U.S. patent application number 17/401054 was filed with the patent office on 2021-12-02 for using multiple diagnostic parameters for predicting heart failure events.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Douglas A. Hettrick, Shantanu Sarkar, Robert W. Stadler.
Application Number | 20210369167 17/401054 |
Document ID | / |
Family ID | 1000005771644 |
Filed Date | 2021-12-02 |
United States Patent
Application |
20210369167 |
Kind Code |
A1 |
Sarkar; Shantanu ; et
al. |
December 2, 2021 |
USING MULTIPLE DIAGNOSTIC PARAMETERS FOR PREDICTING HEART FAILURE
EVENTS
Abstract
Techniques for using multiple physiological parameters to
provide an early warning for worsening heart failure are described.
A medical device monitors a primary diagnostic parameter that is
indicative of worsening heart failure, such as intrathoracic
impedance or pressure, and one or more secondary diagnostic
parameters. The medical device detects worsening heart failure in
the patient based on the primary diagnostic parameter when an index
that is changed over time based on the primary diagnostic parameter
value is outside a range of values, termed the threshold zone. When
the index is within the threshold zone, the medical device detects
worsening heart failure in the patient based on the one or more
secondary diagnostic parameters. Upon detecting worsening heart
failure, the medical device may, for example, provide an alert that
enables the patient to seek medical attention before experiencing a
heart failure event.
Inventors: |
Sarkar; Shantanu;
(Roseville, MN) ; Hettrick; Douglas A.; (Andover,
MN) ; Stadler; Robert W.; (Shoreview, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
1000005771644 |
Appl. No.: |
17/401054 |
Filed: |
August 12, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16422509 |
May 24, 2019 |
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17401054 |
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15676567 |
Aug 14, 2017 |
10299693 |
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16422509 |
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14629027 |
Feb 23, 2015 |
9730601 |
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15676567 |
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12184003 |
Jul 31, 2008 |
9713701 |
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14629027 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/0537 20130101;
A61B 5/361 20210101; A61B 5/0538 20130101; A61B 2562/0219 20130101;
A61M 37/00 20130101; A61M 2230/42 20130101; A61B 5/363 20210101;
A61M 5/1723 20130101; A61B 5/1118 20130101; A61M 2230/04 20130101;
A61B 5/0205 20130101; A61B 5/021 20130101; A61B 5/287 20210101;
A61N 1/36585 20130101; A61B 5/08 20130101 |
International
Class: |
A61B 5/287 20060101
A61B005/287; A61B 5/0537 20060101 A61B005/0537; A61B 5/0538
20060101 A61B005/0538; A61B 5/11 20060101 A61B005/11; A61N 1/365
20060101 A61N001/365; A61B 5/361 20060101 A61B005/361; A61B 5/363
20060101 A61B005/363; A61M 37/00 20060101 A61M037/00; A61B 5/0205
20060101 A61B005/0205; A61B 5/021 20060101 A61B005/021; A61B 5/08
20060101 A61B005/08; A61M 5/172 20060101 A61M005/172 |
Claims
1. A system comprising: at least one sensor; and processing
circuitry configured to: monitor at least one primary diagnostic
parameter and at least one secondary diagnostic parameter of a
patient based on at least one signal from the at least one sensor;
determine a plurality of values of an index over time based on the
primary diagnostic parameter, wherein the index values are
indicative of a degree of heart failure of the patient; compare
each of the determined values of the index to an upper threshold
and a lower threshold, wherein the upper threshold and the lower
threshold define a threshold zone; in response to a first
determined value of the index being outside of the threshold zone,
determine whether to provide an alert to a user indicating
worsening heart failure in the patient based on the determined
value of the index and not based on the at least one secondary
diagnostic parameter; and in response to a second determined value
of the index being within the threshold zone, determine whether to
provide the alert to the user indicating worsening heart failure
based on the at least one secondary diagnostic parameter.
2. The system of claim 1, wherein the processing circuitry is
configured to provide the alert in response to the first determined
value of the index being greater than the upper threshold.
3. The system of claim 1, wherein the processing circuitry is
configured to withhold the alert in response to the first
determined value of the index being less than the lower
threshold.
4. The system of claim 1, wherein the processing circuitry is
configured to: monitor a plurality of secondary diagnostic
parameters, the plurality of secondary diagnostic parameters
including the at least one secondary diagnostic parameter; and
provide the alert indicating worsening heart failure when the index
value is inside the threshold zone and a predetermined number of
the secondary diagnostic parameters indicates worsening heart
failure.
5. The system of claim 1, wherein the at least one sensor comprises
at least one of a plurality of electrodes configured to detect
intrathoracic impedance as the at least one primary diagnostic
parameter, or a pressure sensor configured to detect a
cardiovascular pressure as the at least one primary diagnostic
parameter.
6. The system of claim 1, wherein the at least one secondary
diagnostic parameter comprises one or more of atrial fibrillation
(AF) burden, ventricular rate during AF, ventricular fibrillation
(VF) burden, ventricular rate during VF, atrial tachyarrhythmia
(AT) burden, ventricular rate during AT, ventricular
tachyarrhythmia (VT), or ventricular rate during VT.
7. The system of claim 1, wherein the at least one sensor comprises
an accelerometer, and the at least one secondary diagnostic
parameter comprises activity level.
8. The system of claim 1, wherein the at least one secondary
diagnostic parameter comprises one or more of heart rate
variability, night heart rate, difference between day heart rate
and night heart rate, heart rate turbulence, or heart rate
deceleration capacity.
9. The system of claim 1, wherein the at least one secondary
diagnostic parameter comprises one or more of respiratory rate,
respiratory depth, or respiratory pattern.
10. The system of claim 1, wherein the at least one secondary
diagnostic parameter comprises one or more of percentage of cardiac
resynchronization pacing, baroreflex sensitivity, weight, blood
pressure, metrics of renal function, medication history, or history
of heart failure hospitalization.
11. The system of claim 1, wherein the processing circuitry is
configured to automatically adjust the threshold zone as a function
of time.
12. The system of claim 1, wherein the values of the index are
indicative of fluid accumulation of the patient.
13. The system of claim 1, wherein the processing circuitry is
configured to receive a signal indicative of input from a user via
an external programmer, and adjust, based on the signal indicative
of the input, at least one of the lower threshold or the upper
threshold that defines the threshold zone.
14. The system of claim 1, wherein the processing circuitry is
configured to automatically adjust the threshold zone based on one
or more monitored diagnostic parameters indicative of patient
condition, wherein the one or more monitored diagnostic parameters
comprise at least one of the at least one primary diagnostic
parameter or the at least one secondary diagnostic parameter.
15. The system of claim 1, wherein the processing circuitry is
configured to automatically adjust the threshold zone based on
efficacy of the alert in indicating worsening heart failure.
16. The system of claim 1, further comprising a subcutaneously
implantable device that comprises the at least one sensor.
17. A method comprising: monitoring, by processing circuitry, at
least one primary diagnostic parameter and at least one secondary
diagnostic parameter of a patient based on at least one signal from
at least one sensor; determining, by the processing circuitry, a
plurality of values of an index over time based on the primary
diagnostic parameter, wherein the index values are indicative of a
degree of heart failure of the patient; comparing, by the
processing circuitry, each of the determined values of the index to
an upper threshold and a lower threshold, wherein the upper
threshold and the lower threshold define a threshold zone; in
response to a first determined value of the index being outside of
the threshold zone, determining, by the processing circuitry,
whether to provide an alert to a user indicating worsening heart
failure in the patient based on the determined value of the index
and not based on the at least one secondary diagnostic parameter;
and in response to a second determined value of the index being
within the threshold zone, determining, by the processing
circuitry, whether to provide the alert to the user indicating
worsening heart failure based on the at least one secondary
diagnostic parameter.
18. The method of claim 17, wherein providing the alert comprises
providing the alert in response to the first determined value of
the index being greater than the upper threshold.
19. The method of claim 17, wherein providing the alert comprises
withholding the alert in response to the first determined value of
the index being less than the lower threshold.
20. The method of claim 17, wherein monitoring at least one
secondary diagnostic parameter comprises monitoring a plurality of
secondary diagnostic parameters, the plurality of secondary
diagnostic parameters including the at least one secondary
diagnostic parameters, and wherein providing the alert comprises
providing the alert indicating worsening heart failure when the
index value is inside the threshold zone and a predetermined number
of the secondary diagnostic parameters indicates worsening heart
failure.
21-26. (canceled)
Description
RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/422,509, filed May 24, 2019, which is a
continuation of U.S. patent application Ser. No. 15/676,567, filed
Aug. 14, 2017, which is a continuation of U.S. patent application
Ser. No. 14/629,027, filed Feb. 23, 2015 and issued as U.S. Pat.
No. 9,730,601 on Aug. 15, 2017, which is a continuation of U.S.
patent application Ser. No. 12/184,003, filed Jul. 31, 2008 and
issued as U.S. Pat. No. 9,713,701 on Jul. 25, 2017, each of which
is herein incorporated by reference in its entirety.
TECHNICAL FIELD
[0002] The invention relates to medical devices and, more
particularly, devices for the diagnosis of worsening heart failure
and treatment of related ailments.
BACKGROUND
[0003] A variety of medical devices have been used or proposed for
use to deliver a therapy to and/or monitor a physiological
condition of patients. As examples, such medical devices may
deliver therapy and/or monitor conditions associated with the
heart, muscle, nerve, brain, stomach or other organs or tissue.
Medical devices that deliver therapy include medical devices that
deliver one or both of electrical stimulation or a therapeutic
agent to the patient. Some medical devices are implantable medical
devices (IMDs) that are implanted within the patient.
[0004] Some medical devices have been used or proposed for use to
monitor heart failure or to detect heart failure events. Typically,
such medical devices have been implantable and, in many cases, have
been cardiac pacemakers, cardioverters and/or defibrillators with
added heart failure monitoring functionality. In some cases, such
medical devices have monitored heart failure by monitoring
intrathoracic impedance, which may provide a good indication of the
level of edema in patients. While edema is a sign of many other
conditions it is also a sign of worsening heart failure. Worsening
heart failure may result in cardiac chamber dilation, increased
pulmonary blood volume, and fluid retention in the lungs--all of
which contribute to a decrease in intrathoracic impedance. Other
diagnostic parameters, such as heart rate variability, have been
proposed for use in such devices to identify worsening heart
failure or heart failure events.
[0005] Generally, the first indication that a physician would have
of the occurrence of edema in a patient is not until it becomes a
physical manifestation with swelling or breathing difficulties so
overwhelming as to be noticed by the patient who then proceeds to
be examined by a physician. This is undesirable since
hospitalization at such a time would likely be required for a heart
failure patient. Accordingly, medical devices have been used to
monitor impedance in patients and provide an alert to the patient
to seek medical treatment prior to the onset of worsening heart
failure with symptoms, such as edema, that require
hospitalization.
SUMMARY
[0006] This disclosure describes techniques for using multiple
diagnostic parameters to provide an early warning for worsening
heart failure. A medical device monitors a primary diagnostic
parameter and one or more secondary diagnostic parameters
indicative of worsening heart failure in the patient. In some
examples, the primary diagnostic parameter indicates a level of
pulmonary edema, increased ventricular filling pressure, or other
morbidities associated with worsening heart failure. Examples of
primary diagnostic parameters include intrathoracic impedance or a
cardiovascular pressure. The medical device detects worsening heart
failure in the patient based on the primary diagnostic parameter
when an index that is changed over time based on the primary
diagnostic parameter value is outside a range of values, termed the
threshold zone. When the index is within the threshold zone, the
medical device detects worsening heart failure in the patient based
on the one or more secondary diagnostic parameters.
[0007] When the index is within the threshold zone, the medical
device may look to one or more secondary diagnostic parameters to
corroborate the indication of worsening heart failure provided by
the primary diagnostic parameter. In this manner, the medical
device may more accurately identify instances of worsening heart
failure. Upon detecting worsening heart failure, the medical device
may, for example, provide an alert that enables the patient to seek
medical attention before experiencing a heart failure event. The
alert may be communicated directly to the patient or to the
clinician through a variety of methods, including audible tones,
handheld devices and automatic telemetry to computerized
communication network.
[0008] The device may be a purely diagnostic device or may be a
combination device that monitors diagnostic parameters and delivers
therapy. In some embodiments, the medical device may be configured
as an implantable medical device (IMD) or an external device. In
some cases, an IMD may be implanted subcutaneously. In other
examples, a system may include an IMD and a programmer or other
external device in communication with the IMD. In such embodiments,
the external device may process data received from the IMD to
detect worsening heart failure in the patient and/or provide an
alert if worsening heart failure is detected.
[0009] In operation, the medical device monitors the primary
diagnostic parameter to obtain measured values. The medical device
also periodically changes a value of an index that indicates
worsening heart failure based on the measured values of the primary
diagnostic parameter, e.g., based on whether the values of the
primary diagnostic parameter are increasing or decreasing. The
secondary diagnostic parameter value may not be considered in
determining whether to provide an alert of worsening heart failure
when the index is outside the threshold zone. If the index is
greater than an upper threshold value of the threshold zone,
worsening heart failure may be detected and an alert may be
provided to the patient. If the index is less than a lower
threshold value of the threshold zone, worsening heart failure is
not detected and the medical device continues to monitor the
primary diagnostic parameter. However, when the index is within the
threshold zone, the secondary diagnostic parameter value is used to
detect worsening heart failure in the patient. Worsening heart
failure is detected when the secondary diagnostic parameter
satisfies a corresponding condition.
[0010] In some examples, the secondary diagnostic parameters are
monitored prior to the index being within the threshold zone. The
secondary diagnostic parameters may be monitored prior to the index
being in the threshold zone to provide information regarding trends
in secondary diagnostic parameters that may be used to determine
whether the secondary diagnostic parameters indicate worsening
heart failure when the index is within the threshold zone. For
example, some devices or systems may begin monitoring one or more
secondary diagnostic parameters when the index is greater than a
secondary diagnostic parameter threshold. The secondary diagnostic
parameter threshold may be less than the lower threshold of the
threshold zone, such that the secondary diagnostic parameters may
be monitored prior to the index entering the threshold zone. In
some examples, the device or system may monitor one or more
secondary diagnostic parameters within an observation window
defined by the secondary diagnostic parameter threshold and the
upper threshold of the index.
