Multi-threshold sensing of cardiac electrical signals in an extracardiovascular implantable cardioverter defibrillator

• US 10,252,071 B2
• Filed: 04/29/2016
• Issued: 04/09/2019
• Est. Priority Date: 04/29/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Cao, Jian, Ebeling, Timothy A., Greenhut, Saul E., Heinks, Michael W., Sanchez, Irving J., Solheim, Paul R., Zhang, Xusheng, Arne, Gerald P.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US15/142,171
• Publication Number:
  US 20170312534A1
• Time in Patent Office: 1,075 Days
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/39 Heart defibrillators
• 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 1/3987 characterised by the timing or triggering of the shock

Abstract

An implantable medical device system capable of sensing cardiac electrical signals includes a sensing circuit, a therapy delivery circuit and a control circuit. The sensing circuit is configured to receive a cardiac electrical signal and sense a cardiac event in response to the signal crossing a cardiac event sensing threshold. The therapy delivery circuit is configured to deliver an electrical stimulation therapy to a patient'"'"'s heart via the electrodes coupled to the implantable medical device. The control circuit is configured to control the sensing circuit to set a starting value of the cardiac event sensing threshold and hold the starting value constant for a sense delay interval. The control circuit is further configured to detect an arrhythmia based on cardiac events sensed by the sensing circuit and control the therapy delivery circuit to deliver the electrical stimulation therapy in response to detecting the arrhythmia.

Claims

1. A system comprising an implantable medical device for sensing cardiac electrical events, the system comprising:

a sensing circuit configured to;

receive a cardiac electrical signal from electrodes coupled to the implantable medical device;

sense a plurality of cardiac events, each one of the plurality of cardiac events attendant to a myocardial depolarization and sensed in response to the cardiac electrical signal crossing a cardiac event sensing threshold; and

after each sensed cardiac event, adjust the cardiac event sensing threshold to a starting threshold value for sensing a next one of the plurality of cardiac events;

a control circuit configured to;

determine a gain based on a minimum threshold value;

determine a maximum limit of the starting threshold value based on the gain and the minimum threshold value of the cardiac event sensing threshold;

control the sensing circuit to set the starting value of the cardiac event sensing threshold after each sensed cardiac event to be equal to or less than the maximum limit; and

detect an arrhythmia based on the plurality of cardiac events sensed by the sensing circuit; and

a therapy delivery circuit configured to generate and deliver an electrical stimulation therapy to a patient'"'"'s heart via the electrodes coupled to the implantable medical device in response to the control circuit detecting the arrhythmia.

2. The system of claim 1, wherein the minimum threshold value is a programmed sensitivity setting of the sensing circuit and the control circuit is configured to determine the gain by determining an inverse proportion of the programmed sensitivity setting.

3. The system of claim 1, wherein the control circuit is configured to:

determine a peak amplitude of the sensed cardiac event,

determine a first threshold value as a first percentage of the peak amplitude; and

control the sensing circuit to set a next starting threshold value of the cardiac event sensing threshold as a lower one of the first threshold value and the maximum sensing threshold limit.

4. The system of claim 1, wherein the control circuit is configured to:

set a first blanking interval upon sensing the cardiac event by the sensing circuit;

set a second blanking interval upon sensing the cardiac event by the sensing circuit;

determine a peak amplitude of the sensed cardiac event during the first blanking interval;

determine a threshold value based on the peak amplitude;

enable the sensing circuit to set a next starting value of the R-wave sensing threshold to a lowest one of the threshold value and the maximum threshold limit at the expiration of the second blanking interval.

5. The system of claim 4, comprising a hardware circuit for setting the first blanking interval and a memory storing firmware for setting the second blanking interval as a programmable interval.

6. The system of claim 1, further comprising a memory storing a look-up table comprising a unique value for the gain for each one of a plurality of programmable minimum threshold values;

wherein the control circuit is configured to determine the gain based on the minimum threshold value by;

determining a currently programmed minimum threshold value; and

retrieving the unique value for the gain stored for the currently programmed minimum threshold value from the look-up table.

7. The system of claim 1, wherein the minimum threshold value is a programmable value and the control circuit is configured to determine the gain as a constant added to a coefficient divided by the minimum threshold value, where the constant and the coefficient are greater than zero.

8. The system of claim 1, wherein the control circuit is further configured to control the sensing circuit to:

hold the cardiac event sensing threshold at the starting value for a sense delay interval;

adjust the cardiac event sensing threshold to a second threshold value upon expiration of the sense delay interval;

hold the cardiac event sensing threshold at the second threshold value for a drop time interval; and

adjust the cardiac event sensing threshold from the second threshold value to the minimum threshold value upon expiration of the drop time interval.

9. The system of claim 8, wherein the control circuit is configured to control the sensing circuit to set the sense delay interval to a programmed tachyarrhythmia detection interval.

10. The system of claim 8, wherein the control circuit is further configured to control the sensing circuit to increase the cardiac event sensing threshold from the minimum threshold value to a third threshold value greater than the minimum threshold value upon expiration of a maximum sensitivity time interval after expiration of the drop time interval.

11. The system of claim 2, wherein the programmed sensitivity setting is up to one half of a sensitivity setting tested to successfully detect induced ventricular fibrillation.

12. The system of claim 1, further comprising a processor configured to:

determine a baseline feature from the cardiac electrical signal; and

set a sensing threshold control parameter to a value based on the feature;

wherein the sensing circuit is configured to adjust the cardiac event sensing threshold according to the control parameter.

