Improvements to targeted temperature managements systems including components and methods thereof

Abstract

Targeted temperature management ("TTM") systems are improved. For example, a TTM system can include a control module, a primary fluid delivery line ("FDL"), and one or more pads configured for placement around one or more portions of a patient's body, respectively. The primary FDL can be configured to convey a temperature-controlled fluid from a hydraulic system as a supply fluid and back to the hydraulic system as a return fluid. Each pad of the one-or-more pads can include a multilayered pad body having a conduit layer configured to convey the temperature-controlled fluid through the pad body, a patient-interfacing layer configured with a thermally conductive medium, and a removable cloth liner over one or more areas of the patient-interfacing layer. The cloth liner can be configured to allow a clinician to peel up the pad from the patient's body by a skin-check tab with a gloved hand.

Description

IMPROVEMENTS TO TARGETED TEMPERATURE MANAGEMENTS SYSTEMSINCLUDING COMPONENTS AND METHODS THEREOFPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 638,819, filed April 25, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Targeted temperature management (“TTM”) maintains therapeutic body temperatures (e.g., hypothermia or hyperthermia) in patients to improve their outcomes in different medical situations. Current TTM systems utilize pads placed on different parts of the patients’ bodies, as well as fluid delivery lines and connectors, to circulate temperature- controlled fluid (e.g., cooled or warmed fluid) from TTM control modules to induce or maintain therapeutic body temperatures. Being that such pads, fluid delivery lines, and connectors each play a role in efficiently regulating therapeutic body temperatures, improvements to the pads, fluid delivery lines, and connectors, as well as the TTM control modules to which they are fluidly connected, continues to be an active area of research and development in TTM.

[0003] Disclosed herein are improvements to TTM systems including components and methods thereof.SUMMARY

[0004] Disclosed herein is a TTM system including, in some embodiments, a control module, a primary fluid delivery line (“FDL”), and one or more pads. The control module includes a hydraulic system configured to provide a temperature-controlled fluid. The primary FDL is configured to convey the temperature-controlled fluid from the hydraulic system as a supply fluid. The primary FDL is also configured to convey the temperature-controlled fluid back to the hydraulic system as a return fluid. The one-or-more pads are configured for placement around one or more portions of a patient’s body, respectively. Each pad of the one- or-more pads includes a multilayered pad body, an inlet manifold, and an outlet manifold. The pad body includes a conduit layer including a plurality of conduits configured to convey the temperature-controlled fluid through the pad body, an impermeable film over the conduit layer configured to retain the temperature-controlled fluid in the conduit layer, a patient-interfacinglayer over the impermeable film configured with a thermally conductive medium for placement on the patient’s body, and a removable cloth liner over one or more areas of the patientinterfacing layer including at least a skin-check tab extending from the pad. The cloth liner is configured to allow a clinician to peel up the pad from the patient’s body by the skin-check tab with a gloved hand. The inlet manifold is configured for charging the conduit layer with the supply fluid. The outlet manifold is configured for discharging the return fluid from the conduit layer.

[0005] In some embodiments, each pad of the one-or-more pads includes a chamfered edge to reduce a number of sharp edges in contact with the patient’s body when placed around the one-or-more portions of the patient’s body.

[0006] In some embodiments, the one-or-more pads include a pair of torso pads, a pair of thigh pads, or both the pair of torso pads and the pair of thigh pads. Each thigh pad of the pair of thigh pads is bilaterally symmetric for placement on either a left or right thigh of the patient’s body.

[0007] In some embodiments, the plurality of conduits are configured to reduce flow stagnation in the conduit layer and, thereby, optimize heat transfer between the patient and the one-or-more pads.

[0008] In some embodiments, each manifold of the inlet manifold and the outlet manifold is located in a location on its corresponding pad of the one-or-more pads that remains anterior of the patient when placed around the one-or-more portions of the patient’s body, thereby minimizing patient-weight induced pressure points.

[0009] In some embodiments, the TTM system further includes one or more secondary FDLs corresponding to the one-or-more pads, respectively. Each secondary FDL of the one or more secondary FDLs is configured to supply the supply fluid from the primary FDL to the conduit layer through a single inlet nipple of the inlet manifold to which a supply-fluid conduit 246 of the secondary FDL is fluidly connected. Each secondary FDL of the one or more secondary FDLs is also configured to return the return fluid from the conduit layer to the primary FDL through a single outlet nipple of the outlet manifold to which a return-fluid conduit of the secondary FDL is also fluidly connected.

[0010] In some embodiments, each secondary FDL of the one or more secondary FDLs includes a pad connector having a pair of nipples distributedly inserted into the supply-fluid conduit 246 and the return-fluid conduit of the secondary FDL. A sleeve over a distal portion of the pad connector and a proximal portion of the secondary FDL protects a fluid connection of the pad connector and the secondary FDL. In addition, the sleeve encapsulates any rough edges of the pad connector remaining from manufacturing.

[0011] In some embodiments, the pad connector includes a non-volatile memory chip embedded therein programmed to include manufacturing information for its corresponding pad. The non-volatile memory chip is configured to be optionally updated with therapeutic information for the patient by the control module.

[0012] In some embodiments, the control module further includes a console including one or more processors, primary memory including read-only memory (“ROM”) and randomaccess memory (“RAM”), and instructions stored in the ROM configured to instantiate one or more processes in the RAM for TTM with the control module. The console is configured to communicatively connect with the non-volatile memory chip by way of electrical leads through the primary FDL.

[0013] In some embodiments, a proximal connector of the primary FDL connects the electrical leads to those of a control-module connector of the control module. Electrical connections established between the primary FDL and the control-module connector are established by a communications port above a supply-fluid outlet and a return-fluid inlet of the hydraulic system so as to keep the electrical connections or components therebetween dry.

[0014] In some embodiments, the proximal connector of the primary FDL includes a locking lever configured to lock the proximal connector onto the control module.

[0015] In some embodiments, the control module includes a molded fill-tube-tip holder configured to hold a fill-tube tip of a fill tube for refilling the control module. The fill-tube-tip holder thereby keeps the fill-tube tip together with the fill tube and free of contamination.

[0016] In some embodiments, the control module includes an FDL storage lug for wrapping the primary FDL therearound for storage.

[0017] Also disclosed herein is a method for TTM. The method includes, in some embodiments, placing one or more pads around a patient’s body. Each pad of the one-or-more pads includes a multilayered pad body, an inlet manifold, and an outlet manifold. The pad body includes a conduit layer including a plurality of conduits configured to convey the temperature- controlled fluid through the pad body, an impermeable film over the conduit layer configured to retain the temperature-controlled fluid in the conduit layer, a patient-interfacing layer over the impermeable film configured with a thermally conductive medium for heat transfer with the patient’s body, and a removable cloth liner over one or more areas of the patient-interfacing layer including at least a skin-check tab extending from the pad. The cloth liner is configured to allow a clinician to peel up the pad from the patient’s body by the skin-check tab with a gloved hand. The method also includes circulating the temperature-controlled fluid through the one-or-more pads by way of a combination of fluidly connected FDLs including a primary FDL from a hydraulic system of a control module and one or more secondary FDLs corresponding to the one-or-more pads, respectively, to cool or warm the patient’s body as needed in accordance with TTM. Circulating the temperature-controlled fluid through the one- or-more pads includes charging the conduit layer of each pad of the one-or-more pads with a supply fluid of the temperature-controlled fluid provided by the hydraulic system. Circulating the temperature-controlled fluid through the one-or-more pads also includes discharging a return fluid of the temperature-controlled fluid from the conduit layer of each pad of the one- or-more pad to the hydraulic system.

