Extremely comfortable thermal contact pads

Abstract

Disclosed herein is a medical pad for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient. The medical pad includes a fluid-containing layer configured for circulating a TTM fluid therethrough. The pad is configured to expand with the expansion of the patient's skin. The fluid-containing layer of the pad includes an opening extending therethrough to facilitate expansion. The pad further includes a tab extending away from the periphery such that a clinician can apply a lifting force to the tab to separate an adjacent portion of the pad away from the patient. The pad further includes a hydrogel layer formed from an ultraviolet light curable composition.

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] A patient may experience swelling during TTM treatment, which may occur over the area of ​​skin in contact with the patient. In some cases, the swelling may cause trauma to the skin in contact with the patient, particularly along the periphery of the pad. Disclosed herein are systems, thermal contact pads, and methods for providing TTM treatment while minimizing skin trauma. [Prior art documents] [Patent documents]

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

[0006] Briefly summarized, a medical pad for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient is disclosed herein. According to some embodiments, the medical pad includes a fluid-containing layer having a channel structure and a film disposed across an underside of the channel structure, the film being sealably coupled to the channel structure to form a flow path for the TTM fluid. The pad further includes a plurality of openings extending between an upper side of the channel structure and an underside of the film, and a hydrogel layer disposed across the underside of the film, the hydrogel layer defining a thermal bond between the fluid-containing layer and the patient and an adhesive substance for adhering the fluid-containing layer to the patient's skin. The pad is configured to expand in at least one direction such that, in use, the pad expands with the expansion of the patient's skin.

[0007] In some embodiments, the hydrogel layer comprises a UV-curable composition comprising: (i) a crosslinked copolymer in an amount of about 15% to 30% by weight of the composition; (ii) water in an amount of about 15% to 40% by weight of the composition; and (iii) glycerol in an amount of about 25% to 35% by weight of the composition.

[0008] In some embodiments, the pad may further include one or more tabs coupled to the fluid containing layer, the tabs extending outwardly from one or more perimeters of the pad. Each tab may be rigidly coupled to the fluid containing layer such that a lifting force applied to the tab separates an adjacent portion of the pad from the patient. In some embodiments, at least a subset of the tabs are formed from a resilient material and include a portion extending inwardly from the perimeter. In other embodiments, at least a subset of the tabs are formed from an outer extension of the channel structure.

[0009] The pad can include an inlet port in fluid communication with a first end of the flow channel and an outlet port in fluid communication with a second end of the flow channel. In some embodiments, the expansion of the pad comprises an increase in at least one dimension of one or more of the openings.

[0010] In some embodiments, the openings include clefts extending inwardly from a periphery of the pad across a portion of the pad. In further embodiments, the openings include a first subset of clefts extending inwardly from a first periphery of the pad and a second subset of clefts extending inwardly from a second periphery of the pad, the second periphery being disposed opposite the first periphery. The first subset of clefts and the second subset of clefts may be disposed in an alternating sequence.

[0011] In some embodiments, an extensible material is disposed within each cleft. The extensible material is bonded across the cleft from a first side to a second side opposite the first side, the extensible material configured to allow the cleft to expand in response to expansion of the pad. In some embodiments, the extensible material comprises rubber, a woven elastic material, or neoprene.

[0012] In some embodiments, the channel structure includes a series of interconnected channel segments forming a lattice array, and the openings may include apertures, each aperture having a perimeter defined by three or more channel segments, hi some embodiments, one or more of the apertures define one of a diamond, a square, a rectangle, a hexagon, or a polygon.

[0013] In some embodiments, the pad defines a vest configured to extend around the patient's torso. Also disclosed herein is a targeted temperature management system that includes a system module configured for preparation and delivery of a TTM fluid and any of the medical pads summarized above fluidly coupled to the system module.

[0014] Also disclosed herein is a method of providing targeted temperature management (TTM) therapy to a patient. According to some embodiments, the method includes (i) applying a thermal contact pad to a patient, the pad configured to expand with the expansion of the patient's skin during TTM therapy, (ii) coupling the thermal contact pad to a system module configured for preparation and delivery of a TTM fluid to the thermal contact pad, and (iii) circulating the TTM fluid through a fluid-containing layer of the pad to define a thermal energy exchange between the TTM fluid and the patient.

