Off-wall electrode device and methods for nerve modulation

• US 9,050,106 B2
• Filed: 12/21/2012
• Issued: 06/09/2015
• Est. Priority Date: 12/29/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Hill, Jason P., Jenson, Mark L.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US13/725,785
• Publication Number:
  US 20130172881A1
• Time in Patent Office: 900 Days
• Field of Search: 607/2, 607/42
• 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 2018/00267 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 2018/1435 Spiral

Abstract

Medical devices and methods for making and using the same are disclosed. An example medical device may include an ablative catheter for nerve modulation through a wall of a blood vessel. The catheter may include a catheter sheath having a proximal end, a distal end, and a lumen extending from the proximal to the distal end. An elongate member may extend along a central elongate axis within the lumen of the catheter sheath. The elongate member having a proximal end and a distal end. An expandable ablative member may be coupled to the distal end of the elongate member having an insulative section connected to a bare electrode section. The ablative member may be configured to switch between a collapsed position and an expanded position.

Claims

1. An ablative catheter for nerve modulation through a wall of a blood vessel, the catheter comprising:

a catheter sheath having a proximal end, a distal end, and a lumen extending from the proximal to the distal end;

an elongate member extending along a central elongate axis within the lumen of the catheter sheath, the elongate member having a proximal end and a distal end;

an expandable ablative member coupled to the distal end of the elongate member having one or more insulative sections connected to a bare electrode section;

wherein the ablative member is configured to switch between a collapsed position and an expanded position extending out of the distal end of the catheter sheath such that a portion of the insulative section contacts the wall of the blood vessel and the bare electrode section is disposed at a distance from the wall of the blood vessel, the expandable ablative member having a generally helical shape of variable outer diameter; and

wherein the ablative member is an expandable wire configured to form two or more humps and one or more troughs in between the two or more humps in the expanded position such that the insulative sections form the two or more humps and the bare electrode section forms the one or more troughs.

2. The ablative catheter of claim 1, wherein the ablative member is self-expandable.

3. The ablative catheter of claim 1, wherein the ablative member is expanded by an actuating means.

4. The ablative catheter of claim 1, wherein the ablative member is a spiral coil configured in an hourglass shape having a first end, a second end and a waist therebetween.

5. The ablative catheter of claim 4, wherein the insulative sections form the two ends of the hourglass shape and the bare electrode section forms a waist of the hourglass shape.

6. The ablative catheter of claim 4, wherein the ablative member includes a plurality of spiral coils loosely braided.

7. The ablative catheter of claim 1, wherein the ablative member includes a plurality of expandable wires.

8. The ablative catheter of claim 1, wherein, in the expanded position, an outer diameter of the ablative member increases distally.

9. The ablative catheter of claim 1, further comprising one or more temperature sensors coupled to the portion of the insulative section in contact with the wall of the blood vessel in the expanded position.

10. A renal ablation system for nerve modulation through a wall of a blood vessel, the system comprising:

an elongate member extending along a central elongate axis, the elongate member having a proximal end and a distal end;

an expandable ablative member coupled to the distal end of the elongate member, the ablative member having one or more conductor wires, the conductor wires comprising;

one or more bare electrode sections each having a proximal end and a distal end, and

one or more insulative sections;

the ablative member configured to switch between a collapsed position an expanded position;

wherein in the expanded position, the insulative portions contact the wall of the blood vessel and the bare electrode sections are positioned at a distance from the wall of the blood vessel; and

wherein, in the expanded position, one or more of the conductor wires are configured to form two or more humps and one or more troughs, such that the insulative sections form the two or more humps and the bare electrode sections form the one or more troughs.

11. The renal ablation system of claim 10, wherein the conductor wires are spiral coils.

12. The renal ablation system of claim 11, wherein, in the expanded position, the spiral coils forms an hourglass shape.

13. The renal ablation system of claim 11, wherein the ablative member includes multiple spiral coils loosely braided to form an hourglass shape.

14. The renal ablation system of claim 10, wherein the expandable ablative member is biased to the expanded position.

15. The renal ablation system of claim 10, wherein the expandable ablative member includes at least one insulative section proximal the bare electrode sections and at least one insulative section distal the bare electrode sections.

16. A method for ablating tissue through a vessel lumen, the method comprising:

advancing an ablative catheter intravascularly proximate a desired location in a blood vessel, the ablative catheter including an elongate member and an expandable ablative member having one or more bare electrode sections disposed along a center region of the ablative member and one or more insulative sections extending from the proximal end and distal end of the bare electrode sections;

wherein the ablative member is an expandable wire configured to form two or more humps and one or more troughs in between the two or more humps in the expanded position such that the insulative sections form the two or more humps and the bare electrode sections form the one or more troughs;

deploying the expandable ablative member in an expanded position in the vessel lumen such that portions of the insulative sections contact a wall of the blood vessel and the bare electrode sections maintain a distance from the wall of the blood vessel; and

activating the bare electrode sections to ablate at least a portion of a target tissue.

17. The method of claim 16, wherein the target tissue is perivascular nerve tissue.

18. The method of claim 16, wherein the expandable ablative member includes a plurality of generally helical elongate members, each of the plurality of generally helical elongate members comprising a bare electrode section and an insulative section.