U.S. patent application number 14/699566 was filed with the patent office on 2015-08-27 for system and method for monitoring and diagnosing patient condition based on wireless sensor monitoring data.
The applicant listed for this patent is Peerbridge Health, Inc.. Invention is credited to Angelo Joseph Acquista, Avi Kometz, Leung-Hang Ma, John Shambroom.
Application Number | 20150238107 14/699566 |
Document ID | / |
Family ID | 51530377 |
Filed Date | 2015-08-27 |
United States Patent
Application |
20150238107 |
Kind Code |
A1 |
Acquista; Angelo Joseph ; et
al. |
August 27, 2015 |
SYSTEM AND METHOD FOR MONITORING AND DIAGNOSING PATIENT CONDITION
BASED ON WIRELESS SENSOR MONITORING DATA
Abstract
A system for detecting an electrocardiogram (ECG) signal of a
subject includes a substrate that is placed on and adheres to the
skin over the sternum of the subject. First, second and third
electrodes are disposed on the substrate, each of which has an end
for contacting a respective area of skin. Directional positioning
from the second electrode to the first electrode is substantially
perpendicular to directional positioning from the third electrode
to the first electrode. A circuit on the first substrate is
connected to the electrodes and generates a first ECG channel
measuring a difference in electric signals between the first
electrode and the second electrode, and a second ECG channel
measuring a difference in electric signals between the first
electrode and the third electrode. A communication component on the
substrate wirelessly transmits ECG information from the circuit to
an external device.
Inventors: |
Acquista; Angelo Joseph;
(New York, NY) ; Kometz; Avi; (East Quogue,
NY) ; Ma; Leung-Hang; (Brooklyn, NY) ;
Shambroom; John; (Framingham, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Peerbridge Health, Inc. |
New York |
NY |
US |
|
|
Family ID: |
51530377 |
Appl. No.: |
14/699566 |
Filed: |
April 29, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14216174 |
Mar 17, 2014 |
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14699566 |
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61787772 |
Mar 15, 2013 |
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61924986 |
Jan 8, 2014 |
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Current U.S.
Class: |
600/382 ; 607/17;
607/7 |
Current CPC
Class: |
A61B 5/04085 20130101;
A61B 5/746 20130101; A61B 5/0464 20130101; G16H 50/20 20180101;
A61N 1/3987 20130101; A61B 5/0006 20130101; A61N 1/36585 20130101;
A61N 1/3956 20130101; A61B 5/4848 20130101; A61B 2562/164 20130101;
A61B 5/0452 20130101; A61B 5/04011 20130101; A61B 2562/04 20130101;
A61B 5/046 20130101; A61N 1/365 20130101; A61B 5/6823 20130101;
A61B 5/04028 20130101; A61B 2560/0412 20130101; A61B 5/0456
20130101 |
International
Class: |
A61B 5/0408 20060101
A61B005/0408; A61N 1/39 20060101 A61N001/39; A61N 1/365 20060101
A61N001/365; A61B 5/00 20060101 A61B005/00; A61B 5/04 20060101
A61B005/04 |
Claims
1-19. (canceled)
20. A system for detecting an electrocardiogram (ECG) signal of a
subject, the system comprising: a first substrate configured to be
placed on and adhere to skin over a sternum of the subject; a first
electrode, a second electrode, and a third electrode disposed on
the first substrate, each of the electrodes having an end for
contacting a respective area of the skin; wherein directional
positioning from the second electrode to the first electrode is
substantially perpendicular to directional positioning from the
third electrode to the first electrode; a first circuit in
communication with one or more of the first electrode, the second
electrode and the third electrode, the first circuit configured to
generate at least two channels of ECG data, including a first
channel measuring a difference in electric signals between the
first electrode and the second electrode, and a second channel
measuring a difference in electric signals between the first
electrode and the third electrode; and a first communication
component configured to wirelessly transmit information from the
first circuit to an external device.
21. The system of claim 20, wherein the first substrate is sized to
fit a region of the chest below the clavicle and over the
sternum.
22. The system of claim 21, wherein the first substrate is
star-shaped and the first, second and third electrodes are each
positioned near respective distal ends of the first substrate.
23. The system of claim 20, wherein the system is further
configured to use the at least two channels of ECG data to generate
a third channel of ECG data using vector characteristics of ECG
data.
24. The system of claim 20, wherein the first circuit further
comprises a memory to store ECG data generated or recorded by the
first circuit.
25. The system of claim 20, wherein the information transmitted
from the first communication component comprises ECG data.
26. The system of claim 20 further comprising a ground electrode
disposed on the first substrate and coupled to the first
circuit.
27. The system of claim 20 further comprising a sensor configured
to obtain data from the subject, the sensor comprising a second
communication component configured to wirelessly communicate with
the first circuit to synchronize signal acquisition.
28. The system of claim 27, wherein the sensor further comprises: a
second substrate; a fourth electrode, a fifth electrode, and a
sixth electrode disposed on the second substrate, each of the
fourth, fifth and sixth electrodes having an end for contacting a
respective area of skin of the subject; wherein directional
positioning from the fifth electrode to the fourth electrode is
substantially perpendicular to directional positioning from the
sixth electrode to the fourth electrode; a second circuit in
communication with one or more of the fourth electrode, the fifth
electrode and the sixth electrode, the second circuit configured to
generate at least two channels of ECG data, including a third
channel measuring a difference in electric signals between the
fourth electrode and the fifth electrode, and a third channel
measuring a difference in electric signals between the fourth
electrode and the sixth electrode; and a second power source
disposed on the second substrate; wherein the second communication
component is configured to wirelessly transmit ECG data to one or
more of the first circuit and the external device; and wherein at
least one of the external device and the first circuit is
configured to generate at least five-lead ECG data from ECG data
generated by the first circuit and the ECG data generated by the
second circuit.
29. The system of claim 20, wherein the external device is a mobile
telephone configured to communicate with a remote server to provide
ECG data obtained from the first sensor to the remote server.
30. The system of claim 29, wherein the mobile telephone is further
configured to receive information from the remote server and
forward the information to the first circuit.
31. The system of claim 20, further comprising a first power source
disposed on the substrate.
32. The system of claim 31, wherein the first power source is a
battery.
33. A method of obtaining electrocardiogram (ECG) data from a
subject, the method comprising: applying a first sensor onto skin
over a sternum of the subject, the first sensor comprising: a first
substrate configured to be placed on and adhere to the skin; a
first electrode, a second electrode, and a third electrode disposed
on the first substrate, each of the electrodes having an end for
contacting a respective area of the skin; wherein directional
positioning from the second electrode to the first electrode is
substantially perpendicular to directional positioning from the
third electrode to the first electrode; a first circuit in
communication with one or more of the first electrode, the second
electrode and the third electrode, the first circuit configured to
generate at least two channels of ECG data, including a first
channel measuring a difference in electric signals between the
first electrode and the second electrode, and a second channel
measuring a difference in electric signals between the first
electrode and the third electrode; a first power source disposed on
the first substrate; and a first communication component configured
to wirelessly transmit information from the circuit to an external
device; and utilizing the external device to obtain ECG data from
the first sensor.
34. The method of claim 33, wherein the external device is a mobile
telephone configured to communicate with a remote server to provide
the ECG data obtained from the first sensor to the remote
server.
35. The method of claim 34, wherein the mobile telephone is further
configured to receive information from the remote server and
forward the information to the first sensor.
36. The method of claim 33, further comprising applying a second
sensor onto skin of the subject, the second sensor comprising: a
second substrate; a fourth electrode, a fifth electrode, and a
sixth electrode disposed on the second substrate, each of the
fourth, fifth and sixth electrodes having an end for contacting a
respective area of skin of the subject; wherein directional
positioning from the fifth electrode to the fourth electrode is
substantially perpendicular to directional positioning from the
sixth electrode to the fourth electrode; a second circuit in
communication with one or more of the fourth electrode, the fifth
electrode and the sixth electrode, the second circuit configured to
generate at least two channels of ECG data, including a third
channel measuring a difference in electric signals between the
fourth electrode and the fifth electrode, and a third channel
measuring a difference in electric signals between the fourth
electrode and the sixth electrode; and a second power source
disposed on the second substrate; and a second communication
component configured to wirelessly transmit ECG data to the first
sensor or to the external device; wherein at least one of the
external device and the first circuit is configured to generate at
least five-lead ECG data from ECG data obtained from the first
sensor and the ECG data obtained from the second sensor.
