Method and apparatus for electrically forcing cardiac output in an arrhythmia patient

• US 7,706,864 B2
• Filed: 05/05/2003
• Issued: 04/27/2010
• Est. Priority Date: 05/31/1994
• Status: Expired due to Fees

• Current Assignee: Galvani, Ltd.
• Original Assignee: Galvani, Ltd.
• Inventors: Kroll, Mark W., Kroll, Kai
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/429,509
• Publication Number:
  US 20040044373A1
• Time in Patent Office: 2,549 Days
• Field of Search: 607 4- 9, 607/28, 600/508, 600/509
• US Class Current: 600/509
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3625 External stimulators
• 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 1/3962 in combination with another heart therapy

Abstract

An electrical method and apparatus for stimulating cardiac cells causing contraction to force hemodynamic output during fibrillation, hemodynamically compromising tachycardia, or asystole. Forcing fields are applied to the heart to give cardiac output on an emergency basis until the arrhythmia ceases or other intervention takes place. The device is used as a stand alone external or internal device, or as a backup to an ICD, atrial defibrillator, or an anti-tachycardia pacemaker. The method and apparatus maintain some cardiac output and not necessarily defibrillation.

Claims

1. A method for treating an arrhythmia in a patient, comprising the steps of:

a. attaching a plurality of electrodes to external portions of a patient'"'"'s body proximate the patient'"'"'s thoracic region so that the electrodes may deliver electrical pulses which will be transmitted through portions of the patient'"'"'s upper body;

b. detecting the presence of arrhythmia in the patient;

c. delivering non-defibrillatory electrical current pulses through the patient'"'"'s body via the electrodes after detecting an arrhythmia, the non-defibrillatory electrical current pulses having an amplitude of less than the amplitude of a normal defibrillation shock, and greater than that which would only pace the heart, to force contraction of patient muscle and facilitate a minimum level of cardiac output; and

d. delivering at least one defibrillation pulse having an amplitude sufficient to defibrillate the patient'"'"'s heart.

2. The method of claim 1, wherein the arrhythmia is ventricular fibrillation.

3. The method of claim 1, wherein the arrhythmia is ventricular tachycardia.

4. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 200 and 5000 watts.

5. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 12.5 and 5000 average watts.

6. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 400 volts.

7. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 500 volts.

8. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 700 volts.

9. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 1000 volts.

10. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 2000 volts.

11. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.02 and 25 joules.

12. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.25 and 10 amperes.

13. The method of claim 1, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.5 and 10 amperes.

14. The method of claim 1, wherein the non-defibrillatory electrical current pulses are composed of shorter pulses shorter than the at least one defibrillation pulse.

15. The method of claim 14, wherein the shorter pulses have pulse widths of between 20 us and 2 ms.

16. The method of claim 1, wherein the non-defibrillatory electrical current pulses are composed of at least 10 shorter pulses shorter than the at least one defibrillation pulse.

17. The method of claim 1, wherein the non-defibrillatory electrical current pulses are composed of at most 50 shorter pulses shorter than the at least one defibrillation pulse.

18. The method of claim 1, wherein the step of delivering non-defibrillatory electrical current pulses is administered for a period of less than about 20 seconds.

19. The method of claim 1, wherein the at least one defibrillation pulse has an amplitude of between 25 and 360 joules.

20. A method for treating a tachyarrhythmia in a patient, comprising the steps of:

a. attaching a plurality of electrodes to external portions of a patient'"'"'s body proximate the patient'"'"'s thoracic region so that the electrodes may deliver electrical pulses which will be transmitted through portions of the patient'"'"'s upper body;

b. detecting the presence of tachyarrhythmia in the patient;

c. delivering the non-defibrillatory electrical current pulses through the patient'"'"'s body via the electrodes after detecting an tachyarrhythmia, the non-defibrillatory electrical current pulses having an amplitude of less than the amplitude of a normal defibrillation shock, and greater than that which would only pace the heart, to force contraction of patient muscle and facilitate a minimum level of cardiac output;

d. delivering at least one defibrillation pulse having an amplitude sufficient to defibrillate the patient'"'"'s heart.

