Pressure ulcer prevention device

Abstract

The pressure ulcer prevention device of the invention includes a thermal support member disposed on a massaging member. The massaging member includes at least one manipulation element disposed within a housing component and configured to contact a bottom side of the thermal support member. The thermal support member includes at least one thermal element at least partially enclosed within a polymer member. In some embodiments, the pressure ulcer prevention device can further include a therapeutic member disposed on the thermal support member. The therapeutic member includes a cushioning polymer disposed on at least a top side of the mitigation member. The pressure ulcer prevention device can provide a therapeutic force to a user.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of priority to U.S. Patent Application No. 18 / 105,143, filed with the U.S. Patent and Trademark Office on February 2, 2023 (02.02.2023), entitled "Decubitus Prevention Device," which is hereby incorporated by reference in its entirety.

[0002] The present disclosure (e.g., "this disclosure") relates to the prevention of decubitus ulcers (bed sores, ulcers, pressure sores, etc.). In some more specific embodiments, the present invention relates to an inventive (e.g., original) decubitus ulcer prevention device, for example, in the form of a bed (e.g., bed frame, bedding set) / mattress (e.g., bedding placed on the bed frame, spacer that supports the bedding from below, etc.) combination (e.g., a bed mattress combination). [Background technology]

[0003] Persons who are confined for extended periods of time in a particular position, such as a prone position (i.e., lying on one's back, front, side, etc.) or a sitting position (e.g., hospitalized patients, the elderly, paralyzed persons, comatose patients, burn victims, etc.), are susceptible to pressure ulcers, which occur when pressure against the skin causes some of the capillaries in the blood flow supplying the skin tissue to collapse. These conditions can form when blood vessels narrow or block the capillaries of the skin. This type of narrowing or blockage of blood flow can therefore prevent oxygen and nutrients from reaching those areas of the skin. As a result, pressure sores (e.g., bedsores) tend to form. In some situations, the presence or accumulation of heat and / or moisture in these areas of the skin can exacerbate the problem, which can lead to infection. In other situations, additional heat may actually be required for recovery and / or well-being of a particular person. In still other situations (e.g., burn victims, fever patients, etc.), a cooling effect may be required.In still other situations, therapeutic forces (eg, massage therapy) may be required. [Problem to be solved by the invention] Thus, there is a need for a decubitus prevention (e.g., decubitus ulcer suppression, decubitus ulcer alleviation) device that can reduce or eliminate the development of decubitus ulcers. There is also a need for a decubitus prevention device that can provide massage therapy or other similar therapeutic actions to at least some of the areas of the skin that are susceptible to decubitus ulcers, thereby, for example, increasing blood flow to those areas. There is also a need for a decubitus prevention device that can provide heat (e.g., heating, warming, etc.) or remove heat (e.g., cooling, etc.) and / or remove moisture (e.g., dehumidifying) to at least some of the areas of the skin that are susceptible to decubitus ulcers. Summary of the Invention [Means for solving the problem]

[0004] In contrast, the present invention of the present disclosure addresses one or more of the problems and / or needs described above. More specifically, an inventive pressure ulcer prevention device is provided. Such a device may be useful in the form of a bed / mattress combination, a wheelchair, a lounge chair (e.g., an easy chair), a couch (e.g., a couch, a sofa, a chaise longue), an office chair, an examination table, and the like.

[0005] In one embodiment, the inventive pressure ulcer prevention device can be in the form of a mattress combination including a thermal support member disposed on a massaging member. The massaging member can have, among other things, a housing component, which can have a frame element and one or more cross member elements connected to the frame element for enhanced structural stability. Optionally, the massaging member housing component can further include one or more elevation elements, which can increase the height of the pressure ulcer prevention device. Disposed within the housing component can be one or more manipulation elements, which can apply a massaging action (e.g., a therapeutic force) to at least a portion of a user's body that contacts the inventive pressure ulcer prevention device. The thermal support member can include a thermal element that is at least partially embedded within a polymeric member (e.g., a polymeric member), and in some embodiments, the length and width dimensions of the polymeric member (which generally defines some dimensions of the thermal support member) will be substantially equivalent to (match, correspond to, etc.) the length and width dimensions of the massage member.

[0006] In another embodiment, the pressure ulcer prevention device of the invention can be a mattress combination (e.g., a combination for a mattress) including a thermal support member disposed on a massage member, as described above. In this embodiment, the pressure ulcer prevention device of the invention further includes an optional therapeutic member disposed on the thermal support member. The therapeutic member can include a mitigation member, which can optionally be perforated to form several channels at least partially through its thickness. The therapeutic member can further include a thermally conductive polymer disposed on the top side of the therapeutic member and at least partially present within the interior of the therapeutic member, including within any optional channels that may be present. In some embodiments, the therapeutic member can further include an optional barrier layer disposed on the bottom side of the therapeutic member and / or an optional comfort layer disposed on the top side of the therapeutic member.

[0007] In some embodiments, one or more of the components of the inventive pressure ulcer prevention device (i.e., the massage member, the thermal support member, and the optional therapeutic member) may be at least partially enclosed (e.g., surrounded, surrounded, surrounded) separately or together (e.g., collectively, integrally, etc.) within a sheath member.

[0008] The present invention further provides methods of manufacturing the inventive pressure ulcer prevention device, as well as methods of manufacturing the massage member, the thermal support member, and the optional therapeutic member.

[0009] More specifically, in a first embodiment, the pressure ulcer prevention device includes a massaging member and a thermal support member, each having a top side and a bottom side. The massaging member includes a housing component and at least one manipulation element, the at least one manipulation element being disposed within the housing component. The thermal support member includes a polymeric member and at least one thermal element, the at least one thermal element being at least partially disposed within the polymeric member. In this first embodiment, the thermal support member is disposed on the top side of the massaging member with the bottom side of the thermal support member in contact with the at least one manipulation element.

[0010] In some aspects of this first embodiment, the housing component includes a frame element and at least one cross member element. In other aspects, the massage members further include at least one elevation element, the at least one elevation element being disposed on the bottom side of the massage members. In still other aspects, the at least one manipulation element includes a first type of massage member and a second type of massage member.

[0011] In some aspects of this first embodiment, the polymeric member comprises a cushioning polymer that is viscoelastomeric and cohesive. In other aspects, the cushioning polymer is produced from a reaction medium that comprises: a. from about 3 weight percent to about 20 weight percent of an isocyanate prepolymer or a silicone prepolymer; b. polyols in the range of about 20 weight percent to about 40 weight percent; c. an epoxidized triglyceride plasticizer in the range of about 40 weight percent to about 80 weight percent; Includes: In some further aspects, the polyol comprises a hydroxyl-terminated polyol. In another further aspect, the polyol comprises a polybutadiene polyol. In yet another further aspect, the polyol further comprises a polyether diol. In yet another further aspect, the epoxidized triglyceride plasticizer is an epoxidized soybean oil plasticizer. In yet another further aspect, the reaction medium further comprises a catalyst in the range of from about 0.001 weight percent to about 5 weight percent.

[0012] In some aspects of this first embodiment, the thermal support member has a Shore 00 Hardness in the range of about 0 to about 30. In other aspects, the thermal support member further includes a thermal element support component at least partially disposed within the polymeric member with the thermal element support component contacting the at least one thermal element. In still other aspects, the thermal support member further includes a bottom-side barrier layer disposed on the bottom side of the thermal support member. In still other aspects, the thermal support member further includes a top-side barrier layer disposed on the top side of the thermal support member.

[0013] In some aspects of this first embodiment, the pressure ulcer prevention device further includes a thermal device component connected to the at least one thermal element. In some further aspects, the thermal device component includes a wireless user interface.

[0014] In some aspects of this first embodiment, the thermal support member is at least partially encased within a sheath member. In other aspects, the massage member and the thermal support member are collectively and at least partially encased within a single sheath member.

[0015] In a second embodiment, a decubitus prevention device includes a massaging member, a thermal support member, and a therapeutic member, each having a top side and a bottom side. The massaging member includes a housing component and at least one manipulation element, the at least one manipulation element being disposed within the housing component. The thermal support member includes a polymer member and at least one thermal element, the at least one thermal element being at least partially disposed within the polymer member. The therapeutic member includes a mitigation member having a top side and a bottom side, and a thermally conductive polymer. In this second embodiment, the thermal support member is positioned on the top side of the massage member with the bottom side of the thermal support member in contact with the at least one manipulation element, and further, the therapeutic member is positioned on the top side of the thermal support member.

[0016] In some aspects of this second embodiment, the housing component includes a frame element and at least one cross member element. In other aspects, the massage members further include at least one elevation element, the at least one elevation element being disposed on the bottom side of the massage members. In still other aspects, the at least one manipulation element includes a first type of massage member and a second type of massage member.

[0017] In some aspects of this second embodiment, the polymeric member comprises a viscoelastomeric and cohesive cushioning polymer. In other aspects, the cushioning polymer is formed from a reaction medium comprising: a. from about 3 weight percent to about 20 weight percent of an isocyanate prepolymer or a silicone prepolymer; b. polyols in the range of about 20 weight percent to about 40 weight percent; c. an epoxidized triglyceride plasticizer in the range of about 40 weight percent to about 80 weight percent; Includes: In some further aspects, the polyol comprises a hydroxyl-terminated polyol. In some further aspects, the polyol comprises a polybutadiene polyol. In some further aspects, the polyol further comprises a polyether diol. In some further aspects, the epoxidized triglyceride plasticizer is an epoxidized soybean oil plasticizer. In some further aspects, the reaction medium further comprises a catalyst in the range of from about 0.001 weight percent to about 5 weight percent.

[0018] In some aspects of this second embodiment, the thermal support member has a Shore 00 Hardness in the range of about 0 to about 30. In other aspects, the thermal support member further includes a thermal element support component at least partially disposed within the polymeric member with the thermal element support component contacting the at least one thermal element. In still other aspects, the thermal support member further includes a bottom-side barrier layer disposed on the bottom side of the thermal support member. In still other aspects, the thermal support member further includes a top-side barrier layer disposed on the top side of the thermal support member.

[0019] In some aspects of this second embodiment, the pressure ulcer prevention device further includes a thermal device component connected to the at least one thermal element. In some further aspects, the thermal device component includes a wireless user interface.

[0020] In some aspects of this second embodiment, the mitigation member includes at least one opening (e.g., an aperture, a cylindrical hole, etc.). In some further aspects, the at least one opening is disposed on the top side of the mitigation member and extends at least partially through the mitigation member to form at least one channel. In some further aspects, the at least one channel includes the thermally conductive polymer, and the thermally conductive polymer is at least partially disposed within the at least one channel. In some further aspects, the therapeutic member includes the thermally conductive polymer, and the thermally conductive polymer is disposed on the top side of the mitigation member. In some further aspects, the therapeutic member further includes the thermally conductive polymer, and the thermally conductive polymer is disposed at least partially through the mitigation member. In some further aspects, the therapeutic member further includes a layer of the thermally conductive polymer, and the layer is disposed on the top side of the mitigation member.

[0021] In some aspects of this second embodiment, the thermally conductive polymer is formed from a reaction medium comprising: a. in the range of about 2 weight percent to about 20 weight percent of a prepolymer; b. linear polyols in the range of from about 1 weight percent to about 65 weight percent; c. cross-linking polyols in the range of about 3 weight percent to about 50 weight percent; d. an epoxidized triglyceride plasticizer in the range of from about 40 weight percent to about 80 weight percent; e. a viscosity-reducing plasticizer in the range of 0 weight percent to about 40 weight percent; Includes: In some further aspects, the prepolymer is selected from the group consisting of an isocyanate prepolymer and a silicone prepolymer. In some further aspects, the linear polyol comprises a polyether diol and the crosslinking polyol comprises a polyether triol. In some further aspects, the epoxidized triglyceride plasticizer comprises an epoxidized soybean oil plasticizer. In some further aspects, the viscosity-thinning plasticizer comprises an ester plasticizer. In some further aspects, the reaction medium further comprises a catalyst in the range of about 0.001 weight percent to about 5 weight percent.

[0022] In some aspects of this second embodiment, the therapeutic member further includes a barrier layer disposed on a bottom side thereof. In other aspects, the therapeutic member further includes a comfort layer disposed on a top side thereof.

[0023] In some aspects of this second embodiment, at least one of the thermal support member and the therapeutic member is at least partially contained within a sheath member. In other aspects, the massaging member, the thermal support member, and the therapeutic member are together and at least partially contained within a single sheath member.

[0024] On the other hand, the method for preparing the bedsore prevention device includes: a. providing a massage member having a top side and a bottom side, said massage member including a housing component and at least one manipulation element, said at least one manipulation element being disposed within said housing component; b. providing a thermal support member having a top side and a bottom side, said thermal support member comprising a polymer member and at least one thermal element, said at least one thermal element being at least partially disposed within said polymer member; c. placing the thermal support member on the top side of the massaging member with the bottom side of the thermal support member at least partially contacting the at least one thermal element to form the pressure ulcer prevention device; Includes: In some aspects, the method further comprises: d. providing a therapeutic member having a top side and a bottom side, said therapeutic member including a mitigation member and a thermally conductive polymer, said thermally conductive polymer being at least partially disposed within said mitigation member; e. placing the therapeutic member on the top side of the thermal support member; Includes:

[0025] Numerous other features and advantages of the present invention will become apparent from the following description. In the description, reference will be made to several exemplary embodiments of the present invention. Such embodiments do not represent the full scope of the invention. Accordingly, reference should be made to the claims in this application to interpret the full scope of the invention. For the sake of brevity and simplicity, any ranges of numerical values ​​set forth herein contemplate all values ​​within that range and should also be construed as supporting claims reciting any sub-ranges having endpoints that are real values ​​within the specific range in question. As a hypothetical illustrative example, the disclosure of a range from 1 to 5 in this application should be considered to support claims reciting any of the following ranges: 1-5, 1-4, 1-3, 1-2, 2-5, 2-4, 2-3, 3-5, 3-4, and 4-5. [Brief explanation of the drawings]

[0026] The foregoing and certain other features, aspects and advantages of the present invention will become better understood in connection with the following description, appended claims and accompanying drawings, in which:

[0027] [Figure 1A] FIG. 1A is a perspective view of a non-limiting exemplary embodiment of a pressure ulcer prevention device according to the present disclosure, the embodiment having a mattress combination, the mattress combination having a thermal support member and a massage member;

[0028] [Figure 1B]FIG. 1B is a side cross-sectional view of the inventive pressure ulcer prevention device of FIG. 1A taken along line AA;

[0029] [Figure 2A] FIG. 2A is a perspective view of a non-limiting exemplary embodiment of a thermal support member as a component of a pressure ulcer prevention device according to the invention;

[0030] [Figure 2B] FIG. 2B is a side cross-sectional view of the thermal support member of FIG. 2A taken along line BB;

[0031] [Figure 3A] FIG. 3A is a perspective view of a non-limiting exemplary embodiment of a massage member as a component of the inventive pressure ulcer prevention device;

[0032] [Figure 3B] FIG. 3B is a side cross-sectional view of the massage member taken along line CC;

[0033] [Figure 4A] FIG. 4A is a perspective view of a non-limiting exemplary embodiment of a pressure ulcer prevention device according to the present disclosure, the embodiment being in the form of a mattress combination, the mattress combination including a mitigation member, a thermal support member, and a massage member;

[0034] [Figure 4B] FIG. 4B is a side cross-sectional view of the inventive pressure ulcer prevention device of FIG. 5A taken along line DD;

[0035] [Figure 5A]FIG. 5A is a perspective view of a non-limiting exemplary embodiment of a mitigation member;

[0036] [Figure 5B] FIG. 5B is a side cross-sectional view of the mitigation element of FIG. 6A taken along line EE;

[0037] [Figure 6A] FIG. 6A is a perspective view of a non-limiting exemplary embodiment of a therapeutic element;

[0038] [Figure 6B] FIG. 6B is a side cross-sectional view of the therapeutic member of FIG. 7A taken along line FF.

[0039] The repeated use of certain reference characters in the specification and drawings is intended to represent certain same or similar features or elements of the present invention. It should be understood that the drawings are not intended to be drawn to scale, but rather are drawn to illustrate certain specific elements of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0040] Test Method Shore 00 Hardness Test Using a Durometer Shore 00 hardness can be determined using a durometer in accordance with ASTM D2240-00.

[0041] definition It should be noted that, as used in this disclosure, the terms "a" and "an" are intended to mean "at least one" of the described features, elements, integers, steps, components, or groups of any kind, and are not intended to be limited to only one of such features, elements, integers, steps, components, or groups, unless specifically so expressly stated. Furthermore, the use of the phrase "at least one" is not intended to limit other uses of the terms "a" or "an" to only one of a feature, element, integer, step, component, or group.

[0042] It should be noted that, when used in this disclosure, the terms "comprises," "comprising," and other derivatives of the root "comprises" are intended to be open-ended terms specifying the presence of stated features, elements, integers, steps, components, or groups of any kind, and are not intended to exclude the presence or addition of one or other features, elements, integers, steps, components, or groups thereof.

[0043] As used herein, the term "cell" means a cavity contained within a foam.

[0044] As used herein, the term "cell connectivity" refers to a situation in which at least one wall (e.g., a cell membrane, a cell wall, etc.) of a foam surrounding a cell (e.g., a cell) has orifices or pores that connect adjacent cells in a manner that allows fluid exchange between the adjacent cells.

[0045] As used herein, the term "closed cell" refers to a cell within a foam in which the cell membrane surrounding the cavity is unbroken and all membranes are intact.

[0046] As used herein, the term "catalytic amount" is a term of art recognized by those skilled in the art and means an amount sufficient to obtain a desired response or effect.

[0047] As used herein, the terms "cohesive" and "cohesiveness" refer to the ability of a polymer to return to its original, innate shape upon subjection and subsequent removal of a stretching or compression force.

[0048] As used herein, the term "effective amount" means the amount necessary to obtain a desired effect (result, etc.).

[0049] As used herein, the terms "elastomer," "elastomeric," and "elastic" are used interchangeably and refer to materials that have polymeric elastic or rubber-like properties. Elastometric materials, such as thermoplastic elastomers and thermoplastic vulcanizates, are generally able to restore their shape after deformation when the deforming force is removed. More specifically, as used herein, elastomeric refers to the property of any material that, when subjected to an elongating force in the xy planar dimensions, allows the material to be stretchable to a stretched length greater than its relaxed length, and that substantially restores its stretched state when the stretching elongating force is removed. In addition to being elastomeric in the xy planar dimensions, for a structure containing a substrate, the material can also be elastomeric in the z planar dimension. More specifically, when a compressive force is applied to a structure, the structure will exhibit elastomeric properties and will essentially recover to its original shape upon release (relaxation, relaxation, natural state, etc.).

[0050] As used herein, the term "expand" includes not only expansion by volume, but also extension by virtue of the property of being elastomeric and stretchable in a planar dimension.

[0051] As used herein, the term "foam formulation" means any base resin and any additives combined and used in the foam-making process. The term "foam melt" means the mixture of the components of the foam formulation after the mixture has been heated but before the mixture has cooled and set. The terms "foam" and "foam composite" are used interchangeably to mean the mixture resulting from the foam-making process and allowed to cool and set. As used herein, the composition of the foam is generally considered to be equivalent to the composition of the foam formulation.

[0052] As used herein, the term "meltblown" means nonwoven materials and substrates formed by extruding molten thermoplastic material through a plurality of fine, usually circular, die capillaries, each of which passes as a plurality of molten threads or filaments, into converging, high-velocity gas (e.g., air) streams that attenuate the diameter of the molten thermoplastic filaments to a diameter that may be equivalent to that of a microfiber. The filaments are then carried by the high velocity gas stream and deposited (e.g., deposited) onto a collecting surface to form a web (e.g., web, fabric, entangled filaments, fiber-only sheet, etc.) of randomly dispersed filaments.

[0053] As used herein, the terms "nonwoven" and "nonwoven web" refer to materials and substrates having a structure composed of a plurality of individual fibers or filaments that are interlaid (interspersed, intertwined, etc.) in a manner that is not identifiable, such as in knitted fabrics. The terms "fiber" and "filament" are used interchangeably. Nonwoven materials and substrates can be formed by a number of processes (e.g., meltblown, spunbonding, air laying, bonded-carded web, etc.).

[0054] As used herein, the term "open-cell" means any cell within a foam that has at least one broken or missing membrane or orifice in the membrane that connects the cell to an adjacent cell.

