MEDICAL DEVICES FOR RENAL NERVE ABLATION

• US 20150025532A1
• Filed: 07/21/2014
• Published: 01/22/2015
• Est. Priority Date: 07/22/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: HANSON, CASS A., SUTERMEISTER, DEREK C., QUILLIN, DANIEL T., CAO, HONG, LINDQUIST, JEFFREY S., ROYER, ADAM J., OSTROOT, TIMOTHY A., ANDERSON, JAMES M., WEBER, JAN, SQUIRE, ROBERT N., WILLARD, MARTIN R., HAVERKOST, PATRICK A., HORN, DANIEL J.
• Granted Patent: US 10,342,609 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 2018/00148 with metal
• 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 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

Medical devices and methods for making and using the same are disclosed. An example medical device may include a medical device for tissue ablation. The medical device may include an elongated shaft having a distal region. An inflatable balloon may be mounted to the distal region. The inflatable balloon may include a body region, a proximal waist, a distal waist, a proximal cone region, and a distal cone region. A skirt may be attached to the inflatable balloon and may extend proximally from the body region. An electrode assembly may be applied directly to an outer surface of the body region of the inflatable balloon. The electrode assembly may include a first conductive member applied directly to the outer surface of the body region of the inflatable balloon and extending proximally therefrom along an outer surface of the skirt.

Claims

1. A medical device for tissue ablation, comprising:

an elongated shaft having a distal region;

an inflatable balloon mounted to the distal region, the inflatable balloon including a body region, a proximal waist secured to the elongated shaft, a distal waist secured to the elongated shaft, a proximal cone region intermediate the proximal waist and the body region, and a distal cone region intermediate the body region and the distal waist;

a skirt attached to the inflatable balloon and extending proximally from the body region; and

an electrode assembly applied directly to an outer surface of the body region of the inflatable balloon, the electrode assembly including a first conductive member applied directly to the outer surface of the body region of the inflatable balloon and extending proximally therefrom along an outer surface of the skirt.

2. The medical device of claim 1, wherein the first conductive member is applied directly to the outer surface of the skirt.

3. The medical device of claim 1, wherein the skirt includes a longitudinal strip of material extending proximally from the body region.

4. The medical device of claim 1, wherein the skirt includes an annular portion extending circumferentially around the body region of the inflatable balloon.

5. The medical device of claim 4, wherein the skirt is adhesively bonded to the body region of the inflatable balloon.

6. The medical device of claim 1, wherein the skirt includes a longitudinal strip of material extending proximally from the body region, the first conductive member applied directly to an outer surface of the longitudinal strip of material, and the electrode assembly includes a second conductive member applied directly to the outer surface of the longitudinal strip of material spaced apart from the first conductive member.

7. The medical device of claim 6, wherein the electrode assembly includes an active electrode applied directly to the outer surface of the body region of the inflatable balloon and a return electrode applied directly to the outer surface of the body region of the inflatable balloon.

8. The medical device of claim 7, wherein the first conductive member is in electrical communication with the active electrode and extends proximally therefrom.

9. The medical device of claim 8, wherein the second conductive member is in electrical communication with the return electrode and extends proximally therefrom.

10. The medical device of claim 9, further comprising a first electrical wire attached to the first conductive member at a first termination point proximate a proximal end of the first conductive member.

11. The medical device of claim 10, further comprising a second electrical wire attached to the second conductive member at a second termination point proximate a proximal end of the second conductive member.

12. The medical device of claim 11, wherein the first and second termination points are located proximal of the proximal waist of the inflatable balloon.

13. The medical device of claim 1, wherein a distal portion of the skirt is an overlap region secured to the outer surface of the body region of the inflatable balloon.

14. A medical device for tissue ablation, comprising:

an elongated shaft having a distal region;

an inflatable balloon mounted to the distal region, the inflatable balloon including a body region, a proximal waist secured to the elongated shaft, a distal waist secured to the elongated shaft, a proximal cone region intermediate the proximal waist and the body region, and a distal cone region intermediate the body region and the distal waist;

a skirt having a distal portion attached to an outer surface of the body region of the inflatable balloon and a proximal portion extending proximal of the body region of the inflatable balloon; and

an electrode assembly disposed on the body region of the inflatable balloon, the electrode assembly including;

an active electrode applied directly to the outer surface of the body region of the inflatable balloon;

a return electrode applied directly to the outer surface of the body region of the inflatable balloon;

a first conductive member extending proximally from the active electrode, the first conductive member applied directly to the outer surface of the body region of the inflatable balloon and applied directly to an outer surface of the skirt; and

a second conductive member extending proximally from the return electrode, the second conductive member applied directly to the outer surface of the body region of the inflatable balloon and applied directly to the outer surface of the skirt.

15. The medical device of claim 14, wherein the proximal portion of the skirt extends proximal of the proximal waist of the inflatable balloon.

16. The medical device of claim 14, further comprising:

a first electrical wire attached to the first conductive member at a first termination point proximate a proximal end of the first conductive member; and

a second electrical wire attached to the second conductive member at a second termination point proximate a proximal end of the second conductive member.

17. The medical device of claim 16, wherein the first and second termination points are located proximal of the proximal waist of the inflatable balloon.

18. The medical device of claim 16, wherein the distal portion of the skirt is an annular portion circumferentially surrounding and overlapping the body region of the inflatable balloon, and wherein the annular portion of the skirt is adhesively bonded to the body region of the inflatable balloon.

19. The medical device of claim 18, wherein the skirt includes a strip of material extending proximally from the annular portion of the skirt, the first and second conductive members extending along the strip of material of the skirt.

20. A method of forming a medical device for tissue ablation, comprising:

securing a skirt to an inflatable balloon mounted on a catheter shaft, the skirt extending proximal of a body region of the inflatable balloon;

applying an electrode directly to an outer surface of the body region of the inflatable balloon; and

applying a conductive member directly to the outer surface of the body region of the inflatable balloon and directly to an outer surface of the skirt, the conductive member extending proximally from the electrode to a proximal end region of the skirt.