, for example, the remote device 6870
may comprise a cardiac rhythm management system, such as a
pacemaker, defibrillator, or cardiac resynchronizer.
[1277] In some embodiments, as illustrated in FIGS. 68C and 68D, an
external respiratory therapy device may be used in combination with
an implantable device, such as an implantable cardiac rhythm
management device, to detect and/or monitor a presence of a
non-rhythm pulmonary disease. The system illustrated in FIG. 68C
includes an external respiratory therapy device 6810 and a cardiac
device 6892, such as an implantable pacemaker, defibrillator,
cardioverter, cardiac resynchronizer or cardiac monitor. Both the
respiratory therapy device 6810 and the cardiac device 6892 are
equipped with sensors/input devices 6835, 6836 for sensing
conditions associated with symptoms of one or more non-rhythm
pulmonary diseases.
[1278] The respiratory therapy device 6810 may transmit its sensed
condition information to the cardiac device 6892, e.g., over a
wireless communications link. The cardiac device 6892 includes a
diagnostic unit 6860 configured to assess a presence of one or more
non-rhythm pulmonary diseases by evaluating the conditions sensed
by the respiratory device and/or by evaluating additional
conditions sensed by the cardiac device.
[1279] The diagnostic unit 6860 may assess the one or more
non-rhythm pulmonary diseases, for example, by comparing sensed
conditions to corresponding sets of criteria indicative of the
non-rhythm pulmonary diseases. In this system depicted in FIG. 68C,
the cardiac device 6892 includes a drug therapy controller 6893
that develops control signals to control a drug therapy delivered
to the patient. The cardiac device 6892 transmits signals to the
drug delivery device 6895 to initiate, modify or terminate drug
therapy delivered to the patient based on the assessment of the
pulmonary disease.
[1280] In an alternate implementation one or both of the
diagnostics processor 6860 and the drug therapy controller 6893 may
be disposed in the respiratory therapy device housing.
[1281] The block diagram of FIG. 68D illustrates another
arrangement of a pulmonary disease assessment and drug therapy
delivery system. In this example, the system includes a respiratory
therapy device 6810 and a cardiac device 6892. The respiratory
therapy device 6810 and the cardiac device 6892 communicate with a
remote diagnostic unit 6860, such as may be incorporated in an APM
system. The respiratory therapy device 6810 and the cardiac device
6892 are each equipped with sensors/input devices 6835, 6836 for
sensing conditions associated with one or more non-rhythm pulmonary
diseases. The respiratory therapy device 6810 and the cardiac
device 6892 may transmit sensed condition information to the
diagnostic unit 6860 through a wireless or wired communication
links. The pulmonary disease diagnostic unit 6860 is configured to
use the information transmitted by the respiration therapy device
6810 and the cardiac device 6892 to assess the presence of one or
more non-rhythm pulmonary diseases.
[1282] A drug therapy controller 6893 uses the assessment of the
non-rhythm pulmonary disease to develop signals from controlling
the drug therapy delivered to the patient. In one configuration,
the diagnostic unit 6860 and the drug therapy controller 6893 may
be configured as components of an APM system 6830. A control signal
developed by the drug therapy controller may be used to activate,
modify, terminate or otherwise control therapy delivered by a drug
therapy device 6895.
[1283] Assessment of conditions indicative of non-rhythm pulmonary
diseases/disorders may include assessing the patient's pulmonary
function as previously described. The charts provided in FIGS.
62A-62G illustrate conditions and sensors that may be used to
determine physiological changes associated with various non-rhythm
pulmonary diseases and disorders. The charts depicted in FIGS.
62A-62G illustrate relationships between various physiological
changes and/or disease symptoms associated with non-rhythm
pulmonary diseases. FIG. 62A lists representative sets of
non-rhythm pulmonary diseases that may be assessed in accordance
with embodiments of the invention. The representative set of
non-rhythm pulmonary diseases that may be assessed includes, for
example, obstructive pulmonary diseases (e.g., chronic bronchitis,
emphysema, asthma), restrictive pulmonary diseases (e.g.,
sarcoidosis, pulmonary fibrosis, pneumoconiosis), infections
pulmonary diseases (e.g., bronchitis, pneumonia, bronchiolitis,
tuberculosis, and bronchiectasis), pulmonary vasculature diseases
(e.g., pulmonary hypertension, pulmonary edema, pulmonary embolism,
atalectasis), and diseases of the pleural cavity (e.g., pleural
effusion, pneumothorax, and hemothorax).
[1284] The non-rhythm pulmonary diseases listed in FIG. 62A are
cross-referenced with the physiological changes and/or symptoms
associated with the non-rhythm pulmonary disease. The physiological
changes and/or symptoms are cross referenced with conditions
indicative of the physiological changes and/or symptoms. Sensors
used to sense the conditions indicative of the physiological
changes or symptoms are provided in FIG. 62A. Sensors of the
respiratory therapy device may include, for example, ventilation
gas, ventilation flow and/or ventilation pressure sensors, or other
sensors for example.
[1285] FIG. 69 is a flowchart illustrating various optional methods
for controlling drug therapy in accordance with embodiments of the
invention. In some embodiments, the system generates a control
system for controlling the drug therapy. In other embodiments, the
system includes a drug delivery unit that is controlled by the
control signal.
[1286] One method involves using 6902 an external respiratory
therapy device to sense conditions associated with the non-rhythm
related pulmonary disease. A presence of the non-rhythm pulmonary
disease is assessed 6904 based on the sensed conditions. A control
signal for controlling drug therapy used to treat the detected
pulmonary disease is generated 6905.
[1287] Optionally, the external respiratory therapy device may
sense 6902 one set of conditions and an implantable device may be
used to sense 6903 another set of conditions. The disease presence
may be assessed based on the conditions sensed by the external
respiratory therapy device and the conditions sensed by the
implantable device. In one implementation, the external respiratory
therapy device and the implantable device may be used cooperatively
to sense conditions affecting the patient and to detect and/or
assess a disease presence.
[1288] In some embodiments the system includes a drug delivery
device. The drug delivery device delivers a drug therapy that is
controlled by the control signal. The drug delivery device may be a
component of the external respiratory therapy device, the implanted
device, or a device separate from the external respiratory therapy
device and the implanted device. The drug delivery device may
comprise a drug pump, an activatable drug patch, and/or a gas
therapy delivery device, for example.
[1289] In one scenario, the respiratory device is a CPAP device
that has drug delivery functionality. Upon detection and/or
assessment of a non-rhythm pulmonary disease, such as asthma, the
CPAP device can activate a drug delivery unit to deliver a mist,
e.g., an albuterol mist, into the air stream supplied by the CPAP
device.
[1290] In another scenario, drug therapy may be accomplished using
an implantable drug delivery device such as an implantable drug
pump. In one implementation, the implantable drug delivery device
is configured as a component of an implantable cardiac rhythm
management (CRM) system. In another implementation, the implantable
drug delivery device is separate from the CRM or other implantable
device used for sensing.
[1291] Assessing the presence of pulmonary disease may be enhanced
by the performance of pulmonary function tests. Pulmonary function
testing evaluates lung mechanics, gas exchange, pulmonary blood
flow, and blood gases and pH. These tests may be used to evaluate
patients in the diagnosis of pulmonary disease and assessment of
disease development. According to various aspects of the invention,
pulmonary function testing may be implemented using the sensors of
the respiratory therapy device, and/or using the sensors of the
implantable device.
[1292] Various parameters related to pulmonary performance, some of
which may be measured using sensors of a respiratory therapy device
and/or sensors of an implantable device include, for example, tidal
volume, minute ventilation, inspiratory reserve volume, forced
expiratory volume, residual volume, and forced vital capacity,
among other parameters. According to one embodiment, testing of
some pulmonary function parameters may be performed using the
ventilation pressure and ventilation flow sensors of a CPAP device
or other patient-external respiratory therapy device. The pulmonary
function testing may be used, for example, to assess a presence of
restrictive and/or obstructive pulmonary disorders.
[1293] Pulmonary performance may be evaluated based on data
acquired by the respiratory therapy device during normal and forced
inspiration and expiration. From such data, pulmonary parameters
including tidal volume, minute ventilation, forced expiratory
volume, forced vital capacity, among other parameters may be
determined.
[1294] Because the results of pulmonary function tests vary with
size and age, the normal values are calculated using prediction
equations or nomograms, which give the normal value for a specific
age, height, and sex. The prediction equations are derived using
linear regression on the data from a population of normal subjects.
The observed values are usually reported as a percentage of the
predicted value. Abnormal test results may show either an
obstructive or restrictive pattern. Sometimes, both patterns are
present.
[1295] FIG. 70 is a flowchart illustrating a method in accordance
with embodiments of the invention. Criteria sets for assessment of
the non-rhythm pulmonary diseases are established 7010. A
respiratory therapy device such as a CPAP device is used to sense
conditions modulated by disease symptoms. The sensor information
may be collected 7012 periodically, e.g., nightly, and stored for
evaluation. If a presence of the disease was not previously
determined 7015, then the levels of the sensed conditions are
compared 7020 to a set of criteria associated with the disease. If
levels of the conditions are consistent 7025 with the threshold
criteria levels, then a presence of the disease is determined 7030.
Drug therapy is initiated 7035 to treat the respiratory
disease.
[1296] If levels of the conditions are not consistent 7025 with the
threshold criteria levels, then the system continues to sense
conditions modulated by disease symptoms and collect 7012 and store
data based on the sensed conditions.
[1297] If the presence of the disease was previously determined
7015, then the progression of the disease may be monitored 7040
based on the conditions and/or criteria used to determine a
presence of the disease, or using other conditions and/or criteria.
If the disease presence is still detected 7045 based on the
conditions and criteria used for monitoring, then therapy is
maintained or modified 7050 based on the disease progression.
Disease progression may be determined, for example, by trending one
or more conditions used for monitoring the disease presence over a
period of time. Modifications to the drug therapy may be made based
on the condition trends. If the disease presence is no longer
detected 7045, then the drug therapy may be terminated.
[1298] Therapy Control Based on Cardiopulmonary Status
[1299] Aspects of the invention that include therapy control based
on cardiopulmonary status are directed to methods and systems
configured to monitor, diagnose, and/or provide patient therapy
using one or more individual medical procedures. Each of the
circles 180 illustrated in FIGS. 1B-1D represents an individual
medical procedure providing a specific monitoring, diagnosis or
therapeutic function or set of functions. Each individual medical
procedure may be implemented as a stand-alone system. Two or more
of the individual medical procedures 180 may be used in combination
to provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[1300] Other aspects of the invention involving therapy control
based on cardiopulmonary status are directed to methods and systems
configured to monitor, diagnose, and/or provide therapy using
coordinated medical procedures. Coordinated medical procedures may
involve cooperative operation of two or more of the individual
processes 180. Coordinated medical procedures may also involve
cooperative operation of one or more functions of two or more of
the individual processes 180.
[1301] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1302] Embodiments of the invention involve an individual system
137 (FIG. 1B) for controlling patient therapy based on
cardiopulmonary status. The patient therapy control system 137 may
be implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[1303] Various embodiments of present invention involve methods and
systems for controlling therapy based on the cardiopulmonary status
of the patient. One embodiment of the invention involves a method
for controlling a therapy delivered to a patient based on
cardiopulmonary status. One or more physiological conditions are
sensed using an external respiratory therapy device. The patient's
cardiopulmonary status is assessed based on the sensed
physiological conditions. Therapy delivered to the patient is
controlled based on the patient's cardiopulmonary status. At least
one of assessing the patient's cardiopulmonary status and
controlling the therapy is performed at least in part
implantably.
[1304] According to various aspects of the invention, the
physiological conditions are sensed using the sensors of a
disordered breathing therapy device. The sensed physiological
conditions may include, for example, sensing respiratory pressure,
flow, and/or exhaled gas concentration.
[1305] In accordance with another aspect of the invention, the
sensor system of an additional medical device, different from the
respiratory therapy device may be used to sense additional
physiological conditions used to assess cardiopulmonary status. In
one implementation, the additional medical device comprises an
implantable cardiac therapy device.
[1306] In accordance with another embodiment of the invention, a
medical therapy control system controls therapy based on a
patient's cardiopulmonary status. The control system includes an
external respiratory device including a sensor system configured to
sense one or more physiological conditions. A cardiopulmonary
status processor is coupled to the sensor system. The
cardiopulmonary status processor is configured to determine a
cardiopulmonary status of a patient based on the sensed
physiological conditions. A therapy controller is configured to
control a therapy delivered to the patient based on the patient's
cardiopulmonary status. At least one of the cardiopulmonary status
processor and the therapy controller include an implantable
component.
[1307] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes therapy control system 137. The coordinated system
includes, for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[1308] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy includes a
system 137 configured control patient therapy based on
cardiopulmonary status The therapy control system 137 includes an
external respiratory device having a sensor system configured to
sense one or more physiological conditions. A cardiopulmonary
status processor is coupled to the sensor system and is configured
to determine a patient's cardiopulmonary status using sensed
physiological conditions. The system further includes a therapy
controller coupled to the cardiopulmonary status processor that is
configured to control patient therapy using the patient's
cardiopulmonary status. At least one of the cardiopulmonary status
processor and the therapy controller are at least in part
implantable
[1309] The implantable and respiratory therapy devices 181, 184 may
operate cooperatively based therapies delivered according to a
patient's cardiopulmonary status. For example, control of patient
therapy based on cardiopulmonary status may allow the implantable
and respiratory therapy devices 181, 184 to operate cooperatively
to provide external and implantable sensing capabilities and
external and implantable therapy controlling capabilities. Systems
and methods directed to therapy control based on cardiopulmonary
status may be implemented to include selected features, functions,
and/or structures described in commonly owned, co-pending U.S. Pat.
No. 7,662,101, which is hereby incorporated herein by
reference.
[1310] FIGS. 71A and 71B are block diagrams of medical systems that
may be used to implement therapy control based on cardiopulmonary
status assessment in accordance with embodiments of the invention.
In these embodiments, the system utilizes a sensor system 7110 of a
respiratory therapy device 7120 to sense one or more physiological
conditions. For example, the sensor system 7110 may sense
conditions associated with patient respiration, including breathing
cycles, respiratory pressure, concentration of respiratory gases,
respiratory airflow, and/or other physiological conditions. The
respiratory therapy device 7110 includes a respiratory therapy
delivery system 7115, such as a positive airway pressure delivery
system in the case of a CPAP device, for example.
[1311] The system includes a cardiopulmonary status processor 7130
coupled to the respiratory therapy sensor system 7110. The
cardiopulmonary status processor assesses the patient's
cardiopulmonary status. Assessment of cardiopulmonary status may
include evaluating the patient's pulmonary function as previously
described. In some implementations, the cardiopulmonary status
processor may work in cooperation with the respiratory therapy
device, and/or other therapy or diagnostic devices to perform the
pulmonary function testing required or desired. Cardiopulmonary
status evaluation may comprise determining and/or assessing a
presence of cardiac and/or pulmonary disease.
[1312] As illustrated in FIG. 71A, the system include a therapy
controller 7140, that develops control signals that may be used to
control one or more therapy devices 7160.
[1313] FIG. 71B illustrates another embodiment of the invention.
The embodiment illustrated in FIG. 71B includes a cardiac therapy
device 7150 including a cardiac therapy sensor system 7154 that is
used in combination with the respiratory therapy sensor system 7110
to assess the patient's cardiopulmonary status. Signals from the
cardiac therapy sensor system 7154 and the respiratory therapy
system 7115 are utilized by the cardiopulmonary status processor
7130 to determine the cardiopulmonary status of the patient.
Assessment of the patient's cardiopulmonary status may involve
sensing a presence of a cardiac and/or pulmonary disease. The
sensor systems 7110, 7154, of one or both of the respiratory
therapy device 7120, the cardiac therapy device 7154, and/or other
sensor systems (not shown), may be used for cardiopulmonary status
assessment.
[1314] The sensor systems 7110, 7154, may be used in connection
with performing pulmonary function testing as described above.
Cardiopulmonary status assessment may comprise determining and/or
assessing a presence of cardiac and/or pulmonary disease. According
to one aspect of the invention, the cardiopulmonary status
processor may assess a presence of a cardiac disease/disorder. The
cardiac disease/disorder assessment may involve, for example,
cardiac rhythm related disorders, arterial diseases, heart failure,
and/or hypertension.
[1315] The cardiopulmonary status processor may be used to detect a
presence of one or more rhythm-related and/or non-rhythm related
pulmonary diseases/disorders. Rhythm-related breathing disorders
involve disruption of the normal respiratory cycle. Although
disordered breathing often occurs during sleep, the condition may
also occur while the patient is awake. Disordered breathing may be
detected by sensing and analyzing various conditions associated
with disordered breathing. Table 1 above provides examples of how a
representative subset of physiological and non-physiological,
contextual conditions may be used in connection with disordered
breathing detection.
[1316] Detection of apnea and severe apnea may utilize information
related to the patient's sleep state. Because disordered breathing
occurs more frequently during sleep, assessment of rhythm-related
breathing disorders may involve determination of whether the
patient is asleep. Other types of cardiopulmonary disorders may be
modified by the patient's sleep state. The cardiopulmonary status
processor may use sleep state information in connection with the
assessment of the patient's cardiopulmonary status.
[1317] The cardiopulmonary status processor 7130 develops signals
related to the patient's cardiopulmonary status. These signals are
transmitted to a therapy controller 7140 that utilizes signals to
control therapy delivered to the patient. The controlled therapy
may comprise a respiratory therapy delivered to the patient by a
respiratory therapy delivery system 7115, a cardiac therapy
delivered to the patient by a cardiac therapy delivery system 7152,
or a therapy delivered by another therapy system 7160, e.g.,
internal or external nerve or muscle stimulator and/or internal or
external drug pump.
[1318] FIG. 72 illustrates a block diagram of a therapy system
including a respiratory therapy device 7210, e.g., CPAP device or
other respiratory therapy device, which may be used to provide
external respiratory therapy for disordered breathing. The
respiratory therapy device 7210 includes one or more sensors 7235,
e.g., flow, pressure and/or exhaled gas concentration sensors used
to sense respiratory conditions and/or other conditions useful in
the assessment of the patient's cardiopulmonary status. Signals
generated by the sensors 7235 are processed by signal processing
circuitry 7230 within the respiratory therapy device 7210.
[1319] The respiratory therapy device 7210 may include a device
that provides positive and negative airflow pressure to the
patient. The breathing therapy delivery unit 7220 includes a flow
generator 7221 that pulls in air through a filter. The flow
generator 7221 is controlled by the pressure control circuitry 7222
to deliver an appropriate air pressure to the patient. Air flows
through tubing 7223 and is delivered to the patient's airway
through a mask 7224. In one example, the mask 7224 may be a nasal
mask covering only the patient's nose. In another example, the mask
7224 covers the patient's nose and mouth.
[1320] The respiratory therapy device 7210 may include a
communications unit 7240 for communicating with a compatible
communications unit 7241 of one or more separate devices, such as
an implantable device 7270. In one example, the respiratory therapy
device 7210 sends information about sensed respiratory flow,
pressure, and expired gas to the implantable device. The
respiratory therapy device receives therapy control information
controlling the therapy delivered by the respiratory therapy device
7210 from the implantable device 7270.
[1321] The implantable device 7270, which may comprise an
implantable cardiac device, includes a cardiopulmonary status
processor 7250 used to assess the cardiopulmonary status of the
patient. The cardiopulmonary status processor 7250 uses the sensor
information transferred to the implantable device 7270 from the
respiratory therapy device 7210 to determine the status of the
patient's cardiopulmonary system. Information from the respiratory
therapy device sensors 7235 may be transferred from the respiratory
therapy device 7210 to the implantable device 7270 through
communications units 7240, 7241 of the respective devices 7210,
7270. In some embodiments, the cardiopulmonary assessment processor
7250 may use information acquired by the respiratory therapy device
sensors 7235 in addition to other information received from other
devices and/or sensors in performing the cardiopulmonary status
assessment.
[1322] The implantable device 7270 may additionally or
alternatively include a therapy controller 7260 that develops
therapy control signals based on the patient's assessed
cardiopulmonary status. Therapy control signals developed by the
therapy controller 7260 may be transmitted to the respiratory
therapy device 7210 through the communications units 7241, 7240.
The therapy control signals are used to control the therapy
delivered by the respiratory therapy device. For example, if the
cardiopulmonary assessment processor 7250 detects a presence of a
cardiopulmonary disease, the delivery of respiratory therapy to the
patient may be controlled to treat the detected cardiopulmonary
disease presence. In other examples, delivery of the respiratory
therapy may be controlled to improve patient comfort based on the
assessed cardiopulmonary status, or to meet other therapeutic
goals.
[1323] The therapy controller 7260 may control the respiratory
therapy by initiating, terminating or modifying the respiratory
therapy. Controlling the respiratory therapy may involve
initiating, terminating or modifying one or more therapy
parameters. For example, the therapy controller 7260 may be used to
modify gas pressure or gas flow delivered by the respiratory
therapy device 7210. The therapy controller 7260 may initiate or
terminate a gas flow or modify a gas concentration of the
respiratory therapy, for example.
[1324] Additionally or alternatively, the therapy controller 7260
may develop control signals used to control therapy delivered by
the implantable device 7270. The implantable device therapy may be
controlled to treat a detected cardiopulmonary disease or disorder,
to improve patient comfort, or for other purposes. In one
embodiment, the implantable device comprises a cardiac therapy
device that delivers cardiac electrical stimulation therapy to the
patient. The therapy controller initiate or terminate the cardiac
electrical stimulation therapy and/or control various parameters of
the cardiac electrical stimulation, e.g., stimulation energy,
stimulation timing. The cardiac electrical stimulation therapy may
involve non-excitatory electrical stimulation involving sub-capture
threshold stimulation or stimulation during a refractory period,
for example. The therapy controller may modify one or more
parameters of the non-excitatory electrical stimulation
therapy.
