Targeted temperature management system, targeted temperature management pad, and method of targeted temperature management

Abstract

Systems, pads, and methods for targeted temperature management are disclosed. For example, the pad can include a multi-layer pad body, a pad inlet connector, and a pad outlet connector. The pad body can include a conduit layer and a patient interface layer overlying the conduit layer. The conduit layer can include one or more conduits configured to carry a temperature controlled fluid from a hydraulic system as a supply fluid and return a return fluid to the hydraulic system. The patient interface layer can be configured to be placed on a portion of a patient's body. The patient interface layer can have a patient-facing side that includes a plurality of wells configured to hold a thermally conductive medium. The pad inlet connector can include a pad inlet configured to fill the conduit layer with a supply fluid. The pad outlet connector can include a pad outlet configured to drain the return fluid from the conduit layer.

Description

[Background technology]

[0001] Targeted temperature management ("TTM") is a treatment for maintaining a therapeutic temperature (e.g., hypothermia, hyperthermia, etc.) in a patient to improve patient outcomes in a variety of different medical settings. Current systems for TTM generally circulate a temperature-controlled fluid (e.g., cooling fluid or warming fluid) around the patient using adhesive pads placed on various parts of the patient's body to induce or maintain a therapeutic temperature. Because the adhesive pads are adhered to the patient's body to maintain sufficient contact between the adhesive pad and the patient's body for TTM, improving such pads continues to be an active area of ​​research and development. Summary of the Invention

[0002] Disclosed herein are TTM systems, TTM pads, and methods of TTM. Disclosed herein is a pad for TTM. In some embodiments, the pad includes a multi-layer pad body, a pad inlet connector, and a pad outlet connector. The multi-layer pad body includes a conduit layer and a patient interface layer covering the conduit layer. The conduit layer includes one or more conduits configured to carry temperature-controlled fluid from a hydraulic system as a supply fluid. The one or more conduits are also configured to return a return fluid to the hydraulic system. The patient interface layer is configured to be placed on a portion of a patient's body. The patient interface layer includes a plurality of wells configured to hold a thermally conductive medium. (recess) The pad inlet connector includes a pad inlet configured to fill the conduit layer with a supply fluid, and the pad outlet connector includes a pad outlet configured to drain the return fluid from the conduit layer.

[0003] In some embodiments, the wells are rectangular wells packed into a square shape. In some embodiments, the wells are hexagonally packed circular wells. In some embodiments, the wells are hexagonal wells that are hexagonally packed.

[0004] In some embodiments, the wells are interconnected. In some embodiments, the pad includes a thermally conductive medium within the well. In some embodiments, the heat-conducting medium comprises a polymer, a gel, or a fatty substance.

[0005] In some embodiments, the heat transfer medium includes a solid particle additive, which includes metal flakes, metal oxide particles, salt particles, or carbon particles. In some embodiments, the heat transfer medium is a paste of a fatty substance containing a solid particle additive.

[0006] In some embodiments, the pad body further includes a film covering the patient interface layer that individually seals each well of the plurality of wells, the film being configured to be cut by an instrument, rupture under applied pressure, or melt upon contact with skin or a reagent to expose the thermally conductive medium within the wells.

[0007] In some embodiments, the pad further comprises a release liner covering the patient interface layer, the release liner configured to expose the thermally conductive medium in the wells when the release liner is removed.

[0008] In some embodiments, the pad further comprises a release liner covering the patient interface layer configured to expose the wells when the release liner is removed for subsequent addition of a thermally conductive medium to the wells.

[0009] In some embodiments, the pad body further comprises an impermeable film between the patient interface layer and the conduit layer, the impermeable film configured to contain the temperature-controlled fluid within the conduit layer.

[0010] In some embodiments, the conduit layer includes a plurality of protrusions extending from the conduit layer toward the impermeable film, the protrusions configured to promote uniform flow of the temperature-controlled fluid.

[0011] In some embodiments, the pad further includes a secondary fluid delivery line ("FDL"). The secondary FDL is configured to carry supply fluid from the hydraulic system and return fluid to the hydraulic system. The secondary FDL is split at a pad-connecting end of the secondary FDL. The pad-connecting end of the secondary FDL includes a pair of secondary FDL connectors including a secondary FDL outlet connector and a secondary FDL inlet connector. The secondary FDL outlet connector is configured to fluidly connect to the pad inlet connector. The secondary FDL inlet connector is configured to fluidly connect to the pad outlet connector.

[0012] Also disclosed is a pad package for a TTM. In some embodiments, the pad package includes one or more pads for the TTM, an applicator, and packaging surrounding the one or more pads and the applicator. Each of the one or more pads includes a multi-layer pad body. The pad body includes a conduit layer and a patient interface layer covering the conduit layer. The conduit layer includes one or more conduits configured to carry temperature-controlled fluid from a hydraulic system as a supply fluid. The one or more conduits are also configured to return a return fluid to the hydraulic system. The patient interface layer is configured to be placed on a portion of a patient's body. The patient interface layer has a patient-facing side including multiple wells configured to hold a thermally conductive medium. The applicator includes a thermally conductive medium for adding the thermally conductive medium to the wells.

[0013] In some embodiments, the wells are square-packed rectangular wells, hexagonally packed circular wells, or hexagonally packed hexagonal wells. In some embodiments, the wells are interconnected.

[0014] In some embodiments, the heat-conducting medium comprises a polymer, a gel, or a fatty substance. In some embodiments, the heat transfer medium includes a solid particle additive, which includes metal flakes, metal oxide particles, salt particles, or carbon particles.

[0015] In some embodiments, each pad of the one or more pads further comprises a release liner covering the patient interface layer configured to expose the wells when the release liner is removed for subsequent addition of a thermally conductive medium to the wells.

[0016] In some embodiments, the pad body further comprises an impermeable film between the patient interface layer and the conduit layer, the impermeable film configured to contain the temperature-controlled fluid within the conduit layer.

[0017] In some embodiments, each pad of the one or more pads further comprises a pad inlet connector and a pad outlet connector, the pad inlet connector comprising a pad inlet configured to fill the conduit layer with a supply fluid, and the pad outlet connector comprising a pad outlet configured to drain a return fluid from the conduit layer.

[0018] In some embodiments, the pad package further includes one or more secondary FDLs corresponding in number to the one or more pads. Each of the one or more secondary FDLs is configured to carry a supply fluid from the hydraulic system. Each secondary FDL is also configured to return a return fluid to the hydraulic system. Each of the one or more secondary FDLs is split at a pad-connecting end of the secondary FDL. The pad-connecting end of the secondary FDL includes a pair of secondary FDL connectors, including a secondary FDL outlet connector and a secondary FDL inlet connector. The secondary FDL outlet connector is configured to fluidly connect to the pad inlet connector. The secondary FDL inlet connector is configured to fluidly connect to the pad outlet connector.

[0019] Another pad for TTM is also disclosed herein. In some embodiments, the pad includes a two-piece pad body, a pad inlet connector, and a pad outlet connector. The first piece of the pad body includes an impermeable film covering a conduit layer. The conduit layer includes one or more conduits configured to carry temperature-controlled fluid as a supply fluid from a hydraulic system. The one or more conduits are also configured to return a return fluid to the hydraulic system. The impermeable film is configured to retain the temperature-controlled fluid within the conduit layer. The second, double-sided piece of the pad body includes a patient interface side and a pad interface side. The second piece of the pad body is configured to be placed on a portion of a patient's body. The first piece of the pad body is configured to be placed over the second piece of the pad body. The pad inlet connector includes a pad inlet configured to fill the conduit layer with a supply fluid. The pad outlet connector includes a pad outlet configured to drain the return fluid from the conduit layer.