[0018] In some embodiments, each pad of the one-or-more pads includes a chamfered edge to reduce a number of sharp edges in contact with the patient’s body when placed around the one-or-more portions of the patient’s body.

[0019] In some embodiments, the one-or-more pads include a pair of torso pads, a pair of thigh pads, or both the pair of torso pads and the pair of thigh pads. Each thigh pad of the pair of thigh pads is bilaterally symmetric for placement on either a left or right thigh of the patient’s body.

[0020] In some embodiments, the plurality of conduits are configured to reduce flow stagnation in the conduit layer and, thereby, optimize heat transfer between the patient and the one-or-more pads.

[0021] In some embodiments, each manifold of the inlet manifold and the outlet manifold is located in a location on its corresponding pad of the one-or-more pads that remains anterior of the patient when placed around the one-or-more portions of the patient’s body, thereby minimizing patient-weight induced pressure points.

[0022] In some embodiments, each secondary FDL of the one or more secondary FDLs is configured to supply the supply fluid from the primary FDL to the conduit layer through a single inlet nipple of the inlet manifold to which a supply-fluid conduit 246 of the secondary FDL is fluidly connected. Each secondary FDL of the one or more secondary FDLs is also configured to return the return fluid from the conduit layer to the primary FDL through a single outlet nipple of the outlet manifold to which a return-fluid conduit of the secondary FDL is also fluidly connected.

[0023] In some embodiments, each secondary FDL of the one or more secondary FDLs includes a pad connector having a pair of nipples distributedly inserted into the supply-fluid conduit 246 and the return-fluid conduit of the secondary FDL. A sleeve over a distal portion of the pad connector and a proximal portion of the secondary FDL protects a fluid connection of the pad connector and the secondary FDL. In addition, the sleeve encapsulates any rough edges of the pad connector remaining from manufacturing.

[0024] In some embodiments, the pad connector includes a non-volatile memory chip embedded therein programmed to include manufacturing information for its corresponding pad. The non-volatile memory chip is configured to be optionally updated with therapeutic information for the patient by the control module.

[0025] In some embodiments, the control module further includes a console including one or more processors, primary memory including read-only memory (“ROM”) and randomaccess memory (“RAM”), and instructions stored in the ROM configured to instantiate one or more processes in the RAM for TTM with the control module. The console is configured to communicatively connect with the non-volatile memory chip by way of electrical leads through the primary FDL.

[0026] In some embodiments, a proximal connector of the primary FDL connects the electrical leads to those of a control-module connector of the control module. Electrical connections established between the primary FDL and the control-module connector areestablished by a communications port above a supply-fluid outlet and a return-fluid inlet of the hydraulic system so as to keep the electrical connections or components therebetween dry.

[0027] In some embodiments, the proximal connector of the primary FDL includes a locking lever configured to lock the proximal connector onto the control module.

[0028] In some embodiments, the control module includes a molded fill-tube-tip holder configured to hold a fill-tube tip of a fill tube for refilling the control module. The fill-tube-tip holder thereby keeps the fill-tube tip together with the fill tube and free of contamination.

[0029] In some embodiments, the control module includes an FDL storage lug for wrapping the primary FDL therearound for storage.

[0030] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0031] FIG. 1 illustrates a TTM system including a control module, a primary FDL, a plurality of secondary FDLs, and a plurality of pads in accordance with some embodiments.

[0032] FIG. 2 illustrates a torso pad in accordance with some embodiments.

[0033] FIG. 3 illustrates a thigh pad in accordance with some embodiments.

[0034] FIG. 4 illustrates a chamfered edge of the torso or thigh pad in accordance with some embodiments.

[0035] FIG. 5 illustrates a multilayered pad body of the torso or thigh pad in accordance with some embodiments.

[0036] FIG. 6 illustrates a cloth liner over an area of the torso or thigh pad in accordance with some embodiments.

[0037] FIG. 7 illustrates the cloth liner over a skin-check tab in accordance with some embodiments.

[0038] FIG. 8 illustrates a heat map for flow of a temperature-controlled fluid through a conduit layer of the torso pad in accordance with some embodiments.

[0039] FIG. 9 illustrates a heat map for flow of the temperature-controlled fluid through the conduit layer of the thigh pad in accordance with some embodiments.

[0040] FIG. 10 illustrates an exposed side of an inlet or outlet manifold in accordance with some embodiments.

[0041] FIG. 11 illustrates a pad-interfacing side of the inlet or outlet manifold in accordance with some embodiments.

[0042] FIG. 12 illustrates a first view of a pad connector in accordance with some embodiments.

[0043] FIG. 13 illustrates a second view of the pad connector in accordance with some embodiments.

[0044] FIG. 14 illustrates the pad connector inserted into a secondary FDL with a sleeve therearound in accordance with some embodiments.

[0045] FIG. 15 illustrates a detailed view from a proximal end of the pad connector inserted into the secondary FDL with a sleeve therearound in accordance with some embodiments.

[0046] FIG. 16 illustrates the primary FDL and a pair of distal connectors thereof in accordance with some embodiments.

[0047] FIG. 17 illustrates a proximal connector of the primary FDL in accordance with some embodiments.

[0048] FIG. 18 illustrates the proximal connector of the primary FDL with a back cover removed in accordance with some embodiments.

[0049] FIG. 19 illustrates a posterior of the control module in accordance with some embodiments.

[0050] FIG. 20 illustrates a hydraulic system of the control module in accordance with some embodiments.

[0051] FIG. 21 illustrates a block diagram of a console and some related components of the TTM system in accordance with some embodiments.DESCRIPTION

[0052] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0053] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. In addition, any of the foregoing features or steps can, in turn, further include one or more features or steps unless indicated otherwise. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0054] “Proximal” is used to indicate a portion, section, piece, element, or the like of a medical device or system intended to be near or relatively nearer to a clinician when the medical device or system is used on a patient. For example, “proximal” is used to indicate a portion, section, piece, element, or the like of the TTM system near or relatively nearer to the clinician such as the control module while the clinician operates the control module with the one or more pads placed around the patient. A “proximal portion” or “proximal section” of the medical device or system includes a portion or section of the medical device or system intended to be near the clinician when the medical device is used on the patient. Likewise, a “proximal length” of the medical device or system includes a length of the medical device or system intended to be near the clinician when the medical device is used on the patient. A “proximal end” of themedical device or system is an end of the medical device or system intended to be near the clinician when the medical device or system is used on the patient. The proximal portion, the proximal section, or the proximal length of the medical device or system need not include the proximal end of the medical device or system. Indeed, the proximal portion, the proximal section, or the proximal length of the medical device or system can be short of the proximal end of the medical device or system. However, the proximal portion, the proximal section, or the proximal length of the medical device or system can include the proximal end of the medical device or system. Should context not suggest the proximal portion, the proximal section, or the proximal length of the medical device or system includes the proximal end of the medical device or system, or if it is deemed expedient in the following description, “proximal portion,” “proximal section,” or “proximal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device or system for a “proximal end portion,” a “proximal end section,” or a “proximal end length” of the medical device or system, respectively.

