Patient Contact Systems

Abstract

Disclosed herein are medical systems, pads, and methods for exchanging thermal energy between a circulating fluid and a patient. Some pads are configured for multiple uses on the same patient or across multiple different patients. Some pads include multiple layers of hydrogel disposed on one or both sides of the fluid compartment. A removable hydrogel layer exposes the other hydrogel layer for subsequent use of the pad. A removable storage liner encapsulates one or more hydrogel layers. A separation liner between adjacent hydrogel layers isolates adjacent hydrogels from each other, and removal of the separation liner extends the useful life of the hydrogel layers. An adhesive patch secures the pad to the patient, including an adhesive patch extending through an opening in the pad. Some pads are configured for disinfection, sterilization, and / or laundering. In one embodiment, the fluid is air, and a vacuum within the pad compartment secures the pad to the patient.

Description

[Background technology]

[0001] The effects of temperature on the human body are well documented, and the use of targeted temperature management (TTM) systems to selectively cool and / or heat bodily tissues is known. High temperatures, i.e. hyperthermia, can be detrimental to the brain under normal conditions, and more importantly, during periods of physical stress such as illness or surgery. Conversely, lower temperatures, i.e. mild hypothermia, may provide some degree of neuroprotection. Moderate to severe hypothermia tends to be more detrimental to the body, particularly the cardiovascular system.

[0002] Targeted temperature management can be viewed in two different aspects. The first aspect of temperature management involves treating abnormal body temperature, i.e., cooling the body under conditions of hyperthermia or warming the body under conditions of hypothermia. The second aspect of thermoregulation is advanced therapy using techniques to physically control the patient's temperature to provide physiological benefits, such as cooling stroke patients to provide some degree of neuroprotection. As an example, the TTM system may be utilized in early stroke treatment to reduce neurological damage from stroke and head trauma patients. Further applications include selective patient heating / cooling during surgical procedures such as cardiopulmonary bypass surgery.

[0003] A TTM system circulates a fluid (e.g., water) through one or more thermal contact pads coupled to a patient to affect surface-to-surface thermal energy exchange with the patient. Generally, a TTM system includes a TTM fluid control module coupled to at least one contact pad via a fluid delivery line. One such system including a thermal contact pad is disclosed in U.S. Patent Application Publication No. 2012 / 0133999, entitled "Medical Pad and System for Thermotherpy," filed on October 9, 2019, and is incorporated herein by reference in its entirety.

[0004] Thermal contact pads are typically configured for use with few installations, such as single use or single installation. In some cases, thermal contact pads may become dirty or contaminated with use. However, replacing thermal contact pads after every use can be costly for healthcare providers. Disclosed herein are systems, thermal contact pads, and methods for utilizing thermal contact pads over extended periods of time, including multiple TTM therapies across multiple patients. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] US Patent Application Publication No. 2020 / 0155341 Summary of the Invention

[0006] Briefly summarized, disclosed herein is a patient contact system for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient. According to some embodiments, the patient contact system comprises a gown assembly, the gown assembly including a gown configured to be worn on a patient, and a thermal contact pad coupled to the gown. The pad comprises a fluid compartment configured to receive TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of a TTM therapy. The patient contact system further comprises a hydrogel disposed on a patient contact surface of the pad. The pad is disposed on an inner surface of the gown to facilitate thermal contact between the fluid compartment of the pad and the patient.

[0007] In some embodiments, the patient contact system is configured for multiple use with a single patient, multiple use across different patients, or both.

[0008] The gown assembly may be configured for disinfection and / or sterilization, which may include autoclaving. The gown assembly may also be configured for laundering in an automatic washing machine.

[0009] The hydrogel provided on the pad may be a first portion of hydrogel dispensed from a separate reservoir. In some embodiments, the gown assembly comprises a plurality of thermal contact pads. The plurality of thermal contact pads may include a first pad coupled to the gown to be positioned adjacent a first side of the patient's torso when the gown assembly is placed on the patient, and a second pad coupled to the gown to be positioned adjacent a second side of the torso opposite the first side when the gown assembly is placed on the patient. The plurality of thermal contact pads further includes a third pad coupled to the gown to be positioned adjacent a first thigh of the patient when the gown assembly is placed on the patient, and a fourth pad coupled to the gown to be positioned adjacent a second thigh of the patient when the gown assembly is placed on the patient. In some embodiments, one or more of the plurality of thermal contact pads may be removably coupled to the gown assembly.

[0010] In some embodiments, the plurality of thermal contact pads are fluidly connected to one another. In some embodiments, two or more of the plurality of thermal contact pads are individually coupled to the TTM system module. In some embodiments, one or more of the plurality of thermal contact pads are fluidly disconnectable from the remaining pads.

[0011] In some embodiments, the gown assembly includes a plurality of fastening devices, one or more of which are configured to secure the gown to the patient. The one or more of the fastening devices may also be configured to secure one or more of the plurality of pads in thermal contact with the patient.

[0012] In some embodiments, a support structure is disposed within the fluid compartment to define a minimum thickness of the fluid compartment. Also disclosed herein is a method of providing one or more targeted temperature management (TTM) therapies to one or more patients. The method includes attaching a gown assembly to a first patient, the gown assembly including a gown configured to be worn on the patient and a plurality of thermal contact pads coupled to the gown. Each pad includes a fluid compartment configured to receive TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of the TTM therapy. The method further includes (i) dispensing hydrogel from a hydrogel reservoir onto a patient contacting surface of each pad, (ii) securing each pad in thermal contact with the first patient such that the hydrogel is disposed between each corresponding fluid compartment and the first patient, (iii) coupling the gown assembly to the TTM system module, and (iv) circulating the TTM fluid through the fluid compartment of each pad to administer the first TTM therapy.

[0013] In some embodiments, the method further includes (i) removing the gown assembly from the first patient, (ii) applying the gown assembly to a second patient, (iii) redistributing hydrogel from the hydrogel reservoir to each pad, (iv) securing each pad in thermal contact with the second patient, and (v) recirculating the TTM fluid through the fluid compartment of each pad. In some embodiments of the method, the first patient and the second patient are different patients.

[0014] In some embodiments, the method further comprises disinfecting the gown assembly between the first TTM therapy and the second TTM therapy. In some embodiments, the method further comprises sterilizing the gown assembly between the first TTM therapy and the second TTM therapy. In some embodiments, the method further comprises laundering the gown assembly in an automatic washing machine between the first TTM therapy and the second TTM therapy.

[0015] In some embodiments, the method further includes decoupling the thermal contact pad from the gown assembly and coupling a replacement thermal contact pad to the gown assembly.

[0016] Also disclosed herein is a patient contact system comprising a thermal contact pad configured to be worn on a patient, the pad comprising a fluid compartment configured to receive TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of a TTM therapy. The pad further comprises a plurality of openings extending between an upper surface and a lower surface of the pad. The patient contact system further comprises a plurality of first adhesive patches, each first adhesive patch disposed over an upper portion of each opening. In use, a portion of the first adhesive patch is pressed through a corresponding opening to adhere the portion of the first adhesive patch to the patient and secure the pad to the patient. Each adhesive patch is configured to be detached from the patient and subsequently reattached to the patient.

[0017] In some embodiments, the system is configured for multiple use on a single patient, and in further embodiments, the system is configured for multiple use across different patients. In some embodiments, the pad is configured for disinfection and / or sterilization, which may include autoclaving.

[0018] In some embodiments, the system further comprises a plurality of second adhesive patches, each second adhesive patch including a first portion coupled to the pad on the top surface of the pad along the outer periphery of the pad and a second portion extending away from the outer periphery, wherein in use the second portion is attached to the patient to secure the pad to the patient.

[0019] In some embodiments of the system, the pad is provided with a hydrogel across an underside of the pad, and in some embodiments, a hydrogel liner is disposed between the hydrogel and the fluid compartment. In some embodiments, the hydrogel liner is removably attached to the fluid compartment. The hydrogel liner may include a plurality of liner openings shaped and positioned to correspond to the openings in the pad.

[0020] In some embodiments of the system, the hydrogel is sealably enclosed within a hydrogel compartment, the compartment being defined by a hydrogel liner disposed over an upper surface of the hydrogel and a storage liner disposed over a lower surface of the hydrogel, and during use, the storage liner is removed from the pad to expose the hydrogel.

[0021] In some embodiments of the system, the fluid compartment includes a support structure disposed within the fluid compartment that defines a minimum thickness of the fluid compartment. Also disclosed herein is a method of providing one or more targeted temperature management (TTM) therapies to one or more patients, the method including: (i) attaching a thermal contact pad to a first patient, the thermal contact pad having a plurality of openings extending between an upper surface and a lower surface of the pad; (ii) providing a plurality of first adhesive patches, each of the first adhesive patches being positioned over an upper portion of a respective opening; (iii) pressing a portion of each of the first adhesive patches through a corresponding opening to adhere the first adhesive patch to the first patient, thereby securing the pad to the first patient; (iv) coupling a fluid compartment of the thermal contact pad to a TTM system module, the fluid compartment configured to receive TTM fluid from the TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of the TTM therapy; and (v) circulating the TTM fluid through the fluid compartment of the pad to administer the first TTM therapy.

[0022] In some embodiments, the method includes providing a first amount of hydrogel to the pad across an underside of the pad. In further embodiments of the method, the pad includes a first hydrogel liner coupled to the fluid compartment, and the first amount of hydrogel is provided in the first hydrogel liner. In some embodiments of the method, the first amount of hydrogel is sealably enclosed within a first hydrogel compartment defined by the first hydrogel liner and a first storage liner disposed across an underside of the first amount of hydrogel, and the method further includes removing the first storage liner from the pad to expose the first amount of hydrogel.

