Apparatus and method for timing the delivery of non-excitatory ETC signals to a heart

• US 6,263,242 B1
• Filed: 03/25/1999
• Issued: 07/17/2001
• Est. Priority Date: 03/25/1999
• Status: Expired due to Term

• Current Assignee: Impulse Dynamics NV
• Original Assignee: Impulse Dynamics NV
• Inventors: Mika, Yuval, Belsky, Ziv, Prutchi, David
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/276,460
• Time in Patent Office: 845 Days
• Field of Search: 607/9, 607/11, 607/68, 607/25, 600/510
• US Class Current: 607/9
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A method and devices for timing the delivery of non-excitatory signals for modifying myocardial contractility of a portion of the heart. The method includes the steps of applying electrodes to a plurality of cardiac sites, sensing electrical activity in a first cardiac site through a first electrode for detecting a first electrical depolarization event within a beat cycle, sensing electrical activity in a second cardiac site through a second electrode for detecting a second electrical depolarization event within the beat cycle, and applying a non-excitatory signal to the heart at or near at least the second cardiac site through at least one of the electrodes in response to detecting the second electrical depolarization event within an alert window period. The alert window period starts at a first delay from the time of detection of the first electrical depolarization event and has a first duration. The applying of the non-excitatory signal is delayed from the time of detecting of the second electrical depolarization event. The method may include steps for reducing the probability of delivering of improperly timed non-excitatory signals due to electrical noise and/or ectopic beats and may also include steps for preventing delivery of multiple non-excitatory signals at or near the second cardiac site within a single cardiac beat cycle. Preferably, the first cardiac site is located about the right ventricle or the right atrium of the heart and the second cardiac site is located about the left ventricle of the heart. The devices may also be adapted for pacing the heart and/or for delivering defibrillation signals to the heart.

Claims

1. A method for timing the delivery of a non-excitatory signal to a heart within a cardiac beat cycle, the method comprising the steps of:

applying electrodes to a plurality of cardiac sites;

sensing electrical activity in at least a first site of said plurality of cardiac sites through at least a first electrode of said electrodes for detecting a first electrical depolarization event within said beat cycle;

sensing electrical activity in at least a second site of said plurality of sites through at least a second electrode of said electrodes for detecting at least a second electrical depolarization event within said beat cycle; and

applying said non-excitatory signal to at least one of said cardiac sites through at least one of said electrodes in response to detecting said second electrical depolarization event within an alert window period, said alert window period starts at a first delay from the time of detection of said first electrical depolarization event and has a first duration, said applying is delayed from the time of detecting of said at least second electrical depolarization event.

2. The method according to claim 1 further including the step of inhibiting the applying of said non-excitatory signal of said step of applying in response to detecting at said at least second site a third electrical depolarization event preceding said second electrical depolarization event, said third electrical depolarization event is detected within an inhibition window period, said inhibition window period starts at a second delay from the time of detection of said first electrical depolarization event and terminates before or at the time of starting of said alert window period, said second delay is smaller than said first delay.

3. The method according to claim 2 wherein said step of inhibiting comprises the step of initiating an inhibition refractory period, said inhibition refractory period starts at the time of detecting of said third electrical depolarization event and has a second duration, wherein said sensing of said electrical activity in said at least second site is disabled during said inhibition refractory period.

4. The method according to claim 3 wherein said second duration of said inhibition refractory period is a preset duration.

5. The method according to claim 3 wherein said second duration of said inhibition refractory period is equal to or larger than the value obtained by summing said inhibition window period, said first duration, said second delay and the maximal allowable duration of said non-excitatory signal.

6. The method according to claim 3 wherein said step of initiating comprises the step of determining the value of said second duration for said beat cycle from the time of detecting of said third electrical depolarization event within said beat cycle and from the preset values of said first duration of said alert window, said first delay and the maximal allowable duration of said non-excitatory signal.

7. The method according to claim 6 wherein said second duration is larger than the value obtained by subtracting said time of detecting of said third electrical depolarization event from the sum of said first delay, said first duration, said second delay and said maximal allowable duration of said non-excitatory signal.

