Method and device for applications of selective organ cooling

• US 6,475,231 B2
• Filed: 01/05/2001
• Issued: 11/05/2002
• 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): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/755,919
• Publication Number:
  US 20010001831A1
• Time in Patent Office: 669 Days
• Field of Search: 607/96, 607/104, 607/105, 607/106, 607/113, 128/898, 606/191, 606/192, 606/194, 606/198
• 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 performing stenting of a stenotic lesion during selective vessel hypothermia, comprising:

introducing a guide catheter into a blood vessel;

introducing a guide wire through the guide catheter and across a stenotic lesion;

delivering a balloon catheter loaded with a stent via the guide wire;

positioning the stent across the lesion;

expanding the balloon;

deploying the stent;

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

cooling the heat transfer element, by flowing a working fluid through the heat transfer element,

wherein the heat transfer element is not used to deploy the stent, and

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

2. The method of claim 1, wherein the heat element has a plurality of exterior surface irregularities, the surface irregularities having a depth greater than the boundary layer thickness of flow in the blood vessel.

3. The method of claim 2, further comprising the step of:

creating turbulence around the surface irregularities at a distance from the heat transfer element greater than the boundary layer thickness of flow in the blood vessel, thereby creating turbulence throughout the blood flow in the blood vessel.

4. The method of claim 3, wherein:

the surface irregularities on the heat transfer element comprise a plurality of segments of helical ridges and grooves having alternating directions of helical rotation; and

turbulence is created by establishing repetitively alternating directions of helical blood flow with the alternating helical rotations of the ridges and grooves.

5. The method of claim 1, wherein the step of introducing a supply tube having a heat transfer element occurs at or near the same time as the step of deploying the stent.

6. The method of claim 1, wherein the step of introducing a supply tube having a heat transfer element occurs after the step of deploying the stent.