Method and device for applications of selective organ cooling

• US 6,491,716 B2
• Filed: 02/09/1999
• Issued: 12/10/2002
• 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): Kearney, Rosiland S.
• Application Number:
  US09/246,788
• Publication Number:
  US 20020007202A1
• Time in Patent Office: 1,400 Days
• Field of Search: 607/105, 607/106, 607/104, 606/20, 606/21, 606/22, 606/23, 604/93, 604/52, 604/53, 165/142, 165/179, 165/181, 165/184
• US Class Current: 607/105
• 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 2007/0056 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 heating or cooling a surrounding fluid in a feeding vessel. The device includes a catheter assembly capable of insertion to a selected feeding vessel in the vascular system of a patient. The assembly includes a heat transfer element at a distal end of the catheter assembly, the heat transfer element having a plurality of exterior surface irregularities shaped and arranged to create turbulence in a surrounding fluid, the surface irregularities having a depth at least equal to the boundary layer thickness of flow of the surrounding fluid in the feeding vessel. The assembly also includes a supply catheter to deliver a working fluid to an interior of the heat transfer element, a return catheter to return a working fluid from the interior of the heat transfer element, and a drug delivery catheter running substantially parallel to the axis of the catheter assembly. The method includes selectively controlling the temperature of a selected volume of blood in a patient by introducing a catheter assembly into a blood vessel feeding a selected volume of blood in a patient and delivering a working fluid through a supply catheter in the catheter assembly and returning the working fluid through a return catheter in the catheter assembly. Heat is transferred between a heat transfer element forming a distal end of the catheter assembly and the volume of blood in the feeding vessel. A liquid, such as a drug, is delivered through a drug delivery catheter to the volume of blood in the feeding vessel.

Claims

1. A device for heating or cooling blood in a blood vessel, comprising:

a catheter assembly capable of insertion to a selected vessel in the vascular system of a patient, including;

a heat transfer element at a distal end of the catheter assembly, the heat transfer element having a helical shape to create mixing, the mixing occurring in surrounding blood and in a working fluid, the two mixings caused by the shapes of opposite sides of the same heat transfer surface;

a supply catheter to deliver the working fluid to an interior of the heat transfer element;

a return catheter to return the working fluid from the interior of the heat transfer element; and

a drug delivery catheter running substantially parallel to the axis of the catheter assembly.

2. The device of claim 1, wherein the drug delivery catheter is disposed substantially coaxially with respect to the supply catheter.

3. The device of claim 2, wherein the drug delivery catheter includes an outlet at a distal end thereof, the distal end of the drug delivery catheter distal of a distal end of the return or supply catheters.

4. The device of claim 1, wherein the drug delivery catheter is disposed within one of the return catheter or the supply catheter or both.

5. The device of claim 4, wherein the drug delivery catheter includes an outlet transverse to the axis of the catheter assembly.

6. The device of claim 1, further comprising at least one sealed lumen within one of the return catheter or the supply catheter or both, the sealed lumen in pressure communication with a supply of air to inflate the sealed lumen.

7. The device of claim 1, wherein the return catheter is coaxial with the supply catheter, and the return catheter has a larger radius than the supply catheter.

8. The device of claim 1, wherein the return catheter is coaxial with the supply catheter, and the return catheter has a smaller radius than the supply catheter.

9. A device for beating or cooling blood in a blood vessel, comprising:

a catheter assembly capable of insertion to a selected vessel in the vascular system of a patient, including;

a heat transfer element at a distal end of the catheter assembly, the heat transfer element having a helical shape to create mixing, the mixing occurring in surrounding blood and in a working fluid, the two mixings caused by the shapes of opposite sides of the same heat transfer surface, a distal end of the heat transfer element defining an orifice;

a supply catheter to deliver the working fluid to an interior of the heat transfer element, the supply catheter having a working fluid catheter disposed therein and further having disposed therein a drug delivery catheter running substantially parallel to the axis of the supply catheter, the working fluid catheter having defined thereon a number of outlets to communicate the working fluid from the interior of the supply catheter to a volume defined by the exterior of the supply catheter and the interior of the heat transfer element; and

a return catheter to return the working fluid from the interior of the heat transfer element.

10. A method for selectively controlling the temperature of a selected volume of tissue in a patient, comprising:

introducing a catheter assembly into a blood vessel feeding a selected volume of tissue in a patient;

delivering a working fluid through a supply catheter in the catheter assembly and returning the working fluid through a return catheter in the catheter assembly;

transferring heat between a heat transfer element forming a distal end of the catheter assembly and the blood in the feeding vessel by creating mixing, the mixing occurring in surrounding blood and in a working fluid, the two mixings caused by the shapes of opposite sides of the same heat transfer surface;

delivering a liquid through a drug delivery catheter to the blood in the feeding vessel.

11. The method of claim 10, wherein the liquid is a warm enzyme solution.

12. The method of claim 11, where the warm enzyme solution is selected from the group consisting of tPA, streptokinase, urokinase, pro-urokinase, and combinations thereof.

13. The method of claim 10, further comprising delivering air to at least one sealed lumen within the return catheter to cause the sealed lumen to enlarge.

14. The method of claim 13, further comprising delivering air in a pulsatile fashion to the at least one sealed lumen within the return catheter to cause the sealed lumen to repeatedly enlarge and contract.

15. The method of claim 10, further comprising delivering the liquid to the volume in a longitudinal direction with respect to the axis of the catheter assembly.

16. The method of claim 15, further comprising delivering the liquid to the volume distal of the distal tip of the catheter assembly.

17. The method of claim 16, wherein the volume of blood includes a blood clot, and during the delivering the liquid the distal tip of the catheter assembly is substantially near, adjacent, or embedded in the blood clot.

18. The method of claim 15, further comprising delivering the liquid proximal of the distal tip of the catheter assembly.

19. The method of claim 10, further comprising delivering the liquid to the volume in a transverse direction with respect to the axis of the catheter assembly.