Methods for renal neuromodulation

• US 9,636,173 B2
• Filed: 06/16/2015
• Issued: 05/02/2017
• Est. Priority Date: 10/21/2010
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Goshgarian, Justin, Clark, Benjamin J., Dhamodharasamy, Rajeshkumar, Aboytes, Maria G., Leung, Mark S.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/741,320
• Publication Number:
  US 20150351833A1
• Time in Patent Office: 686 Days
• Field of Search: 606 41, 606 20, 606 22- 25
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• 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 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2018/00047 using Peltier effect
• 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 2018/1807 using light other than laser radiation
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves

Abstract

Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present application, for example, is directed to apparatuses, systems, and methods that incorporate a catheter treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver an energy delivery element to a renal artery via an intravascular path. Thermal or electrical renal neuromodulation may be achieved via direct and/or via indirect application of thermal and/or electrical energy to heat or cool, or otherwise electrically modulate, neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.

Claims

1. A method of treating a human patient diagnosed with hypertension, the method comprising:

advancing a catheter through a radial artery of the patient and into a renal artery of the patient, the catheter having an elongated shaft extending along an axis and comprising a distal portion including a controlled flexure zone and a single distal electrode adjacent to and extending distally beyond the controlled flexure zone;

establishing contact between the electrode and an interior wall of the renal artery, wherein the controlled flexure zone is configured for controlled flexure about the axis to position the electrode in contact with the interior wall;

delivering a thermal fluid infusate through the electrode and into the renal artery; and

delivering energy via the electrode to ablate target tissue along the renal artery.

2. The method of claim 1, wherein advancing a catheter through a radial artery of the patient and into a renal artery of the patient comprises advancing the catheter through the radial artery, through a subclavian artery of the patient, through an aortic arch of the patient, down a descending aorta of the patient, and into the renal artery.

3. The method of claim 1, wherein advancing a catheter through a radial artery of the patient and into a renal artery of the patient comprises advancing the catheter through the radial artery, through a subclavian artery and a brachiocephalic artery of the patient, through an aortic arch of the patient, down a descending aorta of the patient, and into the renal artery.

4. The method of claim 1, wherein at least a portion of the catheter comprises nitinol.

5. The method of claim 1, wherein the thermal fluid infusate comprises a cooling fluid.

6. The method of claim 5, wherein the thermal fluid infusate comprises saline.

7. The method of claim 6, wherein the saline comprises room temperature saline.

8. The method of claim 6, wherein the saline comprises chilled saline.

9. The method of claim 1, wherein delivering a thermal fluid infusate through the electrode and into the renal artery comprises delivering the thermal infusate at an infusion rate of less than or equal to 15 mL/minute.

10. The method of claim 1, wherein delivering a thermal fluid infusate through the electrode and into the renal artery comprises delivering the thermal infusate at an infusion rate of less than or equal to 10 mL/minute.

11. The method of claim 1, wherein the electrode comprises a plurality of ports configured to direct the thermal fluid infusate away from the target tissue along the renal artery during ablation.

12. The method of claim 1, wherein the electrode comprises a plurality of ports arranged around a circumference of the electrode.

13. The method of claim 1, wherein the catheter further comprises one or more irrigation ports positioned proximal of the electrode.

14. The method of claim 1, wherein the distal portion of the catheter further comprises a hypo tube having a helical spine with connecting ribs.