Apparatus for performing a non-continuous circumferential treatment of a body lumen

• US 8,454,594 B2
• Filed: 08/11/2009
• Issued: 06/04/2013
• 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: Demarais, Denise, Gifford, Hanson III, Deem, Mark, Zadno, Nicolas, Clark, Benjamin J., Wu, Andrew, Michlitsch, Kenneth J.
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US12/539,390
• Publication Number:
  US 20100137860A1
• Time in Patent Office: 1,393 Days
• Field of Search: 606 41- 50
• 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 neuromodulation, the apparatus comprising:

a catheter comprising a shaft and an expandable element comprising a wire basket configured to allow blood to flow therethrough, the catheter being configured to vary between a reduced profile delivery configuration and an expanded treatment configuration, wherein the catheter is configured for delivery into a renal blood vessel of a human patient when in the reduced profile delivery configuration;

a first electrode carried by a first strut of the expandable element; and

a second electrode carried by a second strut of the expandable element, wherein the first and second electrodes are configured to engage a wall of the renal blood vessel without passing therethrough,

wherein the first strut and the second strut each include only a single electrode, and wherein the first electrode is at a proximal portion of the first strut and the second electrode is at a distal portion of the second strut such that the first and second electrodes are spaced longitudinally apart and angularly offset from each other along a longitudinal axis of the renal blood vessel when the expandable element is in the expanded treatment configuration,

wherein (a) the first electrode is configured to deliver energy to create a first treatment zone along the renal blood vessel, and (b) the second electrode is configured to deliver energy to create a second treatment zone along the renal blood vessel, and wherein the first and second treatment zones are formed in separate normal radial planes and are not continuous around the circumference of the renal blood vessel.

2. The apparatus of claim 1 wherein the expandable element is configured to self-expand.

3. The apparatus of claim 1 wherein the expandable element is configured to position the first electrode and the second electrode in contact with a wall of the renal blood vessel prior to the delivery of energy.

4. The apparatus of claim 1 wherein the apparatus is configured to energize the first electrode and the second electrode independently to create the first treatment zone and the second treatment zone in sequence.

5. The apparatus of claim 1 wherein the apparatus is configured to energize the first electrode together with the second electrode to create the first treatment zone concurrently with the second treatment zone.

6. The apparatus of claim 1 wherein the first electrode and the second electrode are monopolar electrodes configured to deliver an electric field to an external ground pad.

7. The apparatus of claim 1 wherein at least one of the first electrode and the second electrode comprises a bipolar electrode.

8. The apparatus of claim 1, further comprising a sensor configured to monitor a parameter of the apparatus or tissue within the patient.

9. The apparatus of claim 8, further comprising a feedback control system configured to alter treatment in response to the monitored parameter.

10. The apparatus of claim 1 wherein the wire basket comprises four struts, and wherein the apparatus further comprises:

a single third electrode carried by a third strut; and

a single fourth electrode carried by a fourth strut, wherein each of the third and fourth electrodes are spaced longitudinally apart and angularly offset from each other along the longitudinal axis of the renal blood vessel when the wire basket is in the expanded treatment configuration.

11. The apparatus of claim 10 wherein each of the electrodes are dynamically assignable.

12. The apparatus of claim 1 wherein the first and second electrodes are configured to deliver an electric field across a wall of the renal blood vessel to target renal nerves to achieve renal denervation.

13. An apparatus for renal neuromodulation, the apparatus comprising:

a catheter comprising a shaft extending along an axis, wherein the catheter is configured for intravascular placement within a renal artery of a human patient; and

an expandable basket element carried by the catheter and configured to vary between a delivery configuration and a deployed configuration sized to fit within the renal artery, wherein the basket element comprises a plurality of struts and is configured to allow blood to flow therethrough,

wherein the basket element comprises a first electrode carried by a proximal region of one of the struts and a second electrode carried by a distal region of a different one of the struts, wherein each strut carries a single electrode, and wherein the first and second electrodes are configured to contact a wall of the renal artery without passing therethrough and are spaced longitudinally apart and angularly offset from each other along the axis of the shaft when the basket element is in the deployed configuration,

wherein the first electrode is configured to be selectively energized to create a first lesion at a first radial plane along the renal artery and the second electrode is configured to be selectively energized to create a second lesion at a second radial plane spaced apart from the first radial plane along the renal artery, and wherein the first and second lesions each extend less than a full radial circumference of the renal artery.