WO2025217544A1 - Tubing assemblies for temperature management systems - Google Patents

Tubing assemblies for temperature management systems

Info

Publication number
WO2025217544A1
WO2025217544A1 PCT/US2025/024315 US2025024315W WO2025217544A1 WO 2025217544 A1 WO2025217544 A1 WO 2025217544A1 US 2025024315 W US2025024315 W US 2025024315W WO 2025217544 A1 WO2025217544 A1 WO 2025217544A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubing
fluid
tubing assembly
heat exchange
supply
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/024315
Other languages
French (fr)
Inventor
John Thomas Buckley
Ngoc CHAU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zoll Circulation Inc
Zoll Medical Corp
Original Assignee
Zoll Circulation Inc
Zoll Medical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zoll Circulation Inc, Zoll Medical Corp filed Critical Zoll Circulation Inc
Publication of WO2025217544A1 publication Critical patent/WO2025217544A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/0085—Devices for generating hot or cold treatment fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/032—Automatic limiting or abutting means, e.g. for safety pressure limiting, e.g. hydrostatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0809—Indication of cracks or breakages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water

Definitions

  • hypothermia may be induced to minimize damage to the brain or spinal cord when a patient has suffered a head injury or stroke, or to minimize damage to heart and brain tissue when a patient has undergone cardiac arrest or suffered a myocardial infarct (heart attack).
  • hypothermia has been shown to both increase the contractility of the heart muscle and to reduce its metabolic requirements. Indeed, if the hypothermia is systemic, the metabolic demands of the entire body are generally reduced, so that the demands placed on the heart may be reduced. It may sometimes also be desirable to induce hypothermia during surgery, especially neurosurgery, once again to minimize tissue damage.
  • One method for inducing hypothermia is by intravascular or endovascular temperature management wherein a heat exchange catheter is inserted into a blood vessel and a thermal exchange fluid is circulated through a heat exchanger positioned on the Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 portion of the catheter that is inserted in the blood vessel.
  • the thermal exchange fluid circulates through the catheter's heat exchanger, it exchanges heat with blood flowing past the heat exchanger in the blood vessel.
  • Such technique can be used to cool the patient’s flowing blood thereby resulting in a lowering of the subject's core body temperature to some desired target temperature.
  • Endovascular temperature management is also capable of warming the body and/or of controlling body temperature to maintain a monitored body temperature at some selected temperature. If a controlled rate of re-warming or re-cooling from the selected target temperature is desired, that too can be accomplished by carefully controlling the amount of heat added or removed from the body and thereby controlling the temperature change of the patient. [0005] Other methods for heat exchange are possible.
  • These methods can include heating or cooling materials configured to touch a surface of the patient, such as a patient’s skin. These methods can include placement of a catheter into an orifice of the patient, such as nasal cavity or an esophagus, and circulating heat exchange fluid through the catheter to heat or cool the patient.
  • a temperature management system comprising a heat exchange console that interfaces or couples with a tubing assembly.
  • the tubing assembly is configured to interface or couple with many different types of heat exchange devices.
  • the tubing assembly includes one or more devices, such as a bypass tubing portion, relief valve, and/or pressure sensor(s), configured to ensure that a fluid pressure within the attached heat exchange device does not exceed a threshold pressure.
  • Temperature management systems are configured to include a heat exchange fluid loop (also called a fluid circuit) that circulates heat exchange fluid (such as saline) through a heat exchange device placed on or in a patient.
  • the heat exchange device is configured to control a temperature of the patient by either raising or lowering the patient’s body temperature.
  • the heat exchange fluid flows in the fluid loop through the heat exchange device and can be heated or cooled at a console based heat exchanger at a temperature Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 management console.
  • the heat exchange fluid is cooled at the console heat exchanger and is pumped through a tubing assembly to and from the heat exchange device in a fluid loop. As the heat exchange fluid flows through the heat exchange device, it absorbs heat from the patient, cooling the patient. For example, to warm the patient, the heat exchange fluid is warmed at the console heat exchanger and is pumped through a tubing assembly to and from the heat exchange device in a fluid loop. As the heat exchange fluid flows through the heat exchange device, it transfers heat to the patient, warming the patient.
  • the heat exchange device can include a catheter for placement in various locations in the body, such as a nasal cavity of the patient, a vasculature of the patient, or an esophagus of the patient.
  • the heat exchange device can include one or more pads configured to conform to the body of the patient.
  • the heat exchange device can include multiple instances of catheters and/or pads in parallel, in series, or both configured to be placed on the patient or in the patient for heat exchange.
  • the heat exchange device is disposable and is modular from the rest of the heat exchange loop and temperature management system including the temperature management console.
  • a tubing assembly is configured to connect the heat exchange console with the one or more heat exchange devices included in the fluid circuit(s). The tubing assembly can form a closed loop with the heat exchange device to ensure that the heat exchange fluid is sterile and/or is not infused into the patient’s body.
  • the heat exchange device(s) can be connected and disconnected, via connectors, from tubing that interfaces with the console heat exchanger that is part of the temperature management console.
  • the tubing assembly includes a supply tubing portion that carries heat exchange fluid toward the heat exchange device.
  • the tubing assembly includes a return tubing portion that carries heat exchange fluid from the heat exchange device(s) after the heat exchange fluid has exchanged heat with the patient at the heat exchange device(s).
  • a heat exchange device of the fluid loop is configured to operate at or below a threshold fluid pressure for the heat exchange fluid flowing within the heat exchange device.
  • the threshold fluid pressure is at or below a maximum fluid pressure that is permitted within the heat exchange device.
  • the tubing assembly in an example, can include a bypass tubing portion that allows heat exchange fluid to flow from the supply tubing portion to the return tubing portion by bypassing the heat exchange device.
  • the bypass tubing portion enables the heat exchange fluid to flow directly from the supply tubing portion to the return tubing portion, bypassing the heat exchange device.
  • To control fluid flow through the bypass tubing portion such as a bypass valve or flow control device, can be placed in the bypass tubing portion.
  • the bypass valve or flow control device is configured to open when the threshold pressure value is approached or exceeded in the tubing assembly, e.g., in the supply tubing portion.
  • the bypass valve is a passive, mechanical valve (such as a check valve) configured to open responsive to a threshold pressure being exceeded.
  • the bypass valve or flow control device is controlled by a control signal of a controller associated with the temperature management console.
  • the controller is configured to measure pressure values from a pressure sensor in the bypass tubing portion or in the supply or return tubing portion or the heat exchange device (or both or all). When a threshold pressure is exceeded, the controller controls the bypass valve or flow control device to open and allow the heat exchange fluid to bypass the heat exchange device(s) associated with the threshold pressure.
  • the bypass tubing portion can be located between the supply and return tubing portions at various distances between the heat exchange device and the console pump, e.g., the bypass tubing portion may be located downstream of the console pump. In certain implementations the bypass tubing portion may be located closer to the console pump than the heat exchange device or vice versa.
  • the tubing assembly in another example, can include a relief valve that allows heat exchange fluid to vent from the supply tubing portion when a threshold pressure is exceeded in the tubing assembly, e.g., in the supply tubing portion. To control fluid flow through the heat exchange device, the relief valve can be placed in the supply tubing portion.
  • the relief valve is configured to open when the threshold pressure value is approached or exceeded in the supply tubing portion.
  • the relief valve is a passive, mechanical valve (such as a check valve) configured to open responsive Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 to a threshold pressure being exceeded.
  • the relief valve is controlled by a control signal of a controller associated with the temperature management console.
  • the controller is configured to measure pressure values from a pressure sensor in the tubing assembly, e.g., in the supply tubing portion. When a threshold pressure is exceeded, the controller controls the relief valve to open and allow the heat exchange fluid to be vented and bypass the heat exchange device(s) associated with the threshold pressure.
  • the temperature management system is configured to ensure that a pressure of the heat exchange fluid in a fluid loop does not exceed a threshold pressure associated with the connected heat exchange device or devices.
  • the tubing assembly may be disposable and for single use.
  • the tubing assembly may be modular with respect to each of the temperature management console and the heat exchange device. Based on the tubing assembly selected, any heat exchange device compatible with the selected tubing assembly can be connected and used with the temperature management console in a closed heat exchange fluid loop. In an example, different instances of the tubing assembly can be tuned to different threshold pressures based on the corresponding desired heat exchange devices for use with that tubing assembly.
  • the relatively inexpensive tubing assembly can be removed/exchanged, and the particular heat exchange device can be connected. This ensures a high level of flexibility and modularity with respect to which heat exchange devices are connected and how many of the heat exchange device are connected.
  • the tubing assemblies and pressure management devices (such as the bypass valve, relief valve, pressure sensor(s), etc.) enable different combinations of the heat exchange devices to be attached without requiring modification to the heat exchange device(s) or the temperature management console.
  • FIGS.1A-1D each shows an illustration of an example tubing assembly including a bypass portion.
  • FIGS.2A-2B each shows an illustration of an example tubing assembly including a relief valve.
  • FIG. 3 shows an illustration of an example tubing assembly including a bypass portion.
  • FIG. 4 shows an illustration of an example tubing assembly including a bypass portion.
  • FIG.5 shows an embodiment of a temperature management system for use with a patient including an intravascular catheter as a heat exchange device.
  • FIG.6 shows an embodiment of a temperature management system for use with a patient including a set of surface pads as heat exchange devices.
  • FIGS.7A-7B each shows an embodiment of a temperature management system for use with a patient including an esophageal catheter as a heat exchange device.
  • FIG.8 shows an embodiment of a temperature management system for use with a patient including a nasal catheter as a heat exchange device.
  • FIG.9A shows an embodiment of a temperature management system for use with a patient including a cartridge and heat exchange plates.
  • FIG.9B shows an embodiment of a tubing system including a cartridge.
  • FIGS.10A-10B each shows a flow diagram including an example process.
  • FIG.11 is a diagram of an example computing system for executing operations of certain implementations of temperature management systems of FIGS.5 to 9A.
  • a temperature management system includes a heat exchange console that interfaces with a tubing assembly.
  • the tubing assembly is configured to interface with many different types of heat exchange devices.
  • the tubing assembly includes a device, such as a bypass tubing portion, pressure relief valve, and/or pressure sensor(s)configured to ensure that a fluid pressure within the attached heat exchange device does not exceed a threshold pressure.
  • the tubing assembly is configured to ensure that a maximum heat exchange fluid Attorney Docket No.40200-0508WO1 Client Docket No.
  • the temperature management system and/or tubbing assemblies are configured to ensure that a pressure of the heat exchange fluid in a fluid loop does not exceed a threshold pressure associated with the connected heat exchange device or devices.
  • the tubing assembly may be disposable and for single use.
  • the tubing assembly may be modular with respect to each of the temperature management console and the heat exchange device. Based on the tubing assembly selected, any heat exchange device compatible with the selected tubing assembly can be connected and used with the temperature management console in a closed heat exchange fluid loop.
  • different instances of the tubing assembly may include different threshold pressures based on the corresponding desired heat exchange devices for use with that tubing assembly.
  • the relatively inexpensive tubing assembly can be removed/exchanged, and the particular heat exchange device can be connected. This ensures a high level of flexibility and modularity with respect to which heat exchange devices are connected and how many of the heat exchange device are connected.
  • the tubing assemblies and pressure management devices (such as the bypass valve, relief valve, pressure sensor(s), etc.) ensure that a fluid pressure within the attached heat exchange device does not exceed a threshold pressure and/or enable different combinations of the heat exchange devices to be attached without requiring modification to the heat exchange device(s) or the temperature management console.
  • the bypass tubing portion connecting the supply and return tubing portions of the tubing assembly can enable one or more benefits.
  • FIGS. 1A-1D each show an illustration of an example tubing assembly 100 that includes a bypass portion 112.
  • FIG. 1A shows an illustration of an example tubing assembly 100 that includes a bypass portion 112 with a bypass valve 131.
  • the tubing Attorney Docket No.40200-0508WO1 Client Docket No.
  • Z20896WO-01 assembly is configured to form a fluid loop (also called a fluid circuit) that allows heat exchange fluid (such as saline) to flow from a heat exchange fluid source 102 to a heat exchange device (subsequently described) configured to connect to connectors 116a-b.
  • the tubing assembly 100 is further configured to interface with a heat exchanger on a temperature management console, subsequently described in relation to FIGS.5-9B.
  • the heat exchange fluid within the fluid loop is either warmed or cooled by the heat exchanger of the temperature management console and delivered to the heat exchange device that interfaces with a patient to warm or cool the patient.
  • the patient can be warmed or cooled in order to induce hypothermia or normothermia as needed for one or more medical processes, such as surgery.
  • the tubing assembly 100 includes a supply tubing portion 104 and a return tubing portion 106.
  • the supply tubing portion 104 is configured to be coupled to a patient heat exchange device to transport fluid from a fluid source 102 to the patient heat exchange device.
  • the supply tubing portion 104 includes a tube 108.
  • the supply tubing portion 104 is coupled to the fluid source interface, e.g. via a connector or bonding, and configured to receive fluid from the fluid source 102.
  • the supply tubing portion 104 includes a heat exchanger 121 configured to exchange heat with a corresponding console heat exchanger of the temperature management console, as subsequently described.
  • the heat exchanger 121 is configured to heat or cool the fluid being transported from the fluid source 102 to the patient heat exchange device.
  • the supply tubing portion 104 includes a supply connector 116a configured to connect with the patient heat exchange device.
  • the supply connector 116a is configured to connect to many different kinds of heat exchange devices that are interfaced with the patient.
  • the tubing assembly 100 is therefore usable with many different kinds of heat exchange devices and enables use of the temperature management console with these different kinds of heat exchange devices.
  • the supply tubing portion 104 can include a valve 119a at the supply connector 116a configured to close when the supply connector 116a is not connected to a heat exchange device.
  • the return tubing portion 104 can include a valve 119b at the return connector 116b configured to close when the supply connector 116a is not connected to a heat exchange device.
  • the threshold fluid pressure can include an absolute pressure value.
  • the threshold fluid pressure can include a value measuring a change in the fluid pressure.
  • the tubing assembly 100 includes a return tubing portion 106 configured to be coupled to the patient heat exchange device by connector 116b to transport the fluid from the patient heat exchange device.
  • the return tubing portion 106 includes a tube 110.
  • the return tubing portion 106 returns heat exchange fluid to a reservoir that is different than the fluid source 102 or the return tubing portion 106 returns heat exchange fluid to the supply tubing portion and then back to the heat exchange device in a closed loop.
  • the return tubing portion 106 returns heat exchange fluid to the fluid source 102.
  • the return tubing portion can include a return connector 116b configured to connect with the patient heat exchange device.
  • the tubes 108, 110 are flexible.
  • the tubes 108, 110 can include a diameter of between 0.20-0.35 inches.
  • the tubing assembly is a disposable, single use assembly.
  • the tubing assembly may be a sterile loop and include sterile fluid.
  • a fluid source 102 may be connected to the tubes 108, 110 of the tubing assembly 100 directly or via connectors 114a-b, respectively, as shown in FIG.1D.
  • the fluid source 102 can include a saline bag or another reservoir of heat exchange fluid.
  • the fluid source 102 is a reservoir of heat exchange fluid that receives sterile heat exchange fluid from a different fluid supply.
  • the fluid source 102 stores the heat exchange fluid for use in the recirculation of the heat exchange fluid through the tubing assembly and the heat exchange device that is interfaced with or in thermal contact with the patient.
  • the fluid may flow from the fluid source through the supply tubing portion, through the heat exchange device, through the return tubing portion, and back through the fluid source in a closed loop. In certain embodiments, the fluid may flow from the return tubing portion directly to the supply tubing portion, bypassing the fluid source.
  • a valve 111 can be located in the fluid source or between the fluid source and the supply or return tubing.
  • the valve is configured to prevent the fluid from returning into the fluid source 102 but direct the fluid back into the supply tubing in a closed loop.
  • the fluid may flow from the return tubing portion back into the fluid source, where the fluid source is designed to prevent mixing of the return fluid with fluid remaining Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 in the fluid source.
  • the fluid source may include one or more baffles that prevent said mixing.
  • a one way valve such as the one-way valve 128a (shown in Fig.1D) may be located on the return tubing portion to minimize leakage from the tubing assembly when the tubing assembly is not connected to or is disconnected from the heat exchange device.
  • Valves 128a-b may also be used to ensure that fluid does not leak in an embodiment that includes a removable or detachable bypass tubing portion 112.
  • each of valves 128a-b can include a one-way valve that allow fluid to proceed in the return tubing portion 106 toward the fluid source 102.
  • the fluid source 102 can include a portion (e.g., a reservoir) that is sealed or welded to the supply tubing portion and the return tubing portion to fluidly couple the fluid source 102 to the supply tubing portion 104 and the return tubing portion 106.
  • the fluid source 102 can include a sealable port 103 for adding fluid to the fluid source.
  • the sealable port 103 can be configured to maintain a sterility of the heat exchange fluid.
  • the sealable port can include a feedbag cap.
  • the fluid source 102 can be connected to the supply tubing 104 and the return tubing 106 by a bag spike to form a closed fluid loop, as subsequently described.
  • the fluid source 102 can be bonded or adhered or otherwise coupled to the to the supply tubing 104 and the return tubing 106 to form a closed fluid loop.
  • the tubing assembly 100 includes a bypass tubing portion 112 connecting the supply tubing portion 104 to the return tubing portion 106.
  • the bypass tubing portion 112 includes a bypass valve 124 configured to open the bypass tubing portion to redirect fluid to bypass the supply connector 116a and the return connector 116b for bypassing the patient heat exchange device.
  • the bypass valve 124 can be configured to open when a fluid pressure in the tubbing assembly, e.g., in the supply tubing portion downstream of a pump (e.g., at position 126) or in the return tubing portion upstream of the bypass tubing portion) exceeds a threshold fluid pressure.
  • the bypass portion 112 can ensure that a pressure of the heat exchange fluid in the heat exchange device does not exceed a value that may cause a malfunction of the heat exchange device.
  • a Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 heat exchange device may have a particular maximum allowable pressure for the heat exchange fluid flowing through it while it is in contact with or inserted in a patient.
  • the bypass valve 124 can be set to open before the particular maximum allowable fluid pressure is reached in the supply tubing portion 104 or the bypass tubing portion 112.
  • the bypass valve 124 can therefore be tuned to a threshold pressure corresponding to the heat exchange device that is connected or is to be connected to the connectors 116a-b.