37. The method of claim 36, wherein the first sensor and the second
sensor form a cluster to enable enhanced generation of ECG
data.
38. A method of managing a heart condition for a subject,
comprising: (a) detecting intrathoracic electrogram signals of the
subject over a first defined period of time by at least one
implantable cardiac device having a sensor component implanted in
the heart of the subject; (b) determining whether the subject is
experiencing a heart condition based on the intrathoracic
electrogram signals; (c) detecting electrocardiogram (ECG) signals
of the subject over the first defined period of time by at least
one surface sensor attached to skin of the subject; (d) determining
whether the subject is experiencing the heart condition based on
the ECG signals; (e) based upon the results of each of steps (b)
and (d), determining whether to perform an action by the
implantable cardiac device of a therapy to influence the electrical
system of the heart of the subject in order to address the heart
condition; (f) performing, by the implantable cardiac device, the
action if indicated according to the determination result in step
(e); (g) wirelessly sending, by the at least one implantable
cardiac device, selected information relating to at least one of
the electrogram signals in step (a), the determination result in
step (b), and the determination result in step (e), to the at least
one surface sensor; and (h) wirelessly sending, by the at least one
surface sensor, the information received from the at least one
implantable cardiac device, as well as selected information
relating to at least one of the ECG signals in step (c) and the
determination result in step (d), to an external computing device
for storage or further analysis.
39. The method of claim 38, further comprising sending, by the
external computing device, an alert to a medical personnel based on
information received by the computing device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 14/216,174, filed Mar. 17, 2014, which claims priority to U.S.
provisional application No. 61/787,772, filed on Mar. 15, 2013, and
U.S. provisional application No. 61/924,986, filed Jan. 8, 2014,
the disclosure of each of which is incorporated herein by reference
in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to one or more wireless
sensors, and a network of wireless sensors, for monitoring, in real
time (or quasi real time), a patient's vital signs, such as various
hemodynamic parameters of the patient. In addition, the present
invention relates to using wireless surface-attached sensors with
implantable heart monitoring devices for providing improved
diagnosis, monitoring, and treatment of medical conditions.
Further, the present invention relates to integration of such
wireless sensors with an electronic medical record storage and
management system for managing patient healthcare, such as
providing clinical decision support, facilitating diagnosis and
validating treatment options.
BACKGROUND
[0003] Monitoring various vital signs of a patient has been an
important aspect of hospital patient care, especially for patients
with diseases at advanced stages, suffering from severe trauma, or
in other emergency settings. Additionally, outpatient monitoring of
various physiological conditions are being increasingly used for
evaluation of patient health conditions as well as early detection
and treatment of heart diseases, diabetes, and other diseases. For
example, an electrocardiogram (ECG or EKG) can be used to evaluate
the heart condition of a patient, where electrodes are placed at
certain locations on the chest, arms, and/or legs. These electrodes
can be connected to an ECG machine by lead wires, and the electric
signals received by the ECG machine can be analyzed and displayed
for the physician's information and further interpretation.
[0004] Attempts have also been made to develop systems to improve a
patient's comfort, freedom and privacy by decreasing the number and
volume of devices directly or indirectly attached to the patient.
For example, U.S. Pat. No. 7,979,111 discloses a wireless electrode
arrangement and method for patient monitoring, where a plurality of
wireless electrodes suitable for attachment to the surface of the
body of a patient are capable of continuously monitoring of a
subject wirelessly. Copending U.S. patent application Ser. No.
13/835,049 (published as U.S. Patent Application Publication No.
20130204100) further describes a network of wireless sensors for
monitoring hemodynamic parameters of a subject. The disclosures of
both of these documents are incorporated in its entirety by
reference herein.
[0005] Implantable devices such as implantable cardioverter
defibrillators (ICDs) or pacemakers are often indicated for
patients who have or are at increased risk for various heart
conditions related to the heart's electrical system, such as
ventricular and atrial arrhythmias including but not limited to
ventricular fibrillation, ventricular tachycardia, atrial
fibrillation, and bradycardia, etc. These implantable devices can
monitor and/or manage certain heart conditions of the patients and
prevent or control heart episodes that would otherwise interfere
with daily life or be life threatening, and can therefore allow
patients with certain heart conditions to carry on their normal
lives with relatively few restrictions and generally low level of
discomfort.
[0006] However, there can be limiting factors for these implantable
devices such as inaccuracy in detecting the relevant heart
condition episodes and administering appropriate therapies. For
example, the positioning and contact of the leads of the ICDs with
the heart muscle can be affected by the patient's movement, and the
problem is more acute for young and more active patients. ICDs can
also have lead failures after being worn by a patient for an
extended period of time, e.g., a number of years. Lead positioning
errors and failures can cause inaccurate or distorted electrograms,
and thereby may lead to insufficient, overly aggressive, or
otherwise inappropriate cardiac intervention, such as excessive
number of unwarranted shocks or shocks with unnecessarily large
magnitude, which can cause discomfort, pain, and other undesirable
effects on the quality of life of the patients.
[0007] Since the last decade, and especially after the enactment of
the American Recovery and Reinvestment Act of 2009, healthcare
providers are facing more regulations regarding electronic record
management (EMR) and electronic health records (EHR) (or personal
health record (PHR)). Meanwhile, medical software providers have
been developing a plethora of systems that facilitate electronic
data storage and management to enable healthcare providers to be in
compliance with such increased regulations. For example, a
patient's EHR can provide a longitudinal electronic record of
patient health information gathered during one or more encounters
in a care delivery setting, which can include information such as
patient demographics, medications, vital signs, medical history,
laboratory test results, and radiology reports, etc. The EHR can
also be used to provide decision support, quality management, and
outcomes reporting.
[0008] There is a need for a system that integrates the real time
monitoring capability of wireless sensors worn by a patient with
the data storage and processing capabilities afforded by electronic
health records management systems for personalized monitoring and
clinical decision support, improving accuracy in diagnosis and
validating treatment options proposed by physicians.
SUMMARY OF THE INVENTION
[0009] According to some embodiments of the present invention, a
system for detecting an electrocardiogram (ECG) signal of a subject
is provided. In various embodiments, the system includes a first
substrate that is configured to be placed on and adhere to the skin
over the sternum of the subject. A first electrode, a second
electrode, and a third electrode are disposed on the first
substrate, and each of the electrodes has an end for contacting a
respective area of the skin of the subject. On the first substrate,
the directional positioning from the second electrode to the first
electrode is substantially perpendicular to directional positioning
from the third electrode to the first electrode. A first circuit is
disposed on the first substrate and is connected to one or more of
the first electrode, the second electrode and the third electrode.
The first circuit generates at least two channels of ECG data,
including a first channel measuring a difference in electric
signals between the first electrode and the second electrode, and a
second channel measuring a difference in electric signals between
the first electrode and the third electrode. Finally, a first
communication component is also disposed on the substrate and is
configured to wirelessly transmit information from the first
circuit to an external device. The first substrate may also include
a first power source, such as a battery.
[0010] In preferred embodiments, the first substrate is sized to
fit a region of the chest below the clavicle and over the sternum.
More preferably still, the first substrate is star-shaped and the
first, second and third electrodes are each positioned near
respective distal ends of the first substrate.
[0011] In one aspect, the first circuit uses the at least two
channels of ECG data to generate a third channel of ECG data using
vector characteristics of ECG data.
[0012] In preferred embodiments, the first circuit also has a
memory to store ECG data generated or recorded by the first
circuit. Preferably, the information transmitted from the first
communication component comprises ECG data. In other preferred
embodiment, a ground electrode is also disposed on the first
substrate and is connected to the first circuit.
[0013] In some embodiments, the system further includes another
sensor that is configured to obtain data from the subject. This
sensor includes a second communication component that is configured
to wirelessly communicate with the first circuit to synchronize
signal acquisition. In preferred embodiments the sensor includes a
second substrate; a fourth electrode, a fifth electrode, and a
sixth electrode disposed on the second substrate, each of which has
an end for contacting a respective area of skin of the subject and
arranged on the second substrate so that directional positioning
from the fifth electrode to the fourth electrode is substantially
perpendicular to directional positioning from the sixth electrode
to the fourth electrode. A second circuit is in communication with
one or more of the fourth electrode, the fifth electrode and the
sixth electrode and is configured to generate at least two channels
of ECG data, including a third channel measuring a difference in
electric signals between the fourth electrode and the fifth
electrode, and a third channel measuring a difference in electric
signals between the fourth electrode and the sixth electrode. A
second power source, such as a battery, is disposed on the second
substrate. The second communication component is configured to
wirelessly transmit ECG data to one or more of the first circuit
and the external device, so that at least one of the external
device and the first circuit can generate at least five-lead ECG
data from ECG data generated by the first circuit and the ECG data
generated by the second circuit.
