# US 10,864,378 B2 · Pacemaker with diagnostic intrinsic beat search

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- Number: US 10,864,378 B2
- Document ID: US10864378B2
- Status: Granted
- Kind: B2
- Application number: 15/915,700
- Filed: 2018-03-08
- Published: 2018-09-13
- Granted: 2020-12-15
- Earliest claimed: 2017-03-09
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: David A. Casavant; Jeffrey E. Stahmann; Carolina Villarreal; James O. Gilkerson; Deepa Mahajan; Paul Richard Holleran
- Web page: https://patentgrep.com/patent/US10864378B2

## CPC

- A61N 1/37282: {characterised by communication with experts in remote locations using a network}
- A61N 1/3622: {comprising two or more electrodes co-operating with different heart regions}
- A61N 1/36507: {controlled by gradient or slope of the heart potential}
- A61N 1/36535: {controlled by body position or posture}
- A61N 1/36542: {controlled by body motion, e.g. acceleration}
- A61N 1/36564: {controlled by blood pressure}
- A61N 1/36578: {controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone}
- A61N 1/36592: {controlled by the heart rate variability}
- A61N 1/3712: {Auto-capture, i.e. automatic adjustment of the stimulation threshold}
- A61N 1/37217: {characterised by the communication link, e.g. acoustic or tactile}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61N 1/3787: {from an external energy source}
- A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion}
- 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)

## Abstract

Regulating cardiac activity may include pacing the patient's heart at a starting pacing rate and instigating an intrinsic heart beat search algorithm that includes pacing at a reduced rate for a period of time and capturing electrical signals representative of cardiac electrical activity while pacing at the reduced rate in order to determine a presence or absence of intrinsic heart beats. If intrinsic heart beats are not detected, the heart may be paced at a further reduced rate for a period of time. If intrinsic beats are detected, the heart may be paced again at the starting pacing rate. This may continue until intrinsic heart beats are detected or until a lower search rate limit is reached. Diagnostic data may be collected at each stage and transmitted to a display device for analysis by a physician or the like.

## Claims

### Claim 1

An implantable medical device (IMD) configured to sense electrical cardiac activity of a patient's heart and to pace a ventricle of the patient's heart, the IMD comprising:
a housing;
a plurality of electrodes;
a controller disposed within the housing and operably coupled to the plurality of electrodes such that the controller can receive electrical signals from at least two of the plurality of electrodes representing electrical cardiac activity and can deliver pacing pulses to the ventricle of the patient's heart via at least two of the plurality of electrodes;
a communications module operably coupled to the controller and configured to wirelessly communicate with a remotely located device;
the controller is configured to pace the ventricle of the patient's heart at a therapy based pacing rate using a plurality of pacing pulses but where one or more of the plurality of pacing pulses may be inhibited by a corresponding sensed intrinsic beat;
the controller is further configured to perform an intrinsic beat search algorithm during which the controller is configured to:
identify a first reduced pacing rate representing a reduction relative to the therapy based pacing rate;
pace the ventricle of the patient's heart for a period of time at the first reduced pacing rate using a plurality of pacing pulses but where one or more of the plurality of pacing pulses may be inhibited by a corresponding sensed intrinsic beat; and
determine if there are sustained intrinsic beats at the first reduced pacing rate, wherein the controller determines that there are sustained intrinsic beats when at least 80 percent of the beats are intrinsic beats.

### Claim 2 (depends on 1)

The IMD of claim 1, wherein if there is sustained intrinsic beats at the first reduced pacing rate, the controller is configured to return to pace the ventricle of the patient's heart at the therapy based pacing rate.

### Claim 3 (depends on 2)

The IMD of claim 2, wherein the controller is configured to return to pace the ventricle of the patient's heart at the therapy based pacing rate in a single rate step.

### Claim 4 (depends on 2)

The IMD of claim 2, wherein the controller is configured to return to pace the ventricle of the patient's heart at the therapy based pacing rate increasingly over time.

### Claim 5 (depends on 1)

The IMD of claim 1, wherein if there is not sustained intrinsic beats at the first reduced pacing rate, the controller is configured to:
identify a second reduced pacing rate representing a reduction relative to the first reduced pacing rate;
pace the ventricle of the patient's heart for a period of time at the second reduced pacing rate using a plurality of pacing pulses but where one or more of the plurality of pacing pulses may be inhibited by a corresponding sensed intrinsic beat; and
determine if there are sustained intrinsic beats at the second reduced pacing rate.

### Claim 6 (depends on 5)

The IMD of claim 5, wherein if there is sustained intrinsic beats at the second reduced pacing rate, the controller is configured to return to pace the ventricle of the patient's heart at the therapy based pacing rate.