[0011] Example secondary diagnostic parameters include atrial
fibrillation (AF), heart rate during AF, ventricular fibrillation
(VF), heart rate during VF, atrial tachyarrhythmia (AT), heart rate
during AT, ventricular tachyarrhythmia (VT), heart rate during VT,
activity level, heart rate variability, night heart rate,
difference between day heart rate and night heart rate, heart rate
turbulence, heart rate deceleration capacity, respiratory rate,
baroreflex sensitivity, percentage of cardiac resynchronization
therapy (CRT) pacing, metrics of renal function, weight, blood
pressure, symptoms entered by the patient via a programmer, and
patient history, such as medication history, or history of heart
failure hospitalizations. In one example, the medical device may
monitor one secondary diagnostic parameter and detect worsening
heart failure in the patient based on the secondary diagnostic
parameter when the index is within the threshold zone. In another
example, the device may monitor two or more secondary diagnostic
parameters and detect worsening heart failure in the patient when
at least one of the secondary diagnostic parameters satisfies a
corresponding condition. In another example, the device may monitor
two or more secondary diagnostic parameters and detect worsening
heart failure in the patient when a chosen combination of the
secondary diagnostic parameters satisfies a corresponding
condition.
[0012] The threshold zone may be static or dynamic. For example,
the threshold zone may change as a function of time or based on
knowledge of the condition of the patient. In particular, the
threshold zone may automatically change as a function of time. In
contrast, a clinician or other authorized user may use an external
programmer to manually change the threshold zone based on knowledge
of the condition of the patient.
[0013] In one example, the disclosure provides a method comprising
monitoring at least one primary diagnostic parameter and at least
one secondary diagnostic parameter of a patient, wherein the
primary and secondary diagnostic parameters are associated with
worsening heart failure, changing an index value over time based on
the primary diagnostic parameter, wherein the index value indicates
worsening heart failure of the patient, determining whether
worsening heart failure is detected in the patient based on the
index when the index is outside of a threshold zone defined by a
lower threshold and an upper threshold, and determining whether
worsening heart failure is detected in the patient based on the
secondary diagnostic parameter when the index is inside the
threshold zone.
[0014] In another example, the disclosure provides a system
comprising at least one sensor and a processor. The processor
monitors at least one primary diagnostic parameter and at least one
secondary diagnostic parameter of a patient based on at least one
signal from the at least one sensor, wherein the primary and
secondary diagnostic parameters are associated with worsening heart
failure of the patient, changes an index value over time based on
the primary diagnostic parameter, wherein the index indicates
worsening heart failure in the patient, determines whether
worsening heart failure is detected in the patient based on the
index when the index is outside of a threshold zone defined by a
lower threshold and an upper threshold, and determines whether
worsening heart failure is detected in the patient based on the
secondary diagnostic parameter when the index is inside the
threshold zone.
[0015] In another example, the disclosure provides a
computer-readable medium comprising instructions that cause a
processor to monitor at least one primary diagnostic parameter and
at least one secondary diagnostic parameter of a patient, wherein
the primary and secondary diagnostic parameters are associated with
worsening heart failure, change an index value over time based on
the primary diagnostic parameter, wherein the index indicates
worsening heart failure in the patient, determine whether worsening
heart failure is detected in the patient based on the index when
the index is outside of an threshold zone defined by a lower
threshold and an upper threshold, and determine whether worsening
heart failure is detected in the patient based on the secondary
diagnostic parameter when the index is inside the threshold
zone.
[0016] In another example, the disclosure provides a system
comprising means for monitoring at least one primary diagnostic
parameter and at least one secondary diagnostic parameter of a
patient, wherein the primary and secondary diagnostic parameters
are associated with worsening heart failure, means for changing an
index value over time based on the primary diagnostic parameter,
wherein the index indicates worsening heart failure in the patient,
means for determining whether worsening heart failure is detected
in the patient based on the index when the index is outside of a
threshold zone defined by a lower threshold and an upper threshold,
and means for determining whether worsening heart failure is
detected in the patient based on the secondary diagnostic parameter
when the index is inside the threshold zone.
[0017] The details of one or more embodiments of the invention are
set forth in the accompanying drawings and the description below.
Other features, objects, and advantages of the invention will be
apparent from the description and drawings, and from the
claims.
BRIEF DESCRIPTION OF DRAWINGS
[0018] FIG. 1 is a conceptual diagram illustrating an example
system that detects worsening heart failure using multiple
diagnostic parameters.
[0019] FIG. 2 is a conceptual diagram illustrating the implantable
medical device (IMD) and leads of the system shown in FIG. 1 in
greater detail.
[0020] FIG. 3 is a functional block illustrating an example
configuration of the IMD shown in FIG. 1.
[0021] FIG. 4 is a functional block diagram illustrating an example
configuration of the programmer shown in FIG. 1.
[0022] FIG. 5 is a functional block diagram illustrating an example
configuration of a diagnostic unit shown in FIG. 3 and FIG. 4.
[0023] FIG. 6 is functional block diagram illustrating an example
configuration of an impedance analysis unit shown in FIG. 5.
[0024] FIG. 7 is a functional block diagram illustrating an example
of the functionality of a secondary diagnostic parameter unit shown
in FIG. 5.
[0025] FIG. 8 is a functional block diagram illustrating an example
configuration of a diagnostic module shown in FIG. 5.
[0026] FIG. 9 is a flow diagram illustrating an example method that
may be performed by the IMD or programmer shown in FIG. 1 to detect
worsening heart failure in a patient.
[0027] FIG. 10 is a flow diagram illustrating an example method for
monitoring a primary diagnostic parameter.
[0028] FIGS. 11-15 are flow diagrams illustrating example methods
for monitoring secondary diagnostic parameters.
[0029] FIG. 16 is a graph illustrating an example of a fluid index
that increments over time relative to an example threshold
zone.
[0030] FIG. 17 is a block diagram illustrating an example system
that includes an external device, such as a server, and one or more
computing devices that are coupled to the IMD and programmer shown
in FIG. 1 via a network.
DETAILED DESCRIPTION
[0031] FIG. 1 is a conceptual diagram illustrating an example
system 10 that may be used to detect worsening heart failure in
patient 14 using multiple diagnostic parameters. Generally, system
10 generates an alert in response to detecting worsening heart
failure so that patient 14 can seek appropriate treatment before
experiencing a heart failure hospitalization (HFH) event. Patient
14 ordinarily, but not necessarily, will be a human.
[0032] System 10 includes implantable medical device (IMD) 16,
which is coupled to leads 18, 20, and 22, an electrode 34 located
on the can of IMD 16, and a programmer 24. In some examples, IMD 16
may be a purely diagnostic device that monitors multiple diagnostic
parameters associated with heart failure. In other examples, IMD 16
may additionally operate as a therapy delivery device to deliver
electrical signals to heart 12 via one or more of leads 18, 20, and
22, such as an implantable pacemaker, a cardioverter, and/or
defibrillator. In some examples, IMD 16 may operate as a drug
delivery device that delivers therapeutic substances to patient 14
via catheters (not shown), or as a combination therapy device that
delivers both electrical signals and therapeutic substances.
Moreover, IMD 16 is not limited to devices implanted as shown in
FIG. 1. As an example, IMD 16 may be implanted subcutaneously in
patient 14, or may be an entirely external device with leads
attached to the skin of patient 14 or implanted percutaneously in
patient 14. In some examples, IMD 16 need not include leads, but
may include a plurality of electrodes, like electrode 34, on the
housing of IMD 16.
[0033] In general, IMD 16 monitors a primary diagnostic parameter
that is indicative of fluid accumulation and one or more secondary
diagnostic parameters. In particular, IMD 16 may monitor the
primary diagnostic parameter and the one or more secondary
diagnostic parameters at the same time. Example, primary diagnostic
parameters include intrathoracic impedance and cardiovascular
pressure. Example secondary diagnostic parameters include atrial
fibrillation burden (AF), heart rate during AF, ventricular
fibrillation burden (VF), heart rate during VF, atrial
tachyarrhythmia burden (AT), heart rate during AT, ventricular
tachyarrhythmia burden (VT), heart rate during VT, activity level,
heart rate variability, night heart rate, difference between day
heart rate and night heart rate, heart rate turbulence, heart rate
deceleration capacity, respiratory rate, baroreflex sensitivity,
percentage of cardiac resynchronization therapy (CRT) pacing,
metrics of renal function, weight, blood pressure, symptoms entered
by the patient via a programmer, and patient history, such as
medication history, or history of heart failure hospitalizations.
Thus, IMD 16 may, in various embodiments, monitor either
intrathoracic impedance or pressure and one, all, or any
combination of the previously recited secondary diagnostic
parameters.
[0034] IMD 16 detects worsening heart failure in patient 14 based
on one or both of the primary diagnostic parameters and the one or
more secondary diagnostic parameters. In particular, IMD 16 detects
worsening heart failure based only on the primary diagnostic
parameter when an index that is changed over time based on the
primary diagnostic parameter is outside of a threshold zone. That
is, when the index has a value that is greater than the maximum
threshold value of the threshold zone, the primary diagnostic
parameter may alone be a reliable indictor that patient 14 is
experiencing worsening heart failure. When the index has a value
that is less than the minimum threshold value of the threshold
zone, the primary diagnostic parameter may alone be a reliable
indicator that patient 14 is not experiencing worsening heart
failure.
[0035] If the index is within the threshold zone, then IMD 16
detects worsening heart failure based on the secondary diagnostic
parameter. In other words, the threshold zone may be thought of as
a "maybe zone" with respect to the primary diagnostic parameter.
Accordingly, the secondary diagnostic parameter may be used to
provide additional evidence to confirm that patient 14 is or is not
experience worsening heart failure, when the index is within the
threshold zone. In examples in which system 10 monitors more than
one secondary diagnostic parameter, system 10 may detect worsening
heart failure when the index is within the threshold zone and one
or more of the secondary diagnostic parameters satisfy the
corresponding conditions. The number of secondary diagnostic
parameters required to must meet the corresponding conditions may
be pre-determined and/or selected by a user using programmer
24.
[0036] IMD 16 or programmer 24 may be configured to provide an
alert in response to detecting worsening heart failure in patient
14. The alert may be audible, visual, or tactile and enables
patient 14 to seek medical attention to treat the condition prior
to experiencing a heart failure event, or a clinician to direct
patient 14 to do so. In some examples, the alert may be a silent
alert transmitted to another device associated with a clinician or
other user, such as a silent alert transmitted to a server, as
described below, and relayed to a physician via a computing
device.
[0037] In some examples, system 10 may dynamically change the
threshold zone over time, i.e., change the values over which the
index is conclusive for detecting worsening heart failure. For
example, system 10 may automatically increase or decrease the size
of the threshold zone as a function of time. The primary diagnostic
parameter may become a more reliable indicator of worsening heart
failure over time.
[0038] In another example, an authorized user may use programmer 24
to manually change the size of the threshold zone. In this way, an
authorized user may manually adjust the size of the threshold zone
according to the health of patient 14. As an example, if symptoms
of patient 14 are worsening, an authorized user may use programmer
24 to decrease the size of the threshold zone.
[0039] In the example illustrated in FIG. 1, IMD 16 is configured
to monitor intrathoracic impedance and includes leads 18, 20, and
22 extend into the heart 12 of patient 14. Right ventricular (RV)
lead 18 extends through one or more veins (not shown), the superior
vena cava (not shown), and right atrium 26, and into right
ventricle 28. Left ventricular (LV) coronary sinus lead 20 extends
through one or more veins, the vena cava, right atrium 26, and into
the coronary sinus 30 to a region adjacent to the free wall of left
ventricle 32 of heart 12. Right atrial (RA) lead 22 extends through
one or more veins and the vena cava, and into the right atrium 26
of heart 12. Other configurations, i.e., number and position of
leads, are possible. For example, other leads or lead
configurations may be used to monitor pressure and various
secondary diagnostic parameters. As described above, in some
examples, IMD 16 need not be coupled to leads.
[0040] Intrathoracic impedance, as well as various secondary
diagnostic parameters, may be measured by creating an electrical
path between electrodes (not shown in FIG. 1) located on one or
more of leads 18, 20, and 22 and can electrode 34. In some
embodiments, the can of IMD 16 may be used as an electrode in
combination with electrodes located on leads 18, 20, and 22. For
example, system 10 may measure intrathoracic impedance by creating
an electrical path between RV lead 18 and electrode 34. In
additional embodiments, system 10 may include an additional lead or
lead segment having one or more electrodes positioned at a
different location in the cardiovascular system or chest cavity,
such as within one of the vena cava, subcutaneously at a location
substantially opposite IMD 16 vis-a-vis the thorax of patent 14, or
epicardially, for measuring intrathoracic impedance.
[0041] In embodiments in which IMD 16 operates as a pacemaker, a
cardioverter, and/or defibrillator, IMD 16 may sense electrical
signals attendant to the depolarization and repolarization of heart
12 via electrodes coupled to at least one of the leads 18, 20, 22.
In some examples, IMD 16 provides pacing pulses to heart 12 based
on the electrical signals sensed within heart 12. The
configurations of electrodes used by IMD 16 for sensing and pacing
may be unipolar or bipolar. IMD 16 may also provide defibrillation
therapy and/or cardioversion therapy via electrodes located on at
least one of the leads 18, 20, 22. IMD 16 may detect arrhythmia of
heart 12, such as fibrillation of ventricles 28 and 32, and deliver
defibrillation therapy to heart 12 in the form of electrical
pulses. In some examples, IMD 16 may be programmed to deliver a
progression of therapies, e.g., pulses with increasing energy
levels, until a fibrillation of heart 12 is stopped. IMD 16 detects
fibrillation employing one or more fibrillation detection
techniques known in the art.
[0042] It should be understood that IMD 16 may also include other
types of sensors for monitoring various other primary and secondary
diagnostic parameters, or be coupled to additional medical leads
carrying other types of sensors for monitoring other primary and
secondary diagnostic parameters. In examples in which IMD 16
monitors pressure as the primary diagnostic parameter, one or more
of leads 18, 20, and 22 and/or the device can of IMD 16 may include
one or more pressure sensors, such as capacitive pressure sensors.
