Implantable medical device crosstalk evaluation and mitigation

• US 8,260,412 B2
• Filed: 01/30/2009
• Issued: 09/04/2012
• Est. Priority Date: 10/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Krause, Paul G., Burnes, John E., Donofrio, William T., Peichel, David J., Arne, Gerald P., Zhou, Xiaohong, Reinke, James D., Davis, Timothy
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US12/362,809
• Publication Number:
  US 20100114199A1
• Time in Patent Office: 1,313 Days
• Field of Search: 607/2, 607 4- 5, 607/17, 607/119
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD

Abstract

Electrical crosstalk between two implantable medical devices or two different therapy modules of a common implantable medical device may be evaluated, and, in some examples, mitigated. In some examples, one of the implantable medical devices or therapy modules delivers electrical stimulation to a nonmyocardial tissue site or a nonvascular cardiac tissue site, and the other implantable medical device or therapy module delivers cardiac rhythm management therapy to a heart of the patient.

Claims

1. A method comprising:

delivering therapy to a tissue site within a patient according to a first therapy program;

detecting a potential arrhythmia of a heart of the patient;

upon detecting the potential arrhythmia, adjusting the delivery of therapy to the tissue site within the patient according to the first therapy program;

determining whether the potential arrhythmia is detected after adjusting the delivery of therapy according to the first therapy program;

switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to a second therapy program if the potential arrhythmia is not detected after adjusting the delivery of therapy according to the first therapy program, wherein the first and second therapy programs define at least one different stimulation parameter value; and

prohibiting further delivery of therapy according to the first therapy program based upon a number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program.

2. The method of claim 1, wherein adjusting the delivery of therapy to the tissue site within the patient according to the first therapy program comprises stopping the delivery of therapy to the tissue site within the patient according to the first therapy program.

3. The method of claim 1, wherein the second therapy program defines a suspend state in which no electrical stimulation therapy is delivered to the tissue site.

4. The method of claim 1, wherein prohibiting further delivery of therapy according to the first therapy program comprises prohibiting further delivery of therapy according to the first therapy program based upon the number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program within a predetermined period of time.

5. The method of claim 1, wherein prohibiting further delivery of therapy according to the first therapy program comprises prohibiting further delivery of therapy according to the first therapy program until user intervention is received.

6. The method of claim 1, further comprising:

adjusting a counter after switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program; and

determining the number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program based on a value of the counter.

7. The method of claim 6, further comprising determining a type of potential arrhythmia detected, and adjusting the counter based on the type of potential arrhythmia detected.

8. The method of claim 1, wherein switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program comprises delivering therapy to the tissue site according to the second therapy program for a period of time, the method further comprising stopping delivery of therapy to the tissue site according to the second therapy program and delivering therapy to the patient according to the first therapy program after the period of time.

9. The method of claim 1, further comprising:

determining whether the potential arrhythmia is detected after switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program; and

delivering at least one of pacing, cardioversion or defibrillation therapy to the heart of the patient if the potential arrhythmia is detected after therapy is delivered to the tissue site according to the second therapy program.

10. The method of claim 9, further comprising:

adjusting the delivery of therapy according to the second therapy program if the potential arrhythmia is detected after switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program; and

determining whether the potential arrhythmia is detected after therapy according to the second therapy program is adjusted,

wherein delivering the at least one of pacing, cardioversion or defibrillation therapy to the heart of the patient comprises delivering the at least one of pacing, cardioversion or defibrillation therapy to the heart of the patient if the potential arrhythmia is detected after therapy according to the second therapy program is adjusted.

11. The method of claim 10, wherein adjusting the delivery of therapy according to the second therapy program comprises suspending the delivery of therapy according to the second therapy program.

12. The method of claim 9, wherein delivering therapy according to the first and second therapy programs comprises delivering therapy according to the first and second therapy programs with a first implantable medical device, and delivering the at least one of pacing, cardioversion or defibrillation therapy to the heart comprises delivering the at least one of pacing, cardioversion or defibrillation therapy to the heart via a second implantable medical device that is physically separate from the first implantable medical device.