[0015] In some embodiments, the method further comprises orienting the pad towards the patient such that the direction of expansion of the pad aligns with the expected direction of expansion of the patient's skin. In some embodiments of the method, the pad further includes one or more tabs coupled to the fluid containing layer, the tabs extending outwardly from one or more peripheral edges of the pad, and the method further includes applying a lifting force to one of the one or more tabs to lift a proximal portion of the pad from the patient. The method may further include visually inspecting the area of ​​skin beneath the proximal portion.

[0016] In some embodiments of the method, the pad further comprises a hydrogel layer having an ultraviolet light curable composition comprising: (i) a crosslinked copolymer in an amount of about 15% to 30% by weight of the composition; (ii) water in an amount of about 15% to 40% by weight of the composition; and (iii) glycerol in an amount of about 25% to 35% by weight of the composition.

[0017] In some embodiments of the method, the pad includes a plurality of openings extending between an upper side and a lower side of the fluid containing layer, and the expansion of the pad includes an increase in at least one dimension of one or more of the openings.

[0018] In some embodiments of the method, the opening comprises a split extending inwardly from the periphery of the pad across a portion of the pad. In some embodiments of the method, the pad further includes an extensible material disposed within each cleft, the extensible material being bonded across the cleft from a first side to a second side opposite the first side, the extensible material being configured to allow the cleft to expand in response to expansion of the pad.

[0019] In some embodiments of the method, the fluid containing layer includes a channel structure defining a series of interconnected channel segments forming a lattice arrangement, the openings including apertures, each aperture having a perimeter defined by three or more channel segments.

[0020] 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.

[0021] 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]

[0022] [Figure 1A] FIG. 1 illustrates a targeted temperature management (TTM) system including a thermal contact pad coupled to a patient, according to some embodiments. [Figure 1B] 1B is a top view illustrating a first embodiment of a thermal contact pad for use with the system of FIG. 1A, according to some embodiments. [Figure 1C] 1C is a side cross-sectional view of a portion of the thermal contact pad of FIG. 1B in accordance with some embodiments. [Figure 1D] 1C is a top view illustrating the thermal contact pad of FIG. 1B in an expanded state, according to some embodiments. [Figure 1E] FIG. 1C is a side view illustrating the thermal contact pad of FIG. 1B applied to a patient, with a portion of the thermal contact pad separated from the patient by a lifting force applied to a tab of the pad, according to some embodiments. [Figure 2A] FIG. 2 is an exploded perspective view illustrating a second embodiment of a thermal contact pad, according to some embodiments. [Figure 2B] 3 is a cross-sectional side view of a portion of the thermal contact pad of FIG. 2 in accordance with some embodiments. [Diagram 3] FIG. 13 is a top view of a third embodiment of a thermal contact pad in the form of a vest, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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. 1A illustrates a targeted temperature management (TTM) system 100 connected to a patient 50 for administering 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 110 for preparing and delivering a TTM fluid 102. The TTM system 100 includes a fluid delivery line (FDL) 103 extending from the TTM module 110 to a thermal contact pad (pad) 120 to provide a flow of TTM fluid 102 between the TTM module 110 and the pad.

[0028] The TTM system 100 may include one, two, three, four, or more pads 120, and the TTM system 100 may include one, two, three, four, or more fluid delivery lines 103. In use, the TTM module 110 prepares the TTM fluid 102 for delivery to the pad 120 by heating or cooling the TTM fluid 102 to a prescribed temperature according to a given TTM treatment. The TTM module 110 circulates the TTM fluid 102 within the pad 120 to facilitate thermal energy exchange with the patient 50. During a TTM treatment, the TTM module 110 may continuously control the temperature of the TTM fluid 102 toward a target TTM temperature. As shown, the pad 120 may be applied to different body parts of the patient 50. Thus, the pad 120 may be available in different configurations, such as sizes and shapes, to accommodate different body parts.

[0029] The pad 120 may generally define a rectangular shape. In other embodiments, the pad 120 may define a shape other than a rectangle, such as a circle, an oval, or a shape that matches or matches the shape of a particular body part. In the illustrated embodiment, the pad 120 defines a generally flat shape in the free state, i.e., in the absence of an external force. In other embodiments, the pad 120 may define a curved shape in the free state to more effectively accommodate non-flat body parts, such as the legs.

[0030] Pad 120 may be configured to accommodate bumps and / or depressions along the surface of patient 50. For example, pad 120 may be structurally flexible in one or more directions to extend over bumps and / or fill depressions in the patient's surface such that pad 120 may define intimate thermal contact with an uneven skin surface of the patient.