21. The method of claim 20, wherein the tachyarrhythmia is ventricular fibrillation.

22. The method of claim 20, wherein the tachyarrhythmia is ventricular tachycardia.

23. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 200 and 5000 watts.

24. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 12.5 and 5000 average watts.

25. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 400 volts.

26. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 500 volts.

27. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 700 volts.

28. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 1000 volts.

29. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 2000 volts.

30. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.02 and 25 joules.

31. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.25 and 10 amperes.

32. The method of claim 20, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.5 and 10 amperes.

33. The method of claim 20, wherein the non-defibrillatory electrical current pulses are composed of shorter pulses shorter than the at least one defibrillation pulse.

34. The system of claim 33, wherein the shorter pulses have pulse widths of between 20 us and about 2 ms.

35. The method of claim 20, wherein the non-defibrillatory electrical current pulses are composed of at least 10 shorter pulses shorter than the at least one defibrillation pulse.

36. The method of claim 20, wherein the non-defibrillatory electrical current pulses are composed of at most 50 shorter pulses shorter than the at least one defibrillation pulse.

37. The method of claim 20, wherein the step of delivering non-defibrillatory electrical current pulses is administered for a period of less than about 20 seconds.

38. The method of claim 20, wherein the at least one defibrillation pulse has an amplitude of between 25 and 360 joules.

39. A system, for external use on a human body, for maintaining some cardiac output of a patient'"'"'s heart during arrhythmia using electrical current, comprising:

a. a power supply;

b. an arrhythmia detector connected to the power supply;

c. capacitor charging circuitry connected to the power supply;

d. output circuitry connected to the capacitor charging circuitry and the power supply for delivering at least one non-defibrillatory electrical current pulse through portions of the patient'"'"'s upper body after detection of arrhythmia, the non-defibrillatory electrical current pulse having an amplitude less than the amplitude necessary to defibrillate the patient, and greater than that which would only pace the heart;

e. output control circuitry connected to the arrhythmia detector, the power supply, the capacitor charging circuitry, and the first output circuitry, the output control circuitry providing pulses suitable for producing contraction in the patient'"'"'s muscles sufficient to maintain a level of cardiac output which is a fraction of the normal maximum cardiac output; and

f. the capacitor charging circuitry cooperating with the output control circuitry and the power supply and adapted for delivering at least one defibrillation pulse to the patient'"'"'s body.

40. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 200 and 5000 watts.

41. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 12.5 and 5000 average watts.

42. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 400 volts.

43. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 500 volts.

44. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 700 volts.

45. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 1000 volts.

46. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 2000 volts.

47. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.02 and 25 joules.

48. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.25 and 10 amperes.

49. The system of claim 39, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.5 and 10 amperes.

50. The system of claim 39, wherein the non-defibrillatory electrical current pulses are composed of shorter pulses shorter than the at least one defibrillation pulse.

51. The system of claim 50, wherein the shorter pulses have pulse widths of between 20 us and 2 ms.

52. The system of claim 39, wherein the non-defibrillatory electrical current pulses are composed of at least 10 shorter pulses shorter than the at least one defibrillation pulse.

53. The system of claim 39, wherein the non-defibrillatory electrical current pulses are composed of at most 50 shorter pulses shorter than the at least one defibrillation pulse.

54. The system of claim 39, wherein the at least one defibrillation pulse have an amplitude of between 25 and 360 joules.

55. A system, for external use on a human body, for maintaining some cardiac output of a patient'"'"'s heart during tachyarrhythmia using electrical current, comprising:

a. a power supply;

b. a tachyarrhythmia detector connected to the power supply;

c. capacitor charging circuitry connected to the power supply;

d. output circuitry connected to the capacitor charging circuitry and the power supply for delivering at least one non-defibrillatory electrical current pulse through portions of the patient'"'"'s upper body, the non-defibrillatory electrical current pulses having an amplitude less than the amplitude necessary to defibrillate the patient, and greater than that which would only pace the heart;

e. output control circuitry connected to the tachyarrhythmia detector, the power supply, the capacitor charging circuitry, and the output circuitry, the output control circuitry providing pulses suitable for producing contraction in the patient'"'"'s muscles sufficient to maintain a level of cardiac output which is a fraction of the normal maximum cardiac output; and

f. the capacitor charging circuitry cooperating with the output control circuitry and the power supply and adapted for delivering at least one defibrillation pulse to the patient'"'"'s body.

56. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 200 and 5000 watts.

57. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 12.5 and 5000 average watts.

58. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 400 volts.

59. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 500 volts.

60. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 700 volts.

61. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 1000 volts.

62. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 100 and 2000 volts.

63. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.02 and 25 joules.

64. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.25 and 10 amperes.

65. The system of claim 55, wherein the non-defibrillatory electrical current pulses have an amplitude of between 0.5 and 10 amperes.

66. The system of claim 55, wherein the non-defibrillatory electrical current pulses are composed of shorter pulses shorter than the at least one defibrillation pulse.

67. The system of claim 66, wherein the shorter pulses have pulse widths of between 20 us and about 2 ms.

68. The system of claim 55, wherein the non-defibrillatory electrical current pulses are composed of at least 10 shorter pulses shorter than the at least one defibrillation pulse.

69. The system of claim 55, wherein the non-defibrillatory electrical current pulses are composed of at most 50 shorter pulses shorter than the at least one defibrillation pulse.

70. The system of claim 55, wherein the at least one defibrillation pulse has an amplitude of between 25 and 360 joules.

71. A tachyarrhythmia treating system, comprising:

power supply means;

arrhythmia detection means operably coupleable to the power supply means;

pulse delivery means operably coupleable to the power supply means;

output control means operably coupleable to the arrhythmia detection means, power supply means, and pulse delivery means;

external defibrillation means operably coupleable with said output control means; and

instructions recorded on a tangible medium for operating the system so as to treat an arrhythmia in a patient, the instructing including instructions to;

attach the pulse delivery means to external portions of the patient'"'"'s body proximate the patient'"'"'s thoracic region so that the pulse delivery means can deliver electrical pulses which will be transmitted through portions of the patient'"'"'s upper body;

detect the presence of arrhythmia in the patient with the arrhythmia detection means;

deliver non-defibrillatory electrical current pulses through the patient'"'"'s body via the pulse delivery means after detecting an arrhythmia, the non-defibrillatory electrical current pulses having an amplitude of less than the amplitude of a normal defibrillation shock and greater than that which would only pace the heart, to force contraction of patient muscle and facilitate a minimum level of cardiac output; and

deliver at least one defibrillation pulse having an amplitude sufficient to defibrillate the patient'"'"'s heart with the external defibrillation means.

72. A tachyarrhythmia treating system, comprising:

a power supply;

an arrhythmia detector connected to the power supply;

capacitor charging circuitry connected to the power supply;

output circuitry connected to the capacitor charging circuitry and the power supply;

output control circuitry connected to the arrhythmia detector, the power supply, the capacitor charging circuitry, and the output circuitry, the output control circuitry providing pulses suitable for producing contraction in the patient'"'"'s muscles sufficient to maintain a level of cardiac output which is a fraction of the normal maximum cardiac output;

the capacitor charging circuitry cooperating with the output control circuitry and the power supply and adapted for delivering at least one defibrillation pulse to the patient'"'"'s body; and

instructions recorded on a tangible medium for operating the system so as to treat an arrhythmia in a patient, the instructing including instructions to;

attach electrodes to external portions of the patient'"'"'s body proximate the patient'"'"'s thoracic region so that the output circuitry can deliver electrical pulses which will be transmitted through portions of the patient'"'"'s upper body;

detect the presence of arrhythmia in the patient with the arrhythmia detector;

deliver non-defibrillatory electrical current pulses through the patient'"'"'s body via the output circuitry after detecting an arrhythmia, the non-defibrillatory electrical current pulses having an amplitude of less than the amplitude of a normal defibrillation shock and greater than that which would only pace the heart, to force contraction of patient muscle and facilitate a minimum level of cardiac output; and

deliver at least one defibrillation pulse having an amplitude sufficient to defibrillate the patient'"'"'s heart.