Method and system for control of a patient's body temperature by way of a transluminally insertable heat exchange catheter

• US 20070191918A1
• Filed: 08/20/2003
• Published: 08/16/2007
• Est. Priority Date: 02/28/2000
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Roth, Alex, Keller, Wade, Bloom, Nicole, MacHold, Timothy
• Granted Patent: US 7,963,986 B2
• Time in Patent Office: Days
• US Class Current: 607/105
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• 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 7/0097 Blankets with active heating or cooling sources warming mats A61F7/08
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

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 of any one of several disclosed variations is attached to the circulatory flow lines of the catheter, the heat exchange cassette being sized to engage a cavity within one of various described re-usable control units. The control units include a heater/cooler device, a user input device, and a processor connected to receive input from various sensors around the body and the system. The heater/cooler device may be thermoelectric to enable both heating and cooling based on polarity. A temperature control scheme for ramping the body temperature up or down without overshoot is provided. The disposable heat exchange cassettes may include an integral pump head that engages with a pump drive mechanism within the re-usable control unit. More than one control unit may be provided to receive the same heat exchange cassette so that a large capacity control unit can be used initially, and a smaller, battery-powered unit can be substituted once the patient reaches the desired target temperature.

Claims

1-29. -29. (canceled)

30. A method of controlling the rate of change of a patient'"'"'s body temperature using a heat transfer catheter and associated controller, comprising:

providing a heat transfer catheter for insertion into a body cavity, the heat transfer catheter having a heat transfer region thereon;

sensing the patient'"'"'s body temperature in the body cavity or in another location;

determining the temperature of the catheter heat transfer region;

providing a controller in communication with the heat transfer catheter via conduits, the controller being adapted to elevate or depress the temperature of the catheter heat transfer region relative to the body temperature;

selecting a target temperature different than the body temperature;

selecting a ramp rate equal to the time rate of change of temperature from the body temperature to the target temperature;

setting the temperature of the catheter heat transfer region based on the ramp rate;

monitoring the temperature differential between the target temperature and the body temperature; and

reducing the ramp rate when the temperature differential reduces below a predetermined threshold.

31. The method of claim 30, wherein the heat transfer catheter and conduits define a fluid circulation path therethrough, and wherein the step of setting the temperature of the catheter heat transfer region comprises setting the temperature of a circulating fluid within the fluid circulation path.

32. The method of claim 31, wherein the step of determining the temperature of the catheter heat transfer region comprises sensing the temperature of the circulating fluid.

33. The method of claim 32, further including comparing the target temperature and the temperature of the circulating fluid and using the comparison to adjust the temperature of the circulating fluid.

34. The method of claim 30, wherein the controller includes a microprocessor, and wherein the steps of monitoring and reducing are accomplished automatically by the microprocessor.

35. The method of claim 30, wherein steps of sensing, determining, and monitoring are accomplished at rates of multiple times a second.

36. The method of claim 30, further including:

providing operator inputs for the controller to enable manual adjustment of the target temperature and the ramp rate.