### Claim 7 (depends on 1)

The IMD of claim 1, wherein the controller is configured to record one or more items over time.

### Claim 8 (depends on 7)

The IMD of claim 7, wherein the controller is configured to transmit one or more of the items via the communications module to the remotely located device.

### Claim 9 (depends on 1)

The IMD of claim 1, wherein the controller is further configured to record one or more items, the one or more items comprising one or more of:
a beat type for each beat, wherein the beat type comprises an intrinsic beat or a paced beat;
a beat rate, wherein the beat rate represents the rate at which the beats occur;
a beat rate variability parameter, wherein the beat rate variability parameter represents the rate variability at which the beats occur;
an egram;
one or more respiration parameters;
a posture parameter;
one or more heart sound parameters;
one or more contractility parameters;
a QRS width parameter;
a PR interval parameter
a QRS to S1 interval parameter;
a blood pressure parameter;
an activity level parameter;
an AV delay parameter; and
a p-wave indicator.

### Claim 10 (depends on 1)

The IMD of claim 1, wherein the controller determines that there are sustained intrinsic beats when at least 90 percent of the beats are intrinsic beats.

### Claim 11 (depends on 1)

The IMD of claim 1, wherein the therapy based pacing rate is a lower rate limit.

### Claim 12 (depends on 1)

The IMD of claim 1, wherein the therapy based pacing rate is above a lower rate limit and is based on a detected patient activity level.

### Claim 13 (depends on 12)

The IMD of claim 12, wherein the controller is configured to perform the intrinsic beat search algorithm at each of two or more different therapy based pacing rates that are based on two or more different detected patient activity levels.

### Claim 14 (depends on 13)

The IMD of claim 13, wherein the controller is further configured to record one or more items at each of the two or more different therapy based pacing rates, wherein the one or more items comprising one or more of:
a beat type for each beat, wherein the beat type comprises an intrinsic beat or a paced beat;
a beat rate, wherein the beat rate represents the rate at which the beats occur;
a beat rate variability, wherein the beat rate variability represents the rate variability at which the beats occur; and
an egram.

### Claim 15 (depends on 1)

The IMD of claim 1, further comprising a battery having a battery capacity that is sufficient to power the IMD for 6 months or less when pacing at max pacing power at a rate of 60 beats/minute.

### Claim 16

A method of performing an intrinsic heart beat search in an implantable medical device while delivering pacing therapy to a patient's heart, the method comprising:
identifying a reduced pacing rate representing a reduction relative to a therapy based pacing rate;
pacing a ventricle of the patient's heart for a period of time at the reduced pacing rate using a plurality of pacing pulses but where one or more of the plurality of pacing pulses may be inhibited by a corresponding sensed intrinsic beat;
recording one or more items, the one or more items comprising one or more of:
a beat type for each beat, wherein the beat type comprises an intrinsic beat or a paced beat;
a beat rate, wherein the beat rate represents the rate at which the beats occur;
a beat rate variability, wherein the beat rate variability represents the rate variability at which the beats occur; and
an egram;
determine if there are sustained intrinsic beats at the reduced pacing rate, wherein there is a determination of sustained intrinsic beats when at least 80 percent of the beats are intrinsic beats;
repeating the pacing, recording and determining steps using different reduced pacing rates;
in response to determining that there are sustained intrinsic beats, pacing the ventricle of the patient's heart at the therapy based pacing rate.

### Claim 17 (depends on 16)

The method of claim 16, further comprising transmitting one or more of the items to a remotely located device.

### Claim 18

A method of regulating cardiac activity following a procedure that may temporarily impair a cardiac conduction system within a patient's heart, the method comprising:
pacing the patient's heart at a starting pacing rate;
instigating an intrinsic heart beat search algorithm comprising:
pacing at a reduced rate for a period of time;
capturing electrical signals representative of cardiac electrical activity while pacing at the reduced rate in order to determine a presence or absence of sustained intrinsic heart beats, wherein there is a determination of sustained intrinsic beats when at least 80 percent of the beats are intrinsic beats;
pacing at a further reduced rate for a period of time if sustained intrinsic heart beats are not detected;
returning to pacing at the starting pacing rate if sustained intrinsic heart beats are detected;
continuing to reduce the pacing rate and capturing electrical signals while pacing at the further reduced pacing rate in order to determine a presence or absence of sustained intrinsic heart beats until sustained intrinsic heart beats are detected or until a lower search rate limit is reached.

### Claim 19 (depends on 18)

The method of claim 18, further comprising reporting results of the intrinsic heart beat search algorithm to a remote device.