[1325] The cardiac electrical stimulation may involve cardiac
pacing therapy. The therapy controller may initiate or terminate
the pacing therapy. The therapy controller may modify the cardiac
pacing therapy by alter a pacing rate (e.g., change from a normal
sleep rate to an overdrive pacing rate), pacing timing (e.g.,
modify the AV delay or other pacing timing parameter), pacing mode,
(e.g., switch from DDD to VVI pacing or from a tracking mode to a
non-tracking pacing mode) and/or pacing type (e.g., switch from
dual chamber to biventricular pacing or from single chamber to dual
chamber).
[1326] Embodiments of the invention involve methods of controlling
a therapy delivered to the patient, as illustrated in the flowchart
of FIG. 73. One or more physiological conditions are sensed 7302
using the sensing system of an external respiratory therapy device.
In various implementations, the external respiratory therapy device
may comprise, for example, a gas therapy device, nebulizer,
ventilator, positive airway pressure device, or other type of
respiration therapy device. The patient's cardiopulmonary status is
assessed 7304 based on the sensed physiological conditions. Therapy
delivered to the patient is controlled 7306 based on the patient's
cardiopulmonary status. The therapy may be used to treat breathing
rhythm disorders, non-rhythm related pulmonary diseases/disorders,
cardiac disorders, and/or other diseases or disorders affecting the
patient.
[1327] In one embodiment, an implantable device may be used to
sense 7303 additional physiological conditions. The patient's
cardiopulmonary status is assessed 7304 based on the physiological
conditions sensed by the external respiratory device and the
additional physiological conditions sensed by the implantable
device. At least one of assessing the patient's cardiopulmonary
status and controlling the therapy is performed at least in part
implantably.
[1328] In one implementation, the presence of a cardiac and/or
pulmonary disease or disorder is detected and therapy to treat the
disease or disorder is delivered to the patient. The therapy may be
modified to improve therapy effectiveness based on the assessment
of the cardiac and/or pulmonary disease or disorder. In another
embodiment of the invention, the patient's cardiopulmonary status
is assessed and the therapy delivered to the patient is modified to
enhance patient comfort or to achieve another result.
[1329] For example, the patient's cardiopulmonary status may be
assessed based on sensed physiological conditions indicative of
symptoms or physiological changes associated with a particular
disease or disorder. A respiratory therapy device used to sense the
physiological conditions may comprise, for example, a gas therapy
device, nebulizer, ventilator, positive airway pressure device, or
other type of respiration therapy device. In a preferred
embodiment, the respiratory therapy device comprises a positive
airway pressure device. Continuous positive airway pressure (CPAP)
devices are frequently used to treat sleep apnea and/or other
breathing rhythm disorders. A CPAP device may be used regularly
during a patient's sleep time to prevent or treat sleep disordered
breathing events. Use of a CPAP device for treatment of breathing
rhythm disorders facilitates detection of rhythm-related and
non-rhythm related pulmonary diseases. The CPAP device provides
sensors available on a periodic basis, e.g., nightly, that may be
used to sense conditions indicative of cardiopulmonary status.
[1330] In another implementation, assessment of the cardiopulmonary
status of the patient is based on one or more physiological
conditions sensed using a patient-external respiratory therapy
device and on one or more additional physiological conditions
sensed using a cardiac device. The cardiac device may comprise, for
example, an implantable cardiac therapy device, such as a
pacemaker, defibrillator, cardioverter, cardiac monitor, and/or
cardiac resynchronizer.
[1331] In yet another implementation, assessment of the
cardiopulmonary status of the patient is based on one or more
physiological conditions sensed using a patient-external
respiratory therapy device and one or more additional conditions
sensed or detected using an additional patient-external device. The
patient-external device may comprise, for example, a patient
operated input device, a patient information database, or a
network-connected server, for example.
[1332] According to one aspect of the invention, pulmonary function
testing may be employed to detect physiological changes associated
with the presence of cardiac and/or pulmonary disease. Pulmonary
function tests may be used to evaluate lung mechanics, gas
exchange, pulmonary blood flow, and blood gases and pH. They are
used to evaluate patients in the diagnosis of pulmonary disease,
assessment of disease development, or evaluation of the risk of
pulmonary complications.
[1333] Various parameters related to pulmonary performance, some of
which may be measured using sensors of a respiratory therapy device
include, for example, tidal volume, minute ventilation, inspiratory
reserve volume, forced expiratory volume, residual volume, and
forced vital capacity, among other parameters. According to one
embodiment, testing of some pulmonary function parameters may be
performed using the ventilation pressure and ventilation flow
sensors of a CPAP device or other patient-external respiratory
therapy device. The pulmonary function testing may be used, for
example, to assess a presence of restrictive and/or obstructive
pulmonary disorders.
[1334] In some embodiments, pulmonary function testing may be
performed using a cardiac rhythm management system (CRM) or other
implantable device. In one implementation, the pulmonary function
testing is performed using an implanted transthoracic impedance
sensor. Transthoracic impedance sensing has been used in connection
with rate-adaptive pacemakers to measure respiration cycles. An
impedance sensor may be used to measure the variation in
transthoracic impedance, which increases during the inspiratory and
decreases during the expiratory phase of a respiration cycle. The
sensor injects a sub-threshold stimulating current between the
pacemaker case and an electrode on an intracardiac or subcutaneous
lead, and measures the voltage across the case and another
electrode on the same or another lead. Clinical investigations have
shown that the impedance sensor can measure respiratory rate tidal
volume, and minute ventilation accurately.
[1335] In accordance with various embodiments of the invention, a
properly calibrated impedance sensor, implemented in cooperation
with a pacemaker or other implantable device, may be used to
measure FVC and FEV during forced expiration. From these two
parameters, FEV/FVC can be derived to differentiate obstructive
versus restrictive respiratory patterns as shown in the FIGS. 1C
and 1D, respectively.
[1336] In addition, the forced expiratory flow (FEF.sub.25-75%) may
be measured. The middle half by volume of the total expiration is
marked, and its duration is measured. The FEF.sub.25-75% is the
volume in liters divided by the time in seconds. In patients with
obstructive diseases, the FEF.sub.25-75% is generally greater than
their expected values.
[1337] The implantable device may be used to compare measured FVC,
FEV and FEF.sub.25-75% values derived from the implanted impedance
sensor with predicted values from normal subjects in accordance
with various embodiments. The comparison provides diagnostic
information of lung mechanics.
[1338] Data acquired using the above-described techniques may be
transmitted from the implantable device to an advanced patient
management system or other remote device. Assessment of the
patient's cardiopulmonary status or control of the therapy may be
performed by the advanced patient management system.
[1339] Assessment of cardiopulmonary status may include assessing
the patient's pulmonary function as previously described. In some
implementations, the cardiopulmonary status processor may use
sensed conditions acquired by the respiratory therapy device,
and/or other therapy or diagnostic devices to assess patient's
cardiopulmonary status. Cardiopulmonary status assessment may
comprise evaluating a presence of cardiac and/or pulmonary disease.
The charts provided in FIGS. 6A-6N illustrate conditions and
sensors that may be used to determine physiological changes
associated with various cardiac and/or pulmonary diseases and
disorders.
[1340] The left section 6202 of FIG. 62A illustrates various
conditions that may be sensed using sensors of a respiratory
therapy device (CPAP), a cardiac device (CRM), or an external
non-CPAP, non-CRM device. The top section 6201 lists various
conditions that may be sensed and provides information about
sensors used to sense the conditions. The center section 6204 of
FIG. 62A provides physiological changes and/or symptoms that may be
evaluated using the conditions listed in the left section 6202. The
right section 603 of FIG. 6A provides pulmonary diseases/disorders.
The presence of the pulmonary diseases/disorders of the right
section 6203 may be assessed based on the physiological changes
and/or symptoms of the center section 6204.
[1341] For legibility, the left and right sections 6202, 6203 of
FIG. 62A are divided into six portions, FIGS. 62B-62G. FIG. 62B
represents the upper left portion 6210 of the left section 6202 of
FIG. 62A. FIG. 62C represents the upper right portion 6212 of the
left section 6222 of FIG. 62A. FIG. 62D represents the lower left
portion 6214 of the left section 6202 of FIG. 62A. FIG. 62E
represents the lower right portion 6216 of the left section 6202 of
FIG. 62A. FIG. 62F represents the upper portion 6220 of the right
section 6204 of FIG. 62A. FIG. 62G represents the lower portion
6222 of the right section 6204 of FIG. 62A. Relevant portions of
the center section 6204 and the top section 6201 of FIG. 62A appear
in each of the FIGS. 62B-62G for convenience.
[1342] The charts provided in FIGS. 62H-62N illustrate conditions
and sensors that may be used to determine physiological changes
associated with various cardiac diseases and disorders. The left
section 6232 of FIG. 62H illustrates various conditions that may be
sensed using sensors of a respiratory therapy device (CPAP), a
cardiac device (CRM), or an external non-CPAP, non-CRM device. The
center section 6234 of FIG. 6H provides physiological changes
and/or symptoms that may be evaluated using the conditions listed
in the left section 6232. The right section 6236 of FIG. 62H lists
cardiac diseases/disorders. The presence of the cardiac
diseases/disorders of the right section 6236 may be assessed based
on the physiological changes and/or symptoms of the center section
6234.
[1343] For legibility, the chart of FIG. 6H is divided into six
portions, FIGS. 62I-62N. FIG. 62I represents the upper left portion
6240 of the left section 6232 of FIG. 62H. FIG. 62J represents the
upper right portion 6242 of the left section 6232 of FIG. 62H. FIG.
62K represents the lower left portion 6244 of the left section 6232
of FIG. 62H. FIG. 62L represents the lower right portion 6246 of
the left section 6232 of FIG. 62H. FIG. 62M represents the upper
portion 6250 of the right section 6236 of FIG. 62H. FIG. 62N
represents the lower portion 6252 of the right section 6236 of FIG.
62H. Relevant portions of the center section 6204 and the top
section 6201 of FIG. 62H appear in each of the FIGS. 62I-62N for
convenience.
[1344] An example of how FIGS. 62A-62N may be used follows.
Referring to FIGS. 62 and 62G, the restrictive pulmonary disorder
pneumoconiosis produces the physiological changes non-specific
dyspnea (FIG. 62F) and cough (FIG. 62G). Non-specific dyspnea (FIG.
62F) and cough (FIG. 62G) are indicated by X or D marks in the
column denoted pneumoconiosis in FIGS. 6F and 6G, respectively. An
"X" mark indicates that the symptom or physiological change may be
derived from the sensed condition. A "D" mark indicates that the
symptom or physiological change may be directly determined from the
sensed condition. Non-specific dyspnea may be detected based on one
or more of the conditions listed in the row for non-specific
dyspnea illustrated in FIGS. 62B and 62C. The conditions include
duration of symptoms, abnormal breathing/coughing, blood pO2,
inspiratory flow, expiratory flow, exhaled % CO2 and exhaled % O2,
illustrated in FIG. 62C. The conditions also include
arterial/venous pO2, blood pCO2, blood pO2, exhalation time,
inspiration time, minute ventilation, tidal volume, respiration
rate, and/or respiration sounds illustrated in FIG. 62B.
[1345] FIG. 74 is a flowchart illustrating a method in accordance
with embodiments of the invention. One or more threshold criteria
sets for assessment of cardiopulmonary status based on the
disease/disorder presence are established 7410. A respiratory
therapy device such as a CPAP device may be used to sense 7412
conditions modulated by disease symptoms. The sensor information
may be collected periodically, e.g., nightly, and stored for
evaluation. If a presence of the disease has not been previously
determined 7415, then the levels of the sensed conditions are
compared 7420 to a set of criteria associated with the disease. If
levels of the conditions are consistent 7425 with the threshold
criteria levels, then a presence of the disease is determined 7430.
Therapy may be modified based on the presence of the
disease/disorder. In one implementation, therapy may be initiated
7435 to treat the disease.
[1346] If levels of the conditions are not consistent 7425 with the
threshold criteria levels, then the system continues to sense
conditions modulated by disease symptoms and collect 7412 data
based on the sensed conditions.
[1347] If the presence of the disease was previously determined
7415, then the progression of the disease may be monitored 7440
based on the conditions and/or criteria used to determine a
presence of the disease, or using other conditions and/or criteria.
If the disease presence is still detected 7445 based on the
conditions and criteria used for monitoring, then therapy may be
maintained or modified 7450 based on the disease progression.
Disease progression may be determined, for example, by trending one
or more conditions used for monitoring the disease presence over a
period of time. Modifications to the therapy may be made based on
the condition trends.
[1348] Methods and Systems for Control of Gas Therapy
[1349] Aspects of the invention that include control of gas therapy
are directed to methods and systems configured to monitor,
diagnose, and/or provide patient therapy using one or more
individual medical procedures. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[1350] Other aspects of the invention that include control of gas
therapy are directed methods and systems configured to monitor,
diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[1351] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1352] Embodiments of the invention involve adapting gas therapy
based on blood gas concentration. Methods may involve sensing
concentration of a blood gas and adapting a gas therapy for a
patient. Methods may further involve delivering the adapted gas
therapy to the patient. At least one of sensing the blood gas
concentration and adapting the gas therapy is performed at least in
part implantably.
[1353] Other embodiments of methods involve both sensing the blood
gas concentration and adapting the therapy being performed at least
in part implantably. Adapting a therapy may involve comparing the
sensed blood gas concentration to a threshold and modifying the
therapy if the blood gas concentration is beyond the threshold.
Modifying the therapy may involve increasing or decreasing a gas
pressure of a positive airway pressure device. Adapting a therapy
may involve comparing the sensed blood gas concentration to a
predetermined range and modifying the therapy if the blood gas
concentration is beyond the predetermined range.
[1354] Some embodiments may involve adapting oxygen therapy
delivered to a patient, wherein adapting the therapy involves
comparing a blood oxygen level to a predetermined range and
modifying the therapy if the blood oxygen level is beyond a
predetermined range, such as by increasing oxygen gas pressure in
response to the blood oxygen level falling below a threshold.
Alternatively, or additionally, adding or increasing a vasodilator
or a bronchodilator in response to the blood oxygen level falling
below a threshold may also be performed.
[1355] In other embodiments, a therapy system includes a sensor
unit configured to sense blood gas concentration. A therapy
controller is coupled to the sensor unit and is configured to adapt
a gas therapy. The system further includes a gas therapy delivery
unit coupled to the therapy controller and configured to deliver
the adapted gas therapy to the patient. At least one of the sensor
unit and the controller includes an implantable component.
[1356] Other embodiments include each of a sensor unit and a
therapy controller having an implantable component. The sensor unit
may be a component of an implantable cardiac therapy device or a
component of a patient-external respiratory therapy device. The
sensor unit may include a blood oxygen sensor and/or carbon dioxide
sensor, and may be coupled to an implantable cardiac therapy
device, directly or wirelessly. In further embodiments, the sensor
unit is coupled to the controller through the gas therapy delivery
unit, which may deliver a vasodilating or a bronchodilator
agent.
[1357] According to additional embodiments, a sensor may be
configured to detect disordered breathing, and, in response to
detecting disordered breathing, gas therapy may be modified (e.g.,
initiated, modified, terminated) to suppress the disordered
breathing. In addition, the type of disordered breathing may be
discerned, such as discerning central apnea from obstructive apnea.
If, for example, central apnea is detected, small amounts of carbon
dioxide may be applied to the patient's air supply (e.g., via a
positive airway pressure device) to mitigate the carbon dioxide
instability that is leading to central apnea.
[1358] Embodiments of the invention may involve an individual
system 135 (FIG. 1B) for sensing concentration of a blood gas and
adapting a gas therapy for a patient. Sensing concentration of a
blood gas and adapting a gas therapy for a patient may be
implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS. 1B-1D.
For example, embodiments of the invention may involve a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes sensing 135 concentration of a blood gas and adapting
a gas therapy.
[1359] The coordinated system may include, for example, an
implantable cardiac device 181 and a patient-external respiratory
therapy device 184. The system may further include an external
processor 183 providing a coordination function. A communication
channel couples the implantable device 181 and the respiratory
therapy device 184. The implantable 181 and respiratory therapy
devices 184 operate cooperatively via the communication channel to
provide one or more of patient monitoring, diagnosis, and therapy.
Systems and methods directed to gas therapy control may be
implemented to include selected features, functions, and/or
structures described in commonly owned, co-pending U.S. Publication
No. 2005/0061323, which is hereby incorporated herein by
reference.
[1360] Various embodiments of the present invention are implemented
using medical systems employing one or a number of patient-external
and/or patient-internal medical devices. Medical devices may
communicate or otherwise operate in concert or in a stand-alone
manner to provide more comprehensive patient monitoring, diagnosis,
and therapy. For example, a system of the present invention may
control gas therapy using one or more patient-internal sensors, one
or more patient-external sensors, and/or an implanted device.
[1361] Gas therapy devices may be used to provide a variety of
respiration therapies, including, for example, providing
vasodilating or bronchodilator agents, continuous positive airway
pressure (CPAP), bi-level positive airway pressure (bi-level PAP),
proportional positive airway pressure (PPAP), auto-titrating
positive airway pressure, ventilation, oxygen, carbon dioxide or
other gas therapies. All types of gas therapy and positive airway
pressure devices are referred to generically herein as xTherapy
devices.
[1362] The following discussion, with reference to FIGS. 75 through
78, describes embodiments of the invention involving modulation of
external gas therapy. The processes and systems exemplified by
these embodiments may be implemented alone or in combination with
one or more processes and systems exemplified by other embodiments
described herein to provide a coordinated approach to patient
monitoring, diagnosis, and/or therapy.
[1363] In accordance with embodiments of the invention, a system
controls gas therapy, such as oxygen or carbon dioxide therapy,
using one or more patient-internal sensors, one or more
patient-external sensors and/or an implanted device. The gas
therapy may be delivered to the patient, and measurement of exhaled
gas concentration may be implemented using a respiratory mask, such
as a CPAP mask, for example. The one or more sensors may include,
for example, a gas saturation sensor or other implanted sensor for
determining the patient's blood gas saturation. Other sensors, such
as a disordered breathing detector (internal or external) may be
used to determine the presence of disordered breathing, and then
deliver gas therapy as needed to resolve or treat the disordered
breathing. The patient's blood gas saturation may be determined
externally, e.g., using pulse oximetry techniques, and/or external
sensors positioned on a respiratory mask or nasal cannulae.
[1364] One illustrative approach involves sensing the patient's
blood gas saturation and controlling the delivery of gas by a
patient-external therapy device based on the blood gas saturation.
At least one of sensing the blood gas saturation and controlling
the delivery of gas is performed at least in part implantably.
Another approach involves sensing the body's need for gas, as
manifested, for example, as apnea, hypopnea, hypoxia, hypocapnia,
or myocardial ischemia, and then providing appropriate gas therapy
to remedy the physiological need. Sensing of the body's need for
gas may be effected either internally or externally of the
patient.
[1365] FIG. 75 illustrates a block diagram of a system 7550 for
providing coordinated cardiac and respiratory therapy in accordance
with embodiments of the invention. The system utilizes an xTherapy
device 7582 to provide respiratory therapy to the patient. A
controlled flow of air, oxygen, carbon dioxide or other gas is
developed by the xTherapy device 7582 and delivered to the
patient's airway through tubing and a mask 7584, such as a nasal
mask.
[1366] The system 7550 provides electrical stimulation therapy
using an implantable cardiac rhythm management (CRM) device 7581.
The CRM device 7581 provides electrical stimulation to the heart
7585 through an implanted lead system 7586 with electrodes 7587
positioned in, on, or about the heart 7585 to electrically couple
the heart 7585 to the CRM device 7581. The CRM device 7581 may be
used to sense symptoms of a disease or disorder, such as hypoxemia
and ischemia. The CRM device 7581 may also be used to improve
cardiac output by atrial pacing, bi-ventricular pacing, atrial or
ventricular overdrive pacing, pacing above a programmed pacing
rate, and/or other therapies, which may, in turn, improve blood gas
transport.
[1367] One or both of the xTherapy device 7582 and the CRM device
7581 have one or more sensors 7588, 7589 for sensing conditions
associated with disordered breathing. For example, the CRM sensors
7589 may include, for example, cardiac signal electrodes, a minute
ventilation (MV) sensor, and an accelerometer. The xTherapy device
sensors 7588 may include a microphone and respiratory flow
sensor.
[1368] The sensor signals are analyzed by the xTherapy device 7582,
the CRM device 7581, or both devices 7582, 7581, to determine the
presence and/or severity of a disorders such as ischemia,
hypoxemia, pulmonary, and/or disordered breathing. The xTherapy and
CRM devices 7582, 7581 may have bi-directional or uni-directional
communication capability for communicating information about the
disordered breathing to the other device 7581, 7582. In one
scenario, the xTherapy 7582 and the CRM 7581 have the ability to
communicate directly, e.g., through a wireless link. In another
scenario, the xTherapy 7582 and the CRM 7581 do not have the
ability to communicate directly, but communicate through an
intermediate device 7580, such as a programmer or an information
server 7580 used in connection with an advanced patient management
system. The intermediary device 7580 may receive information from
the xTherapy device 7582 and transmit the information to the CRM
device 7581. Similarly, the intermediary device 7580 may receive
information from the CRM device 7581 and transmit the information
to the xTherapy device 7582.
[1369] In one example, either the CRM device 7581 or the xTherapy
device 7582 may sense a set of patient conditions and transmit the
patient conditions to the other device 7582, 7581. For example, the
CRM device 7581 may sense a set of patient conditions using the
sensors 7589 coupled to the CRM device 7581. The CRM device 7581
may then transmit the sensor information to the xTherapy device
7582. Each device 7581, 7582 may individually detect a disorder
such as ischemia, hypoxemia, pulmonary, and/or disordered breathing
and determine the severity of the disorder based on the sensor
information. Each device 7581, 7582 may adjust the therapy provided
by the device based on the detection and/or severity of the
detected disorder.
[1370] In another example, the xTherapy device 7582 may sense a set
of patient conditions and transmit the patient conditions to the
CRM device 7581. The xTherapy device 7582 and the CRM device 7581
may individually modify their therapies based on the sensed
conditions.
