Neuromodulation catheters having jacketed neuromodulation elements and related devices, systems, and methods

• US 10,166,069 B2
• Filed: 01/27/2015
• Issued: 01/01/2019
• Est. Priority Date: 01/27/2014
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Tran, Don, Beasley, Rudy, Rios, Jaime, Shin, Sukyoung, Som, Sina
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US14/606,821
• Publication Number:
  US 20150209104A1
• Time in Patent Office: 1,435 Days
• 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 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 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 2018/00505 Urinary tract
• 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
• CPC Class Codes: A61N 1/28 Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: B29C 45/0055 Shaping
• CPC Class Codes: B29C 45/14598 Coating tubular articles
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

A neuromodulation catheter in accordance with a particular embodiment includes an elongate shaft and a neuromodulation element operably connected to the shaft. The shaft includes a proximal hypotube segment at its proximal end portion and a jacket disposed around at least a portion of an outer surface of the hypotube segment. The jacket may be made at least partially of a polymer blend including polyether block amide and polysiloxane. The neuromodulation element includes a distal hypotube segment and a tubular jacket disposed around at least a portion of an outer surface of the distal hypotube segment. The jacket has reduced-diameter segments spaced apart along its longitudinal axis. The neuromodulation element further includes band electrodes respectively seated in the reduced-diameter segments and respectively forming closed loops extending circumferentially around the jacket.

Claims

1. A neuromodulation catheter, comprising:

an elongate shaft; and

a neuromodulation element operably connected to the shaft via a distal end portion of the shaft, the neuromodulation element being movable from a low-profile delivery state to a radially expanded deployed state, the neuromodulation element including;

a hypotube segment configured to have a first shape when the neuromodulation element is in the delivery state and a second shape when the neuromodulation element is in the deployed state, the second shape being more helical than the first;

a tubular jacket disposed around at least a portion of an outer surface of the hypotube segment, an outer surface of the jacket defining reduced-diameter segments spaced apart along its longitudinal; and

band electrodes respectively seated in the reduced-diameter segments and respectively forming closed loops extending circumferentially around the jacket,

wherein a minimum inner diameter of the band electrodes is smaller than a maximum outer diameter of jacket between the reduced-diameter segments.

2. The neuromodulation catheter of claim 1 wherein the jacket between the reduced-diameter segments is resilient in response to peristaltic deflection of a magnitude corresponding to a difference between the maximum outer diameter of the jacket between the reduced-diameter segments and the minimum inner diameter of the band electrodes.

3. The neuromodulation catheter of claim 1, further comprising adhesive disposed between the band electrodes and the jacket at the reduced-diameter segments.

4. The neuromodulation catheter of claim 1 wherein the reduced-diameter segments are fully circumferential.

5. The neuromodulation catheter of claim 1 wherein:

the jacket includes openings respectively positioned at the reduced-diameter segments;

the neuromodulation catheter further comprises electrical leads respectively connected to the band electrodes; and

the electrical leads respectively extend through the openings.

6. The neuromodulation catheter of claim 1 wherein a maximum outer diameter of the band electrodes and the maximum outer diameter of the jacket between the reduced-diameter segments are at least generally equal.

7. The neuromodulation catheter of claim 1 wherein at least one of the reduced-diameter segments has a side wall, a floor, and a rounded junction therebetween.

8. The neuromodulation catheter of claim 7 wherein:

a portion of the floor directly adjacent to the rounded junction lies along a plane; and

the wall and the rounded junction do not extend through the plane.

9. The neuromodulation catheter of claim 8 wherein:

the jacket includes a rim bordering a respective reduced-diameter segment of the at least one reduced-diameter segment;

the respective reduced-diameter segment has a depth between the floor and the rim; and

the rounded junction has a radius within a range from 35% to 50% of the depth.

10. The neuromodulation catheter of claim 8 wherein:

the jacket includes a rim bordering a respective reduced-diameter segment of the at least one reduced-diameter segment;

the respective reduced-diameter segment has depth between the floor and the rim; and

the rounded junction has a radius within a range from 0.5 mil to 3 mils.

11. The neuromodulation catheter of claim 8 wherein:

the jacket includes a rim bordering a respective reduced-diameter segment of the at least one reduced-diameter segment; and

the sidewall from the junction to the rim has an average angle greater than 240°

relative to the rim.

12. The neuromodulation catheter of claim 8 wherein:

the jacket includes a rim bordering a respective reduced-diameter segment of the at least one reduced-diameter segment; and

the sidewall from the junction to the rim has an average angle greater than 260°

relative to the rim.

13. The neuromodulation catheter of claim 1 wherein the jacket is made at least partially of a polymer blend including polyurethane and polysiloxane.

14. The neuromodulation catheter of claim 1, wherein the jacket is made at least partially of a polymer blend including polyether block amide and polysiloxane.

15. The neuromodulation catheter of claim 14 wherein the jacket includes polysiloxane at greater than 15% by weight.

16. The neuromodulation catheter of claim 14 wherein the jacket includes polysiloxane at about 20% by weight.

17. The neuromodulation catheter of claim 14 wherein the jacket includes polyether block amide at about 80% by weight.

18. The neuromodulation catheter of claim 1 wherein the hypotube segment is made at least partially of nitinol.

19. The neuromodulation catheter of claim 1 wherein:

the hypotube segment includes a proximal stem; and

the jacket is not disposed around the outer surface of the hypotube segment at the proximal stem.

20. The neuromodulation catheter of claim 1 wherein the jacket is uncoated.

21. The neuromodulation catheter of claim 1 wherein:

the hypotube segment includes a distal skive; and

the jacket is disposed on at least a portion of the outer surface of the hypotube segment at the distal skive.

22. A method comprising forming a neuromodulation element, wherein forming the neuromodulation element comprises:

forming a tubular jacket, an outer surface of the jacket defining reduced-diameter segments spaced apart along its longitudinal axis;

positioning a band electrode in a reduced-diameter segment of the reduced diameter segments, the band electrode forming a closed loop extending circumferentially around the jacket, wherein a minimum inner diameter of the band electrode is smaller than a maximum outer diameter of jacket between the reduced-diameter segments; and

positioning the jacket and a hypotube segment relative to one another so that the jacket is disposed around at least a portion of an outer surface of the hypotube segment, wherein the hypotube segment is configured to have a first shape in a delivery state of the neuromodulation element and a second shape in a deployed state of the neuromodulation element, the second shape being more helical than the first shape.

23. The method of claim 22, wherein the reduced-diameter segments include a first reduced-diameter segment and a second reduced-diameter segment, wherein positioning the band electrode in the reduced-diameter segment comprises positioning a first band electrode in the first reduced-diameter segment, the method further comprising positioning a second band electrode in the second reduced-diameter segment.

24. The method of claim 22 wherein the method does not include swaging the jacket after forming the jacket and before positioning the jacket and the hypotube segment relative to one another.

25. The method of claim 22 wherein forming the jacket includes forming the jacket by injection molding.

26. The method of claim 22 wherein forming the jacket includes:

forming a tubular blank by extrusion; and

removing a portion of the blank to form the reduced-diameter segments.

27. The method of claim 22 wherein removing the portion of the blank includes removing the portion of the blank by laser ablation.