Systems, methods, and apparatus for communication between components of targeted temperature management system

Abstract

Disclosed herein is a system for targeted temperature management (TTM) including a control module that includes 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, wherein the primary FDL includes a conductor configured to transmit electrical signals, and one or more pads configured for placement around one or more portions of a patient body and to exchange the temperature-controlled fluid with the control module via the primary FDL, wherein a first pad includes a pad connector having an electrical interface that electrically couples the first pad with the primary FDL that enables an exchange of the data between the first pad and the control module, the pad connector including a pad integrated circuit.

Description

SYSTEMS, METHODS, AND APPARATUS FOR COMMUNICATION BETWEEN COMPONENTS OF TARGETED TEMPERATURE MANAGEMENT SYSTEMPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 638,876, 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] While TTM systems have provided terrific advances in caring for patients in varying critical states, the underlying technology has not seen significant improvement since its inception. For instance, TTM systems themselves provide no assistance to medical professionals in indicating: a number of TTM pads that are connected to a TTM control module, whether each TTM pad is securely coupled to the TTM control module, whether TTM fluid is currently contained within a TTM pad, whether a TTM pad is expired or has utilized its uselife, whether a TTM pad has been manufactured by the manufacturer of the TTM control module or is otherwise a genuine and approved TTM pad.

[0004] Disclosed herein are improvements to TTM systems that enable communications between components of a TTM system such as a TTM control module and a set of TTM pads thereby providing assistance to a medical professional in many of the manners noted above.SUMMARY

[0005] Disclosed herein is a system for targeted temperature management (TTM), comprising: a control module including a hydraulic system configured to provide a temperature-controlled fluid, and a console integrated circuit; 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, wherein the primary FDL includes a conductor configured to transmit data as electrical signals; and one or more pads configured for placement around one or more portions of a patient body and to exchange the temperature-controlled fluid with the control module via the primary FDL, wherein a first pad of the one or more pads includes a pad connector having an electrical interface that electrically couples the first pad with the primary FDL that enables an exchange of the data between the first pad and the control module, the pad connector including a pad integrated circuit.

[0006] In some embodiments, the electrical interface of the first pad includes one or more electrical receptacles configured to electrically engage with a set of distal terminal pins of a distal connector of the primary FDL. In some embodiments, the pad integrated circuit includes an Electrically Erasable Programmable Read Only Memory (EEPROM). In some embodiments, each of the console integrated circuit and the pad integrated circuit are programmed with a secret code that enables the console integrated circuit to authenticate the first pad. In some embodiments, the pad integrated circuit is configured to receive the electrical signals from the conductor of the primary FDL, wherein the electrical signals are data corresponding to state information of a TTM treatment.

[0007] In some embodiments, the pad integrated circuit is configured to transmit the electrical signals to the control module via the conductor of the primary FDL, wherein the electrical signals are data corresponding to state information of a TTM treatment. In some embodiments, each pad of the one or more pads includes: 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 body; or 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 allowa clinician to peel up the pad from the patient 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.

[0008] In some embodiments, the control module further includes a console including one or more processors and non-transitory, computer-readable medium, wherein the non- transitory, computer-readable medium has stored thereon instructions that, upon execution by the one or more processors, are configured to cause an exchange of the electrical signals between the control module integrated circuit and the pad integrated circuit of the first pad via the conductor of the primary FDL. In some embodiments, the primary FDL includes a proximal connector including a set of electrical leads configured to electrically couple with the control module.

[0009] Also disclosed herein is a targeted temperature management (TTM) control module comprising: a hydraulic system configured to provide a temperature-controlled fluid during a TTM treatment to a patient; a control module connector configured to fluidly and electrically couple the TTM control module with a proximal connector of a primary fluid delivery line (FDL), wherein the primary FDL is 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 a console including one or more processors and non-transitory, computer-readable medium, wherein the non-transitory, computer-readable medium has stored thereon instructions that, upon execution by the one or more processors, are configured to cause performance of operations including exchanging electrical signals with one or more pads via the control module connector, wherein the one or more pads are configured for placement around one or more portions of a patient body and to exchange the temperature-controlled fluid with the hydraulic system via the primary FDL.

[0010] The TTM control module may further comprise: a display screen communicatively coupled to the one or more processors. In some embodiments, the primary FDL includes a conductor configured to transmit electrical signals, and wherein the instructions, upon execution by the one or more processors are configured to cause performance of further operations including: repeatedly scanning the conductor new TTM pad connections, or transmitting read or write commands across the conductor to the one or more pads.

[0011] In some embodiments, the instructions, upon execution by the one or more processors are configured to cause performance of further operations including: obtaining data read from an integrated circuit of a first TTM pad coupled to the TTM control module, and storing the data from the first TTM pad in a pad repository. In some embodiments, the instructions, upon execution by the one or more processors are configured to cause performance of further operations including: detecting the first TTM pad has been decoupled from the TTM control module, and deleting the data from the first TTM pad that is stored in the pad repository.

[0012] Also disclosed herein is a targeted temperature management (TTM) pad configured for placement around one or more portions of a patient body, the TTM pad comprising: 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 body; a fluid delivery line (FDL) extending from the multilayered pad body; and a pad connector disposed at a proximal end of the FDL, wherein the pad connector includes an integrated circuit configured to exchange of data with a control module.

[0013] In some embodiments, the pad connector includes an electrical interface that includes one or more electrical receptacles configured to electrically engage with a set of distal terminal pins of a distal connector of an external FDL, wherein the external FDL is configured to fluidly and electrically couple the pad connector with a TTM control module, wherein the TTM control module includes a hydraulic system configured to provide the temperature- controlled fluid during the TTM treatment to a patient.

[0014] In some embodiments, the integrated circuit is configured to receive a presence pulse from the control module. In some embodiments, in response to the presence pulse, the integrated circuit is configured to pull voltage from the control module. In some embodiments, the integrated circuit includes an Electrically Erasable Programmable Read Only Memory (EEPROM). In some embodiments, the integrated circuit is configured to store a date that the TTM pad was first detected by any of a plurality of control modules including the control module.

