Balloon catheter apparatus for renal neuromodulation

• US 9,023,037 B2
• Filed: 04/23/2013
• Issued: 05/05/2015
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• 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:
  US13/868,426
• Publication Number:
  US 20130296767A1
• Time in Patent Office: 742 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 blood vessel of a human patient;

an expandable balloon at a distal portion of the catheter, wherein the expandable balloon is configured to transform between a delivery configuration and a deployed configuration sized to fit within the renal blood vessel; and

a plurality of electrodes attached to the expandable balloon, wherein each electrode comprises at least one pair of bipolar contacts and is part of a flex circuit on a surface of the balloon configured to deliver thermal radio frequency (RF) energy in a bipolar fashion across an interior wall of the renal blood vessel to targeted renal nerves to achieve at least partial renal denervation,

wherein, when the expandable balloon is in the deployed configuration, all of the electrodes are spaced apart from each other and arranged on an oblique circumference about the balloon that is not normal to a longitudinal axis thereof, and

wherein each electrode occupies a distinct longitudinal position and a distinct radial position with respect to the longitudinal axis.

2. The apparatus of claim 1 wherein the plurality of electrodes comprises:

a first electrode configured to deliver thermal energy to create a first treatment zone along a lengthwise segment of the renal blood vessel; and

a second electrode configured to deliver thermal energy to create a second treatment zone offset from the first treatment zone and along the same lengthwise segment of the renal blood vessel.

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

4. The apparatus of claim 3 wherein the generator is configured to deliver thermal energy to the electrodes sequentially.

5. The apparatus of claim 3 wherein the generator is configured to deliver thermal energy to the electrodes concurrently.

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

7. The apparatus of claim 1 wherein the expandable balloon is configured to position the electrodes in apposition with an interior wall of the renal blood vessel when the expandable balloon is in the deployed configuration.

8. The apparatus of claim 1 wherein, in the deployed configuration, the expandable balloon is sized to occlude the renal blood vessel.

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

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

11. The apparatus of claim 10 wherein the electrodes are equally spaced about a circumference of the expandable balloon.

12. The apparatus of claim 1 wherein at least one of the electrodes further comprises a sensor for monitoring and/or controlling effects of the thermal RF energy delivery.

13. The apparatus of claim 12 wherein the sensor comprises a temperature sensor.

14. The apparatus of claim 13 wherein the temperature sensor is configured to monitor temperature of the balloon, electrodes, and/or non-targeted tissue.

15. The apparatus of claim 12, further comprising a feedback control system configured to maintain or alter treatment in response to a monitored parameter from the sensors.

16. The apparatus of claim 1 wherein the catheter and expandable balloon are configured for placement within the renal blood vessel over a guidewire.