Atrial sensing and multiple site stimulation as intervention for atrial fibrillation

• US 6,337,995 B1
• Filed: 11/13/2000
• Issued: 01/08/2002
• Est. Priority Date: 08/19/1996
• Status: Expired due to Fees

• Current Assignee: MR3 Medical, LLC
• Original Assignee: Mower Family Chf Treatment Irrevocable Trust
• Inventors: Mower, Morton M.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/711,030
• Time in Patent Office: 421 Days
• Field of Search: 607/4, 607/5, 607/9, 607/14, 607/68, 607/70, 607/74
• US Class Current: 607/5
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

Atrial sensing and stimulation as intervention for atrial fibrillation. The present invention relates to a method of atrial defibrillation using an implanted electronic stimulator. 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 stimulator 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. An implantable cardiac stimulator to perform atrial defibrillation, the cardiac stimulator comprising:

sensor adapted to sense the onset of atrial fibrillation;

recorder adapted to record a baseline of cardiac activity;

processor adapted to determining whether capture has occurred; and

electrodes adapted to stimulate the atrium after the onset of atrial fibrillation has been sensed,

wherein, in the event it is determined that capture has not occurred, the atrium is stimulated using a pre-capture stimulation protocol,

wherein, in the event it is determined that capture has occurred, the atrium is stimulated using a post-capture stimulation protocol, and

wherein the pre-capture stimulation protocol and the post-capture stimulation protocol comprise a procedure, the procedure being 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 implantable cardiac stimulator of claim 1, wherein the procedure utilizes biphasic stimulation pre-capture with biphasic stimulation post-capture.

3. The implantable cardiac stimulator of claim 2, where at least two of the electrodes are adapted to be inserted intravenously into a patient, and at least two of the electrodes are adapted to be placed in conjunction with cardiac tissue.

4. The implantable cardiac stimulator of claim 3, wherein at least one of the electrodes is adapted to be located in the right atrial appendage, at least one of the electrodes is adapted to be located in the right atrial septum, and at least one of the electrodes is adapted to be located in the coronary sinus.

5. The implantable cardiac stimulator of claim 4, wherein at least one of the electrodes is adapted to be located in the left free wall.

6. The implantable cardiac stimulator of claim 3, wherein each of the electrodes has an independent generator.

7. The implantable cardiac stimulator of claim 3, wherein the stimulation of the electrodes is sequenced so as to mimic a normal heart beat.

8. The implantable cardiac stimulator of claim 2, wherein the processor determines status of capture by monitoring for changes in the baseline of cardiac activity established by the recorder.

9. The implantable cardiac stimulator 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.

10. The implantable cardiac stimulator 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.

11. The implantable cardiac stimulator of claim 10, wherein the first phase polarity is positive.

12. The implantable cardiac stimulator of claim 10, wherein the first phase amplitude is less than the second phase amplitude.

13. The implantable cardiac stimulator of claim 10, wherein the first phase amplitude is ramped from a baseline value to a second value.

14. The implantable cardiac stimulator of claim 13, wherein the second value is equal to the second phase amplitude.

15. The implantable cardiac stimulator of claim 13, wherein the second value is at a maximum subthreshold amplitude.

16. The implantable cardiac stimulator of claim 15, wherein the maximum subthreshold amplitude is about 0.5 to 3.5 volts.

17. The implantable cardiac stimulator of claim 13, wherein the first phase duration is at least as long as the second phase duration.

18. The implantable cardiac stimulator of claim 13, wherein the first phase duration is about one to nine milliseconds.

19. The implantable cardiac stimulator of claim 13, wherein the second phase duration is about 0.2 to 0.9 milliseconds.

20. The implantable cardiac stimulator of claim 13, wherein the second phase amplitude is about two volts to twenty volts.

21. The implantable cardiac stimulator of claim 13, wherein the second phase duration is less than 0.3 milliseconds and the second phase amplitude is greater than 20 volts.

22. The implantable cardiac stimulator of claim 10, wherein the first stimulation phase further comprises a series of stimulating pulses of a predetermined amplitude, polarity and duration.

23. The implantable cardiac stimulator of claim 22, wherein the first stimulation phase further comprises a series of rest periods.

24. The implantable cardiac stimulator of claim 23, wherein applying the first stimulation phase further comprises applying a rest period of a baseline amplitude after at least one stimulating pulse.

25. The implantable cardiac stimulator of claim 24, wherein the rest period is of equal duration to the stimulating pulse.

26. The implantable cardiac stimulator of claim 10, wherein the first phase amplitude is at a maximum subthreshold amplitude.

27. The implantable cardiac stimulator of claim 26, wherein the maximum subthreshold amplitude is about 0.5 to 3.5 volts.

28. The implantable cardiac stimulator of claim 10, wherein the first phase duration is at least as long as the second phase duration.

29. The implantable cardiac stimulator of claim 10, wherein the first phase duration is about one to nine milliseconds.

30. The implantable cardiac stimulator of claim 10, wherein the second phase duration is about 0.2 to 0.9 milliseconds.

31. The implantable cardiac stimulator of claim 10, wherein the second phase amplitude is about two volts to twenty volts.

32. The implantable cardiac stimulator of claim 10, wherein the second phase duration is less than 0.3 milliseconds and the second phase amplitude is greater than 20 volts.

33. The implantable cardiac stimulator of claim 10, wherein the first stimulation phase is initiated greater than 200 milliseconds after heart beat.

34. The implantable cardiac stimulator of claim 10, wherein the first stimulation phase comprises anodal stimulation.

35. The implantable cardiac stimulator of claim 2, wherein the sensor senses atrial fibrillation by monitoring parameters selected from the group consisting of:

arterial blood pressure, rate of electrocardiogram deflections, and probability density function of the electrocardiogram.

36. The implantable cardiac stimulator of claim 2, further comprising:

sensing circuits, each of the sensing circuits being connected to a respective one of the electrodes and being adapted to provide sensing data concerning the site of one or more atrial ectopic foci.

37. The implantable cardiac stimulator of claim 36, wherein the processor is connected to receive the sensing data from the sensing circuits and determines the site of one or more atrial ectopic foci by triangulating the sensing data.

38. An apparatus for electrical cardiac pacing comprising:

a plurality of electrodes adapted to be disposed proximate atrial tissue;

a sense amplifier connected to at least one of the plurality of electrodes to sense atrial fibrillation;

a memory in electrical communication with the sense amplifier, for recording a baseline of cardiac activity;

an electrical stimulation driver, connected to at least one of the plurality of electrodes, to stimulate atrial tissue; and

processor circuitry programmed to determine status of pacing capture;

wherein, in the event that atrial fibrillation is sensed, the electrical stimulation driver uses a pre-capture stimulation protocol,

wherein, in the event that capture status is determined, the electrical stimulation driver uses a post-capture stimulation protocol, and

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.

39. The apparatus for electrical cardiac pacing of claim 38, wherein the procedure uses biphasic stimulation post-capture.

40. The apparatus for electrical cardiac pacing of claim 39, wherein the biphasic stimulation has a first phase that comprises anodal stimulation.

41. The apparatus for electrical cardiac pacing of claim 38, wherein the procedure uses biphasic stimulation pre-capture.

42. The apparatus for electrical cardiac pacing of claim 41, wherein the biphasic stimulation has a first phase that comprises anodal stimulation.

43. The apparatus for electrical cardiac pacing of claim 38, wherein the procedure uses biphasic stimulation pre-capture with biphasic stimulation post-capture.

44. The apparatus for electrical cardiac pacing of claim 43, wherein the biphasic stimulation has a first phase that comprises anodal stimulation.