Renal nerve stimulation method and apparatus for treatment of patients

• US 7,647,115 B2
• Filed: 06/03/2005
• Issued: 01/12/2010
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Ardian, Inc. (Medtronic Plc)
• Inventors: Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): Bockelman; Mark W
• Application Number:
  US11/144,173
• Publication Number:
  US 20050228459A1
• Time in Patent Office: 1,684 Days
• Field of Search: 607/2, 607/44, 607 40- 41, 604/21
• US Class Current: 607/44
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• 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 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

A method and apparatus for treatment of heart failure, hypertension and renal failure by stimulating the renal nerve. The goal of therapy is to reduce sympathetic activity of the renal nerve. Therapy is accomplished by at least partially blocking the nerve with drug infusion or electrostimulation. Apparatus can be permanently implanted or catheter based.

Claims

1. A method of treating a patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, renal disease, or chronic renal failure, the method of treating the patient comprising:

positioning an electrode proximate to post-ganglionic neural fibers that innervate a kidney of the patient; and

generating an electric field via the electrode such that at least a portion of the neural fibers are in the electric field, wherein the electric field reduces neural communication along the neural fibers.

2. The method of claim 1 wherein the neural fibers comprise a renal nerve, and wherein the electric field impedes neural activity along a portion of the renal nerve.

3. The method of claim 1 wherein the electric field alters at least one of urine production, fluid retention, renin secretion, waste excretion, sodium retention, systemic vasoconstriction, renal function, heart function and blood pressure in the patient.

4. The method of claim 1, further comprising removing the electrode from the patient.

5. The method of claim 1 wherein positioning the electrode proximate to post-ganglionic neural fibers that innervate a kidney further comprises positioning the electrode proximate to a renal nerve.

6. The method of claim 5 further comprising placing the electrode in a renal vessel proximate to the renal nerve.

7. The method of claim 6 wherein the electrode further comprises an anode and a cathode, and wherein placing the electrode further comprises placing the anode and cathode in the renal vessel proximate to the renal nerve.

8. The method of claim 6 wherein placing the electrode in a renal blood vessel further comprises placing the electrode in a renal artery of the patient.

9. The method of claim 6 wherein the renal nerve has a longitudinal section, and wherein at least a portion of the electric field extends along the longitudinal section.

10. The method of claim 9 wherein a longitudinal dimension of the electric field extends in a generally medial or generally lateral direction relative to the patient.

11. The method of claim 6 wherein placing the electrode in the renal vessel further comprises placing the electrode in contact with a wall of the renal vessel.

12. The method of claim 6 wherein the electrode further comprises an anode and a cathode.

13. The method of claim 6 wherein the renal nerve has a longitudinal section, and wherein a portion of the electric field extends along the longitudinal section.

14. The method of claim 13 wherein a longitudinal dimension of the electric field extends in a generally medial or generally lateral direction relative to the patient.

15. The method of claim 5 wherein the electrode comprises an anode and a cathode, and wherein the method further comprise passing an electric current from the anode to the cathode to impede neural activity along the renal nerve.

16. The method of claim 15 wherein the electric current from the anode to the cathode blocks efferent neural activity along the renal nerve.

17. The method of claim 15 wherein the electrical current from the anode to the cathode blocks afferent neural activity.

18. The method of claim 15 wherein the electrical current from the anode to the cathode blocks at least one of efferent and afferent neural activity.

19. The method of claim 5, wherein positioning the electrode comprises implanting the electrode in a vessel near the renal nerve of the patient by fixing the electrode to the vessel.

20. The method of claim 19, wherein implanting the electrode further comprises implanting an anode and a cathode in the vessel near the renal nerve of the patient by attaching the anode and cathode to the vessel.

21. The method of claim 5 wherein positioning the electrode comprises fixing the electrode in tissue near the renal nerve of the patient.

22. The method of claim 21 wherein fixing the electrode further comprises fixing an anode and a cathode in tissue near the renal nerve of the patient.

