System for controlling body temperature of a patient

• US 6,635,076 B1
• Filed: 12/04/2001
• Issued: 10/21/2003
• Est. Priority Date: 01/08/1996
• 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:
  US10/004,579
• Time in Patent Office: 686 Days
• Field of Search: 607/96, 607/104-107, 607/108, 607/712, 607/114, 607/113
• US Class Current: 607/96
• 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 system for controlling body temperature of a patient, said system comprising:

an intravascular catheter that is insertable into a blood vessel, the catheter having at least one heat exchanger which has at least one heat exchange surface capable of alternately introducing heat into and removing heat from blood flowing through the blood vessel;

a temperature sensor positioned on or in the patient'"'"'s body; and

,

a control unit that receives temperature information from the temperature sensor and, in response to said temperature information, selectively causes heat to be a) delivered through the heat exchange surface into the blood or b) absorbed through the heat exchange surface from the blood, thereby maintaining the temperature of at least a portion of the patient'"'"'s body within a target temperature range;

wherein the control unit is programed such that, when the system is being used to cool a patient who'"'"'s body temperature is initially hyperthermic, the control unit will cause heat to be absorbed through the heat exchange surface from the blood until the temperature monitored by the temperature sensor has decreased to about 36.9°

C. at which time the absorption of heat through the heat exchange surface from the blood is stopped; and

wherein the control unit is further programed such that, if the temperature sensed by the temperature sensor continues to fall to a temperature of 36°

C. or below, the controller will then cause heat to be delivered through the heat exchange surface and into the blood.

2. A system according to claim 1 wherein the temperature of the heat exchange surface, when heat is being absorbed through the heat exchange surface from the blood, is between 0°

C. and 30°

C.

3. A system according to claim 2 wherein the temperature of the heat exchange surface, when heat is being absorbed through the heat exchange surface from the blood, is between about 20°

C. and 24°

C.

4. A system according to claim 1 further comprising a resistance heater for warming the blood and wherein the heat exchange surface comprises a metal foil.

5. A system according to claim 4, wherein the resistance heater comprises a coil and the metal foil has an exposed area of at least 2 cm².

6. A system according to claim 4, wherein the control unit comprises an electrical current source connectable to the resistance heater and a thermoelectric cooler connectable to the metal foil.

7. A system according to claim 1, wherein the heat exchanger comprises a flowing fluid heat exchanger through which a heated or cooled heat exchange fluid is circulated and wherein the control unit comprises a heater for heating the heat exchange fluid and a cooler for cooling the heat exchange fluid.

8. A system according to claim 7, wherein the cooler is a thermoelectric cooler.

9. A system according to claim 7, wherein the heater is a thermoelectric heater.

10. A system according to claim 7, wherein the heater and cooler comprise a thermoelectric heater/cooler that alternately heats or cools the heat exchange fluid.

11. A system according to claim 7 wherein the catheter has lumens through which heat exchange fluid is circulated through the heat exchanger.

12. A system according to claim 1, wherein the temperature sensor is located on the catheter and measures blood temperature.

13. A system according to claim 1, wherein the temperature sensor is separate from the catheter.

14. A system according to claim 1, wherein the heat exchange surface is a flexible metal surface.

15. A system according to claim 1 wherein the at least one heat exchange surface comprises a substantially single surface through which heat is alternately introduced into the blood or removed from the blood.

16. A system according to claim 1 wherein the control unit, when causing to be delivered through the heat exchange surface into the blood, causes heat to be delivered through said heat exchange surface at a rate of 50 W-250 W.

17. A system according to claim 16 wherein the control unit, when causing to be delivered through the heat exchange surface into the blood, causes heat to be delivered through said heat exchange surface at a rate of 1-100 W.

18. A system according to claim 1 wherein the control unit, when causing to be absorbed through the heat exchange surface into the blood, causes heat to be absorbed through said heat exchange surface at a rate from 1 W to 100 W.