[0055] As used herein, the term "polymer" generally includes, but is not limited to, homopolymers (polymers formed by the polymerization of a single type of monomer), copolymers (polymers formed by the polymerization of two types of monomers), block copolymers, graft copolymers, random copolymers, and alternating copolymers, as well as terpolymers (polymers formed by the polymerization of three types of monomers), as well as blends and modifications thereof. Furthermore, unless otherwise specifically limited, the term "polymer" is intended to include all possible molecular geometries of the material, including, but not limited to, isotactic, syndiotactic, and atactic symmetries. As used herein, the composition of the polymer is generally considered to be equivalent to the composition of the polymer system reaction medium.

[0056] As used herein, the terms "reaction media" and "polymeric reaction media" refer to the polymer formula and any additives combined and used in the polymer manufacturing process. The term "uncured" refers to the reaction medium in a liquid state prior to the reaction of the constituents therein. The term "partially-cured" refers to the reaction medium in a liquid or semi-liquid state (e.g., a state between liquid and solid, a flowable solid, a viscous liquid, etc.) in which the reaction of the constituents has begun but not yet completed.

[0057] As used herein, the term "reaction product" refers to the result obtained upon curing the reaction medium to produce the polymer of the present disclosure.

[0058] As used herein, the term "spunbond" refers to nonwoven materials and substrates having small diameter fibers produced by extruding molten thermoplastic material as filaments through capillaries in a circular or other shaped spinneret, where the diameter of the extruded fibers is then rapidly reduced. Spunbond fibers are cooled (quenched, etc.), and the fibers are generally not tacky when deposited on a collecting surface to form the nonwoven material or substrate. Spunbond fibers are generally continuous and often have an average denier greater than about 0.3 denier, more specifically, an average denier between about 0.6 denier and 10 denier.

[0059] As used herein, the term "surfactant" means a chemical component that affects the surface tension of a fluid.

[0060] As used herein, the term "thermoplastic" means a material that softens and / or flows when exposed to heat, and that substantially restores its original, hardended state when cooled to room temperature.

[0061] As used herein, the term "thermoset" describes a material that can be permanently cross-linked, and whose physical form cannot be changed by heat without breaking chemical bonds.

[0062] As used herein, the terms "polymeric viscoelastic" and "viscoelastic" are used interchangeably to refer to a material (such as a polymer) that has viscous and elastic properties, and that has viscous flow elastic properties (e.g., elasticity with viscous flow (viscous resistance)) (e.g., as opposed to densifying compressive elastic properties, such as with foam or rubber, whereby when a localized external force is applied to a material, it densifies in that location and can be elastically compressed without changing shape), thereby returning to its original, innate shape upon subjection and subsequent removal of a stretching or compression force.

[0063] These terms may be defined differently in the remainder of this specification.

[0064] DETAILED DESCRIPTION OF THE INVENTION - BEST MODE(S) - INDUSTRIAL APPLICABILITY The present invention is generally directed to an inventive pressure ulcer prevention device, in which at least a portion of a user's body is maintained in contact with such a device, e.g., a bed, wheelchair, etc., for a relatively long period of time. Such devices can be useful for preventing pressure ulcers, relieving pain, providing physical therapy, etc. In some preferred embodiments, the inventive pressure ulcer prevention device of the present disclosure can include a massage member, a thermal support member, and optionally a therapeutic member.

[0065] Although several representative embodiments of the present invention will be described herein, it should be understood that the disclosed embodiments are intended only as some non-limiting examples of the present invention, which may be embodied in various forms. Therefore, the specific details disclosed herein, for example, relating to structure, function, and the like, should not be construed as limiting in any way, but rather as only one of many examples upon which the claims and / or some teachings of one skilled in the art can be based to utilize the present invention in various aspects in virtually any suitable structure or context.

[0066] Therefore, for the sake of brevity and clarity, some descriptions in this document are substantially directed to a non-limiting representative invention of a pressure ulcer prevention device in the form of a combination with a bed or mattress, but it should be understood that the concepts and variations of the embodiments disclosed herein may be employed in other suitable devices, including, but not limited to, wheelchairs, lounge chairs, couches, office chairs, examination tables, and the like.

[0067] 1A-6B, which illustrate, for exemplary purposes, some non-limiting embodiments of the inventive pressure ulcer prevention device 100 of the present disclosure, in the form of a bed or mattress combination. With particular reference to FIGS. 1A-1B, one embodiment of the pressure ulcer prevention device 100 includes a thermal support member 120 disposed on (e.g., in contact with) a massage member 150. In some aspects of some such embodiments, the inventive pressure ulcer prevention device 100 may further include an optional sheath member 110 (e.g., a mattress cover, etc.) that may at least partially cover or encase the thermal support member 120 and / or the massage member 150. This type of sheathing member 110 may, for example, among other things, provide the device 100 with an aesthetically pleasing surface feel, provide the device 100 with an aesthetically pleasing visual appearance, help prevent potential leakage of plasticizer (if present) from the polymeric member 130 that is a component of the thermal support member 120, reduce the level of any sound emitted by the device 100, assist in maintaining the positions of the thermal support member 120 and the massage member 150 relative to each other, and provide the device 100 as a single unit.Some materials suitable for use as the sheathing member 110 are known to those skilled in the art, including, for example, plastics (e.g., polyethylene, polypropylene, polyvinyl chloride (PVC), etc.), polyester, elastic webbing (e.g., elastic, rubbery cords, strips, etc.), damask, spandex, satin, sateen (e.g., sateen), vinyl, thermoplastic foam, thermoset foam, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated or uncoated woven fabrics, and the like. Examples of suitable materials for the sheathing member 110 include textiles, cotton, wool, handwoven fabrics, felt, natural and synthetic leather, natural and synthetic rubbers, and the like, as well as combinations thereof. Desirably, this type of sheathing member 110 will have flexibility at least equal to or greater than that of the thermal support member 120, a component of the inventive pressure ulcer prevention device 100, though this need not be the case. The optional sheathing member 110 may have any functional thickness, but will typically be relatively thin, for example, in the range of about 0.5 mm to about 10 mm. However, it should be understood that the optional sheathing member 110 can have a thickness that is less than 0.5 mm or greater than 10 mm without departing from the scope of the present invention.

[0068] In some embodiments, the pressure ulcer prevention device 100 of the invention may further include additional layers (e.g., a nonwoven layer, a foam layer, a felt layer, etc.) (not shown) that may be positioned atop the thermal support member 120, beneath the massaging members 150, between the thermal support member 120 and the massaging members 150, and / or along side portions (face portions, main surfaces, sides, side edges, end surfaces, etc.) of each of the thermal support member 120 and / or the massaging members 150 without departing from the scope of the present invention.

[0069] As illustrated, the inventive pressure ulcer prevention device 100 generally comprises a first or top (upper) major, flat side 101 extending generally horizontally; an opposing (e.g., disposed opposite the first side 101) and generally horizontally extending second or bottom (lower) major, flat side 102 distal to the first side 101; and a vertically extending third or "head" (i.e., of a person in a prone position) generally flat side or end 103 disposed between the first side 101 and the second side 102, perpendicular to each other, and an opposing (e.g., disposed opposite the first side 101) and second side 102. the vertically extending, generally flat, fourth or "foot" side 104 (i.e., of a person in a prone position, etc.) facing the third side 103 and extending perpendicularly thereto; the vertically extending, generally flat, fifth side 105 positioned perpendicularly thereto between the first side 101 and the second side 102 and between the third side 103 and the fourth side 104; and the vertically extending, generally flat, sixth side 106 facing the fifth side 105 and extending perpendicularly thereto.

[0070] 2A-2B, the thermal support member 120, a component of the pressure ulcer prevention device 100 of the invention, includes a polymer member 130 and at least one thermal element 140 disposed within the thermal support member 120. The thermal support member 120 has a generally horizontally extending first or top (e.g., upper) major, planar side 121, an opposing (e.g., disposed opposite the first side 121) and generally horizontally extending second or bottom (e.g., lower) major, planar side 122 distal to the first side 121, and a vertically extending third or "head" (i.e., for a person in a prone position) generally planar side or end 123 disposed between the first side 121 and the second side 122, perpendicular to each other. a generally flat side or end 124 (i.e., of a person in a prone position, etc.) extending perpendicularly to the first side 121 and the second side 122 and between the third side 123 and the fourth side 124) and distal to the third side 123; a generally flat vertically extending fifth side 125 (i.e., of a person in a prone position, etc.) and distal to the third side 123; a generally flat vertically extending fifth side 125 (i.e., of a person in a prone position, etc.) and distal to the third side 123; a generally flat vertically extending sixth side 126 (i.e., of a person in a prone position, etc.) and distal to the fifth side 125;In some desirable embodiments, the thermal support member 120 may have dimensions in the x-y plane that are substantially equivalent to the dimensions in the x-y plane of the overall (e.g., total) pressure injury prevention device 100. However, it should be understood that the thermal support member 120 may have dimensions along the x-axis 1 or y-axis 2 that are shorter or longer than the dimensions in the x-y plane of the overall (e.g., total) pressure injury prevention device 100 without departing from the scope of the present invention. On the other hand, the top side 121 of the thermal support member 120 may have a generally flat surface or may have contours or other three-dimensional (i.e., non-flat) surface characteristics without departing from the scope of the present invention.

[0071] In some desirable embodiments, the thermal support member 120 includes a polymer member 130 and a thermal element 140, and the thermal element 140 (except for some extended portions 142 (i.e., exterior extending portions) of the thermal element 140) is substantially enclosed (encased, housed, covered, etc.) within the polymer member 130.

[0072] The thickness (i.e., height as measured along z-axis 3) of the polymer member 130 (and thus, in some preferred embodiments, the thickness of the thermal support member 120) is not limited to any particular measurement and may depend on a number of factors, particularly the size (e.g., overall height) of the thermal element 140 disposed therein (within the polymer member 130). The overall outer diameter of the massaging member 150 and the pressure ulcer prevention device 100 will depend on factors such as the desired thickness and / or softness of the thermal element 140, the hardness and / or flexibility of the thermal element 140 (e.g., to achieve a desired overall softness of the thermal support member 120), the softness and / or flexibility of the cushioning polymer 132 component, the desired degree of support for the user, the desired buffering effect between the massaging member 150 and the user, and the desired thickness and / or softness of the pressure ulcer prevention device 100. Desirably, the thickness of the polymer member 130 will be sufficient to at least substantially encase the thermal element 140, though it need not be without departing from the scope of the invention. In some non-limiting exemplary embodiments, the polymer member 130 can have a thickness extending above (e.g., higher than) the top side of the thermal element 140 in a range from about 1 mm to about 15 mm.However, it should be understood that the polymer member 130 can extend above the top side of the thermal element 140 by a dimension that is less than 1 mm or more than 15 mm without departing from the scope of the present invention. In general, the overall thickness of the polymer member 130 will typically be in the range of 1 cm to 20 cm. However, it should be understood that the thickness of the polymer member 130 can be less than 1 cm or more than 20 cm without departing from the scope of the present invention. On the other hand, the thickness of the polymer member 130 can be uniform or non-uniform across its length (x-axis 1) and / or width (y-axis 2).

[0073] The polymer member 130 includes a cushioning polymer 132 as a component of the thermal support member 120, which is desirably a relatively soft, viscoelastomeric, and cohesive polymer. However, any suitable polymer may be utilized for the polymer member 130 of the thermal support member 120, provided that the polymer (and the resulting thermal support member 120) has a Shore 00 Hardness of about 30 or less, e.g., in the range of about 0 to about 30, as measured by the Shore 00 Hardness Test. In some desirable embodiments, the cushioning polymer 132 is also thermally conductive.

[0074] In some non-limiting exemplary embodiments, suitable cushioning polymer 132 can include some of the polymers described in U.S. Patent No. 7,041,719 to Kriesel et al., entitled "Shock Absorbing Compound," the contents of which are incorporated herein by reference. Variations of such polymers, as well as other polymers having similar properties, each including silicone-based polymers, can be compatible with the present invention without departing from the scope of the present invention.

[0075] By way of non-limiting example only, a polymeric reaction medium can be prepared containing from about 3 weight percent (wt%) to about 20 weight percent of an isocyanate prepolymer (e.g., a partially polymerized or condensed intermediate product of monomers), based on the total weight of the reaction medium, from about 20 weight percent to about 40 weight percent of polyols, or greater than about 40 weight percent of an epoxidized triglyceride plasticizer, to formulate a suitable cushioning polymer 132. In another specific, non-limiting example, cushioning polymer 132 as a component of polymer member 130 can be a viscoelastomeric polymer formed from a reaction medium including about 4 to about 20 weight percent prepolymer, about 20 to about 40 weight percent hydroxyl functional polyol, and about 40 to about 80 weight percent epoxidized triglyceride plasticizer. In some aspects, the prepolymer can include an isocyanate prepolymer or a silicone prepolymer. In some aspects, the polyol can include a polybutadiene polyol. Additionally, in some aspects, the polyols can further include a diol (eg, a polyether diol).In some aspects, the epoxidized triglyceride plasticizer can include an epoxidized vegetable oil plasticizer (e.g., an epoxidized soybean oil plasticizer). In some aspects, the reaction medium can be reacted in the presence of about 0.001 weight percent to about 5 weight percent of a catalyst (e.g., a tin-based catalyst).

[0076] As referenced above, the cushioning polymer 132 of the present disclosure can include a prepolymer. Various prepolymers can be utilized, provided they do not substantially impair the desired cohesiveness, viscoelasticity, and shock-attenuating (shock-damping, etc.) attributes of the polymer. In some desirable embodiments, the prepolymer can be an isocyanate. Suitable isocyanates include aliphatic, cycloaliphatic, aromatic, and heterocyclic polyisocyanates, among others. Although not intended to be limiting, some specific examples include aromatic diisocyanates (e.g., diphenylmethane diisocyanate, methylene diphenyl diisocyanate (MDI), or toluene diisocyanate (TDI), etc.), aliphatic diisocyanates (e.g., hexamethylene diisocyanate (HDI), isophorone diisocyanate (IPDI), etc.), ethylene diisocyanate, 1,4-tetramethylene diisocyanate, diisocyanate), 1,6-hexamethylene diisocyanate, 1,12-dodecane diisocyanate, cyclobutane-1,3-Diisocyanate (cyclobutane-1,3-diisocyanate), cyclohexane-1,3- and 1,4-diisocyanate and mixtures of these isomers, 1-isocyanato-3,3,5-trimethyl-5-isocyanato methyl cyclohexane, 2,4- and 2,6-hexahydrotolylene diisocyanate and mixtures of these isomers, perhydro-2,4′- and / or 4,4′-diphenylmethane diisocyanate diisocyanate, 1,3- and 1,4-phenylene diisocyanate, 2,4- and 2,6-tolylene diisocyanate and mixtures of these isomers, diphenylmethane-2,4′- and / or 4,4′-diisocyanate, naphthyl-ene-1,5-diisocyanate, triphenylmethane-4,4′,4"-triisocyanate, and polyphenylpolymethylene polyisocyanates, which are obtained by condensing aniline with formaldehyde followed by phosgenation. Exemplary isocyanates can include prepolymers based on methylene diphenyl isocyanate, which is reacted with polyoxyethylene / polyoxypropylene. These materials are known by several trade names, such as ELASTOCAST TQZ-P23, available from BASF Corporation, having a place of business in Florham Park, New Jersey, USA, and ISONATE, available from Dow Chemical Company, having a place of business in Midland, Michigan, USA. 2181, MONDUR MP210 available from Bayer, Leverkusen, Germany; and RUBINATE 1209 and RUBINATE 1790 available from Huntsman Corporation, Salt Lake City, Utah, USA.

[0077] As referenced above, the cushioning polymer 132 of the present disclosure can also contain a polyol component. Such a polyol component can be comprised of virtually any polymeric compound having elastomeric properties and functional alcohol groups. For example, suitable polymeric compounds include, among others, polydienes. An example of a polydiene is polybutadiene. Typically, the polybutadiene is a low-molecular-weight hydroxyl-terminated polybutadiene resin, such as POLY BD R45 HTLO available from Cray Valley, Inc., Exton, Pennsylvania, USA. Such polyols contain primary allylic alcohol groups that are highly reactive in condensation polymerization reactions.

[0078] As referenced above, the cushioning polymer 132 of the present disclosure can also contain epoxidized triglyceride plasticizers, such as epoxidized animal oils and epoxidized vegetable oils. For example, suitable epoxidized vegetable oil plasticizers include, among others, epoxidized soybean oil, epoxidized linseed oil, epoxidized tall oil, epoxidized corn oil, epoxidized cottonseed oil, epoxidized perilla oil, epoxidized safflower oil, and the like. Epoxidized animal oils and epoxidized vegetable oils are typically obtained by epoxidizing triglycerides of unsaturated fatty acids and are also produced by epoxidizing reactive olefin groups in naturally occurring triglyceride oils. Typically, the olefin groups are epoxidized using peracids. A specific example of a suitable epoxidized triglyceride plasticizer is PARAPLEX G-62, available from Hallstar, Inc., having a place of business in Chicago, Illinois, USA, which is a high molecular weight epoxidized soybean oil on a carrier that has a secondary stabilizer for the vinyl groups. It has been discovered in this document that PARAPLEX G-62 functions as both a plasticizer and a processing aid.

[0079] In some embodiments, the reaction media from which the cushioning polymer 132 is derived (e.g., the starting material) can be reacted in the presence of a catalyst or activator. Suitable catalysts include, inter alia, tertiary amines (e.g., bis(dimethylaminoethyl) ether, trimethylamine, triethylamine, N-methylmorpholine, N-ethylmorpholine, N,N-dimethylbenzylamine, N,N-dimethylethanolamine, N,N,N',N'-tetramethyl-1,3-butanediamine, triethanolamine, 1,4-diazabicyclo[2,2,2]octane, [2,2,2]octane, N,N-dimethylcyclohexylamine, N-methyldicyclohexylamine, 1,8-diazabicyclo[5,4,0]undecene-7, and its salts, such as the phenol salt, hexanoate, and oleate, 2,4,6-tris(diaminomethyl)phenol, and the like, tertiary phosphines,phosphines (e.g., trialkylphosphines, dialkylbenzylphosphines, and the like), strong bases (e.g., alkali and alkaline earth metal hydroxides, alkoxides, and phenoxides), acidic metal salts of strong acids (e.g., ferric chloride, tin(IV) chloride, tin(II) chloride, antimony trichloride, bismuth nitrate and chloride, and the like), chelates of various metals (e.g., acetylacetone, benzoylacetone, trifluoroacetone, ethyl acetoacetate ... acetoacetate, salicylaldehyde, cyclopentanone-2-carboxylate, acetylacetone-imine, bis-acetylacetonealkylenedimines, salicylaldehydeimine, and the like, and from various metals, such as beryllium (Be), magnesium (Mg), zinc (Zn), cadmium (Cd), lead (Pb), titanium (Ti), zirconium (Zr), tin (Sn), arsenic (As), bismuth (Bi), chromium (Cr), molybdenum (Mo), manganese (Mn), iron (Fe), cobalt (Co),and the like); alcoholates and phenolates of various metals (e.g., titanium (OR) (Ti(OR)), tin (OR) (Sn(OR)), aluminum (OR) (Al(OR)), and the like, where R is alkyl or aryl, and the reaction products of the alcoholates include carboxylic acids, beta-diketones, and 2-(N,N-dialkylamino) alkanols, such as the well-known chelates of titanium); salts of organic acids with a variety of metals. metals (e.g., alkali metals, alkaline earth meals, aluminum (Al), tin (Sn), lead (Pb), manganese (Mn), cobalt (Co), nickel (Ni), and copper (Cu), such as sodium acetate, potassium laurate, calcium hexanoate, stannous acetate, stannous octoate, stannous oleate, lead octoate, metallic driers such as manganese and cobalt naphthenate, and the like), and organometallic derivatives of tetravalent tin derivates), trivalent and pentavalentand pentavalent arsenic (As), antimony (Sb), and bismuth (Bi); organometallic derivates of metal carbonyls of iron and cobalt; and organometallic derivates of mercury compounds (e.g., arylmercury carboxylates, phenylmercury acetate, and phenylmercury propionate, and the like).

[0080] Typically, the catalyst is an alkyl tin compound, such as dialkyltin salts of carboxylic acids (e.g., dibutyltin diacetate, dibutyltin dilaurate, dibutyltin maleate, dibutyltin diacetate, dioctyltin diacetate, dibutyltin-bis(4-methylaminobenzoate), dibutyltin-bis(6-methylaminocaproate), etc.), dialkyltin mercaptides (e.g., dialkyltin dimercaptide carboxylic acid ester), esters, etc.), trialkyltin hydroxide, dialkyltin oxide, dialkyltin dialkoxide, dialkyltin dichloride, and the like.Some examples of these compounds include, among others, trimethyltin hydroxide, tributyltin hydroxide, trioctyltin hydroxide, dibutyltin oxide, dioctyltin oxide, dilauryltin oxide, dibutyltin-bis(isopropoxide), dibutyltin-bis-(2-dimethylaminopentylate), dibutyltin dichloride, dioctylin dichloride, etc. A specific example of an alkyl tin compound is COTIN 430, which is available from Cambrex Co., Ltd., having a place of business in Itasca, Illinois, USA. The catalyst is dioctyltin carboxylate, available from Polyvinyl Chloride, Inc., which is a liquid organotin catalyst that is not sensitive to humidity and initiates relatively slower than other organotin catalysts.