23. The method of claim 5 wherein positioning the electrode comprises inserting a catheter having the electrode into a vessel such that the electrode is proximate to the renal nerve of the patient.

24. The method of claim 23 wherein the electrode further comprises an anode and a cathode, and wherein inserting the catheter further comprises inserting the catheter into the vessel such that the anode and the cathode are proximate to the renal nerve of the patient.

25. The method of claim 23, further comprising:

terminating the electric field; and

removing the catheter from the patient after terminating the electric field.

26. The method of claim 5 wherein positioning the electrode comprises inserting a device having the electrode into tissue of the patient such that the electrode is adjacent to the renal nerve of the patient.

27. The method of claim 26 wherein the electrode further comprises an anode and a cathode, and wherein inserting the device further comprises inserting the device into tissue of the patient such that the anode and the cathode are adjacent to the renal nerve of the patient.

28. The method of claim 26, further comprising:

terminating the electric field; and

removing the device from the patient after terminating the electric field.

29. The method of claim 26 wherein the electrode at least partially encircles the renal nerve.

30. The method of claim 1 wherein the electrode further comprises an anode and a cathode.

31. The method of claim 30 further comprising placing the electrode such that the anode is between a kidney of the patient and the cathode.

32. The method of claim 30 further comprising arranging the anode and cathode to produce an anodal nerve block.

33. The method of claim 30 further comprising arranging the anode and cathode to produce a cathodal nerve block.

34. The method of claim 1 wherein:

the neural fibers comprise a renal nerve having a longitudinal section; and

at least a portion of the electric field extends along the longitudinal section of the renal nerve.

35. The method of claim 1, further comprising sensing a physiological parameter.

36. The method of claim 35 wherein the physiological parameter is at least one of blood pressure, blood flow, blood oxygen, cardiac output, and cardiac pulses.

37. The method of claim 35, further comprising modulating the electric field in response to the sensed physiological parameter.

38. The method of claim 1, wherein the electric field is arranged relative to the neural fibers such that current in the electric field travels in a direction opposite to efferent signals in the neural fibers.

39. The method of claim 1, wherein the electric field is arranged relative to the neural fibers such that current in the electric field travels in a direction opposite to afferent signals in the neural fibers.

40. The method of claim 1 wherein generating the electric field comprises selecting a parameter of the electric field such that neural activity along a first nerve fiber having a first size is at least substantially inhibited without substantially affecting neural activity along a second nerve fiber having a second size different than the first size.

41. The method of claim 40 wherein the parameter of the electric field is selected from at least one of frequency, field strength, pulse width and duty cycle.

42. The method of claim 1 wherein the electric field ablates at least one neural fiber.

43. The method of claim 1 wherein the electric field alters afferent neural activity across the neural fibers.

44. The method of claim 1 wherein the electric field alters efferent neural activity across the neural fibers.

45. The method of claim 1 wherein the electric field alters at least one of efferent and afferent neural activity across the neural fibers.

46. A method of treating a patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, renal disease, or chronic renal failure, the method of treating the patient comprising:

positioning an electrode at least proximate to a renal nerve of a patient; and

applying an electric field to the renal nerve via the electrode in a manner that inhibits neural activity along the renal nerve.

47. The method of claim 46 wherein the neural activity comprises efferent neural signals.

48. The method of claim 46 wherein the neural activity comprises afferent activity along a portion of the renal nerve.

49. The method of claim 46 wherein the neural activity comprises at least one of efferent and afferent activity along a portion of the renal nerve.

50. The method of claim 46 further comprising placing the electrode in a blood vessel proximate to the renal nerve.

51. The method of claim 50 wherein placing the electrode in a blood vessel further comprises placing the electrode in a renal artery.

52. The method of claim 51 wherein positioning the electrode comprises advancing a catheter having the electrode into the renal artery such that electrode is proximate to the renal nerve.

53. The method of claim 52 wherein advancing the catheter having the electrode into the renal artery such that electrode is proximate to the renal nerve further comprises positioning the electrode in contact with a wall of the renal artery.