# US 12,263,347 B2 · Medical device system and method for determining His bundle pacing capture

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- Number: US 12,263,347 B2
- Document ID: US12263347B2
- Status: Granted
- Kind: B2
- Application number: 17/692,740
- Filed: 2022-03-11
- Published: 2022-06-23
- Granted: 2025-04-01
- Earliest claimed: 2019-02-18
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Subham Ghosh
- Web page: https://patentgrep.com/patent/US12263347B2

## CPC

- A61N 1/3627: {for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy}
- A61N 1/3704: {Circuits specially adapted therefor, e.g. for sensitivity control}
- A61N 1/36507: {controlled by gradient or slope of the heart potential}
- A61N 1/36571: {controlled by blood flow rate, e.g. blood velocity or cardiac output}
- A61N 1/36578: {controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone}
- A61N 1/3712: {Auto-capture, i.e. automatic adjustment of the stimulation threshold}
- A61N 1/37223: {Circuits for electromagnetic coupling}
- A61N 1/39622: {Pacing therapy}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- 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

In a medical device system, a computer apparatus is configured to receive body surface electrical signals from an electrode apparatus including multiple external electrodes. The computing apparatus generates electrical dyssynchrony data from the body surface electrical signals during delivery of His bundle pacing pulses and identifies effective His bundle capture based on the electrical dyssynchrony data. The computing apparatus generates an indication of His bundle capture in response to identifying the effective His bundle capture.

## Claims

### Claim 1

A medical device system, comprising:
an implantable medical device comprising:
a sensing circuit configured to sense a cardiac electrical signal;
a therapy delivery circuit configured to deliver pacing pulses according to a first pacing output control parameter; and
a control circuit coupled to the sensing circuit and the therapy delivery circuit and configured to:
receive an indication of effective or partial His bundle capture, the indication being a wirelessly transmitted notification signal;
determine confirmed effective or partial His bundle pacing at the pacing output control parameter based on the received indication of effective or partial His bundle capture;
in response to receiving the wirelessly transmitted notification signal as the indication of effective or partial His bundle capture, determine a feature of the cardiac electrical signal sensed by the sensing circuit during the confirmed effective or partial His bundle pacing at the pacing output control parameter; and
establish a corresponding effective or partial His bundle capture detection threshold based on the determined feature of the cardiac electrical signal sensed by the sensing circuit during the confirmed effective or partial His bundle pacing.

### Claim 2 (depends on 1)

The medical device system of claim 1, wherein the control circuit is further configured to control the therapy delivery circuit to maintain capture of at least a portion of the His bundle by:
determining the feature of the cardiac electrical signal received from the sensing circuit following a pacing pulse delivered by the therapy delivery circuit;
comparing the feature to the corresponding effective or partial His bundle capture detection threshold; and
adjusting the first pacing control parameter used by the therapy delivery circuit to deliver the pacing pulses to a second pacing control parameter of a plurality of pacing control parameters in response to the feature not satisfying the corresponding effective or partial His bundle capture detection threshold.

### Claim 3 (depends on 1)

The medical device system of claim 1, wherein the control circuit is configured to determine the feature of the cardiac electrical signal by determining at least one of:
a QRS width, a QRS area, a QRS polarity, a QRS morphology template and a QRS time delay.

### Claim 4 (depends on 1)

The medical device system of claim 1, wherein the control circuit is further configured to:
control the therapy delivery circuit to deliver the pacing pulses at a second pacing pulse output control parameter;
determine that the indication of effective or partial His bundle capture is not received during His bundle pacing at the second pacing pulse output control parameter; and
control the therapy delivery circuit to adjust the second pacing pulse output control parameter to the first pacing pulse output control parameter in response to not receiving the indication of effective or partial His bundle capture during His bundle pacing at the second pacing pulse output control parameter.

### Claim 5 (depends on 1)

The medical device system of claim 1, wherein the control circuit is further configured to:
determine a baseline QRS feature of the cardiac electrical signal during His bundle non-capture; and
establish the corresponding effective or partial His bundle capture detection threshold by setting corresponding effective or partial His bundle capture detection threshold to a value between the baseline QRS feature value and the determined feature of the cardiac electrical signal sensed by the sensing circuit during the confirmed effective or partial His bundle pacing.

### Claim 6 (depends on 1)

The medical device system of claim 1, wherein the control circuit is further configured to determine a percentage of His bundle pacing pulses delivered by the therapy delivery circuit for which capture is detected based on the effective or partial His bundle capture detection threshold.

### Claim 7 (depends on 1)

The medical device system of claim 1, further comprising:
an electrode apparatus comprising a plurality of external electrodes configured for monitoring a plurality of body surface electrical signals of a patient;
a computing apparatus coupled to the electrode apparatus and comprising processing circuitry configured to:
generate cardiac electrical dyssynchrony data from the body surface electrical signals received from the plurality of external electrodes during delivery of pacing pulses from the implantable medical device;
identify effective or partial His bundle capture by the pacing pulses based on the electrical dyssynchrony data.

### Claim 8 (depends on 7)

The medical device system of claim 7, wherein the implantable medical device further comprises:
a telemetry circuit configured to receive the indication of effective or partial His bundle capture from the computing apparatus,
wherein the computing apparatus is configured to generate the indication of effective or partial His bundle capture in response to identifying the effective or partial His bundle capture and transmit the indication of effective or partial His bundle capture by transmitting the notification signal, and wherein the control circuit of the implantable medical device is configured to receive the indication of effective or partial His bundle capture from the computing apparatus via the telemetry circuit.