IMD 16 may also include or be coupled to one or more pressure
sensors, the output of which may be considered with heart rate to
monitor baroreflex sensitivity as a secondary parameter. In another
example, system 10 may include one or more accelerometers for
monitoring activity of patient 14. In such examples, the
accelerometers may be contained within the device can of IMD 16. In
some examples, IMD 16 may include or be coupled to one or more
sensors, e.g., chemical sensors, pressure sensors, or electrodes
for monitoring impedance, to monitor metrics of renal function as
one or more secondary diagnostic parameters. In some examples, IMD
16 may use electrodes on leads 18, 20, or 22, or other leads to
detect respiration, e.g., based on intrathoracic impedance. In an
additional example, IMD 16 may also communicate with an external
sensor, such as a scale for monitoring the weight of patient 14.
Moreover, in embodiments in which IMD 16 is implemented as an
external device (not shown), leads for monitoring primary and
secondary diagnostic parameters may be implanted percutaneously in
patient 14 or attached to the skin of patient 14.
[0043] In some examples, programmer 24 may be a handheld computing
device, computer workstation, or networked computing device.
Programmer 24 may include a user interface that receives input from
a user. The user interface may include, for example, a keypad and a
display, which may for example, be a cathode ray tube (CRT)
display, a liquid crystal display (LCD) or light emitting diode
(LED) display. The keypad may take the form of an alphanumeric
keypad or a reduced set of keys associated with particular
functions. Programmer 24 can additionally or alternatively include
a peripheral pointing device, such as a mouse, via which a user may
interact with the user interface. In some embodiments, a display of
programmer 24 may include a touch screen display, and a user may
interact with programmer 24 via the display. It should be noted
that the user may also interact with programmer 24 remotely via a
networked computing device.
[0044] A user, such as a physician, technician, surgeon,
electrophysiologist, or other clinician, may interact with
programmer 24 to communicate with IMD 16. For example, the user may
interact with programmer 24 to retrieve physiological or diagnostic
information from IMD 16. A user may also interact with programmer
24 to program IMD 16, e.g., select values for operational
parameters of the IMD.
[0045] For example, the user may use programmer 24 to retrieve
information from IMD 16. The information may relate to the primary
and/or secondary diagnostic parameters, i.e., information relating
to intrathoracic impedance, pressure, AF burden, heart rate during
AF, VF burden, heart rate during VF, AT burden, heart rate during
AT, VT burden, heart rate during VT, activity level, heart rate
variability, night heart rate, difference between day heart rate
and night heart rate, heart rate turbulence, heart rate
deceleration capacity, respiratory rate, baroreflex sensitivity,
percentage of CRT pacing, metrics of renal function, weight, blood
pressure, symptoms entered by the patient via a programmer, and
patient history, such as medication history, or history of heart
failure hospitalizations. The information may also include trends
therein over time. In some embodiments, the user may use programmer
24 to retrieve information from IMD 16 regarding other sensed
physiological parameters of patient 14. In addition, the user may
use programmer 24 to retrieve information from IMD 16 regarding the
performance or integrity of IMD 16 or other components of system
10, such as leads 18, 20, and 22, or a power source of IMD 16.
[0046] The user may use programmer 24 to select a primary and one
or more secondary diagnostic parameters and program measurement
parameters for the selected diagnostic parameters. For example, the
user may use programmer 24 to select intrathoracic impedance and/or
cardiovascular pressure as the primary diagnostic parameter and to
select one or more secondary diagnostic parameters from a list of
secondary diagnostic parameters. For example, if the user selects
intrathoracic impedance as the primary diagnostic parameter, the
user may then use programmer 24 to select electrodes and waveforms
for measuring intrathoracic impedance. The user may select or
specify measurement parameters for other diagnostic parameters in a
similar manner.
[0047] In one example, a user may also use programmer 24 to program
other parameters related to detecting worsening heart failure, such
as parameters associated with the threshold zone. In this case, the
user may specify parameters that define the threshold zone, i.e.,
the values over which the fluid index is inconclusive, or
parameters that control how the threshold zone changes over time.
Furthermore, the user may use programmer 24 to enter clinical
information that can be used as secondary parameters, such as
patient history, medication history, history of heart failure
hospitalizations, or other historical or current observations of
patient condition.
[0048] Programmer 24 may also be used to program a therapy
progression, select electrodes to deliver defibrillation pulses,
select waveforms for the defibrillation pulse, or select or
configure a fibrillation detection algorithm for IMD 16. The user
may also use programmer 24 to program aspects of other therapies
provided by IMD 16, such as cardioversion or pacing therapies. In
some examples, the user may activate certain features of IMD 16 by
entering a single command via programmer 24, such as depression of
a single key or combination of keys of a keypad or a single
point-and-select action with a pointing device.
[0049] IMD 16 and programmer 24 may communicate via wireless
communication using any techniques known in the art. Examples of
communication techniques may include, for example, low frequency or
radiofrequency (RF) telemetry, but other techniques are also
contemplated. In some examples, programmer 24 may include a
programming head that may be placed proximate to the patient's body
near the IMD 16 implant site in order to improve the quality or
security of communication between IMD 16 and programmer 24.
[0050] FIG. 2 is a conceptual diagram illustrating IMD 16, leads
18, 20, and 22, and electrode 34 of system 10 in greater detail.
System 10 is generally described in this disclosure as a therapy
system that detects worsening heart failure in patient 14 and
delivers corrective electrical signals to heart 12. In particular,
system 10 is as a therapy system that monitors intrathoracic
impedance of tissue in the body of patient 14 and one or more
secondary diagnostic parameters to detect worsening heart failure
in patient 14. It should be understood, however, that system 10
may, in some embodiments, be implemented as a purely diagnostic
device that monitors a primary diagnostic parameter, such as
intrathoracic impedance or cardiovascular pressure, and one or more
secondary diagnostic parameters.
[0051] In the example illustrated in FIG. 2, system 10 includes
leads 18, 20, and 22 that include electrodes for monitoring
intrathoracic impedance and one or more secondary diagnostic
parameters. Leads 18, 20, and 22 may be electrically coupled to a
stimulation generator and a sensing module of IMD 16 via connector
block 38. In some examples, proximal ends of leads 18, 20, 22 may
include electrical contacts that electrically couple to respective
electrical contacts within connector block 38. In addition, in some
examples, leads 18, 20, 22 may be mechanically coupled to connector
block 38 with the aid of set screws, connection pins, or another
suitable mechanical coupling mechanism.
[0052] Each of the leads 18, 20, 22 includes an elongated
insulative lead body, which may carry a number of concentric coiled
conductors separated from one another by tubular insulative
sheaths. In some cases, each of the leads 18, 20, 22 may include
cable conductors. Bipolar electrodes 40 and 42 are located adjacent
to a distal end of lead 18. In addition, bipolar electrodes 44 and
46 are located adjacent to a distal end of lead 20 and bipolar
electrodes 48 and 50 are located adjacent to a distal end of lead
22.
[0053] Electrodes 40, 44 and 48 may take the form of ring
electrodes, and electrodes 42, 46 and 50 may take the form of
extendable helix tip electrodes mounted retractably within
insulative electrode heads 52, 54 and 56, respectively. In other
embodiments, one or more of electrodes 42, 46 and 50 may take the
form of small circular electrodes at the tip of a tined lead or
other fixation element. Leads 18, 20, 22 also include elongated
electrodes 62, 64, 66, respectively, which may take the form of a
coil. Each of the electrodes 40, 42, 44, 46, 48, 50, 62, 64 and 66
may be electrically coupled to a respective one of the coiled
conductors within the lead body of its associated lead 18, 20, 22,
and thereby coupled to respective ones of the electrical contacts
on the proximal end of leads 18, 20 and 22.
[0054] As discussed above, IMD 16 includes one or more housing
electrodes, such as housing electrode 34, which may be formed
integrally with an outer surface of hermetically-sealed housing 60
of IMD 16 or otherwise coupled to housing 60. In some examples,
housing electrode 34 is defined by an uninsulated portion of an
outward facing portion of housing 60 of IMD 16. Other division
between insulated and uninsulated portions of housing 60 may be
employed to define two or more housing electrodes. In some
examples, housing electrode 34 comprises substantially all of
housing 60. As described in further detail with reference to FIG.
3, housing 60 may enclose a signal generator that generates
therapeutic stimulation, such as cardiac pacing pulses and
defibrillation shocks, as well as a sensing module for monitoring
the rhythm of heart 12.
[0055] IMD 16 may sense electrical signals attendant to the
depolarization and repolarization of heart 12 via electrodes 34,
40, 42, 44, 46, 48, 50, 62, 64 and 66. The electrical signals are
conducted to IMD 16 from the electrodes via the respective leads
18, 20, 22. IMD 16 may sense such electrical signals via any
bipolar combination of electrodes 40, 42, 44, 46, 48, 50, 62, 64
and 66. Furthermore, any of the electrodes 40, 42, 44, 46, 48, 50,
62, 64 and 66 may be used for unipolar sensing in combination with
housing electrode 34. Additionally, any of the electrodes 40, 42,
44, 46, 48, 50, 62, 64 and 66 may be used in combination with
housing electrode 34 to sense intrathoracic impedance of patient
14.
[0056] IMD 16 may process the sensed electrical signals to monitor
secondary diagnostic parameters such as AF burden, heart rate
during AF, VF burden, heart rate during VF, AT burden, heart rate
during AT, VT burden, heart rate during VT, activity level, heart
rate variability, night heart rate, difference between day heart
rate and night heart rate, heart rate turbulence, heart rate
deceleration capacity, or baroreflex sensitivity. IMD 16 may also
process the intrathoracic impedance sensed by electrodes 34, 40,
42, 44, 46, 48, 50, 62, 64, or 66 as a primary diagnostic parameter
to modify an index of worsening heart failure, as well as to detect
respiratory rate, depth, or pattern, which may be secondary
diagnostic parameters.
[0057] In some examples, IMD 16 delivers pacing pulses via bipolar
combinations of electrodes 40, 42, 44, 46, 48 and 50 to produce
depolarization of cardiac tissue of heart 12. In some examples, IMD
16 delivers pacing pulses via any of electrodes 40, 42, 44, 46, 48
and 50 in combination with housing electrode 34 in a unipolar
configuration. Furthermore, IMD 16 may deliver cardioversion or
defibrillation pulses to heart 12 via any combination of elongated
electrodes 62, 64, 66, and housing electrode 34. Electrodes 34, 62,
64, 66 may also be used to deliver cardioversion pulses, e.g., a
responsive therapeutic shock, to heart 12. Electrodes 62, 64, 66
may be fabricated from any suitable electrically conductive
material, such as, but not limited to, platinum, platinum alloy or
other materials known to be usable in implantable defibrillation
electrodes.
[0058] The configuration of therapy system 10 illustrated in FIGS.
1 and 2 is merely one example. In other examples, a therapy system
may include epicardial leads and/or patch electrodes instead of or
in addition to the transvenous leads 18, 20, 22 illustrated in FIG.
1. Further, it should be understood that system 10 may be
configured to include other types of sensors for monitoring
diagnostic parameters. As an example, system 10 may be configured
to monitor cardiovascular pressure in patient 14 as the primary
diagnostic parameter and include one or more pressure sensors on
leads 18, 20, and 22, or on an additional lead coupled to IMD 16
and positioned within or proximate to the cardiovascular system of
patient 14, e.g., within RV 28.
[0059] System 10 may be similarly configured to also include
pressure sensors to monitor the respiratory rate of patient 14. As
an additional example, IMD 16 may, in some embodiments, include one
or more accelerometers to monitor the activity level of patient 14.
The accelerometer may be enclosed in housing 60. In some examples,
IMD 16 may include sensors to monitor renal function. In some
examples, system 10 may include one or more external sensors to
monitor a diagnostic parameter. For example, system 10 may include
a scale for monitoring the weight of patient 14. In such an
example, IMD 16 and the scale communicate with each other via
telemetry or a wired connection.
[0060] Moreover, IMD 16 need not be implanted within patient 14 as
shown in FIG. 1. For example, IMD 16 may be implanted
subcutaneously in patient 14 or may be located outside the body of
patient 14. In such examples, IMD 16 may monitor primary and
secondary diagnostic parameters and deliver defibrillation pulses
and other therapies to heart 12 via percutaneous leads that extend
through the skin of patient 14 to a variety of positions within or
outside of heart 12.
[0061] In addition, in other examples, system 10 may include any
suitable number of leads coupled to IMD 16, and each of the leads
may extend to any location within or proximate to heart 12 or in
the chest of patient 14. For example, other example therapy systems
may include three transvenous leads and an additional lead located
within or proximate to left atrium 36. As other examples, a therapy
system may include a single lead that extends from IMD 16 into
right atrium 26 or right ventricle 28, or two leads that extend
into a respective one of the right ventricle 28 and right atrium
26.
[0062] FIG. 3 is a functional block diagram of one example of IMD
16, which includes a processor 80, memory 82, signal generator 84,
electrical sensing module 86, telemetry module 88, power source 90,
sensor 91 and diagnostic unit 92. Processor 80 may comprise one or
more processors. Memory 82 includes computer-readable instructions
that, when executed by processor 80, cause IMD 16 and processor 80
to perform various functions attributed to IMD 16 and processor 80
herein. Memory 82 may include any volatile, non-volatile, magnetic,
optical, or electrical media, such as a random access memory (RAM),
read-only memory (ROM), non-volatile RAM (NVRAM),
electrically-erasable programmable ROM (EEPROM), flash memory, or
any other digital media.
[0063] Processor 80 may include any one or more of a
microprocessor, a controller, a digital signal processor (DSP), an
application specific integrated circuit (ASIC), a
field-programmable gate array (FPGA), or equivalent discrete or
integrated logic circuitry. In some examples, processor 80 may
include multiple components, such as any combination of one or more
microprocessors, one or more controllers, one or more DSPs, one or
more ASICs, or one or more FPGAs, as well as other discrete or
integrated logic circuitry. The functions attributed to processor
80 herein may be embodied as software, firmware, hardware or any
combination thereof.
[0064] Processor 80 controls signal generator 84 to deliver
stimulation therapy to heart 12 based on a selected one or more of
therapy programs, which may be stored in memory 82. Specifically,
processor 80 may control signal generator 84 to deliver electrical
pulses with the amplitudes, pulse widths, frequency, or electrode
polarities specified by the selected one or more therapy
programs.
