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 7,291,144 B2
• Filed: 01/03/2002
• Issued: 11/06/2007
• 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., Dobak, John D. III, Yon, Steven A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/039,466
• Publication Number:
  US 20020091378A1
• Time in Patent Office: 2,133 Days
• Field of Search: 606 20- 24, 607/96, 607/105, 607/106, 607/100, 607/101, 607/102, 607/103, 607/104, 128/898
• US Class Current: 606/22
• 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 2017/22002 preventing restenosis
• 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 2018/0022 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

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 dual balloon structure, including an outer balloon and an inner balloon contained within the outer balloon, a portion of the dual balloon structure located in the left atrium and a portion of the dual balloon structure located in a pulmonary vein; and

inflating at least the outer balloon with a perfluorocarbon such that an exterior surface of the outer 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 dual balloon structure 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;

funning 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 aver the guidewire into a volume defined by the joint of the right atrium and the pulmonary vein.

4. The method of claim 1, further comprising inflating the inner balloon with a biocompatible liquid.

5. The method of claim 4, wherein the biocompatible liquid is static.

6. The method of claim 4, wherein the biocompatible liquid contains contrast media.

7. The method of claim 5, wherein the biocompatible liquid in the inner balloon chills biocompatible fluid between the dual balloons.