[0081] In some embodiments, the cushioning polymer 132 of the present disclosure can include one or more additional additives. Such additives can include, among other things, fillers, pigments, surfactants, additional plasticizers, blowing agents, stabilizers, and the like. For example, if the reaction medium includes a blowing agent, the cushioning polymer 132 can be in the form of a polymer foam. Suitable blowing agents include, among other things, water, a chemically participating extender, carbon dioxide-producing agents (e.g., trichlorofluoromethane, methylene chloride, low boiling hydrocarbons, ethers, ketones, and the like), and the like.

[0082] In particular, in the production of foams, the reaction medium may have surface-active additives such as emulsifiers and foam stabilizers. Suitable emulsifiers include, among others, sodium salts of castor oil sulfonates, salts of fatty acids with amines (e.g., oleic acid diethylamine, stearic acid diethanol amine, etc.), alkali or ammonium salts of sulfonic acids (e.g., dodecyl benzene sulfonic acid, dinaphthylmethane disulfonic acids, etc.), alkali or ammonium salts of fatty acids (e.g., ricinoleic acid, etc.), polymeric fatty acids, and the like. Suitable foam stabilizers include, inter alia, polyether siloxanes, especially water-soluble block copolymers of siloxane and polyether. These mixtures are generally prepared by joining a copolymer of ethylene oxide and propylene oxide or a homopolymer of ethylene oxide to a polydimethylsiloxane radical.Suitable stabilizers combat the effects of aging and weathering and also have fungistatic and bacteriostatic properties, including, inter alia, phenolic and aromatic amine antioxidants, UV stabilizers, hindered carbodiimides known to retard hydrolysis and oxidation, arsenic fungicidal compounds, tin and arsenic fungicidal compounds, and the like.

[0083] Fillers that can be used for extension or reinforcement of the polymeric elastomers and foams of the present invention include, among others, amorphous silicone hydroxides, carbon black, walnut and pecan shells, cork, cellulose, starch, calcium carbide, zinc oxide, titanium dioxide, clays, calcium wallastonite, and the like.

[0084] 1A-2B, as referenced above, the thermal support member 120 further includes one or more thermal elements 140. The thermal elements 140 can be at least partially, or more preferably entirely, enclosed within the polymer member 130. However, it should be understood that at least a portion of the thermal elements 140 may need to protrude or extend outside the polymer member 130 as an extended portion, for example, for connection to a controller or other operating device, without departing from the scope of the present invention.

[0085] The purpose of the thermal element 140 is to provide a heating and / or cooling effect to the user. In some preferred embodiments, the thermal element 140 can have both heating and cooling capabilities. Preferably, heat / energy transfer between the thermal element 140 and the user is conducted through the cushioning polymer 132, which is a component of the thermal support member 120. In some embodiments, this type of heating and / or cooling effect can be achieved using energy (e.g., electricity). In some more preferred embodiments, such heating and / or cooling effects may be achieved by using heated or cooled liquids and / or gases (e.g., air, water, steam, Freon, etc.) that may be passed through the thermal element 140, which typically has a substantially hollow structure (e.g., tubing, piping, HVAC ducting, etc.). However, it should be understood that other thermal transfer Other heat transfer techniques known to those skilled in the art (e.g., conduction, induction, convection, radiation, etc.) may also be utilized without departing from the scope of the present invention, in which case the thermal element 140 may or may not be substantially hollow. In some embodiments, the present invention may utilize a combination of multiple types of thermal element 140 without departing from the scope of the present invention.

[0086] In one non-limiting example, the thermal element 140 is flexible ¼ inch (6.4 mm) polyethylene (PEX) tubing, such as SHARKBITE SKU No. U850W50 PEX-B pipe available from RWC, Inc., having a business location in Atlanta, Georgia, USA. Other suitable thermal element 140 materials include, among others, plastics (e.g., PVC, polypropylene, styrene-butadiene copolymer, etc.), rubber, and metals (e.g., copper, steel, iron, chromium, nickel, titanium, zirconium, etc.), and combinations thereof, as well as other thermally conductive materials known to those skilled in the art.

[0087] If the inventive pressure ulcer prevention device 100 has the ability to incline, declinate, or fold, it may be desirable for the thermal element 140 to have flexible portions at at least some bending points that allow the pressure ulcer prevention device 100 to conform while the thermal support member 120 remains fully functional.

[0088] 1A , in some preferred embodiments, the thermal support member 120 can include a thermal device component 200 that can be interconnected (e.g., coupled) to the thermal element 140. The purpose of the thermal device component 200 is to provide a heated and / or cooled fluid (e.g., liquid or gas) or energy (e.g., thermal energy) to the thermal element 140. Suitable thermal device components 200 include those known to those skilled in the art, such as heat pumps (e.g., devices that transfer heat from a low-temperature heat source to a high-temperature heat source), air conditioning systems, furnaces (e.g., heating furnaces), boilers (e.g., devices that heat a liquid, such as water, to produce a high-temperature liquid or vapor for circulation), heating elements (e.g., heating wires), electrical connections, and the like.

[0089] In some embodiments, the thermal support member 120 and / or the thermal device component 200 can include sensors (not shown), which can be interconnected (e.g., electrically coupled) to a controller (not shown). Additionally, the thermal support member 120 and / or the thermal device 200 can include a user interface (not shown). For example, such a user interface can be located proximate the thermal support member 120 or the thermal device 200 and / or such a user interface can be located remotely (e.g., wirelessly). Suitable sensors, controllers, and user interfaces include those known to those skilled in the art, and may include those described in U.S. Pat. No. 6,584,628 to Kummer et al., U.S. Pat. No. 7,480,953 to Romano et al., U.S. Pat. No. 7,931,607 to Biondo et al., U.S. Pat. No. 7,975,335 to O'Keefe et al., U.S. Pat. No. 8,108,957 to Richards et al., U.S. Pat. No. 8,108,957 to Newkirk et al., and U.S. Pat. No. 8,108,957 to Newkirk et al. No. 8,973,186 to Bhai, U.S. Pat. No. 9,468,307 to Lafleche et al., U.S. Pat. No. 10,426,681 to Gibson et al., U.S. Pat. No. 10,827,844 to McKnight et al., U.S. Patent Application Publication No. 2016 / 0250088 to Williamson et al., and International Publication No. WO 2016 / 167617 A1, the invention of which is entitled "Mattress for Massage," each of which is incorporated by reference into this document in a manner not inconsistent herewith.

[0090] In some embodiments, the thermal support member 120 can optionally include a thermal element support component (e.g., a component for supporting the thermal element 140) 144. As referenced above, the thermal element 140 can be at least partially enclosed within the polymeric member (e.g., the polymeric member 130). Desirably, the length and width of the thermal element 140 will be substantially parallel to (e.g., in-plane with) the plane of the top side of the polymeric member 130 (and thus the top side of the thermal support member 120), which helps ensure a more uniform or even heating and / or cooling effect, although this may not be necessary (e.g., if a non-uniform heating and / or cooling effect is desired). Depending on the flexibility and / or construction material of a particular thermal element 140, it may be difficult to maintain the thermal element 140 substantially level (i.e., planarly parallel to the top side of the polymeric member 130) during the manufacturing process of the thermal support member 120. Thus, in some instances, it may be desirable to include one or more optional thermal element support components 144 to assist in keeping the thermal element 140 at a specified height (i.e., having a specified contour) along its length and width during the manufacturing process.Desirably, any such thermal element support components 144 will be flexible so as not to interfere with the function of the thermal support member 120. Suitable thermal element support components 144 include those known to those skilled in the art, such as foam, string, tape, hook-and-loop fasteners, and the like, as well as combinations thereof. In one non-limiting example, a flexible thermoplastic foam (e.g., standard mattress foam) can have a length and width generally equivalent to the length and width of a particular thermal element 140 and can have a predetermined height (and / or contour) that corresponds to the height of the thermal element 140 when desired to be disposed within the polymeric member 130. Thus, one or more support component(s) (such as thermal element support component(s) 144) can be placed within or attached to a mold (not shown). Thermal element 140 can then be placed on or attached to the top side of one or more thermal element support components 144 while a polymer-based reaction medium is continuously added to the mold.Alternatively, if the thermal element 140 remains fluid within the reaction medium, it may be desirable to fasten the thermal element 140 to the thermal element support component 144 (e.g., by stitching, tape, glue, hook-and-loop, etc.), or alternatively, to place the thermal element support component 144 on top of the thermal element 140.

[0091] In some embodiments, the thermal support member 120 can optionally include a bottom-side barrier layer 136. This optional bottom-side barrier layer 136 is typically disposed in a laid-flat configuration on the flat bottom side of the polymer member 130 (and thus the bottom side 122 of the thermal support member 120), thereby forming a laminated structure. The purpose of the optional bottom-side barrier layer 136 is, among other things, to prevent direct contact between the polymer member 130 and the top side 151 of the massaging member 150 and / or to prevent potential leakage of plasticizers, if present, that may be generated from the cushioning polymer 132 that is a component of the polymer member 130. A suitable bottom-side barrier layer 136 may desirably have the form of a substrate and may comprise materials known to those skilled in the art, such as plastics (e.g., polyethylene, polypropylene, PVC, etc.), polyester, elastic webbing, spandex, vinyl, thermoplastic foam, thermoset foam, natural and synthetic leather, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated woven textiles, Teflon, and the like, as well as combinations thereof.The optional bottom-side barrier layer 136 may have a functional thickness, but is typically relatively thin, e.g., in the range of about 0.1 mm to about 1 mm. However, it should be understood that the optional bottom-side barrier layer 136 can have a thickness less than 0.1 mm or greater than 1 mm without departing from the scope of the present invention. Typically, the optional bottom-side barrier layer 136 can be adhered (e.g., bonded) to the bottom side 122 of the thermal support member 120 so that the bottom-side barrier layer 136 is placed in contact with the reactive medium (i.e., prior to fully curing), which forms the cushioning polymer 132 as a component of the polymer member 130 during production. Alternatively, such optional bottom-side barrier layer 136 can be attached to the polymeric member 130 post-production using attachment means known to those skilled in the art (e.g., stitching, adhesives, mechanical fasteners, etc.) without departing from the scope of the present invention.

[0092] In some embodiments, the thermal support member 120 can optionally include a top side barrier layer (top side protective layer, etc.) 138. This type of top side barrier layer 138 is typically placed in a laid-flat configuration on the generally flat top side of the polymer member 130 (and thus the top side 121 of the thermal support member 120), thereby forming a laminated-type structure. The purpose of the optional top side barrier layer 138 is, among other things, to prevent direct contact with the polymer member 130, to provide an aesthetically desirable feel to the top side 121 of the thermal support member 120, and / or to prevent potential leakage of plasticizers (if present) that may be generated from the cushioning polymer 132 that is a component of the polymer member 130.Suitable top and side barrier layers 138 may desirably have the form of a substrate or pad and may be made of materials known to those skilled in the art, such as plastics (e.g., polyethylene, polypropylene, PVC, etc.), polyester, elastic webbing, spandex, vinyl, thermoplastic foam, thermoset foam, natural and synthetic leather, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated woven textiles, cotton padding, wool padding, and the like. The optional top-side barrier layer 138 may have a functional thickness, but will typically be relatively thin, for example, in the range of about 0.1 mm to about 10 mm. However, it should be understood that the optional top-side barrier layer 138 can have a thickness that is less than 0.1 mm or greater than 10 mm without departing from the scope of the present invention.Typically, optional top-side barrier layer 138 can be adhered (e.g., bonded) to top side 121 of thermal support member 120 so that top-side barrier layer 138 is placed in contact with the reactive medium (i.e., prior to fully curing), which reactive medium forms cushioning polymer 132 of polymer member 130 during production. Alternatively, such optional top-side barrier layer 138 can be attached to polymer member 130 post-production using attachment means known to those skilled in the art (e.g., stitching, adhesives, mechanical fasteners, etc.) without departing from the scope of the present invention.

[0093] As referenced above, in some embodiments, the thermal support member 120 can optionally include a sheath member 110 that can be disposed over and / or at least partially surround or encase the thermal support member 120 (see, e.g., FIG. 1A ). This type of flexible sheath member 110 can be desirable for a number of reasons, including, among others, visual aesthetics, surface feel, additional structural support, a plasticizer leakage barrier, and the like. Suitable sheath member 110 may be made of materials known to those skilled in the art, such as plastics (e.g., polyethylene, polypropylene, PVC, etc.), polyester, elastic webbing (elastic, rubber-like strings, strips, etc.), spandex (elastic polyurethane fiber), satin (silk, synthetic satin, etc.), sateen (cotton woven satin fabric, etc.), vinyl, thermoplastic foam, thermoset foam, natural and synthetic leather, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated woven fabrics, etc. It is possible to have materials such as textiles, cotton, wool, handwoven fabrics, felt and the like, as well as combinations thereof.Desirably, this type of sheathing member 110 will have flexibility at least equal to or greater than that of the thermal support member 120, which is a component of the inventive pressure ulcer prevention device 100, though this need not be the case. The optional sheathing member 110 may have any functional thickness, but will typically be relatively thin, for example, in the range of about 0.5 mm to about 10 mm. However, it should be understood that the optional sheathing member 110 can have a thickness less than 0.5 mm or greater than 10 mm without departing from the scope of the present invention.

[0094] In some embodiments, the thermal support member 120 can optionally have a flexible or semi-rigid (e.g., horizontal) bottom support member (e.g., a horizontal bottom support member) (not shown) that can be at least partially disposed on the bottom side 122 of the thermal support member 120. Such horizontal bottom support members may be desirable to provide additional support to the polymeric member 130 and / or to provide variable support (e.g., variation in firmness, resistance to external force or deformation, stiffness, etc.) to certain regions of the user's body. Suitable bottom support members are known to those skilled in the art and include, for example, substrates, cushions, pads, air bladders, rails, blocks, and the like.

[0095] In some embodiments, the thermal support member 120 can optionally be flexible or semi-rigid and have vertical (e.g., vertically extending) side support members (e.g., members that support sides or sides) (not shown) that can be positioned at least partially along one or more of the vertical (e.g., vertically extending) side 123, 124, 125, 126 portions of the thermal support member 120 (i.e., at least partially along the outer perimeter of the thermal support member 120 and / or at least partially along the z-axis 3). Such one or more vertical side support members may be desirable to provide additional confining support to the polymeric member 130. Such side support members include those known to those skilled in the art and can include several materials, including, but not limited to, plastic, fiberglass, wood, metal, and the like.

[0096] The present invention also includes a method for manufacturing the thermal support member 120. One exemplary, but non-limiting, method includes: A. Providing a suitable mold (not shown), optionally having a suitably sized opening through which the extension 142 of the thermal element 140 can fit closely (e.g., securely); B. Placing the mold on a suitable surface; C. Optionally, placing a bottom-side barrier layer 136 in the mold in a flat position on the surface; D. Optionally, aligning and placing vertical side support members within the mold at inner periphery locations; E. Optionally, aligning and placing a thermal element support component 144 into the mold or on the top side of the optional bottom side barrier layer 136; F. aligning and placing a thermal element 140 into the mold and / or onto the top side of the optional thermal element support component 144; G. positioning the thermal element 140 and optional thermal element support component 144 so that the extension 142 of the thermal element 140 extends through the designated opening(s) within the mold; H. Preparing a suitable liquid polymer-based reaction medium; I. Disposing (positioning, etc.) a quantity of liquid reaction medium within the mold, preferably so that the reaction medium substantially covers (i.e., envelops) the thermal element 140; J. Optionally, aligning and placing a top-side barrier layer 138 in a flat position on the flat top side of the liquid reaction medium; K. Allowing the reaction medium to fully cure to form a polymeric member 130; L. removing (e.g., removing from the mold, demolding, etc.) the combination (i.e., polymeric member 130 and thermal element 140, along with optional thermal element support component 144, if present, optional bottom side barrier layer 136, optional vertical side support member, if present, and optional top side barrier layer 138) to form an inventive thermal support member 120 of the present disclosure; It is possible to have: It should be understood that, as an alternative to optional step C, optional step D, and / or optional step J, the bottom side barrier layer 136, the vertical side support members, and / or the top side barrier layer 138 can be added to the thermal support member 120 after its fabrication. In some embodiments, the method can optionally include applying a sheathing member 110 to the thermal support member 120 (either before or after fabrication) to at least partially enclose the thermal support member 120. Furthermore, the method can additionally or alternatively include disposing a horizontal bottom support member (e.g., the horizontal bottom support member) on the flat bottom side 122 of the thermal support member 120.

[0097] 1A-1B and further referring to FIGS. 3A-3B, the pressure ulcer prevention device 100 of the invention further includes a massage member 150. The purpose of the massage member 150 is to perform at least slight, and more preferably significant, physical manipulation (manipulation, manual or manual measures to relieve joint contracture, closed joint manipulation, etc.) or physical impact on at least a portion of the user's body. Therefore, the massage member 150 includes one or more manipulation elements 170, which indirectly contact the user via the thermal support member 120.

[0098] The massaging member 150 is typically positioned below the thermal support member 120 such that the manipulation element 170 contacts and impresses into the bottom side 122 of the thermal support member 120. In some desirable embodiments, the massaging member 150 has a generally horizontally extending first or top side 151, an opposing (e.g., disposed opposite the first side 151) and generally horizontally extending second or bottom side 152 that is distal to the first side 151, and a vertically extending third or "head" generally flat side or end 153 that is disposed between the first side 151 and the second side 152 and perpendicular to the respective sides. a vertically extending fourth or "foot" generally flat side or end 154 (e.g., facing the third side 153) distal to the third side 153; a vertically extending fifth generally flat side 155 (e.g., facing the first side 151 and the second side 152, and e.g., facing the third side 153 and the fourth side 154) disposed perpendicular to each other; and a vertically extending sixth generally flat side 156 (e.g., facing the fifth side 155) distal to the fifth side 155. In some embodiments, the massage member 150 may have outer dimensions (e.g., several dimensions, multiple dimensions or dimensions) in the x-y plane that are substantially equivalent to the outer dimensions (e.g., several dimensions, multiple dimensions or dimensions) in the x-y plane of the thermal support member 120 (and thus of the pressure ulcer prevention device 100).In some other embodiments, the length and width of the housing component 160 of the massaging member 150 can be greater than the length and width of the thermal support member 120 such that the bottom side 122 of the thermal support member 120 rests solely on a manipulation element 170 disposed within the massaging member 150. It should be understood that the massaging member 150 can have dimensions along x-axis 1 and / or y-axis 2 that are shorter, equal to, or longer than the dimensions in the x-y plane of the thermal support member 120 without departing from the scope of the present invention. Meanwhile, the massaging member 150 can exist as a single component, or as multiple, separate components each positioned in particular positions adjacent the bottom side 122 of the thermal support member 120. For simplicity, the massaging member 150 will be described herein as having the form of a single component.

[0099] In some preferred embodiments, the massage member 150 may have a framework or housing component 160, in which case one or more manipulation elements 170 may be disposed substantially within an interior portion of such a housing component 160. Thus, the housing component 160 will typically comprise a rigid or semi-rigid material, although flexible materials may be suitable in some embodiments without departing from the scope of the present invention. Suitable materials for use in the housing component 160 include those known to those skilled in the art, such as metal, wood, plastic, fiberglass, and the like, as well as combinations thereof. Alternatively, the housing component 160 may exist as a single component or may comprise a composite of various sections. For example, in one non-limiting representative example, the housing component 160 can have an outer frame element 162 and several interconnecting cross member elements 164, which can provide support structure and / or respective mounting locations for one or more manipulation elements 170.In some desirable embodiments, the housing component 160 may optionally have several elevation elements 166 (e.g., several legs) that can assist in setting the inventive device 100 at a particular height (e.g., measured from the floor, e.g., the surface or floor on which the device 100 is placed). Such optional elevation elements 166 may be fixed or height-adjustable without departing from the scope of the present invention. Suitable elevation elements 166 include those known to those skilled in the art, including rails, pegs, blocks, wheels, rollers, and the like, as well as combinations thereof.

