Method and system for treatment of tachycardia and fibrillation

• US 6,564,096 B2
• Filed: 02/28/2001
• Issued: 05/13/2003
• Est. Priority Date: 02/28/2001
• Status: Expired due to Fees

• Current Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Original Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Inventors: Mest, Robert A.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): Yu, Jeanne
• Application Number:
  US09/795,576
• Publication Number:
  US 20020120304A1
• Time in Patent Office: 804 Days
• Field of Search: 607/1-9, 607/14-132, 607/148, 607/149, 607/154
• US Class Current: 607/14
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3624 occurring in the atrium, i.e. atrial tachycardia
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation

Abstract

A method for regulating the heart rate of a patient comprises inserting into a blood vessel of the patient a catheter having an electrode assembly at its distal end. The electrode assembly comprises a generally circular main region that is generally transverse to the axis of the catheter and on which is mounted at least one electrode. The catheter is directed to an intravascular location wherein the at least one electrode on the electrode assembly is adjacent a selected cardiac sympathetic or parasympathetic nerve. The at least one electrode is stabilized at the intravascular location. A stimulus is delivered through the at least one electrode, the stimulus being selected to stimulate the adjacent sympathetic or parasympathetic nerve to thereby cause a regulation of the patient'"'"'s heart rate.

Claims

1. A method for regulating the heart rate of a patient comprising:

inserting into a blood vessel of the patient a catheter having an electrode assembly at its distal end, the electrode assembly having a continuous generally circular main region comprising a generally circular non-conductive covering that is generally transverse to the axis of the catheter and on which is mounted at least one electrode;

directing the catheter to an intravascular location wherein the at least one electrode on the electrode assembly is adjacent to a selected cardiac sympathetic or parasympathetic nerve;

stabilizing the at least one electrode at the intravascular location; and

delivering a stimulus through the at least one electrode, the stimulus being selected to stimulate the adjacent sympathetic or parasympathetic nerve to thereby cause a regulation of the patient'"'"'s heart rate.

2. The method of claim 1, wherein the stimulation causes a slowing of the heart rate.

3. The method of claim 2, wherein the patient is suffering from atrial or ventricular tachycardia.

4. The method of claim 2, wherein the patient is suffering from atrial flutter.

5. The method of claim 2, wherein the patient is suffering from atrial fibrillation.

6. The method of claim 1, wherein the intravascular location is selected from the group consisting of the coronary sinus, the right pulmonary artery, and the superior vena cava.

7. The method of claim 1, wherein the electrode assembly comprises a support member having shape memory surrounded by the non-conductive covering.

8. The method of claim 7, wherein the electrode assembly carries a plurality of electrodes on the non-conductive covering.

9. The method of claim 1, wherein the electrode assembly further comprises a generally straight proximal region proximal to the generally circular main region, a transition region connecting the proximal region and the main region, and a generally straight distal region distal to the main region.

10. The method of claim 9, wherein the electrode assembly further comprises a support member having shape-memory disposed within at least the main region of the electrode assembly.

11. The method of claim 9, wherein the transition region is slightly curved and formed such that, when viewed from the side of the catheter with the proximal region at the top of the circular main region, the proximal region forms an angle α

with the circular region ranging from about 75°

to about 95°

.

12. The method of claim 9, wherein the generally straight distal region has an atraumatic design to prevent the distal end of the electrode assembly from penetrating tissue.

13. The method of claim 9, wherein the generally straight distal region has a length ranging from about 0.25 inch to about 1.0 inch.

14. The method of claim 1, wherein the generally circular main region has an outer diameter ranging from about 10 mm to about 25 mm.

15. The method of claim 1, wherein the generally circular main region has an outer diameter ranging from about 12 mm to about 20 mm.

16. The method of claim 1, wherein the electrode assembly carries a plurality of electrodes that are approximately evenly spaced around the generally circular main region.

17. The method of claim 1, wherein the stimulus comprises one or more electrical signals having a frequency of from about 1 Hz to about 200 Hz, an intensity of from about 1 V to about 150 V and a duration of from about 0.01 msec to about 10 msec.

