Recovery of cardiac event sensing and rhythm detection following electrical stimulation pulse delivery

• US 10,369,372 B2
• Filed: 10/21/2014
• Issued: 08/06/2019
• Est. Priority Date: 10/21/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stadler, Robert W., Cao, Jian
• Primary Examiner(s): Lee, Erica S
• Application Number:
  US14/519,220
• Publication Number:
  US 20160106991A1
• Time in Patent Office: 1,750 Days
• Field of Search: None
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A medical device is configured to deliver an electrical stimulation pulse to a heart of a patient, determine a pre-stimulation cardiac event amplitude prior to delivering the electrical stimulation pulse and adjust a cardiac event sensing threshold according to a first post-stimulation decay sequence in response to the electrical stimulation pulse delivery. The first post-stimulation decay sequence is controlled by a sensing module of the medical device according to a first set of sensing control parameters including at least one sensing control parameter based on the pre-stimulation cardiac event amplitude.

Claims

1. A method performed by a medical device, comprising:

delivering an electrical shock by a therapy delivery module of the medical device to a heart of a patient via a plurality of electrodes coupled to the medical device;

determining a pre-shock cardiac event amplitude prior to delivering the electrical shock; and

automatically adjusting a cardiac event sensing threshold in response to the electrical shock delivery and according to a post-shock decay sequence, the post-shock decay sequence controlled by a sensing module of the medical device according to a set of sensing control parameters comprising at least one sensing control parameter based on the pre-shock cardiac event amplitude, and wherein adjusting the cardiac event sensing threshold includes adjusting the cardiac event sensing threshold to decay at a post-shock sequence decay rate, wherein the post-shock sequence decay rate is based on the pre-shock cardiac event amplitude.

2. The method of claim 1, wherein the post-shock decay sequence is a first post-shock decay sequence, wherein the set of sensing control parameters is a first set of sensing control parameters, and wherein adjusting the cardiac event sensing threshold according to the first post-shock decay sequence comprises setting an initial amplitude of the cardiac event sensing threshold during the first post-shock decay sequence based on the pre-shock cardiac event amplitude, the method further comprising:

sensing a post-shock cardiac event in response to a cardiac electrical signal received by the sensing module crossing the cardiac event sensing threshold during the first post-shock decay sequence; and

automatically adjusting the cardiac event sensing threshold according to a second post-shock decay sequence in response to sensing the post-shock cardiac event, the second post-shock decay sequence controlled by a second set of sensing control parameters different than the first set of sensing control parameters so that the first post-shock decay sequence is different than the second post-shock decay sequence, and wherein the second post-shock decay sequence is the next post-shock decay sequence following the first post-shock decay sequence.

3. The method of claim 2, further comprising:

starting a blanking interval after delivering the electrical shock and prior to sensing the post-shock cardiac event;

starting a signal analysis time segment upon expiration of the blanking interval;

adjusting the cardiac event sensing threshold according to the first post-shock decay sequence upon starting the signal analysis time segment.

4. The method of claim 3, further comprising:

adjusting the cardiac event sensing threshold according to the second post-shock decay sequence until the signal analysis time segment expires.

5. The method of claim 3, further comprising:

sensing cardiac events during the signal analysis time segment in response to the cardiac signal crossing the cardiac event sensing threshold;

classifying the signal analysis time segment as one of a shockable segment or a non-shockable segment based on at least the sensed cardiac events; and

starting to charge a capacitor of a therapy delivery module of the medical device for delivering a next electrical shock in response to classifying the signal analysis time segment as a shockable segment.

6. The method of claim 5, further comprising:

producing a cardiac event sense signal in response to each cardiac signal crossing of the cardiac event sensing threshold during the signal analysis time segment;

determining a total number of the cardiac event sense signals produced during the signal analysis time segment;

estimating a cardiac cycle length based on the total number of cardiac event sense signals; and

classifying the signal analysis time segment as one of a shockable and a non-shockable segment based on the estimated cardiac cycle length.