[0100] As referenced above, the massage member 150 also includes one or more manipulation elements 170. The purpose of the manipulation elements 170 is to apply an impactful force to at least a portion of the user's body via the thermal support member 120. In some preferred embodiments, a plurality of such forces are applied intermittently to provide a massage or other similar therapeutic effect on at least a portion of the user's body. The plurality of such forces may vary in different areas, for example, to provide a higher force in some areas and a relatively lower force in other areas, though this need not be without departing from the scope of the invention. In some embodiments, this type of differentiation of forces (if desired) can be achieved by using a combination of manipulation elements 170 of different sizes or types, while in other embodiments, the application of varying forces can be achieved using manipulation elements 170 of the same type and size.In one non-limiting example, the massage member 170 can have a housing component 160 having a frame element 162 and multiple cross member elements 164, and can further have a combination of different manipulation elements 170 having a first type of manipulation element 170A (e.g., in the form of a camshaft that rotates around an axis) and a second type of manipulation element 170B (e.g., in the form of roller balls mounted on rotatable wheels) (see, for example, Figures 3A-3B). In this illustrated, non-limiting example, a plurality of the first type manipulation elements 170A may extend substantially along the length (x-axis 1) of the massage member 150 within the housing component 160 and may be spaced apart along the width (y-axis 2) of the massage member 150, while a plurality of the second type manipulation elements 170B may be aligned substantially across the width of the housing component 160, e.g., generally at the user's lower back and buttocks.If some outer edges of the bottom side 122 of the thermal support member 120 are intended to rest on the housing component 160, the height (along the z-axis 3) of each manipulation element 170 can desirably be greater than the height of the housing component 160 to help ensure that the manipulation element 170 can be pushed sufficiently into the thermal support member 120 to generate impactful forces that are perceptible by a user positioned on the top side 121 of the thermal support member 120. In contrast, if the thermal support member 120 is sized to fit within the housing component 160 and rest substantially on the manipulation element 170, such issues are less important.

[0101] Any suitable manipulation element 170 can be utilized for the massage member 150, including those known to those skilled in the art, such as rollers, balls, knobs, cones, ridges, pistons, plungers, cams, augers, bladders, vibrating elements, and the like, as well as combinations thereof. Several such manipulation elements 170 are disclosed and described in the aforementioned U.S. Provisional Patent Application No. 63 / 306,490 to Kriesel et al., entitled "Decubitus Prevention Device," which is incorporated herein by reference in its entirety.Suitable manipulation elements 170 include those disclosed in U.S. Patent No. 5,303,436 to Dinsmoor, III et al., U.S. Patent No. 6,584,628 to Kummer et al., U.S. Patent No. 7,260,860 to Chambers et al., U.S. Patent No. 7,716,766 to Poulos, U.S. Patent No. 7,914,471 to Chen, U.S. Patent No. 7,937,791 to Meyer et al., U.S. Patent No. 8,683,633 to Cao, U.S. Patent No. 8,910,334 to Lafleche et al., U.S. Patent No. 9,204,732 to Wyatt et al., International Publication WO 2018 / 033114 A1 entitled "Massage Mattress," and Chinese Patent No. 109512597 A entitled "A Kind of Multifunctional Ball Massage." The present invention may include those described in Chinese Patent No. 208355066 U, the invention of which is titled "A Kind of Massage Mattress," Chinese Patent No. 210870679 U, the invention of which is titled "Multifunctional Massage Mattress," Korean Patent No. 20140088748A, the invention of which is titled "Massage Chair," Korean Patent No. 20170098740A, the invention of which is titled "Massage Chair with Rollers for Back and Thigh," Korean Patent No. 20170122526A, the invention of which is titled "A Massage Chair," and Korean Patent No. 20170123803A, the invention of which is titled "Massage Mattress," and each of these patents or publications is incorporated herein by reference in a manner not inconsistent with this document.

[0102] Such manipulation elements 170 can be operated using means known to those skilled in the art, such as motors, servos, pumps, vacuums, and the like, as well as combinations thereof. In some embodiments, multiple manipulation elements 170 can be interconnected using drive shafts, belts, and / or other similar means known to those skilled in the art. If the inventive pressure ulcer prevention device 100 is capable of inclining, declining, folding, or otherwise bending, it may be desirable to have several hinges (e.g., hinges, movable fulcrums, movable connections, etc.) on the housing component 160 and several couplings, or other suitable means known to those skilled in the art, present on the actuation mechanism of the manipulation element 170 to enable the pressure ulcer prevention device 100 to conform to the several bends described above while remaining fully functional.

[0103] The thickness (i.e., height as measured along z-axis 3) of massage member 150 is not limited to any particular measurement and will depend, at least in part, on numerous factors, including, among others, certain dimensions of the housing or framework 160, certain dimensions of one or more manipulation elements 170, the type of one or more manipulation elements 170, the desired amount of penetration of the manipulation elements 170 into the bottom side 122 of the thermal support member 120, and the desired gap between the bottom side 152 of the massage member 150 and the bottom side of a particular manipulation element 170. In some embodiments, the thickness or height of the massaging members 150 is such that the housing or framework 160 (housing component 160) is at least substantially equal to or less than the height of the manipulation element 170 disposed therein, though this need not be without departing from the scope of the invention. Generally, the overall height of the massaging members 150 (excluding any optional elevation elements 166) can be in the range of 10 cm to about 40 cm. However, it should be understood that the massaging members 150 can have heights less than 10 cm or greater than 40 cm without departing from the scope of the invention.

[0104] As referenced above, in some embodiments, the massaging members 150 may optionally include a sheath member 110 that may be disposed over and / or at least partially surround or house the massaging members 150. This type of flexible sheath member 110 may be desirable for a number of reasons, including, among others, visual aesthetics, additional structural support, protection of the bottom side 152 of the massaging members 150, protection of the manipulation element 170 from plasticizers (if present) potentially leaking from the thermal support member 120, and the like. Suitable sheathing members 110 may be made of materials known to those skilled in the art, such as plastics (e.g., polyethylene, polypropylene, PVC, etc.), Teflon, polyester, elastic webbing (e.g., elastic, rubber-like cords, strips, etc.), damask, spandex (e.g., polyurethane elastic fiber), satin (e.g., silk, synthetic satin, etc.), sateen (e.g., cotton woven satin fabric), vinyl, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated woven textiles, cotton, wool (e.g., handwoven fabrics), felt, natural and synthetic leather. The material may include, for example, leather, natural and synthetic rubbers, and the like, as well as combinations thereof.Desirably, this type of sheath member 110 will have flexibility that does not attenuate the impact force of the manipulation element 170. This optional sheath member 110 may have any functional thickness, but will typically be relatively thin, for example, in the range of about 0.5 mm to about 10 mm. However, it should be understood that the optional sheath member 110 can have a thickness that is less than 0.5 mm or greater than 10 mm without departing from the scope of the present invention.

[0105] The present disclosure further includes a first method of manufacturing the inventive pressure ulcer prevention device 100. In this embodiment, the method comprises: A. providing a thermal support member 120 as described above; B. Providing a massaging member 150 as described above; C. placing the bottom side 122 of the thermal support member 120 onto the top side 151 of the massaging member 150 to form the pressure ulcer prevention device 100 of the present disclosure; D. Optionally, at least partially encasing the pressure ulcer prevention device 100 within a sheath member 110; It is possible to include:

[0106] 4A-4B, another embodiment of the inventive pressure ulcer prevention device 100 includes a thermal support member 120 (described above) disposed on a top side 151 of a massaging member 150 (described above), and further includes a therapeutic member 300 disposed on the top side 121 of the thermal support member 120. In some aspects of this embodiment, the inventive pressure ulcer prevention device 100 can additionally include an optional sheath member 110 (e.g., a mattress cover, etc.) that can at least partially cover or encase the therapeutic member 300, the thermal support member 120, and / or the massaging member 150. This type of sheath member 110 may, for example, among other things, provide the device 100 with an aesthetically pleasing surface feel, provide the device 100 with an aesthetically pleasing visual appearance, help prevent potential leakage of plasticizer (if any) from the polymer member 130 and / or the therapeutic member 300, reduce the level of any sound emitted by the device 100, assist in maintaining the positions of the therapeutic member 300, the thermal support member 120, and the massage member 150 relative to one another, and provide the device 100 as a single unit.Some materials suitable for use as the sheathing member 110 are known to those skilled in the art, including, for example, plastics (e.g., polyethylene, polypropylene, polyvinyl chloride (PVC), etc.), polyester, elastic webbing (e.g., elastic, rubbery cords, strips, etc.), damask, spandex, satin, sateen (e.g., sateen), vinyl, thermoplastic foam, thermoset foam, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated or uncoated woven fabrics, and the like. Examples of suitable materials for the sheathing member 110 include textiles, cotton, wool, handwoven fabrics, felt, natural and synthetic leather, natural and synthetic rubbers, and the like, as well as combinations thereof. Desirably, this type of sheathing member 110 will have flexibility at least equal to or greater than that of the therapeutic member 300, a component of the inventive pressure ulcer prevention device 100, for this embodiment, though this need not be the case. The optional sheathing member 110 may have any functional thickness, but will typically be relatively thin, for example, in the range of about 0.5 mm to about 10 mm. However, it should be understood that the optional sheathing member 110 can have a thickness less than 0.5 mm or greater than 10 mm without departing from the scope of the present invention.

[0107] In some aspects of this embodiment, the pressure ulcer prevention device 100 of the invention may further include additional layers (e.g., a nonwoven layer, a foam layer, a felt layer, etc.) (not shown) that may be positioned above the therapeutic member 300, below the massaging member 150, between the therapeutic member 300 and the massaging member 150, and / or along side portions (face portions, main surfaces, sides, side edges, end portions, etc.) of each of the therapeutic member 300, the thermal support member 120, and / or the massaging member 150 without departing from the scope of the present invention.

[0108] The purpose of the therapeutic member 300 is to provide additional comfort to the user, to provide a therapeutic effect to the user, to more evenly distribute the heating and / or cooling effect provided by the thermal support member 120, and / or to distribute or absorb some of the impulsive force provided by the massage member 150. In some aspects, despite the presence of the thermal support member 120, the therapeutic member 300 can additionally transfer heat and moisture away from the user.

[0109] As illustrated in the non-limiting examples shown in FIGS. 4A-4B, and with further reference to FIGS. 5A-6B, the therapeutic member 300 includes a generally horizontally extending first or top (top, upper), major, planar side 301, an opposing (e.g., disposed opposite the first side 301) and generally horizontally extending second or bottom (bottom, lower), major, planar side 302 distal to the first side 301, and a vertically extending third or "head," generally planar side, end (e.g., edge) 303 extending between the first side 301 and the second side 302 and perpendicular to each other. a fourth or "foot" generally planar side, end, or edge 304 disposed opposite (e.g., opposite the third side 303) and extending perpendicularly thereto, distal to the third side 303; a fifth generally planar vertical side 305 disposed perpendicularly thereto between the first side 301 and the second side 302 and between the third side 303 and the fourth side 304; and a sixth generally planar vertical side 306 disposed opposite (e.g., opposite the fifth side 305) and extending perpendicularly thereto, distal to the fifth side 305.

[0110] In some desirable aspects of this embodiment, the therapeutic member 300 may have dimensions in the x-y plane that are substantially equivalent to the dimensions in the x-y plane of the thermal support member 120. However, it should be understood that the therapeutic member 300 may have dimensions along the x-axis 1 or y-axis 2 that are shorter or longer than the dimensions in the x-y plane of the thermal support member 120 without departing from the scope of the present invention. On the other hand, the top side 301 of the therapeutic member 300 may have a generally flat surface or may have contours or other three-dimensional (i.e., non-flat) surface characteristics without departing from the scope of this invention. Furthermore, the height or thickness (i.e., measured along the z-axis 3) of the therapeutic member 300 can be generally uniform or variable. For example, the therapeutic member 300 can have a greater thickness in one or more particular locations (e.g., lumbar support, head support, etc.) than in other locations without departing from the scope of this invention. Generally, the therapeutic member 300 can have an average thickness (i.e., measured along the z-axis 3) ranging from about 1 cm to about 40 cm, for example, from about 1.5 cm to about 30 cm, or from about 2 cm to about 20 cm.However, it should be understood that the therapeutic member 300 can have an average thickness that is less than 1 cm or greater than 30 cm without departing from the scope of the present invention.

[0111] 5A-6B, in one non-limiting example of this embodiment, a therapeutic member 300 can include a mitigation member (e.g., a buffer member, a cushioning member, an absorber member, etc.) 310 and a thermally conductive polymer 330, wherein the thermally conductive polymer 330 is disposed to extend at least partially through the mitigation member 310 and generally along the z-axis 3. Typically, the thermally conductive polymer 330 will be applied to the mitigation member 310 in the form of a liquid (i.e., uncured or partially cured) reactive medium. In some embodiments, the thermally conductive polymer 330 can be disposed within the mitigation element 310 (e.g., generally in the z-direction 3) by virtue of the reaction medium soaking (e.g., being drawn into) the mitigation element 310 (e.g., by migrating into and / or through a plurality of continuous cells of a foam). More specifically, the mitigation element 310 can have a plurality of perforations or apertures disposed (typically generally in the z-direction 3) at least partially through the mitigation element 310 to provide a plurality of channels 322 for the reaction medium to flow through.

[0112] 5A-5B, the mitigation member 310 has a generally horizontally extending first or top (e.g., upper) major, planar side 311, an opposing (e.g., disposed opposite the first side 311) and generally horizontally extending second or bottom (e.g., lower) major, planar side 312 distal to the first side 311, and a vertically extending third or "head" generally planar side, end (e.g., end) or edge 313 disposed between the first side 311 and the second side 312 and perpendicular to the respective sides. The first and second sides 311, 312 and the third and fourth sides 313, 314 may include a vertically extending, fourth or "foot" generally planar side, end, end, or edge 314 (e.g., facing, disposed opposite, the third side 313) distal to the third side 313; a vertically extending, fifth, generally planar side 315 (e.g., facing, disposed opposite, the fifth side 315) disposed perpendicular to each other between the first and second sides 311, 312 and between the third and fourth sides 313, 314; and a vertically extending, sixth, generally planar side 316 (e.g., facing, disposed opposite, the fifth side 315) distal to the fifth side 315. In some aspects of this embodiment, the thermally conductive polymer 330 is completely impregnated into the top side 311 of the mitigation member 310 (i.e., the polymer 330 does not form a layer on the top surface of the mitigation member 310), and in some aspects, some dimensions of the mitigation member 310 can substantially define the length (measured along x-axis 1), width (measured along y-axis 2), or height (measured along z-axis 3) of the therapeutic member 300.In other aspects, the thermally conductive polymer 330 forms a layer on top of the top side 311 of the mitigation member 310, and in other aspects, the height of the therapeutic member 300 may be greater than the height of the mitigation member 310 alone. However, depending on the type of material used to form the mitigation member 310, the presence of the thermally conductive polymer 330 may cause the sides 313, 314, 315, and 316 of the mitigation member 310 to expand and / or deform (e.g., blow out) in length and / or width.

[0113] The top side 311 of the mitigation member 310 may have a generally flat surface or may have contours or other three-dimensional (i.e., non-flat) surface characteristics without departing from the scope of the present invention. Furthermore, the height or thickness (measured along the z-axis 3) of the mitigation member 310 can be generally uniform or variable. For example, the mitigation member 310 can have a greater thickness in one or more specific locations (e.g., lumbar support, head support, etc.) without departing from the scope of the present invention. Generally, the mitigation member 310 can have an average thickness ranging from about 1 cm to about 30 cm, such as from about 1.5 cm to about 20 cm, or from about 2 cm to about 10 cm.

[0114] The mitigation member 310 can comprise any material that achieves desired softness (e.g., surface characteristics such as the softness of the material's touch or texture), resiliency (e.g., rebound), flexibility, absorbency (e.g., the ability to absorb liquids or gases), and / or cushioning effect. Typically, the mitigation member 310 will comprise a foam that is relatively soft, flexible, and resilient (e.g., compared to other foams), such as standard mattress foam. In some aspects, the mitigation member 310 is also absorbent. For example, a foam substrate suitable for use in mitigation element 310 has a density of 4200-245848 (a 1.5 pound per cubic foot / 17 ILD (Indentation Load Deflection), open cell polyether foam) available from American Converters, Inc., having a place of business in Fridley, Minnesota, USA.

[0115] By way of non-limiting example only, suitable foams can include elastomeric (e.g., polymer-elastic) thermoplastic foams. Generally, thermoplastic foams have a cellular structure in which cells are defined by membranes and struts. The struts are formed at intersections (junctions, etc.) between the cellular membranes, covering interconnecting cell windows (e.g., connecting adjacent cells to each other) between the struts. The foam may further include cell orifices within the membranes, which can provide doorways into adjacent cells. Thus, the foam may define a plurality of open and / or closed cells separated from one another by a plurality of cell membranes and a plurality of struts. The cell size may be in the range of about 10 microns to about 1000 microns, as measured in accordance with ASTM D3576. In some aspects, a "fine" foam may have a foam cell size in the range of about 10 microns to about 500 microns, e.g., about 20 microns to about 300 microns. In other aspects, a "coarse" foam may have a foam cell size in the range of about 500 microns to about 1000 microns. The specific number and size of cells may be determined by the foam formulation, as well as by selected processing parameters.

[0116] Generally, foams with low density and low bending modulus may achieve enhanced softness and flexibility. Thermoplastic elastomers can be added to further enhance softness, flexibility, and elasticity. Meanwhile, foams can be formulated and manufactured to exhibit low compression set.

[0117] Suitable foams may have substantially closed cells, substantially open cells, or a combination thereof. In some aspects, the foams may have an open cell structure of about 25% or more, e.g., about 50% or more, or about 75% or more, as measured using a gas pycnometer (e.g., a pycnometer) according to ASTM D2856, Method C. In other aspects, the foams may have a closed-cell content of at least about 25%, e.g., at least about 50% or at least about 75%, which may help improve resiliency and / or compression resistance.

[0118] The thermoplastic foam can also have a target basis weight (e.g., weight per unit area). For example, in some aspects, the foam can have a basis weight of about 300 gsm or less. The thermoplastic foam can also have a target density. For example, the foam can have a density within a range of about 0.01 g / cc to about 0.5 g / cc. Furthermore, the foam can be densified at some point after the manufacturing process to improve its functionality for a particular application.

[0119] Non-limiting exemplary thermoplastic foams can be made from at least one polymer that can be repeatedly heated, formed, and cooled. The starting materials utilized in the foam formulation can include at least one suitable base resin, which can include a single thermoplastic polymer, a blend of multiple thermoplastic polymers, or a blend of a thermoplastic polymer and a non-thermoplastic polymer. Some examples of base resins suitable for use in preparing the foams include styrene polymers, such as polystyrene or polystyrene copolymers or other alkenyl aromatic polymers; polyolefins, including homopolymers or copolymers of olefins, such as polyethylene, polypropylene, polybutylene, and the like; polyesters, such as polyalkylene terephthalate; and combinations thereof. For example, in some aspects, a suitable base resin is STYRON 685D polystyrene resin, available from Dow Chemical Company, having a place of business in Freeport, Texas, USA.

[0120] Coagents and compatibilizers (additives that improve the miscibility and interfacial adhesion of mixtures, etc.) can be used to blend several of these resins. Additionally, crosslinking agents can be employed to improve mechanical properties, foamability, and expansion. Such crosslinking can be achieved by several means, including the use of electron beams, or by chemical crosslinkers such as organic peroxides.

[0121] It is preferable to use several base resins that provide effective foamability, softness, and flexibility. In general, resins with branched polymer chains tend to have more foamability. In this sense, flexibility, softness and foamability can be manipulated by using several means, including the use of polymer side groups, the incorporation of chains within the polymer structure to prevent polymer crystallization, lowering the glass transition temperature, lowering the molecular weight distribution for a given polymer, adjusting the strength and viscous / elastic properties of the melt flow, including the elongational viscosity of the polymer melt, the use of block copolymerization, blending of multiple polymers, and the use of polyolefin homopolymers and polyolefin copolymers. homopolymers and copolymers, including low (e.g., linear low density), medium, and high density polyethylene and polypropylene, usually Ziegler-NattaThese include the use of polypropylenes made with tactic or Phillips catalysts, which are relatively linear and can be designed to have elastic and crystalline regions; syndiotactic, atactic, and isotactic polypropylenes, including those made with metallocene-based catalysts and blends of these polymers with other polymers; and olefin elastomers.

