Method and apparatus for regional and whole body temperature modification

• US 8,551,151 B2
• Filed: 05/04/2011
• Issued: 10/08/2013
• Est. Priority Date: 08/24/1998
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Machold, Timothy R., Bloom, Nicole Denise, Roth, Alex T., Scott, Dave J., Alejandro, Jose, Oliver, Edward A.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US13/101,000
• Publication Number:
  US 20110208278A1
• Time in Patent Office: 888 Days
• Field of Search: 607/105
• US Class Current: 607/105
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: F28D 1/0341 with U-flow or serpentine-flow inside the conduits
• CPC Class Codes: F28D 2021/005 for medical applications heating or cooling appliances for medical treatment A61F7/00
• CPC Class Codes: F28F 3/12 Elements constructed in the shape of a hollow panel, e.g. with channels F28D1/02, F28D1/03 take precedence
• CPC Class Codes: F28F 9/0246 Arrangements for connecting header boxes with flow lines

Abstract

A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure.

Claims

1. A system for maintaining or changing the temperature of at least a portion of the body of a subject, comprising:

a disposable heat exchange catheter having at least one recirculating-fluid-type intracorporeal heat exchanger, the disposable heat exchange catheter being insertable into the vasculature of the subject such that the heat exchanger is in contact with blood flowing within the vasculature;

a disposable extracorporeal heat exchanger configured to be fluidly coupled to the disposable heat exchange catheter;

a disposable pump head in fluid communication with the disposable heat exchange catheter and the extracorporeal heat exchanger, the disposable pump head, extracorporeal heat exchanger and disposable heat exchange catheter providing a disposable fluid circuit through which heat exchange fluid flows;

a heater/cooler device in thermal communication with the disposable extracorporeal heat exchanger, the heater/cooler device configured to add heat to the heat exchange fluid or subtract heat from the heat exchange fluid flowing through the disposable extracorporeal heat exchanger;

at least one sensor configured for placement within an organ or vessel of the subject'"'"'s body for monitoring the temperature within the organ or vessel, the at least one sensor providing signals representative of the monitored temperature of the organ or vessel;

a reservoir disposed between and in fluid communication with the external heat exchanger and the pump head; and

a controller configured to control the heater/cooler device, including a pumping of the heat exchange fluid, in response to the signals provided by the at least one sensor to maintain or change the temperature of at least a portion of the subject.

2. The system of claim 1, wherein the controller and heater/cooler device are reusable.

3. The system of claim 1, wherein the pump head is selected from the group consisting of a screw pump, a gear pump, diaphragm pump, and a peristaltic roller pump.

4. The system of claim 1, wherein heat exchange fluid flows through the extracorporeal heat exchanger along a serpentine pathway.

5. The system of claim 1, wherein the disposable heat exchange catheter is a balloon catheter.

6. The system of claim 1, wherein the controller controls the heater/cooler device in response to the signals from the at least one sensor to change the temperature of at least a portion of the subject'"'"'s body to a target temperature.

7. The system of claim 6, wherein the controller controls the heater/cooler device in response to the signals from the at least one sensor to maintain the temperature of at least a portion of the subject'"'"'s body at the target temperature.

8. The system of claim 1, wherein the controller is programmed using software commands and selected operating parameters to control the heater/cooler device.

9. The system of claim 8, further comprising an input device for inputting at least one of the selected operating parameters.

10. The system of claim 9, wherein the at least one of the selected operating parameters is a target temperature.

11. The system of claim 9, wherein the input device provides for inputting an upper variance set point temperature and a lower variance set point temperature.

12. The system of claim 6, wherein the controller controls the heater/cooler device to maintain the temperature of the at least a portion of the subject'"'"'s body within a buffer range of temperatures, the buffer range being based on the target temperature.

13. The system of claim 12, wherein the buffer range includes a upper variance set point temperature and a lower variance set point temperature.

