Method and apparatus for using vagus nerve stimulation in surgery

• US 5,913,876 A
• Filed: 09/22/1997
• Issued: 06/22/1999
• Est. Priority Date: 02/20/1996
• Status: Expired due to Fees

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Cardiothoracic Systems, Inc. (Boston Scientific Corporation)
• Inventors: Taylor, Charles S., Morejohn, Dwight P., Matheny, Robert G.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/935,126
• Time in Patent Office: 638 Days
• Field of Search: 607/2, 607/9, 128/898
• US Class Current: 607/2
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488

Abstract

A method and apparatus for facilitating coronary surgery on the beating heart wherein the vagus nerve is electrically stimulated to purposely temporarily stop or substantially reduce the beating of the heart under precisely controlled conditions. The apparatus controllably applies the electrical stimulus to preselected locations along the vagus nerve and thus to preselected nerve branches related to the heart. The apparatus includes several clip and probe configurations for establishing electrical contact with the vagus nerve. Such purposely caused temporary stoppage or substantial reduction of the beating of the heart facilitates procedures such as suturing of an anastomosis which would otherwise be more difficult because of the motion induced by the beating heart.

Claims

1. A method for performing coronary artery bypass graft surgery on a patient'"'"'s beating heart, wherein a fluid communicating graft is made between an arterial blood supply and the coronary artery distal from a stenosis, comprising the steps of:

locating a position on the patient'"'"'s vagus nerve that, when electrically stimulated, will cause a momentary stoppage or substantial reduction in the beating of the patient'"'"'s heart; and

applying an electrical stimulation to the position on the patient'"'"'s vagus nerve at least once during the construction of the fluid communicating graft to cause the momentary stoppage or substantial reduction in the beating to facilitate construction of the graft.

2. The method of claim 1 wherein the construction of a fluid communicating graft comprises the step of forming an anastomosis between the arterial blood supply and the coronary artery.

3. The method of claim 2 wherein the step of forming comprises a series of suturing steps wherein the vagus nerve is stimulated before each of the suturing steps.

4. The method of claim 2 wherein the step of forming comprises a series of suturing steps wherein the vagus nerve is stimulated before at least one of the suturing steps.

5. The method of claim 1 wherein each step of applying lasts for a period of about 10 or less seconds.

6. The method of claim 1 wherein the stimulations are intermittently applied with at least several seconds between stimulations.

7. The method of claim 6 wherein the stimulation is applied to the patient'"'"'s vagus nerve in the form of a pulse train of selected frequency and electrical energy.

8. The method of claim 1 further comprising the step of:

applying a heart pacing electrical signal to the patient'"'"'s heart during the step of applying an electrical stimulation to revive the heart in the event that it is slow to resume beating after the momentary stoppage or substantial reduction in beating.

9. A method for performing coronary artery bypass graft surgery on a patient'"'"'s beating heart, wherein a selected surgical procedure is performed to provide a fluid communicating graft, comprising the step of:

momentarily arresting or substantially slowing the beating of the patient'"'"'s heart for a precisely controlled period of time without the need for cardiopulmonary bypass support to provide access to the stopped or slowed heart to facilitate performing the selected surgical procedure.

10. The method of claim 9 further comprising the steps of:

supplying an electrical stimulating signal during the selected surgical procedure; and

selectively applying the electrical stimulating signal to a selected position on the patient'"'"'s vagus nerve during the selected surgical procedure to stimulate the vagus nerve to induce said momentarily arrested or substantially slowed beating of the patient'"'"'s heart.

11. The method of claim 10 wherein said electrical stimulating signal is applied on the left vagus nerve as it crosses the transverse aorta, just proximal to the left recurrent nerve branch.

12. The method of claim 10 wherein said electrical stimulating signal is applied on the deep cardiac plexus of the vagus nerve.

13. The method of claim 10 wherein said electrical stimulating signal is applied on the cervical portion of the left or right vagus nerve just proximal to the left or right superior cervical cardiac nerve, respectively.

14. The method of claim 9 wherein said selected surgical procedure comprises:

performing an anastomosis between an arterial blood supply and a coronary artery to effect the selected surgical procedure; and

performing a series of suturing steps in which the patient'"'"'s heart is momentarily arrested or substantially slowed before at least one suturing step of the anastomosis.

