Mode switching by a ventricular leadless pacing device

• US 9,492,669 B2
• Filed: 11/11/2014
• Issued: 11/15/2016
• Est. Priority Date: 11/11/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Demmer, Wade M, Sheldon, Todd J
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US14/538,486
• Publication Number:
  US 20160129263A1
• Time in Patent Office: 735 Days
• US Class Current: 1/1
• 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 1/365 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 1/37205 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 (hereinafter, “LPD”) is configured for implantation in a ventricle of a heart of a patient, and is configured to switch between an atrio-ventricular synchronous pacing mode and an asynchronous ventricular pacing mode in response to detection of one or more sensing events, which may be, for example, undersensing events. In some examples, an LPD is configured to switch from a sensing without pacing mode to an atrio-ventricular synchronous pacing mode in response to determining, for a threshold number of cardiac cycles, a ventricular depolarization was not detected within a ventricular event detection window that begins at an atrial activation event.

Claims

1. A method comprising:

sensing an electrical cardiac signal of a patient with a leadless pacing device while the leadless pacing device is in a sensing without pacing mode;

receiving, by a processing module, the electrical cardiac signal;

detecting, by the processing module and based on the electrical cardiac signal, an atrial activation event;

determining, by the processing module and based on the electrical cardiac signal, a ventricular sense event was not detected within a ventricular event detection window that begins at the atrial activation event; and

controlling, by the processing module, the leadless pacing device to switch from the sensing without pacing mode to an atrio-ventricular synchronous pacing mode based on the determination that the ventricular sense event was not detected within the ventricular event detection window, wherein controlling the leadless pacing device to switch to the atrio-ventricular synchronous pacing mode comprises controlling the leadless pacing device to deliver a pacing pulse to the patient according to the atrio-ventricular synchronous pacing mode after detecting an additional atrial activation event.

2. The method of claim 1, comprising sensing of a first cardiac cycle and a second cardiac cycle immediately following the first cardiac cycle, wherein controlling the leadless pacing device to deliver the pacing pulse to the patient according to the atrio-ventricular synchronous pacing mode comprises controlling the leadless pacing device to deliver the pacing pulse to the patient according to the atrio-ventricular synchronous pacing mode in the first cardiac cycle, the method further comprising, in the second cardiac cycle, controlling, by the processing module, the leadless pacing device to switch from the atrio-ventricular synchronous pacing mode to the sensing without pacing mode.

3. The method of claim 2, wherein the electrical cardiac signal comprises a first electrical cardiac signal and the atrial activation event comprises a first atrial activation event, the method further comprising, after controlling the leadless pacing device to switch from the atrio-ventricular synchronous pacing mode to the sensing without pacing mode:

receiving, by the processing module, a second electrical cardiac signal of the patient sensed by the leadless pacing device after the first cardiac cycle and while the leadless pacing device is in the sensing without pacing mode;

detecting, by the processing module and based on the second electrical cardiac signal, a second atrial activation event;

determining, by the processing module and based on the second electrical cardiac signal, the ventricular sense event was not detected within the ventricular event detection window that begins at the second atrial activation event; and

controlling, by the processing module, the leadless pacing device to switch from the sensing without pacing mode to the atrio-ventricular synchronous pacing mode based on the determination that the ventricular sense event was not detected within the ventricular event detection window that begins at the second atrial activation event.

4. The method of claim 1, wherein controlling the leadless pacing device to switch from the sensing without pacing mode to the atrio-ventricular synchronous pacing mode further comprises:

in response to determining the ventricular sense event was not detected within the detection window, incrementing a counter;

after incrementing the counter, determining, by the processing module, whether a value of the counter is greater than or equal to a threshold value; and

in response to determining the value of the counter is greater than or equal to a threshold value, controlling, by the processing module, the leadless pacing device to deliver the pacing pulse according to the atrio-ventricular synchronous pacing.

5. The method of claim 4, wherein the threshold value is one.

6. The method of claim 4, wherein the threshold value is two or three.

7. The method of claim 1, wherein detecting the atrial activation event comprises detecting a P wave in the sensed electrical cardiac signal.

8. The method of claim 1, wherein detecting the atrial activation event comprises detecting delivery of an atrial pacing pulse by a medical device different than the leadless pacing device.

9. The method of claim 1, further comprising storing A-A intervals for a predetermined number of prior cardiac cycles of the patient and determining the ventricular event detection window based on the stored A-A intervals.

10. The method of claim 9, wherein determining the ventricular event detection window comprises determining at least one of:

a mean A-A interval of the stored A-A intervals, a median A-A interval of the stored A-A intervals, a greatest A-A interval of the stored A-A intervals, a shortest A-A interval of the stored A-A intervals, or a most recent A-A interval of the stored A-A intervals.

11. The method of claim 10, wherein determining the ventricular event detection window comprises determining a predetermined percentage of the at least one of the mean A-A interval, the median A-A interval, the greatest A-A interval, the shortest A-A interval, or the most recent A-A interval.

12. The method of claim 9, wherein determining the ventricular event detection window comprises selecting the smaller of a first ventricular event detection window determined based on the stored A-A intervals for a predetermined number of prior cardiac cycles or a second, fixed ventricular event detection window stored by the leadless pacing device.

13. The method of claim 1, further comprising receiving, by the processing module, data indicating a duration of the ventricular event detection window from a medical device programmer.

