Vascular introducer with temperature monitoring probe and systems for endovascular temperature control

• US 7,186,222 B1
• Filed: 09/10/2002
• Issued: 03/06/2007
• Est. Priority Date: 09/10/2002
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Hammack, Amy L., Dae, Michael W., Callister, Jeffrey P.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US10/238,925
• Time in Patent Office: 1,638 Days
• Field of Search: 600/300, 600/301, 600466-471, 600/526, 600/549, 600/585, 607 96-114, 604/264, 604/523, 606/27, 606/28, 606/108
• US Class Current: 600/549
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 5/0008 Temperature signals
• 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 5/6852 Catheters
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An introducer sheath/temperature probe assembly that is insertable into a blood vessel of a human or veterinary patent to measure the temperature of blood flowing through that blood vessel. The introducer sheath/temperature probe assembly may be used in conjunction with an indwelling heat exchange catheter system to warm or cool all or a portion of the patient'"'"'s body to a desired target temperature and to maintain such target temperature for a desired period of time.

Claims

1. An introducer sheath/temperature probe assembly comprising:

a tubular introducer sheath having a proximal end, a distal end and a lumen which extends longitudinally therethrough, said introducer sheath being insertable into a blood vessel;

an elongate temperature probe having a temperature sensor, a distal end and a proximal end, said temperature probe being insertable, distal end first, into the lumen of the introducer sheath and useable, when inserted into the lumen of the introducer sheath, to sense the temperature of blood flowing through the blood vessel into which the introducer sheath is inserted; and

a tip member disposed on the distal end of the temperature probe such that the tip member protrudes beyond the distal end of the introducer sheath when the temperature probe is inserted into the lumen of the introducer sheath, said tip member being constructed so as not to cause substantial trauma to the wall of the blood vessel as the introducer sheath/temperature probe assembly is inserted into the blood vessel;

said temperature sensor being located within said elongate temperature probe proximal of said tip member so that said tip member may extend substantially out of the distal end of said introducer sheath while said temperature sensor resides within said lumen of said introducer sheath;

wherein said tubular introducer sheath has a proximal opening diameter on said proximal end, said temperature probe has a distal length having a first diameter and a proximal length having a second diameter, said first diameter smaller than said opening diameter and said second diameter larger than said opening diameter, and the length of the probe distal of said second diameter up to said sensor is less than the length of the lumen of said introducer sheath, and the length of said distal portion of said probe between said second diameter and the distal tip of said distal tip member is sized such that when said temperature probe is inserted through said proximal opening the portion of the temperature probe of said first diameter is inserted into the lumen of said introducer sheath but the portion of said probe having said second diameter will be blocked from entering said proximal opening, and when fully inserted into said introducer, said tip member will extend beyond the distal end of the introducer sheath but the sensor will remain within the lumen of said introducer sheath.

2. An introducer sheath/temperature probe assembly according to claim 1 further comprising a hub on the proximal end of the introducer sheath.

3. An introducer sheath/temperature probe assembly according to claim 2 wherein a side port is formed on the hub of the introducer sheath.

4. An introducer sheath/temperature probe assembly according to claim 1 wherein said tip member is coated with a lubricious coating.

5. An introducer sheath/temperature probe assembly according to claim 1 wherein said tip member is coated with a coating that is both lubricious and anti-thrombogenic.

6. An introducer sheath/temperature probe assembly according to claim 3 further comprising a side tube having a proximal end and a distal end, the distal end of the side tube being connected to the side port such that fluid may be infused through the side tube, through the side port and through the lumen of the introducer sheath.

7. An introducer sheath/temperature probe assembly according to claim 1, further comprising:

at least one connection apparatus for connecting the temperature probe to an extracorporeally located temperature monitoring apparatus such that at least one signal indicative of blood temperature sensed by the temperature probe is transmitted to the extracorporeally located temperature monitoring apparatus.

