Integrated multi-device cardiac resynchronization therapy using P-wave to pace timing

• US 10,780,278 B2
• Filed: 08/23/2017
• Issued: 09/22/2020
• Est. Priority Date: 08/24/2016
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hahn, Stephen J., Siejko, Krzysztof Z., Brisben, Amy Jean, Maile, Jr., Keith R.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/684,366
• Publication Number:
  US 20180056075A1
• Time in Patent Office: 1,126 Days
• Field of Search: None
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36507 controlled by gradient or slope of the heart potential
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/39622 Pacing therapy

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 LCP is configured to deliver pacing therapy at a pacing interval. Illustratively, the ED may be configured to analyze the cardiac cycle including a portion preceding the pacing therapy delivery for one or several cardiac cycles, and determine whether an interval from the P-wave to the pace therapy in the cardiac cycle(s) is in a desired range. In an example, if the P-wave to pace interval is outside the desired range, the ED communicates to the LCP to adjust the pacing interval.

Claims

1. A method of providing cardiac pacing therapy to a patient comprising:

delivering pacing pulses using a Pace to Pace interval, the pacing pulses delivered by a first device which stores the Pace to Pace interval and is configured to deliver at least one of the pacing pulses upon expiration of the Pace to Pace interval after a preceding pacing pulse delivery by the first device;

monitoring cardiac activity in a second device; and

adjusting the Pace to Pace interval as stored by the first device in response to communication from the second device to the first device.

2. A method as in claim 1 wherein the step of monitoring cardiac activity in a second device includes identifying a P-wave relative to the at least one of the pacing pulses, and the method further comprises:

calculating a P-wave to Pace interval using at least the cardiac signals monitored by the second device;

determining whether the P-wave to Pace interval is in the predetermined range and;

if the P-wave to pace interval is above the predetermined range, communicating to the first device to shorten the Pace to Pace interval; and

if the P-wave to pace interval is below the predetermined range, communicating to the first device to extend the Pace to Pace interval.

3. A method as in claim 2 wherein analysis of the P-wave to pace interval is performed by the second device:

detecting a pace pulse delivered by the first device; and

searching a predetermined window prior to the detected pace pulse for the P-wave.

4. A method as in claim 2 wherein analysis of the P-wave to pace interval is performed by the second device:

receiving a communication from the first device indicating at time of delivery of a pace pulse; and

searching a predetermined window prior to the communicated time of delivery of the pace pulse for the P-wave.

5. A method as in claim 2 wherein analysis of the P-wave to pace interval is performed by the second device:

detecting an R-wave in the cardiac signal;

searching a predetermined window prior to the R-wave for the P-wave and finding the P-wave; and

communicating to the first device a time of the found P-wave.

6. A method as in claim 2 further comprising setting the predetermined range by calculating a P-R interval for an intrinsic cardiac cycle or cycles of the patient and selecting the predetermined range as a fraction of the P-R interval.

7. A method as in claim 2 further comprising setting the predetermined range by:

delivering a plurality of pacing pulses at a plurality of P-wave to Pace intervals;

determining which of the plurality of pacing pulses causes a desired cardiac response; and

selecting a target P-wave to Pace interval corresponding to the desired cardiac response.

8. The method as in claim 7 wherein the desired cardiac response is a fusion beat.

9. A method as in claim 1 wherein the first device is a leadless cardiac pacemaker implanted in or on the left ventricle of the patient'"'"'s heart, and the second device is a subcutaneous implantable defibrillator.

10. A method as in claim 1 wherein the first device is a leadless cardiac pacemaker implanted in or on the left ventricle of the patient'"'"'s heart, and the second device is a subcutaneous implantable cardiac monitor.

11. An implantable medical device (IMD) configured for use as part of a cardiac therapy system comprising a leadless cardiac pacemaker (LCP) and the IMD, the IMD comprising:

a plurality of electrodes for sensing cardiac activity; and

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

determine when pace therapy is delivered by the LCP;

analyze a segment of the sensed cardiac signals from the plurality of electrodes including a time period prior to pace therapy delivery by the LCP and calculate a P-wave to Pace interval;

determine whether the P-wave to Pace interval is in a desired range, and, if the P-wave to Pace interval is not in the desired range, modifying a Pace to Pace interval that determines timing of the LCP pacing therapy.

12. An IMD as in claim 11 wherein the operational circuitry is further configured to set the desired range by sensing a one or more intrinsic cardiac cycles, calculating a P-R interval of the patient'"'"'s cardiac rhythm, and selecting the desired range as a fraction of the P-R interval.

13. An IMD as in claim 11 wherein the operational circuitry is further configured to set the desired range by sensing a plurality of cardiac cycles paced by the LCP at differing P-wave to Pace intervals, determining which of the plurality of cardiac cycles has been paced in a manner that causes a desired cardiac response;

and selecting a the desired range using a P-wave to Pace interval corresponding to the desired cardiac response.

14. The IMD of claim 11 wherein the operational circuitry is further configured to store a portion of the sensed cardiac signals for retrospective review following a determination that the pace therapy was delivered, and to analyze the segment of the sensed cardiac signals retrospectively using the stored portion.

15. The IMD of claim 11 wherein the desired range for the P-wave to Pulse interval is set such that the pacing therapy will cause fusion beats.

16. The IMD of claim 11 wherein the operational circuitry is configured to communicate an adjustment to a Pace to Pace interval to modify the therapy parameter of the LCP.

17. An implantable leadless cardiac pacemaker (LCP) configured to operate in coordination with an extracardiac device (ED), comprising a plurality of electrodes for delivering pacing therapy;

communication circuitry configured to send and receive messages with the ED;

and operational circuitry configured to;

deliver a pacing pulse using a Pace to Pace interval relative to a previously delivered pacing pulse;

receive a message from the ED indicating a time at which a P-wave occurred in relation to a paced cardiac event;

calculate a P-wave to Pace interval for the paced cardiac event;

analyze the P-wave to Pace interval relative to a desired range; and

;

if the P-wave to pace interval is longer than a first threshold defining the range, shorten the Pace to Pace interval;

or

if the P-wave to pace interval is shorter than a second threshold defining the range, extend the Pace to Pace interval.

18. The LCP of claim 17 wherein the desired range for the P-wave to Pulse interval is set such that the pacing therapy will cause fusion beats.

19. An implantable medical device system comprising an LCP as in claim 17, and an ED comprising a plurality of electrodes for sensing cardiac activity and communications circuitry for communicating with the LCP;

wherein the LCP is configured to communicate to the ED to indicate a time at which a Pace therapy is to be delivered, and, in response thereto, the ED is configured to set a window for sensing the P-wave in order to communicate a time at which the P-wave occurred to the LCP.

20. An implantable medical device system comprising an LCP as in claim 17, and an ED comprising a plurality of electrodes for sensing cardiac activity and communications circuitry for communicating with the LCP;

wherein the ED is configured to detect a pacing pulse delivered by the LCP and maintain a memory storing cardiac activity such that the ED can search a time period prior to the detected pacing pulse to identify the P-wave in order to communicate a time at which the P-wave occurred to the LCP.