[0020] In some embodiments, the pad-interfacing side of the second piece of pad body includes an adhesive thereon, such that the pad-interfacing side is configured to adhere the first and second pieces of pad body to one another when the first piece of pad body is placed over the second piece of pad body.

[0021] In some embodiments, the impermeable film includes an adhesive thereon, and is thus configured to adhere the first and second pieces of the pad body to one another when the first piece of the pad body is placed over the second piece of the pad body.

[0022] In some embodiments, the patient interface side of the second piece of the pad body includes a plurality of wells configured to hold a thermally conductive medium. In some embodiments, the wells are square-packed rectangular wells, hexagonally packed circular wells, or hexagonally packed hexagonal wells.

[0023] In some embodiments, the wells are interconnected. In some embodiments, the pad includes a thermally conductive medium within the well. In some embodiments, the heat-conducting medium comprises a polymer, a gel, or a fatty substance.

[0024] In some embodiments, the heat transfer medium includes a solid particle additive, which includes metal flakes, metal oxide particles, salt particles, or carbon particles. In some embodiments, the second piece of the pad body further includes a film covering the patient interface side that individually seals each well of the plurality of wells, the film being configured to be cut by an instrument, rupture by applied pressure, or melt upon contact with skin or a reagent to expose the thermally conductive medium within the wells.

[0025] In some embodiments, the pad further includes a release liner covering the patient-interface side of the second piece of the pad body, the release liner configured to expose the thermally conductive medium in the well when the release liner is removed.

[0026] In some embodiments, the pad further includes a release liner covering the patient-interface side of the second piece of the pad body, the release liner configured to expose the wells when the release liner is removed for subsequent addition of a thermally conductive medium to the wells.

[0027] In some embodiments, the patient interface side of the second piece of the pad body includes a hydrogel thereon. In some embodiments, the hydrogel comprises a poly(ethylene 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, or a combination of two or more of the foregoing hydrogels.

[0028] In some embodiments, the pad further includes a release liner covering the patient-interface side of the second piece of the pad body, the release liner configured to expose the hydrogel when the release liner is removed.

[0029] In some embodiments, the conduit layer includes a plurality of protrusions extending from the conduit layer toward the impermeable film, the protrusions configured to promote uniform flow of the temperature-controlled fluid.

[0030] In some embodiments, the pad further includes a secondary FDL configured to carry supply fluid from the hydraulic system. The secondary FDL is also configured to return return fluid to the hydraulic system. The secondary FDL is split at a pad-connecting end of the secondary FDL. The pad-connecting end of the secondary FDL includes a pair of secondary FDL connectors including a secondary FDL outlet connector and a secondary FDL inlet connector. The secondary FDL outlet connector is configured to fluidly connect to the pad inlet connector. The secondary FDL inlet connector is configured to fluidly connect to the pad outlet connector.

[0031] Another pad package for a TTM is also disclosed herein. In some embodiments, the pad package includes one or more pads for the TTM, an applicator, and packaging surrounding the one or more pads and the applicator. Each of the one or more pads includes a two-piece pad body. The first piece of the pad body includes an impermeable film covering a conduit layer. The conduit layer includes one or more conduits configured to carry temperature-controlled fluid from a hydraulic system as a supply fluid. The one or more conduits are also configured to return a return fluid to the hydraulic system. The impermeable film is configured to retain the temperature-controlled fluid within the conduit layer. The second, double-sided piece of the pad body includes a patient interface side and a pad interface side. The patient interface side of the second piece of the pad body includes multiple wells configured to hold a thermally conductive medium. The second piece of the pad body is configured to be placed on a portion of a patient's body. The first piece of the pad body is configured to be placed over the second piece of the pad body. The applicator includes a heat transfer medium for applying the heat transfer medium to the well.

[0032] In some embodiments, the wells are square-packed rectangular wells, hexagonally packed circular wells, or hexagonally packed hexagonal wells. In some embodiments, the wells are interconnected.

[0033] In some embodiments, the heat-conducting medium comprises a polymer, a gel, or a fatty substance. In some embodiments, the heat transfer medium includes a solid particle additive, which includes metal flakes, metal oxide particles, salt particles, or carbon particles.

[0034] In some embodiments, each pad of the one or more pads further includes a release liner covering the patient-interface side of the second piece of the pad body, the release liner configured to expose the wells when the release liner is removed for subsequent addition of a thermally conductive medium to the wells.

[0035] In some embodiments, the pad-interfacing side of the second piece of pad body includes an adhesive thereon, and is thus configured to adhere the first and second pieces of pad body to one another when the first piece of pad body is placed over the second piece of pad body.

[0036] In some embodiments, the impermeable film includes an adhesive thereon, and is thus configured to adhere the first and second pieces of the pad body to one another when the first piece of the pad body is placed over the second piece of the pad body.

[0037] In some embodiments, each pad of the one or more pads further comprises a pad inlet connector and a pad outlet connector, the pad inlet connector comprising a pad inlet configured to fill the conduit layer with a supply fluid, and the pad outlet connector comprising a pad outlet configured to drain a return fluid from the conduit layer.

[0038] In some embodiments, the pad package further includes one or more secondary FDLs corresponding in number to the one or more pads. Each of the one or more secondary FDLs is configured to carry a supply fluid from the hydraulic system. Each secondary FDL is also configured to return a return fluid to the hydraulic system. Each of the one or more secondary FDLs is split at a pad-connecting end of the secondary FDL. The pad-connecting end of the secondary FDL includes a pair of secondary FDL connectors, including a secondary FDL outlet connector and a secondary FDL inlet connector. The secondary FDL outlet connector is configured to fluidly connect to the pad inlet connector. The secondary FDL inlet connector is configured to fluidly connect to the pad outlet connector.

[0039] Also disclosed herein is a system for TTM. In some embodiments, the system includes a control module, a primary FDL, and the methods described in paragraphs

[0003] to

[0016] and

[0025] to

[0039] .

[0040] and one or more pads selected from the group consisting of: a control module including a hydraulic system configured to provide a temperature-controlled fluid; a primary FDL configured to convey the temperature-controlled fluid from the hydraulic system as a supply fluid; and a primary FDL configured to return the temperature-controlled fluid to the hydraulic system as a return fluid. The one or more pads are configured to be respectively positioned on one or more portions of the patient's body.

[0040] In some embodiments, the hydraulic system includes a chiller-evaporator, a heater, a hydraulic system outlet, and a hydraulic system inlet. The chiller-evaporator is configured for fluid cooling. The heater is configured for fluid heating. The chiller-evaporator and heater are configured together to provide a temperature-controlled fluid. The hydraulic system outlet is configured to discharge a supply fluid from the hydraulic system. The hydraulic system inlet is configured to charge the hydraulic system with a return fluid to continue producing the temperature-controlled fluid.

[0041] In some embodiments, the control module further includes one or more processors, a primary memory, and instructions stored in the primary memory that, when executed by the one or more processors, are configured to instantiate one or more processes for the TTM using the control module.