  • the tubing assembly 100 can be compatible with that heat exchange device or any other heat exchange devices associated with a maximum pressure that is higher than the threshold pressure at which the bypass valve 124 is set to open.
  • the bypass tubing portion 112 of the tubing assembly 100 can include the following aspects.
  • the bypass tubing portion 112 includes a tube 122 that connects the supply tubing portion 104 to the return tubing portion 106.
  • the bypass tubing 122 can include a bypass valve 124 (e.g., a pressure relief valve) that is configured to automatically open and direct the heat exchange fluid to the return tubing portion 106 from the supply tubing portion 104 when the pressure in the supply tubing portion 104 exceeds the threshold pressure of the bypass valve 124.
  • the bypass valve 124 can therefore be a passive valve that opens or closes responsive to the fluid pressure without receiving a control signal.
  • the bypass valve 124 can include a check valve, such as a spring loaded ball valve, a spring loaded plate valve, or any similar such valve that is responsive to the fluid pressure in the tubing assembly, e.g., in the supply tubing portion 104.
  • the bypass valve 124 is configured to allow fluid to flow from the supply tubing portion 104 to the return tubing portion 106 but not vice versa.
  • a portion of the bypass valve 124 such as a spring or other mechanical device, can be mechanically tuned to respond to a particular threshold pressure value to open the valve 124.
  • the bypass valve 124 can include a check valve having a crack pressure that is the threshold fluid pressure.
  • the bypass valve 124 can include a duck valve.
  • the bypass valve 124 can include a spring loaded valve.
  • the particular threshold pressure to which the bypass valve 124 is tuned can depend on which corresponding one or more heat exchange devices that the tubing assembly 100 is configured to connect.
  • the bypass valve 124 can be set to have a relatively lower threshold pressure for use with surface heat exchange devices such as pads or Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 esophageal heat exchange catheters.
  • a pressure threshold of up to 12 PSI or 5-11 PSI.
  • the bypass valve 124 can be set to have a relatively higher threshold pressure for opening for use with other heat exchange devices such as intravascular catheters.
  • the threshold pressure value for the bypass valve 124 depends on the type of catheter configured to connect to the tubing assembly 100.
  • the tubing assembly 100 can be used with any heat exchange device associated with a maximum internal fluid pressure that is higher than the threshold pressure at which the bypass valve 124 is configured to open. As needed, a tolerance pressure can be added to a threshold pressure to ensure that the pressure within the tubing assembly 100 does not exceed the maximum pressure allowable for a given he exchange device.
  • the heat exchange device can include an esophageal catheter, one more external surface pads, an intravenous catheter, a nasal catheter, and/or a balloon catheter, as subsequently described. Each of these types of heat exchange devices, used either individually or in different combinations, can be associated with different pressure thresholds in the tubing assembly 100.
  • the bypass tubing portion 112 may be removable from the supply tubing portion 104 and the return tubing portion 106 so that the bypass tubing portion is modular relative to the supply tubing portion and the return tubing portion.
  • the bypass tubing portion 112 can be modular such that it can be replaced for a tubing assembly to connect to a particular heat exchange device.
  • one or more connectors can enable the bypass portion to be disconnected and a different bypass portion to be connected, such as one having a different threshold pressure for the pressure relief valve 124. This can allow the tubing assembly 100 to interface with or couple to a heat exchange device having a lower maximum pressure tolerance if needed.
  • the bypass tubing portion 112 can include a pressure sensor 120.
  • the pressure sensor 120 can be configured to measure fluid Attorney Docket No.40200-0508WO1 Client Docket No.
  • a controller associated with the temperature management console, or another device receives a signal from the pressure sensor 120 and causes the bypass valve 124, e.g., via electrical signal, to open or close.
  • the pressure sensor 120 is configured to communicate with the controller that is configured to control the bypass valve 124 to open or close the bypass valve responsive to the pressure sensor measuring the fluid pressure.
  • the pressure sensor 120 is located in the bypass tubing 122 for measuring the fluid pressure.
  • pressure sensor 120 is located in the supply tubing 108 for measuring the fluid pressure.
  • the bypass valve 131 includes a piston 133 and a spring 135. Similar to bypass valve 124 described in relation to FIG. 1C, the valve 131 has a crack pressure configured to allow fluid flow through the bypass portion 112 that is at a pressure threshold less than a pressure tolerance of the heat exchange device.
  • the tubing assembly 100 includes a near field communication (NFC) device 319 configured for being read by an NFC reader on the temperature management console.
  • the NFC device 319 can be configured to provide identification of the tubing assembly 100. For example, if the tubing assembly 100 has already been used with a particular patient the temperature management console can avoid operation until a brand new tubing assembly is used.
  • the identifier of the tubing assembly 100 can be associated with the particular pressure threshold for that tubing assembly.
  • the temperature management console can be configured to detect whether the pressure threshold for the tubing assembly 100 exceeds a pressure threshold for the connected heat exchange device or devices.
  • the NFC reader of the temperature management console comprises a radio frequency identifier (RFID) tag reader, and the NFC device 319 includes an RFID tag.
  • FIG.2A shows an illustration of an example tubing assembly 200 including a relief valve portion 202. Similar to tubing assembly 100, the tubing assembly 200 includes a supply tubing portion 204 configured to transport fluid from a fluid source to a patient heat exchange device configured to exchange heat with a patient.
  • the supply tubing portion 204 is coupled to the fluid source, e.g. via a connector or bonding, and is configured to receive Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 fluid from the fluid source 102.
  • the supply tubing portion 204 can include the supply connector 116a configured to connect with the patient heat exchange device.
  • the supply tubing portion 204 of tubing assembly 200 can include a heat exchanger 121 that is configured to exchange heat with a corresponding console heat exchanger of a temperature management console.
  • the heat exchanger 121 is configured to heat or cool the fluid being transported from the fluid source to the patient heat exchange device.
  • the tubing assembly 200 includes a return tubing portion configured to transport the fluid from the patient heat exchange device.
  • the return tubing portion can be coupled to the fluid source, e.g. via a connector or bonding and is configured to return fluid to the fluid source 102.
  • the return tubing portion 206 returns heat exchange fluid to the fluid source and then to the supply tubing portion 204 and back to the heat exchange device in a closed loop.
  • the return tubing portion 206 can return heat exchange fluid to a reservoir that is different than the fluid source 102.
  • the return tubing portion includes the return connector 116b configured to connect with the patient heat exchange device.
  • the tubing assembly 200 is configured to release the heat exchange fluid out of the fluid loop when a pressure is detected in the supply tubing portion 204 or the return tubing portion that exceeds a threshold pressure.
  • the supply tubing portion 204 includes a relief valve 214 configured to open the supply tubing portion to release fluid from the supply tubing portion when a fluid pressure exceeds a threshold fluid pressure.
  • the relief valve 214 is configured to operate in a manner similar to the bypass valve 124 described previously. In an embodiment, the relief valve opens when a pressure in the supply tubing portion 204 exceeds a threshold pressure at which the relief valve 214 is set or tuned to open.
  • the relief valve 214 can include a cover 212 configured to hinge open from a closed position to an open position when the fluid reaches the threshold pressure.
  • the fluid then follows the path 210 out of the relief valve 214 and into an environment of the tubing assembly 200.
  • the relief valve 214 can be tuned via a spring or other mechanical device to open at the threshold pressure desired for a particular heat exchange device, similar to the bypass valve 124 described previously.
  • the relief valve 214 shown has a cover 212 that is Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 configured to hinge open.
  • a check valve can be used as the relief valve 214 as long as the check valve is responsive to open at the threshold fluid pressure and not allow air (or allow a minimal amount of air) into the supply tubing portion 204.
  • the relief valve 214 is positioned upstream from the supply connector 116a and downstream from the heat exchanger 121.
  • the tubing assembly 200 can include a pressure sensor 220 configured to measure a fluid pressure in the supply tubing portion 204 at or near the connector 116a.
  • the pressure sensor 220 is configured to measure fluid pressure for controlling the relief valve 212 to open when the fluid pressure in the supply tubing portion exceeds the threshold fluid pressure.
  • a controller is configured to receive one or more signals from the pressure sensor 220 to control operation of the relief valve 214.
  • the pressure sensor 220 is configured to communicate with the controller, which is configured to control the relief valve 214 to open or close the relief valve responsive to the pressure sensor measuring the fluid pressure and communicating said measured fluid pressure value or signal to the controller.
  • FIG.2B shows a tubing assembly similar to the tubing assembly 200 of FIG.2A, except that there is a pressure sensor 220 but no relief valve 214.
  • Region 250 shows the supply tubing portion 204 and pressure sensor 220.
  • the pressure sensor 220 is configured to generate a signal representing a pressure in the tubing assembly, e.g., in the supply tubing portion 204.
  • a controller receives the signal from the pressure sensor 220 and can control a pump speed to raise or lower the pressure of the fluid within the patient heat exchange device.
  • any of the tubing assemblies of Figs 1A-1D and 2A-B described herein may include a pump tube configured to interface with a fluid pump of a temperature management console.
  • the pump can be a peristaltic pump configured to compress the pump tube against a raceway portion of the pump.
  • FIG.3 shows an illustration of an example tubing assembly 300. Similar to tubing assembly 100, the tubing assembly 300 can include a fluid source 102, a supply tubing portion 304 similar to supply tubing portion 104, a return tubing portion 306 similar to return tubing portion 106, and a bypass portion 112 including a pressure relief valve 131. In some implementations, the bypass portion 112 can be replaced with the relief valve portion 202 of tubing assembly 200.
  • the return tubing portion 306 can include a flow indicator 320 located between the bypass tubing portion 112 and the return connector 116b.
  • the flow indicator 320 is configured to detect or measure an amount of fluid flowing between the return tubing connector 116b and the bypass tubing portion 112.
  • the flow indicator 320 can indicate whether there are any leaks occurring in the heat exchange device when fluid is circulating.
  • the position of the flow indicator 320 on the return tubing portion 306 upstream from the bypass portion 112 in the return tubing portion can ensure that an accurate fluid flow is measured from the fluid pumped through the heat exchange device, e.g., when a bypass valve or relief valve is opened, the flow indicator may indicate whether there has been a change in the flow of fluid through the heat exchange device.
  • the tubing assembly 300 can include a pump tube 310 configured to interface with a fluid pump of the temperature management console.
  • the pump is a peristaltic pump configured to compress the pump tube 310 against a raceway portion of the pump.
  • the pump is a centrifugal pump connected in-line with the rest of the tubing assembly.
  • the pump tube 310 includes fluid flow through the pump and can be disconnected or reconnected to the tubing assembly.
  • the fluid pump can be configured to move fluid through the supply tubing portion 304 toward the supply connector 116a and into a heat exchange device.
  • the bypass tubing portion 112 can be located between the pump tube 310 and the supply connector 116a.
  • the pump tube 310 can be a different diameter and made of a different material than the tubing 308.
  • the pump tube 310 is configured for compression and expansion in response to contact by rollers of the pump.
  • the pump tube 310 is attached to the tubing 308 and is aligned in an arcuate raceway of the pump when the fluid loop is installed on Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 the temperature management console.
  • the pump drives fluid flow through the tubing 310, through an air trap cylinder 312, through a heat exchange coil 314, and to the heat exchange device.
  • the pump is controlled by a controller that is configured to control a speed of the pump and thus a rate of the fluid flow through the fluid loop.
  • the tubing assembly 300 includes an air trap 312 configured to trap air present in the supply tubing portion 304.
  • the air trap 312 is configured for trapping air in the supply tubing portion 304 during circulation of the heat exchange fluid.
  • the air trap 312 includes a chamber for storing fluid and trapping air bubbles from the fluid loop.
  • the air trap 312 is filled with working fluid during priming of the fluid loop.
  • the air trap 312 is held in an inverted position during priming to trap air bubbles.
  • the air trap 312 includes a cylinder.
  • the air trap 312 has an input and an output at an end of the air trap.
  • a first end of tubing enters the air trap through the input and a second end of tubing (output tubing) enters the air trap through the output, such that both the input and output tubing are in fluid communication with the air trap 312.
  • the end of the air trap having the input and output is at a lowest point on the air trap 312, below the air trap, when the air trap is inverted during priming, and at a highest point, above the air trap, when the air trap is not inverted during temperature management treatment after priming is completed.
  • the air trap 312 may be connected to an evacuation tube 318.
  • the evacuation tube 318 includes tubing configured to remove air from the air trap 312.
  • the tubing assembly 300 can include a heat exchanger that comprises a coil 314.
  • the coil 314 is configured to be disposed in a heat exchange bath of the console heat exchanger of the temperature management console.
  • the heat exchanger 121 previously described may be the coil 314.
  • the coil 314 may include a relatively thin tubular structure (relative to the tubing 308) that is shaped to form a relatively long passageway in a relatively small volume envelope. Generally, the coil 314 forms a spiraled or coiled structure with many loops or windings. This allows a long passageway to be submersed in a reservoir or bath fluid.
  • the bath fluid warms or cools the coil 314, thereby warming or cooling the working fluid flowing through the coil.
  • the Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 relatively long passageway of the coil helps allow the working fluid to be cooled or warmed to the desired temperature (e.g., approximately the bath temperature) by the time the working fluid has been pumped through the coil 314.
  • the coil 314 is made of a material (e.g., metal) that is highly thermally conductive.
  • the working fluid is pumped through the supply tubing portion 304 and through the coil 314, which is immersed in bath liquid (e.g., coolant) within a heat exchange bath of the console (as described in relation to FIG.5).
  • the heat exchange fluid flows through the coil 314.
  • the heat exchange fluid is in thermal communication with the bath liquid (e.g., coolant), and exchanges heat with the bath liquid, resulting in a cooling or warming of the heat exchange fluid to a desired temperature.
  • the temperature of the coolant in the heat exchange bath is controlled by the console, e.g., by exchanging heat with a refrigerant flowing through a refrigerant loop within the console.
  • the coil 314 increases a surface area of the supply tubing portion 304 that is exposed to the coolant in the heat exchange bath such that the heat exchange fluid may be quickly cooled or warmed.
  • the console and/or tubing assembly 300 includes a bubble sensor.
  • the bubble sensor or air sensor is configured to detect air in the supply tubing portion.
  • the supply tubing portion 304 can include a plurality of supply tubing branches. Each supply tubing branch can include an instance of the supply connector 116a, the bypass tubing portion 112, and the bypass valve 124. In an embodiment, each instance of the bypass tubing portion 112 is connected to one or more return tubing portions 306.
  • FIG.4 shows an illustration of an example tubing assembly 400, similar to tubing assemblies 100, 200, and 300 previously described.
  • the tubing assembly 400 fluid source interface can include a spike 402 configured to fluidly couple the supply tubing portion, the return tubing portion, or both to the fluid source 102.
  • the spike 402 (also called a saline spike or bag spike) is provided to tap the fluid source 102 and extract fluid from the fluid source.
  • the spike 402 is configured to puncture a fluid source, e.g., a saline bag, and drain the saline from the saline bag to fill the fluid loop of the tubing assembly 400 with working fluid.
  • the fluid source 102 may be placed above the rest of the working fluid loop so that gravity forces the fluid to exit the fluid source to fill or prime the fluid loop.
  • the spike 402 Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 may include an elongate body extending from a base portion.
  • the elongate body includes a first inflow lumen configured to remove fluid e.g., liquid, from a fluid bag into the fluid loop and a second outflow lumen configured to return liquid and/or air to the fluid bag from the fluid loop.
  • the base portion includes a grip having an angled profile to facilitate ease of insertion of the elongate body into the fluid bag.
  • the spike 402 in addition to preventing fluid leaking, provides for ease of grip of the spike and ease of insertion of the spike. The grip makes it easier for the caregiver to hold the spike and the beveled edge makes it easier for the spike to be inserted it into a fluid source, e.g., saline bag, in a single motion.
  • the tubing assembly 400 can include a heat exchange coil configured to be immersed in a console heat exchange bath, as described above, or alternatively a heat exchange cassette 410 configured to be disposed between heat exchange plates of the temperature management console (e.g., console 902).
  • the cassette may include a heat exchange membrane assembly or bag and a frame surrounding one or more sides of the membrane assembly or bag.
  • FIG. 5 shows an embodiment of a temperature management system 500 for use with a patient (e.g., patient 511) including an intravascular catheter as a heat exchange device.
  • the temperature management system 500 is configured to control a temperature of a patient’s body using a heat exchange device 510.
  • the temperature management system 500 is configured to heat or cool the patient (or both) to manage the temperature of the patient.
  • Managing the temperature of the patient may be referred to as heat exchange treatment of the patient, or heating/warming or cooling treatment of the patient.
  • the temperature management system 500 includes a heat exchange device 510, e.g., an intravascular heat exchange catheter configured to be inserted into a vasculature 505 of a patient, or a heat exchanger applied to the surface of a patient, such as a heat exchange pad.
  • a heat exchange device 510 e.g., an intravascular heat exchange catheter configured to be inserted into a vasculature 505 of a patient, or a heat exchanger applied to the surface of a patient, such as a heat exchange pad.
  • the temperature management system 500 can include other hardware configured for heating or cooling the patient, such as a heat exchange fluid loop, heating or cooling plates, heating or cooling cassettes, heat exchange baths, a refrigerant circuit and so forth as subsequently described for heating or cooling the patient (or both).
  • the heat exchange bath 505 is filled with a bath liquid.
  • the liquid can include water, glycol, or other coolant.
  • the heat exchange bath 505 is configured to be warmed or cooled to provide heating or cooling to the bath liquid, which is in thermal contact with the heat exchange fluid flowing through the tubing assembly and through the heat exchange device 510 to exchange heat with the patient.
  • the heat exchange bath 505 is configured to receive the heat exchanger of the tubing assembly, e.g., coil 314, that is fluidly coupled to, and makes up part of, the heat exchange fluid loop.
  • the heat exchange bath 505 includes an insulated cavity or chamber configured to receive the coil 314.
  • a temperature of the cavity or chamber 505 is controlled by the controller of the temperature management system 500.
  • the cavity or chamber is covered by a bath cap 507.
  • the cap may be attached to the heat exchange bath by a tether 509.
  • the tether 509 prevents the cap 507 from being lost, removed, or from falling into the cavity chamber of the heat exchange bath 505.
  • another retaining device can be used to couple the cap 507 to the heat exchange bath 505, e.g., a wire or strap.
