Method and device for applications of selective organ cooling

• US 6,582,455 B1
• Filed: 07/21/2000
• Issued: 06/24/2003
• Est. Priority Date: 03/24/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Lasheras, Juan C., Werneth, Randell L., Dobak, John D. III
• Primary Examiner(s): Kearney, Rosiland S.
• Application Number:
  US09/621,051
• Time in Patent Office: 1,068 Days
• Field of Search: 606/27, 606/28, 606/20-24, 607/96, 607/104, 607/105, 607/106, 607/113
• US Class Current: 607/105
• CPC Class Codes: A61F 2007/0056 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

Abstract

The invention provides a method and device for selectively controlling the temperature of a selected organ of a patient for performance of a specified application. The method includes introducing a guide catheter into a blood vessel. The guide catheter may have a soft tip and a retaining flange, and may be used to provide treatments such as administration of thrombolytic drug therapies, stenting procedures, angiographic procedures, etc. A supply tube is provided having a heat transfer element attached to a distal end thereof. The heat transfer element having a plurality of exterior surface irregularities, these surface irregularities having a depth greater than the boundary layer thickness of flow in the feeding artery of the selected organ. The supply tube and heat transfer element may be inserted through the guide catheter to place the heat transfer element in the feeding artery of the selected organ. Turbulence is created around the surface irregularities at a distance from the heat transfer element greater than the boundary layer thickness of flow in the feeding artery, thereby creating turbulence throughout the blood flow in the feeding artery. A working fluid is circulated into the heat transfer element via the supply tube and via an internal lumen of the heat transfer element. The fluid may be circulated out of the heat transfer element via an external lumen of the heat transfer element and through the guide catheter. Heat is thereby transferred between the heat transfer element and the blood in the feeding artery to selectively control the temperature of the selected organ during or soon before or after the specified application.

Claims

1. A method for selective thrombolysis by selective vessel hypothermia, comprising:

introducing a guide catheter into a thrombosed blood vessel;

delivering a thrombolytic drug to the blood by flowing the thrombolytic drug into the guide catheter;

introducing a supply tube having a heat transfer element at a distal end thereof into the thrombosed blood vessel through the guide catheter; and

cooling the heat transfer element by flowing a working fluid through the heat transfer element, a return path for the working fluid being formed by an outer wall of the supply tube and an inner wall of the guide catheter,

wherein the blood is cooled to a prespecified temperature range by flowing past the heat transfer element.

2. The method of claim 1, wherein the drug is chosen from the group consisting of tPA, urokinase, streptokinase, precursors of urokinase, and combinations thereof.

3. The method of claim 2, wherein the thrombolytic drug is streptokinase and the prespecified temperature range is between about 30°

C. and 32°

C.

4. The method of claim 2, wherein the thrombolytic drug is urokinase and the prespecified temperature range is below about 28°

C.

5. The method of claim 2, wherein the thrombolytic drug is a precursor to urokinase and the prespecified temperature range is below about 28°

C.

6. A method for selective thrombolysis by selective vessel hyperthermia, comprising:

introducing a guide catheter into a thrombosed blood vessel;

delivering a thrombolytic drug to the blood by flowing the thrombolytic drug into the guide catheter;

introducing a supply tube having a heat transfer element at a distal end thereof into the thrombosed blood vessel through the guide catheter; and

heating the heat transfer element by flowing a working fluid through the heat transfer element, a return path for the working fluid being formed by an outer wall of the supply tube and an inner wall of the guide catheter,

wherein the blood is heated to a prespecified temperature range by flowing past the heat transfer element.

7. The method of claim 6, wherein the drug is chosen from the group consisting of tPA, urokinase, streptokinase, precursors of urokinase, and combinations thereof.

8. The method of claim 7, wherein the drug is tPA and the prespecified temperature range is between about 37°

C. to 40°

C.

9. A method for selective thrombolysis by selective vessel hypothermia, comprising:

introducing a guide catheter into a thrombosed blood vessel;

delivering a thrombolytic drug to the blood by flowing the thrombolytic drug into the guide catheter;

introducing a supply tube having a heat transfer element at a distal end thereof into the thrombosed blood vessel through the guide catheter; and

cooling the heat transfer element by flowing a working fluid through the heat transfer element, the working fluid circulating through the interior of the heat transfer element and a return path for the working fluid being formed by an outer wall of the supply tube and an inner wall of the guide catheter,

wherein the blood is cooled to a prespecified temperature range by flowing past the heat transfer element.

10. A method for selective thrombolysis by selective vessel hyperthermia, comprising:

introducing a guide catheter into a thrombosed blood vessel;

delivering a thrombolytic drug to the blood by flowing the thrombolytic drug into the guide catheter;

introducing a supply tube having a heat transfer element at a distal end thereof into the thrombosed blood vessel through the guide catheter; and

heating the heat transfer element by flowing a working fluid through the heat transfer element, the working fluid circulating through the interior of the heat transfer element and a return path for the working fluid being formed by an outer wall of the supply tube and an inner wall of the guide catheter,

wherein the blood is heated to a prespecified temperature range by flowing past the heat transfer element.