Method and system for nerve stimulation prior to and during a medical procedure

• US 6,449,507 B1
• Filed: 09/26/2000
• Issued: 09/10/2002
• Est. Priority Date: 04/30/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Keogh, James R., Jahns, Scott E., Hill, Michael R. S.
• Primary Examiner(s): Layno, Carl
• Application Number:
  US09/670,441
• Time in Patent Office: 714 Days
• Field of Search: 607/2, 607/3, 607/9, 607/10, 607/14
• US Class Current: 607/9
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• 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 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/385 Devices for inducing an abnormal cardiac function, e.g. fibrillation
• CPC Class Codes: A61N 1/39 Heart defibrillators

Abstract

A method of performing a medical procedure, such as surgery, is provided. A nerve is stimulated in order to adjust the beating of the heart to a first condition, such as a stopped or slowed condition. The medical procedure is performed on the heart or another organ. The stimulation of the nerve is stopped in order to adjust the beating of the heart to a second condition, such as a beating condition. The heart itself may also be stimulated to a beating condition, such as by pacing. The stimulation of the nerve may be continued in order to allow the medical procedure to be continued. Systems and devices for performing the medical procedure are also provided.

Claims

1. A method of performing a medical procedure, comprising:

stimulating a nerve to adjust beating of a heart to a first condition;

performing the medical procedure on an organ;

reducing stimulation of the nerve to adjust beating of a heart to a second condition;

stimulating the nerve a subsequent time in order to re-adjust beating of the heart to the first condition; and

continuing the medical procedure.

2. The method of claim 1 wherein the nerve is stimulated using transvascular stimulation.

3. The method of claim 1 wherein the stimulation is stopped to achieve the second condition.

4. The method of claim 1 wherein the first condition is a stopped condition.

5. The method of claim 1 wherein the first condition is a slowed condition.

6. The method of claim 1 wherein the second condition is a beating condition.

7. The method of claim 1 further comprising:

stimulating the heart in order to adjust beating of the heart to the second condition.

8. The method of claim 7 wherein the heart is stimulated by pacing.

9. The method of claim 1 further comprising:

delivering at least one drug during the medical procedure.

10. The method of claim 9 wherein the drug is selected from the group consisting of:

a beta-blocker, a cholinergic agent, a cholinesterase inhibitor, a calcium channel blocker, a sodium channel blocker, a potassium channel agent, adenosine, an adenosine receptor agonist, an adenosine deaminase inhibitor, dipyridamole, a monoamine oxidase inhibitor, digoxin, digitalis, lignocaine, a bradykinin agent, a serotoninergic agonist, an antiarrythmic agent, a cardiac glycoside a local anesthetic, atropine, a calcium solution, an agent that promotes heart rate, an agent that promotes heart contractions, dopamine, a catecholamine, an inotrope glucagon, a hormone, forskolin, epinephrine, norepinephrine, thyroid hormone, a phosphodiesterase inhibitor, prostacyclin, prostaglandin and a methylxanthine.

11. The method of claim 9 wherein the drug is naturally occurring.

12. The method of claim 9 wherein the drug is chemically synthesized.

13. The method of claim 1 wherein the nerve is selected from the group consisting of;

vagus nerve fibers, parasympathetic nerve fibers, and sympathetic nerve fibers.

14. The method of claim 1 wherein the nerve is selected from the group consisting of

vagal nerve, a carotid sinus nerve, and a nerve located in a fat pad.

15. The method of claim 1 wherein the organ is the heart.

16. The method of claim 1 wherein the medical procedure is selected from the group consisting of:

surgical procedures, non-surgical procedures, endoscopic procedures, fluoroscopic procedures, stent delivery procedures, aortic aneurysm repairs, cranial aneurysm repairs, delivery of drugs, delivery of biological agents, cardiac surgery with cardiopulmonary bypass circuits, cardiac surgery without cardiopulmonary bypass circuits, brain surgery, cardiograms, heart valve repair, heart valve replacement, MAZE procedures, transmyocardial revascularization, CABG procedures, beating heart surgery, vascular surgery, neurosurgery, electrophysiology procedures, diagnostic ablation of arrhythmias, therapeutic ablation of arrhythmias, endovascular procedures, treatment of injuries to the liver, treatment of the spleen, treatment of the heart, treatment of the lungs, treatment of major blood vessels, non-invasive procedures, invasive procedures, and port-access procedures.

