Ventricular leadless pacing device mode switching

• US 9,724,519 B2
• Filed: 04/23/2015
• Issued: 08/08/2017
• Est. Priority Date: 11/11/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sheldon, Todd J, Demmer, Wade M
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US14/694,976
• Publication Number:
  US 20160129261A1
• Time in Patent Office: 838 Days
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

In some examples, a leadless pacing device (LPD) is configured to switch from a sensing without pacing mode to ventricular pacing mode in response to determining that no intrinsic ventricular activity was detected within a ventricular event detection window for at least one cardiac cycle, which may be referred to as loss of conduction. The ventricular pacing mode may be selected based on whether atrial oversensing is detected in combination with the loss of conduction. In some examples, an atrio-ventricular synchronous pacing mode is selected in response to detecting loss of conduction and in response to determining that atrial oversensing is not detected. In addition, in some examples, an asynchronous ventricular pacing mode is selected in response to detecting both atrial oversensing and loss of conduction.

Claims

1. A method comprising:

sensing an electrical cardiac signal;

detecting, by a processing module of a leadless pacing device, atrial oversensing while the leadless pacing device is in a sensing without pacing mode;

determining, by the processing module and based on the electrical cardiac signal, whether intrinsic ventricular activity is occurring in conjunction with the atrial oversensing;

when the determined intrinsic ventricular activity is occurring in conjunction with the atrial oversensing, controlling, by the processing module, the leadless pacing device to continue operating in the sensing without pacing mode; and

when the determined intrinsic ventricular activity is not occurring in conjunction with the atrial oversensing, controlling, by the processing module, the leadless pacing device to deliver a ventricular pacing pulse to the patient according to an asynchronous ventricular pacing mode.

2. The method of claim 1, wherein detecting atrial oversensing comprises:

incrementing a value of an atrial oversensing event counter to track an atrial oversensing metric;

comparing the value of the atrial oversensing event counter to an atrial oversensing event threshold value; and

detecting atrial oversensing in response to determining the value is greater than or equal to the atrial oversensing event threshold value.

3. The method of claim 2, wherein incrementing the value of the atrial oversensing event counter to track an atrial oversensing metric comprises incrementing the value of the atrial oversensing event counter to count the number of successive cardiac cycles in which atrial oversensing was detected.

4. The method of claim 2, wherein incrementing the value of the atrial oversensing event counter to track an atrial oversensing metric comprises incrementing the value of the atrial oversensing event counter to count the number of cardiac cycles out of a predetermined number of consecutive cardiac cycles in which atrial oversensing was detected.

5. The method of claim 2, wherein incrementing the value of the atrial oversensing event counter to track an atrial oversensing metric comprises incrementing the value of the atrial oversensing event counter to count the number of cardiac cycles, within a predetermined period of time, in which atrial oversensing was detected.

6. The method of claim 1, wherein detecting atrial oversensing comprises:

detecting, by the processing module and based on the electrical cardiac signal, a ventricular sense event; and

detecting, by the processing module and based on the electrical cardiac signal, a plurality of atrial activation events within an atrial activation event detection window that begins at the ventricular sense event.

7. The method of claim 6, further comprising:

incrementing a counter in response to detecting the plurality of atrial activation events within the atrial activation event detection window;

comparing a value of the counter to a threshold value; and

detecting atrial oversensing in response to determining the value of the counter is greater than or equal to the threshold value.

8. The method of claim 7, wherein the threshold value is two, three or four.

9. The method of claim 7, wherein the counter is configured to count a number of cardiac cycles in which multiple atrial activation events are detected from among a predetermined number of consecutive cardiac cycles.

10. The method of claim 7, wherein the counter is configured to count a number of cardiac cycles, within a predetermined time window, in which multiple atrial activation events are detected.

11. The method of claim 7, wherein the counter is configured to count a successive number of cardiac cycles in which multiple atrial activation events are detected.

12. The method of claim 6, wherein detecting the plurality of atrial activation events comprises detecting a plurality of P-waves in the sensed electrical cardiac signal.

