EVALUATION OF IMPLANTABLE MEDICAL DEVICE SENSING INTEGRITY BASED ON EVOKED SIGNALS

• US 20090299421A1
• Filed: 07/24/2008
• Published: 12/03/2009
• Est. Priority Date: 06/02/2008
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sawchuk, Robert T.
• Application Number:
  US12/179,166
• Publication Number:
  US 20090299421A1
• Time in Patent Office: Days
• US Class Current: 607/4
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

The disclosure describes techniques for evaluating sensing integrity of an implantable medical device (IMD) based on sensing of evoked signals. Sensing integrity may provide an indication of reliability of implantable leads associated with an IMD. The sensed signals may be signals that are evoked by tissue in response to delivery of electrical stimulation. The techniques may involve evaluation of sensing integrity based on sensing of evoked cardiac potentials generated in response to cardiac stimulation, such as pacing pulses. Signals evoked in response to electrical stimulation may be measured and trended to permit analysis of evoked signals over time. Lead integrity may be inferred from sensing integrity. By analyzing evoked signals, sensing integrity may be evaluated without sensing intrinsic events. Evaluation of sensing integrity can facilitate analysis in the presence of pacing, including pacing delivered by IMDs that pace substantially continuously, such as IMDs configured to support cardiac resynchronization therapy (CRT).

Claims

1. A method comprising:

obtaining one or more sensed signals evoked by tissue in response to electrical stimulation of the tissue by an implantable medical device; and

evaluating sensing integrity of the implantable medical device based on analysis of the sensed signals.

2. The method of claim 1, wherein the tissue is cardiac tissue of a heart, and the electrical stimulation comprises cardiac pacing stimulation.

3. The method of claim 2, further comprising delivering the electrical stimulation to the tissue via an implantable lead, and sensing the signals evoked by the tissue via a second implantable lead.

4. The method of claim 3, wherein the first implantable lead resides in one of a right ventricle and a left ventricle of the heart, and the second implantable lead resides in the other of the right ventricle and the left ventricle of the heart.

5. The method of claim 2, further comprising delivering the electrical stimulation to the tissue via an implantable lead, and sensing the signals evoked by the tissue via the implantable lead.

6. The method of claim 2, further comprising sensing the signals evoked by the tissue via an implantable lead, wherein evaluating sensing integrity comprises evaluating integrity of the implantable lead based on the analysis of the sensed signals.

7. The method of claim 1, wherein the stored data includes trend data for the sensed signals, and evaluating sensing integrity comprises evaluating sensing integrity based on the trend data.

8. The method of claim 7, wherein the trend data indicates at least one of a mean amplitude of the sensed signals over time or a mean time between delivery of the electrical stimulation and sensing of the evoked signals.

9. The method of claim 1, further comprising generating an indication of sensing integrity based on the evaluation.

10. The method of claim 1, wherein generating an indication of sensing integrity comprises generating the indication via at least one of the implantable medical device or an external programmer associated with the implantable medical device.

11. The method of claim 1, further comprising generating a notification in the event the evaluation indicates a sensing integrity condition.

12. The method of claim 1, further comprising sensing the signals via the implantable medical device, and evaluating the sensing integrity automatically within the implantable medical device.

13. The method of claim 1, further comprising sensing the signals via the implantable medical device, and evaluating the sensing integrity automatically within an external programmer associated with the implantable medical device.

14. The method of claim 1, wherein the implantable medical device includes multiple implantable leads, sensing signals comprises sensing signals via each of the implantable leads, and evaluating sensing integrity comprises evaluating lead integrity for each of the leads based on the analysis of the sensed signals.

15. The method of claim 14, wherein the leads comprise a right ventricular lead and a left ventricular lead, and the implantable medical device is configured to deliver cardiac resynchronization therapy (CRT) via the right and left ventricular leads.

16. The method of claim 1, further comprising:

sensing the evoked signals; and

storing data relating to the sensed evoked signals in memory of the implantable medical device.

17. The method of claim 1, further comprising sensing at least some of the evoked signals via a sensing vector including at least one high energy electrode as a sense electrode, wherein the high energy electrode is configured to deliver at least one of defibrillation or cardioversion stimulation.

18. An implantable medical device system comprising:

an implantable stimulation generator configured to deliver electrical stimulation to tissue;

an implantable sensing module configured to sense one or more signals evoked by the tissue in response to the electrical stimulation of the tissue by the implantable stimulation generator;

implantable memory configured to store data relating to the sensed signals; and

an evaluation unit configured to support evaluation of sensing integrity of the implantable sensing module based on analysis of the stored data.

19. The system of claim 18, wherein the implantable stimulation generator is configured to deliver cardiac pacing stimulation to cardiac tissue.

20. The system of claim 19, further comprising first and second implantable leads, wherein the stimulation generator is coupled to deliver the electrical stimulation via the first lead, and the sensing module is coupled to receive the sensed signals via the second implantable lead.