[0014] In preferred embodiments, the external device is a mobile
telephone configured to communicate with a remote server to provide
ECG data obtained from the first sensor to the remote server.
Additionally, the mobile telephone may be configured to receive
information from the remote server and forward such information to
the first circuit.
[0015] In another aspect, a method is disclosed for obtaining
electrocardiogram (ECG) data from a subject. The method includes
applying a first sensor onto skin over a sternum of the subject.
The first sensor includes a first substrate configured to be placed
on and adhere to the skin; a first electrode, a second electrode,
and a third electrode disposed on the first substrate, each of
which has an end for contacting a respective area of the skin.
Directional positioning from the second electrode to the first
electrode is substantially perpendicular to directional positioning
from the third electrode to the first electrode. A first circuit is
in communication with one or more of the first electrode, the
second electrode and the third electrode and configured to generate
at least two channels of ECG data, including a first channel
measuring a difference in electric signals between the first
electrode and the second electrode, and a second channel measuring
a difference in electric signals between the first electrode and
the third electrode. A first power source, such as a battery, is
disposed on the first substrate, along with a first communication
component that is configured to wirelessly transmit information
from the circuit to an external device. The method then further
includes utilizing the external device to obtain ECG data from the
first sensor.
[0016] In preferred embodiments, the external device is a mobile
telephone that communicates with a remote server to provide the ECG
data obtained from the first sensor to the remote server. The
mobile telephone may also be configured to receive information from
the remote server and forward the information to the first
sensor.
[0017] The method may further include applying a second sensor,
similar to the first sensor, onto the skin of the subject. In such
embodiments, at least one of the external device and the first
circuit is configured to generate at least five-lead ECG data from
ECG data obtained from the first sensor and ECG data obtained from
the second sensor. The first sensor and the second sensor may form
a cluster to enable enhanced generation of ECG data.
[0018] In yet another aspect, a method of managing a heart
condition for a subject is disclosed. The method includes: (a)
detecting intrathoracic electrogram signals of the subject over a
first defined period of time by at least one implantable cardiac
device having a sensor component implanted in the heart of the
subject; (b) determining whether the subject is experiencing a
heart condition based on the intrathoracic electrogram signals; (c)
detecting electrocardiogram (ECG) signals of the subject over the
first defined period of time by at least one surface sensor
attached to skin of the subject; (d) determining whether the
subject is experiencing the heart condition based on the ECG
signals; (e) based upon the results of each of steps (b) and (d),
determining whether to perform an action by the implantable cardiac
device of a therapy to influence the electrical system of the heart
of the subject in order to address the heart condition; (f)
performing, by the implantable cardiac device, the action if
indicated according to the determination result in step (e); (g)
wirelessly sending, by the at least one implantable cardiac device,
selected information relating to at least one of the electrogram
signals in step (a), the determination result in step (b), and the
determination result in step (e), to the at least one surface
sensor; and (h) wirelessly sending, by the at least one surface
sensor, the information received from the at least one implantable
cardiac device, as well as selected information relating to at
least one of the ECG signals in step (c) and the determination
result in step (d), to an external computing device for storage or
further analysis. The method may also include sending, by the
external computing device, an alert to a medical personnel based on
information received by the computing device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The various aspects and embodiments disclosed herein will be
better understood when read in conjunction with the appended
drawings, wherein like reference numerals refer to like components.
For the purposes of illustrating aspects of the present
application, there are shown in the drawings certain preferred
embodiments. It should be understood, however, that the application
is not limited to the precise arrangement, structures, features,
embodiments, aspects, and devices shown, and the arrangements,
structures, features, embodiments, aspects and devices shown may be
used singularly or in combination with other arrangements,
structures, features, embodiments, aspects and devices. The
drawings are not necessarily drawn to scale and are not in any way
intended to limit the scope of this invention, but are merely
presented to clarify illustrated embodiments of the invention. In
these drawings:
[0020] FIG. 1 is a schematic block diagram of a network structure
including a plurality of wireless sensors and a master node and
communication modes therebetween in accordance with one embodiment
of the present invention;
[0021] FIG. 2A is an illustrative depiction of an orthogonal
configuration of three electrodes (tripole) of a surface-attached
node according to an embodiment of the present invention;
[0022] FIG. 2B is an illustrative depiction of an arrangement of
multiple surface-attached nodes each having a tripole configuration
on the body of a patient in accordance with one embodiment of the
present invention;
[0023] FIG. 3 depicts a block diagram for electrical design for a
tripole sensor as shown in FIGS. 2A and 2B, in accordance with one
embodiment of the present invention;
[0024] FIG. 4 depicts various types of wireless sensors as attached
on a patient and their communications with a monitoring device and
a server, in accordance with one embodiment of the present
invention;
[0025] FIG. 5 depicts a flowchart illustrating processes utilizing
data from different types of wireless sensors for diagnosing
various conditions of a patient, in accordance with one embodiment
of the present invention;
[0026] FIG. 6 is an illustrative flow chart for a process of
monitoring and managing ventricle fibrillation using an ICD and
surface-attached wireless sensor(s) in accordance with one
embodiment of the present invention;
[0027] FIG. 7 is an illustrative flow chart for a process of
monitoring and managing atrial arrhythmia using a pacemaker and
surface-attached wireless sensor(s) in accordance with one
embodiment of the present invention;
[0028] FIG. 8 depicts a flowchart illustrating a process for
personalized ECG monitoring of a patient according to an embodiment
of the present invention;
[0029] FIG. 9 depicts a flow chart illustrating a process utilizing
the result of a diagnosis based on data from wireless sensors as
well as the patient's existing EMR for clinical decision support
according to an embodiment of the present invention; and
[0030] FIG. 10 depicts a flow chart illustrating an example method
utilizing the result of a diagnosis based on data from wireless
sensors as well as the patient's existing EMR for determining a
cause for the diagnosis and updating the monitoring protocol
according to an embodiment of the present invention.
DETAILED DESCRIPTION
[0031] Certain embodiments of the present invention will now be
discussed with reference to the aforementioned figures. In one
embodiment, the present invention provides a system for managing
healthcare for a subject (which used interchangeably herein with a
"patient"). The system includes a plurality of wireless sensors
suitable for attachment to the skin of a subject or implantable in
the body of the subject. The plurality of wireless sensors can form
a network. The type of network may utilize a routing topology
include: star, mesh, pseudo-mesh network, or any other routing
topology. Each of the sensors can include a sensing component
configured to detect a signal corresponding to at least one
physiological condition of the subject, and a communication
component configured to wirelessly transmit the detected signal to
either another wireless sensor or an external monitoring unit. The
communication component of selected sensors can also be configured
to receive and/or relay signals transmitted from other wireless
sensors.
[0032] As described herein, a wireless sensor includes a sensing
component configured to detect a signal corresponding to a
physiological condition, such as vital signs including hemodynamic
parameters of a patient. Hemodynamics, as known in the art, relates
to the study of blood flow. The circulatory system, including the
heart, the arteries, the microcirculation, and the vein, functions
to transport the blood to deliver O.sub.2, nutrients and chemicals
to the cells of the body, and to remove the cellular waste
products. The heart is the driver of the circulatory system
generating cardiac output (CO) by rhythmically contracting and
relaxing. This creates changes in regional pressures, and, combined
with a complex valvular system in the heart and the veins, ensures
that the blood moves around the circulatory system in one
direction. Hemodynamic parameters (or properties), as described
herein, include the physiological conditions associated with the
blood flow, which includes not only the physical characteristics of
the blood flow itself, e.g., blood flow rate, blood flow pressure,
and pulse rate, but also those parameters relating to the blood
components such as cells, proteins, chemicals, etc.
