Method and apparatus for temporarily electrically forcing cardiac output in a tachyarrhythmia patient

• US 5,978,703 A
• Filed: 12/06/1996
• Issued: 11/02/1999
• 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:
  US08/754,712
• Time in Patent Office: 1,061 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

Abstract

An electrical method and apparatus for stimulating cardiac cells causing contraction to force hemodynamic output during fibrillation, hemodynamically compromising tachycardia, or asystole. High level electrical 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 electrically forcing cardiac output during tachyarrhythmia in a patient, comprising the steps of:

(a) providing a plurality of electrodes in communicative contact with the patient'"'"'s heart;

(b) detecting the presence of tachyarrhythmia in the patient via said electrodes; and

(c) delivering electrical current pulses to the patient'"'"'s heart, via said electrodes after detecting tachyarrhythmia, at a rate between 60 and 200 pulses per minute, said electrical current pulses having a strength between 25 and 200 volts, and greater than 250 mA and directly forcing contraction in the patient'"'"'s heart, whereby a minimum level of cardiac output sufficient to maintain life is provided by said electrical current pulses.

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 forcing 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 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 each electrical current pulse has rounded edges thereby minimizing patient discomfort and chest twitching.

6. The method of claim 1 further comprising the step of forming each electrical current pulse of a train of at least 10 narrow pulses thereby minimizing patient discomfort and chest twitching.

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

8. The device of claim 7 in which additional heart treatment devices are used in combination therewith including means to perform conventional anti-tachycardia pacing or means to perform tachycardia cardioversion or means to perform atrial defibrillation.

9. A device, for implantation in the human body, for maintaining cardiac output of a patient'"'"'s heart during tachyarrhythmia using electrical forcing fields, comprising:

(a) battery power supply means;

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

(c) means to communicatively connect said battery power supply means and said arrhythmia detection means to the patient'"'"'s heart; and

(d) output control means connected to said arrhythmia detection means and to said battery power supply means, and to said means to communicatively connect for delivering multiple electrical current pulses to the human heart after the detection of tachyarrhythmia, said electrical current pulses having a voltage between 25 and 200 volts, and greater than 250 mA, whereby contraction in the patient'"'"'s heart is directly forced and a minimum level of cardiac output sufficient to maintain life is provided by said electrical current pulses.

10. The device of claim 9, in which said electrical current pulses are delivered at a rate between 60 and 200 beats per minute.

11. The device of claim 9, further comprising blood pressure monitoring means connected to said arrhythmia detection means.

12. The device of claim 11, in which said blood pressure monitoring means monitors cardiac output and further comprises the step of adjusting said electrical current pulse amplitude by said output control means to maintain a predetermined level of cardiac output thereby consenting electrical energy.

13. The device cf claim 9, wherein each electrical current pulse has rounded edges, thereby minimizing patient discomfort and chest twitching.

14. The device of claim 9, further comprising the step of forming each electrical current pulse of a train of at least 10 narrow pulses, thereby minimizing patient discomfort and chest twitching.

15. The device of claim 9, in which said arrythmia detection means reassesses the presence of arrhythmia at predetermined intervals and said electrical current pulses are stopped by said output control means if the arrhythmia is no longer present.

16. The device of claim 9, wherein said output control means delivers said electrical current pulses for at least one hour to maintain cardiac output.

17. A device, having a portion designed for implantation in the human body, for maintaining cardiac:

output of a patient'"'"'s heart during tachyarrhythmia using electrical forcing fields, comprising;

(a) battery power supply means;

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

(c) means to communicatively connect said battery power supply means and said arrhythmia detection means to the patient'"'"'s heart; and

(d) output control means connected to said arrhythmia detection means and to said battery power supply means, and to said means to communicatively connect for delivering multiple electrical current pulses to the human heart after the detection of tachyarrhythmia, said electrical current pulses having a voltage between about 25 and about 200 volts, and greater than about 250 mA, whereby contraction in the patient'"'"'s heart is directly forced for at least about 30 minutes and a minimum level of cardiac output sufficient to maintain life is provided by said electrical current pulses.

18. The device of claim 9 or 17 in which the size of the device is less than the size of an implantable cardioverter device.