Multi-device cardiac resynchronization therapy with timing enhancements

• US 10,463,305 B2
• Filed: 10/25/2017
• Issued: 11/05/2019
• Est. Priority Date: 10/27/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: An, Qi, Thakur, Pramodsingh Hirasingh, Hahn, Stephen J., Yu, Yinghong, Siejko, Krzysztof Z., Averina, Viktoria A., Koop, Brendan Early, Maile, Keith R., Mi, Bin
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US15/793,475
• Publication Number:
  US 20180116593A1
• Time in Patent Office: 741 Days
• Field of Search: None
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

Methods, systems and devices for providing cardiac resynchronization therapy (CRT) to a patient using a leadless cardiac pacemaker (LCP) and an extracardiac device (ED). The system is configured to identify atrial events to use as timing markers for the LCP to deliver CRT, and further to determine whether the timing markers are incorrectly sensed and to make adjustment or call for re-initialization as needed.

Claims

1. An implantable medical device (IMD) system comprising:

a leadless cardiac pacemaker (LCP) having a plurality of LCP electrodes, pacing circuitry configured to issue cardiac pacing outputs via the plurality of LCP electrodes, LCP communication circuitry configured to communicate to a second device, and operational circuitry configured to control the pacing circuitry to generate cardiac resynchronization therapy (CRT) using data received with the communication circuitry, the LCP further comprising a sensing input circuit to receive one or more biological signals to determine whether the CRT is achieving a desired result;

an extracardiac device (ED) comprising;

a plurality of electrodes for sensing cardiac signals;

ED communication circuitry configured to communicate with at least the LCP communication circuitry; and

ED operational circuitry configured to receive sensed cardiac signals from the plurality of electrodes and analyze cardiac activity;

wherein the ED operational circuitry is configured to obtain a cardiac signal from the plurality of electrodes, identify occurrence of a P-wave in the cardiac signal using a set of P-wave detection parameters, and use the ED communication circuitry to communicate to the LCP timing information related to the identified P-wave to assist in the CRT, such that the ED serves as a second device for purposes of the LCP communication circuitry; and

wherein the ED and LCP are configured to cooperatively adjust the P-wave detection parameters.

2. The IMD system of claim 1 wherein the ED and LCP are configured to cooperatively adjust the P-wave detection parameters by:

at a first time including at least a first cardiac cycle;

the ED detecting a P-wave using first P-wave detection parameters and using the ED communication circuitry to communicate to the LCP first timing information related to the detected P-wave;

the LCP using the first timing information to deliver one or more CRT pacing therapies;

the LCP determining that a delivered CRT pacing therapy has failed to achieve the desired result; and

the LCP communicating the failure to achieve the desired result to the ED;

in response to the LCP communicating failure to achieve the desired result, the ED adjusting the P-wave detection parameters to second P-wave detection parameters;

at a second time following the first time, the second time including at least a second cardiac cycle;

the ED detecting a P-wave using second P-wave detection parameters and using the ED communication circuitry to communicate to the LCP second timing information related to the detected P-wave; and

the LCP using the second timing information to deliver one or more CRT pacing therapies.

3. The IMD system of claim 2 wherein the ED is configured to detect a P-wave by comparison of a cardiac electrical signal to a template to identify a match to the template, further wherein the ED is configured to adjust the P-wave detection parameters by adjusting a match criteria.

4. The IMD system of claim 2 wherein the ED is configured to detect a P-wave by comparison of a cardiac electrical signal to a template to identify a match to the template, further wherein the ED is configured to adjust the P-wave detection parameters by changing the template.

5. The IMD system of claim 2 wherein the ED is configured to detect a P-wave by identifying a peak among a set of peaks in a set of P-wave indicia;

further wherein the ED is configured to adjust the P-wave detection parameters by storing a parameter for selecting an Nth peak of the set of peaks.

6. The IMD system of claim 2 wherein the ED is configured to detect a P-wave by comparing a set of P-wave indicia to a P-wave detection threshold;

further wherein the ED is configured to adjust the P-wave detection parameters by adjusting the P-wave detection threshold.

7. An IMD system as in claim 2 wherein the ED is configured to detect a P-wave using a tracking analysis to track P-wave detections among a set of P-wave data captured for a series of cardiac cycles;

further wherein the ED is configured to adjust the P-wave detection parameters by adjusting the tracking analysis.

8. The IMD system of claim 1 wherein the LCP operational circuitry is configured to determine whether the CRT is achieving a desired result and to communicate to the ED operational circuitry to indicate whether the CRT is achieving the desired result, wherein the ED and LCP are configured to cooperatively adjust the P-wave detection parameters in response to the LCP determining that the CRT is not achieving the desired result.

