Methods for multi-vessel renal neuromodulation

• US 8,433,423 B2
• Filed: 12/13/2010
• Issued: 04/30/2013
• Est. Priority Date: 10/05/2004
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Ardian, Inc. (Medtronic Plc)
• Inventors: Demarais, Denise
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US12/966,897
• Publication Number:
  US 20110178570A1
• Time in Patent Office: 869 Days
• Field of Search: 607 2- 3, 607/44, 607/62, 607117-118, 604/891.1
• US Class Current: 607/118
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• 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: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• 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 1/0507 Electrodes for the digestive system
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/323 Interference currents, i.e. treatment by several currents summed in the body
• 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 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system
• 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

Abstract

Methods and apparatus are provided for multi-vessel neuromodulation, e.g., via a pulsed electric field. Such multi-vessel 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, the multi-vessel neuromodulation is applied to neural fibers that contribute to renal function. Such multi-vessel neuromodulation optionally may be performed bilaterally.

Claims

1. A method, comprising:

positioning a first electrode within a first vessel of a renal vasculature of a patient at least substantially proximate to a neural fiber that contributes to a function of a kidney of the patient;

positioning a second electrode within a second vessel of the renal vasculature of the patient, wherein the second vessel is a different vessel than the first vessel; and

passing electrical current through the first electrode and the second electrode and modulating the function of the neural fiber.

2. The method of claim 1 wherein positioning the second electrode in the second vessel of the renal vasculature of the patient comprises positioning the second electrode in a second vessel branching of the renal vasculature.

3. The method of claim 1 wherein positioning the first electrode within the first vessel and placing the second electrode within the second vessel comprises positioning the first electrode and the second electrode in different vessels that branch off from a renal artery of the patient.

4. The method of claim 1 wherein:

positioning the first electrode within the first vessel comprises positioning the first electrode within one of the following;

a renal artery, renal artery branchings, a renal vein, renal vein branchings, venous vasculature, and arterial vasculature; and

positioning the second electrode within the second vessel comprises positioning the second electrode within one of the following;

a renal artery, renal artery branchings, a renal vein, renal vein branchings, venous vasculature, and arterial vasculature.

5. The method of claim 1 wherein passing electrical current through the first electrode and the second electrode and modulating the function of the neural fiber comprises at least partially denervating the kidney of the patient.

6. The method of claim 1 wherein passing electrical current through the first electrode and the second electrode and modulating the function of the neural fiber comprises reducing neural traffic to and/or from the kidney of the patient.

7. The method of claim 1 wherein passing electrical current through the first electrode and the second electrode and modulating the function of the neural fiber comprises blocking at least one of afferent and efferent neural activity along the neural fiber.

8. The method of claim 1 wherein passing electrical current through the first electrode and the second electrode and modulating the function of the neural fiber comprises inducing an effect in the neural fiber chosen from the group including irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, cytokine up-regulation alteration, and combinations thereof.

9. The method of claim 1 wherein passing electrical current through the first electrode and the second electrode and modulating the function of the neural fiber comprises thermally modulating the function of the neural fiber.

10. The method of claim 1 wherein passing electrical current through the first electrode and the second electrode and modulating the function of the neural fiber comprises, on average during passage of the electrical current, modulating the function of the neural fiber generally athermally.

11. The method of claim 1 wherein positioning the first electrode in the first vessel and positioning the second electrode in the second vessel comprises positioning the first and second electrodes in a patient with diagnosed hypertension.

12. The method of claim 1 wherein passing electrical current through the first electrode and the second electrode and modulating the function of the neural fiber comprises treating a patient diagnosed with heart failure, myocardial infarction, kidney disease, chronic renal failure, and combinations thereof.

13. A method for renal neuromodulation, the method comprising:

intravascularly positioning a first electrode within a first portion of a renal vasculature of a patient, wherein the first electrode is positioned proximate to a renal nerve of the patient;

intravascularly positioning a second electrode within a second portion of the renal vasculature of the patient, wherein the second electrode is positioned in a different branch of the renal vasculature than the first electrode; and

modulating neural function of the renal nerve via the first electrode and the second electrode in a manner that affects a measurable physiological parameter associated with at least one of heart failure, hypertension, myocardial infarction, and renal disease.

14. The method of claim 13 wherein:

intravascularly positioning the first electrode within the first portion of the renal vasculature of the patient comprises positioning the first electrode in a first vessel distal to a bifurcation in a renal artery of the patient; and

intravascularly positioning the second electrode within the second portion of the renal vasculature of the patient comprises positioning the second electrode in a second, different vessel distal to the bifurcation in the renal artery.

15. The method of claim 13 wherein:

intravascularly positioning the first electrode within the first portion of the renal vasculature of the patient comprises positioning the first electrode within a first branching off a renal artery of the patient; and

intravascularly positioning the second electrode within the second portion of the renal vasculature of the patient comprises positioning the second electrode within a second, different branching off the renal artery.

16. The method of claim 13 wherein modulating neural function of the renal nerve comprises at least partially denervating a kidney of the patient.

17. The method of claim 13 wherein modulating neural function of the renal nerve comprises disabling the renal nerve.

18. The method of claim 13 wherein modulating neural function of the renal nerve comprises modulating at least one of afferent and efferent signals along the renal nerve.