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 6,685,732 B2
• Filed: 08/17/2001
• Issued: 02/03/2004
• 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: Kramer, Hans W.
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/932,402
• Publication Number:
  US 20020045892A1
• Time in Patent Office: 900 Days
• Field of Search: 607/96, 607/104, 607/105, 607/113, 606/20, 606/21, 606/22, 606/23, 606/24, 606/25, 128/898
• 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 2007/126 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 method of reducing atrial fibrillation, comprising:

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

inflating the cold balloon with a perfluorocarbon such that an exterior surface of the cold balloon, and the portion of the perfluorocarbon emergent from the at least one pore, 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 cold balloon has a working region having a length of between about 5 mm and 10 mm.

3. The method of claim 1, wherein the perfluorocarbon is circulated by a gear pump.

4. 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.

5. The method of claim 1, further comprising disposing a warm fluid balloon distal of the cold balloon.

6. 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;

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.;

wherein the cold balloon has at least one pore formed therein; and

further comprising leaking a portion of the perfluorocarbon into the space defined between the cold balloon and the at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium.

7. The method of claim 6, wherein inflating the warm balloon includes pressurizing the warm balloon to a pressure of between about 1 to 2 atmospheres.

8. The method of claim 6, wherein inflating the cold balloon includes pressurizing the cold balloon to a pressure of between about 1 to 2 atmospheres.

9. The method of claim 6, further comprising circulating said cold perfluorocarbon with a gear pump.

10. A device to reduce atrial fibrillation, comprising:

a catheter, the catheter having a warm balloon and a cold balloon proximal of the warm balloon, at least a portion of the cold balloon locatable in the left atrium and at least a portion of the warm balloon locatable in a pulmonary vein;

a source of warm biocompatible fluid to inflate the warm balloon;

a source of cold perfluorocarbon to inflate the cold balloon, such that an exterior surface of the cold balloon is contactable 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.;

wherein the cold balloon has at least one pore formed therein.

11. The device of claim 10, further comprising a gear pump, and wherein the cold perfluorocarbon is circulated by said gear pump.

12. 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;

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; and

a gear pump for circulating the cold working fluid.