[0055] “Distal” is used to indicate a portion, section, piece, element, or the like of a medical device or system intended to be near or relatively nearer a patient when the medical device or system is used on the patient. For example, “distal” is used to indicate a portion, section, piece, element, or the like of the TTM system near or relatively nearer to the patient such as the one-or-more pads around the patient while a clinician operates the control module. A “distal portion” or “distal section” of the medical device or system includes a portion or section of the medical device or system intended to be near, relatively nearer, or even in the patient when the medical device or system is used on the patient. Likewise, a “distal length” of the medical device or system includes a length of the medical device or system intended to be near, relatively nearer, or even in the patient when the medical device or system is used on the patient. A “distal end” of the medical device or system is an end of the medical device or system intended to be near, relatively nearer, or even in the patient when the medical device or system is used on the patient. The distal portion, the distal section, or the distal length of the medical device or system need not include the distal end of the medical device or system. Indeed, the distal portion, the distal section, or the distal length of the medical device or system can be short of the distal end of the medical device or system. However, the distal portion, the distal section, or the distal length of the medical device or system can include the distal end of the medical device or system. Should context not suggest the distal portion, the distal section, or the distal length of the medical device or system includes the distal end of the medical deviceor system, or if it is deemed expedient in the following description, “distal portion,” “distal section,” or “distal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device or system for a “distal end portion,” a “distal end section,” or a “distal end length” of the medical device or system, respectively.

[0056] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0057] As set forth above, TTM maintains therapeutic body temperatures (e.g., hypothermia or hyperthermia) in patients to improve their outcomes in different medical situations. Current TTM systems utilize pads placed on different parts of the patients’ bodies, as well as fluid delivery lines and connectors, to circulate temperature-controlled fluid (e.g., cooled or warmed fluid) from TTM control modules to induce or maintain therapeutic body temperatures. Being that such pads, fluid delivery lines, and connectors each play a role in efficiently regulating therapeutic body temperatures, improvements to the pads, fluid delivery lines, and connectors, as well as the TTM control modules to which they are fluidly connected, continues to be an active area of research and development in TTM.

[0058] Disclosed herein are improvements to TTM systems including components and methods thereof.TTM systems

[0059] FIG. 1 illustrates a TTM system 100 in accordance with some embodiments.

[0060] As shown, the TTM system 100 can include a control module 102, a primary FDL 104, one or more secondary FDLs 106, and one or more pads 108, wherein the one-or- more secondary FDLs 106 correspond in number to the one-or-more pads 108. Notably, such components of the TTM system 100 can be connected in the foregoing order by way connectors (e.g., fluidoelectrical connectors) configured to establish fluidoelectrical connections between the components. Description for the control module 102 is set forth immediately below followed by description of the primary FDL 104. Description for the one-or-more pads 108 and the one-or-more secondary FDLs 106 is set forth in the sections thereafter.Control module

[0061] The control module 102 can include a console 110 and a hydraulic system 112 within a housing 114 of the control module 102. The console 110 is configured to run one or more processes for TTM with the control module 102. The hydraulic system 112 is configured to provide a temperature-controlled fluid for TTM.

[0062] FIG. 21 illustrates a block diagram of the console 110 in accordance with some embodiments.

[0063] As shown, the console 110 can include one or more core computing components disposed or operably connected to a board such as a motherboard like that of a traditional computer system, an embedded board in an embedded or single-board system, a carrier board in a system-on-module architecture, or the like. The console 110 can also include an integrated display screen 116 configured as a touchscreen with a graphical user interface (“GUI”) 118 for operating the control module 102. The console 110 can also include or be operably connected to a wireless communication module 120 to enable wireless communication between the console 110 and external devices. The console 110 can also include or be operably connected to one or more fluid sensors 122 selected from a pressure sensor (Pl), the flow meter 166, a chiller-tank temperature sensor (T4), a mixing-tank temperature sensor (Tl), an outlet temperature sensor (T2), and an inlet temperature sensor (T3), data from any of which fluid sensors 122 can be utilized by the logic modules set forth below to provide the temperature- controlled fluid in a state needed to effectuate a clinician-prescribed patient therapy via TTM or an onboard TTM protocol. The console 110 can also include or be operably connected to one or more fluid control devices 124 of the hydraulic system 112 (e.g., chiller evaporator 148, chiller pump 152, heater 156, mixing pump 160, and circulation pump 164) and, thereby, physically provide the temperature-controlled fluid for TTM in accordance with the clinician- prescribed patient therapy or the onboard TTM protocol. Lastly, a power source 126 can be configured to provide electrical power to the console 110.

[0064] The one-or-more core computing components can include one or more processors 128, at least primary memory 130 including read-only memory (“ROM”) and random-access memory (“RAM”), and instructions 132 stored in the ROM. The instructions 132 can be configured to instantiate one or more processes in the RAM to effectuate the clinician-prescribed patient therapy or the onboard TTM protocol with the control module 102 when executed by the one-or-more processors 128. In addition, the primary memory 130 caninclude various logic modules selected form patient therapy logic 134, fluid-temperature control logic 136, fluid-flow control logic 138, and pad identification logic 140. Such logic modules and any data from the one-or-more fluid sensors 122 can be utilized in the one-or- more processes to effectuate the clinician-prescribed patient therapy or the onboard TTM protocol with the control module 102.

[0065] The patient therapy logic 134 can receive input from a clinician via the GUI 118 to establish operating parameters in accordance with the clinician-prescribed patient therapy. Such input can include a target temperature for a patient or a thermal energy exchange rate with the patient, which input can be utilized by the patient therapy logic 134 to establish a timebased target temperature profile for achieving the target temperature in the patient.

[0066] The fluid-temperature control logic 136 can be utilized to establish and maintain a temperature of the temperature-controlled fluid delivered to the one-or-more pads 108 in accordance with the target temperature. In an example, when cooling the fluid within the chiller circuit 142, the fluid-temperature control logic 136 can utilize temperature data from the chiller-tank temperature sensor (T4) to control operation of the chiller evaporator 148 to establish and maintain the temperature of the cooled fluid within the chiller circuit 142 including the chiller tank 150. In another example, when heating the mixed fluid within the mixing circuit 144, the fluid-temperature control logic 136 can utilize temperature data from the mixing-tank temperature sensor (Tl) to control operation of the heater 156 to establish and maintain the temperature of the heated fluid within the mixing circuit 144 including the mixing tank 154.

[0067] The fluid-flow control logic 138 can be utilized to control operation of at least the circulation pump 164 of the circulating circuit 146. As the thermal energy exchange rate with the patient is at least partially defined by a flow rate of the temperature-controlled fluid through the one-or-more pads 108, the fluid-flow control logic 138 can be utilized to control the operation of the circulation pump 164 in accordance with the thermal energy exchange rate for the clinician-prescribed patient therapy or the onboard TTM protocol.

