Electrical muscle controller

• US 7,167,748 B2
• Filed: 06/10/2004
• Issued: 01/23/2007
• Est. Priority Date: 01/08/1996
• Status: Expired due to Fees

• Current Assignee: Impulse Dynamics NV
• Original Assignee: Impulse Dynamics NV
• Inventors: Darvish, Nissim, Fenster, Maier, Yuval, Mika, Ben-Haim, Shiomo
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/866,213
• Publication Number:
  US 20040243190A1
• Time in Patent Office: 957 Days
• Field of Search: 607 2- 4, 607/9, 607/14
• US Class Current: 607/9
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6856 with a distal loop
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/326 : for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36146 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/3621 : for treating or preventing abnormally high heart rate
• 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 1/365 : controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36514 : controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36557 : controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 : controlled by blood pressure
• CPC Class Codes: A61N 1/368 : comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

A method of modifying the force of contraction of at least a portion of a heart chamber, including providing a subject having a heart, comprising at least a portion having an activation, and applying a non-excitatory electric field having a given duration, at a delay after the activation, to the portion, which causes the force of contraction to be increased by a least 5%.

Claims

1. Heart control apparatus for modifying the activity of at least part of a heart, comprising:

(a) a sensor adapted for sensing a parameter characterizing the activity of at least part of the heart;

(b) circuitry adapted to determining at least one of the parameters of a stimulus, said parameters being selected from the group comprised of the magnitude, shape, duty cycle, phase, frequency, duration, and time of application of said stimulus, wherein said determining is responsive to said sensed characterizing parameter and said circuitry is adapted to generate a stimulus comprising at least one non-excitatory portion, which is applied after a delay from the activation time of the portion at which said stimulus is applied, and is unable to generate a propagating action potential or prevent propagation of a propagating action potential and is adapted to modify contraction of said heart; and

(c) at least one stimulus applying element adapted to apply said stimulus.

2. Heart control apparatus according to claim 1, wherein the stimulus further comprises at least one excitatory portion, which is able to propagate, generate or prevent a propagating action potential.

3. Heart control apparatus according to claim 1, wherein the stimulus comprises contiguous excitatory and non-excitatory portions.

4. Heart control apparatus according to claim 1, wherein the delay is calculated from sensing of the activation at the stimulus application site.

5. Heart control apparatus according to claim 1, wherein the delay is calculated from sensing activation at a different site of the heart.

6. Heart control apparatus according to claim 1, wherein the delay is calculated from the time of pacing of at least one of the heart chambers.

7. Heart control apparatus according to claim 1, wherein the delay is greater than 7 msec and less than 100 msec.

8. Heart control apparatus according to claim 1, wherein the delay is greater than 30 msec and less than 70 msec.

9. Heart control apparatus according to claim 1, wherein the delay is greater than 1 msec and less than 40 msec.

10. Heart control apparatus according to claim 1, wherein the delay is essentially 0 ms.

11. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for generating an electric current.

12. Heart control apparatus according to claim 11, wherein the amplitude of said electric current is less than 20 ma.

13. Heart control apparatus according to claim 11, wherein the amplitude of the electric current is greater than 3ma and less than 20 ma.

14. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for generating an electric voltage;

characterized in that the amplitude of said electric voltage is such that the current that can be generated in the heart tissue is less than 20 ma.

15. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for generating an electric voltage;

characterized in that the amplitude of said electric voltage is such that the current that can be generated in the heart tissue is substantially in the range of 3 ma to 20 ma.

16. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for generation of a stimulus characterized in that the width of said stimulus is in the range of 10 to 100 msec.

17. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for the generation of a stimulus characterized in that the width of said stimulus is in the range of 1 to 20 msec.

18. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for the generation of a stimulus characterized in that the width of said stimulus is less than 70 msec.

19. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for the generation of a stimulus characterized in that the width of said stimulus is substantially in the range of 20 to 40 msec.

20. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for the generation of a stimulus characterized in that the width of said stimulus is several tens of msec.

21. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for the generation of a stimulus which is a pulse train, characterized in that the width of at least one of the pulses in said pulse train is in the range of 10 to 100 msec.

22. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for the generation of a stimulus which is a pulse train, characterized in that the width of at least one of the pulses in said pulse train is in the range of 1 to 20 msec.

23. Heart control apparatus according to claim 1, wherein the stimulus is comprised of at least one biphasic pulse.

24. Heart control apparatus according to claim 1, wherein the stimulus is comprised of at least one monophasic pulse.

25. Heart control apparatus according to either of claims 21, or 22, wherein the pulses include at least one biphasic pulse.

26. Heart control apparatus according to either of claims 21, or 22, wherein the pulses include at least one monophasic pulse.

27. Heart control apparatus according to claim 1, wherein the circuitry for generating the non-excitatory portion of the stimulus comprises circuitry for generating biphasic pulses,

characterized in that the width of each phase of said pulses is greater than 1 msec and less than 20 msec.

28. Heart control apparatus according to any one of claims 21, 22, or 23, wherein the pulses are biphasic pulses generated in a train of two pulses.

29. Heart control apparatus according to claim 1, wherein the stimulus application devices comprise unipolar electrodes.

30. Heart control apparatus according to claim 1, wherein the stimulus application devices comprise bipolar electrodes.

31. Heart control apparatus according to claim 1, wherein the stimulus application devices comprise one or more electrodes mounted on a lead that is introduced into the heart intravenously, passing through the coronary vessels to locate said electrodes on the left ventricle.

32. Heart control apparatus according to claim 1, wherein the stimulus application devices comprise one or more electrodes mounted on at least one lead that is designed to be introduced into the heart'"'"'s right ventricle.

