WO2025226753A1

WO2025226753A1 - Improvements to targeted temperature managements systems including components and methods thereof

Info

Publication number: WO2025226753A1
Application number: PCT/US2025/025873
Authority: WO
Inventors: Sean E. Walker; Matthew SOJKA
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2024-04-25
Filing date: 2025-04-22
Publication date: 2025-10-30
Anticipated expiration: 2026-10-25

Abstract

Targeted temperature management ("TTM") systems are improved. For example, a TTM system can include a fill tube (120) and a control module. The fill tube can include a fill-tube tip (122) inserted into a fluid-filling end portion of the fill tube. The control module can include a hydraulic system configured to provide a temperature- controlled fluid to one or more pads. The control module can also include accommodations in a housing thereof for various connections thereto including an inlet and a fill-tube-tip holder (246). The inlet can be fluidly connected to a control-module-connecting end potion of the fill tube for filling a tank of the hydraulic system with a stock fluid. The fill-tube-tip holder (246) can have a contour to match that of a longitudinal portion of the fill-tube tip, the fill-tube-tip holder thereby configured to longitudinally hold the fill-tube tip therein for storage when the fill tube is not in use.

Description

IMPROVEMENTS TO TARGETED TEMPERATURE MANAGEMENTS SYSTEMS

INCLUDING COMPONENTS AND METHODS THEREOF

PRIORITY

[0001] This application claims the benefit of priority to U.S. Patent Application No. 63/638,865, 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 system for targeted temperature management (“TTM”) including, in some embodiments, a fill tube and a control module. The fill tube includes a filltube tip inserted into a fluid-filling end portion of the fill tube. The fluid-filling end portion of the fill tube is opposite a control-module-connecting end portion of the fill tube. The control module includes a housing and a hydraulic system within the housing. The hydraulic system is configured to provide a temperature-controlled fluid to one or more pads by way of a combination of fluidly connected fluid delivery lines (“FDLs”). Further, the control module includes accommodations in the housing for various connections to the control module including an inlet and a fill-tube-tip holder. The inlet is configured for filling a tank of the hydraulic system with a stock fluid. The inlet is fluidly connected to the control-module- connecting end potion of the fill tube for filling the tank with the stock fluid. The fill-tube-tip holder is molded into the housing with a contour to match that of a longitudinal portion of the fill-tube tip. The fill-tube-tip holder is thereby configured to longitudinally hold the fill-tube tip therein for storage when the fill tube is not in use.

[0005] In some embodiments, the fill-tube tip has a saddle-shaped mouth in a mouthed end portion of the fill-tube tip.

[0006] In some embodiments, the mouth of the fill-tube tip being saddle shaped prevents the mouth from vacuum attaching to a surface of a receptacle holding the stock fluid while filling the tank with the stock fluid.

[0007] In some embodiments, the fill-tube tip includes a flange in a flanged end portion of the fill-tube tip opposite the mouthed end portion of the fill-tube tip.

[0008] In some embodiments, the fill-tube tip includes a fill-tube fitting extending from the flanged end portion of the fill-tube tip. The fill-tube fitting includes an extension tube and one or more barbs around the extension tube.

[0009] In some embodiments, the fill-tube-tip holder includes a pair of pincer-like protrusions configured to pinch the fill tube over the fill-tube fitting about a middle portion of the extension tube between the flange and the one-or-more barbs.

[0010] In some embodiments, each protrusion of the pair of pincer-like protrusions includes a lip configured to interface with the flange of the fill-tube tip. The lip allows the flange of the fill-tube tip to sit upon the lip.

[0011] In some embodiments, the fill-tube tip includes a waist between the mouthed end portion of the fill-tube tip and the flanged end portion of the fill-tube tip.

[0012] In some embodiments, the fill-tube-tip holder includes a pair of protuberances configured to interface with the waist of the fill-tube tip.

[0013] In some embodiments, the fill-tube-tip holder being configured to longitudinally hold the fill-tube tip therein allows the fill tube to lie against the housing of the control module when the fill tube is not in use. [0014] In some embodiments, the fill-tube tip is molded from a polymeric material to have a stiffness sufficient to withstand vacuum collapse of the fill-tube tip while filling the tank with the stock fluid.