13. The method of claim 9, wherein delivering therapy according to the first and second therapy programs comprises delivering therapy according to the first and second therapy programs with an electrical stimulation therapy module of an implantable medical device, and delivering the at least one of pacing, cardioversion or defibrillation therapy to the heart comprises delivering the at least one of pacing, cardioversion or defibrillation therapy to the heart via a cardiac therapy module of the implantable medical device.

14. The method of claim 1, wherein the first and second therapy programs each define at least one of a current amplitude value, a voltage amplitude value, a pulse width, a pulse rate, a frequency, a duty cycle of an electrical stimulation signal or an electrode combination with which the electrical stimulation is delivered to the tissue site.

15. The method of claim 1, wherein the first and second therapy programs comprise stimulation parameter values that define different stimulation signal waveforms or signal envelopes.

16. The method of claim 1, wherein the second therapy program defines a stimulation signal comprising at least one of a ramped square waveform, a stair step ramped square waveform, a rounded square ramped square waveform, a trapezoidal waveform, a triangular waveform, a sinusoidal waveform, a half sinusoidal waveform, a rectified sine waveform, a stair step half sinusoidal waveform, a biphasic waveform or a triphasic waveform.

17. The method of claim 1, wherein the second therapy program defines a guarded electrode combination, and wherein delivering therapy to the tissue site according to the second therapy program comprises delivering therapy to the tissue site via the guarded cathode electrode combination.

18. The method of claim 1, further comprising generating an interference indication if the potential arrhythmia is detected after switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program.

19. The method of claim 18, further comprising transmitting the interference indication to a user via an external device.

20. A system comprising:

an electrical stimulator that delivers therapy to a tissue site within a patient according to a first therapy program;

a sensing module that senses an electrical cardiac signal of a heart of the patient; and

a processor that detects a potential arrhythmia of a heart of the patient based on the sensed electrical cardiac signal, controls the electrical stimulator to adjust the delivery of therapy to the tissue site within the patient according to the first therapy program upon detecting the potential arrhythmia, determines whether the potential arrhythmia is detected after adjusting the delivery of therapy according to the first therapy program, controls the electrical stimulator to switch therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to a second therapy program if the potential arrhythmia is not detected after adjusting the delivery of therapy according to the first therapy program, wherein the first and second therapy programs define at least one different stimulation parameter value, and prohibits the electrical stimulator from further delivering therapy according to the first therapy program based upon a number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program.

21. The system of claim 20, wherein the electrical stimulator adjusts the delivery of therapy to the tissue site within the patient according to the first therapy program by at least stopping the delivery of therapy to the tissue site within the patient according to the first therapy program.

22. The system of claim 20, wherein the second therapy program defines a suspend state in which the electrical stimulator does not deliver electrical stimulation to the tissue site.

23. The system of claim 20, wherein the processor controls the electrical stimulator to prohibit further delivery of therapy according to the first therapy program based upon the number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program within a predetermined period of time.

24. The system of claim 20, wherein the processor controls the electrical stimulator to prohibit further delivery of therapy according to the first therapy program until the processor receives user input.

25. The system of claim 20, wherein the processor adjusts a counter after controlling the electrical stimulator to switch therapy delivery to the tissue site from therapy delivery according to the first therapy program to therapy delivery according to the second therapy program, and determines the number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program based on a value of the counter.

26. The system of claim 25, wherein the processor determines a type of detected potential arrhythmia, and adjusts the counter based on the type of potential arrhythmia detected.

27. The system of claim 20, wherein the processor controls the electrical stimulator to switch therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program by at least controlling the electrical stimulator to deliver therapy to the tissue site according to the second therapy program for a period of time, and wherein the processor controls the electrical stimulator to stop delivering therapy according to the second therapy program and deliver therapy to the patient according to the first therapy program after the period of time.

28. The system of claim 20, wherein the electrical stimulator comprises a first electrical stimulator, the system further comprising a second electrical stimulator, wherein the processor determines whether the potential arrhythmia is detected after the processor controls the electrical stimulator to switch therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program, and controls the second electrical stimulator to deliver at least one of pacing, cardioversion or defibrillation therapy to a heart of the patient if the potential arrhythmia is detected after switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program.