[0023] In some embodiments, the method includes (i) removing the pad from the first patient, (ii) removing the first adhesive patch from the pad, (iii) attaching the pad to a second patient, (iv) attaching a second plurality of first adhesive patches to the pad, (v) pressing a portion of each of the second plurality of first adhesive patches through a corresponding opening to adhere the second plurality of first adhesive patches to the first patient, thereby securing the pad to the second patient, and (vi) recirculating the TTM fluid through the fluid compartment of the pad to perform a second TTM therapy. In some embodiments of the method, the first patient and the second patient are different patients.

[0024] In some embodiments, the method further comprises disinfecting the pad between the first and second TTM therapy.In some embodiments, the method further comprises sterilizing the pad between the first and second TTM therapy.

[0025] In some embodiments, the method further includes removing the first amount of hydrogel from the pad after the first TTM therapy and applying a second amount of hydrogel to the pad before the second TTM therapy.

[0026] In some embodiments, the method further includes removing the first hydrogel liner from the pad after the first TTM therapy, attaching a second hydrogel compartment to the pad, and removing the second storage liner from the second hydrogel compartment to expose a second amount of hydrogel.

[0027] Also disclosed herein is a medical pad comprising: (i) a fluid compartment configured to receive TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of a TTM therapy; (ii) a first hydrogel layer coupled to the fluid compartment on an underside of the fluid compartment; and (iii) a second hydrogel layer coupled to the first hydrogel layer on an underside of the first hydrogel layer.

[0028] In some embodiments of the pad, the second hydrogel layer is removably bonded to the first hydrogel layer, in some embodiments a separation liner is disposed between the first and second hydrogel layers, and in further embodiments the separation liner is bonded to the fluid compartment so as to sealably encapsulate the first hydrogel layer.

[0029] In some embodiments of the pad, the separation liner includes a pull tab extending away from the outer periphery of the separation liner to facilitate removal of the separation liner along with the second hydrogel layer.

[0030] In some embodiments, the pad further comprises a first liner disposed between the fluid compartment and the first hydrogel layer, and in further embodiments, the separate liner is bonded to the first liner so as to sealably encapsulate the first hydrogel layer.

[0031] In some embodiments, the pad further comprises a storage liner disposed over a lower surface of the second hydrogel layer, the storage liner bonded to one or more of the fluid compartment, the separation liner, or the first liner so as to sealably enclose the second hydrogel layer, hi some embodiments, the pad further comprises a foam layer bonded to the fluid compartment on an upper surface of the fluid compartment.

[0032] Also disclosed herein is a method of providing one or more targeted temperature management (TTM) therapies to one or more patients. The method includes providing a thermal contact pad, the thermal contact pad comprising: (i) a fluid compartment configured to receive TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of the TTM therapy; (ii) a first hydrogel layer coupled to the fluid compartment; and (iii) a second hydrogel layer coupled to the first hydrogel layer on an opposite side to the fluid compartment. The method further includes attaching the pad to a first patient such that the second hydrogel layer is positioned in contact with the first patient, coupling the fluid compartment to the TTM system module, and circulating the TTM fluid through the fluid compartment to administer the first TTM therapy.

[0033] In some embodiments, the method includes (i) removing the pad from the first patient, (ii) removing the second hydrogel layer from the pad to expose the first hydrogel layer, (iii) attaching the pad to the second patient such that the first hydrogel layer is placed in contact with the second patient, and (vi) recirculating the TTM fluid in the fluid compartment to perform a second TTM therapy. In some embodiments of the method, the first patient and the second patient are different patients.

[0034] In some embodiments of the method, the pad further comprises a separation liner disposed between the first hydrogel layer and the second hydrogel layer, and the method further comprises removing the separation liner from the pad along with the second hydrogel layer.

[0035] In some embodiments of the method, the separation liner is bonded to the fluid compartment so as to sealably encapsulate the first hydrogel layer. In some embodiments of the method, the pad further comprises a storage liner disposed over a lower surface of the second hydrogel layer, and the method further comprises removing the storage liner from the pad to expose the second hydrogel layer prior to attaching the pad to the first patient. In some embodiments of the method, the storage liner is bonded to one or more of the fluid compartment or separation liner to sealably encapsulate the second hydrogel layer.

[0036] Also disclosed herein is a medical pad, the medical pad comprising a foam layer and a first fluid compartment coupled to the foam layer on a first side of the foam layer, the first fluid compartment configured to receive TTM fluid from a TTM system module via a first fluid delivery line, the TTM system module configured to circulate TTM fluid within the first fluid compartment during administration of a first TTM therapy. The pad further comprises (i) a first hydrogel layer coupled to the first fluid compartment on a side opposite the foam layer, (ii) a second fluid compartment coupled to the foam layer on a second side of the foam layer opposite the first side, the second fluid compartment configured to receive TTM fluid from the TTM system module via a second fluid delivery line, and (iii) a second hydrogel layer coupled to the second fluid compartment on a side opposite the foam layer.

[0037] In some embodiments of the pad, the first hydrogel layer is removably associated with the first fluid compartment and the second hydrogel layer is removably associated with the second fluid compartment.

[0038] In some embodiments of the method, the pad further comprises a first liner disposed between the first hydrogel layer and the first fluid compartment, and in further embodiments, the first liner is removably attached to the first fluid compartment.

[0039] In some embodiments of the method, the pad further comprises a second liner disposed between the second hydrogel layer and the second fluid compartment, and in further embodiments, the second liner is displaceably attached to the second fluid compartment.

[0040] In some embodiments of the pad, the first liner includes a first pull tab extending away from an outer periphery of the first liner to facilitate removal of the first liner from the first fluid compartment, and similarly in further embodiments, the second liner includes a second pull tab extending away from an outer periphery of the second liner to facilitate removal of the second liner from the second fluid compartment.

[0041] In some embodiments, the pad further comprises a first storage liner disposed over an exterior of the first hydrogel layer, the first storage liner bonded to one or more of the first fluid compartment or the first liner to sealably enclose the first hydrogel layer. Similarly, in some embodiments, the pad further comprises a second storage liner disposed over an exterior of the second hydrogel layer, the second storage liner bonded to one or more of the second fluid compartment or the second liner to sealably enclose the second hydrogel layer.

[0042] Also disclosed herein is a method of providing one or more targeted temperature management (TTM) therapies to one or more patients, the method including providing a thermal contact pad, the pad comprising: (i) a first fluid compartment configured to receive TTM fluid from a TTM system module via a first fluid delivery line, the TTM system module configured to circulate TTM fluid within the first fluid compartment during administration of the first TTM therapy; (ii) a first hydrogel layer coupled to the first fluid compartment; (iii) a second fluid compartment coupled to the first fluid compartment opposite the first hydrogel layer, the second fluid compartment configured to receive TTM fluid from the TTM system module via the second fluid delivery line during administration of the second TTM therapy; and (iv) a second hydrogel layer coupled to the second fluid compartment opposite the first fluid compartment. The method further includes attaching the pad to the first patient such that the first hydrogel layer is positioned in contact with the first patient, coupling the first fluid compartment to the TTM system module, and circulating TTM fluid through the first fluid compartment to perform a first TTM therapy.

[0043] In some embodiments of the method, the pad further comprises a first storage liner disposed over an exterior of the first hydrogel layer, and the method further includes removing the first storage liner from the pad to expose the first hydrogel layer prior to attaching the pad to the first patient.

[0044] In some embodiments, the method further includes (i) removing the pad from the first patient, (ii) inverting the pad, (iii) attaching the pad to a second patient such that the second hydrogel layer is placed in contact with the second patient, and (iv) circulating a TTM fluid through the second fluid compartment to perform a second TTM therapy. In some embodiments, the first patient and the second patient are different patients.

[0045] In some embodiments of the method, the first hydrogel layer is removably coupled to the first fluid compartment, and the method further includes removing the first hydrogel layer from the pad after removing the pad from the first patient.

[0046] In some embodiments of the method, the pad further comprises a first liner disposed between the first hydrogel layer and the first fluid compartment, and the method further comprises removing the first liner together with the first hydrogel layer from the pad.

[0047] In some embodiments of the method, the pad further comprises a second storage liner disposed over an exterior of the second hydrogel layer, and the method further includes removing the second storage liner from the pad to expose the second hydrogel layer prior to attaching the pad to a second patient.

[0048] Also disclosed herein is a medical pad for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient, the pad comprising: (i) a fluid compartment configured to receive TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of a TTM therapy; (ii) a first hydrogel layer coupled to the fluid compartment at an underside of the fluid compartment; (iii) a second hydrogel layer coupled to the first hydrogel layer at an underside of the first hydrogel layer; and (iv) a separation liner disposed between the first hydrogel layer and the second hydrogel layer, the separation liner isolating the second hydrogel layer from the first hydrogel layer, and the separation liner being removably coupled to the first hydrogel layer and the second hydrogel layer.

[0049] In some embodiments of the pad, removing the separation liner from between the first and second hydrogel layers causes one or more components of the first hydrogel layer to migrate into the second hydrogel layer. In some embodiments, the migration of the one or more components extends the useful life of the pad. In further embodiments, the migration of the one or more components provides an extended duration of TTM therapy. In some embodiments, the migration of the one or more components promotes rehydration of the second hydrogel layer. In yet other embodiments, the chemical composition of the second hydrogel layer is different from the chemical composition of the first hydrogel layer.

[0050] In some embodiments of the pad, the separation liner is bonded to the fluid compartment to sealably encapsulate the first hydrogel layer, hi some embodiments, the separation liner includes a pull tab extending away from the outer periphery of the separation liner to facilitate removal of the separation liner along with the second hydrogel layer.