[0065] Signal generator 84 is electrically coupled to electrodes
34, 40, 42, 44, 46, 48, 50, 62, 64, and 66, e.g., via conductors of
the respective lead 18, 20, 22, or, in the case of housing
electrode 34, via an electrical conductor disposed within housing
60 of IMD 16. A switch matrix may also be provided to connect
signal generator 84 to one or more of electrodes 34, 40, 42, 44,
46, 48, 50, 62, 64, and 66. Signal generator 84 is configured to
generate and deliver electrical stimulation therapy to heart
12.
[0066] For example, signal generator 84 may deliver defibrillation
shocks to heart 12 via at least two of electrodes 34, 62, 64, 66.
Signal generator 84 may also deliver pacing pulses via ring
electrodes 40, 44, 48 coupled to leads 18, 20, and 22,
respectively, and/or helical electrodes 42, 46, and 50 of leads 18,
20, and 22, respectively. In some examples, signal generator 84
delivers pacing, cardioversion, or defibrillation stimulation in
the form of electrical pulses. In other examples, signal generator
84 may deliver one or more of these types of stimulation in the
form of other signals, such as sine waves, square waves, or other
substantially continuous time signals.
[0067] Signal generator 84 may include a switch module, and
processor 80 may use the switch module to select, e.g., via a
data/address bus, which of the available electrodes are used to
deliver defibrillation pulses or pacing pulses. The switch module
may include a switch array, switch matrix, multiplexer, transistor
array, microelectromechanical switches, or any other type of
switching device suitable to selectively couple stimulation energy
to selected electrodes.
[0068] Electrical sensing module 86 monitors signals from at least
one of electrodes 34, 40, 42, 44, 46, 48, 50, 62, 64 or 66 in order
to monitor electrical activity of heart 12. Sensing module 86 may
also include a switch module to select which of the available
electrodes are used to sense the heart activity. In some examples,
processor 80 may select the electrodes that function as sense
electrodes via the switch module within sensing module 86, e.g., by
providing signals via a data/address bus. In some examples, sensing
module 86 includes one or more sensing channels, each of which may
comprise an amplifier. In response to the signals from processor
80, the switch module within sensing module 86 may couple the
outputs from the selected electrodes to one of the sensing
channels.
[0069] In some examples, one channel of sensing module 86 may
include an R-wave amplifier that receives signals from electrodes
40 and 42, which are used for pacing and sensing in right ventricle
28 of heart 12. Another channel may include another
[0070] R-wave amplifier that receives signals from electrodes 44
and 46, which are used for pacing and sensing proximate to left
ventricle 32 of heart 12. In some examples, the R-wave amplifiers
may take the form of an automatic gain controlled amplifier that
provides an adjustable sensing threshold as a function of the
measured R-wave amplitude of the heart rhythm.
[0071] In addition, in some examples, one channel of sensing module
86 may include a P-wave amplifier that receives signals from
electrodes 48 and 50, which are used for pacing and sensing in
right atrium 26 of heart 12. In some examples, the P-wave amplifier
may take the form of an automatic gain controlled amplifier that
provides an adjustable sensing threshold as a function of the
measured P-wave amplitude of the heart rhythm. Examples of R-wave
and P-wave amplifiers are described in U.S. Pat. No. 5,117,824 to
Keimel et al., which issued on Jun. 2, 1992 and is entitled,
"APPARATUS FOR MONITORING ELECTRICAL PHYSIOLOGIC SIGNALS," and is
incorporated herein by reference in its entirety. Other amplifiers
may also be used. Furthermore, in some examples, one or more of the
sensing channels of sensing module 84 may be selectively coupled to
housing electrode 34, or elongated electrodes 62, 64, or 66, with
or instead of one or more of electrodes 40, 42, 44, 46, 48 or 50,
e.g., for unipolar sensing of R-waves or P-waves in any of chambers
26, 28, 36, or 32 of heart 12.
[0072] In some examples, sensing module 84 includes a channel that
comprises an amplifier with a relatively wider pass band than the
R-wave or P-wave amplifiers. Signals from the selected sensing
electrodes that are selected for coupling to this wide-band
amplifier may be provided to a multiplexer, and thereafter
converted to multi-bit digital signals by an analog-to-digital
converter for storage in memory 82 as an electrogram (EGM). In some
examples, the storage of such EGMs in memory 82 may be under the
control of a direct memory access circuit. Processor 80 may employ
digital signal analysis techniques to characterize the digitized
signals stored in memory 82 to detect and classify the patient's
heart rhythm from the electrical signals. Processor 80 may detect
and classify the patient's heart rhythm by employing any of the
numerous signal processing methodologies known in the art.
[0073] If IMD 16 is configured to generate and deliver pacing
pulses to heart 12, processor 80 may include pacer timing and
control module, which may be embodied as hardware, firmware,
software, or any combination thereof. The pacer timing and control
module may comprise a dedicated hardware circuit, such as an ASIC,
separate from other processor 80 components, such as a
microprocessor, or a software module executed by a component of
processor 80, which may be a microprocessor or ASIC. The pacer
timing and control module may include programmable counters which
control the basic time intervals associated with DDD, VVI, DVI,
VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR and other modes
of single and dual chamber pacing. In the aforementioned pacing
modes, "D" may indicate dual chamber, "V" may indicate a ventricle,
"I" may indicate inhibited pacing (e.g., no pacing), and "A" may
indicate an atrium. The first letter in the pacing mode may
indicate the chamber that is paced, the second letter may indicate
the chamber that is sensed, and the third letter may indicate the
chamber in which the response to sensing is provided.
[0074] Intervals defined by the pacer timing and control module
within processor 80 may include atrial and ventricular pacing
escape intervals, refractory periods during which sensed P-waves
and R-waves are ineffective to restart timing of the escape
intervals, the pulse widths of the pacing pulses, A-V intervals,
and V-V intervals for cardiac resynchronization therapy (CRT). As
another example, the pacer timing and control module may define a
blanking period, and provide signals sensing module 86 to blank one
or more channels, e.g., amplifiers, for a period during and after
delivery of electrical stimulation to heart 12. As another example,
the pacer timing and control module may control intervals for
delivery of refractory period stimulation or cardiac potentiation
therapy. The durations of these intervals may be determined by
processor 80 in response to stored data in memory 82. The pacer
timing and control module of processor 80 may also determine the
amplitude of the cardiac pacing pulses.
[0075] During pacing, escape interval counters within the pacer
timing/control module of processor 80 may be reset upon sensing of
R-waves and P-waves. Stimulation generator 84 may include pacer
output circuits that are coupled, e.g., selectively by a switching
module, to any combination of electrodes 34, 40, 42, 44, 46, 48,
50, 62, or 66 appropriate for delivery of a bipolar or unipolar
pacing pulse to one of the chambers of heart 12. Processor 80 may
reset the escape interval counters upon the generation of pacing
pulses by stimulation generator 84, and thereby control the basic
timing of cardiac pacing functions, including anti-tachyarrhythmia
pacing (ATP).
[0076] The value of the count present in the escape interval
counters when reset by sensed R-waves and P-waves may be used by
processor 80 to measure the durations of R-R intervals, P-P
intervals, P-R intervals and R-P intervals, which are measurements
that may be stored in memory 82. Processor 80 may use the count in
the interval counters to detect an arrhythmia event, such as an
atrial or ventricular fibrillation or tachycardia.
[0077] In some examples, processor 80 may operate as an interrupt
driven device, and is responsive to interrupts from pacer timing
and control module, where the interrupts may correspond to the
occurrences of sensed P-waves and R-waves and the generation of
cardiac pacing pulses. Any necessary mathematical calculations to
be performed by processor 80 and any updating of the values or
intervals controlled by the pacer timing and control module of
processor 80 may take place following such interrupts. A portion of
memory 82 may be configured as a plurality of recirculating
buffers, capable of holding series of measured intervals, which may
be analyzed by processor 80 in response to the occurrence of a pace
or sense interrupt to determine whether the patient's heart 12 is
presently exhibiting atrial or ventricular tachyarrhythmia.
[0078] In some examples, an arrhythmia detection method may include
any suitable tachyarrhythmia detection algorithms. In one example,
processor 80 may utilize all or a subset of the rule-based
detection methods described in U.S. Pat. No. 5,545,186 to Olson et
al., entitled, "PRIORITIZED RULE BASED METHOD AND APPARATUS FOR
DIAGNOSIS AND GREATMENT OF ARRHYTHMIAS," which issued on Aug. 13,
1996, or in U.S. Pat. No. 5,755,736 to Gillberg et al., entitled,
"PRIORITIZED RULE BASED METHOD AND APPARATUS FOR DIAGNOSIS AND
TREATMENT OF ARRHYTHMIAS," which issued on May 26, 1998. U.S. Pat.
No. 5,545,186 to Olson et al. and U.S. Pat. No. 5,755,736 to
Gillberg et al. are incorporated herein by reference in their
entireties. However, other arrhythmia detection methodologies may
also be employed by processor 80 in other examples.
[0079] In the event that processor 80 detects an atrial or
ventricular tachyarrhythmia based on signals from sensing module
86, and an anti-tachyarrhythmia pacing regimen is desired, timing
intervals for controlling the generation of anti-tachyarrhythmia
pacing therapies by signal generator 84 may be loaded by processor
80 into the pacer timing and control module to control the
operation of the escape interval counters therein and to define
refractory periods during which detection of R-waves and P-waves is
ineffective to restart the escape interval counters.
[0080] If IMD 16 is configured to generate and deliver
defibrillation pulses to heart 12, signal generator 84 may include
a high voltage charge circuit and a high voltage output circuit. If
IMD 16 is configured to generate and deliver pacing pulses to heart
12, signal generator 84 may include a low voltage charge circuit
and a low voltage output circuit. In the event that generation of a
cardioversion or defibrillation pulse is required, processor 80 may
employ the escape interval counter to control timing of such
cardioversion and defibrillation pulses, as well as associated
refractory periods. In response to the detection of atrial or
ventricular fibrillation or tachyarrhythmia requiring a
cardioversion pulse, processor 80 may activate a
cardioversion/defibrillation control module, which may, like pacer
timing and control module, be a hardware component of processor 80
and/or a firmware or software module executed by one or more
hardware components of processor 80. The
cardioversion/defibrillation control module may initiate charging
of the high voltage capacitors of the high voltage charge circuit
of signal generator 84 under control of a high voltage charging
control line.
[0081] Processor 80 may monitor the voltage on the high voltage
capacitor may be monitored, e.g., via a voltage charging and
potential (VCAP) line. In response to the voltage on the high
voltage capacitor reaching a predetermined value set by processor
80, processor 80 may generate a logic signal that terminates
charging. Thereafter, timing of the delivery of the defibrillation
or cardioversion pulse by signal generator 84 is controlled by the
cardioversion/defibrillation control module of processor 80.
Following delivery of the fibrillation or tachycardia therapy,
processor 80 may return signal generator 84 to a cardiac pacing
function and await the next successive interrupt due to pacing or
the occurrence of a sensed atrial or ventricular
depolarization.
[0082] Signal generator 84 may deliver cardioversion or
defibrillation pulses with the aid of an output circuit that
determines whether a monophasic or biphasic pulse is delivered,
whether housing electrode 34 serves as cathode or anode, and which
electrodes are involved in delivery of the cardioversion or
defibrillation pulses. Such functionality may be provided by one or
more switches or a switching module of signal generator 84.
[0083] Telemetry module 88 includes any suitable hardware,
firmware, software or any combination thereof for communicating
with another device, such as programmer 24 (FIG. 1). Under the
control of processor 80, telemetry module 88 may receive downlink
telemetry from and send uplink telemetry to programmer 24 with the
aid of an antenna, which may be internal and/or external. Processor
80 may provide the data to be uplinked to programmer 24 and the
control signals for the telemetry circuit within telemetry module
88, e.g., via an address/data bus. In some examples, telemetry
module 88 may provide received data to processor 80 via a
multiplexer.
[0084] In some examples, processor 80 may transmit atrial and
ventricular heart signals (e.g., electrocardiogram signals)
produced by atrial and ventricular sense amp circuits within
sensing module 86 to programmer 24. Programmer 24 may interrogate
IMD 16 to receive the heart signals. Processor 80 may store heart
signals within memory 82, and retrieve stored heart signals from
memory 82. Processor 80 may also generate and store marker codes
indicative of different cardiac events that sensing module 86
detects, and transmit the marker codes to programmer 24. An example
pacemaker with marker-channel capability is described in U.S. Pat.
No. 4,374,382 to Markowitz, entitled, "MARKER CHANNEL TELEMETRY
SYSTEM FOR A MEDICAL DEVICE," which issued on Feb. 15, 1983 and is
incorporated herein by reference in its entirety.
[0085] As illustrated in FIG. 3, sensing module 86 may include an
impedance measurement module 87. Processor 80 may control impedance
measurement module 87 to periodically measure an electrical
parameter to determine an impedance, such as a intrathoracic
impedance. For a intrathoracic impedance measurement, processor 80
may control stimulation generator 84 to deliver an electrical
signal between selected electrodes and impedance measurement module
87 to measure a current or voltage amplitude of the signal.
Processor 80 may select any combination of electrodes 34, 40, 42,
44, 46, 48, 50, 62, 64, and 66, e.g., by using switch modules in
signal generator 84 and sensing module 86. Impedance measurement
module 87 includes sample and hold circuitry or other suitable
circuitry for measuring resulting current and/or voltage
amplitudes. Processor 80 determines an impedance value from the
amplitude value(s) received from impedance measurement module
87.
[0086] In some examples, processor 80 may perform an impedance
measurement by causing signal generator 84 to deliver a voltage
pulse between two electrodes and examining resulting current
amplitude value measured by impedance measurement module 87. In
these examples, signal generator 84 delivers signals that do not
necessarily deliver stimulation therapy to heart 12, due to, for
example, the amplitudes of such signals and/or the timing of
delivery of such signals. For example, these signals may comprise
sub-threshold amplitude signals that may not stimulate heart 12. In
some cases, these signals may be delivered during a refractory
period, in which case they also may not stimulate heart 12.