[0015] 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 THE DRAWINGS

[0016] Illustrative examples are described in detail below with reference to the following figures:

[0017] FIG. 1 illustrates a targeted temperature management (TTM) system including a control module, a primary fluid delivery line (FDL), a plurality of secondary FDLs, and a plurality of pads in accordance with some embodiments.

[0018] FIG. 2 illustrates a torso pad in accordance with some embodiments.

[0019] FIG. 3 illustrates a thigh pad in accordance with some embodiments.

[0020] FIG. 4 illustrates a chamfered edge of the torso or thigh pad in accordance with some embodiments.

[0021] FIG. 5 illustrates a multilayered pad body of the torso or thigh pad in accordance with some embodiments.

[0022] FIG. 6 illustrates a cloth liner over an area of the torso or thigh pad in accordance with some embodiments.

[0023] FIG. 7 illustrates the cloth liner over a skin-check tab in accordance with some embodiments.

[0024] 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.

[0025] 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.

[0026] FIG. 10 illustrates an exposed side of an inlet or outlet manifold in accordance with some embodiments.

[0027] FIG. 11 illustrates a pad-interfacing side of the inlet or outlet manifold in accordance with some embodiments.

[0028] FIG. 12 illustrates a first view of a pad connector in accordance with some embodiments.

[0029] FIG. 13 illustrates a second view of the pad connector in accordance with some embodiments.

[0030] FIG. 14 illustrates the pad connector inserted into a secondary FDL with a sleeve therearound in accordance with some embodiments.

[0031] 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.

[0032] FIG. 16 illustrates the primary FDL and a pair of distal connectors thereof in accordance with some embodiments.

[0033] FIG. 17 illustrates a proximal connector of the primary FDL in accordance with some embodiments.

[0034] FIG. 18 illustrates the proximal connector of the primary FDL with a back cover removed in accordance with some embodiments.

[0035] FIG. 19 illustrates a posterior of the control module in accordance with some embodiments.

[0036] FIG. 20 illustrates a hydraulic system of the control module in accordance with some embodiments.

[0037] FIG. 21 A provides an illustrative example of a TTM system deployed on a patient in accordance with some embodiments.

[0038] FIG. 21B provides an example diagrammatic illustration of components of the TTM system of FIG. 21 A in accordance with some embodiments.

[0039] FIG. 22 illustrates a primary FDL including a proximal connector and a pair of distal connectors thereof in accordance with some embodiments.

[0040] FIG. 23 illustrates a detailed view of the pad connector in accordance with some embodiments.

[0041] FIG. 24A illustrates a block diagram of a console and some related components of the TTM system in accordance with some embodiments.

[0042] FIG. 24B is a logic diagram of logic modules comprising the pad communication logic as shown in FIG. 24A in accordance with some embodiments.

[0043] FIG. 25 is a flowchart illustrating operations of a methodology for performing a TTM pad detection methodology in accordance with some embodiments.

[0044] FIG. 26 is a flowchart illustrating operations of a methodology for detecting disconnection of a TTM pad in accordance with some embodiments.

[0045] FIG. 27 is a flowchart illustrating operations of a methodology performing an initial status check on a TTM pad in accordance with some embodiments.

[0046] FIG. 28 is a flowchart illustrating operations of a methodology for performing a TTM pad authentication methodology in accordance with some embodiments.

[0047] FIG. 29 is a flowchart illustrating operations of a methodology for automating selection of a heat generation mode to display to the user in accordance with some embodiments.

[0048] FIG. 30A is a first view of an illustrative graphical user interface depicting connection information for a first TTM pad in accordance with some embodiments.

[0049] FIG. 30B is a second view of the graphical user interface of FIG. 30A depicting connection information for a plurality of TTM pads in accordance with some embodiments.DESCRIPTION

[0050] 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 andoptionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0051] 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.

[0052] “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 medicaldevice 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.

[0053] “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.

[0054] 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.

[0055] 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.

[0056] Disclosed herein are improvements to TTM systems including components and methods thereof.TTM systems

[0057] FIG. 1 illustrates a TTM system 100 in accordance with some embodiments. 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.

[0058] FIG. 20 illustrates the hydraulic system 112 of the control module 102 in accordance with some embodiments. 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.

[0059] 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 setforth 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.

[0060] 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.

[0061] 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.

[0062] FIG. 19 illustrates a posterior of the control module 102 in accordance with some embodiments. 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 (see FIG. 24 A) 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 electricalconnections or components therebetween dry. Notably, the hydraulic system 112 can also be refilled via the return-fluid inlet 170 of the hydraulic system 112 present in the control-module connector 172. Indeed, a fill-tube sleeve 176 of a fill tube 178 can be securely inserted into the return-fluid inlet 170 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 of the hydraulic system 112 present in the control-module connector 172. When the fill tube 178 and the fill-tube sleeve 176 thereof are not in use, the fill-tube sleeve 176 can be inserted into a molded fill tube-sleeve holder 180 of the housing 114 of the control module 102. The fill tubesleeve holder 180 can be configured to securely hold the fill-tube sleeve 176 of the fill tube 178, thereby keeping the fill-tube sleeve 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-sleeve holder 180 can keep the fill tube 178 free of contamination by securely holding the fill tube 178 by the fill-tube sleeve 176 instead of allowing it rest on the ground between uses.

[0063] 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 separable components 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

[0064] 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.

[0065] 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 pads108. Such a primary FDL 104 can also be configured to relay electrical communications between the console 110 and the one or more pads 108.

[0066] 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 186 for any electrical connections between the console 110 and the one or more pads 108 when connected via the primary FDL 104.

[0067] 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 104and 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.

[0068] 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 connectors 186 of the primary FDL 104 can include a pair of tube ends 202 to connect the supply and returnfluid 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

[0069] FIGS. 1-3 illustrate a plurality of pads 108 in accordance with some embodiments. 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 theone 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.

[0070] FIG. 5 illustrates the pad body 206 in accordance with some embodiments. 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 patient-interfacing layer 216.

[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] 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. 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.

[0073] 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.

[0074] 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.

[0075] 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 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.

[0076] 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. 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 non-woven 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 patientinterfacing layer 216 as needed. As to the cloth liner 218 over the skin-check 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 ordamaging 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.

