EP2310467A2 - Cushioning device - Google Patents

Cushioning device

Info

Publication number
EP2310467A2
EP2310467A2 EP09771091A EP09771091A EP2310467A2 EP 2310467 A2 EP2310467 A2 EP 2310467A2 EP 09771091 A EP09771091 A EP 09771091A EP 09771091 A EP09771091 A EP 09771091A EP 2310467 A2 EP2310467 A2 EP 2310467A2
Authority
EP
European Patent Office
Prior art keywords
cushioning device
gel
styrene
pressure sensitive
sensitive adhesive
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09771091A
Other languages
German (de)
French (fr)
Inventor
Philip C. Yang
Charles E. Lundy, Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Consumer Care Holdings LLC
Original Assignee
Schering Plough Healthcare Products Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schering Plough Healthcare Products Inc filed Critical Schering Plough Healthcare Products Inc
Publication of EP2310467A2 publication Critical patent/EP2310467A2/en
Withdrawn legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/40Layered products comprising a layer of synthetic resin comprising polyurethanes
    • AHUMAN NECESSITIES
    • A43FOOTWEAR
    • A43BCHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B13/00Soles; Sole-and-heel integral units
    • A43B13/14Soles; Sole-and-heel integral units characterised by the constructive form
    • A43B13/18Resilient soles
    • A43B13/189Resilient soles filled with a non-compressible fluid, e.g. gel, water
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/06Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings
    • A61F13/061Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings for knees
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/06Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings
    • A61F13/064Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings for feet
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/003Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor characterised by the choice of material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/02Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C39/10Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. casting around inserts or for coating articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00Layered products comprising a layer of synthetic resin
    • B32B27/06Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04Interconnection of layers
    • B32B7/12Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09JADHESIVES; NON-MECHANICAL ASPECTS OF ADHESIVE PROCESSES IN GENERAL; ADHESIVE PROCESSES NOT PROVIDED FOR ELSEWHERE; USE OF MATERIALS AS ADHESIVES
    • C09J7/00Adhesives in the form of films or foils
    • C09J7/20Adhesives in the form of films or foils characterised by their carriers
    • C09J7/29Laminated material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2075/00Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/48Wearing apparel
    • B29L2031/50Footwear, e.g. shoes or parts thereof
    • B29L2031/507Insoles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2255/00Coating on the layer surface
    • B32B2255/10Coating on the layer surface on synthetic resin layer or on natural or synthetic rubber layer
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2255/00Coating on the layer surface
    • B32B2255/26Polymeric coating
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2437/00Clothing
    • B32B2437/02Gloves, shoes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2479/00Furniture
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2666/00Composition of polymers characterized by a further compound in the blend, being organic macromolecular compounds, natural resins, waxes or and bituminous materials, non-macromolecular organic substances, inorganic substances or characterized by their function in the composition
    • C08L2666/02Organic macromolecular compounds, natural resins, waxes or and bituminous materials
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09JADHESIVES; NON-MECHANICAL ASPECTS OF ADHESIVE PROCESSES IN GENERAL; ADHESIVE PROCESSES NOT PROVIDED FOR ELSEWHERE; USE OF MATERIALS AS ADHESIVES
    • C09J2301/00Additional features of adhesives in the form of films or foils
    • C09J2301/10Additional features of adhesives in the form of films or foils characterized by the structural features of the adhesive tape or sheet
    • C09J2301/16Additional features of adhesives in the form of films or foils characterized by the structural features of the adhesive tape or sheet by the structure of the carrier layer
    • C09J2301/162Additional features of adhesives in the form of films or foils characterized by the structural features of the adhesive tape or sheet by the structure of the carrier layer the carrier being a laminate constituted by plastic layers only
    • CCHEMISTRY; METALLURGY
    • C09DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09JADHESIVES; NON-MECHANICAL ASPECTS OF ADHESIVE PROCESSES IN GENERAL; ADHESIVE PROCESSES NOT PROVIDED FOR ELSEWHERE; USE OF MATERIALS AS ADHESIVES
    • C09J2475/00Presence of polyurethane
    • C09J2475/006Presence of polyurethane in the substrate

Definitions

  • the subject invention is directed to cushioning devices comprising a pressure sensitive adhesive
  • the invention concerns the use of pressure sensitive adhesive materials to improve the hold of soft gel cushioning devices
  • One of the key attributes of the footwear cushions is to prevent the footwear from rubbing sensitive areas of skin, in particular in the heel areas
  • the cushion needs to stay sn place firmly during movement associated with normal use of footwear
  • Cushioning devices made of soft gels are known in the art and are desirable for their comfort, flexibility, durability and look.
