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

• US 10,085,880 B2
• Filed: 06/20/2011
• Issued: 10/02/2018
• Est. Priority Date: 02/28/2000
• Status: Expired due to Fees

• Current Assignee: ZELL Circulation Incorporated
• Original Assignee: ZELL Circulation Incorporated
• Inventors: Machold, Timothy R., Keller, Wade A., Roth, Alex T., Bloom, Nicole Denise
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Avigan, Adam
• Application Number:
  US13/164,648
• Publication Number:
  US 20120095536A1
• Time in Patent Office: 2,661 Days
• Field of Search: 607104-106
• 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 conduits 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 15″ 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, for example, 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. A system for controlling the rate of change of a patient'"'"'s body temperature using a heat transfer catheter and associated controller, comprising:

a heat transfer catheter for insertion into a body cavity, the heat transfer catheter having a heat transfer region disposed thereon and in fluid communication with a heat exchange unit having a pump head having a toothed head gear;

a sensor for sensing the patient'"'"'s body temperature, the sensor providing a signal representative of the patient'"'"'s body temperature;

a housing configured to removably receive the heat exchange unit, the housing including a pump motor and a toothed drive gear actuated by the pump motor, the teeth of the drive gear being engaged with the teeth of the head gear of the heat exchange unit only when the heat exchange unit is received by the housing;

an input for selecting a target temperature of the patient;

a controller in communication with the input to receive the inputted target temperature, and also in communication with the sensor to receive the signal representative of the patient'"'"'s body temperature, the controller also in communication with the heat transfer catheter via fluid conduits, the controller being adapted to increase or decrease the amount of heat being added to or removed from the body cavity by the heat transfer catheter in response to the signal received from the sensor, the controller configured to select a ramp rate equal to a selected time rate of change of temperature from the sensed patient'"'"'s body temperature to the target temperature, to monitor the temperature differential between the target temperature and the body temperature, to sample the sensor signal and monitor the temperature differential at a rate of multiple times per minute, and to control the ramp rate by adjusting the speed of a fluid circulating through the heat transfer catheter by adjusting the speed of the motor in accordance with the monitored temperature differential as the patient'"'"'s body temperature approaches the target temperature.

2. The system of claim 1, wherein the heat transfer catheter and conduits define a fluid circulation path therethrough.

3. The system of claim 1, further comprising a sensor for directly or indirectly sensing the temperature of the circulating fluid.

4. The system of claim 3, wherein the controller is further configured to compare the target temperature and the temperature of the circulating fluid and to use the comparison to adjust the temperature of the circulating fluid.

5. The system of claim 1, wherein the controller includes a microprocessor.

6. The system of claim 1, further comprising an input for inputting a selected ramp rate.

7. The system of claim 1, wherein the heat exchange unit is a cassette.