[0031] The pad 120 may also be configured to change shape with changes in the shape of the patient 50 during TTM treatment. For example, in some cases, exchanging thermal energy with the patient 50 may cause a portion of the patient to swell. This swelling may cause a larger area of ​​skin to come into contact with the pad 120, i.e., stretch in one or more directions. In some embodiments, the pad 120 may be configured to expand in one or more directions with the stretching of the skin.

[0032] 1B-1E show a first embodiment of a pad 120 for use with a targeted temperature management (TTM) system 100, according to some embodiments. FIG. 1B is a top view of the pad 120. The pad 120 generally defines an upper side 121 disposed away from the patient 50 during use, and a lower side 122 configured to contact the patient 50. For illustrative purposes, the pad 120 defines a front side 125, a rear side 126, a left side 127, and a right side 128. A connector / port 123 couples with the FDL 103 to provide for the flow of the TTM fluid 102 into and out of the pad 120. In the illustrated embodiment, the connector 123 is located on the upper side 121 of the pad 120. In other embodiments, the connector may be located on the lower side 122 or along any of the sides 125-128.

[0033] The clefts 130A-130C extend partially across the pad 120. The clefts 130A-130C also extend from the top side 121 to the bottom side 122 of the pad 120, with the connector material 131 extending across the clefts 130A-130C. The clefts 130A-130C define channels 129A-129D for the flow of the TTM fluid 102 therethrough. The flow of the TTM fluid 102 within the channels 129A-129D may be unidirectional or bidirectional.

[0034] In the illustrated embodiment, the pad 120 includes three clefts 130A-130C. In other embodiments, the pad 120 may include more or less than three clefts. The clefts extend inwardly and partially across the pad 120, i.e., the clefts 130A, 130C extend inwardly from the front side 125 toward the rear side 126, and the cleft 130B extends inwardly from the rear side 126 toward the front side 125. In the illustrated embodiment, the three clefts 130A-130C extend inwardly from both sides of the pad 120 in an alternating arrangement. In other embodiments, the pad 120 may include two or more adjacent clefts extending inwardly from the same side. Although not shown, in some embodiments, the pad 120 may also include clefts extending inwardly from the left side 127 and / or right side 128.

[0035] In the illustrated embodiment, the pad 120 includes a channel connecting portion that extends between adjacent channels. For example, a channel connecting portion 129E extends between adjacent channels 129A, 129B to provide for the flow of TTM fluid 102 between adjacent channels 129A, 129B. Although not shown, in some embodiments, adjacent channels may be fluidly coupled via one or more fluid lines (e.g., tubes) instead of channel connecting portions. In such embodiments, a corresponding cleft may extend across the entire pad 120.

[0036] 1C is a side cross-sectional view of pad 120, according to some embodiments. Pad 120 includes multiple layers disposed between upper side 105 and lower side 106. Pad 120 generally includes a fluid-containing layer 150 having TTM fluid 102 circulating therethrough, which defines a heat sink or heat source for patient 50 depending on the temperature of TTM fluid 102. Fluid-containing layer 150 is formed from a channel structure 151 sealably coupled with film 152 to define channels 129A-129D, i.e., flow paths for TTM fluid 102 extending between connectors 123.

[0037] The channel structure 151 may be constructed of any suitable material, such as, for example, silicone, a thermoplastic material, and may be manufactured via any suitable process, such as, for example, thermoforming, injection molding, or casting. The channel structure 151 may be deflectable to form a curvature in one or more directions. The deflectability of the channel structure 151 may allow the pad 120 to conform to an uneven skin surface of the patient 50. The deflectability may allow the pad 120 to extend around or partially around a portion of the patient, such as, for example, the patient's torso or legs.

[0038] Although not required, the channel structure 151 may include internal protrusions 153 extending into any or all of the channels 129A-129D toward the film 152 to define subchannels within the channels 129A-129D. The protrusions 153 may direct the flow of the TTM fluid 102 along the channels 129A-129D to prevent stagnation areas or areas of low flow rate of the TTM fluid 102. In general, the protrusions 153 may promote enhanced thermal convection between the TTM fluid 102 and the film 152. In some embodiments, the protrusions 153 may extend to and / or be coupled to the film 152. The protrusions 153 may also prevent collapse of the channels 129A-129D when the pressure in the channels 129A-129D is negative, i.e., less than atmospheric pressure.