  • the assignee of this invention markets a cushioning c device under the trade name Dr Scholl's® Gel Heel Liner, which comprises a thermoplastic polyurethane (TPU) film bonded to a polyurethane (PU) gel where the PU get is produced tn a way to have a stfcky surface
  • Dr Scholl's® Gel Heel Liner which comprises a thermoplastic polyurethane (TPU) film bonded to a polyurethane (PU) gel where the PU get is produced tn a way to have a stfcky surface
  • TPU thermoplastic polyurethane
  • PU polyurethane
  • the subject invention provides a cushioning device comprising a layer of polyurethane gel material comprising top and bottom surfaces, at least one layer of thermopiastic polyurethane film material bonded to the one or both of said top and bottom surfaces thereof and a layer of pressure sensitive adhesive bonded to one of said at least one thermoplastic polyurethane film material wherein the pressure sensitive adhesive is located on a surface of the thermoplastic polyurethane film opposite to the surface contacting said bottom surface of said polyurethane gel material.
  • the subject invention also provides a gel cushioning device comprising a sticky surface, the device comprising a gei material bound to a thermopiastic film material having good compatibility with the gei material, wherein the thermoplastic film material further comprises a pressure sensitive adhesive located on a surface of the film materia! opposite to the surface that is bonded to the gel material.
  • the subject invention further provides ge! cushioning device comprising a sticky surface, the device comprising a layer of gel material having an upper and lower surface and two layers of thermoplastic film material, each film material comprising upper and lower surfaces, wherein the upper surface of the gel material is bonded with the lower surface of one of said layers of film material and the lower surface of the ge! material is bonded with the upper surface of the other of said layers of film material, wherein at least one of the layers of film material comprises a pressure sensitive adhesive on a surface opposite the surface bonded to the gei material thereby providing the sticky surface of the device.
  • the subject invention also provides a method of constructing a ge ⁇ cushioning device comprising a sticky surface, which comprises loading ge) materia! into a mold cavity comprising at least one layer of thermoplastic film material, said at least one layer of thermoplastic film material comprising upper and lower surfaces, and curing the gel materia! to form a solid gel. such that the cured gel materia! is bonded with the film materia! and wherein said at least one of the layer of thermoplastic film material comprises a pressure sensitive adhesive 5 on a surface opposite the surface bonded to the gel material thereby providing the sticky surface of the device.
  • Figure 1 A depicts a cross section of a prior art cushioning element.
  • Figure 1 B depicts a cross section of an example embodiment of the cushioning element of the invention.
  • Figure 2 depicts a cross section of a second example embodiment of the cushioning element of the invention.
  • the products of the invention comprise an advance over prior art TPU/PU molded cushioning elements in that they provide for a means to attach a pressure sensitive adhesive to a gel material to provide extra holding capabilities.
  • Figure 1 A shows a cross section of a prior art material comprising gel materia! (104) bonded to a film material (102). The film material 5 provides an exterior surface that resists friction to aliow for smooth contact with skin or articies of clothing.
  • Figure 1 B shows a cross section of an example embodiment of the subject invention wherein a layer of gel material having top and bottom surfaces comprises two layers of f ⁇ im materia! (102, 103) bonded to each surface of the gel material In the practice of the invention, the gel materia!
  • K may comprise, for example poiyurethane gel, styrenic based gels, or silicone gefe.
  • the ge! materials useful in the invention may typically have a Shore 00 hardness of between about 10 and about 80, preferably between about 30 and about 60. In certain embodiments of the invention, the poiyurethane gel materials are used and may have a Shore 00 hardness of about 50.
  • the ge! material may typically D have a thickness of between 0.3 and 3 mm.
  • the film materia! may comprise thermoplastic polymeric fiim materia! that is compatible with the ge! material used in the cushion For exampte, where a poiyurethane ge! materia! is used in the 5 cushion, the film materia!
  • thermoplastic polyurethane film material Ukewise ) when an SEBS ge! material is used in the cushion, the film material will likely comprise SEBS thermoplastic film.
  • the film materials may typically have a Shore A hardness of between about 40 to about 95 and may typically have a thickness of between 0.025 mm and 0.25 mm. In certain
  • the individual layers of film will have the same thickness. In certain additional embodiments according to this invention, individual layers of film will have different thicknesses. Sn practice, varying the thickness of the film will affect the softness and flexibility of the film and will likewise affect the softness and
  • thermoplastic polyurethane film is used and may be at least 0.025 mm thick,
  • poiyurethane material will be understood to encompass polymers that contain a plurality of urethane linkages and comprised of either aliphatic or aromatic isocyanate prepolymers, and combinations thereof, both with 0 either di or trifunctional polyol polymers or prepolymers.