8. An introducer sheath/temperature probe assembly according to claim 7 wherein the connection apparatus comprises at least one wire for establishing a wired connection between the temperature probe and the extracorporeally located temperature monitoring apparatus.

9. An introducer sheath/temperature probe assembly according to claim 7 wherein the connection apparatus comprises at least one wireless signal transmitting and receiving apparatus for establishing a wireless connection between the temperature probe and the extracorporeally located temperature monitoring apparatus.

10. An introducer sheath/temperature probe assembly according to claim 1 wherein the temperature probe comprises first and second temperature sensors such that the temperature probe generates first and second temperature signals indicative of the temperature of the blood flowing through the blood vessel into which the introducer sheath/temperature probe assembly is inserted.

11. An introducer sheath/temperature probe assembly according to claim 1 further comprising a hemostatic valve for preventing blood from backflowing out of the lumen of the introducer sheath.

12. An introducer sheath/temperature probe assembly according to claim 6 further comprising a stopcock attached to the proximal end of the side tube.

13. An introducer sheath/temperature probe assembly according to claim 1 further comprising a hub on the proximal end of the temperature probe.

14. An introducer sheath/temperature probe assembly according to claim 1 further comprising a first hub on the proximal end of the introducer sheath and a second hub on the proximal end of the temperature probe.

15. An introducer sheath/temperature probe assembly according to claim 14 wherein a portion of the second hub is received within the first hub when the temperature probe is inserted into the introducer sheath.

16. An introducer sheath/temperature probe assembly according to claim 15 wherein a first engagement surface is formed on the first hub and a second engagement surface is formed on the second hub, the first engagement surface becoming frictionally engaged with the second engagement surface when the temperature probe is inserted into the lumen of the introducer sheath, thereby deterring unintentional withdrawal of the temperature probe from the introducer sheath.

17. An introducer sheath/temperature probe assembly according to claim 16 wherein the first and second engagement surfaces comprise helical threads such that the first hub of the introducer sheath becomes threadably engaged to the second hub of the temperature probe.

18. An introducer sheath/temperature probe assembly according to claim 3 wherein a hemostatic valve is positioned within the hub of the introducer sheath, proximal to the side port.

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

an introducer sheath/temperature probe assembly comprising i) a tubular introducer sheath having a proximal end, a distal end and a lumen which extends longitudinally therethrough, said introducer sheath being insertable into a blood vessel and ii) an elongate temperature probe having a temperature sensor, a distal end and a proximal end, said temperature probe being insertable, distal end first, into the lumen of the introducer sheath and useable, when inserted into the lumen of the introducer sheath, to sense the temperature of blood flowing through the blood vessel into which the introducer sheath is inserted and iii) a tip member disposed on the distal end of the temperature probe such that the tip member protrudes beyond the distal end of the introducer sheath when the temperature probe is inserted into the lumen of the introducer sheath, said tip member being constructed so as not to cause substantial trauma to the wall of the blood vessel as the introducer sheath/temperature probe assembly is inserted into the blood vessel, said temperature sensor being located within said elongate temperature probe proximal of said tip member so that said tip member may extend substantially out of the distal end of said introducer sheath while said temperature sensor resides within said lumen of said introducer sheath;

a heat exchange catheter having a heat exchanger that is positionable within the vasculature of the patient and useable to alternately add heat to and remove heat from the patient'"'"'s blood;

a heater/cooler apparatus for alternately heating and cooling the heat exchanger of the heat exchange catheter, thereby adjusting the amount and direction of heat exchange occurring between the heat exchanger and the patient'"'"'s blood;

a controller which receives i) a target temperature input and ii) an indication of the body temperature sensed by the temperature probe when the temperature probe is inserted into the introducer sheath, said controller being operative to control the heater/cooler apparatus in response to the received indication of the body temperature to heat or cool the patients body to approximately the target temperature;

wherein the temperature probe comprises first and second temperature sensors such that the temperature probe generates first and second temperature signals indicative of the temperature of the blood flowing through the blood vessel into which the introducer sheath/temperature probe assembly is inserted; and

wherein the controller receives the first and second temperature signals and determines whether the difference between the first and second temperature signals exceeds a predetermined maximum acceptable temperature difference.