[0051] In some embodiments, the pad further comprises a liner disposed between the fluid compartment and the first hydrogel layer, hi further embodiments, the pad further comprises a storage liner disposed over a lower surface of the second hydrogel layer, the storage liner bonded to one or more of the fluid compartment, the separation liner, or the liner so as to sealably encapsulate the second hydrogel layer.

[0052] In some embodiments, the pad further comprises a foam layer coupled to the fluid compartment on an upper surface of the fluid compartment opposite the first hydrogel layer. Also disclosed herein is a method of providing targeted temperature management (TTM) therapy to a patient, the method including providing a thermal contact pad comprising: (i) a fluid compartment configured to receive TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of the TTM therapy, (ii) a first hydrogel layer coupled to the fluid compartment, (iii) a separation liner coupled to the first hydrogel layer opposite the fluid compartment, and (iv) a second hydrogel layer coupled to the separation liner opposite the first hydrogel layer, the separation liner isolating the second hydrogel layer from the first hydrogel layer and the separation liner is bondably coupled to the first hydrogel layer and the second hydrogel layer. The method further includes attaching the pad to the patient such that the second hydrogel layer is positioned in contact with the patient, coupling the fluid compartment to a TTM system module, and circulating a TTM fluid within the fluid compartment to perform a first TTM therapy.

[0053] In some embodiments, the method further includes removing the separation liner from between the first and second hydrogel layers to allow one or more components of the first hydrogel layer to migrate into the second hydrogel layer.

[0054] In some embodiments of the method, the pad further comprises a storage liner disposed over a lower surface of the second hydrogel layer, and the method further comprises removing the storage liner to expose the second hydrogel layer.

[0055] Also disclosed herein is a medical system for providing a targeted temperature management (TTM) therapy to a patient. According to some embodiments, the medical system includes a targeted temperature management (TTM) system module configured to provide a flow of TTM air at a prescribed pressure and temperature according to a TTM therapy, and a thermal contact pad fluidly coupled to the system module, the pad configured to be worn on a patient. The pad is configured to sealably couple to the patient along a periphery of the pad to form a compartment between an upper wall of the pad and a skin surface of the patient, the compartment configured to receive TTM air from the system module via a bidirectional air delivery line to circulate the TTM air within the compartment, the prescribed pressure being a vacuum, which provides a downward force on the pad to secure the pad to the patient during TTM therapy.

[0056] In some embodiments of the system, the pad comprises a support structure extending downwardly from the top wall within the compartment, the support structure defining a minimum distance between the skin surface and the top wall. In some embodiments of the system, the support structure defines a number of channels between the inlet and outlet ports for the TTM air to flow during circulation through the compartment.

[0057] In some embodiments, the system comprises a plurality of thermal contact pads coupled to the system module, and in some embodiments, each pad of the plurality of pads is individually coupled to the system module.

[0058] Also disclosed herein is a method of providing targeted temperature management (TTM) therapy to a patient, the method including: (i) attaching a thermal contact pad to the patient, the pad forming a circumferential seal with the patient's skin surface to define a compartment between an upper wall of the pad and the skin surface; (ii) fluidly coupling the pad to a TTM system module via a bidirectional air delivery line, the TTM system module configured to circulate TTM air within the compartment; (iii) defining a vacuum within the fluid compartment to secure the pad to the patient; and (vi) circulating TTM air within the fluid compartment at a defined temperature to perform TTM therapy.

[0059] In some embodiments, the method further comprises removing the vacuum from the compartment to release the pad from the patient. These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts.

[0060] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0061] [Figure 1] FIG. 1 illustrates a targeted temperature management (TTM) system including multiple thermal contact pads coupled to a patient, according to some embodiments. [Figure 2A] FIG. 2 illustrates a first embodiment of a patient contact system, including a front view of a gown assembly incorporating multiple thermal contact pads, that may be employed with the system of FIG. 1, in accordance with some embodiments. [Figure 2B] 2B is an interior view of the gown assembly of FIG. 2A according to some embodiments. [Figure 2C] 2C is a cross-sectional view showing the thermal contact pad of the gown assembly of FIG. 2A taken along section line 2C-2C according to some embodiments. [Figure 3A] FIG. 2 illustrates a second embodiment of a patient contact system that may be employed with the system of FIG. 1 including a thermal contact pad having an opening extending through the pad, in accordance with some embodiments. [Figure 3B] 3B is a cross-sectional view of the thermal contact pad of FIG. 3A taken along section line 3B-3B, according to some embodiments. [Figure 3C] FIG. 3B is a top view of the hydrogel containment of FIG. 3A, according to some embodiments. [Figure 3D] FIG. 3D is a cross-sectional view of the hydrogel containment of FIG. 3C taken along section line 3D-3D, according to some embodiments. [Figure 4A] 2 illustrates another embodiment of a thermal contact pad that may be employed with the system of FIG. 1, according to some embodiments. [Figure 4B] 4B is a cross-sectional view of the pad of FIG. 4A taken along section line 4B-4B, according to some embodiments. [Figure 5A] 2 illustrates another embodiment of a thermal contact pad that may be employed with the system of FIG. 1, according to some embodiments. [Figure 5B] 5B is a cross-sectional view of the pad of FIG. 5A taken along section line 5B-5B, according to some embodiments. [Figure 6A] 2 illustrates another embodiment of a thermal contact pad that may be employed with the system of FIG. 1, according to some embodiments. [Figure 6B] FIG. 6B is a cross-sectional view of the pad of FIG. 6A taken along cut line 6B-6B, according to some embodiments. [Figure 7A] FIG. 2 illustrates another embodiment of a TTM system, in accordance with some embodiments. [Figure 7B] 7B is a top view showing the thermal contact pads of the TTM system of FIG. 7A in accordance with some embodiments. [Figure 7C]FIG. 7C is a cross-sectional view of the pad of FIG. 7B taken along section line 7C-7C, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0062] Before some specific embodiments are disclosed 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 the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0063] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that 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 within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise. The words "including," "has," and "having" have the same meaning as the word "comprising" when used herein, including the claims. Furthermore, the terms "or" and "and / or" when used herein shall be construed to mean inclusive or any one or any combination. As an example, "A, B, or C" or "A, B, and / or C" means "any of the following: A only, B only, C only, A and B, A and C, B and C, and A, B, and C." Exceptions to this definition occur only when combinations of elements, components, features, steps, or acts are in some way essentially mutually exclusive.

[0064] The phrases "connected to" and "coupled to" refer to any form of interaction between two or more entities, including mechanical, fluid, and thermal interactions. Two components may be connected or coupled to one another even if they are not in direct contact with one another. For example, two components may be coupled to one another through an intermediate component.

[0065] Any method disclosed herein includes one or more steps or acts of performing the described method. Method steps and / or acts may be interchanged with one another. In other words, the order and / or use of certain steps and / or acts may be changed unless a certain order of steps or acts is required for proper operation of the embodiment. Furthermore, only subroutines or portions of the methods described herein may be separate methods within the scope of the present disclosure. In other words, some methods may include only some of the steps described in a more detailed method.

[0066] 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. 1 illustrates a targeted temperature management (TTM) system 100 connected to a patient 50 for administering a TTM therapy to the patient 50, which may include cooling and / or warming the patient 50, according to some embodiments. The TTM system 100 includes a TTM module 105 for preparing and delivering a TTM fluid 102 to a thermal contact system 110, which in some embodiments may include one or more thermal contact pads. The TTM system 100 includes a bidirectional fluid delivery line (FDL) 103 extending from the TTM module 105 to the thermal contact system 110 to provide a flow of the TTM fluid 102 between the TTM module 105 and the contact system 110.

[0067] In use, the TTM module 105 prepares the TTM fluid 102 for delivery to the contact system 110 by heating or cooling the TTM fluid 102 to a prescribed temperature according to a prescribed TTM therapy. The TTM module 105 circulates the TTM fluid 102 in / through the contact system 110 to facilitate thermal energy exchange with the patient 50. During TTM therapy, the TTM module 105 may continuously control the temperature of the TTM fluid 102 toward a target TTM temperature. As shown, the contact system 110 may be attached to various body sites of the patient 50. Thus, the contact system 110 may be available in a variety of forms, e.g., sizes and shapes, to accommodate various body sites.

[0068] 2A-2C generally illustrate a first embodiment of a thermal contact system 210 including a gown assembly and a hydrogel source. FIG. 2A is a front view of a gown assembly 215 with a hydrogel source 240. The gown assembly 215 includes a gown 230 and one or more thermal contact pads (pads) 220 coupled to the gown 230. The thermal contact system 210 includes an FDL 203 for fluidly coupling the pads 220 with the system module 105 (see FIG. 1). The hydrogel source 240 includes a housing 241 having a hydrogel 245 disposed therein.

[0069] The gown 230 is configured to be fitted to the patient 50. In some embodiments, the gown 230 may include a main fabric panel (panel) 231 with sleeves 232 coupled thereto for receiving the patient's arms therethrough. In the illustrated embodiment, the gown 230 (or more specifically the panel 231) is configured to be fitted over the front of the patient 50 and wrapped around the back of the patient 50. In another embodiment, the gown 230 is configured to be fitted over the back of the patient 50 and wrapped around the front of the patient 50. The pad 220 may be coupled to the panel 231 such that the underside of the pad 220 may be fitted in direct contact with the skin of the patient 50. In some embodiments, the pad 220 may be disposed on the underside of the panel 231. In some embodiments, the panel 231 may include a slit 232 extending upward from a lower edge of the panel 231 to accommodate wrapping a portion of the panel 231 around (or partially around) one or both legs of the patient 50.