  • the polyurethane material may optionally also contain other kinds of chemical linkages formed from the reactions of polyisocyanates, including but not limited to urea linkages, isocyanurate linkages, oxazolidone linkages, biuret linkages, allophanate linkages, combinations of these, and the like.
  • Polyurethane gel materials are 5 typically formed by reacting polyisocyanates with polyois.
  • poiy isocyanates include those formed from aliphatic or aromatic isocyanate prepolymers or combinations thereof.
  • polyois include di or trifunctionaf polyol polymers or prepolymers
  • polyois used include po ⁇ yether polyois such as poiy(ethyfene oxide) and po!y(propyfene oxide), 0 modified polyether polyois, poiytetramethylene glycol, condensation polyester polyoSs produced by reacting dicarboxyiic acids with diois, factone-type polyester polyois produced by ring opening polymerization of epsilon-caprolactone or the (ike, and polycarbonate polyois, vinyl polymers into which hydroxy! groups are introduced such as polyois having pofyisobutyfene as the main chain,
  • the gei layer can also be made from a non-foam elastomer such as the cSass of materials known as viscoeSasfic polymers or silicone gels, which show high levels of damping when tested by dynamic mechanical analysis performed in the range of -50 degree Celsius to 100 degrees Celsius.
  • Gels material can include, but not limited to, the Kraton family of styrene-olefin-rubber block copolymers, thermoplastic poiyurethanes, thermoset poiyurethanes, thermoplastic poly olefins, polyamides, pofyureas. polyesters and other polymer materials that reversibly soften as a function of temperature.
  • the preferred elastomers are a Kraton block copolymer of styrene/ethylene-co-butylene/styrene (SEBS) or styrene/butad ⁇ ene/styrene (SBS) with mineral oil incorporated into the matrix as a plastic ⁇ zer.
  • SEBS styrene/ethylene-co-butylene/styrene
  • SBS styrene/butad ⁇ ene/styrene
  • pressure sensitive adhesives also known as contact adhesives
  • contact adhesives are those that form viscoelastic bonds that are aggressively and permanently tacky, adhere without the need of more than slight pressure, and require no activation by water, solvent or heat.
  • Pressure sensitive adhesives are typically available in solvent and latex or water based forms and are often based on non-crosslinked rubber adhesives, acrylics or poiyurethanes,
  • the pressure sensitive adhesives may comprise acrylic and methacrylate adhesives, rubber-based pressure sensitive adhesives, styrene copolymers such as styrene-isoprene-styrene (SiS) and styrene-butadiene-styrene (SBS) copolymers with at least one tackifier, and silicones.
  • Acrylic adhesives often use an acrylate system such as ethylene ethyl acrylate (EEA) or ethylene methyl acrylate (EMA) copolymers, which are used to form hot melt PSA adhesives.
  • Natural rubber, synthetic rubber or elastomer adhesives may typically comprise a variety of materials such as silicone, polyurethane, chloroprene, butyl, polybutadiene, isoprene or neoprene. Rubber and eSastomers are characterized by their high degree of flexibility and elasticity.
  • the pressure sensitive adhesive material may comprise acryiate-bas ⁇ d adhesive materials.
  • the thickness of the layer of the pressure sensitive adhesive material may be varied by those of ordinary skill in the art according to the adhesive material used and the desired tack, in the practice of certain example embodiments of t ⁇ e invention, the pressure sensitive adhesive may have a thickness of between about 0.0125 mm and about 0.25 rum- 5
  • An additional aspect of the invention comprises a method of manufacturing a cushioning element comprising a potyurethane gel material, which method comprises the step of bonding a polyurethane gel and a thermoplastic film material, wherein the thermoplastic film material comprises a pressure sensitive adhesive, in preparation of one embodiment of the invention it was discovered 10 that the pressure sensitive adhesive layer cannot bond directly to the soft polyurethane gel during the molding process.
  • a layer of thermoplastic film material comprising the pressure sensitive adhesive layer was added to the mold and bonded to the polyurethane gel,
  • the cushioning element is : 5 prepared by a direct molding process where the gel material is applied directly to the mold, for example by injecting the gel prepolymer into the mold cavity.
  • the film material layer comprising the pressure sensitive adhesive is applied to the mold cavity with the adhesive on the side of the film material closest to the mold and then the PU gel 20 material is injected into the mold over the film material.
  • the moid can be treated to resist bonding of the pressure sensitive adhesive or a release liner material can be applied in the mold first before the film material is applied to the mold, in certain embodiments of the invention, the mold may be preheated to the desired curing temperature prior to injecting the gel material or heated after all materials
  • the mold temperature is typically between 85 -95C and the cycle time is approximately 8 min.
