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

• US 6,185,457 B1
• Filed: 03/26/1999
• Issued: 02/06/2001
• Est. Priority Date: 05/31/1994
• Status: Expired due to Term

• Current Assignee: Galvani, Ltd.
• Original Assignee: Galvani, Ltd.
• Inventors: Kroll, Mark W., Kroll, Kai
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/277,311
• Time in Patent Office: 683 Days
• Field of Search: 607/4-7, 607/9-10, 607/74
• US Class Current: 607/5
• 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 forcing cardiac output during 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) providing means for detecting the presence of tachyarrhythmia in the patient;

(c) detecting the presence of tachyarrhythmia in the patient; and

(d) delivering electrical current pulses through the patient'"'"'s body, via said electrodes after detecting tachyarrhythmia, at a rate between about 60 and 200 pulses per minute, said electrical current pulses having a voltage less than a normal defibrillation voltage level, to force contraction in the patient'"'"'s heart and facilitate a minimum level of cardiac output until cessation of the tachyarrhythmia or until other medical intervention is provided.

2. The method of claim 1, further comprising the steps of reassessing the presence of an arrhythmia at predetermined intervals and terminating said delivery of electrical pulses if the arrhythmia is no longer present.

3. The method of claim 1, in which each electrical current pulse has an energy of less than about 360 joules.

4. The method of claim 1, further comprising the steps of monitoring cardiac output and adjusting said electrical current pulse with respect to amplitude to maintain a predetermined level of cardiac output, thereby conserving electrical energy.

5. The method of claim 1, wherein a plurality of said electrical current pulses have rounded edges.

6. The method of claim 1 further comprising the step of forming a plurality of said electrical current pulses as a train of at least about 10 narrow pulses.

7. The method of claim 1, wherein said step of delivering electrical current pulses is repeated for at least thirty minutes to maintain some cardiac output.

8. The method of claim 1, wherein the step of delivering electrical current pulses comprises delivery of a plurality of pulses which are greater than about 250 mA.

9. The method of claim 1, wherein said step of delivering electrical current pulses is performed immediately after detecting tachyarrythmia.

10. A method for producing minimal cardiac output on an emergency basis in a patient experiencing arrhythmia, comprising the steps of:

(a) attaching a plurality of electrodes to external portions of a patient'"'"'s chest so that the electrodes may deliver electrical pulses which will be transmitted through portions of the patient'"'"'s upper body;

(b) providing means for detecting the presence of arrhythmia in the patient;

(c) detecting the presence of arrhythmia in the patient; and

(d) delivering electrical current pulses through the patient'"'"'s body, via said electrodes immediately after detecting arrhythmia, at a rate between about 60 and 200 pulses per minute, said electrical current pulses having a voltage greater than that which would only pace the heart and less than that which would defibrillate the patient'"'"'s heart, so as to force some contraction in the patient'"'"'s heart, whereby a minimum level of cardiac output is maintained until cessation of the arrhythmia or until other medical intervention is provided.

11. The method of claim 10, in which the power supply means provides electrical current pulses through the electrodes in a voltage range of greater than about 25 volts and less than about 2000 volts.

12. The method of claim 10, in which the arrythmia includes either tachycardia or bradycardia.

13. The method of claim 10, further comprising the step of electronically interfacing said means for detecting the presence of arrythmia in the patient with said other medical intervention.

14. The method of claim 10, wherein the step of delivering electrical current pulses comprises delivery of a plurality of pulses which are greater than about 250 mA.

15. A device, for external attachment to a human body, for maintaining some cardiac output of a patient'"'"'s heart during arrhythmia using electrical forcing fields, comprising:

(a) power supply means;

(b) arrhythmia detection means connected to said power supply means;

(c) pulse delivery means connected to said power supply means for delivering multiple electrical current pulses through portions of the patient'"'"'s upper body; and

(d) output control means connected to said arrhythmia detection means, said power supply means, and said pulse delivery means for controlling the delivery of multiple electrical current pulses to the patient'"'"'s upper body after the detection of arrhythmia, said electrical current pulses having a voltage greater than about 25 volts and less than the voltage necessary to defibrillate the patient, said output control means providing pulses suitable for only producing contraction in the patient'"'"'s heart sufficient to maintain a level of cardiac output which is a fraction of the normal maximum cardiac output until cessation of the arrhythmia or until other medical intervention is provided.

16. The device of claim 15, in which said electrical current pulses are delivered at a rate between about 60 and 200 beats per minute.

17. The device of claim 15, further comprising cardiac output sensing means.

18. The device of claim 15, further comprising cardiac pressure sensing means.

19. The device of claim 15, further comprising blood pressure monitoring means connected to said arrhythmia detection means.

20. The device of claim 15, further comprising doppler sensing means for monitoring cardiac output, said doppler sensing means functionally operable with said arrhythmia detection means.

21. The device of claim 15, in which said blood pressure monitoring means monitors cardiac output and further comprises means for adjusting said electrical current pulse amplitude by said output control means to maintain an optimum therapy for maintaining cardiac output.

22. The device of claim 15, wherein a plurality of said electrical current pulses have rounded edges.

23. The device of claim 15, further comprising the step of providing means for forming a plurality of said electrical current pulses as a train of at least 10 narrow pulses.

24. The device of claim 15, in which said arrythmia detection means comprises means for reassessing the presence of arrhythmia at predetermined intervals and stopping said electrical current pulses with said output control means if the arrhythmia is no longer present.

25. The device of claim 15, in which said arrythmia detection means comprises means for reassessing the presence of arrhythmia and cardiac output at predetermined intervals and adjusting said electrical current pulses with said output control means according to said reassessment.

26. The device of claim 15, in which said power supply means and said output control means deliver said electrical current pulses at a level to maintain cardiac output for at least about 30 minutes.