[0087] In other examples, processor 80 may perform an impedance
measurement by causing signal generator 84 to deliver a current
pulse across two selected electrodes. Impedance measurement module
87 holds a measured voltage amplitude value. Processor 80
determines an impedance value based upon the amplitude of the
current pulse and the amplitude of the resulting voltage that is
measured by impedance measurement module 87. IMD 16 may use defined
or predetermined pulse amplitudes, widths, frequencies, or
electrode polarities for the pulses delivered for these various
impedance measurements. In some examples, the amplitudes and/or
widths of the pulses may be sub-threshold, e.g., below a threshold
necessary to capture or otherwise activate tissue, such as cardiac
tissue.
[0088] In certain cases, IMD 16 may measure intrathoracic impedance
values that include both a resistive and a reactive (i.e., phase)
component. In such cases, IMD 16 may measure impedance during
delivery of a sinusoidal or other time varying signal by signal
generator 84, for example. Thus, as used herein, the term
"impedance" is used in a broad sense to indicate any collected,
measured, and/or calculated value that may include one or both of
resistive and reactive components.
[0089] In the illustrated example shown in FIG. 3, IMD 16 includes
diagnostic unit 92. Diagnostic unit 92 provides functionality that
enables IMD 16 to detect worsening heart failure in patient 14. To
avoid confusion, although diagnostic unit 92 is described as
performing the various monitoring and detecting techniques
proscribed to IMD 16, it should be understood that these techniques
may also be performed by processor 80, e.g., that diagnostic unit
92 may be a functional module provided or executed by processor 80.
Accordingly, although processor 80 and diagnostic unit 92 are
illustrated as separate modules in FIG. 3, processor 80 and
diagnostic unit 92 may be incorporated in a single processing unit
or equivalent circuitry.
[0090] In operation, diagnostic unit 92 monitors a primary
diagnostic parameter and one or more secondary diagnostic
parameters to detect worsening heart failure in patient 14.
Diagnostic unit 92 may operate in accordance with any detection
algorithm described in this disclosure. The detection algorithm may
be loaded from memory 82 or any other memory. Example detection
algorithms specify physiological parameters that are used as the
primary and second diagnostic parameters, threshold zone
characteristics, and detection rules. As an example, a detection
algorithm may specify thransthoracic impedance for the primary
diagnostic parameter, AT/AF burden for the secondary diagnostic
parameter, the range of index values for the threshold zone, and
one or more AT/AF burden conditions. If the detection algorithm
provides for multiple secondary diagnostic parameters, such as
AT/AF burden and activity level, the detection algorithm specifies
the rules used for detecting worsening heart failure based on the
AT/AF burden and activity level conditions, i.e., whether one or
both of the AT/AF burden and the activity level conditions must be
satisfied in order to detect worsening heart failure in patient
14.
[0091] In the example illustrated in FIG. 3, diagnostic unit 92 may
receive signals or indications from processor 80, sensing module 86
or other sensors 91 to monitor the primary and secondary diagnostic
parameters. Thus, IMD 16 may be configured to monitor physiological
parameters that are capable of being sensed using any combination
of electrodes 34, 40, 42, 44, 46, 48, 50, 62, 64 and 66. For
example, IMD 16 may be configured to monitor intrathoracic
impedance and/or electrical activity of heart 12, using any
combination of electrodes 34, 40, 42, 44, 46, 48, 50, 62, 64 and
66.
[0092] Based on the electrical activity of heart 12 as indicated by
sensing module 86, diagnostic unit 92 may monitor AF burden, heart
rate during AF, VF burden, heart rate during VF, AT burden, heart
rate during AT, VT burden, heart rate during VT, heart rate
variability, night heart rate difference between day heart rate and
night heart rate, heart rate turbulence, heart rate deceleration
capacity, or baroreflex sensitivity. As previously described,
sensing module 86 monitors signals from a selected combination of
electrodes 34, 40, 42, 44, 46, 48, 50, 62, 64, and 66 and processor
80/diagnostic unit 92 may detect atrial or ventricular
tachyarrhythmia based on signals or indications from sensing module
86. An AT burden may be determined based on the number and/or
duration (individual, average, or collective) of incidents of AT,
as well as the ventricular rate during AT. AF, VT and VF burdens
may be similar determined. In some examples, AT and AF burdens are
combined as an AT/AF burden. VT and VF burdens may likewise be
combined, in some examples. Such tachyarrhythmia burdens, as well
as heart rate variability and night heart rate, are examples of
secondary diagnostic parameters that may be monitored by diagnostic
unit 92.
[0093] IMD 16 may also be configured, in various examples, to
monitor other diagnostic parameters. In some examples, IMD 16 may
be configured to include other types of sensors, such as sensor 91
illustrated in FIG. 3, suitable for monitoring other primary and
secondary diagnostic parameters, such as one or more pressure
sensors for monitoring a cardiovascular pressure in patient 14, one
or more accelerometers for monitoring the activity level of patient
14, one or more pressure sensors for monitoring the heart rate
variability and night heart rate of patient 14, and/or one or more
pressure sensors for monitoring the respiratory rate, depth or
pattern of patient 14. In such embodiments, pressure sensors may be
carried by leads 18, 20, or 22 or by one or more additional leads
coupled to IMD 16. In embodiments in which IMD 16 monitors the
activity level of patient 14, one or more accelerometers may be
contained within or positioned on the housing of IMD 16, may be
carried by one or more of leads 18, 20, and 22 or one or more
additional leads, or may be a remote sensor in communication with
IMD 16. In addition to fluid accumulation as a primary diagnostic
parameter, in some examples, diagnostic unit 92 may monitor
respiratory rate, depth or pattern of patient 14 as a secondary
diagnostic parameter based on the intrathoracic impedance
determined based on signals received from impedance measurement
module 87. In some examples, IMD 16 may include sensors, such as
chemical, pressure or fluid sensors, for monitoring renal function.
Furthermore, in some examples, diagnostic unit 92 may receive
signals or information from external sources, such as programmer 24
or an external sensor, such as a scale, and monitor such
information or signals as secondary diagnostic parameters.
Additionally, diagnostic unit 92 may receive information from
processor 80, or may maintain information in memory 82, indicating
percentage of CRT pacing as a secondary diagnostic parameter.
Diagnostic unit 92 or processor 80 may determine whether or not CRT
pacing is delivered based on information from processor 80 of a
pacer timing and control module thereof.
[0094] If diagnostic unit 92 detects worsening heart failure of
patient 14, diagnostic unit 92 may provide an alert to patient 14.
Diagnostic unit 92 may include or be coupled to an alert module
(not shown) that provides, as examples, an audible or tactile alert
to patient 14 of the worsening heart failure. In some examples,
diagnostic unit 92 additionally or alternatively provide an
indication of worsening heart failure to programmer 24 or another
device via telemetry module 88 and/or network, which may provide an
alert to a user, such as patient 14 or a clinician.
[0095] The various components of IMD 16 are coupled to power source
90, which may include a rechargeable or non-rechargeable battery. A
non-rechargeable battery may be capable of holding a charge for
several years, while a rechargeable battery may be inductively
charged from an external device, e.g., on a daily or weekly
basis.
[0096] FIG. 4 is block diagram of an example programmer 24. As
shown in FIG. 4, programmer 24 includes processor 100, memory 102,
user interface 104, telemetry module 106, and power source 108. In
some examples, programmer 24, as illustrated in FIG. 4, includes a
diagnostic unit 110. Programmer 24 may be a dedicated hardware
device with dedicated software for programming of IMD 16.
Alternatively, programmer 24 may be an off-the-shelf computing
device running an application that enables programmer 24 to program
IMD 16.
[0097] A user may use programmer 24 to select worsening heart
failure detection algorithms, e.g., select primary and secondary
diagnostic parameters from a list of possible diagnostic
parameters, select threshold zone characteristics, and select rules
for detecting worsening heart failure in patient 14 based on the
selected diagnostic parameters and threshold zone. A user may also
use programmer 24 to configure other sensing or any therapy
provided by IMD 16. The clinician may interact with programmer 24
via user interface 104, which may include display to present
graphical user interface to a user, and a keypad or another
mechanism for receiving input from a user.
[0098] Processor 100 can take the form one or more microprocessors,
DSPs, ASICs, FPGAs, programmable logic circuitry, or the like, and
the functions attributed to processor 100 herein may be embodied as
hardware, firmware, software or any combination thereof. Diagnostic
unit 110, although illustrated as a separate module in FIG. 4, may
be incorporated in a single processing unit with processor 100 or
functional module executed or provided by processor 100. Memory 102
may store instructions that cause processor 100 and/or diagnostic
unit 110 to provide the functionality ascribed to programmer 24
herein, and information used by processor 100 and/or diagnostic
unit 110 to provide the functionality ascribed to programmer 24
herein. Memory 102 may include any fixed or removable magnetic,
optical, or electrical media, such as RAM, ROM, CD-ROM, hard or
floppy magnetic disks, EEPROM, or the like. Memory 102 may also
include a removable memory portion that may be used to provide
memory updates or increases in memory capacities. A removable
memory may also allow patient data to be easily transferred to
another computing device, or to be removed before programmer 24 is
used to program therapy for another patient. Memory 102 may also
store information that controls operation of IMD 16, such as
therapy delivery values.
[0099] A user, such as a clinician, technician, or patient 14, may
interact with programmer 24 via user interface 104. User interface
106 may include display to present graphical user interface to a
user, and a keypad or another mechanism for receiving input from a
user. In some examples, user interface 106 may include a touch
screen display.
[0100] Programmer 24 may communicate wirelessly with IMD 16, such
as using RF communication or proximal inductive interaction. This
wireless communication is possible through the use of telemetry
module 106, which may be coupled to an internal antenna or an
external antenna. An external antenna that is coupled to programmer
24 may correspond to the programming head that may be placed over
heart 12, as described above with reference to FIG. 1. Telemetry
module 106 may be similar to telemetry module 88 of IMD 16 (FIG.
3).
[0101] Programmer 24 may also be configured to communicate with
another computing device via wireless communication techniques, or
direct communication through a wired, e.g., network, connection.
Examples of local wireless communication techniques that may be
employed to facilitate communication between programmer 24 and
another computing device include RF communication based on the
802.11 or Bluetooth specification sets, infrared communication,
e.g., based on the IrDA standard.
[0102] Power source 108 delivers operating power to the components
of programmer 24. Power source 108 may include a battery and a
power generation circuit to produce the operating power. In some
embodiments, the battery may be rechargeable to allow extended
operation. Recharging may be accomplished by electrically coupling
power source 108 to a cradle or plug that is connected to an
alternating current (AC) outlet. In addition or alternatively,
recharging may be accomplished through proximal inductive
interaction between an external charger and an inductive charging
coil within programmer 24. In other embodiments, traditional
batteries (e.g., nickel cadmium or lithium ion batteries) may be
used. In addition, programmer 24 may be directly coupled to an
alternating current outlet to power programmer 24. Power source 108
may include circuitry to monitor power remaining within a battery.
In this manner, user interface 104 may provide a current battery
level indicator or low battery level indicator when the battery
needs to be replaced or recharged. In some cases, power source 108
may be capable of estimating the remaining time of operation using
the current battery.
[0103] In some examples, IMD 16 may detect worsening heart failure
using any of the techniques described herein, and provide an
indication of worsening heart failure to programmer 24. In such
examples, programmer 24 need not include diagnostic module 110.
Processor 100 may control user interface 106 to provide an alert of
worsening heart failure of patient 14 to the patient, a clinician,
or other users. In some examples, processor 100 may provide an
alert of worsening heart failure of patient 14 to one or more
computing devices via a network. A user may use programmer 24 to
retrieve and/or view data regarding primary and secondary
diagnostic parameters.
[0104] In some examples, programmer 24 includes diagnostic module
110 that receives diagnostic data from IMD 16, or other implanted
or external sensors or devices, i.e., data regarding the primary
and secondary diagnostic parameters, and processes the received
data to detect worsening heart failure in patient 14. In this
manner, diagnostic unit 110 may perform substantially the same
functionality as described with respect to diagnostic unit 92 in
FIG. 3. IMD 16 may not need to include diagnostic unit 92 in
examples in which programmer 24 includes diagnostic unit 110.
Diagnostic unit 110 may include an alert module that provides an
alert to patient 14 or a clinician via user interface 104 when
worsening heart failure is detected in patient 14, and/or provides
a notification to one or more computing devices via a network.
[0105] Alerts provided via user interface 104 may include a silent,
audible, visual, or tactile alert. For example, user interface 104
may emit a beeping sound, display a text prompt, cause various
buttons or screens to flash, or vibrate to alert patient 14 or
another user that a heart failure decompensation event may be
likely to occur. Patient 14 may then seek medical attention, e.g.,
check in to a hospital or clinic, to receive appropriate treatment,
or the other user may instruct patient 14 to do so.
[0106] Although illustrated and described in the context of
examples in which programmer 24 is able to program the
functionality of IMD 16, in other examples a device capable of
communicating with IMD 16 and providing functionality attributed to
programmer 24 herein need not be capable of programming the
functionality of the IMD. For example, an external home or patient
monitor may communicate with IMD 16 for any of the purposes
described herein, but need not independently be capable of
programming the functionality of the IMD. Such as a device may be
capable of communicating with other computing devices via a
network, as discussed in greater detail below.
[0107] The components of and functionality provided by a diagnostic
unit for detecting worsening heart failure are described in greater
detail below with respect to diagnostic unit 92 of IMD 16. However,
it is understood that any diagnostic unit provided in any device,
such as diagnostic unit 110 of programmer 24, may include the same
or similar components and provide the same or similar
functionality.
[0108] FIG. 5 is a block diagram of an example configuration of
diagnostic unit 92. As shown in FIG. 5, diagnostic unit 92 includes
multiple components including diagnostic module 120, impedance
analysis unit 122, and secondary parameter unit 124, and alert
module 128. Because either IMD 16 or programmer 24 may be
configured to include a diagnostic unit, modules 120, 122, 124, and
128 (and their sub-modules described below with reference to FIGS.
6-8) may be implemented in one or more processors, such as
processor 80 of IMD 16 or processor 100 of programmer 24. The
modules of diagnostic unit 92 (and their sub-modules described
below with reference to FIGS. 6-8) may be embodied as one or more
hardware modules, software modules, firmware modules, or any
combination thereof. As illustrated in FIG. 5, the modules and
sub-modules of diagnostic unit 92 may have access to memory for
buffering or storing any of the values discussed with reference to
FIGS. 5-8, e.g., at locations accessible by and known to these
modules.