  • the pressure is typically low and not critical for this type of operation provided that the pressure is high enough to fill the cavity-mold with polyurethane prepolymer.
  • a reiease liner 106 is shown contacting the exposed surface of the PSA layer depicted in Figure 1 B.
  • the gel cushion can be manufactured by direct molding process.
  • the thin release liner laminate comprises the bottom iayer assembly of the ge! cushioning eteme-nt and atso aids in the ease of ⁇ j removing the formed gei cushioning element from a mold.
  • the top thermoplastic film comprises the cover layer of the liner during the molding process.
  • the release liner can be kept on the product when packaged for sale and discarded before applying the gel cushioning element to a surface, such as a shoe or other article of footwear, in certain embodiments the cushioning device may further comprise a synthetic rubber foam, a woven cotton fabric, a synthetic fiber, a knit fabric, a polyvinyl chloride film, and/or a synthetic non-woven fabric.
  • the products of the invention can be formed into any shape suitable for use as a cushioning device, for example for insertion into footwear to prevent rubbing between sensitive skin and hard or exposed surfaces of the footwear.
  • the cushioning elements can also be applied to other garments e.g., hats, helmets, protective sporting gear such as elbow and knee pads and other garments requiring extra padding for comfort, sizing and/or safety.
  • Cushioning elements according to the invention may also be applied to surfaces which come in contact with body parts to provide protection from injury such as, e.g., chairs, desks, cabinets, tables, doors and door frames, among others. Depending on the size and shape of the object to which the cushioning element is applied, certain shapes will better protect different areas of the body from contact with the object.
  • the products are molded in the shape of, e.g., circles, parabolas, stars, squares, rectangles, rounded rectangles, naif-moon, among others.
  • the appropriate shape of the cushioning element can be determined based on the size and surface of the object to which the cushioning element will be applied.
  • the cushioning element can be provided as a sheet of material that the user can cut to a desired shape.
  • the sheet of material can also be provided with preformed shapes that can be removed as desired for the appropriate protection from contact with the object.
  • a human wear test was conducted to compare the unmodified polyurethane gel cushion containing a sticky gel surface with a modified pofyyrefhane gei cushion of the present invention containing a pressure sensitive adhesive The test was run to determine if a cushioning device according to the invention would provide appropriate adhesion performance when compared to the unmodified polyurethane gel heel liner. Prior to the wear test, a probe tack test was conducted on both devices according to ASTM D 2979-01 to measure the force required to separate an adhesive and adherend shortly after they have been contacted under a defined load of known duration and at a specified temperature.
  • the devices were also tested for shear hold according to PSTC-107 A 1 which measures the adhesive material's ability to remain adhered under a constant load applied parallel to the surface of the material and substrate, in particular measuring the shear adhesion when applied to a vertical standard steel panel.
  • the two devices were determined to have the following adhesion tack and shear hold:
  • the two heel liner devices have essentially the same adhesion tack and shear hold, and would be expected to have the same adhesion performance in use, i.e., the ability to stay in place in a shoe under normal wear.
  • heel liner cushions formed according to the invention was then evaluated in a wear test by volunteers who inserted the devices into their shoes and wore them for three days of norma! use.
  • the test subjects were divided such that 23 subjects evaluated the unmodified heef ⁇ ners while 22 subjects evaluated the heel ⁇ ner modified with PSA. Both the unmodified heel liners and the modified heei liners were similar in appearance so the test subjects did not know which device they were wearing.
  • the test subjects were asked to rate their agreement or disagreement with whether the cushion stayed m place during norma! use. rating according to a seven point scale. Answer j Rating agree extremely agree moderately agree slightly neither agree or disagree disagree slightly disagree moderately disagree extremely , 7
  • the modified heel liners produced according to the subject invention containing the PSA produced an overwhelmingly positive feed back from users.
  • the unmodified heel liners showed equivocal results of positive and negative feed back.
  • the statistical analysis (p of 0.0041) of the wear test results indicated that the liners modified with PSA according to the invention provide a better adhesion performance during wear than the unmodified version, which result was unexpected based on the probe tack and shear hold tests on trie cushions.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Laminated Bodies (AREA)
  • Adhesive Tapes (AREA)
  • Adhesives Or Adhesive Processes (AREA)
  • Footwear And Its Accessory, Manufacturing Method And Apparatuses (AREA)
  • Vibration Prevention Devices (AREA)

Abstract

A cushioning device comprising a sticky surface, the device comprising a gel material bound to a thermoplastic film material having a polarity compatible with the gel material, wherein the thermoplastic film material further comprises a pressure sensitive adhesive located on a surface of the film material opposite to the surface that is bonded to the gel material.