17. A system for performing a medical procedure comprising:

a nerve stimulator to inhibit beating of the heart;

a cardiac stimulator in communication with the transvenous nerve stimulator to stimulate beating of the heart; and

drug delivery means for delivering at least one drug dunng the medical procedure.

18. The system of claim 17 wherein the drug delivery means is selected from the group consisting of:

a spray, a cream, an ointment, a medicament a pill a patch, a catheter, a cannula, a needle and syringe a pump, and an iontophoretic drug delivery device.

19. The system of claim 18 wherein the drug is selected from the group consisting of:

beta-blocker, a cholinergic agent, a cholinesterase inhibitor, a calcium channel blocker, a sodium channel blocker, a potassium channel agent, adenosine, an adenosine receptor agonist, an adenosine deaminase inhibitor, dipyridamole, a monoamine oxidase inhibitor, digoxin, digitalis, lignocaine, a bradykinin agent, a serotoninergic agonist, an antiarrythmic agent, a cardiac glycoside, a local anesthetic, atropine, a calcium solution, an agent that promotes heart rate, an agent that promotes heart contractions dopamine, a catecholamine, an inotrope glucagon, a hormone, forskolin, epinephrine, norepinephrine. thyroid honnone, a phosphodiesterase inhibitor, prostacyclin prostaglandin and a methylxanthine.

20. A system for performing a medical procedure, comprising;

a nerve stimulator to inhibit beating of the heart;

a physician operated switch in communication with the nerve stimulator, the switch regulating the output of the nerve stimulator; and

a cardiac stimulator in communication with the nerve stimulator to stimulate beating of the heart.

21. The system of claim 20 wherein the nerve stimulator stimulates a nerve from the group consisting of:

vagus nerve fibers, parasympathetic nerve fibers, and sympathetic nerve fibers.

22. The system of claim 20 wherein the nerve stimulator simulates a nerve selected from the group consisting of:

a vagal nerve, a carotid sinus nerve, and a nerve located in a fat pad.

23. The system of claim 20 wherein the nerve stimulator comprises at least one electrode.

24. The system of claim 23 wherein the electrode is selected from the group consisting of:

nerve stimulation electrodes, endotracheal electrodes, endoesophageal electrodes, intravascular electrodes, transcutaneous electrodes, intracutaneous electrodes, balloon-type electrodes, basket-type electrodes, umbrella-type electrodes, tape-type electrodes, suction-type electrodes, screw-type electrodes, barb-type electrodes, bipolar electrodes, monopolar electrodes, metal electrodes, wire electrodes, patch electrodes, cuff electrodes, clip electrodes, needle electrodes and probe electrodes.

25. The system of claim 20 wherein the cardiac stimulator comprises at least one electrode.

26. The system of claim 25 wherein the electrode is selected from the group consisting of:

cardiac stimulation electrodes, clip electrodes, needle electrodes, probe electrodes, pacing electrodes, epicardial electrodes, patch electrodes, intravascular electrodes, balloon-type electrodes, basket-type electrodes, tape-type electrodes, umbrella-type electrodes, suction-type electrodes,endotracheal electrodes, endoesophageal electrodes, transcutaneous electrodes, intracutaneous electrodes, screw-type electrodes, barb-type electrodes, bipolar electrodes, monopolar electrodes, metal electrodes, wire electrodes and cuff electrodes.

27. The device of claim 20 wherein the switch is a hand switch.

28. The device of claim 20 wherein the switch is a foot switch.

29. The device of claim 20 wherein the switch is a voice-activated switch.

30. A system for performing a medical procedure comprising:

a nerve stimulator to inhibit beating of the heart;

a cardiac stimulator in communication with the transvenous nerve stimulator to stimulate beating of the heart; and

a respiratory controller for controlling respiration.

31. The system of claim 30 wherein the respirator controller comprises one or more electrodes.

32. The system of claim 31 wherein the electrodes are selected from the group consisting of:

phrenic nerve stimulation electrodes, bipolar electrodes, monopolar electrodes, patch electrodes, balloon electrodes, basket electrodes, umbrella electrodes, tape electrodes, cuff electrodes. suction electrodes, screw electrodes, barb electrodes, clip electrodes, needle electrodes, probe electrodes, metal electrodes, metal foil electrodes wire electrodes, endotracheal electrodes, endoesophageal electrodes, intravascular electrodes, transcutaneous electrodes, intracuraneous electrodes and electrode arrays.

