Indwelling heat exchange catheter and method of using same

• US 6,893,419 B2
• Filed: 09/04/2001
• Issued: 05/17/2005
• Est. Priority Date: 04/21/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Alsius Corporation
• Inventors: Gobin, Yves Pierre, Worthen, William J., Walker, Blair D., Jones, Mike L., Evans, Scott M., Noda, Wayne A.
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US09/946,835
• Publication Number:
  US 20020049409A1
• Time in Patent Office: 1,351 Days
• Field of Search: 604/43, 604/22, 604104- 6, 604113- 14, 604/170, 604/264, 604/291, 604/523, 604/531, 604/538, 604/6.13, 422 44- 48, 606 21- 28, 607/96, 607/98, 607104-107, 607113- 14
• US Class Current: 604/113
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• 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
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: A61P 7/12 Antidiuretics, e.g. drugs for diabetes insipidus ADH A61P5/10

Abstract

A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Claims

1. A catheter having an elongate configuration with a proximal end and a distal end, the catheter configured to contain a heat exchange fluid in heat exchange relationship with at least a portion of the body of a patient and comprising:

an outer tube having an elongate configuration and a first lumen;

an inner tube disposed in the first lumen of the outer tube and having a second lumen extending between the proximal end and the distal end of the catheter;

portions of the inner tube defining a first heat exchange fluid flow path extending along the second lumen between the proximal end and the distal end of the catheter;

portions of the outer tube and the inner tube defining a second heat exchange fluid flow path extending between the proximal end and the distal end of the catheter; and

a plurality of hollow fibers having walls defining lumens for containing the heat exchange fluid, the hollow fibers being sealingly coupled to the first heat exchange fluid flow path and the second heat exchange fluid flow path to thereby provide a closed fluid connection between the first fluid flow path and the second fluid flow path for transport of heat exchange fluid between the first fluid flow path and the second fluid flow path, the heat exchange fluid being a circulating liquid.

2. The catheter cited in claim 1, wherein:

each of the hollow fibers has a proximal end and a distal end;

the distal end of each of the hollow fibers has a fixed relationship with the distal end of the inner tube; and

the proximal end of each of the hollow fibers has a fixed relationship with the distal end of the inner tube.

3. The catheter of claim 1 further comprising:

a cap disposed over the distal ends of the inner tube and the hollow fibers.

4. The catheter recited in claim 1, wherein the hollow fibers are adapted to receive a heat exchange fluid from the first flow path and to release the heat exchange fluid into the second flow path.

5. The catheter recited in claim 1, wherein the hollow fibers are adapted to receive a heat exchange fluid from the second flow path and to release the heat exchange fluid into the first flow path.

6. A catheter adapted to exchange heat with a body fluid flowing through a body conduit, the catheter comprising:

a shaft having an axis extending between a proximal end and a distal end, the shaft having an input lumen and an output lumen, the shaft further including an inner tube disposed within an outer tube;

a heat exchange region disposed at the distal end of the shaft and including a plurality of hollow fibers each having an outer surface adapted to be operatively placed in heat exchange relationship with the body fluid flowing in the first direction;

the hollow fibers being disposed in fluid communication with the input lumen and the output lumen to facilitate a flow of heat exchange fluid through the hollow fibers to cool the body fluid in the conduit without allowing the heat exchange fluid to enter the bloodstream;

a first manifold and a second manifold; and

the hollow fibers being coupled to the inner tube at the first manifold and to the outer tube at the second manifold.

7. A catheter adapted to exchange heat with fluid flowing through a blood vessel, comprising;

a catheter body having at least one heat exchange fluid supply lumen and at least one heat exchange fluid return lumen; and

plurality of elongated hollow heat exchange elements communicating with the supply lumen and with the return lumen, each element defining an outer heat exchange surface across which heat can be exchanged with a fluid flowing in the blood vessel, a heat exchange liquid circulating through the catheter without mixing with blood in the blood vessel.

8. The catheter recited in claim 7, wherein each heat exchange element defines a respective proximal end and a respective distal end, and the proximal and distal ends of the elements are connected to the catheter body.

9. The catheter of claim 8, wherein the distal ends of the heat exchange elements are connected to a distal manifold communicating with the supply lumen.

10. The catheter of claim 9, wherein the supply lumen is centrally formed in the catheter body.

11. The catheter of claim 8, wherein each heat exchange element defines a respective element body between the respective proximal and distal ends, the element body being spaced from the catheter body.

12. The catheter recited in claim 7, wherein each heat exchange element defines a respective proximal end and a respective distal end, and the distal ends receive heat exchange fluid from the supply lumen and the proximal ends return heat exchange fluid to the return lumen.

13. The catheter of claim 12, wherein the supply lumen is centrally formed in the catheter body.

14. The catheter of claim 13, wherein each heat exchange element defines a respective element body between the respective proximal and distal ends, the element body being spaced from the catheter body.

15. The catheter of claim 12, wherein each heat exchange element defines a respective element body between the respective proximal and distal ends, the element body being spaced from the catheter body.

16. The catheter of claim 7, wherein the supply lumen is centrally formed in the catheter body.

17. The catheter of claim 16, wherein each heat exchange element defines a respective proximal end, a respective distal end, and an element body therebetween, the element body being spaced from the catheter body.

18. The catheter of claim 7, wherein each heat exchange element defines a respective proximal end, a respective distal end, and an element body therebetween, the element body being spaced from the catheter body.

19. The catheter of claim 7, wherein each heat exchange element is made of a flexible material.