14. The method of claim 1, further comprising, after controlling the leadless pacing device to deliver the pacing pulse to the patient according to an atrio-ventricular synchronous pacing mode:

performing, by the processing module, an intrinsic conduction check;

in response to detecting intrinsic conduction based on the intrinsic conduction check, controlling, by the processing module, the leadless pacing device to return to the sensing without pacing mode; and

in response to not detecting intrinsic conduction based on the intrinsic conduction check, controlling, by the processing module, the leadless pacing device to remain in the atrio-ventricular synchronous pacing mode.

15. 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 atrio-ventricular synchronous pacing mode; and

a processing module configured to;

receive the electrical cardiac signal sensed by a leadless pacing device while the leadless pacing device is in the sensing without pacing mode,

detect, based on the electrical cardiac signal, an atrial activation event,

determine, based on the electrical cardiac signal, a ventricular sense event was not detected within a ventricular event detection window that begins at the atrial activation event, and

control the leadless pacing device to switch from the sensing without pacing mode to the atrio-ventricular synchronous pacing mode based on the determination that the ventricular sense event was not detected within the ventricular event detection window, wherein the processing module is configured to control the leadless pacing device to switch to the atrio-ventricular synchronous pacing mode by at least controlling the leadless pacing device to deliver a pacing pulse to the patient according to the atrio-ventricular synchronous pacing mode after detecting an additional atrial activation event.

16. The leadless pacing system of claim 15, comprising means for sensing of a first cardiac cycle and a second cardiac cycle immediately following the first cardiac cycle wherein the processing module is configured to control the leadless pacing device to deliver the pacing pulse to the patient according to the atrio-ventricular synchronous pacing mode by at least controlling the leadless pacing device to deliver the pacing pulse to the patient according to the atrio-ventricular synchronous pacing mode in the first cardiac cycle, wherein the processing module is further configured to, in the second cardiac cycle, control the leadless pacing device to switch from the atrio-ventricular synchronous pacing mode to the sensing without pacing mode.

17. The leadless pacing system of claim 16, wherein the electrical cardiac signal comprises a first electrical cardiac signal and the atrial activation event comprises a first atrial activation event, wherein the processing module is configured to, after controlling the leadless pacing device to switch from the atrio-ventricular synchronous pacing mode to the sensing without pacing mode:

receive a second electrical cardiac signal of the patient sensed by the leadless pacing device after the first cardiac cycle and while the leadless pacing device is in the sensing without pacing mode;

detect, based on the second electrical cardiac signal, a second atrial activation event;

determine, based on the second electrical cardiac signal, the ventricular sense event was not detected within the ventricular event detection window that begins at the second atrial activation event; and

control the leadless pacing device to switch from the sensing without pacing mode to the atrio-ventricular synchronous pacing mode based on the determination that the ventricular sense event was not detected within the ventricular event detection window that begins at the second atrial activation event.

18. The leadless pacing system of claim 15, wherein the processing module is further configured to control the leadless pacing device to switch from the sensing without pacing mode to the atrio-ventricular synchronous pacing mode by at least:

in response to determining the ventricular sense event was not detected within the detection window, incrementing a counter,

after incrementing the counter, determining, by the processing module, whether a value of the counter is greater than or equal to a threshold value, and in response to determining the value of the counter is greater than or equal to a threshold value, controlling, by the processing module, the leadless pacing device to deliver the pacing pulse according to the atrio-ventricular synchronous pacing.

19. The leadless pacing system of claim 18, wherein the threshold value is one.

20. The leadless pacing system of claim 18, wherein the threshold value is two or three.

21. The leadless pacing system of claim 15, wherein the processing module is configured to detect the atrial activation event by at least detecting a P wave in the sensed electrical cardiac signal.

22. The leadless pacing system of claim 15, wherein the processing module is configured to detect the atrial activation event by at least detecting delivery of an atrial pacing pulse by a medical device different than the leadless pacing device.

23. The leadless pacing system of claim 15, further comprising a means for sensing A-A intervals and a memory that stores the A-A intervals for a predetermined number of prior cardiac cycles of the patient, wherein the processing module is further configured to determine the ventricular event detection window based on the stored A-A intervals.

24. The leadless pacing system of claim 23, wherein the processing module is configured to determine the ventricular event detection window by at least determining at least one of:

a mean A-A interval of the stored A-A intervals, a median A-A interval of the stored A-A intervals, a greatest A-A interval of the stored A-A intervals, a shortest A-A interval of the stored A-A intervals, or a most recent A-A interval of the stored A-A intervals.

25. The leadless pacing system of claim 24, wherein the processing module is configured to determine the ventricular event detection window by at least determining a predetermined percentage of the at least one of the mean A-A interval, the median A-A interval, the greatest A-A interval, the shortest A-A interval, or the most recent A-A interval.

26. The leadless pacing system of claim 23, wherein the processing module is configured to determine the ventricular event detection window by at least selecting the smaller of a first ventricular event detection window determined based on the stored A-A intervals for a predetermined number of prior cardiac cycles or a second, fixed ventricular event detection window stored by the leadless pacing device.

27. The leadless pacing system of claim 15, wherein the processing module is configured to receive data indicating a duration of the ventricular event detection window from a medical device programmer.

28. The leadless pacing system of claim 15, wherein the processing module is configured to, after controlling the leadless pacing device to deliver the pacing pulse to the patient according to an atrio-ventricular synchronous pacing mode:

control the leadless pacing device to perform an intrinsic conduction check,

in response to detecting intrinsic conduction based on the intrinsic conduction check, control the leadless pacing device to return to the sensing without pacing mode, and

in response to not detecting intrinsic conduction based on the intrinsic conduction check, control the leadless pacing device to remain in the atrio-ventricular synchronous pacing mode.

29. The leadless pacing system of claim 15, wherein the processing module is housed in the leadless pacing device.