[0042] Also disclosed herein is a method for a system for TTM. In some embodiments, the method includes a pad positioning step, a pad filling step, and a fluid circulation step. The pad positioning step includes placing at least a portion of the pad on the patient's body in contact with the patient's skin. The portion of the pad that contacts the patient's skin includes a plurality of wells on the patient-facing side of a patient interface layer of a multi-layer pad body of the pad. Alternatively, the portion of the pad that contacts the patient's skin includes a plurality of wells in a second of the two-piece pad. The wells contain a thermally conductive medium therein. The pad filling step includes filling one or more conduits in a conduit layer of the pad with a supply of temperature-controlled fluid. The conduit layer is either part of the multi-layer pad body or part of the first of the two-piece pad. The supply fluid is provided by a hydraulic system of the control module through a combination of fluid-connected FDLs, including a secondary FDL and a primary FDL. The fluid circulation step involves circulating a supply fluid through the conduit layer to cool or warm the patient's body as needed according to the TTM.

[0043] In some embodiments, the method includes a film cutting step, which includes using an instrument to cut a film covering the wells to expose the thermally conductive medium in any one or more individually sealed wells of the plurality of wells, and which occurs before the pad placement step.

[0044] In some embodiments, the method includes a film-rupturing step, which includes rupturing a film covering the wells by applying pressure to expose the heat-conducting medium within any one or more individually sealed wells of the plurality of wells. The film-rupturing step occurs before the pad-positioning step.

[0045] In some embodiments, the method includes a film dissolving step, which includes dissolving a film covering the well upon contact with the patient's skin or a reagent to expose the heat transfer medium within any one or more individually sealed wells of the plurality of wells, which occurs before the pad placement step.

[0046] In some embodiments, the method further comprises a release liner removal step, which comprises removing the release liner from the pad to expose the wells containing the thermally conductive medium therein, which is performed before the pad placement step.

[0047] In some embodiments, the method further includes a release liner removal step and a dispensing step. The release liner removal step includes removing the release liner from the pad to expose the wells. The dispensing step includes dispensing the thermally conductive medium into the wells. Both the release liner removal step and the dispensing step occur before the pad placement step.

[0048] In some embodiments, the method further includes an FDL connecting step, which includes fluidly connecting a secondary FDL outlet connector at the split pad-connecting end of the secondary FDL to a pad inlet connector, and which also includes fluidly connecting a secondary FDL inlet connector at the split pad-connecting end of the secondary FDL to a pad outlet connector.

[0049] In some embodiments, the fluid circulating step includes transferring heat between the temperature-controlled fluid and the patient's body by thermal conduction through the conduit layer. In some embodiments, the fluid circulating step includes circulating a cool fluid through the conduit layer to bring the patient from normothermic to hypothermic.

[0050] In some embodiments, the fluid circulating step includes circulating a warm fluid through the conduit layer to bring the patient from hypothermia to normothermia. In some embodiments, the fluid circulating step comprises circulating a warm fluid through the conduit layer to bring the patient from normothermic to hyperthermic.

[0051] In some embodiments, the fluid circulating step includes circulating a cool fluid through the conduit layer to bring the patient from hyperthermia to normothermia. Another method of a system for TTM is also disclosed herein. In some embodiments, the method includes a pad placement step, a pad filling step, and a fluid circulation step. The pad placement step includes placing a second piece of a two-piece pad on the patient's body in contact with the patient's skin. The second piece of the pad includes a hydrogel on the patient-facing side of the second piece. The pad placement step also includes placing a first piece of the pad over the second piece of the pad. The pad filling step includes filling one or more conduits in the conduit layer or the first piece of the pad with a supply of temperature-controlled fluid. The supply fluid is provided by a hydraulic system of the control module through a combination of fluid-connected FDLs, including a secondary FDL and a primary FDL. The fluid circulation step includes circulating the supply fluid through the conduit layer to cool or warm the patient's body as needed in accordance with TTM.

[0052] In some embodiments, the method further comprises a release liner removal step, which comprises removing a release liner from the patient-facing side of the second piece of the pad to expose the hydrogel. The release liner removal step occurs before the pad placement step.

[0053] In some embodiments, the method further includes a separate release liner removal step, which includes removing a release liner from a pad-facing side of the second piece of pad to expose an adhesive configured to bond the first and second pieces of pad body to one another when the first piece of pad is positioned over the second piece of pad in the pad positioning step.

[0054] In some embodiments, the method further includes an FDL connecting step, which includes fluidly connecting a secondary FDL outlet connector at the split pad-connecting end of the secondary FDL to a pad inlet connector, and which also includes fluidly connecting a secondary FDL inlet connector at the split pad-connecting end of the secondary FDL to a pad outlet connector.

[0055] In some embodiments, the fluid circulating step includes transferring heat between the temperature-controlled fluid and the patient's body by thermal conduction through the conduit layer. In some embodiments, the fluid circulating step includes circulating a cool fluid through the conduit layer to bring the patient from normothermic to hypothermic.

[0056] In some embodiments, the fluid circulating step includes circulating a warm fluid through the conduit layer to bring the patient from hypothermia to normothermia. In some embodiments, the fluid circulating step comprises circulating a warm fluid through the conduit layer to bring the patient from normothermic to hyperthermic.

[0057] In some embodiments, the fluid circulating step includes circulating a cool fluid through the conduit layer to bring the patient from hyperthermia to normothermia. These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0058] [Figure 1] 1 illustrates a system for TTM including a console and one or more pads, according to some embodiments. [Figure 2A] 1 illustrates a left torso pad and a right torso pad of one or more pads according to some embodiments. [Figure 2B] 1 illustrates a left leg pad and a right leg pad of one or more pads according to some embodiments. [Figure 3A] 1 illustrates a multi-layer pad body of one of the one or more pads according to some embodiments. [Figure 3B] 1 illustrates a two-piece pad body of one of the one or more pads according to some embodiments. [Figure 4A] 3C illustrates multiple wells in the pad of FIG. 3A or FIG. 3B, according to some embodiments. [Figure 4B] 3C illustrates another plurality of wells in the pad of FIG. 3A or FIG. 3B, according to some embodiments. [Figure 4C] 3C illustrates yet another plurality of wells in the pad of FIG. 3A or FIG. 3B, according to some embodiments. [Figure 4D] 3C illustrates yet another plurality of wells in the pad of FIG. 3A or FIG. 3B, according to some embodiments. [Figure 4E] 3C illustrates one or more channels in the pad of FIG. 3A or FIG. 3B, according to some embodiments. [Figure 5] 1 illustrates a hydraulic system for a control module, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0059] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein can have features that can be readily separated from the specific embodiment and, optionally, combined with or substituted for features of any of several other embodiments disclosed herein.

[0060] With regard to the terms used herein, it should also be understood that these terms are intended to describe certain specific embodiments and are not intended to 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 within a group of features or steps and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and particular embodiments including such features or steps are not necessarily limited to three features or steps. In addition, any of the aforementioned features or steps may further include one or more features or steps. Labels such as "left," "right," "top," "bottom," "front," and "back" are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative positions, orientations, or directions. The singular forms "a," "an," and "the" include the plural forms unless the context clearly indicates otherwise.

