Methods and Apparatus for Regional and Whole Body Temperature Modification

• US 20080228141A1
• Filed: 10/31/2007
• Published: 09/18/2008
• Est. Priority Date: 02/10/1993
• Status: Active Grant

• Current Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Machold, Timothy R., Ginsburg, Robert, Dineen, Michael T., Ginsburg, Arlene S.
• Granted Patent: US 7,771,460 B2
• Time in Patent Office: Days
• US Class Current: 604/113
• 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 18/245 for removing obstructions in blood vessels or calculi
• 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: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/0097 Blankets with active heating or cooling sources warming mats A61F7/08
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• 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 2025/0078 for fluid inflow from the body into the catheter lumen
• 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 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 2206/10 : Flow characteristics
• CPC Class Codes: A61M 2230/50 : Temperature
• 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

Abstract

Methods and apparatus for temperature modification of selected body regions including an induced state of local hypothermia of the brain region for neuroprotection. A heat exchange catheter is provided with heat transfer fins projecting or extending outward from the catheter which may be inserted into selected blood vessels or body regions to transfer heat with blood or fluid in the selected blood vessels or body regions. Another aspect of the invention further provides methods and apparatus for controlling the internal body temperature of a patient. By selectively heating or cooling a portion of the catheter lying within a blood vessel, heat may be transferred to or from blood flowing within the vessel to increase or decrease whole body temperature or the temperature of a target region. Feed back from temperature sensors located within the patient'"'"'s body allow for control of the heat transfer from the catheter to automatically control the temperature of the patient or of the target region within the patient. The apparatus may include a blood channeling sleeve that directs body fluid over a heat exchanger where the body fluid'"'"'s temperature is altered, and then is discharged out the distal end of the sleeve to a desired location, for example, cooled blood to the brain for neuroprotection. The catheter may be used alone or in conjunction with other heat exchangers to cool one region of a patients body while heating another.

Claims

1-84. -84. (canceled)

85. A catheter device for placement in a fluid containing portion of the body of a mammalian patient to effect in situ heat exchange, said catheter device comprising:

an elongate flexible catheter having a proximal end and a distal. end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end;

said flexible catheter having an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end;

a heat exchanger located at a first location on the catheters said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter, said heat exchanger being curved and having an outer surface along its outer radius of curvature, and having an inner surface along its inner radius of curvature, said outer surface and said inner surface having substantially different thermal transmissivity.

86. A catheter device as in claim 85 wherein the upper surface is substantially more thermally transmissive than said lower surface.

87. A catheter device as in claim 86 sized and configured for placement along the curve of the aortic arch of a human patient such that blood flowing to the head region will pass in heat transfer proximity to the upper surface.

88. A system comprising a catheter device according to claim 85 further in combination with:

a sensor that senses data from the patient, generates a signal in response thereto;

a manual input whereby an operator may specify a target parameter;

a controller unit for receiving said signal and said target parameter, and controlling the operation of said catheter device in response to said sensed data and in relation to said target parameter.

89. A system as in claim 88, further comprising a heating unit, said heating unit operative to exchange heat with said heat exchange fluid.

90. A system as in claim 89 wherein said heating unit is a solid-state thermoelectric cooler.

91. A system as in claim 89 wherein said target parameter is a temperature, and said sensor is a temperature sensor, said controller operable to activate said heating unit.

92. A system as in claim 88 further comprising a plurality of sensors each generating a separate signal, said controller operable to control said catheter in response to a plurality of signals.

93. A System as in claim 92, further comprising a plurality of catheter devices, said controller operable to control each of said catheter devices.

94. A system as in claim 93 wherein at least one catheter device imparts heat to said body fluid at a first location, and at least one catheter device removes heat from said body fluid at a second location.