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

• US 6,602,276 B2
• Filed: 03/21/2001
• Issued: 08/05/2003
• Est. Priority Date: 03/31/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Yon, Steve A., Kramer, Hans W., Dobak, John D. III
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/787,599
• Publication Number:
  US 20020169489A1
• Time in Patent Office: 867 Days
• Field of Search: 607/96, 607/104, 607/105, 607/113, 606/20-25
• US Class Current: 607/105
• 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 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/0298 with a section for heating and a section for cooling
• 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
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

The present invention provides an enhanced method and device to inhibit or reduce the rate of restenosis following angioplasty or stent placement. The invention involves placing a balloon tipped catheter 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 from a balloon angioplasty. A fluid such as a perfluorocarbon may be flowed into the balloon to freeze the tissue adjacent the balloon, this cooling being associated with reduction of restenosis. The catheter may also be used to reduce atrial fibrillation by inserting and inflating the balloon such that an exterior surface of the balloon is in contact with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium.

Claims

1. A method of reducing atrial fibrillation, comprising:

inserting a catheter at least partially into the heart, the catheter having a balloon, a portion of the balloon located in the left atrium and a portion of the balloon located in a pulmonary vein;

inflating the balloon with a perfluorocarbon such that an exterior surface of the balloon is in contact with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium, the perfluorocarbon having a temperature in the range of about −

10°

C. to −

50°

C.

2. The method of claim 1, wherein the balloon has a working region having a length of between about 5 mm and 10 mm.

3. The method of claim 1, further comprising:

inserting a wire capable of rupturing the atrial septum from the femoral vein into the right atrium;

forming a hole using the wire in the interatrial septum between the right atrium and the left atrium;

inserting a guide catheter into the right atrium;

inserting a guide wire through the guide catheter into the right atrium and further into a pulmonary vein;

disposing the catheter over the guidewire into a volume defined by the joint of the right atrium and the pulmonary vein.

4. A catheter system for vessel ablation, 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 fluidically coupled to two lumens for circulating a cold working fluid to and from the cold balloon, such that said cold balloon is located adjacent but proximal to said warm balloon.

5. The system of claim 4, wherein said warm balloon is made of silicone tubing.

6. The system of claim 5, wherein said warm balloon is secured by heat shrink tubing.

7. The system of claim 5, wherein said warm balloon is secured by an adhesive.

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

9. The system of claim 8, wherein said bands are metal.

10. The system of claim 4, wherein said working fluid is a perfluorocarbon.

11. The system of claim 10, wherein said working fluid is Galden fluid.

12. The system of claim 4, wherein said warm balloon is structured and configured to anchor in a pulmonary vein.

13. The system of claim 12, wherein said cold balloon is structured and configured to be disposed partially in a pulmonary vein and partially in the left atrium.

14. The system of claim 13, wherein said cold balloon has a length of between about 1 to 2½

cm and a diameter of between about 1 to 2½

cm.

15. The system of claim 4, further comprising at least one marker band disposed within one or both of the cold balloon and the warm balloon.

16. The system of claim 4, further comprising a set of mapping electrodes disposed distal of the warm balloon.

17. The system of claim 4, further comprising an insulation sleeve disposed around the catheter shaft.

18. The system of claim 17, wherein the insulation sleeve is formed of a foamed extrusion.

19. The system of claim 4, 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.

20. The system of claim 4, wherein the cold balloon is doped with a biocompatible agent to promote heat transfer.

21. A method of reducing atrial fibrillation, comprising:

inserting a catheter at least partially into the heart, the catheter having a warm balloon and a cold balloon proximal of the warm balloon, at least a portion of the cold balloon located in the left atrium and at least a portion of the warm balloon located in a pulmonary vein;

inflating the warm balloon with a biocompatible fluid; and

inflating the cold balloon with a perfluorocarbon such that an exterior surface of the cold balloon is in contact with at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium, the perfluorocarbon having a temperature in the range of about −

10°

C. to −

70°

C.

22. The method of claim 21, wherein inflating the warm balloon includes pressurizing the warm balloon to a pressure of between about 1 to 2 atmospheres.

23. The method of claim 21, wherein inflating the cold balloon includes pressurizing the cold balloon to a pressure of between about 5 to 7 atmospheres.