[0109] Generally, diagnostic module 120 processes data received
from impedance analysis unit 122 and secondary diagnostic parameter
unit 124 to detect worsening heart failure in patient 14.
Accordingly, impedance analysis unit 122 and secondary diagnostic
parameter unit 124 may operate in a coordinated manner with
diagnostic module 120. In one example embodiment, diagnostic module
120 may retrieve timing information from memory 126. The timing
information may provide periodic intervals for monitoring primary
and secondary diagnostic parameters and detecting worsening heart
failure based on the parameters. Accordingly, diagnostic module 120
may invoke impedance analysis unit 122 and secondary parameter unit
124 based on the timing information. Alternatively, diagnostic
module 120 may load the timing information into impedance analysis
unit 122 and secondary parameter unit 124, and units 122 and 124
may monitor corresponding parameters according to the timing
information. In either case, diagnostic module 120, impedance
analysis unit 122, and secondary parameter unit 124 operate
together to periodically monitor primary and secondary diagnostic
parameters of patient 14 and detect worsening heart failure in
patient 14 based on the diagnostic parameters.
[0110] Impedance analysis unit 122 monitors the intrathoracic
impedance of patient 14 as previously described with respect to
FIG. 3. That is, impedance analysis unit 122 may receive
intrathoracic impedance values measured using the techniques
described above with respect to FIG. 3. Although impedance analysis
unit 122 is illustrated in FIG. 5, it should be understood that
impedance analysis unit 122 is one example of various primary
diagnostic parameter analysis units that may be utilized. In other
example embodiments, diagnostic unit 92 may be configured to
include, in place of impedance analysis unit 122, a pressure
analysis unit that monitors one or more cardiovascular pressures of
patient 14.
[0111] Secondary parameter unit 124 may monitor one or more
secondary diagnostic parameters and output corresponding data to
diagnostic module 120. For example, secondary diagnostic unit 124
may obtain measured values, process the measured values to detect
worsening heart failure, and output secondary parameter data that
indicates whether worsening heart failure is detected in patient
14. With respect to FIG. 3, secondary diagnostic unit 124 may
monitor secondary diagnostic parameters, e.g., AT/AF or VT burden,
activity level, night heart, difference between day heart rate and
night heart rate, heart rate turbulence, heart rate deceleration
capacity, percentage of CRT pacing, heart rate variability,
respiratory rate, and other parameters that indicate worsening
heart failure, based on signals or indications received from
sensing module 86.
[0112] Diagnostic module 120 processes data received from impedance
analysis unit 122 and secondary parameter unit 124 according to a
detection technique or algorithm. The detection technique may be
loaded from memory 82. Memory 82 may store a plurality of detection
techniques. Each detection technique may specify primary and
secondary diagnostic parameters, rules regarding determining a
value of an index of worsening heart failure based on the primary
diagnostic parameter, rules regarding the threshold zone, and rules
for detecting worsening heart failure based on the index, threshold
zone, and secondary diagnostic parameter.
[0113] The rules regarding the threshold zone may specify the range
of values for the threshold zone. If the threshold zone dynamically
changes over time, the rules may also control how the threshold
zone changes as a function of time or as a function of knowledge,
such as knowledge of the condition of patient 14. The rules for
detecting worsening heart failure may specify threshold values
associated with the primary and secondary diagnostic parameters.
The threshold values correspond to a condition that must be
satisfied to detect worsening heart failure. As an example, when
multiple secondary diagnostic parameters are used one detection
technique may require that at least one secondary diagnostic
parameter exceed a corresponding threshold value, and another
detection technique may require that each of the secondary
diagnostic parameters exceed a corresponding threshold value.
[0114] Diagnostic module 120 invokes alert module 128 in response
to detecting worsening heart failure in patient 14. Alert module
128 provides an alert to patient 14 by, for example, providing an
audible, visual, or tactile alert. Alert module 128 may cause IMD
16 to emit a beeping a sound or vibrate. In some examples, alert
module 128 may provide an alert by communicating with an external
device, such as programmer 24. In response to the communication
from alert module 128, programmer 24 may emit a beeping sound,
display a text prompt, vibrate, or cause buttons and/or screens of
programmer 24 to flash. Similarly, if the alert module is
implemented in programmer 24, alert module 128 may cause programmer
24 to send a telemetry signal to IMD 16 that causes IMD 16 to
generate the alert.
[0115] FIG. 6 is a block diagram of an example configuration of
impedance analysis unit 122. As shown in FIG. 6, impedance analysis
unit 122 includes a current impedance module 130, a reference
impedance module 132 and a fluid index module 134. In general,
impedance analysis unit 122 periodically receives (or accesses)
intrathoracic impedance values measured as described above, and
determines, e.g., updates, a value of a fluid index 138 based on
the impedance values. Impedance analysis unit 122 provides the
current fluid index value 140 to diagnostic module 120 (FIG. 5) for
comparison to the threshold zone.
[0116] The fluid index may reflect a level of fluid accumulation,
e.g., pulmonary edema. The fluid index is one example of an index
that indicates worsening heart failure. Other examples include
indices or metrics of increased ventricular filling pressures or
other morbidities associated with worsening heart failure
experienced by a patient. In general, any parameter described
herein as indicating worsening heart failure may be a primary
diagnostic parameter, and an index that indicates worsening heart
failure may be any index that is incremented to indicate a trend in
the primary diagnostic parameter (that reflects worsening heart
failure).
[0117] Impedance measurement module 87 and/or processor 80 (FIG. 3)
may measure impedance values on an hourly basis, daily basis,
weekly basis, or other periodic interval. In one example
embodiment, impedance measurement module 87 may measure impedance
values during a particular portion of a day. As an example,
impedance measurement module 87 may measure impedance values every
twenty minutes during the afternoon. In some examples, current
impedance module 130 determines a current impedance value 136 as an
average or median of a plurality of such measured values, e.g., a
daily average. Current impedance module 130 may utilize a buffer to
store a plurality of measured impedance values to determine current
impedance value 136. In other examples, current impedance value 136
may be a single, most recently measured impedance value.
[0118] Reference impedance module 132 generates a reference
impedance value 138 based on the current impedance values 136
determined by current impedance module 130 over time. For example,
reference impedance module 132 may compare current impedance value
136 to a previous current impedance value, and determine a new
reference impedance value 138 based on the comparison. Reference
impedance module 132 may generate a new reference impedance value
138 based on the prior reference impedance value.
[0119] For example, when the current impedance value 136 is greater
than the previous impedance value, reference impedance module 132
may generate a new reference impedance value 138 by adding a
predetermined value to the previous reference impedance value.
Similarly, reference impedance module 132 may generate a new
reference impedance value 138 by subtracting a predetermined value
from the prior reference impedance value if the current impedance
value is less than a previous impedance value. In other words,
reference impedance module 132 may generate reference impedance
values 138 by incrementing or decrementing the reference impedance
value based on the comparison of the current impedance value 136 to
the previous impedance value. In other examples, reference
impedance module 132 may determine reference impedance value as an
average or median, e.g., over a window, of previous impedance
values 136. Reference impedance module 132 may utilize buffers or
other memory to store previous impedance values 136.
[0120] Fluid index value 140 represents decreasing intrathoracic
impedance in patient 14, and is accumulated over time to detect
worsening heart failure. Fluid index module 134 determines, e.g.,
changes, fluid index value 140 based on a comparison of current
impedance value 136 to reference impedance value 138. For example,
fluid index module 134 may increment fluid index value 134 by the
difference between current impedance value 136 and reference
impedance value 138 when the current impedance value is less than
the reference impedance value for a particular measurement
interval. Fluid index module 134 may decrement fluid index value
140 when the current impedance value is greater than the reference
impedance value for a particular measurement interval. The
decrement may be by the difference between current impedance value
136 and reference impedance value 138, by or to a predetermined
value, or to a value of zero. In some examples, impedance analysis
unit may determine current impedance value 136, reference impedance
value 138 and fluid index value 140 using any of the techniques
described in a commonly-assigned and co-pending U.S. application
Ser. No. 12/184,149 by Sarkar et al., entitled "DETECTING WORSENING
HEART FAILURE BASED ON IMPEDANCE MEASUREMENTS," filed on even date
herewith, and/or commonly-assigned U.S. application Ser. No.
10/727,008 by Stadler et al., entitled "METHOD AND APPARATUS FOR
DETECTING CHANGE IN INTRATHORACIC IMPEDANCE," filed on Dec. 3,
2003. Each of these preceding applications by Sarkar et al. and
Stadler et al. are incorporated herein by reference in their
entirety. As mentioned above, impedance analysis unit 122 provides
the fluid index value 140 to diagnostic module 120 (FIG. 5) for
comparison to the threshold zone in the described in greater detail
below. Diagnostic module 120 compares fluid index value 140 to the
threshold zone to determine whether to provide an alert to patient
14, continue monitoring patient 14, or examine the secondary
diagnostic parameter.
[0121] FIG. 7 is a block diagram illustrating the functionality of
secondary parameter unit 124. In general, secondary parameter unit
124 receives physiological parameter or therapy data 150, and
determines secondary parameter values 152 based on the
physiological parameter or therapy data. Secondary parameter values
152 may be used by diagnostic module 120 (FIG. 5) to detect
worsening heart failure in patient 14.
[0122] Although secondary parameter unit 124 is described generally
with respect to FIG. 7, i.e., described without reference to a
specific secondary diagnostic parameter, it should be understood
that secondary parameter unit 124 may be used to determine
secondary parameter values 152 for any of the secondary diagnostic
parameters discussed above. Furthermore, second parameter unit 124
may determine secondary parameter values 152 for a plurality of
secondary diagnostic parameters or, alternatively, diagnostic unit
92 may include a secondary parameter unit 124 for each secondary
diagnostic parameter used to detect worsening heart failure in
patient 14.
[0123] For example, secondary parameter unit 124 or multiple
secondary parameter units may generate secondary parameter values
152 for AF burden, AT burden, AT/AF burden, VT burden, patient
activity, night heart rate, difference between day heart rate and
night heart rate, heart rate turbulence, heart rate deceleration
capacity, baroreflex sensitivity, percentage of CRT pacing, heart
rate variability, respiration rate, respiration depth, respiration
pattern, renal function, patient weight, or patient history.
Secondary parameter unit 124 may receive physiological parameter
data 150 from one or more of electrical sensing module 86,
implanted or external sensors 91, processor 80, or programmer 24 to
determine the secondary parameter values 152, e.g., to process data
150 such that is in a form that may be indicative of worsening
heart failure. Physiological parameter data 150 may include, as
examples, heart rate, indications of the number and duration of AF,
AT, or VT episodes, as well as the ventricular rate during such
episodes, or digitized intrathoracic impedance signals for
determining respiration rate, depth or pattern. In some examples,
secondary parameter values 152 may include variable values, such as
count variables that are updated, i.e., incremented or decremented
or set to a predetermined value, based on received physiological
parameter data 150.
[0124] FIG. 8 is a block diagram of an example configuration of
diagnostic module 120. As shown in FIG. 8, diagnostic module 120
includes comparison module 160, threshold zone module 162, time
update module 164, knowledge update module 166, threshold zone
values 168, and secondary parameter threshold values 169.
Generally, comparison module 160 detects worsening heart failure in
patient 14 by comparing primary diagnostic parameter values, e.g.,
fluid index values 140 received from impedance analysis unit 122
(FIG. 6), to values retrieved from threshold zone module 162, and
secondary parameter values 152 received from secondary parameter
unit 124 (FIG. 7) to secondary parameter threshold values 169.
Comparison module 160 activates alert module 128 (FIG. 5) in
response to detecting worsening heart failure.
[0125] Threshold zone module 162 stores values in threshold zone
values 168 that may be variable values and may be output to
comparison module 160. The variable values in threshold zone values
168 define the threshold zone and may include threshold values,
THRESHOLD_HIGH and THRESHOLD_LOW. In other words, THRESHOLD_HIGH
and THRESHOLD_LOW define a range of values that is the threshold
zone.
[0126] Time update module 164 and knowledge update module 166 may
update the threshold values in threshold zone values 168. As an
example, time update module 164 may automatically update the
threshold values as a function of time to, for example, increase or
decrease the size of the threshold zone as time lapses. Time update
module 164 may also automatically update the threshold values such
that the threshold zone is defined differently over predetermined
intervals of time. As another example, knowledge update module 166
may update the threshold values in threshold zone values 168 based
on input received from an authorized user of programmer 24. In this
way, the size and range of the threshold zone may be manually
controlled and adapted based on the symptoms of patient 14.
Furthermore, in some examples, knowledge update module 166 may
automatically update the threshold values of threshold zones values
168 based on, for example, changes in patient condition observed
via one or more of the monitored diagnostic parameters, or
indications of efficacy of the diagnostic module 120 in identifying
worsening heart failure.
[0127] Initially, comparison module 160 compares fluid index value
140, which is determined based on the primary diagnostic parameter,
e.g., intrathoracic impedance, as described above to threshold zone
values 168. When the fluid index value is outside the range of the
threshold zone values 168, i.e., greater than THRESHOLD_HIGH and
less than THRESHOLD_LOW, the primary diagnostic parameter value is
conclusive. That is, if the fluid index value is greater than
THRESHOLD_HIGH, then comparison module 160 activates alert module
128. If, on the other hand, fluid index value 140 is less than
THRESHOLD_LOW, IMD 16 continues to monitor patient 14.
[0128] However, when fluid index value 140 is within the range of
the threshold zone values 138, the primary diagnostic parameter is
considered "inconclusive" and comparison module 160 compares one or
more secondary diagnostic parameter values 152 to the corresponding
secondary parameter threshold values 169. Comparison module 160
detects worsening heart failure in patient 14 based on these
comparisons. More specifically, comparison module 160 detects
worsening heart failure based on the comparisons in accordance with
the particular detection technique.
[0129] As previously described, a detection technique specifies the
secondary diagnostic parameters, threshold values for comparison to
the parameter values, and a condition. Comparison module 160
detects worsening heart failure and invokes alert module 128 (FIG.