  • the temperature management system 500 includes an extracorporeal control console 502 with a hardware interface 504, subsequently described.
  • the interface 504 allows the heat exchange device 510 to be coupled to the control console 502 via a heat exchange fluid loop that includes the heat exchange device and a tubing assembly as subsequently described.
  • the control console 502 includes a controller and/or processor for controlling the heat exchange device 510.
  • the control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 500 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 500.
  • the user interface 506 may present or display various types of information associated with temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions.
  • Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [0066]
  • the temperature management system 500 is configured to measure operational data representing operation of one or more aspects of the temperature management system 500.
  • the temperature management system 500 is configured to measure patient data representing one or more physiological parameters of the patient, e.g., patient temperature, during treatment of the patient.
  • the operational data and the patient data that are measured during treatment of the patient may be referred to as treatment data.
  • the temperature management system may be configured to control the temperature of the patient’s body based on the operational data (e.g., pump speed, coolant temperature, heat exchange bath temperature, working fluid temperature and power), and/or patient data, (e.g., patient temperature feedback received from temperature sensors located in or on the patient).
  • the temperature management system 500 is configured to display, by a user interface 506, an operational status of the temperature management system 500 and a physiological status of the patient during treatment.
  • the operational status can include whether the temperature management system 500 is working at a maximum cooling or heating power (e.g., effort) or a percentage of the maximum heating or cooling power.
  • the physiological status can include the temperature of the patient.
  • the temperature management system may be configured to circulate fluid through the tubing assembly and heat exchange device at a given temperature without temperature sensor feedback.
  • the user interface 506 is configured to display operational data and patient data on the user interface in a configuration that allows a user to determine a stage of a temperature management treatment (e.g., a treatment cycle or treatment process) being performed on the patient.
  • the user interface 506 shows a current operational treatment period (also called a stage).
  • Each treatment period of the temperature management treatment is associated with a target patient temperature and a rate of cooling or heating the patient to control the patient temperature to the target temperature.
  • a cooling or heating power exerted by the temperature management system 500 to cool or heat the patient is displayed on the user interface 506.
  • the cooling or heating power (also called “effort” or simply “power”) represents how hard the temperature management system 500 is working to heat or cool the patient.
  • the actual value of the power may represent a percentage of a maximum possible cooling or heating rate or capacity or capability of the system to cool or heat the patient based on a relationship between a heat Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 exchange bath, fluid or coolant temperature of the temperature management system 500 and the patient’s current temperature.
  • the extracorporeal control console 502 includes hardware for managing the patient temperature.
  • the hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop, and the fluid loop is configurable for connecting to the heat exchange device 510.
  • the fluid loop includes the tubing assembly 100, 200, 300, 400, etc. which facilitates connection of the heat exchange device 510 with the control console 502.
  • One or more temperature sensors 520a, 520b may be located on or in the heat exchange device 510 and/or may be located on a separate device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient.
  • an intravascular heat exchange catheter (which is device 510) comprises an elongate catheter body 522 and one or more heat exchangers 523a-c positioned on a distal portion of the catheter body 522, through which a thermal exchange fluid circulates.
  • the heat exchangers in the example of FIG.5, include inflatable cylindrical balloons.
  • the heat exchanger may include a serpentine or helical balloon or tubing (not shown).
  • Inflow and outflow lumens are present within the catheter body 522 to facilitate circulation of the thermal exchange fluid (e.g., sterile 0.9% sodium chloride solution or other suitable thermal exchange fluid) through the elongate catheter body 522 and through the heat exchange balloons.
  • the catheter body 522 may also include one or more working or through lumens 524 which extend through the catheter body 522 and terminate distally at one or more openings in the distal end of the catheter body.
  • the working lumens can each serve as a guidewire lumen to facilitate insertion and positioning of the catheter and/or may be used after insertion of the catheter for delivery of fluids, medicaments or other devices.
  • the temperature sensors 520a-b may be inserted through the working lumen of the catheter and advanced out of the distal end opening to a location beyond the distal end of the catheter body 522.
  • the temperature sensors 520a-b may be positioned at various other locations (e.g., the esophagus or rectum), using a separate device, catheter or probe, on or in the subject's body to sense the desired body temperature(s).
  • Various heat exchange catheters may be used in the embodiments described herein.
  • Non-limiting examples of various heat exchange devices, heat exchange catheters and/or heat exchange pads or body surface heat exchangers that may be used are described in U.S. Pat. No.9,492,633, titled Heat exchange catheter and their methods of manufacture and use and issued on November 15, 2016, and U.S. Application Pub. No.2013/0090708, titled Endovascular Cooling Catheter System Which Employs Phase-Changing Heat Exchange Media and filed on September 28, 2012, U.S. Pat. No. 9,662,243, titled Heat Exchange Catheters with Bi-Directional Fluid Flow and Their Methods of Manufacture and Use and issued on May 30, 2017, U.S. Pat.
  • the extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506.
  • the main housing 526 contains various Attorney Docket No.40200-0508WO1 Client Docket No.
  • the console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 500.
  • a display device or user interface 506 such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 500.
  • connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses.
  • One or more connectors 536 can connect the tubing 511 of the tubing assembly 100, 200, 300, 400, etc.
  • FIG. 6 shows an embodiment of a temperature management system 600 for use with a patient including a set of surface pads 602, 604, and 606 as heat exchange devices.
  • a single pad or a combination of the pads may be used with a patient.
  • the surface pad 602 can be configured to conform to a torso of the patient 511.
  • the surface pad 602 can be connected to the tubing assembly 100, via tubing 612,and connectors 616.
  • Tubing 612 can be used to connect the surface pads to the branching device 614.
  • the branching device 614 can be used to enable multiple pads to be connected to the same tubing assembly 100.
  • the surface pads 604, 606 can be connected in series to the branching device 614.
  • An additional tubing portion 610 can be used to connect pad 604 to pad 606 to create a continuous fluid loop.
  • the temperature management system 600 includes an extracorporeal control console 502 with a hardware interface 504, subsequently described.
  • the interface 504 allows the heat exchange devices 602, 604, 606, e.g., heat exchange surface pads, to be coupled to the control console 502 by interfacing with a heat exchange fluid loop that includes the heat exchange device and a tubing assembly as subsequently described.
  • the control console 502 includes a controller and/or processor for controlling the heat exchange devices 602, 604, 606.
  • the control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 600 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 600.
  • the user interface 506 may present or display various types of information associated with Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions.
  • the extracorporeal control console 502 includes hardware for managing the patient temperature.
  • the hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop, and the fluid loop is configurable for connecting to the heat exchange devices 602, 604, 606.
  • the fluid loop includes the tubing assembly 100 which facilitates connection of the heat exchange pads 602, 604, and 606 with the control console 502.
  • One or more temperature sensors may be located on or in the heat exchange devices 602, 604, 606 and/or may be located on a separate device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient.
  • the heat exchange devices 602, 604, 606, fluid loop, tubing assembly, and/or the temperature sensors may be disposable items intended for a single use.
  • the control console 502 may be a non- disposable system intended for multiple uses and to interface with the single-use device(s).
  • the extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506.
  • the main housing 526 contains various apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled thermal exchange fluid through the heat exchange devices 602, 604, 606 to effectively modify and/or control the subject's body temperature.
  • the console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 600.
  • connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses.
  • One or more connectors 616 can connect the tubing of the tubing assembly 100, 200, 300, 400, etc. to the inflow and outflow tubes of the heat exchange surface pads 602, 604, 606.
  • the heat exchange pads 602, 604, 606 are configured to receive heat exchange fluid from the tubing assembly 100, 200, 300, 400, etc. and heat or cool the patient 511.
  • the heat exchange pads 602, 604, and 606 are configured to heat or cool the patient based on the temperature set by the user on the control console 502.
  • FIG.7A shows an embodiment of a temperature management system 700 for use with a patient including an esophageal catheter as a heat exchange device.
  • the temperature management system 700 is similar to the temperature management system 500 described previously.
  • the heat exchange device of the temperature management system 700 includes an esophageal catheter 702.
  • the esophageal catheter 702 is placed inside an esophagus 704 of the patient 511 to exchange heat with the patient.
  • the catheter 702 has a gastric lumen 710 (e.g., a through lumen).
  • the through lumen 710 can extend to the stomach 714 of the patient 511 at a second end 712 of the through lumen.
  • the temperature management system 700 includes an extracorporeal control console 502 with a hardware interface 504, subsequently described.
  • the interface 504 allows the heat exchange device 702 to be coupled to the control console 502 by interfacing with a heat exchange fluid loop that includes the heat exchange device and a tubing assembly as subsequently described.
  • the control console 502 includes a controller and/or processor for controlling the heat exchange device 702.
  • the control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 700 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 700.
  • the user interface 506 may present or display various types of information associated with temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions.
  • the extracorporeal control console 502 includes hardware for managing the patient temperature.
  • the hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop, and the fluid loop is configurable for connecting to the heat exchange device 702.
  • the fluid loop includes the tubing assembly 100 which facilitates connection of the esophageal catheter 702 with the control console 502.
  • One or more temperature sensors may be located on or in the heat exchange device 702 and/or may be located on a separate Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient.
  • the heat exchange device 702, fluid loop, tubing assembly and/or the temperature sensors may be disposable items intended for a single use.
  • the control console 502 may be a non-disposable system intended for multiple uses and to interface with the single-use device(s).
  • the extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506.
  • the main housing 526 contains various apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled thermal exchange fluid through the esophageal catheter 702 to effectively modify and/or control the subject's body temperature.
  • the console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 700.
  • connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses.
  • One or more connectors 616 can connect the tubing of the tubing assembly 100, 200, 300, 400, etc. to the inflow and outflow tubes of the esophageal catheter 702.
  • the esophageal catheter 702 is configured to receive heat exchange fluid from the tubing assembly 100, 200, 300, 400, etc. and heat or cool the patient 511.
  • the catheter 702 can include a heat transfer device or region that includes a fluid path defined by an inflow lumen and an outflow lumen. Heat exchange fluid may flow along the fluid path in a closed loop.
  • the heat exchange fluid is circulated along the fluid path for a time sufficient to control a body temperature in the patient 511.
  • the esophageal catheter 702 may include a heat transfer region having a splined inner surface surrounding the heat exchange fluid flow path.
  • the esophageal catheter may include a heat exchange region along the length of the catheter or along a discrete heat transfer region that is confined to one or more sections of the patient's esophagus.
  • the esophageal catheter 702 is configured to heat or cool the patient based on the temperature set by the user on the control console 502. [0083]
  • the esophageal catheter 702 is configured to heat or cool the patient 511 by being placed in the esophagus of the patient 511.
  • FIG.7B shows an embodiment of a temperature management system 701 for use with a patient including an esophageal catheter as a heat exchange device.
  • the temperature management system 701 is similar to the temperature management system 500 described previously.
  • the heat exchange device of the temperature management system 701 includes a stomach/esophageal catheter 720.
  • the stomach/esophageal catheter 720 is placed inside an esophagus 704 of the patient 511 and extends to the stomach of the patient.
  • the temperature management system 701 includes an extracorporeal control console 502 with a hardware interface 504, subsequently described.
  • the interface 504 allows the heat exchange device 720 to be coupled to the control console 502 by interfacing with a heat exchange fluid loop that includes the heat exchange device and a tubing assembly.
  • the control console 502 includes a controller and/or processor for controlling the heat exchange device 720.
  • the control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 701 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 701.
  • the user interface 506 may present or display various types of information associated with temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions.
  • the extracorporeal control console 502 includes hardware for managing the patient temperature.
  • the hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop that, and the fluid loop is configurable for connecting to the heat exchange device 720.
  • the fluid loop includes the tubing assembly 100 which facilitates connection of the stomach/esophageal catheter 720with the control console 502.
  • One or more temperature sensors may be located on or in the heat exchange device 720 and/or may be located on a separate device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient.
  • the heat exchange device 720, fluid loop, tubing assembly and/or the temperature sensors 520a-b may be disposable items intended for a single use.
  • the control console 502 may be a non-disposable system intended for multiple uses and to interface with the single-use device(s).
  • Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [0087]
  • the extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506.
  • the main housing 526 contains various apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled thermal exchange fluid through the stomach/esophageal catheter 720 to effectively modify and/or control the subject's body temperature.
  • the console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 701.
  • connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses.
  • One or more connectors 616 can connect the tubing of the tubing assembly 100, 200, 300, 400, etc.
  • the catheter 720 is configured to receive heat exchange fluid from the tubing assembly 100, 200, 300, 400, etc. and heat or cool the patient 511.
  • the catheter 720 can include a heat transfer device or region that includes a fluid path defined by an inflow lumen and an outflow lumen. Heat exchange fluid flows along the fluid path. The heat exchange fluid is circulated along the fluid path for a time sufficient to control a body temperature in the patient 511.
  • the catheter 720 is configured to heat or cool the patient based on the temperature set by the user on the control console 502.
  • the catheter 720 is configured to heat or cool the patient 511 by being advanced through the esophagus and into the stomach of the patient 511.
  • An example of the catheter 720 can include an expandable balloon at its distal end. Fluid flows through the catheter into the balloon and then a balloon 722 is expanded with the heat exchange fluid, which exchanges heat with the stomach of the patient. Examples of the stomach/esophageal catheter 720 are described in U.S. Pat. No.9,138,344, issued on September 22, 2015, the entire contents of which are incorporated by reference herein.
  • FIG. 8 shows an embodiment of a temperature management system 800 for use with a patient including a nasal catheter 802 as a heat exchange device.
  • the nasal catheter 802 can be placed inside a nasal cavity 804 of the patient 511.
  • the heat exchange fluid can flow through the catheter 802 to heat or cool the patient's head from the nasal cavity 804.
  • Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01
  • the heat exchange fluid can be expelled into the nasal cavity 804 of the patient by the catheter 802.
  • the temperature management system 701 includes an extracorporeal control console 502 with a hardware interface 504.
  • the interface 504 allows the heat exchange device 802 to be coupled to the control console 502 by interfacing with a heat exchange fluid loop that includes the heat exchange device and a tubing assembly.
  • the control console 502 includes a controller and/or processor for controlling the heat exchange device 802.
  • the control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 800 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 800.
  • the user interface 506 may present or display various types of information associated with temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions.
  • the extracorporeal control console 502 includes hardware for managing the patient temperature.
  • the hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop that, and the fluid loop is configurable for connecting to the heat exchange device 802.
  • the fluid loop includes the tubing assembly 100 which facilitates connection of the nasal catheter 802 with the control console 502.
  • One or more temperature sensors may be located on or in the heat exchange device 802 and/or may be located on a separate device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient.
  • the heat exchange device 802, fluid loop, tubing assembly and/or the temperature sensors 520a-b may be disposable items intended for a single use.
  • the control console 502 may be a non-disposable system intended for multiple uses and to interface with the single-use device(s).
  • the extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506.
  • the main housing 526 contains various apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 thermal exchange fluid through the heat exchange device 802 to effectively modify and/or control the subject's body temperature.
  • thermal exchange fluid e.g., coolant, refrigerant, saline
  • the console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 800.
  • a display device or user interface 506 such as a touch screen system
  • connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses.
  • One or more connectors can connect the tubing assembly 100, 200, 300, 400, etc. to the inflow and outflow tubes of the nasal catheter 802.
  • the catheter 802 is configured to heat or cool the patient 511 by being placed in the nasal cavity of the patient 511. In some implementations, the catheter 802 can release heat exchange fluid into the nasal cavity to cool the patient 511.
  • Heat exchange fluid can circulate in the catheter 802 in either a closed loop or sprayed into the nasal cavity.
  • the catheter 802 are described in U.S. Pat. No.8,512,280, issued on August 20, 2013, the entire contents of which are incorporated by reference herein.
  • the nasal catheter 802 can include the RhinoChill TM intranasal cooling system of Benechill Inc. of San Diego CA, USA.
  • FIG.9A shows an embodiment of a temperature management system 900 for use with a patient including a tubing assembly 902 and heat exchange plates.
  • FIG.9B shows an embodiment of a tubing assembly 902 including a cassette 904. The cassette 904 is inserted between heat exchange plates of the temperature management console 900.
  • the cassette 904 includes a heat exchange membrane or bag 906 fillable with heat exchange fluid that is warmed or cooled by the heat exchange plates of the temperature management console 900.
  • a data connector 908 is configured to obtain data from one or more sensors of a sensor package 910 of the tubing assembly 902.
  • the sensor package 910 can include one or more sensors such as a pressure sensor configured to measure a fluid pressure in the tubing assembly 902, e.g., in the supply tubing portion, similar to the pressure sensors described previously in relation to tubing assembly 100.
  • a pump tube 910 is connected to the cassette 904 and to the rest of the tubing assembly 902 through a cartridge housing 912.
  • the tubing assembly 902 may include a bypass tubing portion 112 connecting supply and return tubing portions of the tubing assembly and including a bypass valve or pressure relief valve as described herein to ensure that a Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 connected heat exchange device does not exceed a maximum pressure.
  • the tubing assembly may be connectable to any of the heat exchange devices described herein, e.g., esophageal catheters, intravascular catheters or surface pads.
  • FIG. 10A shows a flow diagram of an example process 1000 for treatment of a patient by the temperature management system (e.g., temperature management systems of any of FIGS.5 to 9B, described previously.
  • the process 1000 is configured to be performed by a controller included in the temperature management system.
  • the controller is configured to process instructions for performing the process 1000.
  • the process 1000 includes receiving (1002) a pressure measurement from a pressure sensor.
  • the pressure sensor is located within a supply tubing portion of the tubing assembly.
  • the pressure sensor is located within a bypass tubing portion of the tubing assembly.
  • the process 1000 includes identifying (1004) a heat exchange device or devices connected to the tubing assembly.
  • the heat exchange device or devices can include one or more surface pads, an intravascular catheter, a nasal catheter, an esophageal catheter, or a combination thereof.
  • the process 1000 includes determining (1006), based on the identified heat exchange device or devices, a threshold pressure for operation of at least one connected heat exchange device.
  • the threshold pressure is calculated depending on which heat exchange device or devices are detected or identified.
  • a pressure sensor is associated with each branch of one or more branches of the fluid loop. Each branch is associated with a respective heat exchange device and a respective threshold fluid pressure for operation of the heat exchange device.
