Methods and devices for multi-stage ventricular therapy

• US 10,099,062 B2
• Filed: 12/02/2016
• Issued: 10/16/2018
• Est. Priority Date: 12/11/2007
• Status: Active Grant

• Current Assignee: Washington University In St Louis
• Original Assignee: Washington University In St Louis
• Inventors: Efimov, Igor R., Li, Wenwen, Janardhan, Ajit H.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US15/367,927
• Publication Number:
  US 20170080243A1
• Time in Patent Office: 683 Days
• Field of Search: 607 5, 607 9
• CPC Class Codes: A61N 1/3624 occurring in the atrium, i.e. atrial tachycardia
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3981 High voltage charging circuitry

Abstract

Methods and apparatus for a three-stage ventricular cardioversion and defibrillation therapy that treats ventricular tachycardia and fibrillation at low energy levels. An implantable therapy generator adapted to generate and selectively deliver a three-stage ventricular therapy and at least two leads operably each having at least one electrode adapted to be positioned proximate the ventricle of the patient. The device is programmed to deliver a three-stage therapy via both a far-field configuration and a near-field configuration of the electrodes upon detection of a ventricular arrhythmia. The three-stage therapy includes a first stage for unpinning of one or more singularities associated with the ventricular arrhythmia, a second stage for anti-repinning of the one or more singularities, both of which are delivered via the far-field configuration of the electrodes, and a third stage for extinguishing of the one or more singularities associated delivered via the near-field configuration of the electrodes.

Claims

1. An implantable therapy generator, comprising:

detection circuitry configured to detect a ventricular arrhythmia;

control circuitry operably connected to the detection circuitry that, in response to detection of a ventricular arrhythmia, controls generation and selective delivery of a therapy without confirmation of conversion of the ventricular arrhythmia during the therapy, the therapy including;

a first set of electrical pulses to destabilize a reentry associated with the ventricular arrhythmia; and

a second set of electrical pulses to terminate the reentry associated with the ventricular arrhythmia, wherein the first set of pulses is greater in number than the second set of pulses.

2. The implantable therapy generator of claim 1, further comprising:

at least one far field implantable electrode to deliver at least one of the first and second sets of electrical pulses.

3. The implantable therapy generator of claim 1, further comprising:

at least one far field implantable electrode to deliver the first set of pulses; and

at least one near field implantable electrode to deliver the second set of pulses.

4. The implantable therapy generator of claim 3, wherein the first set of electrical pulses have a voltage lower than the second set of electrical pulses.

5. The implantable therapy generator of claim 1, further comprising:

at least one near field implantable electrode to deliver the first set of pulses; and

at least one far field implantable electrode to deliver the second set of pulses.

6. The implantable therapy generator of claim 1, further comprising:

at least one near field implantable electrode to deliver at least one of the first and second sets of electrical pulses.

7. The implantable therapy generator of claim 1, wherein each electrical pulse of the first set of pulses includes at least one parameter configured to destabilize the reentry.

8. The implantable therapy generator of claim 1, wherein each electrical pulse of the first set of pulses is delivered according to at least one parameter configured to destabilize the reentry.

9. The implantable therapy generator of claim 1, wherein each electrical pulse of the second set of electrical pulses includes at least one parameter configured to terminate the reentry.

10. The implantable therapy generator of claim 1, wherein each electrical pulse of the second set of pulses is delivered according to at least one parameter configured to terminate the reentry.

11. The implantable therapy generator of claim 1, wherein the therapy further includes a delay separating the first set of pulses and the second set of pulses.

12. The implantable therapy generator of claim 11, wherein the delay is greater than a duration of the first set of pulses and greater than a duration of the second set of pulses.

13. The implantable therapy generator of claim 11, wherein the delay has a predetermined duration.

14. An implantable therapy generator, comprising:

detection circuitry configured to detect a ventricular arrhythmia;

control circuitry operably connected to the detection circuitry that, in response to detection of a ventricular arrhythmia, controls generation and selective delivery of a therapy without confirmation of conversion of the ventricular arrhythmia during the therapy, the therapy including;

a first set of electrical pulses to destabilize a reentry associated with the ventricular arrhythmia; and

a second set of electrical pulses to terminate the reentry associated with the ventricular arrhythmia, wherein the second set of pulses is greater in number than the first set of pulses.

15. The implantable therapy generator of claim 14, further comprising:

at least one far field implantable electrode to deliver at least one of the first and second sets of electrical pulses.

16. The implantable therapy generator of claim 14, further comprising:

at least one far field implantable electrode to deliver the first set of pulses; and

at least one near field implantable electrode to deliver the second set of pulses.

17. The implantable therapy generator of claim 16, wherein the first set of electrical pulses have a voltage lower than the second set of electrical pulses.

18. The implantable therapy generator of claim 14, further comprising:

at least one near field implantable electrode to deliver the first set of pulses; and

at least one far field implantable electrode to deliver the second set of pulses.

19. The implantable therapy generator of claim 14, further comprising:

at least one near field implantable electrode to deliver at least one of the first and second sets of electrical pulses.

20. The implantable therapy generator of claim 14, wherein each electrical pulse of the first set of pulses includes at least one parameter configured to destabilize the reentry.

21. The implantable therapy generator of claim 14, wherein each electrical pulse of the first set of pulses is delivered according to at least one parameter configured to destabilize the reentry.

22. The implantable therapy generator of claim 14, wherein each electrical pulse of the second set of electrical pulses includes at least one parameter configured to terminate the reentry.

