Atrial sensing and multiple site stimulation as intervention means for atrial fibrillation

• US 6,178,351 B1
• Filed: 01/11/1999
• Issued: 01/23/2001
• Est. Priority Date: 08/19/1996
• Status: Expired due to Term

• Current Assignee: MR3 Medical, LLC
• Original Assignee: Mower Family Chf Treatment Irrevocable Trust
• Inventors: Mower, Morton M.
• Primary Examiner(s): NGUYEN, TRAM A
• Application Number:
  US09/228,262
• Time in Patent Office: 743 Days
• Field of Search: 607/4, 607/5, 607/7, 607/28, 128/898
• 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 1/3624 occurring in the atrium, i.e. atrial tachycardia
• 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 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

Atrial sensing and stimulation as intervention for atrial fibrillation. The present invention relates to a method of atrial defibrillation. In a variety of protocols varying combinations of conventional and biphasic stimulation are applied at threshold and sub-threshold levels. In a preferred embodiment, the implantable electronic stimulation device of the present invention includes multiple electrodes having stimulating and sensing capabilities. The small size of these electrodes allows for intravenous insertion into the patient.

Claims

1. A method of atrial defibrillation comprising:

sensing atrial fibrillation;

recording a baseline of cardiac activity;

stimulating the atrium using a pre-capture stimulation protocol;

determining status of capture; and

stimulating the atrium using a post-capture stimulation protocol, wherein the pre-capture stimulation protocol and the post-capture stimulation protocol comprise a procedure and wherein the procedure is selected from the group consisting of pre-capture stimulation at threshold with post-capture stimulation at threshold, pre-capture stimulation subthreshold with post-capture stimulation subthreshold and pre-capture stimulation at threshold with post-capture stimulation subthreshold.

2. The method of atrial defibrillation of claim 1, wherein the procedure is further selected from the group consisting of conventional stimulation pre-capture with biphasic stimulation post-capture, biphasic stimulation pre-capture with conventional stimulation post-capture, and biphasic stimulation pre-capture with biphasic stimulation post-capture.

3. The method of atrial defibrillation of claim 2, comprising:

inserting at least two electrodes intravenously into a patient; and

placing the at least two electrodes in conjunction with cardiac tissue.

4. The method of atrial defibrillation of claim 3 comprising:

locating at least one electrode in the right atrial appendage;

locating at least one electrode in the right atrial septum; and

locating at least one electrode in the coronary sinus.

5. The method of atrial defibrillation of claim 4 comprising:

locating at least one electrode in the left free wall.

6. The method of atrial defibrillation of claim 3 wherein each of the at least two electrodes has an independent generator.

7. The method of atrial defibrillation of claim 3 comprising:

entraining the cardiac tissue in conjunction with each of the at least one electrodes separately; and

bringing the cardiac tissue in conjunction with each of the at least one electrodes to the same phase.

8. The method of atrial defibrillation of claim 3 comprising:

sequencing the stimulation of the at least two electrodes to mimic a normal heart beat.

9. The method of atrial defibrillation of claim 3, wherein each of the at least two electrodes comprise sensing circuits and wherein the sensing circuits provide sensing data comprising:

determining the site of at least one atrial ectopic foci.

10. The method of atrial defibrillation of claim 9 wherein determining the site of at least one atrial ectopic foci comprises:

triangulating the sensing data.

11. The method of atrial defibrillation of claim 2 wherein determining status of capture comprises:

establishing a baseline of cardiac activity; and

monitoring the baseline for changes.

12. The method of atrial defibrillation of claim 2 wherein the baseline of cardiac activity comprises a template of parameters selected from the group consisting of electrocardiogram data, mechanical motion, and probability density function data.

13. The method of atrial defibrillation of claim 2 wherein biphasic stimulation comprises:

defining a first stimulation phase with a first phase polarity, a first phase amplitude, a first phase shape and a first phase duration;

defining a second stimulation phase with a polarity opposite to the first phase polarity, a second phase amplitude, a second phase shape and a second phase duration; and

applying the first stimulation phase and the second stimulation phase in sequence to cardiac tissue.

14. The method of atrial defibrillation of claim 13 wherein the first phase polarity is positive.

15. The method for electrical cardiac pacing of claim 13 wherein the first phase amplitude is less than the second phase amplitude.

16. The method for electrical cardiac pacing of claim 13 wherein the first phase amplitude is ramped from a baseline value to a second value.

17. The method for electrical cardiac pacing of claim 16 wherein the second value is equal to the second phase amplitude.

18. The method for electrical cardiac pacing of claim 16 wherein the second value is at a maximum subthreshold amplitude.

19. The method for electrical cardiac pacing of claim 18 wherein the maximum subthreshold amplitude is about 0.5 to 3.5 volts.

20. The method for electrical cardiac pacing of claim 16 wherein the first phase duration is at least as long as the second phase duration.

21. The method for electrical cardiac pacing of claim 16 wherein the first phase duration is about one to nine milliseconds.

22. The method for electrical cardiac pacing of claim 16 wherein the second phase duration is about 0.2 to 0.9 milliseconds.

23. The method for electrical cardiac pacing of claim 16 wherein the second phase amplitude is about two volts to twenty volts.

24. The method for electrical cardiac pacing of claim 16 wherein the second phase duration is less than 0.3 milliseconds and the second phase amplitude is greater than 20 volts.

25. The method for electrical cardiac pacing of claim 13 wherein the first stimulation phase further comprises a series of stimulating pulses of a predetermined amplitude, polarity and duration.

26. The method for electrical cardiac pacing of claim 25 wherein the first stimulation phase further comprises a series of rest periods.

27. The method for electrical cardiac pacing of claim 26 wherein applying the first stimulation phase further comprises applying a rest period of a baseline amplitude after at least one stimulating pulse.

28. The method for electrical cardiac pacing of claim 27 wherein the rest period is of equal duration to the stimulating pulse.

29. The method for electrical cardiac pacing of claim 13 wherein the first phase amplitude is at a maximum subthreshold amplitude.

30. The method for electrical cardiac pacing of claim 29 wherein the maximum subthreshold amplitude is about 0.5 to 3.5 volts.

31. The method for electrical cardiac pacing of claim 13 wherein the first phase duration is at least as long as the second phase duration.

32. The method for electrical cardiac pacing of claim 13 wherein the first phase duration is about one to nine milliseconds.

33. The method for electrical cardiac pacing of claim 13 wherein the second phase duration is about 0.2 to 0.9 milliseconds.

34. The method for electrical cardiac pacing of claim 13 wherein the second phase amplitude is about two volts to twenty volts.

35. The method for electrical cardiac pacing of claim 13 wherein the second phase duration is less than 0.3 milliseconds and the second phase amplitude is greater than 20 volts.

36. The method for electrical cardiac pacing of claim 13 wherein the first stimulation phase is initiated greater than 200 milliseconds after heart beat.

37. The method of atrial defibrillation of claim 2 wherein sensing atrial fibrillation comprises:

monitoring parameters selected from the group consisting of arterial blood pressure, rate of electrocardiogram deflections, and probability density function of the electrocardiogram.