20. A system according to claim 19 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a femoral vein of the patient.

21. A system according to claim 19 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a femoral artery of the patient.

22. A system according to claim 19 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a subclavian vein of the patient.

23. A system according to claim 19 wherein the heat exchanger on the heat exchange catheter comprises a flowing fluid heat exchanger and wherein the heater/cooler apparatus comprises at least one apparatus for alternately heating or cooling a heat transfer fluid and at least one apparatus for circulating the heated or cooled heat transfer fluid through the heat exchanger of the heat exchange catheter.

24. A system according to claim 23 wherein the heater/cooler apparatus comprises i) a housing having an opening formed therein;

ii) a heating/cooling element positioned within the housing; and

iii) a cassette which contains heat transfer fluid and is connected to the heat exchange catheter such that the heat transfer fluid may be circulated through the heat exchanger of the heat exchange catheter, said cassette being insertable through the opening and into the housing to a position adjacent the heating/cooling element such that the heating/cooling element will heat or cool the heat transfer fluid contained within the cassette.

25. A system according to claim 19 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into an external jugular vein of the patient.

26. A system according to claim 19 wherein the heat exchange catheter is sized and configured to be inserted into one of the patient'"'"'s femoral veins and advanced into the patient'"'"'s inferior and/or superior vena cava and the introducer sheath/temperature probe assembly is sized and configured to be inserted into the other femoral vein of the patient.

27. A system according to claim 19 wherein the controller causes the system to shut down when the difference between the first and second temperature signals exceeds the predetermined maximum acceptable temperature difference.

28. A system according to claim 19 wherein the controller causes an error signal to be emitted when the difference between the first and second temperature signals exceeds the predetermined maximum acceptable temperature difference.

29. A system according to claim 19 wherein the controller selects one of the temperature signals as a driver signal if the difference between the first and the second temperature signal does not exceed a predetermined maximum amount.

30. A system according to claim 29 wherein the controller the controller selects the higher temperature signal as the driver signal.

31. A system according to claim 29 wherein the controller selects the lower temperature signal as the driver signal.

32. A system according to claim 19 wherein the introducer sheath/temperature probe assembly further comprises a hemostatic valve for preventing blood from backflowing out of the lumen of the introducer sheath.

33. A system according to claim 19 wherein a hub is positioned on the proximal end of the introducer sheath.

34. A system according to claim 19 wherein a hub is positioned on the proximal end of the temperature probe.

35. A system according to claim 19 wherein a first hub is positioned on the proximal end of the introducer sheath and a second hub is positioned on the proximal end of the temperature probe.

36. A system according to claim 35 wherein a portion of the second hub is received within the first hub when the temperature probe is inserted into the introducer sheath.

37. A system according to claim 36 wherein a first engagement surface is formed on the first hub and a second engagement surface is formed on the second hub, the first engagement surface becoming frictionally engaged with the second engagement surface when the temperature probe is inserted into the lumen of the introducer sheath, thereby deterring unintentional withdrawal of the temperature probe from the introducer sheath.

38. A system according to claim 37 wherein the first and second engagement surfaces comprise helical threads such that the first hub of the introducer sheath becomes threadably engaged to the second hub of the temperature probe.

39. A system according to claim 33 wherein a side port is formed on the hub of the introducer sheath.

40. A system according to claim 39 further comprising a side tube having a proximal end and a distal end, the distal end of the side tube being connected to the side port such that fluid may be infused through the side tube, through the side port and through the lumen of the introducer sheath.

41. A system according to claim 40 further comprising a stopcock attached to the proximal end of the side tube.

42. A system according to claim 39 wherein a hemostatic valve is positioned within the hub of the introducer sheath, proximal to the side port.

