Leadless pacemaker using pressure measurements for pacing capture verification

• US 10,426,962 B2
• Filed: 06/28/2017
• Issued: 10/01/2019
• Est. Priority Date: 07/07/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: An, Qi, Stahmann, Jeffrey E., Thakur, Pramodsingh Hirasingh, Yu, Yinghong, Kane, Michael J.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US15/635,921
• Publication Number:
  US 20180008831A1
• Time in Patent Office: 825 Days
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Methods, devices, and systems for performing pacing capture verification in implantable medical devices such as a leadless cardiac pacemakers using a pressure signal. An example medical device includes a pressure sensor and is configured to monitor for an evoked capture response using the pressure sensor following pace delivery. Various factors of the pressure waveform may be used including the use of threshold, templating, and slope, as well as comparing cross-domain sensed events including using a fiducial point from the pressure signal for comparison to an acoustic, electrical, or motion event, or the use of data obtained from a second device which may be implanted, wearable, or external to the patient.

Claims

1. An implantable medical device in the form of a cardiac pacemaker, comprising:

at least first and second electrodes for at least one of delivering therapy or sensing electrical signals;

a pressure sensor for sensing intracardiac pressure;

operational circuitry coupled to the electrodes and the pressure sensor; and

a housing sized and adapted for placement in or on the heart of a patient, the housing containing at least the operational circuitry;

wherein the operational circuitry is configured to perform a pressure based capture verification process including the following;

deliver an electrical pacing stimulus to the heart of a patient using the at least first and second electrodes;

obtaining a pressure signal received with the pressure sensor over a period of time following delivery of the electrical pacing stimulus;

monitor for an evoked capture response indicating the electrical pacing stimulus was captured using the pressure sensor by identifying a peak in the pressure signal and determining a temporal relationship of the peak in the pressure signal to a second signal event; and

if the evoked capture response is detected, conclude that the electrical pacing stimulus captured at least a portion of the patient'"'"'s heart; and

if the evoked capture response is not detected, conclude that the electrical pacing stimulus did not capture the patient'"'"'s heart.

2. The medical device of claim 1 wherein the operational circuitry is configured to monitor for an evoked capture response by obtaining a signal received with the pressure sensor over a period of time following delivery of the electrical pacing stimulus, extracting a feature from the pressure signal, and comparing the extracted feature to a feature threshold, such that:

if the feature threshold is exceeded, the operational circuitry is configured to conclude that the evoked capture response has been detected; and

if the feature threshold is not exceeded, the operational circuitry is configured to conclude that the evoked capture response has not been detected.

3. The medical device of claim 2 wherein the extracted feature is a peak pressure during systole and the feature threshold is a pressure threshold.

4. The medical device of claim 2 wherein the extracted feature is a minimum pressure during diastole, and the feature threshold is a minimum pressure threshold for diastole.

5. The medical device of claim 2 wherein the extracted feature is a peak rate of change of pressure during systole, and the feature threshold is a minimum rate of change of pressure.

6. The medical device of claim 2 wherein the extracted feature is a minimum rate of change of pressure, and the feature threshold is a minimum rate of change of pressure.

7. The medical device of claim 2 wherein the extracted feature is an area under the curve of a measured pressure over a period of time, and the feature threshold is a minimum area.

8. The medical device of claim 2 wherein the operational circuitry is configured to perform an evoked pressure signal initialization process in which:

the operational circuitry issues one or more electrical pacing stimulus to the heart of the patient using the at least first and second electrodes, the one or more electrical pacing stimulus being delivered using pacing parameters that are expected to capture the heart;

the operational circuitry obtains signals from the pressure sensor and determines an expected feature value using obtained pressure signals corresponding to evoked capture responses;

the operational circuitry sets the feature threshold in relation to the expected feature value.

9. The medical device of claim 2 wherein the operational circuitry is configured to perform an evoked pressure signal initialization process in which:

the medical device communicates with a second device, the second device being configured to determine whether pacing pulses delivered by the medical device capture the heart;

the operational circuitry issues at least one electrical pacing stimulus to the heart of the patient using the at least first and second electrodes and receives confirmation from the second device that capture has occurred generating one or more confirmed evoked capture responses;

the operational circuitry obtains signals from the pressure sensor and determines an expected feature value corresponding to the one or more confirmed evoked capture responses;

the operational circuitry sets the feature threshold in relation to the expected feature value.

10. The medical device of claim 2 wherein the operational circuitry is configured to perform an evoked pressure signal initialization process in which:

the operational circuitry issues at least one electrical pacing stimulus to the heart of the patient using the at least first and second electrodes;

the operational circuitry analyzes an electrical signal sensed from the heart and determines that capture has occurred generating one or more confirmed evoked capture responses;

the operational circuitry obtains signals from the pressure sensor and determines an expected feature value corresponding to the one or more confirmed evoked capture responses;

the operational circuitry sets the feature threshold in relation to the expected feature value.

11. The medical device of claim 1 wherein the operational circuitry is configured to monitor for an evoked capture response by obtaining a signal received with the pressure sensor over a period of time following delivery of the electrical pacing stimulus, and comparing the obtained pressure signal to an evoked pressure signal template, such that:

if the evoked pressure signal template matches the obtained pressure signal, the operational circuitry is configured to conclude that the evoked capture response has been detected; and

if the evoked pressure signal template fails to match the obtained pressure signal, the operational circuitry is configured to conclude that the evoked capture response has not been detected.