[0033] The vital signs to be monitored as contemplated in the
disclosed embodiments can include, but are not limited to, ECG
(electrocardiogram), EEG (electroencephalogram), EMG
(electromyogram), EOG (electrooculogram), ERG (electroretinogram),
temperature, pulse oximetry, oxygen saturation, oxyhemoglobin
saturation, blood component concentration (e.g., glucose level,
lipid level, cholesterol level, triglyceride level, levels of
different salts, concentration of different types of cells,
concentration of blood proteins such as thrombin, cancer markers,
heart failure markers), renal function test components (e.g.,
concentration of albumin, urea, and creatinine in the urine), liver
function test components, organ functions, blood pressure (such as
atrial pressure, ventricular pressure, pulmonary artery pressure,
systolic pressure, diastolic pressure, etc.), blood velocity,
respiration rate, pulse rate, (end tidal) CO.sub.2 level, blood
drug concentration, organic or inorganic substance concentration in
the blood (e.g. uric acid, vitamins, heavy metals, carbon monoxide,
bacterial toxin), cardiac output, heart rate, heart rhythm, heart
rate variability, pH, pathogens, motion, weight, etc. Additionally,
the system can be used to monitor migraines, a patient's galvanic
skin response, and responses to electrical nerve and muscle
stimulation, etc. Depending on the types of underlying
physiological conditions to be monitored, the sensing component can
include, but is not limited to, an electrochemical detector (such
as an needle electrode galvanic electrode or a band electrode for
detecting a surface potential or current), an electromagnetic
detector (e.g., an optical detector such as an infrared detector
and visible light detector, as well as an x-ray detector, gamma-ray
detector, etc.), a thermal detector, a pressure detector, an
ultrasonic detector, a chemical detector, a magnetic detector, an
x-ray detector, an accelerometer, a gyrometer, a motion detector,
etc. Other detectors in emerging sensor technology, such as laser
Doppler, paper sensors, sensor tattoos, etc., can also be used.
[0034] Further, each wireless sensor includes a communication
component configured for wireless communication with other sensors.
For example, the wireless electrodes described in U.S. Pat. No.
7,979,111 (including the transmitting circuit, such as the remote
telemeter 52), can be such a wireless sensor. A wireless sensor can
include a mote as described in the above patent, or can include a
fully integrated and functional communication circuit that includes
an amplifier, a processor, a memory, a battery, and an RF module.
Each or selected ones of the wireless sensors can further include a
memory of suitable size (for example, 4 GB or 8 GB, to store a
large volume or size of relevant medical records of a patient), a
data processor, power supply, etc.
[0035] In some embodiments, the wireless sensors form a mesh
network, where each sensor (also referred to as a "node", "sensor
node" or "regular node" hereinafter) not only captures and
disseminates its own data, but also serve as a relay for other
nodes, that is, the nodes in the mesh network collaborate with each
other to propagate the data in the network. In certain embodiments,
the mesh network further includes one or more control nodes (or
master nodes), which communicate with selected or all of the
regular nodes. The master nodes can serve as a data acquisition,
processing, and command center, and will be further described
below. In other embodiments, the wireless sensors communicate only
with each other, e.g., for purpose of synchronizing signal
acquisition. In further embodiments, the wireless sensors
communicate only with an external control node, but do not
communicate with each other or form a mesh network.
[0036] The wireless sensors or the network of the wireless sensors
can continuously monitor selected vital signs of the subject, and
communicates the signals acquired from the sensing components via
the communicating components of the sensors to a control or master
node. Each of the wireless sensors can be programmed such that
signals detected by the sensor falling into a predetermined (e.g.,
an acceptable or normal) range are not transmitted, or transmitted
at a lower frequency. The acceptable range for signals for
different patients and for each wireless sensor can be set
individually, for example, based on the type of the sensor, the
patient's condition, the therapy being used by the patient, etc. As
described herein, the control or master node includes a
communication component configured to wireless receive signals from
each of the plurality of wireless sensors, and send data and/or
command to each of the plurality of wireless sensors. The control
or master node can further include a monitoring unit coupled with
the communication component. For example, the monitoring unit can
include a readable medium and a processor coupled to the computer
readable medium. The computer readable medium can store coded
instructions for execution by the computer processor, which, upon
the execution of the instructions, carries out pre-designed
tasks.
[0037] In some embodiments, the master node of a mesh network can
be a PC or workstation computer equipped with a communication
component, such as a dongle, for communicating with the wireless
sensors. The master node can also include a portable device having
a processor, a memory, a display and/or other audiovisual output
capabilities to present information to a user, and capabilities of
wirelessly communicating with the wireless sensors. In other
examples, the master node can include a commercial portable
computing device, such as a smart phone (e.g., an iPhone, an
Android-based phone, a Windows Mobile-based phone, etc.), a tablet
(such as an iPad, a Samsung Galaxy Tab, Google Nexus 7 or 10,
etc.), or other similar devices. In further examples, the control
and communication capabilities of a master node can also be
implemented on one or more regular nodes to "upgrade" such regular
nodes into "super nodes" that include both sensing capabilities and
the functionalities of the master node as discussed herein.
[0038] In the following, wireless sensors including ECG electrodes
suitable for acquiring electrophysiological signals related to
cardiac function are used for illustrating the operating principles
of the sensors and the network formed therefrom. In these sensors,
each of the sensors include one or more electrodes which can
acquire data related to the quality of the ECG signal, such as the
amplitude of a detected voltage, a detected current, and/or
electrical skin resistance, and transmit such data to other sensors
or the master nodes. The ECG electrodes may be incorporated into a
single unit, or they can utilize off-the-shelf snap connector ECG
electrodes to adhere to the thorax and to electrically connect to
the skin.
[0039] In ECG applications, multiple wireless sensors are typically
required, which are placed on the patient's body in predetermined
locations. As will be further discussed below, these wireless
sensors can further self-configure into a set or group which
wirelessly sends diagnostic quality ECG signals in a synchronous
fashion to a master node, which can derive or synthesize ECG
spectrum for display or other forms usable by a physician (or other
users) based on the transmitted ECG signals. These sensors can also
be configured to send and/or receive signals to/from the master
node when a proximity criterion is satisfied, e.g., when the master
node is within a predetermined distance from the wireless sensor,
e.g., within 3 feet.
[0040] For illustration purposes and not limitation, a mesh or
pseudo-mesh network formed by a plurality of sensors can be
represented by a schematic block diagram as shown in FIG. 1. The
illustrated network consists of six sensor nodes and a single
master node 110. The sensor nodes can be divided into three
clusters: cluster 120 (including node 1 and node 6), cluster 130
(node 2 and node 5), and cluster 140 (node 4 and node 9). The
arrows in FIG. 1 represent communication paths between the nodes.
As depicted in this example, the network supports at least two
modes of communication: (1) communication between the master node
and each of the nodes, and (2) communication between nodes. Such a
configuration allows for the sensor nodes make their own decisions
and reconfigure the network independently of the master node. The
wireless communication within the mesh network can be based on
proprietary communication stacks utilizing the principles of time
domain multiple access (TDMA), with frequencies selected from
various MICS bands (Medical Implant Communications Service
frequencies) or from the ISM (Industrial, Scientific, and Medical
frequency bands (900 MHz, 2.4 GHz, or 5.8 GHz)) as would be
appreciated by one of ordinary skill in the art.
[0041] For wireless sensors that are configured to detect ECG
signals, examples of which are described herein, the sensors can be
attached to the skin of a patient for ECG signals recordation in a
manner that is similar to the configuration of traditional 3-lead,
5-lead, or 12-lead ECG leads. In certain embodiments, the wireless
sensors can be arranged in one or more groups of electrodes each
arranged in an orthogonal configuration, such as those illustrated
in FIGS. 2A and 2B.
[0042] As shown in FIG. 2A, a surface node 200 can include three
electrodes 210, 220, and 230 (cross-sectional view, each circle
representing the center position of each electrode contacting the
skin) attached on the skin in an orthogonal configuration. The
three electrodes are disposed near the distal end of a star-shaped
substrate or pad, which can be made of polymeric materials, fabric,
or other materials. As is well known, an ECG measures the voltage
resulting from electrical currents conducting through the heart in
the vector of the two ECG electrodes making the measurement. When
the vector of the ECG is exactly the same as the vector of
conduction, the signal reaches maximum, and when the vectors are
orthogonal, the signal is zero. The conduction angles may vary from
person to person and change with body position and breathing. A
tripole sensor as shown in FIG. 2A measures signals on two vectors
that are orthogonal to one another, channel 1 between electrode 210
and electrode 220, channel 2 between electrode 210 and electrode
230 (i.e., electrode 210 is common to both channels).