[0122] In some applications, it may be preferable to utilize resins that provide soft and / or extensively elastic foam composites. Softness and extensibility can be manipulated by several means, including the use of ethylene and α-olefin copolymers, especially those produced using Ziegler-Natta or metallocene catalysts, such as metallocene-catalyzed polyolefins; polyethylene crosslinked with α-olefins and various ethylene ionomer resins; and ethyl-vinyl acetate copolymers with other polyolefin-type resins.

[0123] Common modifiers for various polymers can be reacted with the chain groups to achieve the desired functionality. This includes the use of alkenyl aromatic polymers and ionomer resins. Suitable alkenyl aromatic polymers include alkenyl aromatic homopolymers, copolymers of alkenyl aromatic compounds with copolymerizable ethylenically unsaturated comonomers and minor proportions of some non-alkenyl aromatic polymers, and blends thereof.

[0124] The thermoplastic base resin can also include blends of the thermoplastic polymer with other polymers, such as natural and synthetic organic polymers (e.g., carbon-based polymers), including cellulosic polymers, methyl cellulose, polylactic acids, polyvinyl acids, polyacrylates, polycarbonates, starch-based polymers, polyetherimides, polyamides, polymethylmethacrylates, and copolymer / polymer blends.

[0125] In some aspects, the foam formulation can include a polyurethane base resin, such as a hydrophilic urethane prepolymer. Examples of suitable hydrophilic urethane prepolymers include isocyanate-terminated or capped polyoxyalkylene ethers, including polyoxyethylene polyol prepolymers. Other examples of suitable prepolymers are described in U.S. Pat. No. 4,137,200 to Woods et al., U.S. Pat. No. 4,209,605 to Hoy et al., U.S. Pat. No. 2,993,013 to Wolfe, Jr., and U.S. Pat. No. 3,805,532 to Kistner, each of which is incorporated herein by reference in a manner consistent with this disclosure. General procedures for the preparation of such prepolymers are described by J.H. Saunders and X.C. Frisch in "Polyurethanes Chemistry and Technology," published by Interscience Publishers; and in "Foam Systems," pp. 7-26, of "Vol. XVI, Part 2, High Polymer Series," published by John Wiley & Sons, New York, 1987; and in "Procedures for the Preparation of Prepolymers," p. 26 and subsequent portions, the contents of each of which are incorporated herein by reference in a manner consistent with this document.

[0126] In some aspects, the foam formulation can have a toluene diisocyanate (TDI) base resin terminated with a polyethylene polyol having less than 6% available unreacted NCO (isocyanate) groups and a component functionality of 2 or less, such as TREPOL, available from Rynel Ltd., Boothbay, Maine, USA. In other aspects, the base resin can have HYPOL 2000 / 3000 grade prepolymers, available from Dow Chemical Co., which are TDI-based water-activated polymeric liquid polyurethanes. Generally, a hydrophilic prepolymer is activated by the aqueous phase for polymerization upon mixing.

[0127] In addition to the base resin polymer described above, the foam formulation can also include at least one thermoplastic elastomer. For example, in some aspects, the foam formulation can contain up to about 95% (wt%) base resin, based on the weight of the foam formulation, e.g., about 50% to about 95% base resin, or about 50% to about 80% base resin and at least about 5% thermoplastic elastomer, e.g., about 5% to about 50% or about 20% to about 50% thermoplastic elastomer. In some aspects, the foam formulation can contain substantially equal amounts of base resin and thermoplastic elastomer.

[0128] Suitable thermoplastic elastomers include, but are not limited to, rubbers, including natural rubber, styrene-butadiene rubber (SBR), polybutadiene, ethylene propylene terpolymers, and vulcanized rubbers having thermoplastic vulcanizates (TPVs); rubber-modified polymers (rubber particle dispersed polymers, etc.), such as styrene elastomers, ethylene elastomers, butadiene, polybutadiene resins, diblock, triblock, tetrablock, or other multi-block thermoplastic elastomerics, and / or flexible copolymers; The copolymers are, for example, polyolefin-based thermoplastic elastomers, and the elastomers include random block copolymers including ethylene α-olefin copolymers, block copolymers including hydrogenated butadiene-isoprene-butadiene block copolymers, stereoblock polypropylenes, and graft copolymers, such as ethylene-propylene-diene terpolymers.These include ethylene-propylene-diene monomer (EPDM), ethylene-propylene random copolymers (EPM), ethylene-propylene rubbers (EPR), ethylene vinyl acetate (EVA), and ethylene-methyl acrylate (EMA), as well as styrenic block copolymers with diblock and triblock copolymers. Examples of suitable copolymers include styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-isoprene-butadiene-styrene (SIBS), styrene-ethylene / butylene-styrene (SEBS), or styrene-ethylene / propylene-styrene (SEPS). For example, the foam formulation can utilize KRATON, a thermoplastic elastomer available from Kraton Polymers, Inc., having a place of business in Houston, Texas, USA. In another example, the foam formulation can utilize VECTOR SIS and SBS, a thermoplastic elastomer available from Dexco, a division of ExxonMobil Chemical Company, having a place of business in Houston, Texas, USA. In yet another example, the foam formulation can utilize SEPTONSEBS is available, which is a thermoplastic elastomer available from Kuraray America, Inc., having a place of business in New York City, NY, USA.

[0129] Some other suitable thermoplastic elastomers can include blends of thermoplastic elastomers, such as dynamic vulcanized elastomer-thermoplastic blends, thermoplastic polyether ester elastomers, ionomeric thermoplastic elastomers, thermoplastic elastic polyurethanes, such as LYCRA polyurethanes available from EI DuPont de Nemours, Inc., having a place of business in Wilmington, Delaware, USA, and ESTANE, available from Noveon, Inc., having a place of business in Cleveland, Ohio, USA, thermoplastic elastic polyamides, such as polyether block amides, such as LYCRA polyurethanes available from EI DuPont de Nemours, Inc., having a place of business in Philadelphia, Pennsylvania, USA, and Atofina Chemicals, Inc., having a place of business in Philadelphia, Pennsylvania, USA, and ESTANE, available from Noveon, Inc., having a place of business in Philadelphia, Ohio ... Inc., thermoplastic elastic polyesters such as HYTREL available from EI DuPont de Nemours and ARNITEL available from DSM Engineering Plastics, Inc., Evansville, Indiana, USA; and single-site or metallocene-catalyzed polyolefins having a yield of about 0.89 g / cm. 3(0.89 grams / cubic centimeter), such as the AFFINITY metallocene polyethylene resins available from Dow Chemical Company, as well as some combinations thereof.

[0130] As used herein, a triblock copolymer has an ABA structure, where A refers to multiple repeat units of type A and B refers to multiple repeat units of type B. As mentioned above, some examples of styrenic block copolymers are SBS, SIS, SIBS, SEBS, and SEPS. In these copolymers, the A block is polystyrene and the B block is the rubbery component. Generally, these triblock copolymers can have molecular weights ranging from the low thousands (e.g., 1,000 to less than 5,000) to hundreds of thousands, and the styrene content can range from 5% to 75% by weight of the triblock copolymer. Diblock copolymers are similar to the triblock copolymers, but have an AB structure. Suitable diblock copolymers have styrene-isoprene diblocks with a molecular weight approximately one-half that of the triblock and the same ratio of A blocks to B blocks (i.e., the ratio of the number of A blocks to the number of B blocks in the triblock).If the diblock has an A block to B block ratio different from that of the triblock copolymer, or a molecular weight larger than half or greater than that of the triblock copolymer, the diblock may be suitable for modifying the foam formulation to produce low density, soft, flexible, and absorbent foams using polymer extrusion.

[0131] It may be particularly beneficial to have a thermoplastic elastomer having a high diblock content and a high molecular weight as part of a foam formulation to extrude a low density, soft, flexible, resilient, and absorbent thermoplastic foam. For example, the thermoplastic elastomer may have a diblock content between about 50% and about 80% by weight of the total weight of the thermoplastic elastomer.

[0132] KRATON thermoplastic elastomers can function as a discontinuous phase in styrenic foams and, when used in small amounts, can also function as cell-opener generators. However, when used in large amounts, the cell-opening effect may be somewhat secondary to the resiliency, flexibility, elasticity, absorbency, and softness imparted.

[0133] Foam formulations can further include blowing agents to aid in the foaming process and to aid in the formation of a foamable melt. Blowing agents are compounds that decompose at extrusion temperatures, thereby releasing large amounts of gas, volatile liquids such as refrigerants and hydrocarbons, ambient gases such as nitrogen and carbon dioxide, water, or combinations thereof. Both physical and chemical blowing agents, including inorganic and organic physical blowing agents, can be utilized to initiate or enhance foaming.

[0134] Suitable inorganic physical blowing agents include water, nitrogen, carbon dioxide, air, argon, and helium. Suitable organic blowing agents include hydrocarbons such as methane, ethane, propane, butane, pentane, hexane, and the like. Aliphatic alcohols and halogenated hydrocarbons, including various fluorocarbons such as Freon and R-134A, can also be utilized (although their use may be avoided for environmental reasons). Endothermic and exothermic chemical blowing agents that are typically fed into the hopper of an extruder include azodicarbonamide, paratoluene sulfonyl hydrazide, azodiisobutyronitrile, benzene sulfonyl hydrazide, p-toluene sulfonyl hydrazide, barium azodicarboxylate, sodium bicarbonate, sodium carbonate, ammonium carbonate, citric acid, toluene sulfonyl semicarbazide, and toluene sulfonyl hydrazide. semicarbazide, dinitroso-pentamethylene-tetramine, phenyltetrazole, sodium borohydride, and the like.

[0135] Meanwhile, mixtures and combinations of various physical and chemical blowing agents can be utilized to control the cell structure. Blowing agent activators (those that adjust the decomposition temperature of the blowing agent, etc.) can be added to further lower the decomposition temperature / profile of such chemical blowing agents. Such blowing agent activators include metals in the form of salts, oxides, or organometallic complexes.

[0136] The blowing agent can be added directly to the foam formulation, or alternatively, after the melt has been heated to a temperature at or above its glass transition temperature or melting temperature. The inlet for the blowing agent is typically located between the metering zone and the mixing zone, for example, in an extrusion process (not shown). The blowing agent is then thoroughly mixed into the molten polymer at a temperature sufficiently elevated to prevent melt expansion. For example, the blowing agent can be added to the foam formulation in an amount ranging from about 1% to about 10% by weight.

[0137] Other additives can be added to the foam formulation to improve various properties. For example, nucleating agents can be used to improve foam gas bubble formation and achieve a desired open-cell structure. Suitable nucleating agents include talc, magnesium carbonate, nanoclay, silica, calcium carbonate, blends of citric acid and sodium bicarbonate, coated citric acid / sodium bicarbonate particles, silica, barium stearate, diatomaceous earth, titanium dioxide, pulverized wood, clay, calcium stearate, stearic acid, salicylic acid, fatty acids, metal oxides, modified nucleant complexes, and combinations thereof. An example of a commercially available nucleating agent is nanoclay available under the trade name CLOISITE® 20A, which is available from Southern Clay Products, Inc., having a business office in Gonzales, Texas, USA. Various thermoplastic polymers can also be utilized for this type of application.

[0138] Nucleating agents can typically be mixed with or added to the polymer concentrate in a dry state. The amount of nucleating agent will vary based on several variables, including the desired cell structure, foaming temperature, pressure, polymer composition, and the type of nucleating agent utilized. For example, nucleating agents can be added to foam formulations in amounts ranging between about 0.1% and about 5% by weight. Typically, as the amount of nucleating agent increases, cell density increases as well.

[0139] Still other additives that may be used include surface active agents (e.g., surfactants), which may be used to control properties such as surface tension, foam formation, and wettability.

[0140] Generally, during the formation of a foam composite, the bubble walls (e.g., walls formed by bubbles, which are foam-like cavities generated by gas) may drain due to several factors, such as gravity and capillary forces. This type of drainage often results in wall thinning before the cell struts, or ribs, have fully solidified, which can result in cell rupture. La Place and Young proposed that capillary pressure decreases at the points where two or more struts connect to each other, thereby forming a flow from the membrane toward the struts, resulting in a tendency for the cell membrane to thin. If multiple surfactant molecules are arranged in a sufficient amount to migrate to the film membrane, the presence of the surfactant at the thin film surface of the film may provide resistance to the loss of the molten plastic. When the film layer is sufficiently thick, as in foam cell membranes, it can be further stabilized by an ionic double layer of molecules due to the orientation of ionic surfactants. Both nonionic and ionic surfactants can provide additional stabilizing forces when the film is sufficiently thin. This can be achieved by the orientation (alignment, registration, etc.) of some surfactants to create a bi-layer structure, such as that found in biological cells held together by van der Waals forces, thereby stabilizing the foam cell membrane.Further discussion can be found in Polymeric Foams, by Daniel Klempner and Kurt Frisch, published by Hanser Publishers in 1991; Foam Extrusion, by S.T. Lee, published by Technomic Publishing Co., Inc. in 2000; Polymeric Foams, by S.T. Lee and N.S. Ramesh, published by CRC Press in 2004; and Polymeric Foams and Foam Technology, 2nd Edition, by Daniel Klempner and Vahid Sendijarevic, published in 2004, the contents of each of which are incorporated by reference into this document in a manner consistent with this document.

[0141] Without intending to be limited to a particular theory, it is recognized that surfactants also provide resistance to gas diffusion from the foam cells to their surroundings, which helps resist collapse. The reduced gas permeability attributed to the drainage resistance discussed above is related to the degree to which the surfactant packs into the film surface of the foam cells and may explain the performance differences between various surfactants. This slowing of diffusion allows sufficient cooling for strut formation to prevent cell coalescence. The surfactant need not necessarily prevent drainage completely; rather, it can slow drainage sufficiently so that the cell struts substantially cool and harden, thereby preventing cell coalescence. In general, if a surfactant tends to be highly mobile in the melt, highly surface active, and / or can be packed tightly to help prevent membrane drainage, the surfactant will typically provide excellent cell stabilization.

[0142] Suitable surfactants for the absorbent composite can be single-component or multi-component surfactants. A multi-component surfactant is a combination of two or more surfactants. It has been recognized that certain multi-component surfactants can achieve comparable or better foam formulations than certain single-component surfactants at lower dosages. For example, in some aspects, foams using multi-component surfactants have densities comparable to foams using three times or more the amount of single-component surfactant. Because surfactants tend to be expensive additives, the use of certain multi-component surfactants can result in foam composites with comparable foam properties at a lower price than foams containing higher amounts of single-component surfactants.

[0143] Surfactants can be added at various points in the foam-making process, such as directly into the foam formulation, into the composition during the foaming process, and / or as a post-treatment after the formation of the foam composite. For example, surfactants can be added to the foam formulation in a gaseous phase, such as by using a blowing agent (e.g., supercritical carbon dioxide).

[0144] Some examples of suitable surfactants include cationic, anionic (including alkylsulfonates), amphoteric, and nonionic surfactants. Some representative surfactants include SCHERCOPOL™ OMS-NA, a disodium monooleamido MEA sulfosuccinate surfactant available from Scher Chemicals, Inc., Clifton, New Jersey, USA, and PLURONIC F68, a polypropylene glycol non-ionic surfactant, a block copolymer of propylene oxide and ethylene oxide available from BASF Corporation. Some other examples include HOSTASTAT HS-1, available from Clariant Corporation, having a place of business in Winchester, Virginia, USA; EMEREST 2650, EMEREST 2648, and EMEREST 3712, each available from Cognis Corporation, having a place of business in Cincinnati, Ohio, USA; and DOW CORNING 193, available from Dow Corning Corporation, having a place of business in Midland, Michigan, USA. Alkyl sulfonates are also suitable as surfactants, although the use of this class of surfactants in some specific applications may be limited due to product safety concerns.However, some combinations, each consisting of multiple surfactants, are beneficial when an alkyl sulfonate is added at a substantially lower level in conjunction with another surfactant to produce good foaming and wettability.

[0145] The amount of surfactant utilized will vary depending on the specific surfactant and the desired properties. For example, the surfactant can be utilized in the foam formulation in an amount between about 0.05% and about 10% by weight, e.g., between about 0.1% and about 5% by weight. In one specific example, the surfactant can be a multi-component surfactant utilized in the foam formulation in an amount between about 0.05% and about 8.0% by weight, e.g., between about 0.1% and about 3.0% by weight.

[0146] Various other additives, such as lubricants, acid scavengers, stabilizers, colorants, adhesive promoters, fillers, smart-chemicals (substances that change their properties in response to external stimuli such as temperature, pressure, pH, or light, etc.), foam regulators, various UV / infrared radiation stabilizing agents, antioxidants, flame retardants, smoke suppressants, anti-shrinking agents, thermal stabilizers, rubbers (including thermosets), anti-statics, permeability modifiers, etc., and other processing and extrusion aids. and extrusion aids, mold release agents, anti-blocking agents, and the like, can also be added to the foam formulation, while fibers (e.g., wood fibers) can be added to the foam formulation to improve water (e.g., perspiration) absorbency.

[0147] In one non-limiting exemplary embodiment, the foam can comprise a thermoplastic polymer foam derived from a foam formulation comprising: an alkenyl aromatic base resin in the range of about 50% to about 95% by weight; a thermoplastic elastomer in the range of about 10% to about 50% by weight having a styrenic block copolymer content in the range of about 50% to about 80% by weight of the elastomer; a surfactant in the range of about 0.05% to about 10% by weight; and a blowing agent in the range of about 0% to about 10% by weight.

[0148] Once the target ingredients for the foam formulation are determined, the materials are added together and prepared to be formed in a foam-making process, including foam-making processes known to those skilled in the art. For example, various continuous plastic extrusion processes known in the art can be used to produce the foam. Other suitable foam-making processes known in the art include injection molding, batch processing, and air-forming processes.

[0149] Generally, the materials can be heated to form a molten foam, at which point the materials can form a substantially homogeneous mixture. In some aspects, the materials are preferably heated to a temperature between about 100°C and about 500°C to produce a foam melt. The foam melt is then foamed to create cells within the melt using a suitable foaming technique known to those skilled in the art. Once formed, the foam melt is then processed, such as using an extrusion process, and cooled to form the foam mitigation element 310.

[0150] In some aspects, continuous resin extrusion processes known in the art can be used to produce the mitigation member 310 as a foam. When this type of extrusion process is used, a tandem screw-type extruder can be used. This type of extruder may be particularly suitable in some aspects because it provides tight control of extrusion temperatures to produce open-cell foams. When a tandem extruder is used, the first extruder section typically has multiple zones, including a feed and conveying zone, a compression zone, a melting zone, and a metering and mixing zone, and the second extruder section often has a cooling zone and a shaping zone prior to discharge. The first-stage extruder typically has a hopper into which the one or more base resins and one or more thermoplastic elastomers, plus any other additives, are loaded. Techniques known in the art for accomplishing this include using dry / blend / metering equipment and / or incorporating the components into a pelletized polymer concentrate, such as in a master batch (colorant).The components of the foam formulation are then heated in the extruder to form a plasticized or melt polymer system, often using zoned temperature control with the extruder's cooling / heating system.

[0151] The foamable melt is then typically cooled to a lower temperature to control the desired foam cell structure (foam cell structure, foam bubble size, etc.). When tandem extruders are used, the cooling is typically achieved in the second-stage extruder, which is connected downstream of the first-stage extruder via a heated crossover supply pipe (hot manifold, U-shaped pipe, etc.). When a single extruder is used, the cooling is typically achieved upstream of the discharge orifice (discharge port, etc.). Often, a cooling / heating system using process temperature control loops is incorporated to precisely control foam bubble nucleation / growth within the gas-laden melt. The optimal cooling temperature is typically at or slightly above the glass transition temperature or melting point of the melt.

[0152] The melt is then extruded through a die (e.g., a mold, a die, etc.) into lower pressure conditions (typically atmospheric or vacuum pressure), resulting in the formation of a stable foam that subsequently densifies to form a web (e.g., a web, a fiber, a film, etc.) or layer due to thermodynamic instability and subsequent foaming as the resin cools and crystallizes. Circular, annular, or slit dies, including curtain dies, are often utilized, often with a mandrel to shape and draw the web to achieve a desired gauge (e.g., thickness or diameter of the extruded foam), shape, and orientation upon expansion and cooling of the foam.

[0153] Various equipment configurations can be used to produce the foam mitigation element 310 of the present invention using this type of extrusion. Meanwhile, various specialized equipment can be employed upstream of specially designed dies to improve mixing, cooling, cell structure, metering, and foaming. Examples of such equipment include static mixers, gear pumps, and various extruder screw designs. Stretching equipment, including roller nips, tenters, and belts, can also be used immediately downstream of the discharge section to elongate the cell shape for improved absorbency. Microwave irradiation for crosslinking, foaming activation, and mechanical means can also be used to improve foam properties. Foam contouring, foam shaping (e.g., patterning, perforating, etc.), and the like, thermoforming and other such thermal processes with thermal bonding can be utilized to control shaping, flexibility, softness, aesthetics, and absorbent swelling.

