Pacing with hemodynamic enhancement

• US 7,460,907 B1
• Filed: 07/18/1999
• Issued: 12/02/2008
• Est. Priority Date: 07/20/1998
• Status: Expired due to Fees

• Current Assignee: Impulse Dynamics NV
• Original Assignee: Impulse Dynamics NV
• Inventors: Darvish, Nissim, Felsen, Bella, Kornfeld, Judith, Shemer, Itzik
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/720,639
• Time in Patent Office: 3,425 Days
• Field of Search: 607 4- 9, 607/11, 607 13- 15, 607/17, 607/18, 607/72, 607/74
• US Class Current: 607/9
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Apparatus (170) for heart pacing with hemodynamic improvement, including one or more electrodes (36), which convey electrical signals to respective cardiac muscle segments. Signal generation circuitry (50) applies an extended pacing signal (60, 61), having an overall duration greater than three times a chronaxie time, to the one or more electrodes so as to pace the heart. The signal preferably includes a train of a plurality of biphasic pulses, and has an amplitude at least three times as great as a threshold for pacing the heart, but not sufficient for cardioversion.

Claims

1. Apparatus for heart pacing with hemodynamic improvement, comprising:

one or more electrodes, which are adapted to convey electrical signals to respective cardiac muscle segments; and

signal generation circuitry, which applies an extended pacing signal, having an overall duration greater than 8 ms, to the one or more electrodes so as to pace the heart,

wherein the signal has a leading edge and a trailing edge, and wherein the trailing edge is characterized by an absolute rate of voltage change substantially smaller than that of the leading edge.

2. Apparatus according to claim 1, wherein the absolute rate of the voltage change is less than a minimum rate of change necessary to generate an action potential in the cardiac muscle segments.

3. A method for heart pacing with enhancement of cardiac contraction, comprising:

applying one or more electrodes to a subject'"'"'s heart; and

conveying an extended pacing signal, having an overall duration greater than 8 ms, to the one or more electrodes so as to pace the heart,

wherein the signal has a leading edge and a trailing edge, and wherein the trailing edge is characterized by an absolute rate of voltage change substantially smaller than that of the leading edge.

4. A method according to claim 3, wherein the absolute rate of the voltage change is less than a minimum rate of change necessary to generate an action potential in the cardiac muscle segments.

5. A method for heart pacing with enhancement of cardiac contraction, comprising:

applying one or more implantable electrodes to a ventricle of a human subject'"'"'s heart; and

conveying an extended pacing signal to the one or more electrodes so as to pace the ventricle, the extended pacing signal having an overall duration greater than 8 ms from a time of initiation of application of that portion of the signal that initiates action potential propagation,

wherein conveying the extended pacing signal comprises conveying a train of pulses,

wherein the signal has an amplitude that is at least three times as great as a threshold for pacing the ventricle and that is sufficient neither for cardioversion nor for defibrillation, and

wherein the cardiac muscle segments to which the one or more electrodes are applied are characterized by a refractory period, and wherein the overall duration of the signal is such that the signal terminates during the refractory period.

6. A method according to claim 5, wherein each of the pulses in the train has a pulse duration of at least 1 ms.

7. A method according to claim 6, wherein the train includes at least two pulses having a duration of at least 5 ms per pulse.

8. A method according to claim 5, wherein the train of pulses has a period of at least 5 ms.

9. A method according to claim 8, wherein the train of pulses has a period of at least 20 ms.

10. A method according to claim 5, wherein conveying the train of pulses comprises conveying a plurality of biphasic pulses.

11. A method according to claim 5, wherein the train of pulses has a duty cycle between about 10% and 50%.

12. A method according to claim 5, wherein conveying the extended pacing signal comprises modifying a characteristic of pulsatile flow of blood in the heart.

13. A method according to claim 12, wherein modifying the characteristic comprises increasing a stroke volume of the heart by at least 5% relative to the stroke volume when the heart is paced with pulses less than 2 ms in duration.