[0077] 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 the patient’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.

[0078] 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.

[0079] FIG. 4 illustrates a chamfered edge 234 of the one or more pads 108 in accordance with some embodiments. 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 aroundthe 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.

[0080] 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.

[0081] 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 106 is 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.

[0082] 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

[0083] FIGS. 2 and 3 illustrate secondary FDLs 106 in accordance with some embodiments. 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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 manufacturingas 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.

[0091] FIG. 15 also illustrates a non-volatile memory chip 262 of the pad connector 242 in accordance with some embodiments. 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 therapy data (e.g., the clinician-prescribed patient therapy, the onboard TTM protocol, etc.) for the patient written by the control module 102. As above, such therapy data 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.

[0092] Referring now to FIG. 21 A, an illustrative example of a TTM system deployed on a patient is shown in accordance with some embodiments. The TTM system 2100 of FIG. 21 A is shown during provision of a TTM treatment to a patient. The TTM system 2100 includes a control module 2102 that includes a body or housing 2014, a display screen 2106, and a primary FDL connection point 2108. The TTM system 2100 also includes a primary FDL 2110 and a set of TTM pads 2116 (2116A-2116D). The primary FDL 2110 includes a body component 2111, a proximal connector 2112, and a distal connector 2114. Each of the TTM pads 2116 has attached thereto a secondary FDL 2118 (2118 A-2118D). As shown, the proximal connector 2112 of the primary FDL 2110 couples to the primary FDL connection point 2108 of the control module 2102, the distal connector 2114 of the primary FDL 2110 couples to a pad connector 2120 (2120A-2120D), which is the proximal end of the secondary FDLs 2118 (2118A-2118D), where each of the secondary FDLs may include a supply fluid conduit and a return fluid conduit. Logic of the control module 2102 controls fluid flow between the controlmodule 2100 and the TTM pads 2116 through the primary FDL 2110 and the secondary FDLs 2118.

[0093] As noted above, in current technology implementations, in order to replace the control module 2102 with a second control module (not shown) includes either (1) disconnecting of the primary FDL 2110 from the control module 2102 and connecting the primary FDL 2110 to the second control module, or (2) disconnecting the secondary FDLs 2118 from the primary FDL 2110 and reconnecting the secondary FDLs 2118 to a second primary FDL (not shown) that is coupled to a second control module. However, either implementation using current technology loses the state of the current TTM treatment and the second TTM control module is not able to resume the current TTM treatment.

[0094] The disclosure provided herein highlights the technological improvements of the TTM system 2100 that enables the TTM system 2100 to pause a TTM treatment being performed by a first TTM control module and a first set of TTM pads and resume the TTM treatment through performance by a second TTM control module with the first set of TTM pads.

[0095] Referring to FIG. 2 IB, an example diagrammatic illustration of components of the TTM system of FIG. 21A is shown in accordance with some embodiments. FIG. 21B illustrates detail as to a subset of the components of the console 2102, the chipsets with EEPROM 2117A-2117F of the TTM pads 2116 (e.g., the chipset with EEPROM 2117A corresponds to the TTM pad 2116A), and a communication medium therebetween. The terms “chipset” or “chipset with EEPROM” should be understood to refer to an integrated circuit. In the embodiment of FIG. 2 IB, the console 2102 is shown to include a printed circuit board 2103 that includes a display microprocessor 128A and a communication microprocessor 128B, with the two communicatively coupled via a communication bus that utilizes the inter-integrated circuit (I2C) protocol, which is configured to enable communication between integrated circuits, typically disposed on the same circuit board. The display microprocessor 128A and a communication microprocessor 128B should be understood to represent integrated circuits.

[0096] In some embodiments, the illustrated components of the console 2102 function such that data is exchanged between the display screen 2106 and the display microprocessor 128A via a universal serial bus (USB) protocol, the display microprocessor 128A exchanges data with the communication microprocessor 128B via the I2C protocol, and thecommunication microprocessor 128B exchanges data with one or more peripheral devices (TTM pads 2116) via a communication bus, which may be a wired half-duplex serial bus.

[0097] In some embodiments, each of the display microprocessor 128A and the communication microprocessor 128B may be configured to perform certain operations. For example, the display microprocessor 128A may be configured to facilitate transmission of user input received at the display screen 2106 to the communication microprocessor 128B and facilitate display of graphical user interfaces on the display screen 2106. Additionally, the communication microprocessor 128B (also known as a coprocessor) may be configured to perform operations including reading data from and writing data to the chipsets 2117A-2117F of the TTM pads 2116. In some embodiments, the data is encrypted prior to writing to the chipsets 2117A-2117F and is decrypted upon reading data from the chipsets 2117A-2117F. In some embodiments, the encryption may be performed with AES256.

[0098] Referring now to FIG. 22, a primary FDL including a proximal connector and a pair of distal connectors thereof is shown in accordance with some embodiments. While the primary FDL 2110 is discussed previously with respect to FIGS. 16-18, FIG. 22 and the accompanying description highlights technical novelty that enables the TTM system 2100 to pause a TTM treatment and write state information of the TTM treatment at the time of the pausing to memory of the TTM pads. Additionally, the primary FDL 2110 facilitates the reading of the state information from the TTM pads by a second TTM control module.

[0099] The primary FDL 2110 is shown to include a proximal connector 2112 and two distal connectors 2114A-2114B (although other number of distal connectors may be utilized) fluidly coupled by primary tubing 2111. The proximal connector 2112 includes double piston seals 2200 (2200A-2200B) configured to couple with a TTM control module and enable the flow of fluid between the TTM control module and the TTM pads (e.g., one double piston seal acts as a fluid-supply opening and the other acts as a fluid-return opening). The proximal connector 2112 also includes a set of proximal terminal pins 2202 that electrically couple with a TTM control module. The proximal terminal pins 2202 are electrically coupled with a conductor 2206 that extends to the each of distal terminal pins 2210 of the distal connectors 2114A-2114B. The conductor 2206 may be a wire comprised of a material that conducts electrical signals (e.g., copper) or a fiber optic cable, for example. The primary FDL connector 2112 also includes a locking lever 2204 configured to lock the proximal connector 2112 onto a TTM control module, e.g., when rotated.