8. The method according to claim 1 wherein the sensing of said second step of sensing at said at least second site starts after the end of a refractory time period, said refractory period begins at the time of detection of said first electrical depolarization event and has a refractory period duration.

9. The method according to claim 8 further including the step of pacing the heart by applying at least one pacing pulse to said heart through said at least first electrode, wherein said refractory period prevents the sensing of electrical artifact signals by said at least second electrode due to said at least one pacing pulse.

10. The method according to claim 1 wherein said at least first site is located in or about the right ventricle of said heart and said at least second site is located in or about the left ventricle of said heart.

11. The method according to claim 1 wherein said at least first site is located in or about the right atrium of said heart and said at least second site is located in or about the left ventricle of said heart.

12. The method according to claim 1 further including the step of pacing the heart by applying within said beat cycle a pacing pulse to at least one of said electrodes prior to said second step of applying.

13. The method according to claim 12 wherein said at least first site is located in or about the right ventricle of said heart and said at least second site is located in or about the left ventricle of said heart.

14. The method according to claim 13 wherein said step of pacing comprises pacing said right ventricle by applying a pacing pulse to said at least first electrode or to one of said electrodes applied to said right ventricle.

15. The method according to claim 13 wherein said step of pacing comprises pacing said left ventricle by applying a pacing pulse to said at least second electrode or to one of said electrodes applied to said left ventricle.

16. The method according to claim 13 wherein said step of pacing comprises pacing the right atrium of said heart by delivering a pacing pulse to said right atrium through one of said electrodes applied to said right atrium.

17. The method according to claim 12 wherein said at least first site is located in or about the right atrium of said heart and said at least second site is located in or about the left ventricle of said heart.

18. The method according to claim 17 wherein said step of pacing comprises pacing said right atrium by applying a pacing pulse to said at least first electrode or to one of said electrodes applied to said right atrium.

19. The method according to claim 17 wherein said step of pacing comprises pacing said left ventricle by applying a pacing pulse to said at least second electrode or to one of said electrodes applied to said left ventricle.

20. The method according to claim 17 wherein said step of pacing comprises pacing the right ventricle of said heart by delivering a pacing pulse to said right ventricle through one of said electrodes applied to said right ventricle.

21. The method according to claim 1 wherein said detecting of at least one of said first step of sensing and said second step of sensing comprises detecting a depolarization event using an event detection method selected from a threshold crossing detection method, a detection method based on one or more morphological parameters of said electrical activity, a slope based detection method and any combination thereof.

22. The method according to claim 1 wherein said first electrical depolarization event is an electrical depolarization wave initiated by the intrinsic pacing activity of said heart or by a pacing pulse delivered to said heart through one of said electrodes.

23. The method according to claim 1 wherein said second electrical depolarization event is an electrical depolarization wave initiated by the intrinsic pacing activity of said heart or by a pacing pulse delivered to said heart through one of said electrodes.

24. The method according to claim 1 wherein the applying of said non-excitatory signal of said second step of applying is performed through said at least second electrode.

25. The method according to claim 1 wherein said applying of said second step of applying is performed in response to the earliest occurring electrical depolarization event of said at least second electrical depolarization event detected within said alert window period.

26. The method according to claim 25 further including the step of initiating an alert refractory period in response to the detection of said earliest occurring electrical depolarization event within said alert window period, said alert refractory period starts at the time of detection of said earliest occurring electrical depolarization event and has a third duration, said alert refractory period ends within the duration of said beat cycle, wherein during said alert refractory period said sensing and said detecting of said second step of sensing at said at least second site are disabled.

27. The method according to claim 26 wherein said third duration of said alert refractory period is a preset value.

28. The method according to claim 26 wherein said third duration of said alert refractory period is larger than the sum of said first duration, said second delay and the maximal allowable duration of said non-excitatory signal.