19. A system according to claim 1 wherein the control unit is programed such that, when the system is being used to cool a patient who'"'"'s body temperature is initially hyperthermic, the control unit will cause heat to be absorbed through the heat exchange surface from the blood until the temperature monitored by the temperature sensor has decreased to about 36.9°

C. at which time the absorption of heat through the heat exchange surface from the blood is stopped.

20. A system according to claim 19 wherein the control unit is further programed such that, if the temperature sensed by the temperature sensor continues to fall to a temperature of 36°

C. or below, the controller will then cause heat to be delivered through the heat exchange surface and into the blood.

21. A system according to claim 1 wherein the control unit is programed such that, when the system is being used to warm a patient who'"'"'s body temperature is initially hypothermic, the control unit will cause heat to be delivered through the heat exchange surface and into the blood until the temperature monitored by the temperature sensor has increased to about 36.9°

C. at which time the delivery of heat through the heat exchange surface and into the blood is stopped.

22. A system according to claim 21 wherein the control unit is further programed such that, if the temperature sensed by the temperature sensor continues to rise to a temperature of 39°

C. or above, the controller will then cause heat to be absorbed through the heat exchange surface from the blood.

23. A system for controlling the temperature of all or part of the body of a human or veterinary patient, said system comprising:

a heat exchange catheter that has a heat transfer region, said heat transfer region being configured for placement in contact with blood flowing through the patient'"'"'s vasculature to heat or cool the blood;

a temperature sensor located on said catheter, said temperature sensor generating a signal which corresponds to a sensed temperature;

a controller which receives a) a desired temperature and b) the signal which corresponds to the sensed temperature and, in response thereto, causes the heat transfer region to either heat or cool the patient'"'"'s blood as necessary to attain the desired temperature.

24. A system according to claim 23 wherein the temperature sensor is located distal to the heat exchange region.

25. A system according to claim 23 wherein there are a plurality of temperature sensors located on said catheter, each of said temperature sensors generating a signal which corresponds to a sensed temperature.

26. A system according to claim 23 wherein the temperature sensor is positioned so as to sense the temperature of blood.

27. A system according to claim 23 wherein the temperature sensor is positioned to sense body temperature of the patient.

28. A system according to claim 23 wherein there are a plurality of temperature sensors, at least one temperature sensor being located proximal to the heat exchange region and at least one temperature sensor being located distal to the heat exchange region.

29. A system according to claim 23 wherein the temperature sensor is located on the heat exchange region.

30. A system according to claim 29 wherein the temperature sensor is operative to sense the temperature of the heat exchange region.

31. A system according to claim 23 wherein the temperature of the heat transfer region has a temperature of between 0°

C. and 30°

C. when the system is cooling the patient'"'"'s blood.

32. A system according to claim 23 wherein the heat transfer region comprises a resistance heater and a heat transfer surface through which heat is transferred into the blood.

33. A system according to claim 32, wherein the resistance heater comprises a coil.

34. A system according to claim 23 wherein the heat exchange region comprises a heat transfer surface which is formed at least in part of a metal foil.

35. A system according to claim 23 wherein the heat exchange region comprises a heat transfer surface through which heat is exchanged with the patient'"'"'s blood, said heat transfer surface having an area of at least 2 cm².

36. A system according to claim 23, wherein the heat exchange region comprises a flowing fluid heat exchanger through which a heated or cooled heat exchange fluid is circulated and wherein the system further comprises a heater for heating the heat exchange fluid and a cooler for cooling the heat exchange fluid.

37. A system according to claim 36, wherein the cooler is a thermoelectric cooler.

38. A system according to claim 36, wherein the heater is a thermoelectric heater.

39. A system according to claim 36 wherein the heater and cooler comprise a thermoelectric heater/cooler that alternately heats or cools the heat exchange fluid.

40. A system according to claim 36, wherein the heater and cooler are connected to and controlled by the controller.

41. A system according to claim 36 wherein the catheter has lumens through which heat exchange fluid is circulated through the flowing fluid heat exchanger.

42. A system according to claim 23 wherein the heat exchange region comprises one continuous heat exchange surface through which heat is alternately introduced into the blood or removed from the blood.

43. A system according to claim 23 wherein the heat exchange region comprises a heat exchange surface which has a temperature between about 20°

C. and about 24°

C. when the system is cooling the patient'"'"'s blood.

44. A system according to claim 23 wherein the controller causes heat to be delivered through said heat exchange region and into the blood a rate of 50 W-250 W when the system is warming the patient'"'"'s blood.

45. A system according to claim 44 wherein the controller causes heat to be delivered through said heat exchange region and into the blood a rate of about 1-100 W when the system is warming the patient'"'"'s blood.

46. A system according to claim 44 wherein the controller causes the heat exchange region to absorb heat from the blood at a rate of about 1-100 W when the system is cooling the patient'"'"'s blood.