[0100] The primary FDL 2110 also includes one or more distal connectors 2114A- 2114B, each of which may include the same components. As a result, only the components of distal connector 2114A will be discussed below for purposes of conciseness. As illustrated in FIG. 21 A, the distal connector 2114A is configured to fluidly and electrically couple with a plurality of pad connectors (e.g., up to three of the pad connectors 2120A-2120D). Thus, the distal connector 2114A is configured to enable the flow of fluid between the control module and the TTM pad 2116A via a secondary FDL 2118A. Additionally, the distal connector 2114A is configured to (i) transmit electrical signals that to a pad connector 242 of the TTM pad 2116A, which may be stored on memory thereof, and / or (ii) receive electrical signals from the pad connector 242 of the TTM pad 2116A, corresponding to data stored on the memory thereof, and pass such electrical signals to the control module 2102. As shown in FIG. 22, the electrical signals may flow along the conductor 2206. In some examples, the conductor 2206 may be disposed between supply and return-fluid lumens 192 and 194 as shown in FIG. 18.

[0101] Specifically, the distal connector 2114A includes a plurality (e.g., three) connection points 2208 configured to fluidly and electrically couple with the pad connector 242 of the TTM pad 2116A. The connection point 2208 includes a pair of tube ends 2210 to connect the supply and return-fluid lumens the primary tubing 2111 to the supply and returnfluid conduits of the secondary tubing 2118A (FIG. 21 A). The connection point 2208 also includes distal terminal pins 2212 that are configured to transmit electrical signals between the control module 2102 and the pad connector 2120 A.

[0102] Referring to FIG. 23, a detailed view of the pad connector is shown in accordance with some embodiments. The pad connector 242 illustrated in FIG. 13 is shown with specific emphasis on structure components enabling functionality pertaining to the transmission of electrical signals between the pad connector 242 and the control module 2102 of FIG. 21A. Specifically, the pad connector 242 of FIG. 23 is shown to include an electrical interface 2300, which may be a recess of a proximal facing side of the pad connector 242. In some examples, the electrical interface 2300 may be disposed between the diaphragms 258, which may correspond to supply- and return-conduits for the fluid exchanged between the control module 2102 and one of the TTM pads. Disposition of the electrical interface 2300 as shown in FIG. 23 enables quick, efficient, and easy electrical coupling between the pad connector 242 and one of the distal connectors 2114A-2114B.

[0103] The electrical interface 2300 is shown to include the memory 262, which may be for example, a non-volatile memory chip, and receptacles 2302, which may be electrical receptacles configured to electrically engage with the distal terminal pins 2212 of a distal connector 2114A-2114B. In some examples, the memory 262 may be an Electrically Erasable Programmable Read Only Memory (EEPROM). In some embodiments, the memory 262 may be a DS28E25 chip is a 1-Wire EEPROM with 512 bytes of user-addressable memory that contains internal circuitry to provide cryptographically secure functions. As will be discussed in further detail below, the combination of the user-addressable memory having built in cryptographic functionality enables the control module 2102 to determine the authenticity of a TTM pad, read pad manufacturing data, and support the TTM control module transfer procedure.

[0104] In embodiments in which the memory 262 represents a DS28E25 chip, each chip may include a unique 64-bit ROM identification number (ROM-ID) that is factory programmed into the chip, which serves as an identifier for the control module 2012 to use in authenticating the corresponding TTM pad. For example, the control module 2102 may maintain a repository listing of unique 64-bit ROM-IDs for TTM pads with which the control module 2102 may be used. Thus, following coupling of the pad connector 262 with a distal connector 2114A-2114B of a primary FDL 2110 that is coupled to a control module 2102, the control module 2102 receives the unique 64-bit ROM-ID via the conductor 2206 and compares such against the repository listing. When the unique 64-bit ROM-ID appears on the repository listing, the control module 2102 may determine the TTM pad is an authentic TTM pad. In some instances, the 64-bit ROM-ID is stored as an encrypted hash, e.g., using the secure hash algorithm (SHA) 256 or 512. In some examples, the memory 262 communicates with the control module 262 via a serial protocol, such as 1-WIRE® technology. In some instances, the control module 2102 acts as the master device and the TTM pads act at the slave device, where the memory 262 may receive voltage (e.g., 2.8-5.25V) over the conductor 2206 from the control module 2102 and, in response, transmit the 64-bit ROM-ID of the memory 262.

[0105] Additionally, the repository listing may include an expiration date and / or expiration status (e.g., based on number of uses) for each TTM pad. Following determination that the TTM pad is authentic (“authentication”), the control module 2102 may then assess whether the TTM pad is expired by comparing the current date against the expiration date and / or confirming the expiration status is not set to “expired” (e.g., the number uses have notexceeded a threshold number). In some examples, the expiration status is populated or determined by alternative logic and provided to the control module 2102, such as a via a wireless software update. In other examples, the control module 2102 performs the comparison of the expiration data against a current date and / or receives a number of uses from the TTM pad (e.g., as stored on the memory 262 and incremented thereon upon each use) and performs a comparison between the number of uses and a predetermined threshold. In some instances, upon determining that the status of the control module 262 is expired, the control module 2102 may write the expiration status to the memory 262 such that upon coupling with a control module 2102 in the future, the expiration status will be received by the control module 2102, enabling the control module 2102 to bypass the expiration determination and automatically reject the expired TTM pads (e.g., provide an alert on the display screen of the control module 2102 and prevent initiation / resuming of a TTM treatment).Control module

[0106] 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.

[0107] Referring to FIG. 24A, a block diagram of the console 110 is shown in accordance with some embodiments. 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 alsoinclude 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.

[0108] 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 can include various logic modules selected form patient therapy logic 134, fluid-temperature control logic 136, fluid-flow control logic 138, and patient transfer 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.

[0109] The patient therapy logic 134 may be configured, upon execution by the processors 128, to 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 time-based target temperature profile for achieving the target temperature in the patient.

