Methods and apparatus for performing renal neuromodulation via catheter apparatuses having inflatable balloons

• US 8,721,637 B2
• Filed: 07/12/2013
• Issued: 05/13/2014
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Zarins, Denise, Gifford, Hanson III, Deem, Mark, Zadno, Nicolas, Clark, Benjamin J., Wu, Andrew, Michlitsch, Kenneth J.
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US13/941,331
• Publication Number:
  US 20130304054A1
• Time in Patent Office: 305 Days
• Field of Search: 606 49- 52
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• 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 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• 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 7/022 : intracavitary

Abstract

Methods and apparatus are provided for non-continuous circumferential treatment of a body lumen. Apparatus may be positioned within a body lumen of a patient and may deliver energy at a first lengthwise and angular position to create a less-than-full circumferential treatment zone at the first position. The apparatus also may deliver energy at one or more additional lengthwise and angular positions within the body lumen to create less-than-full circumferential treatment zone(s) at the one or more additional positions that are offset lengthwise and angularly from the first treatment zone. Superimposition of the first treatment zone and the one or more additional treatment zones defines a non-continuous circumferential treatment zone without formation of a continuous circumferential lesion. Various embodiments of methods and apparatus for achieving such non-continuous circumferential treatment are provided.

Claims

1. An apparatus for renal denervation, the apparatus comprising:

a catheter configured for intravascular placement within a renal artery of a human patient;

an inflatable balloon at a distal portion of the catheter, wherein the inflatable balloon is configured to vary between a delivery configuration and a deployed configuration sized and shaped to fit within the renal artery; and

a plurality of electrodes attached to the inflatable balloon, wherein each electrode comprises at least one pair of bipolar contacts,

wherein, when the inflatable balloon is in the deployed configuration, the electrodes are offset from each other and positioned at different lengthwise positions along the balloon to define, at least in part, a helical pattern about the balloon,

wherein the electrodes are configured to deliver thermal radio frequency (RF) energy across an interior wall of the renal artery to target renal nerves to achieve at least partial renal denervation.

2. The apparatus of claim 1 wherein the plurality of electrodes comprises a first electrode and a second electrode, and wherein the first and second electrodes are parts of a flex circuit on a surface of the inflatable balloon.

3. The apparatus of claim 2 wherein the flex circuit terminates proximally of a distal end portion of the inflatable balloon.

4. The apparatus of claim 1 wherein the inflatable balloon is configured to bring the individual electrodes into apposition with an interior wall of the renal artery when the inflatable balloon is in the deployed configuration.

5. The apparatus of claim 1 wherein, in the deployed configuration, the inflatable balloon is sized to occlude the renal artery.

6. The apparatus of claim 1 wherein each of the electrodes is dynamically assignable.

7. The apparatus of claim 1 wherein the electrodes are configured to be energized concurrently.

8. The apparatus of claim 1 wherein the electrodes are configured to be energized sequentially.

9. The apparatus of claim 1 wherein the plurality of electrodes comprises four or more electrodes.

10. The apparatus of claim 1 wherein the individual electrodes are configured to deliver the thermal RF energy through an inner wall of the renal artery to the target renal nerves to reduce renal sympathetic nerve activity.

11. The apparatus of claim 1 wherein the thermal RF energy from the electrodes is sufficient to reduce neural communication to and from a kidney of the patient.

12. The apparatus of claim 1 wherein the thermal RF energy from the electrodes is sufficient to cause at least partial ablation of the target renal nerves of the patient.

13. The apparatus of claim 1, further comprising one or more sensors at the distal portion of the catheter for monitoring and/or controlling effects of the thermal RF energy delivery.

14. The apparatus of claim 13 wherein at least one of the sensors comprises a thermocouple for monitoring temperature.

15. The apparatus of claim 1 wherein the catheter and inflatable balloon are configured for placement within the renal artery over a guidewire.

16. The apparatus of claim 1, further comprising a field generator external to the patient and electrically coupled to the plurality of electrodes.

17. A renal neuromodulation system for treatment of a human patient, the system comprising:

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

a catheter comprising (a) a shaft having a lumen therethrough, (b) an inflatable distal balloon, and (c) a plurality of bipolar RF electrodes, wherein each electrode comprises a pair of bipolar contacts, and wherein the catheter is transformable between—

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

an expanded treatment configuration for delivering the thermal RF field to one or more of the renal nerves,

wherein the plurality of bipolar RF electrodes are electrically connectable to the electric field generator and are arranged about the inflatable balloon in a helical configuration for delivering the thermal RF field to one or more of the renal nerves to thermally induce modulation of a function of the one or more renal nerves when the inflatable balloon is at least partially located within the renal vasculature.

18. The system of claim 17 wherein the electric field generator is configured to independently control each electrode.

19. The system of claim 17 wherein, when the catheter is in the expanded treatment configuration, the inflatable balloon is configured to maintain apposition with an interior wall of the renal vasculature throughout treatment.

20. The system of claim 17 wherein the lumen is sized and shaped to receive a guide wire.

21. The system of claim 17 wherein the individual bipolar RF electrodes comprise a plurality of bipolar contacts.