47. A system according to claim 23 wherein the temperature sensor senses a body temperature of the patient and wherein the controller is programed such that, when the system is being used to warm a patient who'"'"'s body temperature is initially hypothermic, the controller will cause heat to be delivered through the heat exchange region and into the blood until the body temperature sensed by the temperature sensor has increased to about 36.9°

C. at which time the delivery of heat through the heat exchange region is at least temporarily stopped.

48. A system according to claim 46 wherein the controller is further programed such that, if the body temperature sensed by the temperature sensor rises above about 39°

C., the controller will then cause the system to cool the patient'"'"'s blood.

49. A system for controlling body temperature of a patient, said system comprising:

an intravascular catheter that is insertable into a blood vessel, the catheter having at least one heat exchanger which has at least one heat exchange surface capable of alternately introducing heat into and removing heat from blood flowing through the blood vessel;

a temperature sensor positioned on or in the patient'"'"'s body; and

,

a control unit that receives temperature information from the temperature sensor and, in response to said temperature information, selectively causes heat to be a) delivered through the heat exchange surface into the blood or b) absorbed through the heat exchange surface from the blood, thereby maintaining the temperature of at least a portion of the patient'"'"'s body within a target temperature range;

wherein the control unit is programed such that, when the system is being used to warm a patient who'"'"'s body temperature is initially hypothermic, the control unit will cause heat to be delivered through the heat exchange surface and into the blood until the temperature monitored by the temperature sensor has increased to about 36.9°

C. at which time the delivery of heat through the heat exchange surface and into the blood is stopped; and

wherein the control unit is further programed such that, if the temperature sensed by the temperature sensor continues to rise to a temperature of 39°

C. or above, the controller will then cause heat to be absorbed through the heat exchange surface from the blood.

50. A system according to claim 49 wherein the temperature of the heat exchange surface, when heat is being absorbed through the heat exchange surface from the blood, is between 0°

C. and 30°

C.

51. A system according to claim 49 further comprising a resistance heater for heating the blood and wherein the heat exchange surface comprises a metal foil.

52. A system according to claim 51, wherein the resistance heater comprises a coil and the metal foil has an exposed area of at least 2 cm².

53. A system according to claim 51, wherein the control unit comprises an electrical current source connectable to the resistance heater and a thermoelectric cooler connectable to the metal foil.

54. A system according to claim 49, wherein the heat exchanger comprises a flowing fluid heat exchanger through which a heated or cooled heat exchange fluid is circulated and wherein the control unit comprises a heater for heating the heat exchange fluid and a cooler for cooling the heat exchange fluid.

55. A system according to claim 54, wherein the cooler is a thermoelectric cooler.

56. A system according to claim 54, wherein the heater is a thermoelectric heater.

57. A system according to claim 54 wherein the heater and cooler comprise a thermoelectric heater/cooler that alternately heats or cools the heat exchange fluid.

58. A system according to claim 49, wherein the temperature sensor is located on the catheter and measures blood temperature.

59. A system according to claim 49, wherein the temperature sensor is separate from the catheter.

60. A system according to claim 49 wherein the heat exchange surface is a flexible metal surface.

61. A system according to claim 49 wherein the at least one heat exchange surface comprises a substantially single surface through which heat is alternately introduced into the blood or removed from the blood.

62. A system according to claim 49 wherein the catheter has lumens through which heat exchange fluid is circulated through the heat exchanger.

63. A system according to claim 49 wherein the temperature of the heat exchange surface, when heat is being absorbed through the heat exchange surface from the blood, is between about 20°

C. and about 24°

C.

64. A system according to claim 49 wherein the control unit, when causing to be delivered through the heat exchange surface into the blood, causes heat to be delivered through said heat exchange surface at a rate of 50 W-250 W.

65. A system according to claim 49 wherein the control unit, when causing to be delivered through the heat exchange surface into the blood, causes heat to be delivered through said heat exchange surface at a rate of 1-100 W.

66. A system according to claim 49 wherein the control unit, when causing to be absorbed through the heat exchange surface into the blood, causes heat to be absorbed through said heat exchange surface at a rate from 1 W to 100 W.

67. A system according to claim 49 wherein the control unit is programed such that, when the system is being used to cool a patient who'"'"'s body temperature is initially hyperthermic, the control unit will cause heat to be absorbed through the heat exchange surface from the blood until the temperature monitored by the temperature sensor has decreased to about 36.9°

C. at which time the absorption of heat through the heat exchange surface from the blood is stopped.

68. A system according to claim 67 wherein the control unit is further programed such that, if the temperature sensed by the temperature sensor continues to fall to a temperature of 36°

C. or below, the controller will then cause heat to be delivered through the heat exchange surface and into the blood.