[0068] The pad identification logic 140 can be utilized to keep track of each pad of the one-or-more pads 108 and its status by way of at least the manufacturing information programmed into the non-volatile memory chip 262 thereof. Indeed, using the manufacturing information programmed into the non-volatile memory chip 262 of each pad of the one-or-more pads 108, at least connection status, input temperature of the supply fluid, and output temperature of the return fluid can be tracked. Further, the pad identification logic 140 can be utilized to program the non-volatile memory chip 262 of each pad of the one-or-more pads 108 with therapeutic information for the patient. Such therapeutic information can be utilized by a second control module in a second location to resume TTM if a patient needs to be moved away from a first control module in a first location.

[0069] FIG. 20 illustrates the hydraulic system 112 of the control module 102 in accordance with some embodiments.

[0070] As shown, the hydraulic system 112 can include a chiller circuit 142, a mixing circuit 144, and a circulating circuit 146 for providing the temperature-controlled fluid.

[0071] The chiller circuit 142 can be configured for cooling a fluid (e.g., water, ethylene glycol, a combination of water and ethylene glycol, etc.) to produce a cooled fluid, which cooled fluid, in turn, can be for mixing with the mixed fluid in the mixing tank 154 set forth below to produce a supply fluid for the one-or-more pads 108. The chiller circuit 142 can include a chiller evaporator 148 configured for the cooling of the fluid passing therethrough. The fluid for the cooling by the chiller evaporator 148 is provided by a chiller tank 150 using a chiller pump 152 of the chiller circuit 142.

[0072] The mixing circuit 144 can be configured for mixing spillover of the cooled fluid from the chiller tank 150 with a mixed fluid in a mixing tank 154 of the mixing circuit 144. The mixing circuit 144 can include a heater 156 in the mixing tank configured for heating the mixed fluid to produce a heated fluid, which can be mixed with the cooled fluid in any ratio to provide a supply tank 158 of the circulating circuit 146 with the supply fluid of a desired temperature for the one-or-more pads 108. Indeed, the chiller evaporator 148 and the heater 156, together, are configured to cooperate to provide the temperature-controlled fluid. The mixing circuit 144 can include a mixing pump 160 configured to pump the fluid from the mixing tank 154 into the chiller tank 150 for producing the cooled fluid as well as the spillover of the cooled fluid for the mixing tank 154.

[0073] The circulating circuit 146 can be configured for circulating the supply fluid for the one-or-more pads 108, which includes circulating the supply fluid provided by a manifold 162 through the one-or-more pads 108 using a circulation pump 164 directly or indirectly governed by a flow meter 166 of the circulating circuit 146. The manifold 162 can include asupply-fluid outlet 168 configured for discharging the supply fluid (e.g., a cooled fluid or a warmed fluid as indicated) from the hydraulic system 112 and a return-fluid inlet 170 configured for charging the hydraulic system 112 with return fluid from the one-or-more pads 108 to continue to produce the supply fluid.

[0074] FIG. 19 illustrates a posterior of the control module 102 in accordance with some embodiments.

[0075] As shown, the housing 114 of the control module 102 can be configured to accommodate various connections to the control module 102 in the posterior of the control module 102. For example, the posterior of the control module 102 can include a control-module connector 172 configured to connect with the proximal connector 188 of the primary FDL 104 and, thereby, establish fluid connections between the hydraulic system 112 and the one-or- more pads 108 as well as any electrical connections between the console 110 and the one-or- more pads 108. Such electrical connections are established by a communications port 174 of the console 110 above the supply-fluid outlet 168 and the return-fluid inlet 170 of the hydraulic system 112 in the control-module connector 172 so as to keep the electrical connections or components therebetween dry. Notably, the hydraulic system 112 can also be refilled via the return-fluid inlet 170 or a dedicated fill inlet 177 of the hydraulic system 112 present in the control-module connector 172. Indeed, a fill-tube tip 176 of a fill tube 178 can be disposed in a receptacle including a stock fluid while a control module-connecting end portion of the fill tube 178 is securely inserted into the return-fluid inlet 170 or the fill inlet 177 of the hydraulic system 112 to refill the hydraulic system 112. If need be, the hydraulic system 112 can likewise be drained via the supply-fluid outlet 168 or the fill inlet 177 of the hydraulic system 112 present in the control-module connector 172. When the fill tube 178 and the fill-tube tip 176 thereof are not in use, the fill-tube tip 176 can be inserted into a molded fill-tube-tip holder 180 of the housing 114 of the control module 102. The fill-tube-tip holder 180 can be configured to securely hold the fill-tube tip 176 of the fill tube 178, thereby keeping the fill-tube tip 176 together with the fill tube 178 so that it will not be accidentally discarded and unavailable for refilling the hydraulic system 112. Further, the fill-tube-tip holder 180 can keep the fill tube 178 free of contamination by securely holding the fill tube 178 by the fill-tube tip 176 instead of allowing it rest on the ground between uses.

[0076] In addition, the housing 114 of the control module 102 can be configured to accommodate handling the control module 102 as well as storing one or more separablecomponents of the TTM system 100. In an example, the housing 114 of the control module 102 can include a handle 182 for positioning the control module 102 in a first location or moving the control module 102 to second location. In another example, the housing 114 of the control module 102 can include an FDL storage lug 184 for wrapping the primary FDL 104 therearound for storage.Primary FDL

[0077] FIGS. 1 and 16 illustrate the primary FDL 104 in accordance with some embodiments. In addition, FIG. 16 illustrates a pair of distal connectors 186 of the primary FDL 104, and FIGS. 17 and 18 illustrate a proximal connector 188 of the primary FDL 104 in accordance with some embodiments.

[0078] As shown, the primary FDL 104 can include the proximal connector 188 and the pair of distal connectors 186 at either end of some primary tubing 190. Such a primary FDL 104 can be configured to convey the temperature-controlled fluid from the hydraulic system 112 to the one-or-more pads 108 as the supply fluid as well as convey the temperature- controlled fluid back to the hydraulic system 112 as the return fluid from the one-or-more pads 108. Such a primary FDL 104 can also be configured to relay electrical communications between the console 110 and the one-or-more pads 108.

[0079] The primary tubing 190 can be configured with a supply-fluid lumen 192 to convey the supply fluid from the hydraulic system 112 to the one-or-more pads 108 and a return-fluid lumen 194 to convey the return fluid from the one-or-more pads 108 to the hydraulic system 112. Each lumen of the supply-fluid lumen 192 and the return-fluid lumen 194 can be furcated as needed from a location distal of the proximal connector 188 into the pair of distal connectors 186. As such, when the proximal connector 188 of the primary FDL 104 is fluidly connected to the hydraulic system 112 via the control-module connector 172 of the control module 102 and a distal connector 186 of the pair of distal connectors 186 of the primary FDL 104 is fluidly connected to a pad 108 of the one-or-more pads 108 via a pad connector 242 of the pad, the supply-fluid lumen 192 can convey the supply fluid from the hydraulic system 112 to the one-or-more pads 108 and the return-fluid lumen 194 can convey the return fluid from the one-or-more pads 108 to the hydraulic system 112. Further, the primary tubing 190 can be configured with electrical leads 196 distributed as needed from the foregoing location distal of the proximal connector 188 into the pair of distal connectors 186for any electrical connections between the console 110 and the one-or-more pads 108 when connected via the primary FDL 104.