29. A method for timing the delivery of a non-excitatory signal to a heart within a cardiac beat cycle, the method comprising the steps of:

sensing electrical activity in at least a first site of said heart through at least a first electrode applied to said at least first site for detecting a first electrical depolarization event within said beat cycle;

sensing electrical activity in at least a second site of said heart through at least a second electrode applied to said at least second site for detecting at least a second electrical depolarization event within said beat cycle; and

applying said non-excitatory signal at or in the vicinity of said at least second site of said heart in response to detecting said second electrical depolarization event within an alert window period, said alert window period starts at a first delay from the time of detection of said first electrical depolarization event and has a first duration, said applying is delayed from the time of detecting of said at least second electrical depolarization event.

30. The method according to claim 29 further including the step of inhibiting the applying of said non-excitatory signal of said step of applying in response to detecting at said at least second site a third electrical depolarization event preceding said second electrical depolarization event, said third electrical depolarization event is detected within an inhibition window period, said inhibition window period starts at a second delay from the time of detection of said first electrical depolarization event and terminates at or before the time of starting of said alert window period, said second delay is smaller than said first delay.

31. The method according to claim 30 wherein said step of inhibiting comprises the step of initiating an inhibition refractory period, said inhibition refractory period starts at the time of detecting of said third electrical depolarization event and has a second duration, wherein said sensing of said electrical activity in said at least second site is disabled during said inhibition refractory period.

32. The method according to claim 31 wherein said second duration of said inhibition refractory period is a preset duration.

33. The method according to claim 31 wherein said second duration of said inhibition refractory period is equal to or larger than the value obtained by summing said inhibition window period, said first duration, said second delay and the maximal allowable duration of said non-excitatory signal.

34. The method according to claim 31 wherein said step of initiating comprises the step of determining the value of said second duration for said beat cycle from the time of detecting of said third electrical depolarization event within said beat cycle and from the preset values of said first duration of said alert window, said first delay and the maximal allowable duration of said non-excitatory signal.

35. The method according to claim 34 wherein said second duration is larger than the value obtained by subtracting said time of detecting of said third electrical depolarization event from the sum of said first delay, said first duration, said second delay and said maximal allowable duration of said non-excitatory signal.

36. The method according to claim 29 wherein said at least first site is located in or about the right ventricle of said heart and said at least second site is located in or about the left ventricle of said heart.

37. The method according to claim 29 wherein said at least first site is located in or about the right atrium of said heart and said at least second site is located in or about the left ventricle of said heart.

38. The method according to claim 29 further including the step of pacing the heart within said beat cycle by delivering a pacing pulse to said heart prior to said step of applying.

39. The method according to claim 38 wherein said delivering of said pacing pulse comprises applying said pacing pulse to an electrode selected from said at least first electrode, said at least second electrode and a third electrode applied to a third site of said heart.

40. The method according to claim 38 wherein said at least first site is located in or about the right ventricle of said heart and said at least second site is located in or about the left ventricle of said heart.

41. The method according to claim 40 wherein said step of pacing comprises pacing said right ventricle by applying a pacing pulse to said at least first electrode or to a pacing electrode applied to said right ventricle.

42. The method according to claim 40 wherein said step of pacing comprises pacing said left ventricle by applying a pacing pulse to said at least second electrode or to a pacing electrode applied to said left ventricle.

43. The method according to claim 40 wherein said step of pacing comprises pacing the right atrium of said heart by delivering a pacing pulse to said right atrium through a third electrode applied to said right atrium.

44. The method according to claim 39 wherein said at least first site is located in or about the right atrium of said heart and said at least second site is located in or about the left ventricle of said heart.

45. The method according to claim 44 wherein said at least first electrode is applied to the right atrium of the heart, said at least second electrode is applied to the left ventricle of the heart and said third electrode is applied to the right atrium of said heart.

46. The method according to claim 44 wherein said at least first electrode is applied the right atrium of the heart, said at least second electrode is applied to the left ventricle of the heart and said third site is the right ventricle of said heart.

47. The method according to claim 29 further including the step of pacing the heart by delivering a pacing pulse to said heart prior to said step of applying through at least one electrode selected from said at least first electrode, said at least second electrode and a third electrode applied to a third site of said heart.

48. The method according to claim 47 wherein said at least first site is located in or about the right ventricle of the heart, said at least second site is located in or about the left ventricle of the heart and said third site is the right atrium of said heart.