15. The method of claim 14 further comprising the step of:

applying an electrical stimulus to the patient'"'"'s vagus nerve for a period of from one to a plurality of seconds to purposely effect the momentary arrest or substantial slowing of the heart before said at least one suturing step of the anastomosis.

16. The method of claim 9 wherein said selected surgical procedure comprises:

forming an arteriotomy in a coronary artery to be bypassed; and

applying an electrical stimulus to the patient'"'"'s vagus nerve for a period of from one to a plurality of seconds to purposely effect the momentary arrest or substantially slowing of the heart during said step of forming an arteriotomy.

17. The method of claim 9 wherein said selected surgical procedure comprises:

placing ligatures around a coronary artery to be bypassed; and

applying an electrical stimulus to the patient'"'"'s vagus nerve for a period of from one to a plurality of seconds to purposely effect the momentary arrest or substantially slowing of the heart during said step of placing ligatures.

18. Apparatus for performing coronary artery bypass graft surgery on a patient'"'"'s beating heart, wherein a selected surgical procedure is performed on the patient, comprising:

means for supplying an electrical stimulating signal during the selected surgical procedure; and

means responsive to the supplying means for momentarily arresting or substantially slowing the patient'"'"'s heart for a controllable period of time during the selected surgical procedure without the need for cardiopulmonary bypass support.

19. The apparatus of claim 18 wherein:

said means for supplying generates an electrical stimulating signal capable of stimulating the patient'"'"'s vagus nerve; and

said means for momentarily arresting or substantially slowing the heart comprises means for applying the electrical stimulating signal to a selected position on the patient'"'"'s vagus nerve during the selected surgical procedure.

20. The apparatus of claim 19 wherein the applying means comprises attachment means electrically coupled to said means for supplying for establishing electrical contact with the patient'"'"'s vagus nerve to insure the application thereto of the electrical stimulating signal.

21. The apparatus of claim 20 wherein:

the selected surgical procedure comprises forming an anastomosis between an arterial blood supply and the coronary artery; and

said applying means further comprises control means for selectively enabling the application of the electrical stimulating signal to the patient'"'"'s vagus nerve via the attachment means at selected times during the anastomosis.

22. The apparatus of claim 21 wherein the anastomosis comprises a series of suturing steps in which the vagus nerve is stimulated via the applying means for about 10 or less seconds prior to at least one suturing step.

23. The apparatus of claim 20 wherein the attachment means comprises electrically non-conductive clip means embodying an electrically conductive nerve contacting electrode.

24. The apparatus of claim 20 wherein the attachment means comprises an electronically insulated surgical instrument embodying an electrically conductive nerve contacting probe means.

25. The apparatus of claim 20 wherein said attachment means comprises:

a pair of electrically non-conducting members each terminating at one end in an enlarged handle and at the opposite end in confronting jaws, the members being secured together in pivotable relation;

electrodes electrically coupled to the supplying means embedded within the confronting jaws and adapted to make firm electrical contact only with the vagus nerve; and

spring means for maintaining the confronting jaws and electrodes normally closed firmly on the vagus nerve.

26. The apparatus of claim 25 further comprising:

applicator means having clip applying jaws for attaching the attachment means to the vagus nerve; and

wherein said enlarged handles each include, in combination with respective ends of the clip applying jaws, a spherical ball/depression structure which enables swiveling the attachment means relative to the applicator means while still firmly holding the attachment means within the applicator'"'"'s jaws.

27. The apparatus of claim 25 wherein:

one of the members comprises a pair of parallel spaced apart jaws each with its respective electrode embedded in confronting relation therein; and

wherein the confronting jaw and electrode of the opposite member is laterally disposed between the confronting spaced apart jaws and provides a gentle shearing force when urged by the spring means towards the confronting spaced apart jaws to confine therebetween the vagus.

28. The apparatus of claim 25 wherein the electrodes have a circular or arcuate cross section.

29. The apparatus of claim 25 wherein the electrodes have a square or rectangular cross section.

30. The apparatus of claim 25 wherein the electrodes comprise selectively roughened confronting surfaces to enhance their electrical contact with the vagus nerve.

