Atrial defibrillator and method

• US 5,282,837 A
• Filed: 04/12/1991
• Issued: 02/01/1994
• Est. Priority Date: 04/12/1991
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: InControl, Inc. (Daikin Industries Ltd)
• Inventors: Alferness, Clifton A., Adams, John M.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US07/685,130
• Time in Patent Office: 1,026 Days
• Field of Search: 128/419 D, 128/419 PG, 128/901, 607/5, 607/4
• US Class Current: 607/5
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• 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 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

An implantable atrial defibrillator provides a pulse of defibrillating electrical energy to the atria of the heart in synchronism with sensed R waves in response to non-coincident sensing of an R wave at first and second areas of the heart. The defibrillating pulse is provided after a predetermined number of consecutive R waves are non-coincidently sensed to assure reliable synchronization. The atrial defibrillator is also operational in a marker mode wherein a number of synchronization marker pulses are delivered to the heart for detection on an externally generated electrocardiogram. The atrial fibrillation detector of the defibrillator is normally disabled and is activated when the sensed ventricular activity indicates a probability of atrial fibrillation to conserve a depletable power source. An endocardial lead is also described which ensures that the delivered atrial defibrillating electrical energy is substantially confined to the atria of the heart.

Claims

1. An atrial defibrillator for applying an electrical defibrillating pulse to the atria of a human heart, said atrial defibrillator being arranged to apply said electrical defibrillating pulse to the atria in synchronism with depolarization activation waves and comprising:

first means for sensing depolarization activation waves at a first area of the heart;

second means for sensing said depolarization activation waves at a second area of the heart;

means for detecting non-coincident sensing of said depolarization activation waves at said first area of the heart by said first means and at said second area of the heart by said second means;

storage means for storing electrical energy; and

delivery means coupled to said storage means and being responsive to the non-coincident sensing of a depolarization activation wave at said first and second areas of the heart for applying a predetermined amount of said stored electrical energy to the atria.

2. An atrial defibrillator as defined in claim 1 wherein said means for detecting includes delay establishing means for establishing a range of normal delay times between a depolarization activation wave being sensed at said first area of the heart by said first means and being sensed at said second area of the heart by said second means, and wherein said delivery means is responsive to the sensing of a depolarization activation wave at said first and second areas of the heart within said range of normal delay times for applying a predetermined amount of said stored electrical energy to the atria.

3. An atrial defibrillator as defined in claim 2 wherein said first means include first lead means arranged for establishing electrical contact with the right ventricle of the heart for sensing said depolarization activation waves at the right ventricle and wherein said second means include second lead means arranged for establishing electrical contact with the left ventricle of the heart for sensing said depolarization activation waves at the left ventricle of the heart.

4. An atrial defibrillator as defined in claim 3 where said range of normal delay times is between five milliseconds and thirty milliseconds.

5. An atrial defibrillator as defined in claim 3 wherein said first lead means comprises an endocardial lead and said second lead means comprises an intravascular lead.

6. An atrial defibrillator as defined in claim 2 wherein said delivery means include timer means for determining a time span between a depolarization activation wave being sensed by said first means and being sensed by said second means.

7. An atrial defibrillator as defined in claim 6 wherein said delivery means further include means for comparing the time span determined by said timer means to said range of normal delay times.

8. An atrial defibrillator as defined in claim 7 wherein said delivery means further includes synchronizing pulse generating means for generating a synchronizing pulse responsive to said comparing means when the time span determined by said timer means is within said range of normal delay times.

9. An atrial defibrillator as defined in claim 8 wherein said delivery means further includes counter means for counting said synchronizing pulses and wherein said delivery means applies said electrical energy to the atria when a predetermined number of said synchronizing pulses have been counted.

10. An atrial defibrillator as defined in claim 9 further including reset means responsive to said comparing means for resetting said counter means when the time span determined by said timer means is outside said range of normal delay times.