[0039] The connector material 131 extends across the clefts 130A-130C and couples adjacent channels to one another. For example, the connector material 131 disposed in the cleft 130A extends between adjacent channels 129A, 129B and couples channel 129A to channel 129B. The connector material 131 is a stretchable material. The connector material 131 may be constructed of a woven or net structure to allow for stretchability, or the connector material 131 may be stretchable due to its source of origin. In some embodiments, the connector material 131 may include rubber, a woven stretchable material, or neoprene. In some embodiments, the connector material 131 may be breathable, i.e., provide for the passage of air through the cleft from the top side 121 to the bottom side 122 of the pad 120. In some embodiments, the connector material 131 may be omitted along all or part of the cleft.

[0040] With further reference to FIG. 1C, the pad 120 includes a hydrogel layer 160 disposed along the underside 122 of the pad 120. In use, the hydrogel layer 160 is in direct contact with the skin of the patient 50 to define a thermally intimate contact between the fluid-containing layer 150 and the patient 50. The hydrogel layer 160 may also define an adhesive material between the film 152 and the patient's skin. The hydrogel layer 160 may be formed from a UV-curable composition 160A that includes (i) a cross-linked copolymer in an amount of about 15%-30% by weight of the composition, (ii) water in an amount of about 15%-40% by weight of the composition, and (iii) glycerol in an amount of about 25%-35% by weight of the composition. In the illustrated embodiment, the hydrogel layer 160 does not extend across the crevices 130A-C. In other embodiments, the hydrogel layer 160 may extend across the clefts 130A-130C.

[0041] FIG 1D is a top view of pad 120 in an expanded state / shape. As discussed above, pad 120 is configured to change shape in response to changes in the shape or size of a patient during TTM treatment. FIG 1B shows pad 120 in an unexpanded shape, which in some embodiments may correlate to the free state of pad 120, i.e., the shape of pad 120 when no external force is applied to pad 120. FIG 1D shows pad 120 in an exemplary expanded shape.

[0042] As shown, the width of cleft 130B is greater adjacent the posterior side 126 than adjacent the anterior side 125, such that the length of pad 120 along the posterior side 126 is greater in the expanded state than in the unexpanded state. Similarly, the width of clefts 130A, 130C is greater adjacent the anterior side 125 than adjacent the posterior side 126, such that the length of pad 120 along the anterior side 125 is greater in the expanded state than in the unexpanded state.

[0043] In use, the channels 129A-129D may be adhesively coupled to the patient's skin via the hydrogel layer 160 such that sliding of the channels 129A-129D relative to the skin is resisted. The connector material 131 may be sufficiently stretchable to allow the tear or a portion thereof to be widened in the instance of patient swelling during TTM treatment. In other words, the connector material 131 may be sufficiently stretchable to allow the channels 129A-129D to move along the patient's skin during swelling.

[0044] 1B and 1C, pad 120 includes one or more tabs 140 disposed along any or all of sides 125-128. Tab 140 includes an inner portion 141 extending inwardly from a periphery of pad 120 and an outer portion 142 extending outwardly from the periphery. Tab 140 is configured to separate a portion of pad 120 from the skin along a corresponding periphery adjacent tab 140 when a lifting force is applied to tab 140. In use, tab 140 can be utilized by a clinician to separate a portion of pad 120 adjacent tab 140 from the skin to visually inspect the skin adjacent the portion of pad 120.

[0045] The tab 140 may generally be more rigid than the pad 120 such that a clinician can apply a lifting force to the tab 140 to separate a portion of the pad 120 from the patient 50. The resiliency / rigidity of the tab 140 may be dictated by the material of the tab 140. In the illustrated embodiment, the tab 140 defines a generally thin shape and is constructed of a rigid material. The tab 140 is coupled to the fluid containing layer 150 at a bottom side of the fluid containing layer 150. In other embodiments, the tab 140 may be coupled to the fluid containing layer 150 at any location between the top side 121 and bottom side 122 of the pad 120, on the top side of the fluid containing layer 150 or along the top side 121 of the pad 120.