33. Heart control apparatus according to claim 32, wherein the one or more electrodes deliver the stimulus to the septum muscle.

34. Heart control apparatus according to claim 32, wherein the one or more electrodes deliver the stimulus to the base of the ventricle.

35. Heart control apparatus according to claim 32, wherein the one or more electrodes deliver the stimulus to the apex of the ventricle.

36. Heart control apparatus according to either of claims 31 or 32, wherein the stimulus is delivered through two pairs of electrodes.

37. Heart control apparatus according to either of claims 31 or 32, wherein the stimulus is delivered through multiple electrodes.

38. Heart control apparatus according to claim 32, wherein the stimulus delivered to the tissue is comprised of at least a single pulse which combines a pacing electric field and a non-excitatory electric field.

39. A method for modifying the activity of the heart or a portion thereof, comprising:

sensing the local activation time of said portion or other parameters characterizing the activity of said heart or said portion thereof;

determining at least one of the parameters of a stimulus comprising at least one non-excitatory portion;

generating said non-excitatory portion of the stimulus; and

applying said non-excitatory portion of the stimulus to said heart or to said portion thereof,

wherein, said non-excitatory portion of the stimulus is applied after a delay from the activation time of the portion at which said stimulus is applied, and is unable to generate a propagating action potential or prevent propagation of propagating action potentials.

40. A method according to claim 39, wherein the parameters of the stimulus are selected from the group comprised of:

the magnitude, shape, duty cycle, phase, frequency, duration, and time of application of the non-excitatory portion of the stimulus.

41. A method according to claim 39, wherein the stimulus further comprises at least one excitatory portion, which is able to propagate, generate or prevent propagation of a propagating action potential.

42. A method according to claim 39, wherein the stimulus comprises contiguous excitatory and non-excitatory portions.

43. A method according to claim 39, wherein the delay is calculated from sensing of the activation at the stimulus application site.

44. A method according to claim 39, wherein the delay is calculated from sensing activation at a different site of the heart.

45. A method according to claim 39, wherein the delay is calculated from the time of pacing of at least one of the heart chambers.

46. A method according to claim 39, wherein the delay is greater than 7 msec and less than 100 msec.

47. A method according to claim 39, wherein the delay is greater than 30 msec and less than 70 msec.

48. A method according to claim 39, wherein the delay is greater than 1 msec and less than 40 msec.

49. A method according to claim 39, wherein the delay is essentially 0 ms.

50. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating an electric current.

51. A method according to claim 50, wherein the amplitude of said electric current is less than 20 ma.

52. A method according to claim 50, wherein the amplitude of the electric current is greater than 3 ma and less than 20 ma.

53. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating an electric voltage,

characterized in that the amplitude of said electric voltage is such that a current can be generated in the heart tissue that is less than 20 ma.

54. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating an electric voltage,

characterized in that the amplitude of said electric voltage is such that a current can be generated in the heart tissue that is substantially in the range of 3 ma to 20 ma.

55. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating of a stimulus characterized in that the width of said stimulus is in the range of 10 to 100 msec.

56. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating of a stimulus characterized in that the width of said stimulus is in the range of 1 to 20 msec.

57. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating of a stimulus characterized in that the width of said stimulus is less than 70 msec.

58. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating of a stimulus characterized in that the width of said stimulus is substantially in the range of 20 to 40 msec.

59. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating of a stimulus characterized in that the width of said stimulus is several tens of msec.

60. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating of a stimulus which is a pulse train, characterized in that the width of at least one of the pulses in said pulse train is in the range of 10 to 100 msec.

61. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating of a stimulus which is a pulse train, characterized in that the width of at least one of the pulses in said pulse train is in the range of 1 to 20 msec.

62. A method according to claim 39, wherein the stimulus is comprised of at least one biphasic pulse.

63. A method according to claim 39, wherein the stimulus is comprised of at least one monophasic pulse.

64. A method according to either of claims 60 or 61, wherein the pulses include at least one biphasic pulse.

65. A method according to either of claims 60 or 61, wherein the pulses include at least one monophasic pulses.

66. A method according to claim 39, wherein the non-excitatory portion of the stimulus is generated by circuitry comprising circuitry for generating biphasic pulses,

characterized in that the width of each phase of said pulses is greater than 1 msec and less than 20 msec.

67. A method according to any one of claims 60, 61, and 64, wherein the pulses are biphasic pulses generated in a train of two pulses.

68. A method according to claim 39, wherein the stimulus is applied by devices comprising unipolar electrodes.

69. A method according to claim 39, wherein the stimulus is applied by devices comprising bipolar electrodes.

70. A method according to claim 39, wherein the stimulus is applied by devices comprising one or more electrodes mounted on a lead that is introduced into the heart intravenously, passing through the coronary vessels to locate said electrodes on the left ventricle.

71. A method according to claim 39, wherein the stimulus is applied by devices comprising one or more electrodes mounted on at least one lead that is designed to be introduced into the heart'"'"'s right ventricle.

72. A method according to claim 71, wherein the one or more electrodes deliver the stimulus to the septum muscle.

73. A method according to claim 71, wherein the one or more electrodes deliver the stimulus to the base of the ventricle.

74. A method according to claim 71, wherein the one or more electrodes deliver the stimulus to the apex of the ventricle.

75. A method according to either of claims 70 or 71, wherein the stimulus is delivered through two pairs of electrodes.

76. A method according to either of claims 70 or 71, wherein the stimulus is delivered through multiple electrodes.

77. A method according to claim 71, wherein the stimulus delivered to the tissue is comprised of at least a single pulse which combines a pacing electric field and a non-excitatory electric field.