12. The medical device of claim 11 wherein the operational circuitry is configured to perform an evoked pressure signal initialization process in which:

the operational circuitry issues one or more electrical pacing stimulus to the heart of the patient using the at least first and second electrodes, the one or more electrical pacing stimulus being delivered at an energy that is expected to capture the heart;

the operational circuitry obtains signals from the pressure sensor and determines an evoked pressure signal template.

13. The medical device of claim 11 wherein the operational circuitry is configured to perform an evoked pressure signal initialization process in which:

the medical device communicates with a second device, the second device being configured to determine whether pacing pulses delivered by the medical device capture the heart;

the operational circuitry issues at least one electrical pacing stimulus to the heart of the patient using the at least first and second electrodes and receives confirmation from the second device that capture has occurred generating one or more confirmed evoked capture responses;

the operational circuitry obtains signals from the pressure sensor corresponding to the confirmed evoked capture responses, and determines an evoked pressure signal template.

14. The medical device of claim 11 wherein the operational circuitry is configured to perform an evoked pressure signal initialization process in which:

the operational circuitry issues at least one electrical pacing stimulus to the heart of the patient using the at least first and second electrodes;

the operational circuitry analyzes an electrical signal sensed from the heart and determines that capture has occurred generating one or more confirmed evoked capture responses;

the operational circuitry obtains signals from the pressure sensor corresponding to the confirmed evoked capture responses, and determines an evoked pressure signal template.

15. The medical device of claim 11 further comprising a posture sensor, wherein the operational circuitry is configured to store a plurality of evoked pressure signal templates corresponding to at least first and second postures of the patient.

16. The medical device of claim 1 wherein the operational circuitry is configured to determine a temporal relationship of the peak in the pressure signal to the second signal event by:

identifying a first point in time at which the peak in the pressure signal occurs;

identifying a second point in time at which a selected cardiac event takes place using a heart sound, the heart sound being the second signal event, the heart sound relating to an atrial event, wherein the electrical pacing stimulus is configured to excite a ventricle;

calculating an interval between the first and second points in time; and

determining whether an evoked capture response has been detected using the interval;

wherein;

if the interval is shorter than a threshold, the operational circuitry is configured to conclude that the evoked capture response has occurred; and

if the interval is longer than a threshold, the operational circuitry is configured to conclude that the evoked capture response has not occurred.

17. The medical device of claim 1 wherein the operational circuitry is configured to determine a temporal relationship of the peak in the pressure signal to the second signal event by;

determining an R-wave time at which the electrical R-wave signal of the heart occurs following the electrical pacing stimulus, the R-wave time being the second signal event;

determining a pressure time at which the peak in the pressure signal occurs;

calculating an interval between the R-wave time and the pressure time;

comparing the interval to a threshold and;

if the interval exceeds the threshold, determining that the evoked capture response has occurred; and

if the interval does not exceed the threshold, determining that the evoked capture response has not occurred.

18. The medical device of claim 1 further comprising a motion sensor, wherein the operational circuitry is configured to determine a temporal relationship of the peak in the pressure signal to the second signal event;

determining a motion time at which the motion sensor detects cardiac movement following the electrical pacing stimulus, the motion time being the second signal event;

determining a pressure time at which the peak in the pressure signal occurs;

determining whether each of;

a) the pressure signal exceeds a pressure threshold; and

b) the motion time and the pressure time temporally correlate to one another;

if both a) and b) occur, determining that the evoked capture response has occurred; and

if one or both of a) and b) do not occur, determining that the evoked capture response has not occurred.

19. An implantable medical device in the form of a cardiac pacemaker, comprising:

at least first and second electrodes for at least one of delivering therapy or sensing electrical signals;

a pressure sensor for sensing intracardiac pressure;

operational circuitry coupled to the electrodes and the pressure sensor; and

a housing sized and adapted for placement in or on the heart of a patient, the housing containing at least the operational circuitry;

wherein the operational circuitry is configured to obtain a pressure signal received with the pressure sensor over a period of time following delivery of the electrical signals;

wherein the operational circuitry is configured to perform a pressure based capture verification process by using the pressure sensor to determine whether a delivered pacing therapy to the heart of a patient has generated an evoked response by identifying a peak in the pressure signal and determining a temporal relationship of the peak in the pressure signal to a second signal event; and

wherein the operational circuitry is configured to perform an electrical pacing capture verification process by using an electrical signal captured via the at least first and second electrodes to determine whether a delivered pacing therapy to the heart of a patient has generated an evoked response;

wherein the operational circuitry is configured to use one, the other, or both of the pressure based capture verification process and the electrical pacing capture verification process to assess efficacy of pacing stimuli.

20. A method of verifying pacing capture in an implantable cardiac pacemaker comprising at least first and second electrodes for at least one of delivering therapy or sensing electrical signals, a pressure sensor for sensing intracardiac pressure, operational circuitry coupled to the electrodes and the pressure sensor configured to obtain a pressure signal received with the pressure sensor over a period of time following delivery of the electrical signals, and a housing sized and adapted for placement in or on the heart of a patient, the housing containing at least the operational circuitry;

wherein the method comprises;

delivering an electrical pacing stimulus to the heart of a patient using the at least first and second electrodes;

monitoring for an evoked capture response indicating the electrical pacing stimulus was captured using the pressure sensor by identifying a peak in the pressure signal and determining a temporal relationship of the peak in the pressure signal to a second signal event; and

if the evoked capture response is detected, concluding that the electrical pacing stimulus captured at least a portion of the patient'"'"'s heart; and

if the evoked capture response is not detected, concluding that the electrical pacing stimulus did not capture the patient'"'"'s heart.