43. A system according to claim 19 wherein the heat exchanger comprises a multi-lobed balloon through which heat transfer fluid is circulated.

44. A system according to claim 43 wherein at least one lobe of the multi-lobed balloon is disposed helically about a central axis.

45. A system according to claim 19 wherein the heat exchange catheter is sized and configured to be capable of being inserted such that its heat exchanger is positioned within the patient'"'"'s inferior vena cava.

46. A system according to claim 19 wherein the heat exchange catheter is sized and configured to be capable of being inserted such that its heat exchanger is positioned within the patients superior vena cava.

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

a tubular introducer sheath having a proximal end, a distal end and a lumen which extends longitudinally therethrough, said introducer sheath being insertable into a blood vessel;

an elongate temperature probe having a temperature sensor, a distal end and a proximal end, said temperature probe being insertable, distal end first, into the lumen of the introducer sheath to form a temperature probe/introducer sheath assembly;

a heat exchange catheter having a heat exchanger through which a heat exchange fluid flows, said heat exchange catheter being positionable within the vasculature of the patient and useable to alternately add heat to and remove heat from the patient'"'"'s blood;

a heater/cooler apparatus for alternately heating and cooling a heat exchange fluid that flows through the heat exchanger said heater/cooler apparatus comprising i) a housing having an opening formed therein;

ii) a heating/cooling element positioned within the housing; and

iii) a cassette which contains heat exchange fluid and is connected to the heat exchange catheter such that the heat exchange fluid may be circulated through the heat exchanger of the heat exchange catheter, said cassette being insertable through the opening and into the housing to a position adjacent the heating/cooling element such that the heating/cooling element will heat or cool the heat exchange fluid contained within the cassette; and

a controller which receives a target temperature input and an indication of the body temperature sensed by the temperature probe when the temperature probe is inserted into the introducer sheath, said controller being operative to control the heater/cooler apparatus in response to the received indication of the body temperature to heat or cool the patient'"'"'s body to approximately the target temperature;

wherein the temperature probe comprises first and second temperature sensors such that the temperature probe generates first and second temperature signals indicative of the temperature of the blood flowing through the blood vessel into which the introducer sheath/temperature probe assembly is inserted; and

wherein the controller receives the first and second temperature signals and determines whether the difference between the first and second temperature signals exceeds a predetermined maximum acceptable temperature difference.

48. A system according to claim 47 wherein the heat exchange catheter is sized and configured to be capable of being inserted such that its heat exchanger is positioned within the patient'"'"'s inferior vena cava.

49. A system according to claim 47 wherein the heat exchange catheter is sized and configured to be capable of being inserted such that its heat exchanger is positioned within the patient'"'"'s superior vena cava.

50. A system according to claim 47 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a femoral vein of the patient.

51. A system according to claim 47 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a femoral artery of the patient.

52. A system according to claim 47 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a subclavian vein of the patient.

53. A system according to claim 47 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into an external jugular vein of the patient.

54. A system according to claim 47 wherein the heat exchange catheter is sized and configured to be inserted into one of the patients femoral veins and advanced into the patients inferior and/or superior vena cava and the introducer sheath/temperature probe assembly is sized and configured to be inserted into the other femoral vein of the patient.

55. A system according to claim 47 wherein the controller causes the system to shut down when the difference between the first and second temperature signals exceeds the predetermined maximum acceptable temperature difference.

56. A system according to claim 47 wherein the controller causes an error signal to be emitted when the difference between the first and second temperature signals exceeds the predetermined maximum acceptable temperature difference.

57. A system according to claim 47 wherein the controller selects one of the temperature signals as a driver signal if the difference between the first and the second temperature signal does not exceed a predetermined maximum amount.

58. A system according to claim 57 wherein the controller selects the higher temperature signal as a driver signal.

59. A system according to claim 57 wherein the controller selects the lower temperature signal as a driver signal.

60. A system according to claim 47 wherein the introducer sheath/temperature probe assembly further comprises a hemostatic valve for preventing blood from backflowing out of the lumen of the introducer sheath.