[0154] The formation of open cells can be regulated by elevated processing pressures and / or temperatures, as well as by using additives such as nucleating agents, chemical blowing agents, and low additions of immiscible polymers and / or surfactants that can control both cell density and cell structure. Certain base resins can also sometimes be used to extend the blowing temperature range for producing open-cell foams. For example, the open-cell level (i.e., the percentage of open cells in a polystyrenic-based foam) can be facilitated by adding small amounts of various immiscible polymers to the foam formulation, such as polyethylene or ethylene / vinyl acetate copolymers, to create interphase domains that cause cell wall rupture. In another example, ethylene-styrene interpolymers can be added to alkenyl aromatic polymers to control open-cell quality and improve surface quality and processability. In yet another example, small amounts of polystyrene-based polymers can be added to polyolefin-based foams to increase the open-cell content.The open cell ratio and microporous cell membrane uniformity can be controlled by regulating several elements of the polymer system (components, processing pressure, processing temperature, use of additives, etc.) and the crystallization onset temperature.

[0155] Suitable foams may be commercially available. For example, foams that maintain their bulk thickness after hydraulic needling (i.e., resilient foams) are available as RYNEL 562-B medical grade polyurethane and RYNEL 562-D medical grade polyurethane, both available from Rynel Ltd., Inc., a division of Molnlycke Health Care AB, having a place of business in Gothenburg, Sweden. Other suitable foam layers include MINICELL STD cross-linked polyethylene, available from Voltek, a division of Sekisui America Corporation, having a place of business in Lawrence, Massachusetts, USA, and latex foams such as those described in U.S. Pat. No. 6,627,670 to Mork et al. foams, the patents of which are incorporated herein by reference in a manner consistent with this document; High Internal Phase Emulsion (HIPE) foams, such as those described in U.S. Pat. No. 5,260,345 to DesMarais et al., the patents of which are incorporated herein by reference in a manner consistent with this document; and extruded thermoplastic foams, such as those described in U.S. Pat. No. 7,358,282 to Krueger et al. and U.S. Pat. No. 6,071,580 to Bland et al., the respective patents of which are incorporated herein by reference in a manner consistent with this document.

[0156] In addition to the above, secondary post-processing operations can be performed to provide or enhance desirable properties, including, among others, perforating, softening, flexibility, absorbency, cell orientation, aesthetics, and the like. This can be accomplished by numerous techniques known in the art, including mechanical needling and other mechanical perforation, stretching and drawing, calendaring or creping, brushing, scarfing, buffing / sanding, and thermoforming / shaping. Often, a foam surface skin is formed during extrusion, and the skin can be later (e.g., after extrusion) skived or sliced ​​off, needle-punched, brushed, scraped, buffed, scarved, sanded, or perforated to remove the barrier (e.g., unfoamed layer) or portions thereof. Mechanical, hydraulic, thermal, or laser perforation can also be used.Mechanical, laser, and / or hydraulic micro-serrations can be employed (e.g., to improve permeability), while post-foaming or post-needling surfactant applications can also be utilized to achieve targeted wettability.

[0157] Several processes can be utilized to make open-cell foams, low-density foams, absorbent foams, soft, resilient, and elastomeric foams. Examples of some of these processes are described in U.S. Patent No. 5,962,545 to Chaudhary et al., U.S. Patent No. 5,728,406 to Halberstadt et al., and U.S. Patent No. 6,451,865 to Migchels et al., each of which is incorporated by reference into this document in a manner consistent with this document.

[0158] Plasticizers are sometimes used as cell openers in foam manufacturing. When used as cell openers, these types of plasticizers are added to foam formulations in small amounts, as described in U.S. Pat. No. 6,071,580 to Bland et al., which is incorporated herein by reference in a manner consistent with this document. More specifically, two plasticizers can function to increase cell expansion and produce high expansion rates. As cells expand, the membranes between the cells thin, become unstable, and can rupture, further creating porous connections between the cells. On the other hand, when a thermoplastic polymer cools, along with the volume contraction associated with crystallization, the thinned portions of the membranes can increase the connections or voids between the cells, thereby rupturing sufficiently to create multiple interconnected cells.

[0159] Although plasticizers function as softeners, adding plasticizers can make foaming to low densities more difficult. For example, in high-density, essentially open-cell, non-absorbent foams containing plasticizers, thermoplastic elastomers, and additives such as surfactants, the plasticizers can reduce the viscosity of the polymer melt and lead to melt drainage, which causes cell collapse and makes foaming difficult, as described, for example, in U.S. Pat. No. 6,653,360 to Gupta, which is incorporated herein by reference in a manner consistent with this disclosure.

[0160] A wide range of plasticizers are available. Desirable properties for selecting a plasticizer include its flexibility, temperature stability upon extrusion, resistance to migration, cost, odor, biodegradability, and manufacturing and consumer safety. Typical plasticizers include citrates, phthalates, stearates, fats, and oils. It is known that glycerol fatty acids, such as glycerol monostearate, stabilize cells by reducing the rate of gas diffusion from the cells.

[0161] Therefore, in some aspects, plasticizers can be included in foam formulations. Plasticizers are chemicals that impart flexibility, stretchability, and workability. The type of plasticizer affects the foam's gel properties, blowing agent migration resistance, and cell structure, including fine cell size and number of interconnected cells. Typically, desirable plasticizers have low molecular weights (e.g., less than 1,000). The increase in polymer chain mobility and free volume caused by the introduction of plasticizers results in a decrease in the glass transition temperature (Tg), and this measurement is often used to characterize the effectiveness of plasticizers. Petroleum-derived fatty acids and esters are commonly used and function as external plasticizers or solvents because they are not chemically bound to the polymer but remain intact within the polymer matrix upon crystallization.

[0162] The plasticizer increases cell interconnectivity by thinning the membranes between the cells to the point where some porous connections are formed between the cells, thereby increasing the proportion of interconnected cells. If desired, the plasticizer can be included in the foam formulation in an amount ranging from about 0.5% to about 10% by weight, for example, from about 1% to about 10% by weight. This type of plasticizer should be gradually and carefully metered into the foam formulation during the foaming process, as adding too much plasticizer all at once can cause cell instability and result in foam collapse.

[0163] Other examples of suitable plasticizers include polyethylene, ethylene vinyl acetate, mineral oil, palm oil, waxes, esters based on alcohols and organic acids, naphthalene oil, paraffin oil, and combinations thereof. A commercially available plasticizer is small-chain polyethylene (low-molecular-weight polyethylene), which is produced by a catalytic polymerization of ethylene and is often referred to in the industry as a "wax" due to its low molecular weight. One example of such a low-density, highly branched polyethylene "wax" is EPOLENE C-10, available from Eastman Chemical Company, Kingsport, Tennessee, USA.

[0164] Some further examples of plasticizers are acetyl tributyl citrate, acetyl triethyl citrate, p-tert-butylphenyl salicylate, butyl stearate, butylphthalyl butyl glycolate, dibutyl sebacate, di-(2-ethylhexyl) phthalate, diethyl phthalate, diisobutyl adipate, diisooctyl phthalate, diphenyl-2-ethylhexyl phosphate, epoxidized soybean oil, ethyl phthalyl ethyl glycolate, ethyl phthalyl ethyl ester, ethyl phthalate ... glycolate, glyceryl monooleate, monoisopropyl citrate, mono-, di-, and tristearyl citrate, triacetin (glycerol triacetate), triethyl citrate, and 3-(2-xenoyl)-1,2-epoxypropane.

[0165] 5A-5B, as referenced above, the mitigation member 310 can optionally include one or more apertures (e.g., full or partial holes, cylindrical holes, etc.) 320. The purpose of these optional apertures 320 is to provide tunnels or channels 322 into or through (e.g., fully or partially through) the mitigation member 310 (typically in a direction generally aligned with the z-axis 3), which allow the reaction medium to migrate toward the bottom side 312 of the mitigation member 310. In some such embodiments, at least a portion of the thermally conductive polymer 330 can extend through the entire thickness (measured along the z-axis 3) of the mitigation member 310. Such channels 322 can have any functional cross-sectional shape profile known to those skilled in the art, such as circular, oval, square, rectangular, star-shaped, irregular, and the like, and combinations thereof. The openings 320 can have any suitable dimensions. For example, if the openings 320 have a circular profile, the resulting cylindrical channels 322 can have a cross-sectional diameter (e.g., a diameter of about 1 mm to about 10 mm, e.g., about 2 mm to about 7 mm, or about 3 mm to about 4 mm) to enhance usefulness. However, it should be understood that the dimensions can be less than 1 mm or greater than 10 mm without departing from the scope of the present invention.

[0166] 4A-6B, depending on the characteristics of the particular mitigation element 310 and the thermally conductive polymer 330, the cross-sectional dimensions of any channel 322 within the mitigation element 310 will tend to increase or enlarge (e.g., the volume of the channel 322 will expand) upon introduction of the reaction medium from which the thermally conductive polymer 330 is derived. Such expansion may typically be in the range of about 50% to about 500%, e.g., in the range of about 100% to about 400%, or in the range of about 200% to about 400%. It should be understood that such expansion may be less than 50% or more than 500% without departing from the scope of the present invention. However, it should be understood that the expansion of each channel 322 created by the openings 320 need not be equivalent (e.g., identical to other channels 322), but rather may vary throughout the mitigation member 310 without departing from the scope of the present invention. Generally, a greater increase in the dimension of one particular channel 322 relative to another will indicate a greater amount of weight and / or volume of polymer 330 present within that channel 322.

[0167] 4A-6B, as referenced above, the therapeutic member 300 can also include a thermally conductive polymer 330. The purpose of the thermally conductive polymer 330 is, among other things, to conduct thermal energy (e.g., heat) away from the user, provide cushioning support for the user, attenuate forceful impacts, and reduce or eliminate pressure points (e.g., areas where the skin receives localized pressure that can lead to pressure sores). The thermally conductive polymer 330 can be present on the top side 311 of the mitigation member 310 and / or can be disposed at least partially through the thickness of the mitigation member 310 (i.e., transitioning from the top side 311 toward the bottom side 312). The amount of thermally conductive polymer 330 present on the top side 311 of the mitigation member 310 will depend on the total amount of the reactive medium applied to the mitigation member 310, the amount of liquid reactive medium that migrates within and / or through the thickness of the mitigation member 310, the absorption rate of the mitigation member 310 (e.g., the rate of open cells), the viscosity of the reactive medium, the hardening rate of the reactive medium, the size of any optional openings 320 that may be disposed in the mitigation member 310, etc.

[0168] While still in liquid form (i.e., uncured or partially cured), the reactive medium can be applied relatively uniformly to the top side 311 of a suitable mitigation member 310 (e.g., a soft, resilient, elastomeric foam having a plurality of optional openings 320) and then allowed to fully cure, thereby forming an exemplary embodiment of an inventive therapeutic member 300 of the present disclosure. Suitable methods for applying the reactive medium to the mitigation member 310 include those known to those skilled in the art, such as pouring, spraying, printing, injecting, and the like.

[0169] In some aspects, the reactive medium will completely soak into the mitigation member 310. In other aspects, the reactive medium may be cured to form an optional polymer layer 335 on the top side 311 of the mitigation member 310. Typically, the thickness (measured along the z-axis 3) of such a polymer layer 335 will range from about 0 mm to about 5 mm. However, it should be understood that the thickness of the polymer layer 335 located on the top side 311 of the mitigation member 310 can be greater than 5 mm without departing from the scope of the present invention.

[0170] The amount of thermally conductive polymer 330 used with the inventive therapeutic member 300 will vary depending on the desired properties. Typically, the amount of thermally conductive polymer 330 will range from about 1 gram of polymer per gram of mitigation member 310 (1 g / g) to about 10 grams of polymer per gram of mitigation member 310 (10 g / g). However, it should be understood that amounts less than 1 g / g or greater than 10 g / g may be suitable without departing from the scope of the present invention.

[0171] Some examples of polymers suitable for forming the thermally conductive polymer 330 of the present invention are described in U.S. Patent No. 7,041,719 to Kriesel et al., U.S. Patent No. 11,124,596 to Kriesel et al., U.S. Patent Application No. 14 / 756,152 to Goodenough, and U.S. Patent Application No. 17 / 460,196 to Kriesel et al., each of which is incorporated by reference into this document in a manner consistent with this document. Variations of these types of polymers, as well as other polymers having similar properties, including silicone-based polymers, may also be suitable for the present invention without departing from the scope of the present invention.

[0172] By way of non-limiting example, a reaction medium for producing thermally conductive polymer 330 can be prepared that includes a prepolymer (e.g., an isocyanate prepolymer, a silicone prepolymer, etc.) ranging from about 2 percent by weight (wt%) to about 20 wt% based on the weight of the total reaction medium, a hydroxyl functional thermoplastic elastomer ranging from about 20 wt% to about 40 wt%, and an epoxidized triglyceride plasticizer in excess of about 40 wt%. In another non-limiting example, a reaction medium can be prepared that includes a prepolymer having a weight ratio of about 2 percent (wt%) to about 20 wt%, based on the weight of the total reaction medium; straight chain polyols having a weight ratio of about 1 wt% to about 65 wt%; crosslinking polyols (e.g., polyols that crosslink the associated polymer) having a weight ratio of about 3 wt% to about 50 wt%; an epoxidized triglyceride plasticizer having a weight ratio of about 40 wt% to about 80 wt%; and a viscosity reducing plasticizer (e.g., a plasticizer that also functions as a viscosity reducing agent) having a weight ratio of about 0 wt% to about 40 wt%. In some aspects, the prepolymer can include an isocyanate prepolymer (e.g., a diisocyanate), a silicone prepolymer, or the like. In some aspects, the linear polyol can include a diol (e.g., a polyether diol).In some aspects, the crosslinking polyol can comprise a triol or higher (e.g., a polyether triol). In some aspects, the epoxidized triglyceride plasticizer can comprise an epoxidized vegetable oil plasticizer (e.g., an epoxidized soybean oil plasticizer). In some aspects, the optional viscosity-thinning plasticizer can comprise an ester plasticizer. In some aspects, the reaction medium can be reacted in the presence of from about 0.001% to about 5% by weight of a catalyst (e.g., a tin-based catalyst).

[0173] As referenced above, in some aspects, the reaction medium forming the thermally conductive polymer 330 can include a quantity of prepolymer that forms the backbone of the polymer 330. Such prepolymers can typically range from about 2% to about 20% by weight of the total weight of the reaction medium. Suitable prepolymers can include ring-opening species hardeners (e.g., amines, amides, mercaptans, anhydrides, isocyanates, including polyisocyanates (e.g., diisocyanates), etc.). Suitable polyisocyanates include, but are not limited to, aromatic diisocyanates (e.g., diphenylmethane diisocyanate, methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI), etc.) and aliphatic diisocyanates (e.g., hexamethylene diisocyanate (HDI), isophorone diisocyanate (IPDI), etc.), typically in prepolymer form. In one non-limiting example, methylene diphenyl diisocyanate (MDI), available from BASF Corporation under the designation ELASTOCAST TQZ-P23, can provide a suitable prepolymer for forming the thermally conductive polymer 330 of the present disclosure.

[0174] As referenced above, in some aspects, the reaction medium forming the thermally conductive polymer 330 can include a thermoplastic elastomer. Suitable thermoplastic elastomers can include almost any thermoplastic compound having elastomeric properties. In some desirable aspects, such resins or thermoplastics can have primary allylic alcohol groups that are highly reactive in condensation polymerization reactions. Some suitable thermoplastic elastomers can include, but are not limited to, polydienes (e.g., polybutadiene). In one non-limiting example, suitable thermoplastic elastomers include POLY BD R45 HTLO and POLY BD R45 V, each of which is a low molecular weight hydroxyl-terminated polybutadiene resin available from Cray Valley.

[0175] As referenced above, in some aspects, the reaction medium forming the thermally conductive polymer 330 can include a quantity of polyol, typically in the range of about 10% to about 75% by weight of the total weight of the reaction medium. More specifically, such polyols can include linear polyols and cross-linking polyols. In some desirable aspects, the linear polyol can be in the form of a diol (e.g., a polyol having two terminal reactive groups), and the cross-linking polyol can be in the form of a triol or higher (e.g., a polyol having two terminal reactive groups and at least one additional reactive group). Such linear polyols and cross-linking polyols are desirably liquid at room temperature (i.e., about 21° C.) and generally have a molecular weight in the range of about 1,000 to about 20,000. The cohesiveness of the resulting thermally conductive polymer 330 depends on the use of a controlled polyol balance (i.e., linear polyol and crosslinking polyol) in the reaction medium. It has been discovered herein that the amounts of linear polyol and crosslinking polyol (desirably reacted in the presence of an effective amount of plasticizer in the reaction medium) can preferably satisfy a recommended (prescribed, specified, disclosed herein, etc.) weight ratio of linear polyol to crosslinking polyol in the range of about 1:3 to about 3:1, e.g., about 1:2 to about 2:1, or about 7:13 to about 13:7, to achieve target viscoelastic and cohesive attributes. Generally, decreasing the linear polyol to crosslinking polyol ratio (i.e., increasing the crosslinking polyol content relative to the linear polyol content) generally results in improved cohesiveness of the thermally conductive polymer 330.

[0176] In general, diols allow for highly effective intermolecular plasticizer attraction and alignment, thereby allowing for straight chain infrastructure formation and sufficient crosslinkage disruption to allow for an unusually high and effective loading of plasticizer. In some desirable aspects, the linear diol can be a polyether diol having a molecular weight in the range of about 1,000 to about 10,000, e.g., about 1,000 to about 8,000, or about 2,000 to about 6,000, for improved utility, and desirably having two terminal reactive groups (e.g., hydroxyl groups). The linear polyol as a component of the reaction medium can be present in an amount in the range of about 1 wt. % to about 65 wt. % of the total weight of the reaction medium, e.g., about 3 wt. % to about 35 wt. % or about 5 wt. % to about 15 wt. % of the total weight of the reaction medium, for improved utility. In one example, a bifunctional polyether diol, such as ELASTOCAST®, available from BASF Corporation, can be used. One known as C-4057 can provide a suitable linear polyol as a component for forming the thermally conductive polymer 330 as a component of the therapeutic member 300 .

[0177] Generally, a crosslinking polyol (e.g., a triol) can provide sufficient crosslinking support to the polymer 330 and contribute to its cohesion. In some desirable aspects, the crosslinking polyol can be a polyether triol having a molecular weight in the range of about 1,000 to about 10,000, desirably having three reactive groups (e.g., hydroxyl groups), two of which are terminal reactive groups. The crosslinking polyol as a component of the reaction medium can be present in an amount of about 3% to about 50% by weight of the total weight of the reaction medium, e.g., about 10% to about 45% by weight, or about 20% to about 40% by weight of the total weight of the reaction medium, for enhanced utility. In one example, a tri-functional polyether polyol designated ELASTOCAST C-4018, available from BASF Corporation, can provide a suitable cross-linking polyol as a component for forming thermally conductive polymer 330 as a component of therapeutic device 300.

[0178] As referenced above, in some aspects, the reaction medium forming the thermally conductive polymer 330 can contain an amount of plasticizer. Typically, the total amount of plasticizer will be greater than about 40 wt. % of the total weight of the reaction medium for improved utility, such as from about 40 wt. % to about 80 wt. % or from about 45 wt. % to about 70 wt. %. More specifically, the plasticizer can include an epoxidized triglyceride plasticizer and, optionally, can further include a viscosity-thinning plasticizer, desirably an ester plasticizer. Some components of the plasticizer are desirably liquid at room temperature (i.e., about 21° C.). Controlled amounts of epoxidized triglyceride plasticizer and optional viscosity-thinning plasticizer (e.g., ester plasticizer) within the specified ranges can provide an effective reaction medium for preparing a thermally conductive polymer 330 having the target compositional attributes for use herein. Desirably, the plasticizer component is uniformly dispersed and cohesively bound (with other polymerizable components) throughout the reaction medium and tenaciously maintained in a uniformly dispersed state within the resulting thermally conductive polymer 330, which has a cohesive and stabilized morphology.