[0110] The fluid-temperature control logic 136 may be configured, upon execution by the processors 128, 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 theheater 156 to establish and maintain the temperature of the heated fluid within the mixing circuit 144 including the mixing tank 154.[oni] The fluid-flow control logic 138 may be configured, upon execution by the processors 128, 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.

[0112] The pad communication logic 140 may be configured, upon execution by the processors 128, to control communications between the console 110 and the TTM pads 2116. As discussed above, the console 110 may be fluidly and electrically coupled to the TTM pads 2116. The pad communication logic 140 is configured to exchange electrical signals with the TTM pads 2116, which may include provision of the chipsets 2117A-2117F of the TTM pads 2116 with a power supply, detection of a new connection (e.g., by detecting a low-voltage pull on the communication bus), transmission of read and write commands to the chipsets 2117A- 2117F, receive responses from the chipsets 2117A-2117F, maintain a pad repository and an operational log (see FIG. 24B), and generate and update graphical user interfaces (GUIs) to be displayed on the display screen 116. Additional detail as to the functionality of the pad communication logic 140 is provided with respect to FIG. 24B.

[0113] Referring now to FIG. 24B, a logic diagram of logic modules comprising the pad communication logic as shown in FIG. 24A is shown in accordance with some embodiments. The pad communication logic 140 as originally shown in FIG. 24 A may be include several logic sub-modules including a patient transfer logic 141 A, a wizard GUI logic 141B, and a pad monitor module 141C.

[0114] The patient transfer logic 141A may be configured, upon execution by the processor 128, to transmit electrical signals to the chipsets 2117A-2117F (e.g., a memory chip 262) of a TTM pad to program the chipsets 2117A-2117F. The patient transfer logic 141 A may write data to the chipsets 2117A-2117F of a TTM pad including, but not limited or restricted to, an indication (value) as to whether the TTM pad is filled with water, an indication (value) as to whether the chipsets 2117A-2117F has therapy data stored thereon, a date and time valueindicating a first time that the TTM pad was detected by a console, a value indicating whether the TTM pad is a genuine pad, therapy data, etc. The patient transfer logic 141 A may also read the same data from the chipsets 2117A-2117F as well as additional data such as header information (generation of pad, pad name, expiration date, max usage time limit, lot number).

[0115] As discussed throughout the disclosure, the therapy data may refer to state information of a current TTM treatment and may be utilized by a console of a second control module in a second location to resume the TTM treatment if a patient needs to be moved away from a first control module in a first location. In some embodiments, the patient transfer logic 141 A encrypts data to be written to the chipsets 2117A-2117F and decrypts data upon reading from the chipsets 2117A-2117F. In some embodiments, the encryption may be performed with AES256.

[0116] The wizard GUI logic 141B may be configured, upon execution by the processor 128, to generate and update user interface screens displayed on the display screen 116 of the console 110.

[0117] The pad monitor module 141C may include a pad command queue 14 ID, a background thread 141E, a pad repository 141F, and an operational logic 141G. The pad monitor module 141C may be configured, upon execution by the processor 128, to scan for new connections, read data, write data, or perform any of the commands supported by the chipsets 2117A-2117F. The console 110 is regularly looking for pad connections and disconnections but also periodically issues read and write commands, a command queuing system has been implemented. When the logic of the console 110 (e.g., the patient transfer logic 141A) needs to issue a read or write command, this command is put into the command queue 141D. The background thread 141E may continually monitor the pad command queue 141D. If the command queue 141D is empty, then a scan of the communication medium connecting the console 11 with the TTM pads 2116 is executed. If the command queue 141D is not empty, the next command is dequeued and executed, e.g., by the communication microprocessor 128B.

[0118] When a pad command finishes executing, a record of the pad command is placed in the operational log 141G, which is an in-memory repository of a set of most-recent operations (e.g., 10, 15, 20, etc.) which have been sent to the communication medium. The operational log 141G may be utilized for purposes debugging.

[0119] The pad repository 141F may be an in-memory repository of all TTM pads connected to the console 110. The pad repository 141F may be managed using the operations of create, retrieve, update, delete (often referred to as CRUD). For example, if a new pad is detected, the pad is inserted into the pad repository 141F (created). If a pad is disconnected, the pad is removed from the repository (deleted). When a pad is read, the data read from the pad is updated for the corresponding pad in the pad repository (updated). If the rest of the patient transfer logic 141A or the wizard GUI logic 141B needs to make use of the pad data, the data is requested from the pad monitor module 141C, which then returns the data from the pad repository 141F (retrieve). In this way, the pad monitor module 141C, with its in-memory pad repository 141F, acts as an abstraction layer between the TTM pads 2116 and the rest of logic of the console 110.

[0120] In some embodiments, in maintaining a listing of each of the TTM pads 2116 coupled to the console 110, the pad repository 141F may store information such as unique 64- bit ROM-IDs for each TTM pad as well as the data discussed about (e.g., header data, status data, and therapy data). Additionally, certain status information of each TTM pad may be tracked by the sensors on or coupled to a pad connector such as connection status, input temperature of the supply fluid, and output temperature of the return fluid can be tracked.

[0121] In some embodiments, the pad repository 141F, the pad command queue 141D, and the operational log 141G are all in-memory constructs and initialized as new (empty) during each power cycle of the console 110. The pad command queue 141D and the operational log 141G may both be limited to a set number of records (e.g., 10, 15, 20) each to mitigate against memory leaks.

[0122] Referring now to FIG. 25, a flowchart illustrating operations of a methodology for performing a TTM pad detection methodology is shown in accordance with some embodiments. Each block illustrated in FIG. 25 represents an operation performed in the method 2500 performed by a TTM control module (or simply, control module). It should be understood that not every operation illustrated in FIG. 25 is required. In fact, the completion of certain operations may be optional to complete aspects of the method 2500. Further, some of the operations of the method 2500 may be performed in an alternative ordering as shown. The discussion of the operations of method 2500 may be done so with reference to any of accompanying drawings.

[0123] The method 2500 begins when a new connection of a peripheral device is detected at a distal connector of a primary FDL (block 2502). In some embodiments, the console 110 may transmit a presence pulse command on a communication medium that runs from the console 110 to the distal connector of a primary FDL, such as the primary FDL 2110. A TTM pad connected to the distal connector may respond to the presence pulse by puling the communication medium (e.g., data line) low to indicate its presence. Based on a ROM-ID of the TTM pad, a new connection made be detected (e.g., if the ROM-ID is not currently included in a pad repository maintained by the console 110).