[0080] The proximal connector 188 of the primary FDL 104 can be configured to connect with the control-module connector 172 of the control module 102 and, thereby, establish fluid connections between the hydraulic system 112 and the one-or-more pads 108 as well as any electrical connections between the console 110 and the one-or-more pads 108. Indeed, the proximal connector 188 of the primary FDL 104 can connect the supply and returnfluid lumens 192 and 194 of the primary tubing 190 to the supply-fluid outlet 168 and the return-fluid inlet 170 of the hydraulic system 112 of the control module 102 by way of, for example, double piston seals 198. While not shown, each double piston seal of the double piston seals 198 of the proximal connector 188 can include a primary hydraulic seal and a secondary stabilizing seal for centering and stabilizing the proximal connector 188 on the control-module connector 172. Further, the proximal connector 188 of the primary FDL 104 can connect the electrical leads 196 of the primary FDL 104 or the proximal terminal pins 199 thereof to those of the control module 102 via the control -module connector 172. Again, the electrical connections established between the proximal connector 188 of the primary FDL 104 and the control-module connector 172 of the control module 102 are established by the communications port 174 above the supply-fluid outlet 168 and the return-fluid inlet 170 of the hydraulic system 112 so as to keep the electrical connections or components therebetween dry. The electrical leads 196 of the proximal connector 188 of the primary FDL 104 (or any electrical connector of which the electrical leads 196 or the proximal terminal pins 199 thereof are part) are likewise above the double piston seals 198 of the proximal connector 188, which respectively correspond to the supply-fluid lumen 192 and the return-fluid lumen 194 of the primary tubing 190. Notably, to ensure a secure connection of the proximal connector 188 of the primary FDL 104 and the control -module connector 172 of the control module 102, the proximal connector 188 can include a toolless locking lever 200 configured to lock the proximal connector 188 onto the control module 102 when rotated.

[0081] Each distal connector of the pair of distal connectors 186 of the primary FDL 104 can be configured to connect with a plurality of pad connectors 242 (e.g., three pad connectors 242) and, thereby, establish fluid connections between the hydraulic system 112 and the one-or-more pads 108 as well as any electrical connections between the console 110 and the one-or-more pads 108. Indeed, each distal connector of the pair of distal connectors186 of the primary FDL 104 can include a pair of tube ends 202 to connect the supply and return-fluid lumens 192 and 194 of the primary tubing 190 to the supply and return-fluid conduits 246 and 248 of the secondary tubing 244 as well as the electrical leads 196 of the primary FDL 104 or the distal terminal pins 203 thereof to those of a pad connector of the plurality of pad connectors 242. Notably, to ensure a secure connection of each distal connector of the pair of distal connectors 186 of the primary FDL 104 and a pad connector 242 of the plurality of pad connectors 242, each distal connector of the pair of distal connectors 186 can include a plurality of locking mechanisms (of a same kind) configured to lock the plurality of pad connectors 242 thereon. Indeed, each locking mechanism of the plurality of locking mechanisms can include a displaceable button 204 or pair of opposing displaceable buttons 204 configured to release a locked pad connector 242 when pressed in toward a centerline of the distal connector 186 or portion thereof to which the pad connector 242 is locked.Pads

[0082] FIGS. 1-3 illustrate a plurality of pads 108 in accordance with some embodiments.

[0083] As shown, each pad of the one-or-more pads 108 can include a multilayered pad body 206, an inlet manifold 208, and an outlet manifold 210. While not shown, each pad of the one-or-more pads 108 can include a backing over the pad body 206 in a ready -to-use state thereof to protect at least the patient-interfacing layer 216 prior to use. Indeed, such a backing or backings should be removed before placement of the one-or-more pads 108 around one or more portions of a patient’s body, respectively.

[0084] FIG. 5 illustrates the pad body 206 in accordance with some embodiments.

[0085] As shown, the pad body 206 can include a conduit layer 212, an impermeable film 214 over the conduit layer 212, a patient-interfacing layer 216 over the impermeable film 214, and, optionally, a removable cloth liner 218 over one or more areas of the patientinterfacing layer 216.

[0086] The conduit layer 212 can include a plurality of conduits 220 as well as a plurality of protrusions 222 configured to convey the temperature-controlled fluid through the pad body 206 with an even flow. Such a conduit layer 212 can include a perimetrical wall 224 and one or more inner walls 226 extending from the conduit layer 212 toward the impermeablefilm 214. Together, the perimetrical wall 224 and the one-or-more inner walls 226 form the plurality of conduits 220 configured to convey the supply fluid through the conduit layer 212. The plurality of protrusions 222 can likewise extend from the conduit layer 212 toward the impermeable film 214. The plurality of protrusions 222 are configured to promote the even flow of the temperature-controlled fluid when the temperature-controlled fluid is conveyed through the conduit layer 212.

[0087] FIGS. 8 and 9 illustrate heat maps for flow of the temperature-controlled fluid through the conduit layer 212 of two different pads of the one-or-more pads 108 in accordance with some embodiments.

[0088] As shown, the plurality of conduits 220 can be configured to reduce flow stagnation in the conduit layer 212 and, thereby, optimize heat transfer between the patient and the one-or-more pads 108. Indeed, FIG. 8 illustrates a heat map for the flow of the temperature- controlled fluid through the conduit layer 212 of a torso pad of the pair of torso pads set forth below, wherein heat transfer is optimized between the patient’s torso and the torso pad. FIG. 9 illustrates a heat map for flow of the temperature-controlled fluid through the conduit layer 212 of a thigh pad of the pair of thigh pads set forth below, wherein heat transfer is optimized between the patient’s thigh and the thigh pad. Indeed, such heat maps show no shunting of the flow of the temperature-controlled fluid through the conduit layer 212 of the torso pad of the pair of torso pads or the thigh pad of the pair of thigh pads.

[0089] Notably, the conduit layer 212 can be formed of an insulating foam such as a closed-cell ethylene-vinyl acetate (“EVA”) foam, which has a relatively low thermal conductivity of about 0.3 W / m-K, thereby minimizing heat transfer with an ambient environment such as an examination, procedure, or operating room.

[0090] The impermeable film 214 over the conduit layer 212 can be configured to retain the temperature-controlled fluid in the conduit layer 212 when the temperature-controlled fluid is conveyed through the conduit layer 212. In addition, the impermeable film 214 can be configured to allow efficient energy transfer between the conduit layer 212 and the patientinterfacing layer 216.

[0091] The patient-interfacing layer 216 over the impermeable film 214 can be configured with a thermally conductive medium for placement on skin S of a portion (e.g., torso, thigh, etc.) of a patient’s body for direct thermal conduction through the patient-interfacing layer 216. The patient-interfacing layer 216 cam include a thermally conductive medium configured to conformably adhere to the patient’s body for the direct thermal conduction. The thermally conductive medium can include a hydrogel selected from a polyethylene glycol) hydrogel, an alginate-based hydrogel, a chitosan-based hydrogel, a collagen-based hydrogel, a dextran-based hydrogel, a hyaluronan-based hydrogel, a xanthan- based hydrogel, a konjac-based hydrogel, a gelatin-based hydrogel, and a combination of two or more of the foregoing hydrogels.

[0092] FIGS. 6 and 7 illustrate the cloth liner 218 over the one-or-more areas of the patient-interfacing layer 216 in accordance with some embodiments.