[0179] Suitable epoxidized triglyceride plasticizers include epoxidized animal oils and epoxidized vegetable oils. Among these suitable epoxidized triglyceride plasticizers, epoxidized vegetable oils (e.g., epoxidized soybean oil, epoxidized castor oil, epoxidized corn oil, epoxidized cottonseed oil, epoxidized perilla oil, epoxidized safflower oil, epoxidized linseed oil, epoxidized tall oil, etc.) are particularly effective epoxidized triglyceride plasticizers. Other suitable epoxidized triglyceride plasticizers have been more extensively described in several of the aforementioned patents and applications, which are incorporated herein by reference. Such epoxidized triglyceride plasticizers may be present in an amount greater than 40% by weight of the total weight of the reaction medium, such as from about 40% to about 80% by weight, or from about 45% to about 70% by weight of the total weight of the reaction medium. In one desirable example, epoxidized soybean oil may provide a highly suitable epoxidized triglyceride plasticizer for forming thermally conductive polymer 330 as a component of therapeutic device 300.

[0180] As referenced above, in some aspects, the reaction medium forming the thermally conductive polymer 330 can also optionally include a suitable reaction medium viscosity-reducing plasticizer. Generally, some plasticizers suitable as plasticizing agents for plasticizing polyvinyl chlorides can be utilized as viscosity-reducing plasticizers for the reaction medium. Typically, the optional viscosity-reducing plasticizer can be present in an amount ranging from about 0 wt % to about 40 wt % of the total weight of the reaction medium.

[0181] Representative viscosity-thinning plasticizers for preparing the thermally conductive polymer 330 can include, but are not limited to, ester plasticizers. These types of ester plasticizers are particularly useful as optional plasticizers in the reaction medium. Suitable ester plasticizers have a relatively low molecular weight, typically less than about 750, e.g., less than about 500, and also include, but are not limited to, alcohols (e.g., C1-C6 10 Alcohols, e.g., C2-C6 alcohols) and dicarboxylic acids (e.g., C2-C 12Condensation products of dicarboxylic acids, such as C4-C8 dicarboxylic acids, can be used. Among the more fluid ester plasticizers, for example, diester plasticizers, are the lower dialkyl esters of dicarboxylic acids, such as dialkyl esters with alkyl groups of less than 12 carbon atoms, such as sebacic acid, adipic acid, phthalates, isophthalates, maleates, azelates, glutaric acid, and the like, which have C1-C8 dialkyl ester groups.

[0182] In some aspects, the introduction of the optional relatively low molecular weight ester plasticizer in combination with the epoxidized triglyceride plasticizer can be utilized to provide an easier fabricating form for the reaction medium (e.g., casting, molding, injection, pouring, etc.) by reducing the viscosity of the reaction medium without adversely affecting some of the desirable characteristics of the thermally conductive polymer 330. For example, the addition of polar ester plasticizers or the substitution of the epoxidized triglyceride plasticizer with a polar ester plasticizer has been found to effectively reduce the viscosity of the reaction medium while still maintaining desirable levels of the heat dissipation, cohesion, viscoelasticity, and impact dispersion, as well as excellent stability properties, of the resulting polymer 330. What was discovered in this document is that including an ester plasticizer having a relatively low molecular weight (e.g., less than about 750) in the reaction medium while having a fluid (i.e., liquid) consistency (consistency, properties, characteristics, stickiness, stiffness, resistance to external forces, uniformity, density, concentration, hardness, etc.) at room temperature (i.e., about 21°C) can contribute to ideal working viscosities (dynamic viscosity, etc.) during the initial curing stage, while making the reaction medium more effective for forming thermally conductive polymer 330 as a component of therapeutic device 300.

[0183] In some aspects involving viscosity-thinning plasticizers, the total quantity of all plasticizers can be about 40% by weight or more of the total amount of the reaction medium, for example, in the range of about 40% to about 85% by weight, e.g., at least 45% to about 75% by weight, or in the range of about 50% to about 70% by weight of the total amount of the reaction medium, for improved utility. Plasticizers as components of the reaction medium are typically fluid at room temperature (i.e., about 21° C.). In some such embodiments, it has been discovered herein that the weight ratio of epoxidized triglyceride plasticizer to viscosity-thinning plasticizer can preferably be in the range of about 1:0 to about 1:1, e.g., in the range of about 6:1 to about 1:3, or in the range of about 3:1 to about 1:2, in order to provide a workable reaction media viscosity and achieve certain target attributes of kinematic viscosity, impact dissipation, and heat dissipation in the resulting polymer 330.

[0184] It should be understood that the reaction medium forming the thermally conductive polymer 330 can optionally further include additional components, including, but not limited to, catalysts, initiators, other additional plasticizers, colorants, UV inhibitors, antioxidants, and the like, as known to those skilled in the art and without departing from the scope of the present invention. For example, polymerization of the reaction medium can be carried out in the presence of a catalyzing amount (as defined above) of a catalyst (desirably a slow-acting catalyst or a heat-activated catalyst) to control the curing rate of the reaction medium. Such catalysts are typically used in relatively small amounts, for example, in an amount ranging from about 0.001% to about 5% by weight of the total amount of the reaction medium.

[0185] Suitable catalysts can include tertiary amines, tertiary phosphines, strong bases (e.g., alkali, alkaline earth metal hydroxides, alkoxides, phenoxides, etc.), acidic metal salts of strong acids, metal chelates, metal alcoholates, metal phenolates, organic acid salts, organo metallic derivatives, and the like. In one non-limiting example, a slow-acting organobismuth catalyst available under the trade name COSCAT 83 (available from Vertellus Holdings LLC, having a place of business in Zeeland, Michigan, USA) can provide a suitable catalyst for controlling the cure rate of the thermosetting reaction medium to form the thermally conductive polymer 330 as a component of the therapeutic component 300. In another non-limiting example, a heat-activated tin thioglycolate catalyst available under the trade name FOMREZ CATALYST UL-29 and FOMREZ CATALYST UL-54 (both available from Momentive Performance Materials Inc., having a place of business in Wilton, Connecticut, USA) can provide a suitable catalyst for controlling the cure rate of the thermosetting reaction medium to form the thermally conductive polymer 330 as a component of the therapeutic component 300.

[0186] Other suitable catalysts include (a) tertiary amines, such as bis(dimethylaminoethyl) ether, trimethylamine, triethylamine, N-methylmorpholine, N-ethylmorpholine, N,N-dimethylbenzylamine, N,N-dimethylethanolamine, N,N,N',N'-tetramethyl-1,3-butanediamine, triethanolamine, 1,4-diazabicyclo[2,2,2]octane, and the like. [2,2,2]octane, N,N-dimethylcyclohexylamine, N-methyldicyclohexylamine, 1,8-diazabicyclo[5,4,0]undecene-7, and its salts, such as the phenol salt, hexanoate, and oleate, 2,4,6-tris(diaminomethyl)phenol, and the like; (b) tertiary phosphines, such as trialkylphosphines, dialkylbenzylphosphines, and the like; (c) strong bases bases, such as alkali and alkaline earth metal hydroxideshydroxides, alkoxides, and phenoxides; (d) acidic metal salts of strong acids, such as ferric chloride, stannic chloride, stannous chloride, antimony trichloride, bismuth nitrate and chloride, and the like; (e) chelates of various metals, such as acetylacetone, benzoylacetone, trifluoroacetone, ethyl acetoacetate, and the like; acetoacetate, salicylaldehyde, cyclopentanone-2-carboxylate, acetylacetone-imine, bis-acetylacetonealkylenedimines, salicylaldehydeimine, and the like, and from various metals, such as beryllium (Be), magnesium (Mg), zinc (Zn), cadmium (Cd), lead (Pb), titanium (Ti), zirconium (Zr), tin (Sn), arsenic (As), bismuth (Bi), chromium (Cr), molybdenum (Mo), manganese (Mn), iron (Fe), cobalt (Co), (f) those which can be obtained using ions such as nickel (Ni), or molybdenum oxide (MoO++), uranium oxide (UO++), and the like; (g) various metals(g) alcoholates and phenolates of metals, such as titanium (OR) (Ti(OR)), tin (OR) (Sn(OR)), aluminum (OR) (Al(OR)), and the like, where R is alkyl or aryl, and reaction products of the alcoholates include carboxylic acids, beta-diketones, and 2-(N,N-dialkylamino) alkanols, such as the well-known titanium chelates; (g) salts of organic acids with a variety of metals, such as alkali metals, alkaline earth metals, and the like; meals, aluminum (Al), tin (Sn), lead (Pb), manganese (Mn), cobalt (Co), nickel (Ni), and copper (Cu), salts of organic acids such as sodium acetate, potassium laurate, calcium hexanoate, stannous acetate, stannous octoate, stannous oleate, lead octoate, metallic driers such as manganese and cobalt naphthenate, and the like; and (h) organometallic derivatives of tetravalent tin, trivalent and pentavalentThese include organometallic derivatives of pentavalent arsenic (As), antimony (Sb), and bismuth (Bi), organometallic derivatives of metal carbonyls of iron and cobalt, and organometallic derivatives of mercury compounds (e.g., arylmercury carboxylates, phenylmercury acetate, and phenylmercury propionate, and the like).

[0187] Still other suitable catalysts can include alkyl tin compounds, such as dialkyltin salts of carboxylic acids, for example, dibutyltin diacetate, dibutyltin dilaurate, dibutyltin maleate, dibutyltin diacetate, dioctyltin diacetate, dibutyltin-bis(4-methylaminobenzoate), dibutyltin-bis(6-methylaminocaproate), and the like. Dialkyltin mercaptides, particularly dialkyltin dimercaptide carboxylic acid esters, can also be used. Similarly, trialkyltin hydroxide, dialkyltin oxide, dialkyltin dialkoxide, or dialkyltin dichloride can be used.Some examples of these compounds include trimethyltin hydroxide, tributyltin hydroxide, trioctyltin hydroxide, dibutyltin oxide, dioctyltin oxide, dilauryltin oxide, dibutyltin-bis(isopropoxide), dibutyltin-bis-(2-dimethylaminopentanoate), dibutyltin dichloride, dioctylin dichloride, and the like. For example, a suitable alkyl tin compound is COTIN 430, which is available from Cambrex Company, having a place of business in Itasca, Illinois, USA. It is a dioctyltin carboxylate available from

[0188] It was discovered in this document that blends of catalysts can be beneficial in some embodiments. For example, in one non-limiting example, COTIN 430 and FOMREZ CATALYST UL-54 were utilized with the reaction medium to enhance the benefits.

[0189] In a typical procedure, the reaction product forming the thermally conductive polymer 330 is combined with carefully measured amounts of straight chain polyols and crosslinking polyols (to provide the necessary bridging between the crosslinks) and an isocyanate prepolymer curing agent (e.g., diisocyanates, e.g., aliphatic, aromatic, heterocyclic, etc. polyisocyanates, cycloaliphatic isocyanates, and arylaliphatic isocyanates) or a silicone prepolymer from a thermosetting reaction media homogeneously loaded with one or more plasticizers, including an epoxidized triglyceride plasticizer, and optionally any other effective polar plasticizer. with), and typically in the presence of a suitable catalyst (eg, preferably a relatively slow-acting catalyst).The reaction medium desirably includes the necessary plasticizer loading (e.g., plasticizer additive or filler) specifically configured to provide a curable reaction medium that, upon curing, produces a viscoelastomeric reaction product (i.e., thermally conductive polymer 330) having a unique polymerizate structure (e.g., polymer) effectively filled with a number of polar oriented plasticizers uniformly and homogeneously distributed throughout the entire thermoset mass of the polymer and supported by an entangled, flexible, plasticizer-entrapping thermoset polymerizate structure therein.

[0190] 5A-6B, in some aspects, the therapeutic member 300 can include an optional barrier layer 340. This type of optional barrier layer 340 would typically be disposed on the bottom side 312 of the mitigation member 310 (and thus the bottom side 302 of the therapeutic member 300), thereby forming a laminated structure. The purpose of the optional barrier layer 340 is, among other things, to inhibit migration of the liquid reaction medium during fabrication (i.e., to substantially confine the reaction medium to the channels 322 formed by the optional openings 320, as opposed to migrating over the entire bottom side 312 of the mitigation member 310), to prevent direct contact between the thermally conductive polymer 330 and the top side 121 of the thermal support member 120, and to prevent any potential leakage of the plasticizer, if present, that may result from migrating into the thermal support member 120. Desirably, such optional barrier layer 340 will be flexible (desirably similar in flexibility to that of the mitigation member 310), resilient (i.e., resistant to deformation due to external forces, resilient, etc.), elastic, and / or at least partially resistant to leakage of plasticizer.A suitable barrier layer 340 desirably has the form of a substrate and may be made of any of a number of materials known to those skilled in the art, such as plastics (e.g., polyethylene, polypropylene, polyvinyl chloride (PVC), etc.), polyester, elastic webbing (e.g., elastic, rubbery strings, strips, etc.), spandex, vinyl, thermoplastic foam (e.g., substantially closed cell), thermoset foam (e.g., substantially closed cell), natural and synthetic leather, natural and synthetic rubbers, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated woven fabrics, and the like. textiles), and the like, and combinations thereof. Optional barrier layer 340 can have any functional thickness but will typically be relatively thin, for example, between about 0.1 mm and about 1 mm. However, it should be understood that optional barrier layer 340 can have a thickness less than 0.1 mm or greater than 1 mm without departing from the scope of the present invention. In some desirable aspects, optional barrier layer 340 can be adhered (bonded, adhered, etc.) to bottom side 302 of therapeutic member 300 during production by being placed in contact with the reaction medium while curing to form thermally conductive polymer 330.However, the optional barrier layer 340 can be attached to the bottom side 302 of the therapeutic member 300 post-production via any suitable attachment means known to those skilled in the art (e.g., stitching, adhesives, mechanical fasteners, etc.) without departing from the scope of the present invention.

[0191] 5A-6B, in some aspects, the therapeutic element 300 can include an optional comfort layer (e.g., comfort layer, feel-enhancing layer, pressure distribution layer, etc.) 350. This type of optional comfort layer 350 is typically disposed on the top side 311 of the mitigation element 310 (and thus the top side 301 of the therapeutic element 300), thereby forming a laminated-type structure. The purpose of the optional comfort layer 350 is, among other things, to add an additional layer of comfort to the user, to provide aesthetically pleasing visual attributes, to provide an aesthetically pleasing feel, to reduce the user's perception of the presence of the optional channels 322 with the thermally conductive polymer 330, and to reduce or eliminate pressure points (such as areas where the skin receives localized pressure that can lead to bedsores), to prevent direct contact between the thermally conductive polymer 330 and the bedding sheet (not shown) or optional sheathing member 110 (if present), and to prevent any potential leakage of the plasticizer (if present) that may result from migration from the inventive therapeutic member 300. Desirably, such optional comfort layer 350 will be flexible (desirably similar in flexibility to that of the mitigation member 310), resilient (i.e., resistant to deformation due to external forces, resilient, etc.), elastic, and / or at least partially resistant to leakage of plasticizer.Suitable comfort layer 350 may optionally have the form of a substrate or pad and may be made of several materials known to those skilled in the art, such as plastics (e.g., polyethylene, polypropylene, polyvinyl chloride (PVC), etc.), polyester, elastic webbing (e.g., elastic, rubber-like strings, strips, etc.), damask, spandex, satin, sateen (e.g., sateen), vinyl, thermoplastic foam, thermoset foam, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated or uncoated woven fabrics, etc. The optional comfort layer 350 can have any functional thickness but will typically be relatively thinner than the mitigation member 310, for example, between about 0.1 mm and about 3 cm, or between about 0.5 mm and about 1.5 cm. However, it should be understood that the optional comfort layer 350 can have a thickness less than 0.1 mm or greater than 3 cm without departing from the scope of the present invention.In some desirable aspects, optional comfort layer 350 can be adhered (bonded, adhered, etc.) to top side 301 of therapeutic member 300 during production by virtue of being placed in contact with the reactive medium while curing to form thermally conductive polymer 330 as a component of therapeutic member 300. However, optional comfort layer 350 can be adhered to top side 301 of therapeutic member 300 post-production via suitable attachment means, such as those known to those skilled in the art (e.g., stitching, adhesives, mechanical fasteners, etc.), without departing from the scope of the present invention.

[0192] As referenced above, in some aspects, the therapeutic member 300 may optionally include a sheath member 110 that may be disposed over and / or at least partially surround or house the therapeutic member 300. This type of flexible sheath member 110 may be preferred for a number of reasons, including, among others, visual aesthetics, surface feel, increased structural support, a plasticizer leakage barrier, maintaining the various components of the inventive pressure ulcer prevention device 100 aligned with respect to each other, etc. Suitable sheathing members 110 can comprise several materials known to those skilled in the art, such as, for example, plastics (e.g., polyethylene, polypropylene, polyvinyl chloride (PVC), etc.), polyester, elastic webbing (e.g., elastic, rubber-like cords, strips, etc.), damask, spandex, satin, sateen (e.g., sateen), vinyl, thermoplastic foam, thermoset foam, Gortex, nonwovens (e.g., meltblown, spunbond, etc.), coated wovens, etc. textiles, cotton, wool, handwoven fabrics, etc., felt, natural and synthetic leather, natural and synthetic rubbers, and the like, and combinations thereof.Desirably, such a sheath member 110 will have a flexibility at least equal to or greater than that of the therapeutic member 300, though it need not be. The optional sheath member 110 may have any functional thickness, but will typically be relatively thin, for example, in the range of about 0.5 mm to about 10 mm. However, it should be understood that the optional sheath member 110 can have a thickness less than 0.5 mm or greater than 10 mm without departing from the scope of the present invention.

[0193] The present invention further includes a method for manufacturing the therapeutic device 300. One exemplary, non-limiting method includes: A. Providing a suitable mitigation member 310; B. Optionally, processing the mitigation member 310 to create a plurality of openings 320 and channels 322 extending generally in the z-direction within the mitigation member 310; C. Providing a suitable mold (not shown), the mold having several internal dimensions in the xy plane, the internal dimensions being approximately equivalent to the mitigation member 310; D. Optionally, aligning and placing a barrier layer 340 in a flat position inside the mold; E. aligning and placing a mitigation member 310 within the mold such that the bottom side 312 is positioned on an optional barrier layer 340; F. Preparing a suitable liquid polymeric reaction medium; G. disposing a quantity of said liquid polymeric reactive medium on the top side 311 of the mitigation member 310 (preferably so that said reactive medium is relatively evenly (e.g., uniformly) disposed on the top side 311); H. Optionally, placing a comfort layer 350 in a flat position on the top side 311 of the mitigation member 310 (in contact with the reaction medium); I. Allowing the reaction medium to fully cure into a thermally conductive polymer 330; J. Removing (e.g., removing from the mold, demolding, etc.) the combination (i.e., mitigation member 310, thermally conductive polymer 330, optional barrier layer 340, and optional comfort layer 350) to form the therapeutic member 300 of the presently disclosed invention. It is possible to have:

[0194] In some aspects, the method can optionally include applying a sheathing member 110 to the therapeutic member 300 to at least partially encase the therapeutic member 300. It should be understood that the method can be modified to omit the use of a mold. In such an embodiment, the bottom side 312 of the mitigation member 310 (or optional barrier layer 340) may simply be disposed on a suitably flat surface.

[0195] The present invention in this disclosure further includes a second method of manufacturing the inventive pressure ulcer prevention device 100. In this embodiment, the method includes a method for manufacturing the therapeutic member 300. One exemplary, but non-limiting, method includes: A. providing a thermal support member 120 as described above; B. Providing a massaging member 150 as described above; C. Providing a therapeutic element 300 as described above; D. Disposing the bottom side 122 of the thermal support member 120 onto the top side 151 of the massage member 150; E. Disposing the bottom side 302 of the therapeutic member 300 onto the top side 121 of the thermal support member 120 to form the pressure ulcer prevention device 100 of the present disclosure; F. Optionally, at least partially encasing (e.g., encasing) the pressure ulcer prevention device 100 within a sheathing member 110; It is possible to have:

[0196] The present invention may be better understood with reference to the following examples. [Example]

[0197] Example 1 A massage member 150 was constructed and provided. The massage member 150 had a housing component 160 having a steel outer frame element 162 (which generally formed the periphery of the housing component 160) with a length of approximately 190.5 cm, a width of approximately 99 cm, and a height of approximately 18 cm. The housing component 160 also had several cross-member elements 164 extending across the width of the frame element 162 and generally attached to bottom portions of the frame element 162 to enhance structural support of the housing component 160. Extending downwardly near each corner of frame element 162 were optional steel elevation elements 166 (i.e., legs), each having a length of approximately 17 cm, thereby elevating the bottom side of housing component 160 approximately 17 cm above the floor. Disposed extending horizontally and lengthwise (i.e., along x-axis 1) within housing component 160 were a plurality of first manipulation elements 170A having the shape of camshafts and each having a plurality of cams extending therefrom.These first manipulation elements 170A were rotatably mounted in a number of bearings (e.g., bearings) located at the "head" end (e.g., end closest to the user's head) and "foot" end (e.g., end closest to the user's feet) of the frame elements 162, and were additionally secured (e.g., secured in addition to being secured by the bearings) via a number of collars (e.g., cylindrical support members, rotating support members, etc.) mounted on a number of cross member elements 164. Meanwhile, extending vertically and along the width of the housing component 160 (i.e., along the y-axis 2) and adjacent to a location where the user's lower back / buttocks would be positioned during use of the inventive pressure ulcer prevention device 100 were a plurality of second manipulation elements 170B in the form of wheels having a plurality of roller balls disposed around the top side circumference thereof. The plurality of second manipulation elements 170B were rotatably mounted in a number of bearings located within the cross-member element 164 located at that location. Both the first manipulation elements 170A and the second manipulation elements 170B may be engageable via several electric motors and may be controlled via a suitable wired and / or wireless controller.Thus, a representative invention of the present disclosure was provided: a massaging member 150. The massaging member 150 in Example 1 was similar to the massaging member 150 shown in Figures 3A-3B.