23. The implantable therapy generator of claim 14, wherein each electrical pulse of the second set of pulses is delivered according to at least one parameter configured to terminate the reentry.

24. The implantable therapy generator of claim 14, wherein the therapy further includes a delay separating the first set of pulses and the second set of pulses.

25. The implantable therapy generator of claim 24, wherein the delay is greater than a duration of the first set of pulses and greater than a duration of the second set of pulses.

26. The implantable therapy generator of claim 24, wherein the delay has a predetermined duration.

27. A method for treating a ventricular arrhythmia, the method comprising:

detecting a ventricular arrhythmia with an implantable electrical stimulator, the implantable electrical stimulator operably coupled to at least one electrode implantable proximate a heart of a patient, the implantable electrical stimulator including;

detection circuitry configured to evaluate at least one biological signal to detect the ventricular arrhythmia, wherein the at least one biological signal corresponds to electrical activity of the heart; and

control circuitry configured to deliver a plurality of sets of electrical stimulation to the heart in response to the detected ventricular arrhythmia, the plurality of sets of electrical stimulation having at least a first set and a second set, wherein the first set includes a first plurality of pulses and is configured to destabilize a reentry associated with the ventricular arrhythmia, and wherein the second set includes a second plurality of pulses and is configured to terminate the reentry associated with the ventricular arrhythmia, wherein the first plurality of pulses in the first set is greater in number than the second plurality of pulses in the second set; and

delivering the plurality of sets of electrical stimulation without confirmation of conversion of the detected ventricular arrhythmia during delivery of the plurality of sets of electrical stimulation.

28. The method of claim 27, wherein at least one of the first and second sets of electrical stimulation are delivered from at least one far field implantable electrode.

29. The method of claim 27, wherein the first set of electrical stimulation is delivered from at least one far field implantable electrode, and wherein the second set of electrical stimulation is delivered from at least one near field implantable electrode.

30. The method of claim 29, wherein the first set of electrical pulses have a voltage lower than the second set of electrical pulses.

31. The method of claim 27, wherein the first set of electrical stimulation is delivered from at least one near field implantable electrode, and wherein the second set of electrical stimulation is delivered from at least one far field implantable electrode.

32. The method of claim 27, wherein at least one of the first and second sets of electrical stimulation are delivered from at least one near field implantable electrode.

33. The method of claim 27, wherein each electrical pulse of the first set of pulses includes at least one parameter configured to destabilize the reentry.

34. The method of claim 27, wherein each electrical pulse of the first set of pulses is delivered according to at least one parameter configured to destabilize the reentry.

35. The method of claim 27, wherein each electrical pulse of the second set of electrical pulses includes at least one parameter configured to terminate the reentry.

36. The method of claim 27, wherein each electrical pulse of the second set of pulses is delivered according to at least one parameter configured to terminate the reentry.

37. The method of claim 27, wherein the first set and the second set are separated by a delay.

38. The method of claim 37, wherein the delay between the first and second sets is greater than a duration of the first set and greater than a duration of the second set.

39. The method of claim 37, wherein the delay has a predetermined duration.

40. A method for treating a ventricular arrhythmia, the method comprising:

detecting a ventricular arrhythmia with an implantable electrical stimulator, the implantable electrical stimulator operably coupled to at least one electrode implantable proximate a heart of a patient, the implantable electrical stimulator including;

detection circuitry configured to evaluate at least one biological signal to detect the ventricular arrhythmia, wherein the at least one biological signal corresponds to electrical activity of the heart; and

control circuitry configured to deliver a plurality of sets of electrical stimulation to the heart in response to the detected ventricular arrhythmia, the plurality of sets of electrical stimulation having at least a first set and a second set, wherein the first set includes a first plurality of pulses and is configured to destabilize a reentry associated with the ventricular arrhythmia, and wherein the second set includes a second plurality of pulses and is configured to terminate the reentry associated with the ventricular arrhythmia, wherein the second plurality of pulses in the second se is greater in number than the first plurality of pulses in the first set; and

delivering the plurality of sets of electrical stimulation without confirmation of conversion of the detected ventricular arrhythmia during delivery of the plurality of sets of electrical stimulation.

41. The method of claim 40, wherein at least one of the first and second sets of electrical stimulation are delivered from at least one far field implantable electrode.

42. The method of claim 40, wherein the first set of electrical stimulation is delivered from at least one far field implantable electrode, and wherein the second se of electrical stimulation is delivered from at least one near field implantable electrode.

43. The method of claim 42, wherein the first set of electrical pulses have a voltage lower than the second set of electrical pulses.

44. The method of claim 40, wherein the first set of electrical stimulation is delivered from at least one near field implantable electrode, and wherein the second set of electrical stimulation is delivered from at least one far field implantable electrode.

45. The method of claim 40, wherein at least one of the first and second sets of electrical stimulation are delivered from at least one near field implantable electrode.

46. The method of claim 40, wherein each electrical pulse of the first set of pulses includes at least one parameter configured to destabilize the reentry.

47. The method of claim 40, wherein each electrical pulse of the first set of pulses is delivered according to at least one parameter configured to destabilize the reentry.

48. The method of claim 40, wherein each electrical pulse of the second set of electrical pulses includes at least one parameter configured to terminate the reentry.

49. The method of claim 40, wherein each electrical pulse of the second set of pulses is delivered according to at least one parameter configured to terminate the reentry.

50. The method of claim 40, wherein the first set and the second set are separated by a delay.

51. The method of claim 50, wherein the delay between the first and second sets is greater than a duration of the first se and greater than a duration of the second set.

52. The method of claim 50, wherein the delay has a predetermined duration.