Methods and apparatus for monopolar renal neuromodulation

• US 20060265015A1
• Filed: 04/13/2006
• Published: 11/23/2006
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• Current Assignee: Medtronic Ireland Manufacturing Unlimited Company (Medtronic Plc)
• Original Assignee: Ardian, Inc. (Medtronic Plc)
• Inventors: Zadno, US, Levin, Howard R., Demarais, Denise, Gelfand, Mark, Gifford, Hanson III, Deem, Mark
• Granted Patent: US 8,131,371 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• 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

Abstract

Methods and apparatus are provided for monopolar neuromodulation, e.g., via a pulsed electric field. Such monopolar 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, monopolar neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such monopolar neuromodulation is performed bilaterally.

Claims

1. A method for renal neuromodulation of a patient, the method comprising:

placing a monopolar electrode in proximity to a neural fiber that contributes to renal function of a kidney of a patient;

electrically coupling a ground electrode to an exterior of the patient; and

delivering an electric field between the monopolar electrode and the ground electrode to modulate a function of the neural fiber.

3. The method of claim 1, wherein modulating the function of the neural fiber further comprises at least partially denervating the kidney.

4. The method of claim 1, wherein modulating the function of the neural fiber further comprises inducing an effect in the neural fiber chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, cytokine up-regulation alteration, and combinations thereof.

5. The method of claim 1, wherein modulating the function of the neural fiber further comprises thermally modulating the function of the neural fiber.

6. The method of claim 1, wherein modulating the function of the neural fiber further comprises, on average during delivery of the electric field, modulating the function of the neural fiber substantially athermally.

7. The method of claim 1, wherein placing the monopolar electrode in proximity to the neural fiber that contributes to renal function further comprises placing the electrode at a position chosen from the group consisting of within renal vasculature, external to renal vasculature, external to renal vasculature via a laparoscopic approach, external to renal vasculature via an intra-to-extravascular approach and combinations thereof.

8. The method of claim 1, wherein electrically coupling the ground electrode to the exterior of the patient further comprises attaching a ground pad to skin of the patient.

9. The method of claim 1, wherein modulating the function of the neural fiber further comprises treating a medical condition afflicting the patient.

10. The method of claim 9, wherein treating the medical condition afflicting the patient further comprises treating a medical condition chosen from the group consisting of heart failure, hypertension, myocardial infarction, renal disease, contrast nephropathy and combinations thereof.

2. The method of claim 2, wherein delivering the electric field further comprises delivering a pulsed electric field.

11. A method for a renal neuromodulation of a patient, comprising:

placing a monopolar electrode at least substantially proximate to a neural fiber that contributes to renal function of a kidney of a patient;

electrically coupling a ground electrode to an exterior of the patient; and

delivering an electric field between the monopolar electrode and the ground electrode such that the resulting electric field is generally aligned with a longitudinal axis of a renal artery associated with the kidney, thereby modulating a function of the neural fiber.

12. The method of claim 11 wherein:

delivering the electric field further comprises delivering a pulsed electric field; and

modulating the function of the neural fiber further comprises at least partially denervating the kidney.

13. The method of claim 11 wherein placing the monopolar electrode further comprises positioning the electrode at a location chosen from the group consisting of within the renal vasculature, external to the renal vasculature, through a vessel wall of the renal vasculature, and combinations thereof.

14. Apparatus for performing renal neuromodulation of a patient, the apparatus comprising:

a pulsed electric field generator;

a device configured for percutaneous placement proximate a renal vasculature of the patient, the device comprising a monopolar electrode electrically coupled to the pulsed electric field generator; and

a ground electrode configured for electrical coupling to an exterior of the patient,

wherein the apparatus is configured for delivery of a pulsed electric field between the monopolar electrode and the ground electrode to modulate a neural fiber that contributes to renal function while the device is located proximate the renal vasculature.

15. The apparatus of claim 14, wherein the monopolar electrode is configured for placement at a position chosen from the group consisting of within the renal vasculature, adjacent to the renal vasculature, external to the renal vasculature, external to the renal vasculature via a laparoscopic approach, external to the renal vasculature via an intra-to-extravascular approach and combinations thereof.

16. The apparatus of claim 14, wherein the device is configured for intravascular placement, the device further comprising an expandable element configured for expansion from a collapsed delivery configuration to an expanded deployed configuration within the renal vasculature of the patient.

17. The apparatus of claim 16, wherein the expandable element is configured to center the monopolar electrode within the renal vasculature of the patient.

18. The apparatus of claim 16, wherein the expandable element is configured to position the monopolar electrode in contact with a wall of the renal vasculature of the patient.

19. The apparatus of claim 16, wherein the expandable element is configured to position the monopolar electrode external to the renal vasculature of the patient via an intra-to-extravascular approach.

20. The apparatus of claim 16, wherein the expandable element is configured to alter impedance between the monopolar electrode and the ground electrode when positioned within the renal vasculature of the patient.

21. The apparatus of claim 16, wherein the expandable element comprises an inflatable balloon.

22. The apparatus of claim 21, wherein the inflatable balloon comprises the monopolar electrode.

23. The apparatus of claim 22, wherein the inflatable balloon is fabricated from a conductive polymer.

24. The apparatus of claim 14, wherein the ground electrode further comprises a ground pad configured for attachment to skin of the patient.

25. A method for at least partially denervating a kidney of a patient, the method comprising:

placing a monopolar electrode in proximity to a neural fiber that contributes to renal function of the kidney;

electrically coupling a ground electrode to an exterior of the patient; and

delivering an electric field between the monopolar electrode and the ground electrode to at least partially denervate the kidney.