Method and apparatus for controlling a patient's body temperature by in situ blood temperature modification

• US 5,837,003 A
• Filed: 01/11/1996
• Issued: 11/17/1998
• Est. Priority Date: 02/10/1993
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Ginsburg, Robert
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/584,013
• Time in Patent Office: 1,041 Days
• Field of Search: 607/96, 607/104-112, 607/113, 607/114, 607/115, 606/27-32
• US Class Current: 607/106
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00084 Temperature
• 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: A61B 2018/00095 high, i.e. heat conducting
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0086 with a thermostat
• 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 7/007 characterised by electric heating
• 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 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: H10K 2102/3031 : Two-side emission, e.g. transparent OLEDs [TOLED]
• CPC Class Codes: H10K 2102/351 : Thickness
• CPC Class Codes: H10K 50/165 : comprising dopants
• CPC Class Codes: H10K 50/171 : Electron injection layers
• CPC Class Codes: H10K 50/18 : Carrier blocking layers
• CPC Class Codes: H10K 50/828 : Transparent cathodes, e.g. comprising thin metal layers
• CPC Class Codes: H10K 85/311 : Phthalocyanine
• CPC Class Codes: H10K 85/324 : comprising aluminium, e.g. Alq3

Abstract

The present invention provides a method and apparatus for controlling the internal body temperature of a patient. According to the present invention, a catheter is inserted through an incision into a large blood vessel of a patient. By selectively heating or cooling a portion of the catheter lying within the blood vessel, heat may be transferred to or from blood flowing within the vessel and the patient'"'"'s body temperature may thereby be increased or decreased as desired. The invention will find use in treating undesirable conditions of hypothermia and hyperthermia, or for inducing a condition of artificial hypothermia when desired. The method and system further provide for the cooling of initially hypothermic patients whose blood or body temperature has been warmed above the desired target level and the warming of initially hyperthermic patients whose blood or body temperature has been cooled below the desired target temperature.

Claims

1. A method for restoring normal body temperature to a patient having a body temperature above or below normal body temperature, said method comprising;

selectively introducing heat to the blood flow for a hypothermic patient having a body temperature that is below normal body temperature or removing heat from the blood flow from a hyperthermic patient having a body temperature that is above normal body temperature;

monitoring a temperature characteristic of the hypothermic or hyperthermic patient to detect indication of temperature overshoot; and

selectively removing heat through a catheter from the blood flow of the initially hypothermic patient to lower the patient'"'"'s core body temperature if the temperature characteristic indicates that the patient has or will become hyperthermic, wherein the catheter includes a region that is in contact with the blood, and the region is at a temperature below normal body temperature, or introducing heat through the catheter to the blood flow of the initially hyperthermic patient to raise the patient'"'"'s core body temperature if the temperature characteristic indicates that the patient has or will become hypothermic, wherein the catheter includes a region that is in contact with the blood, and the region is at a temperature above normal body temperature.

2. A method as in claim 1, wherein the heat is transferred via the catheter which is inserted into a blood vessel selected from the group consisting of the femoral artery, the jugular artery, and the jugular vein.

3. A method as in claim 1, wherein the heat introducing step comprises directing current through a resistance heater near the distal end of the catheter, passing radiofrequency current from the distal end of the catheter through the blood, circulating a heated medium through a heat exchanger near the distal end of the catheter, or directing light energy through a wave guide to the distal end of the catheter.

4. A method as in claim 3, wherein the heat introducing step after monitoring the temperature characteristic comprises directing current through a resistance heater near the distal end of the catheter, passing radiofrequency current from the distal end of the catheter through the blood, circulating a heated medium through a heat exchanger near the distal end of the catheter, or directing light energy through a wave guide to the distal end of the catheter.

5. A method as in claim 1, wherein the heat removing steps comprise removing heat at a rate between 1 W and 100 W.

6. A method as in claim 5, wherein the heat removing step after monitoring the temperature characteristic comprises (a) engaging a proximal end of the catheter against a cooler in order to conductively remove heat from a distal portion of the catheter along a heat conductive path on the catheter and to the cooler or (b) circulating a cooling fluid from the proximal end of the catheter, through a distal portion of the catheter, and back to the proximal end.

7. A method as in claim 5, wherein the heat removing step after monitoring the temperature characteristic comprises (a) engaging a proximal end of the catheter against a cooler in order to conductively remove heat from a distal portion of the catheter along a heat conductive path on the catheter and to the cooler or (b) circulating a cooling fluid from the proximal end of the catheter, through a distal portion of the catheter, and back to the proximal end.

8. A method as in claim 1, wherein the temperature characteristic monitoring step comprises monitoring at least one of body temperature and blood temperature.

9. A method as in claim 1, wherein the surface temperature of the heating surface is maintained below 42°

C.

10. A method as in claim 1, wherein blood is being heated, wherein heating is stopped when the blood temperature reaches 36.9°

C.

11. A method as in claim 1, wherein blood is being cooled, wherein cooling is stopped when the blood temperature drops to 36.9°

C.

12. A method for restoring normal body temperature to a patient having a body temperature above or below normal body temperature, said method comprising:

introducing into the blood stream a catheter which can selectively add heat to or remove heat from the blood by heating a heating region of the catheter to a temperature above normal body temperature or cooling a cooling region of the catheter to a temperature below normal body temperature;

selectively introducing heat to the blood flow of a hypothermic patient by heating the heating region of the catheter to a temperature above normal body temperature or removing heat from the blood flow of a hyperthermic patient by cooling the cooling region of the catheter to a temperature below normal body temperature;

monitoring body temperature and blood temperature of the hypothermic or hyperthermic patient; and

selectively removing heat through the catheter from the blood flow of the initially hypothermic patient if the body temperature and blood temperature indicate that the patient has or will become hyperthermic or introducing heat through the catheter to the blood flow of the initially hyperthermic patient if the body temperature and blood temperature indicate that the patient has or will become hypothermic.

13. A method as in claim 12, herein the heat introducing steps comprise introducing heat at a rate between 10 W and 250 W.

14. A method as in claim 13, wherein the heat introducing step after monitoring the temperature characteristic comprises directing current through a resistance heater near the distal end of the catheter, passing radiofrequency current from the distal end of the catheter through the blood, circulating a heated medium through a heat exchanger near the distal end of the catheter, or directing light energy through a wave guide to the distal end of the catheter.

15. A method as in claim 12, wherein the heat removing steps comprise removing heat at a rate between 1 W and 100 W.

16. A method as in claim 12, wherein the surface temperature of the heating surface is maintained below 42°

C.

17. A method as in claim 12, wherein blood is being heated, wherein heating is stopped when the blood temperature reaches 36.9°

C.

18. A method as in claim 12, wherein blood is being cooled, wherein cooling is stopped when the blood temperature drops to 36.9°

C.

19. A method as in claim 12, wherein the heating region is heated to a temperature in the range from about 40 degrees C. to about 42 degrees C., and wherein the cooling region is cooled to a temperature in the range from about 0 degrees C. to about 35 degrees C.