Method and device for performing cooling- or cryo-therapies for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation employing microporous balloon

• US 7,449,018 B2
• Filed: 01/07/2004
• Issued: 11/11/2008
• Est. Priority Date: 03/31/1998
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Kramer, Hans W.
• Primary Examiner(s): Cohen; Lee S
• Application Number:
  US10/753,913
• Publication Number:
  US 20040147914A1
• Time in Patent Office: 1,770 Days
• Field of Search: 606 20- 26, 607/96, 607/104, 607/105, 607/113
• US Class Current: 606/21
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

An enhanced method and device are provided to inhibit or reduce restenosis following angioplasty or stent placement. A porous balloon-tipped catheter is disposed in the area treated or opened through balloon angioplasty immediately following angioplasty. The balloon, which can have a dual balloon structure, may be delivered through a guiding catheter and over a guidewire already in place. A fluid such as a perfluorocarbon flows into the balloon to freeze the tissue adjacent the balloon, this cooling being associated with reduction of restenosis. A similar catheter may be used to reduce atrial fibrillation by inserting and inflating the porous balloon such that an exterior surface of the balloon, as well as a portion of the cold working fluid, from the microporosity contacts at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium.

Claims

1. A catheter system to treat restenosis or atrial fibrillation, comprising:

a catheter shaft;

a warm balloon disposed on the catheter shaft, said warm balloon fluidically coupled to at least one lumen for inflating and deflating the warm balloon; and

a cold balloon disposed on the catheter shaft, said cold balloon having at least one pore formed therein, and fluidically coupled to two lumens for circulating a cold working fluid to and from the cold balloon, such tat said cold balloon is located adjacent but proximal to said warm balloon,

wherein said warm balloon is structured and configured to anchor in a pulmonary vein, and

wherein said cold balloon is structured and configured to be disposed partially in the pulmonary vein and partially in the left atrium.

2. The system of claim 1, wherein said warm balloon is made of silicone tubing.

3. The system of claim 2, wherein said warm balloon is secured by heat shrink tubing.

4. The system of claim 2, wherein said warm balloon is secured by an adhesive.

5. The system of claim 2, wherein said warm balloon is secured by bands.

6. The system of claim 5, wherein said bands are metal.

7. The system of claim 1, wherein said working fluid is a perfluorocarbon.

8. The system of claim 1, wherein said cold balloon has a length of between about 1 to 2½

cm and a diameter of between about 1 to 2½

cm.

9. The system of claim 1, further comprising at least one marker band disposed within one or both of the cold balloon and the warm balloon.

10. The system of claim 1, further comprising a set of mapping electrodes disposed distal of the warm balloon.

11. The system of claim 1, further comprising an insulation sleeve disposed around the catheter shaft.

12. The system of claim 11, wherein the insulation sleeve is formed of a foamed extrusion.

13. The system of claim 1, further comprising a silicone sleeve disposed circumferentially about the catheter shaft adjacent a point at which at least one of the cold or warm balloons attaches to the catheter shaft.

14. The system of claim 1, further comprising a gear pump, and wherein the cold working fluid is circulated by said gear pump.