Methods for renal neuromodulation

• US 8,145,317 B2
• Filed: 03/06/2006
• Issued: 03/27/2012
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Ardian, Inc. (Medtronic Plc)
• Inventors: Demarais, Denise, Gifford, III, Hanson, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US11/368,577
• Publication Number:
  US 20060276852A1
• Time in Patent Office: 2,213 Days
• Field of Search: 607/40, 607/44, 607/96, 607/98, 607/133, 607/99, 607/118
• US Class Current: 607/44
• CPC Class Codes: A61M 2210/1082 Kidney
• 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 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36117 for treating hypertension
• 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

Abstract

Methods and apparatus are provided for treating hypertension, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Claims

1. A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising:

positioning a nerve modulation device in a vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

reducing neural communication to and from the kidney by at least partially ablating the neural fibers of the patient via the nerve modulation device,

wherein the kidney continues to secrete renin in the patient after reducing neural communication with the nerve modulation device,

wherein reducing neural communication to and from the kidney results in improved cardio-renal function of the patient.

2. The method of claim 1 wherein positioning a nerve modulation device in a vicinity of post-ganglionic neural fibers comprises positioning the nerve modulation device within a renal vasculature the patient.

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

4. The method of claim 1 wherein positioning the nerve modulation device in a vicinity of post-ganglionic neural fibers comprises percutaneously advancing the nerve modulation device within a renal blood vessel of the patient proximate to the renal nerve.

5. The method of claim 1 wherein positioning a nerve modulation device comprises positioning a thermal transfer device in a vicinity of the post-ganglionic neural fibers of the patient.

6. The method of claim 5 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises cooling afferent and efferent nerves of the patient via the thermal transfer device.

7. The method of claim 6 wherein cooling afferent and efferent nerves of the patient comprises delivering a chilled fluid to a target region at least proximate to the afferent and efferent nerves.

8. The method of claim 6 wherein positioning a thermal transfer device in a vicinity of the post-ganglionic neural fibers of the patient comprises positioning a Peltier device in a vicinity of the post-ganglionic neural fibers.

9. The method of claim 5 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises heating afferent and efferent nerves of the patient via the thermal transfer device.

10. The method of claim 9 wherein heating afferent and efferent nerves comprises heating the nerves with RF energy.

11. The method of claim 1 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises delivering an electric field via the nerve modulation device to afferent and efferent nerves of the patient.

12. The method of claim 1 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises delivering a chemical agent to afferent and efferent nerves proximate the nerve modulation device.

13. The method of claim 12 wherein delivering a chemical agent comprises delivering alcohol.

14. The method of claim 12 wherein delivering a chemical agent comprises delivering phenol.

15. The method of claim 1 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises irreversibly ablating afferent and efferent nerves of the patient.

16. The method of claim 1, further comprising removing the nerve modulation device from the patient after at least partially ablating the renal nerve.

17. A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising:

positioning an energy element in a renal vasculature of the patient and in a vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

at least partially ablating a renal nerve of the patient via the energy element,

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

18. The method of claim 17 wherein positioning an energy element in a renal vasculature of the patient comprises positioning a thermal transfer device in the renal vasculature of the patient and in a vicinity of the neural fibers.

19. The method of claim 18 wherein at least partially ablating a renal plexus of the patient comprises cooling afferent and efferent nerves of the patient via the thermal transfer device.

20. A method for therapeutic renal denervation of a human patient having a diagnosed condition or disease associated with central sympathetic overactivity, the method comprising:

positioning a thermal element in a renal vasculature of the patient and in a vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

at least partially ablating the neural fibers of the patient via the thermal element,

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

21. The method of claim 20 wherein positioning a thermal element in a renal vasculature of the patient comprises positioning a renal denervation catheter having an energy element in the renal vasculature of the patient.

22. The method of claim 21 wherein positioning a renal denervation catheter having an energy element in the renal vasculature of the patient comprises positioning a renal denervation catheter having an electrode in the renal vasculature of the patient.

23. The method of claim 20 wherein at least partially ablating the neural fibers of the patient via the thermal element comprises at least partially ablating the neural fibers via cold.

24. The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

25. The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of heart failure in the patient.

26. The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of chronic renal failure in the patient.

27. The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of impaired renal function in the patient.

28. The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of acute myocardial infarction in the patient.