Description

5
CUSHIONING DEVICE
Background of The Invention o The subject invention is directed to cushioning devices comprising a pressure sensitive adhesive In particular the invention concerns the use of pressure sensitive adhesive materials to improve the hold of soft gel cushioning devices One of the key attributes of the footwear cushions is to prevent the footwear from rubbing sensitive areas of skin, in particular in the heel areas However, sn order to achieve all the desired attributes of the cushion, the cushion needs to stay sn place firmly during movement associated with normal use of footwear Cushioning devices made of soft gels are known in the art and are desirable for their comfort, flexibility, durability and look. The assignee of this invention, Schering-Plough Healthcare Products, lnc , markets a cushioning c device under the trade name Dr Scholl's® Gel Heel Liner, which comprises a thermoplastic polyurethane (TPU) film bonded to a polyurethane (PU) gel where the PU get is produced tn a way to have a stfcky surface However, no additional adhesive is used in this product The Heel Liner is packaged with a release film to preserve the tackiness of the PU gel sticky surface, which is then applied to the5 shoe to hold the liner in place The TPU film provides a nonstick surface opposite the sticky surface, which nonstick contacts the wearers foot, sock, or hosiery
It has now been determined, however, that the sticky PU gel does not hold the liner sn place for extended periods of use as may be desired for a cushioning element Pressure sensitive adhesive materials have been used in the art o However direct modification of a sticky PU gel with a pressure sensitive adhesive did not produce a cushioning element with a stronger hold Thus a cushioning device that provides the benefit of a ge! and provides for Song term hold sn the shoe whe^e placed would be desirable Further a method of manufacturing a gel cushioning device wtth a pressure sensitive adhesive would also be desirable 5 These and other advantages follow from the invention described and claimed here Summary Of The Invention
The subject invention provides a cushioning device comprising a layer of polyurethane gel material comprising top and bottom surfaces, at least one layer of thermopiastic polyurethane film material bonded to the one or both of said top and bottom surfaces thereof and a layer of pressure sensitive adhesive bonded to one of said at least one thermoplastic polyurethane film material wherein the pressure sensitive adhesive is located on a surface of the thermoplastic polyurethane film opposite to the surface contacting said bottom surface of said polyurethane gel material.
The subject invention also provides a gel cushioning device comprising a sticky surface, the device comprising a gei material bound to a thermopiastic film material having good compatibility with the gei material, wherein the thermoplastic film material further comprises a pressure sensitive adhesive located on a surface of the film materia! opposite to the surface that is bonded to the gel material.
The subject invention further provides ge! cushioning device comprising a sticky surface, the device comprising a layer of gel material having an upper and lower surface and two layers of thermoplastic film material, each film material comprising upper and lower surfaces, wherein the upper surface of the gel material is bonded with the lower surface of one of said layers of film material and the lower surface of the ge! material is bonded with the upper surface of the other of said layers of film material, wherein at least one of the layers of film material comprises a pressure sensitive adhesive on a surface opposite the surface bonded to the gei material thereby providing the sticky surface of the device.
The subject invention also provides a method of constructing a geϊ cushioning device comprising a sticky surface, which comprises loading ge) materia! into a mold cavity comprising at least one layer of thermoplastic film material, said at least one layer of thermoplastic film material comprising upper and lower surfaces, and curing the gel materia! to form a solid gel. such that the cured gel materia! is bonded with the film materia! and wherein said at least one of the layer of thermoplastic film material comprises a pressure sensitive adhesive 5 on a surface opposite the surface bonded to the gel material thereby providing the sticky surface of the device.
Brief Description Of The Drawings
1 o Figure 1 A depicts a cross section of a prior art cushioning element.
Figure 1 B depicts a cross section of an example embodiment of the cushioning element of the invention.
13 Figure 2 depicts a cross section of a second example embodiment of the cushioning element of the invention.
Detailed Description C As depicted in Figure 1, the products of the invention comprise an advance over prior art TPU/PU molded cushioning elements in that they provide for a means to attach a pressure sensitive adhesive to a gel material to provide extra holding capabilities. Figure 1 A shows a cross section of a prior art material comprising gel materia! (104) bonded to a film material (102). The film material 5 provides an exterior surface that resists friction to aliow for smooth contact with skin or articies of clothing. Figure 1 B shows a cross section of an example embodiment of the subject invention wherein a layer of gel material having top and bottom surfaces comprises two layers of fϊim materia! (102, 103) bonded to each surface of the gel material In the practice of the invention, the gel materia!