14. The system of claim 1, further comprising a disposable fluid source in fluid communication with the fluid circuit for providing heat exchange fluid to the fluid circuit.

15. The system of claim 14, wherein the disposable fluid source is an IV bag.

16. The system of claim 14, wherein the disposable fluid source is disposed above a horizontal level selected from the group of horizontal levels defined by the group consisting of the subject, the extracorporeal heat exchanger and the pump head.

17. The system of claim 1, wherein the disposable fluid circuit, the at least one sensor and the controller are configured for use in a treatment area of a health care institution.

18. The system of claim 1, wherein the disposable fluid circuit, the at least one sensor and the controller are configured for use outside of a treatment area of a health care institution.

19. The system of claim 1, wherein the disposable fluid circuit, the at least one sensor and the controller are configured for use in an ambulance.

20. The system of claim 1, wherein the at least one sensor is selected from the group consisting of a temperature probe for the head, temperature probe for the brain, a rectal temperature probe, an ear temperature probe and a bladder temperature probe.

21. The system of claim 1, wherein the at least one sensor is a solid state thermocouple.

22. The system of claim 1, further comprising at least one other sensor for monitoring a condition selected from the group consisting of a heart rate of the subject, a temperature from a different location than that sensed by the at least one sensor, a pressure within the disposable fluid circuit and a pressure within the subject, the at least one other sensor in operable communication with the controller, and wherein the controller receives signals from the at least one other sensor.

23. The system of claim 1, wherein the at least one sensor is reusable.

24. The system of claim 1, wherein the at least one sensor is disposable.

25. The system of claim 1, wherein the fluid circuit is disposable.

26. A system for maintaining or changing the temperature of at least a portion of the body of a subject, comprising:

a disposable heat exchange catheter having at least one recirculating-fluid-type intracorporeal heat exchanger, the disposable heat exchange catheter being insertable into the vasculature of the subject such that the heat exchanger is in contact with blood flowing within the vasculature;

a disposable extracorporeal heat exchanger configured to be fluidly coupled to the disposable heat exchange catheter;

a reusable pump head in fluid communication with the disposable heat exchange catheter and the extracorporeal heat exchanger, the reusable pump head, extracorporeal heat exchanger and disposable heat exchange catheter providing a fluid circuit through which heat exchange fluid flows;

a heater/cooler device in thermal communication with the disposable extracorporeal heat exchanger, the heater/cooler device configured to add heat to the heat exchange fluid or subtract heat from the heat exchange fluid flowing through the disposable extracorporeal heat exchanger;

at least one disposable sensor configured for placement within an organ of the subject'"'"'s body for monitoring the temperature of the organ, the at least one disposable sensor providing signals representative of the monitored temperature of the organ;

a reservoir disposed between and in fluid communication with the external heat exchanger and the pump head; and

a controller configured to control the heater/cooler device, including a pumping of the heat exchange fluid, in response to the signals provided by the at least one disposable sensor to maintain or change the temperature of at least a portion of the subject.

27. The system of claim 26, wherein the fluid circuit, the at least one sensor and the controller are configured for use in a treatment area of a health care institution.

28. The system of claim 26, wherein the fluid circuit, the at least one sensor and the controller are configured for use outside of a treatment area of a health care institution.

29. The system of claim 26, wherein the fluid circuit, at least one sensor and the controller are configured for use in an ambulance.

30. The system of claim 26, wherein the at least one sensor is selected from the group consisting of a temperature probe for the head, temperature probe for the brain, a rectal temperature probe, an ear temperature probe and a bladder temperature probe.

31. The system of claim 26, wherein the at least one sensor is a solid state thermocouple.

32. The system of claim 26, further comprising at least one other sensor for monitoring a condition selected from the group consisting of a heart rate of the subject, a temperature from a different location than that sensed by the at least one sensor, a pressure within the fluid circuit and a pressure within the subject, the at least one other sensor in operable communication with the controller, and wherein the controller receives signals from the at least one other sensor.