Method and apparatus for cardiopulmonary bypass patient temperature control

• US 6,572,640 B1
• Filed: 11/21/2001
• Issued: 06/03/2003
• Est. Priority Date: 11/21/2001
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Alsius Corporation (Asahi Kasei Corporation)
• Inventors: Balding, David P., Worthen, William J.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/990,211
• Time in Patent Office: 559 Days
• Field of Search: 607/96-106, 606/20-27, 604/113-114
• US Class Current: 607/105
• CPC Class Codes: A61F 2007/0288 during operations
• 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

Abstract

A cardiopulmonary bypass patient is precooled using an indwelling catheter. Cardiopulmonary bypass is initiated when a target temperature or range are achieved, as determined by automatic temperature feedback provided to a control module. The patient may also be rewarmed at a controlled rate during or after termination of cardiopulmonary bypass such that faster and safer termination is realized.

Claims

1. A method for treating a patient comprising:

reducing the core body temperature of the patient below normal body temperature by placing a catheter in a blood flow path of the patient and transferring heat from the blood in the blood flow path to the catheter; and

initiating cardiopulmonary bypass of the patient when the core body temperature of the patient is below normal body temperature.

2. The method of claim 1, wherein the core body temperature of the patient is reduced to about 32°

C.

3. The method of claim 1, wherein reducing the core body temperature of the patient further comprises:

determining the core body temperature; and

controlling the rate of heat transfer from the blood in the blood flow path to the catheter based on the determination of core body temperature.

4. The method of claim 1, wherein the catheter is placed in the central venous system of the patient.

5. The method of claim 1, wherein transferring comprises circulating in the catheter a heat exchange fluid having a temperature below the temperature of the blood in the blood flow path.

6. The method of claim 5, wherein circulating comprises:

inflating one or more balloons of the catheter; and

circulating the heat exchange fluid in the inflated one or more balloons.

7. The method of claim 5, wherein the temperature of the heat exchange fluid is about 4°

C.

8. The method of claim 5, wherein reducing the core body temperature of the patient further comprises:

determining the core body temperature; and

controlling the rate of heat transfer from the blood in the blood flow path to the catheter based on the determination of core body temperature.

9. The method of claim 8, wherein controlling comprises selectively removing heat from the heat exchange fluid.

10. The method of claim 1, further comprising:

.

terminating cardiopulmonary bypass when the core body temperature of the patient is below normal body temperature.

11. The method of claim 10, wherein terminating comprises weaning off of bypass.

12. The method of claim 10, wherein terminating comprises discontinuing a blood pumping function of cardiopulmonary bypass.

13. The method of claim 10, wherein terminating comprises removing a cross clamp associated with cardiopulmonary bypass.

14. The method of claim 10, wherein terminating comprises removing a cannula associated with cardiopulmonary bypass.

15. The method of claim 10, wherein terminating comprises closing the chest of the patient.

16. The method of claim 10, wherein terminating is conducted when the core body temperature is about 32°

C.-34°

C.

17. The method of claim 10, further comprising:

increasing the core body temperature of the patient at an operator selected rate.

18. A method for treating a patient comprising:

performing cardiopulmonary bypass of the patient, including lowering the body temperature of the patient to below normal body temperature;

terminating cardiopulmonary bypass of the patient at a core body temperature below normal body temperature; and

during or after terminating cardiopulmonary bypass, selectively adding heat to the patient to thereby raise the core body temperature of the patient, wherein at least one of;

the act of lowering the body temperature, and the act of selectively adding heat to the patient, is undertaken at least in part by placing a catheter in a blood flow path of the patient, and transferring heat between the catheter and the blood in the blood flow path.

19. The method of claim 18, wherein terminating comprises weaning off of bypass.

20. The method of claim 18, wherein terminating comprises discontinuing a blood pumping function of cardiopulmonary bypass.

21. The method of claim 18, wherein terminating comprises removing a cross clamp associated with cardiopulmonary bypass.

22. The method of claim 18, wherein terminating comprises removing a cannula associated with cardiopulmonary bypass.

23. The method of claim 18, wherein terminating comprises closing the chest of the patient.

24. The method of claim 18, wherein terminating is conducted when the core body temperature is about 32°

C.-34°

C.

25. The method of claim 18, wherein selectively adding comprises adding heat at an operator controlled rate.

26. The method of claim 18, wherein selectively adding heat further comprises:

determining the core body temperature; and

controlling the rate of heat transfer from the catheter to the blood in the blood flow path based on the determination of core body temperature.

27. The method of claim 18, wherein the catheter is placed in the central venous system of the patient.

28. The method of claim 18, wherein transferring comprises circulating in the catheter a heat exchange fluid having a temperature above the temperature of the blood in the blood flow path.

29. The method of claim 28, wherein circulating comprises:

inflating one or more balloons of the catheter; and

circulating the heat exchange fluid in the inflated one or more balloons.