K may comprise, for example poiyurethane gel, styrenic based gels, or silicone gefe. The ge! materials useful in the invention may typically have a Shore 00 hardness of between about 10 and about 80, preferably between about 30 and about 60. In certain embodiments of the invention, the poiyurethane gel materials are used and may have a Shore 00 hardness of about 50. The ge! material may typically D have a thickness of between 0.3 and 3 mm. The film materia! may comprise thermoplastic polymeric fiim materia! that is compatible with the ge! material used in the cushion For exampte, where a poiyurethane ge! materia! is used in the 5 cushion, the film materia! will likely comprise a thermoplastic polyurethane film material. Ukewise) when an SEBS ge! material is used in the cushion, the film material will likely comprise SEBS thermoplastic film. The film materials may typically have a Shore A hardness of between about 40 to about 95 and may typically have a thickness of between 0.025 mm and 0.25 mm. In certain
10 embodiments according to this invention where more than one layer of film is used, the individual layers of film will have the same thickness. In certain additional embodiments according to this invention, individual layers of film will have different thicknesses. Sn practice, varying the thickness of the film will affect the softness and flexibility of the film and will likewise affect the softness and
15 flexibility of the final gel cushion product. In certain embodiments, a thermoplastic polyurethane film is used and may be at least 0.025 mm thick,
As used herein poiyurethane material will be understood to encompass polymers that contain a plurality of urethane linkages and comprised of either aliphatic or aromatic isocyanate prepolymers, and combinations thereof, both with 0 either di or trifunctional polyol polymers or prepolymers. The polyurethane material may optionally also contain other kinds of chemical linkages formed from the reactions of polyisocyanates, including but not limited to urea linkages, isocyanurate linkages, oxazolidone linkages, biuret linkages, allophanate linkages, combinations of these, and the like. Polyurethane gel materials are 5 typically formed by reacting polyisocyanates with polyois. Examples of poiy isocyanates include those formed from aliphatic or aromatic isocyanate prepolymers or combinations thereof. Examples of polyois include di or trifunctionaf polyol polymers or prepolymers Examples of polyois used include poϊyether polyois such as poiy(ethyfene oxide) and po!y(propyfene oxide), 0 modified polyether polyois, poiytetramethylene glycol, condensation polyester polyoSs produced by reacting dicarboxyiic acids with diois, factone-type polyester polyois produced by ring opening polymerization of epsilon-caprolactone or the (ike, and polycarbonate polyois, vinyl polymers into which hydroxy! groups are introduced such as polyois having pofyisobutyfene as the main chain,
;:, The gei layer can also be made from a non-foam elastomer such as the cSass of materials known as viscoeSasfic polymers or silicone gels, which show high levels of damping when tested by dynamic mechanical analysis performed in the range of -50 degree Celsius to 100 degrees Celsius. Gels material can include, but not limited to, the Kraton family of styrene-olefin-rubber block copolymers, thermoplastic poiyurethanes, thermoset poiyurethanes, thermoplastic poly olefins, polyamides, pofyureas. polyesters and other polymer materials that reversibly soften as a function of temperature. The preferred elastomers are a Kraton block copolymer of styrene/ethylene-co-butylene/styrene (SEBS) or styrene/butadϊene/styrene (SBS) with mineral oil incorporated into the matrix as a plasticϊzer.
As used herein, pressure sensitive adhesives (also known as contact adhesives) are those that form viscoelastic bonds that are aggressively and permanently tacky, adhere without the need of more than slight pressure, and require no activation by water, solvent or heat. Pressure sensitive adhesives are typically available in solvent and latex or water based forms and are often based on non-crosslinked rubber adhesives, acrylics or poiyurethanes,
In certain embodiments of the invention, the pressure sensitive adhesives may comprise acrylic and methacrylate adhesives, rubber-based pressure sensitive adhesives, styrene copolymers such as styrene-isoprene-styrene (SiS) and styrene-butadiene-styrene (SBS) copolymers with at least one tackifier, and silicones. Acrylic adhesives often use an acrylate system such as ethylene ethyl acrylate (EEA) or ethylene methyl acrylate (EMA) copolymers, which are used to form hot melt PSA adhesives. Natural rubber, synthetic rubber or elastomer adhesives may typically comprise a variety of materials such as silicone, polyurethane, chloroprene, butyl, polybutadiene, isoprene or neoprene. Rubber and eSastomers are characterized by their high degree of flexibility and elasticity.
