Catheter apparatuses, systems, and methods for renal neuromodulation

• US 9,855,097 B2
• Filed: 03/22/2017
• Issued: 01/02/2018
• 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:
  US15/466,734
• Publication Number:
  US 20170258522A1
• Time in Patent Office: 286 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 catheter apparatus for intravascular renal neuromodulation, comprising:

an elongated shaft comprising a proximal portion and a distal portion configured for percutaneous placement within a renal blood vessel of a human patient and proximate to neural fibers along the renal blood vessel that innervate a kidney of the patient,

wherein the distal portion includes a first flexure zone and a second flexure zone extending distally from the first flexure zone, the second flexure zone being configured for helical deflection; and

a plurality of energy delivery elements carried by the second flexure zone,

wherein the second flexure zone is configured to be transformable between a low-profile delivery configuration and an expanded treatment configuration that tends to assume the helically deflected shape and positions the energy delivery elements carried thereon in apposition with target tissue at or near the neural fibers,

wherein the catheter apparatus is configured to reduce renal sympathetic nerve activity by delivering radio frequency (RF) energy via the energy delivery elements to the neural fibers, and

wherein the second flexure zone comprises a plurality of infusion ports or lumens configured to allow infusion of an infusate into a lumen of the renal blood vessel before, during, and/or after delivery of the RF energy to the neural fibers.

2. The catheter apparatus of claim 1 wherein at least one energy delivery element includes one of the infusion ports or lumens therein for delivery of the infusate.

3. The catheter apparatus of claim 1 wherein each energy delivery element includes a plurality of infusion ports configured to direct the infusate away from the target tissue along the renal blood vessel during delivery of the RF energy.

4. The catheter apparatus of claim 1 wherein the infusion ports or lumens are configured for delivering the infusate into the lumen of the renal blood vessel at an infusion rate of less than or equal to 15 mL/minute.

5. The catheter apparatus of claim 1 wherein the infusion ports or lumens are configured for delivering the infusate into the lumen of the renal blood vessel at an infusion rate of less than or equal to 10 mL/minute.

6. The catheter apparatus of claim 1 wherein the plurality of energy delivery elements comprise four electrodes.

7. The catheter apparatus of claim 1 wherein the infusate comprises saline.

8. The catheter apparatus of claim 1 wherein the infusate comprises chilled saline.

9. The catheter apparatus of claim 1 wherein the plurality of energy delivery elements are positioned to provide a non-continuous circumferential ablation treatment of the target tissue at or near the neural fibers when the second flexure zone is positioned in its helically deflected expanded treatment configuration.

10. The catheter apparatus of claim 1, further comprising a temperature sensor coupled to at least one energy delivery element.

11. The catheter apparatus of claim 10, further comprising a feedback control system configured to alter infusion of the infusate into the lumen of the renal blood vessel in response to a monitored temperature via the temperature sensor.

12. The catheter apparatus of claim 10, further comprising a feedback control system configured to alter delivery of the RF energy in response to a monitored temperature via the temperature sensor.

13. The catheter apparatus of claim 1 wherein the RF energy from the energy delivery elements is sufficient to cause partial ablation of at least one neural fiber.

14. The catheter apparatus of claim 1 wherein the RF energy from the energy delivery elements is sufficient to cause ablation of at least one neural fiber.

15. The catheter apparatus of claim 1 wherein the RF energy from the energy delivery elements is sufficient to cause at least partial renal denervation.

16. A renal neuromodulation system, comprising:

an electric field generator configured to deliver a thermal RF field to renal nerves that modulate renal neural activity of a human patient; and

a catheter comprising (a) a shaft having a lumen therethrough, (b) a first flexure zone at a distal region of the shaft, (c) a second flexure zone extending distally from the first flexure zone, the second flexure zone being configured for helical deflection, and (d) a plurality of electrodes carried by the second flexure zone and electrically coupled to the field generator,

wherein the distal region of the shaft is transformable between—

a low-profile delivery configuration for percutaneous intravascular placement within renal vasculature of the patient, and

an expanded treatment configuration,

wherein, in the expanded treatment configuration, the helically deflected shape is adapted to bring the electrodes into contact with an interior wall of the renal vasculature for delivery of the thermal RF field to the renal nerves along the renal vasculature of the patient, and

wherein the second flexure zone comprises infusion outlets through which an infusate may be delivered into a lumen of the renal vasculature during therapy.

17. The system of claim 16 wherein the electric field generator is adapted to remain external to the patient throughout therapy.

18. The system of claim 16 wherein at least one electrode includes one of the infusion outlets therein for delivery of the infusate.

19. The system of claim 16 wherein each electrode includes a plurality of the infusion outlets.