Balloon catheter apparatus for renal neuromodulation

• US 9,757,193 B2
• Filed: 04/28/2016
• Issued: 09/12/2017
• 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, III, Hanson, Deem, Mark, Zadno, Nicolas, Clark, Benjamin J., Wu, Andrew, Michlitsch, Kenneth J.
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US15/141,527
• Publication Number:
  US 20160331448A1
• Time in Patent Office: 502 Days
• Field of Search: 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, comprising:

a renal denervation catheter configured for intravascular delivery to a target site within a renal artery of a human patient;

a balloon at a distal region of the catheter, wherein the balloon is transformable between a low-profile delivery state and a deployed state sized and shaped to fit within the renal artery; and

a plurality of electrodes attached to the balloon,

wherein, when the balloon is in the deployed state, each electrode occupies a distinct longitudinal position and a distinct radial position with respect to a longitudinal axis of the balloon,

wherein each electrode comprises a pair of bipolar contacts and is part of a flex circuit on a surface of the balloon,

wherein, during therapy, the electrodes are configured to deliver radio frequency (RF) energy in a bipolar fashion to renal nerves adjacent the target site to achieve at least partial renal denervation.

2. The apparatus of claim 1 wherein all of the electrodes are positioned on an oblique circumference about the balloon that is not normal to the longitudinal axis thereof.

3. The apparatus of claim 1 wherein the plurality of electrodes comprises at least a first electrode and a second electrode attached to the balloon, and wherein the first electrode and the second electrode are configured to deliver RF energy in a bipolar fashion to renal nerves adjacent the target site to produce respective first and second non-overlapping treatment zones.

4. The apparatus of claim 1 wherein the flex circuit terminates proximally of a distal end portion of the balloon.

5. The apparatus of claim 1 wherein the balloon is configured to position the electrodes in apposition with an interior wall of the renal artery when the balloon is in the deployed state.

6. The apparatus of claim 1 wherein, in the deployed state, the balloon is sized to occlude the renal artery.

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

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

9. The apparatus of claim 1 wherein the electrodes are equally spaced about a circumference of the balloon.

10. The apparatus of claim 1, further comprising a generator external to the patient, wherein the generator is configured to be electrically coupled to the electrodes and to independently control each electrode.

11. The apparatus of claim 10 wherein the generator is further configured to monitor a parameter of the balloon, electrodes, and/or tissue proximate the electrodes within the patient during therapy.

12. The apparatus of claim 11 wherein the generator is further configured to maintain or alter treatment in response to the monitored parameter.

13. The apparatus of claim 11 wherein the generator is configured to deactivate an electrode that the monitored parameter indicates is not in apposition with an inner wall of the renal artery.

14. The apparatus of claim 10 wherein the generator is further configured to monitor a temperature of the balloon, electrodes, and/or tissue, and to maintain a desired temperature throughout therapy.

15. The apparatus of claim 1 wherein the RF energy from the plurality of electrodes is sufficient to ablate renal nerves along the renal artery.

16. The apparatus of claim 1 wherein the RF energy from the plurality of electrodes is sufficient to modulate renal nerves along the renal artery and at least partially block neural traffic to and/or from a kidney of the patient.

17. An apparatus, comprising:

a renal denervation catheter sized and shaped for intravascular placement within a renal artery of a human patient;

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

a plurality of electrodes attached to the inflatable balloon, wherein the plurality of electrodes comprises at least a first electrode and a second electrode, wherein the first electrode and the second electrode each occupy a distinct longitudinal position and a distinct radial position with respect to a longitudinal axis of the inflatable balloon,

wherein the first and second electrodes are part of a first flex circuit and a second flex circuit, respectively, attached to the balloon, and wherein the first flex circuit terminates at the first electrode and the second flex circuit terminates at the second electrode,

wherein, when the inflatable balloon is in the deployed configuration, the first electrode and the second electrode are circumferentially disposed about the inflatable balloon and each configured to deliver thermal radio frequency (RF) energy in a bipolar fashion to produce first and second treatment zones, respectively, along a common lengthwise segment of the renal artery without formation of a continuous circumferential lesion about a radial plane normal to an inner wall of the renal artery.

18. The apparatus of claim 17 wherein the thermal RF energy from the first and second electrodes is sufficient to ablate renal nerves along the renal artery.

19. The apparatus of claim 17 wherein the thermal RF energy from the first and second electrodes is sufficient to modulate renal nerves along the renal artery and at least partially block neural traffic to and/or from a kidney of the patient.

20. The apparatus of claim 17 wherein the first electrode and the second electrode are positioned about the inflatable balloon to create, respectively, first and second non-overlapping treatment zones.

21. The apparatus of claim 17, further comprising an energy generator external to the patient, wherein the energy generator is configured to be electrically coupled to the plurality of electrodes and to independently control each electrode.

22. The apparatus of claim 21 wherein the energy generator is further configured to monitor a parameter of the balloon, the electrodes, and/or tissue proximate the electrodes within the patient during treatment.

23. The apparatus of claim 21 wherein the energy generator is further configured to maintain or alter treatment in response to the monitored parameter.

24. The apparatus of claim 21 wherein the energy generator is further configured to monitor a temperature of the balloon, the electrodes, and/or tissue proximate the electrodes within the patient during treatment, and to maintain a desired temperature throughout therapy.

25. The apparatus of claim 21 wherein the energy generator is configured to deliver thermal RF energy to the electrodes sequentially.

26. The apparatus of claim 21 wherein the energy generator is configured to deliver thermal RF energy to the electrodes concurrently.

27. The apparatus of claim 17 wherein the renal denervation catheter is configured for placement within the renal artery over a guidewire.