27. The device of claim 15, wherein said output control means comprises means for delivering said electrical current pulses for at least one hour to maintain cardiac output.

28. The device of claim 15, in which additional heart treatment devices are used in combination therewith including means to perform conventional anti-tachycardia pacing, means to perform tachycardia cardioversion, or means to perform defibrillation.

29. The device of claim 15, in which the power supply means, the output control means, and the arrhythmia detection means operate to produce a cardiac output of between about 10% and about 90% of the normal maximum cardiac output for the patient.

30. The device of claim 15, in which the power supply means, the output control means, and the arrhythmia detection means operate to produce a cardiac output of between about 20% and about 80% of the normal maximum cardiac output for the patient.

31. The device of claim 15, in which the power supply means, the output control means, and the arrhythmia detection means operate to produce a cardiac output of greater than about 30% of the normal maximum cardiac output for the patient.

32. The device of claim 15, wherein the electrical current pulses are greater than about 250 mA.

33. A device, for external attachment to a human body, for maintaining some cardiac output of a patient'"'"'s heart during dysrhythmia using electrical forcing fields, comprising:

(a) power supply means for providing power to pulse delivery means, arrythmia detection means, and output control means;

(b) arrhythmia detection means operatively connected to said power supply means;

(c) pulse delivery means operatively connected to said power supply means for delivering multiple electrical current pulses through portions of the patient'"'"'s upper body, said multiple electrical pulses comprising cardiac therapy responsive to the particular patient'"'"'s cardiac rhythm; and

(d) output control means operatively connected to said arrhythmia detection means, said power supply means, and said pulse delivery means for controlling the delivery of multiple electrical current pulses to the human heart after the detection of arrhythmia;

said electrical current pulses having an amplitude suitable for delivery through the patient'"'"'s upper body and for contributing to the mechanical and electrical mechanisms adequate to produce contractions in the patient'"'"'s heart and to cause only a fraction of the normal maximum cardiac output but enough cardiac output to maintain cardiac viability until cessation of the dysrhythmia or until other medical intervention is provided.

34. The device of claim 33 in which the amplitude of the electrical current pulses is greater than a cardiac pacing level of about 20 volts and less than a normal cardiac defibrillating voltage of about 2000 volts.

35. The device of claim 33, in which said electrical current pulses comprise pulses which are greater than about 140 mA.

36. The device of claim 33, in which said electrical current pulses comprise pulses which are less than about 20 ms.

37. A method for providing hemodynamic output of a heart during arrythmia, comprising the steps of:

(a) attaching a plurality of electrodes to external portions of a patient'"'"'s body proximate the patient'"'"'s chest so that the electrodes may deliver or receive electrical pulses transmitted through portions of the patient'"'"'s upper body;

(b) providing means for detecting the presence of arrhythmia in the patient;

(c) detecting the presence of arrhythmia in the patient;

(d) delivering a first series of electrical current pulses for a first period of time, through the patient'"'"'s body, via said electrodes after detecting arrhythmia, at a rate between about 60 and 200 pulses per minute;

said electrical current pulses having a voltage less than a normal defibrillation voltage level, and having a current of greater than about 140 mA, to force hemodynamic activity by contraction of the patient'"'"'s heart and to facilitate a minimum level of cardiac output; and

(e) determining the output status of the heart.

38. The method of claim 37, in which the step of determining the output status of the heart comprises detecting whether arrythmia still exists.

39. The method of claim 37, in which the step of determining the output status of the heart comprises detecting whether there is an abnormal low pressure within the heart.

40. The method of claim 37, further comprising the step of delivering at least one further series of electrical current pulses after determining the output status of the heart and if said determination indicates a continued existence of arrythmia or the presence of a low pressure in the heart indicative of inadequate cardiac output.

41. The method of claim 37, in which the electrical current pulses are timed to coincide with the natural pumping of the patient'"'"'s atria.

42. The method of claim 37, in which said step of determining the output status of the heart comprises initiation by said output control means of an adjustment of the characteristics of said electrical current pulses according to said determined output status.

43. A method for providing hemodynamic output of a heart during arrythmia, comprising the steps of:

(a) attaching a plurality of electrodes to external portions of a patient'"'"'s body proximate the patient'"'"'s chest so that the electrodes may deliver or receive electrical pulses transmitted through portions of the patient'"'"'s upper body;

(b) providing means for detecting the presence of arrhythmia in the patient;

(c) detecting the presence of arrhythmia or low cardiac output in the patient;

(d) delivering a first series of electrical current pulses for a first period of time, through a portion of the patient'"'"'s body, via said electrodes after detecting arrhythmia, at a rate between about 60 and 200 pulses per minute;

said electrical current pulses having a voltage less than a normal defibrillation voltage level, and having a pulse width of less than about 100 ms, to force hemodynamic activity by contraction of the patient'"'"'s heart and facilitate a minimum level of cardiac output; and

(e) determining the output status of the heart.

44. The method of claim 43, in which the pulse widths are between about 1 ms and about 50 ms.

45. The method of claim 43, in which the pulse widths are greater than about 1 ms and less than about 20 ms.

46. A method for conducting emergency electrical cardiopulmonary resuscitation in a human, 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) providing means for detecting the presence of arrhythmia in the patient;

(c) detecting the presence of arrhythmia in the patient; and

(d) delivering electrical current pulses through the patient'"'"'s body to the patient'"'"'s heart, via said electrodes after detecting arrhythmia, at a rate between about 60 and 200 pulses per minute and at a voltage of less than a normal defibrillation voltage level, to force contraction in the patient'"'"'s heart and to facilitate a minimum level of cardiac output until cessation of the arrhythmia or until other medical intervention is provided.