[0070] The thermal contact system 210 may be configured for multiple use on a single patient or multiple use across multiple patients. The gown assembly 215 may be configured to be repeatedly cleaned, such cleaning including disinfection and / or sterilization. In some embodiments, the gown assembly 215 may be configured to be repeatedly laundered by an automatic washing machine. In some embodiments, the gown assembly 215 may be configured to be repeatedly autoclaved.

[0071] 2B is an underside view of the gown assembly 215. The pad 220 is shown coupled to the panel 231 on the underside of the panel 231 such that the pad 220 directly contacts the skin when the gown assembly 215 is placed on the patient 50. In some embodiments, the gown 230 may be configured to secure one portion of the gown 230 to another portion. Thus, the gown 230 may include a fastening device 236. The fastening device 236 may include straps, ties, buttons, snaps, hook and loop patches, or any other suitable fastening device. In some embodiments, the fastening device 236 may exert a downward force on one or more pads 220 to facilitate establishing and maintaining intimate thermal contact between the pads 220 and the patient's skin, i.e., securing the pads to the patient. For example, the fastening device 236 in the form of a strap may be wrapped around the patient's thigh such that the tensile force of the strap exerts a downward force on the pads 220 attached to the thighs.

[0072] In the illustrated embodiment, pad 220 includes four individual pads 220A-220D. Pads 220A, 220B are configured (i.e., positioned and sized) to fit on the patient's torso. In some embodiments, each of pads 220A, 220B are configured to fit on the front of the torso next to each other. Pads 220A, 220B may also be configured to extend from around the sides of the torso to the back of the torso. Similarly, pad 220 includes pads 220C, 220D configured (i.e., positioned and sized) to fit on and extend around each leg (e.g., thigh) of patient 50.

[0073] In some embodiments, the contact system 210 may include FDL segments 203A that extend between the pads 220 to provide flow of the TTM fluid 102 to and from each of the pads 220. In some embodiments, any or all of the pads 220 may individually include an FDL 203 that extends between the pad 220 and the system module 105.

[0074] Although not required, the FDL segment 203A may be fluidly coupled to the corresponding pads 220 via a set of connectors 223 such that the FDL segment 203A may be selectively connected and disconnected to the pads 220. The connectors 223 may facilitate omitting the use of any pads 220 for a given TTM therapy. The connectors 223 may also facilitate replacement of a subset of the pads 220. For example, a pad in the gown assembly 215 may be deemed unsuitable for further use (e.g., defective). In such a case, the clinician may cut off the defective pad and replace it with another pad.

[0075] Although not required, in some embodiments, the housing 241 of the hydrogel source 240 may be configured to facilitate application of the hydrogel 245 to the pad 220. For example, the housing 241 may facilitate spraying the hydrogel 245 onto the underside of the pad 220. In other embodiments, a clinician may remove a portion of the hydrogel 245 from the housing 241 and manually apply the hydrogel 245 to the underside of the pad 220.

[0076] The pad 220 is secured to the panel 231 by any suitable fastening technique. In some embodiments, the pad 220 may be fixedly (i.e., permanently) attached to the gown 230. For example, the pad 220 may be attached to the gown 230 by permanent fasteners (e.g., rivets) located along the perimeter of the pad 220. In other embodiments, the pad 220 may be sewn to the panel 231. In yet other embodiments, the pad 220 (or more specifically the top film 225) may be affixed to the panel 231. In further embodiments, the pad 220 may be bonded to the panel by injection molding a portion of the pad 220.

[0077] In other embodiments, pad 220 may be removably attached to gown 230. For example, pad 220 may be attached to panel 231 by non-permanent fasteners such as, for example, snaps, buttons, or hooks. Gown 230 may be formed of a fabric configured to be repeatedly sterilized by exposure to high temperatures, such as, for example, by autoclaving.

[0078] 2C is a cross-sectional view of a portion of gown assembly 215 taken along section line 2C-2C. Shown is a cross-section of pad 220C, which may represent any or all of pads 220. Pad 220 comprises top film 225 and bottom film 226. Top film 225 is sealably joined to bottom film 226 to form a fluid compartment 224 for containing TTM fluid 102.

[0079] Either or both of the films 225, 226 may be formed from flat sheets or may comprise a preformed shape. The films 225, 226 may be formed from any suitable material, such as plastic, silicone, rubber, and the like. The films 226, 226 may be flexible to define the flexibility of the pad 220 to accommodate application of the pad 220 along uneven portions of the patient's body, such as around the legs. The material of the films 225, 226 may be selected to allow for repeated disinfection and / or sterilization of the pad 220. In some embodiments, the films 225, 226 may be adapted for repeated sterilization by autoclaving.

[0080] The pad 220 includes an internal support structure 227. The support structure 227 may ensure a minimum separation distance between the films 225, 226 across the pad 220. The support structure 227 may prevent the fluid compartment 224 from collapsing or flattening. The support structure 227 may also define fluid channels within the pad 220. In some embodiments, the support structure 227 may be attached to one or both of the films 225, 226.

[0081] The method of performing TTM therapy using the thermal contact system 210 may include all or any subset of the steps or processes in the flow. The clinician may provide a layer of hydrogel 245 on the underside of the pad 220. The application of the hydrogel 245 may include spraying the hydrogel 245 on the underside of the pad 220. The clinician may place the thermal gown assembly 215 on the patient 50. The clinician may place one or more of the pads 220 on the patient 50 at a predetermined position on the patient 50. In some embodiments, the clinician may secure one or more of the pads 220 to the patient with a securement device. In some embodiments, the clinician may omit the use of one or more of the pads 220 of the gown assembly 215, and in some embodiments, omitting the use of one or more of the pads 220 may include fluidically disconnecting one or more of the pads 220 from the remaining pads 220. The clinician may couple the FDL 203 of the thermal contact system 210 to the system module 105 and initiate the flow of the TTM fluid 102 through the pads 220 to perform a first TTM therapy. In some embodiments, the clinician may replace one or more of the pads 220 of the gown assembly 215 during the first TTM therapy. At the end of the first TTM therapy, the clinician may remove the gown assembly 215 from the patient. In some embodiments, the TTM therapy may be a first TTM therapy and the patient may be a first patient.

[0082] The clinician may then prepare the gown assembly 215 for a second TTM therapy. Preparing the gown assembly 215 may include removing the hydrogel 245 from the pads 220. In some embodiments, the clinician may launder the gown assembly 215, which may include disinfecting the pads 220. In some embodiments, the clinician may sterilize the gown assembly 215, which may include exposing the gown assembly 215 (or a portion thereof) to a temperature high enough to effect sterilization. In some embodiments, the clinician may remove and / or replace one or more pads 220 of the gown assembly 215. The clinician may then utilize the same gown assembly 215 to perform a second TTM therapy following all or a subset of the processes described above for the first TTM therapy. In some embodiments, the clinician may perform the second TTM therapy on a second patient that is different from the first patient.

[0083] 3A-3D provide various views of a second embodiment of a thermal contact system 310 that may be similar in some respects to the components of the thermal contact system 210 described with respect to FIGS. 2A-2C. It will be understood that the illustrated embodiments may all have similar features. Thus, similar features are designated with similar reference numbers with the leading digit incremented to "3." For example, a fluid compartment is designated "224" in FIGS. 2A-2C, and a similar fluid compartment is designated "324" in FIGS. 3A-3D. Thus, the relevant disclosure set forth above with respect to similarly identified features may not be repeated hereafter. Furthermore, specific features of the thermal contact system 210 and related components illustrated in FIGS. 2A-2C may not be shown or identified with reference numbers in the drawings, or specifically discussed in the ensuing text. However, such features may be specifically identical or nearly identical to features shown in and / or described with respect to other embodiments. Thus, the relevant descriptions of such features apply equally to the features of the thermal contact system 310 of Figures 3A-3D. Any suitable combinations of features and variations of such features described with respect to the thermal contact system 210 and components shown in Figures 2A-2C may be used with the thermal contact system 310 and components of Figures 3A-3C, and vice versa. This pattern of disclosure applies equally to further embodiments shown in subsequent figures and described below.

[0084] FIG. 3A is a top view of a thermal contact system (system) 310 that may be used with the TTM system 100 of FIG. 1. In some embodiments, multiple contact systems 310 may be used with the TTM system 100. FIG. 3A shows the thermal contact system 310 attached to a patient 50. The thermal contact system 310 generally comprises a thermal contact pad 320, multiple adhesive patches 351, and a hydrogel 345 disposed on a lower surface 321 of the pad 320 for placement in contact with the patient 50 (i.e., the patient's skin). In some embodiments, the adhesive patches 351 may be sterilized. The thermal contact system 310 comprises a fluid delivery line 303 for fluidly coupling the pad 320 to the TTM system module 105 (see FIG. 1).

[0085] The thermal contact system 310 may be configured for multiple use on a single patient or multiple use across multiple patients. The pad 320 may be configured to be repeatedly cleaned, such cleaning including disinfection and / or sterilization. In some embodiments, the pad 320 may be configured to be sterilized by autoclaving.

[0086] The pad 320 includes a number of openings 328 extending between the upper surface 322 and the lower surface 321 of the pad 320. The openings 328 can facilitate visual inspection of the patient's skin during TTM therapy without separating the pad 320 from the patient 50.

[0087] The adhesive patches 351 are utilized to secure the pad 320 to the patient 50. A first subset of adhesive patches 351A are utilized to secure the pad 320 to the patient 50 at the openings 328, as described further below. Another subset of adhesive patches 351B are utilized to secure the pad 320 to the patient 50 along the perimeter edge of the pad 320.