11. An atrial defibrillator as defined in claim 9 wherein said predetermined number is five.

12. An implantable atrial cardioverter arranged to be powered by a depletable power source for delivering electrical energy to the atria of a human heart in need of cardioversion, said atrial cardioverter comprising:

sensing means for sensing electrical activations of the heart, said sensing means being continuously operable;

means responsive to said sensing means for determining time intervals between said sensed electrical activations;

atrial arrhythmia detector means for detecting the presence of an atrial arrhythmia of the heart;

disable means for maintaining said atrial arrhythmia detector means normally disabled to avoid excessive consumption of said depletable power source;

enable means for enabling said atrial arrhythmia detector means responsive to said determined time intervals; and

delivery means responsive to said atrial arrhythmia detector means for delivering said electrical energy to the atria of the heart in response to said atrial arrhythmia detector means detecting atrial arrhythmia of the heart.

13. An atrial cardioverter as defined in claim 12 wherein said enable means include averaging means for determining the average time interval of a last predetermined number of determined time intervals responsive to each sensed electrical activation and wherein said enable means enable said atrial arrhythmia detector means when one of said average time intervals is less than a predetermined time interval.

14. An atrial cardioverter as defined in claim 13 wherein said predetermined time interval is 500 milliseconds.

15. An atrial cardioverter as defined in claim 13 when said predetermined number of determined time intervals is equal to twenty.

16. An atrial cardioverter as defined in claim 12 wherein said atrial cardioverter is an atrial defibrillator and wherein said atrial arrhythmia detector means is an atrial fibrillation detector means for detecting the presence of atrial fibrillation of the heart.

17. An atrial cardioverter as defined in claim 16 wherein said enable means include time interval variation determining means for determining the variation in the time intervals of a last predetermined number of determined time intervals responsive to each sensed electrical activation and wherein said enable means enable said atrial fibrillation detector means when one of said variations exceeds a predetermined variation.

18. An atrial defibrillator as defined in claim 17 wherein said variation determining means comprises a standard deviation determining means.

19. An atrial defibrillator as defined in claim 18 wherein said predetermined variation is a standard deviation equal to twenty milliseconds.

20. An atrial defibrillator as defined in claim 18 wherein said predetermined number of determined time intervals is equal to twenty.

21. An atrial defibrillator as defined in claim 16 wherein said enable means comprises averaging means for determining the average time interval of a last predetermined number of determined time intervals responsive to each sensed electrical activation and standard deviation determining means for determining the standard deviation in the time intervals of said last predetermined number of determined time intervals responsive to each sensed electrical activation and wherein said enable means enable said atrial fibrillation detector means when one of said average time intervals is less than a predetermined time interval and when the corresponding standard deviation exceeds a predetermined standard deviation.

22. An atrial defibrillator as defined in claim 21 wherein said predetermined number of determined time intervals is equal to twenty.

23. An atrial defibrillator as defined in claim 21 wherein said predetermined time interval is 500 milliseconds and said predetermined standard deviation is twenty milliseconds.

24. An atrial defibrillator as defined in claim 16 further including storing means for storing said determined time intervals.

25. An atrial defibrillator as defined in claim 24 wherein said enable means enable said atrial fibrillation detector means responsive to the average of said stored time intervals.

26. An atrial defibrillator as defined in claim 25 wherein said enable means enable said atrial fibrillation detector means also responsive to the standard deviation of said stored time intervals.

27. An atrial defibrillator as defined in claim 26 wherein said stored time intervals comprises a last predetermined number of determined time intervals.

28. An atrial defibrillator as defined in claim 16 wherein said sensing means include lead means arranged to establish electrical contact with the right ventricle of the heart for sensing electrical activations in the right ventricle of the heart.

29. An atrial defibrillator as defined in claim 16 wherein said disable means include timer means for timing the time in which said atrial fibrillation detector means has been enabled for disabling said atrial fibrillation detector means when said atrial fibrillator detector means has been enabled for a predetermined time period and has failed to detect the presence of atrial fibrillation of the heart.