[0046] In other embodiments, the tab 140 may be integrally formed with the channeling structure 151. Thus, the stiffness of the tab 140 may be dictated by the structural geometry of the tab 140, e.g., the thickness of the tab 140. In such embodiments, the structure of the channeling structure 151 proximate the tab 140 may dictate the stiffness of the inner portion 141 of the tab 140. In other words, the tab 140 may be integral with the channeling structure 151, i.e., the tab 140 may be formed from the channeling structure material during the manufacturing process of the channeling structure 151. Thus, the tab 140 may be an extension of the channeling structure 151.

[0047] FIG. 1E shows the pad 120 being used on a patient 50. In some cases, the skin surface adjacent the peripheral edge 170 of the pad 120 may be subject to trauma, such as may be caused by frictional contact between the pad 120 and the skin 150. Thus, the clinician may wish to inspect the skin 51 for any signs of trauma. The pad 120 is shown applied to the patient 50. Also shown is a hydrogel layer 160 disposed on the underside of the pad 120, and a tab 140 extending from the peripheral edge 170. In use, the clinician may apply a lifting force 141 to the tab 140 to lift / separate a portion of the pad 120 from the patient 50 to inspect the portion of the skin 51 adjacent the tab 140 of the pad 120. In lifting the pad 120 / 220, the clinician may use a finger or thumb 105 to apply a lifting force 141 to the tab 140. By using the tab 140 , the clinician can avoid touching or disturbing the hydrogel layer 160 .

[0048] 2A-2B are top views of a second embodiment of a thermal contact pad 220 that may be similar in some respects to the components of the pad 120 described in connection with FIGS. 1A-1E. It will be understood that all of the illustrated embodiments may have similar features. Accordingly, similar features are indicated with similar reference numbers with the leading digit incremented to "2." For example, a fluid-containing layer is indicated as "150" in FIGS. 1A-1E, and a similar fluid-containing layer is indicated as "250" in FIGS. 2A-2B. Accordingly, the relevant disclosure above with respect to similarly identified features may not be repeated below. Additionally, certain features of the thermal contact pad 120 and related components shown in FIGS. 1A-1E may not be indicated or identified by reference numbers in the drawings or specifically described in the following description. However, such features may be clearly the same or substantially the same as features shown in and / or described in connection with other embodiments. Thus, the relevant descriptions of such features apply equally to the features of the thermal contact pad 220 of Figures 2A-2B. Any suitable combination of features and variations thereof described with respect to the thermal contact pad 120 and components shown in Figures 1A-1E may be used with the thermal contact pad 220 and components of Figures 2A-2B, and vice versa. This pattern of disclosure applies equally to further embodiments shown in subsequent figures and described below.

[0049] 2A-2B illustrate a thermal contact pad 220 configured for use with a targeted temperature management (TTM) system 100 (see FIG. 1A), according to some embodiments. FIG. 2A is a perspective exploded view (as viewed from the rear left corner) of the thermal contact pad 220, and FIG. 2B is a side cross-sectional view of a portion of the assembled pad 220 cut along cut line 2B-2B. With reference to FIGS. 2A-2B, the pad 220 generally defines an upper side 221 disposed away from the patient 50 (see FIG. 1A) during use, and a lower side 222 configured to contact the patient 50. For illustrative purposes, the pad 220 defines a front side 225, a rear side 226, a left side 227, and a right side 228.

[0050] The fluid containing layer 250 is comprised of a channel structure 251 sealably coupled to a film 252 along an underside of the channel structure 251. The channel structure 251 is comprised of a series of interconnected channel segments 253 that, in combination with the film 252, form one or more flow paths for the TTM fluid 102 extending between the inlet connector 223A and the outlet connector 223B. The interconnected channel segments 253 form a lattice arrangement that defines openings 254 that extend through the fluid containing layer 250, i.e., between the top side of the channel structure 251 and the bottom side of the film 252. The shape of the openings 254 may include a diamond, parallelogram, rhombus, square, rectangle, hexagon, or any other polygon. Each of the openings 254 may include a perimeter defined by three or more channel segments 253.

[0051] The channel structure 251 may be constructed of any suitable material, such as, for example, a silicone or a thermoplastic material. The channel structure 251 may be deflectable to form a curvature in one or more directions. The deflectability of the channel structure 251 may allow the pad 220 to conform to an uneven skin surface of the patient 50. The deflectability may allow the pad 220 to extend around or partially around a portion of the patient, such as, for example, the patient's torso or legs.

[0052] The pad 220 may generally define a rectangular shape defining a length 229A extending between a front side 225 and a rear side 226, and a width 229B extending between a left side 227 and a right side 228. In a free state, the length 229A may be longer than the width 229B, or vice versa.

