Catheter with radiofrequency cutting tip and heated balloon

• US 9,913,649 B2
• Filed: 05/28/2015
• Issued: 03/13/2018
• Est. Priority Date: 05/28/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Howard, John F., Fredrickson, Gerald, Regan, Kristin, Jordan, Gary A.
• Primary Examiner(s): Peffley, Michael
• Application Number:
  US14/724,480
• Publication Number:
  US 20150342770A1
• Time in Patent Office: 1,020 Days
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• 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 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Methods for draining pseudocysts and stent delivery systems for use therein are disclosed. An illustrative system may include a catheter shaft having an inflatable balloon affixed to a distal end region thereof. A cutting electrode may be disposed at the distal end of the system and at least one heating electrode may be disposed within the inflatable balloon. A self expandable stent may be disposed about the inflatable balloon. The stent may be formed of a shape memory polymer. The inflation fluid may be heated within the balloon to facilitate expansion of the stent.

Claims

1. A method for delivering a stent between a first body lumen and a second body lumen through adjacent opposing luminal walls, the method comprising:

advancing an endoscope having a working channel to a target location near a lumen wall of the first body lumen;

advancing a stent delivery system through the working channel of the endoscope, the stent delivery system comprising;

a catheter shaft having a proximal end and a distal end;

an inflatable balloon having an inner region and an outer surface, the inflatable balloon disposed adjacent to the distal end of the catheter shaft;

a first cutting electrode positioned at the distal end of the catheter shaft;

a second heating electrode disposed within the inner region of the inflatable balloon;

a control console in electrical communication with each of the first cutting electrode and the second heating electrode; and

a shape memory polymer stent disposed about the outer surface of the inflatable balloon, the stent transformable from a non-expanded state to an expanded state; and

contacting the lumen wall of the first body lumen with the first cutting electrode;

supplying an electrical current to the first cutting electrode to create an opening in the lumen wall of the first body lumen;

contacting a lumen wall of the second body lumen with the first cutting electrode;

supplying an electrical current to the first cutting electrode to create an opening in the lumen wall of the second body lumen;

disposing the inflatable balloon within the opening in the first body lumen and the opening in the second body lumen;

inflating the inflatable balloon; and

heating an inflation fluid within the balloon to transform the stent to the expanded state within the opening in the first body lumen and the opening in the second body lumen.

2. The method of claim 1, wherein inflating the inflatable balloon comprises pre-inflating the balloon to a first pressure prior to heating the inflation fluid.

3. The method of claim 2, wherein inflating the inflatable balloon further comprises inflating the balloon to a second pressure greater than the first pressure after heating the inflation fluid.

4. The method of claim 1, wherein heating the inflation fluid within the balloon comprises supplying an electrical current to the second heating electrode.

5. The method of claim 1, further comprising a heat shrink tube disposed over the first cutting electrode.

6. The method of claim 1, wherein the first cutting electrode and the second heating electrode are in electrical communication with the control console through separate electrical circuits.

7. The method of claim 1, wherein the first cutting electrode is configured to be operated in a first cutting mode and the second heating electrode is configured to be operated in a second heating mode.

8. The method of claim 1, wherein the stent is cross-linked in the non-expanded state.

9. The method of claim 1, wherein the stent is cross-linked in the expanded state.

10. The method of claim 1, wherein the expanded state of the stent includes a flared proximal end region and a flared distal end region.

11. The method of claim 1, wherein inflating the inflatable balloon comprises inflating the balloon to a dumbbell shape.

12. The method of claim 1, further comprising a third heating electrode disposed within the inner region of the inflatable balloon.

13. A method for delivering a stent between a first body lumen and a second body lumen, the method comprising:

advancing an endoscope having a working channel to a target location near a lumen wall of the first body lumen;

advancing a stent delivery system through the working channel of the endoscope, the stent delivery system comprising;

a catheter shaft extending from a proximal end to a distal end;

an inflatable balloon having a proximal end and a distal end affixed to the catheter shaft proximal to the distal end of the catheter shaft;

a first cutting electrode positioned at the distal end of the catheter shaft;

a second heating electrode disposed within an inner region of the inflatable balloon;

a control console in electrical communication with each of the first electrode and the second electrode; and

a stent disposed about an outer surface of the inflatable balloon, the stent having a first collapsed configuration and a second expanded configuration; and

contacting the lumen wall of the first body lumen with the first cutting electrode;

supplying an electrical current to the first cutting electrode to create an opening in the lumen wall of the first body lumen;

contacting a lumen wall of the second body lumen with the first cutting electrode;

supplying an electrical current to the first cutting electrode to create an opening in the lumen wall of the second body lumen;

disposing the inflatable balloon within the opening in the first body lumen and the opening in the second body lumen; and

inflating the inflatable balloon to expand the stent to the second expanded configuration within the opening in the first body lumen and the opening in the second body lumen.

14. The method of claim 13, wherein an outer diameter of the inflatable balloon varies from the proximal end to the distal end thereof.

15. The method of claim 13, wherein the inflatable balloon has a first region having a first outer diameter, a second region having a second diameter, and a third region having a third diameter, the second diameter smaller than the first and third diameters.

16. The method of claim 15, wherein the first region is positioned adjacent and distal to the proximal end of the balloon, the third region is positioned adjacent and proximal to the distal end of the balloon, and the second region is positioned between the first and third regions.

17. The method of claim 13, wherein the stent comprises a shape memory polymer.

18. The method of claim 17, further comprising heating an inflation fluid within the inflatable balloon to transform the stent to the second expanded configuration within the opening in the first body lumen and the opening in the second body lumen.

19. The method of claim 18, wherein inflating the inflatable balloon comprises pre-inflating the balloon to a first pressure prior to heating the inflation fluid.

20. The method of claim 19, wherein inflating the inflatable balloon further comprises inflating the balloon to a second pressure greater than the first pressure after heating the inflation fluid.