30. An atrial defibrillator as defined in claim 29 wherein said disable means includes a timer for timing said predetermined time period.

31. An atrial defibrillator as defined in claim 16 further including atrial sense means coupled to said atrial fibrillation detector means for sensing atrial activity of the heart and wherein said enable means enable said atrial sense means upon enabling said atrial fibrillation detector means.

32. An atrial defibrillator arranged to be implanted beneath the skin of a patient for applying electrical energy to the atria of a human heart, said atrial defibrillator comprising:

sensing means for sensing electrical activations of the heart;

means for establishing an electrical activation sensing criteria;

first delivery means for delivering a first quantity of electrical energy to the atria of the heart responsive to one of said sensed electrical activations satisfying said criteria for cadioverting the atria;

second delivery means for delivering at least one pulse of electrical energy to the heart responsive to one of said sensed electrical activations satisfying said criteria, said pulse of electrical energy being of insufficient quantity to cardiovert the heart but of sufficient quantity so as to be detected on an electrocardiogram generated externally to the skin of the patient; and

select means for selecting either said first delivery means or said second delivery means.

33. An atrial defibrillator as defined in claim 32 wherein said second delivery means are arranged to deliver said pulse of electrical energy to the right ventricle of the heart.

34. An atrial defibrillator as defined in claim 32 wherein said sensing means includes lead means arranged to establish electrical contact with the right ventricle of the heart for sensing said electrical activations in the right ventricle of the heart.

35. An atrial defibrillator as defined in claim 34 wherein said second delivery means are arranged to deliver said pulse of electrical energy to the right ventricle through said lead means.

36. An atrial defibrillator as defined in claim 32 wherein said at least one pulse comprise a plurality of said pulses of electrical energy, each said pulse of said plurality of pulses being delivered in succession in response to successive sensed electrical activations satisfying said criteria.

37. An atrial defibrillator as defined in claim 36 wherein said second delivery means includes terminating means for terminating the delivery of said pulses after a predetermined number of said pulses have been delivered to the heart.

38. An atrial defibrillator as defined in claim 37 wherein said terminating means include a counter for counting said delivered pulses and means for comparing said counted pulses to said predetermined number.

39. An atrial defibrillator as defined in claim 38 wherein said predetermined number is sixty.

40. An atrial defibrillator as defined in claim 32 wherein said first delivery means include lead means for delivering said first quantity of electrical energy across the atria of the heart.

41. An atrial defibrillator as defined in claim 32 wherein said first quantity of electrical energy is in the range of 0.1 to 3 joules and wherein said pulse of electrical energy has a quantity in the range of 5 to 50 microjoules.

42. An atrial defibrillator as defined in claim 32 further including means for generating a synchronizing pulse for each sensed electrical activation satisfying aid criteria and enable means for activating the selected one of said first or second delivery means in response to the generating of said synchronizing pulses.

43. An atrial defibrillator for applying an electrical defibrillating pulse to the atria of a human heart in synchronism with an electrical activation of the heart, said atrial defibrillator comprising:

sensing means for sensing electrical activations of the heart;

synchronizing pulse generating means responsive to said sensing means for generating a synchronizing pulse for each said sensed electrical activation;

counting means for counting said synchronizing pulses provided by said synchronizing pulse generating means; and

delivery means responsive to said counting means for applying said electrical defibrillating pulse to the atria after a predetermined number of said synchronizing pulses have been counted by said counter means.

44. An atrial defibrillator as defined in claim 43 wherein said predetermined number is five.

45. An atrial defibrillator as defined in claim 43 wherein said sensing means include lead means arranged to establish electrical contact with the right ventricle of the heart for sensing said electrical activations in the right ventricle.

46. An atrial defibrillator as defined in claim 43 wherein said sensing means include first means for sensing said electrical activations at a first area of the heart and second means for sensing said electrical activations at a second area of the heart, wherein said atrial defibrillator further comprises delay establishing means for establishing a range of normal delay times between an electrical activation being sensed at said first area of the heart by said first means and being sensed at said second area of the heart by said second means and wherein said synchronizing pulse generating means is responsive to the sensing of an electrical activation at said first and second areas of the heart within said range of normal delay times for generating each said synchronizing pulse.