5) when the condition is satisfied. As an example, the condition
may be satisfied when a secondary diagnostic parameter value 152
exceeds the corresponding secondary diagnostic parameter threshold
value 169. However, in an example using multiple secondary
diagnostic parameters, different detection techniques specify
different conditions, such as a condition that all parameter values
exceed corresponding threshold values or, a condition that at least
one parameter value exceeds the corresponding threshold value.
[0130] FIG. 9 is a flow diagram illustrating an example method for
detecting worsening heart failure in patient 14. The method may be
performed entirely by IMD 16 or by a combination of IMD 16 and
programmer 24. When the method is performed by IMD 16 and
programmer 24, the steps for monitoring primary and secondary
diagnostic parameters, i.e., measuring the primary and secondary
diagnostic parameters, may be performed by IMD 16 and the steps for
detecting worsening heart failure in patient 14 based on the
primary and secondary diagnostic parameters may be performed by
programmer 24. In such examples, IMD 16 transmits parameter
information to programmer 24 via wireless signals as previously
described in this disclosure. For purposes of illustration only, it
will be assumed in the subsequent description that IMD 16 performs
the method illustrated in FIG. 9. Additionally, the method will be
described with respect to diagnostic unit 92 (FIG. 5) and
diagnostic module 120 (FIG. 6), but may be performed by any
diagnostic unit(s) in any one or more devices.
[0131] In the example shown in FIG. 9, IMD 16 monitors primary and
secondary diagnostic parameters (180). Based on the primary
diagnostic parameter, IMD 16 determines a fluid index value 140
(181). In one example, IMD 16 may periodically measure
intrathoracic impedance, and an impedance analysis unit 122 may
determine the fluid index value in the manner described above.
[0132] Diagnostic module 120 receives the fluid index value 140
value from impedance analysis unit 122 and compares it to a higher
threshold value, THRESH_HIGH (182). In particular, comparison
module 160 compares the fluid index value 140 to the high threshold
value stored in threshold zone values 168. If the fluid index value
is greater than the high threshold value ("YES" branch of step
182), then alert module 128 of diagnostic unit 92 generates an
alert (190) that indicates worsening heart failure to patient 14.
If, however, the fluid index value 140 is less than the high
threshold value ("NO" branch of step 182), then diagnostic module
120 compares the fluid index value to a lower threshold value,
THRESH_LOW (184). In particular, comparison module 160 may compare
fluid index value 140 to the low threshold value stored in
threshold zone values 168.
[0133] When fluid index value 140 is less than the low threshold
value, then IMD 16 may update the threshold zone (192). As
previously described, the threshold zone may be updated, i.e., the
size and range of the threshold zone may change, as a function of
time or based on knowledge of the condition of patient 14. Time
update module 164 and knowledge update module 166 of threshold zone
module 162 (FIG. 8) may update the threshold zone by updating the
higher and lower threshold values stored in threshold zone values
168. Threshold zone module 162 may update threshold zone values 168
periodically, and such updating need not occur after each
comparison of fluid index value 140 to the threshold zone values.
In some embodiments, the threshold zone is constant and not
updated. Whether or not the threshold zone is updated, IMD 16 may
continue to monitor the primary and secondary diagnostic parameters
(180).
[0134] When fluid index value 140 is within the threshold zone,
e.g., greater than the lower threshold value and less than the
higher threshold value, or between the threshold values ("NO"
branch of step 184), diagnostic module 120 determines whether the
secondary diagnostic parameter(s). That is, diagnostic module 120
looks to the secondary diagnostic parameters for determining
whether the patient is experiencing worsening heart failure when
fluid index value 140 is within the threshold zone.
[0135] As discussed above, secondary parameter unit 124 may monitor
one or more secondary diagnostic parameters to determine secondary
diagnostic parameter values, and comparison module 160 of
diagnostic module 120 may compare the values to corresponding
threshold values to detect worsening heart failure in patient 14.
As will be described in greater detail in FIGS. 11-14, comparison
module 160 generates secondary parameter data, SECONDARY_DATA,
based on the comparison. The secondary parameter data may be a
Boolean variable that is set to a true value to indicate worsening
heart failure, or a false value if the secondary diagnostic
parameter does not indicate worsening heart failure.
[0136] Diagnostic module 120 examines the secondary diagnostic
parameter data to detect worsening heart failure in patient 14
(186). When the secondary parameter data value is equal to a true
value ("YES" branch of step 188), the secondary diagnostic
parameter corroborates the primary diagnostic parameter and alert
module 128 generates an alert (190) to indicate worsening heart
failure to patient 14. On the other hand, when the secondary
parameter value is not equal to a true value
[0137] ("NO" branch of step 188), i.e., equal to a false value, IMD
16 may update the threshold zone (192) and/or continue to monitor
the primary and secondary diagnostic parameters (180).
[0138] The method shown in FIG. 9 may be performed periodically.
That is, the method may be repeated recursively over periodic
intervals. For example, the method may repeat once per day, once
every hour, once every several hours, once an hour for a sub-period
of several hours every day, and the like.
[0139] FIG. 10 is a flow diagram illustrating an example method for
measuring intrathoracic impedance and determining a fluid index
value 140 in patient 14. In particular, the method illustrated in
FIG. 10 is described with respect to impedance analysis unit 122
and fluid index module 134 of FIG. 6. Initially, impedance analysis
unit 122 determines a current impedance value, CURRENT_Z, based on
one or more measured impedance values received from impedance
measurement module 87 and/or processor 80 (200). The measured
impedance values may be collected at regular intervals throughout
the day or during a particular portion of the day. In one example
embodiment, impedance analysis unit 122 may determine the current
impedance value as the average of impedance values measured every
20 minutes from the hours of 12 p.m. to 5 p.m. during one day.
Impedance analysis unit 122 then determines a short term mean
impedance value (MEAN_Z) (201). The short-term mean may be the mean
or weighted mean of the CURRENT_Zs from a plurality of days, e.g.,
the last three days. To determine the current and mean impedances,
impedance analysis unit 122 may employ the techniques described in
U.S. application Ser. No. 10/727,008 by Stadler et al., entitled
"METHOD AND APPARATUS FOR DETECTING CHANGE IN INTRATHORACIC
IMPEDANCE," filed on Dec. 3, 2003, and incorporated herein by
reference in its entirety.
[0140] Fluid index module 134 compares the mean impedance value to
a reference impedance value (202). When the mean impedance value is
less than the reference impedance value ("YES" branch of step 202),
fluid index module 134 increases fluid index value 140 (204). As
previously described, fluid index module 134 may increase the fluid
index value by adding the difference between the current impedance
value and the reference impedance value to the previous fluid index
value. In this way, the fluid index value accumulates over time
while the mean impedance value is less than the reference impedance
value. However, when the mean impedance value is greater than or
equal to the reference impedance value ("NO" branch of step 202),
fluid index module 134 resets the fluid index value 140, e.g., to
zero (206). In some examples, fluid index module 134 may
alternatively decrease fluid index 140 by the difference between
the current and reference impedances, by a fixed or predetermined
amount, or to a fixed or predetermined value.
[0141] In either case, reference impedance module 132 also
determines the reference impedance value 138 (REF_Z) for the next
iteration of the method based on the mean impedance value (208).
For example, reference impedance module 132 may increment reference
impedance value 138 by a fixed amount if the mean impedance value
136 is greater than the reference impedance value 138. Reference
impedance module 132 may decrement reference impedance value 138 by
the same or a different fixed amount if the mean impedance value
136 is less than the reference impedance value 138. In other
examples, reference impedance module 132 may update a running
average or median (e.g., over a window) based on the current
impedance value 136.
[0142] FIGS. 11-15 are flow diagrams illustrating example methods
for monitoring secondary diagnostic parameters to determine whether
a patient is experiencing worsening heart failure. In particular,
the flow diagrams illustrated in FIGS. 11-15 are described with
respect to secondary parameter unit 124 shown in FIG. 7 and
diagnostic unit 120 of FIG. 8.
[0143] FIG. 11 is a flow diagram illustrating an example method for
determining whether a patient is experiencing worsening heart
failure based on atrial tachycardia and atrial fibrillation in
patient 14. Initially, secondary parameter unit 124 measures an AF
burden of patient 14 (210). For example, secondary parameter unit
124 may determine an AF burden value based on the number and/or
duration, e.g., average or cumulative duration, of AF episodes
experienced by patient 14, as well as the ventricular rate, e.g.,
average ventricular rate during the episodes.
[0144] Next, comparison module 160 compares the measured AF burden
value (AFburden) to a corresponding minimum threshold value 212
(minAFburden). If the AF burden value is greater than the minimum
threshold value ("YES" branch of step 212), comparison module 160
sets the value of a count variable, ATAFevidenceCounter equal to a
predetermined value, AFwin (214). If, however, the AF burden value
is less than or equal to the minimum threshold value ("NO" branch
of step 212), comparison module 160 decrements the count variable
(216). The value of the count variable is generally not decremented
lower than zero.
[0145] Secondary parameter unit 124 may also measure an AT/AF
burden of patient 14 (218). For example, secondary parameter unit
124 may determine an AT/AF burden value based on the AF burden
value and an AT burden value, e.g., the sum of these values. The AT
burden value may be determined based on the number and/or duration,
e.g., average or cumulative duration, of AT episodes experienced by
patient 14, as well as the ventricular rate, e.g., average
ventricular rate, during the episodes.
[0146] Comparison module 160 compares the AT/AF burden value
(ATAFburden) to a corresponding maximum threshold value
(maxAFburden) (220). When the AT/AF value is greater than the
maximum threshold value ("YES" branch of step 220), comparison
module 160 increments a count variable, chronicATAFcounter (224).
However, when the AT/AF value is not greater than the maximum
threshold value ("NO" branch of step 220), comparison module 160
resets the count variable (226). In some examples, comparison
module 160 may additionally consider the ventricular rate during
AT/AF, e.g., determine whether the AT/AF burden was greater than a
threshold number of hours and the ventricular rate during the AT/AF
was greater than a threshold rate, to determine whether to
increment the chronic AT/AF counter. In other examples, only AT/AF
associated with a threshold ventricular rate may be counted as
AT/AF burden that is compared to the maxAFburden threshold. In
these ways, the devices according to this disclosure may consider
whether AT/AF was conducted to the ventricles.
[0147] Diagnostic module 120 compares the count variable,
chronicATAFcounter, to a threshold value, chronicAFduration, and
the count variable, ATAFevidenceCounter, to a threshold value, zero
(228). In this way, this comparison is used to determine whether
the AT/AF burden satisfies corresponding conditions that
corroborate worsening heart failure in patient 14. In some
examples, when both conditions are satisfied ("YES" branch of step
228), comparison module 160 sets a Boolean variable (ATAF_DATA)
equal to true (230). However, when either condition is not
satisfied in such examples ("NO" branch of step 228), the
comparison module 160 sets the AT/AF variable equal to false
(232).
[0148] Diagnostic module 120 uses the secondary parameter data,
e.g., the Boolean variable to determine whether the secondary
diagnostic parameters satisfy the predetermined condition (186 of
FIG. 9), e.g., when the variable is true, to detect worsening heart
failure in patient 14. In some examples, diagnostic module 120 does
not maintain a Boolean variable (ATAF_DATA), but instead determines
whether both conditions are satisfied in response to determining
that the fluid index is within the threshold zone (182 and 184 of
FIG. 9). The various values and counters discussed with respect to
FIG. 11 may be modified on periodic basis, e.g., hourly or daily,
and the example method of FIG. 11 may also be performed on a
periodic basis. The various values, e.g., AT/AF burden values, may
be daily values, weekly values, or the like, and may be average or
median values.
[0149] FIG. 12 is a flow diagram illustrating an example method for
determining whether a patient is experiencing worsening heart
failure based on ventricular tachycardia and ventricular
fibrillation in patient 14. The method illustrated in FIG. 12
begins with secondary parameter unit 124 determining a VT/VF burden
value (240). In particular in this example, secondary parameter
unit 124 determines a number of VT and/or VF episodes. The number
of VT/VF episodes may be a daily (or weekly or monthly) total, or
an average or median of a number of such totals, e.g., of the
totals for the previous N days. In other examples, a VT/VF burden
value may be determined based on the duration of the episodes, or
the ventricular rate during such episodes, as examples.
[0150] Comparison module 160 may compare the number of episodes
(VTVFepi) to a threshold value (minVTepi) (242). When the number of
measured VT/VF episodes is greater than the threshold value ("YES"
branch of step 242), comparison module 160 sets the value of a
count variable (VTVFevidenceCounter) equal to a predetermined value
(VTwin) (244). On the other hand, each day (or other period) when
the number of measured VT/VF episodes is not greater than the
threshold value ("NO" branch of step 242), comparison module 160
decrements the count variable (246).
[0151] In some examples, comparison module 160 may additionally
consider the ventricular rate during VT/VF, e.g., determine whether
the VT/VF burden was greater than a threshold number of hours and
the ventricular rate during the VT/VF was greater than a threshold
rate, to determine whether to set or decrement the VT/VF counter.
In other examples, only VT/VF associated with a threshold
ventricular rate may be counted as VT/VF burden for setting or
decrementing the counter.
[0152] To determine whether the VT/VF condition corroborates the
primary diagnostic parameter evidence indicating worsening heart
failure in patient 14, comparison module 160 compares the count
variable to a corresponding threshold value (248). In the
illustrated example the threshold value is equal to zero.
Accordingly, if the count variable is greater than zero ("YES"
branch of step 248), then comparison module 160 sets the secondary
parameter data, e.g., Boolean variable VTVF_DATA equal to true
(250). However if the count variable is not greater than zero ("NO"
branch of step 248), comparison module 160 sets the secondary
parameter data value equal to false (252).
[0153] Diagnostic module 120 uses the secondary parameter data,
e.g., the Boolean variable, to determine whether the secondary
diagnostic parameters satisfy the predetermined condition (186 of
FIG. 9 to detect worsening heart failure in patient 14. In some
examples, diagnostic module 120 does not maintain a Boolean
variable (VTVF_DATA), but instead determines whether
VTVFevidenceCounter is greater than the threshold, e.g., zero, in
response to determining that the fluid index is within the
threshold zone (182 and 184 of FIG. 9).
