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 tissue protection

• US 20050228368A1
• Filed: 06/13/2005
• Published: 10/13/2005
• Est. Priority Date: 03/31/1998
• Status: Active Grant

• 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., Inderbitzen, Rebecca S.
• Granted Patent: US 7,288,089 B2
• Time in Patent Office: Days
• 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 2017/00243 cardiac
• 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 treat atrial fibrillation or inhibit or reduce restenosis following angioplasty or stent placement. A 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 balloon such that an exterior surface of the balloon contacts at least a partial circumference of the portion of the pulmonary vein adjacent the left atrium. In another embodiment, blood perfusion is performed simultaneously. In another embodiment, tissue contacted by the cryoablation catheter, undesired to be ablated, is protected against damage by a separate heating step.

Claims

1. A method of treating atrial fibrillation while preventing tissue damage to the atrial septum, comprising:

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

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

inserting an introducer sheath into the hole, the introducer sheath at least partially contacting the atrial septum;

inserting a guide wire through the introducer sheath into the right atrium and left atrium and further into a pulmonary vein;

disposing an ablation catheter over the guidewire into a volume defined by the joint of the left atrium and the pulmonary vein;

flowing a cryofluid into a balloon disposed within the ablation catheter to ablate tissue adjacent the joint of the left atrium and the pulmonary vein; and

operating and controlling a heater disposed adjacent or within the introducer sheath, the heater thermally coupled to the atrial septum.

2. The method of claim 1, wherein the operating and controlling a heater including providing power to a resistive heater.

3. The method of claim 1, wherein the operating and controlling a heater includes flowing a warming fluid into an inlet tube fluidically coupled to an interior of the introducer sheath, and flowing the warming fluid out of at least one outlet orifice disposed in the introducer sheath.

4. The method of claim 1, wherein the operating and controlling a heater includes allowing a body fluid to flow in an inlet sleeve having an input for the body fluid at a distal end of the introducer sheath, wherein the inlet sleeve is fluidically coupled to an interior of the introducer, and allowing the body fluid to flow out of the at least one outlet orifice disposed in the introducer.

5. The method of claim 1, wherein the cryofluid is selected from the group consisting essentially of Galden®

|fluid, DMSO, and d-limonene.

6. The method of claim 1, further comprising circulating the cryofluid with a gear pump.

7. The method of claim 6, wherein the gear pump is one selected from the group consisting of a radial spur gear pump and a helical tooth gear pump.

8. A method of reducing atrial fibrillation, comprising:

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

inflating the cold balloon with a working fluid including DMSO 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 working fluid having a temperature in the range of about −

10°

C. to −

100°

C.

9. The method of claim 8, wherein the working fluid is circulated by a gear pump.

10. The method of claim 9, wherein the gear pump is one selected from the group consisting of a radial spur gear pump and a helical tooth gear pump.

11. A method of reducing atrial fibrillation, comprising:

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

inflating the cold balloon with a working fluid including d-limonene 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 working fluid having a temperature in the range of about −

10°

C. to −

100°

C.

12. The method of claim 11, wherein the working fluid is circulated by a gear pump.

13. The method of claim 12, wherein the gear pump is one selected from the group consisting of a radial spur gear pump and a helical tooth gear pump.