Methods for therapeutic renal neuromodulation

Patent metadata

Field	Value
Publication number	US-9636174-B2
Application number	US-201615059332-A
Country	US
Kind code	B2
Filing date	Mar 3, 2016
Priority date	Apr 8, 2002
Publication date	May 2, 2017
Grant date	May 2, 2017

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.

First claim

We claim:

1. A method for treating a hypertensive human patient, the method comprising:
intravascularly delivering a renal denervation catheter having one or more needles and one or more electrodes through an abdominal aorta of the patient to a renal blood vessel of the patient and proximate to renal nerves;
delivering an infusate and an electrode extravascularly via the one or more needles;
delivering electrical energy via the one or more electrodes to attenuate or block neural signaling along the renal nerves; and
removing the renal denervation catheter from the patient after delivering the infusate to conclude the procedure.

2. The method of claim 1 wherein delivering the electrical energy to attenuate or block neural signaling along the renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

3. The method of claim 1 wherein the renal denervation catheter comprises an expandable element at a distal region of the catheter, and wherein the method further comprises:
transforming the expandable element from a low-profile delivery configuration to an expanded treatment configuration within the renal blood vessel after intravascularly delivering the catheter to the renal artery of the patient and before delivering the infusate.

4. The method of claim 3 wherein transforming the expandable element from the low-profile delivery configuration to the expanded treatment configuration centers the renal denervation catheter within the renal blood vessel.

5. The method of claim 1 wherein the renal denervation catheter further comprises a plurality of ports with needles extendable therefrom, and wherein each needle houses an electrode, and wherein the method further comprises:
advancing the individual needles from the corresponding needle ports away from the catheter and piercing a vessel wall of the patient such that at least a tip of each needle is positioned extravascularly before delivering the infusate.

6. The method of claim 5 wherein advancing the individual needles comprises advancing the needles simultaneously.

7. The method of claim 1 wherein delivering the infusate via the one or more needles comprises delivering the infusate to tissue external to the renal blood vessel of the patient and adjacent to the renal nerves.

8. The method of claim 1 wherein delivering the electrical enemy to attenuate or block neural signaling along the renal nerves comprises systemically reducing sympathetic tone in the patient.

9. The method of claim 1 wherein delivering the electrical energy to attenuate or block neural signaling along the renal nerves comprises reducing afferent and/or efferent renal neural activity.

10. The method of claim 1 wherein delivering an infusate comprises delivering a drug.

11. The method of claim 1 wherein delivering an infusate comprises delivering saline.

12. The method of claim 1 wherein delivering an infusate comprises delivering a gas, solid or liquid.

13. The method of claim 1 wherein delivering an infusate comprises delivering a heated or chilled fluid.

14. The method of claim 1 wherein delivering electrical energy to attenuate or block neural signaling along the renal nerves comprises delivering the electrical energy to ablate the renal nerves.

15. The method of claim 1 wherein intravascularly delivering a renal denervation catheter through an abdominal aorta of the patient to a renal blood vessel comprises delivering the renal denervation catheter to the renal blood vessel via a guidewire.

Assignees

• Medtronic Ardian Luxembourg

Inventors

• Zarins Denise
• Gifford Iii Hanson
• Deem Mark
• Sutton Douglas
• Levin Howard R
• Gelfand Mark

Classifications

• A61N1/36117

  for treating hypertension · CPC title

• A61B2018/00511

  Kidney · CPC title

• A61B2018/00351

  Heart · CPC title

• A61B18/1492 Primary

  having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence) · CPC title

• A61B2018/00404

  Blood vessels other than those in or around the heart · CPC title