7. The method of claim 6, further comprising:

estimating the cardiac cycle length as unknown in response to the total number of cardiac event sense signals being less than a threshold number of cardiac event sense signals;

estimating the cardiac cycle length based on at least an n^th longest interval between two consecutive ones of the cardiac event sense signals when the total number of cardiac event sense signals falls into a first range greater than the threshold number of cardiac event sense signals;

or

estimating the cardiac cycle length as a mean of at least a portion of cardiac event intervals determined between consecutive ones of the cardiac event sense signals when the total number of cardiac event sense signals falls into a second range greater than the threshold number of cardiac event sense signals and greater than the first range.

8. The method of claim 6, wherein adjusting the cardiac event sensing threshold comprises:

adjusting a first cardiac event sensing threshold according to the first post-shock decay sequence and the second post-shock decay sequence, the first cardiac event sensing threshold used by a first sensing channel of a sensing module of the medical device configured to receive the cardiac signal from a first pair of the plurality of electrodes;

adjusting a second cardiac event sensing threshold according to the first post-shock decay sequence and the second post-shock decay sequence, the second cardiac event sensing threshold used by a second sensing channel of the sensing module configured to receive a second cardiac signal from a second pair of the plurality of electrodes coupled to the medical device;

producing first cardiac event sense signals in response to crossings of the first cardiac event sensing threshold by the cardiac signal during the signal analysis time segment;

producing second cardiac event sense signals in response to crossings of the second cardiac event sensing threshold by the second cardiac signal during the signal analysis time segment; and

classifying the signal analysis time segment as one of a shockable segment or a non-shockable segment based on the first cardiac event sense signals and the second cardiac event sense signals.

9. The method of claim 3, further comprising:

starting a next signal analysis time segment upon expiration of the signal analysis time segment; and

adjusting the cardiac event sensing threshold according to the second post-shock decay sequence during the next signal analysis time segment, and not according to any other decay sequence during the next signal analysis time segment.

10. The method of claim 3, further comprising:

sensing cardiac events during the signal analysis time segment in response to the cardiac signal crossing the cardiac event sensing threshold;

estimating a cycle length of the signal analysis time segment based on the sensed cardiac events during the signal analysis time segment; and

starting to charge a capacitor of the therapy delivery module in response to at least the estimated cycle length of at least the signal analysis time segment.

11. The method of claim 1, wherein determining the pre-shock cardiac event amplitude comprises producing a cardiac event template during a known pre-shock cardiac rhythm and determining a maximum peak cardiac event amplitude from the template.

12. The method of claim 1, wherein adjusting the cardiac event sensing threshold according to the post-shock decay sequence comprises:

adjusting the cardiac event sensing threshold to decay at the post-shock sequence decay rate during a post-shock sequence drop interval, the method further comprising;

adjusting the cardiac event sensing threshold prior to delivering the electrical shock according to a pre-shock decay sequence by adjusting the cardiac event sensing threshold to decay at a pre-shock decay rate during a pre-shock drop interval, the pre-shock drop interval being greater than the post-shock sequence drop interval of the post-shock decay sequence;

sensing pre-shock cardiac events in response to a cardiac electrical signal crossing the cardiac event sensing threshold as it is adjusted according to the pre-shock decay sequence; and

delivering the electrical shock in response to the pre-shock cardiac events satisfying a therapy delivery criterion.

13. The method of claim 12, wherein the post-shock decay sequence is a first post-shock decay sequence, wherein the post-shock sequence decay rate is a first post-shock sequence decay rate, and wherein the post-shock sequence drop interval is a first post-shock sequence drop interval, the method further comprising:

automatically adjusting the cardiac event sensing threshold according to a second post-shock decay sequence in response to sensing a post-shock cardiac event and by at least adjusting the cardiac event sensing threshold to decay at a second post-shock sequence decay rate over a second post-shock sequence drop interval, the second post-shock sequence drop interval greater than the first post-shock sequence drop interval and less than the pre-shock drop interval.