[0015] In some embodiments, the fill-tube tip has a stiffness sufficient to withstand deformation of the fill-tube tip if rolled over by a wheel of the system or stepped on by a person.

[0016] Also disclosed herein is a fill-tube tip for a fill tube of a TTM system. The filltube tip includes, in some embodiments, a saddle-shaped mouth in a mouthed end portion of the fill-tube tip; a flange in a flanged end portion of the fill-tube tip opposite the mouthed end portion of the fill-tube tip; and a fill-tube fitting extending from the flanged end portion of the fill-tube tip. The fill-tube fitting is configured to insert into a fluid-filling end portion of the fill tube opposite a control-module-connecting end portion of the fill tube.

[0017] In some embodiments, the mouth of the fill-tube tip being saddle shaped prevents the mouth from vacuum attaching to a surface of a receptacle holding a stock fluid while drawing the stock fluid from the receptacle.

[0018] In some embodiments, the fill-tube fitting includes an extension tube and one or more barbs around the extension tube. The extension tube has a length sufficient for a pair of pincer-like protrusions of a fill-tube-tip holder to pinch the fill tube over the fill-tube fitting about a middle portion of the extension tube between the flange and the one-or-more barbs.

[0019] In some embodiments, the fill-tube tip further includes a waist between the mouthed end portion of the fill-tube tip and the flanged end portion of the fill-tube tip.

[0020] In some embodiments, the fill-tube tip is molded from a polymeric material to have a stiffness sufficient to withstand vacuum collapse of the fill-tube tip while drawing any fluid through the fill-tube tip.

[0021] In some embodiments, the fill-tube tip has a stiffness sufficient to withstand deformation of the fill-tube tip if rolled over by a wheel of a piece of medical equipment or stepped on by a person.

[0022] 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. DRAWINGS

[0023] 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.

[0024] FIG. 2 illustrates a posterior of the control module including a fill tube and a fill-tube-tip holder in a housing of the control module in accordance with some embodiments.

[0025] FIG. 3 illustrates a detailed view of the posterior of the control module including the fill tube and the fill-tube-tip holder in the housing of the control module in accordance with some embodiments.

[0026] FIG. 4 illustrates a fill-tube tip of the fill tube held in the fill-tube-tip holder of the housing of the control module in accordance with some embodiments.

[0027] FIG. 5 illustrates the fill-tube tip inserted into a tubing body of the fill tube in accordance with some embodiments.

[0028] FIG. 6 illustrates an isometric view of the fill-tube-tip holder of the housing of the control module in accordance with some embodiments.

[0029] FIG. 7 illustrates a hydraulic system of the control module in accordance with some embodiments.

[0030] FIG. 8 illustrates filling or refilling a hydraulic system of the control module with the fill tube in accordance with some embodiments.

[0031] FIG. 9 illustrates a pad body of a pad of the plurality of pads in in accordance with some embodiments.

DESCRIPTION

[0032] 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. [0033] 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.

[0034] “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 the medical 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.

[0035] “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 device or 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.

[0036] 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.

[0037] 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.

[0038] Disclosed herein are improvements to TTM systems including components and methods thereof.

TTM systems

[0039] FIG. 1 illustrates a TTM system 100 in accordance with some embodiments.

[0040] 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. As such, the hydraulic system 112 set forth below can thusly provide a temperature-controlled fluid to the one-or-more pads 108 by way of a combination of fluidly connected FDLs.

Control module

[0041] FIGS. 1-3 and 8 illustrate the control module 102 of the TTM system in accordance with some embodiments.

[0042] 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 the temperature-controlled fluid for TTM.

[0043] 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 one-or-more core computing components can include one or more processors, at least primary memory including read-only memory (“ROM”) and random-access memory (“RAM”), and instructions stored in the ROM. The instructions can be configured to instantiate one or more processes in the RAM to effectuate a clinician-prescribed patient therapy or an onboard TTM protocol with the control module 102 when executed by the one-or-more processors. In addition, the primary memory can include various logic modules accessible to the one-or-more processes instantiated in the RAM.