13. The system of claim 12, further comprising:

a memory storing tachyarrhythmia detection sensitivity data;

wherein the processor is configured to;

determine an expected tachyarrhythmia detection sensitivity for the control parameter value from the stored tachyarrhythmia detection sensitivity data; and

generate an alert in response to the tachyarrhythmia detection sensitivity being below an alert threshold for the control parameter value.

14. The system of claim 1, wherein the implantable medical device is an implantable cardioverter defibrillator and the electrodes are carried by an extra-cardiovascular lead.

15. A method performed by a system comprising an implantable medical device for sensing cardiac electrical signals, comprising:

receiving a cardiac electrical signal by a sensing circuit of the implantable medical device via electrodes coupled to the implantable medical device;

setting a cardiac event sensing threshold to a starting threshold value;

sensing a cardiac event attendant to a myocardial depolarization in response to the cardiac electrical signal crossing the cardiac event sensing threshold;

detecting an arrhythmia based on a plurality of cardiac events sensed by the sensing circuit; and

generating and delivering an electrical stimulation therapy by a therapy delivery circuit in response to detecting the arrhythmia,

wherein setting the starting threshold value comprises;

determining by a control circuit of the implantable medical device a gain based on a minimum threshold value of the cardiac event sensing threshold;

determining a maximum limit of the starting threshold value based on the gain and the minimum threshold value; and

setting the starting value of the cardiac event sensing threshold to be equal to or less than the maximum limit.

16. The method of claim 15, wherein the minimum threshold value is a programmed sensitivity setting of the sensing circuit and determining the gain comprises determining an inverse proportion of the programmed sensitivity setting.

17. The method of claim 15, further comprising:

determining a peak amplitude of the sensed cardiac event,

determining a first threshold value as a first percentage of the peak amplitude; and

controlling the sensing circuit to set a next starting threshold value of the cardiac event sensing threshold as a lower one of the first threshold value and the maximum sensing threshold limit.

18. The method of claim 15, further comprising:

setting a first blanking interval upon sensing the cardiac event by the sensing circuit;

setting a second blanking interval upon sensing the cardiac event by the sensing circuit;

determining a peak amplitude of the sensed cardiac event during the first blanking interval;

determining a threshold value based on the peak amplitude;

enabling the sensing circuit to set a next starting value of the R-wave sensing threshold to a lowest one of the threshold value and the maximum threshold limit at the expiration of the second blanking interval.

19. The method of claim 18, further comprising setting the first blanking interval by a hardware circuit and setting the second blanking interval as a programmable interval by firmware stored in a memory of the implantable medical device system.

20. The method of claim 15, further comprising:

storing a look-up table in a memory of the implantable medical device, the look-up table comprising a unique value for the gain for each one of a plurality of programmable minimum threshold values; and

determining the gain based on the minimum threshold value by determining a currently programmed minimum threshold value and retrieving the unique value for the gain stored for the currently programmed minimum threshold value from the look-up table.

21. The method of claim 15, wherein the minimum threshold value is a programmable value and the control circuit is configured to determine the gain as a constant added to a coefficient divided by the minimum threshold value, where the constant and the coefficient are greater than zero.

22. The method of claim 15, further comprising:

holding the cardiac event sensing threshold at the starting value for a sense delay interval;

adjusting the cardiac event sensing threshold to a second threshold value upon expiration of the sense delay interval;

holding the cardiac event sensing threshold at the second threshold value for a drop time interval; and

adjusting the cardiac event sensing threshold from the second threshold value to the minimum threshold value upon expiration of the drop time interval.

23. The method of claim 22, further comprising setting the sense delay interval to a programmed tachyarrhythmia detection interval.

24. The method of claim 22, further comprising increasing the cardiac event sensing threshold from the minimum threshold value to a third threshold value greater than the minimum threshold value upon expiration of a maximum sensitivity time interval after expiration of the drop time interval.

25. The method of claim 16, wherein the programmed sensitivity setting is up to one half of a sensitivity setting tested to successfully detect induced ventricular fibrillation.

26. The method of claim 15, further comprising:

determining a baseline feature from the cardiac electrical signal; and

setting a sensing threshold control parameter to a value based on the feature; and

adjusting the cardiac event sensing threshold according to the control parameter.

27. The method of claim 26, further comprising:

storing tachyarrhythmia detection sensitivity data in a memory of the system;

determining an expected tachyarrhythmia detection sensitivity for the control parameter value from the stored tachyarrhythmia detection sensitivity data; and

generating an alert in response to the expected tachyarrhythmia detection sensitivity being below an alert threshold for the control parameter value.

28. The method of claim 15, further comprising:

receiving the cardiac electrical signal by a sensing circuit of the implantable medical device via electrodes carried by an extra-cardiovascular lead coupled to the implantable medical device, wherein the implantable medical device is an implantable cardioverter defibrillator.

29. A non-transitory, computer-readable storage medium comprising a set of instructions which, when executed by processor of an implantable medical device system, cause the system to:

set a cardiac event sensing threshold to a starting threshold value;

sense a cardiac event attendant to a myocardial depolarization by a sensing circuit of the implantable medical device in response to a cardiac electrical signal crossing the cardiac event sensing threshold;

detect an arrhythmia based on a plurality of cardiac events sensed by the sensing circuit; and

generate and deliver an electrical stimulation therapy by a therapy delivery circuit of the implantable medical device in response to detecting the arrhythmia,

wherein setting the cardiac event sensing threshold to the starting threshold value comprises;

determining a gain based on a minimum threshold value of the cardiac event sensing threshold;

determining a maximum limit of the starting threshold value based on the gain and the minimum threshold value; and

setting the starting value of the cardiac event sensing threshold to be equal to or less than the maximum limit.