[1371] In yet another example the xTherapy device 7582 may sense a
first set of patient conditions and transmit the first set of
patient conditions to the CRM device 7581. The CRM device 7581 may
detect a second set of patient conditions and transmit the second
set of patient conditions to the xTherapy device 7582. The xTherapy
and CRM devices 7582, 7581 may then individually modify their
therapies based on the first and the second sets of conditions.
[1372] In another example, the detection and/or determination of
the severity of a disorder, such as ischemia, hypoxemia, pulmonary,
and/or disordered breathing, may be performed in one device and the
information transmitted to the other device. For example, the CRM
device 7581 may sense a first set of patient conditions from
sensors 7589 coupled to the CRM device 7581 and receive a second
set of patient conditions from the xTherapy device 7582. The CRM
device 7581 may detect a disorder such as ischemia, hypoxemia,
pulmonary, and/or disordered breathing and determine the severity
of the disorder based on the first and the second set of
conditions. The CRM device 7581 may transmit information about the
detection/severity of a condition such as ischemia, hypoxemia,
pulmonary, and/or disordered breathing to the xTherapy device 7582.
The CRM device 7581 may modify its therapy based on the
detection/severity of the disorder. The xTherapy device 7582 may
also modify its therapy based on the detection/severity of the
disorder. In an alternate embodiment, the detection and severity
determination may be performed by the xTherapy device 7582 and
transmitted to the CRM device 7581.
[1373] Therapy provided by the xTherapy device 7582 may include,
for example, therapy delivery at a variable pressure, e.g.,
autotitration PAP, gas therapy, among others. Therapy provided by
the CRM device 7581 may include, for example, cardiac
resynchronization therapy, bi-ventricular pacing, atrial or
ventricular overdrive pacing, and/or pacing above a programmed
sleep rate.
[1374] The detection of a disorder such as ischemia, hypoxemia,
pulmonary, and/or disordered breathing and determination of the
severity of the disorder may be used to implement an adaptive
therapy utilizing both the xTherapy device 7582 and the CRM device
7581. The adaptive therapy techniques described above may be used
in connection with the xTherapy device 7582 alone or with the CRM
and xTherapy devices 7581, 7582 together. Thus, the therapy
provided by either or both devices 7581, 7582 may be initiated,
terminated, or modified based on the effectiveness of the therapy,
the impact of the therapy on the patient, or both effectiveness and
impact.
[1375] FIG. 76 illustrates the use of one or more external sensors
with the patient-internal device operating as the gas therapy
control unit in accordance with embodiments of the invention. A
patient-external therapy device 7620 provides gas therapy to a
patient, for example, through a nasal or facial mask 7601. In this
example, the therapy control unit 7615, located in a
patient-internal device 7610, such as a CRM device, receives blood
gas information from an external sensor 7605, such as, but not
limited to, a sensor positioned on a respiratory mask. It is
understood that other sensors may be used which are not positioned
on a respiratory mask, such as a finger oximetry sensor. The sensor
7605 may communicate with the patient-internal device 7610 through,
for example, a wireless communication link.
[1376] Alternatively, the sensor signals may be received by the
patient-external therapy device 7620, e.g., CPAP device or other
xTherapy device, and transmitted from the patient-external device
7620 to the patient-internal device 7610, for example. The therapy
control unit 7615 compares the sensed gas saturation level to a
predetermined threshold or range. When the gas saturation is beyond
the threshold or range, the patient-internal device 7610 may
transmit control signals to the patient-external therapy delivery
device 7620 to initiate, terminate, or modify the gas therapy.
[1377] FIG. 77A illustrates another implementation of gas therapy
control in accordance with an embodiment of the invention. In the
example depicted in FIG. 77A, gas saturation is sensed using one or
more patient-internal sensors 7706 positioned on an endocardial
lead. In this implementation, the patient-internal sensors 7706 may
include a gas saturation sensing lead used with an implantable CRM
device. The gas sensing device need not be positioned on a lead,
but may alternatively be located on the CRM device housing or
header, or on a sensor lead independent from the pacing leads. The
patient-internal device 7610 includes a gas therapy control unit
7615. In this example, the therapy control unit 7615 receives blood
gas information from the blood gas sensor 7706. The therapy control
unit 7615 compares the sensed gas saturation level to a
predetermined threshold or range. When the gas saturation is beyond
the threshold or range, the patient-internal device 7610 may
transmit control signals to the patient-external therapy delivery
device 7620 to initiate, terminate, or modify the gas therapy.
[1378] FIG. 77B illustrates another implementation of gas therapy
control in accordance with an embodiment of the invention. In the
example depicted in FIG. 77B, gas saturation is sensed using one or
more patient-internal sensors 7706 positioned in or on the
patient-internal device 7610, such as the can of a cardiac
monitoring and/or stimulation device. In this implementation, the
patient-internal sensors 7706 may include a gas saturation sensing
lead used with an implantable CRM device. The patient-external
device 7620 includes a gas therapy control unit 7615. In this
example, the therapy control unit 7615 receives blood gas
information from the blood gas sensor 7706 via, for example,
wireless link. The therapy control unit 7615 compares the sensed
gas saturation level to a predetermined threshold or range. When
the gas saturation is beyond the threshold or range, the
patient-external device 7620 may initiate, terminate, or modify the
gas therapy.
[1379] FIG. 78 is a flow chart illustrating a method 7800 of gas
therapy control based on signals from a patient-internal device in
accordance with embodiments of the present invention. The method
7800 may be useful for controlling any gas therapy system, such as
those illustrated with reference to FIGS. 75 through 77. For
clarity of understanding, and not by way of limitation, the sensing
of blood oxygen level will be used as an example of one particular
use of the method 7800.
[1380] Block 7802 provides for the sensing of blood gas, such as
blood oxygen level. A disorder is detected 7804 using the sensed
blood gas information. For example, a blood oxygen level may be
compared to a range of acceptable blood oxygen levels to detect
whether the blood gas is within an acceptable range, or whether
some disorder is indicated.
[1381] If no disorder is detected at block 7804, blood gas sensing
continues at block 7802. Sensing may occur continuously,
intermittently, by-request, periodically, or as otherwise desired
or needed.
[1382] If a disorder is detected at detection block 7804, a
determination of one or more possible actions and/or interventions
is made at block 7806, relative to the detected disorder. For
example, detecting a blood oxygen level below a lower threshold may
suggest that more oxygen is needed by the patient. A decision is
made at block 7808, based on the determination from block 7806, as
to whether therapy initiation or therapy modification is desired to
increase the patient's blood oxygen level. For example, if a
patient is receiving oxygen therapy, the oxygen level administered
to the patient may be increased. In another embodiment, if the
patient is sleeping and wearing a CPAP device, the air pressure may
be increased.
[1383] In a further embodiment, the patient may be administered a
vasodilating or bronchodilator agent, or have a level of
vasodilating or bronchodilator agent therapy modified. Combined
therapies may also be performed, such as increasing gas pressure
and adding a vasodilating or bronchodilator agent, increasing the
heart rate of a patient using a pacemaker and increasing oxygen
therapy, or other desired combined therapies.
[1384] If no therapy change is desired, the disorder may be
recorded, monitored, or alerted, for example, before returning to
the sense block 7802. If a therapy change is desired, the therapy
is modified at block 7810 before again returning to the blood sense
block 7802. For example, if a patient is receiving oxygen therapy,
the oxygen level administered to the patient is increased, and the
method 7800 may be performed again after an appropriate time to
determine if the change was effective, or whether other action is
necessary.
[1385] Synergistic Use of Medical Devices for Detecting Medical
Disorders
[1386] Aspects of the invention that include synergistic use of
medical devices for detecting medical disorders are directed to
methods and systems configured to monitor, diagnose, and/or provide
patient therapy using one or more individual medical procedures.
Each of the circles 180 illustrated in FIGS. 1B-1D represents an
individual medical procedure providing a specific monitoring,
diagnosis or therapeutic function or set of functions. Each
individual medical procedure may be implemented as a stand-alone
system. Two or more of the individual medical procedures 180 may be
used in combination to provide more comprehensive patient
monitoring, diagnosis and/or therapy. One or more functions of two
or more individual medical procedures 180 may be used in
combination to enhanced patient monitoring, diagnosis and/or
therapy.
[1387] Other aspects of the invention involving synergistic use of
medical devices to detect disorders are directed to methods and
systems configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures. Coordinated medical
procedures may involve cooperative operation of two or more of the
individual processes 180. Coordinated medical procedures may also
involve cooperative operation of one or more functions of two or
more of the individual processes 180.
[1388] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1389] Embodiments of the invention involve a system providing
synergistic use of medical devices for detecting medical disorders
126 (FIG. 1B). The medical disorder detection system may be
implemented as a stand alone system or in combination with other
individual medical systems, such as those described in FIGS.
1B-1D.
[1390] A system for assessing a disease presence includes a
plurality of medical devices, each medical device comprising a
sensing system configured to sense one or more physiological
conditions. A selection processor is coupled to the plurality of
medical devices. The selection processor is configured to select
one or more medical devices to sense one or more physiological
conditions. A diagnosis processor is coupled to the sensing systems
of the plurality of medical devices. The diagnosis processor is
configured to assess a presence of a medical disorder based on the
one or more physiological conditions.
[1391] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes a disease assessment system 126. The coordinated
system may include, for example, an implantable cardiac device 181
and a patient-external respiratory therapy device 184. The system
may further include an external processor 183 providing a
coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 184 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[1392] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy involves a
disease assessment system. The implantable device and the
respiratory therapy device work cooperatively to implement the
disease assessment system and/or to perform a function involving
the assessment of disease presence.
[1393] Embodiments of the invention are directed to synergistic use
of medical devices for detecting the presence of a medical disease
or disorder. Processes described herein involve automatically
selecting one or more medical devices to sense one or more
physiological conditions. A monitoring unit, which may be
distributed among the selected medical devices, for example,
collects data based on the one or more sensed conditions. A
diagnostics unit detects a presence of a medical disorder based on
the collected data and may assess the progression of the disorder.
Systems and methods directed to synergistic use of medical devices
for detecting medical disorders may be implemented to include
selected features, functions, and/or structures described in
commonly owned, co-pending U.S. Pat. No. 7,610,094.
[1394] FIG. 1A illustrates an implantable device 110 and a
patient-external medical device 220. The medical devices 110, 120
may comprise circuitry for implementing synergistic use of medical
devices for disease assessment.
[1395] In accordance with embodiments of the invention, the medical
system 100 includes a selection processor and a diagnostics
processor. The selection and diagnostics processors may be
implemented as components of the patient-internal medical device
110, the patient-external medical device 120, or as a unit separate
from the patient-internal medical device 110 and the
patient-external medical device 120. The selection and diagnostics
processors 114, 124 may be implemented as components of an advanced
patient management (APM) system 170, for example.
[1396] The selection processor is configured to select one or more
medical devices to sense patient conditions. The selection of the
medical devices may be based, for example, on patient usage and/or
on the proficiency or accuracy of the sensing system associated
with a particular medical device. In one implementation, if the
selection processor determines that the patient is not using the
patient-external device, then the sensing function may be
transferred to the patient-internal device.
[1397] The block diagram of FIG. 79 provides an example of a
coordinated monitoring, diagnosis and/or therapeutic system 7900 in
accordance with embodiments of the invention. The system 7900
employs a medical device 7901 that may be fully or partially
implantable, or may be positioned on, near, or at a remote location
external to the patient. The medical device 7901 may be coupled to
an array of data acquisition devices, including patient-internal
sensors 7911, patient-external sensors 7912, patient input devices
7913, and/or other information systems 7914 as described herein.
The patient-internal sensors 7911, patient-external sensors 7912,
patient input devices 7913, and/or other information systems 7914
are used to input a variety of conditions affecting the patient and
useful for the monitoring, diagnostic, and/or therapeutic functions
of the medical device 7901. One or more patient conditions may also
be sensed using a remote system 7940.
[1398] The medical device 7901 of FIG. 79 includes a medical
disease/disorder assessment unit 7920 that processes data collected
from one or more of the patient-internal sensors 7911,
patient-external sensors 7912, patient input devices 7913,
information systems 7914, and/or data collected from the remote
system 7940 to assess the presence of various medical diseases
and/or disorders. The assessment unit 7920 may include detection
circuitry for detecting the occurrence of various physiological
events. For example, the assessment unit 7920 may include one or
more of a cardiovascular system event/condition detector 7922, a
respiratory event/condition detector 7924, a muscle system
event/condition detector 7926 and/or a sleep stage detector 7928.
Other event detection components may also be included in the
assessment unit 7920. The event/condition detectors 7922, 7924,
7926, 7928 may be used to detect normal and/or abnormal
physiological system events or conditions. For example, the
cardiovascular system event/condition detector 7922 may used to
detect abnormal or unusual events of the cardiovascular system such
as ventricular tachycardia or fibrillation. The cardiovascular
system event/condition detector 7922 may also be used to detect
normal cardiac beats or other events or conditions associated with
the usual functioning of the heart. The respiratory system event
detector 7924 may be used to detect events or conditions associated
with various respiratory system disorders, such as a disordered
breathing event or a pulmonary congestion condition. The
respiratory system event/condition detector 7924 may also be used
to detect the inspiratory and expiratory phases of normal
respiration cycles, for example.
[1399] The muscle system event/condition detector 7926 may be used
to detect normal or abnormal conditions, such as normal muscle
atonia associated with REM sleep or abnormal muscle tone of the
upper airway associated with obstructive sleep apnea events. The
muscle system event/condition detector 7926 may also be used, for
example, to detect the level of patient activity. Patient activity
information may be useful, for example, in assessing the overall
activity level of the patient, or determining if the patient is
asleep.
[1400] The assessment unit 7920 may also include a sleep stage
detector 7928. The sleep stage detector 7928 may analyze various
inputs from the patient-internal sensors 7911, patient-external
sensors 7912, patient input devices 7913, other information systems
7914 and/or events/conditions detected by the event/condition
detectors 7922, 7924, 7926, to detect sleep-related events,
including, for example, sleep onset, sleep offset, sleep stages,
and arousals from sleep.
[1401] Components of the detection unit 7920 may cooperate with a
monitoring unit 7902. The monitoring unit 7902 may incorporate a
memory to store data derived from signals produced by the
patient-internal sensors 7911, patient-external sensors 7912,
patient input devices 7913, and/or other information systems 7914
and information derived from the event/condition detectors 7922,
7924, 7926, 7928. The stored data may be transmitted to another
component of the medical device 7901 or to a separate device for
storage, further processing, trending, analysis and/or display, for
example. In one scenario, the stored data can be downloaded to a
separate device periodically or on command. The stored data may be
presented to the patient's health care professional on a real-time
basis, or as a long-term, e.g., month long or year long, trend of
daily measurements.
[1402] The assessment unit 7920 includes a selection processor 7980
for selecting one or more medical devices used for sensing various
conditions used for the detection and/or assessment of the medical
disease/disorder. Data collected from the one or more medical
devices is evaluated in a diagnostics processor 7904. The
diagnostics unit 7904 may evaluate events or conditions detected by
the selected medical devices to provide diagnostic information
related to various medical disorders or diseases affecting the
patient. The diagnostics processor 7904 may detect a presence of a
medical disease or disorder based on the data collected by the
selected medical devices. The diagnostics processor 7904 may also
assess the onset, progression, regression, and/or offset of the
medical disease or disorder. Information related to the sensed
conditions and/or disease or disorder diagnostics may be stored,
analyzed, trended, transmitted to a separate device, printed and/or
displayed, for example. In some implementations, the information
may be transmitted to a device not used to sensed physiological
conditions for medical disease diagnosis, for example. In some
implementations, an alert may be activated based on detection or
assessment of one or more medical diseases/disorders, for example a
visual or audible alert.
[1403] The medical device 7901 may also include a therapy control
unit 7930 that controls one or more types of therapy delivered to
the patient. For example, the medical device may include a cardiac
therapy control unit 7952 for controlling cardiac electrical
stimulation delivered to the heart through one or more cardiac
electrodes 7958. The therapy control unit 7930 may also include
respiration therapy control unit 7934 that provides control signals
to a respiratory therapy device 7954 and a drug control unit 7936
that provides control signals to a drug delivery device 7956. In
one configuration, the medical device 7901 may control the therapy
delivered by a separate therapy delivery device 7954, 7956 by
communicating directly with the separate therapy delivery device
7954, 7956. In another configuration, the medical device 7901 may
communicate with another medical device, e.g., APM system or
programmer, to indirectly affect or control the therapy delivery
device 7954, 7956.
[1404] The medical device 7901 may further include a communications
unit 7906 that controls communications between the medical device
7901 and other devices or systems. For example, the communications
unit 7906 may be used to provide wireless or wired communications
links between the medical device 7901 and one or more of the
patient-internal sensors 7911, patient-external sensors 7912,
patient input devices 7913, and information systems 7914. The
communications unit 7906 may also facilitate communication between
the medical device 7901 and the therapy delivery devices 7954, 7956
through wireless or wired connections. The communications unit 7906
may also facilitate communications between the medical device 7901
and a remote device 7940 such as another medical device, a remote
programmer and/or an APM system as described previously in
connection with FIG. 1. The wireless connections coupling the
medical device 7901 to various other devices and systems may
utilize a variety of wireless protocols, including, for example,
Bluetooth, IEEE 802.11, and/or a proprietary wireless protocol.
[1405] Embodiments of the invention are directed to the synergistic
use of patient external and patient internal devices to detect a
presence of and/or assess a variety of medical disorders, including
cardiac disorders and/or pulmonary disorders. FIGS. 62A-62N list
various cardiac and/or pulmonary diseases/disorders that may be
detected using the approaches of the present invention.
[1406] As referenced in FIGS. 62A-62N, the term "condition,"
denotes an parameter that may be sensed and/or measured based on a
signal generated by a sensor or other input device of the one or
more medical devices. Typically, a physiological sensor generates a
signal modulated by a physiological parameter. In some cases, a
physiological condition may be directly measured based on the
sensor signal. For example, a blood pressure measurement may
directly correlate to the signal generated by a blood pressure
sensor. In other cases, a condition may be derived from the sensor
signal. For example, tidal volume is a respiratory system condition
that may be derived from the signal generated by a transthoracic
impedance sensor. In another example, heart rate is a cardiac
system condition that may be derived from a cardiac electrogram
sensor.
[1407] The terms "symptom" and "physiological change" refer to a
manifestation of a medical disease or disorder. Symptoms and/or
physiological changes may be detectable based on a sensed presence
of one or more physiological conditions and/or measured values
associated with the one or more sensed physiological conditions.
The terms "disease" and/or "disorder" are used to refer to a
medical dysfunction that is characterizable by a collection of
symptoms or physiological changes.
[1408] The chart depicted in FIGS. 62A-62N illustrates
relationships between various physiological changes and/or disease
symptoms with medical disorders. The chart lists a representative
set of medical disorders that may be evaluated in accordance with
embodiments of the invention.
[1409] The presence of a disorder/disease, such as those listed in
FIGS. 6A-6N, may be assessed by based on physiological changes
and/or symptoms associated with the disorder/disease. The
physiological changes and/or symptoms may be detected using
conditions sensed by a sensor system of a respiratory therapy alone
or in combination with the sensor systems of other therapeutic or
diagnostic medical devices. If the sensed conditions indicate that
the physiological changes or symptoms of a disease or disorder are
consistent with a threshold level, the presence of the disease or
disorder may be determined.
[1410] In another example, assessment of disease presence may be
based on relative changes in one or more conditions indicative of
physiological changes or symptoms caused by the disease. For
example, assessment of a presence of a disease or disorder may be
accomplished by evaluating the changes in conditions indicative of
physiological changes or symptoms caused by the disease. The
changes in the one or more conditions may be compared to threshold
criteria. If changes in the conditions indicative of physiological
changes or symptoms caused by the disease are consistent with
threshold levels, a presence of the disease or disorder may be
determined.
[1411] In a further example, the threshold criteria may involve
relationships between the conditions indicative of physiological
changes or symptoms caused by the disease. The presence of a
disease may be assessed by evaluating relationships between
conditions indicative of physiological changes or symptoms caused
by the disease. For example, assessment of a disease may involve
the determination that levels or amounts of two or more conditions
have a certain relationship with one another. If relationships
between the conditions indicative of physiological changes or
symptoms caused by the disease are consistent with threshold
relationship criteria, the disease or disorder may be present.
[1412] FIG. 80 is a flowchart of a method of detecting the presence
of medical disorders in accordance with embodiments of the
inventions. The method involves selecting 8002 one or more medical
devices to sense one or more patient conditions associated with
symptoms of the medical disorder. The medical devices selected may
comprise for example, one or more implantable devices, one or more
patient-external devices, or a combination of implantable and
patient-external devices. The medical devices selected may comprise
any number of therapeutic and/or diagnostic devices, including, for
example, various therapeutic or diagnostic devices, including
cardiac devices (pacemakers, cardioverter/defibrillators, cardiac
resynchronizers, cardiac monitors), muscle stimulators,
neurostimulators, implantable or patient-external drug delivery
devices (drug pumps, electrically activate drug patches),
patient-external respiratory devices (respiratory monitors,
nebulizers, oxygen or gas therapy devices, ventilators,
respirators, respiratory therapy devices providing positive and/or
negative airway pressure), and the like.
[1413] The selection of the medical devices may be based, for
example, on patient usage and/or on the proficiency or accuracy of
the sensing system associated with a particular medical device. The
one or more patient conditions are sensed 8004 using the selected
devices. Data may be collected based on the one or more sensed
physiological conditions. The presence of a medical disorder is
detected 8008 based on the one or more sensed physiological
conditions. Data pertaining to the sensed physiological conditions
may be collected and stored, for example, continuously, or
periodically, or according to some other time basis.
[1414] In some embodiments of the invention, portions of the data
collection may be initiated upon detection of a medical event. For
example, data collection may be initiated upon detection of an
arousal event, a respiratory event, such as a sleep apnea event,
and/or a cardiac event, such as a cardiac arrhythmia event.
