Renal nerve modulation devices with weeping RF ablation balloons

• US 10,321,946 B2
• Filed: 08/23/2013
• Issued: 06/18/2019
• Est. Priority Date: 08/24/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Horn, Daniel J., Hanson, Cass A., Sutermeister, Derek C., Ostroot, Timothy A., Quillin, Daniel T.
• Primary Examiner(s): Della, Jaymi E
• Application Number:
  US13/975,021
• Publication Number:
  US 20140058376A1
• Time in Patent Office: 2,125 Days
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• 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 2018/00285 Balloons
• 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 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

The disclosure pertains to an intravascular catheter, comprising an elongate member having a proximal end and a distal end, a balloon having an interior surface, an exterior surface, a lumen defined by the interior surface and a cylindrical wall extending between the interior surface and the exterior surface, the cylindrical wall having a proximal end and a distal end, the balloon having a plurality of weeping windows disposed in the wall and able to pass an electric current between the interior surface and the exterior surface and wherein the balloon wall is otherwise electrically insulative, and an electrode disposed in the balloon. The intravascular system is suited for modulation of renal nerves, for example.

Claims

1. An intravascular catheter, comprising:

an elongate member having a proximal end and a distal end;

a balloon having a longitudinal axis, an interior surface, an exterior surface, a lumen defined by the interior surface and a balloon wall extending between the interior surface and the exterior surface, the balloon having a plurality of discrete windows disposed in the balloon wall that are capable of passing an electric current between the interior surface and the exterior surface and wherein the balloon wall is otherwise electrically insulative, each of the plurality of discrete windows comprising a plurality of micropores and being spaced apart from one another by a region of the balloon wall that does not contain micropores, wherein at least two of the plurality of discrete windows only partially circumferentially overlap about the balloon with one another while being axially spaced from one another, and wherein the plurality of discrete windows are arranged in a spiral pattern that extends for a full rotation about the longitudinal axis; and

an electrode disposed within the balloon.

2. The catheter of claim 1, wherein at least some of the plurality of micropores have an average diameter of between 15-30 micro inches.

3. The catheter of claim 1, wherein the balloon has a single balloon wall layer and wherein each of the plurality of discrete windows comprise a portion of the plurality of micropores.

4. The catheter of claim 1, wherein the balloon wall includes a first layer and a second layer,

wherein the first layer comprises the plurality of micropores,

wherein the second layer comprises a fluid-impermeable material, and

wherein the plurality of discrete windows are formed by the selective omission of the second layer from portions of the balloon wall.

5. The catheter of claim 4, wherein the first layer comprises a woven material.

6. The catheter of claim 4, wherein the first layer comprises an expanded polymer material.

7. The catheter of claim 4, wherein the first layer is inside the second layer.

8. The catheter of claim 4, wherein the second layer is inside the first layer.

9. The catheter of claim 1, wherein the plurality of discrete windows are arranged such that every line extending along the balloon wall the shortest distance from the proximal end of the balloon wall to the distal end of the balloon wall passes through at least one window of the plurality of discrete windows.

10. The catheter of claim 1, wherein at least one of the plurality of discrete windows extends further in a circumferential direction than in an axial direction.

11. The catheter of claim 1, wherein at least one of the plurality of discrete windows is circular.

12. The catheter of claim 1, wherein at least one of the plurality of discrete windows is non-circular.

13. The catheter of claim 1, further comprising a temperature sensor disposed on the elongate member.

14. The catheter of claim 1, wherein the electrode is helically disposed about the elongate member.

15. A method of nerve modulation, comprising:

inserting the intravascular catheter in accordance with claim 1 into a patient;

moving the balloon to a region of interest;

inflating the balloon with an electrically conductive fluid; and

activating the electrode.

16. The catheter of claim 1, wherein the electrode is helically disposed about the elongate member.

17. The catheter of claim 1, wherein all of the plurality of discrete windows are collectively arranged in a spiral pattern that extends for a full rotation about the longitudinal axis.

18. An intravascular catheter, comprising:

an elongate member having a proximal end and a distal end;

a balloon having a longitudinal axis, an interior surface, an exterior surface, a lumen defined by the interior surface and a balloon wall extending between the interior surface and the exterior surface, the balloon having a plurality of discrete weeping windows disposed in the balloon wall and able to pass an electric current between the interior surface and the exterior surface and wherein the balloon wall is otherwise electrically insulative, the plurality of discrete weeping windows being spaced apart from one another by a non-weeping region of the balloon wall wherein the plurality of discrete weeping windows only partially circumferentially overlap about the balloon with each other and are spaced axially from each other, and wherein the plurality of discrete weeping windows are arranged in a spiral pattern that extends for a full rotation about the longitudinal axis, and wherein the plurality of discrete weeping windows are arranged such that every line extending along the balloon wall the shortest distance from the proximal end of the balloon wall to the distal end of the balloon wall passes through at least one discrete weeping window; and

an electrode disposed in the balloon.

19. The catheter of claim 18, wherein each of the plurality of discrete weeping windows comprises a plurality of micropores.

20. The catheter of claim 18, wherein all of the plurality of weeping discrete weeping windows are collectively arranged in a spiral pattern that extends for a full rotation about the longitudinal axis.