Renal nerve stimulation method and apparatus for treatment of patients

• US 8,150,518 B2
• Filed: 06/03/2005
• Issued: 04/03/2012
• 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:
  US11/145,122
• Publication Number:
  US 20050234523A1
• Time in Patent Office: 2,496 Days
• Field of Search: 607/2, 607 40- 41, 607/44, 607/96, 607 98- 99, 607/133, 604/891.1
• 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 disease of a human patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, impaired renal function, or chronic renal failure, the method of treating the patient comprising:

positioning an energy delivery element proximate to a renal nerve of the patient; and

delivering an energy field via the energy delivery element to modulate neural function of the renal nerve,

wherein delivering the energy field results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein positioning an energy delivery element comprises extravascularly positioning the energy delivery element.

3. The method of claim 1 wherein positioning an energy delivery element comprises positioning the energy delivery element within a blood vessel.

4. The method of claim 3 wherein positioning the energy delivery element within a blood vessel further comprises positioning the energy delivery element within a renal blood vessel.

5. The method of claim 4 wherein positioning the energy delivery element within a renal blood vessel further comprises positioning the energy delivery element within a renal artery.

6. The method of claim 5 wherein positioning the energy delivery element within a renal artery further comprises positioning the energy delivery element in contact with a wall of the renal artery.

7. The method of claim 1 wherein modulating the renal nerve of the patient further comprises at least partially denervating a renal tissue of the patient.

8. The method of claim 7 wherein at least partially denervating the renal tissue of the patient further comprises at least partially denervating at least one kidney of the patient.

9. The method of claim 1 wherein positioning the energy delivery element proximate to the renal nerve of the patient comprises percutaneously advancing the energy delivery element into position under guidance.

10. The method of claim 9 wherein percutaneously advancing the energy delivery element into position under guidance further comprises percutaneously advancing the energy delivery element into position using a minimally invasive camera.

11. The method of claim 1 wherein modulating the renal nerve of the patient further comprises delivering thermal energy to the renal nerve.

12. The method of claim 11 wherein delivering thermal energy to the renal nerve comprises heating the renal nerve.

13. The method of claim 12 wherein heating the renal nerve comprises at least partially ablating the renal nerve.

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

delivering a device to a vicinity of a post-ganglionic neural fiber that innervates a kidney of the patient; and

thermally inducing modulation of a function of the neural fiber with the device

wherein thermally inducing modulation significantly improves a measureable physiological parameter corresponding to the disease of the patient.

15. The method of claim 14 wherein thermally inducing modulation of the function of the neural fiber further comprises heating the neural fiber.

16. The method of claim 15 wherein heating the neural fiber further comprises delivering RF energy to the neural fiber.

17. The method of claim 14 wherein thermally inducing modulation of the function of the neural fiber further comprises cooling the neural fiber.

18. The method of claim 17 wherein cooling the neural fiber further comprises cooling the neural fiber via a Peltier element.

19. The method of claim 14 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering a thermal electric field to the neural fiber via at least one electrode.

20. The method of claim 19 wherein delivering a device to a vicinity of the neural fiber further comprises intravascularly delivering the device, and wherein delivering a thermal electric field to the neural fiber via at least one electrode further comprises delivering the thermal electric field via at least one wall-contacting electrode.

21. The method of claim 14 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering a thermal fluid to a vicinity of the neural fiber.

22. The method of claim 21 wherein delivering a thermal fluid to a vicinity of the neural fiber further comprises delivering chilled saline to a vicinity of the neural fiber.

23. A method of treating a human patient diagnosed with a condition associated with central sympathetic overactivity, the method of treating the patient comprising:

introducing a modulation instrument proximate to a post-ganglionic neural fiber that innervates a kidney of the patient; and

reducing sympathetic neural activity in the patient by delivering energy to the neural fiber via the modulation instrument in order to modulate a function of the neural fiber,

wherein reducing sympathetic neural activity results in a therapeutically beneficial reduction in blood pressure in the patient.

24. The method of claim 23 wherein delivering energy further comprises delivering an electric field.

25. The method of claim 24 wherein delivering the electric field further comprises delivering a pulsed electric field.

26. The method of claim 23 wherein modulating the function of the neural fiber further comprises at least partially denervating the kidney.

27. The method of claim 23 wherein delivering energy further comprises delivering thermal energy.

28. The method of claim 23 wherein reducing sympathetic neural activity in the patient further comprises systemically reducing sympathetic tone in the patient.

29. The method of claim 23 wherein reducing sympathetic neural activity in the patient further comprises inducing neurohormonal changes in the patient.

30. The method of claim 29 wherein inducing neurohormonal changes further comprises reducing renin secretion.

31. The method of claim 30 wherein reducing renin secretion further comprises reducing systemic vasoconstriction.

32. The method of claim 23 wherein reducing sympathetic neural activity in the patient further comprises increasing urine output.

33. The method of claim 23 wherein reducing sympathetic neural activity in the patient further comprises increasing sodium excretion.

34. The method of claim 33 wherein increasing sodium excretion results in a reduction in total body sodium in the patient.

35. The method of claim 23 wherein introducing the modulation instrument proximate to a post-ganglionic neural fiber further comprises introducing the modulation element within a renal artery of the patient.

36. The method of claim 23 wherein reducing sympathetic neural activity in the patient results in improved renal function in the patient.

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

positioning an energy transfer element at least proximate to a neural fiber that innervates a kidney of the patient; and

transferring energy via the energy transfer element in a manner that at least partially ablates the neural fiber,

wherein at least partially ablating the neural fiber results in a significant reduction in blood pressure of the patient.

38. The method of claim 37 wherein positioning an energy transfer element at least proximate to the neural fiber further comprises positioning an RF electrode at least proximate to the neural fiber.