[1415] In an embodiment of the invention, data collection may occur
periodically, e.g., daily or hourly. In some implementations, the
data collection may occur continuously or according to a random
schedule. In some scenarios, it may be desirable to collect data
only when the patient is asleep or only when the patient is awake.
The system may detect sleep events to implement nocturnal and/or
diurnal data collection, for example. The system may select one set
of medical devices for sensing conditions during the day and alter
the selection to include a second set of medical devices for
sensing conditions at night.
[1416] In one example, a patient may have an implanted cardiac
pacemaker and may also use, on a periodic basis, e.g., nightly, an
external respiratory therapy device, such as a CPAP device. One or
more conditions, including respiration may be sensed each night
using the cardiac pacemaker and the CPAP device. The airflow sensor
of the CPAP device may be automatically selected to sense patient
respiration due to the higher accuracy of the airflow measurement
in the CPAP device compared to the cardiac pacemaker. However, on
some nights the patient may not use the CPAP device. If the patient
does not use the CPAP device during a particular period, then
patient respiration may be sensed using a surrogate measure, such
as the transthoracic impedance sensor of the cardiac pacemaker. The
cardiac pacemaker may be automatically selected as the medical
device used for sensing patient respiration.
[1417] The medical devices used for sensing may be selected based
on the proficiency of the sensing system associated with a
particular medical device. For example, respiration sounds may be
detectable using the accelerometer of a CRM or a patient-external
microphone. If patient movements or other interference degrades
respiration sound detection acquired by the CRM accelerometer, then
the system may select the microphone as the preferred method of
sensing respiration sounds.
[1418] Assessment of disease presence may be based on relative
changes in one or more conditions indicative of physiological
changes or symptoms caused by the disease. For example, detection
of a presence of a medical disorder may be accomplished by
evaluating the changes in one or more conditions indicative of
physiological changes or symptoms caused by the disease. The
changes in the one or more conditions may be compared to threshold
criteria. If changes in the conditions indicative of physiological
changes or symptoms caused by the disease are consistent with
threshold levels, the non-rhythm pulmonary disease or disorder may
be present. For example, if the levels of one or more conditions
increase or decrease by a threshold amount of change, then a
determination that the medical disorder is present may be made.
[1419] The threshold criteria may involve relationships between the
conditions indicative of physiological changes or symptoms caused
by the disease or disorder. The presence of a medical disorder may
be assessed by evaluating relationships between conditions
indicative of physiological changes or symptoms caused by the
disease. For example, detection of the presence of a medical
disorder may involve the determination that levels or amounts of
two or more conditions have a certain relationship with one
another. If relationships between the conditions indicative of
physiological changes or symptoms caused by the disease are
consistent with threshold relationship criteria, the system may
determine that a particular medical disorder is present.
[1420] If the presence of a medical disease/disorder is determined,
then the progression of the disease may be monitored. Monitoring
the progression of the disease or disorder may involve, for
example, collecting data and periodically evaluating one or more
physiological changes or symptoms of the disease. Evaluating the
one or more physiological changes or symptoms may be accomplished
by comparing patient conditions to thresholds or other quantifiable
indices. Monitoring the medical disorder may involve, for example,
monitoring the progression and/or regression of the medical
disorder, determining a severity of the disease, detecting disease
onset and offset, and/or monitoring other aspects and/or events
associated with the disorder.
[1421] As illustrated in FIGS. 62H-62N, cardiac disorders may be
organized into disorders of cardiac rhythm, such as bradycardia,
ventricular tachyarrhythmia, ventricular fibrillation, paroxymal
atrial tachyarrhythia/fibrillation and chronic atrial
tachyarrhythmia/fibrillation). Heart failure may cause contractions
of the ventricles to become uncoordinated. Non-rhythm cardiac
disorders include coronary artery disease (acute myocardial
infarction, ischemia), and hypertension, which may be associated
with systolic or diastolic types.
[1422] According to one aspect of the invention, pulmonary function
testing may be employed to detect physiological changes associated
with the presence of cardiac and/or pulmonary disease. Pulmonary
function tests may be used to evaluate lung mechanics, gas
exchange, pulmonary blood flow, and blood gases and pH. They are
used to evaluate patients in the diagnosis of pulmonary disease,
assessment of disease development, or evaluation of the risk of
pulmonary complications.
[1423] Data acquired using the above-described techniques may be
transmitted from the implantable device to an advanced patient
management system or other remote device. Assessment of the
patient's cardiopulmonary status or control of the therapy may be
performed by the advanced patient management system.
[1424] In accordance with various embodiments of the invention, the
presence of a medical disease or disorder, such as those listed in
FIGS. 62A-62N, may be assessed by evaluating sensed conditions
indicative of the a medical disease or disorder. Sensing the
conditions may be accomplished using a synergistic process
involving selection of one or more medical devices based on various
parameters, including, for example, usage of the medical device,
quality of the available sensed signals and/or other factors.
[1425] In one implementation, the presence of medical disease or
disorder may be assessed by comparing levels or values associated
with conditions indicative of physiological changes or symptoms
caused by the medical disease/disorder to threshold criteria. If
the condition levels or values are determined to be beyond
threshold criteria levels, the system may determine that the
non-rhythm pulmonary disease or disorder is present. The system may
use the comparison of condition levels or values to threshold
criteria to detect a presence of the medical disease/disorder, the
progression of the medical disease/disorder, the regression of the
medical disease/disorder and/or the offset of the medical
disease/disorder, for example.
[1426] The system may initially determine the threshold criteria
for one or more medical diseases or disorders by establishing
baseline conditions for an individual patient. The baseline
conditions may be established using data collected from the patient
over a period of time. Clinical data acquired from a number of
patients may alternatively or additionally used for establishing
the threshold criteria.
[1427] In one implementation, assessment of disease presence may be
based on relative changes in one or more conditions indicative of
physiological changes or symptoms caused by the disease. In this
implementation, the threshold criteria may involve a rate of
change. For example, diagnosis of a medical disease or disorder may
be accomplished by evaluating the rate of change in conditions
indicative of physiological changes or symptoms caused by the
disease. The changes in the one or more conditions may be compared
to threshold criteria involving rate of change. If changes in the
conditions indicative of physiological changes or symptoms caused
by the disease are consistent with threshold criteria, then the
medical disease or disorder may be present.
[1428] In a further example, the threshold criteria may involve
relationships between the conditions indicative of physiological
changes or symptoms caused by the medical disease/disorder. The
presence of a medical disease or disorder may be assessed by
evaluating relationships between conditions indicative of
physiological changes or symptoms caused by the disease. For
example, assessment of a medical disease or disorder may involve
the determination that levels or amounts of two or more conditions
have a certain relationship with one another. If relationships
between the conditions indicative of physiological changes or
symptoms caused by the disease are consistent with threshold
relationship criteria, the medical disease or disorder may be
present.
[1429] The system may establish a number of thresholds used for
monitoring the progress of the disease. Following detection of the
presence of the medical disease or disorder, the system may track
the progression, regression and/or offset of the disease by
comparing the sensed conditions to the established thresholds.
[1430] FIG. 81 is a flowchart illustrating a method of assessing a
presence of a medical disease in accordance with embodiments of the
invention. Criteria sets for assessment of the non-rhythm pulmonary
diseases are established 8110. The usage of one or more medical
devices is determined 8112. Usage of a medical device may be
implemented, for example, by determining a proximity of the patient
to the medical device.
[1431] In one implementation, the proximity of the patient to an
external breathing therapy device may be determined using a
transmitter coupled to the external breathing therapy device and a
receiver in the selection processor. If the patient is near the
external breathing therapy device, the receiver receives a signal
broadcast by the transmitter. The transmitter may be located on a
bedside unit of the external breathing therapy device, or on the
respiratory mask of the external breathing therapy device, for
example.
[1432] Further, usage of an external device may be implemented in
other ways, involving, for example, notification by the patient
that the external device is in use, or by examining one or more
sensed signals to determine if the sensed signals correspond to
nominal signal values when the medical device is in use by the
patient.
[1433] One or more medical devices are selected 8114 to sense one
or more conditions associated with a medical disorder. The selected
medical devices are used to sense 8116 the one or more conditions.
The system may select the medical devices based on at least one of
a sensing parameter of the medical devices. For example, the system
may select the medical devices based on sensing characteristics
including the type, quality, reliability, repeatability,
efficiency, availability, accuracy, resolution, dynamic range,
specificity, sensitivity or predictive value of the sensing or
measurement provided by the medical device. In one implementation,
a medical device may be selected based on patient usage. For
example, if first and second medical devices are available to sense
patient conditions, the first medical device may be selected to
sense a first condition and a second medical device may be selected
to sense a second condition. However, if only the first medical
device is in use, then both conditions may be sensed using the
first medical device.
[1434] In another implementation, medical device selection may
depend on the sleep/wake cycle of the patient. A first medical
device may be selected to monitor a physiological condition while
the patient is awake, and a second medical device may be selected
to monitor the physiological condition while the patient is
asleep.
[1435] Data is collected 8118 based on the sensed information. In
some implementations, data collection may be initiated based on the
detection of a triggering event. For example, data collection may
be initiated and/or terminated based on the detection of a
respiratory system event, a cardiac event, a sleep event, and/or
other types of events.
[1436] If a presence of the medical disorder was previously
determined 8120, marking an onset of the medical disorder, then the
progression, regression, and/or offset of the medical disorder is
monitored 8122.
[1437] If the presence of the disease was not previously determined
8122, then the levels of the sensed conditions are compared 8124 to
a set of criteria associated with the disease. If levels of the
conditions are consistent 8126 with the threshold levels, then a
presence of the medical disorder is detected 8128.
[1438] The system may continue to collect data based on the sensed
conditions to monitor the progression, regression and/or offset of
the medical disorder. The system may modify the selection of the
medical devices used to sense patient conditions before the
disorder presence is detected and/or during the time that the
system monitors the disorder. For example, the system may check
nightly to determine the usage of a CPAP device. If the CPAP device
is in use on a particular night, the CPAP device may be used to
sense conditions associated with the medical disorder. However, on
a different night, the patient may not use the CPAP. In this
situation, the system may automatically shift the sensing function
previously performed by the CPAP to another medical device.
[1439] Therapy Control Based on Physiologic Cycle
[1440] Aspects of the invention that include therapy control based
on physiologic cycle are directed to methods and systems configured
to monitor, diagnose, and/or provide patient therapy using one or
more individual medical procedures. Each of the circles 180
illustrated in FIGS. 1B-1D represents an individual medical
procedure providing a specific monitoring, diagnosis or therapeutic
function or set of functions. Each individual medical procedure may
be implemented as a stand-alone system. Two or more of the
individual medical procedures 180 may be used in combination to
provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[1441] Other aspects of the invention involving therapy control
based on physiologic cycle are directed to methods and systems
configured to monitor, diagnose, and/or provide therapy using
coordinated medical procedures. Coordinated medical procedures may
involve cooperative operation of two or more of the individual
processes 180. Coordinated medical procedures may also involve
cooperative operation of one or more functions of two or more of
the individual processes 180.
[1442] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1443] Embodiments of the invention involve an individual system
140 (FIG. 1B) for controlling respiratory therapy based on a
patient's cardiac cycle. The respiratory therapy control system 140
may be implemented as a stand alone system or in combination with
other individual medical systems, such as those described in FIGS.
1B-1D.
[1444] Various embodiments of present invention involve methods and
systems for matching intrathoracic pressure with cardiac cycle
phase. One embodiment of the invention involves a method for
delivering airway pressure to a patient. The method includes
determining the cardiac cycle phase and controlling the airway
pressure based on the cardiac cycle phase. Controlling the airway
pressure is performed at least in part implantably.
[1445] In accordance with another embodiment of the invention, a
therapy control system includes a detector system configured to
determine cardiac cycle phase and control unit coupled to the
detector system. The control unit is configured to control airway
pressure based on the cardiac cycle phase. The control unit
includes at least one implantable component.
[1446] In yet another embodiment of the invention, a method for
controlling airway pressure comprises delivering cardiac pacing
pulses to a patient and controlling airway pressure delivered to
the patient based on the delivery of the cardiac pacing pulses.
[1447] A further embodiment of the invention involves a medical
system is configured to control airway pressure delivered to a
patient. The medical system includes a pulse generator configured
to deliver cardiac pacing pulses to a patient's heart and control
circuitry coupled to the pulse generator. The control unit
configured to control airway pressure delivered to the patient
based on the delivery of the cardiac pacing pulses.
[1448] Yet a further embodiment involves a method of delivering and
external respiratory therapy to a patient. The external respiratory
therapy is delivered to a patient to treat disordered breathing.
The cardiac cycle phase of the patient is determined. The delivery
of the external respiratory therapy is controlled based on the
cardiac cycle phase.
[1449] In another embodiment of the invention, a medical system
controls delivery of a patient-external respiratory therapy based
on cardiac cycle phase. The medical system includes a respiratory
therapy unit configured to deliver a patient-external respiratory
therapy to a patient to treat disordered breathing. The system also
includes detector circuitry configured to determine cardiac cycle
phase. A control unit is coupled to the detector system and the
respiratory therapy unit. The control unit is configured to control
delivery of the respiratory therapy based on the cardiac cycle
phase.
[1450] Various embodiments of present invention involve methods and
systems for matching intrathoracic pressure with cardiac cycle
phase. One embodiment of the invention involves a medical system
configured to control cardiac pacing via a respiratory therapy
device. The respiratory therapy device includes a sensor system and
a therapy delivery unit. The system is configured to sense
respiration cycles. The therapy delivery unit is configured to
deliver an external respiratory therapy to the patient.
[1451] The system also includes a pulse generator configured to
deliver cardiac pacing pulses to the patient. A controller is
coupled to the sensing system and the pulse generator. The control
unit configured to adjust a cardiac pacing rate based on the
respiration cycles.
[1452] Another embodiment of the invention involves a method for
controlling cardiac pacing therapy. Respiration cycles are sensed
using one or more sensors of an external respiratory therapy
device. The cardiac pacing is adjusted based on the respiration
cycles.
[1453] Another embodiment of the invention involves a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes the system 140 control of respiratory therapy based
on cardiac cycle. The coordinated system includes, for example, an
implantable cardiac device 181 and a patient-external respiratory
therapy device 184. The system may further include an external
processor 183 providing a coordination function. A communication
channel couples the implantable device 181 and the respiratory
therapy device 184. The implantable 181 and respiratory therapy
devices 184 operate cooperatively via the communication channel to
provide one or more of patient monitoring, diagnosis, and
therapy.
[1454] According to this embodiment, the system providing
coordinated patient monitoring, diagnosis and/or therapy further
includes a system 140 configured to control respiratory therapy
based on cardiac cycle. The respiratory therapy control system 140
includes a detector system configured to determine cardiac cycle
phase, and a control unit coupled to the detector system. The
control unit is configured to control airway pressure based on the
cardiac cycle phase and includes at least one implantable
component.
[1455] Alternatively this embodiment can include a system for
delivering respiratory therapy based on cardiac cycle using a
system 140 that includes a pulse generator configured to deliver
cardiac pacing pulses to a patient's heart; and a control unit
coupled to the pulse generator. The control unit configured to
control airway pressure delivered to the patient based on the
delivery of the cardiac pacing pulses.
[1456] Another alternative embodiment can include a system for
delivering respiratory therapy based on cardiac cycle using a
system 140 that includes a respiratory therapy unit configured to
deliver a patient-external respiratory therapy to a patient to
treat disordered breathing, detector circuitry configured to
determine cardiac cycle phase, and a control unit coupled to the
detector system and the respiratory therapy unit. The control unit
configured to control delivery of the respiratory therapy based on
the cardiac cycle phase. Systems and methods directed to
respiratory therapy control based on cardiac cycle may be
implemented to include selected features, functions, and/or
structures described in commonly owned, co-pending U.S. Publication
No. 2005/0109339, which is hereby incorporated herein by
reference.
[1457] Under healthy conditions, heart rate and blood pressure vary
with respiration. The heart rate varies in response to autonomic as
well as other regulatory inputs to the sinoatrial node (SA). FIG.
82 is a graph comparing respiration 8202, blood pressure 8206, and
heart rate 8204 in a healthy individual. Modulation of heart rate
with respiration is known as respiratory sinus arrhythmia (RSA).
The rate variations of RSA have been found to be important to
survival. Individuals without RSA have higher rates of overall
mortality than those with RSA.
[1458] Respiratory sinus arrhythmia has a role in increasing the
efficiency of the cardiovascular system. In many patients with
cardiovascular disease or heart failure, RSA is attenuated or
absent. Studies have shown that RSA improves pulmonary gas exchange
and circulatory efficiency. Mimicking RSA behavior using a cardiac
pacemaker enhances cardiac function over fixed pacing.
[1459] Some patients suffer from multiple disorders affecting the
cardiac and pulmonary systems. For example, patients suffering from
congestive heart failure (CHF) may experience disordered breathing
as well as a decrease in the pumping action of the heart. In some
cases, patients receive therapy from multiple units to improve
cardiac and respiratory functioning. For example, a patient may
receive treatment for disordered breathing from a patient-external
respiratory therapy unit and the patient may receive cardiac
resynchronization pacing therapy from a patient-internal cardiac
rhythm management (CRM) system.
[1460] Various aspects of the invention are directed to coordinated
use of multiple therapy devices to increase cardiopulmonary
functioning. Some embodiments of the invention utilize information
acquired by sensors of a respiratory therapy device to control
cardiac pacing based on the interactions of cardiac and pulmonary
systems associated with RSA. The cardiac pacing rate may be
modulated by respiration to mimic RSA. Systems and methods directed
to cardiac pacing controllable by use of a respiration therapy
device may be implemented to include selected features, functions,
and/or structures described in commonly owned, co-pending U.S. Pat.
No. 7,302,295, which is hereby incorporated herein by
reference.
[1461] Other embodiments of the invention modulate intrathoracic
pressure based on cardiac cycle phase. In these embodiments,
although the cause/effect relationship of RSA is reversed, the
cardiovascular system may benefit from similar efficiencies as RSA
because intrathoracic pressure is matched to cardiac cycle.
[1462] Methods, devices, and systems in accordance with the present
invention may incorporate one or more of the features, structures,
methods, or combinations thereof described herein below. For
example, a medical system may be implemented to include one or more
of the features and/or processes described below. It is intended
that such a method, device, or system need not include all of the
features and functions described herein, but may be implemented to
include one or more selected features and functions that provide
unique structures and/or functionality.
[1463] FIGS. 83A-83C are diagrams of systems employing a therapy
controller that controls airway pressure delivered by the
respiratory therapy device based on cardiac cycle phase. FIG. 83A
is a block diagram illustrating a system 8300 that may be used to
modulate intrathoracic pressure based on cardiac cycle phase in
accordance with embodiments of the invention. In this example,
intrathoracic pressure is modulated by a positive airway pressure
therapy system 8300 comprising a positive airway pressure therapy
controller unit 8330 and airway pressure delivery components 8348,
8346. Respiratory therapy devices, including positive airway
pressure (xPAP) devices may be used to treat disordered breathing,
heart failure and/or other pulmonary disorders.
[1464] Positive airway pressure therapy is particularly useful in
the treatment of disordered breathing. Disordered breathing may be
caused by an obstructed airway or by derangement of the signals
controlling respiration from the brain. Disordered breathing
typically occurs while the patient is asleep, and is associated
with excessive daytime sleepiness, systemic hypertension, increased
risk of stroke, angina and myocardial infarction. Disordered
breathing is related to congestive heart failure and can be
particularly serious for patients concurrently suffering from
cardiovascular deficiencies. Treatment for disordered breathing
and/or heart failure may involve the used of an xPAP therapy
system. An xPAP therapy system develops a positive air pressure
that is delivered to the patient's airway, keeping the patient's
airway open and reducing the severity and/or number of occurrences
of disordered breathing due to airway obstruction. Reducing the
number of occurrences of disordered breathing lessens the strain on
the heart, thus providing therapy for heart failure.
[1465] The positive airway pressure (xPAP) device 8310 of FIG. 83A,
which is typically a bedside unit, delivers air or other gas
through tubing 8346 to a facial or nasal mask 8348 worn by the
patient. The airway pressure supplied by the xPAP device 8310 acts
as a pneumatic splint keeping the patient's airway open and
reducing the severity and/or number of occurrences of disordered
breathing due to airway obstruction.
[1466] The xPAP device 8310 includes a flow generator 8342 that
pulls in air through a filter. The flow generator 8342 is
controlled by the pressure control circuitry 8344 to deliver an
appropriate air pressure to the patient. Air flows through tubing
8346 coupled to the xPAP device 8310 and is delivered to the
patient's airway through a mask 8348. In one example, the mask 8348
may be a nasal mask covering only the patient's nose. In another
example, the mask 8348 covers the patient's nose and mouth.
[1467] The xPAP device 8310 may include a communications unit for
communicating with one or more separate devices, including
patient-external and/or patient-internal monitoring, diagnostic
and/or therapeutic devices. In one example, the xPAP device 8310
may receive control signals for controlling delivery of the
respiratory therapy from an implantable therapy or monitoring
device. In another example, the xPAP device 8310 may receive
control signals for controlling delivery of the respiratory therapy
from a patient management server or other computing device.
[1468] In one configuration, the xPAP unit 8310 includes a control
unit 8330 that further contains a cardiac cycle sensor 8322. The
cardiac cycle sensor 8322 measures a physiological parameter
associated with the patient's cardiac cycle and sends cardiac cycle
information to a phase detector 8332. The phase detector 8332
detects cardiac cycle phase based on the monitored physiological
parameter. In one implementation, the cardiac cycle information may
be determined from cardiac electrical activity detected using
implantable electrogram (EGM) sensors or patient-external
electrocardiogram (ECG) sensors. In other implementations the
cardiac cycle information may be detected, for example, based on
various parameters that may be sensed by the cardiac cycle sensor
8322, including one or more of blood pressure, blood oxygen
saturation, e.g., via pulse oximetry, thoracic motion, e.g., via
thoracic electrical impedance, heart sounds, airway pressure
modulation, and/or atrial tonometry.
