System and method for determining and controlling core body temperatue

• US 8,435,278 B2
• Filed: 01/23/2012
• Issued: 05/07/2013
• Est. Priority Date: 09/12/2002
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Callister, Jeffrey, Stull, Paul M., Wu, Andrew E., Scott, David J.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US13/356,538
• Publication Number:
  US 20120191166A1
• Time in Patent Office: 470 Days
• Field of Search: 607104-106, 607/113
• US Class Current: 607/105
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0086 with a thermostat
• 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 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: G05D 23/1925 using a combination of auxiliary electric and non-electric power

Abstract

Systems and methods for accurate temperature modification of a patient, or selected regions thereof, including inducing 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 attached to the circulatory flow lines of the catheter, the heat exchange cassette being sized to engage a cavity within a control unit. A temperature measurement scheme for obtaining body core temperature is provided, including methods of obtaining and analyzing temperature data to provide feedback to the control unit for use in controlling the heating and cooling of the heat exchange medium so as to heat or cool a patient to a desired target temperature.

Claims

1. A heat transfer catheter system, comprising:

a heat transfer catheter insertable into a patient;

a heat exchange unit having a fluid pathway therewithin and incorporating an integral pump head adapted to move fluid through the fluid pathway;

conduits coupled to the heat transfer catheter and heat exchange unit that enable circulation of a heat exchange medium therebetween upon operation of the pump head;

a diverter unit that periodically redirects the fluid pathway, bypassing the heat transfer catheter; and

a master control unit having a heater/cooler and a pump driver, the heat exchange unit being adapted to couple to the master control unit such that the pump driver engages the integral pump head and so that the fluid pathway is in thermal communication with the heater/cooler, the master control unit controlling the diverter unit to periodically interrupt fluid circulation within the heat exchange unit and the heat transfer catheter, the master control unit configured

to receive a target temperature input from an input device and a sensor signal from a temperature sensor,

to analyze the signal from the sensor during the fluid flow interruption to determine a rate of change of the temperature as a function of time,

to compare the determined temperature to a target temperature,

to restart the flow of heat exchange medium through the heat transfer catheter, and

to control the rate at which the patient temperature approaches the target temperature by controlling the heater/cooler to add or remove thermal energy from the heat exchange medium.

2. The system of claim 1, wherein the diverter unit is a diverter valve activated by the controller.

3. The system of claim 1, wherein the diverter unit is a flow actuated valve.

4. The system of claim 1, wherein the master control unit defines a cavity into which the heat exchange unit couples.

5. The system of claim 1, wherein the heater/cooler comprises a thermoelectric heater/cooler.

6. The system of claim 1, further including a plurality of sensors supplying patient data to the master control unit, the master control unit being adapted to operate the heater/cooler based on the supplied patient data.

7. The controller of claim 1 wherein the master control unit comprises a microprocessor responsive to each of the sensors to control the heater/cooler.

8. A system for regulating the temperature of at least a portion of a patient'"'"'s body, comprising:

a heat remover;

a heat exchange catheter for insertion into a lumen of the patient'"'"'s body, the heat exchange catheter having conduits that enable circulation of a heat exchange medium between a heat exchange portion of the catheter and the heat remover for removing thermal energy from the heat exchange medium;

a temperature sensor disposed in the lumen downstream of the heat exchange catheter for providing temperature signals representative of the temperature of body fluid flowing through the lumen; and

a controller including a processor and a memory, the processor capable of being programmed by software to

sample the temperature signals at a selected interval,

determine a peak temperature value occurring during the selected interval and store that determined value in a memory of the controller,

increment the selected range of selected intervals a selected number of times and, after each increment, repeating determining the peak temperature value sampled within the incremented selected range of selected intervals and storing that value, and

calculate a dynamic offset value as follows;

9. The system of claim 8, wherein the temperature sensor is configured to move within the lumen in response to the flow of body fluid within the lumen.