[0061] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As described above, TTM is a treatment for maintaining a therapeutic temperature (e.g., hypothermia, hyperthermia, etc.) in a patient to improve patient outcomes in a variety of different medical settings. Current systems for TTM generally circulate a temperature-controlled fluid (e.g., cooling fluid or warming fluid) around the patient using adhesive pads placed on various different parts of the patient's body to induce or maintain a therapeutic temperature. Because the adhesive pads are adhered to the patient's body to maintain sufficient contact between the adhesive pad and the patient's body for TTM, improvements to such pads continue to be an active area of ​​research and development. Disclosed herein are TTM systems, TTM pads, and methods of TTM.

[0062] System for TTM FIG. 1 illustrates a system 100 for TTM, including a control module 102 and one or more pads 104, according to some embodiments.

[0063] As shown, system 100 may include a control module 102, one or more pads 104, such as any of those described below, a primary FDL 106, and one or more secondary FDLs 108 that correspond in number to the one or more pads 104. The control module 102 is described immediately below. The one or more pads 104 and the one or more secondary FDLs 108 are described in the next section.

[0064] The control module 102 may include a console 110 having an integrated display configured as a touchscreen for operating the control module 102. The control module 102 may include one or more processors, primary and secondary memory, and instructions stored in the primary memory that, when executed by the one or more processors, are configured to instantiate one or more processes for the TTM using the control module 102.

[0065] FIG. 5 illustrates the hydraulic system 112 of the control module 102 according to some embodiments. The control module 102 may also include a hydraulic system 112, which may include a chiller circuit 114, a mixing circuit 116, and a circulation circuit 118 for providing a temperature-controlled fluid.

[0066] The chiller circuit 114 may be configured to chill a fluid (e.g., water, ethylene glycol, a combination of water and ethylene glycol, etc.) to produce a chilled fluid, which may then be mixed with a mixed fluid in a mixing tank 126, described below, to produce a supply fluid for the TTM. The chiller circuit 114 may include a chiller evaporator 120 configured to chill a fluid passing therethrough. The fluid cooled by the chiller evaporator 120 is provided by a chiller tank 122 using a chiller pump 124 of the chiller circuit 114.

[0067] The mixing circuit 116 can be configured to mix cooling fluid spillover from the chiller tank 122 with a mixed fluid in a mixing tank 126 of the mixing circuit 116. The mixing circuit 116 can include a heater 128 in the mixing tank 126 configured to heat the mixed fluid to produce a heated fluid, which can be mixed with the cooling fluid in any ratio to provide a supply fluid at a desired temperature for the TTM to a supply tank 130 of the circulation circuit 118. In practice, the chiller evaporator 120 and the heater 128 together are configured to cooperatively provide a temperature-controlled fluid. The mixing circuit 116 can include a mixing pump 132 configured to pump fluid from the mixing tank 126 into the chiller tank 122 to produce the cooling fluid and the cooling fluid spillover into the mixing tank 126.

[0068] The circulation circuit 118 can be configured to circulate a supply fluid for the TTM, which includes circulating the supply fluid provided by the manifold 134 through one or more pads 104 using a circulation pump 136 controlled directly or indirectly by a flow meter 138 in the circulation circuit 118. The manifold 134 can include an outlet 140 configured to exhaust the supply fluid (e.g., a cooling fluid or a warming fluid as described above) from the hydraulic system 112 and an inlet 142 configured to charge the hydraulic system 112 with return fluid from the one or more pads 104 to continue producing the supply fluid.

[0069] The primary FDL 106 can include primary piping 144 that, when fluidly connected to the hydraulic system 112, is configured to carry a supply fluid from the hydraulic system 112 via a lumen of the primary piping 144. Similarly, the primary piping 144, when fluidly connected to the hydraulic system 112, is configured to carry a return fluid back to the hydraulic system 112 via a lumen of the primary piping 144.

[0070] The primary piping 144 of the primary FDL 106 of FIG. 1 can include a pair of opposing connector ends, each connector end of the pair including a corresponding primary FDL connector. For example, one connector end of the pair can include a control module-connected primary FDL connector 146 configured to fluidly connect to a control module connector (not shown) of the control module 102. The control module connector can include both an outlet 140 and an inlet 142 of the hydraulic system 112. The other connector end of the pair can include a secondary FDL-connected primary FDL connector (not shown) configured to fluidly connect to a primary FDL-connected secondary FDL connector 188, described below. (See FIGS. 2A and 2B.) The secondary FDL-connected primary FDL connector can include both an outlet and an inlet.

[0071] Pads for TTM 2A and 2B show left and right pads of one or more pads 104 for the patient's torso and legs, respectively, according to some embodiments. However, the one or more pads 104 can be configured to be placed on any one or more parts of the patient's body, not just the torso or legs. FIG. 3A shows a multi-layer pad body 148 according to some embodiments of one of the one or more pads 104, and FIG. 3B shows a two-piece pad body 168 according to some other embodiments of one of the one or more pads 104.

[0072] Starting with an embodiment of one of the pads of one or more pads 104 shown in Figures 2A, 2B, and 3A, the pad may include a multi-layer pad body 148, a pad inlet connector 150, and a pad outlet connector 152.

[0073] The pad body 148 may include a conduit layer 154 , an impermeable film 156 covering the conduit layer 154 , and a patient interface layer 158 covering both the conduit layer 154 and the impermeable film 156 .

[0074] Conduit layer 154 may include a peripheral wall 160 and one or more interior walls 162s extending from conduit layer 154 toward impermeable film 156. Peripheral wall 160 and one or more interior walls 162, together with impermeable film 156, form one or more conduits 164 configured to convey temperature-controlled fluid through conduit layer 154 as a supply fluid from hydraulic system 112 or a return fluid back to hydraulic system 112.

[0075] The conduit layer 154 may include a plurality of protrusions 166 extending from the conduit layer 154 toward the impermeable film 156. The protrusions 166 may be configured to promote a uniform flow of the temperature-controlled fluid, either as a supply fluid or a return fluid, as the temperature-controlled fluid is conveyed through the conduit layer 154.

[0076] The conduit layer 154 may be a unitary piece of an opaque polymer (eg, foam) or a translucent polymer such as an elastomer (eg, silicone). The impermeable film 156 can be configured to retain the temperature-controlled fluid, either as a supply fluid or a return fluid, within the conduit layer 154 as the temperature-controlled fluid is conveyed through the conduit layer 154. Additionally, the impermeable film 156 can be configured to allow efficient energy transfer between the conduit layer 154 and the patient interface layer 158.

[0077] The patient interface layer 158 can be configured to be placed on the skin S (see FIG. 3A) of a portion of the patient's body (e.g., torso, legs, etc.) for thermal conduction through the patient interface layer 158.

[0078] Referring to an embodiment of one of the one or more pads 104 shown in Figures 2A, 2B, and 3B, the pad may include a two-piece pad body 168, a pad inlet connector 150, and a pad outlet connector 152.

[0079] The first piece 170 of the pad body 148, similar to the pad body 168 described above, may include a conduit layer 154 and an impermeable film 156 covering the conduit layer 154. Again, the conduit layer 154 may include one or more conduits 164 configured to carry a temperature-controlled fluid through the conduit layer 154, either as a supply fluid from the hydraulic system 112 or a return fluid back to the hydraulic system 112. The impermeable film 156 may be configured to contain the temperature-controlled fluid within the conduit layer 154, as described above.

