Spiral balloon catheter for renal nerve ablation

• US 9,084,609 B2
• Filed: 07/18/2011
• Issued: 07/21/2015
• Est. Priority Date: 07/30/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Smith, Scott
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Zink, Amanda
• Application Number:
  US13/184,673
• Publication Number:
  US 20120029509A1
• Time in Patent Office: 1,464 Days
• Field of Search: 606 32- 45
• US Class Current: 1/1
• 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 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• 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 2018/1467 using more than two electrodes on a single probe

Abstract

A catheter comprises a flexible shaft having a length for accessing the renal artery. A balloon arrangement, dimensioned for deployment within the renal artery, is provided at the shaft'"'"'s distal end and fluidly coupled to a lumen arrangement. A balloon body is configured to complete at least one revolution of the shaft'"'"'s distal end to form a spiral configuration thereabout, and is secured to the shaft by one or more movable mounting arrangements. The balloon body supports an electrode arrangement for ablating perivascular renal nerves in a substantially spiral pattern. A cooling arrangement cools at least the electrode contact regions during ablation. The distal end of the shaft has a stiffness sufficient to oppose a force produced by the balloon body when inflated that tends to contort the shaft'"'"'s distal end and to maintain a substantially constant apposition force between the electrodes and an inner wall of the renal artery.

Claims

1. An apparatus, comprising:

a catheter comprising a flexible shaft having a lumen arrangement, a proximal end, a distal end, and a length sufficient to access at least the renal artery from a percutaneous access location of a patient;

a balloon arrangement provided at the distal end of the shaft and fluidly coupled to the lumen arrangement, the balloon arrangement dimensioned for deployment within the renal artery and comprising;

an elongated balloon body configured to complete at least one revolution of the shaft'"'"'s distal end to form a spiral configuration thereabout; and

a mounting arrangement provided at the distal end of the shaft and configured to maintain the balloon body in the spiral configuration during expansion and contraction of the balloon body;

an electrode arrangement provided on the balloon body and defining one or more electrode contact regions of the balloon body, the electrode arrangement configured to ablate perivascular nerves of the renal artery in a substantially spiral pattern; and

wherein at least the distal end of the shaft has a stiffness sufficient to oppose a force produced by the balloon body when inflated that tends to contort the shaft'"'"'s distal end and to maintain a substantially constant apposition force between the electrode contact regions and an inner wall of the renal artery.

2. The apparatus of claim 1, comprising:

a flexible elongated member having a proximal end, a distal end, and a length sufficient to access at least the balloon arrangement, the elongated member dimensioned for displacement within a lumen of the lumen arrangement and extendable to at least a portion of the shaft that includes the balloon body;

wherein at least the respective distal ends of the shaft and the elongated member have a combined stiffness sufficient to oppose the force produced by the balloon body when inflated that tends to contort the respective distal ends and to maintain the substantially constant apposition force between the electrode contact regions and the inner wall of the renal artery.

3. The apparatus of claim 1, wherein the electrode arrangement comprises a plurality of spaced-apart discrete electrodes.

4. The apparatus of claim 1, wherein the electrode arrangement comprises one or more ribbon electrodes.

5. The apparatus of claim 1, wherein the balloon body is coupled to the shaft at a plurality of discrete locations along a length of the balloon body.

6. The apparatus of claim 1, wherein the balloon body is coupled to the shaft by a plurality of flexible members situated at a plurality of discrete locations along a length of the balloon body.

7. The apparatus of claim 1, wherein the balloon body is coupled to the shaft by a plurality of movable attachment members situated at a plurality of discrete locations along a length of the balloon body, each of the attachment members configured to traverse a predefined section of the shaft and facilitate circumferential and longitudinal movement of the balloon body on the shaft.

8. The apparatus of claim 1, wherein the balloon body is coupled to the shaft by an attachment arrangement configured to facilitate changes in a pitch of the spiral during inflation of the balloon body.

9. The apparatus of claim 1, wherein the balloon body is coupled to the shaft by at a continuous interface along a length of the balloon body, the continuous interface allowing for a degree of longitudinal and circumferential shifting of the balloon body during inflation and deflation.

10. The apparatus of claim 1, wherein the balloon body comprises electrically insulating material at least at or near regions of the balloon body where the electrodes are situated.

