Apparatus and method for providing enhanced heat transfer from a body

• US 7,806,915 B2
• Filed: 04/27/2006
• Issued: 10/05/2010
• Est. Priority Date: 04/27/2005
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Scott, David J., Brian, Ben F., Logan, Mark A., Chin, Leo A., Wright, Lloyd F., Hollmen, Edward W., Seegars, Daniel W.
• Primary Examiner(s): Farah; Ahmed M
• Application Number:
  US11/413,564
• Publication Number:
  US 20060293734A1
• Time in Patent Office: 1,622 Days
• Field of Search: 607/96, 607/102, 607104-107, 604 27- 30, 604/93.01, 604/113, 604506-508
• US Class Current: 607/106
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• 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: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2205/3372 Temperature compensation
• CPC Class Codes: F28D 2021/005 for medical applications heating or cooling appliances for medical treatment A61F7/00
• CPC Class Codes: F28F 2280/02 Removable elements

Abstract

Methods and apparatuses for temperature modification of a patient, or selected regions thereof, including an induced state of hypothermia. The temperature modification is accomplished using an in-dwelling heat exchange catheter within which a fluid heat exchange medium circulates. A heat exchange cassette is attached to the circulatory conduits of the catheter, the heat exchange cassette being sized to engage a cavity within a control unit. The control unit includes a heater/cooler device for providing heated or cooled fluid to a heat exchanger in thermal communication with the fluid heat exchange medium circulating to the heat exchange catheter, a user input device, and a processor connected to receive input from various sensors around the body and the system. A temperature control scheme for ramping the body temperature up or down without overshoot is provided.

Claims

1. A system for adjusting the temperature of a patient, comprising:

a primary fluid circuit, the circuit including;

a primary fluid circuit pump,

heater/cooler,

primary fluid circuit lines connecting the primary fluid circuit pump to the heater/cooler such that a continuous flow path for circulating primary fluid from the pump to the heater/cooler and back to the heater/cooler is formed;

access points in the primary fluid circuit, the access points fluidly connecting the primary fluid circuit to a primary fluid circuit side of a heat exchanger, the heat exchanger also having a secondary fluid circuit side;

a heat exchange catheter insertable within a patient, the catheter configured to increase, decrease or maintain the temperature of the patient;

a secondary fluid circuit for flowing secondary fluid through the secondary circuit side of the heat exchanger and the heat exchange catheter, the secondary fluid circuit including a secondary fluid circuit pump for flowing a secondary heat exchange fluid through the secondary fluid circuit to the heat exchange catheter and back through the secondary fluid circuit to the secondary fluid pump;

at least one fluid sensor configured to provide a signal representative of a temperature of the primary or secondary fluid circuit;

a patient sensor configured to provide a signal representative of a temperature of the patient;

a controller configured to receive the signals from the patient sensor and the primary fluid sensor and being responsive to the signals to control the heater/cooler to adjust the temperature of the fluid flowing within the fluid circuits.

2. The system of claim 1, wherein the controller includes a microprocessor configured to be responsive to sensors and to provide control signals as needed to control the operation of the system.

3. The system of claim 2, further comprising:

a power supply for supplying power to the system, including the heater/cooler;

controller circuitry for controlling the operation of the system, the controller circuitry including means for determining if the power supply is operative and operating within parameters determined to be appropriate, means for monitoring the operation of the system, means for determining an error state of the monitored system, and means for alerting an operator of the presence of an error state.

4. The system of claim 2, further comprising a secondary fluid reservoir in fluid communication with the secondary fluid circuit.

5. The system of claim 4, wherein the secondary fluid reservoir includes an air trap disposed between an inlet to the reservoir and the secondary fluid circuit pump.

6. The system of claim 5, wherein the air trap is a semi-permeable member permitting at least a portion of the secondary fluid to flow through the semi-permeable member.

7. The system of claim 5, wherein the air trap is formed from foam.

8. The system of claim 1, wherein the controller controls the heater/cooler to drive the temperature of the fluid in the primary fluid circuit towards a predetermined temperature prior to fluidly connecting the heat exchanger to the primary fluid circuit.

9. The system of claim 1, wherein the controller controls the heater/cooler to drive the temperature of the fluid in the primary fluid circuit towards a predetermined temperature prior to initiation of treatment of a patient.

10. The system of claim 1, wherein the primary fluid circuit includes temperature sensors disposed in the primary fluid circuit, the temperature sensors providing signals representative of the temperature of the primary fluid passing through the access points flowing into and out of the primary fluid circuit side of the heat exchanger.

11. The system of claim 10, wherein the temperature difference between the fluid flowing into and out of the primary fluid circuit side of the heat exchanger is proportional to the heat exchange being delivered to the secondary fluid circuit, and is representative of the heat exchange being delivered to the patient.

12. The system of claim 10, wherein the controller is responsive to the signals provided by the temperature sensors to determine the difference in the temperature of the primary fluid flowing into and out of the access points, and to provide an alert if the determined difference is indicative of a problem condition.

13. The system of claim 10, wherein the controller is responsive to the signals provided by the temperature sensors to provide an alert if the signals are indicative of a problem condition.