[1469] Cardiac cycle phase may be determined by the timing of
cardiac paces delivered to the patient. In one embodiment,
illustrated in FIG. 83B, the phase detector determines cardiac
cycle phase based on cardiac pacing information received from a
pacemaker control unit 8321. Cardiac pacing information may be used
to determine cardiac cycle phase alternatively or in addition to
sensed physiological parameters acquired by sensors as described in
connection with FIG. 83A.
[1470] FIG. 83C illustrates a medical system for controlling
respiratory therapy in accordance with embodiments of the
invention. The system includes an external respiratory therapy
controller unit 8310 that delivers airway pressure through tubing
8346 and mask 8348. An implantable or patient-external cardiac
cycle sensor is coupled a therapy controller 8330 disposed within a
housing of an implantable cardiac device 8390. The implantable
cardiac device 8390 may comprise, for example, a cardiac therapy
device, cardiac rhythm management (CRM) system, pacemaker,
defibrillator, bi-ventricular pacemaker, intrathoracic cardiac
sensing and/or stimulation (ITCS) system, cardiac resynchronizer,
cardiac monitor, or other implantable cardiac device.
[1471] In one example, cardiac electrodes may be positioned in, on
or about the heart in appropriate locations to sense the cardiac
electrical activity of one or more heart chambers and/or to deliver
pacing pulses to the heart. The cardiac electrodes may be coupled
to the implantable cardiac device 8390 through an intracardiac,
intrathoracic, or subcutaneous lead system.
[1472] In one configuration, cardiac electrical activity is sensed
by intracardiac EGM electrodes. Signals corresponding to the
cardiac electrical activity are transmitted to a control unit 8330
disposed within the implantable housing of the cardiac therapy or
monitoring device 8390. The control unit 8330 evaluates the cardiac
electrical signals to determine cardiac cycle phase. Control
signals for controlling the airway pressure therapy are developed
by the control unit 8330 based on the sensed cardiac electrical
activity. The control signals direct the respiratory therapy
controller unit 8310 to modulate therapy based on cardiac cycle
phase.
[1473] In another configuration, the implantable cardiac device
8390 comprises a cardiac rhythm management (CRM) system including a
pacemaker that delivers cardiac pacing pulses to one or more heart
chambers. The cardiac pacing pulses may be delivered to treat
bradycardia, tachycardia and/or cardiac mechanical dysynchrony.
[1474] The pacing pulses produce contractions of the heart chambers
that may be used to regulate and/or synchronize the heart
contractions to enhance the pumping action of the heart. In this
configuration, the cardiac cycle phase information may be
determined from the timing of the cardiac paces. Cardiac pacing
information, e.g., the timing of pacing pulses delivered to the
heart chambers, may be provided to the therapy control unit 8330 by
the pacemaker of the CRM system 8390. The cardiac pacing
information is used by the therapy control unit 8330 to develop
control signals for controlling the respiratory therapy based on
cardiac phase.
[1475] FIGS. 84A and 84B illustrate systems employing a therapy
controller that develops a signal to control cardiac pacing based
on respiration information acquired from sensors of a respiratory
therapy system. In the block diagram of FIG. 84A, the control
processor 8434 is implemented as a component of the xPAP controller
unit 8310. The control processor 8434 receives respiration
information from a sensor 8422 that senses a parameter modulated by
respiration. In one example, the sensor 8422 may comprise an
airflow sensor of the respiratory therapy device. In other
examples, the sensor 8422 may comprise a motion sensor, such as a
thoracic or abdominal motion sensor.
[1476] The control processor 8434 utilizes the respiration
information to develop a signal for controlling cardiac pacing. The
control information is transmitted to the cardiac pulse generator
8420 through a wireless communications link 8407. Cardiac pacing
pulses, delivered to the heart via the pacemaker 8430 of the
cardiac pulse generator 8420, are modulated with respiration based
on the control signals provided by the control processor 8434.
[1477] FIG. 84B illustrates an embodiment wherein the control
processor 8434 is disposed within the implantable housing of the
cardiac pulse generator 8420. The control processor 8434 receives
respiration information acquired by the respiration sensor 8422 of
the respiratory therapy device. Respiration information is
transmitted to the cardiac pulse generator 8420 through a wireless
communications link 8407. The control processor develops a signal
for controlling cardiac pacing based on the respiration
information. Cardiac pacing pulses, delivered to the heart 8490 via
the pacemaker 8430 of the cardiac pulse generator 8420, are
modulated by respiration.
[1478] FIGS. 85A and 85B are flowcharts of methods that may be
implemented by the systems depicted herein to adjust intrathoracic
pressure based on cardiac cycle phase in accordance with
embodiments of the invention. As illustrated in FIG. 85A, a method
involves determining 8510 cardiac cycle phase by sensing a
physiological parameter associated with a cardiac cycle. Control of
airway pressure is based on 8520 the cardiac cycle phase. In one
embodiment, the physiological parameter used to determine cardiac
cycle comprises cardiac electrical activity which may be sensed
using an EGM sensor. In other implementations, the cardiac cycle
phase may be determined based on a cardiac stroke signal acquired
via a transthoracic impedance sensor or a heart sound signal
acquired via a microphone or an accelerometer.
[1479] The method depicted by the flowchart of FIG. 85B involves
sensing 8530 a physiological parameter indicative of cardiac phase.
During systole 8540, the therapy pressure is increased 8550, e.g.,
above a baseline pressure. During diastole 8560, the therapy
pressure is decreased 8570.
[1480] FIG. 85C illustrates a method of controlling cardiac pacing
in accordance with embodiments of the invention. A parameter
associated with respiration is sensed 8580 using a sensor of a
respiratory therapy device. For example, the respiratory therapy
device may comprise a positive airway pressure device, gas therapy
device, nebulizer, ventilator, or other device that delivers
respiratory therapy to the patient and includes a sensing system
configured to sense a parameter that is modulated by respiration.
In one example, the respiratory therapy device may include or be
coupled to a blood pressure sensor. In another example, the
respiratory therapy device may include or be coupled to an air flow
sensor.
[1481] According to some aspects of the invention, the therapy
controller may control the cardiac device to adjust cardiac pacing
based on respiration information acquired from sensors of the
respiratory therapy system. The therapy controller may modulate
cardiac pacing rate based on respiration cycle information acquired
from the sensors of the respiratory therapy unit. Cardiac pacing is
controlled based on the sensed parameter associated with
respiration. For example, the cardiac pacing rate may be modulated
above and below a base rate to mimic RSA. Modulating the cardiac
pacing rate with respiration restores normal respiratory sinus
arrhythmia in patients who have lost this functionality. Such
therapy is particularly useful for patient's suffering from
cardiopulmonary diseases such as congestive heart failure. In one
embodiment a phase shift is imposed between the respiratory phase
and the cardiac phase produced by the cardiac pacing to more
closely mimic RSA. Methods and systems for controlling cardiac
pacing rate based on respiration, aspects of which may be
incorporated into embodiments of the invention described herein,
are discussed in U.S. Pat. No. 5,964,788, which is incorporated
herein by reference.
[1482] FIG. 86 graphically illustrates modulation of respiratory
therapy pressure based on cardiac phase in accordance with
embodiments of the invention. FIG. 86 compares graphs of an ECG
signal 8610, cardiac stroke signal from an implanted impedance
sensor 8620, therapy pressure 8630, and net respiration flow 8640
(as measured into the patient). The net respiration flow 8640
illustrates the patient's respiration cycle modulated by the
therapy pressure delivered to the patient. As shown in FIG. 86, the
therapy pressure 8630 delivered by the respiratory therapy device
is modulated by the phase of the cardiac cycle. The phase of the
cardiac cycle may be determined based on the ECG signal 8610 and/or
the cardiac impedance stroke signal 8620. Thus, the therapy
pressure is increased above its otherwise static positive value
8632 during cardiac systole. The increased thoracic pressure
reinforces the cardiac contraction and thus reduces cardiac
afterload. During cardiac diastole, the respiratory therapy
pressure is decreased from its otherwise static positive value
8632. Although reduced, the therapy pressure is still positive in
this embodiment. However, in other embodiments the applied pressure
may be zero or negative during cardiac diastole. The reduced
ventilation pressure during cardiac diastole assists the heart in
filling and thereby increases preload. The control unit may
anticipate the cardiac cycle phase based on recent cardiac cycle
history.
[1483] System and Method for Moderating a Therapy Delivered during
Sleep using Physiologic Data Acquired during Non-Sleep
[1484] Aspects of the invention that include moderating a therapy
delivered during sleep using physiologic data acquired during
non-sleep are directed to methods and systems configured to
monitor, diagnose, and/or provide patient therapy using one or more
individual medical procedures. Each of the circles 180 illustrated
in FIGS. 1B-1D represents an individual medical procedure providing
a specific monitoring, diagnosis or therapeutic function or set of
functions. Each individual medical procedure may be implemented as
a stand-alone system. Two or more of the individual medical
procedures 180 may be used in combination to provide more
comprehensive patient monitoring, diagnosis and/or therapy. One or
more functions of two or more individual medical procedures 180 may
be used in combination to enhance patient monitoring, diagnosis
and/or therapy.
[1485] Other aspects of the invention that include moderating a
therapy delivered during sleep using physiologic data acquired
during non-sleep are directed to methods and systems configured to
monitor, diagnose, and/or provide therapy using coordinated medical
procedures. Coordinated medical procedures may involve cooperative
operation of two or more of the individual processes 180.
Coordinated medical procedures may also involve cooperative
operation of one or more functions of two or more of the individual
processes 180.
[1486] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1487] System and method embodiments provide for gathering patient
related data during non-sleep periods and modulating a therapy
delivered to the patient during sleep using the gathered data.
According to one approach, data associated with a patient is
gathered while the patient is awake. A therapy delivered to the
patient during patient sleep is adjusted using the acquired data.
The therapy includes one or both of a respiratory therapy and a
therapy to treat a sleep-related disorder.
[1488] For example, the therapy delivered to the patient may
include one or more of a respiratory therapy, such as a positive
airway pressure (xPAP) therapy, a sleep disordered breathing
therapy, a cardiac rhythm management therapy, such as a cardiac
overdrive pacing therapy, a medication therapy, or a drug delivery
therapy. The therapy delivered to the patient may be enhanced or
optimized using the acquired data. For example, therapy adjustment
and/or optimization may involve performing therapy titration using
the acquired data.
[1489] A pathological disorder may also be detected using the
acquired data. A rate of change in the pathological condition may
be computed and evaluated. In one approach, a pathological
condition may be detected using the acquired data, and a therapy
delivered to the patient may be adjusted in response to the
detected pathological condition.
[1490] The acquired data may include one or more of the following:
respiratory data, breathing pattern data, breathing rate data,
transthoracic impedance data, heart rate data, heart rate
variability (HRV) data, PR interval data, cardiac arrhythmia data,
patient activity data, cardiac sound data or pulmonary sound data,
contextual data impacting the patient, glucose level data,
autonomic nervous system activity data, medication use data, blood
pressure data, blood oxygen level data, and/or symptom-based data.
Contextual data may include environmental parameters, examples of
which include temperature, humidity, pollution, barometric
pressure, and body related parameters such as posture and
location.
[1491] Embodiments of the invention involve an individual system
129 (FIG. 1B) for moderating a therapy delivered during sleep using
physiologic data acquired during non-sleep. The system 129 for
moderating a therapy delivered during sleep using physiologic data
acquired during non-sleep may be implemented as a stand alone
system or in combination with other individual medical systems,
such as those described in FIGS. 1B-1D.
[1492] Embodiments of the invention involve a system for providing
coordinated patient monitoring, diagnosis and/or therapy that
utilizes moderation 129 of a therapy delivered during sleep using
physiologic data acquired during non-sleep. The coordinated system
may include, for example, an implantable cardiac device 181 and a
patient-external respiratory therapy device 184. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the implantable device
181 and the respiratory therapy device 184. The implantable 181 and
respiratory therapy devices 184 operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy. Systems and methods directed to moderating
a therapy delivered during sleep using physiologic data acquired
during non-sleep may be implemented to include selected features,
functions, and/or structures described in commonly owned,
co-pending U.S. Publication No. 2005/0080461, which is hereby
incorporated herein by reference.
[1493] The following discussion, with reference to FIGS. 87A-87C,
describes embodiments of the invention involving use of diurnal
data to aid nocturnal therapy and diagnosis of sleep disorders. The
processes and systems exemplified by these embodiments may be
implemented alone or in combination with one or more processes and
systems exemplified by other embodiments described herein to
provide a coordinated approach to patient monitoring, diagnosis,
and/or therapy.
[1494] In accordance with embodiments of the invention, many types
of data acquired during non-sleep periods may be used to adjust or
enhance therapy during periods of sleep. The data acquired during
non-sleep may also be used to provide enhanced diagnostic
capabilities for sleep-related disorders. The data acquired during
non-sleep may be used, for example, to determine the existence of a
condition that occurs during non-sleep periods and is caused, or
results from, a sleep-related disorder. The data acquired during
non-sleep may determine the extent of the condition, the rate of
change of the condition, the amount of change of the condition
relative to a baseline, and/or the effect of nocturnal therapy for
the condition.
[1495] Examples of data acquired during non-sleep that may aid in
nocturnal therapy and diagnosis include: transthoracic impedance or
other arrangement to assess pathological breathing patterns or
conditions such as Cheyne-Stokes breathing, periodic breathing,
rapid breathing, respiratory rates, inspiration/expiration
intervals, pulmonary function parameters, including for example,
forced expiratory volume (FEV) and forced vital capacity (FVC);
heart rates, postventricular (PV) intervals and cardiac
arrhythmias; activity level; cardiac and pulmonary sounds, (e.g.,
S3, rales, coughs); environmental data, (e.g., air pollution,
humidity); glucose levels; autonomic nervous system activity;
medication use, particularly for patients whose use is aperiodic
and patient determined (e.g., albuterol for asthma); blood pressure
(e.g., average arterial, left atrial end diastolic); blood oxygen
level; posture; and symptom-based data (e.g., dyspnea, daytime
sleepiness, fatigue, restless leg syndrome (RLS) symptoms).
[1496] A variety of sleep-time therapy may be modulated using the
data acquired during non-sleep. In one implementation, data
acquired during non-sleep may be used to modulate respiration
therapy for disordered breathing, e.g., xPAP therapy. In another
implementation, data acquired during non-sleep may be used to
adjust cardiac overdrive pacing for sleep disordered breathing. In
yet another implementation, data acquired during non-sleep may be
used to adjust medications used for sleep disorders, e.g.,
benzodiazepine, tricyclic antidepressants, and theophylline, among
others. In another implementation, data acquired during non-sleep
may be provided to the patient for behavior modification (e.g.,
excessive activity too close to sleep time).
[1497] Referring to FIG. 87A, a system 8700 in accordance with an
embodiment of the present invention includes a data acquisition
unit 8704 configured to acquire data associated with a patient
while the patient is awake. The data acquisition unit 8704 is
coupled to a therapy delivery system 8706 configured to adjust a
therapy delivered to the patient, during patient sleep, using the
acquired data. One or more sensor(s) 8702 are used to sense
physiological signals useful to the data acquisition unit 8704.
[1498] As illustrated in FIG. 87B, a system, in accordance with an
embodiment of the invention, includes one or more patient-internal
and/or patient-external sensors 8720 for sensing non-sleep
conditions related to disordered breathing. Signals from the one or
more sensors 8720 may be acquired by a disordered breathing
detector 8712 in a patient-internal or patient-external medical
device 8710 and used to detect non-sleep episodes of disordered
breathing. In one implementation, respiratory signals, sensed using
the sensor 8720, such as a transthoracic impedance sensor, are
detected during non-sleep periods.
[1499] The respiration signals may be stored in the memory of a
monitoring unit 8714 within the medical device 8710. The
respiration signals may be trended, displayed, and/or transmitted
to another device, such as an advanced patient management (APM)
system 8730 or a programmer 8740 periodically or on command.
[1500] The non-sleep respiration signals may be used to modify
therapy for sleep disordered breathing. In one example, the APM
system 8730 analyzes the non-sleep respiration signals to determine
the presence and/or severity of non-sleep time periodic breathing.
The APM system 8730 may use information about disordered breathing,
such as the onset or extent of periodic and/or Cheyne-Stokes
breathing during non-sleep periods, to determine the optimal sleep
time xPAP therapy for Cheyne-Stokes breathing and/or central sleep
apnea therapy. The APM system 8730 determines a modified therapy
based on the non-sleep respiration signals.
[1501] In one example, when periodic and/or Cheyne-Stokes breathing
increases or decreases, the pressure delivered by an xPAP therapy
unit may be increased or decreased, respectively. In another
example, non-sleep time breathing information may be used to modify
the initial pressures for an auto-titrating PAP device. The APM
system 8730 may transmit control signals to a therapy device 8750,
e.g., a respiration therapy device such as an xPAP device, to
modify therapy delivered to the patient during sleep.
[1502] Although the example provided in FIG. 87B contemplates the
use of the APM system 8730 to analyze the non-sleep signals and
modify the sleep time delivered therapy, the medical device 8710
may perform one or both of these functions.
[1503] In another embodiment of the invention, illustrated in FIG.
87C, cardiac information is used to adjust cardiac overdrive pacing
prescribed for the treatment of sleep disordered breathing. In this
embodiment, a cardiac signal detector unit 8716 within an implanted
or external device 8780 detects cardiac signal information from
cardiac electrodes 8760, e.g., implanted, subcutaneous, surface
electrodes or combinations thereof, during non-sleep periods. The
cardiac information may be saved in the memory of a monitoring unit
8712 within the medical device 8780. The cardiac information may be
trended, displayed, or transmitted to another device, such as a
programmer 8740 or an APM system 8730.
[1504] The non-sleep period cardiac information may be analyzed to
determine an enhanced or optimum cardiac electrical stimulation
therapy for sleep disordered breathing. In this example, the
non-sleep cardiac information is analyzed in a data analysis unit
8790 within the medical device 8780. In another implementation, the
cardiac information may be analyzed by the APM 8730 or other
device.
[1505] In this example configuration, the medical device 8780 uses
the cardiac information to adjust timing parameters in an implanted
therapy device 8770, such as a CRM device. For example, the data
analysis unit 8790 may determine an average intrinsic heart rate
and/or an average PR interval during non-sleep periods. These
values may be used to enhance the rate and AV delay used by the
cardiac overdrive pacing therapy prescribed to treat sleep
disordered breathing in subsequent sleep periods.
[1506] In one illustrative configuration, the functions of the
medical device 8780, including the cardiac signal detector 8716,
the monitoring unit 8712 and/or the data analysis unit 8790, and
the implanted therapy device 8770 are located within an implantable
CRM device 181. In this configuration, the data analysis unit 8790
receives cardiac signals from implanted cardiac electrodes during
non-sleep times. The data analysis unit 8790 analyzes the cardiac
signals to adjust therapy delivered by the CRM device 181 to treat
sleep disordered breathing.
[1507] FIG. 88 illustrates a method 8800 of moderating sleep
therapy using physiologic data acquired during non-sleep. A sensor
(internal or external to the patient, such as an EEG sensor) is
used at block 8802 to sense a patient's non-sleep state physiologic
condition. The data, trends, or selected parameters may then be
stored in memory of an implantable device and/or a patient-external
device such as an APM device or server system.
[1508] A determination 8804 is made that the patient is asleep. If
the patient is sleeping, the information stored during the
non-sleep period is used at block 8806 to, for example, compare the
current paced heart rate to the non-sleep intrinsic heart rate. A
decision 8808 is then made to select continuation of the current
therapy or to modify patient therapy based at least in part on
physiologic data acquired during non-sleep. If treatment
modification is desired, the modification is performed at block
8810 before re-starting the method 8800.
[1509] In certain embodiments, sounds, such as hearts sounds and
pulmonary sounds, are used to aid in moderating sleep therapy using
physiologic information acquired during non-sleep. Because heart
sounds are time correlated with respect to the cardiac
electrophysiological signals, the non-electrophysiologic signal may
provide information about a patient's rhythm state even in the
presence of electrical noise and/or electrocardiographic artifacts.
A subcutaneous sensor, such as an accelerometer or acoustic
transducer, may be used to detect heart sounds. It should also be
noted that other sensor derived signals could replace heart sounds.
For example, impedance, pulse pressure, blood volume/flow, or
cardiac accelerations could be used.
[1510] Various types of acoustic sensors may be used to detect
heart sounds. Examples of such acoustic sensors include diaphragm
based acoustic sensors, MEMS-based acoustic sensors such as a
MEMS-based acoustic transducer, fiber optic acoustic sensors,
piezoelectric sensors, and accelerometer based acoustic sensors and
arrays. These sensors may be used to detect audio frequency (and/or
subsonic frequency) pressure waves associated with the heart
sounds, and may also be used to detect other non-electrophysiologic
cardiac related signals.
[1511] The presence of cardiac pulse, or heartbeat, in a patient is
generally detected by palpating the patient's neck and sensing
changes in the volume of the patient's carotid artery due to blood
pumped from the patient's heart. A graph of a carotid pulse signal
8910, representative of the physical expansion and contraction of a
patient's carotid artery during two consecutive pulses, or
heartbeats, is shown at the top of FIG. 89. When the heart's
ventricles contract during a heartbeat, a pressure wave is sent
throughout the patient's peripheral circulation system. The carotid
pulse signal 8910 shown in FIG. 89 rises with the ventricular
ejection of blood at systole and peaks when the pressure wave from
the heart reaches a maximum. The carotid pulse signal 8910 falls
off again as the pressure subsides toward the end of each
pulse.
[1512] The opening and closing of the patient's heart valves during
a heartbeat causes high-frequency vibrations in the adjacent heart
wall and blood vessels. These vibrations may be heard in the
patient's body as heart sounds, and may be detected by sensors, as
described earlier. A conventional phonocardiogram (PCG) transducer
placed on a patient converts the acoustical energy of the heart
sounds to electrical energy, resulting in a PCG waveform 8920 that
may be recorded and displayed, as shown by the graph in the upper
middle portion of FIG. 89.