21. The system of claim 20, wherein the first implantable lead is one of a right or left ventricular lead and the second implantable lead is the other of the right or left ventricular lead.

22. The system of claim 19, further comprising an implantable lead, wherein the stimulation generator is coupled to deliver the electrical stimulation via the lead, and the sensing module is coupled to receive the sensed signals via the lead.

23. The system of claim 19, further comprising an implantable lead, wherein the sensing module is coupled to receive the sensed signals via the lead, and wherein the evaluation unit is configured to support evaluation of integrity of the lead based on the analysis of the stored data.

24. The system of claim 18, wherein the stored data includes trend data for the sensed signals, and the evaluation unit is configured to support evaluation of sensing integrity based on analysis of the trend data.

25. The system of claim 24, wherein the trend data indicates at least one of a mean amplitude of the sensed signals over time or a mean time between delivery of the electrical stimulation and sensing of the evoked signals.

26. The system of claim 18, wherein the evaluation unit is configured to generate an indication of sensing integrity based on the evaluation.

27. The system of claim 18, wherein the evaluation unit is implantable and is configured to automatically evaluate the sensing integrity, and wherein the stimulation generator, the sensing module and the evaluation unit form part of an implantable medical device.

28. The system of claim 18, further comprising an external programmer, wherein the evaluation unit forms part of the external programmer, and wherein the evaluation unit is configured to perform at least one of display of the stored data to a user or automatic evaluation of the sensing integrity.

29. The system of claim 28, wherein the evaluation unit is configured to perform automatic evaluation of the sensing integrity, and generate an indication of the sensing integrity to the user.

30. The system of claim 18, further comprising a notification module configured to generate a notification in the event the evaluation indicates a sensing integrity condition.

31. The system of claim 18, further comprising multiple implantable leads coupled to the sensing module to sense the signals via each of the implantable leads, wherein the memory is configured to store data relating to the sensed signals for each of the leads, and the evaluation unit is configured to support evaluation of lead integrity for each of the leads based on the analysis of the stored data.

32. The system of claim 31, wherein the leads comprise a right ventricular lead and a left ventricular lead, and the stimulation generator is configured to deliver cardiac resynchronization therapy (CRT) via the right and left ventricular leads.

33. The system of claim 31, wherein at least one of the leads comprises at least one high energy electrode as a sense electrode, the high energy electrode being configured to deliver at least one of defibrillation or cardioversion stimulation, and wherein the implantable sensing module is configured to sense the signals via a sensing vector comprising the high energy electrode.

34. An implantable medical device system comprising:

means for obtaining one or more sensed signals evoked by tissue in response to electrical stimulation of the tissue by an implantable medical device; and

means for evaluating sensing integrity of the implantable medical device based on analysis of the sensed signals.

35. The system of claim 34, wherein the tissue is cardiac tissue of a heart, and the electrical stimulation comprises cardiac pacing stimulation.

36. The system of claim 35, further comprising means for delivering the electrical stimulation to the tissue via an implantable lead, and means for sensing the signals evoked by the tissue via a second implantable lead, wherein the first implantable lead resides in one of a right ventricle and a left ventricle of the heart, and the second implantable lead resides in the other of the right ventricle and the left ventricle of the heart.

37. The system of claim 35, further comprising means for delivering the electrical stimulation to the tissue via an implantable lead, and means for sensing the signals evoked by the tissue via the implantable lead.

38. The system of claim 34, further comprising means for sensing the signals evoked by the tissue via an implantable lead, wherein the means for evaluating sensing integrity comprises means for automatically evaluating integrity of the implantable lead based on the analysis of the sensed signals.

39. The system of claim 34, wherein the implantable medical device includes multiple implantable leads, sensing signals comprises sensing signals via each of the implantable leads, storing data comprises storing data relating to the sensed signals for each of the leads, and evaluating sensing integrity comprises evaluating lead integrity for each of the leads based on the analysis of the stored data, and wherein the leads comprise a right ventricular lead and a left ventricular lead, and the implantable medical device is configured to deliver cardiac resynchronization therapy (CRT) via the right and left ventricular leads.

40. The system of claim 34, further comprising:

means for sensing the evoked signals; and

means for storing data relating to the sensed evoked signals in memory of the implantable medical device.

41. The system of claim 34, further comprising means for sensing at least some of the evoked signals via a sensing vector including at least one high energy electrode as a sense electrode, wherein the high energy electrode is configured to deliver at least one of defibrillation or cardioversion stimulation.

42. A computer-readable storage medium comprising instruction for causing a programmable processor to:

obtain one or more sensed signals evoked by tissue in response to electrical stimulation of the tissue by an implantable medical device; and

evaluate sensing integrity of the implantable medical device based on analysis of the sensed signals.