Renal neuromodulation for treatment of patients

• US 9,314,630 B2
• Filed: 11/20/2014
• Issued: 04/19/2016
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• Current Assignee: Medtronic Ireland Manufacturing Unlimited Company (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/549,071
• Publication Number:
  US 20150080872A1
• Time in Patent Office: 516 Days
• Field of Search: 607/2, 607/17, 607/101, 607/116, 607/118
• US Class Current: 1/1
• 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 within renal vasculature of the patient and adjacent to a renal nerve of at least one kidney of the patient; and

at least partially blocking the renal nerve of the kidney 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 within renal vasculature of the patient comprises positioning the nerve modulation device within a renal artery of the patient.

3. The method of claim 1 wherein positioning the nerve modulation device within renal vasculature of the patient comprises positioning a catheter within the renal vasculature of the patient.

4. The method of claim 3 wherein positioning the catheter within the renal vasculature of the patient comprises positioning an electrode within the renal vasculature of the patient.

5. The method of claim 4 wherein positioning the electrode within the renal vasculature of the patient comprises positioning a unipolar electrode within the renal vasculature of the patient.

6. The method of claim 5 wherein at least partially ablating the renal nerve comprises delivering an electric field via the electrode to affect the renal nerve.

7. The method of claim 5 wherein at least partially ablating the renal nerve further comprises heating the renal nerve with energy delivered via the electrode.

8. The method of claim 7 wherein the energy delivered via the electrode comprises RF energy.

9. The method of claim 4 wherein positioning the electrode within the renal vasculature of the patient comprises positioning a bipolar electrode pair within the renal vasculature of the patient.

10. The method of claim 4 wherein positioning the electrode within the renal vasculature of the patient comprises positioning the electrode in apposition with a wall of the renal vasculature of the patient.

11. The method of claim 1, further comprising monitoring at least one condition of the patient with a sensor.

12. 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 comprising:

positioning an energy delivery element within a renal blood vessel and 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.

13. The method of claim 12 wherein positioning the energy delivery element within a renal blood vessel comprises positioning the energy delivery element within a renal artery of the patient.

14. The method of claim 12 wherein positioning the energy delivery element within a renal blood vessel comprises positioning the energy delivery element in contact with an inner wall of a renal artery of the patient.

15. The method of claim 12 wherein delivering an energy field to modulate neural function of the renal nerve comprises delivering thermal energy to the renal nerve.

16. The method of claim 15 wherein delivering thermal energy to the renal nerve comprises heating the renal nerve.

17. The method of claim 16 wherein heating the renal nerve comprises partially ablating the renal nerve.

18. The method of claim 16 wherein heating the renal nerve comprises ablating the renal nerve.

19. A method for reducing blood pressure in a human patient, the method comprising:

intravascularly positioning a nerve modulation device within a renal artery of the patient and adjacent to a renal nerve of the patient;

at least partially blocking the renal nerve 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; and

removing the nerve modulation device from the renal artery after at least partially ablating the renal nerve.

20. The method of claim 19 wherein intravascularly positioning a nerve modulation device within a renal artery of the patient comprises intravascularly positioning a catheter within the renal artery of the patient.

21. The method of claim 20 wherein intravascularly positioning the catheter within the renal artery of the patient comprises intravascularly positioning an electrode within the renal artery of the patient.

22. The method of claim 21 wherein intravascularly positioning the electrode within the renal artery of the patient comprises intravascularly positioning a unipolar electrode within the renal artery of the patient.

23. The method of claim 21 wherein at least partially ablating the renal nerve comprises delivering an electric field via the electrode to affect the renal nerve.

24. The method of claim 21 wherein at least partially ablating the renal nerve further comprises heating the renal nerve with energy delivered via the electrode.

25. The method of claim 24 wherein the energy delivered via the electrode comprises RF energy.

26. The method of claim 20 wherein intravascularly positioning the electrode within the renal artery of the patient comprises intravascularly positioning a bipolar electrode pair within the renal artery of the patient.

27. The method of claim 20 wherein intravascularly positioning the electrode within the renal artery of the patient comprises intravascularly positioning the electrode in apposition with a wall of the renal artery of the patient.

28. The method of claim 19, further comprising monitoring at least one condition of the patient with a sensor.

29. The method of claim 19 wherein:

intravascularly positioning a nerve modulation device within a renal artery of the patient comprises intravascularly positioning a distal portion of the nerve modulation device within the renal artery and adjacent to the renal nerve and a proximal portion of the nerve modulation device external to the patient; and

removing the nerve modulation device from the renal artery after at least partially ablating the renal nerve comprises removing the distal portion of the nerve modulation device from the renal artery of the patient.