[1513] As indicated by the PCG waveform 8920 shown in FIG. 89, a
typical heartbeat produces two main heart sounds and may produce
other sounds depending on pathology. A first heart sound 8930,
denoted S1, is generated by vibration generally associated with the
closure of the tricuspid and mitral valves at the beginning of
systole. Typically, the heart sound 8930 is about 14 milliseconds
long and contains frequencies up to approximately 500 Hz. A second
heart sound 8940, denoted S2, is generally associated with
vibrations resulting from the closure of the aortic and pulmonary
valves at the end of systole. While the duration of the second
heart sound 8940 is typically shorter than the first heart sound
8930, the spectral bandwidth of the second heart sound 8940 is
typically larger than that of the first heart sound 8930. A third
heart sound 8942, denoted S3, is also seen in the PCG waveform
8920. The S3 heart sound 8942 is created when the ventricles relax
and pressure from the filling blood rapidly distends the ventricle.
When the stiff, non-compliant ventricular wall reaches its physical
limits, it suddenly tenses, and the S3 sound is created. In
children an S3 is common and normal. After age 40, it almost always
indicates the failing heart in congestive heart failure. As stated
earlier, an accelerometer or acoustic transducer may also detect
pulmonary sounds, such as rales and/or coughs, to provide
physiologic data.
[1514] An electrocardiogram (ECG) waveform 8950 describes the
electrical activity of a patient's heart. The graph in the lower
middle portion of FIG. 89 illustrates an example of the ECG
waveform 8950 for two heartbeats and corresponds in time with the
carotid pulse signal 8910 and PCG waveform 8920 also shown in FIG.
89. Referring to the first shown heartbeat, the portion of the ECG
waveform 8950 representing depolarization of the atrial muscle
fibers is referred to as the "P" wave. Depolarization of the
ventricular muscle fibers is collectively represented by the "Q."
"R," and "S" waves of the ECG waveform, referred to as the QRS
complex. Finally, the portion of the waveform representing
repolarization of the ventricular muscle fibers is known as the "T"
wave. Between heartbeats, the ECG waveform 8950 returns to an
isopotential level.
[1515] Fluctuations in a patient's transthoracic impedance signal
8960 also correlate with blood flow that occurs with each cardiac
pulse wave as well as provide breathing information. The bottom
graph of FIG. 89 illustrates an example of a filtered transthoracic
impedance signal 8960 for a patient in which fluctuations in
impedance correspond in time with the carotid pulse signal 8910,
the PCG waveform 8920, and ECG waveform 8950, also shown in FIG.
89.
[1516] Automatic Activation of Medical Processes
[1517] Aspects of the invention that include automatic activation
of medical processes are directed to methods and systems configured
to monitor, diagnose, and/or provide patient therapy using one or
more individual medical procedures. Each of the circles 180
illustrated in FIGS. 1B-1D represents an individual medical
procedure providing a specific monitoring, diagnosis or therapeutic
function or set of functions. Each individual medical procedure may
be implemented as a stand-alone system. Two or more of the
individual medical procedures 180 may be used in combination to
provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[1518] Other aspects of the invention that include automatic
activation of medical processes are directed to methods and systems
configured to monitor, diagnose, and/or provide therapy using
coordinated medical procedures. Coordinated medical procedures may
involve cooperative operation of two or more of the individual
processes 180. Coordinated medical procedures may also involve
cooperative operation of one or more functions of two or more of
the individual processes 180.
[1519] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1520] Embodiments of the invention may involve automatic control
of therapies or other medical processes based on sleep stage, such
as is determined by brain activity. Automatic control may involve
automatic activation, de-activation and/or modification of such
therapies and processes. In various embodiments, a system includes
a sensor system having one or more sensors configured to sense
signals related to the brain activity of the patient. A brain
activity analyzer detects various brain states, including, for
example, sleep state/stage and/or brain seizures. The brain
activity detector may also be configured to discriminate between
sleep and wakefulness. A controller uses the brain state detection
information to control a medical system configured to perform at
least one respiratory or cardiac process.
[1521] Other embodiments include at least one of an EEG sensor and
an EMG sensor configured for one or more of detecting brain state.
One or more sensors may be positioned on a respiratory mask of a
respiratory device, such as a positive airway pressure therapy
device. Further embodiments include a cardiac rhythm management
device, wherein the cardiac process may involve one or both of a
cardiac therapy process and a breathing therapy process. The
cardiac process may further involve a diagnostic process and/or a
monitoring process.
[1522] According to other embodiments, a method involves sensing
signals related to brain state and determining the brain state of a
patient based on the sensed signals. At least one respiratory or
cardiac medical process is activated, de-activated, modified or
otherwise controlled based on the patient's brain state.
[1523] Further embodiments involve sensing the signals related to
brain state using EEG signals and/or EMG signals. Sensing signals
related to brain state may further involve sensing signals related
to sleep stage. Sensing signals related to brain state may involve
sensing seizure, and activating the medical process may involve
activating, de-activating, modifying or otherwise controlling
arrhythmia therapy based on seizure detection.
[1524] Embodiments of the invention involve an individual system
132 (FIG. 1B) for automatic activation of medical processes based
on brain state. A system employing automatic activation of medical
processes 132 may be implemented as a stand alone system or in
combination with other individual medical systems, such as those
described in FIGS. 1B-1D.
[1525] Other embodiments involve a system for providing coordinated
patient monitoring, diagnosis and/or therapy that employ automatic
activation of medical processes 132. A coordinated system may
include, for example, one or both of an implantable cardiac device
181 and a patient-external respiratory therapy device 184. The
system may further include an external processor 183 providing a
coordination function. A communication channel couples the
implantable device 181 and the respiratory therapy device 184. The
implantable 181 and respiratory therapy devices 184 operate
cooperatively via the communication channel to provide one or more
of patient monitoring, diagnosis, and therapy.
[1526] Two or more of the implantable device 181, respiratory
therapy device 184, and external processor 183 may operate
cooperatively based on brain state for employing automatic
activation of medical processes 132. For example, detection of
brain state may allow two or more of the implantable device 181,
respiratory therapy device 184, and external processor 183 to
operate cooperatively to provide a therapy to treat a cardiac,
respiratory, or other condition.
[1527] The following discussion, with reference to FIGS. 90A-91,
describes embodiments of the invention involving automatic
activation, de-activation, modification and/or control of therapy
based on sleep stage. Sleep stage may be detected using various
approaches, including, for example, by detecting brain activity,
skeletal muscle movement, heart rate or other cardiac timing or
intervals (e.g., PR interval), respiratory patterns, and/or other
activity/signal that can be used as a surrogate measurement of
sleep. The processes and systems exemplified by these embodiments
may be implemented alone or in combination with one or more
processes and systems exemplified by other embodiments described
herein to provide a coordinated approach to patient monitoring,
diagnosis, and/or therapy. Systems and methods directed to
automatically activating medical processes may be implemented to
include selected features, functions, and/or structures described
in commonly owned, co-pending U.S. Pat. No. 7,668,591, which is
hereby incorporated herein by reference.
[1528] Although disordered breathing may occur while the patient is
awake, the disorder is much more prevalent while the patient is
sleeping. In various embodiments of the invention, sleep stage
information is used to enhance sleep disordered breathing therapy
and/or diagnosis of a variety of sleep related disorders.
[1529] In accordance with various embodiments, sleep stage
detection may be used to trigger therapy for disordered breathing.
Using this approach, administration of disordered breathing therapy
may be coordinated with a particular sleep stage. For example,
disordered breathing episodes are typically more frequent during
stage 1 or stage 2 sleep. The system may use sleep stage detection
to deliver the therapy during these sleep stages. REM sleep and
sleep stages 3 and 4 are the most restful sleep stages, therefore
it is desirable to avoid interruption of sleep during these stages.
The system may terminate or reduce the level of therapy during REM
sleep and sleep stages 3 and 4 when avoidance of sleep
interruptions are most desirable.
[1530] Sleep stage detection may be accomplished using a number of
techniques, including, for example, a technique using muscle atonia
sensors. Sleep stage detection may also be effected using
patient-internal or patient-external sensors, including, for
example EEG sensors and/or EMG sensors. In one configuration, the
sensors, e.g., EEG and/or EMG sensors, used in combination with a
respiratory therapy device, such as an xPAP device, may be
positioned on the xPAP mask. Sleep stage detection may also be
derived from heart rate, cardiac PR intervals (or other cardiac
timing), tidal volume, respiratory rate, minute ventilation, body
core temperature, or other physiological measurements that are
affected by autonomic control.
[1531] Sleep stage information may also be valuable in the context
of diagnosing various disorders, including sleep-related disorders.
In accordance with one embodiment, sleep information, including
sleep onset, offset, sleep stages, sleep efficiency, sleep latency,
and the number and degree of arousals may be collected by the
system for storage, display, or transmission to a remote device.
The sleep-related information may be evaluated along with
information about detected disordered breathing episodes to more
fully understand how sleep disordered breathing affects a
particular patient. The use of EEG sensors also allows detection of
abnormal brain activity, including seizures. The EEG sensor
information may be collected and used for a variety of diagnostic
and therapeutic purposes.
[1532] FIG. 90A is a flow chart illustrating a system 9001 useful
for activating, de-activating or modifying a medical process using
brain state information in accordance with embodiments of the
invention. The system 9001 involves sensing brain activity with a
sensor 9002, either directly, such as by using an EEG sensor to
measure brain-waves, or indirectly, such as by using an EMG sensor
to measure muscular response to neurostimulation. An EMG sensor may
be implemented, for example, using an electromyogram (EMG)
electrode or force responsive sensor positioned on the housing of
an implantable medical device. An EMG sensor may, for example, be
positioned on the header of the implantable medical device.
Alternatively, an EMG sensor (e.g., EMG electrode or strain gauge)
may be positioned on a lead system or may be coupled to the housing
through a catheter or lead system.
[1533] A brain activity detector 9003 receives information from the
sensor 9002 and determines a brain state, which is used by a
controller 9004. The controller 9004 may control one or both of an
implantable medical device 9005 and a respiratory therapy unit
9006. The implantable medical device 9005 and/or the respiratory
therapy unit 9006 provides therapy based on information about the
sensed brain activity.
[1534] A system utilizing sleep stage sensors in connection with
the control of diagnostic and/or therapeutic functions of a
disordered breathing system in accordance with an embodiment of the
invention is illustrated in FIG. 90B. In this embodiment,
patient-internal or patient-external sensors 9014, for example EEG
and/or EMG sensors, are coupled to a therapy device 9011. The
therapy device 9011 includes a sleep stage processor 9012 that
analyzes the sensor signals to detect the patient's sleep state,
including sleep offset, onset, and stages of sleep.
[1535] The sleep stage processor 9012 is coupled to a therapy
control unit 9013. The therapy control unit 9013 may control
various types of therapy, including, for example, disordered
breathing therapy, cardiac pacing therapy, respiratory therapy,
electrical stimulation therapy, muscle stimulation therapy, nerve
stimulation therapy, and/or pharmacological therapy, among other
therapy types. The therapy control unit 9013 uses the sleep
information to initiate, terminate or adjust therapy to the patient
based on the patient's sleep stage.
[1536] The therapy device 9011 may further include a memory 9014
that receives and stores information from the sleep stage processor
9012, the sensors 9014 and/or other components. The information
stored in the memory 9015 may be displayed and/or downloaded to a
remote device, or used for a variety of diagnostic purposes.
[1537] Another embodiment of the invention is illustrated in FIG.
90C. In accordance with this embodiment, a first therapy device
9070 is used to control therapy delivery of a second therapy device
9090. The first therapy device 9070 includes a sleep stage
processor 9072 coupled to sensors 9080, e.g., EEG and/or EMG
sensors. The sleep stage processor receives signals from the
sensors 9080 and analyzes the sensor signals to determine sleep
onset, offset, and stages of sleep.
[1538] Sleep stage information is transferred from the sleep stage
processor 9072 to a first therapy control unit 9074 and a second
therapy control unit 9076. The therapy control units 9074, 9076 use
the sleep stage information to initiate, terminate or modify the
therapy delivered by the first and the second therapy devices 9070,
9090, respectively, based on the patient's sleep state.
[1539] The first therapy device 9070 may also include a memory 9077
that receives and stores information from the sleep stage processor
9072, the sensors 9080 and/or other components. The information
stored in the memory 9077 may be displayed and/or downloaded to a
remote device, or used for a variety of diagnostic purposes.
[1540] A further embodiment of the invention is illustrated in FIG.
90D. According to this embodiment, first and second therapy devices
9010, 9030 deliver first and second therapies to a patient. The
first therapy device 9010 may be implemented as a CRM device,
providing cardiac pacing and/or defibrillation therapies to treat
various arrhythmias and/or to provide resynchronization therapy,
for example. The CRM device 9010 may also deliver electrical
stimulation therapy to the heart to treat disordered breathing.
[1541] The second therapy device 9030 may be implemented as
respiratory therapy device, such as an xPAP device. The xPAP device
9030 delivers air or other gas therapy at a controlled pressure to
the patient's airway.
[1542] EEG sensors 9020 are coupled to a sleep stage processor 9060
located in the CRM device 9010. Other sensors, such as EMG sensors,
may also be included. Signals from the EEG and/or other sensors
9020 are analyzed by the sleep stage processor 9060 to determine
various stages of sleep, including sleep onset, offset, sleep
stage, the number and frequency of arousals, and the degree of
arousal.
[1543] Information from the sleep stage processor 9060 is provided
to the respiratory therapy controller 9050 located in the CRM
device 9010. The respiratory therapy controller 9050 uses the sleep
stage information to initiate, terminate, or modify the respiratory
therapy based on the sleep stage.
[1544] Information from the sleep stage processor 9060 and a brain
wave analyzer 9062 is provided to the CRM therapy controller 9040.
The CRM therapy controller 140 includes a disordered breathing (DB)
therapy control unit 9042 that uses the sleep stage information to
initiate, terminate, or modify electrical stimulation DB therapy
delivered by the CRM device 9010 based on the patient's sleep
state.
[1545] The CRM therapy controller 9040 may further include an
arrhythmia therapy control unit 9044. Information from the sleep
stage processor 9060 and the brain wave analyzer 9062 may be used
by the arrhythmia therapy control unit to 9044 initiate, terminate,
or modify arrhythmia therapy delivered to the patient.
[1546] For example, the CRM therapy controller 9040 may decrease
the cardiac pacing rate to a sleep rate upon sleep onset and raise
the pacing rate at sleep offset. Further, the CRM therapy
controller 9040 may adjust the pacing therapy delivered to the
patient during proarrhythmic sleep periods, such as REM sleep or
the during morning arousal. In one example, the arrhythmia therapy
control unit 9044 may deliver atrial overdrive pacing during
proarrhythmic sleep periods to prevent the occurrence of
arrhythmia.
[1547] The EEG sensor signals may also be used by a brain wave
analyzer 9062 to evaluate brain activity. The brain wave analyzer
9062 detects abnormal brain activity, such as seizures. Patients
may have seizures during the night and not realize that the
seizures have occurred. Some seizures are accompanied by cardiac
rhythm disturbances. The brain wave analyzer 9062 may detect the
occurrence of seizures and provide information about the seizures
to the arrhythmia therapy control unit 9044. The arrhythmia therapy
control unit 9044 may modify the CRM therapy to treat cardiac
rhythm disturbances cause by, or associated with, seizures. The
arrhythmia therapy control unit 9044 may also withhold therapy for
rhythm disturbances that are associated with seizures.
[1548] The CRM device 9010 may include a memory 9064 for storing
information from the sleep stage processor 9060, the brain wave
analyzer 9062 and other components of the CRM device 9010. Stored
information may be transferred to a display or other device.
[1549] Autonomic arousal responses, as detected using EEG sensors
and EMG sensors, are indicative of brain state. Arousal may be
detected from changes in the sympathetic or parasympathetic nervous
system. These changes may be either short-term (i.e., changes
associated with individual arousals) or long-term (i.e., aggregate
effect of multiple arousals). A short-term effect of arousal
includes, for example, the activation of sympathetic nerve
activities. Sympathetic or parasympathetic changes, or the changes
of autonomic balance, may be assessed, for example, by heart rate
variability (HRV), which may be readily detected using a CRM
device.
[1550] Arousal information may be also used by the sleep stage
processor 9060 to augment disordered breathing detection. For
example, arousal information may be used to confirm occurrences of
disordered breathing. Arousal information may be used to
distinguish between correctly and incorrectly identified disordered
breathing occurrences indicated by the disordered breathing
detector. Further, information from arousal detection may be used
to separate disordered breathing episodes, e.g., apnea and/or
hypopnea, followed by arousal versus those terminated without
arousal. The disordered breathing events that are followed by
arousal are considered to be the most disruptive, as these arousals
interrupt the normal course of sleep and prevent the patient from
receiving a full sleep cycle each night. Detecting these types of
disordered breathing events may enhance the specificity of
disordered breathing detection.
[1551] FIG. 91 illustrates a method 9100 for implantably sensing
and detecting brain state. A brain state sense signal is sensed at
a block 9102. Brain state may be sensed, for example, directly
using EEG sensors, and/or indirectly using ECG sensors, EEG
sensors, EMG sensors, transthoracic impedance sensors, or other
sensors suitable for determining patient brain state. If the
patient is sleeping, brain state may be detected using the brain
state sense signal illustrated by determination block 9104.
[1552] The brain state detected at determination block 9104
provides various types of information recorded at block 9106. For
example, date, time, sensor data, sense signal amplitudes and/or
cycle lengths. This and other information may be useful for
updating, developing, and/or determining an arousal index, an
apnea/hypopnea index, a composite index and other parameters useful
for patient diagnosis and treatment, such as the automatic
activation, de-activation or modification of medical processes.
This information may be useful for detecting abnormal brain
activity, such as seizures. The information recorded at block 9106
may be useful, for example, to predict, verify, classify, and/or
determine the severity of a disordered breathing episode and
abnormal brain activity.
[1553] If intervention and/or treatment is desired at determination
block 9108, the intervention and/or treatment may be performed at
block 9110 before re-starting the method 9100. For example, the
intervention at block 9110 may be the automatic activation of a
medical process, modification of a patient's CRM stimulation,
modification of a disordered breathing therapy, or other desirable
action.
[1554] Implantable Device Employing Movement Sensing for Detecting
Sleep-Related Disorders
[1555] Aspects of the invention that include movement sensing for
detecting sleep-related disorders are directed to methods and
systems configured to monitor, diagnose, and/or provide patient
therapy using one or more individual medical procedures. Each of
the circles 180 illustrated in FIGS. 1B-1D represents an individual
medical procedure providing a specific monitoring, diagnosis or
therapeutic function or set of functions. Each individual medical
procedure may be implemented as a stand-alone system. Two or more
of the individual medical procedures 180 may be used in combination
to provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[1556] Other aspects of the invention that include movement sensing
for detecting sleep-related disorders are directed to methods and
systems configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures. Coordinated medical
procedures may involve cooperative operation of two or more of the
individual processes 180. Coordinated medical procedures may also
involve cooperative operation of one or more functions of two or
more of the individual processes 180.
[1557] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1558] Embodiments of the invention are directed to systems and
methods for detecting sleep-related disorders involving sensing
physiological signals including at least muscle movement signals.
Sleep-related disorders are detected using the sensed physiological
signals. The sleep-related disorders include at least an
involuntary muscle movement disorder and sleep-disordered
breathing. The physiological signals may include movement signals,
such as electromyogram signals, at least some of which may be
sensed from one or more intramuscular and/or skin/surface
locations. The physiological signals may include transthoracic
impedance signals, which may be sensed implantably.
[1559] Embodiments of methods of detecting sleep-related disorders
may involve detecting one or more sleep stages using muscle
movement signals. Methods may also involve delivering and/or
controlling a therapy to treat one or more of the detected
sleep-related disorders, such as a respiratory therapy, a cardiac
pacing therapy, a nerve stimulation therapy, and/or a drug
therapy.
[1560] Embodiments may involve detecting the sleep-related
disorders patient-externally and/or patient-internally. Detecting
the sleep-related disorders may involve detecting a first
sleep-related disorder patient-internally and detecting a second
sleep-related disorder patient-externally. Methods may further
involve detecting one or more sleep stages using the muscle
movement signals.
[1561] Sleep-disordered breathing may include sleep apnea,
hypopnea, and/or Cheyne-Stokes respiration, and sleep-related
disorders may include bruxism, periodic limb movement disorder,
and/or restless leg syndrome. One or both of the physiological
signals and information associated with the detected sleep-related
disorders may be communicated to a patient-external processing
system or an implantable medical device. Methods may further
involve delivering and/or controlling a therapy to treat one or
more of the detected sleep-related disorders, such as by delivering
a respiratory therapy, a cardiac pacing therapy, a nerve
stimulation therapy, and/or a drug therapy.
[1562] According to other embodiments, systems for detecting
sleep-related disorders include one or more movement sensors, such
as electromyogram (EMG) sensors, configured for sensing (internally
and/or externally) movement of skeletal musculature and a sensor
configured to sense a parameter associated with sleep-disordered
breathing (SDB). A processor may be communicatively coupled to the
movement sensors and the SDB sensor for detecting sleep-disordered
breathing based on the sensed parameter and detecting an
involuntary muscle movement disorder using signals produced by the
movement sensors. The processor may be disposed in an implantable
housing.
[1563] The processor may be disposed in a patient-external and/or
patient-internal processing system. For example, the processor may
be a networked processor, a component of a cardiac rhythm
management system, a component of a respiratory therapy system,
and/or a component of a positive airway pressure device.
