Catheter apparatuses, systems, and methods for renal neuromodulation

• US 10,342,612 B2
• Filed: 11/14/2017
• Issued: 07/09/2019
• 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, Leung, Mark S., Aboytes, Maria G.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/812,947
• Publication Number:
  US 20180147005A1
• Time in Patent Office: 602 Days
• 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:

intravascularly positioning a catheter within a renal artery of the patient and adjacent to target neural fibers innervating a kidney of the patient, the catheter comprising a distal region including a first flexure zone and a second flexure zone extending distally from the first flexure zone, wherein the second flexure zone includes a plurality of electrodes, and wherein the second flexure zone is configured for spiral deflection;

delivering a thermal fluid infusate through one or more of the individual electrodes and into the renal artery; and

at least partially ablating the target neural fibers via radio frequency (RF) energy delivered via the electrodes.

2. The method of claim 1 wherein each of the electrodes includes a plurality of infusion outlets through which the thermal fluid infusate is delivered.

3. The method of claim 1 wherein delivering the thermal fluid infusate through one or more of the individual electrodes and into the renal artery comprises delivering the thermal infusate at an infusion rate of less than or equal to 15 mL/minute.

4. The method of claim 1 wherein delivering the thermal fluid infusate through one or more of the individual electrodes and into the renal artery comprises delivering the thermal infusate at an infusion rate of less than or equal to 10 mL/minute.

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

6. The method of claim 1 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 each of the electrodes comprises a plurality of ports configured to direct the thermal fluid infusate into the renal artery and away from the target neural fibers during ablation.

10. The method of claim 1 wherein each of the electrodes comprises a plurality of ports arranged around a circumference of the respective electrode.

11. The method of claim 1 wherein the second flexure zone comprises four electrodes.

12. The method of claim 1 wherein intravascularly positioning the catheter within a renal artery of the patient comprises advancing the catheter through a 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.

13. The method of claim 1 wherein intravascularly positioning the catheter within a renal artery of the patient comprises advancing the catheter through a 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.

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

15. The method of claim 1 wherein the catheter further comprises one or more irrigation ports positioned proximal of the electrodes.

16. The method of claim 1 wherein the plurality of electrodes provide a non-continuous circumferential ablation treatment of the target neural fibers when the second flexure zone is positioned in its spiral deflected configuration.

17. The method of claim 1 wherein the second flexure zone further comprises a hypo tube having a spiral spine with connecting ribs.

18. The method of claim 1, further comprising monitoring a parameter of target tissue and/or non-target tissue within the patient before and during delivery of the RF energy.

19. The method of claim 18 wherein monitoring the parameter comprises monitoring a temperature of target tissue, and wherein the method further comprises maintaining the target tissue at a desired temperature during delivery of the RF energy.

20. The method of claim 18, further comprising altering delivery of the RF energy in response to the monitored parameter.

21. The method of claim 18, further comprising altering delivery of the thermal fluid infusate into the renal artery in response to the monitored parameter.

22. The method of claim 1 wherein at least partially ablating the target neural fibers results in a therapeutically beneficial reduction in blood pressure of the patient.