  • the process 1000 includes, when the measured pressure exceeds the threshold pressure, causing (1008), by the controller, a valve to open to lower a pressure in the tubing assembly, e.g., a supply tubing portion that is connected to the at least one connected heat exchange device.
  • the controller is configured for causing (1010) a pump to circulate heat exchange fluid through the at least one connected heat exchange device.
  • the process includes, when the measured pressure falls below another threshold value, causing (1012) the valve to close while causing the pump to continue pumping the heat exchange fluid through the at least one heat exchange device.
  • Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [0098]
  • FIG. 10B shows a flow diagram of an example process 1020 for treatment of a patient by the temperature management system (e.g., temperature management systems of any of FIGS.5 to 9B, described previously.
  • the process 1020 is configured to be performed by a controller included in the temperature management system.
  • the controller is configured to process instructions for performing the process 1020.
  • the process 1020 includes identifying (1022) a heat exchange device or devices connected to a tubing assembly that has a bypass tubing portion for causing heat exchange fluid to bypass the heat exchange device.
  • the process 1020 includes determining (1024), based on the identified heat exchange device or devices, a threshold pressure for operation of at least one connected heat exchange device.
  • the process 1020 includes, when the pressure exceeds the threshold pressure, causing a bypass valve to open and directing (1026) flow of heat exchange fluid from a supply tubing portion through the bypass tubing portion to a return tubing portion.
  • the process 1020 includes causing (1028) a pump to circulate some heat exchange fluid through the at least one connected heat exchange device and some heat exchange fluid through the bypass tubing portion.
  • FIG.11 shows an example computer system 1500 that includes a processor 1500, a memory 1520, a storage device 1530 and an input/output device 1140. Each of the components 1500, 1520, 1530 and 1140 can be interconnected, for example, by a system bus 1150.
  • the processor 1500 is capable of processing instructions for execution within the system 1500. In some implementations, the processor 1500 is a single-threaded processor, a multi-threaded processor, or another type of processor.
  • the processor 1500 is capable of processing instructions stored in the memory 1520 or on the storage device 1530.
  • the memory 1520 and the storage device 1530 can store information within the system 1500.
  • the input/output device 1140 provides input/output operations for the system 1500.
  • the input/output device 1140 can include one or more of a network interface device, e.g., an Ethernet card, a serial communication device, Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 e.g., an RS-232 port, and/or a wireless interface device, e.g., an 802.11 card, a 3G wireless modem, a 4G wireless modem, a 5G wireless modem, etc.
  • the input/output device can include driver devices configured to receive input data and send output data to other input/output devices, e.g., keyboard, printer and display devices 1160.
  • driver devices configured to receive input data and send output data to other input/output devices, e.g., keyboard, printer and display devices 1160.
  • mobile computing devices, mobile communication devices, and other devices can be used.
  • Some implementations described in this specification e.g., the processor of the temperature management system, etc.
  • Some implementations described in this specification can be implemented as one or more computer programs, i.e., one or more modules of computer program instructions, encoded on computer storage medium for execution by, or to control the operation of, data processing apparatus.
  • a computer storage medium can be, or can be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them.
  • a computer storage medium is not a propagated signal
  • a computer storage medium can be a source or destination of computer program instructions encoded in an artificially generated propagated signal.
  • the computer storage medium can also be, or be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices).
  • the term “data processing apparatus” encompasses all kinds of apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, a system on a chip, or multiple ones, or combinations, of the foregoing.
  • the apparatus can include special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).
  • the apparatus can also include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross- Attorney Docket No.40200-0508WO1 Client Docket No.
  • a computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages.
  • a computer program may, but need not, correspond to a file in a file system.
  • a program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code).
  • a computer program can be deployed for execution on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.
  • Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read only memory or a random access memory or both.
  • a computer includes a processor for performing actions in accordance with instructions and one or more memory devices for storing instructions and data.
  • a computer may also include or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto optical disks, or optical disks.
  • data e.g., magnetic, magneto optical disks, or optical disks.
  • Devices suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices (e.g., EPROM, EEPROM, flash Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 memory devices, and others), magnetic disks (e.g., internal hard disks, removable disks, and others), magneto optical disks, and CD-ROM and DVD-ROM disks.
  • semiconductor memory devices e.g., EPROM, EEPROM, flash Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 memory devices, and others
  • magnetic disks e.g., internal
  • processors and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.
  • operations can be implemented on a computer having a display device (e.g., a monitor, or another type of display device) for displaying information to the user and a keyboard and a pointing device (e.g., a mouse, a trackball, a tablet, a touch sensitive screen, or another type of pointing device) by which the user can provide input to the computer.
  • a display device e.g., a monitor, or another type of display device
  • a keyboard and a pointing device e.g., a mouse, a trackball, a tablet, a touch sensitive screen, or another type of pointing device
  • a computer can interact with a user by sending documents to and receiving documents from a device that is used by the user; for example, by sending web pages to a web browser on a user’s client device in response to requests received from the web browser.
  • a computer system may include a single computing device, or multiple computers that operate in proximity or generally remote from each other and typically interact through a communication network.
  • Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an inter-network (e.g., the Internet), a network comprising a satellite link, and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
  • LAN local area network
  • WAN wide area network
  • inter-network e.g., the Internet
  • peer-to-peer networks e.g., ad hoc peer-to-peer networks.

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Abstract

A tubing assembly for use with a temperature management system, the tubing assembly comprising: a supply tubing portion configured to be coupled to a patient heat exchange device to transport fluid from a fluid source to the patient heat exchange device, a return tubing portion configured to be coupled to the patient heat exchange device to transport the fluid from the patient heat exchange device, the return tubing portion, a bypass tubing portion connecting the supply tubing portion to the return tubing portion; and a bypass valve or relief valve.

Description

Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 TUBING ASSEMBLIES FOR TEMPERATURE MANAGEMENT SYSTEMS CLAIM OF PRIORITY [0001] This application claims priority to U.S. Patent Application Serial No.63/633,624, filed on April 12, 2024, the entire contents of which are hereby incorporated by reference. TECHNICAL FIELD [0002] The present disclosure relates generally to the fields of medicine and engineering and more particularly to improved devices, systems and methods for controlling a body temperature of a patient. BACKGROUND [0003] Normothermia is a condition of normal body temperature. Though temperature does vary at different parts of the body, the normal core body temperature of a human adult is often stated to be at 98.6 degrees Fahrenheit or 37.0 degrees Celsius. There are numerous therapeutic reasons for inducing hypothermia (a decrease in the core body temperature), or warming a hypothermic patient to normothermia, or (rarely) to hyperthermia, or inducing normothermia (approximately 37 degrees Celsius) in a patient suffering from an elevated temperature. For example, hypothermia may be induced to minimize damage to the brain or spinal cord when a patient has suffered a head injury or stroke, or to minimize damage to heart and brain tissue when a patient has undergone cardiac arrest or suffered a myocardial infarct (heart attack). Mild hypothermia has been shown to both increase the contractility of the heart muscle and to reduce its metabolic requirements. Indeed, if the hypothermia is systemic, the metabolic demands of the entire body are generally reduced, so that the demands placed on the heart may be reduced. It may sometimes also be desirable to induce hypothermia during surgery, especially neurosurgery, once again to minimize tissue damage. [0004] One method for inducing hypothermia is by intravascular or endovascular temperature management wherein a heat exchange catheter is inserted into a blood vessel and a thermal exchange fluid is circulated through a heat exchanger positioned on the Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 portion of the catheter that is inserted in the blood vessel. As the thermal exchange fluid circulates through the catheter's heat exchanger, it exchanges heat with blood flowing past the heat exchanger in the blood vessel. Such technique can be used to cool the patient’s flowing blood thereby resulting in a lowering of the subject's core body temperature to some desired target temperature. Endovascular temperature management is also capable of warming the body and/or of controlling body temperature to maintain a monitored body temperature at some selected temperature. If a controlled rate of re-warming or re-cooling from the selected target temperature is desired, that too can be accomplished by carefully controlling the amount of heat added or removed from the body and thereby controlling the temperature change of the patient. [0005] Other methods for heat exchange are possible. These methods can include heating or cooling materials configured to touch a surface of the patient, such as a patient’s skin. These methods can include placement of a catheter into an orifice of the patient, such as nasal cavity or an esophagus, and circulating heat exchange fluid through the catheter to heat or cool the patient. SUMMARY [0006] This document describes a temperature management system comprising a heat exchange console that interfaces or couples with a tubing assembly. The tubing assembly is configured to interface or couple with many different types of heat exchange devices. The tubing assembly includes one or more devices, such as a bypass tubing portion, relief valve, and/or pressure sensor(s), configured to ensure that a fluid pressure within the attached heat exchange device does not exceed a threshold pressure. The tubing assembly is configured to ensure that a maximum heat exchange fluid pressure tolerance of the connected heat exchange device cannot be exceeded. [0007] Temperature management systems are configured to include a heat exchange fluid loop (also called a fluid circuit) that circulates heat exchange fluid (such as saline) through a heat exchange device placed on or in a patient. The heat exchange device is configured to control a temperature of the patient by either raising or lowering the patient’s body temperature. The heat exchange fluid flows in the fluid loop through the heat exchange device and can be heated or cooled at a console based heat exchanger at a temperature Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 management console. For example, to cool the patient, the heat exchange fluid is cooled at the console heat exchanger and is pumped through a tubing assembly to and from the heat exchange device in a fluid loop. As the heat exchange fluid flows through the heat exchange device, it absorbs heat from the patient, cooling the patient. For example, to warm the patient, the heat exchange fluid is warmed at the console heat exchanger and is pumped through a tubing assembly to and from the heat exchange device in a fluid loop. As the heat exchange fluid flows through the heat exchange device, it transfers heat to the patient, warming the patient. The heat exchange device can include a catheter for placement in various locations in the body, such as a nasal cavity of the patient, a vasculature of the patient, or an esophagus of the patient. The heat exchange device can include one or more pads configured to conform to the body of the patient. In some implementations, the heat exchange device can include multiple instances of catheters and/or pads in parallel, in series, or both configured to be placed on the patient or in the patient for heat exchange. In some implementations, the heat exchange device is disposable and is modular from the rest of the heat exchange loop and temperature management system including the temperature management console. [0008] A tubing assembly is configured to connect the heat exchange console with the one or more heat exchange devices included in the fluid circuit(s). The tubing assembly can form a closed loop with the heat exchange device to ensure that the heat exchange fluid is sterile and/or is not infused into the patient’s body. As described herein, the heat exchange device(s) can be connected and disconnected, via connectors, from tubing that interfaces with the console heat exchanger that is part of the temperature management console. The tubing assembly includes a supply tubing portion that carries heat exchange fluid toward the heat exchange device. The tubing assembly includes a return tubing portion that carries heat exchange fluid from the heat exchange device(s) after the heat exchange fluid has exchanged heat with the patient at the heat exchange device(s). [0009] Generally, a heat exchange device of the fluid loop is configured to operate at or below a threshold fluid pressure for the heat exchange fluid flowing within the heat exchange device. In some implementations, the threshold fluid pressure is at or below a maximum fluid pressure that is permitted within the heat exchange device. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [0010] To ensure that a maximum fluid pressure in the heat exchange device is not exceeded, the tubing assembly, in an example, can include a bypass tubing portion that allows heat exchange fluid to flow from the supply tubing portion to the return tubing portion by bypassing the heat exchange device. In other words, the bypass tubing portion enables the heat exchange fluid to flow directly from the supply tubing portion to the return tubing portion, bypassing the heat exchange device. To control fluid flow through the bypass tubing portion, such as a bypass valve or flow control device, can be placed in the bypass tubing portion. The bypass valve or flow control device is configured to open when the threshold pressure value is approached or exceeded in the tubing assembly, e.g., in the supply tubing portion. In some implementations, where a bypass valve is used, the bypass valve is a passive, mechanical valve (such as a check valve) configured to open responsive to a threshold pressure being exceeded. In some implementations, the bypass valve or flow control device is controlled by a control signal of a controller associated with the temperature management console. The controller is configured to measure pressure values from a pressure sensor in the bypass tubing portion or in the supply or return tubing portion or the heat exchange device (or both or all). When a threshold pressure is exceeded, the controller controls the bypass valve or flow control device to open and allow the heat exchange fluid to bypass the heat exchange device(s) associated with the threshold pressure. In certain implementations, the bypass tubing portion can be located between the supply and return tubing portions at various distances between the heat exchange device and the console pump, e.g., the bypass tubing portion may be located downstream of the console pump. In certain implementations the bypass tubing portion may be located closer to the console pump than the heat exchange device or vice versa. [0011] To ensure that a maximum fluid pressure in the heat exchange device is not exceeded, the tubing assembly, in another example, can include a relief valve that allows heat exchange fluid to vent from the supply tubing portion when a threshold pressure is exceeded in the tubing assembly, e.g., in the supply tubing portion. To control fluid flow through the heat exchange device, the relief valve can be placed in the supply tubing portion. The relief valve is configured to open when the threshold pressure value is approached or exceeded in the supply tubing portion. In some implementations, the relief valve is a passive, mechanical valve (such as a check valve) configured to open responsive Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 to a threshold pressure being exceeded. In some implementations, the relief valve is controlled by a control signal of a controller associated with the temperature management console. The controller is configured to measure pressure values from a pressure sensor in the tubing assembly, e.g., in the supply tubing portion. When a threshold pressure is exceeded, the controller controls the relief valve to open and allow the heat exchange fluid to be vented and bypass the heat exchange device(s) associated with the threshold pressure. [0012] The implementations described herein can provide one or more advantages. The temperature management system is configured to ensure that a pressure of the heat exchange fluid in a fluid loop does not exceed a threshold pressure associated with the connected heat exchange device or devices. The tubing assembly may be disposable and for single use. The tubing assembly may be modular with respect to each of the temperature management console and the heat exchange device. Based on the tubing assembly selected, any heat exchange device compatible with the selected tubing assembly can be connected and used with the temperature management console in a closed heat exchange fluid loop. In an example, different instances of the tubing assembly can be tuned to different threshold pressures based on the corresponding desired heat exchange devices for use with that tubing assembly. To use a different heat exchange device with the temperature management console, the relatively inexpensive tubing assembly can be removed/exchanged, and the particular heat exchange device can be connected. This ensures a high level of flexibility and modularity with respect to which heat exchange devices are connected and how many of the heat exchange device are connected. The tubing assemblies and pressure management devices (such as the bypass valve, relief valve, pressure sensor(s), etc.) enable different combinations of the heat exchange devices to be attached without requiring modification to the heat exchange device(s) or the temperature management console. [0013] The implementations described herein can include one or more of the following embodiments of the claims section below. The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIGS.1A-1D each shows an illustration of an example tubing assembly including a bypass portion. [0015] FIGS.2A-2B each shows an illustration of an example tubing assembly including a relief valve. [0016] FIG. 3 shows an illustration of an example tubing assembly including a bypass portion. [0017] FIG. 4 shows an illustration of an example tubing assembly including a bypass portion. [0018] FIG.5 shows an embodiment of a temperature management system for use with a patient including an intravascular catheter as a heat exchange device. [0019] FIG.6 shows an embodiment of a temperature management system for use with a patient including a set of surface pads as heat exchange devices. [0020] FIGS.7A-7B each shows an embodiment of a temperature management system for use with a patient including an esophageal catheter as a heat exchange device. [0021] FIG.8 shows an embodiment of a temperature management system for use with a patient including a nasal catheter as a heat exchange device. [0022] FIG.9A shows an embodiment of a temperature management system for use with a patient including a cartridge and heat exchange plates. [0023] FIG.9B shows an embodiment of a tubing system including a cartridge. [0024] FIGS.10A-10B each shows a flow diagram including an example process. [0025] FIG.11 is a diagram of an example computing system for executing operations of certain implementations of temperature management systems of FIGS.5 to 9A. DETAILED DESCRIPTION [0026] A temperature management system includes a heat exchange console that interfaces with a tubing assembly. The tubing assembly is configured to interface with many different types of heat exchange devices. The tubing assembly includes a device, such as a bypass tubing portion, pressure relief valve, and/or pressure sensor(s)configured to ensure that a fluid pressure within the attached heat exchange device does not exceed a threshold pressure. The tubing assembly is configured to ensure that a maximum heat exchange fluid Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 pressure tolerance of the connected heat exchange device is not exceeded, as described herein. [0027] The implementations described herein can provide one or more advantages. The temperature management system and/or tubbing assemblies are configured to ensure that a pressure of the heat exchange fluid in a fluid loop does not exceed a threshold pressure associated with the connected heat exchange device or devices. The tubing assembly may be disposable and for single use. The tubing assembly may be modular with respect to each of the temperature management console and the heat exchange device. Based on the tubing assembly selected, any heat exchange device compatible with the selected tubing assembly can be connected and used with the temperature management console in a closed heat exchange fluid loop. In an example, different instances of the tubing assembly may include different threshold pressures based on the corresponding desired heat exchange devices for use with that tubing assembly. To use a different heat exchange device with the temperature management console, the relatively inexpensive tubing assembly can be removed/exchanged, and the particular heat exchange device can be connected. This ensures a high level of flexibility and modularity with respect to which heat exchange devices are connected and how many of the heat exchange device are connected. The tubing assemblies and pressure management devices (such as the bypass valve, relief valve, pressure sensor(s), etc.) ensure that a fluid pressure within the attached heat exchange device does not exceed a threshold pressure and/or enable different combinations of the heat exchange devices to be attached without requiring modification to the heat exchange