Method and apparatus for regulating patient temperature by irrigating the bladder with a fluid

• US 6,648,906 B2
• Filed: 04/05/2001
• Issued: 11/18/2003
• Est. Priority Date: 04/06/2000
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Magers, Michael, Lasheras, Juan C., Yon, Steven A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/827,010
• Publication Number:
  US 20010039440A1
• Time in Patent Office: 957 Days
• Field of Search: 607/96, 607/105, 607/113, 604/19, 604/27, 604/28, 604/30, 604/35
• US Class Current: 607/105
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• CPC Class Codes: A61F 2007/0069 with return means
• 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 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

A method and apparatus is provided for heating or cooling at least a selected portion of a patient'"'"'s body. The method begins by inserting a catheter through the urethra and into the bladder of the patient. A heated or chilled fluid is conducted through a supply lumen of the catheter and into the bladder. The fluid is evacuated from the bladder through a return lumen of the catheter. Finally, a quantity of urine is monitored which flows out of the bladder and through the return lumen of the catheter. The rate of fluid flowing through the supply lumen of the catheter may be adjusted in a manner that is based at least in part on the monitored quantity of urine flowing out of the bladder.

Claims

1. A method for heating or cooling at least a selected portion of a body, said method comprising:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a quantity of urine flowing out of the bladder.

2. The method of claim 1 further comprising adjusting the flow rate, pressure, or temperature of fluid flowing through the supply lumen of the catheter based at least in part on the monitored quantity of urine flowing out of the bladder.

3. The method of claim 2 further comprising monitoring a temperature differential between the fluid conducted into the supply lumen and the fluid flowing through the return lumen.

4. A The method of claim 1 wherein the fluid is conducted into the supply lumen at a substantially constant flow rate.

5. The method of claim 4 wherein the flow rate is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

6. The method of claim 1 wherein the fluid is conducted into the supply lumen with a periodically interrupted flow of fluid.

7. The method of claim 6 wherein the flow of fluid is interrupted for at least a period of time sufficient to allow the bladder to be substantially evacuated of fluid.

8. The method of claim 1 wherein a flow rate of fluid conducted into the supply lumen is substantially equal to a flow rate of fluid being evacuated from the bladder.

9. The method of claim 1 further comprising monitoring the pressure of the fluid flowing into the supply lumen.

10. The method of claim 9 further comprising monitoring the pressure of the fluid flowing through the return lumen.

11. The method of claim 10 further comprising adjusting the rate of fluid flowing through the supply lumen of the catheter based on the monitored quantity of urine flowing out of the bladder and the pressure of the fluid flowing in the supply and return lumens.

12. The method of claim 1 further comprising monitoring a temperature differential between the fluid conducted into the supply lumen and the fluid flowing through the return lumen.

13. the method of claim 1 further comprising dispersing the fluid as it exits the catheter and enters the bladder.

14. The method of claim 13 wherein the dispersing includes diffusing the fluid as it exits the catheter.

15. The method of claim 13 wherein the fluid is dispersed by a floating ball valve.

16. The method of claim 1, wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

17. A method for heating or cooling at least a selected portion of a body, said method comprising:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a pressure differential between the fluid conducted into the supply lumen and the fluid flowing through the return lumen.

18. The method of claim 17 further comprising adjusting the rate of fluid flowing through the supply lumen of the catheter based at least in part on the monitored pressure differential.

19. The method of claim 18 further comprising monitoring a temperature differential between the fluid conducted into the supply lumen and the fluid flowing through the return lumen.

20. The method of claim 18 wherein the flow rate is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

21. The method of claim 17 wherein the fluid is conducted into the supply lumen at a substantially constant flow rate.

22. The method of claim 17 wherein the fluid is conducted into the supply lumen at a periodically interrupted rate.

23. The method of claim 17 wherein a flow rate of fluid conducted into the supply lumen is substantially equal to a flow rate of fluid being evacuated from the bladder.

24. The method of claim 17 further comprising monitoring the quantity of the fluid flowing into the supply lumen.

25. The method of claim 24 further comprising monitoring the quantity of the fluid flowing through the return lumen.

26. The method of claim 25 further comprising adjusting the rate of fluid flowing through the supply lumen of the catheter based on the monitored quantity of urine flowing into the supply lumen and out of the return lumen and the monitored pressure differential of the fluid flowing in the supply and return lumens.

27. The method of claim 17 further comprising monitoring a temperature differential between the fluid conducted into the supply lumen and the fluid flowing through the return lumen.

28. The method of claim 17, wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

29. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

wherein the at least one measurable parameter is selected from the group consisting of the flow rate of the fluid and the pressure differential between the fluid flowing into and out of the bladder.

30. The method of claim 29 wherein irrigating the bladder includes the step of irrigating the bladder with a continuous flow of fluid.

31. The method of claim 29 wherein irrigating the bladder includes the step of inserting a catheter through the urethra and into the bladder to conduct the fluid into the bladder.

32. The method of claim 29 further comprising monitoring a temperature differential between the fluid flowing into and out of the bladder.