[0088] 3B is a cross-sectional view of a portion of the system 320 cut along cut line 3B-3B, where the pad 320 is secured to the patient 50. The pad 320 comprises a fluid compartment 324 sealed between an upper film 325 and a lower film 326. Either or both of the films 325, 326 may be formed from a flat sheet or may comprise a preformed shape. The films 325, 326 may be formed from any suitable material, such as plastic, silicone, rubber, and the like. The films 326, 326 may be flexible to define the flexibility of the pad 320 to accommodate for the wearing of the pad 320 along an uneven portion of the patient's body, such as the leg. The material of the films 325, 326 may be selected to allow for repeated disinfection and / or sterilization of the pad 320. In some embodiments, the films 325, 326 may be adapted for repeated sterilization.

[0089] The pad 320 may include an internal support structure 327. The support structure 327 may ensure a minimum separation distance between the films 325, 326 across the pad 320. The support structure 327 may prevent the fluid compartment 324 from collapsing or flattening. The support structure 327 may also define a fluid channel within the fluid compartment 324. In some embodiments, the support structure 327 may be attached to one or both of the films 325, 326.

[0090] The hydrogel 345 is disposed on the underside 321 of the pad 320 to define an intimate thermal contact with the patient 50. The hydrogel 345 does not extend across the opening 328. In some embodiments, the hydrogel 345 may be coupled with a hydrogel liner 346 disposed between the hydrogel 345 and the bottom film 326. The hydrogel liner 346 may be removably attached (e.g., by an adhesive) to the bottom film 326. In some embodiments, the hydrogel liner 346 may prevent direct contact between the hydrogel 345 and the pad 320. In some embodiments, the hydrogel 345 may be separate from (i.e., not coupled with) the pad 320 when the pad 320 is not attached to the patient 50, as described further below. In some embodiments, the hydrogel liner 346 may be omitted.

[0091] The adhesive patch 351A secures the pad 320 to the patient 50 through the opening 328. As in the illustrated embodiment, the adhesive patch 351 overlaps the top surface 322 of the pad 320 along the perimeter of the opening 328. In some embodiments, the adhesive patch 351 may overlap the top surface 322 along only a portion of the perimeter, such as along opposite sides of the opening 328. In other embodiments, the adhesive patch 351 may overlap the top surface 322 along the entire perimeter of the opening 328. A central portion of the adhesive patch 351A is pressed through the opening 328 to contact and adhere to the skin of the patient 50 by the adhesive disposed on the underside of the adhesive patch 351A. In use, a clinician can separate all or a portion of the adhesive patch 351a from the pad 320 to allow visual inspection of the patient's skin through the opening 328.

[0092] 3C-3D show an exemplary hydrogel containment 341 that may, but is not required to, be included in the system 310 in some embodiments. FIG. 3C shows a top view of the containment 341, and FIG. 3D shows a cross-sectional view of a portion of the containment 341. In some cases, the hydrogel may generally dry out over time if not sealed within the containment. The containment 341 prevents dehydration of the hydrogel 345. As discussed above, the hydrogel 345 may be provided to the bottom film 326 prior to attachment of the pad 320 to the patient 50. The hydrogel containment 341 is configured to facilitate application of the hydrogel 345 to the pad 320 such that the hydrogel 345 is prevented from entering the openings 328.

[0093] The hydrogel reservoir 341 is formed in a similar shape to the pad 320 and includes reservoir openings 349 aligned with the openings 328 of the pad 320. The hydrogel reservoir 341 includes a bottom liner 347 sealably coupled to the hydrogel liner 346 along the outer periphery of the hydrogel reservoir 341 and along the periphery of each reservoir opening 349 to define a hydrogel compartment 344. The bottom liner 347 is removably attached to the hydrogel liner 346 such that a clinician can separate the bottom liner 347 from the hydrogel liner 346 to expose the hydrogel 345. An adhesive 342 is disposed along an upper surface of the hydrogel liner 346 to facilitate removable attachment of the hydrogel reservoir 341 to the pad 320 (i.e., the bottom film 326).

[0094] The hydrogel container 341 is shown as a single container that holds all of the hydrogel 345. In other embodiments, the hydrogel 345 may be divided into multiple hydrogel containers. In other words, the hydrogel container 341 may comprise multiple separate pouches that are attached to the pad 320. In some embodiments, the pouches may be formed in a strip.

[0095] Because the thermal contact system 310 is configured for multiple use, i.e., the pad 320 is configured to be attached multiple times to one or more patients, and the hydrogel 345 is configured for single use, the thermal contact system 310 may include multiple hydrogel containers 341 such that the first hydrogel container 341 can be replaced with a second hydrogel container 341 between uses of the pad 320.

[0096] The method of using the thermal contact pad system 310 to perform TTM therapy may include all or any subset of the steps or processes in the flow. The clinician may provide hydrogel 345 to the underside of the pad 320. The application of the hydrogel 345 may include bonding the hydrogel containment body 341 to the underside of the pad 320. The application of the hydrogel 345 may further include removing the bottom liner 347 from the hydrogel liner 346 to expose the hydrogel 345. The clinician may attach the pad 320 to the patient 50 at a predetermined position on the patient 50. The clinician may then secure the pad 320 to the patient 50 by placing one or more adhesive patches along the periphery of the pad 320. The clinician may further secure the pad 320 by pressing the adhesive patches through any or all of the openings in the pad 320. The clinician may couple the FDL 303 of the system 310 to the system module 105 and initiate the flow of TTM fluid 102 through the pad 320 to perform a first TTM therapy. At the end of the first TTM therapy, the clinician may remove the pad 320 from the first patient.

[0097] The clinician may then prepare the pad 320 for a second TTM therapy. Preparing the gown assembly 320 may include removing the hydrogel 345 from the pad 320, which may include separating the hydrogel liner 346 from the underside of the pad 320. The clinician may then utilize the same pad 320 to perform the second TTM therapy following all or a subset of the processes described above for the first TTM therapy. In some embodiments, the clinician may perform the second TTM therapy on a second patient that is different from the first patient.

[0098] 4A is a top view of a thermal contact pad 420 that may be used with the TTM system 100 of FIG. 1. In some embodiments, multiple pads 420 may be used with the TTM system 100. The pad 420 includes a fluid delivery line 403 for fluidly coupling the pad 420 to the TTM system module 105 (see FIG. 1). The pad 420 may be configured for multiple uses on a single patient or multiple uses across multiple patients. The pad 420 includes multiple layers disposed between an upper surface 422 and a lower surface 421.

[0099] 4B is a cross-sectional view of a portion of the pad 420 taken along cut line 4B-4B. The pad 420 comprises a fluid compartment 424 sealed between an upper film 425 and a lower film 426, i.e., the upper film 425 may be sealably joined to the lower film 426 along the circumferential periphery of the pad 420. Either or both of the films 425, 426 may be formed from a flat sheet or may comprise a preformed shape. The films 425, 426 may be formed from any suitable material, such as plastic, silicone, rubber, and the like. The films 426, 426 may be flexible to define the flexibility of the pad 420 to accommodate the wearing of the pad 420 along uneven portions of the patient's body, such as the legs.

[0100] The pad 420 may include an internal support structure 427 disposed within the fluid compartment 424. The support structure 427 may ensure a minimum separation distance between the films 425, 426 across the pad 420. The support structure 427 may prevent the compartment 424 from collapsing or flattening. The support structure 427 may also define fluid channels within the pad 420. In some embodiments, the support structure 427 may be attached to one or both of the films 425, 426.

[0101] The pad 420 includes multiple layers of hydrogel 445 to facilitate multiple uses of the pad 420. In the illustrated embodiment, the pad 420 includes two hydrogel layers: a first hydrogel layer 441 and a second hydrogel layer 448. However, in other embodiments, the pad 420 may include three or more hydrogel layers. Each hydrogel layer is configured to directly contact the patient's skin to define an intimate thermal contact with the patient 50.

[0102] The hydrogel layer is coupled to the fluid compartment 424 to facilitate thermal energy exchange with the patient. The first hydrogel layer 441 is disposed adjacent to the fluid compartment 424. Although not required, in some embodiments, a first hydrogel liner 446 may be disposed between the hydrogel layer 441 and the lower film 426. In some embodiments, the first hydrogel liner 446 may be omitted. A second hydrogel liner 447 is disposed along the lower surface of the first hydrogel layer 441. The second hydrogel liner 447 may be sealably and removably bonded to either the first hydrogel liner 446 or the lower film 426 along the periphery of the pad 420 to encapsulate the hydrogel 445 disposed within the first hydrogel layer 441, thereby preventing the hydrogel 445 within the first hydrogel layer 441 from drying out or otherwise deteriorating.

[0103] A second hydrogel layer 448 is disposed along the underside of the second hydrogel liner 447. A third hydrogel liner 449 may be removably coupled to the second hydrogel liner 447, the first hydrogel liner 446, or the bottom film 426 along the periphery of the pad 420 to encapsulate the hydrogel 445 disposed within the second hydrogel layer 448, thereby preventing the hydrogel 445 within the second hydrogel layer 448 from deteriorating.

[0104] Although not required, in some embodiments, the pad 420 may include a foam layer 451 disposed along an upper surface of the fluid compartment 424. In some embodiments, the foam layer 451 may be formed from a polychloroprene material, such as, for example, Neoprene®.

[0105] In some embodiments, the hydrogel 445 may be configured to provide an indication to a clinician that one or more operational characteristics (e.g., flexibility, thermal conductivity, adhesion, or hydration) have deteriorated sufficiently to require replacement. According to one example, the hydrogel 445 may be configured to change color during use to indicate that replacement of the hydrogel 445 may be advantageous. As another example, the hydrogel 445 may include electrical intelligence, such as embedded circuitry (not shown), to provide a visual indication (e.g., LED illumination or dimming). In some embodiments, the hydrogel 445 may be compostable and / or biodegradable.