[0080] The second double-sided piece 172 of the pad body 168 can include a patient interface side 174 and a pad interface side 176. The second piece 172 of the pad body 168 can be configured to be placed on a portion of a patient's body with the patient interface side 174 of the second piece 172 in contact with the patient's skin S. (See, for example, FIG. 3A .) The first piece 170 of the pad body 168 can be configured to be placed over the pad interface side 176 of the second piece 172 of the pad body 168.

[0081] Starting with the pad-interfacing side 176 of the second piece 172 of the pad body 168, the pad-interfacing side 176 can include an adhesive thereon that is configured to adhere the first and second pieces 170, 172 of the pad body 168 to one another when the first piece 170 is placed over the second piece 172. Alternatively, the impermeable film 156 of the first piece 170 of the pad body 168 can include an adhesive thereon that adheres the first and second pieces 170, 172 of the pad body 168 to one another when the first piece 170 is placed over the second piece 172. Although not shown, the pad-interfacing side 176 of the second piece 172 of the pad body 168 can include a release liner that covers the adhesive, if any, on the pad-interfacing side 176 of the second piece 172. Similarly, the impermeable film 156 of the first piece 170 of the pad body 168 may include a release liner to cover the adhesive, if any, on the impermeable film 156 of the first piece 170. Such a release liner may be configured to maintain the integrity of the pad-interface side 176 of the second piece 172 of the pad body 168 or the impermeable film 156 of the second piece 172 of the pad body 168, and expose the adhesive when the release liner is removed from the pad.

[0082] Referring to the patient interface side 174 of the second piece 172 of the pad body 168, the patient interface side 174 may include a hydrogel thereon. The hydrogel may be configured to adhere snugly to a portion of the patient's body for optimal thermal conduction without causing irritation. Such hydrogels may be selected from poly(ethylene glycol) hydrogels, alginate-based hydrogels, chitosan-based hydrogels, collagen-based hydrogels, dextran-based hydrogels, hyaluronan-based hydrogels, xanthan-based hydrogels, konjac-based hydrogels, gelatin-based hydrogels, and combinations of two or more of the foregoing hydrogels. Although not shown, the patient interface side 174 of the second piece 172 of the pad body 168 may include a release liner covering the hydrogel on the patient interface side 174. Such a release liner maintains the integrity of the patient interface side 174 of the second piece 172 of the pad body 168 and may be configured to expose the hydrogel when the release liner is removed from the pad.

[0083] Figures 4A-4D show multiple wells 178 in the pad of Figure 3A or 3B according to some embodiments. Figure 4E shows one or more channels 179 in the pad of Figure 3A or 3B according to some embodiments.

[0084] Returning to the embodiment of one of the one or more pads 104 shown in Figures 2A, 2B, and 3A, and the other embodiment of the one or more pads 104 shown in Figures 2A, 2B, and 3B, each of the patient interface sides 180 of the patient interface layer 158 of the pad body 148 and the patient interface side 174 of the second piece 172 of the pad body 168 can include wells 178 or one or more channels 179 therein. The wells 178 can be rectangular wells packed in a square shape as shown in Figures 4A and 4D, circular wells packed in a hexagonal shape as shown in Figure 4B, hexagonal wells packed in a hexagonal shape as shown in Figure 4C, etc. Indeed, the wells 178 can have any shape or combination of shapes in any arrangement or combination of arrangements sufficient for thermal conduction through the wells 178 when combined with a thermally conductive medium, as described below. Additionally, the wells 178 can be interconnected with connecting channels 181, as shown for the rectangular wells packed in a square shape in FIG. 4E. The interconnection of the wells 178 by connecting channels 181 can facilitate the initial application and dispensing of the heat transfer medium from, for example, an applicator described below. The interconnection of the wells 178 by connecting channels 181 can also facilitate the continued dispensing of the heat transfer medium, for example, as the patient moves. Although not shown, one or more of the channels 179 can also include connecting channels 181. As with the wells 178, the connecting channels 181 can also facilitate the application and dispensing of the heat transfer medium within the one or more channels 179.

[0085] The well 178 and one or more channels 179 are configured to hold a thermally conductive medium therein, which may be contained within the well 178 or one or more channels 179 of each of the one or more packaged pads 104. Alternatively, the thermally conductive medium may be provided separately, either in the same package as the one or more pads 104 or in a different package. The thermally conductive medium may include, but is not limited to, a polymer, a gel, or a fatty substance. For example, the polymer may be a polysiloxane such as silicone; the gel may be a network polymer such as poly(acrylic acid), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethylene glycol), or polyacrylamide that includes a swelling agent such as water, thereby providing a hydrogel; and the fatty substance may be a lipid such as petrolatum or an ester of one or more fatty acids. Additionally, the thermally conductive medium may include solid particle additives. The solid particle additives may include metal flakes, metal oxide particles, salt particles, carbon particles (e.g., one or more allotropes of carbon, such as amorphous carbon, graphite, or diamond), and the like. For example, the thermally conductive medium can be a paste of a fatty substance containing solid particle additives. Advantageously, such a thermally conductive medium can be configured to be compatible with ultrasound imaging, magnetic resonance imaging ("MRI"), computer-assisted tomography ("CT") scanning, electrocardiography, defibrillation, and the like.

[0086] Although not shown, pad body 148 or pad body 168 can include a film covering patient interface layer 158 of pad body 148 or second piece 172 of pad body 168, which film can individually seal each of the wells 178 or each of the one or more channels 179 on the patient interface side 180 of patient interface layer 158 or the patient interface side 174 of second piece 172. The film can be configured to expose the thermally conductive medium within the wells 178 or one or more channels 179 when cut with an instrument (e.g., a scalpel), ruptured by applied pressure (e.g., squeezing the pad, manipulating the pad over a portion of the patient, etc.), or melted upon contact with the patient's skin or a reagent for the skin. In this manner, cutting, rupturing, or dissolving the film to open the wells 178 or one or more channels 179 allows convenient selection of the wells 178 or one or more channels 179 as desired, thereby minimizing mess associated with using excess thermally conductive medium.

[0087] As an alternative to a film covering the patient interface layer 158 of the pad body 148 or the second piece 172 of the pad body 168, the pad body 148 or the pad body 168 can include a release liner covering it. The release liner can be configured to expose up to the entire patient interface side 180 of the patient interface layer 158 or the patient interface side 174 of the second piece 172 when the release liner is removed, which contains the thermally conductive medium in the wells 178 or one or more channels 179. However, in some embodiments, the thermally conductive medium can be provided separately in the same or different package as the one or more pads 104. In such embodiments, the release liner can be configured to expose up to the entire patient interface side 180 of the patient interface layer 158 or the patient interface side 174 of the second piece 172 when the release liner is removed, for later addition of the thermally conductive medium to the wells 178 or one or more channels 179. In either case, the release liner may be beneficial in maintaining the integrity of the patient interface side 180 of the patient interface layer 158 or the patient interface side 174 of the second piece 172 .

[0088] The pad inlet connector 150 may include a pad inlet configured to fill the conduit layer 154 with a supply fluid, and the pad outlet connector 152 may include a pad outlet configured to drain the return fluid from the conduit layer 154.

[0089] One of the one or more pads 104 may include one of the one or more secondary FDLs 108. For example, the secondary FDL may be pre-connected to the pad in a packaged state, or the secondary FDL may be provided in the same package as the pad or in a different package, but may not be connected to the pad.