[0053] The channel structure 251 is configured to change shape in response to an external force. For example, tension between the left side 227 and the right side 228 may cause the width 229B to increase. Similarly, tension between the front side 225 and the back side 226 may cause the length 229A to increase. In some embodiments, an increase in length may result in a decrease in width, or vice versa. In some embodiments, the pad 120 may increase in width more easily than in length, i.e., require less tension to cause expansion.

[0054] The pad 220 includes a hydrogel layer 260 disposed along an underside of the pad 220. In use, the hydrogel layer 260 is in direct contact with the skin of the patient 50 to define a thermally intimate contact between the fluid containing layer 250 and the patient 50. The hydrogel layer 260 may be composed of a material similar to the UV-curable composition 160A of FIG. 1C. In the illustrated embodiment, the hydrogel layer 260 may extend across the opening 253. In some embodiments, one or more openings 253 may extend through the hydrogel layer 260.

[0055] The pad 220 includes one or more tabs 240 disposed along any or all of the sides 225-228. The tabs 240 extend away from the periphery of the pad 220. The tabs 240 may be integrally formed with a channeling structure 251. Thus, the channeling structure 251 may help define the rigidity of the tabs 240. The tabs 240 may generally be more rigid than the pad 220 such that a clinician can apply a lifting force to the tabs 240 to separate a portion of the pad 220 from the patient 50. In some embodiments, the tabs 240 may be a separate component coupled with the fluid-containing layer 250. The rigidity of the tabs 240 may be defined by the material of the tabs 240.

[0056] Although not shown, the thermal contact pad 120 of FIGS. 1A-1E and the thermal contact pad 220 of FIGS. 2A-2B may include a combination of the channel structure 151 and the channel structure 251.

[0057] FIG. 3 illustrates a third embodiment of a pad 320 in the form of a vest configured to extend around the torso of a patient 50 (see FIG. 1A). The pad 320 defines an upper / outer side 321 and an underside 322. A hydrogel layer 360 is disposed along the underside 322. A connector 323 couples the FDL 303 to the pad 320 to provide for the flow of TTM fluid 102 to the pad 320. The pad 320 includes a number of clefts 330 to provide an expandable portion of the pad 320. As illustrated, one expandable portion may be disposed along the right side of the pad 320 (e.g., adjacent the patient's right arm). Although hidden in FIG. 3, the pad 320 may include another expandable portion disposed along the left side opposite the right side. In some embodiments, the pad 320 may include additional expandable portions. For example, in some embodiments, the pad 320 may include an expandable portion disposed along the front and / or back side of the pad 320.

[0058] The pad 320 includes a fluid-containing layer 350 disposed along the outer side 321. Channels 329 disposed between the crevices 330 provide for flow of the TTM fluid across the expandable portion. The fluid-containing layer 350 includes a channel structure 351 extending along the expandable portion and the non-expandable portion. Although not required, the channel structure 351 may include an internal protrusion 353. The protrusion 353 may define sub-channels within the fluid-containing layer 350 to direct the flow of the TTM fluid 102 to prevent areas of stagnation or low flow of the TTM fluid 102. In general, the protrusion 353 may facilitate improved thermal energy exchange between the TTM fluid 102 and the patient 50. The protrusion 353 may also prevent collapse of the fluid-containing layer 350 when pressure within the fluid-containing layer 350 is negative, i.e., less than atmospheric pressure.

[0059] The pad 320 may include fastening devices 371 to provide attachment of adjacent portions of the pad 320. For example, a pair of fastening devices 371 may extend between the front and back sides of the pad 320 to extend over the shoulders of the patient 50. Another fastening device 371 may extend between the right and left front portions of the pad 320. The fastening devices 371 may provide for selective attachment and detachment of adjacent portions of the pad 320.

[0060] Pad 320 includes one or more tabs 340 disposed about the periphery of pad 320 to provide for the skin test as shown and described above (see FIG. 1E). Although not shown, in some embodiments, the pad 320 (or more specifically the fluid containing layer 350) may include a lattice channel structure (see FIGS. 2A, 2B) instead of or in addition to the clefts 330. For example, one or more portions of the front side and / or back side may include a lattice channeling structure.

