Dual balloon central venous line catheter temperature control system

• US 6,299,599 B1
• Filed: 10/27/1999
• Issued: 10/09/2001
• Est. Priority Date: 02/19/1999
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Alsius Corporation (Asahi Kasei Corporation)
• Inventors: Walker, Blair D., Evans, Scott M., Shimada, Lynn M., Pham, Nora Tran
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/427,745
• Time in Patent Office: 713 Days
• Field of Search: 604/113, 604/96.01, 604/101.01, 604/101.05, 604/101.03, 604/97.01, 604/99.01, 604/99.02, 607/96, 607/104, 607/105, 607/106
• US Class Current: 604/113
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• 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 5/44 having means for cooling or heating the devices or media

Abstract

A system for controlling patient temperature uses a central venous line catheter having axially spaced distal and proximal heat exchange balloons. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the balloons. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Claims

1. A heat exchange catheter comprising:

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

at least a distal balloon and a proximal balloon on the catheter body, the balloons and lumens being arranged such that heat exchange fluid flows serially through the balloons.

2. The catheter of claim 1, further comprising an intermediate fluid pathway between the distal and proximal balloons and a heat exchange fluid inlet port formed in the supply lumen, the inlet port allowing heat exchange fluid to flow into the distal balloon and intermediate fluid pathway.

3. The catheter of claim 2, further comprising an occlusion in the heat exchange fluid return lumen, the occlusion causing heat exchange fluid to flow from the distal balloon into the proximal balloon.

4. The catheter of claim 1, further comprising first and second access lumens terminating in respective first and second access ports communicating with the exterior of the catheter, the access ports being axially spaced from each other.

5. The catheter of claim 4, wherein the catheter is provided with a distal tip, the first access port being disposed at the distal tip and the second access port being disposed between the distal and proximal balloons.

6. A central venous line catheter comprising:

a substantially elongate structure configured for establishing venous access, said structure having a proximal portion and a distal portion and defining at least a first access lumen in communication with the exterior of the structure at said proximal and distal portions;

a proximal and a distal balloon disposed axially along the substantially elongate structure, the proximal and distal balloons adapted to effect heat exchange with the central venous system;

a heat exchange fluid supply lumen in fluid communication with the distal balloon;

a heat exchange fluid return lumen in fluid communication with the proximal balloon;

wherein a serial fluid flow path is established from the distal balloon to the proximal balloon such that fluid flows from the supply lumen, to the distal balloon, a segment of the return lumen, then to the proximal balloon, then to the remainder of a return lumen.

7. The catheter of claim 6, further comprising an occlusion for preventing fluid flow between the segment of the return lumen and the remainder of the return lumen.

8. The catheter of claim 6, further comprising a second access lumen in communication with the exterior of the structure at said proximal and distal portions.

9. The catheter of claim 8, wherein the first and second access lumens are in fluid communication with the exterior of the substantially elongate structure at respective first and second access ports, the first access port being disposed distally of the distal balloon and the second access port being disposed proximally of the distal balloon.

10. The catheter of claim 9, wherein the second access port is disposed distally of the proximal balloon.

11. A patient temperature control system comprising:

a central venous line catheter having a proximal portion and a distal portion and defining at least a first access lumen in communication with the exterior of the catheter at the proximal and distal portions;

a proximal and a distal balloon disposed axially along the central venous line catheter, the proximal and distal balloons adapted to effect heat exchange with the central venous system;

a heat exchange fluid supply lumen in fluid communication with the distal balloon;

a heat exchange fluid return lumen in fluid communication with the proximal balloon; and

a temperature control unit for providing heat exchange fluid to the heat exchange fluid supply lumen and for receiving heat exchange fluid from the heat exchange fluid return lumen, the heat exchange control unit adapted to change the temperature of a heat exchange fluid circulated in the proximal and distal balloons,

wherein a serial fluid flow path is established between the proximal and distal balloons.

12. The patient temperature control system of claim 11, further comprising at least one probe for sensing patient temperature, the temperature control unit automatically changing the temperature of the heat exchange fluid in accordance with the sensed patient temperature.

13. The patient temperature control system of claim 12, further comprising a temperature controller for activating the temperature control unit when patient temperature deviates from a predetermined range.

14. The patient temperature control system of claim 12, wherein the temperature control unit comprises at least one cooling device for cooling the heat exchange fluid.

15. The patient temperature control system of claim 12, wherein the temperature control unit comprises at least one heating device for heating the heat exchange fluid.

16. The patient temperature control system of claim 11, further comprising at least one tubing set in fluid communication with the heat exchange fluid supply and return lumens and the temperature control unit, the tubing set delivering fluid between the central venous line catheter and the temperature control unit.

17. The patient temperature control system of claim 11, further comprising means for providing an indication of patient temperature change.

18. The patient temperature control system of claim 11, further comprising at least one central venous line catheter anchor engaged with the catheter and including structure configured to affix the catheter to the patient.

19. The patient temperature control system of claim 11, wherein a serial fluid flow path is established from the distal balloon to the proximal balloon such that fluid flows from the supply lumen, to the distal balloon, then to a segment of the return lumen, then to the proximal balloon, then to the remainder of a return lumen.

20. The catheter of claim 19, further comprising an occlusion for preventing fluid flow between the segment of the return lumen and the remainder of the return lumen.

21. The catheter of claim 11, further comprising a second access lumen in communication with the exterior of the central venous line catheter at said proximal and distal portions.

22. The catheter of claim 21, wherein the first and second access lumens are in fluid communication with the exterior of the central venous line catheter at respective first and second access ports, the first access port being disposed distally of the distal balloon and the second access port being disposed proximally of the distal balloon.

23. The catheter of claim 22 wherein the second access port is disposed distally of the proximal balloon.

24. A heat exchange catheter comprising:

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

a first coolant tube in communication with said fluid supply lumen;

a second coolant tube in communication with said fluid return lumen;

at least two balloons on said catheter body, said balloons and said fluid supply lumen and said fluid return lumen being arranged such that heat exchange fluid flows serially through said balloons;

at least one infusing tube connected to said catheter body; and

a clamp engaged with said infusing tube, said clamp for selectively blocking fluid flow through said infusing tube.

25. The heat exchange catheter of claim 24 wherein said coolant tubes are constructed from a first material, and said infusing tube is constructed from a second material being more compressible than said first material.

26. The heat exchange catheter of claim 24 wherein:

said coolant tubes further comprises coolant tubing walls;

said infusing tube further comprises infusing tubing walls; and

said coolant tubing walls are thicker than said infusing tubing walls.

27. A heat exchange catheter comprising:

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

a first coolant tube in communication with said fluid supply lumen, said first coolant tube being constructed of a first material;

a second coolant tube in communication with said return lumen, said second coolant tube being constructed of said first material;

at least two balloons on the catheter body, said balloons and said fluid supply lumen and said return lumen being arranged such that heat exchange fluid flows serially through said balloons; and

at least one infusing tube connected to said catheter body, said infusing tube is constructed of a second material being more compressible than said first material.

28. The heat exchange catheter of claim 27 further comprises a clamp in communication with said infusing tube, said clamp for selectively blocking fluid flow through said infusing tube.

29. The heat exchange catheter of claim 27 wherein said first material is thicker than said second material.

30. The heat exchange catheter of claim 27 wherein said catheter body further comprises at least one balloon, said balloon communicating with said coolant tubes.