13. The method of claim 6, wherein detecting the plurality of atrial activation events comprises:

obtaining a signal indicative of mechanical motion of an atrium; and

detecting the plurality of atrial activation events based on the signal indicative of mechanical motion of the atrium.

14. The method of claim 1, wherein determining whether intrinsic ventricular activity is occurring comprises:

beginning a ventricular event detection window;

incrementing a value of a loss of conduction counter in response to a ventricular sense event not being detected within the ventricular event detection window;

comparing the value of the loss of conduction counter to a loss of conduction event threshold value; and

determining intrinsic ventricular activity is occurring in response to determining the value is less than or equal to the loss of conduction event threshold value.

15. The method of claim 1, wherein determining whether intrinsic ventricular activity is occurring comprises:

detecting, by the processing module and based on the electrical cardiac signal, a ventricular sense event;

beginning a ventricular activation detection window in response to detecting the ventricular sense event; and

determining, by the processing module and based on the electrical cardiac signal, a ventricular activation event is detected within the ventricular activation event detection window.

16. The method of claim 15, further comprising:

incrementing a counter in response to determining no ventricular activation event is detected within the second ventricular activation event detection window;

comparing a value of the counter to a threshold value; and

determining intrinsic ventricular activity is occurring in response to determining the value of the counter is less than or equal to the threshold value.

17. The method of claim 16, wherein the threshold value is two, three or four.

18. The method of claim 16, wherein the counter is configured to count a number of cardiac cycles of a predetermined number of cardiac cycles in which no ventricular sense event is detected.

19. The method of claim 16, wherein the counter is configured to count a number of cardiac cycles, within a predetermined time window, in which no ventricular sense event is detected.

20. The method of claim 16, wherein the counter is configured to count a successive number of cardiac cycles in which no ventricular sense event is detected.

21. The method of claim 1, wherein controlling, by the processing module, the leadless pacing device to deliver the ventricular pacing pulse to the patient according to the asynchronous ventricular pacing mode comprises:

detecting a ventricular activation event;

determining whether intrinsic depolarization of the ventricle is detected within a detection window that begins at the ventricular activation event; and

in response to determining that intrinsic depolarization of the ventricle is not detected within the detection window, controlling the leadless pacing device to deliver a pacing pulse to the ventricle.

22. The method of claim 21, wherein detecting the ventricular activation event comprises detecting a plurality of ventricular activation events, the method further comprising determining an average V-V interval based on the plurality of ventricular activation events and controlling the leadless pacing device to deliver pacing pulses according to the asynchronous ventricular pacing mode at a rate equal to the average V-V interval plus an offset.

23. The method of claim 1, wherein detecting atrial oversensing comprises:

determining a ventricular activation event detection window having a beginning and an end;

detecting, by the processing module and based on the electrical cardiac signal, the end of a ventricular activation event detection window; and

detecting, by the processing module and based on the electrical cardiac signal, a plurality of atrial activation events within an atrial activation event detection window that begins at the end of the ventricular activation event detection window.

24. The method of claim 1, wherein determining whether intrinsic ventricular activity is occurring comprises:

determining a first ventricular activation event detection window having a beginning and an end;

detecting, by the processing module and based on the electrical cardiac signal, the end of the first ventricular activation event detection window;

beginning a second ventricular activation detection window in response to detecting the end of the first ventricular activation event detection window; and

determining, by the processing module and based on the electrical cardiac signal, a ventricular activation event is detected within the second ventricular activation event detection window.

25. A leadless pacing system comprising:

a leadless pacing device configured to sense an electric cardiac signal and configured to operate in a sensing without pacing mode and an asynchronous ventricular pacing mode; and

a processing module configured to;

detect atrial oversensing while the leadless pacing device is in a sensing without pacing mode,

determine, based on the electrical cardiac signal, whether intrinsic ventricular activity is occurring in conjunction with the atrial oversensing,

when the determined intrinsic ventricular activity is occurring in conjunction with the atrial oversensing, control the leadless pacing device to continue operating in the sensing without pacing mode, and

when the determined intrinsic ventricular activity is not occurring in conjunction with the atrial oversensing, control the leadless pacing device to deliver a ventricular pacing pulse to the patient according to the asynchronous ventricular pacing mode.