Sn certain embodiments, the pressure sensitive adhesive material may comprise acryiate-basβd adhesive materials. The thickness of the layer of the pressure sensitive adhesive material may be varied by those of ordinary skill in the art according to the adhesive material used and the desired tack, in the practice of certain example embodiments of tπe invention, the pressure sensitive adhesive may have a thickness of between about 0.0125 mm and about 0.25 rum- 5 An additional aspect of the invention comprises a method of manufacturing a cushioning element comprising a potyurethane gel material, which method comprises the step of bonding a polyurethane gel and a thermoplastic film material, wherein the thermoplastic film material comprises a pressure sensitive adhesive, in preparation of one embodiment of the invention it was discovered 10 that the pressure sensitive adhesive layer cannot bond directly to the soft polyurethane gel during the molding process. To overcome this limitation, a layer of thermoplastic film material comprising the pressure sensitive adhesive layer was added to the mold and bonded to the polyurethane gel,
In certain embodiments of the invention, the cushioning element is : 5 prepared by a direct molding process where the gel material is applied directly to the mold, for example by injecting the gel prepolymer into the mold cavity. During a direct molding process, before the gel material is injected, the film material layer comprising the pressure sensitive adhesive is applied to the mold cavity with the adhesive on the side of the film material closest to the mold and then the PU gel 20 material is injected into the mold over the film material. The moid can be treated to resist bonding of the pressure sensitive adhesive or a release liner material can be applied in the mold first before the film material is applied to the mold, in certain embodiments of the invention, the mold may be preheated to the desired curing temperature prior to injecting the gel material or heated after all materials
25 are loaded into the mold. For example, when using polyurethane gel materials according to the invention the mold temperature is typically between 85 -95C and the cycle time is approximately 8 min. The pressure is typically low and not critical for this type of operation provided that the pressure is high enough to fill the cavity-mold with polyurethane prepolymer.
3 C As depicted in Figure 2, a reiease liner 106 is shown contacting the exposed surface of the PSA layer depicted in Figure 1 B. In this example embodiment of the invention, the gel cushion can be manufactured by direct molding process. in this manner, the thin release liner laminate comprises the bottom iayer assembly of the ge! cushioning eteme-nt and atso aids in the ease of ~ j removing the formed gei cushioning element from a mold. The top thermoplastic film comprises the cover layer of the liner during the molding process. The release liner can be kept on the product when packaged for sale and discarded before applying the gel cushioning element to a surface, such as a shoe or other article of footwear, in certain embodiments the cushioning device may further comprise a synthetic rubber foam, a woven cotton fabric, a synthetic fiber, a knit fabric, a polyvinyl chloride film, and/or a synthetic non-woven fabric.
The products of the invention can be formed into any shape suitable for use as a cushioning device, for example for insertion into footwear to prevent rubbing between sensitive skin and hard or exposed surfaces of the footwear. The cushioning elements can also be applied to other garments e.g., hats, helmets, protective sporting gear such as elbow and knee pads and other garments requiring extra padding for comfort, sizing and/or safety. Cushioning elements according to the invention may also be applied to surfaces which come in contact with body parts to provide protection from injury such as, e.g., chairs, desks, cabinets, tables, doors and door frames, among others. Depending on the size and shape of the object to which the cushioning element is applied, certain shapes will better protect different areas of the body from contact with the object. in certain example embodiments the products are molded in the shape of, e.g., circles, parabolas, stars, squares, rectangles, rounded rectangles, naif-moon, among others. The appropriate shape of the cushioning element can be determined based on the size and surface of the object to which the cushioning element will be applied. In alternative example embodiments, the cushioning element can be provided as a sheet of material that the user can cut to a desired shape. The sheet of material can also be provided with preformed shapes that can be removed as desired for the appropriate protection from contact with the object.
Experimental
A human wear test was conducted to compare the unmodified polyurethane gel cushion containing a sticky gel surface with a modified pofyyrefhane gei cushion of the present invention containing a pressure sensitive adhesive The test was run to determine if a cushioning device according to the invention would provide appropriate adhesion performance when compared to the unmodified polyurethane gel heel liner. Prior to the wear test, a probe tack test was conducted on both devices according to ASTM D 2979-01 to measure the force required to separate an adhesive and adherend shortly after they have been contacted under a defined load of known duration and at a specified temperature. The devices were also tested for shear hold according to PSTC-107 A1 which measures the adhesive material's ability to remain adhered under a constant load applied parallel to the surface of the material and substrate, in particular measuring the shear adhesion when applied to a vertical standard steel panel. The two devices were determined to have the following adhesion tack and shear hold:
PU gel without PSA PU gel with PSA
Probe Tack (g) I 449 +/- 9 422 +/- 39
Shear Hold (min) ! 445 +/- 220 325 +/- 173
Based on the results of the probe tack test and the shear hold test, those of ordinary skill in the art would recognize that the two heel liner devices have essentially the same adhesion tack and shear hold, and would be expected to have the same adhesion performance in use, i.e., the ability to stay in place in a shoe under normal wear.
