Medical devices for modulating nerves

• US 9,956,033 B2
• Filed: 02/28/2014
• Issued: 05/01/2018
• Est. Priority Date: 03/11/2013
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Squire, Robert N., Royer, Adam J., Lindquist, Jeffrey S., Horn, Daniel J.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): ZINK, AMANDA L
• Application Number:
  US14/194,524
• Publication Number:
  US 20140257281A1
• Time in Patent Office: 1,523 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 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00107 Coatings on the energy applicator
• 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 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril

Abstract

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a medical device for modulating nerves. The medical device may include an elongate shaft having a distal region. A balloon may be coupled to the distal region. An electrode may be disposed within the balloon. A virtual electrode may be defined on the balloon. The virtual electrode may include a conductive region having an edge and a peripheral region disposed at least partially along the edge of the conductive region. The peripheral region may be configured to dissipate forces, electrical current, or both accumulating along the edge of the conductive region.

Claims

1. A medical device for modulating nerves, the medical device comprising:

an elongate shaft having a distal region;

a balloon coupled to the distal region;

an electrode disposed within the balloon; and

one or more virtual electrodes defined on the balloon, the virtual electrodes including a conductive region having an edge and a peripheral region disposed at least partially along the edge of the conductive region, the peripheral region being configured to dissipate physical forces, electrical current, or both accumulating along the edge of the conductive region;

wherein the balloon includes an inner conductive layer, an outer non-conductive layer, and an intermediate non-conductive layer disposed between the inner conductive layer and the outer non-conductive layer;

wherein the conductive region is defined along a first portion of the balloon that includes the inner conductive layer, is free of the outer non-conductive layer, and is free of the intermediate non-conductive layer; and

wherein the peripheral region is defined along a second portion of the balloon that includes the inner conductive layer, includes the outer non-conductive layer, and is free of the intermediate non-conductive layer.

2. The medical device of claim 1, wherein the balloon includes a plurality of intermediate non-conductive layers disposed between the inner conductive layer and the outer non-conductive layer.

3. The medical device of claim 1, wherein the intermediate non-conductive layer has a substantially constant thickness.

4. The medical device of claim 1, wherein the intermediate non-conductive layer has a variable thickness along the peripheral region.

5. The medical device of claim 1, herein the medical device comprises a plurality of said virtual electrodes.

6. The medical device of claim 1, wherein the peripheral region completely surrounds the conductive region.

7. A medical device for modulating nerves, the medical device comprising:

an elongate shaft having a distal region;

a balloon coupled to the distal region;

an electrode disposed within the balloon; and

one or more virtual electrodes defined on the balloon, the virtual electrodes including a conductive region having an edge and a peripheral region disposed at least partially along the edge of the conductive region, the peripheral region being configured to dissipate physical forces, electrical current, or both accumulating along the edge of the conductive region;

wherein the balloon includes an inner conductive layer and an outer non-conductive layer;

wherein the inner conductive layer is plasma treated along at least a portion thereof;

wherein the conductive region is defined along a first portion of the balloon that includes the inner conductive layer and is free of the outer non-conductive layer;

wherein the peripheral region is defined along a second portion of the balloon that includes the inner conductive layer and the outer non-conductive layer; and

wherein the conductive region and the peripheral region are free of plasma treatment.

8. The medical device of claim 7, wherein the balloon includes an adhered region where the inner conductive layer is adhered to the outer non-conductive layer and a non-adhered region wherein the inner conductive layer is not adhered to the outer non-conductive layer.

9. The medical device of claim 7, wherein the medical device comprises a plurality of said virtual electrodes.

10. The medical device of claim 7, wherein the peripheral region completely surrounds the conductive region.

11. The medical device of claim 7, wherein the balloon includes an adhered region in which the inner conductive layer is plasma treated and is adhered to the outer non-conductive layer and a non-adhered region in which the inner conductive layer is free of plasma treatment and is not adhered to the outer non-conductive layer.

12. A balloon catheter for modulating renal nerves, the catheter comprising:

an elongate catheter shaft having a distal region;

a balloon coupled to the distal region;

wherein the balloon includes an inner conductive layer, an outer insulating layer, and an intermediate layer disposed between the inner conductive layer and the outer insulating layer;

an electrode coupled to the catheter shaft and disposed within the balloon;

one or more virtual electrodes defined on the balloon, the virtual electrodes including a conductive region and an edge region disposed at least partially along the conductive region;

wherein the conductive region includes the inner conductive layer, is free of the intermediate layer, and is free of the outer insulating layer; and

wherein the edge region includes the inner conductive layer, includes the outer insulating layer and is free of the intermediate layer.

13. The balloon catheter of claim 12, wherein the medical device comprises a plurality of said virtual electrodes.

14. The balloon catheter medical device of claim 12, wherein the edge region completely surrounds the conductive region.