14. The system of claim 10, wherein a duty cycle of the heater/cooler is reduced when the controller determines that the sensed temperature is within a predetermined range for a predetermined amount of time.

15. The system of claim 1, further comprising a primary fluid reservoir in fluid communication with the primary fluid circuit.

16. The system of claim 1, wherein the secondary fluid circuit contains a particulate filter.

17. The system of claim 16, wherein the particulate filter is a semi-permeable member permitting at least a portion of the secondary fluid to flow through the semi-permeable member.

18. The system of claim 16, wherein the particulate filter is formed from foam.

19. The system of claim 16, wherein the particulate filter is a screen.

20. The system of claim 1, further comprising a level detector disposed in the secondary fluid circuit to detect a level of the fluid within the secondary fluid circuit, the level detector providing a signal representative of the level of fluid in the secondary fluid circuit to the controller.

21. The system of claim 20, wherein the level detector is disposed in cooperation with the secondary fluid reservoir to detect a level of the fluid within the secondary fluid reservoir.

22. The system of claim 20, wherein the controller sends a start signal to the secondary fluid pump in response to a signal from the level detector representative of a predetermined fluid level.

23. The system of claim 20, wherein the controller sends a stop signal to the secondary fluid pump in response to a signal from the level detector representative of a predetermined low fluid level.

24. The system of claim 20, wherein the level detector is a bubble detector.

25. The system of claim 20, wherein the level detector is an air in line detector.

26. The system of claim 1, wherein the secondary fluid circuit pump and secondary fluid reservoir and heat exchanger are included in a cassette configuration that is provided in a sterile condition.

27. The system of claim 26, further comprising a reusable housing in which are disposed the primary fluid reservoir, primary fluid circuit pump, microprocessor and a secondary fluid circuit pump motor, the housing being configured to removably receive the cassette such that the secondary fluid circuit pump releasably engages the secondary fluid circuit pump motor.

28. The system of claim 26, wherein the cassette and catheter may be disconnected from the primary fluid circuit and connected to a different primary circuit without compromising sterility or fluid isolation of the secondary fluid circuit of the cassette and catheter.

29. The system of claim 1, wherein the access points include releasable couplers for releasably coupling the heat exchanger to the primary fluid circuit.

30. The system of claim 29, wherein the releasable couplers fluidly seal when not connected to the primary fluid circuit to minimize primary fluid loss from the primary fluid circuit side of the heat exchanger and the primary fluid circuit.

31. The system of claim 1, wherein the primary fluid circuit further comprises a check valve for controlling a fluid pressure within the primary fluid circuit such that the fluid pressure does not exceed a predetermined value.

32. The system of claim 1, wherein a duty cycle of the heater/cooler is reduced when the controller determines that a sensed temperature is within a predetermined range.

33. The system of claim 1, wherein a duty cycle of the primary and/or secondary fluid pump is reduced when the controller determines that a sensed temperature is within a predetermined range.

34. The system of claim 1, wherein a duty cycle of the primary and/or secondary pump is reduced when the controller determines that demand for patient temperature change is reduced.

35. The system of claim 1, wherein the primary fluid circuit is configured such that the majority of volume of primary fluid contained with the heat exchanger is recovered to a primary fluid reservoir prior to disconnection of the heat exchanger from the primary fluid circuit.

36. The system of claim 1, wherein the heat exchanger is provided to the operator with the primary fluid side pre-filled with primary fluid.

37. The system of claim 36, wherein the means includes a sensor configured to sense an electrical characteristic of the fluid within the fluid circuit.

38. The system of claim 1, wherein the heat exchanger is provided with the secondary fluid side pre-filled with secondary fluid.

39. The system of claim 1, wherein the primary fluid circuit includes a means for maintaining an electrical conductivity at a value below a predetermined value.

40. The system of claim 1, further comprising a priming fluid circuit for providing secondary heat exchange fluid to the secondary fluid circuit.

41. The system of claim 40, wherein the priming fluid circuit includes a prime line and a vent line, at least of one of the prime line and vent line having a valve, and at least one sensor for determining when the secondary circuit is sufficiently filled with fluid.

42. The system of claim 41, wherein at least one of the valves in the prime line and vent line is a clamp that engages the line to obstruct fluid flow in the line.

43. The system of claim 42, wherein the at least one of the valves in the prime line and vent line are controlled by the controller to initiate and complete filling the secondary fluid circuit with secondary fluid.

44. The system of claim 1, wherein the access points are configured to receive primary circuit fluid to fill a primary fluid reservoir.

45. The system of claim 1, wherein the controller controls the temperature of the primary fluid circuit at a level sufficient to prevent freezing of the secondary fluid in the secondary fluid circuit.

46. The system of claim 1, wherein the primary fluid side of the heat exchanger is a primary intermediate fluid pathway and the secondary fluid side of the heat exchanger is a secondary intermediate fluid pathway.

47. The system of claim 46, wherein the primary fluid circuit has a volume, and the volume is increased when the primary intermediate fluid pathway is placed in fluid communication with the primary fluid circuit.

48. The system of claim 1, wherein the secondary side of the heat exchanger has releasable couplings for coupling and uncoupling the secondary side of the heat exchanger with a heat exchange catheter circulating heat exchange fluid therethrough.