[0044] The console 110 can also include an integrated display screen 116 configured as a touchscreen with a graphical user interface (“GUI”) for operating the control module 102. The console 110 can also include or be operably connected to one or more fluid sensors selected from at least pressure sensor (Pl), a 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 can be utilized by the foregoing logic modules to provide the temperature-controlled fluid in a state needed to effectuate the clinician-prescribed patient therapy or the onboard TTM protocol with the control module 102.

[0045] The console 110 can also include or be operably connected to one or more fluid control devices of the hydraulic system 112 including, for example, the chiller evaporator 148, the chiller pump 152, the heater 156, the mixing pump 160, and the circulation pump 164. Thus, the console 110 can physically provide the temperature-controlled fluid for TTM in accordance with the clinician-prescribed patient therapy or the onboard TTM protocol. While not shown, a power source can be configured to provide electrical power to the console 110.

[0046] The housing 114 of the control module 102 can be configured to accommodate various connections to the control module 102, for example, in the posterior of the control module 102; however, accommodations for such connections can be distributed among any one or more sides of the control module 102. In the 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 supply-fluid outlet 168 of the hydraulic system 112 and the one-or-more pads 108, the returnfluid inlet 170 of the hydraulic system 112 and the one-or-more pads 108, and any electrical connections between the console 110 and the one-or-more pads 108. Notably, such electrical connections are established by a communications port 174 of the console 110 above the supplyfluid 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. Further in the example, the posterior of the control module 102 can include a dedicated fill inlet 177 for filling or refilling a tank (e.g., the mixing tank 154, the supply tank 158, etc.) of the hydraulic system 112 by way of a fill tube 118; however, the hydraulic system 112 can alternatively be configured for filling or refilling the tank of the hydraulic system 112 via the return-fluid inlet 170 present in the control -module connector 172. If need be, a same tank of the hydraulic system 112 can also be drained through the fill inlet 177 by way of the fill tube 118, or the hydraulic system 112 can alternatively be configured for draining the hydraulic system 112 via the supply-fluid outlet 168 present in the control-module connector 172.

[0047] FIG. 5 illustrates the fill tube 118 in accordance with some embodiments.

[0048] As to the fill tube 118, the fill tube 118 can include a tubing body 120 extending from a control-module-connecting end portion of the fill tube 118 to a fluid-filling end portion of the fill tube 118 opposite the control-module-connecting end portion of the fill tube 118. The control-module-connecting end portion of the fill tube 118 such as the tubing body 120 thereof can be securely inserted into the fill inlet 177 or the return-fluid inlet 170 of the hydraulic system 112, thereby forming a fluid connection therebetween for filling or refilling the tank (e.g., the mixing tank 154, the supply tank 158, etc.) of the hydraulic system 112. While not shown, the fill tube 118 can alternatively include a fill-tube connector inserted into the tubing body 120 at the control-module-connecting end portion of the fill tube 118 or disposed over the tubing body 120 at the control-module-connecting end portion of the fill tube 118, and the fill-tube connector can be securely inserted into the fill inlet 177 or the returnfluid inlet 170 of the hydraulic system 112 to form the fluid connection for filling or refilling the tank of the hydraulic system 112. Whether by the tubing body 120 or the fill-tube connector inserted therein, when the control -module-connecting end portion of the fill tube 118 is inserted into the fill inlet 177 in the posterior of the control module 102, a contoured portion of the proximal connector 188 distal of the double piston seals 198 can provide a space to accommodate extension of the fill tube 118 from the fill inlet 177. Notably, when the proximal connector 188 is coupled to the control-module connector 172, the contoured portion of the proximal connector 188 can advantageously interfere with removal of the fill tube 118 from the fill inlet 177, thereby preventing its accidental removal form the fill inlet 177. The fluidfilling end portion of the fill tube 118 can include a fill-tube tip 122 securely inserted therein, such as in the tubing body 120 thereof, which fill-tube tip 122 is set forth in more detail below. Notably, such a fill tube 118 can be a length of medical grade tubing such as one or more formulations of Tygon® tubing (Saint-Gobain Corporation, La Defense, Courbevoie, France).

