Renal nerve stimulation method for treatment of patients

• US 8,131,372 B2
• Filed: 03/19/2007
• Issued: 03/06/2012
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• 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
• Application Number:
  US11/688,178
• Publication Number:
  US 20070173899A1
• Time in Patent Office: 1,814 Days
• Field of Search: 607/44, 607/96, 607 98- 99, 607/118, 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 for reducing blood pressure in a human patient, the method comprising:

positioning a nerve modulation device adjacent to a renal nerve of at least one kidney in a body of the patient; and

at least partially blocking the renal nerve of the kidney in the body of the patient by at least partially ablating the renal nerve,

wherein at least partially blocking the renal nerve results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1, wherein positioning the nerve modulation device adjacent to the renal nerve further comprises positioning the nerve modulation device within a renal vasculature of the patient.

3. The method of claim 2, wherein positioning the nerve modulation device within the renal vasculature of the patient further comprises positioning the nerve modulation device within a renal artery of the patient.

4. The method of claim 2, wherein positioning the nerve modulation device within the renal vasculature of the patient further comprises positioning the nerve modulation device within a renal vein of the patient.

5. The method of claim 2, wherein positioning the nerve modulation device within the renal vasculature of the patient further comprises positioning a catheter within the renal vasculature of the patient.

6. The method of claim 5, wherein positioning the catheter within the renal vasculature of the patient further comprises positioning an electrode within the renal vasculature of the patient.

7. The method of claim 6, wherein positioning the electrode within the renal vasculature further comprises positioning a unipolar electrode within the renal vasculature of the patient.

8. The method of claim 6, wherein at least partially ablating the renal nerve further comprises delivery of an electric field via the electrode to affect the renal nerve.

9. The method of claim 8 further comprising monitoring with a sensor at least one condition of the patient.

10. The method of claim 9 further comprising regulating delivery of the electric field based on a monitored condition of the patient.

11. The method of claim 6, wherein at least partially ablating the renal nerve further comprises heating the renal nerve with energy delivered via the electrode.

12. The method of claim 11, wherein the energy delivered via the electrode comprises RF energy.

13. The method of claim 6, wherein positioning the electrode within the renal vasculature of the patient further comprises positioning a bipolar electrode pair within the renal vasculature of the patient.

14. The method of claim 6, wherein positioning the electrode within the renal vasculature of the patient further comprises contacting the electrode with a wall of the renal vasculature of the patient.

15. The method of claim 1, wherein at least partially ablating the renal nerve further comprises at least partially ablating the renal nerve by transferring thermal energy.

16. The method of claim 15, wherein at least partially ablating the renal nerve by transferring thermal energy further comprises heating the renal nerve.

17. The method of claim 16, wherein heating the renal nerve further comprises heating the renal nerve with RF energy.

18. The method of claim 15, wherein at least partially ablating the renal nerve by transferring thermal energy further comprises cooling the renal nerve.

19. The method of claim 1, wherein positioning the nerve modulation device adjacent to a renal nerve of the patient further comprises positioning a drug delivery device adjacent to the renal nerve.

20. The method of claim 19, wherein at least partial ablation of the renal nerve further comprises at least partial ablation of the renal nerve via delivery of chemical agents to the renal nerve.

21. The method of claim 1, wherein treating the patient further comprises treating the patient for a condition chosen from the group consisting of heart failure, acute myocardial infarction, cardio-renal disease, chronic renal failure, end stage renal disease, proteinuria, hypertension, neuro-hormonal imbalance, elevated sympathetic activity and combinations thereof.

22. A method for treating at least one of heart failure, acute myocardial infarction, cardio-renal disease, chronic renal failure, end stage renal disease, proteinuria, hypertension, neuro-hormonal imbalance, and elevated sympathetic activity in a human patient, the method comprising:

intravascularly positioning a distal section of an electrical nerve modulation device adjacent to a renal nerve of at least one kidney of the patient and a proximal section of the electrical nerve modulation device outside of the patient;

at least partially ablating the renal nerve of the kidney via the electrical nerve modulation device; and

removing the distal section of the electrical nerve modulation device from the patient.

23. The method of claim 22, wherein positioning the electrical nerve modulation device adjacent the renal nerve of the patient further comprises positioning the electrical nerve modulation device within a renal vasculature of the patient.

24. The method of claim 23, wherein positioning the electrical nerve modulation device within the, renal vasculature of the patient further comprises positioning the electrical nerve modulation device within a renal artery of the patient.

25. The method of claim 23, wherein positioning the electrical nerve modulation device within the renal vasculature of the patient further comprises positioning the electrical nerve modulation device within a renal vein of the patient.

26. The method of claim 23, wherein positioning the electrical nerve modulation device within the renal vasculature of the patient further comprises positioning an electrode within the renal vasculature of the patient.

27. The method of claim 26, wherein positioning the electrode within the renal vasculature of the patient further comprises positioning a unipolar electrode within the renal vasculature of the patient.

28. The method of claim 26, wherein at least partially ablating the renal nerve further comprises delivery of an electric field via the electrode to affect the renal nerve.

29. The method of claim 26, wherein at least partially ablating the renal nerve further comprises heating the renal nerve with energy delivered via the electrode.

30. The method of claim 29, wherein the energy delivered via the electrode comprises RF energy.

31. The method of claim 29 further comprising monitoring at least one condition of the patient with a sensor.

32. The method of claim 31 further comprising regulating delivery of the electric field based on a monitored condition of the patient.

33. The method of claim 26, wherein positioning the electrode within the renal vasculature of the patient further comprises positioning a bipolar electrode pair within the renal vasculature of the patient.

34. The method of claim 26, wherein positioning the electrode within the renal vasculature of the patient further comprises contacting the electrode with a wall of the renal vasculature of the patient.

35. The method of claim 22, wherein at least partially ablating the renal nerve further comprises at least partial ablation of the renal nerve by transferring thermal energy.

36. The method of claim 35, wherein at least partially ablating the renal nerve by transferring thermal energy further comprises heating the renal nerve.

37. The method of claim 36, wherein heating of the renal nerve further comprises heating of the renal nerve with RF energy.

38. The method of claim 35, wherein at least partially ablating the renal nerve by transferring thermal energy further comprises cooling the renal nerve.

39. A method for treatment of a human patient via renal denervation, the method comprising:

intravascularly positioning a renal denervation catheter proximate to a renal nerve of at least one kidney in a body of the patient; and

at least partially ablating the renal nerve of the kidney in the body of the patient,

wherein at least partially ablating the renal nerve results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

40. The method of claim 39, wherein at least partially ablating the renal nerve further comprises reducing afferent neural signals along the renal nerve.

41. The method of claim 39, wherein at least partially ablating the renal nerve further comprises reducing efferent neural signals along the renal nerve.

42. The method of claim 39, wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

43. The method of claim 39, wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of heart failure in the patient.

44. The method of claim 39, wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of chronic renal failure in the patient.

45. The method of claim 39, wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of chronic impaired renal function in the patient.

46. The method of claim 39, wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of acute myocardial infarction in the patient.