Indwelling heat exchange catheter and method of using same

• US 6,126,684 A
• Filed: 04/21/1998
• Issued: 10/03/2000
• Est. Priority Date: 04/21/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation), Regents of the University of California (University of California)
• Original Assignee: California and Alsius Corporation, Regents of the University of California (University of California)
• Inventors: Jones, Mike, Evans, Scott, Gobin, Yves Pierre, Noda, Wayne
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/063,984
• Time in Patent Office: 896 Days
• Field of Search: 607/96, 607/104-106, 607/113, 604/101, 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 exchange heat with a body fluid flowing in a first direction 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 output lumen;

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

the input lumen of the shaft being coupled to the first balloon at a first location, and the output lumen of the shaft being coupled to the first balloon at a second location so that a heat exchange fluid introduced into the input lumen will enter the first balloon at the first location and will exit the first balloon at the second location through the output lumen; and

the first location being disposed in the first direction relative to the second location when the catheter is operatively disposed in the body fluid.

2. The catheter recited in claim 1 wherein the second location is distal of the first location.

3. The catheter recited in claim 1, wherein:

the first balloon is disposed I the heat exchange region and having an outer wall forming the outer surface, the balloon being adapted to receive the heat exchange fluid flowing through the body conduit.

4. The catheter recited in claim 3 wherein:

the first balloon has a first flow of the heat exchange fluid;

this second balloon has a second flow of the heat exchange fluid; and

the first flow of the heat exchange fluid in the first balloon is balanced relative to the second flow of the heat exchange fluid in the second balloon.

5. The catheter recited in claim 4, further comprising:

a covering disposed over at least a portion of the first balloon and a portion of the second balloon to facilitate laminar flow around the catheter.

6. The catheter recited claim 5 wherein in the covering has elastomeric characteristics and comprises a third balloon disposed to cover the first balloon and the second balloon.

7. The catheter recited in claim 4 wherein the first balloon is disposed radially of the second balloon.

8. The catheter recited in claim 4 where in the first balloon and the second balloon are disposed longitudinally of the shaft and axially of each other.

9. The catheter recited in claim 3 wherein the balloon has an inner geometry which promotes mixing of the heat exchange fluid.

10. The catheter recited in claim 3 wherein the balloon has an outer geometry which promotes mixing of the body fluid.

11. The catheter recited in claim 9 wherein the inner geometry is defined at least in part by a spring disposed within the balloon.

12. The catheter recited in claim 11 wherein the spring is disposed generally coaxially of the shaft interiorally of the balloon.

13. The catheter recited in claim 1, further comprising:

a heat pipe disposed in the heat exchange region of the catheter in fluid communication with the input lumen and the output lumen of the shaft.

14. The catheter recited in claim 13, further comprising:

a wick included in the heat pipe, the wick having properties facilitating a flow of the heat exchange fluid between the input lumen and the output lumen of the shaft.

15. The catheter recited in claim 1 wherein the heat exchange region includes:

a balloon having an internal cavity;

first portions of the shaft and defining a first inlet hole extending in fluid communication between the input lumen of the shaft and the internal cavity of the balloon, and a first output hole extending in fluid communication between the output lumen of the shaft and the internal cavity.

16. The catheter recited in claim 15 wherein at least one of the inlet hole and the outlet hole has the configuration of a longitudinal slit.

17. The catheter recited in claim 15 wherein the balloon is a first balloon and the heat exchange region further comprises:

a second balloon having an internal cavity;

second portions of the shaft defining a second inlet hole extending between the input lumen of the shaft and the internal cavity of the second balloon, and an output hole extending in fluid communication between the output lumen of the shaft and the interior cavity of the second balloon;

the first outlet hole is larger than the first inlet hole; and

the second outlet hole is larger than the second inlet hole.

18. The catheter recited in claim 1 further comprising:

a coating disposed over at least a portion of the catheter and having thromboresistant characteristics.

19. The catheter recited in claim 18 wherein the coating includes an anticoagulant.

20. The catheter recited in claim 18 wherein the coating is adapted to receive an electrical charge providing the thromboresistant properties to the coating.

21. A heat exchange catheter, comprising:

a shaft having an axis, a fluid inlet lumen, and a fluid outlet lumen each extending generally between a proximal end and a distal end of the shaft;

a hub disposed at the proximal end of the shaft and providing access to the fluid inlet lumen and the fluid outlet lumen;

a first balloon disposed at the distal end of the shaft and defining with the shaft an inflatable first cavity;

portions of the shaft define a first inlet hole extending in fluid communication between the fluid inlet lumen of the shaft and the first cavity of the first balloon;

portions of the shaft defining a first outlet hole extending in fluid communication between the first cavity and the fluid outlet lumen of the shaft;

a second balloon disposed relative to the first balloon at the distal end of the shaft and defining with the shaft an inflatable second cavity;

portions of the shaft defining a second inlet hole extending in fluid communication with the fluid inlet lumen of the shaft and the second cavity of the balloon; and

portions of the shaft defining a second outlet hole extending in fluid communication with the second cavity and the fluid outlet lumen.