[0124] An authentication method is performed by the control module, which determines whether the peripheral device is an authentic, genuine TTM pad. The authentication methodology is discussed in detail at least with respect to FIGS. 24A-24B and 28. A determination is then made as to whether the peripheral device has been authenticated as a genuine TTM pad (block 2504). When the peripheral device has not been authenticated as a genuine TTM pad, the peripheral device is rejected and an alert is generated (block 2506). However, when the peripheral device is authenticated as a genuine TTM pad, the control module obtains TTM pad information from the memory of the TTM pad and writes the TTM pad information to a pad repository (block 2508).

[0125] Following the writing of the pad information into the pad repository, the control module may perform various status checks. For example, the control module may determine whether the pad information indicates that the TTM pad is full of TTM fluid (block 2570). When the pad information indicates that the TTM pad is full of TTM fluid, an alert is generated (block 2512). In some instances, the alert provide a prompt to begin a TTM fluid purging methodology.

[0126] When the pad information indicates that the TTM pad is empty, a determination is made as to whether the pad information indicates that the TTM pad is expired (block 2514). When the pad information indicates that the TTM pad is expired, the TTM pad is rejected and an alert is generated (block 2516). However, when the pad information indicates that the TTM pad is not expired, a determination is made as to whether therapy data is included in the pad information (block 2518). For example, the chipset of a TTM pad (e.g., chipset with EEPROM 2117A of FIG. 21B) may be configured to store certain data including header information, status information, and therapy data. In some embodiments, the header information may comprise 64 bytes, the status information may comprise 128 bytes, and the therapy datacomprise 320 bytes. Following authentication, the TTM pad information is read from the chipset EEPROM and stored in the pad repository, which includes reading / storing of therapy data when present. When therapy data is not included, a GUI is displayed presenting new therapy options, e.g., on the display screen of the control module (block 2520). When therapy data is included, the GUI is displayed presenting new therapy and resume therapy options (block 2522).

[0127] Referring to FIG. 26, a flowchart illustrating operations of a methodology for detecting disconnection of a TTM pad is shown in accordance with some embodiments. Each block illustrated in FIG. 26 represents an operation performed in the method 2600 performed by a TTM control module (or simply, control module). It should be understood that not every operation illustrated in FIG. 26 is required. In fact, the completion of certain operations may be optional to complete aspects of the method 2600. Further, some of the operations of the method 2600 may be performed in an alternative ordering as shown. The discussion of the operations of method 2600 may be done so with reference to any of accompanying drawings.

[0128] The method 2600 begins when a console transmits a presence pulse across a communication medium configured to connect the console with one or more TTM pads (block 2602). The console may periodically transmit presence pulses across the communication medium to maintain any accounting of TTM pads coupled with a distal connector of a primary FDL that is coupled to the console. The transmissions may occur at regular intervals and / or when a pad command queue of the console (e.g., the pad command queue 141D of FIG. 24B) does not contain any commands to be transmitted across the communication medium.

[0129] The console determines whether the one or more responses received correspond to the information in the pad repository maintained by the console (block 2604). For example, the console may obtain the ROM-IDs corresponding to the one or more TTM pads that responded to the presence pulse, which are then compared to a listing of ROM-IDs in a pad repository maintained by the console. When the ROM-IDs received on the communication medium match those in the pad repository, the console is able to conclude that there has not been a change in the connections at the distal connector (yes at block 2604). When the ROM- IDs match, the console may proceed to checking a pad command queue for instructions to be sent to the TTM pads or may proceed with a subsequent scan of the communication medium (block 2606).

[0130] However, when the ROM-IDs received on the communication medium do not match those in the pad repository and specifically when a ROM-ID included in the pad repository was not included in those received in response to the presence pulse, the console is able to conclude that a TTM pad has be disconnected from the distal connector. The console determines which TTM pads are no longer connected to the distal connector based on the ROM-IDs listed on the pad repository but not received in response to the presence pulse (block 2608). The console then removes the entry and any information corresponding to the ROM-ID that was not received in response to the presence pulse (block 2610).

[0131] Referring to FIG. 27, a flowchart illustrating operations of a methodology for performing an initial status check on a TTM pad is shown in accordance with some embodiments. Each block illustrated in FIG. 27 represents an operation performed in the method 2700 performed by a TTM control module (or simply, control module). It should be understood that not every operation illustrated in FIG. 27 is required. In fact, the completion of certain operations may be optional to complete aspects of the method 2700. Further, some of the operations of the method 2700 may be performed in an alternative ordering as shown. The discussion of the operations of method 2700 may be done so with reference to any of accompanying drawings.

[0132] The method 2700 begins when a genuine TTM pad is authenticated and TTM information of the TTM pad is stored in a pad repository (block 2702). The console may then read an expiration date of the TTM pad from the pad repository and determine whether the current date is past the expiration date of the TTM pad (blocks 2704, 2706). When the current date is past the expiration date, the TTM pad is rejected, and an alert may be generated for display on a display screen of the console (block 2708). However, when the current date is not past the expiration date, the console may read a date and time that the TTM pad was first detected by a console (not necessarily the current console) (block 2710). When the date and time information are empty (e.g., as part of the TTM pad information stored in the repository) (yes at block 2712), a write operation is initiated to write the current date and time to the TTM pad (block 2714). Effectively, initiating the write operation to write the current date and time to the TTM pad indicates that the TTM pad has not been previously used. Subsequently, when user input is received to start a TTM treatment, a write operation is initiated to mark the TTM pad as being full of TTM fluid (block 2718).

[0133] However, when the date and time information is not empty (no at block 2712), a determination is made as to whether the date and time information indicate that usage of the TTM pad has exceeded the maximum usage time limit (block 2716). For example, the TTM pad information may indicate a number of days of maximum usage. The console may then calculate whether the number of days since the date that the TTM pad was first detected by a TTM console exceeds the number of days of maximum usage time. When the date and time do not indicate usage has exceeded the maximum usage time, the console may wait until user input is received to start a TTM treatment, and at which time, a write operation is initiated to mark the TTM pad as being full of TTM fluid (block 2718). However, when the date and time indicates usage has exceeded the maximum usage time, the TTM pad is rejected, and an alert may be generated for display on a display screen of the console (block 2708).