[0043] An example block diagram of the structure of such a tripole
sensor is illustrated in FIG. 3. The three electrodes 310 are
connected to instrumentation amplifiers 330 via input protection
circuit 320 that protect against electric shock and radio frequency
interference. The instrumentation amplifiers 330 measure the
difference between its two inputs and amplify that with a gain,
e.g., of approximately 10. The amplified signals are filtered by
bandpass filters 340 (typically to the frequency response of 0.05
Hz to 60 Hz or alternatively 100 Hz or 150 Hz). Additional gain can
be provided in the bandpass filter stage to reach a total system
gain of approximately 300. This results in input range of
approximately 10 mV between any pair of electrodes. The individual
channel signals can then be digitized by A/D converters 350. The
converters' resolution may be 12 bits or 16 bits. The digitized ECG
signals are passed through the micro processing unit (MPU) 360. The
processed signals may be stored on board in a memory 370 coupled
with the MPU 360, e.g., a flash memory. Additionally or
alternatively, the processed signals can be sent to an RF
transmitter 380 and transmitted via an antenna 390 to, directly or
indirectly, to an external device (not shown), e.g., a smartphone,
a tablet, or a computer.
[0044] The configuration of the tripole sensor as shown in FIGS. 2
and 3 do not include a ground electrode. However, a ground
electrode can be added as a fourth electrode if needed or desired
(e.g., to reduce artifact). Each of the electrodes shown can be
attached to the skin of a patient using common electrode
technology, such as silver/silver chloride (Ag/AgCl) "floating"
electrodes which are attached to the skin of the patient via
electrode gel (with a base of a foam pad, a cloth, etc. with
medical grade adhesive) to facilitate ionic conduction.
[0045] The signals acquired from the two orthogonal channels can be
combined using vector mathematics to obtain a signal corresponding
to any desired vector angle. This can be used to optimize the
measurement of any particular waveform signals of interest, thereby
assist in detecting various heart conditions. For example, the
absence of P wave can be an important characteristic for diagnosis
of atrial fibrillation. As P waves are typically very small,
improving signal to noise ratio can be crucial. For example, the
presence of p waves can be confirmed by adjusting the vector angle
to coincide with the axis of depolarization of the atrium, which
coincides with maximum amplitude of the p wave. This can overcome
the problem known to those skilled in the art that some patients
exhibit very small p waves in the standard ECG vectors.
[0046] Adjusting the vector angle of the combined channel can also
be used to confirm the absence of p waves in certain conditions
such as atrial fibrillation. For example, the vector angles can be
incremented in in an attempt to detect the presence of p waves,
which are seen as a deflection in the ECO typically 0.12 to 0.20
seconds prior to the R wave. If the deflections are not seen in
multiple beats of all angles then the absence of the p wave can be
confirmed. The vector angle can also be adjusted to find maximum R
wave amplitude, which can improve the accuracy of detecting the
time of the R wave peak, leading to improvement in the measurement
of R to R interval, which is a feature important to the detection
of atrial fibrillation because in atrial fibrillation the R to R
interval varies chaotically. It is important to distinguish true R
to R variability due to noisy measurement of the interval. As
another example, S-T segment of a patient's ECG waveform can also
be optimized, which is relevant to myocardial infarction (MI) and
myocardial ischemia. Those skilled in the art will appreciate that
other ECG features and cardiac conditions can be optimized with
this technique.
[0047] In some embodiments, multiple surface nodes can be placed on
the skin of the patient. As shown in FIG. 2B, a first surface node
can be placed high on the sternum just below the clavicle. This can
be advantageous for detection of atrial rhythm, as it is nearest
the heart's atria, affording the best opportunity to monitor atrial
fibrillation. There is less muscle in this location to contaminate
the ECG with any electromyogram (EMG) artifact, and it can be on a
tissue that is less likely to move and contaminate the ECG with
motion artifact. An optional second surface node 270 may be added
nearest the ventricles. Two electrodes of this group can be at
locations V4 and V5 of a standard 12-lead ECG, and the third a
proxy for the left leg location. The signals from the two surface
nodes may be combined in various ways to provide a faithful
representation of a standard 3, 5, or 12 lead ECG. The second
surface node can also be able to measure ventricular ischemia due
to blockage of the major vessels. An optional third tripole surface
node 280 may be further added to provide enough signals to derive a
full 12-lead ECG.
[0048] In a system where there are more than one wireless sensors
(as shown the three tripole sensors shown in FIG. 2B, all of the
wireless sensors can each individually transmit the collected
physiological data to an external device (e.g., a monitoring device
as described herein). Alternatively, one of the wireless sensors
can include hardware and software necessary to serve as a master
node or gateway that receives detected physiological data from
other wireless sensors, and forward such signals via a radio or
WiFi link to the external monitoring device at an appropriate rate
(e.g., to save battery power of the sensors). The transmission can
also be optionally compressed with little or no information loss.
The transmitted physiological data can be processed by the
monitoring device with appropriate program, or can be further
uploaded to a server for processing and/or analysis, which are
described further below.
[0049] Further, the wireless sensors according to one embodiment of
the present invention can include different sensing components for
monitoring a plurality of different vital signs. For example, one
sensor can include a pressure detector for monitoring the pulse
rate, and another sensor can include an electrochemical detector
for blood glucose level measurement (the glucose level can also be
measured by an infrared detector or eye scanner). For another
example, one wireless sensor can include a surface-attached sensing
component, such as one or more ECG electrodes, and another sensor
can include an implantable sensing component, such as an implanted
intracardiac pressure transducer coupled to a heart chamber (e.g.,
the right ventricle). Thus, wireless sensors of different types for
monitoring different vital signs can be conveniently worn by or
implanted in the patient depending on the needs of care for the
patient. For purpose of illustration and not limitation, FIG. 4
depicts the use of different types of wireless sensors, including
three surface-attached nodes 410, 420, 430 (each containing an ECG
sensor, e.g., the tripole sensors described herein), weight sensor
460, leg monitor sensor 450, and oxygen saturation (SpO.sub.2)
sensor (such as pulse oximeter worn on a patient's finger) 470
which can also be used to monitor ECG. Additional sensors (not
shown) can include a wrist sensor or a pendant that can be used for
monitoring heart rate, blood pressure, temperature or other
hemodynamic properties. Node 410 includes an ECG sensor 412, a
temperature sensor 414, and an accelerometer 416, as well as a
wireless transmission module. Thus, node 410 can serves as a master
node to receive ECG measurement signals sent by nodes 420 and 430
as well as the signals from other sensors, and wireless relaying
data collected from all the sensors to an external device, e.g., a
monitoring device 480 or cloud 485, either of which can be
connected to the patient's EMR records. Like Node 410, Node 420 and
430 can also each include other sensors, such an accelerometer, a
gyrometer, a temperature sensor, a GPS receivers, etc. (not shown).
The real-time monitoring data gathered from the various sensors can
be combined with the information from the patient's EMR records to
optimize the signal detecting algorithm used by the sensors, and/or
to make diagnosis assistance or clinical support decisions, as will
be further described below.
[0050] The use of hybrid sensors can also provide a caregiver with
more comprehensive information regarding the patient's condition in
a more efficient and/or more reliable manner. For example,
monitoring different vital signs simultaneously using different
types of wireless sensors can provide redundancy and improved
robustness of monitoring quality as well as facilitate
reconciliation of inconsistencies among the data gathered from
different types of sensors (for different vital signs), reduce
false alarm rates, etc. Certain vital signs can also be considered
as having higher priorities (e.g., because the sensors for
monitoring these vital signs have higher reliability or accuracy),
and as such, the data gathered for these vital signs can be given
more weight when data gathered for other vital signs may suggest a
different condition the patient is in. In addition, when implanted
wireless sensors are used, especially those implanted relatively
deep within the patient's body (e.g., in the patient's heart), one
or more surface-attached sensors, e.g., those located near the
implanted sensors, can be used to relay the signals acquired from
the implanted sensors, e.g., to a master node, thereby providing
potentially better quality signals for further processing and
analysis. For example, for a wireless sensor implanted in a
patient's heart chamber, another wireless sensor can be attached at
the patient's chest to receive and re-broadcast the signals
obtained by the implanted sensor. The wireless sensors can be
further used in conjunction with certain medical devices worn by
the patient (e.g., rehabilitating devices, robotics, prostheses,
etc.), for collecting and transmitting sensed signals as a feedback
or input for these devices so as to further enhance their
functionalities.
[0051] The data collected from different types of sensors can be
weighted, ranked, processed, validated, transmitted to an EMR
server, and utilized with other data in the EMR of a patient. The
ECG and other vitals can be prioritized by the patient disease
conditions and health status. For example, an otherwise health
patient having AF surgery has a limited set of parameters, whereas
a patient just discharged with Congestive Heart Failure (CHF) with
co-morbidities of diabetes, and obesity, and multiple medications
can be monitored for those vital sign signals relevant to disease
specific algorithms based on ECG, blood glucose levels and
weight.