[1564] The SDB sensor and/or sleep detector may include a
transthoracic impedance sensor. The sleep detector may be
communicatively coupled to the processor. Conditions detected by
the processor include hypopnea, bruxism, involuntary muscle
movement disorder, periodic limb movement disorder, and/or restless
leg syndrome. A therapy delivery system may be configured to treat
the sleep-disordered breathing and involuntary muscle movement
disorder. A cardiac rhythm management system, a drug delivery
device, a nerve stimulation device, and/or a positive airway
pressure device may be configured to treat the sleep-related
disorder.
[1565] Movement sensors may include one or more accelerometers, one
or more electromyogram (EMG) sensors, or a combination of these
sensors. The system may include a communications interface for
communicating acquired movement data and/or detection information
to a patient-external and/or patient-internal processing system.
Control signals may also be communicated unidirectionally or
bidirectionally between the system and a remote processing
system.
[1566] Embodiments of the invention involve an individual system
127 (FIG. 1C) that provides movement sensing for detecting
sleep-related disorders. The 127 may be implemented as a stand
alone system or in combination with other individual medical
systems, such as those described in FIGS. 1B-1D and in FIG. 92.
[1567] Other embodiments of the invention involve a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes movement sensing for detecting sleep-related
disorders 127. The coordinated system may include, for example, an
implantable cardiac device 181, a patient-external respiratory
therapy device 184, and/or other devices, such as a drug therapy
device and/or a nerve stimulation therapy device. The system may
further include an external processor 183 providing a coordination
function. A communication channel couples the various devices. The
devices (e.g., implantable device 181, respiratory therapy device
184, drug therapy device, nerve stimulation therapy device, and/or
external processing device) operate cooperatively via the
communication channel to provide one or more of patient monitoring,
diagnosis, and therapy.
[1568] The devices may operate cooperatively based on sensed
movement indicative of sleep-related disorders 127. For example,
sensing movement indicative of sleep-related disorders 127 may
allow the various implantable and/or external devices to operate
cooperatively to provide an appropriate therapy to treat a detected
sleep-related disorder.
[1569] A number of disorders, for example, sleep-disordered
breathing and movement disorders such as PLMD, occur primarily
while the patient is asleep. Information about the patient's sleep
stage may be used to enhance sleep monitoring and/or diagnosis of a
variety of disorders. In addition, it may be useful to provide a
first therapy while the patient is awake and a second therapy while
the patient is asleep. Detection of muscle movement, such as
indicated by EMG, may be used to diagnose disorders as well as
trigger the sleep-time therapy in a respiratory and/or cardiac
device. Data acquired during sleep may assist in diagnosing various
sleep-related disorders. The collected data may be stored,
displayed, printed, or transmitted to a separate device.
[1570] Systems and methods may acquire and process electromyogram
signals in an implantable or partially implantable device.
Information acquired from electromyogram sensors may be used in
connection with patient monitoring, diagnosis, and therapy. An
implantable system may incorporate EMG and SDB detection for
various purposes, including disease/disorder diagnosis, sleep
detection, and therapy control, among other functions. The system
may include one or more EMG sensors, which may be implemented as
one or more patient-internal and/or one or more patient external
EMG sensors. Systems and methods directed to movement sensing for
detecting sleep-related disorders may be implemented to include
selected features, functions, and/or structures described in
commonly owned, co-pending U.S. Publication No. 2005/0113710, which
is hereby incorporated herein by reference.
[1571] An electromyogram sensor detects the electrical activity of
muscles during muscle activity. When muscles are active, they
produce an electrical current that is proportional to the level of
the muscle activity. The use of EMG sensing devices is helpful in
the diagnosis of many pathological conditions.
[1572] Electromyogram sensing devices may facilitate diagnosis of
many pathological conditions. These conditions include, for
example, muscular dystrophy, inflammation of muscles, pinched
nerves, peripheral nerve damage (damage to nerves in the arms and
legs), amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig
disease), myasthenia gravis, disc herniation, sleep-disordered
breathing, and movement disorders such as periodic limb movement,
restless limb movement, and bruxism.
[1573] Embodiments are directed to systems and methods for
screening and/or diagnosing and subsequently treating an
involuntary limb movement condition, such as RLS or PLMD. PLMD,
RLS, and/or other movement disorders such as bruxism, for example,
may be diagnosed using a system that is fully or partially
implantable. A partially or fully implantable device, such as a
cardiac rhythm management system, may incorporate a movement
detector. One or more movement sensors are coupled to the movement
detector within the implantable device. The movement sensors may
include any sensor or any combination of sensors capable of
detecting motion and/or muscle activity associated with motion,
such as accelerometers, electromyogram (EMG) sensors, and/or a
combination of one or more accelerometers and one or more EMG
sensors.
[1574] Signals from the movement sensors may be received and
processed by the movement detector in the implantable device. The
movement data may be stored in the implantable device or
communicated to an external processing system, either of which may
process the sensed movement information. Movement information may
be processed, trended, displayed, etc. locally or remotely to
detect presence of an involuntary limb movement condition.
[1575] Various therapies have been used to treat central and/or
obstructive disordered breathing episodes, and may further be used
to treat sleep-related muscle disorders. Obstructive sleep apnea
has been associated with prolapse of the tongue and its surrounding
structure into the pharynx, thus occluding the respiratory pathway.
A commonly prescribed treatment for obstructive apnea is continuous
positive airway pressure (CPAP). The application of continuous
positive airway pressure keeps the patient's throat open, reducing
or eliminating the obstruction causing apnea.
[1576] The following discussion, with reference to FIG. 92,
describes embodiments of the invention involving disease/disorder
diagnosis using an EMG detector and SDB detector in an implanted or
partially implanted device. The processes and systems exemplified
by these embodiments may be implemented alone or in combination
with one or more processes and systems exemplified by other
embodiments described herein to provide a coordinated approach to
patient monitoring, diagnosis, and/or therapy. Information acquired
from EMG detector and the SDB detector may be used in connection
with patient monitoring, diagnosis, and therapy.
[1577] FIG. 92 illustrates an implantable system 9200 incorporating
EMG and SDB detection that may be used for sleep-related
disease/disorder diagnosis, sleep detection, and therapy control,
among other functions. In accordance with various embodiments, the
system 9200 includes one or more EMG sensors 9220, which may be
implemented as one or more patient-internal and/or one or more
patient external EMG sensors.
[1578] The EMG sensor or sensors 9220 may be positioned in or on
the patient's body at one or more selected locations to sense
electrical muscular activity at the one or more selected locations.
The location of the EMG sensor or sensors 9220 depends on the
specific application. For example, one or more EMG sensors 9220 may
be positioned intramuscularly or on the surface of the skin above
the muscle to detect the electrical activity of the muscle.
[1579] Intramuscular placement of EMG sensors involves inserting a
needle electrode through the skin into the muscle whose electrical
activity is to be measured. Because skeletal muscles are often
large, several needle electrodes may need to be placed at various
locations to obtain an accurate reading of muscle activity.
[1580] Signals from EMG sensor or sensors 9220 may be transmitted
to an EMG detector 9212 of the implanted device 9210 through leads
or using a wireless communications link. The EMG detector 9212
receives signals from the EMG sensor or sensors 9220 and processes
the signals for use by a diagnosis processor 9216 and/or a sleep
detector 9214, for example.
[1581] The sleep detector 9214 may use EMG information to determine
various sleep stages, including REM sleep. The sleep detector 9214
may also provide information from the EMG detector 9212 to a sleep
disordered breathing detector 9213, which may use the EMG sensors
9220 to detect sleep disordered breathing episodes, and/or may be
coupled to one or more SDB sensors 9215. It is understood that
other component connection/communication architectures are possible
in addition to those shown in FIG. 92. In one implementation, one
or more EMG sensors 9220 may be placed on the patient's face to
facilitate the detection of REM sleep. For example, one or more
surface EMG sensors 9220 may be placed on the patient's chin or
jaw, e.g., on the mentalis muscle and/or submentalis muscle, to
detect muscle atonia associated with rapid eye movement sleep.
[1582] In another implementation, one or more EMG sensors 9220
and/or SDB sensors 9215 may be placed on the housing, header, or
lead of an implanted device 9210 positioned in the pectoral region
of the patient. In one configuration, the EMG sensors 9220 may be
used to detect atonia of the pectoral muscles during REM sleep. A
sleep detector 9214 may use information from the EMG detector 9212
to facilitate the detection of sleep onset and offset, and to
determine the various stages of sleep. Detection of sleep stages
may be used, for example, in patient monitoring, diagnosis and/or
therapy for various disorders, including sleep-disordered
breathing.
[1583] The diagnosis processor 9216 may use EMG-related information
and SDB detection to diagnose a variety of diseases or disorders
such as those listed above. Disease/disorder diagnosis may be
facilitated using information acquired from the EMG detector 9212
associated with the patient's muscle activity, limb movements, and
respiratory motions, for example. The diagnosis processor 9216 may
also use information about the patient's sleep stages to aid in
diagnosis.
[1584] In various embodiments, the diagnosis processor 9216 may use
EMG-related information and SDB detection to diagnose disorders and
diseases involving muscle dysfunction, such as those caused by
muscle inflammation and/or muscular dystrophy for example. The EMG
information may be used to diagnose muscle weakness due to nerve
disorders, including pinched nerves, peripheral nerve damage,
amyotrophic lateral sclerosis (ALS), myasthenia gravis, and disc
herniation, for example. The EMG- and SDB-related information may
be used to diagnose a variety of movement disorders, such as
periodic limb movement disorders and/or restless legs syndrome.
[1585] In other embodiments, the diagnosis processor may use
information from the EMG detector 9212 to diagnose disordered
breathing. For example, EMG sensor or sensors 9220 may be used to
sense activity of the intercostal muscles produced by expansion of
the chest during respiration. As previously described, the absence
or presence of chest motion may be used to discriminate between
central or obstructive apnea.
[1586] Alternatively, or additionally, an EMG sensor 9220 may be
used to detect obstructive apnea based on the degree of patency of
the upper airway. Obstructive apnea is caused by upper airway
occlusion due to the collapse of soft tissue in the rear of the
throat. One or more EMG sensors 9220 placed on the patient's chin
or jaw may be used to detect muscle activity associated with tongue
movement opening the upper airway.
[1587] A majority of disordered breathing episodes occur while the
patient is sleeping. Sleep-related disorders such as
sleep-disordered breathing may be more prevalent during particular
sleep stages. Information about sleep stages, and about the
frequency, number, and degree of arousals from sleep may be useful
in the diagnosis of disordered breathing. Thus, a diagnosis of
disordered breathing may be enhanced using sleep information from
the sleep detector 9214.
[1588] In other embodiments, diagnosis of various movement
disorders, such as periodic limb movement disorder (PLMD), restless
leg syndrome (RLS), and bruxism (nighttime teeth grinding) may be
facilitated using one or more EMG sensors 9220 coupled to an
implantable device 9210. Periodic limb movement disorder and
restless leg syndrome are disorders that involve undesirable
movements of the limbs as described in more detail below.
[1589] One or more EMG sensors 9220 may be placed in or on the
muscles of the limbs or other muscles to detect limb movements. For
example, EMG sensors 9220 placed on or in the anterior tibialis
muscles may be used to identify leg movements associated with PLMD
and/or RLS. EMG sensors 9220 placed on the jaw may be used to
identify tempomanidibular disorders such as nighttime teeth
grinding or other involuntary jaw movements.
[1590] EMG-related information may be trended, stored, displayed,
or transmitted from the implantable device 9210 to another device.
In one embodiment, information from the EMG detector 9212, the
sleep detector 9214, and/or the diagnosis processor 9216 is
downloaded to a remote device, such as a programmer 9260 or
advanced patient management system 9230 for further analysis by the
remote device 9230, 9260 and/or the patient's physician.
[1591] Information from the EMG detector, 9212 the sleep detector
9214, the SDB detector 9213, and/or the diagnosis processor 9216
may optionally be used to adjust therapy provided to a patient.
Therapy provided by the implanted device 9210 may be adjusted by
the patient's physician or by a remote device, such as an APM 9230
device or programmer 9260. In one example, the patient's physician
may send a command through the programmer 9260 or APM device 9230
to a therapy control unit 9218 in the implanted device 9210 to
initiate, terminate, or modify therapy. In another example, the APM
device 9230, 9260 may automatically command the implanted device
9210 to adjust therapy based on analysis performed in the remote
device 9230, 9260. In another embodiment, the therapy control unit
9218 of the implanted device 9210 may use information from the EMG
detector 9212, the sleep detector 9214, and/or the diagnosis
processor 9216, to automatically adjust therapy provided to a
patient.
[1592] The EMG-related information and SDB detection information
acquired by the implantable device 9210 may be transferred to other
therapy devices, such as drug delivery devices 9250, respiration
therapy devices 9240, and/or nerve stimulation therapy devices
9255, such as devices that deliver a transcutaneous electric nerve
stimulation therapy.
[1593] The EMG-related information acquired by the implantable
device 9210 may be transferred to other therapy devices (internal
or external), such as drug delivery devices 9250 and/or nerve
stimulation therapy devices 9255. For example, transcutaneous
electric nerve stimulation may improve symptoms in some RLS
sufferers who also have PLMD. Electrical stimulation may be applied
to an area of the legs or feet, usually before bedtime, for about
15 to 30 minutes. Transcutaneous electric nerve stimulation therapy
has been found to be helpful in reducing nighttime leg jerking.
[1594] The transferred information may be used to adjust the
therapy delivered by one or more of the therapy devices 9240, 9250,
9255, or used in further diagnosis and/or monitoring functions, for
example. Examples of drugs useful with the drug therapy device 9250
include dopamine agents (muscle relaxers), benzodiazepines
(sedatives), anti-convulsants (to reduce muscle activity), and
opioids (narcotics to reduce motor activity).
[1595] Although the sleep detector 9214, the diagnosis processor
9216, and the therapy control unit 9218 are illustrated internal to
the implantable device 9210, it is contemplated that any or all of
these components may be patient-external in alternate embodiments,
and may be incorporated into other components such as the APM 9230,
for example. Similarly, the respiration therapy devices 9240, drug
delivery devices 9250, and/or nerve stimulation therapy devices
9255 illustrated as patient-external in FIG. 92, may be included in
the implantable device 9210 in alternate embodiments. Moreover, all
or particular component(s) of these devices 9240, 9250, 9255 may be
configured for patient-internal placement, patient-external
placement, or both patient-internal and patient-external
placement.
[1596] The following discussion, with reference to FIGS. 93-95,
describes embodiments involving detection of movement disorders.
The processes and systems exemplified by these embodiments may be
implemented alone or in combination with one or more processes and
systems exemplified by other embodiments described herein to
provide a coordinated approach to patient monitoring, diagnosis,
and/or therapy.
[1597] In accordance with embodiments of the invention, PLMD, RLS,
and/or other movement disorders such as bruxism, for example, may
be diagnosed using a system that is fully or partially implantable.
FIG. 93 illustrates an implantable medical device, e.g., a CRM that
incorporates a movement/SDB detector 9312. One or more movement/SDB
sensor(s) 9320 are coupled to the movement/SDB detector 9312 within
an implantable device 9310. Although illustrated as a single block
9312 in FIG. 93 (and in FIG. 94) for simplicity, it is understood
that the movement detector and SDB detector may be represented as
separate blocks. Similarly, it is understood that the movement
sensor(s) and SDB sensors(s) of block 9320 may be represented as
separate blocks.
[1598] The movement/SDB sensor(s) 9320 may include any sensor or
any combination of sensors capable of detecting motion and/or
muscle activity associated with motion. For example, the patient's
movements may be detected using one or more accelerometers, one or
more EMG sensors, and/or a combination of one or more
accelerometers and one or more EMG sensors.
[1599] In various embodiments, one or more movement sensors (e.g.,
accelerometers and/or EMG sensors) are coupled to the patient at
appropriate locations to detect movements of the extremities, e.g.,
limb movements, or other movements. Signals from the movement/SDB
sensor(s) 9320 are received and processed by a movement/SDB
detector 9312 in the implantable device 9310. The movement/SDB
detector 9312 may cooperate with a memory in a monitoring unit 9314
to store information about the detected movements. Movement
information may be stored, trended, displayed, and/or transmitted
to a separate device, such as an APM system 9330 or a programmer
9340 for further operations.
[1600] In other embodiments, as illustrated in FIG. 94, one or more
movement/SDB sensor(s) 9320 are coupled to a movement/SDB detector
9312 within the implantable device 9310, as previously discussed.
The implantable device 9310 also includes a movement disorder
diagnosis processor 9415 that receives movement information from
the movement/SDB detector 9312. The movement disorder diagnosis
processor 9415 evaluates the movement information to determine if
the movements are consistent with various movement disorders such
as RLS and/or PLMD.
[1601] In one example, the movement/SDB sensor(s) 9320 may include
one or more EMG sensors placed on or in the anterior tibialis.
Typical EMG bursts due to PLMD movements may last between 0.5-5
seconds and may recur every 20-40 seconds, for example. The
movement disorder diagnosis processor 9415 may make a diagnosis of
PLMD if at least about 40 EMG bursts are detected within an 8-hour
sleep period, for example. Sleep disruption caused by the PLMD
movements may be determined by any or a combination of the sleep
detection techniques described herein, including, for example,
brain wave (EEG) sensing and/or a combination of respiration (MV)
and activity sensing, among others. Movement disorder diagnosis may
be downloaded to a programmer 9340, an APM system 9330, or other
therapeutic or diagnostic device.
[1602] In accordance with another embodiment, RLS diagnosis may
involve patient input regarding their symptoms. For example, as
illustrated in FIGS. 93 and 94, a patient input device 9350 may be
used to acquire information from the patient regarding the
patient's perception of symptoms. The patient may be prompted to
rate their symptoms on a scale of 0 to 4, or some other scale, for
example with a lower number representing fewer RLS symptoms and
higher number representing greater RLS symptoms, for example. The
patient input may be acquired using the patient input device 9350
over a period of days, for example, about three days to about nine
days to establish a diagnosis. Patient input through the patient
input device 9350 may also be acquired after diagnosis and/or
treatment, for example to assess status of the disorder or the
efficacy of treatment.
[1603] For example, if the patient input is acquired over a period
of six days, the maximum score is 24, i.e., a score of four for
each or six days. In this scenario, a score greater than about 12
suggests a diagnosis of severe RLS. A score of about six to about
twelve suggests a diagnosis of moderate RLS.
[1604] In the embodiment illustrated in FIG. 93, information about
SDB and RLS symptoms may be acquired by the patient input device
9350 and transmitted to an APM device 9330, the programmer 9340, or
other device for monitoring, display, storage, evaluation, and/or
diagnosis. In the embodiment illustrated in FIG. 94, the
information acquired by the patient input device 9350, along with
the movement information, may be used by the movement disorder
diagnosis processor 9415 in the implantable device 9310 to make a
diagnosis of RLS.
[1605] Embodiments of the present invention are directed to methods
and systems for diagnosis of SDB and movement disorders such as
PLMD and RLS. RLS diagnosis may be complicated due to the symptom
based nature of the RLS diagnosis. The use of patient input through
a patient-input device provides a system for collection of symptom
based information. Because PLMD and RLS are related disorders, the
diagnosis of PLMD through movement detection techniques described
herein may be used to enhance the RLS diagnosis.
[1606] Use of such methods and systems may reduce the need for
in-clinic sleep studies typically used for movement disorder
diagnosis. Further, daily measurements may be made over a number of
days, which is not practical for in-clinic studies. Earlier and
more frequent diagnosis of movement disorders may be enabled using
the systems and methods of the invention.
[1607] FIG. 95 illustrates a method 9500 of implantably sensing and
detecting movement useful for diagnosing sleep-related muscle
disorders and sleep disordered breathing. A muscle activity signal
is sensed at a block 9502. Muscle activity may be sensed, for
example, using EMG sensors, accelerometers, or other sensors
suitable for determining patient movement. A determination block
9504 is used to decide if the patient is sleeping. If determination
9504 concludes that the patient is not sleeping, the method 9500
loops back to the beginning.
[1608] If the patient is determined to be sleeping at block 9504,
the muscle activity sensed at block 9502 provides information
recorded at block 9506. For example, date, time, sensor data, sense
signal amplitudes or other information may be useful for updating,
developing, and/or determining an muscle disorder index, a
diagnosis, a sleep-related muscle activity history, and other
parameters useful for patient diagnosis and treatment. The
information recorded at block 9506 may be useful, for example, to
predict, verify, classify, and/or determine the existence of a
sleep-related muscle disorder and sleep disordered breathing.
[1609] If intervention and/or treatment is desired at determination
block 9508, the intervention and/or treatment may be performed at
block 9510 before re-starting the method 9500. For example, the
intervention at block 9510 may be the automatic activation of a
medical process, modification of a disordered breathing therapy,
notification to a patient-external device and/or a physician, or
other desirable action.
[1610] System and Method for Detecting an Involuntary Muscle
Movement Disorder
[1611] Aspects of the invention that include involuntary muscle
movement disorder detection are directed to methods and systems
configured to monitor, diagnose, and/or provide patient therapy
using one or more individual medical procedures. Each of the
circles 180 illustrated in FIGS. 1B-1D represents an individual
medical procedure providing a specific monitoring, diagnosis or
therapeutic function or set of functions. Each individual medical
procedure may be implemented as a stand-alone system. Two or more
of the individual medical procedures 180 may be used in combination
to provide more comprehensive patient monitoring, diagnosis and/or
therapy. One or more functions of two or more individual medical
procedures 180 may be used in combination to enhance patient
monitoring, diagnosis and/or therapy.
[1612] Other aspects of the invention that include involuntary
muscle movement disorder detection are directed to methods and
systems configured to monitor, diagnose, and/or provide therapy
using coordinated medical procedures. Coordinated medical
procedures may involve cooperative operation of two or more of the
individual processes 180. Coordinated medical procedures may also
involve cooperative operation of one or more functions of two or
more of the individual processes 180.
[1613] Coordinated use of two or more medical procedures typically
involves transfer of some form of information, such as data and/or
control signals, that is used by, or influences the behavior of the
medical procedures or devices implementing such medical procedures.