61. A system according to claim 47 wherein a hub is positioned on the proximal end of the introducer sheath.

62. A system according to claim 47 wherein a hub is positioned on the proximal end of the temperature probe.

63. A system according to claim 47 wherein a first hub is positioned on the proximal end of the introducer sheath and a second hub is positioned on the proximal end of the temperature probe.

64. A system according to claim 63 wherein a portion of the second hub is received within the first hub when the temperature probe is inserted into the introducer sheath.

65. A system according to claim 64 wherein a first engagement surface is formed on the first hub and a second engagement surface is formed on the second hub, the first engagement surface becoming frictionally engaged with the second engagement surface when the temperature probe is inserted into the lumen of the introducer sheath, thereby deterring unintentional withdrawal of the temperature probe from the introducer sheath.

66. A system according to claim 65 wherein the first and second engagement surfaces comprise helical threads such that the first hub of the introducer sheath becomes threadably engaged to the second hub of the temperature probe.

67. A system according to claim 61 wherein a side port is formed on the hub of the introducer sheath.

68. A system according to claim 67 further comprising a side tube having a proximal end and a distal end, the distal end of the side tube being connected to the side port such that fluid may be infused through the side tube, through the side port and through the lumen of the introducer sheath.

69. A system according to claim 68 further comprising a stopcock attached to the proximal end of the side tube.

70. A system according to claim 67 wherein a hemostatic valve is positioned within the hub of the introducer sheath, proximal to the side port.

71. A system according to claim 47 wherein the heat exchanger comprises a multi-lobed balloon through which heat exchange fluid is circulated.

72. A system according to claim 71 wherein at least one lobe of the multi-lobed balloon is disposed helically about a central axis.

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

a tubular introducer sheath having a proximal end, a distal end and a lumen which extends longitudinally therethrough, said introducer sheath being insertable into a blood vessel;

an elongate temperature probe having a proximal end, a distal end, a first temperature sensor and a second temperature sensor, said temperature probe being insertable, distal end first, into the lumen of the introducer sheath to form a temperature probe/introducer sheath assembly, said temperature probe being operative to generate first and second signals indicating the temperature of blood flowing through the blood vessel as sensed by the first and second temperature sensors;

a heat exchange catheter having a heat exchanger that is positionable within the vasculature of the patient and useable to alternately add heat to and remove heat from the patient'"'"'s blood;

a heater/cooler apparatus for alternately heating and cooling the heat exchanger of the heat exchange catheter, thereby adjusting the amount and direction of heat exchange occurring between the heat exchanger and the patient'"'"'s blood;

a controller which receives a target temperature input and an indication of the body temperature sensed by the temperature probe when the temperature probe is inserted into the introducer sheath, said controller being operative to control the heater/cooler apparatus in response to the received indication of the body temperature to heat or cool the patients body to approximately the target temperature;

said controller performing at least one function selected from the group of functions consisting of;

a) receiving the first and second temperature signals and determining whether the difference between the first and second temperature signals exceeds a predetermined maximum acceptable temperature difference;

b) causing the system to shut down when the difference between the first and second temperature signals exceeds the predetermined maximum acceptable temperature difference;

c) causing an error signal to be emitted when the difference between the first and second temperature signals exceeds the predetermined maximum acceptable temperature difference; and

d) selecting one of the temperature signals as a driver signal if the difference between the first and the second temperature signal does not exceed a predetermined maximum amount.

74. A system according to claim 73 wherein the heat exchange catheter is sized and configured to be capable of being inserted such that its heat exchanger is positioned within the patients inferior vena cava.

75. A system according to claim 73 wherein the heat exchange catheter is sized and configured to be capable of being inserted such that its heat exchanger is positioned within the patient'"'"'s superior vena cava.