[0093] As shown, the one-or-more areas of the patient-interfacing layer 216 that the cloth liner 218 can be over include at least a chest portion of the torso pad near the patient’s neck and any skin-check tab 228 extending from the pad. Such a cloth liner 218 can be a nonwoven cloth liner. As to the cloth liner 218 over the chest portion of the torso pad, such a cloth liner 218 can be configured to prevent the patient’s hair from sticking to the patient-interfacing layer 216 if the patient is relatively shorter. Indeed, the cloth liner 218 allows for treatment of a wide range of patient sizes with the same one-or-more pads 108 as full or partial removal of the cloth liner 218 is possible via one or more tabbed extensions 230 thereof to reveal up to an entirety of the patient-interfacing layer 216 as needed. As to the cloth liner 218 over the skincheck tab 228, such a cloth liner 218 can be configured to allow a clinician to peel up the pad 108 from the patient’s body by the skin-check tab 228 with a gloved hand, notably, without injuring the patient or damaging the skin-check tab 228 or pad 108 to which the skin-check tab 228 is connected. Notably, skin checks can be important for releasing pressure from swelling under any pad of the one-or-more pads 108 as well as for making sure that the patient’s skin remains healthy.

[0094] The pad body 206 can vary in shape. Indeed, while FIGS. 1-3 illustrate the one- or-more pads 108 as a pair of torso pads configured for placement on a patient’s torso and a pair of thigh pads configured for placement on the patient’s thighs, the one-or-more pads 108 can be configured for placement on any one or more portions of the patient’s body, respectively, not just the torso or thighs. Further, while FIGS. 1 and 2 illustrate left and right pads for left and right sides of the patient’s torso, FIGS. 1 and 3 illustrate each thigh pad of the pair of thigh pads as bilaterally symmetric for placement on either a left or right thigh of the patient’s body. Notably, such a symmetric thigh pad is configured to allow access to thepatient’s femoral artery while avoiding his or her groin area and maintaining beneficial coverage for heat transfer. Further, such a symmetric thigh pad can save time by minimizing confusion when determining which thigh pad goes where in high-pressure, time-sensitive situations that can be better used to provide better patient outcomes. Indeed, each thigh pad of the pair of thigh pads can be similarly placed about the patient’s thighs with the secondary tubing of each secondary FDL 106 extending toward the patient’s feet.

[0095] The pad body 206 can also include one or more slits 232 extending from a perimeter of the pad body 206 into a main portion of the pad body 206. The one-or-more slits 232 can be configured to facilitate fitting each pad of the one-or-more pads 108 to a patient, thereby increasing patient comfort. For example, each thigh pad of the pair of thigh pads can include a pair of slits 232 flanking a knee portion of the thigh pad to facilitate fitting the thigh pad around larger or smaller thighs, thereby increasing patient comfort around the upper thigh and knee.

[0096] FIG. 4 illustrates a chamfered edge 234 of the one-or-more pads 108 in accordance with some embodiments.

[0097] As shown, the perimeter of each pad of the one-or-more pads 108 can be rounded, and the perimeter can also include the chamfered edge 234 therearound to reduce a number of sharp edges in contact with the patient’s body when placed around the one-or-more portions of the patient’s body. In addition, the chamfered edge 234 around the perimeter of each pad of the one-or-more pads 108 can provide increased flexibility around the pad 108, thereby increasing patient comfort. Indeed, the chamfered edge 234 around the perimeter of each pad of the one-or-more pads 108 reduces stiffness of the chamfered edge 234 such that it deflects easier and, thereby, applies less pressure to the patient’s body.

[0098] FIGS. 10 and 11 illustrate different sides of the inlet manifold 208 or the outlet manifold 210 in accordance with some embodiments. Indeed, FIG. 10 illustrates an exposed side of the inlet manifold 208 or the outlet manifold 210, and FIG. 11 illustrates a padinterfacing side of the inlet manifold 208 or the outlet manifold 210.

[0099] As shown, each manifold of the inlet manifold 208 and the outlet manifold 210, which are effectively the same but in different locations on a pad of the one-or-more pads 108, can include a single nipple 236. Indeed, the inlet manifold 208 can include the nipple 236 configured as an inlet nipple to which the supply-fluid conduit 246 of the secondary FDL 106is fluidly connected for charging the plurality of conduits 220 of the conduit layer 212 with the supply fluid. Further, the nipple 236 can be fluidly connected to a septum-split channel 238 configured to evenly distribute the supply fluid from the supply-fluid conduit 246 of the secondary FDL 106 to the conduit layer 212 of the pad 108 thereunder. As to the outlet manifold 210, the outlet manifold 210 can also include the nipple 236 but configured as an outlet nipple to which the return-fluid conduit 248 of the secondary FDL 106 is fluidly connected for discharging the return fluid from the plurality of conduits 220 of the conduit layer 212. Further, the nipple 236 can be fluidly connected to the septum-split channel 238 configured to evenly collect the return fluid from the conduit layer 212 of the pad 108 and return the return fluid to the return-fluid conduit 248 of the secondary FDL 106.

[0100] Each manifold of the inlet manifold 208 and the outlet manifold 210 can be located in a location on its corresponding pad of the one-or-more pads 108 that remains anterior of the patient when placed around the one-or-more portions of the patient’s body, thereby minimizing patient-weight induced pressure points in its corresponding pad. Further, as evidenced by the exposed side of the inlet manifold 208 or the outlet manifold 210, the inlet manifold 208 or the outlet manifold 210 can be contoured to further minimize such pressure points should the patient need to be positioned in a way that might put patient weight over the inlet manifold 208 or the outlet manifold 210. Notably, the pad-facing side of the inlet manifold 208 or the outlet manifold 210 opposite the exposed side can include a base 240 configured for optimized thermal bonding with the insulating foam of the conduit layer 212 of each pad of the one-or-more pads 108.Secondary FDLs

[0101] FIGS. 2 and 3 illustrate secondary FDLs 106 in accordance with some embodiments.

[0102] First, a pad of the one-or-more pads 108 can include a secondary FDL of the one-or-more secondary FDLs 106 pre-connected to the pad 108 as packaged; however, the secondary FDL 106 can be alternatively provided in a same package as the pad 108 but not pre-connected to the pad 108. Further, the secondary FDL 106 can be alternatively provided in a different package than the pad 108. But it should be appreciated that pre-connecting the one- or-more secondary FDLs 106 respectively to the one-or-more pads 108 can save time in high- pressure, time-sensitive situations that can be better used to provide better patient outcomes.

[0103] As shown, each secondary FDL of the one-or-more secondary FDLs 106 can include a pad connector 242 at a proximal, primary FDL-connecting end of the secondary FDL 106. At a distal, pad-connecting end of the secondary FDL 106, secondary tubing 244 of the secondary FDL 106 can be connected to each manifold of the inlet manifold 208 and the outlet manifold 210.

[0104] The secondary tubing 244 can be configured with a supply-fluid conduit 246 to convey the supply fluid from the primary FDL 104 to the conduit layer 212 of its corresponding pad 108 through the inlet manifold 208 when the primary FDL 104 is connected to the hydraulic system 112 of the control module 102. Likewise, the secondary tubing 244 can be configured with a return-fluid conduit 248 to convey the return fluid from the conduit layer 212 of its corresponding pad 108 through the outlet manifold 210 back to the primary FDL 104 when the primary FDL 104 is connected to the hydraulic system 112 of the control module 102.