14. The method of claim 13, wherein the first post-shock sequence decay rate is a first post-shock sequence first decay rate, wherein the second post-shock sequence decay rate is a second post-shock sequence first decay rate, and wherein:

adjusting the cardiac event sensing threshold according to the first post-shock decay sequence comprises adjusting the cardiac event sensing threshold according to the first post-shock decay sequence having a first post-shock sequence initial amplitude, the first post-shock sequence first decay rate, a first post-shock sequence drop interval over which the first post-shock sequence first decay rate is applied, and a first post-shock sequence second decay rate started at the expiration of the first post-shock sequence drop interval, wherein at least one of the first post-shock sequence initial amplitude, the first post-shock sequence first decay rate and the first post-shock sequence second decay rate is based on the pre-shock cardiac event amplitude;

adjusting the cardiac event sensing threshold according to the second post-shock decay sequence comprises adjusting the cardiac event sensing threshold according to the second post-shock decay sequence having at least a second post-shock sequence first decay rate, a second post-shock sequence drop interval over which the second post-shock sequence first decay rate is applied, and a second post-shock sequence second decay rate started at the expiration of the second post-shock sequence drop interval,

wherein at least one of the second post-shock sequence first decay rate, the second post-shock sequence drop interval and the second post-shock sequence second decay rate is different than a respective one of the first post-shock sequence first decay rate, the first post-shock sequence drop interval and the first post-shock sequence second decay rate.

15. The method of claim 1, further comprising adjusting the cardiac event sensing threshold according to the post-shock decay sequence a single time in response to the delivery of the electrical shock to sense only one cardiac event following the delivered electrical shock.

16. The method of claim 1, wherein the electrical shock is at least 10 Joules.

17. A medical device comprising:

a therapy delivery module configured to generate and deliver an electrical shock to a patient'"'"'s heart via a plurality of electrodes coupled to the medical device;

a sensing module configured to receive a cardiac electrical signal and produce cardiac event signals in response to the cardiac electrical signal crossing a cardiac event sensing threshold; and

a control module coupled to the sensing module and the therapy delivery module and configured to receive the cardiac event signals from the sensing module and control the therapy delivery module to deliver the electrical shock, the control module configured to determine a pre-shock cardiac event amplitude prior to delivery of the electrical shock,

the sensing module further configured to adjust a cardiac event sensing threshold in response to delivery of the electrical shock by the therapy delivery module and according to a post-shock decay sequence, the post-shock decay sequence controlled by a set of sensing control parameters comprising at least one sensing control parameter based on the pre-shock cardiac event amplitude, and wherein to adjust the cardiac event sensing threshold according to the post-shock decay sequence, the sensing module is configured to adjust the cardiac event sensing threshold to decay at a post-shock sequence decay rate, wherein the post-shock sequence decay rate is based on the pre-shock cardiac event amplitude.

18. The device of claim 17, wherein the post-shock decay sequence is a first post-shock decay sequence, wherein the set of sensing control parameters is a first set of sensing control parameters, and wherein the sensing module is configured to:

adjust the cardiac event sensing threshold according to the first post-shock decay sequence by setting an initial amplitude of the cardiac event sensing threshold during the first post-shock decay sequence based on the pre-shock cardiac event amplitude;

sense a post-shock cardiac event in response to the cardiac electrical signal crossing the cardiac event sensing threshold during the first post-shock decay sequence;

adjust the cardiac event sensing threshold according to a second post-shock decay sequence in response to sensing the post-shock cardiac event, wherein the second post-shock decay sequence is controlled by a second set of sensing control parameters different than the first set of sensing control parameters so that the first post-shock decay sequence is different than the second post-shock decay sequence, and wherein the second post-shock decay sequence is the next post-shock decay sequence following the first post-shock decay sequence.

19. The device of claim 18, wherein:

the sensing module is further configured to start a blanking interval after delivery of the electrical shock;

the control module is configured to start a signal analysis time segment upon expiration of the blanking interval; and

the sensing module is configured to adjust the cardiac event sensing threshold according to the first post-shock decay sequence upon starting the signal analysis time segment.