26. The system of claim 25, wherein the system includes an atrial oversensing event counter and the processing module is configured to detect atrial oversensing by at least:

increment a value of the atrial oversensing event counter to track an atrial oversensing metric;

comparing the value of the atrial oversensing event counter to an atrial oversensing event threshold value, and

detecting atrial oversensing in response to determining the value is greater than or equal to the atrial oversensing event threshold value.

27. The system of claim 26, wherein the processor is configured to increment the value of the atrial oversensing event counter to count the number of successive cardiac cycles in which atrial oversensing was detected.

28. The system of claim 26, wherein the processor is configured to increment the value of the atrial oversensing event counter to count the number of cardiac cycles out of a predetermined number of consecutive cardiac cycles in which atrial oversensing was detected.

29. The system of claim 26, wherein the processor is configured to increment the value of the atrial oversensing event counter to count the number of cardiac cycles, within a predetermined period of time, in which atrial oversensing was detected.

30. The system of claim 25, wherein the processing module is configured to detect atrial oversensing by at least:

detecting, based on the electrical cardiac signal, a ventricular sense event,

determining an atrial activation event detection window that begins at the ventricular sense event; and

detecting, based on the electrical cardiac signal, a plurality of atrial activation events within the atrial activation event detection window that begins at the ventricular sense event.

31. The system of claim 30, wherein the system further includes a counter and the processing module is further configured to increment the counter in response to detecting the plurality of atrial activation events within the atrial activation event detection window, compare a value of the counter to a threshold value, and detect atrial oversensing in response to determining the value of the counter is greater than or equal to the threshold value.

32. The system of claim 31, wherein the threshold value is two, three or four.

33. The system of claim 31, wherein the counter is configured to count a number of cardiac cycles in which multiple atrial activation events are detected from among a predetermined number of consecutive cardiac cycles.

34. The system of claim 31, wherein the counter is configured to count a number of cardiac cycles, within a predetermined time window, in which multiple atrial activation events are detected.

35. The system of claim 31, wherein the counter is configured to count a successive number of cardiac cycles in which multiple atrial activation events are detected.

36. The system of claim 30, wherein the processing module is configured to detect the plurality of atrial activation events by at least detecting a plurality of P-waves in the sensed electrical cardiac signal.

37. The system of claim 30, further comprising a motion sensor configured to obtain a signal indicative of mechanical motion of an atrium and wherein the processor is configured to detect the plurality of atrial activation events by at least detecting the plurality of atrial activation events based on the signal indicative of mechanical motion of the atrium.

38. The system of claim 37, wherein the motion sensor comprises an accelerometer.

39. The system of claim 25, wherein the system includes a loss of conduction counter and the processing module is configured to determine whether intrinsic ventricular activity is occurring by at least:

begin a ventricular event detection window;

comparing a value of the loss of conduction counter to a loss of conduction event threshold value, the loss of conduction counter being incremented in response to a ventricular sense event not being detected within the ventricular event detection window, and

determining intrinsic ventricular activity is occurring in response to determining the value is less than or equal to the loss of conduction event threshold value.

40. The system of claim 25, wherein the processing module is configured to determine whether intrinsic ventricular activity is occurring by at least:

detecting, based on the electrical cardiac signal, a ventricular sense event,

beginning a ventricular activation detection window in response to detecting the ventricular sense event; and

determining, based on the electrical cardiac signal, a ventricular activation event is detected within the ventricular activation event detection window.

41. The system of claim 40, wherein the system further includes a counter and the processing module is further configured to increment the counter in response to determining no ventricular activation event is detected within the second ventricular activation event detection window, compare a value of the counter to a threshold value, and determine intrinsic ventricular activity is occurring response to determining the value of the counter is less than or equal to the threshold value.