[0134] Referring to FIG. 28, a flowchart illustrating operations of a methodology for performing a TTM pad authentication methodology is shown in accordance with some embodiments. Each block illustrated in FIG. 28 represents an operation performed in the method 2800 performed by a TTM control module (or simply, control module). It should be understood that not every operation illustrated in FIG. 28 is required. In fact, the completion of certain operations may be optional to complete aspects of the method 2800. Further, some of the operations of the method 2800 may be performed in an alternative ordering as shown. The discussion of the operations of method 2800 may be done so with reference to any of accompanying drawings.

[0135] The method 2800 begins when a connection of a peripheral device to a distal connector of a primary FDL coupled to a console is detected (block 2802). For example, detection of detection of a new connection made include detection of a low voltage pull on the communication bus of the primary FDL.

[0136] Following detection of the new connection, the console may receive initial information from the peripheral device (block 2804). The initial information may include header information such as pad generation date, pad name, pad expiration date, pad maximum usage time limit, and / or lot number.

[0137] The console then generates a hash value of the initial information using a secret code programmed into the console and receives a hash value (e.g., of the same header information) generated by the peripheral device (blocks 2806, 2808). In some embodiments,both the communication microprocessor of the console and the chipset with EEPROM of a genuine, authentic TTM pad are programmed with a 256 byte secret code, which cannot be read back by any users of the chips and is write-protected to prevent unauthorized modification. Thus, comparing the console-generated hash value and the peripheral device-generated hash value (block 2810) provides an indication as to whether the peripheral device is a genuine, authentic TTM pad. For instance, any TTM pad that is not authentic or genuine (e.g., not manufactured by or authorized by the manufacturer of the console, or improperly altered) may not include a legitimate secret code. As a result, such a TTM pad would not generate a hash value that matches that generated by the console. Thus, upon detection that the hash values match, the console authenticates the peripheral device as a genuine TTM pad for use with the console (block 2812).

[0138] Referring to FIG. 29, a flowchart illustrating operations of a methodology for automating selection of a heat generation mode to display to the user is shown in accordance with some embodiments. Each block illustrated in FIG. 29 represents an operation performed in the method 2900 performed by a TTM control module (or simply, control module). It should be understood that not every operation illustrated in FIG. 29 is required. In fact, the completion of certain operations may be optional to complete aspects of the method 2900. Further, some of the operations of the method 2900 may be performed in an alternative ordering as shown. The discussion of the operations of method 2900 may be done so with reference to any of accompanying drawings.

[0139] The method 2900 begins when a connection of a peripheral device to a distal connector of a primary FDL coupled to a console is detected (block 2902). For example, detection of detection of a new connection made include detection of a low voltage pull on the communication bus of the primary FDL. Following detection of the peripheral device, the control module may perform an authentication process to determine whether the peripheral device is a genuine TTM pad for use with the control module (block 2904). One example of the authentication process is illustrated in FIG. 28 and discussed in accordance therewith.

[0140] Following a determination that the peripheral device is a genuine TTM pad, the control module obtains TTM pad information from the peripheral device (block 2906). As one example of obtaining TTM pad information, the control module may obtain TTM pad information from a memory of the TTM pad, and optionally, write the TTM pad information to a pad repository stored on non-transitory memory of the control module.

[0141] From the TTM pad information, the control module detects a pad size, and automatically generates a first display screen when the pad size indicates a first pad size and generate a second display screen when the pad size indicates a second pad size (blocks 2908, 2910). In some embodiments, the first or second display screen may be displayed on a display screen, such as the integrated display screen of the console 110 as seen in FIG. 1. However, in other embodiments, the first or second display screen may be displayed on a display screen of a mobile device (e.g., cellphone or tablet) that is separate and distinct from the control module 102. In some examples, the first display screen may be displayed when the pad size indicates that the TTM pad is above a first size threshold, e.g., indicating that the TTM pad is sized for an adult patient, and the second display screen may be displayed when the pad size indicates that the TTM pad is below the first size threshold, e.g., indicating that the TTM pad is sized for pediatric or neonatal patients. In some examples, the first display screen may correspond to a display of an amount of power currently being utilized to cool (or warm) the patient. In some examples, the first display screen may include a tachometer-like dial providing a range of power (e.g., in Watts) and a dial pointing to a position within the range indicative of the power usage. In some embodiments, the range may include a visual threshold (e.g., line or change in color in the range) that indicates whether the control module is utilizing a power above the threshold, which may correspond to an unsafe level of power, or indicate that the patient body is warming itself (e.g., due to an onset of fever). In some examples, the second display screen may correspond to one or more arrows pointing in opposite directions (e.g., up or down, or left or right), where the arrows are indicative of a trend of a measured metric, such as temperature of TTM fluid, body temperature of the patient, power usage, etc.

[0142] Referring to FIG. 30A, a first view of an illustrative graphical user interface (GUI) depicting connection information for a first TTM pad is shown in accordance with some embodiments. FIG. 30A illustrates a GUI 3000 that may be configured to be displayed on the display screen 2106 or on an alternative display screen, such as of a networking device, e.g., a mobile device or laptop computer. The GUI 3000 as depicted in FIG. 30A illustrates an instance when a single TTM pad has been connected to and authenticated by the console 110. Information of the single TTM pad is shown in display portion 3002. The depicted information is that read from the chipset of the TTM pad, e.g., a pad name (Neonatal / Specialty), a TTM fluid fill status (“Water Status: Full”), a lot number, a use life left (164 hours), and an expiration date. As shown in FIG. 30A, the GUI 3000 includes additional display portions configured todisplay information of additional TTM pads upon connection to and authentication by the console 110.