### Claim 9 (depends on 7)

The medical device system of claim 7, wherein the computing apparatus is configured to:
generate electrical dyssynchrony data by:
determining electrical activation times from a plurality of QRS waveforms received from the electrode apparatus, and
determining a metric of the electrical activation times; and
identify the effective or partial His bundle capture by comparing the metric of the electrical activation times to one or more thresholds.

### Claim 10 (depends on 7)

The medical device system of claim 7, wherein the computing apparatus is further configured to:
generate electrical dyssynchrony data by:
determining a right ventricular metric of electrical activation times from a first plurality of QRS waveforms received from the electrode apparatus corresponding to body surface electrical signals received along a right side of the patient, and
determining a left ventricular metric of electrical activation times from a second plurality of QRS waveforms of the body surface electrical signals received from external electrodes of the electrode apparatus along a left side of the patient; and
identify effective or partial His bundle capture by:
comparing the right ventricular metric and the left ventricular metric to a respective right bundle branch capture threshold and left bundle branch capture threshold; and
identifying effective or partial His bundle capture based on at least one of the right ventricular metric meeting the respective right bundle branch capture threshold or the left ventricular metric meeting the left bundle branch capture threshold.

### Claim 11 (depends on 1)

The medical device system of claim 1, wherein the control circuit of the implantable medical device is further configured to:
discriminate between two or more different types of His bundle capture from among selective His bundle capture, non-selective His bundle capture, ventricular myocardial only capture, right bundle branch capture, and left bundle branch capture based on the cardiac electrical signal; and
adjust the pacing output control parameter in response to the feature of the cardiac electrical signal sensed by the sensing circuit not satisfying the corresponding effective or partial His bundle capture detection threshold.

### Claim 12 (depends on 11)

The medical device system of claim 11, wherein the implantable medical device is configured to adjust the pacing output control parameter to maintain left bundle branch capture.

### Claim 13 (depends on 11)

The medical device system of claim 11, wherein the implantable medical device is configured to adjust the pacing output control parameter to maintain effective His bundle capture.

### Claim 14

A method performed by an implantable medical device, comprising:
delivering pacing pulses according to a first pacing output control parameter;
receiving an indication of confirmed effective or partial His bundle capture during pacing at the pacing output control parameter by receiving the indication as a wirelessly transmitted notification signal;
in response to receiving the indication of confirmed effective or partial His bundle capture, determining a feature of a cardiac electrical signal sensed by a sensing circuit of the implantable medical device during the confirmed effective or partial His bundle pacing at the pacing output control parameter;
establishing a corresponding effective or partial His bundle capture detection threshold based on the determined feature of the cardiac electrical signal sensed by the sensing circuit; and
controlling a therapy delivery circuit to maintain capture of at least a portion of the His bundle using the corresponding effective or partial His bundle capture detection threshold.

### Claim 15 (depends on 14)

The method of claim 14, further comprising discriminating between two or more different types of His bundle capture from among selective His bundle capture, non-selective His bundle capture, ventricular myocardial only capture, right bundle branch capture, and left bundle branch capture based on the cardiac electrical signal; and
adjusting the pacing output control parameter in response to the feature of the cardiac electrical signal sensed by the sensing circuit not satisfying the corresponding effective or partial His bundle capture detection threshold.

### Claim 16 (depends on 15)

The method of claim 15, wherein adjusting the pacing output control parameter comprising adjusting the pacing output control parameter to maintain left bundle branch capture or effective His bundle capture.

### Claim 17 (depends on 14)

The method of claim 14, wherein controlling a therapy delivery circuit to maintain capture of at least a portion of the His bundle comprises
determining the feature of the cardiac electrical signal following a pacing pulse delivered by the therapy delivery circuit;
comparing the feature to the corresponding effective or partial His bundle capture detection threshold; and
adjusting the first pacing control parameter used by the therapy delivery circuit to deliver the pacing pulses to a second pacing control parameter of a plurality of pacing control parameters in response to the feature not satisfying the corresponding effective or partial His bundle capture detection threshold.

### Claim 18 (depends on 14)

The method of claim 14, wherein determining the feature of the cardiac electrical signal comprises determining at least one of a QRS width, a QRS area, a QRS polarity, a QRS morphology template and a QRS time delay.

### Claim 19

A non-transitory, computer-readable storage medium comprising a set of instructions which, when executed by a processor of a computing apparatus of a medical device system, cause the computing apparatus to:
receive body surface electrical signals from an electrode apparatus comprising a plurality of external electrodes;
generate electrical dyssynchrony data from the body surface electrical signals received from the plurality of external electrodes during delivery of His bundle pacing pulses;
identify effective or partial His bundle capture based on the electrical dyssynchrony data, wherein the effective or partial His bundle capture comprises capture of both a left bundle branch and a right bundle branch of a His bundle, the left bundle branch only, or the right bundle branch only;
generate a corresponding indication of effective or partial His bundle capture in response to identifying the effective or partial His bundle capture His bundle capture; and
transmit the indication of effective or partial His bundle capture as a wirelessly transmitted notification signal to an implantable medical device configured to receive the wirelessly transmitted notification signal and establish an effective or partial His bundle capture detection threshold in response to receiving the wirelessly transmitted notification signal.

### Claim 20 (depends on 19)

The computer-readable storage medium of claim 19, wherein the set of instructions which, when executed by a processor of a computing apparatus of a medical device system, further causes the computing apparatus to:
discriminate between two or more different types of His bundle capture from among selective His bundle capture, non-selective His bundle capture, ventricular myocardial only capture, right bundle branch capture, and left bundle branch capture based on the cardiac electrical signal; and
generate corresponding indications of the two or more different types of His bundle capture.
