Methods and systems for renal neuromodulation

• US 9,980,766 B1
• Filed: 03/13/2015
• Issued: 05/29/2018
• Est. Priority Date: 03/28/2014
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Brar, Sandeep S., Liu, Minglei, Negoita, Manuela
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/656,900
• Time in Patent Office: 1,173 Days
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• 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 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• 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 1/0558 Anchoring or fixation means therefor

Abstract

Methods for treating preventing or decreasing the likelihood of a human patient developing hypertension and associated systems and methods are disclosed herein. One aspect of the present technology, for example, is directed to methods for therapeutic renal neuromodulation that partially inhibit sympathetic neural activity in renal nerves proximate a renal blood vessel of a human patient. This reduction in sympathetic neural activity is expected to therapeutically treat one or more conditions associated with hypertension or prehypertension of the patient. Renal sympathetic nerve activity can be modulated, for example, using an intravascularly positioned catheter carrying a neuromodulation assembly, e.g., a neuromodulation assembly configured to use mechanically-induced, electro-magnetically-induced, and/or chemically-induced approaches to modulate the renal nerves.

Claims

1. A method of treating hypertension in a human patient having a systolic blood pressure at or above 140 mm Hg, the method comprising:

inserting a mechanical device through vasculature of the human patient to a renal blood vessel;

pressing a distal portion of the mechanical device against an interior wall of the renal blood vessel, whereby the distal portion imparts mechanical force against the interior wall in a manner that at least partially disrupts function of renal neural fibers without delivery of electrical energy to the renal neural fibers,

wherein disrupting function of the renal neural fibers results in a therapeutically beneficial decrease in blood pressure of the patient; and

removing the mechanical device from the renal blood vessel after pressing the device against the interior wall.

2. The method of claim 1 wherein removing the mechanical device from the renal blood vessel includes removing the distal portion of the mechanical device from the patient.

3. The method of claim 1 wherein the mechanical device comprises a basket having a plurality of expandable legs, and wherein pressing a distal portion of the mechanical device against an interior wall of the renal blood vessel comprises transforming the basket between a low profile configuration for delivery through the vasculature to a deployed configuration in which the legs press against the wall of the renal blood vessel.

4. The method of claim 1 wherein the mechanical device comprises a balloon, and wherein pressing a distal portion of the mechanical device against an interior wall of the renal blood vessel comprises transforming the balloon from a low profile configuration for delivery through the vasculature to a deployed configuration in which the balloon presses against the wall of the renal blood vessel.

5. The method of claim 1 wherein the mechanical device comprises an expandable mesh, and wherein pressing a distal portion of the mechanical device against an interior wall of the renal blood vessel comprises transforming the mesh from a low profile configuration for delivery through the vasculature to a deployed configuration in which the mesh presses against the wall of the renal blood vessel.

6. The method of claim 1 wherein the mechanical device comprises a probe having a bendable distal tip, and wherein pressing a distal portion of the mechanical device against an interior wall of the renal blood vessel comprises pressing the distal tip of the probe against the wall of the renal blood vessel.

7. The method of claim 1 wherein pressing a distal portion of the mechanical device against an interior wall of the renal blood vessel comprises imparting force against the interior wall at a plurality of treatment locations, and wherein the treatment locations are spaced apart from each other and arranged in a helical pattern about an interior wall of the renal blood vessel, and further wherein the helical pattern includes at least one treatment location in each of an inferior, anterior, superior and posterior position about the interior wall.

8. The method of claim 1 wherein pressing a distal portion of the mechanical device against an interior wall of the renal blood vessel comprises imparting force against the interior wall for about 30 minutes or less.

9. The method of claim 1 wherein the therapeutically beneficial decrease in blood pressure of the patient is a decrease in blood pressure of at least about 12 mm Hg.

10. The method of claim 1 wherein the therapeutically beneficial decrease in blood pressure of the patient is a decrease in office blood pressure of at least about 14 mm Hg.

11. The method of claim 1 wherein the therapeutically beneficial decrease in blood pressure of the patient is a decrease in office blood pressure of at least about 21 mm Hg.

12. The method of claim 1 wherein the therapeutically beneficial decrease in blood pressure of the patient is a decrease in ambulatory blood pressure of at least about 5 mm Hg.

13. The method of claim 1 wherein, prior to inserting the mechanical device, the patient is on a maximum tolerable dosage of one or more antihypertensive medications.

14. The method of claim 1 wherein the patient achieves the therapeutically beneficial decrease in blood pressure no more than 6 months after disrupting function of the renal neural fibers.

15. The method of claim 1 wherein imparting mechanical force against the interior wall via the mechanical device in a manner that at least partially disrupts function of renal neural fibers further comprises imparting mechanical force without delivery of drug therapy to the renal neural fibers.

16. The method of claim 1 wherein imparting mechanical force against the interior wall via the mechanical device in a manner that at least partially disrupts function of renal neural fibers further comprises imparting mechanical force without delivery of cryotherapy to the renal neural fibers.