device(s) or the temperature management console. [0028] The bypass tubing portion connecting the supply and return tubing portions of the tubing assembly can enable one or more benefits. When supply and return tubing portions include valved connectors, the tubing assembly allows a priming of the tubing assembly and fluid loop prior to attaching a patient heat exchange device. The bypass tubing directs fluid from the supply to return tubing and prevents fluid from leaking out of the circuit, e.g., via a pressure relief valve, and onto the floor. [0029] FIGS. 1A-1D each show an illustration of an example tubing assembly 100 that includes a bypass portion 112. FIG. 1A shows an illustration of an example tubing assembly 100 that includes a bypass portion 112 with a bypass valve 131. The tubing Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 assembly is configured to form a fluid loop (also called a fluid circuit) that allows heat exchange fluid (such as saline) to flow from a heat exchange fluid source 102 to a heat exchange device (subsequently described) configured to connect to connectors 116a-b. The tubing assembly 100 is further configured to interface with a heat exchanger on a temperature management console, subsequently described in relation to FIGS.5-9B. The heat exchange fluid within the fluid loop is either warmed or cooled by the heat exchanger of the temperature management console and delivered to the heat exchange device that interfaces with a patient to warm or cool the patient. As previously described, the patient can be warmed or cooled in order to induce hypothermia or normothermia as needed for one or more medical processes, such as surgery. [0030] The tubing assembly 100 includes a supply tubing portion 104 and a return tubing portion 106. The supply tubing portion 104 is configured to be coupled to a patient heat exchange device to transport fluid from a fluid source 102 to the patient heat exchange device. The supply tubing portion 104 includes a tube 108. The supply tubing portion 104 is coupled to the fluid source interface, e.g. via a connector or bonding, and configured to receive fluid from the fluid source 102. The supply tubing portion 104 includes a heat exchanger 121 configured to exchange heat with a corresponding console heat exchanger of the temperature management console, as subsequently described. The heat exchanger 121 is configured to heat or cool the fluid being transported from the fluid source 102 to the patient heat exchange device. [0031] The supply tubing portion 104 includes a supply connector 116a configured to connect with the patient heat exchange device. The supply connector 116a is configured to connect to many different kinds of heat exchange devices that are interfaced with the patient. The tubing assembly 100 is therefore usable with many different kinds of heat exchange devices and enables use of the temperature management console with these different kinds of heat exchange devices. In an embodiment, the supply tubing portion 104 can include a valve 119a at the supply connector 116a configured to close when the supply connector 116a is not connected to a heat exchange device. In an embodiment, the return tubing portion 104 can include a valve 119b at the return connector 116b configured to close when the supply connector 116a is not connected to a heat exchange device. In an embodiment, the threshold fluid pressure can include an absolute pressure value. In an Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 embodiment, the threshold fluid pressure can include a value measuring a change in the fluid pressure. [0032] The tubing assembly 100 includes a return tubing portion 106 configured to be coupled to the patient heat exchange device by connector 116b to transport the fluid from the patient heat exchange device. The return tubing portion 106 includes a tube 110. In an embodiment, the return tubing portion 106 returns heat exchange fluid to a reservoir that is different than the fluid source 102 or the return tubing portion 106 returns heat exchange fluid to the supply tubing portion and then back to the heat exchange device in a closed loop. In an embodiment, the return tubing portion 106 returns heat exchange fluid to the fluid source 102. The return tubing portion can include a return connector 116b configured to connect with the patient heat exchange device. [0033] Generally, the tubes 108, 110 are flexible. In an embodiment, the tubes 108, 110 can include a diameter of between 0.20-0.35 inches. In an embodiment, the tubing assembly is a disposable, single use assembly. In certain embodiments, the tubing assembly may be a sterile loop and include sterile fluid. [0034] A fluid source 102 may be connected to the tubes 108, 110 of the tubing assembly 100 directly or via connectors 114a-b, respectively, as shown in FIG.1D. The fluid source 102 can include a saline bag or another reservoir of heat exchange fluid. In an embodiment, the fluid source 102 is a reservoir of heat exchange fluid that receives sterile heat exchange fluid from a different fluid supply. The fluid source 102 stores the heat exchange fluid for use in the recirculation of the heat exchange fluid through the tubing assembly and the heat exchange device that is interfaced with or in thermal contact with the patient. The fluid may flow from the fluid source through the supply tubing portion, through the heat exchange device, through the return tubing portion, and back through the fluid source in a closed loop. In certain embodiments, the fluid may flow from the return tubing portion directly to the supply tubing portion, bypassing the fluid source. For example, as shown in FIG.1B, a valve 111 can be located in the fluid source or between the fluid source and the supply or return tubing. The valve is configured to prevent the fluid from returning into the fluid source 102 but direct the fluid back into the supply tubing in a closed loop. In another embodiment, the fluid may flow from the return tubing portion back into the fluid source, where the fluid source is designed to prevent mixing of the return fluid with fluid remaining Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 in the fluid source. For example, the fluid source may include one or more baffles that prevent said mixing. In certain embodiments, where there are no valves in the connectors, a one way valve such as the one-way valve 128a (shown in Fig.1D) may be located on the return tubing portion to minimize leakage from the tubing assembly when the tubing assembly is not connected to or is disconnected from the heat exchange device. Valves 128a-b may also be used to ensure that fluid does not leak in an embodiment that includes a removable or detachable bypass tubing portion 112. For example, each of valves 128a-b can include a one-way valve that allow fluid to proceed in the return tubing portion 106 toward the fluid source 102. [0035] In an embodiment, the fluid source 102 can include a portion (e.g., a reservoir) that is sealed or welded to the supply tubing portion and the return tubing portion to fluidly couple the fluid source 102 to the supply tubing portion 104 and the return tubing portion 106. In an embodiment, the fluid source 102 can include a sealable port 103 for adding fluid to the fluid source. The sealable port 103 can be configured to maintain a sterility of the heat exchange fluid. In some implementations, the sealable port can include a feedbag cap. [0036] In some implementations, the fluid source 102 can be connected to the supply tubing 104 and the return tubing 106 by a bag spike to form a closed fluid loop, as subsequently described. In some implementations, the fluid source 102 can be bonded or adhered or otherwise coupled to the to the supply tubing 104 and the return tubing 106 to form a closed fluid loop. [0037] Turning to FIG.1C, the tubing assembly 100 includes a bypass tubing portion 112 connecting the supply tubing portion 104 to the return tubing portion 106. The bypass tubing portion 112 includes a bypass valve 124 configured to open the bypass tubing portion to redirect fluid to bypass the supply connector 116a and the return connector 116b for bypassing the patient heat exchange device. The bypass valve 124 can be configured to open when a fluid pressure in the tubbing assembly, e.g., in the supply tubing portion downstream of a pump (e.g., at position 126) or in the return tubing portion upstream of the bypass tubing portion) exceeds a threshold fluid pressure. The bypass portion 112 can ensure that a pressure of the heat exchange fluid in the heat exchange device does not exceed a value that may cause a malfunction of the heat exchange device. For example, a Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 heat exchange device may have a particular maximum allowable pressure for the heat exchange fluid flowing through it while it is in contact with or inserted in a patient. The bypass valve 124 can be set to open before the particular maximum allowable fluid pressure is reached in the supply tubing portion 104 or the bypass tubing portion 112. The bypass valve 124 can therefore be tuned to a threshold pressure corresponding to the heat exchange device that is connected or is to be connected to the connectors 116a-b. The tubing assembly 100 can be compatible with that heat exchange device or any other heat exchange devices associated with a maximum pressure that is higher than the threshold pressure at which the bypass valve 124 is set to open. [0038] The bypass tubing portion 112 of the tubing assembly 100 can include the following aspects. The bypass tubing portion 112 includes a tube 122 that connects the supply tubing portion 104 to the return tubing portion 106. The bypass tubing 122 can include a bypass valve 124 (e.g., a pressure relief valve) that is configured to automatically open and direct the heat exchange fluid to the return tubing portion 106 from the supply tubing portion 104 when the pressure in the supply tubing portion 104 exceeds the threshold pressure of the bypass valve 124. The bypass valve 124 can therefore be a passive valve that opens or closes responsive to the fluid pressure without receiving a control signal. The bypass valve 124 can include a check valve, such as a spring loaded ball valve, a spring loaded plate valve, or any similar such valve that is responsive to the fluid pressure in the tubing assembly, e.g., in the supply tubing portion 104. The bypass valve 124 is configured to allow fluid to flow from the supply tubing portion 104 to the return tubing portion 106 but not vice versa. A portion of the bypass valve 124, such as a spring or other mechanical device, can be mechanically tuned to respond to a particular threshold pressure value to open the valve 124. In an embodiment, the bypass valve 124 can include a check valve having a crack pressure that is the threshold fluid pressure. In an embodiment, the bypass valve 124 can include a duck valve. In an embodiment, the bypass valve 124 can include a spring loaded valve. [0039] The particular threshold pressure to which the bypass valve 124 is tuned can depend on which corresponding one or more heat exchange devices that the tubing assembly 100 is configured to connect. For example, the bypass valve 124 can be set to have a relatively lower threshold pressure for use with surface heat exchange devices such as pads or Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 esophageal heat exchange catheters. For example, a pressure threshold of up to 12 PSI or 5-11 PSI. In another example, the bypass valve 124 can be set to have a relatively higher threshold pressure for opening for use with other heat exchange devices such as intravascular catheters. For example, a pressure threshold of up to 70 PSI or 50-60 PSI. In another example, the threshold pressure value for the bypass valve 124 depends on the type of catheter configured to connect to the tubing assembly 100. The tubing assembly 100 can be used with any heat exchange device associated with a maximum internal fluid pressure that is higher than the threshold pressure at which the bypass valve 124 is configured to open. As needed, a tolerance pressure can be added to a threshold pressure to ensure that the pressure within the tubing assembly 100 does not exceed the maximum pressure allowable for a given he exchange device. For example, the heat exchange device can include an esophageal catheter, one more external surface pads, an intravenous catheter, a nasal catheter, and/or a balloon catheter, as subsequently described. Each of these types of heat exchange devices, used either individually or in different combinations, can be associated with different pressure thresholds in the tubing assembly 100. [0040] In an embodiment, the bypass tubing portion 112 may be removable from the supply tubing portion 104 and the return tubing portion 106 so that the bypass tubing portion is modular relative to the supply tubing portion and the return tubing portion. The bypass tubing portion 112 can be modular such that it can be replaced for a tubing assembly to connect to a particular heat exchange device. For example, one or more connectors can enable the bypass portion to be disconnected and a different bypass portion to be connected, such as one having a different threshold pressure for the pressure relief valve 124. This can allow the tubing assembly 100 to interface with or couple to a heat exchange device having a lower maximum pressure tolerance if needed. If a higher pressure threshold is needed, such as to operate multiple heat exchange devices or a different type of heat exchange device, that bypass portion can be removed and replaced with another bypass portion having a bypass valve 124 with a higher pressure threshold. In an embodiment, the threshold fluid pressure for a pressure relief valve may be up to 12 PSI, e.g., between 5-11 pounds per square inch (PSI). [0041] In certain embodiments, as shown in Fig. 1D, the bypass tubing portion 112 can include a pressure sensor 120. The pressure sensor 120 can be configured to measure fluid Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 pressure for controlling the bypass valve 124 to open when the fluid pressure in the tubbing assembly, e.g., in the supply tubing portion, exceeds the threshold fluid pressure. In this example, a controller associated with the temperature management console, or another device receives a signal from the pressure sensor 120 and causes the bypass valve 124, e.g., via electrical signal, to open or close. Specifically, the pressure sensor 120 is configured to communicate with the controller that is configured to control the bypass valve 124 to open or close the bypass valve responsive to the pressure sensor measuring the fluid pressure. In an embodiment, the pressure sensor 120 is located in the bypass tubing 122 for measuring the fluid pressure. In an embodiment, pressure sensor 120 is located in the supply tubing 108 for measuring the fluid pressure. [0042] Returning to FIG.1A, the bypass valve 131 includes a piston 133 and a spring 135. Similar to bypass valve 124 described in relation to FIG. 1C, the valve 131 has a crack pressure configured to allow fluid flow through the bypass portion 112 that is at a pressure threshold less than a pressure tolerance of the heat exchange device. [0043] In an embodiment, the tubing assembly 100 includes a near field communication (NFC) device 319 configured for being read by an NFC reader on the temperature management console. The NFC device 319 can be configured to provide identification of the tubing assembly 100. For example, if the tubing assembly 100 has already been used with a particular patient the temperature management console can avoid operation until a brand new tubing assembly is used. In an embodiment, the identifier of the tubing assembly 100 can be associated with the particular pressure threshold for that tubing assembly. The temperature management console can be configured to detect whether the pressure threshold for the tubing assembly 100 exceeds a pressure threshold for the connected heat exchange device or devices. In an embodiment, the NFC reader of the temperature management console comprises a radio frequency identifier (RFID) tag reader, and the NFC device 319 includes an RFID tag. [0044] FIG.2A shows an illustration of an example tubing assembly 200 including a relief valve portion 202. Similar to tubing assembly 100, the tubing assembly 200 includes a supply tubing portion 204 configured to transport fluid from a fluid source to a patient heat exchange device configured to exchange heat with a patient. The supply tubing portion 204 is coupled to the fluid source, e.g. via a connector or bonding, and is configured to receive Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 fluid from the fluid source 102. The supply tubing portion 204 can include the supply connector 116a configured to connect with the patient heat exchange device. Similar to tubing assembly 100, the supply tubing portion 204 of tubing assembly 200 can include a heat exchanger 121 that is configured to exchange heat with a corresponding console heat exchanger of a temperature management console. The heat exchanger 121 is configured to heat or cool the fluid being transported from the fluid source to the patient heat exchange device. [0045] Similar to tubing assembly 100, the tubing assembly 200 includes a return tubing portion configured to transport the fluid from the patient heat exchange device. The return tubing portion can be coupled to the fluid source, e.g. via a connector or bonding and is configured to return fluid to the fluid source 102. In an embodiment the return tubing portion 206 returns heat exchange fluid to the fluid source and then to the supply tubing portion 204 and back to the heat exchange device in a closed loop. In certain, embodiments, the return tubing portion 206 can return heat exchange fluid to a reservoir that is different than the fluid source 102. The return tubing portion includes the return connector 116b configured to connect with the patient heat exchange device. [0046] The tubing assembly 200 is configured to release the heat exchange fluid out of the fluid loop when a pressure is detected in the supply tubing portion 204 or the return tubing portion that exceeds a threshold pressure. The supply tubing portion 204 includes a relief valve 214 configured to open the supply tubing portion to release fluid from the supply tubing portion when a fluid pressure exceeds a threshold fluid pressure. The relief valve 214 is configured to operate in a manner similar to the bypass valve 124 described previously. In an embodiment, the relief valve opens when a pressure in the supply tubing portion 204 exceeds a threshold pressure at which the relief valve 214 is set or tuned to open. The relief valve 214 can include a cover 212 configured to hinge open from a closed position to an open position when the fluid reaches the threshold pressure. The fluid then follows the path 210 out of the relief valve 214 and into an environment of the tubing assembly 200. [0047] The relief valve 214 can be tuned via a spring or other mechanical device to open at the threshold pressure desired for a particular heat exchange device, similar to the bypass valve 124 described previously. The relief valve 214 shown has a cover 212 that is Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 configured to hinge open. In another example, a check valve can be used as the relief valve 214 as long as the check valve is responsive to open at the threshold fluid pressure and not allow air (or allow a minimal amount of air) into the supply tubing portion 204. In an embodiment, the relief valve 214 is positioned upstream from the supply connector 116a and downstream from the heat exchanger 121. [0048] In certain embodiments, the tubing assembly 200 can include a pressure sensor 220 configured to measure a fluid pressure in the supply tubing portion 204 at or near the connector 116a. The pressure sensor 220 is configured to measure fluid pressure for controlling the relief valve 212 to open when the fluid pressure in the supply tubing portion exceeds the threshold fluid pressure. In this example, a controller is configured to receive one or more signals from the pressure sensor 220 to control operation of the relief valve 214. Specifically, the pressure sensor 220 is configured to communicate with the controller, which is configured to control the relief valve 214 to open or close the relief valve responsive to the pressure sensor measuring the fluid pressure and communicating said measured fluid pressure value or signal to the controller. [0049] FIG.2B shows a tubing assembly similar to the tubing assembly 200 of FIG.2A, except that there is a pressure sensor 220 but no relief valve 214. Region 250 shows the supply tubing portion 204 and pressure sensor 220. The pressure sensor 220 is configured to generate a signal representing a pressure in the tubing assembly, e.g., in the supply tubing portion 204. A controller receives the signal from the pressure sensor 220 and can control a pump speed to raise or lower the pressure of the fluid within the patient heat exchange device. Specifically, the pump can stop pumping heat exchange fluid into the patient head exchange device to lower a pressure within the heat exchange device. When the pressure drops to a low threshold pressure, the controller can cause the pump to resume pumping the heat exchange fluid to raise the pressure within the heat exchange device within the working pressure range and resume heat exchange with the patient. [0050] In certain embodiments, any of the tubing assemblies of Figs 1A-1D and 2A-B described herein may include a pump tube configured to interface with a fluid pump of a temperature management console. In an example, the pump can be a peristaltic pump configured to compress the pump tube against a raceway portion of the pump. In certain Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 embodiments, any of the tubing assemblies of Figs 1A-1D and 2A-B described herein may include a centrifugal pump connected in-line with the rest of the tubing assembly. [0051] FIG.3 shows an illustration of an example tubing assembly 300. Similar to tubing assembly 100, the tubing assembly 300 can include a fluid source 102, a supply tubing portion 304 similar to supply tubing portion 104, a return tubing portion 306 similar to return tubing portion 106, and a bypass portion 112 including a pressure relief valve 131. In some implementations, the bypass portion 112 can be replaced with the relief valve portion 202 of tubing assembly 200. [0052] The return tubing portion 306 can include a flow indicator 320 located between the bypass tubing portion 112 and the return connector 116b. The flow indicator 320 is configured to detect or measure an amount of fluid flowing between the return tubing connector 116b and the bypass tubing portion 112. The flow indicator 320 can indicate whether there are any leaks occurring in the heat exchange device when fluid is circulating. The position of the flow indicator 320 on the return tubing portion 306 upstream from the bypass portion 112 in the return tubing portion can ensure that an accurate fluid flow is measured from the fluid pumped through the heat exchange device, e.g., when a bypass valve or relief valve is opened, the flow indicator may indicate whether there has been a change in the flow of fluid through the heat exchange device. [0053] The tubing assembly 300 can include a pump tube 310 configured to interface with a fluid pump of the temperature management console. In an example, the pump is a peristaltic pump configured to compress the pump tube 310 against a raceway portion of the pump. In some implementations, the pump is a centrifugal pump connected in-line with the rest of the tubing assembly. The pump tube 310 includes fluid flow through the pump and can be disconnected or reconnected to the tubing assembly. The fluid pump can be configured to move fluid through the supply tubing