20. The device of claim 19, wherein the sensing module is further configured to adjust the cardiac event sensing threshold according to the second post-shock decay sequence until the signal analysis time segment expires.

21. The device of claim 19, wherein:

the therapy delivery module comprises a capacitor that is discharged for delivering the electrical shock;

the sensing module is further configured to sense cardiac events during the signal analysis time segment in response to the cardiac signal crossing the cardiac event sensing threshold; and

the control module is configured to;

classify the signal analysis time segment as one of a shockable segment or a non-shockable segment based at least on the sensed cardiac events; and

control the therapy delivery module to start charging the capacitor for delivering a next electrical shock in response to classifying at least the signal analysis time segment as a shockable segment.

22. The device of claim 21, wherein:

the sensing module is configured to produce a cardiac event sense signal in response to each cardiac signal crossing of the cardiac event sensing threshold during the signal analysis time segment; and

the control module is further configured to;

determine a total number of the cardiac event sense signals produced during the signal analysis time segment;

estimate a cardiac cycle length based on the total number of cardiac event sense signals; and

classify the signal analysis time segment as one of shockable and non-shockable based on the estimated cardiac cycle length.

23. The device of claim 22, wherein the control module is further configured to:

estimate the cardiac cycle length as unknown in response to the total number of cardiac event sense signals being less than a threshold number of cardiac event sense signals;

estimate the cardiac cycle length based on at least an n^th longest interval between two consecutive ones of the cardiac event sense signals when the total number of cardiac event sense signals falls into a first range greater than the threshold number of cardiac event sense signals;

or

estimate the cardiac cycle length as a mean of at least a portion of cardiac event intervals determined between consecutive ones of the cardiac event sense signals when the total number of cardiac event sense signals falls into a second range greater than the threshold number of cardiac event sense signals and greater than the first range.

24. The device of claim 22, wherein:

the sensing module is further configured to;

adjust a first cardiac event sensing threshold according to the first post-shock decay sequence and the second post-shock decay sequence, the first cardiac event sensing threshold used by a first sensing channel of the sensing module and configured to receive the cardiac signal from a first pair of the plurality of electrodes,

adjust a second cardiac event sensing threshold according to the first post-shock decay sequence and the second post-shock decay sequence, the second cardiac event sensing threshold used by a second sensing channel of the sensing module and configured to receive a second cardiac signal from a second pair of the plurality of electrodes, and

produce first cardiac event sense signals in response to crossings of the first cardiac event sensing threshold by the cardiac signal during the signal analysis time segment and produce second cardiac event sense signals in response to crossings of the second cardiac event sensing threshold by the second cardiac signal during the signal analysis time segment; and

the control module is further configured to classify the signal analysis time segment as one of a shockable segment or a non-shockable segment based on the first cardiac event sense signals and the second cardiac event sense signals.

25. The device of claim 19, wherein:

the control module is configured to start a next signal analysis time segment upon expiration of the signal analysis time segment; and

the sensing module is configured to adjust the cardiac event sensing threshold according to the second post-shock decay sequence during the next signal analysis time segment, and not according to any other decay sequence during the next signal analysis time segment.

26. The device of claim 19, wherein:

the therapy delivery module comprises a capacitor that is discharged for delivering the electrical shock;

the sensing module is further configured to sense cardiac events during the signal analysis time segment in response to the cardiac signal crossing the cardiac event sensing threshold; and

the control module is configured to;

estimate a cycle length of the signal analysis time segment based on the sensed cardiac events during the signal analysis time segment, and

start charging the capacitor in response to at least the estimated cycle length of at least the signal analysis time segment.

27. The device of claim 17, wherein the control module is configured to determine the pre-shock cardiac event amplitude by:

producing a cardiac event template during a known pre-shock cardiac rhythm; and

determining the pre-shock cardiac event amplitude as a maximum peak amplitude of the template.