39. The method of claim 37 wherein positioning an energy transfer element at least proximate to the neural fiber further comprises positioning a cryoablation device at least proximate to the neural fiber.

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

positioning a modulation device proximate to a first renal nerve corresponding to a first kidney of the patient;

positioning the modulation device proximate to a second renal nerve corresponding to a second kidney of the patient; and

delivering an energy field via the modulation device to modulate neural function of the first renal nerve and the second renal nerve,

wherein delivering the energy field significantly improves a measureable physiological parameter corresponding to the disease of the patient.

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

positioning an energy transfer device in a vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

thermally modulating a function of the neural fibers with the device,

wherein thermally modulating the function of the neural fibers results in a therapeutically beneficial reduction in blood pressure of the patient.

42. The method of claim 41 wherein thermally modulating a function of a neural fiber comprises thermally modulating an afferent neural fiber.

43. The method of claim 41 wherein thermally modulating a function of a neural fiber comprises thermally modulating an efferent neural fiber.

44. The method of claim 41 wherein thermally modulating a function of the neural fiber with the device comprises at least partially ablating at least one of an efferent neural fiber and an afferent neural fiber with the device.

45. The method of claim 41 wherein positioning an energy transfer device in a vicinity of post-ganglionic neural fibers that innervate a kidney of the patient comprises positioning an energy transfer device proximate to a renal blood vessel.

46. The method of claim 45 wherein positioning an energy transfer device proximate to a renal blood vessel comprises positioning an energy transfer device within a renal blood vessel.

47. The method of claim 46 wherein thermally modulating a function of a neural fiber with the device comprises reducing neural activity across the neural fiber with the device from within the renal blood vessel.

48. The method of claim 47 wherein reducing neural activity across the neural fiber with the device from within the renal blood vessel comprises reducing afferent neural activity across the neural fiber with the device.

49. The method of claim 47 wherein reducing neural activity across the neural fiber with the device from within the renal blood vessel comprises reducing efferent neural activity across the neural fiber with the device.

50. The method of claim 41 wherein thermally modulating a function of a neural fiber reduces systemic sympathetic neural activity in the patient.

51. A method of treating a disease of a human patient associated with central sympathetic overactivity, the method comprising:

introducing a modulation instrument proximate to a post-ganglionic neural fiber that innervates a kidney of the patient; and

reducing afferent and/or efferent renal neural activity in the patient by delivering energy to the neural fiber via the modulation instrument,

wherein reducing afferent and/or efferent renal neural activity significantly improves a measureable physiological parameter corresponding to the disease of the patient.

52. The method of claim 51 wherein reducing afferent and/or efferent renal neural activity significantly improves a measureable physiological parameter of the patient corresponding to hypertension.

53. The method of claim 51 wherein reducing afferent and/or efferent renal neural activity significantly improves a measureable physiological parameter of the patient corresponding to heart failure.

54. The method of claim 51 wherein reducing afferent and/or efferent renal neural activity significantly improves a measureable physiological parameter of the patient corresponding to acute myocardial infarction.

55. The method of claim 51 wherein reducing afferent and/or efferent renal neural activity significantly improves a measureable physiological parameter of the patient corresponding to impaired renal function.

56. The method of claim 51 wherein reducing afferent and/or efferent renal neural activity significantly improves a measureable physiological parameter of the patient corresponding to chronic renal failure.

57. A method of renal denervation for treating a disease of a human patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, impaired renal function, or chronic renal failure, the method of renal denervation for treating the patient comprising:

positioning an energy delivery element proximate to a renal nerve of the patient; and

delivering an energy field via the energy delivery element to modulate neural function of the renal nerve,

wherein delivering the energy field significantly improves a measureable physiological parameter corresponding to the disease of the patient.

58. A method of treating a disease of a human patient diagnosed with at least one of heart failure, hypertension, acute myocardial infarction, impaired renal function, or chronic renal failure via renal denervation, the method of treating the patient comprising:

positioning an energy delivery element proximate to a renal nerve of the patient; and

delivering an energy field via the energy delivery element to modulate neural function of the renal nerve,

wherein delivering the energy field results in a therapeutically beneficial reduction in central sympathetic overactivity in the patient.

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

delivering a device to a vicinity of a post-ganglionic neural fiber that innervates a kidney of the patient; and

thermally inducing modulation of a function of the neural fiber with the device,

wherein thermally inducing modulation results in a therapeutically beneficial reduction in blood pressure of the patient.

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

delivering a device to afferent and efferent neural fibers corresponding to a kidney of the patient; and

thermally reducing neural communication along the neural fibers with the device,

wherein thermally reducing neural communication along the neural fibers results in a therapeutically beneficial reduction in central sympathetic overactivity in the patient.

61. A method of treating a human patient diagnosed with a condition associated with central sympathetic overstimulation, the method of treating the patient comprising:

introducing a modulation instrument proximate to a post-ganglionic neural fiber that innervates a kidney of the patient; and

reducing sympathetic neural activity in the patient by delivering energy to the neural fiber via the modulation instrument to modulate a function of the neural fiber,

wherein reducing sympathetic neural activity results in a therapeutically beneficial reduction in blood pressure of the patient.

62. A method of treating a human patient diagnosed with a condition associated with central sympathetic overstimulation, the method of treating the patient comprising:

introducing a modulation instrument proximate to a post-ganglionic neural fiber that innervates a kidney of the patient; and

reducing sympathetic neural activity in the patient by delivering energy to the neural fiber via the modulation instrument to modulate a function of the neural fiber,

wherein reducing sympathetic neural activity significantly improves a measureable physiological parameter corresponding to the disease of the patient.