portion 304 toward the supply connector 116a and into a heat exchange device. The bypass tubing portion 112 can be located between the pump tube 310 and the supply connector 116a. [0054] The pump tube 310 can be a different diameter and made of a different material than the tubing 308. The pump tube 310 is configured for compression and expansion in response to contact by rollers of the pump. The pump tube 310 is attached to the tubing 308 and is aligned in an arcuate raceway of the pump when the fluid loop is installed on Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 the temperature management console. The pump drives fluid flow through the tubing 310, through an air trap cylinder 312, through a heat exchange coil 314, and to the heat exchange device. The pump is controlled by a controller that is configured to control a speed of the pump and thus a rate of the fluid flow through the fluid loop. The controller can control a heating or cooling rate of the patient by controlling the temperature of the working fluid and/or a rate of the working fluid flow through the fluid loop. [0055] In an embodiment, the tubing assembly 300 includes an air trap 312 configured to trap air present in the supply tubing portion 304. The air trap 312 is configured for trapping air in the supply tubing portion 304 during circulation of the heat exchange fluid. The air trap 312 includes a chamber for storing fluid and trapping air bubbles from the fluid loop. The air trap 312 is filled with working fluid during priming of the fluid loop. The air trap 312 is held in an inverted position during priming to trap air bubbles. In some implementations, the air trap 312 includes a cylinder. The air trap 312 has an input and an output at an end of the air trap. A first end of tubing (input tubing) enters the air trap through the input and a second end of tubing (output tubing) enters the air trap through the output, such that both the input and output tubing are in fluid communication with the air trap 312. The end of the air trap having the input and output is at a lowest point on the air trap 312, below the air trap, when the air trap is inverted during priming, and at a highest point, above the air trap, when the air trap is not inverted during temperature management treatment after priming is completed. The air trap 312 may be connected to an evacuation tube 318. The evacuation tube 318 includes tubing configured to remove air from the air trap 312. The evacuation tube 318 can extend from the air trap 312. [0056] The tubing assembly 300 can include a heat exchanger that comprises a coil 314. The coil 314 is configured to be disposed in a heat exchange bath of the console heat exchanger of the temperature management console. In some implementations, the heat exchanger 121 previously described may be the coil 314. The coil 314 may include a relatively thin tubular structure (relative to the tubing 308) that is shaped to form a relatively long passageway in a relatively small volume envelope. Generally, the coil 314 forms a spiraled or coiled structure with many loops or windings. This allows a long passageway to be submersed in a reservoir or bath fluid. The bath fluid warms or cools the coil 314, thereby warming or cooling the working fluid flowing through the coil. The Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 relatively long passageway of the coil helps allow the working fluid to be cooled or warmed to the desired temperature (e.g., approximately the bath temperature) by the time the working fluid has been pumped through the coil 314. Generally, the coil 314 is made of a material (e.g., metal) that is highly thermally conductive. [0057] The working fluid is pumped through the supply tubing portion 304 and through the coil 314, which is immersed in bath liquid (e.g., coolant) within a heat exchange bath of the console (as described in relation to FIG.5). As the heat exchange fluid flows through the coil 314, the heat exchange fluid is in thermal communication with the bath liquid (e.g., coolant), and exchanges heat with the bath liquid, resulting in a cooling or warming of the heat exchange fluid to a desired temperature. The temperature of the coolant in the heat exchange bath is controlled by the console, e.g., by exchanging heat with a refrigerant flowing through a refrigerant loop within the console. The coil 314 increases a surface area of the supply tubing portion 304 that is exposed to the coolant in the heat exchange bath such that the heat exchange fluid may be quickly cooled or warmed. [0058] In an embodiment, the console and/or tubing assembly 300 includes a bubble sensor. The bubble sensor or air sensor is configured to detect air in the supply tubing portion. If air is detected, a flow of the heat exchange fluid can be stopped. [0059] In an embodiment, the supply tubing portion 304 can include a plurality of supply tubing branches. Each supply tubing branch can include an instance of the supply connector 116a, the bypass tubing portion 112, and the bypass valve 124. In an embodiment, each instance of the bypass tubing portion 112 is connected to one or more return tubing portions 306. [0060] FIG.4 shows an illustration of an example tubing assembly 400, similar to tubing assemblies 100, 200, and 300 previously described. The tubing assembly 400 fluid source interface can include a spike 402 configured to fluidly couple the supply tubing portion, the return tubing portion, or both to the fluid source 102. The spike 402 (also called a saline spike or bag spike) is provided to tap the fluid source 102 and extract fluid from the fluid source. The spike 402 is configured to puncture a fluid source, e.g., a saline bag, and drain the saline from the saline bag to fill the fluid loop of the tubing assembly 400 with working fluid. The fluid source 102 may be placed above the rest of the working fluid loop so that gravity forces the fluid to exit the fluid source to fill or prime the fluid loop. The spike 402 Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 may include an elongate body extending from a base portion. The elongate body includes a first inflow lumen configured to remove fluid e.g., liquid, from a fluid bag into the fluid loop and a second outflow lumen configured to return liquid and/or air to the fluid bag from the fluid loop. The base portion includes a grip having an angled profile to facilitate ease of insertion of the elongate body into the fluid bag. [0061] The spike 402, in addition to preventing fluid leaking, provides for ease of grip of the spike and ease of insertion of the spike. The grip makes it easier for the caregiver to hold the spike and the beveled edge makes it easier for the spike to be inserted it into a fluid source, e.g., saline bag, in a single motion. This facilitates fast and easy connection of the fluid loop to the fluid source, which allows the caregiver to quickly set up the system for priming and operation, providing the patient with temperature management treatment as quickly and efficiently as possible. In certain embodiments, instead of using a spike, the return tubing portion and supply tubing portion may be adhered or bonded in fluid communication to the fluid source. [0062] The tubing assembly 400 can include a heat exchange coil configured to be immersed in a console heat exchange bath, as described above, or alternatively a heat exchange cassette 410 configured to be disposed between heat exchange plates of the temperature management console (e.g., console 902). The cassette may include a heat exchange membrane assembly or bag and a frame surrounding one or more sides of the membrane assembly or bag. In some implementations, the heat exchanger 121 may be a cassette 410. [0063] FIG. 5 shows an embodiment of a temperature management system 500 for use with a patient (e.g., patient 511) including an intravascular catheter as a heat exchange device. The temperature management system 500 is configured to control a temperature of a patient’s body using a heat exchange device 510. The temperature management system 500 is configured to heat or cool the patient (or both) to manage the temperature of the patient. Managing the temperature of the patient may be referred to as heat exchange treatment of the patient, or heating/warming or cooling treatment of the patient. The temperature management system 500 includes a heat exchange device 510, e.g., an intravascular heat exchange catheter configured to be inserted into a vasculature 505 of a patient, or a heat exchanger applied to the surface of a patient, such as a heat exchange pad. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 The temperature management system 500 can include other hardware configured for heating or cooling the patient, such as a heat exchange fluid loop, heating or cooling plates, heating or cooling cassettes, heat exchange baths, a refrigerant circuit and so forth as subsequently described for heating or cooling the patient (or both). [0064] The heat exchange bath 505 is filled with a bath liquid. The liquid can include water, glycol, or other coolant. The heat exchange bath 505 is configured to be warmed or cooled to provide heating or cooling to the bath liquid, which is in thermal contact with the heat exchange fluid flowing through the tubing assembly and through the heat exchange device 510 to exchange heat with the patient. The heat exchange bath 505 is configured to receive the heat exchanger of the tubing assembly, e.g., coil 314, that is fluidly coupled to, and makes up part of, the heat exchange fluid loop. Generally, the heat exchange bath 505 includes an insulated cavity or chamber configured to receive the coil 314. A temperature of the cavity or chamber 505 is controlled by the controller of the temperature management system 500. The cavity or chamber is covered by a bath cap 507. The cap may be attached to the heat exchange bath by a tether 509. The tether 509 prevents the cap 507 from being lost, removed, or from falling into the cavity chamber of the heat exchange bath 505. In some implementations, another retaining device can be used to couple the cap 507 to the heat exchange bath 505, e.g., a wire or strap. [0065] The temperature management system 500 includes an extracorporeal control console 502 with a hardware interface 504, subsequently described. The interface 504 allows the heat exchange device 510 to be coupled to the control console 502 via a heat exchange fluid loop that includes the heat exchange device and a tubing assembly as subsequently described. The control console 502 includes a controller and/or processor for controlling the heat exchange device 510. The control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 500 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 500. The user interface 506 may present or display various types of information associated with temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [0066] The temperature management system 500 is configured to measure operational data representing operation of one or more aspects of the temperature management system 500. The temperature management system 500 is configured to measure patient data representing one or more physiological parameters of the patient, e.g., patient temperature, during treatment of the patient. The operational data and the patient data that are measured during treatment of the patient may be referred to as treatment data. The temperature management system may be configured to control the temperature of the patient’s body based on the operational data (e.g., pump speed, coolant temperature, heat exchange bath temperature, working fluid temperature and power), and/or patient data, (e.g., patient temperature feedback received from temperature sensors located in or on the patient). The temperature management system 500 is configured to display, by a user interface 506, an operational status of the temperature management system 500 and a physiological status of the patient during treatment. The operational status can include whether the temperature management system 500 is working at a maximum cooling or heating power (e.g., effort) or a percentage of the maximum heating or cooling power. The physiological status can include the temperature of the patient. Optionally, the temperature management system may be configured to circulate fluid through the tubing assembly and heat exchange device at a given temperature without temperature sensor feedback. [0067] The user interface 506 is configured to display operational data and patient data on the user interface in a configuration that allows a user to determine a stage of a temperature management treatment (e.g., a treatment cycle or treatment process) being performed on the patient. The user interface 506 shows a current operational treatment period (also called a stage). Each treatment period of the temperature management treatment is associated with a target patient temperature and a rate of cooling or heating the patient to control the patient temperature to the target temperature. [0068] A cooling or heating power exerted by the temperature management system 500 to cool or heat the patient is displayed on the user interface 506. The cooling or heating power (also called “effort” or simply “power”) represents how hard the temperature management system 500 is working to heat or cool the patient. The actual value of the power may represent a percentage of a maximum possible cooling or heating rate or capacity or capability of the system to cool or heat the patient based on a relationship between a heat Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 exchange bath, fluid or coolant temperature of the temperature management system 500 and the patient’s current temperature. [0069] The extracorporeal control console 502 includes hardware for managing the patient temperature. The hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop, and the fluid loop is configurable for connecting to the heat exchange device 510. The fluid loop includes the tubing assembly 100, 200, 300, 400, etc. which facilitates connection of the heat exchange device 510 with the control console 502. One or more temperature sensors 520a, 520b may be located on or in the heat exchange device 510 and/or may be located on a separate device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient. In some implementations, the heat exchange device 510, tubing assembly, fluid loop, and/or the temperature sensors 520a-b may be disposable items intended for a single use. The control console 502 may be a non- disposable system intended for multiple uses and to interface with the single-use device(s). [0070] In the implementation shown, an intravascular heat exchange catheter (which is device 510) comprises an elongate catheter body 522 and one or more heat exchangers 523a-c positioned on a distal portion of the catheter body 522, through which a thermal exchange fluid circulates. The heat exchangers, in the example of FIG.5, include inflatable cylindrical balloons. In an alternative implementation, the heat exchanger may include a serpentine or helical balloon or tubing (not shown). Inflow and outflow lumens (not shown) are present within the catheter body 522 to facilitate circulation of the thermal exchange fluid (e.g., sterile 0.9% sodium chloride solution or other suitable thermal exchange fluid) through the elongate catheter body 522 and through the heat exchange balloons. Optionally, the catheter body 522 may also include one or more working or through lumens 524 which extend through the catheter body 522 and terminate distally at one or more openings in the distal end of the catheter body. The working lumens can each serve as a guidewire lumen to facilitate insertion and positioning of the catheter and/or may be used after insertion of the catheter for delivery of fluids, medicaments or other devices. For example, as shown in FIG.5, in some embodiments, the temperature sensors 520a-b may be inserted through the working lumen of the catheter and advanced out of the distal end opening to a location beyond the distal end of the catheter body 522. Alternatively, in other Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 embodiments, the temperature sensors 520a-b may be positioned at various other locations (e.g., the esophagus or rectum), using a separate device, catheter or probe, on or in the subject's body to sense the desired body temperature(s). Various heat exchange catheters may be used in the embodiments described herein. [0071] Non-limiting examples of various heat exchange devices, heat exchange catheters and/or heat exchange pads or body surface heat exchangers that may be used are described in U.S. Pat. No.9,492,633, titled Heat exchange catheter and their methods of manufacture and use and issued on November 15, 2016, and U.S. Application Pub. No.2013/0090708, titled Endovascular Cooling Catheter System Which Employs Phase-Changing Heat Exchange Media and filed on September 28, 2012, U.S. Pat. No. 9,662,243, titled Heat Exchange Catheters with Bi-Directional Fluid Flow and Their Methods of Manufacture and Use and issued on May 30, 2017, U.S. Pat. No.500,045,881, titled Patient Temperature Control Catheter with Helical Heat Exchange Paths and issued on 8/14/2018, U.S. Pat. No. 9,314,370 titled Self-Centering Patient Temperature Control Catheter and issued on April 19, 2016, U.S. Pat. No. 9,241,827 titled Intravascular Heat Exchange Catheter with Multiple Spaced Apart Discrete Coolant Loops and issued on January 26, 2016, U.S. Pat. No. 9,717,625 titled Intravascular Heat Exchange Catheter with Non-Round Coiled Coolant Path and issued on August 1, 2017, U.S. Pat. No. 9,433,526 titled Intravascular Heat Exchange Catheter With Rib Cage-Like Coolant Path and issued on September 6, 2016, U.S. Application Pub. No. 2018/0185193, titled High Efficiency Heat Exchange Catheters For Control Of Patient Body Temperature and filed on December 30, 2016, U.S. Application Pub. No. 2018/018519, filed on December 30, 2016, titled Fluid-Circulating Catheters Useable for Endovascular Heat Exchange, and U.S. Application Pub. No. 2018/0207024, titled Managing Patient Body Temperature Using Endovascular Heat Exchange in Combination with Body Surface Heat Exchange and filed on January 23, 2017, the entire disclosure of each such patent and application being expressly incorporated herein by reference. Other examples of catheters that may be used herein include those commercially available from ZOLL Circulation, Inc., San Jose, Calif., such as the Cool Line® Catheter, Icy® Catheter, Quattro® Catheter, and Solex 7® Catheter. [0072] The extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506. The main housing 526 contains various Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled thermal exchange fluid through the heat exchange device 510 to effectively modify and/or control the subject's body temperature. The console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 500. On the housing 526, there may be provided connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses. One or more connectors 536 can connect the tubing 511 of the tubing assembly 100, 200, 300, 400, etc. to the inflow and outflow tubes of the heat exchange device 510. [0073] FIG. 6 shows an embodiment of a temperature management system 600 for use with a patient including a set of surface pads 602, 604, and 606 as heat exchange devices. A single pad or a combination of the pads may be used with a patient. The surface pad 602 can be configured to conform to a torso of the patient 511. The surface pad 602 can be connected to the tubing assembly 100, via tubing 612,and connectors 616. Tubing 612 can be used to connect the surface pads to the branching device 614. The branching device 614 can be used to enable multiple pads to be connected to the same tubing assembly 100. The surface pads 604, 606 can be connected in series to the branching device 614. An additional tubing portion 610 can be used to connect pad 604 to pad 606 to create a continuous fluid loop. [0074] Similar to system 500 discussed in relation to FIG.5, the temperature management system 600 includes an extracorporeal control console 502 with a hardware interface 504, subsequently described. The interface 504 allows the heat exchange devices 602, 604, 606, e.g., heat exchange surface pads, to be coupled to the control console 502 by interfacing with a heat exchange fluid loop that includes the heat exchange device and a tubing assembly as subsequently described. The control console 502 includes a controller and/or processor for controlling the heat exchange devices 602, 604, 606. The control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 600 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 600. The user interface 506 may present or display various types of information associated with Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions. [0075] The extracorporeal control console 502 includes hardware for managing the patient temperature. The hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop, and the fluid loop is configurable for connecting to the heat exchange devices 602, 604, 606. The fluid loop includes the tubing assembly 100 which facilitates connection of the heat exchange pads 602, 604, and 606 with the control console 502. One or more temperature sensors may be located on or in the heat exchange devices 602, 604, 606 and/or may be located on a separate device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient. In some implementations, the heat exchange devices 602, 604, 606, fluid loop, tubing assembly, and/or the temperature sensors may be disposable items intended for a single use. The control console 502 may be a non- disposable system intended for multiple uses and to interface with the single-use device(s). [0076] The extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506. The main housing 526 contains various apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled thermal exchange fluid through the heat exchange devices 602, 604, 606 to effectively modify and/or control the subject's body temperature. The console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 600. On the housing 526, there may be provided connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses. One or more connectors 616can connect the tubing of the tubing assembly 100, 200, 300, 400, etc. to the inflow and outflow tubes of the heat exchange surface pads 602, 604, 606. [0077] The heat exchange pads 602, 604, 606 are configured to receive heat exchange fluid from the tubing assembly 100, 200, 300, 400, etc. and heat or cool the patient 511. The heat exchange pads 602, 604, and 606 are configured to heat or cool the patient based on the temperature set by the user on the control console 502. In some implementations, the Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 heat exchange pads 602, 604, and 606 can include the ZOLL® STx™ Surface Pads from ZOLL Circulation, Inc., San Jose, California, USA. In some implementations, the heat exchange pads 602, 604, 606 can include the IQool™ Surface Pads [0078] FIG.7A shows an embodiment of a temperature management system 700 for use with a patient including an esophageal catheter as a heat exchange device. The temperature management system 700 is similar to the temperature management system 500 described previously. The heat exchange device of the temperature management system 700 includes an esophageal catheter 702. The esophageal catheter 702 is placed inside an esophagus 704 of the patient 511 to exchange heat with the patient. The catheter 702 has a gastric lumen 710 (e.g., a through lumen). The through lumen 710 can extend to the stomach 714 of the patient 511 at a second end 712 of the through lumen. [0079] Similar to the system 500 discussed in relation to FIG. 5, the temperature management system 700 includes an extracorporeal control console 502 with a hardware interface 504, subsequently described. The interface 504 allows the heat exchange device 702 to be coupled to the control console 502 by interfacing with a heat exchange fluid loop that includes the heat exchange device and a tubing assembly as subsequently described. The control console 502 includes a controller and/or processor for controlling the heat exchange device 702. The control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 700 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 700. The user interface 506 may present or display various types of information associated with temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions. [0080] The extracorporeal control console 502 includes hardware for managing the patient temperature. The hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop, and the fluid loop is configurable for connecting to the heat exchange device 702. The fluid loop includes the tubing assembly 100 which facilitates connection of the esophageal catheter 702 with the control console 502. One or more temperature sensors may be located on or in the heat exchange device 702 and/or may be located on a separate Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient. In some implementations, the heat exchange device 702, fluid loop, tubing assembly and/or the temperature sensors may be disposable items intended for a single use. The control console 502 may be a non-disposable system intended for multiple uses and to interface with the single-use device(s). [0081] The extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506. The main housing 526 contains various apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled thermal exchange fluid through the esophageal catheter 702 to effectively modify and/or control the subject's body temperature. The console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 700. On the housing 526, there may be provided connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses. One or more connectors 616 can connect the tubing of the tubing assembly 100, 200, 300, 400, etc. to the inflow and outflow tubes of the esophageal catheter 702. [0082] The esophageal catheter 702 is configured to receive heat exchange fluid from the tubing assembly 100, 200, 300, 400, etc. and heat or cool the patient 511. The catheter 702 can include a heat transfer device or region that includes a fluid path defined by an inflow lumen and an outflow lumen. Heat exchange fluid may flow along the fluid path in a closed loop. The heat exchange fluid is circulated along the fluid path for a time sufficient to control a body temperature in the patient 511. The esophageal catheter 702 may include a heat transfer region having a splined inner surface surrounding the heat exchange fluid flow path. The esophageal catheter may include a heat exchange region along the length of the catheter or along a discrete heat transfer region that is confined to one or more sections of the patient's esophagus. The esophageal catheter 702 is configured to heat or cool the patient based on the temperature set by the user on the control console 502. [0083] The esophageal catheter 702 is configured to heat or cool the patient 511 by being placed in the esophagus of the patient 511. In certain embodiments, the system 700 may provide a heat exchange fluid flow rate of about 200 – 1500 ml/min. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [0084] FIG.7B shows an embodiment of a temperature management system 701 for use with a patient including an esophageal catheter as a heat exchange device. The temperature management system 701 is similar to the temperature management system 500 described previously. The heat exchange device of the temperature management system 701 includes a stomach/esophageal catheter 720. The stomach/esophageal catheter 720 is placed inside an esophagus 704 of the patient 511 and extends to the stomach of the patient. [0085] Similar to the system 500 discussed in relation to FIG. 5, the temperature management system 701 includes an extracorporeal control console 502 with a hardware interface 504, subsequently described. The interface 504 allows the heat exchange device 720 to be coupled to the control console 502 by interfacing with a heat exchange fluid loop that includes the heat exchange device and a tubing assembly. The control console 502 includes a controller and/or processor for controlling the heat exchange device 720. The control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 701 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 701. The user interface 506 may present or display various types of information associated with temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions. [0086] The extracorporeal control console 502 includes hardware for managing the patient temperature. The hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop that, and the fluid loop is configurable for connecting to the heat exchange device 720. The fluid loop includes the tubing assembly 100 which facilitates connection of the stomach/esophageal catheter 720with the control console 502. One or more temperature sensors may be located on or in the heat exchange device 720 and/or may be located on a separate device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient. In some implementations, the heat exchange device 720, fluid loop, tubing assembly and/or the temperature sensors 520a-b may be disposable items intended for a single use. The control console 502 may be a non-disposable system intended for multiple uses and to interface with the single-use device(s). Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [0087] The extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506. The main housing 526 contains various apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled thermal exchange fluid through the stomach/esophageal catheter 720 to effectively modify and/or control the subject's body temperature. The console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 701. On the housing 526, there may be provided connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses. One or more connectors 616 can connect the tubing of the tubing assembly 100, 200, 300, 400, etc. to the inflow and outflow tubes of the stomach/esophageal catheter 720. [0088] The catheter 720 is configured to receive heat exchange fluid from the tubing assembly 100, 200, 300, 400, etc. and heat or cool the patient 511. The catheter 720 can include a heat transfer device or region that includes a fluid path defined by an inflow lumen and an outflow lumen. Heat exchange fluid flows along the fluid path. The heat exchange fluid is circulated along the fluid path for a time sufficient to control a body temperature in the patient 511. The catheter 720 is configured to heat or cool the patient based on the temperature set by the user on the control console 502. [0089] The catheter 720 is configured to heat or cool the patient 511 by being advanced through the esophagus and into the stomach of the patient 511. An example of the catheter 720 can include an expandable balloon at its distal end. Fluid flows through the catheter into the balloon and then a balloon 722 is expanded with the heat exchange fluid, which exchanges heat with the stomach of the patient. Examples of the stomach/esophageal catheter 720 are described in U.S. Pat. No.9,138,344, issued on September 22, 2015, the entire contents of which are incorporated by reference herein. [0090] FIG. 8 shows an embodiment of a temperature management system 800 for use with a patient including a nasal catheter 802 as a heat exchange device. The nasal catheter 802 can be placed inside a nasal cavity 804 of the patient 511. The heat exchange fluid can flow through the catheter 802 to heat or cool the patient's head from the nasal cavity 804. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 In some implementations, the heat exchange fluid can be expelled into the nasal cavity 804 of the patient by the catheter 802. [0091] Similar to the system 500 discussed in relation to FIG. 5, the temperature management system 701 includes an extracorporeal control console 502 with a hardware interface 504. The interface 504 allows the heat exchange device 802 to be coupled to the control console 502 by interfacing with a heat exchange fluid loop that includes the heat exchange device and a tubing assembly. The control console 502 includes a controller and/or processor for controlling the heat exchange device 802. The control console includes a user interface 506 for allowing a user to input data or control signals to the temperature management system 800 and to present information, such as treatment data, indicative of treatment of the patient using the temperature management system 800. The user interface 506 may present or display various types of information associated with temperature management treatment of the patient and use of the temperature management system, including, e.g., patient data, operational data, priming instructions, and/or setup instructions. [0092] The extracorporeal control console 502 includes hardware for managing the patient temperature. The hardware includes components that make up an interface 504 of the extracorporeal control console 502, which are configured to interface with components of a fluid loop that, and the fluid loop is configurable for connecting to the heat exchange device 802. The fluid loop includes the tubing assembly 100 which facilitates connection of the nasal catheter 802 with the control console 502. One or more temperature sensors may be located on or in the heat exchange device 802 and/or may be located on a separate device or probe positioned elsewhere in the body, e.g., in the esophagus or rectum of the patient. In some implementations, the heat exchange device 802, fluid loop, tubing assembly and/or the temperature sensors 520a-b may be disposable items intended for a single use. The control console 502 may be a non-disposable system intended for multiple uses and to interface with the single-use device(s). [0093] The extracorporeal control console 502 generally comprises a main housing and a console head having a user interface 506. The main housing 526 contains various apparatuses and circuitry for warming/cooling thermal exchange fluid, e.g., coolant, refrigerant, saline, to controlled temperature(s) and for pumping such warmed or cooled Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 thermal exchange fluid through the heat exchange device 802 to effectively modify and/or control the subject's body temperature. The console head includes a display device or user interface 506, such as a touch screen system, whereby certain information may be input by, and certain information may be displayed to, users of the system 800. On the housing 526, there may be provided connection ports 530, 532 for connection of additional or alternative types of temperature sensors and/or other apparatuses. One or more connectors can connect the tubing assembly 100, 200, 300, 400, etc. to the inflow and outflow tubes of the nasal catheter 802. [0094] The catheter 802 is configured to heat or cool the patient 511 by being placed in the nasal cavity of the patient 511. In some implementations, the catheter 802 can release heat exchange fluid into the nasal cavity to cool the patient 511. Heat exchange fluid can circulate in the catheter 802 in either a closed loop or sprayed into the nasal cavity. Examples of the catheter 802 are described in U.S. Pat. No.8,512,280, issued on August 20, 2013, the entire contents of which are incorporated by reference herein. In some implementations, the nasal catheter 802 can include the RhinoChillTM intranasal cooling system of Benechill Inc. of San Diego CA, USA. [0095] FIG.9A shows an embodiment of a temperature management system 900 for use with a patient including a tubing assembly 902 and heat exchange plates. FIG.9B shows an embodiment of a tubing assembly 902 including a cassette 904. The cassette 904 is inserted between heat exchange plates of the temperature management console 900. The cassette 904 includes a heat exchange membrane or bag 906 fillable with heat exchange fluid that is warmed or cooled by the heat exchange plates of the temperature management console 900. In some implementations, a data connector 908 is configured to obtain data from one or more sensors of a sensor package 910 of the tubing assembly 902. The sensor package 910 can include one or more sensors such as a pressure sensor configured to measure a fluid pressure in the tubing assembly 902, e.g., in the supply tubing portion, similar to the pressure sensors described previously in relation to tubing assembly 100. A pump tube 910 is connected to the cassette 904 and to the rest of the tubing assembly 902 through a cartridge housing 912. The tubing assembly 902 may include a bypass tubing portion 112 connecting supply and return tubing portions of the tubing assembly and including a bypass valve or pressure relief valve as described herein to ensure that a Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 connected heat exchange device does not exceed a maximum pressure. The tubing assembly may be connectable to any of the heat exchange devices described herein, e.g., esophageal catheters, intravascular catheters or surface pads. [0096] FIG. 10A shows a flow diagram of an example process 1000 for treatment of a patient by the temperature management system (e.g., temperature management systems of any of FIGS.5 to 9B, described previously. In some implementations, the process 1000 is configured to be performed by a controller included in the temperature management system. The controller is configured to process instructions for performing the process 1000. The process 1000 includes receiving (1002) a pressure measurement from a pressure sensor. In some implementations, the pressure sensor is located within a supply tubing portion of the tubing assembly. In some implementations, the pressure sensor is located within a bypass tubing portion of the tubing assembly. The process 1000 includes identifying (1004) a heat exchange device or devices connected to the tubing assembly. The heat exchange device or devices can include one or more surface pads, an intravascular catheter, a nasal catheter, an esophageal catheter, or a combination thereof. The process 1000 includes determining (1006), based on the identified heat exchange device or devices, a threshold pressure for operation of at least one connected heat exchange device. In some implementations, the threshold pressure is calculated depending on which heat exchange device or devices are detected or identified. In some implementations, a pressure sensor is associated with each branch of one or more branches of the fluid loop. Each branch is associated with a respective heat exchange device and a respective threshold fluid pressure for operation of the heat exchange device. [0097] The process 1000 includes, when the measured pressure exceeds the threshold pressure, causing (1008), by the controller, a valve to open to lower a pressure in the tubing assembly, e.g., a supply tubing portion that is connected to the at least one connected heat exchange device. The controller is configured for causing (1010) a pump to circulate heat exchange fluid through the at least one connected heat exchange device. The process includes, when the measured pressure falls below another threshold value, causing (1012) the valve to close while causing the pump to continue pumping the heat exchange fluid through the at least one heat exchange device. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [0098] FIG. 10B shows a flow diagram of an example process 1020 for treatment of a patient by the temperature management system (e.g., temperature management systems of any of FIGS.5 to 9B, described previously. In some implementations, the process 1020 is configured to be performed by a controller included in the temperature management system. The controller is configured to process instructions for performing the process 1020. [0099] The process 1020 includes identifying (1022) a heat exchange device or devices connected to a tubing assembly that has a bypass tubing portion for causing heat exchange fluid to bypass the heat exchange device. The process 1020 includes determining (1024), based on the identified heat exchange device or devices, a threshold pressure for operation of at least one connected heat exchange device. The process 1020 includes, when the pressure exceeds the threshold pressure, causing a bypass valve to open and directing (1026) flow of heat exchange fluid from a supply tubing portion through the bypass tubing portion to a return tubing portion. The process 1020 includes causing (1028) a pump to circulate some heat exchange fluid through the at least one connected heat exchange device and some heat exchange fluid through the bypass tubing portion. The process 1020 includes, when the measured pressure falls below another threshold value, closing (1030) the bypass valve in the bypass tubing portion to direct the flow of the heat exchange fluid through the at least one heat exchange device. [00100] FIG.11 shows an example computer system 1500 that includes a processor 1500, a memory 1520, a storage device 1530 and an input/output device 1140. Each of the components 1500, 1520, 1530 and 1140 can be interconnected, for example, by a system bus 1150. The processor 1500 is capable of processing instructions for execution within the system 1500. In some implementations, the processor 1500 is a single-threaded processor, a multi-threaded processor, or another type of processor. The processor 1500 is capable of processing instructions stored in the memory 1520 or on the storage device 1530. The memory 1520 and the storage device 1530 can store information within the system 1500. [00101] The input/output device 1140 provides input/output operations for the system 1500. In some implementations, the input/output device 1140 can include one or more of a network interface device, e.g., an Ethernet card, a serial communication device, Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 e.g., an RS-232 port, and/or a wireless interface device, e.g., an 802.11 card, a 3G wireless modem, a 4G wireless modem, a 5G wireless modem, etc. In some implementations, the input/output device can include driver devices configured to receive input data and send output data to other input/output devices, e.g., keyboard, printer and display devices 1160. In some implementations, mobile computing devices, mobile communication devices, and other devices can be used. [00102] Some implementations described in this specification (e.g., the processor of the temperature management system, etc.) can be implemented as one or more groups or modules of digital electronic circuitry, computer software, firmware, or hardware, or in combinations of one or more of them. Although different modules can be used, each module need not be distinct, and multiple modules can be implemented on the same digital electronic circuitry, computer software, firmware, or hardware, or combination thereof. [00103] Some implementations described in this specification can be implemented as one or more computer programs, i.e., one or more modules of computer program instructions, encoded on computer storage medium for execution by, or to control the operation of, data processing apparatus. A computer storage medium can be, or can be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. Moreover, while a computer storage medium is not a propagated signal, a computer storage medium can be a source or destination of computer program instructions encoded in an artificially generated propagated signal. The computer storage medium can also be, or be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices). [00104] The term “data processing apparatus” encompasses all kinds of apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, a system on a chip, or multiple ones, or combinations, of the foregoing. The apparatus can include special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit). The apparatus can also include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross- Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 platform runtime environment, a virtual machine, or a combination of one or more of them. The apparatus and execution environment can realize various different computing model infrastructures, such as web services, distributed computing and grid computing infrastructures. [00105] A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages. A computer program may, but need not, correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program can be deployed for execution on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network. [00106] Some of the processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatus can be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit). [00107] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read only memory or a random access memory or both. A computer includes a processor for performing actions in accordance with instructions and one or more memory devices for storing instructions and data. A computer may also include or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto optical disks, or optical disks. However, a computer need not have such devices. Devices suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices (e.g., EPROM, EEPROM, flash Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 memory devices, and others), magnetic disks (e.g., internal hard disks, removable disks, and others), magneto optical disks, and CD-ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry. [00108] To provide for interaction with a user, operations can be implemented on a computer having a display device (e.g., a monitor, or another type of display device) for displaying information to the user and a keyboard and a pointing device (e.g., a mouse, a trackball, a tablet, a touch sensitive screen, or another type of pointing device) by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback, e.g., visual feedback, auditory feedback, or tactile feedback; and input from the user can be received in any form, including acoustic, speech, or tactile input. In addition, a computer can interact with a user by sending documents to and receiving documents from a device that is used by the user; for example, by sending web pages to a web browser on a user’s client device in response to requests received from the web browser. [00109] A computer system may include a single computing device, or multiple computers that operate in proximity or generally remote from each other and typically interact through a communication network. Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an inter-network (e.g., the Internet), a network comprising a satellite link, and peer-to-peer networks (e.g., ad hoc peer-to-peer networks). A relationship of client and server may arise by virtue of computer programs running on the respective computers and having a client-server relationship to each other. [00110] While this specification contains many details, these should not be construed as limitations on the scope of what may be claimed, but rather as descriptions of features specific to particular examples. Certain features that are described in this specification in the context of separate implementations can also be combined. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple embodiments separately or in any suitable sub-combination. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 [00111] A number of embodiments have been described. For example, the detailed description and the accompanying drawings to which it refers are intended to describe some, but not necessarily all, examples or embodiments of the system. The described embodiments are to be considered in all respects only as illustrative and not restrictive. Nevertheless, it will be understood that various modifications may be made without departing from the scope of the devices, systems, and methods described herein. Accordingly, other embodiments are within the scope of the following claims.

