Renal nerve ablation catheter having twist balloon

• US 10,695,124 B2
• Filed: 07/22/2014
• Issued: 06/30/2020
• Est. Priority Date: 07/22/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Groff, Joel N., Haverkost, Patrick A., Willard, Martin R., Cao, Hong, Horn, Daniel J., Larson, Kenneth R., Chen, John Jianhua
• Primary Examiner(s): Peffley, Michael F
• Assistant Examiner(s): Ouyang, Bo
• Application Number:
  US14/338,085
• Publication Number:
  US 20150025533A1
• Time in Patent Office: 2,170 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 2018/00232 having an irregular shape
• 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 2018/00505 Urinary tract
• 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 2018/1467 using more than two electrodes on a single probe

Abstract

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter shaft. An expandable balloon may be coupled to the catheter shaft. The balloon may be capable of shifting between a folded configuration and an expanded configuration. A support structure may be coupled to the balloon. The support structure may be capable of shifting the balloon toward the folded configuration. A plurality of elongate flexible electrode assemblies may be disposed on the balloon. The elongate flexible electrode assemblies may be oriented at an angle relative to a longitudinal axis of the balloon.

Claims

1. A medical device, comprising:

a catheter shaft;

an expandable balloon coupled to the catheter shaft, the balloon having a proximal end, a distal end, and a length extending therebetween, and the balloon comprising a plurality of pre-formed channels extending along the length of the balloon;

a support structure coupled to the balloon, the support structure configured to twist and fold the balloon in a pre-determined manner upon retraction of the balloon and support structure into a guide catheter, and the support structure comprising a plurality of elongate support elements extending along the length of the balloon, the elongate support elements being disposed in the pre-formed channels; and

a plurality of flexible electrode assemblies coupled to the balloon between adjacent pre-formed channels.

2. The medical device of claim 1, wherein the elongate support elements are connected to each other at their proximal ends, and wherein the elongate support elements extend along the length of the balloon and are twisted at an angle from a longitudinal axis of the balloon.

3. The medical device of claim 1, wherein the elongate support elements are connected together at their proximal ends and wherein the channels and elongate support elements extend along the length of the balloon and are twisted at an angle from a longitudinal axis of the balloon.

4. The medical device of claim 1, wherein the electrode assemblies are offset longitudinally.

5. The medical device of claim 1, wherein at least some of the electrode assemblies include a pair of adjacent bipolar electrodes.

6. The medical device of claim 1, wherein at least some of the electrode assemblies include a monopolar electrode.

7. The medical device of claim 1, wherein at least some of the electrode assemblies include a temperature sensor.

8. The medical device of claim 1, wherein the balloon is a compliant balloon.

9. The medical device of claim 1, wherein the balloon is a non-compliant balloon.

10. The medical device of claim 1, wherein the elongate support elements are connected to each other at their proximal ends, and extend in a helix over the body of the expandable balloon.

11. The medical device of claim 10, wherein the elongate support elements are connected to each other at their proximal ends and at their distal ends.

12. The medical device of claim 1, wherein the elongate support elements are connected to each other at their proximal ends and at their distal ends.

13. A medical device, comprising:

a catheter shaft;

an expandable balloon coupled to the catheter shaft, the balloon being capable of shifting between a folded configuration and an expanded configuration, and the balloon comprising a plurality of pre-formed channels extending along a length of the balloon;

a support structure coupled to the balloon, the support structure comprising a plurality of elongate support elements extending along the length of the balloon, the elongate support elements being disposed in the pre-formed channels, and the support structure being configured to twist and fold the balloon in a pre-determined manner upon retraction of the balloon and support structure into a guide catheter; and

a plurality of elongate flexible electrode assemblies coupled to the balloon between adjacent pre-formed channels, wherein the elongate flexible electrode assemblies are twisted at an angle relative to a longitudinal axis of the balloon.

14. The medical device of claim 13, wherein at least some of the flexible elongate electrode assemblies are disposed between the elongate support elements.

15. The medical device of claim 13, wherein at least some of the electrode assemblies include a pair of adjacent bipolar electrodes.

16. The medical device of claim 13, wherein at least some of the electrode assemblies include a temperature sensor.

17. The medical device of claim 16, wherein the temperature sensor is positioned between a bottom surface of one of the electrode assemblies and an outer surface of the balloon.

18. The medical device of claim 13, wherein the elongate support elements are connected to each other at their proximal ends and at their distal ends.

19. The medical device of claim 13, wherein the elongate support elements extend in a helix over the body of the expandable balloon and wherein the elongate support elements are connected to each other at their proximal ends and at their distal ends.

20. A method for ablating renal nerves, the method comprising:

advancing the medical device of claim 13 through a guide catheter and into a blood vessel to a position within a renal artery;

expanding the balloon;

activating at least some of the elongate flexible electrode assemblies; and

retracting the balloon into the guide catheter, wherein the interaction between the support structure and the guide catheter twists and folds the balloon to the folded configuration.