[0049] The fill-tube tip 122 can include a mouth 124 in a mouthed end portion of the fill-tube tip 122 and a flange 126 in a flanged end portion of the fill-tube tip 122 opposite the mouthed end portion of the fill-tube tip 122. While a body of the fill-tube tip 122 can vary between the mouthed end portion and the flanged end portion of the fill-tube tip 122, the filltube tip 122 shown in FIGS. 3-5 can include a waist 128 between the mouthed end portion of the fill-tube tip 122 and the flanged end portion of the fill-tube tip 122. Such a waist 128 of the fill-tube tip 122 advantageously provides an additional interfacing means to the flange 126 for interfacing with the fill-tube-tip holder 246.

[0050] The mouth 124 of the fill-tube tip 122 can be saddle shaped for a saddle-shaped mouth 124 in the mouthed end portion of the fill-tube tip 122. As shown, a lip 130 around the mouth 124 of the fill-tube tip 122 so shaped resembles a trace around a center of a hyperbolic paraboloid surface. The mouth 124 of the fill-tube tip 122 being saddle shaped prevents the mouth 124 from vacuum attaching to a surface 131 of a receptacle 132 holding a stock fluid (e.g., water, ethylene glycol, a combination of water and ethylene glycol, etc., optionally, including chloramine-T) while drawing the stock fluid from the receptacle 132 or filling the tank (e.g., the mixing tank 154, the supply tank 158, etc.) of the hydraulic system 112 with the stock fluid. Indeed, even if the mouth 124 of the fill-tube tip 122 is drawn toward the surface 131 of the receptacle 132 while drawing the stock fluid therefrom, openings 134 on opposite sides of the mouth 124 prevent the mouth 124 from vacuum attaching to the surface 131 of the receptacle 132.

[0051] The fill-tube tip 122 can also include a fill-tube fitting 136 extending from the flanged end portion of the fill-tube tip 122. As shown, the fill-tube fitting 136 can include an extension tube 138 and one or more barbs 140 around the extension tube 138, the fill-tube fitting 136 thereby configured for insertion into the tubing body 120 at the fluid-filling end portion of the fill tube 118 opposite the control -module-connecting end portion of the fill tube 118. Notably, a middle portion of the extension tube 138 between the flange 126 and the one- or-more barbs 140 has a length sufficient to allow the pair of pincer-like protrusions of the fill- tube-tip holder 246 to pinch or compress the fill tube 118 over the fill-tube fitting 136 about the middle portion of the extension tube 138. [0052] The fill-tube tip 122 can be molded from a polymeric material to have a stiffness sufficient to withstand vacuum collapse of the fill-tube tip 122 while drawing the stock fluid from the receptacle 132 or filling the tank (e.g., the mixing tank 154, the supply tank 158, etc.) of the hydraulic system 112 with the stock fluid. Further, the stiffness of the fill-tube tip 122 can be sufficient to withstand deformation of the fill-tube tip 122 when it is rolled over by a wheel of the TTM system 100 (or another piece of medical equipment) or stepped on by a person.

[0053] FIG. 4 illustrates the fill-tube tip 122 of the fill tube 118 held in a fill-tube-tip holder 246 of the housing 114 of the control module 102 in accordance with some embodiments. FIG. 6 illustrates an isometric view of the fill-tube-tip holder 246 of the housing 114 of the control module 102 in accordance with some embodiments.

[0054] Adverting back to the housing 114 of the control module 102 and the accommodations therein for various connections to the control module 102, the control module 102 can include the fill-tube-tip holder 246 on a same side of the control module 102 as the fill inlet 177, which, in the example set forth above, is in the posterior of the control module 102. The fill-tube-tip holder 246 can be molded into the housing 114 or a molded piece corresponding to the fill-tube-tip holder 246 can be affixed to the housing 114 such that the fill-tube-tip holder 246 is raised or otherwise protrudes from the side of the control module 102 including the fill-tube-tip holder 246 as shown. However, the fill-tube-tip holder 246 can alternatively be molded into the housing 114 such that the fill-tube-tip holder 246 is recessed into its side of the control module 102 with a corresponding channel extending therefrom to hold the tubing body 120 of the fill tube 118. In such embodiments, one or two grasp recesses can also be molded into the housing 114 along the channel extending from the fill-tube-tip holder 246 for grasping the tubing body 120 of the fill tube 118 and removing the fill-tube tip 122 from the fill-tube-tip holder 246 thereby.