47. An atrial defibrillator as defined in claim 46 wherein said first means include first lead means arranged for establishing electrical contact with the right ventricle of the heart for sensing said electrical activations at the right ventricle and wherein said second means include second lead means arranged for establishing electrical contact with the left ventricle of the heart for sensing said electrical activations at the left ventricle of the heart.

48. An atrial defibrillator as defined in claim 47 where said range of normal delay times is between five milliseconds and thirty milliseconds.

49. An atrial defibrillator as defined in claim 46 further including timer means for determining a time span between an electrical activation being sensed by said first means and being sensed by said second means.

50. An atrial defibrillator as defined in claim 49 further including means for comparing the time span determined by said timer means to said range of normal delay times.

51. An atrial defibrillator as defined in claim 50 wherein said synchronizing pulse generating means is responsive to said comparing means for generating a synchronizing pulse when the time span determined by said timer means is within said range of normal delay times.

52. An atrial defibrillator as defined in claim 51 further including reset means responsive to said comparing means for resetting said counter means when the time span determined by said timer means is outside said range of normal delay times.

53. An atrial defibrillator as defined in claim 52 wherein said predetermined number is five.

54. An implantable atrial defibrillator for applying an electrical defibrillating pulse to the atria of a human heart, said atrial defibrillator comprising:

first means for sensing electrical activations of the heart at the right ventricle;

second means for sensing electrical activations of the heart at the left ventricle;

enable means responsive to said first means for detecting an abnormal rhythm of the right ventricle and providing an enable control signal;

atrial fibrillation detector means including atrial sensing means for sensing atrial activity of at least one of the atria, said atrial fibrillation detector means being activated by said enable control signal for detecting atrial fibrillation of the heart;

storage means for storing electrical energy responsive to said atrial fibrillation detector means detecting atrial fibrillation;

means for detecting non-coincident sensing of said electrical activations by said first means and said second means; and

delivery means responsive to said atrial fibrillation detector means, coupled to said storage means, and being responsive to non-coincident sensing of an electrical activation by said first and second means for applying a predetermined amount of said stored electrical energy to the atria of the heart.

55. An atrial defibrillator as defined in claim 54 wherein said enable means comprises means for determining the time intervals between said electrical activations sensed by said first means, averaging means for determining the average time interval of a last predetermined number of determined time intervals responsive to each sensed electrical activation and standard deviation determining means for determining the standard deviation in the time intervals of said last predetermined number of determined time intervals responsive to each sensed electrical activation and wherein said enable means provide said enable control signal to said atrial fibrillation detector means when one of said average time intervals is less than a predetermined time interval and when the corresponding standard deviation exceeds a predetermined standard deviation.

56. An atrial defibrillator as defined in claim 55 wherein said predetermined number of determined time intervals is equal to twenty.

57. An atrial defibrillator as defined in claim 55 wherein said predetermined time interval is 500 milliseconds and said predetermined standard deviation is twenty milliseconds.

58. An atrial defibrillator as defined in claim 54 further including delay establishing means for establishing a range of normal delay times between an electrical activation being sensed at the right ventricle of the heart by said first means and being sensed at the left ventricle of the heart by said second means, and wherein said delivery means is responsive to the sensing of an electrical activation by said first and second means within said range of normal delay times for applying said predetermined amount of said stored electrical energy to the atria.

59. An atrial defibrillator as defined in claim 58 where said range of normal delay times is between five milliseconds and thirty milliseconds.

60. An atrial defibrillator as defined in claim 58 wherein said delivery means further includes synchronizing pulse generating means for generating a synchronizing pulse when said first and second means sense an electrical activation within said range of normal delay times.

61. An atrial defibrillator as defined in claim 60 wherein said delivery means further includes counter means for counting said synchronizing pulses and applies said electrical energy to the atria when a predetermined number of said synchronizing pulses have been counted.

