# US 11,026,619 B2 · Determining cardiac pacing capture effectiveness of an implantable medical device

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- Number: US 11,026,619 B2
- Document ID: US11026619B2
- Status: Granted
- Kind: B2
- Application number: 15/486,095
- Filed: 2017-04-12
- Published: 2017-10-19
- Granted: 2021-06-08
- Earliest claimed: 2016-04-13
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: David J. Ternes; Qi An; Pramodsingh H. Thakur; Keith R. Maile; Sunipa Saha
- Web page: https://patentgrep.com/patent/US11026619B2

## CPC

- A61B 5/352: Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/1116: {Determining posture transitions}
- A61B 5/318: Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B 5/33: specially adapted for cooperation with other devices
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/7285: {for synchronizing or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal}
- A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots}
- A61B 7/00: Instruments for auscultation
- A61N 1/371: {Capture, i.e. successful stimulation}
- G16H 40/67: for remote operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A cardiac rhythm management system includes at least one sensing component configured to obtain a first physiological parameter signal, an indication of a cardiac response to a stimulation therapy, and temporal information corresponding to the first physiological parameter signal and the cardiac response; and at least one processor configured to: receive the first physiological parameter signal, the indication of the cardiac response, and the temporal information; and to classify the cardiac response into a first cardiac response class to generate a classified cardiac response. The at least one processor also is configured to determine a correlation, based on the temporal information, between the first physiological parameter signal and the classified cardiac response.

## Claims

### Claim 1

A cardiac rhythm management system, comprising:
at least one sensing component configured to obtain a first physiological parameter signal, an indication of a cardiac response to a stimulation therapy, and temporal information corresponding to the first physiological parameter signal and the cardiac response; and
at least one processor configured to:
receive the first physiological parameter signal, the indication of the cardiac response, and the temporal information; and
classify the cardiac response into a first cardiac response class to generate a classified cardiac response, the first cardiac response class comprising one of a plurality of cardiac response classes, the plurality of cardiac response classes comprising a pace-dominant response class, a non-capture response class, a fusion response class, a pseudo-fusion response class, a bi-ventricle (BiV) fusion response class, a left ventricle (LV) only BiV capture response class, and a right ventricle (RV) only BiV capture response class;
determine a correlation, based on the temporal information, between the first physiological parameter signal and the classified cardiac response;
cause a display device to present a representation of the correlation; and
generate a therapy programming change recommendation that is different for different cardiac response classes of the plurality of cardiac response classes.

### Claim 2 (depends on 1)

The system of claim 1, wherein the first physiological parameter comprises at least one of a heart rate, a respiration rate, a blood pressure, a posture, an S1 heart sound, an S2 heart sound, and a cardiac interval within a cardiac cycle.

### Claim 3 (depends on 2)

The system of claim 2, the first physiological parameter comprising an S1 heart sound, wherein the processor is configured to classify the cardiac response based on at least one of a morphology of the S1 heart sound and an intensity of the S1 heart sound.

### Claim 4 (depends on 2)

The system of claim 2, the first physiological parameter comprising an S2 heart sound, wherein the processor is configured to:
determine an S2-R interval; and
classify the cardiac response based on the determined S2-R interval.

### Claim 5 (depends on 1)

The system of claim 1, further comprising at least one additional sensing component configured to obtain a second physiological parameter signal, wherein the at least one processor is further configured to verify the classification of the cardiac response based on the second physiological parameter signal.

### Claim 6 (depends on 5)

The system of claim 5, wherein the second physiological parameter comprises at least one of an S1 heart sound and an S2 heart sound.

### Claim 7 (depends on 1)

The system of claim 1, wherein the processor is further configured to:
receive a plurality of additional indications of a plurality of additional cardiac responses and the first physiological parameter signal;
classify each of the plurality of additional cardiac responses to generate a plurality of additional classified cardiac responses;
correlate each of the plurality of additional classified cardiac responses with the first physiological parameter signal to generate a plurality of additional correlations; and
cause the display device to present a representation of the plurality of additional correlations.

