Apparatuses and methods for renal neuromodulation

• US 9,072,527 B2
• Filed: 07/15/2013
• Issued: 07/07/2015
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Deem, Mark, Zarins, Denise, Sutton, Douglas, Gifford, Hanson III, Levin, Howard R., Gelfand, Mark, Clark, Benjamin J.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US13/942,223
• Publication Number:
  US 20140018879A1
• Time in Patent Office: 722 Days
• Field of Search: 604 20- 21, 607/2, 607/40, 607/44
• US Class Current: 1/1
• 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 2018/00267 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: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/1435 Spiral
• 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
• 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 1/36128 Control systems
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

Methods and apparatus are provided for renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for extravascular delivery of pulsed electric fields to achieve such neuromodulation.

Claims

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

extravascularly positioning a distal tip of a probe in an annular space between renal fascia and renal vasculature of a human patient and in proximity to renal nerves along the renal vasculature of the patient;

delivering a catheter through the probe to a treatment location proximate the renal nerves, wherein the catheter comprises an anchoring mechanism having—

a first collar;

a second collar located distally relative to the first collar;

an expandable member connected to the first and second collars,

wherein the expandable member is transformable between a collapsed configuration and an expanded configuration; and

a plurality of electrodes at the expandable member; and

delivering an electric field to the renal nerves via the electrodes to at least partially inhibit neural signaling along the renal nerves.

2. The method of claim 1, further comprising monitoring a response of at least one physiological parameter of the patient to treatment of the renal nerves.

3. The method of claim 1, further comprising infusing an agent via the catheter to create a working space to facilitate placement of the electrodes.

4. The method of claim 1, further comprising infusing an agent via the catheter to enhance the neurodestructive or neuromodulatory effect of the applied electric field.

5. The method of claim 1, further comprising removing the catheter and probe from the patient after therapy.

6. The method of claim 1, wherein the expandable member is a braid, mesh or woven member.

7. The method of claim 1, further comprising moving at least one of the first and second collars toward the other of the first and second collars to reduce the distance between the first and second collars.

8. The method of claim 1, further comprising reducing a distance between the first collar and the second collar to expand the expandable member to the expanded configuration.

9. The method of claim 1, wherein the electric field is a pulsed electric field.

10. The method of claim 1, wherein the patient has clinical symptoms of hypertension and wherein the method reduces or alleviates the clinical symptoms of hypertension.

11. The method of claim 1, wherein the patient has clinical symptoms of congestive heart failure and wherein the method reduces or alleviates the clinical symptoms of congestive heart failure.

12. The method of claim 1, wherein the patient has clinical symptoms of renal disease and wherein the method reduces or alleviates the clinical symptoms of renal disease.