28. The device of claim 17, wherein the sensing module is configured to:

adjust the cardiac event sensing threshold according to the post-shock decay sequence by adjusting the cardiac event sensing threshold to decay at the post-shock sequence decay rate during a post-shock sequence drop interval;

adjust the cardiac event sensing threshold according to a pre-shock decay sequence prior to delivery of the electrical shock by adjusting the cardiac event sensing threshold to decay at a pre-shock decay rate during a pre-shock drop interval, the pre-shock drop interval greater than the post-shock sequence drop interval of the post-shock decay sequence;

sense pre-shock cardiac events in response to the cardiac electrical signal crossing the cardiac event sensing threshold as it is automatically adjusted according to the pre-shock decay sequence; and

control the therapy delivery module to deliver the electrical shock in response to the pre-shock cardiac events satisfying a therapy delivery criterion.

29. The device of claim 28, wherein the post-shock decay sequence is a first post-shock decay sequence, wherein the post-shock sequence decay rate is a first post-shock sequence decay rate, and wherein the post-shock sequence drop interval is a first post-shock sequence drop interval, and wherein the sensing module is further configured to adjust the cardiac event sensing threshold according to a second post-shock decay sequence in response to receiving the cardiac electrical signal and by adjusting the cardiac event sensing threshold to decay at a second post-shock sequence decay rate during a second post-shock sequence drop interval, the second post-shock sequence drop interval greater than the first post-shock sequence drop interval and less than the pre-shock drop interval.

30. The device of claim 29, wherein the first post-shock sequence decay rate is a first post-shock sequence first decay rate, wherein the second post-shock sequence decay rate is a second post-shock sequence first decay rate, and wherein the sensing module is further configured to:

adjust the cardiac event sensing threshold according to the first post-shock decay sequence comprising a first post-shock sequence initial amplitude, the first post-shock sequence first decay rate, a first post-shock sequence drop interval over which the first post-shock sequence first decay rate is applied, and a first post-shock sequence second decay rate started at the expiration of the first post-shock sequence drop interval, wherein at least one of the first post-shock sequence initial amplitude, the first post-shock sequence first decay rate and the first post-shock sequence second decay rate is based on the pre-shock cardiac event amplitude; and

adjust the cardiac event sensing threshold according to the second post-shock decay sequence comprising a second post-shock sequence first decay rate, a second post-shock sequence drop interval over which the second post-shock sequence first decay rate is applied, and a second post-shock sequence second decay rate started at the expiration of the second post-shock sequence drop interval,

wherein at least one of the second post-shock sequence first decay rate, the second post-shock sequence drop interval and the second post-shock sequence second decay rate is different than a respective one of the first post-shock sequence first decay rate, the first post-shock sequence drop interval and the first post-shock sequence second decay rate.

31. The device of claim 17, wherein the sensing module is configured to adjust the cardiac event sensing threshold according to the post-shock decay sequence a single time in response to the delivery of the electrical shock to sense only one cardiac event following the delivered electrical shock.

32. The device of claim 17, further comprising an implantable medical lead coupled to the device and carrying a plurality of electrodes.

33. The medical device of claim 17, wherein the electrical shock is at least 10 Joules.

34. A non-transitory, computer-readable medium storing a set of instructions which, when executed by a control module of a medical device, cause the medical device to:

deliver an electrical shock to a heart of a patient via a plurality of electrodes coupled to the medical device;

determine a pre-shock cardiac event amplitude prior to delivering the electrical shock; and

adjust a cardiac event sensing threshold in response to the electrical shock delivery and according to a post-shock decay sequence, the post-shock decay sequence controlled by a set of sensing control parameters comprising at least one sensing control parameter based on the pre-shock cardiac event amplitude, and wherein to adjust the cardiac event sensing threshold, the instructions cause the medical device to adjust the cardiac event sensing threshold to decay at a post-shock sequence decay rate, wherein the post-shock sequence decay rate is based on the pre-shock cardiac event amplitude.

35. The computer-readable medium of claim 34, wherein the electrical shock is at least 10 Joules.