49. The method according to claim 29 wherein said detecting of at least one of said first step of sensing and said second step of sensing comprises detecting a depolarization event using an event detection method selected from a threshold crossing detection method, a detection method based on one or more morphological parameters of said electrical activity, a slope based detection method, and any combination thereof.

50. The method according to claim 29 wherein said first electrical depolarization event is an electrical depolarization wave initiated by the intrinsic pacing activity of said heart or by a pacing pulse delivered to said heart.

51. The method according to claim 29 wherein said second electrical depolarization event is an electrical depolarization wave initiated by the intrinsic pacing activity of said heart or by a pacing pulse.

52. The method according to claim 29 wherein the applying of said non-excitatory signal of said step of applying is performed through said at least second electrode of said second step of sensing.

53. The method according to claim 29 wherein said applying of said step of applying is performed in response to the detection of the earliest occuring electrical depolarization event of said at least second electrical depolarization event detected within said alert window period.

54. The method according to claim 53 further including the step of initiating an alert refractory period in response to the detection of said earliest occurring electrical depolarization event, said alert refractory period starts at the time of detection of said earliest occurring electrical depolarization event and has a third duration, said alert refractory period ends within the duration of said beat cycle, wherein during said alert refractory period said sensing and said detecting of said second step of sensing at said at least second site are disabled.

55. The method according to claim 54 wherein said third duration of said alert refractory period is a preset value.

56. The method according to claim 54 wherein said third duration of said alert refractory period is larger than the sum of said first duration, said second delay and the maximal allowable duration of said non-excitatory signal.

57. Apparatus for timing the delivery of a non-excitatory signal to a heart within a cardiac beat cycle of said heart, the apparatus comprising:

a plurality of electrodes adapted to be implanted in said heart;

an excitable tissue control unit operatively connected to at least one electrode of said plurality of electrodes for delivering said non-excitatory signal to said heart;

a detecting unit operatively connected to a first electrode of said plurality of electrodes for sensing electrical activity in a first cardiac site and for detecting a first electrical depolarization event within said beat cycle, said detecting unit is also connected to a second electrode of said plurality of electrodes for sensing electrical activity in a second cardiac site and for detecting at least a second electrical depolarization event within said beat cycle;

a controller unit operatively connected to said excitable tissue control unit and said detecting unit for controlling the operation of said excitable tissue control unit and said detecting unit, for receiving from said detecting unit signals representing the detection of said first electrical depolarization event and said second electrical depolarization event and for controlling the applying, through at least one of said plurality of electrodes, of said non-excitatory signal to said second cardiac site or in the vicinity thereof in response to the detecting of said at least second electrical depolarization event by said detecting unit within an alert window period, said alert window period starts at a first delay from the time of detection of said first electrical depolarization event and has a first duration, said applying is delayed from the time of detecting of said at least second electrical depolarization event; and

a power source for providing power to said excitable tissue control unit, said detection unit and said controller unit.

58. The apparatus according to claim 57 wherein said controller is adapted to inhibit said applying of said non-excitatory signal in response to receiving from said detecting unit a signal representing the detecting at said second site of a third electrical depolarization event preceding said second electrical depolarization event, said third electrical depolarization event is detected within an inhibition window period, said inhibition window period starts at a second delay from the time of detection of said first electrical depolarization event and terminates at or before the time of starting of said alert window period, said second delay is smaller than said first delay.

59. The apparatus according to claim 58 wherein said controller is adapted for initiating an inhibition refractory period, said inhibition refractory period is initiated by said signal representing the detecting at said second site of said third electrical depolarization event by said detecting unit, said inhibition refractory period has a second duration, said controller is adapted for disabling the sensing by said detecting unit of said electrical activity in said at least second site during said inhibition refractory period.

60. The apparatus according to claim 59 wherein said second duration of said inhibition refractory period is a preset duration.

61. The apparatus according to claim 59 wherein said second duration of said inhibition refractory period is equal to or larger than the value obtained by summing said inhibition window period, said first duration, said second delay and the maximal allowable duration of said non-excitatory signal.