18. The method of claim 17, wherein the frequency of the electrical signal(s) ranges from about 20 Hz to about 30 Hz.

19. The method of claim 17, wherein the intensity of the electrical signal(s) is from about 8 V to about 15 V.

20. The method of claim 17, wherein the duration of the electrical signal(s) is from about 0.05 msec to about 0.1 msec.

21. The method of claim 1, wherein the stimulation is timed to occur during a myocardial refractory period.

22. The method of claim 21, wherein the refractory period is regulated by myocardial pacing.

23. The method of claim 22, wherein the myocardial pacing is elicited from the at least one electrode or a second electrode on the catheter.

24. A method of selectively ablating a sympathetic or parasympathetic innervation of at least one portion of the heart of a patient comprising:

inserting into a blood vessel of the patient a catheter having an electrode assembly at its distal end, the electrode assembly having a continuous generally circular main region comprising a generally circular non-conductive covering that is generally transverse to the axis of the catheter and on which is mounted at least one electrode;

directing the catheter to an intravascular location wherein the at least one electrode on the electrode assembly is adjacent to a selected cardiac sympathetic or parasympathetic nerve;

stabilizing the electrode at the intravascular location; and

delivering an ablation stimulus through the electrode, the ablating stimulus being sufficient to damage the nerve so that it no longer conducts impulses to the heart.

25. The method of claim 24, wherein the electrode assembly comprises a support member having shape memory surrounded by the non-conductive covering.

26. The method of claim 25, wherein the electrode assembly carries a plurality of electrodes on the non-conductive covering.

27. The method of claim 24, wherein the electrode assembly further comprises a generally straight proximal region proximal to the generally circular main region, a transition region connecting the proximal region and the main region, and a generally straight distal region distal to the main region.

28. The method of claim 27, wherein the transition region is slightly curved and formed such that, when viewed from the side of the catheter with the proximal region at the top of the circular main region, the proximal region forms an angle α

with the circular region ranging from about 75°

to about 95°

.

29. The method of claim 24, wherein the generally circular main region has an outer diameter ranging from about 10 mm to about 25 mm.

30. The method of claim 24, wherein the generally circular main region has an outer diameter ranging from about 12 mm to about 20 mm.

31. The method of claim 24, wherein the electrode assembly carries a plurality of electrodes that are approximately evenly spaced around the generally circular main region.

32. A system to regulate the heart rate of a patient comprising:

a catheter having an electrode assembly at its distal end, the electrode assembly having a generally circular main region comprising a continuous generally circular non-conductive covering that is generally transverse to the axis of the catheter and on which is mounted at least one electrode; and

a signal generator electrically connected to the at least one electrode on the generally circular main region, the signal generator being capable of generating stimulating pulses having a frequency of from about 1 Hz to about 200 Hz, an intensity of from about 1V to about 200 V and a duration of from about 0.01 msec to about 10 msec.

33. The system of claim 32, wherein the electrode assembly comprises a support member having shape memory surrounded by the non-conductive covering.

34. The system of claim 33, wherein the electrode assembly carries a plurality of electrodes on the non-conductive covering.

35. The system of claim 32, wherein the electrode assembly further comprises a generally straight proximal region proximal to the generally circular main region, a transition region connecting the proximal region and the main region, and a generally straight distal region distal to the main region.

36. The system of claim 35, wherein the electrode assembly further comprises a support member having shape-memory disposed within at least the main region of the electrode assembly.

37. The system of claim 35, wherein the transition region is slightly curved and formed such that, when viewed from the side of the catheter with the proximal region at the top of the circular main region, the proximal region forms an angle α

with the circular region ranging from about 75°

to about 95°

.

38. The system of claim 35, wherein the generally straight distal region has an atraumatic design to prevent the distal end of the electrode assembly from penetrating tissue.

39. The system of claim 35, wherein the generally straight distal region has a length ranging from about 0.25 inch to about 1.0 inch.

40. The system of claim 32, wherein the generally circular main region has an outer diameter ranging from about 10 mm to about 25 mm.

41. The system of claim 32, wherein the generally circular main region has an outer diameter ranging from about 12 mm to about 20 mm.

42. The system of claim 32, wherein the electrode assembly carries a plurality of electrodes that are approximately evenly spaced around the generally circular main region.