33. The method of claim 29 wherein the irrigating includes dispersing the fluid as it exits the catheter.

34. The method of claim 33 wherein the dispersing includes diffusing the fluid as it exits the catheter.

35. The method of claim 33 wherein the fluid is dispersed by a floating ball valve.

36. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

wherein the at least one measurable parameter includes the flow rate of the fluid and the pressure differential between the fluid flowing into and out of the bladder.

37. A method for heating or cooling at least a selected portion of a body said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

wherein irrigating the bladder includes the step of irrigating the bladder with a pulsed flow of fluid.

38. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

further comprising adjusting the at least one measurable parameter based at least in part on a monitored quantity of urine flowing out of the bladder.

39. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

wherein the bladder is irrigated with fluid flowing at a substantially constant flow rate.

40. The method of claim 39 wherein the flow rate is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

41. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

wherein the bladder is irrigated with fluid flowing at a periodically interrupted flow rate.

42. The method of claim 41 wherein the flow of fluid is interrupted for at least a period of time sufficient to allow the bladder to be substantially evacuated of fluid.

43. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

further comprising adjusting the at least one measurable parameter fluid based on a monitored quantity of urine flowing out of the bladder and a pressure differential between the fluid flowing into and out of the bladder.

44. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

further comprising monitoring a temperature differential between the fluid flowing into and out of the bladder.

45. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the at least one measurable parameter is the flow rate of the fluid irrigating the bladder.

46. The apparatus of claim 45 wherein the flow of the fluid is continuous.

47. The apparatus of claim 45 wherein the flow of fluid is periodically interrupted.

48. The apparatus of claim 47 wherein the flow of fluid is interrupted for at least a period of time sufficient to allow the bladder to be substantially evacuated of fluid.

49. The apparatus of claim 45 wherein said catheter is a Foley catheter.

50. The apparatus of claim 45 wherein said catheter includes a supply lumen having a supply orifice at its distal end and further comprising a dispersing element associated with the orifice for dispersing the fluid before it exits the catheter.

51. The apparatus of claim 50 wherein said dispersing element is one selected from the group consisting of:

a diffusing element;

a floating ball valve; and

a deflecting element.

52. The apparatus of claim 50 wherein said catheter further includes a return lumen having at least one return orifice, said return orifice being spatially separate from said supply orifice.

53. The apparatus of claim 45, further comprising an inflatable balloon coupled to said catheter for maintaining an operative position of said catheter when inserted into a patient.

54. The apparatus of claim 45, wherein the means for monitoring the core temperature of the body is an esophageal temperature probe.

55. The apparatus of claim 45, wherein the means for monitoring the core temperature of the body is a tympanic temperature probe.

56. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the at least one measurable parameter is the pressure differential between the fluid flowing into and out of the bladder.

57. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a healed or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the at least one measurable parameter includes the flow rate of the fluid and the pressure differential between the fluid flowing into and out of the bladder.

58. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out or the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

further comprising means for adjusting the at least one measurable parameter based at least in part on a monitored quantity of urine flowing out of the bladder.

59. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

further comprising means for adjusting the at least one measurable parameter fluid based on a monitored quantity of urine flowing out of the bladder and a pressure differential between the fluid flowing into and out of the bladder.

60. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

further comprising means for monitoring a temperature differential between the fluid flowing into and out of the bladder.

61. A catheter, comprising:

a manifold having a proximal end with at least first and second input ports and a distal end with an output port;

at least first and second flexible tubes defining a supply lumen and a return lumen, respectively, said first and second flexible tubes having proximal ends removably connectable to the output port of the manifold and having distal ends with a supply and return orifice, respectively; and

a dispersing element associated with the supply orifice for dispersing fluid exiting the supply orifice into a portion of the body.

62. The catheter of claim 61 wherein said dispersing element is a diffusing element.

63. The catheter of claim 61 wherein said dispersing element is a floating ball valve.

64. The catheter of claim 61 wherein said dispersing element is a deflecting element.

65. The catheter of claim 61 wherein said return orifice is spatially separated from said supply orifice.

66. The catheter of claim 65 wherein said spatial separation between said supply and return orifices is sufficient to prevent a substantial flow of fluid directly from said supply orifice to said return orifice.

67. The catheter of claim 61 further comprising an inflatable balloon for maintaining an operative position of said tubes when inserted into a patient.

68. The catheter of claim 61 wherein said first and second flexible tubes are concentrically oriented with respect to one another.

69. The apparatus of claim 61, further comprising a gas-driven heat exchanger for chilling the fluid.

70. The apparatus of claim 61, further comprising a resistive heater for heating the fluid.

71. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a pressure of the combined urine and heated or chilled fluid in the bladder.

72. The method of claim 71, further comprising maintaining the pressure of the urine and heated or chilled fluid in the bladder to between about 0.2 and 0.3 psi.

73. The method of claim 71 wherein the flow rate of the heated or chilled fluid is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

74. The method of claim 71, wherein the conducting includes delivering the heated or chilled fluid at a substantially constant rate.

75. The method of claim 74, wherein the substantially constant rate is less than about 15 cc/sec.

76. The method of claim 71, wherein the conducting includes delivering the heated or chilled fluid at a periodically interrupted rate.