22. The heat exchange catheter recited in claim 21 wherein the first balloon is disposed axially of the second balloon.

23. The heat exchange catheter recited in claim 22 wherein:

the first balloon is disposed distally of the second balloon; and

the first inlet hole is larger than the second inlet hole.

24. The heat exchange catheter recited in claim 21 wherein the first balloon is disposed radially of the second balloon.

25. The heat exchange catheter recited in claim 24 wherein the first outlet hole is larger than the first inlet hole.

26. The heat exchange catheter recited in claim 24 wherein the first inlet hole is disposed distally of the first outlet hole.

27. The catheter recited in claim 21 wherein portions of the catheter are provided with properties including thromboresistance.

28. The catheter recited in claim 27 wherein the thromboresistance properties are provided in the form of a coating having thromboresistant characteristics.

29. The catheter recited in claim 28 wherein the coating includes an anticoagulant.

30. The catheter recited in claim 27 wherein the thromboresistant properties are provided in the form of an electrical charge on the portions of the catheter.

31. A heat exchange catheter, comprising:

a shaft having an axis, a fluid inlet lumen, and a fluid outlet lumen each extending generally between a proximal end and a distal end of the shaft;

a hub disposed at the proximal end of the shaft and providing access to the fluid inlet lumen and the fluid outlet lumen;

a first balloon disposed at the distal end of the shaft and defining with the shaft an inflatable first cavity;

portions of the shaft define a first inlet hole extending in fluid communication between the fluid inlet lumen of the shaft and the first cavity of the first balloon;

a second balloon disposed relative to the first balloon at the distal end of the shaft and defining with the shaft an inflatable second cavity;

portions of the shaft defining a second outlet hole extending in fluid communication with the second cavity and the fluid outlet lumen; and

an elastomeric coating disposed to cover a volume between the first balloon and the second balloon to facilitate laminar flow around the catheter.

32. A heat exchange catheter, comprising:

a shaft having an axis, a fluid inlet lumen, and a fluid outlet lumen each extending generally between a proximal end and a distal end of the shaft;

a hub disposed at the proximal end of the shaft and providing access to the fluid inlet lumen and the fluid outlet lumen;

a first balloon disposed at the distal end of the shaft and defining with the shaft an inflatable first cavity;

portions of the shaft define a first inlet hole extending in fluid communication between the fluid inlet lumen of the shaft and the first cavity of the first balloon;

portions of the shaft defining a first outlet hole extending in fluid communication between the first cavity and the fluid outlet lumen of the shaft;

a second balloon disposed radially of the first balloon at the distal end of the shaft and defining with the shaft an inflatable second cavity;

portions of the shaft defining a second inlet hole extending in fluid communication with the fluid inlet lumen of the shaft and the second cavity of the balloon; and

portions of the shaft defining a second outlet hole extending in fluid communication with the second cavity and the fluid outlet lumen.

33. 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 output lumen;

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

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.

34. The catheter recited in claim 33, further comprising:

a first manifold included in the heat exchange region and being in fluid communication with the input lumen of the shaft;

a second manifold included in the heat exchange region and included in fluid communication with the output lumen of the shaft; and

the hollow fibers extending between the first manifold and the second manifold in the heat exchange region of the catheter.

35. A heat exchange catheter, comprising:

a shaft having an axis, a fluid inlet lumen, and a fluid outlet lumen each extending generally between a proximal end and a distal end of the shaft;

a hub disposed at the proximal end of the shaft and providing access to the fluid inlet lumen and the fluid outlet lumen;

a first balloon disposed at the distal end of the shaft and defining with the shaft an inflatable first cavity;

portions of the shaft define a first inlet hole extending in fluid communication between the fluid inlet lumen of the shaft defining a first outlet hole extending in fluid communication between the first cavity and the fluid outlet hole extending in fluid communication between the first cavity and the fluid outlet lumen of the shaft, the first outlet hole being larger than the first inlet hole;

a second balloon disposed axially of the first balloon at the distal end of the shaft and defining with the shaft an inflatable second cavity;

portions of the shaft defining a second inlet hole extending in fluid communication with the fluid inlet lumen of the shaft and the second cavity of the balloon; and

portions of the shaft defining a second outlet hole extending in fluid communication with the second cavity and the fluid outlet lumen, the second outlet hole being larger than the second inlet hole.