The transfer of information may implicate one of the medical
procedures, some of the medical procedures, or all of the medical
procedures. The transfer of information may implicate other
processes that interact with one or more medical procedures, such
as processes implemented by a patient-external processing system.
The transfer of information may be unidirectional or bi-directional
with respect to medical procedures and/or other processes.
[1614] System and method embodiments provide for evaluating
pathological conditions associated with an involuntary limb
movement disorder. According various embodiments, evaluating a
pathological condition involves sensing muscle movement signals,
and implantably detecting presence of an involuntary muscle
movement disorder using the muscle movement signals. Sensing the
muscle movement signals may be preformed implantably and
externally. Detecting presence of the involuntary muscle movement
disorder may involve detecting a sleep-related involuntary muscle
movement disorder and/or a non sleep-related involuntary muscle
movement disorder using the sensed muscle movement signals.
[1615] Detecting presence of the involuntary muscle movement
disorder may involve detecting a disease or pathological syndrome
using the muscle movement signals. Detecting presence of the
involuntary muscle movement disorder may involve detecting
conditions associated with bruxism, periodic limb movement
disorder, restless leg syndrome, muscular dystrophy, muscle
inflammation, pinched nerves, peripheral nerve damage, amyotrophic
lateral sclerosis, myasthenia gravis, and disc herniation, for
example.
[1616] Sensing muscle movement signals may involve acquiring data
from a sensor directly detecting physical movement, such as an
accelerometer. Sensing muscle movement signals may involve
acquiring data from a sensor detecting bio-electrical changes
associated with movement, such as an electromyogram sensor. Sensing
muscle movement signals may involve acquiring data from sensors
detecting physical movement and bio-electrical changes.
[1617] Onset and offset of sleep may be detected, for purposes of
discriminating between sleep-related and non sleep-related
involuntary limb movement conditions, for example. Sensed muscle
movement signals and/or information associated with the detected
involuntary muscle movement disorder may be communicated to a
patient-external processing system, such as a network, or to a
patient-internal processing system.
[1618] A therapy based on one or both of the muscle movement
signals and the detected involuntary muscle movement disorder may
be delivered to the patient. For example, a drug therapy, nerve
stimulation therapy, or other therapy may be delivered to treat the
detected involuntary muscle movement disorder.
[1619] According other embodiments, systems for evaluating a
pathological condition include a sensor configured to sense
movement of skeletal musculature, a detector coupled to the sensor,
and an implantable processor coupled to the detector. The processor
is configured to determine presence of an involuntary muscle
movement disorder, such as those discussed above.
[1620] In one configuration, one of the sensor and detector
includes an implantable component. In another configuration, each
of the sensor and detector includes an implantable component. The
sensor may include one or both of electromyogram (EMG) sensors and
an accelerometer. A sleep detector may be coupled to the processor,
and the processor may detect a sleep-related involuntary muscle
movement disorder and/or a non sleep-related involuntary muscle
movement disorder.
[1621] Systems may include a communication interface coupled to the
processor. The communication interface may be configured to effect
connectivity between the processor and a patient-external
processing system, such as an external network. Systems may also
include a therapy delivery system configured to deliver a therapy
to treat the involuntary muscle movement disorder, such as a drug
therapy device, nerve stimulation therapy, or other therapy
device.
[1622] Embodiments of the invention involve an individual system
141 (FIG. 1D) for detecting involuntary muscle movement disorder
detection. The involuntary muscle movement disorder detection
system 141 may be implemented as a stand alone system or in
combination with other individual medical systems, such as those
described in FIGS. 1B-1D and in FIG. 96.
[1623] Other embodiments of the invention involve a system for
providing coordinated patient monitoring, diagnosis and/or therapy
that utilizes involuntary muscle movement disorder detection 141.
The coordinated system may include, for example, an implantable
cardiac device 181, a patient-external respiratory therapy device
184, and/or other devices, such as a drug therapy device and/or a
nerve stimulation therapy device. The system may further include an
external processor 183 providing a coordination function. A
communication channel couples the various devices. The devices
(e.g., implantable device 181, respiratory therapy device 184, drug
therapy device, nerve stimulation therapy device, and/or external
processing device) operate cooperatively via the communication
channel to provide one or more of patient monitoring, diagnosis,
and therapy. The devices may operate cooperatively based on
detection of an involuntary muscle movement disorder 141. For
example, involuntary muscle movement disorder detection 141 may
allow the various implantable and/or external devices to operate
cooperatively to provide an appropriate therapy to treat the
involuntary muscle movement disorder or other associated disorder.
Systems and methods directed to detecting an involuntary muscle
movement disorder may be implemented to include selected features,
functions, and/or structures described in commonly owned,
co-pending U.S. Pat. No. 7,616,988, which is hereby incorporated
herein by reference.
[1624] Systems and methods provide for acquisition and processing
of muscle movement signals in an implantable or partially
implantable device. Information acquired from muscle movement
sensors may be used in connection with patient monitoring,
diagnosis, and therapy. An implantable system may incorporate
muscle movement detection for various purposes, including disease
diagnosis, sleep detection, and therapy control, among other
functions. Systems may include one or more movement sensors, which
may be implemented as one or more patient-internal and/or one or
more patient external movement sensors. For example, systems may
include one or more electromyogram (EMG) sensors, which may be
implemented as one or more patient-internal and/or one or more
patient external EMG sensors. Systems may alternatively, or
additionally, include one or more accelerometers to detect muscle
movement, and may further be used to detect patient sleep and non
sleep.
[1625] An EMG sensor detects the electrical activity of muscles
during muscle activity. When muscles are active, they produce an
electrical current that is proportional to the level of the muscle
activity. Electromyogram sensing devices of the present invention
may facilitate diagnosis of many pathological conditions. These
conditions include, for example, muscular dystrophy, inflammation
of muscles, pinched nerves, peripheral nerve damage (damage to
nerves in the arms and legs), amyotrophic lateral sclerosis (ALS,
also known as Lou Gehrig disease), myasthenia gravis, disc
herniation, and movement disorders such as periodic limb movement,
restless limb movement, and bruxism.
[1626] Various embodiments are directed to systems and methods for
screening and/or diagnosing an involuntary limb movement condition,
such as Restless Leg Syndrome (RLS) or Periodic Limb Movement
Disorder (PLMD). PLMD, RLS, and/or other movement disorders such as
bruxism, for example, may be diagnosed using a system that is fully
or partially implantable. A partially or fully implantable system,
such as a cardiac rhythm management system, may incorporate a
movement detector. One or more movement sensors are coupled to the
movement detector within the implantable device. The movement
sensors may include any sensor or any combination of sensors
capable of detecting motion and/or muscle activity associated with
motion, such as accelerometers, electromyogram (EMG) sensors,
and/or a combination of one or more accelerometers and one or more
EMG sensors.
[1627] Signals from the movement sensors may be received and
processed by the movement detector in the implantable device. The
movement data may be stored in the implantable device or
communicated to an external processing system, either of which may
process the sensed movement information. Movement information may
be processed, trended, displayed, etc. locally or remotely to
detect presence of an involuntary limb movement condition.
[1628] Embodiments of the present invention are directed to
implementing components and/or functions of an electromyogram
sensor in an implanted or partially implanted medical device.
Information acquired from the electromyogram sensor(s) may be used
in connection with patient monitoring, diagnosis, and therapy.
[1629] The following discussion, with reference to FIG. 96,
describes embodiments of the invention involving disease diagnosis
using an EMG in an implanted device. The processes and systems
exemplified by these embodiments may be implemented alone or in
combination with one or more processes and systems exemplified by
other embodiments described or incorporated herein to provide a
coordinated approach to patient monitoring, diagnosis, and/or
therapy.
[1630] FIG. 96 illustrates an implantable system 9600 incorporating
EMG detection that may be used for disease diagnosis, sleep
detection, and therapy control, among other functions. In
accordance with various embodiments, the system 9600 includes one
or more EMG sensors 9620, which may be implemented as one or more
patient-internal and/or one or more patient external EMG
sensors.
[1631] The EMG sensor or sensors 9620 may be positioned in or on
the patient's body at one or more selected locations to sense
electrical muscular activity at the one or more selected locations.
The location of the EMG sensor or sensors 9620 depends on the
specific application. For example, one or more EMG sensors 9620 may
be positioned intramuscularly or on the surface of the skin above
the muscle to detect the electrical activity of the muscle.
[1632] Intramuscular placement of EMG sensors involves inserting a
needle electrode through the skin into the muscle whose electrical
activity is to be measured. Because skeletal muscles are often
large, several needle electrodes may need to be placed at various
locations to obtain an accurate reading of muscle activity.
[1633] Signals from EMG sensor or sensors 9620 may be transmitted
to an EMG detector 9612 of the implanted device 9610 through leads
or using a wireless communications link. The EMG detector 9612
receives signals from the EMG sensor or sensors 9620 and processes
the signals for use by a diagnosis processor 9616 and/or a sleep
detector 9614, for example.
[1634] A number of muscle-related disorders occur primarily while
the patient is asleep. Information about the patient's sleep stage
may be used to enhance sleep monitoring and/or diagnosis of a
variety of disorders. In addition, it may be useful to provide a
first therapy while the patient is awake and a second therapy while
the patient is asleep. Detection of EMG signals may be used to
diagnose disorders as well as trigger sleep-time therapy. Collected
data may be stored, displayed, printed, or transmitted to a
separate device.
[1635] By way of example, the sleep detector 9614 may use EMG
information to determine various sleep stages, including REM sleep.
In one implementation, one or more EMG sensors 9620 may be placed
on the patient's face to facilitate the detection of REM sleep. For
example, one or more surface EMG sensors 9620 may be placed on the
patient's chin or jaw, e.g., on the mentalis muscle and/or
submentalis muscle, to detect muscle atonia associated with rapid
eye movement sleep.
[1636] In another implementation, one or more EMG sensors 9620 may
be placed on the housing, header, or lead of an implanted device
9610 positioned in the pectoral region of the patient. In this
configuration, the EMG sensors 9620 may be used to detect atonia of
the pectoral muscles during REM sleep. A sleep detector 9614 may
use information from the EMG detector 9612 to facilitate the
detection of sleep onset and offset, and to determine the various
stages of sleep. Detection of sleep stages may be used, for
example, in patient monitoring, diagnosis and/or therapy for
various disorders.
[1637] The diagnosis processor 9616 may use EMG-related information
to diagnose a variety of diseases or disorders such as those listed
above. Disease/disorder diagnosis may be facilitated using
information acquired from the EMG detector 9612 associated with the
patient's muscle activity, limb movements, and respiratory motions,
for example. The diagnosis processor 9616 may also use information
about the patient's sleep stages to aid in diagnosis.
[1638] In various embodiments, the diagnosis processor 9616 may use
EMG information to diagnose muscle and/or nerve disorders, such as
those caused by muscle inflammation and/or muscular dystrophy for
example. The EMG information may be used to diagnose muscle
weakness due to nerve disorders, including pinched nerves,
peripheral nerve damage, amyotrophic lateral sclerosis (ALS),
myasthenia gravis, and disc herniation, for example. The EMG
information may be used to diagnose a variety of movement
disorders, such as periodic limb movement disorders and/or restless
legs syndrome.
[1639] In yet another embodiment, diagnosis of various movement
disorders, such as PLMD, RLS, and bruxism (nighttime teeth
grinding) may be facilitated using one or more EMG sensors 9620
coupled to an implantable device 9610. Periodic limb movement
disorder and restless leg syndrome are disorders that involve
undesirable movements of the limbs as described in more detail
below.
[1640] One or more EMG sensors 9620 may be placed in or on the
muscles of the limbs or other muscles to detect limb movements. For
example, EMG sensors 9620 placed on or in the anterior tibialis
muscles may be used to identify leg movements associated with PLMD
and/or RLS. EMG sensors 9620 placed on the jaw may be used to
identify tempomanidibular disorders such as nighttime teeth
grinding or other involuntary jaw movements.
[1641] EMG-related information may be trended, stored, displayed,
or transmitted from the implantable device 9610 to another device.
In one embodiment, information from the EMG detector 9612, the
sleep detector 9614, and/or the diagnosis processor 9616 is
downloaded to a remote device, such as a programmer 9660 or an
advanced patient management (APM) device 9630 for further analysis
by the APM device 9630, programmer 9660 and/or the patient's
physician.
[1642] Information from the EMG detector, 9612 the sleep detector
9614, and/or the diagnosis processor 9616 may optionally be used to
adjust therapy provided to a patient. Therapy provided by the
implanted device 9610 may be adjusted by the patient's physician or
by a remote device, such as the APM device 130 or programmer 9660.
In one example, the patient's physician may send a command through
the programmer 9660 or APM device 9630 to a therapy control unit
9618 in the implanted device 9610 to initiate, terminate, or modify
therapy.
[1643] In another example, the APM device 9630 and/or the
programmer 9660 may automatically command the implanted device 9610
to adjust therapy based on analysis performed in the APM device
9630 and/or the programmer 9660. In another embodiment, the therapy
control unit 9618 of the implanted device 9610 may use information
from the EMG detector 9612, the sleep detector 9614, and/or the
diagnosis processor 9616, to automatically adjust therapy provided
to a patient.
[1644] The EMG-related information acquired by the implantable
device 9610 may be transferred to other therapy devices (internal
or external), such as drug delivery devices 9650 and/or nerve
stimulation therapy devices 9655. For example, transcutaneous
electric nerve stimulation may improve symptoms in some RLS
sufferers who also have PLMD. Electrical stimulation may be applied
to an area of the legs or feet, usually before bedtime, for about
15 to 30 minutes. Transcutaneous electric nerve stimulation therapy
has been found to be helpful in reducing nighttime leg jerking.
[1645] The transferred information may be used to adjust the
therapy delivered by the drug therapy device 9650, nerve
stimulation therapy device 9655, and/or other therapy device, or
used in further diagnosis and/or monitoring functions, for example.
Examples of drugs useful with the drug therapy device 9650 include
dopamine agents (muscle relaxers), benzodiazepines (sedatives),
anti-convulsants (to reduce muscle activity), and opioids
(narcotics to reduce motor activity).
[1646] Although the sleep detector 9614, the diagnosis processor
9616, and the therapy control unit 9618 are illustrated internal to
the implantable device 9610, it is contemplated that any or all of
these components may be patient-external in alternate embodiments,
and may be incorporated into other components such as the APM 9630,
for example. Similarly, the drug delivery devices 9650 and/or nerve
stimulation devices 9655, illustrated patient-external in FIG. 96,
may be included in the implantable device 9610 in alternate
embodiments.
[1647] The following discussion, with reference to FIGS. 97A-97B,
describes embodiments of the invention involving detection of
movement disorders. The processes and systems exemplified by these
embodiments may be implemented alone or in combination with one or
more processes and systems exemplified by other embodiments
described herein to provide a coordinated approach to patient
monitoring, diagnosis, and/or therapy.
[1648] In accordance with embodiments of the invention, PLMD, RLS,
and/or other movement disorders such as bruxism, for example, may
be diagnosed using a system that is fully or partially implantable.
FIG. 97A illustrates an implantable medical device, e.g., a CRM
that incorporates a movement detector 9712. One or more movement
sensors 9720 are coupled to the movement detector 9712 within an
implantable device 9710.
[1649] The movement sensors 9720 may include any sensor or any
combination of sensors capable of detecting motion and/or muscle
activity associated with motion. For example, the patient's
movements may be detected using one or more accelerometers, one or
more EMG sensors, and/or a combination of one or more
accelerometers and one or more EMG sensors.
[1650] In one embodiment, one or more movement sensors (e.g.,
accelerometers and/or EMG sensors) are coupled to the patient at
appropriate locations to detect movements of the extremities, e.g.,
limb movements, or other movements. Signals from the movement
sensors 9720 are received and processed by a movement detector 9712
in the implantable device 9710. The movement detector 9712 may
cooperate with a memory in a monitoring unit 9714 to store
information about the detected movements. Movement information may
be stored, trended, displayed, and/or transmitted to a separate
device, such as an APM system 9730 or a programmer 9740 for further
operations.
[1651] In another embodiment, illustrated in FIG. 97B, one or more
movement sensors 9720 are coupled to a movement detector 9712
within the implantable device 9710, as previously discussed. The
implantable device 9710 also includes a movement disorder diagnosis
processor 9715 that receives movement information from the movement
detector 9712. The movement disorder diagnosis processor 9715
evaluates the movement information to determine if the movements
are consistent with various movement disorders such as RLS and/or
PLMD.
[1652] In one example, the movement sensors 9720 may include one of
more EMG sensors placed on or in the anterior tibialis. Typical EMG
bursts due to PLMD movements may last between 0.5-5 seconds and may
recur every 20-40 seconds, for example. The movement disorder
diagnosis processor 9715 may make a diagnosis of PLMD if at least
about 40 EMG bursts are detected within an 8-hour sleep period, for
example.
[1653] Sleep disruption caused by the PLMD movements may be
determined by any or a combination of the sleep detection
techniques described herein, including, for example, brain wave
(EEG) sensing and/or a combination of respiration (e.g., minute
ventilation) and activity sensing, among others. Alternately or
additionally, detection of sleep disruption, such as by using a
minute ventilation sensor, may be used to confirm PLMD. Movement
disorder diagnosis may be downloaded to a programmer 9740, an APM
system 9730, or other therapeutic or diagnostic device.
[1654] In accordance with another embodiment of the invention, RLS
diagnosis may involve patient input regarding their symptoms. For
example, as illustrated in FIGS. 97A and 97B, a patient input
device 9750 may be used to acquire information from the patient
regarding the patient's perception of symptoms. The patient may be
prompted to rate their symptoms on a scale of 0 to 4, or some other
scale, for example with a lower number representing fewer RLS
symptoms and higher number representing greater RLS symptoms, for
example. The patient input may be acquired using the patient input
device 9750 over a period of days, for example, about three days to
about nine days to establish a diagnosis. Patient input through the
patient input device 9750 may also be acquired after diagnosis
and/or treatment, for example to assess status of the disorder or
the efficacy of treatment.
[1655] For example, if the patient input is acquired over a period
of six days, the maximum score is 24, i.e., a score of four for
each or six days. In this scenario, a score greater than about 12
suggests a diagnosis of severe RLS. A score of about six to about
twelve suggests a diagnosis of moderate RLS.
[1656] In the embodiment illustrated in FIG. 97A, information about
RLS symptoms may be acquired by the patient input device 9750 and
transmitted to an APM device 9730, the programmer 9740, or other
device for monitoring, display, storage, evaluation, and/or
diagnosis. In the embodiment illustrated in FIG. 97B, the
information acquired by the patient input device 9750, along with
the movement information, may be used by the movement disorder
diagnosis processor 9715 in the implantable device 9710 to make a
diagnosis of RLS.
[1657] Embodiments of the present invention are directed to methods
and systems for diagnosis of movement disorders such as PLMD and
RLS. RLS diagnosis may be complicated due to the symptom based
nature of the RLS diagnosis. The use of patient input through a
patient-input device provides a system for collection of symptom
based information. Because PLMD and RLS are related disorders, the
diagnosis of PLMD through movement detection techniques described
herein may be used to enhance the RLS diagnosis.
[1658] Use of the methods and systems of the invention may reduce
the need for in-clinic sleep studies typically used for movement
disorder diagnosis. Further, daily measurements may be made over a
number of days which is not practical for in-clinic studies.
Earlier and more frequent diagnosis of movement disorders may be
enabled using the systems and methods of the invention.
[1659] FIGS. 98A-98D illustrate various configurations of an EMG
sensor mechanically coupled to an implanted medical device 9820,
such as an implantable pacemaker or implantable
cardioverter/defibrillator in accordance with embodiments of the
invention, which may be useful for diagnosing diseases such as
sleep-related muscle disorders. The implantable medical device 9820
may include a housing 9822 enclosing the medical device circuitry
and a header 9824 for coupling a lead system 9840 to the circuitry
of the medical device 9820.
[1660] A movement sensor may be implemented, for example, to
include an EMG sensor that employs one or more EMG electrodes 9826
or a force responsive sensor 9830 positioned on the housing 9822 of
the medical device 9820 as illustrated in FIGS. 98C and 98D,
respectively. FIG. 98C illustrates one or more EMG electrodes 9828
positioned on the header 9824 of the medical device 9820.
Alternatively, a movement sensor 9842 (e.g., one that includes one
or more EMG electrodes or a strain gauge) may be positioned on the
lead system 9840 or may be coupled to the housing 9822 through a
catheter or lead system 9840, such as by using the header 9824, as
illustrated in FIG. 98D.
[1661] FIG. 99 illustrates a method 9900 of implantably sensing and
detecting movement used for diagnosis of sleep-related muscle
disorders. A muscle activity signal is sensed at a block 9902.
Muscle activity may be sensed, for example, using EMG sensors,
accelerometers, or other sensors suitable for determining patient
movement. A determination block 9904 is used to decide if the
patient is sleeping. If determination 9904 decides the patient is
not sleeping, the method 9900 loops back to the beginning.
[1662] If the patient is determined to be sleeping at block 9904,
the muscle activity sensed at block 9902 provides information
recorded at block 9906. For example, date, time, sensor data, sense
signal amplitudes or other information may be useful for updating,
developing, and/or determining an muscle disorder index, a
diagnosis, a sleep-related muscle activity history, and other
parameters useful for patient diagnosis and treatment. The
information recorded at block 9906 may be useful, for example, to
predict, verify, classify, and/or determine the existence of a
sleep-related muscle disorder.
[1663] If intervention and/or treatment is desired at determination
block 9908, the intervention and/or treatment may be performed at
block 9910 before re-starting the method 9900. For example, the
intervention at block 9910 may be the automatic activation of a
medical process, modification of a patient's CRM stimulation,
modification of a therapy, notification to a patient-external
device and/or a physician, or other desirable action.
[1664] It will, of course, be understood that various modifications
and additions can be made to the preferred embodiments discussed
hereinabove without departing from the scope of the present
invention. Accordingly, the scope of the present invention should
not be limited by the particular embodiments described above, but
should be defined only by the claims set forth below and
equivalents thereof.
* * * * *