[0055] The fill-tube-tip holder 246 can be molded into the housing 114 of the control module 102 with an inner contour to match an outer contour of a longitudinal portion of the fill-tube tip 122; however, it should be understood the fill-tube-tip holder 246 can be molded into the housing 114 of the control module 102 with any inner contour capable of holding the fill-tube tip 122 of the fill tube 118 therein. In an example, the inner contour of the fill-tube-tip holder 246 can match the outer contour of a longitudinal half of the fill-tube tip 122, wherein the fill-tube-tip holder 246 is molded to include a negative space corresponding to approximately half the fill-tube tip 122 as if split along a longitudinal plane including a centerline of the fill-tube tip 122. Such a negative space encompassed by the fill-tube-tip holder 246 is rounded in accordance with the half of the fill-tube tip 122 that the fill-tube-tip holder 246 is molded to hold. In another example, the inner contour of the fill-tube-tip holder 246 can match a profile or outline of a great longitudinal slice of the fill-tube tip 122, wherein the fill- tube-tip holder 246 is molded to include a negative space corresponding to the profile or outline of the fill-tube tip 122 taken along the foregoing longitudinal plane including the centerline of the fill-tube tip 122 with a depth ranging from approximately half a depth or width of the filltube tip 122 up to approximately double the depth or width of the fill-tube tip 122. Such a negative space encompassed by the fill-tube-tip holder 246 is shown in FIG. 6. Combinations of the foregoing examples are possible when the depth of the negative space encompassed by the fill-tube-tip holder 246 is deeper than approximately half the depth or width of the fill-tube tip 122. Indeed, a posterior portion of the fill-tube-tip holder 246 can be rounded in accordance with the longitudinal half of the fill-tube tip 122, and an anterior portion of the fill-tube-tip holder 246 can extend from the posterior portion of the fill-tube-tip holder 246 with the profile of the great longitudinal slice of the fill-tube tip 122. When the depth of the negative space encompassed by the fill-tube-tip holder 246 is approximately equal to the depth or width of the fill-tube tip 122 or greater, the mouth 124 of the fill-tube tip 122 can be adequately covered by a top portion or hood 128 of the fill-tube-tip holder 246, thereby preventing contamination of the fill tube 118 by the settling of any dust in the fill-tube tip 122 by way of the mouth 124 thereof.

[0056] The fill-tube-tip holder 246 can be molded into the housing 114 of the control module 102 to include an interfacing means for interfacing with the fill-tube tip 122 and holding the fill-tube tip 122 therewith. In an example, the interfacing means for interfacing with the fill-tube tip 122 can include a pair of pincer-like protrusions 250 configured to pinch or otherwise compress the fill tube 118 or the tubing body 120 thereof over the fill-tube fitting 136 about the middle portion of the extension tube 138 between the flange 126 and the one-or- more barbs 140. Whether or not the pair of pincer-like protrusions 250 are configured to actually pinch or compress the fill tube 118 or the tubing body 120 thereof in accordance with the foregoing, each protrusion of the pair of pincer-like protrusions 250 can include a lip 252 in another example of the interfacing means for interfacing with the fill-tube tip 122. When present, such a lip 252 allows the flange 126 of the fill-tube tip 122 to sit upon the lip 252 in accordance with the force of gravity thereon, the lip 252 thereby holding the fill-tube tip 122. In another example, the interfacing means for interfacing with the fill-tube tip 122 can include a pair of protuberances 254 configured to interface with the waist 128 of the fill-tube tip 122. Like the lip 252 of the pair of pincer-like protrusions 250, the pair of protuberances 254 allows the mouthed end portion of the fill-tube tip 122 to sit upon the pair of protuberances 254 in accordance with the force of gravity thereon, the pair of protuberances 254 thereby holding the fill-tube tip 122.