[0105] Each secondary FDL of the one-or-more secondary FDLs 106 or the secondary tubing 244 thereof can be split at the distal, pad-connecting end of the secondary FDL 106; however, the secondary FDL 106 need not be split when used with a combined inlet-outlet manifold (not shown) akin to the pad connector 242. When the secondary FDL 106 is split, the distal end of the secondary FDL 106 can be connected to the inlet manifold 208 and the outlet manifold 210 as set forth above. Indeed, the supply-fluid conduit 246 of the secondary FDL 106 can be fluidly connected to the nipple 236 of the inlet manifold 208 for charging the plurality of conduits 220 of the conduit layer 212 of the corresponding pad 108 with the supply fluid. Likewise, the return-fluid conduit 248 of the secondary FDL 106 can be fluidly connected to the nipple 236 of the outlet manifold 210 for discharging the return fluid from the plurality of conduits 220 of the conduit layer 212 of the pad.

[0106] Each secondary FDL of the one-or-more secondary FDLs 106 or the secondary tubing 244 thereof need not be split at the proximal, primary FDL-connecting end of the secondary FDL 106 like the distal end of the secondary FDL 106. Indeed, an unsplit proximal end of the secondary FDL 106 facilitates quickly connecting the one-or-more secondary FDLs 106 to the primary FDL 104. Accordingly, the proximal end of each secondary FDL of the one- or-more secondary FDLs 106 can include a single pad connector 242 configured to fluidly connect the secondary FDL 106 to the primary FDL 104.

[0107] FIGS. 12 and 13 illustrate different views of the pad connector 242 in accordance with some embodiments. FIGS. 14 and 15 illustrate the pad connector 242 inserted into the secondary FDL 106 or the secondary tubing 244 thereof in accordance with some embodiments.

[0108] As shown, the pad connector 242 can have a pair of nipples 250 and 252 distributedly inserted into the supply-fluid conduit 246 and the return-fluid conduit 248 of the secondary tubing 244. Indeed, the pair of nipples 250 and 252 can include an inlet nipple 250 inserted into the supply-fluid conduit 246 of the secondary tubing 244 and an outlet nipple 252 inserted into the return-fluid conduit 248 of the secondary tubing 244. Proximal of each nipple of the pair of nipples 250 and 252, the pad connector 242 can include a grip pad 254 for a pair of opposing grip pads 254. Inboard of the pair of opposing grip pads 254, the pad connector 242 can include an embossed feature 256 proximal of each nipple of the pair of nipples 250 and 252 such as a chevron or “eagle claw,” thereby providing a pair of embossed features 256 configured to indicate the pad connector 242 is part of the single-use or disposable equipment as well as to physically prevent the pad connector 242 from being connected to the controlmodule connector 172. Opposite each nipple of the pair of nipples 250 and 252 inserted into the secondary tubing 244, the pad connector 242 can have a diaphragm 258 through which the supply-fluid conduit 246 and the return-fluid conduit 248 of the secondary tubing 244 fluidly connects to the supply-fluid lumen 192 and the return-fluid lumen 194 of the primary FDL 104 via insertion of the pair of tube ends 202 of each distal connector of the pair of distal connectors 186 of the primary FDL 104.

[0109] The pad connector 242 can also have a sleeve 260 over a distal portion of the pad connector 242 and a proximal portion of the secondary tubing 244 that protects the fluid connection between the pad connector 242 and the secondary tubing 244. In addition, the sleeve 260 can encapsulate any rough edges of the pad connector 242 remaining from manufacturing as well as provide a gripping point for clinicians handling the pad connector 242. Should different pad sizes be manufactured to increase the already wide range of patient sizes for which the one-or-more pads 108 are configured, the sleeve 260 can be color coded to the different pad sizes.

[0110] FIG. 15 also illustrates a non-volatile memory chip 262 of the pad connector242 in accordance with some embodiments.[oni] As shown, the pad connector 242 can include the non-volatile memory chip 262 embedded in the pad connector 242 such as in a proximal end portion of the connector where the non-volatile memory chip 262 can communicatively connect with the electrical leads 196 of the primary FDL 104 or the distal terminal pins 203 thereof and, thus, the console 110. Advantageously, the non-volatile memory chip 262 can be programmed to include console- readable manufacturing information (e.g., pad type, manufacture date, expiration date, etc.) for its corresponding pad 108. Further, the non-volatile memory chip 262 can include an authentication technology such as a console-verifiable digital signature, thereby preventing use of counterfeit pads with the TTM system 100. Optionally, the non-volatile memory chip 262 can be configured to be updated with therapeutic information (e.g., the clinician-prescribed patient therapy, the onboard TTM protocol, etc.) for the patient written by the control module 102. As above, such therapeutic information can be utilized by a second control module in a second location to resume TTM if the patient needs to be moved away from a first control module in a first location.Methods

[0112] Methods include methods of TTM using the TTM system 100. For example, the method can include placing the one-or-more pads 108 around a patient’s body; circulating the temperature-controlled fluid through the one-or-more pads 108 by way of a combination of fluidly connected FDLs including the primary FDL 104 from the hydraulic system 112 of the control module 102 and the one-or-more secondary FDLs 106 corresponding to the one-or- more pads 108, respectively, to cool or warm the patient’s body as needed in accordance with TTM. Circulating the temperature-controlled fluid through the one-or-more pads 108 can include charging the conduit layer 212 of each pad of the one-or-more pads 108 with the supply fluid of the temperature-controlled fluid provided by the hydraulic system 112. Circulating the temperature-controlled fluid through the one-or-more pads 108 can also include discharging the return fluid of the temperature-controlled fluid from the conduit layer 212 of each pad of the one-or-more pad 108 to the hydraulic system 112.

[0113] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations or modifications are encompassed as well. Accordingly, departurescan be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A system for targeted temperature management (“TTM”), comprising: a control module including a hydraulic system configured to provide a temperature-controlled fluid; a primary fluid delivery line (“FDL”) configured to convey the temperature- controlled fluid from the hydraulic system as a supply fluid and convey the temperature-controlled fluid back to the hydraulic system as a return fluid; and one or more pads configured for placement around one or more portions of a patient’s body, respectively, each pad of the one-or-more pads including: a multilayered pad body including: a conduit layer including a plurality of conduits configured to convey the temperature-controlled fluid through the pad body; an impermeable film over the conduit layer configured to retain the temperature-controlled fluid in the conduit layer; a patient-interfacing layer over the impermeable film configured with a thermally conductive medium for placement on the patient’s body; and a removable cloth liner over one or more areas of the patient-interfacing layer including at least a skin-check tab extending from the pad, the cloth liner configured to allow a clinician to peel up the pad from the patient’s body by the skin-check tab with a gloved hand; an inlet manifold configured for charging the conduit layer with the supply fluid; and an outlet manifold configured for discharging the return fluid from the conduit layer.

2. The system according to claim 1, wherein each pad of the one-or-more pads includes a chamfered edge to reduce a number of sharp edges in contact with the patient’s body when placed around the one-or-more portions of the patient’s body.

3. The system according to either claim 1 or 2, wherein the one-or-more pads include a pair of torso pads, a pair of thigh pads, or both the pair of torso pads and the pair of thigh pads, each thigh pad of the pair of thigh pads being bilateral symmetric for placement on either a left or right thigh of the patient’s body.