9. The IMD system of claim 8 wherein the LCP is configured to determine whether the CRT is achieving a desired result by:

storing one or more templates for a physiological signal sensed by the sensing input circuit, at least one of the templates representing the physiological signal corresponding to a preferred pace timing; and

determining whether a test physiological signal captured in relation to a CRT pace therapy matches the template representing the physiological signal corresponding to the preferred pace timing.

10. The IMD system of claim 9 wherein:

the one or more templates comprises at least one offset template each representing the physiological signal corresponding to a known offset from the preferred pace timing; and

wherein the LCP is configured to determine whether the test physiological signal matches one of the at least one offset templates and, if so, to communicate to the ED that an offset template match has occurred.

11. The IMD system of claim 10 wherein the ED is configured, in response to the LCP communicating that an offset template match has occurred, to analyze the cardiac signal to determine whether a P-wave may have occurred at an offset relative to the detected P-wave, and, if so, making an adjustment to P-wave detection criteria.

12. The IMD system of claim 10 wherein the ED is configured, in response to the LCP communicating that an offset template match has occurred, to reanalyze the cardiac signal to determine whether one or more adjustments to a P-wave detection criteria would result in detection of a P-wave correlated to the offset of the offset template that matched the test physiological signal.

13. The IMD system of claim 10 wherein, in response to the LCP communicating that an offset template match has occurred, the ED is configured to make an adjustment to P-wave detection criteria using the offset.

14. The IMD system of claim 10 wherein, if the test physiological signal does not match any of the one or more templates, the LCP is configured to communicate that no template match occurred to the ED and further wherein, if the LCP finds at least a threshold quantity of test physiological signals fail to match any of the one or more templates, the IMD system is configured to perform a re-initialization of one or more CRT system settings.

15. An IMD system as in claim 1 wherein the LCP is configured to deliver CRT pacing output in response to communication of timing information related to the P-wave from the ED.

16. An IMD system as in claim 1 wherein the LCP is configured to deliver CRT pacing output according to a calculated interval relative to a prior CRT pacing output, and the LCP is configured to use the communication of timing information related to the P-wave to adjust the calculated interval.

17. An implantable medical device (IMD) system comprising:

a leadless cardiac pacemaker (LCP) for delivering cardiac resynchronization therapy (CRT), the LCP comprising;

a plurality of electrodes for delivering pacing therapy;

a sensing input circuit to receive one or more biological signals;

a pacing output circuit;

LCP communication circuitry; and

LCP operational circuitry configured to receive and analyze signals from the sensing input;

an extracardiac device (ED) comprising;

a plurality of electrodes for sensing cardiac signals;

ED communication circuitry configured to communicate with at least the LCP communication circuit; and

ED operational circuitry configured to receive sensed cardiac signals from the plurality of electrodes and analyze cardiac activity;

wherein the ED operational circuitry is configured to obtain a cardiac signal from the plurality of electrodes, identify occurrence of a P-wave in the cardiac signal, and use the ED communication circuitry to communicate to the LCP that the P-wave has been detected; and

wherein the LCP operational circuitry is configured to determine from its analysis of signals received from the sensing input whether the ED is incorrectly detecting the P-wave.

18. An IMD system as in claim 17 wherein the LCP is configured to deliver CRT pacing output in response to communication of timing information related to the P-wave from the ED.

19. An implantable medical device (IMD) system comprising:

a leadless cardiac pacemaker (LCP) for delivering cardiac resynchronization therapy (CRT), the LCP comprising;

a plurality of electrodes for delivering pacing therapy;

a sensing input circuit to receive one or more biological signals;

a pacing output circuit;

LCP communication circuitry; and

LCP operational circuitry configured to receive and analyze signals from the sensing input;

an extracardiac device (ED) comprising;

a plurality of electrodes for sensing cardiac signals;

ED communication circuitry configured to communicating with at least the LCP communication circuit; and

ED operational circuitry configured to receive sensed cardiac signals from the plurality of electrodes and analyze cardiac activity;

wherein the ED operational circuitry is configured to obtain a cardiac signal from the plurality of electrodes, identify occurrence of a P-wave in the cardiac signal, and use the ED communication circuitry to communicate to the LCP that the P-wave has been detected;

wherein the LCP operational circuitry is configured to use the pacing output circuit to deliver pace therapy and to use the sensing input circuit to determine whether a cardiac response to the pace therapy matches a desired metric; and

wherein the LCP operational circuitry is configured to communicate to the ED operational circuitry to indicate that the pace therapy does not match the desired metric.

20. An IMD system as in claim 19 wherein the LCP is configured to deliver CRT pacing output in response to communication of timing information related to the P-wave from the ED.