[0090] The secondary FDL may include secondary piping 182 configured to carry supply fluid from the primary FDL 106 when connected to the hydraulic system 112 of the control module 102. Similarly, the secondary piping 182 may be configured to carry return fluid back to the primary FDL 106 when connected to the hydraulic system 112 of the control module 102.

[0091] The secondary FDL can be split at a pad-connecting end of the secondary FDL. The pad-connecting end of the secondary FDL can include a pair of pad-connecting secondary FDL connectors. A pad-connecting secondary FDL outlet connector 184 of the pair of pad-connecting secondary FDL connectors can be configured to fluidly connect to the pad inlet connector 150. A pad-connecting secondary FDL inlet connector 186 of the pair of pad-connecting secondary FDL connectors can be configured to fluidly connect to the pad outlet connector 152.

[0092] The secondary FDL need not be split at its primary FDL connection end, such as at its pad connection end. Indeed, the unsplit primary FDL connection end of the secondary FDL facilitates rapid connection of one or more secondary FDLs 108 to the primary FDL 106. Accordingly, the primary FDL connection end of the secondary FDL may include one primary FDL-connected secondary FDL connector 188 configured to fluidly connect to the aforementioned secondary FDL-connected primary FDL connector (not shown). The primary FDL-connected secondary FDL connector 188 may include both an inlet and an outlet corresponding to the outlet and inlet of the secondary FDL-connected primary FDL connector.

[0093] Package for TTM Although not shown, a package for the TTM can include one or more pads 104, one or more secondary FDLs 108 whose numbers correspond to the one or more pads 104, instructions for use, and packaging around at least the one or more pads 104, the one or more secondary FDLs 108, and the applicator, where the instructions for use can be printed on the package. One or more pads 104 can include one or more secondary FDLs 108, each pre-connected to one or more secondary FDLs 108 within the pad package. Alternatively, one or more pads 104 are not connected to one or more secondary FDLs 108 within the package. In other embodiments, one or more pads 104 and one or more secondary FDLs 108 can even be provided in separate packages.

[0094] If one or more pads 104 include a well 178 or one or more channels 179 on the patient interface side 180 of the patient interface layer 158 of the pad body 148 or the patient interface side 174 of the second piece 172 of the pad body 168 that does not have a thermally conductive medium disposed therein, the package may further include a container or applicator containing a thermally conductive medium for addition to the well 178 or one or more channels 179.

[0095] method Methods of using the system 100 or one or more pads 104 include methods of use. For example, a method of using the system 100 for TTM can include one or more steps selected from a thermally conductive medium preparation step, a pad placement step, an FDL connection step, a pad filling step, and a fluid circulation step.

[0096] The pad positioning step may include placing at least a portion of one of the one or more pads 104 on the patient's body in contact with the skin S of the patient's body. (See, e.g., FIG. 3A.) Depending on the one of the one or more pads 104 described above, the portion of the pad positioned in contact with the skin of the patient's body may include a well 178 or one or more channels 179 on the patient interface side 180 of the patient interface layer 158 of the pad body 148 or on the patient interface side 174 of the second piece 172 of the pad body 168, the well 178 or one or more channels 179 including a thermally conductive medium disposed therein. Alternatively, the portion of the pad positioned in contact with the skin of the patient's body may include a hydrogel on the patient interface side 174 of the second piece 172 of the pad body 168 in place of the well 178, one or more channels 179, or a thermally conductive medium therein.

[0097] The pad placement step may further include, for pad embodiments including a two-piece pad body 168, placing a first piece 170 of the pad over a second piece 172 of the pad.

[0098] The thermally conductive medium preparation step can be performed before or together with the pad placement step, depending on which of the one or more pads 104 described above.

[0099] As described above, pad body 148 or pad body 168 can include a film covering patient interface layer 158 of pad body 148 or second piece 172 of pad body 168, which can individually seal each of the wells 178 or each of the one or more channels 179 on patient interface side 180 of patient interface layer 158 or patient interface side 174 of second piece 172. In such embodiments, the thermally conductive medium providing step can include a film cutting step, a film rupturing step, or a film dissolving step. The film cutting step can include cutting the film covering wells 178 or one or more channels 179 with an instrument (e.g., a scalpel) to expose the thermally conductive medium in any one or more individually sealed wells of wells 178 or channels of one or more channels 179. The film rupturing step can include rupturing the film covering the wells 178 or one or more channels 179 with applied pressure (e.g., squeezing a pad, manipulating the pad over a patient, etc.) to expose the heat transfer medium within any one or more individually sealed wells of the wells 178 or channels of one or more channels 179. The film dissolving step can include dissolving the film covering the wells 178 or one or more channels 179 upon contact with the patient's skin or contact with an applied reagent to expose the heat transfer medium within any one or more individually sealed wells of the wells 178 or channels of one or more channels 179.

[0100] As described above, the pad body 148 or the pad body 168 may include a release liner covering the patient interface layer 158 of the pad body 148 or the second piece 172 of the pad body 168 as an alternative to a film. In such embodiments, the thermally conductive medium preparation step may include a release liner removal step. The release liner removal step may include removing the release liner from the pad to expose wells 178 or one or more channels 179 containing the thermally conductive medium therein. However, in some embodiments described above, the thermally conductive medium may be provided separately in a container or applicator, either in the same package as the pad or in a different package. In such embodiments, the release liner removal step may be combined with the dispensing step. Indeed, in this case, the dispensing step may be performed following the release liner removal step, which exposes wells 178 or one or more channels 179 without the thermally conductive medium disposed therein. Such a dispensing step may include dispensing the thermally conductive medium into the wells 178, into one or more channels 179, or onto the patient. However, if the thermally conductive medium is dispensed onto the patient, a release liner removal step can be performed afterwards if desired.

[0101] Notwithstanding the above, the release liner may alternatively cover the hydrogel on the patient-interface side 174 of the second piece 172 of the pad body 168 instead of the well 178 or one or more channels 179. In such embodiments, the release liner removal step may include removing the release liner from the patient-facing side 174 of the second piece 172 of the pad body 168 to expose the hydrogel.

[0102] The method may further include a separate release liner removal step for pad embodiments including a two-piece pad body 168. Indeed, the separate release liner removal step may include removing a release liner from a pad-facing side 176 of a second piece 172 of the pad body 168 to expose adhesive on the pad-facing side 176 for adhering the first and second pieces 170, 172 of the pad body 168 to one another when the first piece 170 is placed over the second piece 172 in the pad-positioning step. However, if the first piece 170 of the pad body 168 includes adhesive instead of the second piece 172 of the pad body 168, the release liner removal step may include removing a release liner from an impermeable film 156 of the first piece 170 to expose adhesive on the impermeable film 156 for adhering the first and second pieces 170, 172 of the pad body 168 to one another when the first piece 170 is placed over the second piece 172 in the pad-positioning step.

[0103] If the secondary FDL is not pre-connected to the pad, the method can include an FDL connection step that can include fluidly connecting a pad-connected secondary FDL outlet connector 184 at the split pad-connection end of the secondary FDL to the pad inlet connector 150. The FDL connection step can also include fluidly connecting a pad-connected secondary FDL inlet connector 186 at the split pad-connection end of the secondary FDL to the pad outlet connector 152.