14. A method according to claim 13, wherein increasing the stroke volume comprises increasing the stroke volume by at least 10% relative to the stroke volume when the heart is paced with pulses less than 2 ms in duration.

15. A method according to claim 12, wherein modifying the characteristic comprises modifying a cardiac output of the heart by at least 5% relative to the cardiac output when the heart is paced with pulses less than 2 ms in duration at a pacing rate equal to that of the extended pacing signal.

16. A method according to claim 12, wherein modifying the characteristic comprises increasing a contractility of at least a portion of the heart by at least 10% relative to the contractility thereof when the heart is paced with pulses less than 2 ms in duration.

17. A method according to claim 12, wherein modifying the characteristic comprises decreasing a contractility of at least a portion of the heart by at least 10% relative to the contractility thereof when the heart is paced with pulses less than 2 ms in duration.

18. A method according to claim 12, wherein modifying the characteristic comprises modifying a muscular tension in the heart by at least 10% relative to the tension when the heart is paced with pulses less than 2 ms in duration.

19. A method according to claim 5, wherein conveying the extended pacing signal comprises modifying the duration of an action potential in the respective cardiac muscle segments by at least 10% relative to the duration when the heart is paced with pulses less than 2 ms in duration.

20. A method according to claim 5, wherein conveying the extended pacing signal increases a muscular tension in the respective cardiac muscle segments by at least 50% relative to the duration when the heart is paced with pulses less than 2 ms in duration.

21. A method according to claim 20, wherein conveying the extended pacing signal increases the muscular tension in the respective cardiac muscle segments by at least 100% relative to the duration when the heart is paced with pulses less than 2 ms in duration.

22. A method according to claim 5, wherein applying the one or more electrodes comprises applying a plurality of electrodes in different chambers of the heart.

23. A method according to claim 22, wherein conveying the extended pacing signal comprises conveying a plurality of waveforms respectively to the electrodes in the different chambers according to a predetermined time sequence.

24. A method according to claim 22, and comprising conveying a pacing pulse having a duration less than 8 ms to one or more of the electrodes positioned in a first one of the different chambers, and wherein conveying the extended pacing signal comprises conveying the signal to another one or more of the electrodes positioned in a second one of the different chambers.

25. A method according to claim 5, wherein conveying the extended pacing signal comprises conveying the signal to the one or more electrodes in response to a demand for an enhancement of hemodynamic performance of the heart.

26. A method according to claim 25, wherein the enhancement of hemodynamic performance comprises an increase in cardiac output.

27. A method according to claim 25, and comprising receiving an output signal responsive to a physiological parameter indicative of the demand for the enhancement, and wherein conveying the extended pacing signal comprises conveying the pacing signal responsive to the output signal.

28. A method according to claim 25, and comprising, in the absence of the demand for the enhancement, conveying pacing pulses to the electrodes of substantially lower energy than the extended pacing signal.

29. A method according to claim 5, wherein applying the one or more electrodes comprises applying electrodes endocardially.

30. A method according to claim 5, wherein applying the one or more electrodes comprises applying electrodes epicardially.

31. A method according to claim 5, wherein applying the one or more electrodes comprises applying electrodes transmyocardially.

32. A method according to claim 5, wherein applying the one or more electrodes comprises applying electrodes transvenously.

33. A method according to claim 5, and comprising receiving an output signal responsive to activity of the heart, and wherein conveying the extended pacing signal comprises modifying the pacing signal responsive to the output signal.

34. A method according to claim 33, wherein receiving the output signal comprises receiving an electrophysiological signal.

35. A method according to claim 34, wherein the electrophysiological signal comprises a Monophasic Action Potential signal.

36. A method according to claim 34, wherein receiving the electrophysiological signal comprises placing a pair of bipolar electrodes in close mutual proximity in contact with the ventricle and receiving a bipolar signal from the bipolar electrodes.