4. The system according to any of the preceding claims, wherein the plurality of conduits are configured to reduce flow stagnation in the conduit layer and, thereby, optimize heat transfer between the patient and the one-or-more pads.

5. The system according to any of the preceding claims, wherein each manifold of the inlet manifold and the outlet manifold is located in a location on its corresponding pad of the one-or-more pads that remains anterior of the patient when placed around the one-or-more portions of the patient’s body, thereby minimizing patient- weight induced pressure points.

6. The system according to claim 5, further comprising one or more secondary FDLs corresponding to the one-or-more pads, respectively, each secondary FDL of the one or more secondary FDLs configured to i) supply the supply fluid from the primary FDL to the conduit layer through a single inlet nipple of the inlet manifold to which a supply-fluid conduit 246 of the secondary FDL is fluidly connected and ii) return the return fluid from the conduit layer to the primary FDL through a single outlet nipple of the outlet manifold to which a returnfluid conduit of the secondary FDL is also fluidly connected.

7. The system according to claim 6, wherein each secondary FDL of the one or more secondary FDLs includes a pad connector having a pair of nipples distributedly inserted into the supply-fluid conduit 246 and the return-fluid conduit of the secondary FDL, a sleeve over a distal portion of the pad connector and a proximal portion of the secondary FDL protecting a fluid connection of the pad connector and the secondary FDL and encapsulating any rough edges of the pad connector remaining from manufacturing.

8. The system according to claim 7, wherein the pad connector includes a nonvolatile memory chip embedded therein programmed to include manufacturing information for its corresponding pad, the non-volatile memory chip configured to be optionally updated with therapeutic information for the patient by the control module.

9. The system according to claim 8, the control module further including a console including one or more processors, primary memory including read-only memory (“ROM”) andrandom-access memory (“RAM”), and instructions stored in the ROM configured to instantiate one or more processes in the RAM for TTM with the control module, the console configured to communicatively connect with the non-volatile memory chip by way of electrical leads through the primary FDL.

10. The system according to claim 9, wherein a proximal connector of the primary FDL connects the electrical leads to those of a control-module connector of the control module, electrical connections established between the primary FDL and the control-module connector established by a communications port above a supply-fluid outlet and a return-fluid inlet of the hydraulic system so as to keep the electrical connections or components therebetween dry.

11. The system according to claim 10, wherein the proximal connector of the primary FDL includes a locking lever configured to lock the proximal connector onto the control module.

12. The system according to any of the preceding claims, wherein the control module includes a molded fill-tube-tip holder configured to hold a fill-tube tip of a fill tube for refilling the control module, the fill-tube-tip holder thereby keeping the fill-tube tip together with the fill tube and free of contamination.

13. The system according to any of the preceding claims, wherein the control module includes an FDL storage lug for wrapping the primary FDL therearound for storage.

14. A method for targeted temperature management (“TTM”), comprising: placing one or more pads around a patient’s body, each pad of the one-or-more pads including: a multilayered pad body including: a conduit layer including a plurality of conduits configured to convey a temperature-controlled fluid through the pad body; an impermeable film over the conduit layer configured to retain the temperature-controlled fluid in the conduit layer; a patient-interfacing layer over the impermeable film configured with a thermally conductive medium for heat transfer with the patient’s body; and a removable cloth liner over one or more areas of the patient-interfacing layer including at least a skin-check tab of the pad, the cloth linerconfigured to allow a clinician to peel up the pad from the patient’s body by the skin-check tab with a gloved hand; an inlet manifold; and an outlet manifold; and circulating the temperature-controlled fluid through the one-or-more pads by way of a combination of fluidly connected fluid delivery lines (“FDLs”) including a primary FDL from a hydraulic system of a control module and one or more secondary FDLs corresponding to the one-or-more pads, respectively, to cool or warm the patient’s body as needed in accordance with TTM, which includes: charging the conduit layer of each pad of the one-or-more pads with a supply fluid of the temperature-controlled fluid provided by the hydraulic system; and discharging a return fluid of the temperature-controlled fluid from the conduit layer of each pad of the one-or-more pad to the hydraulic system.

15. The method according to claim 14, wherein each pad of the one-or-more pads includes a chamfered edge to reduce a number of sharp edges in contact with the patient’s body when placed around the one-or-more portions of the patient’s body.

16. The method according to either claim 14 or 15, wherein the one-or-more pads include a pair of torso pads, a pair of thigh pads, or both the pair of torso pads and the pair of thigh pads, each thigh pad of the pair of thigh pads being bilateral symmetric for placement on either a left or right thigh of the patient’s body.

17. The method according to any of claims 14-16, wherein the plurality of conduits are configured to reduce flow stagnation in the conduit layer and, thereby, optimize heat transfer between the patient and the one-or-more pads.

18. The method according to any of claims 14-17, wherein each manifold of the inlet manifold and the outlet manifold is located in a location on its corresponding pad of the one-or-more pads that remains anterior of the patient when placed around the one-or-more portions of the patient’s body, thereby minimizing patient- weight induced pressure points.

19. The method according to any of claims 14-18, wherein each secondary FDL of the one or more secondary FDLs is configured to i) supply the supply fluid from the primary FDL to the conduit layer through a single inlet nipple of the inlet manifold to which a supplyfluid conduit 246 of the secondary FDL is fluidly connected and ii) return the return fluid from the conduit layer to the primary FDL through a single outlet nipple of the outlet manifold to which a return-fluid conduit of the secondary FDL is also fluidly connected.

20. The method according to claim 19, wherein each secondary FDL of the one or more secondary FDLs includes a pad connector having a pair of nipples distributedly inserted into the supply-fluid conduit 246 and the return-fluid conduit of the secondary FDL, a sleeve over a distal portion of the pad connector and a proximal portion of the secondary FDL protecting a fluid connection of the pad connector and the secondary FDL and encapsulating any rough edges of the pad connector remaining from manufacturing.

21. The method according to claim 20, wherein the pad connector includes a nonvolatile memory chip embedded therein programmed to include manufacturing information for its corresponding pad, the non-volatile memory chip configured to be optionally updated with therapeutic information for the patient by the control module.

22. The method according to claim 21, the control module further including a console including one or more processors, primary memory including read-only memory (“ROM”) and random-access memory (“RAM”), and instructions stored in the ROM configured to instantiate one or more processes in the RAM for TTM with the control module, the console configured to communicatively connect with the non-volatile memory chip by way of electrical leads through the primary FDL.

23. The method according to claim 22, wherein a proximal connector of the primary FDL connects the electrical leads to those of a control-module connector of the control module, electrical connections established between the primary FDL and the control-module connector established by a communications port above a supply-fluid outlet and a return-fluid inlet of the hydraulic system so as to keep the electrical connections or components therebetween dry.

24. The method according to claim 23, wherein the proximal connector of the primary FDL includes a locking lever configured to lock the proximal connector onto the control module.

25. The method according to any of claims 14-24, wherein the control module includes a molded fill-tube-tip holder configured to hold a fill-tube tip of a fill tube for refilling the control module, the fill-tube-tip holder thereby keeping the fill-tube tip together with the fill tube and free of contamination.26 . The method according to any of claims 14-25, wherein the control module includes an FDL storage lug for wrapping the primary FDL therearound for storage.

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