11. The apparatus of claim 1, comprising a cooling arrangement, the cooling arrangement comprising:

a supply lumen of the lumen arrangement configured to deliver a thermal transfer fluid to the balloon body; and

a return lumen of the lumen arrangement configured to remove spent thermal transfer fluid from the balloon body.

12. The apparatus of claim 1, comprising a cooling arrangement, the cooling arrangement comprising:

an inner balloon provided at the distal end of the shaft and encompassed by the elongated balloon body, the inner balloon fluidly coupled to a supply lumen of the lumen arrangement configured to deliver a thermal transfer fluid to the inner balloon; and

a return lumen of the lumen arrangement configured to remove spent thermal transfer fluid from the inner balloon.

13. The apparatus of claim 1, wherein the elongated balloon body comprises a pre-formed undulating shape.

14. The apparatus of claim 1, wherein the elongated balloon body is configured as a semi-compliant balloon or a non-compliant balloon.

15. An apparatus, comprising:

a catheter comprising a flexible shaft having a lumen arrangement, a proximal end, a distal end, and a length sufficient to access at least a target vessel within the body from a percutaneous access location of a patient;

a balloon arrangement provided at the distal end of the shaft and fluidly coupled to the lumen arrangement, the balloon arrangement dimensioned for deployment within the target vessel and comprising;

an elongated balloon body configured to complete at least one revolution of the shaft'"'"'s distal end to form a spiral configuration thereabout; and

a mounting arrangement provided at the distal end of the shaft and configured to maintain the balloon body in the spiral configuration during expansion and contraction of the balloon body;

an electrode arrangement provided on the balloon body and defining one or more electrode contact regions of the balloon body, the electrode arrangement configured to ablate target tissue of or adjacent the target vessel in a substantially spiral pattern; and

wherein at least the distal end of the shaft has a stiffness sufficient to oppose a force produced by the balloon body when inflated that tends to contort the shaft'"'"'s distal end and to maintain a substantially constant apposition force between the electrode contact regions and an inner wall of the target vessel.

16. The apparatus of claim 15, comprising:

a flexible elongated member having a proximal end, a distal end, and a length sufficient to access at least the balloon arrangement, the elongated member dimensioned for displacement within a lumen of the lumen arrangement and extendable to at least a portion of the shaft that includes the balloon body;

wherein at least the respective distal ends of the shaft and the elongated member have a combined stiffness sufficient to oppose the force produced by the balloon body when inflated that tends to contort the respective distal ends and to maintain the substantially constant apposition force between the electrode contact regions and the inner wall of the target vessel.

17. The apparatus of claim 15, wherein the balloon body is coupled to the shaft by a plurality of movable attachment members situated at a plurality of discrete locations along a length of the balloon body, each of the attachment members configured to traverse a predefined section of the shaft and facilitate circumferential and longitudinal movement of the balloon body on the shaft.

18. The apparatus of claim 15, wherein the balloon body is coupled to the shaft by an attachment arrangement configured to facilitate changes in a pitch of the spiral during inflation of the balloon body.

19. The apparatus of claim 15, wherein the balloon body is coupled to the shaft by at a continuous interface along a length of the balloon body, the continuous interface allowing for a degree of longitudinal and circumferential shifting of the balloon body during inflation and deflation.

20. The apparatus of claim 15, wherein the elongated balloon body comprises a pre-formed undulating shape.

21. A method, comprising:

supplying a pressurized fluid to an elongated balloon body of a balloon arrangement provided on a catheter shaft and positionable within a renal artery, the balloon body configured to complete at least one revolution of the shaft'"'"'s distal end to form a spiral configuration thereabout;

inflating the elongated balloon body to assume an expanded spiral configuration in response to supplying the pressurized fluid so that an electrode arrangement provided on the balloon body engages an inner wall of the renal artery at one or more electrode contact regions;

opposing, at least by the distal end of the shaft, a force produced by the balloon body when inflated that tends to contort the shaft'"'"'s distal end to maintain a substantially constant apposition force between the one or more electrode contact regions and the inner wall of the renal artery; and

ablating perivascular nerves of the renal artery in a substantially spiral pattern using the electrode arrangement while the balloon body is inflated.

22. The method of claim 21, comprising providing cooling to an electrode-renal tissue interface during ablation.

23. The method of claim 21, comprising adjusting the apposition force between the one or more electrode contact regions and the inner wall of the renal artery.

24. The method of claim 21, comprising accommodating a degree of longitudinal and circumferential shifting of the balloon body during inflation and deflation.