Medical device balloon

• US 9,962,223 B2
• Filed: 10/13/2014
• Issued: 05/08/2018
• Est. Priority Date: 10/15/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Lindquist, Jeffrey S., Hanson, Cass A., Haverkost, Patrick A., Horn, Daniel J., Willard, Martin R., Sutermeister, Derek C.
• Primary Examiner(s): DELLA, JAYMI E
• Application Number:
  US14/513,101
• Publication Number:
  US 20150105774A1
• Time in Patent Office: 1,303 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• 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 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier

Abstract

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter shaft. An expandable member may be coupled to the catheter shaft. The expandable member may be capable of shifting between a folded configuration and an expanded configuration. A plurality of flexible elements may be attached to the expandable member, with a plurality of electrode assemblies disposed on the flexible elements. The flexible elements may have a grooved substrate.

Claims

1. A medical device for sympathetic nerve ablation, comprising:

a catheter shaft;

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

a plurality of flexible elements attached to the body of the expandable member, the plurality of flexible elements including a plurality of electrode assemblies, each of the plurality of flexible elements including a respective one of the plurality of electrode assemblies, wherein each of the plurality of flexible elements includes a substrate in the form of a base layer of insulation having a plurality of elongate grooves formed therein and wherein each of the plurality of electrode assemblies is disposed over the substrate and at least a portion of the plurality of elongate grooves formed therein.

2. The medical device of claim 1, wherein the substrate includes a polymer.

3. The medical device of claim 1, wherein the plurality of elongate grooves are disposed in only one of an upper and a lower surface of the substrate.

4. The medical device of claim 1, wherein the plurality of elongate grooves are disposed in both an upper and a lower surface of the substrate.

5. The medical device of claim 1, wherein at least a portion of the plurality of elongate grooves extend along the substrate at an angle from the longitudinal axis of the expandable member.

6. The medical device of claim 1, wherein the plurality of elongate of grooves extend along the substrate in more than one direction.

7. The medical device of claim 1, wherein at least a portion of the plurality of elongate grooves are substantially parallel to each other.

8. The medical device of claim 1, wherein the plurality of elongate grooves define a cross-hatched pattern.

9. The medical device of claim 1, wherein the plurality of elongate grooves are disposed in a pattern correlating with a pre-determined folding pattern.

10. The medical device of claim 1, wherein the plurality of elongate grooves extends over substantially the entire length of the substrate.

11. The medical device of claim 1, wherein the plurality of elongate grooves extends over only select regions of the substrate.

12. The medical device of claim 1, wherein one or more of the plurality of elongate grooves are arranged along proximal edges of the plurality of electrode assemblies.

13. The medical device of claim 1, wherein electrode assemblies on adjacent flexible elements are longitudinally offset.

14. The medical device of claim 1, wherein the plurality of flexible elements extend along the expandable member at an angle relative to the longitudinal axis of the expandable member.

15. The medical device of claim 1, wherein a temperature sensor is positioned between a bottom surface of one of the plurality of electrode assemblies and an outer surface of the expandable member.

16. A method of making the medical device of claim 1, the method comprising:

forming the plurality of elongate grooves in a substrate;

forming an electrical circuit on the grooved substrate;

affixing the grooved substrate onto an expandable member; and

attaching the expandable balloon to the catheter shaft.

17. A medical device, comprising:

a catheter shaft;

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

a flexible substrate attached to the expandable balloon, the substrate including a plurality of grooves formed therein; and

a plurality of electrode assemblies disposed over the flexible substrate and at least a portion of the plurality of the grooves formed therein.

18. The medical device of claim 17, wherein at least some of the plurality of electrode assemblies include a temperature sensor.

19. The medical device of claim 17, wherein the flexible substrate includes a distal electrode pad, a proximal electrode pad, and a proximal tail extending proximally from the proximal electrode pad;

and wherein the proximal electrode pad is centered with the proximal tail.

20. The medical device of claim 17, wherein the flexible substrate includes a distal electrode pad, a distal tail extending proximally from the distal electrode pad, a proximal electrode pad, a proximal tail extending proximally from the proximal electrode pad, and a central axis;

and wherein the proximal electrode pad is laterally offset from the distal electrode pad with respect to the central axis.