[0052] For example, the system can store "diagnostic templates"
containing threshold levels of specific vital signs, which can
trigger a diagnosis when the threshold levels for the vital signs
are reached by a patient undergoing monitoring. In response to
information patient-specific information, the system can adjust the
"diagnostic templates" based on disease-specific risk factors (e.g.
heart rate variability in patients having atrial fibrillation) as
well as patient-specific risk factors (e.g. fluctuation in blood
pressure in patients with hypertension). The system can also
differentially weigh different vital signs according to the
indication and patient's existing conditions, measure the patient's
vital sign variability, trends over time, and deviations from
previous states using predetermined statistical models, for
example, statistical models that use measurements such as average,
standard deviation, and covariance. The data processing and
analysis can be performed on the sensor nodes, a monitoring device
that is configured to receive the sensor data from the various
sensors (or from the gateway sensor node as shown in FIG. 4), or a
server connected to the monitoring device.
[0053] In an example embodiment, the configuration of different
types of wireless sensors as depicted in FIG. 5 can be used to
diagnose various conditions of a patient. The chest node 510
includes an ECG module/sensor 512 and an accelerometer module 514,
and abdomen node 520 includes SpO.sub.2 module/sensor 522 and an
accelerometer module 524. The ECG measurement data 516 can be used
as an input for an arrhythmia detection algorithm 530. When
arrhythmia is detected at 532, it can be determined that the
patient has arrhythmia at 534. In addition, the ECG data 516
together with the SpO.sub.2 data 526 can be used an input for a
sleep apnea detection algorithm 540. When apnea is not detected at
542, and there is no arrhythmia detected, a diagnosis of no apnea
is reached at 544. Chest movement data 518 and abdomen movement
data 528 from the accelerometer modules 514 and 524, respectively,
can be used together as input for a respiration detection algorithm
550. When the presence of respiration is detected at 552 based on
the respiration detection algorithm and the detection of sleep
apnea, the patient is diagnosed as having obstructive apnea 554.
When the presence of respiration is not detected (while sleep apnea
is detected), the patient is diagnosed as having central sleep
apnea at 556.
[0054] In certain embodiments, the present invention provides a
system for monitoring a heart condition for a subject (or a
patient) using an implantable cardiac device in combination with
one or more wireless sensors suitable for attachment to the skin of
a subject for monitoring the patient's ECG. In such a manner, the
electrograms (EGM) obtained by the internal electrodes of the
implantable cardiac device (which are subject to positioning errors
or failure and difficult to adjust or replace) can be cross-checked
with the ECG signals collected from skin-attached wireless sensors
or nodes (which are more robust in positioning stability and easier
to adjust/manipulate), thereby improving the confidence and
accuracy of detection and management of certain heart conditions by
implantable devices.
[0055] In some embodiments of the invention, the implantable
cardiac device can include an ICD, a single or multi-chamber
pacemaker, a cardiac resynchronization therapy device, and other
implantable electronic devices that are capable of monitoring,
intervening, or influencing the electrical system of the patient's
heart. It is understood that modern-day ICD can be designed to
perform functions of conventional pacemakers, and therefore ICD can
represent a broader category of implantable cardiac devices.
[0056] In some embodiments of the invention, the one or more
wireless sensors (e.g., surface sensor(s), surface node(s)) can
each include a sensing component configured to detect ECG signals.
Additionally, the wireless sensors can include a communication
component configured to wirelessly transmit the detected signal or
other information to other surface nodes, as well as wirelessly
receive detected signal or other information from other surface
nodes. Selected surface nodes can also wirelessly communicate with
the implantable device. In some embodiments, selected surface nodes
can also receive signals transmitted from the implantable device.
For example, the wireless sensors can be used to detect one or more
of heart conditions based on ECG signals, such as ventricular and
atrial arrhythmias including but not limited to ventricular
fibrillation, ventricular tachycardia, atrial fibrillation, and
bradycardia. The implantable device and the surface nodes can
interact with each other on a number of different ways, such as:
(1) the surface nodes provide diagnostic information to the
implantable device which can use such information to make
adjustments in its operation; (2) the surface nodes and the
implantable device exchanges information such that the operations
of both the implantable device and the surface nodes can be
affected by each other; and/or (3) the surface nodes actively
participates in the monitoring/treatment decision making, e.g., in
determining whether and when to administer a therapy to the patient
(such as shock or pacing) to influence the electrical system of the
heart so as to address the detected condition. The implantable
device can include a communication component to wirelessly transmit
information to, and/or receive information from one or more of the
surface nodes, as will be further described below, where the
communication can be conducted through RF, magnetic, acoustic,
electrical, optical, and other transmission means as appropriate.
The implantable device can also include software configured to
process information received from the sensor of the implantable
device and the information received from the surface nodes, as well
as components for administering the therapies appropriate to
address the heart conditions detected.
[0057] In certain embodiments, additional components, such as a
remote or central server, can be used to make such a
diagnostic/treatment decision based on information received from
the implantable device and the surface nodes. Again, the
implantable device can be used to execute the action corresponding
to the decision made with the information provided by the surface
nodes.
[0058] In some embodiments, the surface-attached wireless sensors
include ECG electrodes suitable for acquiring electrophysiological
signals related to cardiac function are used for illustrating the
operating principles of the sensors and the network formed
therefrom. In other embodiments, the surface-attached wireless
sensors can include one or more tripole sensors, as illustrated in
FIGS. 2A and 2B, as discussed above.
[0059] In some embodiments where a plurality of wireless sensors
are employed, the wireless sensors can be configured to form a
network which can be use a routing strategy such as star, mesh,
pseudo-mesh, or any other routing topology. The network can include
one or more master nodes or other devices which can receive signals
from the wireless sensors and have additional signal processing,
decision making, and other supervising or coordinating
functionalities. The master node(s) or other devices do not need to
be attached to the patient's body. For example, the master code can
be a desktop or laptop PC, a tablet, a smartphone, etc., as
discussed above.
[0060] In some embodiments, one or more surface-attached sensors,
e.g., those located near an implanted cardiac device, can be used
to relay the signals acquired from the implanted sensors, e.g., to
an external monitoring device, thereby providing potentially better
quality signals for further processing and analysis. For example,
for an ICD, a wireless sensor can be attached at the patient's
chest to receive and resend the signals obtained by the implanted
sensor of the ICD.
[0061] FIG. 6 illustrates the operations of a system including an
ICD and one or more surface nodes (SNs) in accordance with one
embodiment of the invention. During step 1010, the ICD continuously
scans electrogram data to detect ventricular fibrillation (VF). It
is understood that VF is used herein only as an example, and other
conditions that an ICD typically monitors or manages, such as
arrhythmia, tachycardia, etc., can also be addressed by appropriate
modification of the process described herein. Accordingly, when VF
is used herein, it should be considered as referring to other
conditions that an ICD can monitor or manage.
[0062] As shown in FIG. 6, If VF is detected in decision block
1020, control flows to Step 1030 and the ICD scans for the presence
of surface node(s) on the body of the patient via wireless
communications. If no SN(s) is detected by the ICD in decision
block 1040, control flows to step 1050 and the ICD deploys a
predetermined defibrillation therapy based on the programming of
the ICD. If the ICD detects the SN(s), secure wireless link(s) can
be set up between the ICD and the SN(s) using, but not limited to,
RF, electric, magnetic, acoustic, or optical communication
protocol(s) as appropriate. Then, control flows to step 1060 and
the ICD cross-references VF diagnosis with SN(s). If the SN(s) also
detects VF in decision block 1070 (e.g., by using techniques known
in the art), control flows to step 1080 and the ICD deploys a
predetermined defibrillation therapy (e.g., by administering a
shocking current of a predetermined magnitude and duration). If the
SN(s) does not detect a VF episode, control flows to step 1090 and
triggers an evaluation algorithm in the ICD using weighted or
non-weighted data or diagnoses from both the ICD and the SN(s). An
example of such evaluation algorithm is a voting system based on
diagnoses of both the SN(s) and the ICD. For example, after the
algorithm is triggered in step 1090, control flows to step 1100 and
the ICD and the SN(s) each perform five consecutive diagnoses using
data acquired independently by the two devices.