76. A system according to claim 73 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a femoral vein of the patient.

77. A system according to claim 73 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a femoral artery of the patient.

78. A system according to claim 73 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into a subclavian vein of the patient.

79. A system according to claim 73 wherein the introducer sheath/temperature probe assembly is sized and configured to be inserted into an external jugular vein of the patient.

80. A system according to claim 73 wherein the heat exchange catheter is sized and configured to be inserted into one of the patients femoral veins and advanced into the patients inferior and/or superior vena cava and the introducer sheath/temperature probe assembly is sized and configured to be inserted into the other femoral vein of the patient.

81. A system according to claim 73 wherein the controller selects the higher temperature signal as the driver signal.

82. A system according to claim 73 wherein the controller selects the lower temperature signal as the driver signal.

83. A system according to claim 73 wherein the introducer sheath/temperature probe assembly further comprises a hemostatic valve for preventing blood from backflowing out of the lumen of the introducer sheath.

84. A system according to claim 73 wherein a hub is positioned on the proximal end of the introducer sheath.

85. A system according to claim 73 wherein a hub is positioned on the proximal end of the temperature probe.

86. A system according to claim 73 wherein a first hub is positioned on the proximal end of the introducer sheath and a second hub is positioned on the proximal end of the temperature probe.

87. A system according to claim 86 wherein a portion of the second hub is received within the first hub when the temperature probe is inserted into the introducer sheath.

88. A system according to claim 87 wherein a first engagement surface is formed on the first hub and a second engagement surface is formed on the second hub, the first engagement surface becoming frictionally engaged with the second engagement surface when the temperature probe is inserted into the lumen of the introducer sheath, thereby deterring unintentional withdrawal of the temperature probe from the introducer sheath.

89. A system according to claim 88 wherein the first and second engagement surfaces comprise helical threads such that the first hub of the introducer sheath becomes threadably engaged to the second hub of the temperature probe.

90. A system according to claim 84 wherein a side port is formed on the hub of the introducer sheath.

91. A system according to claim 90 further comprising a side tube having a proximal end and a distal end, the distal end of the side tube being connected to the side port such that fluid may be infused through the side tube, through the side port and through the lumen of the introducer sheath.

92. A system according to claim 91 further comprising a stopcock attached to the proximal end of the side tube.

93. A system according to claim 90 wherein a hemostatic valve is positioned within the hub of the introducer sheath, proximal to the side port.

94. A system according to claim 73 wherein the heat exchanger comprises a multi-lobed balloon through which heat transfer fluid is circulated.

95. A system according to claim 94 wherein at least one lobe of the multi-lobed balloon is disposed helically about a central axis.

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

an introducer sheath/temperature probe assembly comprising i) a tubular introducer sheath having a proximal end, a distal end and a lumen which extends longitudinally therethrough, said introducer sheath being insertable into a blood vessel, ii) an elongate temperature probe having a temperature sensor, a distal end and a proximal end, said temperature probe being insertable, distal end first, into the lumen of the introducer sheath and useable, when inserted into the lumen of the introducer sheath, to sense the temperature of blood flowing through the blood vessel into which the introducer sheath is inserted and iii) a tip member disposed on the distal end of the temperature probe such that the tip member protrudes beyond the distal end of the introducer sheath when the temperature probe is inserted into the lumen of the introducer sheath, said tip member being constructed so as not to cause substantial trauma to the wall of the blood vessel as the introducer sheath/temperature probe assembly is inserted into the blood vessel, said temperature sensor being located within said elongate temperature probe proximal of said tip member so that said tip member may extend substantially out of the distal end of said introducer sheath while said temperature sensor resides within said lumen of said introducer sheath;

a heat exchange catheter having a heat exchanger that is positionable within the vasculature of the patient and useable to alternately add heat to and remove heat from the patients blood;

a heater/cooler apparatus for alternately heating and cooling the heat exchanger of the heat exchange catheter, thereby adjusting the amount and direction of heat exchange occurring between the heat exchanger and the patients blood;