29. The system of claim 28, wherein the processor controls the first electrical stimulator to adjust the delivery of therapy according to the second therapy program if the potential arrhythmia is detected after switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to a second therapy program, and determines whether the potential arrhythmia is detected after therapy according to the second therapy program is adjusted, wherein the processor controls the second electrical stimulator to deliver the at least one of pacing, cardioversion or defibrillation therapy to the heart of the patient if the potential arrhythmia is detected after therapy according to the second therapy program is adjusted.

30. The system of claim 28, further comprising a first implantable medical device that comprises the first electrical stimulator and a second implantable medical device that comprises the second electrical stimulator, wherein the second implantable medical device is physically separate from the first implantable medical device.

31. The system of claim 28, further comprising an implantable medical device that comprises the first and second electrical stimulators enclosed within a common housing.

32. The system of claim 28, wherein the processor generates an interference indication if the potential arrhythmia is detected after the processor controls the electrical stimulator to switch therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to the second therapy program.

33. The system of claim 32, further comprising a medical device programmer, wherein the processor transmits the interference indication to the medical device programmer.

34. The system of claim 20, wherein the first and second therapy programs comprise stimulation parameter values that define different stimulation signal waveforms or signal envelopes.

35. The system of claim 20, wherein the second therapy program defines a guarded electrode combination, and wherein the electrical stimulator delivers therapy to the tissue site according to the second therapy program via the guarded cathode electrode combination.

36. A system comprising:

means for delivering therapy to a tissue site within a patient according to a first therapy program;

means for detecting a potential arrhythmia of a heart of the patient;

means for adjusting the delivery of therapy to the tissue site within the patient according to the first therapy program upon detecting the potential arrhythmia;

means for determining whether the potential arrhythmia is detected after adjusting the delivery of therapy according to the first therapy program;

means for switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to a second therapy program if the potential arrhythmia is not detected after adjusting the delivery of therapy according to the first therapy program, wherein the first and second therapy programs define at least one different stimulation parameter value; and

means for prohibiting further delivery of therapy according to the first therapy program based upon a number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program.

37. The system of claim 36, further comprising:

means for adjusting a counter after adjusting the delivery of therapy to the tissue site within the patient according to the first therapy program and switching therapy delivery to the tissue site to therapy delivery according to the second therapy program; and

means for determining the number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program based on a value of the counter.

38. The system of claim 36, further comprising:

means for determining whether the potential arrhythmia is detected after switching therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to a second therapy program; and

means for delivering at least one of a pacing, cardioversion or defibrillation therapy to the heart of the patient if the potential arrhythmia is detected after therapy is delivered to the tissue site according to the second therapy program.

39. A non-transitory computer-readable medium comprising instructions that cause a programmable processor to:

control an electrical stimulator to deliver therapy to a tissue site within a patient according to a first therapy program;

detect a potential arrhythmia of a heart of the patient;

upon detecting the potential arrhythmia, control the electrical stimulator to adjust the delivery of therapy to the tissue site within the patient according to the first therapy program;

determine whether the potential arrhythmia is detected after controlling the electrical stimulator to adjust the delivery of therapy according to the first therapy program;

control the electrical stimulator to switch therapy delivery to the tissue site from therapy according to the first therapy program to therapy according to a second therapy program if the potential arrhythmia is not detected after controlling the electrical stimulator to adjust the delivery of therapy according to the first therapy program, wherein the first and second therapy programs define at least one different stimulation parameter value; and

control the electrical stimulator to prohibit further delivery of therapy according to the first therapy program based upon a number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program.

40. The computer-readable medium of claim 39, wherein the instructions cause the programmable processor to adjust a counter after controlling the electrical stimulator to adjust the delivery of therapy to the tissue site within the patient according to the first therapy program and switch therapy delivery to the tissue site to therapy delivery according to the second therapy program, and determine the number of times therapy delivery to the tissue site is switched from therapy according to the first therapy program to therapy according to the second therapy program based on a value of the counter.