[0061] A method of providing targeted temperature management (TTM) therapy to a patient may include all or a subset of the following steps or processes: A clinician may apply a thermal contact pad to a patient over a defined area of ​​the patient to facilitate thermal energy exchange with the patient. The clinician may couple the pad with a system module and initiate circulation of TTM fluid through a fluid-containing layer of the pad to initiate thermal energy exchange between the TTM fluid and the patient.

[0062] Because the pad may be configured to expand (or expand more easily in a single direction), the clinician may orient the pad to align with the expected direction of expansion of the patient's skin. For example, in some cases, a patient's thigh may expand / swell more significantly along the circumference of the thigh than along the length of the thigh. Thus, the clinician may orient the pad to align the direction of pad expansion with the circumference of the thigh.

[0063] In performing this method, the clinician can apply a lifting force to the tab of the pad to lift / separate the portion of the pad adjacent the tab from the patient to expose the skin on the adjacent portion of the pad. The clinician can then visually inspect the skin underneath the adjacent portion to identify potential skin trauma. The clinician can engage the tab to avoid touching the hydrogel layer.

[0064] 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 medical pad for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient, comprising: A fluid containing layer, A channel structure; a film disposed across an underside of the channel structure, the film sealably coupled to the channel structure to form a flow path for the TTM fluid; a plurality of openings extending between an upper side of the channel structure and an underside of the film; A fluid containing layer comprising: a hydrogel layer disposed across the underside of the film, a thermal connection between the fluid containing layer and the patient; an adhesive material for adhering the fluid containing layer to the skin of a patient; A hydrogel layer defining the Equipped with The pad is configured to expand in at least one direction such that, in use, the pad expands with the expansion of the patient's skin.

2. 10. The pad of claim 1, wherein the hydrogel layer comprises an ultraviolet curable composition, the ultraviolet curable composition comprising: a crosslinked copolymer in an amount of about 15% to 30% by weight of the composition; Water in an amount of about 15% to 40% by weight of the composition; glycerol in an amount of about 25% to 35% by weight of the composition; Including the pad.

3. The pad according to claim 1 or 2 further comprises: The pad further comprises one or more tabs coupled to the fluid containment layer, the tabs extending outwardly from one or more peripheral edges of the pad.

4. The pad of claim 3 , wherein each tab is rigidly coupled to the fluid containing layer such that a lifting force applied to the tab separates an adjacent portion of the pad from the patient.

5. 5. A pad according to claim 3 or 4, wherein at least a subset of the tabs are: formed from a resilient material; and The pad includes a portion extending inwardly from the periphery.

6. A pad according to any one of claims 3 to 5, wherein at least a subset of the tabs are formed from outer extensions of the channel structure.

7. The pad according to any one of claims 1 to 6 further comprises: an inlet port in fluid communication with a first end of the flow passage; an outlet port in fluid communication with a second end of the flow channel; A pad comprising:

8. A pad according to any preceding claim, wherein the expansion of the pad comprises an increase in at least one dimension of one or more of the openings.

9. 9. The pad according to claim 8, wherein the opening is: extending inwardly from the periphery of the pad; and A pad including a breach extending across a portion of the pad.

10. 10. The pad of claim 9, wherein the opening is: a first subset of fissures extending inwardly from a first periphery of the pad; a second subset of fissures extending inwardly from a second periphery of the pad; and wherein the second perimeter is disposed opposite the first perimeter.

11. The pad of claim 10 , wherein the first subset of clefts and the second subset of clefts are arranged in an alternating sequence.

12. The pad of claim 9 or 10 further comprises an extensible material disposed within each cleft; the extensible material is bonded across the gap from a first side to a second side opposite the first side; A pad configured to allow the breach to expand in response to expansion of the pad.

13. 13. The pad of claim 12, wherein the extensible material comprises rubber, a woven elastic material, or neoprene.

14. 14. A pad according to any preceding claim, wherein the channel structure comprises a series of interconnected channel segments forming a lattice array.

15. The pad of claim 14 , wherein the openings include apertures, each aperture having a periphery defined by three or more channel segments.

16. 16. The pad of claim 15, wherein the one or more apertures define one of a diamond, a square, a rectangle, a hexagon, or a polygon.

17. 17. A pad according to any preceding claim, wherein the pad defines a vest configured to extend around a patient's torso.

18. A target temperature management system, a system module configured for preparation and delivery of the TTM fluid; 18. The medical pad of claim 1, fluidly coupled to the system module. A targeted temperature management system comprising:

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