33. The system of claim 30 wherein the respiratory controller comprises a connector which interfaces with a patient'"'"'s respirator.

34. A method of performing heart surgery, comprising:

transvenously stimulating a nerve to reduce beating of a heart;

operating on the heart;

reducing stimulation of the nerve;

stimulating the heart to cause beating of the heart;

re-stimulating the nerve to re-inhibit beating of the heart; and

continuing the surgery.

35. The method of claim 34 further comprising:

stopping stimulation of the nerve before stimulating the heart.

36. A device for performing a medical procedure comprising:

a processor;

a nerve stimulation electrode operatively connected to the processor;

a physician operated switch operatively connected to the processor to allow the physician to regulate the output of the nerve stimulation electrode; and

a cardiac stimulation electrode operatively connected to the processor, wherein the processor processes output from the nerve stimulation electrode and adjusts output from the cardiac stimulation electrode based on output from the nerve stimulation electrode.

37. The device of claim 36 wherein stimulation from the nerve stimulation electrode occurs in an inverse relationship to stimulation from the cardiac stimulation electrode.

38. The device of claim 36 wherein the switch is a hand switch.

39. The device of claim 36 wherein the switch is a foot switch.

40. The device of claim 36 wherein the switch is a voice-activated switch.

41. A method of performing a medical procedure comprising:

stimulating a first nerve to reduce or stop a patient'"'"'s heart beat;

stimulating a second nerve to reduce or stop the patient'"'"'s heart thing;

performing the medical procedure on an organ;

reducing stimulation of the first nerve to increase or start the patient'"'"'s heart beat,

reducing stimulation of the second nerve to increase or stan the patient'"'"'s breathing;

restimulating the first nerve to reduce or stop a patient'"'"'s heart beat a subsequent time;

re-stimulating the second nerve To reduce or stop the patient'"'"'s breathing a subsequent time;

continuing the medical procedure.

42. The method of claim 41 further comprising:

stimulating the patient'"'"'s heart in order to increase or start the patient'"'"'s heart beat.

43. The method of claim 42 wherein the heart is stimulated by pacing.

44. The method of claim 41 further comprising. administering at least one drug during the medical procedure.

45. The system of claim 44 wherein the drug is selected from the group consisting of:

a beta-blocker, a cholinergic agent, a cholinesrerase inhibitor, a calcium channel blocker, a sodium channel blocker, a potassium channel agent, adenosine, an adenosine receptor agonist, an adenosine deaminase inhibitor, dipyridamole, a monoamine oxidase inhibitor, digoxin, digitalis, lignocaine, a bradykinin agent, a serotoninergic agonist, an antiarrythmic agent a cardiac glycoside, a local anesthetic, atropine, a calcium solution, an agent that promotes heart rate, an agent that promotes heart contractions, dopamine, a catecholamine, an inotrope glucagon, a hormone, forskolin, epinephrine, norepinephrine, thyroid honnone, a phosphodiesterase inhibitor, prostacyclin, prostaglandin and a methylxanthine.

46. The method of claim 41 wherein the first nerve is a parasympathetic nerve.

47. The method of claim 46 wherein the parasympathetic nerve is a vagus nerve.

48. The method of claim 41 wherein the second nerve is a phrenic nerve.

50. The method of claim 41 wherein the medical procedure is selected from the group consisting of:

surgical procedures, non-surgical procedures, endoscopic procedures fluoroscopic procedures, stent delivery procedures, aortic aneurysm repairs, cranial aneurysm repairs, delivery of drugs, delivery of biological agents, cardiac surgery with cardiopulmonary bypass circuits, cardiac surgery without cardiopulmonary bypass circuits, brain surgery, cardiograms, heart valve repair, heart valve replacement, MAZE procedures, transmyocardial revascularization, CABG procedures, beating heart surgery, vascular surgery, neurosurgery, electrophysiology procedures, diagnostic ablation of arrhythmias, therapeutic ablation of arrhythmias, endovascular procedures, treatment of injuries to the liver, treatment of the spleen, treatment of the heart, treatment of the lungs, treatment of major blood vessels, non-invasive procedures, invasive procedures, and port-access procedures.

49. The method of clam 41 wherein the organ is the heart.