a controller which receives i) a target temperature input and ii) an indication of the body temperature sensed by the temperature probe when the temperature probe is inserted into the introducer sheath, said controller being operative to control the heater/cooler apparatus in response to the received indication of the body temperature to heat or cool the patient'"'"'s body to approximately the target temperature;

wherein the heat exchanger on the heat exchange catheter comprises a flowing fluid heat exchanger and wherein the heater/cooler apparatus comprises at least one apparatus for alternately heating or cooling a heat exchange fluid and at least one apparatus for circulating the heated or cooled heat exchange fluid through the heat exchanger of the heat exchange catheter; and

wherein the heater/cooler apparatus comprises i) a housing having an opening formed therein;

ii) a heating/cooling element positioned within the housing; and

iii) a cassette which contains heat transfer fluid and is connected to the heat exchange catheter such that the heat transfer fluid may be circulated through the heat exchanger of the heat exchange catheter, said cassette being insertable through the opening and into the housing to a position adjacent the heating/cooling element such that the heating/cooling element will heat or cool the heat transfer fluid contained within the cassette;

wherein the temperature probe comprises first and second temperature sensors such that the temperature probe generates first and second temperature signals indicative of the temperature of the blood flowing through the blood vessel into which the introducer sheath/temperature probe assembly is inserted;

wherein the controller receives the first and second temperature signals and determines whether the difference between the first and second temperature signals exceeds a predetermined maximum acceptable temperature difference; and

wherein the controller causes the system to perform a responsive action when the difference between the first and second temperature signals exceeds the comprising at least one action selected from the group consisting of;

a) causing the system to shut down and b) causing an error signal to be emitted.

97. A system according to claim 96 wherein a hub is positioned on the proximal end of the introducer sheath.

98. A system according to claim 97 wherein a side port is formed on the hub of the introducer sheath.

99. A system according to claim 98 further comprising a side tube having a proximal end and a distal end, the distal end of the side tube being connected to the side port such that fluid may be infused through the side tube, through the side port and through the lumen of the introducer sheath.

100. A system according to claim 99 further comprising a stopcock attached to the proximal end of the side tube.

101. A system according to claim 98 wherein a hemostatic valve is positioned within the hub of the introducer sheath, proximal to the side port.

102. A system according to claim 96 wherein a hub is positioned on the proximal end of the temperature probe.

103. A system according to claim 96 wherein a first hub is positioned on the proximal end of the introducer sheath and a second hub is positioned on the proximal end of the temperature probe.

104. A system according to claim 103 wherein a portion of the second hub is received within the first hub when the temperature probe is inserted into the introducer sheath.

105. A system according to claim 104 wherein a first engagement surface is formed on the first hub and a second engagement surface is formed on the second hub, the first engagement surface becoming frictionally engaged with the second engagement surface when the temperature probe is inserted into the lumen of the introducer sheath, thereby deterring unintentional withdrawal of the temperature probe from the introducer sheath.

106. A system according to claim 105 wherein the first and second engagement surfaces comprise helical threads such that the first hub of the introducer sheath becomes threadably engaged to the second hub of the temperature probe.

107. A system according to claim 96 wherein the heat exchanger comprises a multi-lobed balloon through which heat transfer fluid is circulated.

108. A system according to claim 96 wherein the controller selects one of the temperature signals as a driver signal if the difference between the first and the second temperature signal does not exceed a predetermined maximum amount.

109. A system according to claim 108 wherein the controller selects the higher temperature signal as the driver signal.

110. A system according to claim 108 wherein the controller selects the lower temperature signal as the driver signal.

111. A system according to claim 96 wherein the introducer sheath/temperature probe assembly further comprises a hemostatic valve for preventing blood from backflowing out of the lumen of the introducer sheath.

112. A system according to claim 107 wherein at least one lobe of the multi-lobed balloon is disposed helically about a central axis.