Renal denervation balloon catheter with ride along electrode support

• US 9,943,365 B2
• Filed: 06/20/2014
• Issued: 04/17/2018
• Est. Priority Date: 06/21/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Haverkost, Patrick A., Groff, Joel N., Willard, Martin R., Ostroot, Timothy A., Sutermeister, Derek C., Hanson, Cass A., Quillin, Daniel T., Munsinger, Joel R.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Vahdat, Khadijeh
• Application Number:
  US14/310,901
• Publication Number:
  US 20140378966A1
• Time in Patent Office: 1,397 Days
• Field of Search: 606 41- 50
• 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 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 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1495 Electrodes being detachable from a support structure
• CPC Class Codes: A61B 2018/162 located on the probe body

Abstract

A renal nerve ablation device may include an elongate tubular member having a distal region. An expandable member may be coupled to the distal region. An electrode support may be coupled to the distal region of the elongate tubular member and extend over a body of the expandable member. The electrode support may be free of connection to the body of the expandable member. One or more electrodes may be coupled to the electrode support.

Claims

1. A medical device for nerve ablation, comprising:

a catheter shaft;

an expandable member coupled to the catheter shaft, the expandable member having a proximal region, a distal region, and a body extending therebetween, the expandable member being a balloon; and

an electrode support coupled to the catheter shaft and positioned over the body of the expandable member, the electrode support including a plurality of spaced apart flexible elongate members, each having a distal end, a proximal end, and a body extending therebetween, and a plurality of electrode assemblies disposed on the electrode support, the electrode support capable of expanding with the expandable member, wherein the electrode support is free from attachment with the body of the expandable member and wherein the plurality of spaced apart flexible elongate members are connected to each other at their proximal and distal ends,

wherein the plurality of spaced apart flexible elongate members extend in a helix over the body of the expandable member.

2. The medical device of claim 1, wherein each of the plurality of spaced apart flexible elongate members includes at least two of the electrode assemblies in a spaced apart arrangement.

3. The medical device of claim 1, wherein the electrode support includes a proximal section, wherein the electrode support and the expandable member are attached to each other only at the proximal section of the electrode support and the proximal region of the expandable member.

4. The medical device of claim 1, wherein the electrode support includes two or more spaced apart sets of three of the plurality of spaced apart flexible elongate members, wherein each of the spaced apart sets includes a first spaced apart flexible elongate member carrying active electrodes, a second spaced apart flexible elongate member including one or more temperature sensors, and a third spaced apart flexible elongate member carrying ground electrodes.

5. The medical device of claim 1, wherein at least some of the plurality of electrode assemblies include a pair of bipolar electrodes.

6. The medical device of claim 1, wherein at least some of the plurality of electrode assemblies include a temperature sensor.

7. The medical device of claim 6, wherein the temperature sensor is positioned between a bottom surface of one of the plurality of electrode assemblies and an outer surface of the expandable member.

8. The medical device of claim 1, wherein the expandable member includes one or more channels in an outer surface extending from a distal region to a proximal region of the expandable member.

9. The medical device of claim 1, wherein the expandable member is a compliant balloon.

10. The medical device of claim 1, wherein the expandable member is a non-compliant balloon.

11. The medical device of claim 1, wherein the expandable member has one or more channels extending along the body, the one or more channels positioned between the plurality of spaced apart flexible elongate members.

18. A method for treating hypertension, the method comprising:

advancing a medical device in accordance with claim 1 through a blood vessel to a position within a renal artery;

expanding the expandable member, thereby expanding the electrode support;

energizing the electrode assemblies;

collapsing the expandable member, and thereafter, withdrawing the expandable member and the electrode support into a delivery sheath, thereby collapsing the electrode support.

12. A medical device, comprising:

a catheter shaft;

an expandable balloon having a distal waist, proximal waist, and a body extending therebetween, the proximal waist being coupled to the catheter shaft;

a flexible elongate electrode assembly coupled to the catheter shaft and extending in a helix over the body of the expandable balloon, the electrode assembly being free from attachment to the body of the expandable balloon, the elongate electrode assembly comprising a plurality of spaced apart elongate members each having a distal region, a proximal region, and a body extending therebetween;

a plurality of electrodes disposed on at least a first one of the plurality of spaced apart elongate members; and

one or more elongate supports having a distal region, a proximal region, and a body extending therebetween, the one or more elongate supports extending in a helix over the body of the expandable balloon and spaced apart from the plurality of spaced apart elongate members.

13. The medical device of claim 12, wherein the plurality of spaced apart elongate members include three spaced apart elongate members and wherein the three elongate members are free from attachment to each other along their respective bodies.

14. The medical device of claim 12, wherein the one or more elongate supports are connected to the plurality of spaced apart elongate members only at their distal and proximal regions.

15. The medical device of claim 14, further comprising a first circuitry and a second circuitry connected to the electrode elements, wherein the first circuitry extends proximally along the first one of the plurality of spaced apart elongate members, wherein the second circuitry extends distally along the first one of the plurality of spaced apart elongate members to a first one of the one or more elongate supports, the second circuitry then extending proximally along the first one of the one or more elongate supports.

16. A medical device, comprising:

a catheter shaft;

an expandable balloon having a distal waist, proximal waist, and a body extending therebetween, the proximal waist being coupled to the catheter shaft;

a flexible elongate electrode assembly coupled to the catheter shaft and extending in a helix over the body of the expandable balloon, the electrode assembly free from attachment to the body of the expandable balloon, wherein the elongate electrode assembly includes three spaced apart elongate members each having a distal region, a proximal region, and a body extending therebetween, and wherein the three spaced apart elongate members are free from attachment to each other along their respective bodies;

a plurality of electrode elements disposed on the flexible elongate electrode assembly; and

one or more elongate supports each having a distal region, a proximal region, and a body extending therebetween, the one or more elongate supports extending in a helix over the body of the expandable balloon and spaced apart from the three spaced apart elongate members, the one or more elongate supports connected to the three spaced apart elongate members only at their distal and proximal regions.

17. The medical device of claim 16, further comprising a first circuitry and a second circuitry connected to the electrode elements, wherein the first circuitry extends proximally along a first one of the three spaced apart elongate members on which at least a portion of the plurality of electrode elements reside, wherein the second circuitry extends distally along the first one of the three spaced apart elongate members on which at least a portion of the plurality of electrode elements reside to a first one of the one or more elongate supports, the second circuitry then extending proximally along the first one of the one or more elongate supports.