[0106] A method of using the pad 420 to perform a TTM therapy may include all or any subset of the steps or processes of the flow. The clinician may separate the third hydrogel liner 449 from the pad 420 to expose the second hydrogel layer 448. The clinician may attach the pad 420 to the patient 50 at a predetermined position on the patient such that the second hydrogel layer 448 defines an intimate thermal contact with the patient. The clinician may couple the FDL 403 of the pad 420 to the system module 105 and initiate the flow of the TTM fluid 102 through the pad 420 to perform the first TTM therapy. At the end of the first TTM therapy, the clinician may remove the pad 420 from the first patient.

[0107] The clinician may then prepare the pad 420 for a second TTM therapy. Preparing the pad 420 may include removing the second hydrogel layer from the pad 420 and separating the second hydrogel liner 447 from the pad 420 to expose the hydrogel 445 of the first hydrogel layer 441. The clinician may then attach the pad 420 to the patient 50 at a predetermined position thereon such that the first hydrogel layer 448 defines an intimate thermal contact with the patient. The clinician may couple the FDL 403 of the pad 420 to the system module 105 and initiate the flow of the TTM fluid 102 through the pad 420 to perform the second TTM therapy.

[0108] FIG. 5A is a top view of a thermal contact pad 520 that may be similar in some respects to the pad 420 illustrated and described above. FIG. 5B is a cross-sectional view of a portion of the pad 520 taken along section line 5B-5B. The thermal contact pad 520 may be used with the TTM system 100 of FIG. 1 to perform TTM therapy. In some embodiments, multiple pads 520 may be used with the TTM system 100. The pad 520 may be configured for multiple uses with a single patient or multiple uses across multiple patients. The pad 520 is configured to define thermal contact with the patient when the pad 520 is positioned in a first orientation and / or a second orientation. In the first orientation, the pad 520 is attached to the patient such that the first surface 521 faces toward the patient and the second surface 522 faces away from the patient. In the second orientation, pad 520 has second side 522 facing towards the patient and first side 521 facing away from the patient.

[0109] Pad 520 comprises multiple layers disposed between first side 521 and second side 522. Pad 520 includes a foam layer 551 that may be centrally disposed between first side 521 and second side 522. In some embodiments, foam layer 551 may be formed from a polychloroprene material, such as, for example, Neoprene®.

[0110] The pad 520 includes a first set of layers disposed between the foam layer 551 and the first surface 521. The pad 520 includes a first fluid compartment 524A for containing and circulating the TTM fluid 102 (FIG. 1) therein. The first fluid compartment 524A is sealed between a first inner film 525A and a first outer film 526A. The pad 520 includes a first fluid delivery line 503A coupled to the first fluid compartment 524A to facilitate flow of the TTM fluid 102 between the first fluid compartment 524A and the TTM system module 105 (see FIG. 1). The first fluid compartment 524A can include a first support structure 527A disposed therein. The first support structure 527A can ensure a minimum separation distance between the films 525A, 526A across the pad 520. The first support structure 527A can prevent the compartment 524A from collapsing or flattening. The first support structure 527A can also define a fluid channel within the first fluid compartment 524A. In some embodiments, the first support structure 527A can be attached to one or both of the films 525A, 526A.

[0111] The pad 520 includes a first hydrogel layer 541A coupled to the first fluid compartment 524A opposite the foam layer 551. In some embodiments, a first hydrogel liner 546A may be disposed between the first hydrogel layer 541A and the first outer film 526A. The first hydrogel liner 546A may include a first pull tab 555A to facilitate separation / removal of the first hydrogel liner 546A from the pad 520. Removal of the first hydrogel liner 546A may include removing the first hydrogel layer 541A along with the first hydrogel liner 546A.

[0112] Although not required, in some embodiments, a first storage liner 547A may be disposed along the outside of the first hydrogel layer 541 A. The first storage liner 547A may be removably coupled to either the first hydrogel liner 546A or the first outer film 526A along the periphery of the pad 520 to sealably encapsulate the first hydrogel layer 541 A, thereby preventing the hydrogel 545 within the first hydrogel layer 541 A from drying out or otherwise deteriorating over time.

[0113] Pad 520 also includes a second set of layers disposed between foam layer 551 and second surface 522. The layers disposed between foam layer 551 and second surface 522 may be similar to the first set of layers disposed between foam layer 551 and first surface 521. Accordingly, reference numbers for the first set of layers are designated with an "A" suffix and the second set of layers are designated with a "B" suffix. As illustrated, the second set of layers are symmetrically disposed with respect to the first set of layers.

[0114] One or more of the layers of the pad 520 shown and described may be optional, i.e. not required. In some embodiments, the foam layer 551 may be omitted, and in such embodiments, either the first fluid compartment 524A or the second fluid compartment 524B may also be omitted.

[0115] In some embodiments, the first and second fluid compartments 524A, 524B may be fluidly coupled to one another. In such embodiments, a single FDL may facilitate the flow of the TTM fluid 102 through both the first and second fluid compartments 524A, 524B. Thus, either the first FDL 603A or the second FDL 603B may be omitted.

[0116] The method of using the pad 520 to perform a TTM therapy may include all or any subset of the steps or processes of the flow. The clinician may separate the first storage liner 547A from the pad 520 to expose the first hydrogel layer 541A. The clinician may attach the pad 520 to the patient 50 at a predetermined position on the patient 50 such that the first hydrogel layer 541A defines thermal contact with the patient. The clinician may couple the first FDL 503A of the pad 520 to the system module 105 and initiate the flow of the TTM fluid 102 through the first fluid compartment 524A to perform the first TTM therapy. At the end of the first TTM therapy, the clinician may remove the pad 520 from the patient.

[0117] The clinician may then prepare the pad 520 for a second TTM therapy. The clinician may remove the first hydrogel layer 541A from the pad 520. The clinician may also remove the first hydrogel liner 546A from the pad 520. The clinician may remove the second storage liner 547B from the pad 520 to expose the second hydrogel layer 541B. The clinician may then attach the pad 520 to the patient at a predetermined position on the patient 50 in an inverted orientation relative to the orientation of the pad during the first TTM therapy such that the second hydrogel layer 541B defines thermal contact with the patient. The clinician may couple the second FDL 503B of the pad 520 to the system module 105 and initiate the flow of the TTM fluid 102 through the second fluid containing layer 524B to perform the second TTM therapy. Upon completion of the second TTM therapy, the clinician may remove the pad 520 from the patient. The first TTM therapy and the second TTM therapy may be performed on the same or different patients.

[0118] FIG. 6A is a top view of a thermal contact pad 620 that may be used with the TTM system 100 of FIG. 1. In some embodiments, multiple pads 620 may be used with the TTM system 100. The pad 620 includes a fluid delivery line 603 for fluidly coupling the pad 620 to the TTM system module 105 (see FIG. 1). The pad 620 includes multiple layers disposed between an upper surface 622 and a lower surface 621. The pad 620 is configured for extended use. In some current examples, the hydrogel of the thermal contact pad may dry out prior to completion of a TTM therapy, which may require replacement of the pad to complete the therapy. The pad 620 is configured to extend the useful life of the hydrogel layer disposed on the lower surface 221 of the pad 620 when the pad 620 is attached to a patient. The pad 620 includes a pull tab 655 that is configured to provide extended hydration of the hydrogel layer of the pad 620 when the pull tab 655 is pulled by a clinician, as described further below.

[0119] 6B is a cross-sectional view of a portion of the pad 620 taken along section line 6B-6B. The pad 620 includes a fluid compartment 624 sealed between an upper film 625 and a lower film 626. The pad 620 may include an internal support structure 627 disposed within the fluid compartment 624. The support structure 627 may ensure a minimum separation distance between the films 625, 626 across the pad 620. The support structure 627 may prevent the compartment 624 from collapsing or flattening. The support structure 627 may also define a fluid channel within the pad 620. In some embodiments, the support structure 627 may be attached to one or both of the films 625, 626.

[0120] In the illustrated embodiment, the pad 620 includes a foam layer 651 disposed along an upper surface of the fluid compartment 624. In some embodiments, the foam layer 651 may be formed from a polychloroprene material, such as, for example, Neoprene. In some embodiments, the foam layer 651 may be omitted.

[0121] The pad 620 comprises multiple layers of hydrogel. In the embodiment shown, the pad 620 comprises two hydrogel layers: a first hydrogel layer 641 and a second hydrogel layer 648. However, in other embodiments, the pad 620 may comprise three or more hydrogel layers. The second hydrogel layer 648 is configured to directly contact the patient's skin to define thermal contact with the patient 50.

[0122] The hydrogel layers 641, 648 are coupled to the fluid compartment 624 to facilitate thermal energy exchange between the fluid compartment 624 and the patient. The first hydrogel layer 641 is disposed adjacent to the fluid compartment 624. Although not required, in some embodiments, a first hydrogel liner 646 may be disposed between the hydrogel layer 641 and the bottom film 626. In some embodiments, the first hydrogel liner 646 may be omitted.

[0123] A separation liner 647 is disposed along the underside of the first hydrogel layer 641. The separation liner 647 may be removably bonded to either the first hydrogel liner 646 or the bottom film 626 along the periphery of the pad 620 to encapsulate the hydrogel 645 disposed within the first hydrogel layer 641.