### Claim 8 (depends on 7)

The system of claim 7, wherein the representation of the plurality of additional correlations comprises a graph including representations of the first physiological parameter signal and the plurality of additional classified cardiac responses by time of day.

### Claim 9

A cardiac rhythm management system, comprising:
at least one sensing component configured to obtain a heart sound signal, a plurality of indications of a plurality of cardiac responses to a stimulation therapy, and temporal information corresponding to the heart sound signal and the cardiac responses; and
at least one processor configured to:
receive the heart sound signal, the plurality of indications of the plurality of cardiac responses, and the temporal information; and
classify each of the plurality of cardiac responses into one of a plurality of cardiac response classes to generate a plurality of classified cardiac responses;
determine a correlation, based on the temporal information, between the heart sound signal and the plurality of classified cardiac responses;
cause a display device to present a representation of the correlation; and
generate a therapy change recommendation that is different for different cardiac response classes of the plurality of cardiac response classes.

### Claim 10 (depends on 9)

The system of claim 9, the plurality of cardiac response classes comprising a pace-dominant response class, a non-capture response class, a fusion response class, a pseudo-fusion response class, a bi-ventricle (BiV) fusion response class, a left ventricle (LV) only BiV capture response class, and a right ventricle (RV) only BiV capture response class.

### Claim 11 (depends on 9)

The system of claim 9, wherein the heart sound signal comprises at least one of an S1 heart sound signal and an S2 heart sound signal.

### Claim 12 (depends on 11)

The system of claim 11, wherein the heart sound signal comprises an S1 heart sound signal, the processor further configured to determine a morphology of the S1 heart sound signal and/or an intensity of the S1 heart sound signal, wherein the processor is configured to classify each of the plurality of cardiac responses based on the morphology of the S1 heart sound signal and/or the intensity of the S1 heart sound signal.

### Claim 13 (depends on 11)

The system of claim 11, wherein the heart sound signal comprises an S2 heart sound signal, wherein the processor is configured to:
determine an S2-R interval; and
classify the cardiac response based on the determined S2-R interval.

### Claim 14 (depends on 9)

The system of claim 9, wherein the at least one processor is further configured to generate, based on at least one of the classified cardiac response and the correlation, a therapy programming change recommendation.

### Claim 15

A method of evaluating an effectiveness of a pacing therapy, the method comprising:
obtaining a first physiological parameter signal, an indication of a cardiac response to a stimulation therapy, and temporal information corresponding to the first physiological parameter signal and the cardiac response, wherein the first physiological parameter comprises at least one of a heart rate, a respiration rate, a blood pressure, a posture, an S1 heart sound, and an S2 heart sound;
obtaining a second physiological parameter signal;
classifying the cardiac response into a first cardiac response class to generate a classified cardiac response, the first cardiac response class comprising one of a plurality of cardiac response classes, the plurality of cardiac response classes comprising a pace-dominant response class, a non-capture response class, a fusion response class, a pseudo-fusion response class, a bi-ventricle (BiV) fusion response class, a left ventricle (LV) only BiV capture response class, and a right ventricle (RV) only BiV capture response class;
verifying the classification of the cardiac response based on the second physiological parameter signal;
determining a correlation, based on the temporal information, between the first physiological parameter signal and the classified cardiac response;
causing a display device to present a representation of the correlation; and
generating a therapy change recommendation that is different for different cardiac response classes of the plurality of cardiac response classes.

### Claim 16 (depends on 15)

The method of claim 15, wherein the second physiological parameter comprises at least one of an S1 heart sound and an S2 heart sound.

### Claim 17 (depends on 15)

The method of claim 15, further comprising:
obtaining a plurality of additional indications of a plurality of additional cardiac responses and the first physiological parameter signal;
classifying each of the plurality of additional cardiac responses to generate a plurality of additional classified cardiac responses;
correlating each of the plurality of additional classified cardiac responses with the first physiological parameter signal to generate a plurality of additional correlations; and
causing the display device to present a representation of the plurality of additional correlations.