[0198] Next, a generally rectangular mold (not shown) with an open top side was provided. The mold had rounded corners and resembled a raised frame-like structure. Its interior dimensions were approximately 190 cm long, 98.5 cm wide, and 30 cm high. A first circular aperture and a second circular aperture were positioned to pass through the "foot" end of the mold. Each opening had a diameter of approximately 2.5 cm and was generally transversally aligned, with a height of approximately 20.5 cm from the bottom side of the mold to the center point of each opening, while the first opening was positioned approximately 15 cm from one corner of the mold and the second opening was positioned approximately 25 cm from the same corner of the mold (i.e., the centers of the openings were approximately 10 cm apart).

[0199] An optional bottom-side barrier layer 136 was disposed in a laid-flat configuration within the bottom portion of the mold. Barrier layer 136 comprised polypropylene and had a length of approximately 190 cm, a width of approximately 98.5 cm, and a thickness of approximately 1 mm.

[0200] Next, thermal element 140 was provided. Thermal element 140 comprised PEX tubing having an outer diameter of 2.5 cm and had a curved, zigzag overall shape with two inlet / outlet ends at each end, similar to that shown in FIG. 2A. The optional thermal element support component 144 is in the form of a rectangular piece of standard mattress foam having a length of approximately 160 cm, a width of approximately 69 cm, and a height of approximately 19 cm, and the thermal element support component 144 is then placed in a laid-flat configuration on the top side of the barrier layer 136 within the interior of the mold and subsequently centered therein. The thermal element 140 was then aligned with and carefully placed on the top side of the support component 144, and the combination (i.e., the thermal element 140 and the support component 144) was then positioned so that the ends of the thermal element 140 were inserted into and passed through the corresponding first and second circular openings to form extensions 142 of the thermal element 140, extending approximately 1 cm from the outer surface of the mold.It was observed that the PEX tubing extending through the circular openings in the mold each had a snug fit within the openings (to prevent leakage of the liquid reaction media).

[0201] A sufficient amount of liquid polymeric reaction medium was prepared containing about 7.5 weight percent methylene diphenyl diisocyanate-based glycol prepolymer (ELASTOCAST TQZP23 available from BASF Corporation), about 27 weight percent hydroxyl-terminated polybutadiene resin (POLY BD R45 HTLO available from Cray Valley), about 65 weight percent epoxidized soybean oil plasticizer, and about 0.5 weight percent slow-acting organobismuth catalyst (COSCAT 83 available from Vertellus Holdings LLC). Immediately after the components were thoroughly mixed, the liquid reactive medium was poured into the mold until the height of the reactive medium reached approximately 25.5 cm, measured from the bottom of the mold. While the reactive medium was still partially cured, an optional top-side barrier layer 138 was aligned with and placed flat on top of the top surface of the reactive medium. The top-side barrier layer 138 comprised polypropylene and had a length of approximately 190 cm, a width of approximately 98.5 cm, and a thickness of approximately 0.5 mm. The reactive medium was then allowed to fully cure into the cushioning polymer 132 to form the polymer member 130, thereby providing the thermal support element 120, a representative invention of the present disclosure.

[0202] The resulting thermal support member 120 was released from the mold and then aligned with and placed on the massage member 150, thereby providing a non-limiting exemplary embodiment of the inventive pressure ulcer prevention device 100 of the present disclosure. Then, the motors of the manipulation elements 170 were electrically connected, and the ends (i.e., the extensions 142) of the thermal elements 140 were coupled to a thermal device 200 in the form of a heat pump (which used water). The inventive pressure ulcer prevention device 100 of Example 1 was then used by a user in a prone position (such as lying face down). It was observed that the inventive pressure ulcer prevention device 100 of Example 1 appeared to reduce the sensation of pressure points on the user's body, and it was further observed that the inventive pressure ulcer prevention device 100 was successful in providing therapeutic massage, heating and cooling effects as desired.

[0203] Example 2 The massage member 150 of the invention was prepared and provided as described in Example 1. Similarly, the thermal support member 120 of the invention was prepared and provided as described in Example 1. Meanwhile, a mitigation member 310 having a generally rectangular shape (e.g., a shape whose representative cross section is a quadrilateral) (having a plurality of rounded corners similar to those of the thermal support member 120 of Example 1) was provided. The mitigation element 310 was made of 1.5 pounds per cubic foot / 17 ILD (Indentation Load Deflection) open-cell polyether foam (4200-245848 available from American Converters) and had a length of approximately 190 cm, a width of approximately 98.5 cm, and a height (i.e., thickness) of approximately 2.5 cm. The mitigation element 310 had a plurality of perforations in the form of a plurality of uniform, cylindrical channels 322, each having a diameter of 3 mm. The channels 322 extended entirely through the mitigation member 310 (from the top side 311 to the bottom side 312 along the z-axis 3) and were uniformly spaced apart by a distance of approximately 2.5 mm as measured between the center points of each of the channels 322 in both the lengthwise direction (i.e., along the x-axis 1) and the widthwise direction (i.e., along the y-axis 2).

[0204] The optional barrier layer 340 was placed in a laid-flat configuration on a suitable flat surface. The barrier layer 136 had a substantially clear, colorless polypropylene film substrate and was approximately 200 cm long, 100 cm wide, and 0.1 mm thick. The bottom side 312 of the mitigation element 310 was then substantially centered and aligned with the barrier layer 340 and placed on the top side of the barrier layer 340.

[0205] A sufficient amount of liquid polymeric reaction medium was then prepared. The reaction medium contained about 6.34 weight percent methylene diphenyl diisocyanate-based glycol prepolymer (ELASTOCAST TQZP23 available from BASF Corporation), about 10.83 weight percent 2-functional polyether diol (ELASTOCAST C4057 available from BASF Corporation), about 32.33 weight percent 3-functional polyether triol (ELASTOCAST C4018 available from BASF Corporation), about 50.05 weight percent epoxidized soybean oil plasticizer, and about 0.30 weight percent blended catalyst of a slow-acting (e.g., sustained-release) organobismuth catalyst. The reaction medium contained approximately 0.15 weight percent of a heat-activated tin thioglycolate catalyst (COSCAT 83 available from Vertellus Holdings LLC) and approximately 0.15 weight percent of a heat-activated tin thioglycolate catalyst (FOMREZ CATALYST UL-54 available from Momentive Performance Materials Inc.). Immediately after thoroughly mixing the ingredients, the liquid reaction medium was poured and spread relatively evenly over the entire top side 311 of the mitigation member 310. The amount of reaction medium applied was approximately 5 grams polymer per gram mitigation member.While the reactive medium was still partially curing, an optional comfort layer (e.g., comfort layer, feel-enhancing layer, pressure-relieving layer, etc.) 350 was aligned with and placed on the top side 311 of the mitigation member 310 (with the reactive medium thereon) in a laid-flat configuration, with the bottom side of the comfort layer 350 substantially in contact with both the reactive medium and the top side 311 of the mitigation member 310. The comfort layer 350 comprised a soft, flexible, resilient thermoplastic foam (i.e., standard mattress foam) having a length of approximately 190 cm, a width of approximately 98.5 cm, and a thickness of approximately 1 cm. It was observed that the thickness of the reactive medium disposed on the mitigation member 310 decreased over time as the reactive medium was soaked into the mitigation member 310. The reactive medium was then allowed to fully cure to form the inventive thermally conductive polymer 330 of the present disclosure, thereby providing the inventive therapeutic member 300 of the present disclosure. Subsequently, any excess portions (e.g., flash) of the bottom-side barrier layer 340 were trimmed to fit the dimensions of the mitigation member 310.

[0206] Upon inspection of the therapeutic member 300, it was observed that a layer 335 of polymer 330 was formed on the top side 301, having a thickness of approximately 1 mm. Upon inspection of the bottom side 302 of the therapeutic member 300, it was observed that each channel 322 was substantially entirely filled with thermally conductive polymer 330, and that the diameter of the channels 322 was randomly expanded to a value ranging from approximately 6 mm to 10 mm.

[0207] The bottom side 122 of the thermal support member 120 was aligned with and placed on the top side 151 of the massage member 150, and then the bottom side 302 of the therapeutic member 300 was aligned with and placed on the top side 121 of the thermal support member 120, thereby providing another non-limiting exemplary embodiment of the pressure ulcer prevention device 100 of the presently disclosed invention.

[0208] The motor of the manipulation element 170 was then electrically connected, and the ends (i.e., the extended portions 142) of the thermal element 140 were connected to a thermal device 200 in the form of a heat pump (using water). The pressure ulcer prevention device 100 of Example 2 was then used by a user in a prone position. It was observed that the pressure ulcer prevention device 100 of Example 2 completely eliminated the sensation of any pressure points on the user's body. It was also observed that the pressure ulcer prevention device 100 of Example 2 successfully provided therapeutic massage, heating, and cooling effects as desired. It was noted that the massage effect of the embodiment of Example 2 was slightly less pronounced and more widely distributed than that of Example 1. It was also noted that the heating and cooling effects of the embodiment of Example 2 appeared to be generally equivalent to those of the embodiment of Example 1, but the time required to reach the endpoint temperature was several minutes longer. It was also noted that the embodiment of Example 2 subjectively felt slightly more soothing and comfortable than the embodiment of Example 1.

[0209] It will be understood that the details of the foregoing several examples are given for illustrative purposes and should not be construed as limiting the scope of the present invention. Although only a few representative embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that many variations exist in the several examples without substantially departing from the novel teachings and advantages of the present invention. For example, several features described in connection with one example may be incorporated into any other example of the present invention.

[0210] Accordingly, all such variations are intended to be encompassed within the scope of the present invention, which is specified in the following claims and all equivalents thereto. Furthermore, it is recognized that while many embodiments may be conceived as not achieving all of the advantages of some embodiments, particularly some preferred embodiments, the absence of a particular advantage should not be interpreted as necessarily meaning that such an embodiment is outside the scope of the present invention. Because various changes can be made in the above interpretation without departing from the scope of the present invention, it is intended that all of the matter contained in the above description (such as the detailed description of the invention) be interpreted as illustrative and not limiting.

Claims

1. A pressure ulcer prevention device, comprising: a massage member and a thermal support member, each having a top side and a bottom side; the massaging member includes a housing component and at least one manipulation element, the at least one manipulation element being disposed within the housing component; the thermal support member includes a polymer member and at least one thermal element, the at least one thermal element being at least partially disposed within the polymer member; The thermal support member is positioned on the top side of the massage member with the bottom side of the thermal support member in contact with the at least one manipulation element.

2. The pressure ulcer prevention device of claim 1 , wherein the housing component includes a frame element and at least one cross member element.

3. 10. The pressure ulcer prevention device of claim 1, wherein the massaging member further comprises at least one elevation element, the at least one elevation element being positioned on the bottom side of the massaging member.

4. The pressure ulcer prevention device of claim 1 , wherein the at least one manipulation element includes a first type of massage member and a second type of massage member.

5. The pressure ulcer prevention device of claim 1 , wherein the polymer member comprises a cushioning polymer having high molecular viscoelasticity and cohesive properties.

6. 6. The pressure ulcer prevention device of claim 5, wherein the cushioning polymer is produced from a reaction medium comprising: a. 3 to 20 weight percent of an isocyanate or silicone prepolymer; and b. 20 to 40 weight percent of a polyol; c. an epoxidized triglyceride plasticizer in the range of 40 to 80 weight percent; 1. A pressure ulcer prevention device comprising:

7. The pressure ulcer prevention device according to claim 6, wherein the polyol comprises a hydroxyl-terminated polyol.

8. The anti-bed sore device of claim 6, wherein the polyol comprises a polybutadiene polyol.

9. The pressure ulcer prevention device according to claim 8, wherein the polyol further comprises a polyether diol.

10. 7. The pressure ulcer prevention device of claim 6, wherein the epoxidized triglyceride plasticizer is an epoxidized soybean oil plasticizer.

11. The pressure ulcer prevention device of claim 6, wherein the reaction medium further comprises a catalyst in the range of 0.001 to 5 weight percent.

12. 10. The pressure ulcer prevention device of claim 1, wherein the thermal support member has a Shore 00 hardness in the range of 0 to 30.

13. 2. The pressure ulcer prevention device of claim 1, wherein the thermal support member further includes a thermal element support component, the thermal element support component being at least partially positioned within the polymer member in contact with the at least one thermal element.

14. The pressure ulcer prevention device of claim 1 , wherein the thermal support member further comprises a bottom side barrier layer disposed on the bottom side thereof.

15. The pressure ulcer prevention device of claim 1 , wherein the thermal support member further comprises a top side barrier layer disposed on the top side thereof.

16. The pressure ulcer prevention device of claim 1 , further comprising a thermal device component connected to the at least one thermal element.

17. 17. The pressure ulcer prevention device of claim 16, wherein the thermal device component includes a wireless user interface.

18. The pressure ulcer prevention device of claim 1 , wherein the thermal support member is at least partially contained within a sheath member.

19. 10. The pressure ulcer prevention device of claim 1, wherein the massaging member and the thermal support member are housed together and at least partially within a single sheath member.

20. A pressure ulcer prevention device, comprising: a massage member, a thermal support member, and a therapeutic member, each having a top side and a bottom side; the massaging member includes a housing component and at least one manipulation element, the at least one manipulation element being disposed within the housing component; the thermal support member includes a polymer member and at least one thermal element, the at least one thermal element being at least partially disposed within the polymer member; the therapeutic member comprises a mitigation member having a top side and a bottom side, and a thermally conductive polymer; the thermal support member is disposed on the top side of the massage member with the bottom side of the thermal support member in contact with the at least one manipulation element; The pressure ulcer prevention device, wherein the therapeutic member is disposed on the top side of the thermal support member.

21. 21. The pressure ulcer prevention device of claim 20, wherein the housing component includes a frame element and at least one cross member element.

22. 21. The pressure ulcer prevention device of claim 20, wherein the massaging member further comprises at least one elevation element, the at least one elevation element being positioned on the bottom side of the massaging member.

23. 21. The pressure ulcer prevention device of claim 20, wherein the at least one manipulation element includes a first type of massaging member and a second type of massaging member.

24. 21. The pressure ulcer prevention device of claim 20, wherein the polymer member comprises a cushioning polymer having high molecular viscoelastic and cohesive properties.

25. 21. The pressure ulcer prevention device of claim 20, wherein the cushioning polymer is produced from a reaction medium comprising: a. 3 to 20 weight percent of an isocyanate or silicone prepolymer; and b. 20 to 40 weight percent of a polyol; c. an epoxidized triglyceride plasticizer in the range of 40 to 80 weight percent; 1. A pressure ulcer prevention device comprising:

26. 26. The anti-bedsore device of claim 25, wherein the polyol comprises a hydroxyl-terminated polyol.

27. 26. The anti-bedsore device of claim 25, wherein the polyol comprises a polybutadiene polyol.

28. 28. The anti-bed sore device of claim 27, wherein the polyol further comprises a polyether diol.

29. 26. The anti-bedsore device of claim 25, wherein the epoxidized triglyceride plasticizer is an epoxidized soybean oil plasticizer.

30. 26. The pressure ulcer prevention device of claim 25, wherein the reaction medium further comprises a catalyst in the range of 0.001 to 5 weight percent.

31. 21. The pressure ulcer prevention device of claim 20, wherein the thermal support member has a Shore 00 hardness in the range of 0 to 30.

32. 21. The pressure ulcer prevention device of claim 20, wherein the thermal support member further includes a thermal element support component, the thermal element support component being at least partially positioned within the polymer member with the thermal element support component in contact with the at least one thermal element.

33. 21. The pressure ulcer prevention device of claim 20, wherein the thermal support member further includes a bottom side barrier layer disposed on the bottom side thereof.

34. 21. The pressure ulcer prevention device of claim 20, wherein the thermal support member further includes a top side barrier layer disposed on the top side thereof.

35. 21. The pressure ulcer prevention device of claim 20, further comprising a thermal device component connected to the at least one thermal element.

36. 36. The pressure ulcer prevention device of claim 35, wherein the thermal device component includes a wireless user interface.

37. 21. The pressure ulcer prevention device of claim 20, wherein the mitigation member includes at least one opening.

38. 38. A bedsore prevention device as described in claim 37, wherein the at least one opening is positioned on the top side of the mitigation member and extends at least partially through the mitigation member to form at least one channel.

39. 39. The pressure ulcer prevention device of claim 38, wherein the at least one channel comprises the thermally conductive polymer, the thermally conductive polymer being at least partially disposed within the at least one channel.

40. 21. The pressure ulcer prevention device of claim 20, wherein the therapeutic member includes the thermally conductive polymer, the thermally conductive polymer being disposed on the top side of the mitigation member.

41. 41. The pressure ulcer prevention device of claim 40, wherein the therapeutic member further comprises the thermally conductive polymer, the thermally conductive polymer being positioned to at least partially pass through the mitigation member.

42. 42. The pressure ulcer prevention device of claim 41, wherein the therapeutic member further comprises a layer of the thermally conductive polymer, the layer being disposed on the top side of the mitigation member.

43. 21. The pressure ulcer prevention device of claim 20, wherein the thermally conductive polymer is formed from a reactive medium comprising: a. in the range of 2 to 20 weight percent of a prepolymer; and b. in the range of 1 weight percent to 65 weight percent of a linear polyol; c. a cross-linking polyol in the range of 3 to 50 weight percent; d. an epoxidized triglyceride plasticizer in the range of 40 to 80 weight percent; e. a viscosity reducing plasticizer in the range of 0 to 40 weight percent; 1. A pressure ulcer prevention device comprising:

44. 44. The anti-bed sore device of claim 43, wherein the prepolymer is selected from the group consisting of isocyanate prepolymers and silicone prepolymers.

45. 44. The anti-bedsore device of claim 43, wherein the linear polyol comprises a polyether diol and the cross-linking polyol comprises a polyether triol.

46. 44. The anti-bedsore device of claim 43, wherein the epoxidized triglyceride plasticizer comprises an epoxidized soybean oil plasticizer.

47. 44. The pressure ulcer prevention device of claim 43, wherein the viscosity-reducing plasticizer comprises an ester plasticizer.

48. 44. The anti-bed sore device of claim 43, wherein the reaction medium further comprises a catalyst in the range of 0.001 to 5 weight percent.

49. 21. The pressure ulcer prevention device of claim 20, wherein the therapeutic member further comprises a barrier layer disposed on a bottom side thereof.

50. 21. The pressure ulcer prevention device of claim 20, wherein the therapeutic member further comprises a comfort layer disposed on a top side thereof.

51. 21. The pressure ulcer prevention device of claim 20, wherein at least one of the thermal support member and the therapeutic member is at least partially contained within a sheath member.

52. 21. The pressure ulcer prevention device of claim 20, wherein the massaging member, the thermal support member, and the therapeutic member are housed together and at least partially within a single sheath member.

53. 1. A method for preparing a pressure ulcer prevention device, comprising: a. providing a massage member having a top side and a bottom side, said massage member including a housing component and at least one manipulation element disposed within said housing component; b. providing a thermal support member having a top side and a bottom side, said thermal support member comprising a polymer member and at least one thermal element, said at least one thermal element being at least partially disposed within said polymer member; c. placing the thermal support member on the top side of the massaging member with the bottom side of the thermal support member at least partially contacting the at least one thermal element to form the pressure ulcer prevention device; A method comprising:

54. 54. The method of claim 53, further comprising: d. providing a therapeutic member having a top side and a bottom side, said therapeutic member comprising a mitigation member and a thermally conductive polymer, said thermally conductive polymer being at least partially disposed within said mitigation member; e. placing the therapeutic member on the top side of the thermal support member; A method comprising:

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