62. The apparatus according to claim 59 wherein said controller is adapted to determine the value of said second duration for said inhibition refractory period from the time of detecting of said third electrical depolarization event within said beat cycle and from the preset values of said first duration of said alert window, said first delay and the maximal allowable duration of said non-excitatory signal.

63. The apparatus according to claim 62 wherein said second duration is larger than the value obtained by subtracting said time of detecting of said third electrical depolarization event from the sum of said first delay, said first duration, said second delay and said maximal allowable duration of said non-excitatory signal.

64. The apparatus according to claim 57 wherein said detecting unit is adapted for detecting at least one of said first electrical depolarization event and said second electrical depolarization event by using an event detection method selected from a threshold crossing detection method, a detection method based on one or more morphological parameters of said electrical activity, a slope based detection method, and any combination thereof.

65. The apparatus according to claim 57 wherein said detecting unit is selected from an analog detecting unit and a digital detecting unit.

66. The apparatus according to claim 57 wherein said controller unit is selected from a central processing unit, a micro-controller unit, a digital signal processing unit, a computer, a workstation, and any combination thereof.

67. The apparatus according to claim 57 further including an implantable housing, wherein said power unit, said detecting unit, said excitable tissue control unit and said controller unit are contained within said housing.

68. The apparatus according to claim 67 further including a telemetry unit disposed within said housing and operatively connected to said controller.

69. The apparatus according to claim 57 wherein said plurality of electrodes is implanted within said patient, and wherein said excitable tissue control unit, said detecting unit, said controller unit and said power unit are disposed outside of said patient.

70. The apparatus according to claim 57 wherein said first electrode is implanted in or about the right ventricle of said heart and said second electrode is implanted in or about the left ventricle of said heart.

71. The apparatus according to claim 57 wherein said first electrode is implanted in or about the right atrium of said heart and said second site is located in or about the left ventricle of said heart.

72. The apparatus according to claim 57 further including a pacing unit powered by said power source and operatively connected to at least one electrode of said plurality of electrodes for delivering pacing pulses to said heart, said controller unit is operatively connected to said pacing core unit for controlling the operation thereof.

73. The apparatus according to claim 72 wherein said first electrode is implanted in or about the right ventricle of said heart and said second electrode is implanted in or about the left ventricle of said heart.

74. The apparatus according to claim 73 wherein said first electrode is operatively connected to said pacing unit for pacing said right ventricle.

75. The apparatus according to claim 73 wherein said second electrode is operatively connected to said pacing unit for pacing said left ventricle.

76. The apparatus according to claim 73 wherein at least one electrode of said plurality of electrodes is operatively connected to said pacing unit and is implanted in or about the right atrium for pacing said right atrium.

77. The apparatus according to claim 72 wherein said first electrode is implanted in or about the right atrium of said heart and said second electrode is implanted in or about the left ventricle of said heart.

78. The apparatus according to claim 77 wherein said first electrode is operatively connected to said pacing unit for pacing said right atrium.

79. The apparatus according to claim 77 wherein said second electrode is operatively connected to said pacing unit for pacing said left ventricle.

80. The apparatus according to claim 77 wherein at least one of said electrodes is implanted in or about the right ventricle of said heart and is operatively connected to said pacing unit for pacing said right ventricle.

81. The apparatus according to claim 57 wherein said controller is adapted to control said excitable tissue control unit to deliver said non-excitatory signal in response to the detection of the earliest electrical depolarization event of said at least second electrical depolarization event within said alert window period.

82. The apparatus according to claim 81 wherein said controller is configured an alert refractory period in response to the detection of said earliest electrical depolarization event, said alert refractory period starts at the time of detection of said earliest electrical depolarization event and has a third duration, said alert refractory period ends within the duration of said beat cycle, wherein during said alert refractory period said sensing and said detecting of said detecting unit is disabled.

83. The apparatus according to claim 82 wherein said third duration of said alert refractory period is a preset value.

84. The apparatus according to claim 82 wherein said third duration of said alert refractory period is larger than the sum of said first duration, said second delay and the maximal allowable duration of said non-excitatory signal.