[0057] Advantageously, the fill-tube-tip holder 246 is configured in accordance with the foregoing to conspicuously hold the fill-tube tip 122 therein for storage when the fill tube 118 is not in use, thereby preventing both contamination and loss of the fill-tube tip 122. Indeed, without such a fill-tube-tip holder 246, the fluid-filling end portion of the fill tube 118 might instead be allowed to rest on the ground between uses, thereby contaminating the filltube tip 122 thereof and increasing a risk that the fill-tube tip 122 works loose from the tubing body 120 of the fill tube 118 and gets accidentally discarded. Further advantageously, the fill- tube-tip holder 246 is configured, as set forth above, to longitudinally hold the fill-tube tip 122 therein for storage when the fill tube 118 is not in use. So configured, the fill-tube-tip holder 246 allows the fill tube 118 or the tubing body 120 thereof to lie straight against the housing of the control module 102 when the fill tube 118 is not in use. When compared to an alternative of the fill-tube-tip holder 246 configured to perpendicularly hold the fill-tube tip 122 therein with the centerline of the fill-tube-tip holder 246 normal to a plane of the housing 114 of the control module 102, this reduces a risk of a loop of the fill tube 118 or the tubing body 120 thereof from catching on fixtures or fittings such as other medical equipment in a same room as the TTM system 100 while the TTM system 100 is moved. This also reduces a risk of a person’s limb such a clinician’s leg catching the fill tube 118 or the tubing body 120 thereof when moving about the room including the TTM system 100. Clearly, catching a loop of the fill tube 118 or the tubing body 120 thereof on fixtures, fittings, or people’s limbs can damage or contaminate the fill tube 118. Also, when compared to the foregoing alternative or an alternative of the fill-tube-tip holder 246 configured to transversely hold the fill-tube tip 122 therein, the fill-tube-tip holder 246 configured to longitudinally hold the fill-tube tip 122 therein also reduces a risk of developing a kink in a loop of the fill tube 118 or the tubing body 120 thereof.

[0058] FIG. 7 illustrates the hydraulic system 112 of the control module 102 in accordance with some embodiments. [0059] 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.

[0060] The chiller circuit 142 can be configured for cooling a fluid (e.g., water, ethylene glycol, a combination of water and ethylene glycol, etc., optionally, including chloramine-T) 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.

[0061] 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.

[0062] 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 a supply-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.

Primary FDL

[0063] FIGS. 1 and 3 illustrate the primary FDL 104 in accordance with some embodiments. [0064] As shown, the primary FDL 104 can include a proximal connector 188 and a pair of distal connectors 186 at either end of some primary tubing 190. Such a primary FDL 104 can be configured with supply-fluid and return-fluid lumens to respectively convey the temperature-controlled fluid from the hydraulic system 112 to the one-or-more pads 108 as the supply fluid and 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 with electrical leads to relay electrical communications between the console 110 and the one- or-more pads 108.

[0065] 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 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. Further, the proximal connector 188 of the primary FDL 104 can connect the electrical leads 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.

[0066] 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.

Pads

[0067] FIG. 1 illustrate a plurality of pads 108 in accordance with some embodiments.

[0068] 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. [0069] FIG. 9 illustrates a pad body 206 of a pad of the one-or-more pads 108 in accordance with some embodiments.

[0070] As shown, the pad body 206 can include a conduit layer 212, an impermeable film 214 over the conduit layer 212, and a patient-interfacing layer 216 over the impermeable film 214.

[0071] 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 impermeable film 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.

[0072] 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.

[0073] 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 patientinterfacing layer 216. The patient-interfacing layer 216 can 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. Secondary FDLs

[0074] FIG. 1 illustrates secondary FDLs 106 in accordance with some embodiments.

[0075] 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.

[0076] 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. Such a secondary FDL 106 can be configured with supply-fluid and return-fluid conduits to respectively convey the supply fluid from the primary FDL 104 to the conduit layer 212 of its corresponding pad 108 through the inlet manifold 208 and convey the return fluid back to the primary FDL 104 from the conduit layer 212 of its corresponding pad 108 through the outlet manifold 210.

[0077] 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. 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. While not shown, the supply-fluid conduit of the secondary FDL 106 can be fluidly connected to a nipple 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 of the secondary FDL 106 can be fluidly connected to a nipple of the outlet manifold 210 for discharging the return fluid from the plurality of conduits 220 of the conduit layer 212 of the pad.

[0078] 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.