31. The apparatus of claim 20 wherein the attachment means comprises:

clip means incorporating at least one electrode adapted for electrical contact with the vagus nerve; and

means for supporting the clip means in selected orientation to allow the attachment thereof at a predetermined position on the vagus nerve.

32. The apparatus of claim 31 wherein:

said clip means comprises a pair of confronting jaws, with respective nerve contacting electrodes embedded in the jaws and energized by said supplying means; and

said supporting means comprises a pair of handles integral with the pair of confronting jaws, said handles being adapted to open the jaws upon application of force on the handles to allow said attachment to the vagus nerve.

33. The apparatus of claim 32 wherein the clip means comprises a jaw with an embedded electrode generally confronting two laterally spaced jaws with embedded electrodes which, when attached to the vagus nerve, provide a slight shearing affect to enhance the attachment.

34. The apparatus of claim 32 wherein the clip means further comprises two pair of confronting jaws with respective embedded electrodes in the jaws, wherein one pair of electrodes confronts a second pair of electrodes at a selected laterally spaced distance.

35. The apparatus of claim 32 wherein the clip means further comprises a pair of laterally spaced apart jaws with embedded electrodes of selected positive and negative polarities, and including a confronting paddle shaped jaw.

36. The apparatus of claim 35 wherein the paddle shaped jaw comprises electrodes of selected positive and negative polarities embedded therein which confront the electrodes of the spaced apart jaws.

37. The apparatus of claim 32 wherein the clip means further comprises a pair of confronting paddle shaped jaws with respective embedded paddle shaped electrodes of selected polarities.

38. The apparatus of claim 32 wherein said supporting means further comprises:

applicator means having at a distal end thereof a pair of jaws adapted to firmly engage said pair of handles to maintain the clip means at said selected orientation, whereupon application of force by the applicator means jaws opens the clip means jaws to allow the attachment of the clip means to the vagus nerve.

39. The apparatus of claim 20 wherein the attachment means comprises:

endoscopic means comprising a lumen therein and having an elongate member adapted for controllable translation in the lumen; and

wherein a distal end of the endoscopic means comprises nerve contacting means comprising confronting jaws and electrodes selectively manipulated by the translation of the elongate member to close upon, and establish the electrical contact of the electrodes with, the patient'"'"'s vagus nerve.

40. The apparatus of claim 39 wherein the nerve contacting means comprises:

a cone-shaped cap fixed to a distal end of the elongate member;

a first electrode disposed in the distal end of the endoscopic means and confronting the cap; and

a second electrode disposed in the cap and confronting the first electrode, such that translation of the elongate member into the lumen brings the electrodes together to allow capturing the vagus nerve therebetween.

41. The apparatus of claim 39 wherein the nerve contacting means comprises:

a pair of confronting jaws pivotably secured to a distal end of the elongate member, said jaws having confronting electrodes of selected polarities embedded therein; and

said jaws being adapted to close upon translation of the elongate member and jaws into the lumen, to thus establish the electrical contact between the electrodes and the patient'"'"'s vagus nerve.

42. The apparatus of claim 39 comprising an endoscope disposed within the endoscopic means for providing a view of the jaws and the vagus nerve to facilitate establishing the electrical contact.

43. The apparatus of claim 20 wherein the attachment means comprises:

endoscopic means comprising a lumen therein and having an elongate member adapted for controllable translation in the lumen;

said elongate member comprising a pair of spring-like jaws of respective electrical polarities formed at the distal end of the member, wherein the spring-like jaws diverge upon their translation from within the distal end of the endoscopic means; and

said spring-like jaws having notches formed in their ends for capturing the patient'"'"'s vagus nerve upon selected rotation of the endoscopic means.

44. The apparatus of claim 20 wherein the attachment means comprises:

a pair of electrically insulated members, said members terminating in respective sharpened probes adapted to penetrate the patient'"'"'s vagus nerve to establish the electrical contact therewith.

45. The apparatus of claim 20 wherein the attachment means further comprises:

endoscopic means comprising a lumen therein, and having an elongate member adapted for controllable translation in the lumen;

said elongate member terminating at its distal end in at least one sharpened probe adapted to penetrate the patient'"'"'s vagus nerve to establish the electrical contact therewith.