[0063] Control then flows to step 1110 and the ICD cross-references
diagnoses with the SN(s). If ICD detects VF in all five diagnoses
in decision block 1120, control flows to step 1130 in which the ICD
ignores the diagnoses by SN(s) and deploys a predetermined
defibrillation therapy. If the ICD diagnoses is less than 100% for
VF in decision block 1120, the ICD can incorporate diagnoses by the
SN(s) in the decision-making For example, in decision block 1140,
if the SN(s) detects any episode of VF, control flows to step 1080
and the ICD deploys defibrillation current. If the SN(s) does not
detect any VF in all five episodes, control then flows to step 1150
and the ICD can decide not to administer defibrillation, or
administering a defibrillation current with modified parameters
(e.g., with a modified waveform, reduced energy, or reduced
duration, as desired or needed).
[0064] Independent of the final decision, the ICD can further
transmit relevant electrogram data and decision of the episode to
the SN(s), using, but not limited to, RF, electric, magnetic,
acoustic, or optical communication protocol(s) with proper
encryption as in step 1160. The control then flows to step 1170
where the SN(s) (or selected SNs from a plurality of SNs) further
packages the data from both ICD and SN(s) for the episode and
transmits to a remote server using, but not limited to, RF,
electric, magnetic, acoustic, or optical communication protocol(s).
The transfer of data to the server may route through secured relay
station(s). The data package can also contain an alert to the
server (in-house or third-party) such that the server can generate
a notification for, but not limited to, medical professional(s),
caregiver(s) and/or care providers(s). The server also generates an
entry documenting the episode to an EMR system.
[0065] FIG. 7 illustrates the operations of a system including a
pacemaker and one or more surface nodes in accordance with one
embodiment of the invention. It is understood that the pacemaker
described herein can also be an ICD having the pacemaking
capability. During step 2010, the pacemaker (PM) continuously scans
electrogram data for atrial arrhythmias that may be a precursor to
atrial fibrillation (AF), such as atrial ectopic beats (sometimes
referred to as premature atrial contractions or PACs). If one or
more PACs are detected in decision block 2020, control flows to
Step 2030 and the PM scans for the presence of body surface node(s)
via wireless communications that may include, but not limited to,
RF, electric, magnetic, acoustic, and optical channel(s). If no
SN(s) is detected by the PM in decision block 2040, control flows
to step 2050 and the PM determines the parameters of the pacemaking
therapy for subsequent deployment. If the PM detects the SN(s),
secure wireless link(s) can be set up between the PM and the SN(s)
using, but not limited to, RF, electric, magnetic, acoustic, or
optical communication protocol(s). Then, control flows to step 2060
and the PM collects ECG data from the SN(s). In step 2070, the PM
derives parameters for the pacemaking therapy (such as magnitude of
the pacing current, timing of administering the pacing current,
etc.) using the data from both the PM and the SN(s). Then the PM
deploys administers the therapy in step 2080.
[0066] After the pacing episode, the PM can transmit relevant
electrogram data and pacing current parameters to the SN(s), using,
but not limited to, RF, electric, magnetic, acoustic, or optical
communication protocol(s) with proper encryption as in step 2090.
The control then flows to step 2100 where the SN(s) further
packages the data from both PM and SN(s) for the episode and
transmits to a remote server using, but not limited to, RF,
electric, magnetic, acoustic, or optical communication protocol(s).
The transfer of data to the server may route through secured relay
station(s). The data package also contains an alert to the platform
(in-house or third-party) such that the server will generate a
notification for, but not limited to, medical professional(s),
caregiver(s) and/or care providers(s). The server can also generate
an entry documenting the episode to an EMR system.
[0067] It is understood that in the voting algorithm illustrated
above with respect to FIG. 6, the numbers and duration of
consecutive diagnoses can be varied as desired or needed. Other
schemes of the voting or decision algorithm can be designed.
Further, for the processes described in connection with both FIG. 6
and FIG. 7, when information from SN(s) and the implantable device
is both available and used in conjunction for the evaluation of the
heart condition, the SN(s) and the implantable device can be
assigned different weights based on the design and condition of the
ICD, the design and configuration of the SN(s), as well as other
considerations affecting the relative trustworthiness between the
ICD and SN(s) for diagnosing or interpreting the same heart
episode. Alternatively, a multivariate optimization approach can be
employed by taking into account of information received from the
SN(s) and the implantable cardiac device to make a diagnostic
conclusion that has the best probability to be correct, and/or
derive a set of parameters for the therapy to be administered
within the capability of the implantable cardiac device that can
best address the episode detected.
[0068] According to another embodiment of the present invention, an
integrated system is provided for acquiring, transmitting,
analyzing, and utilizing vital signs (e.g., hemodynamic parameters,
organ functions, blood test results) monitored in real time by
wireless sensors worn by the patient together with the patient's
medical records for clinical decision support and other patient
health care objectives. Such an integrated system includes the
wireless sensors and a monitoring unit, and can further include a
remote server(s) that stores the patient's EMR data.
[0069] As discussed herein, the monitoring unit or device (and/or a
remote server connected to the monitoring unit or device) can
include a computer program that manages the transmission of the
real time data from the wireless sensors, as well as perform
certain specified tasks based on the real time monitoring data as
well as the patient's EMR, e.g., diagnosing a condition of the
patient, alerting the patient or a physician of a diagnosed
condition of the patient, making a suggestion for the diagnosis or
treatment of the subject, and/or validating a diagnosis or
treatment proposed by a physician, etc. The monitoring unit (or a
remote server coupled thereto) can further integrate such received
real time monitoring data from the wireless sensors with the
patient's past medical history and/or other relevant data (e.g.,
stored demographics, vital signs history, previous diagnosis,
medications, allergies, etc.).
[0070] The EMR and other relevant data of a patient can be stored
in a permanent storage medium (e.g., a hard drive, a solid state
drive, a flash drive, or other types of memories) of the monitoring
unit, or transmitted from a physician computer or a remote server
(such as a remotely located server operated by a healthcare
provider, or a cloud server) accessible by the monitoring unit by
wired and/or wireless communications. Also, the data acquired and
stored by one or more of the wireless sensors can also be
asynchronously or simultaneously uploaded to the monitoring unit
and/or further to the remote server for long term storage and/or
further analysis. In other words, the patient's EMR can be updated
continuously or from time to time by incorporating the data
gathered by the wireless sensors. Without departing from the scope
of the invention, this data can be stored either locally on the
sensor or remotely anywhere on the network. For example, selected
portion of a patient's medical history in the patients EMR can be
retrieved from a remote server or computer to be stored on selected
wireless sensors having a storage medium having a sufficient
storage capacity such that relevant patient data can be carried
around on the wireless sensors worn by the patient and readily
accessible in a clinical setting or another setting where the
patient medical records are not otherwise available.
[0071] The real-time monitoring data gathered and transmitted by
the wireless sensors can be processed if necessary to extract
clinically relevant information (e.g., as a diagnosis) and
formatted for specific EMR systems, and entered into EMR database
located on a computer or data server as individual entries and/or
file attachments in a format that complies with current regulatory
standards. The data transmission frequency, data format, security
and other settings can be preset before the wireless sensors are
activated, but can made adjustable according to a patient's current
conditions detected by the monitoring system and/or clinical
information obtained from other sources (e.g., medications,
allergies, lab results, past/present diagnoses). For example, the
parameters of the monitoring by the wireless sensors can be
adjusted in response to updated patient EMR. When the patient's EMR
information is updated (including a change in patient conditions or
detection of a "health event," updated lab results, changes
in/initiation of medications, imaging results, or new diagnosis),
the monitoring system can change the protocol of the monitoring,
e.g., data transmission frequencies of uploading the wireless data
to the monitoring unit, threshold levels for alerts and alarms,
etc. As an example, if a patient's EMR is updated to include a new
medication (e.g., a beta blocker) that the patient starts to take,
the monitoring program installed at the monitoring unit or the
remote server can decide if the patient monitoring protocol needs
to be altered. If the patient having a low heart rate, a beta
blocker can make the patient prone to develop bradycardia. In this
case, the monitoring system can adjust the transmission frequencies
of the heart rate appropriate to monitor signs of bradycardia.