[0143] Referring now to FIG. 3 OB, a second view of the graphical user interface of FIG. 31 A depicting connection information for a plurality of TTM pads is shown in accordance with some embodiments. FIG. 30B illustrates the GUI 3000 in the instance when multiple TTM pads have been connected to and authenticated by the console 110. As a result, the display portions 3004-3012 each display information for a particular TTM pad that is currently coupled with the console 110.Alternative embodiments

[0144] In some embodiments, the state information of a current TTM treatment (therapy data), and optionally, the pad identification information, may be written to an external memory device, such as a flash drive. In such embodiments, the TTM treatment may be paused on the first control module, the state information of the current TTM treatment may then be written to the external memory device. The TTM pads may be disconnected from the first control module and the patient may be transported as needed and / or otherwise the TTM pads may be coupled to a second control module. The external memory device may be coupled to the second control module such that the state information, and optionally, the pad identification information may be shared with the second control module, which may provide the option to resume the current TTM treatment as discussed above.

[0145] In yet other embodiments, the state information of a current TTM treatment, and optionally, the pad identification information, may be transmitted to a selected control module via a wireless protocol or wired / wireless network. For example, the wireless protocol may adhere to the BLUETOOTH® protocol. As another example, the wired / wireless network may be a public or private network and the state information of a current TTM treatment, and optionally, the pad identification information, may be stored in non-transitory, computer- readable medium by the first control module (e.g., cloud or local storage) and retrieved by the second control module.

[0146] 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 broaderaspects, 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

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, and a console integrated circuit; 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, wherein the primary FDL includes a conductor configured to transmit data as electrical signals; and one or more pads configured for placement around one or more portions of a patient body and to exchange the temperature-controlled fluid with the control module via the primary FDL, wherein a first pad of the one or more pads includes a pad connector having an electrical interface that electrically couples the first pad with the primary FDL that enables an exchange of the data between the first pad and the control module, the pad connector including a pad integrated circuit.

2. The system according to claim 1, wherein the electrical interface of the first pad includes one or more electrical receptacles configured to electrically engage with a set of distal terminal pins of a distal connector of the primary FDL.

3. The system according to either claim 1 or 2, wherein the pad integrated circuit includes an Electrically Erasable Programmable Read Only Memory (EEPROM).

4. The system according to any of the preceding claims, wherein each of the console integrated circuit and the pad integrated circuit are programmed with a secret code that enables the console integrated circuit to authenticate the first pad.

5. The system according to any of the preceding claims, wherein the pad integrated circuit is configured to receive the electrical signals from the conductor of the primary FDL, wherein the electrical signals are data corresponding to state information of a TTM treatment.

6. The system according to any of the preceding claims, wherein the pad integrated circuit is configured to transmit the electrical signals to the control module via the conductorof the primary FDL, wherein the electrical signals are data corresponding to state information of a TTM treatment.

7. The system according to any of the preceding claims, wherein each pad of the one or more pads includes: 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 body; or 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 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.

8. The system according to any of the preceding claims, wherein the control module further includes a console including one or more processors and non-transitory, computer-readable medium, wherein the non-transitory, computer-readable medium has stored thereon instructions that, upon execution by the one or more processors, are configured to cause an exchange of the electrical signals between the control module integrated circuit and the pad integrated circuit of the first pad via the conductor of the primary FDL.

9. The system according to claim 8, wherein the primary FDL includes a proximal connector including a set of electrical leads configured to electrically couple with the control module.

10. A targeted temperature management (TTM) control module, comprising: a hydraulic system configured to provide a temperature-controlled fluid during a TTM treatment to a patient; a control module connector configured to fluidly and electrically couple the TTM control module with a proximal connector of a primary fluid delivery line (FDL),wherein the primary FDL is 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 a console including one or more processors and non-transitory, computer-readable medium, wherein the non-transitory, computer-readable medium has stored thereon instructions that, upon execution by the one or more processors, are configured to cause performance of operations including exchanging electrical signals with one or more pads via the control module connector, wherein the one or more pads are configured for placement around one or more portions of a patient body and to exchange the temperature-controlled fluid with the hydraulic system via the primary FDL.

11. The TTM control module according to claim 10, further comprising a display screen communicatively coupled to the one or more processors.

12. The TTM control module according to either claim 10 or 11, and wherein the primary FDL includes a conductor configured to transmit electrical signals, and wherein the instructions, upon execution by the one or more processors are configured to cause performance of further operations including: repeatedly scanning the conductor new TTM pad connections, or transmitting read or write commands across the conductor to the one or more pads.

13. The TTM control module according to any of claims 10-12, wherein the instructions, upon execution by the one or more processors are configured to cause performance of further operations including: obtaining data read from an integrated circuit of a first TTM pad coupled to the TTM control module, and storing the data from the first TTM pad in a pad repository.

14. The TTM control module according to claim 13, wherein the instructions, upon execution by the one or more processors are configured to cause performance of further operations including: detecting the first TTM pad has been decoupled from the TTM control module, and deleting the data from the first TTM pad that is stored in the pad repository.

15. A targeted temperature management (TTM) pad configured for placement around one or more portions of a patient body, the TTM pad comprising: 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 body; a fluid delivery line (FDL) extending from the multilayered pad body; and a pad connector disposed at a proximal end of the FDL, wherein the pad connector includes an integrated circuit configured to exchange of data with a control module.

16. The TTM pad according to claim 15, wherein the pad connector includes an electrical interface that includes one or more electrical receptacles configured to electrically engage with a set of distal terminal pins of a distal connector of an external FDL, wherein the external FDL is configured to fluidly and electrically couple the pad connector with a TTM control module, wherein the TTM control module includes a hydraulic system configured to provide the temperature-controlled fluid during the TTM treatment to a patient.

17. The TTM pad according to either claim 15 or 16, wherein the integrated circuit is configured to receive a presence pulse from the control module.

18. The TTM pad according to claim 17, wherein, in response to the presence pulse, the integrated circuit is configured to pull voltage from the control module.

19. The TTM pad according to any of claims 15-18, wherein the integrated circuit includes an Electrically Erasable Programmable Read Only Memory (EEPROM).

20. The TTM pad according to any of claims 15-19, wherein the integrated circuit is configured to store a date that the TTM pad was first detected by any of a plurality of control modules including the control module.

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