[0104] The pad filling step may include filling one or more conduits 164 of the pad body 148 or the conduit layer 154 of the pad body 168 with a supply of temperature-controlled fluid. As described above, the supply fluid may be provided by the hydraulic system 112 of the control module 102 via a combination of fluidly connected FDLs, including the secondary FDL and the primary FDL 106.

[0105] The fluid circulating step may include circulating a supply fluid through the conduit layer 154 of the pad body 148 or the pad body 168 to cool or warm the patient's body as needed, in accordance with the TTM. Indeed, the fluid circulating step may include transferring heat between the temperature-controlled fluid and the patient's body by thermal conduction through the conduit layer 154. For example, the fluid circulating step may include circulating a cool fluid through the conduit layer 154 to bring the patient from normothermia to hypothermia. In another example, the fluid circulating step may include circulating a warm fluid through the conduit layer 154 to bring the patient from hypothermia to normothermia. In yet another example, the fluid circulating step may include circulating a warm fluid through the conduit layer 154 to bring the patient from normothermia to hyperthermia. In yet another example, the fluid circulating step may include circulating a cool fluid through the conduit layer 154 to bring the patient from hyperthermia to normothermia.

[0106] Although the above-described method is described with reference to one pad of the one or more pads 104, it should be understood that any number of pads of the one or more pads 104 may be used as needed to implement the desired treatment with the system 100 for TTM.

[0107] Although some specific embodiments have been disclosed herein and those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and the broader aspects encompass those adaptations and / or modifications as well. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. Pads for targeted temperature management (TTM) So, A multi-layer pad body, a conduit layer including one or more conduits configured to carry a temperature-controlled fluid from a hydraulic system as a supply fluid and return a return fluid to said hydraulic system; a patient interface layer overlying the conduit layer, the patient interface layer having a patient-facing side including a plurality of recesses configured to hold a thermally conductive medium; and a pad inlet connector including a pad inlet configured to fill the conduit layer with the supply fluid; a pad outlet connector including a pad outlet configured to drain the return fluid from the conduit layer. Pads for Targeted Temperature Management ("TTM").

2. The recess is a rectangular recess, and the plurality of recesses are arranged to form a quadrangle. The pad of claim 1.

3. The recess is a circular recess, and the plurality of recesses are arranged to form a hexagon. The pad of claim 1.

4. The recess is a hexagonal recess, and the plurality of recesses are arranged to form a hexagon. The pad of claim 1.

5. the recesses are interconnected; The pad of claim 1.

6. the pad contains the thermally conductive medium within the recess; The pad of claim 1.

7. the heat-conducting medium comprises a polymer, a gel, or a fatty substance; The pad according to claim 6.

8. the heat transfer medium comprises a solid particle additive comprising metal flakes, metal oxide particles, salt particles, or carbon particles; 8. The pad according to claim 7.

9. the heat-conducting medium is a paste of the fatty substance containing the solid particle additive; The pad according to claim 8.

10. the pad body further includes a film covering the patient interface layer, the film individually sealing each recess of the plurality of recesses, the film configured to be ruptured by an incision by an instrument or by application of pressure. The pad according to any one of claims 6 to 9.

11. a release liner covering the patient interface layer, the release liner configured to expose the thermally conductive medium within the recess when the release liner is removed. The pad according to any one of claims 6 to 9.

12. and a release liner covering the patient interface layer, the release liner configured to expose the recesses when the release liner is removed for subsequent addition of the thermally conductive medium to the recesses. The pad according to any one of claims 1 to 5.

13. the pad body further comprising an impermeable film between the patient interface layer and the conduit layer configured to contain the temperature-controlled fluid within the conduit layer. The pad according to any one of claims 1 to 9.

14. the conduit layer includes a plurality of protrusions extending from the conduit layer toward the impermeable film, the protrusions configured to promote uniform flow of the temperature-controlled fluid.

14. The pad of claim 13.

15. a secondary fluid delivery line ("FDL") configured to carry the supply fluid from the hydraulic system and return the return fluid to the hydraulic system; the secondary FDL is split at a pad connection end of the secondary FDL, the pad connection end of the secondary FDL including a pair of secondary FDL connectors including a secondary FDL outlet connector configured to fluidly connect to the pad inlet connector and a secondary FDL inlet connector configured to fluidly connect to the pad outlet connector; The pad according to any one of claims 1 to 9.

16. 1. A pad package for targeted temperature management ("TTM"), comprising: One or more pads for a TTM, each pad of the one or more pads comprising: A multi-layer pad body, a conduit layer including one or more conduits configured to carry a temperature-controlled fluid from a hydraulic system as a supply fluid and return a return fluid to said hydraulic system; one or more pads including a multi-layer pad body configured to be placed on a portion of a patient's body, the pad body including a patient interface layer overlying the conduit layer, the patient interface layer having a patient-facing side including a plurality of recesses configured to hold a thermally conductive medium; an applicator containing the thermally conductive medium for applying the thermally conductive medium to the recess; and wrapping around the one or more pads and the applicator. Pad package for targeted temperature management ("TTM").

17. The recess is a rectangular recess and the plurality of recesses are arranged to form a quadrangle, or The recess is a circular recess and the plurality of recesses are arranged to form a hexagon, or The recess is a hexagonal recess, and the plurality of recesses are arranged to form a hexagon.

17. The pad package of claim 16.

18. the recesses are interconnected; 17. The pad package of claim 16.

19. the heat-conducting medium comprises a polymer, a gel, or a fatty substance; The pad package according to any one of claims 16 to 18.

20. the heat transfer medium comprises a solid particle additive comprising metal flakes, metal oxide particles, salt particles, or carbon particles; The pad package according to any one of claims 16 to 18.

21. each pad of the one or more pads further comprising a release liner covering the patient interface layer, the release liner configured to expose the recesses when the release liner is removed for subsequent addition of the thermally conductive medium to the recesses. The pad package according to any one of claims 16 to 18.

22. the pad body further comprising an impermeable film between the patient interface layer and the conduit layer configured to contain the temperature-controlled fluid within the conduit layer. The pad package according to any one of claims 16 to 18.

23. each pad of said one or more pads: a pad inlet connector including a pad inlet configured to fill the conduit layer with the supply fluid; a pad outlet connector including a pad outlet configured to discharge the return fluid from the conduit layer. The pad package according to any one of claims 16 to 18.

24. and one or more secondary fluid delivery lines ("FDL") corresponding in number to the one or more pads, each secondary FDL of the one or more secondary FDLs being connected to the supply configured to carry a supply fluid from the hydraulic system and return the return fluid to the hydraulic system, each secondary FDL of the one or more secondary FDLs being split at a pad connection end of the secondary FDL, the pad connection end of the secondary FDL including a pair of secondary FDL connectors including a secondary FDL outlet connector configured to fluidly connect to the pad inlet connector and a secondary FDL inlet connector configured to fluidly connect to the pad outlet connector; 24. The pad package of claim 23.

25. 1. A pad for targeted temperature management ("TTM"), comprising: A two-piece pad body, a first piece including an impermeable film covering a conduit layer, the conduit layer including one or more conduits configured to carry a temperature-controlled fluid from a hydraulic system as a supply fluid and return a return fluid to the hydraulic system, the impermeable film configured to contain the temperature-controlled fluid within the conduit layer; a two-piece pad body including a double-sided second piece including a patient interface side and a pad interface side, the second piece of the pad body configured to be placed on a portion of a patient's body and the first piece of the pad body configured to be placed over the second piece of the pad body, the patient interface side of the second piece of the pad body including a plurality of recesses configured to hold a thermally conductive medium; a pad inlet connector including a pad inlet configured to fill the conduit layer with the supply fluid; a pad outlet connector including a pad outlet configured to drain the return fluid from the conduit layer. Pads for Targeted Temperature Management ("TTM").