[0124] The second hydrogel layer 648 is disposed along the underside of the second hydrogel liner 647. The pad 620 includes a third hydrogel liner 649 that is removably coupled to the separation liner 647, the first hydrogel liner 646, or the bottom film 626 along the periphery of the pad 620 to encapsulate the hydrogel 645 disposed within the second hydrogel layer 648. The separation liner 647 is disposed between the first hydrogel layer 641 and the second hydrogel layer 648 to define isolation of the first hydrogel layer 641 from the second hydrogel layer 648.

[0125] The pull tab 655 is attached to (or is an integral part of) the separation liner 647. The pull tab 655 extends outwardly from the outer periphery of the pad 620 to provide manual access of the tab 655 by a clinician. The pad 620 is generally configured such that pulling the pull tab 655 removes the separation between the first hydrogel layer 641 and the second hydrogel layer 648. Removing the separation can include removing the separation liner 647 (or a portion thereof) from between the first hydrogel layer 641 and the second hydrogel layer 648. Removing the separation causes one or more components of the first hydrogel layer 641 (e.g., water) to migrate into the second hydrogel layer 648.

[0126] Generally speaking, the second hydrogel layer 648 is configured to be in direct contact with the patient's skin to define thermal contact with the patient, and the first hydrogel layer 641 is configured to extend the service life of the second hydrogel layer 648 upon removal of the separation liner 647. In some embodiments, the first hydrogel layer 641 is configured to rehydrate (or extend hydration) upon removal of the separation liner 647.

[0127] In some embodiments, the first hydrogel layer 641 can include a hydrogel 645A, and the second hydrogel layer 648 can include a hydrogel 645B that is different from hydrogel 645A. For example, the second hydrogel 645B can include an ultraviolet light curable composition that includes (i) a crosslinkable copolymer in an amount of about 15%-30% by weight of said composition, (ii) water in an amount of about 15%-40% by weight of said composition, and (iii) glycerol in an amount of about 25%-35% by weight of said composition. In some embodiments, the first hydrogel 645A can include a composition having similar ingredients but with a higher relative amount of water than the second hydrogel 645B. In other embodiments, the hydrogels 645A, 648B can be identical.

[0128] In some embodiments, one or both of hydrogels 645A, 648B may be configured to provide an indication to a clinician that one or more operational characteristics (e.g., flexibility, thermal conductivity, viscosity, or hydration) have been sufficiently degraded as described above with respect to hydrogel 445 of Figure 4B. For example, hydrogel 645B may provide an indication to a clinician that hydrogel 645B has been sufficiently dehydrated to require pulling pull tab 655 to initiate rehydration of hydrogel 645B.

[0129] A method of using the pad 620 to perform TTM therapy may include all or any subset of the flow steps or processes. The clinician may separate the third hydrogel liner 649 from the pad 620 to expose the second hydrogel layer 648. The clinician may attach the pad 620 to the patient 50 at a predetermined position thereon such that the second hydrogel layer 648 defines an intimate thermal contact with the patient. The clinician may couple the FDL 603 of the pad 620 to the system module 105 and initiate the flow of the TTM fluid 102 through the pad 620 to perform the TTM therapy.

[0130] The clinician may then prepare the pad 620 for extended use. Preparing the pad 620 includes removing the separation liner 647 (or a portion thereof) from between the first hydrogel layer 641 and the second hydrogel layer 648 of the pad 620 to allow the hydrogel 645A to rehydrate (or extend the hydration of) the second hydrogel 645B within the second hydrogel layer 648. In some embodiments, removing the separation liner 647 may include pulling the pull tab 655. In some embodiments, the clinician may pull the pull tab 655 to remove the separation liner 647 while the pad 620 is still attached to the patient. In further embodiments, the clinician may pull the pull tab 655 to remove the separation liner 647 while the TTM fluid 102 (see FIG. 1 ) is flowing through the pad 620.

[0131] 7A illustrates another embodiment of a targeted temperature management (TTM) system 700 connected to a patient 50 for administering TTM therapy to the patient 50, which may include cooling and / or warming of the patient 50, according to some embodiments. The TTM system 700 includes a TTM system module 705 for preparing and delivering a TTM fluid (e.g., air) 704 to a thermal contact system 710, which in some embodiments may include one or more thermal contact pads 720. The TTM system 700 includes one or more bidirectional fluid delivery lines (FDLs) 703 extending from the TTM module 105 to the pads 720 to provide a flow of TTM air 704 between the TTM module 705 and the pads 720.

[0132] In use, the TTM module 705 prepares the TTM air 704 for delivery to the pad 720 by heating or cooling the TTM air 704 to a prescribed temperature according to a prescribed TTM therapy. The TTM module 705 circulates the TTM air 704 in / through the pad 720 to facilitate thermal energy exchange with the patient 50. During TTM therapy, the TTM module 705 may continuously control the temperature of the TTM air 704 toward a target TTM temperature. As shown, the pad 720 may be attached to various body parts of the patient 50. Thus, the pad 720 may be available in various forms, such as sizes and shapes, to accommodate various body parts. The TTM module 705 delivers the TTM air 704 to the pad 720 such that the pressure of the TTM air 704 is negative (i.e., vacuum).

[0133] FIG. 7B is a top view of an exemplary pad 720, and FIG. 7C is a side cross-sectional view of the pad 720 attached to a patient 50. The pad 720 includes a top wall 725A coupled to a circumferential side wall 725B that extends along the periphery of the pad 720. A circumferential sealing member 726 extends along the lower edge of the side wall 725B to form a fluid / air seal with the patient 50. The pad 720 is flexible to allow the pad 720 to conform to the contoured surface (i.e., conform to the curvature) of the patient 50. The sealing member 726 is also flexible to extend over protrusions and / or into recesses of the patient 50 to form a fluid-tight seal. In some embodiments, the flexibility of the sealing member 726 exceeds the flexibility of the top wall 725A and the side wall 725B. The top wall 725A, side wall 725B, and sealing member 726 in combination with the patient's skin form a compartment 724 for containing air 704. In use, the pressure within the compartment 724 is a vacuum such that atmospheric pressure defines a downward force 708 of the pad 720 towards / against the patient 50.

[0134] Although not required, the pad 720 may include a support structure 727 within the compartment 724 to prevent collapse of the compartment 724 due to the downward force 708 or any other external force. The support structure 727 may also define a flow channel 728 between the inlet port 722A and the outlet port 722B for the air 704 to flow within the compartment 724. The support structure 727 may be coupled to the top wall 725A. In use, the air 704 flows adjacent to the skin of the patient 50 such that a temperature differential between the air 704 and the patient 50 defines a thermal energy exchange with the patient 50. The top wall 725A and the side wall 725B may be formed from any suitable material, such as, for example, rubber, silicone, ethylene propylene diene terpolymer (EPDM), or a flexible thermoplastic. The sealing member 726 may be formed from a material similar to the top wall 725A and the side wall 725B, further including a foam material, such as, for example, neoprene.

[0135] A method of using the TTM system 700 to perform TTM therapy may include all or any subset of the steps or processes in the sequence. The clinician may attach the pad 620 to the patient at a predetermined position on the patient 50. The clinician may begin the delivery of TTM air 704 to the pad 720 at negative pressure, which may cause the pad 720 to be secured to the patient by a downward force 708 of atmospheric pressure. At the end of the TTM therapy, the clinician may stop the delivery of TTM air 704 to the pad 720 at negative pressure, which may eliminate the downward force 708. The clinician may remove the pad 720 from the patient. In some embodiments, the clinician may first remove the pad 720 from the patient and then stop the delivery of the TTM air 704. In an alternative embodiment, the clinician may first stop the delivery of the TTM air 704 and then remove the pad 720 from the patient.

[0136] Without further elaboration, it is believed that one skilled in the art can utilize the present invention to its fullest extent using the preceding description. The claims and embodiments disclosed herein are merely illustrative and exemplary and should not be construed as limiting the scope of the present disclosure in any way. It will be apparent to one skilled in the art that, with the aid of the present disclosure, changes can be made to the details of the above embodiments without departing from the basic principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the above description are within the scope of the appended claims. Furthermore, the order of steps or operations of the methods disclosed herein may be changed by one skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or operations is necessary for the proper operation of the embodiment, the order or use of specific steps or operations may be changed. The scope of the present invention is therefore defined by the following claims.

Claims

1. 1. A patient contact system for exchanging thermal energy with a patient, comprising:

1. A gown assembly comprising: a gown configured to be worn by the patient; a thermal contact pad coupled to the gown, the thermal contact pad including a fluid compartment configured to receive TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of a TTM therapy; a gown assembly comprising: a quantity of hydrogel disposed on the patient-contacting surface of the pad; wherein the quantity of hydrogel is dispensed from a hydrogel reservoir.

2. The system of claim 1 , wherein the system is configured for multiple use on a single patient.

3. The system of claim 1 or 2, wherein the system is configured for multiple use across different patients.

4. 4. The system of claim 1, wherein the gown assembly is adapted to be disinfected.

5. 5. The system of claim 1, wherein the gown assembly is adapted for sterilization.

6. The system of claim 5 , wherein the sterilization comprises autoclaving.

7. 7. The system of claim 1, wherein the gown assembly is configured for washing in an automatic washing machine.

8. The system of claim 1 , wherein the gown assembly comprises a plurality of thermal contact pads.

9. 9. The system of claim 8, wherein the plurality of thermal contact pads comprises: a first pad coupled to the gown for positioning adjacent a first side of the patient's torso when the gown assembly is placed on the patient; a second pad coupled to the gown for positioning adjacent a second side of the torso opposite the first side when the gown assembly is placed on the patient; A system comprising:

10. 10. The system of claim 8 or 9, wherein the plurality of thermal contact pads further comprises: a third pad coupled to the gown for positioning adjacent a first thigh of the patient when the gown assembly is placed on the patient; a fourth pad coupled to the gown for positioning adjacent a second thigh of the patient when the gown assembly is placed on the patient; and A system comprising:

11. 11. The system of claim 8, wherein one or more of the plurality of thermal contact pads are removably coupled to the gown assembly.