37. A method according to claim 32, wherein modifying the pacing signal comprises detecting a possible arrhythmic stimulation of the ventricle and modifying the extended pacing signal so as to prevent the arrhythmic stimulation.

38. A method according to claim 5, wherein applying the one or more electrodes comprises applying electrodes such that conveying the extended pacing signal engenders a redistribution of cardiac muscle mass.

39. A method according to claim 5, wherein the extended pacing signal comprises a plurality of extended pacing signals, wherein conveying comprises conveying the plurality of extended pacing signals so as to pace the heart by initiating a respective plurality of consecutive heartbeats, wherein each of the extended pacing signals has the overall duration greater than 8 ms from the time of initiation of application of that portion of the signal that initiates action potential propagation, wherein conveying each of the extended pacing signals comprises conveying the train of pulses, wherein each of the extended pacing signals has the amplitude that is at least three times as great as the threshold for pacing the heart and that is sufficient neither for cardioversion nor for defibrillation, and wherein the overall duration of each of the extended pacing signals is such that the signal terminates during the refractory period.

40. A method according to claim 5, wherein the overall duration of the extended pacing signal is greater than 10 ms.

41. A method according to claim 40, wherein the overall duration of the extended pacing signal is greater than 20 ms.

42. A method for heart pacing with enhancement of cardiac contraction, comprising:

applying one or more implantable electrodes to a human subject'"'"'s heart; and

conveying a plurality of extended pacing signals to the one or more electrodes so as to pace the heart by initiating a respective plurality of consecutive heartbeats, each of the extended pacing signals having an overall duration greater than 8 ms from a time of initiation of application of that portion of the signal that initiates action potential propagation,

wherein conveying each of the extended pacing signals comprises conveying a train of pulses,

wherein each of the extended pacing signals has an amplitude that is at least three times as great as a threshold for pacing the heart and that is sufficient neither for cardioversion nor for defibrillation, and

wherein the cardiac muscle segments to which the one or more electrodes are applied are characterized by a refractory period, and wherein the overall duration of each of the extended pacing signals is such that the signal terminates during the refractory period.

43. A method according to claim 42, wherein applying the one or more electrodes comprises applying the one or more electrodes to a ventricle of the heart, wherein conveying comprises conveying the extended pacing signals to the one or more electrodes so as to pace the ventricle, and wherein the amplitude of each of the signals is at least three times as great as the threshold for pacing the ventricle.

44. A method according to claim 43, wherein the train includes at least two pulses having a duration of at least 5 ms per pulse.

45. A method according to claim 42, wherein each of the pulses in the train has a pulse duration of at least 1 ms.

46. A method according to claim 42, wherein the train of pulses has a period of at least 5 ms.

47. A method according to claim 46, wherein the train of pulses has a period of at least 20 ms.

48. A method according to claim 42, wherein conveying the train of pulses comprises conveying a plurality of biphasic pulses.

49. A method according to claim 42, wherein the train of pulses has a duty cycle between about 10% and 50%.

50. A method according to claim 42, wherein conveying the extended pacing signal comprises modifying a characteristic of pulsatile flow of blood in the heart.

51. A method according to claim 50, wherein modifying the characteristic comprises increasing a stroke volume of the heart by at least 5% relative to the stroke volume when the heart is paced with pulses less than 2 ms in duration.

52. A method according to claim 51, wherein increasing the stroke volume comprises increasing the stroke volume by at least 10% relative to the stroke volume when the heart is paced with pulses less than 2 ms in duration.

53. A method according to claim 50, wherein modifying the characteristic comprises modifying a cardiac output of the heart by at least 5% relative to the cardiac output when the heart is paced with pulses less than 2 ms in duration at a pacing rate equal to that of the extended pacing signal.