77. The method of claim 76, wherein the periodic rate has a frequency of between about once every 1 minute and once every 15 minutes.

78. The method of claim 71, further comprising controlling a temperature, flow rate, or pressure of the heated or chilled fluid based on the monitored pressure.

79. The method of claim 71 wherein a flow rate of fluid conducted into the bladder is substantially equal to a flow rate of fluid being evacuated from the bladder.

80. The method of claim 71, wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

81. The method of claim 71 wherein the flow rate of the heated or chilled fluid is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

82. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a temperature of the heated or chilled fluid in the supply lumen or in the return lumen,

further comprising controlling the flow rate, pressure, or temperature of the heated or chilled fluid based on the monitored temperature.

83. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder; and

periodically flushing the fluid from the bladder.

84. The method of claim 83, wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

85. The method of claim 83 wherein the flow rate of the heated or chilled fluid is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

86. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a physiologic parameter of the body, such that a neutral physiology is maintained.

87. The method of claim 86, further comprising controlling the flow rate, pressure, or temperature of the heated or chilled fluid based on the monitored physiologic parameter.

88. The method of claim 86 wherein a flow rate of fluid conducted into the bladder is substantially equal to flow rate of fluid being evacuated from the bladder.

89. The method of claim 86, wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

90. The method of claim 86 wherein the flow rate of the heated or chilled fluid is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

91. The method of claim 86, wherein the conducting includes delivering the heated or chilled fluid at a substantially constant rate.

92. The method of claim 86, wherein the conducting includes delivering the heated or chilled fluid at a periodically interrupted rate.

93. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a temperature of the combination of the urine and heated or chilled fluid in the bladder.

94. The method of claim 93, further comprising controlling the flow rate, pressure, or temperature of the heated or chilled fluid based on the monitored temperature.

95. The method of claim 93 wherein a flow rate of fluid conducted into the bladder is substantially equal to a flow rate of fluid being evacuated from the bladder.

96. The method of claim 93, wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

97. The method of claim 93 wherein the flow rate of the heated or chilled fluid is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

98. The method of claim 93, wherein the conducting includes delivering the heated or chilled fluid at a substantially constant rate.

99. The method of claim 93, wherein the conducting includes delivering the heated or chilled fluid at a periodically interrupted rate.

100. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

101. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating the bladder with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the bladder;

evacuating the fluid from the bladder; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the bladder,

wherein a flow rate of fluid conducted into the bladder is substantially equal to a flow rate of fluid being evacuated from the bladder.

102. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein a flow rate of fluid conducted into the bladder is substantially equal to a flow rate of fluid being evacuated from the bladder.

103. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

104. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the flow rate of the heated or chilled fluid is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

105. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the conducting includes delivering the heated or chilled fluid at a substantially constant rate.

106. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the conducting includes delivering the heated or chilled fluid at a periodically interrupted rate.

107. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a core temperature of the body,

wherein a flow rate of fluid conducted into the bladder is substantially equal to a flow rate of fluid being evacuated from the bladder.

108. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a core temperature of the body,

wherein the heated or chilled fluid is a chilled fluid, and further comprising chilling the fluid with a gas-driven heat exchanger.

109. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a core temperature of the body,

wherein the flow rate of the heated or chilled fluid is less than a flow rate substantially preventing fluid from flowing from the kidneys to the bladder.

110. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a core temperature of the body,

wherein the conducting includes delivering the heated or chilled fluid at a substantially constant rate.

111. A method for heating or cooling at least a selected portion of a body, said method comprising the steps of:

inserting a catheter through the urethra and into the bladder;

conducting a heated or chilled fluid through a supply lumen of the catheter and into the bladder;

evacuating the fluid from the bladder through a return lumen of the catheter; and

monitoring a core temperature of the body,

wherein the conducting includes delivering the heated or chilled fluid at a periodically interrupted rate.

112. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

further comprising a gas-driven heat exchanger for chilling the fluid.

113. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at lest one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

further comprising a resistive heater for heating the fluid.

114. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter or the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the means for monitoring the pressure of the bladder is a pressure transducer mounted adjacent the distal tip of the catheter.

115. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder,

wherein the at least one measurable parameter of fluid flowing out of the bladder is the output of urine.

116. The apparatus of claim 115, further comprising a sensor for measuring the output of urine.

117. The apparatus of claim 116, wherein the sensor is an optical sensor.

118. The apparatus of claim 116, wherein the sensor is a weight scale coupled to a reservoir, said reservoir holding the heated or chilled fluid as well as collected urine.

119. A Foley catheter for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating the bladder with a heated or chilled fluid, the catheter including;

a manifold having a proximal end with at least first and second input ports and a distal end with an output port;

at least first and second flexible tubes defining a supply lumen and a return lumen, respectively, said first and second flexible tubes having proximal ends removably connectable to the output port of the manifold and having distal ends with a supply and return orifice, respectively;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the bladder; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the bladder while it is being irrigated, a core temperature of the body, and a pressure of the combined heated or chilled fluid and urine in the bladder.