[0079] 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, departures can be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMS What is claimed is:

1. A system for targeted temperature management (“TTM”), comprising: a fill tube including a fill-tube tip inserted into a fluid-filling end portion of the fill tube opposite a control-module-connecting end portion of the fill tube; and a control module including: a housing; a hydraulic system within the housing, the hydraulic system configured to provide a temperature-controlled fluid to one or more pads by way of a combination of fluidly connected fluid delivery lines (“FDLs”); and accommodations in the housing for various connections to the control module including: an inlet for filling a tank of the hydraulic system with a stock fluid, the inlet fluidly connected to the control-module-connecting end potion of the fill tube for filling the tank with the stock fluid; and a fill-tube-tip holder molded into the housing with a contour to match that of a longitudinal portion of the fill-tube tip, the fill-tube-tip holder thereby configured to longitudinally hold the fill-tube tip therein for storage when the fill tube is not in use.

2. The system of claim 1, wherein the fill-tube tip has a saddle-shaped mouth in a mouthed end portion of the fill-tube tip.

3. The system of claim 2, wherein the mouth of the fill-tube tip being saddle shaped prevents the mouth from vacuum attaching to a surface of a receptacle holding the stock fluid while filling the tank with the stock fluid.

4. The system of either claim 2 or 3, wherein the fill-tube tip includes a flange in a flanged end portion of the fill-tube tip opposite the mouthed end portion of the fill-tube tip.

5. The system of claim 4, wherein the fill-tube tip includes a fill-tube fitting extending from the flanged end portion of the fill-tube tip, the fill-tube fitting including an extension tube and one or more barbs around the extension tube.

6. The system of claim 5, wherein the fill-tube-tip holder includes a pair of pincerlike protrusions configured to pinch the fill tube over the fill-tube fitting about a middle portion of the extension tube between the flange and the one-or-more barbs.

7. The system of claim 6, wherein each protrusion of the pair of pincer-like protrusions includes a lip configured to interface with the flange of the fill-tube tip, the lip allowing the flange of the fill-tube tip to sit upon the lip.

8. The system of any claim of claims 4-7, wherein the fill-tube tip includes a waist between the mouthed end portion of the fill-tube tip and the flanged end portion of the fill-tube tip.

9. The system of claim 8, wherein the fill-tube-tip holder includes a pair of protuberances configured to interface with the waist of the fill-tube tip.

10. The system of any of the preceding claims, wherein the fill-tube-tip holder being configured to longitudinally hold the fill-tube tip therein allows the fill tube to lie against the housing of the control module when the fill tube is not in use.

11. The system of any of the preceding claims, wherein the fill-tube tip is molded from a polymeric material to have a stiffness sufficient to withstand vacuum collapse of the fill-tube tip while filling the tank with the stock fluid.

12. The system of claim 11, wherein the fill-tube tip has a stiffness sufficient to withstand deformation of the fill-tube tip if rolled over by a wheel of the system or stepped on by a person.

13. A fill-tube tip for a fill tube of a targeted temperature management (“TTM”) system, comprising: a saddle-shaped mouth in a mouthed end portion of the fill-tube tip; a flange in a flanged end portion of the fill-tube tip opposite the mouthed end portion of the fill-tube tip; and a fill-tube fitting extending from the flanged end portion of the fill-tube tip configured to insert into a fluid-filling end portion of the fill tube opposite a control-module-connecting end portion of the fill tube.

14. The system of claim 13, wherein the mouth of the fill-tube tip being saddle shaped prevents the mouth from vacuum attaching to a surface of a receptacle holding a stock fluid while drawing the stock fluid from the receptacle.

15. The system of either claim 13 or 14, wherein the fill-tube fitting includes an extension tube and one or more barbs around the extension tube, the extension tube having a length sufficient for a pair of pincer-like protrusions of a fill-tube-tip holder to pinch the fill tube over the fill-tube fitting about a middle portion of the extension tube between the flange and the one-or-more barbs.

16. The system of any of claims 13-15, wherein the fill-tube tip further includes a waist between the mouthed end portion of the fill-tube tip and the flanged end portion of the fill-tube tip.

17. The system of any of claims 13-16, wherein the fill-tube tip is molded from a polymeric material to have a stiffness sufficient to withstand vacuum collapse of the fill-tube tip while drawing any fluid through the fill-tube tip.

18. The system of claim 17, wherein the fill-tube tip has a stiffness sufficient to withstand deformation of the fill-tube tip if rolled over by a wheel of a piece of medical equipment or stepped on by a person.