Claims

Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 WHAT IS CLAIMED IS: 1. A tubing assembly for use with a temperature management system, the tubing assembly comprising: a supply tubing portion configured to be coupled to a patient heat exchange device to transport fluid from a fluid source to the patient heat exchange device, the supply tubing portion comprising: a tubing assembly heat exchanger configured to exchange heat with a corresponding console heat exchanger of a temperature management console wherein the tubing assembly heat exchanger is configured to heat or cool the fluid being transported from the fluid source to the patient heat exchange device; and a supply connector configured to connect with the patient heat exchange device; a return tubing portion configured to be coupled to the patient heat exchange device to transport the fluid from the patient heat exchange device, the return tubing portion comprising: a return connector configured to connect with the patient heat exchange device; a bypass tubing portion connecting the supply tubing portion to the return tubing portion; and a bypass valve configured to open the bypass tubing portion to direct fluid to bypass the supply connector and the return connector for bypassing the patient heat exchange device when a fluid pressure in the tubing assembly exceeds a threshold fluid pressure. 2. The tubing assembly of claim 1, further comprising a pressure sensor configured to measure fluid pressure for controlling the bypass valve to open when the fluid pressure in the supply tubing portion exceeds the threshold fluid pressure. 3. The tubing assembly of claim 2, wherein the pressure sensor is configured to communicate with a controller that is configured to control the bypass valve to open or close the bypass valve responsive to the pressure sensor measuring the fluid pressure. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 4. The tubing assembly of claim 2, wherein the pressure sensor is located in the bypass tubing portion for measuring the fluid pressure. 5. The tubing assembly of claim 2, wherein the pressure sensor is located in the supply tubing portion for measuring the fluid pressure. 6. The tubing assembly of claim 1, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an esophageal catheter. 7. The tubing assembly of claim 1, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an external pad. 8. The tubing assembly of claim 1, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an intravenous catheter. 9. The tubing assembly of claim 1, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising a nasal catheter. 10. The tubing assembly of claim 1, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising a balloon catheter. 11. The tubing assembly of claim 1, wherein the bypass valve comprises a check valve having a crack pressure that is the threshold fluid pressure. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 12. The tubing assembly of claim 1, wherein the bypass valve comprises a duck valve. 13. The tubing assembly of claim 1, wherein the bypass valve comprises a spring loaded valve. 14. The tubing assembly of claim 1, wherein the return tubing portion further comprises a flow indicator located between the bypass tubing portion and the return connector, the flow indicator configured to measure the fluid flowing between the return tubing connector and the bypass tubing portion. 15. The tubing assembly of claim 1, wherein the threshold fluid pressure is between 5-11 pounds per square inch (PSI). 16. The tubing assembly of claim 1, further comprising a pump tube configured to interface with a fluid pump of the temperature management console, the fluid pump configured to move fluid through the supply tubing portion toward the supply connector, wherein the bypass tubing portion is located between the pump tube and the supply connector. 17. The tubing assembly of claim 1, further comprising an air trap configured to trap air present in the supply tubing portion. 18. The tubing assembly of claim 1, further comprising a tubing portion configured to interface with a bubble flow sensor of the temperature management console. 19. The tubing assembly of claim 1, wherein the supply tubing portion comprises a plurality of supply tubing branches, each supply tubing branch including an instance of the supply connector, the bypass tubing portion, and the bypass valve, Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 wherein each instance of the bypass tubing portion is connected to the return tubing portion. 20. The tubing assembly of claim 1, further comprising a spike configured to fluidly couple the supply tubing portion, the return tubing portion, or both to the fluid source. 21. The tubing assembly of claim 20, wherein the spike comprises a first lumen to fluidly couple the fluid source to the supply tubing portion, and wherein the spike comprises a second lumen to fluidly couple the fluid source to the return tubing portion. 22. The tubing assembly of claim 20, the spike further comprising: a stepped portion; and an elongate body extending from the stepped portion, wherein the elongate body has a smaller dimeter than the stepped portion. 23. The tubing assembly of claim 1, wherein the fluid source comprises a reservoir that is sealed or welded to the supply tubing portion and the return tubing portion to fluidly couple the fluid source to the supply tubing portion and the return tubing portion. 24. The tubing assembly of claim 23, wherein the fluid source further comprises a sealable port for adding fluid to the fluid source, the sealable port configured to maintain a sterility of the fluid. 25. The tubing assembly of claim 24, wherein the sealable port comprises a feedbag cap. 26. The tubing assembly of claim 1, wherein the supply tubing portion, the return tubing portion, or both comprise a diameter of between 0.20-0.35 inches. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 27. The tubing assembly of claim 1, wherein the supply tubing portion further comprises a valve at the supply connector configured to close when the fluid pressure near the supply connector exceeds the threshold fluid pressure. 28. The tubing assembly of claim 1, wherein the bypass tubing portion is removable from the supply tubing portion and the return tubing portion so that the bypass tubing portion is modular relative to the supply tubing portion and the return tubing portion. 29. The tubing assembly of claim 1, wherein the tubing assembly heat exchanger comprises a coil configured to be disposed in a heat exchange bath of the temperature management console heat exchanger of the temperature management console. 30. The tubing assembly of claim 1, wherein the tubing assembly heat exchanger comprises a cassette configured to be disposed between heat exchange plates of the temperature management console. 31. The tubing assembly of claim 1, further comprising a near field communication (NFC) device configured for being read by an NFC reader on the temperature management console, the NFC device configured to identify the tubing assembly. 32. The tubing assembly of claim 30, wherein the NFC reader comprises a radio frequency identifier (RFID) tag reader. 33. The tubing assembly of claim 1, wherein the tubing assembly is a disposable, single use loop. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 34. The tubing assembly of claim 1, wherein the threshold fluid pressure comprises an absolute pressure value. 35. The tubing assembly of claim 1, wherein the threshold fluid pressure comprises a value measuring a change in the fluid pressure. 36. The tubing assembly of claim 1, wherein the fluid is returned to a fluid supply that is configured to receive fluid from the fluid source. 37. The tubing assembly of claim 1, further comprising a valve configured to prevent the fluid from returning to the fluid source once the fluid has left the fluid source. 38. A tubing assembly configured to integrate with a temperature management system, the tubing assembly comprising: a supply tubing portion configured to transport fluid from a fluid source to a patient heat exchange device configured to exchange heat with a patient, the supply tubing portion comprising: a tubing assembly heat exchanger configured to exchange heat with a corresponding console heat exchanger of a temperature management console, the tubing assembly heat exchanger configured to heat or cool the fluid being transported from the fluid source to the patient heat exchange device; a relief valve configured to open the supply tubing portion to release fluid from the tubing assembly when a fluid pressure exceeds a threshold fluid pressure; and a supply connector configured to connect with the patient heat exchange device; and a return tubing portion configured to transport the fluid from the patient heat exchange device to the fluid source, the return tubing portion comprising: a return connector configured to connect with the patient heat exchange device. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 39. The tubing assembly of claim 38, wherein the relief valve is positioned upstream from the supply connector and downstream from the tubing assembly heat exchanger. 40. The tubing assembly of claim 38, further comprising a pressure sensor configured to measure fluid pressure for controlling the relief valve to open when the fluid pressure in the supply tubing portion exceeds the threshold fluid pressure. 41. The tubing assembly of claim 40, wherein the pressure sensor is configured to communicate with a controller that is configured to control the relief valve to open or close the relief valve responsive to the pressure sensor measuring the fluid pressure. 42. The tubing assembly of claim 40, wherein the pressure sensor is located in the supply tubing portion for measuring the fluid pressure. 43. The tubing assembly of claim 38, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an esophageal catheter. 44. The tubing assembly of claim 38, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an external pad. 45. The tubing assembly of claim 38, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an intravenous catheter. 46. The tubing assembly of claim 38, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising a nasal catheter. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 47. The tubing assembly of claim 38, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising a balloon catheter. 48. The tubing assembly of claim 38, wherein the relief valve comprises a check valve having a crack pressure that is the threshold fluid pressure. 49. The tubing assembly of claim 38, wherein the relief valve comprises a duck valve. 50. The tubing assembly of claim 38, wherein the relief valve comprises a spring loaded valve. 51. The tubing assembly of claim 38, wherein the return tubing portion further comprises a flow indicator, the flow indicator configured to measure the fluid flowing from the return tubing connector. 52. The tubing assembly of claim 38, wherein the threshold fluid pressure is between 5-11 pounds per square inch (PSI). 53. The tubing assembly of claim 38, further comprising a pump tube configured to interface with a fluid pump of the temperature management console, the fluid pump configured to move fluid through the supply tubing portion toward the supply connector, wherein the relief valve is located between the pump tube and the supply connector. 54. The tubing assembly of claim 38, further comprising an air trap configured to trap air present in the supply tubing portion. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 55. The tubing assembly of claim 38, further comprising a tubing portion configured to interface with a bubble flow sensor of the temperature management console. 56. The tubing assembly of claim 38, wherein the supply tubing portion comprises a plurality of supply tubing branches, each supply tubing branch including an instance of the supply connector and the relief valve. 57. The tubing assembly of claim 38, further comprising a spike configured to fluidly couple the supply tubing portion, the return tubing portion, or both to the fluid source. 58. The tubing assembly of claim 57, wherein the spike comprises a first lumen to fluidly couple the fluid source to the supply tubing portion, and wherein the spike comprises a second lumen to fluidly couple the fluid source to the return tubing portion. 59. The tubing assembly of claim 58, the spike further comprising: a stepped portion; and an elongate body extending from the stepped portion, wherein the elongate body has a smaller dimeter than the stepped portion. 60. The tubing assembly of claim 59, wherein the fluid source comprises a reservoir that is sealed or welded to the supply tubing portion and the return tubing portion to fluidly couple the fluid source to the supply tubing portion and the return tubing portion. 61. The tubing assembly of claim 60, wherein the fluid source further comprises a sealable port for adding fluid to the fluid source, the sealable port configured to maintain a sterility of the fluid. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 62. The tubing assembly of claim 61, wherein the sealable port comprises a feedbag cap. 63. The tubing assembly of claim 38, wherein the supply tubing portion, the return tubing portion, or both comprise a diameter of between 0.20-0.35 inches. 64. The tubing assembly of claim 38, wherein the supply tubing portion further comprises a valve at the supply connector configured to close when the fluid pressure near the supply connector exceeds the threshold fluid pressure. 65. The tubing assembly of claim 38, wherein the tubing assembly heat exchanger comprises a coil configured to be disposed in a heat exchange bath of the temperature management console heat exchanger of the temperature management console. 66. The tubing assembly of claim 38, wherein the tubing assembly heat exchanger comprises a cassette configured to be disposed between heat exchange plates of the temperature management console. 67. The tubing assembly of claim 38, further comprising a near field communication (NFC) device configured for being read by an NFC reader on the temperature management console, the NFC device configured to identify the tubing assembly. 68. The tubing assembly of claim 67, wherein the NFC reader comprises a radio frequency identifier (RFID) tag reader. 69. The tubing assembly of claim 38, wherein the tubing assembly is a disposable, single use loop. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 70. The tubing assembly of claim 38, wherein the threshold fluid pressure comprises an absolute pressure value. 71. The tubing assembly of claim 38, wherein the threshold fluid pressure comprises a value measuring a change in the fluid pressure. 72. The tubing assembly of claim 38, wherein the fluid is returned to a fluid supply that is configured to receive fluid from the fluid source. 73. The tubing assembly of claim 38, further comprising a valve configured to prevent the fluid from returning to the fluid source once the fluid has left the fluid source. 74. A tubing assembly configured to integrate with a temperature management system, the tubing assembly comprising: a supply tubing portion configured to transport fluid from a fluid source to a patient heat exchange device configured to exchange heat with a patient, the supply tubing portion comprising: a tubing assembly heat exchanger configured to exchange heat with a corresponding console heat exchanger of a temperature management console, the tubing heat exchanger configured to heat or cool the fluid being transported from the fluid source to the patient heat exchange device; and a pressure sensor configured to measure fluid pressure in the tubing assembly; a return tubing portion configured to transport the fluid from the patient heat exchange device to the fluid source, the return tubing portion comprising: a return connector configured to connect with the patient heat exchange device; and a communication interface connecting the pressure sensor to a controller to enable the controller to receive a signal comprising a pressure measurement from the pressure sensor. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 75. The tubing assembly of claim 74, wherein the pressure sensor is configured to communicate with a controller that is configured to control a bypass valve to open or close the bypass valve responsive to the pressure sensor measuring the fluid pressure, the bypass valve being located in a bypass tubing portion connecting the supply tubing portion to the return tubing portion. 76. The tubing assembly of claim 75, wherein the bypass valve comprises a check valve having a crack pressure that is the threshold fluid pressure. 77. The tubing assembly of claim 75, wherein the bypass valve comprises a duck valve. 78. The tubing assembly of claim 75, wherein the bypass valve comprises a spring loaded valve. 79. The tubing assembly of claim 74, wherein the pressure sensor is located in a bypass tubing portion, connecting the supply tubing portion to the return tubing portion, for measuring the fluid pressure. 80. The tubing assembly of claim 74, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an esophageal catheter. 81. The tubing assembly of claim 74, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an external pad. 82. The tubing assembly of claim 74, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising an intravenous catheter. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 83. The tubing assembly of claim 74, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising a nasal catheter. 84. The tubing assembly of claim 74, wherein the supply connector and the return connector are configured to connect to the patient heat exchange device comprising a balloon catheter. 85. The tubing assembly of claim 74, wherein the return tubing portion further comprises a flow indicator configured to measure the fluid flowing in the return tubing portion. 86. The tubing assembly of claim 74, wherein the threshold fluid pressure is between 5-11 pounds per square inch (PSI). 87. The tubing assembly of claim 74, further comprising a pump tube configured to interface with a fluid pump of the temperature management console, the fluid pump configured to move fluid through the supply tubing portion toward the supply connector, wherein the bypass tubing portion is located between the pump tube and the supply connector. 88. The tubing assembly of claim 74, further comprising an air trap configured to trap air present in the supply tubing portion. 89. The tubing assembly of claim 74, further comprising a tubing portion configured to interface with a bubble flow sensor of the temperature management console. 90. The tubing assembly of claim 74, wherein the supply tubing portion comprises a plurality of supply tubing branches, each supply tubing branch including an instance of the supply connector and the pressure sensor. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 91. The tubing assembly of claim 74, further comprising a spike configured to fluidly couple the supply tubing portion, the return tubing portion, or both to the fluid source. 92. The tubing assembly of claim 91, wherein the spike comprises a first lumen to fluidly couple the fluid source to the supply tubing portion, and wherein the spike comprises a second lumen to fluidly couple the fluid source to the return tubing portion. 93. The tubing assembly of claim 92, the spike further comprising: a stepped portion; and an elongate body extending from the stepped portion, wherein the elongate body has a smaller dimeter than the stepped portion. 94. The tubing assembly of claim 74, wherein the fluid source comprises a reservoir that is sealed or welded to the supply tubing portion and the return tubing portion to fluidly couple the fluid source to the supply tubing portion and the return tubing portion. 95. The tubing assembly of claim 94, wherein the fluid source further comprises a sealable port for adding fluid to the fluid source, the sealable port configured to maintain a sterility of the fluid. 96. The tubing assembly of claim 95, wherein the sealable port comprises a feedbag cap. 97. The tubing assembly of claim 74, wherein the supply tubing portion, the return tubing portion, or both comprise a diameter of between 0.20-0.35 inches. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 98. The tubing assembly of claim 74, wherein the supply tubing portion further comprises a valve at the supply connector configured to close when the fluid pressure near the supply connector exceeds the threshold fluid pressure. 99. The tubing assembly of claim 74, wherein the tubing assembly heat exchanger comprises a coil configured to be disposed in a heat exchange bath of the temperature management console heat exchanger of the temperature management console. 100. The tubing assembly of claim 74, wherein the tubing assembly heat exchanger comprises a cassette configured to be disposed between heat exchange plates of the temperature management console. 101. The tubing assembly of claim 74, further comprising a near field communication (NFC) device configured for being read by an NFC reader on the temperature management console, the NFC device configured to identify the tubing assembly. 102. The tubing assembly of claim 101, wherein the NFC reader comprises a radio frequency identifier (RFID) tag reader. 103. The tubing assembly of claim 74, wherein the tubing assembly is a disposable, single use loop. 104. The tubing assembly of claim 74, wherein the threshold fluid pressure comprises an absolute pressure value. 105. The tubing assembly of claim 74, wherein the threshold fluid pressure comprises a value measuring a change in the fluid pressure. Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 106. The tubing assembly of claim 74, wherein the fluid is returned to a fluid supply that is configured to receive fluid from the fluid source. 107. The tubing assembly of claim 74, further comprising a valve configured to prevent the fluid from returning to the fluid source once the fluid has left the fluid source. 108. The tubing assembly of claim 1, wherein the tubing assembly forms a sterile loop. 109. The tubing assembly of claim 38, wherein the tubing assembly forms a sterile loop. 110. The tubing assembly of claim 74, wherein the tubing assembly forms a sterile loop. 111. A temperature management system comprising: a console heat exchanger; a pump; a patient heat exchange device configured to exchange heat with a patient; a tubing assembly that is removable from the console heat exchanger and that forms a closed fluid loop when coupled to the patient heat exchange device, the tubing assembly comprising: a fluid source configured to supply a fluid; a supply tubing portion configured to transport fluid from the fluid source to the patient heat exchange device based on action of the pump; a tubing assembly heat exchanger configured to exchange heat with the console heat exchanger, the tubing assembly heat exchanger configured to heat or cool the fluid being transported from the fluid source to the patient heat exchange device; a pressure sensor configured to measure fluid pressure; and Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 a return tubing portion configured to transport the fluid from the patient heat exchange device to the fluid source; and a controller configured to receive a signal comprising a pressure measurement from the pressure sensor and control operation of the pump, wherein the controller is configured to cause the pump to stop pumping when a value of the pressure exceeds a threshold pressure. 112. The temperature management system of claim 111, wherein the pump comprises a peristaltic pump. 113. The temperature management system of claim 111, wherein the pump comprises a centrifugal pump. 114. A temperature management system comprising: a console heat exchanger; a pump; a patient heat exchange device configured to exchange heat with a patient; a tubing assembly that is removable from the console heat exchanger and that forms a closed fluid loop when coupled to the patient heat exchange device, the tubing assembly comprising: a fluid source configured to supply a fluid; a supply tubing portion configured to transport fluid from the fluid source to the patient heat exchange device based on action of the pump; a tubing assembly heat exchanger configured to exchange heat with the console heat exchanger, the tubing assembly heat exchanger configured to heat or cool the fluid being transported from the fluid source to the patient heat exchange device; a return tubing portion configured to transport the fluid from the patient heat exchange device to the fluid source; a bypass tubing portion connecting the supply tubing portion to the return tubing portion; and Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 a bypass valve configured to open the bypass tubing portion to direct fluid to bypass the patient heat exchange device when a fluid pressure exceeds a threshold fluid pressure; and a controller configured to control operation of the pump to pump the fluid from the fluid source through the supply tubing portion, the tubing heat exchanger, the patient heat exchange device, and the return tubing portion back to the fluid source. 115. The temperature management system of claim 114, wherein the pump comprises a peristaltic pump. 116. The temperature management system of claim 114, wherein the pump comprises a centrifugal pump. 117. The temperature management system of claim 111,wherein the pressure measurement from the pressure sensor is measured in the tubing assembly. 118. The tubing assembly of claim 1, the bypass valve configured to open the bypass tubing portion to direct fluid to bypass the supply connector and the return connector for bypassing the patient heat exchange device when a fluid pressure in the supply tubing portion exceeds a threshold fluid pressure. 119. The tubing assembly of claim 38, the relief valve configured to open the bypass tubing portion to direct fluid to bypass the supply connector and the return connector for bypassing the patient heat exchange device when a fluid pressure in the supply tubing portion exceeds a threshold fluid pressure. 120. A temperature management system comprising: a console heat exchanger; a pump; a patient heat exchange device configured to exchange heat with a patient; Attorney Docket No.40200-0508WO1 Client Docket No. Z20896WO-01 a tubing assembly that is removable from the console heat exchanger and that forms a closed fluid loop when coupled to the patient heat exchange device, the tubing assembly comprising any one of the tubing assemblies of claims 1 to 110 and 118 to 119.
PCT/US2025/024315 2024-04-12 2025-04-11 Tubing assemblies for temperature management systems Pending WO2025217544A1 (en)

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