Indwelling heat exchange catheter and method of using same

• US 6,416,533 B1
• Filed: 04/11/2000
• Issued: 07/09/2002
• Est. Priority Date: 04/21/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Alsius Corporation (Asahi Kasei Corporation), Regents of the University of California (University of California)
• Inventors: Jones, Michael, Gobin, Yves Pierre, Evans, Scott M., Noda, Wayne A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/546,814
• Time in Patent Office: 819 Days
• Field of Search: 607/104, 607/105, 607/106, 607/113, 607/107, 606/20-26, 604/113
• US Class Current: 607/113
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

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 at least one balloon which is adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. Embodiments including multiple balloons enhance the surface area of contact, and the mixing of both the heat exchange and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body without cooling the entire body system. It is of particular advantage in brain surgeries where stroke, trauma or cryogenic tumors can best be addressed under hypothermic conditions.

Claims

1. A catheter adapted to be disposed in a body conduit to facilitate an exchange of heat between the catheter and a body fluid flowing in the body conduit, comprising:

a shaft having an axis, a first lumen, and a second lumen each extending generally between a proximal end and a distal end of the shaft;

a first sheet material disposed to define a first cavity exteriorly of the shaft;

a second sheet material disposed to define a second cavity exteriorly of the shaft;

portions of the shaft defining separate inlet holes providing fluid communication between the first lumen and each of the first cavity and the second cavity;

portions of the shaft defining separate outlet holes providing fluid communication between the second lumen and each of the first cavity and the second cavity;

whereby

a heat exchange fluid can be introduced into the first lumen and through the inlet and outlet holes to and from the first and second cavities to facilitate the exchange of heat with the body fluid flowing in the body conduit.

2. The catheter recited in claim 1 wherein the body conduit is a vessel and the body fluid is blood.

3. The catheter recited in claim 2 wherein the vessel is an artery and the catheter is adapted to be operatively positioned in the artery with the blood flowing distally along the distal end of the catheter.

4. The catheter recited in claim 3 wherein the inlet hole is disposed distally of the outlet hole in the first cavity.

5. The catheter recited in claim 4 wherein the inlet hole associated with the first cavity is larger than the inlet hole associated with the second cavity.

6. The catheter recited in claim 2 wherein the vessel is a vein and the catheter is adapted to be operatively positioned within the vein with the blood flowing proximally along distal end of the catheter.

7. The catheter recited in claim 6 wherein the inlet hole is disposed proximally of the outlet hole in the first cavity.

8. The catheter recited in claim 7 wherein the inlet hole associated with the first cavity is larger than the inlet hole associated with the second cavity.

9. The catheter recited in claim 1 wherein the first cavity is formed by a first balloon extending circumferentially of the shaft;

the second cavity is formed by a second balloon extending circumferentially of the shaft distally of the first balloon.

10. A method for exchanging heat with a body fluid in a body conduit, comprising the steps of:

introducing into the body conduit a catheter having an inlet lumen and an outlet lumen;

providing the catheter with a first cavity and a second cavity in heat transfer relationship with the body fluid in the body conduit;

introducing a heat exchange fluid into the inlet lumen through an inlet hole and into the first cavity;

exchanging heat between the heat exchange fluid and the body fluid in the body conduit; and

removing the heat exchange fluid from each of the first cavity and the second cavity through an outlet hole and the outlet lumen.

11. The method recited in claim 10 wherein the introducing step includes the step of introducing the catheter into the body conduit in the direction of flow of the body fluid.

12. The method recited in claim 10 wherein the body conduit is an artery and the body fluid is blood.

13. The method recited in claim 10 wherein the introducing step includes the step of introducing the catheter into the body conduit against the direction of flow of the body fluid.

14. The method recited in claim 13 wherein the providing step includes the step of positioning the inlet hole proximally of the outlet hole.

15. The method recited in claim 10 wherein the providing step includes the step of forming the outlet hole larger than the inlet hole.

16. The method recited in claim 10 wherein the providing step includes the step of positioning the outlet hole proximal of the inlet hole.

17. The method recited in claim 10 wherein the providing step further comprises the step of positioning a first balloon exteriorly of the inlet lumen and the outlet lumen to form the first cavity.

18. The method recited in claim 17 wherein the providing step further comprises the steps of:

positioning a second balloon exteriorly of the inlet lumen and the outlet lumen to form the second cavity; and

positioning a third balloon to cover the first balloon and the second balloon.

19. The method recited in claim 10 wherein the step of exchanging heat includes the step of withdrawing heat from the body fluid to cool the body fluid.