62. An atrial defibrillator as defined in claim 60 wherein said predetermined number is five.

63. An atrial defibrillator as defined in claim 60 further comprising second delivery means for delivering at least one pulse of electrical energy to the heart in response to one of said synchronizing pulses, said pulse of electrical energy being of insufficient quantity to cardiovert the heart so as to be detected on an electrocardiogram generated externally to the skin of the patient and select means for selecting either said first delivery means or said second delivery means.

64. An atrial defibrillator as defined in claim 63 wherein said second delivery means are arranged to deliver said pulse of electrical energy to the right ventricle of the heart.

65. An atrial defibrillator as defined in claim 63 wherein said at least one pulse comprise a plurality of said pulses of electrical energy, each said pulse of said plurality of pulses being delivered in succession in response to successive synchronizing pulses.

66. An atrial defibrillator as defined in claim 65 wherein said second delivery means includes terminating means for terminating the delivery of said pulses after a predetermined number of said pulses have been delivered to the heart.

67. An atrial defibrillator as defined in claim 66 wherein said predetermined number is sixty.

68. An implantable atrial defibrillator for applying cardioverting electrical energy to the atria of the heart when the atria are in need of cardioversion and for pacing a ventricle of the heart, said atrial defibrillator comprising:

an enclosure adapted to be implanted beneath the skin of a patient;

first sensing means within said enclosure for sensing atrial activity of the heart;

atrial fibrillation detecting means within said enclosure and responsive to said first sensing means for determining when the atria are in need of cardioversion;

cardioverting means within said enclosure and responsive to said atrial fibrillation detecting means for applying cardioverting electrical energy to the atria of the heart when the atria are in need of cardioversion; and

pacing means within said enclosure for pacing said ventricle of the heart,

said atrial defibrillator further including second sensing means within said enclosure and at least one electrode adapted for electrical contact with said ventricle for sensing electrical activations of said ventricle, wherein said cardioverting means is also responsive to an electrical activation of said ventricle sensed by said second sensing means for applying said cardioverting electrical energy to the atria when the atria are in need of cardioversion and wherein said pacing means is coupled to said at least one electrode for applying pacing electrical energy to said at least one electrode.

69. An atrial defibrillator as defined in claim 68 wherein said pacing means is responsive to said second sensing means for applying said pacing electrical energy to said at least one electrode in the absence of a sensed electrical activation of said ventricle.

70. An atrial defibrillator as defined in claim 69 further including timing means within said enclosure responsive to said second sensing means for timing a predetermined time interval after each sensed electrical activation of said ventricle in the absence of an immediately succeeding sensed electrical activation of said ventricle within said predetermined time interval and wherein said pacing means is responsive to said timing means for applying said pacing electrical energy to said at least one electrode when said timing means completes the timing of said predetermined time interval.

71. An implantable atrial defibrillator for applying cardioverting electrical energy to the atria of a patient'"'"'s heart in need of cardioversion, said atrial defibrillator comprising:

lead means including a first electrode and a second electrode, said first electrode adapted to make electrical connection to the heart at a point within the coronary sinus or the great vein and said second electrode being adapted to make electrical connection to the heart within a region near to or within the right atrium;

sensing means coupled to said first and second electrodes for sensing atrial activity of the heart;

atrial fibrillation detecting means coupled to said sensing means for determining, responsive to the sensed atrial activity, if the atria of the heart are in need of cardioversion; and

cardioverting means responsive to said atrial fibrillation detecting means and coupled to said first and second electrodes for applying cardioverting electrical energy between said first and second electrodes when the atria are in need of cardioversion.

72. An atrial defibrillator as defined in claim 71 wherein said lead means is a single lead.

73. An atrial defibrillator as defined in claim 71 further including second sensing means for sensing electrical activations of the heart and wherein said cardioverting means applies said cardioverting electrical energy between said first and second electrodes responsive to an electrical activation sensed by said second sensing means.