46. The apparatus of claim 20 wherein the attachment means comprises:

clip means for establishing the electrical contact, said clip means comprising;

a sleeve member having a laterally protruding jaw and an embedded electrode;

a second member slidably disposed within the sleeve member and having a laterally protruding jaw and embedded electrode confronting the sleeve member'"'"'s jaw and electrode;

spring means disposed to urge the jaws into a closed condition; and

said second member being translated relative to the sleeve member upon application of force thereto to allow the attachment of the confronting electrodes to the vagus nerve.

47. The apparatus of claim 19 further comprising:

means electrically coupled to the patient'"'"'s heart for supplying a heart pacing electrical signal to revive the heart during the selected surgical procedure in the event that the heart is slow to resume beating upon removal of the momentarily arresting stimulating signal.

48. A system for performing a selected surgical procedure on a patient'"'"'s beating heart, comprising:

means for providing at least one opening in the patient'"'"'s chest which provides access to the heart and surrounding tissues and vessels, comprising a coronary artery;

means for providing access to a vagus nerve of the patient;

means for supplying a vagus nerve stimulating electrical signal; and

means detachably attached to the vagus nerve and responsive to the supplying means for temporarily applying the stimulating signal to the vagus nerve to temporarily stop or substantially reduce the beating of the heart during the selected surgical procedure without need for cardiopulmonary bypass support.

49. The system of claim 48, further comprising an instrument to assist in connecting via an anastomosis procedure an arterial blood supply to the coronary artery distal from a stenosis therein.

50. The system of claim 48 wherein the selected surgical procedure comprises supplying a free graft means having first and second ends, forming a first anastomosis between the first end of the graft means and an arterial blood supply and forming a second anastomosis between the second end of the graft means and the coronary artery.

51. The system of claim 48 wherein the coronary artery is connected to an arterial blood supply via a series of applied sutures in which the vagus nerve is stimulated before at least one of the applied sutures.

52. The system of claim 51 wherein a stimulation signal is applied for a period of about 10 or less seconds.

53. The system of claim 48 wherein the applying means comprises:

clip means electrically coupled to the supplying means for establishing a detachable but firm electrical contact with the patient'"'"'s vagus nerve while being substantially insulated from the surrounding tissues and vessels.

54. The system of claim 53 wherein the clip means is attachable to one or more preselected positions on the vagus nerve, the clip means being adapted to apply the vagus nerve stimulating electrical signal to the one or more positions such that each position, when stimulated, affects a respective region of the heart to cause the temporary stoppage or substantial reduction in the heart beat.

55. The system of claim 53 wherein the clip means include:

a pair of generally confronting jaws of electrically insulating material;

a respective electrode embedded in the confronting jaws and adapted to make the firm electrical contact with the patient'"'"'s vagus nerve; and

wherein the supplying means supplies a positive electrical potential to one electrode and a negative electrical potential to the other electrode.

56. The system of claim 53 further comprising:

spring means integral with the clip means for maintaining the clip means normally closed; and

means demountably secured to the clip means for overcoming the clip means normally closed condition to enable the application of the clip means to the vagus nerve, said spring means maintaining the clip means in said firm electrical contact.

57. The system of claim 48 further comprising:

means electrically coupled to the patient'"'"'s heart for applying a heart pacing electrical signal to the heart during the bypass graft surgery to revive the heart if needed after the stimulating signal is removed.

58. The system of claim 48 wherein the applying means comprises:

a pair of electrically insulated leads, said leads terminating in respective sharpened probes adapted to penetrate the patient'"'"'s vagus nerve to temporarily apply the stimulating signal thereto.

59. A method of performing coronary artery bypass graft surgery on a patient'"'"'s beating heart, wherein a fluid communicating graft is made between an arterial blood supply and the coronary artery, comprising the steps of:

providing at least one opening in the patient'"'"'s chest which provides access to the arterial blood supply and the coronary artery, and to the vagus nerve;

forming an anastomosis between the arterial blood supply and the coronary artery;

electrically stimulating the vagus nerve during the step of forming the anastomosis to momentarily stop or substantially slow the beating of the heart;

performing at least one suturing step of the anastomosis during the momentary stop or substantially slow beating of the heart; and

repeating the steps of electrically stimulating and performing at least one suturing step until the anastomosis is completed.