26. the pad interface side of the second piece of the pad body includes an adhesive on the pad interface side configured to bond the first and second pieces of the pad body to each other when the first piece of the pad body is positioned over the second piece of the pad body; 26. The pad of claim 25.

27. the impermeable film includes an adhesive thereon configured to adhere the first and second pieces of the pad body to one another when the first piece of the pad body is positioned over the second piece of the pad body; 26. The pad of claim 25.

28. The recess is a rectangular recess and the plurality of recesses are arranged to form a quadrangle, or The recess is a circular recess and the plurality of recesses are arranged to form a hexagon, or The recess is a hexagonal recess, and the plurality of recesses are arranged to form a hexagon.

26. The pad of claim 25.

29. the recesses are interconnected; 26. The pad of claim 25.

30. the pad contains the thermally conductive medium within the recess; 26. The pad of claim 25.

31. the heat-conducting medium comprises a polymer, a gel, or a fatty substance; 31. The pad of claim 30.

32. the heat transfer medium comprises a solid particle additive comprising metal flakes, metal oxide particles, salt particles, or carbon particles; 31. The pad of claim 30.

33. the second piece of the pad body further includes a film covering the patient interface side, the film individually sealing each of the plurality of recesses, the film being configured to be ruptured by being cut by an instrument or by applying pressure.

31. The pad of claim 30.

34. the pad further includes a release liner covering the patient interface side of the second piece of the pad body, the release liner configured to expose the thermally conductive medium within the recess when the release liner is removed.

31. The pad of claim 30.

35. a release liner covering the patient interface side of the second piece of the pad body, the release liner configured to expose the recess when the release liner is removed for subsequent addition of the thermally conductive medium to the recess.

26. The pad of claim 25.

36. the patient interface side of the second piece of the pad body includes a hydrogel on the patient interface side.

26. The pad of claim 25.

37. The hydrogel comprises a poly(ethylene 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, or a combination of two or more of the foregoing hydrogels.

37. The pad of claim 36.

38. and a release liner covering the patient interface side of the second piece of the pad body, the release liner configured to expose the hydrogel when the release liner is removed.

37. The pad of claim 36.

39. the conduit layer includes a plurality of protrusions extending from the conduit layer toward the impermeable film, the protrusions configured to promote uniform flow of the temperature-controlled fluid. A pad according to any one of claims 25 to 38.

40. a secondary fluid delivery line ("FDL") configured to carry the supply fluid from the hydraulic system and return the return fluid to the hydraulic system; the secondary FDL is split at a pad connection end of the secondary FDL; the pad connection end of the secondary FDL includes a pair of secondary FDL connectors including a secondary FDL outlet connector configured to fluidly connect to the pad inlet connector and a secondary FDL inlet connector configured to fluidly connect to the pad outlet connector; A pad according to any one of claims 25 to 38.

41. 1. A pad package for targeted temperature management ("TTM"), comprising: One or more pads for a TTM, each pad of the one or more pads comprising: A two-piece pad body, a first piece including an impermeable film covering a conduit layer, the conduit layer including one or more conduits configured to carry a temperature-controlled fluid from a hydraulic system as a supply fluid and return a return fluid to the hydraulic system, the impermeable film configured to contain the temperature-controlled fluid within the conduit layer; one or more pads, including a two-piece pad body including a double-sided second piece including a patient interface side and a pad interface side, the patient interface side of the second piece of the pad body including a plurality of recesses configured to hold a thermally conductive medium, the second piece of the pad body configured to be placed on a portion of a patient's body, and the first piece of the pad body configured to be placed over the second piece of the pad body; an applicator containing the thermally conductive medium for applying the thermally conductive medium to the recess; and wrapping around the one or more pads and the applicator. Pad package for targeted temperature management ("TTM").

42. The recess is a rectangular recess and the plurality of recesses are arranged to form a quadrangle, or The recess is a circular recess and the plurality of recesses are arranged to form a hexagon, or The recess is a hexagonal recess, and the plurality of recesses are arranged to form a hexagon.

42. The pad package of claim 41.

43. the recesses are interconnected; 42. The pad package of claim 41.

44. the heat-conducting medium comprises a polymer, a gel, or a fatty substance; 42. The pad package of claim 41.

45. the heat transfer medium comprises a solid particle additive comprising metal flakes, metal oxide particles, salt particles, or carbon particles; 42. The pad package of claim 41.

46. each pad of the one or more pads includes a release liner covering the patient interface side of the second piece of the pad body, the release liner configured to expose the recess when the release liner is removed for subsequent addition of the thermally conductive medium to the recess; A pad package according to any one of claims 41 to 45.

47. the pad interface side of the second piece of the pad body includes an adhesive on the pad interface side configured to bond the first and second pieces of the pad body to each other when the first piece of the pad body is positioned over the second piece of the pad body; A pad package according to any one of claims 41 to 45.

48. the impermeable film includes an adhesive thereon configured to adhere the first and second pieces of the pad body to one another when the first piece of the pad body is positioned over the second piece of the pad body; A pad package according to any one of claims 41 to 45.

49. each pad of said one or more pads: a pad inlet connector including a pad inlet configured to fill the conduit layer with the supply fluid; a pad outlet connector including a pad outlet configured to discharge the return fluid from the conduit layer. A pad package according to any one of claims 41 to 45.

50. one or more secondary fluid delivery lines ("FDL") corresponding in number to the one or more pads; each secondary FDL of the one or more secondary FDLs configured to convey the supply fluid from the hydraulic system and convey the return fluid back to the hydraulic system; each secondary FDL of the one or more secondary FDLs is split at a pad connection end of the secondary FDL; the pad connection end of the secondary FDL includes a pair of secondary FDL connectors including a secondary FDL outlet connector configured to fluidly connect to the pad inlet connector and a secondary FDL inlet connector configured to fluidly connect to the pad outlet connector; 50. The pad package of claim 49.

51. 1. A system for target thermal management (“TTM”), comprising: a control module including a hydraulic system configured to provide a temperature controlled fluid; a primary fluid delivery line ("FDL") configured to carry the temperature-controlled fluid from the hydraulic system as a supply fluid and return the temperature-controlled fluid to the hydraulic system as a return fluid; one or more pads configured to be placed respectively on one or more parts of a patient's body, each pad of the one or more pads being selected from the pads of any one of claims 1 to 9 and claims 25 to 37. A system for targeted thermal management ("TTM").

52. the hydraulic system comprises: a chiller evaporator configured for fluid cooling; a heater configured for fluid heating, the chiller evaporator and the heater together configured to provide the temperature-controlled fluid; a hydraulic system outlet configured to discharge the supply fluid from the hydraulic system; a hydraulic system inlet configured to charge the hydraulic system with the return fluid to continue producing the temperature-controlled fluid.

52. The system of claim 51.

53. the control module: one or more processors; A primary memory; instructions stored in the primary memory configured to instantiate one or more processes for a TTM using the control module; 52. The system of claim 51.

Images