42. The system of claim 41, wherein the threshold value is two, three or four.

43. The system of claim 41, wherein the counter is configured to count a number of cardiac cycles of a predetermined number of cardiac cycles in which no ventricular sense event is detected.

44. The system of claim 41, wherein the counter is configured to count a number of cardiac cycles, within a predetermined time window, in which no ventricular sense event is detected.

45. The system of claim 41, wherein the counter is configured to count a successive number of cardiac cycles in which no ventricular sense event is detected.

46. The system of claim 25, wherein the processing module is configured to control the leadless pacing device to deliver the ventricular pacing pulse to the patient according to the asynchronous ventricular pacing mode by at least:

detecting a ventricular activation event,

beginning a detection window in response to detecting the ventricular activation event;

determining whether intrinsic depolarization of the ventricle is detected within the detection window that begins at the ventricular activation event, and

in response to determining that intrinsic depolarization of the ventricle is not detected within the detection window, controlling the leadless pacing device to deliver a pacing pulse to the ventricle.

47. The system of claim 25, wherein the processing module is configured to detect a plurality of ventricular activation events, determine an average V-V interval based on the plurality of ventricular activation events, control the leadless pacing device to deliver pacing pulses according to the asynchronous ventricular pacing mode at a rate equal to the average V-V interval plus an offset.

48. The system of claim 25, wherein the processing module is configured to detect atrial oversensing by at least:

determining a ventricular activation event detection window having a beginning and an end;

detecting, based on the electrical cardiac signal, the end of a ventricular activation event detection window; and

detecting, based on the electrical cardiac signal, a plurality of atrial activation events within an atrial activation event detection window that begins at the end of the ventricular activation event detection window.

49. The system of claim 25, wherein the processing module is configured to determine whether intrinsic ventricular activity is occurring by at least:

determining a first ventricular activation event detection window having a beginning and an end;

detecting, based on the electrical cardiac signal, the end of the first ventricular activation event detection window,

beginning a second ventricular activation detection window in response to detecting the end of the first ventricular activation event detection window; and

determining, based on the electrical cardiac signal, a ventricular activation event is detected within the second ventricular activation event detection window.

50. A leadless pacing device configurable to operate in a sensing without pacing mode and an asynchronous ventricular pacing mode, the leadless pacing device comprising:

means for sensing an electrical cardiac signal;

means for detecting atrial oversensing while the leadless pacing device is in a sensing without pacing mode;

means for determining, based on the electrical cardiac signal, whether intrinsic ventricular activity is occurring in conjunction with the atrial oversensing;

means for controlling the leadless pacing device to continue operating in the sensing without pacing mode when the determined intrinsic ventricular activity is occurring in conjunction with the atrial oversensing; and

means for controlling the leadless pacing device to deliver a ventricular pacing pulse to the patient according to the asynchronous ventricular pacing mode when the determined intrinsic ventricular activity is not occurring in conjunction with the atrial oversensing.

51. The device of claim 50, further comprising counting means, wherein the means for detecting atrial oversensing compares a value of the counting means to an atrial oversensing event threshold value, and detects atrial oversensing in response to determining the value is greater than or equal to the atrial oversensing event threshold value.

52. A non-transitory computer-readable storage medium comprising instructions that, when executed by a processing module of a leadless pacing device configurable to operate in a sensing without pacing mode and an asynchronous ventricular pacing mode, cause the processing module to:

sense an electrical cardiac signal;

detect atrial oversensing while the leadless pacing device is in a sensing without pacing mode;

determine, based on the electrical cardiac signal, whether intrinsic ventricular activity is occurring in conjunction with the atrial oversensing;

when the determined intrinsic ventricular activity is occurring in conjunction with the atrial oversensing, control the leadless pacing device to continue operating in the sensing without pacing mode; and

when the determined intrinsic ventricular activity is not occurring in conjunction with the atrial oversensing, control the leadless pacing device to deliver a ventricular pacing pulse to the patient according to the asynchronous ventricular pacing mode.