12. The system of claim 8 , wherein the thermal contact pads are fluidly connected to each other.

13. The system of claim 12 , wherein one or more of the plurality of thermal contact pads are fluidly disconnectable from the remaining pads.

14. 12. The system of claim 8, wherein two or more of the plurality of thermal contact pads are individually coupled to the TTM system module.

15. A system according to any one of claims 1 to 14, comprising: The gown assembly includes a plurality of fastening devices; One or more of the plurality of fastening devices are configured to secure the gown to the patient.

16. 16. The system of claim 15, wherein one or more of the plurality of fixation devices are configured to secure one or more of the plurality of pads in thermal contact with the patient.

17. 17. The system of claim 1, wherein the fluid compartment includes a support structure disposed within the fluid compartment to define a minimum thickness of the fluid compartment.

18. 1. A patient contact system comprising: A thermal contact pad configured to be attached to a patient, comprising: a fluid compartment configured to receive a TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of a TTM therapy; a plurality of openings extending between the upper and lower surfaces of the pad; a thermal contact pad comprising: a plurality of first adhesive patches; wherein each first adhesive patch is positioned over a respective opening, and in use, a portion of the first adhesive patch is pressed through a corresponding opening to adhere the portion of the first adhesive patch to the patient and secure the pad to the patient.

19. 20. The system of claim 18, wherein the system is configured for multiple use on a single patient.

20. 20. The system of claim 18 or 19, wherein the system is configured for multiple use across different patients.

21. 21. The system of any one of claims 18 to 20, wherein the pad is adapted to be disinfected.

22. 22. The system of any one of claims 18 to 21, wherein the pad is adapted to be sterilizable.

23. 23. The system of claim 22, wherein the sterilization comprises autoclaving.

24. 24. The system of any one of claims 18 to 23, further comprising a plurality of second adhesive patches, each second adhesive patch comprising: a first portion coupled to the pad at the top surface of the pad along a periphery of the pad; a second portion extending away from the outer periphery; Including, In use, the second portion is adhered to the patient to secure the pad to the patient.

25. 25. The system of any one of claims 18 to 24, further comprising a hydrogel disposed on the pad across an underside of the pad.

26. 27. The system of claim 26, further comprising a hydrogel liner disposed between the hydrogel and the fluid compartment.

27. 28. The system of claim 27, wherein the hydrogel liner is removably attached to the fluid compartment.

28. 28. The system of claim 26 or 27, wherein the hydrogel liner comprises a plurality of liner openings shaped and positioned to correspond to the openings in the pad.

29. 29. A system according to any one of claims 26 to 28, comprising: the hydrogel is sealably enclosed within a hydrogel compartment, the hydrogel compartment being defined by the hydrogel liner disposed over an upper surface of the hydrogel and a storage liner disposed over a lower surface of the hydrogel; During use, the storage liner is removed from the pad to expose the hydrogel.

30. 30. The system of claim 18, wherein the fluid compartment includes a support structure disposed within the fluid compartment to define a minimum thickness of the fluid compartment.

31. A medical pad, comprising: a fluid compartment configured to receive a TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of a TTM therapy; a first hydrogel layer coupled to the fluid compartment at a lower surface of the fluid compartment; a second hydrogel layer removably bonded to the first hydrogel layer on an underside of the first hydrogel layer; A medical pad comprising:

32. The pad according to claim 31 further comprises: The pad comprises a separation liner between the first and second hydrogel layers.

33. 33. The pad of claim 32, wherein the separation liner is bonded to the fluid compartment so as to sealably encapsulate the first hydrogel layer.

34. 34. The pad of claim 32 or 33, wherein the separation liner includes a pull tab extending away from a periphery of the separation liner to facilitate removal of the separation liner along with the second hydrogel layer.

35. 35. The pad of any one of claims 31 to 34, further comprising a first liner disposed between the fluid compartment and the first hydrogel layer.

36. 36. The pad of claim 35, wherein the separate liner is bonded to the first liner to sealably encapsulate the first hydrogel layer.

37. 37. The pad of claim 35 or 36, further comprising a storage liner disposed over an underside of the second hydrogel layer, the storage liner being bonded to one or more of the fluid compartment, the separation liner, or the first liner so as to sealably enclose the second hydrogel layer.

38. 38. A pad according to any one of claims 31 to 37, further comprising a foam layer bonded to the fluid compartment on an upper surface of the fluid compartment.

39. A medical pad, comprising: A foam layer; a first fluid compartment coupled to the foam layer at a first surface of the foam layer, the first fluid compartment configured to receive a TTM fluid from a TTM system module via a first fluid delivery line, the TTM system module configured to circulate the TTM fluid within the first fluid compartment during administration of a first TTM therapy; a first hydrogel layer removably coupled to the first fluid compartment opposite the foam layer; and a second fluid compartment coupled to the foam layer on a second side of the foam layer opposite the first side, the second fluid compartment configured to receive the TTM fluid from the TTM system module via a second fluid delivery line; a second hydrogel layer removably bonded to the second fluid compartment opposite the foam layer; and A medical pad comprising:

40. 40. The pad of claim 39, further comprising a first liner disposed between the first hydrogel layer and the first fluid compartment, the first liner being removably attached to the first fluid compartment.

41. 41. The pad of claim 40, wherein the first liner includes a first pull tab extending away from an outer periphery of the first liner to facilitate removal of the first liner from the first fluid compartment.

42. 42. The pad of claim 40 or 41, further comprising a first storage liner disposed over an exterior of the first hydrogel layer, the first storage liner being bonded to one or more of the first fluid compartment or the first liner so as to sealably enclose the first hydrogel layer.

43. 43. The pad of any one of claims 39 to 42, further comprising a second liner disposed between the second hydrogel layer and the second fluid compartment, the second liner being removably attached to the second fluid compartment.

44. 44. The pad of claim 43, wherein the second liner includes a second pull tab extending away from an outer periphery of the second liner to facilitate removal of the second liner from the second fluid compartment.

45. 45. The pad of claim 43 or 44, further comprising a second storage liner disposed over an exterior of the second hydrogel layer, the second storage liner being bonded to one or more of the second fluid compartment or the second liner so as to sealably enclose the second hydrogel layer.

46. A medical pad, comprising: a fluid compartment configured to receive a TTM fluid from a TTM system module via a fluid delivery line, the TTM system module configured to circulate the TTM fluid within the fluid compartment during administration of a TTM therapy; a first hydrogel layer coupled to the fluid compartment at a lower surface of the fluid compartment; a second hydrogel layer bonded to the first hydrogel layer on an underside of the first hydrogel layer; a separation liner disposed between the first hydrogel layer and the second hydrogel layer, separating the second hydrogel layer from the first hydrogel layer; removably bonded to the first and second hydrogel layers. Separated liner and A medical pad comprising:

47. 47. The pad of claim 46, wherein removing a separation liner from between the first and second hydrogel layers causes one or more components of the first hydrogel layer to migrate into the second hydrogel layer.

48. 48. The pad of claim 47, wherein the migration of the one or more components extends the useful life of the pad.

49. 49. The pad of claim 47 or 48, wherein the transfer of the one or more components results in an extension of the duration of the TTM therapy.

50. 50. The pad of any one of claims 47 to 49, wherein the migration of the one or more components promotes rehydration of the second hydrogel layer.

51. 51. A pad according to any one of claims 46 to 50, wherein the chemical composition of the second hydrogel layer is different from the chemical composition of the first hydrogel layer.

52. 52. The pad of any one of claims 46 to 51, wherein the separation liner is bonded to the fluid compartment so as to sealably encapsulate the first hydrogel layer.

53. 53. The pad of any one of claims 46-52, wherein the separation liner includes a pull tab extending away from an outer periphery of the separation liner to facilitate removal of the separation liner from between the first hydrogel layer and the second hydrogel layer.

54. 54. The pad of any one of claims 46 to 53, further comprising a first liner disposed between the fluid compartment and the first hydrogel layer.

55. 55. The pad of any one of claims 46 to 54, further comprising a storage liner disposed over a lower surface of the second hydrogel layer, the storage liner being bonded to one or more of the fluid compartment, the separation liner, or the first liner so as to sealably enclose the second hydrogel layer.

56. 56. A pad according to any one of claims 46 to 55, further comprising a foam layer coupled to the fluid compartment on an upper surface of the fluid compartment opposite the first hydrogel layer.

57. 1. A health care system comprising: a targeted temperature management (TTM) system module configured to provide a flow of TTM air at a prescribed pressure and temperature in accordance with a TTM therapy; a thermal contact pad fluidly coupled to the system module; the pad being adapted to be attached to a patient; the pad is configured for sealable engagement with the patient along a periphery of the pad to form a compartment between an upper wall of the pad and a skin surface of the patient; the compartment is configured to receive the TTM air from the system module for circulation of the TTM air within the compartment; The medical system, wherein the prescribed pressure is a vacuum that creates a downward force on the pad to secure the pad to the patient during the TTM therapy.

58. 58. The system of claim 57, wherein the pad includes a support structure extending downwardly from the top wall within the compartment, the support structure defining a minimum distance between the skin surface and the top wall.

59. 60. The system of claim 58, wherein the support structure defines a plurality of channels for the flow of the TTM air during circulation through the compartment between an inlet port and an outlet port.

60. 60. The system of any one of claims 57 to 59, further comprising a plurality of the thermal contact pads coupled to the system module.

61. 61. The system of claim 60, wherein each pad of the plurality of pads is individually coupled to the system module.

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