[0154] FIG. 13 is a flow diagram illustrating an example method for
determining whether a patient is experiencing worsening heart
failure based on the activity level of patient 14. Initially,
secondary parameter unit 124 receives a signal, e.g., from a sensor
91, or data that indicates an activity level of patient 14 (260).
In some embodiments, the activity level of patient 14 may be
measured at periodic intervals throughout the day or over a portion
of the day. Multiple measurements may be averaged to obtain a daily
value, or a value associated with some other period greater than
the measurement frequency. Next, secondary parameter unit 124 may
determine a median activity level (MEDIAN_ACTIVITY) of patient 14
(262). The median value may be determined as the median of the last
"X" number of daily (or some other period) average activity level
values.
[0155] Comparison module 160 determines the ratio of the median
activity level to a baseline activity level, and compares the ratio
to a first threshold value (activityFRACTION) and the median
activity level to another threshold value (minACTIVITY) (264). The
baseline activity level may be defined as the median activity level
prior to the fluid index entering the threshold zone. The
activityFRACTION threshold value may be computed as a predetermined
or variable fraction of the previous median activity level, i.e.,
the median activity level prior to inclusion of the current daily
value.
[0156] In this manner, a secondary diagnostic parameter, in this
case activity level, may be compared to both an absolute threshold,
in this case minAcCTIVITY, which indicates whether the parameter
has reached a level at which it is considered indicative of
worsening heart failure, and a threshold that indicates a rate of
change, in this case activityFRACTION, which indicates whether the
parameter has changed at a rate that considered indicative of
worsening heart failure. Other secondary parameters, such as heart
rate variability and night heart rate, which are discussed below,
may be similarly compared to multiple thresholds, which may be
absolute and related to a rate of change.
[0157] When the current median activity level is less than either
of these threshold values, the activity level condition is
satisfied ("YES" branch of step 264), and comparison module 160
sets the secondary parameter data equal to true (266). However,
when both conditions are not satisfied ("NO" branch of step 264),
comparison module 160 sets the secondary parameter data value equal
to false (268). In some examples, the analysis of activity level
may include use of an activity level index similar to the fluid
index, which may accumulate over time as the median activity or
ratio of median to baseline activity is less than an adaptive
threshold, such as activity fraction. The index may be compared to
a threshold to determine whether to set the secondary parameter
data value to a true or false value. Secondary parameter unit 124
outputs the secondary parameter data to diagnostic module 120 in
diagnostic unit 92 for use in step 188 (FIG. 9) to detect worsening
heart failure in patient 14.
[0158] Diagnostic module 120 uses the secondary parameter data,
e.g., the Boolean variable, to determine whether the secondary
diagnostic parameters satisfy the predetermined condition (186 of
FIG. 9 to detect worsening heart failure in patient 14. In some
examples, diagnostic module 120 does not maintain a Boolean
variable, but instead determines whether the median activity level
is less than one or more thresholds in response to determining that
the fluid index is within the threshold zone (182 and 184 of FIG.
9).
[0159] FIG. 14 is a flow diagram illustrating an example method for
determining whether a patient is experiencing worsening heart
failure based on the heart rate variability (HRV) of patient 14.
Initially, secondary parameter unit 124 determines a
[0160] HRV value for patient 14 based on, for example, ventricular
rate information received from electrical sensing module 86 and/or
processor 80 (FIG. 3) (270). Similar to the activity level of
patient 14, the HRV of patient 14 may be a daily (or other period)
value, e.g., the variability of a plurality of heart rates
determined over the course of a day. Similar to the activity level
of patient 14, secondary parameter unit 124 may determine a median
HRV value (MEDIAN_HRV) of patient 14 (272) as the median of the
last "X" number of daily (or other period) HRV values. Secondary
parameter unit 124 may also determine a baseline HRV value
[0161] Comparison module 160 determines the ratio of the median HRV
to a baseline HRV, and compares the ratio to a first threshold
value (HRVfraction) and the median
[0162] HRV to a second threshold value (minHRV) (274). The baseline
HRV may be defined as the median HRV prior to the fluid index
entering the threshold zone. The HRVfraction value may be computed
as a predetermined or variable fraction of the previous median HRV,
e.g., the median HRV prior to inclusion of the current daily value.
When either condition is satisfied ("YES" branch of step 274),
comparison module 160 sets the secondary parameter data equal to
true (276). That is, when the median HRV value is less than
HRVfraction or when the median HRV value is less than minHRV,
comparison module 160 sets the Boolean variable ACTIVITY_DATA equal
to zero. However, when both conditions are not satisfied ("NO"
branch of step 274), control logic 178 sets the secondary parameter
data value equal to false (278). In some examples, the analysis of
HRV may include use of an HRV index similar to the fluid index,
which may accumulate over time as the median HRV or ratio of median
to baseline HRV is less than an adaptive threshold, such as
HRVfraction. The index may be compared to a threshold to determine
whether to set the secondary parameter data value to a true or
false value.
[0163] Diagnostic module 120 uses the secondary parameter data,
e.g., the Boolean variable, to determine whether the secondary
diagnostic parameters satisfy the predetermined condition (186 of
FIG. 9 to detect worsening heart failure in patient 14. In some
examples, diagnostic module 120 does not maintain a Boolean
variable, but instead determines whether the median activity level
is less than one or more thresholds in response to determining that
the fluid index is within the threshold zone (182 and 184 of FIG.
9).
[0164] FIG. 15 is a flow diagram illustrating an example method for
determining whether a patient is experiencing worsening heart
failure based on the night heart rate (NHR) of patient 14. Although
illustrated with respect to night heart rate, this method may be
similarly applied to other secondary diagnostic parameters, such as
the difference between day and night heart rate, alone or in
conjunction with NHR. In general, the difference between day and
night heart rate may satisfy a secondary diagnostic parameter
condition, and thereby indicated worsening heart failure, when it
is less than a threshold rate. The threshold may be absolute,
adaptive, or may involve multiple thresholds, which may be absolute
or adaptive.
[0165] With respect to NHR and the example of FIG. 15, initially,
secondary parameter unit 124 determines the NHR of patient 14
(280), e.g., based on ventricular rate information received from
electrical sensing module 86 and/or processor 80 (FIG. 3) at night.
The NHR of patient 14, similar to the activity level and HRV of
patient 14, may be measured at periodic intervals throughout the
night, and a daily (or other period) average may be determined.
Secondary parameter unit 124 may determine a median NHR value
(MEDIAN_NHR) of patient 14 (282). The median value may be
determined as the median of the last "X" number of daily (or other
period) NHR values.
[0166] Comparison module 160 determines the ratio of the median NHR
to a baseline NHR, and compares the ratio to a first threshold
(NHRdiff), and compares the median NHR value to a second threshold
value (maxNHR) (284). The baseline NHR may be defined as the median
NHR prior to the fluid index entering the threshold zone. The
NHRdiff value may be as an example, 20 beats per minute, or any
value that would represent a clinically significant increase in
NHR. When either condition is satisfied ("YES" branch of step 274),
comparison module 160 sets the secondary parameter data equal to
true (286). However, when both conditions are not satisfied ("NO"
branch of step 264), comparison module 160 sets the secondary
parameter data value equal to false (268). In some examples, the
analysis of NHR may include use of an NHR index similar to the
fluid index, which may accumulate over time as the median NHR or
ratio of median to baseline NHR is greater than an adaptive
threshold. The index may be compared to a threshold to determine
whether to set the secondary parameter data value to a true or
false value.
[0167] Diagnostic module 120 uses the secondary parameter data,
e.g., the Boolean variable, to determine whether the secondary
diagnostic parameters satisfy the predetermined condition (186 of
FIG. 9 to detect worsening heart failure in patient 14. In some
examples, diagnostic module 120 does not maintain a Boolean
variable, but instead determines whether the median activity level
is less than one or more thresholds in response to determining that
the fluid index is within the threshold zone (182 and 184 of FIG.
9).
[0168] FIG. 16 is a graph illustrating an example of a fluid index
290 that increments over time relative to an example threshold
zone. As illustrated in FIG. 16, the threshold zone is defined by a
higher and lower threshold (THRESH_HIGH and THRESH_LOW), e.g., as
being between the thresholds. When fluid index 290 is within the
threshold zone, e.g., between the thresholds, as shown in FIG. 16,
diagnostic module 120 looks to the one or more secondary diagnostic
parameters to determine whether the patient is experiencing
worsening heart failure.
[0169] FIG. 16 also illustrates a secondary diagnostic parameter
monitoring threshold 292, and an observation window 294. In some
examples, an IMD or other device may begin monitoring secondary
diagnostic parameters when the fluid index meets threshold 292,
such that the observation window 294 includes some time prior to
entry into the threshold zone. In this manner, the analysis of the
secondary parameters may include data prior to entry into the
threshold zone, such as medians of secondary diagnostic parameters
prior to entry into the zone that may be used as baselines, e.g.,
FIGS. 13-15.
[0170] FIG. 17 is a block diagram illustrating an example system
300 that includes an external device, such as a server 314, and one
or more computing devices 316A-316N ("computing devices 316") that
are coupled to IMD 16 and programmer 24 shown in FIG. 1 via a
network 312. In this example, IMD 16 may use its telemetry module
88 to communicate with programmer 24 via a first wireless
connection, and to communication with an access point 310 via a
second wireless connection. In the example of FIG. 17, access point
310, programmer 24, server 314, and computing devices 316A-216N are
interconnected, and able to communicate with each other, through
network 312. In some cases, one or more of access point 310,
programmer 24, server 314, and computing devices 316A-316N may be
coupled to network 312 through one or more wireless connections.
IMD 16, programmer 24, server 314, and computing devices 316A-216N
may each comprise one or more processors, such as one or more
microprocessors, DSPs, ASICs, FPGAs, programmable logic circuitry,
or the like, that may perform various functions and operations,
such as those described herein. For example, as illustrated in FIG.
17, server 314 may comprise one or more processors 315 and an
input/output device 313, which need not be co-located.
[0171] Server 314 may, for example, monitor primary and secondary
diagnostic parameters, e.g., based on signals or information
received from IMD 16 and/or programmer 24 via network 312, to
detect worsening heart failure of patient 14 using any of the
techniques described herein. Server 314 may provide alerts relating
to worsening heart failure of patient 16 via network 312 to patient
14 via access point 310, or to one or more clinicians via computing
devices 316. In examples such as those described above in which IMD
16 and/or programmer 24 monitor the primary and secondary
diagnostic parameters, server 314 may receive an alert from the IMD
or programmer via network 312, and provide alerts to one or more
clinicians via computing devices 316. Server 314 may generate
web-pages to provide alerts and information regarding the primary
and secondary diagnostic parameters, and may comprise a memory to
store alerts and diagnostic or physiological parameter information
for a plurality of patients.
[0172] Access point 310 may comprise a device that connects to
network 312 via any of a variety of connections, such as telephone
dial-up, digital subscriber line (DSL), or cable modem connections.
In other embodiments, access point 310 may be coupled to network
312 through different forms of connections, including wired or
wireless connections. Network 312 may comprise a local area
network, wide area network, or global network, such as the
Internet. System 300 may be implemented, in some aspects, with
general network technology and functionality similar to that
provided by the Medtronic CareLink.RTM. Network developed by
Medtronic, Inc., of Minneapolis, Minn.
[0173] Additionally, using programmers 24, access points 310 or
computing devices 316, physicians and/or event patients may input
clinical information regarding the patients (such as symptoms, lab
results, health care utilizations, etc.) that may be used as
secondary parameters by the detection algorithm. Furthermore, the
functionality described herein with respect to monitoring worsening
heart failure may be provided by any one or more of the programmers
24, access points 310, server 314, or computing devices 316.
[0174] The techniques described in this disclosure, including those
attributed to image IMD 16, programmer 24, or various constituent
components, may be implemented, at least in part, in hardware,
software, firmware or any combination thereof. For example, various
aspects of the techniques may be implemented within one or more
processors, including one or more microprocessors, digital signal
processors (DSPs), application specific integrated circuits
(ASICs), field programmable gate arrays (FPGAs), or any other
equivalent integrated or discrete logic circuitry, as well as any
combinations of such components, embodied in programmers, such as
physician or patient programmers, stimulators, image processing
devices or other devices. The term "processor" or "processing
circuitry" may generally refer to any of the foregoing logic
circuitry, alone or in combination with other logic circuitry, or
any other equivalent circuitry.
[0175] Such hardware, software, firmware may be implemented within
the same device or within separate devices to support the various
operations and functions described in this disclosure. In addition,
any of the described units, modules or components may be
implemented together or separately as discrete but interoperable
logic devices. Depiction of different features as modules or units
is intended to highlight different functional aspects and does not
necessarily imply that such modules or units must be realized by
separate hardware or software components. Rather, functionality
associated with one or more modules or units may be performed by
separate hardware or software components, or integrated within
common or separate hardware or software components.
[0176] When implemented in software, the functionality ascribed to
the systems, devices and techniques described in this disclosure
may be embodied as instructions on a computer-readable medium such
as random access memory (RAM), read-only memory (ROM), non-volatile
random access memory (NVRAM), electrically erasable programmable
read-only memory (EEPROM), FLASH memory, magnetic data storage
media, optical data storage media, or the like. The instructions
may be executed to support one or more aspects of the functionality
described in this disclosure.
[0177] Various examples have been described. However, one of
ordinary skill in the art will appreciate that various
modifications may be made to the described examples without
departing from the scope of the claims. For example, although
described primarily with reference to intrathoracic impedance, in
some examples a cardiovascular pressure may additionally or
alternatively be used as a primary diagnostic parameter. In some
examples, a fluid index may increase based on increasing
cardiovascular pressure over time, in a substantially similar
manner to that which the fluid index discussed above increased
based on decreasing intrathoracic impedance over time. Examples of
cardiovascular pressures that may be monitored are right
ventricular pressure, left atrial pressure, or estimated pulmonary
artery diastolic pressure.
[0178] Furthermore, although described primarily with reference to
examples that provide an alert in response to detecting worsening
heart failure, other examples may additionally or alternatively
automatically modify a therapy in response to detecting worsening
heart failure in the patient. The therapy may be, as examples, a
substance delivered by an implantable pump, cardiac
resynchronization therapy, refractory period stimulation, or
cardiac potentiation therapy. These and other examples are within
the scope of the following claims.
* * * * *