54. A method according to claim 50, wherein modifying the characteristic comprises increasing a contractility of at least a portion of the heart by at least 10% relative to the contractility thereof when the heart is paced with pulses less than 2 ms in duration.

55. A method according to claim 50, wherein modifying the characteristic comprises decreasing a contractility of at least a portion of the heart by at least 10% relative to the contractility thereof when the heart is paced with pulses less than 2 ms in duration.

56. A method according to claim 50, wherein modifying the characteristic comprises modifying a muscular tension in the heart by at least 10% relative to the tension when the heart is paced with pulses less than 2 ms in duration.

57. A method according to claim 42, wherein conveying the extended pacing signal comprises modifying the duration of an action potential in the respective cardiac muscle segments by at least 10% relative to the duration when the heart is paced with pulses less than 2 ms in duration.

58. A method according to claim 42, wherein conveying the extended pacing signal increases a muscular tension in the respective cardiac muscle segments by at least 50% relative to the duration when the heart is paced with pulses less than 2 ms in duration.

59. A method according to claim 58, wherein conveying the extended pacing signal increases the muscular tension in the respective cardiac muscle segments by at least 100% relative to the duration when the heart is paced with pulses less than 2 ms in duration.

60. A method according to claim 42, wherein applying the one or more electrodes comprises applying a plurality of electrodes in different chambers of the heart.

61. A method according to claim 60, wherein conveying the extended pacing signal comprises conveying a plurality of waveforms respectively to the electrodes in the different chambers according to a predetermined time sequence.

62. A method according to claim 60, and comprising conveying a pacing pulse having a duration less than 8 ms to one or more of the electrodes positioned in a first one of the different chambers, and wherein conveying the extended pacing signal comprises conveying the signal to another one or more of the electrodes positioned in a second one of the different chambers.

63. A method according to claim 42, wherein conveying the extended pacing signal comprises conveying the signal to the one or more electrodes in response to a demand for an enhancement of hemodynamic performance of the heart.

64. A method according to claim 63, wherein the enhancement of hemodynamic performance comprises an increase in cardiac output.

65. A method according to claim 63, and comprising receiving an output signal responsive to a physiological parameter indicative of the demand for the enhancement, and wherein conveying the extended pacing signal comprises conveying the pacing signal responsive to the output signal.

66. A method according to claim 63, and comprising, in the absence of the demand for the enhancement, conveying pacing pulses to the electrodes of substantially lower energy than the extended pacing signal.

67. A method according to claim 42, wherein applying the one or more electrodes comprises applying electrodes endocardially.

68. A method according to claim 42, wherein applying the one or more electrodes comprises applying electrodes epicardially.

69. A method according to claim 42, wherein applying the one or more electrodes comprises applying electrodes transmyocardially.

70. A method according to claim 42, wherein applying the one or more electrodes comprises applying electrodes transvenously.

71. A method according to claim 42, and comprising receiving an output signal responsive to activity of the heart, and wherein conveying the extended pacing signal comprises modifying the pacing signal responsive to the output signal.

72. A method according to claim 71, wherein receiving the output signal comprises receiving an electrophysiological signal.

73. A method according to claim 72, wherein the electrophysiological signal comprises a Monophasic Action Potential signal.

74. A method according to claim 72, wherein receiving the electrophysiological signal comprises placing a pair of bipolar electrodes in close mutual proximity in contact with the heart and receiving a bipolar signal from the bipolar electrodes.

75. A method according to claim 71, wherein modifying the pacing signal comprises detecting a possible arrhythmic stimulation of the heart and modifying the extended pacing signal so as to prevent the arrhythmic stimulation.

76. A method according to claim 42, wherein applying the one or more electrodes comprises applying electrodes such that conveying the extended pacing signal engenders a redistribution of cardiac muscle mass.

77. A method according to claim 42, wherein the overall duration of the extended pacing signal is greater than 10 ms.

78. A method according to claim 77, wherein the overall duration of the extended pacing signal is greater than 20 ms.