[0072] In addition, a list of the medications (and their dosages)
that have been prescribed to the patient may be stored in the
patient EMR with the schedule for taking them. The monitoring
system can also access the patient EMR and download the
medications, their dosages, and schedule in order to provide alerts
(e.g., sound or vibration alarm, text message, or other types of
notification) to healthcare professionals or the patient. If the
medications or schedule are changed in the patient EMR, then
notifications can be sent to the monitoring system and the alert
schedule can be updated accordingly. Additionally, the monitoring
unit can also make determination, based on the data received from
the wireless sensors, whether the patient has been taking the
medications, and/or the correct dosages of medications as
prescribed by physicians. The monitoring program can be configured
such that a detected noncompliance by the patient can trigger
alerts or notification to the patient, as well to the responsible
physicians. In this way, the monitoring system could also act as a
"compliance monitor."
[0073] It is noted that the diagnosis may be based on both the
transmitted data from the wireless sensors and the patient's
existing EMR (i.e., before the EMR is updated to incorporate the
new diagnosis).
[0074] FIG. 8 illustrates a method for personalized ECG monitoring
of patient conditions according to an embodiment of the present
invention. Using a tripole ECG sensor described previously as an
example, the raw two-channel ECG data is acquired at 610, and may
be used to derive parameters of the patient's anatomy, e.g.,
orientation of the ventricular and/or atrial heart axis, at 620. At
630, anatomy-adjusted 3-lead ECG can be developed. At 640, the
patient's EMR is cross checked for known or suspected cardiac
complications, or absence thereof. If there is anything in the
patient's EMR that shed light on or is inconsistent with the ECG
data, the ECG data can be modified to take that information into
account at 650. The result of the modified ECG data to a diagnostic
algorithm at 660.
[0075] Additionally, after the patient EMR is updated, the
monitoring program can reevaluate the patient's condition and
decides if additional actions to be performed (e.g., if certain
alerts are be sent to appropriate recipients or if the monitoring
protocol has to be adjusted. FIG. 9 illustrates an example method
utilizing the result of a diagnosis based on data from wireless
sensors as well as the patient's existing EMR for clinical decision
support according to an embodiment of the present invention. At
710, a diagnosis is made by the monitoring program based on data
received from wireless sensors (e.g., by the algorithm described in
connection with FIG. 4). At 720, the diagnosis is automatically
(without a user's assistance or intervention) entered into the
patient's EMR. The new diagnosis and the patient's medical history
are together used in a clinical decision support platform 730,
which include a decision support algorithm 732. The decision
support algorithm cross-references new diagnosis and patient's
medical history to determine whether the patient's current
condition is a known or benign condition (at 733), a medical
emergency (at 734), or a drug interaction (at 735). Based on the
result of determination, different actions can be performed (e.g.,
alerts to be sent to medical personnel at 737, alert to be sent to
caregivers at 738, and logging the evaluation result into the
patient EMR at 736). Additionally, the decision support algorithm
can adjust, in real-time, parameters of any treatment that is
currently being given to the patient, such as the pressure of the
ventilator, at 740.
[0076] FIG. 10 illustrates an example method utilizing the result
of a diagnosis based on data from wireless sensors (e.g., shown in
FIG. 4) as well as the patient's existing EMR for determining a
cause for the diagnosis and updating the monitoring protocol
according to an embodiment of the present invention. At 810, vital
sign data are collected from wireless ECG sensors attached to the
skin of a patient. At 820, the vital sign data are transmitted from
the wireless sensors (or selected relay sensor or sensors as
described above) to a server (e.g., a monitoring unit, a physician
computer, a cloud server, etc.). At 830, the uploaded data are
processed by a diagnostic algorithm and a particular condition
(e.g., ventricular tachycardia) is preliminarily diagnosed as a
result. At 840, the diagnostic algorithm further cross-references
the data from accelerometers and SpO.sub.2 sensor, and rules out
sudden increase in physical activity.
[0077] Further, the diagnostic algorithm cross-references patient's
EMR and determines what may be associated or a cause for the
detected condition (e.g., a haloperidol medication being taken by
the patient). Accordingly, the medical personnel is notified or
alerted with the appropriate message at 870, and the diagnostic
event is entered into the patient's EMR at 880. Also, the
monitoring protocol or settings can be updated at 860 based on the
determined cause of the condition (e.g., the frequency of
transmitting ECG data is updated to be 30 minutes), and the new
settings are sent to the wireless sensors or relay sensor(s) at
860.
[0078] As additional examples, the integrated monitoring system can
allow a physician to provide a correct diagnosis of symptoms
exhibited by a patient and detected by the wireless sensors. For
example, although oxygen saturation for a healthy person is
90-100%, for a patient having a chronic obstructive pulmonary
disease, the "normal" oxygen saturation is much lower. Thus, if the
patient has an oxygen saturation level of lower than 90% (e.g.,
86%) detected by the sensor network, the monitoring unit will not
produce an alarm condition, and can remind the physician if the
physician makes a treatment recommendation under a mistaken belief
regarding the "normal" oxygen saturation of this patient. In
another example, if a patient who has been taking beta-blockers has
a low heart rate, e.g., lower than 40/min, as sensed by the
wireless sensor and reported to a physician either remotely or in
the physician's office, the system can make that determination and
alert the physician that the patient should no longer be prescribed
beta-blockers, but should consider other medicine or therapies. As
a further example, if a patient is taking an antibiotic, the
appropriate dosage of the antibiotic can depend on the weight of
the patient such that the patient's kidney function and liver
function are not compromised. If the patient's weight has been
mistaken when a prescription is given by the physician, the dosage
can be incorrect as well, which can lead to ineffective treatment
or undesired side effects. In this scenario, the system can
validate the dosage prescribed by the physician based on a weight
sensor worn by the patient, or by the patient's EMR information
stored on a physician computer or downloaded from a server, and
alert the physician if the dosage prescribed is not within a
predetermined range appropriate for such a patient. As a further
example, if a patient visiting a healthcare provider complains
about a fever and chest pains, the physician can check the
patient's past medical records, which can be stored in the wireless
sensors worn by the patient, including the patient's X-ray test
result, and determine that the patient is suffering from a
pneumonia. If the patient also has a history of alcohol (or other
substance) dependence or abuse as indicated by the patient's past
medical history, an antibiotic can be prescribed for the patient
with an appropriate dosage based on this information as well as the
patient's weight and other relevant information, or another therapy
can be prescribed for the patient. The prescription can be entered
into the monitoring unit of the system or a computer in the
physician's office that is wirelessly coupled to the monitoring
unit for sending and receiving information. Further, the system can
further notify a pharmacy of the entered prescription, and direct
the patient to fill the prescription at such a pharmacy. The
physiological conditions of a patient of interest, including the
effects of a prescribed therapy (including drug treatment, surgical
procedures, etc.) on a patient can also be monitored by the patient
or the physician by wireless sensors monitoring the vital signs
relevant to the prescribed therapy, either in real time (e.g., the
data acquired by the sensors can be transmitted in real time or
intermittently to a monitoring device accessible by the physician
(intermittent transmission refers to transmission of acquired data
at a lower interval than the data acquisition or sampling rate by
the sensor)), or at each visit to the physician's office by the
patient.
[0079] The present invention is not to be limited in scope by the
specific embodiments described herein. Various modifications of the
invention in addition to those described herein will become
apparent to those skilled in the art from the foregoing description
and the accompanying figures.
[0080] One having ordinary skill in the art will recognize that the
various mechanisms described for the preferred embodiments of the
device may be adapted and interchanged between the preferred
embodiments, without significantly impacting the structure and
operation of the device. Use of the words "preferred embodiment" or
"preferably" is not intended to imply that any other embodiment is
less preferred or is not encompassed in the scope of the invention.
Those skilled in the art will recognize that the present invention
has many applications, may be implemented in many manners and, as
such is not to be limited by the foregoing embodiments and
examples.
[0081] Any number of the features of the different embodiments
described herein may be combined into one single embodiment, the
locations of particular elements can be altered and alternate
embodiments having fewer than or more than all of the features
herein described are possible. Functionality may also be, in whole
or in part, distributed among multiple components, in manners now
known or to become known.
[0082] It will be appreciated by those skilled in the art that
changes could be made to the embodiments described above without
departing from the broad inventive concept thereof It is
understood, therefore, that this invention is not limited to the
particular embodiments disclosed, but it is intended to cover
modifications within the spirit and scope of the present invention.
While there had been shown and described fundamental features of
the invention as applied to being exemplary embodiments thereof, it
will be understood that omissions and substitutions and changes in
the form and details of the disclosed invention may be made by
those skilled in the art without departing from the spirit of the
invention. Therefore, the appended claims are intended to cover
conventionally known, future developed variations and modifications
to the components described herein as would be understood by those
skilled in the art.
* * * * *