The adhesion performance of heel liner cushions formed according to the invention was then evaluated in a wear test by volunteers who inserted the devices into their shoes and wore them for three days of norma! use. The test subjects were divided such that 23 subjects evaluated the unmodified heef ϋners while 22 subjects evaluated the heel ϋner modified with PSA. Both the unmodified heel liners and the modified heei liners were similar in appearance so the test subjects did not know which device they were wearing. After three days, the test subjects were asked to rate their agreement or disagreement with whether the cushion stayed m place during norma! use. rating according to a seven point scale. Answer j Rating agree extremely agree moderately agree slightly neither agree or disagree disagree slightly disagree moderately disagree extremely , 7
The sum of the top three rating answers indicated a positive feedback of the performance of the heel Hner cushion adhesion and the sum of the bottom three rating answers indicated the negative feedback to the performance of the heel liner cushion. The results were as follows:
As shown, the modified heel liners produced according to the subject invention containing the PSA produced an overwhelmingly positive feed back from users. Conversely, the unmodified heel liners showed equivocal results of positive and negative feed back. The statistical analysis (p of 0.0041) of the wear test results indicated that the liners modified with PSA according to the invention provide a better adhesion performance during wear than the unmodified version, which result was unexpected based on the probe tack and shear hold tests on trie cushions.
Several embodiments of the present invention are specifically described herein. However, it wilt be appreciated that modifications and variations of the present invention are covered by the above teachings and within tne purvtew of the appended claims without departing from the spirit and intended scope of the invention.

Claims

5
WHAT IS CLAIMED IS:
1. A cushioning device comprising a layer of polyurethane ge! material comprising top and bottom surfaces, at least one layer of thermoplastic poiyurethane film C material bonded to the one or both of said top and bottom surfaces thereof, and a layer of pressure sensitive adhesive bonded to one of said at least one thermoplastic polyurethane film materia!, wherein the pressure sensitive adhesive is located on a surface of the thermoplastic polyurethane film opposite to the surface contacting said bottom surface of said polyurethane gel material. 5
2. The cushioning device of ciaim 1 wherein the pressure sensitive adhesive comprises acrylic adhesives, methacrySate adhesives, rubber-based adhesives,
3. The cushioning device of claim 1 wherein the pressure sensitive adhesive is an j adhesive based on styrene copolymers or silicones and combinations thereof.
4. The cushioning device of claim 3« wherein the styrene copolymers comprise styrene-isoprene-styrene (SiS), styrene-ethySene-butylene-styrene (SEBS), styrene-butadiene-styrene (SBS) copolymers with at least one tackifier, or 5 combinations thereof.
5. The cushioning device of claim 2, wherein the acrylic adhesive comprises ethylene ethyl acryiate (EEA), ethylene methyl acryiate (EMA) copolymers, or combinations thereof. C
8 The cushioning device of claim 1 , wherein the layer of pressure sensitive adhesive has a thickness of between about 0.0125 mm and about 0.25 mm.
7. The cushioning device of claim 1 , wherein the polyurethane geS materia! has a - ^ Shore 00 hardness of between about 10 and about 80
5 8. The cushioning device of claim 1 , wherein the polyurethane gel material has a Shore 00 hardness of between about 30 and about 60.
9. The cushioning device of claim 1 , wherein the polyurethane get material has a Shore 00 hardness of Shore 00 hardness of about 50.
10. The cushioning device of claim 1 , wherein the poSyurethane gel material has a thickness of between 0.3 and 3 mm.
11. The cushioning device of claim 1. wherein the thermoplastic polyurethane film 5 material has a Shore A hardness of between about 40 to about 95.
12. The cushioning device of claim 1 , wherein the thermoplastic polyurethane film material has a thickness of between 0.025 mm and 0.25 mm.
o 13. The cushioning device of claim 1 , wherein a layer of thermoplastic polyurethane film material is bonded to both of said top and bottom surfaces of polyurethane gel materials.
14. The cushioning device of claim 13, wherein the individual layers of 5 thermoplastic polyurethane film have the same thickness.
15. The cushioning device of claim 13, wherein the individual layers of thermoplastic polyurethane film have different thicknesses. 0 18 The cushioning device of claim 1 , wherein at feast one layer of the thermoplastic poϊyurethane film has a thickness of at least 0.025 mm.
17. A gel cushioning device comprising a sticky surface, the device comprising a ge! mateπai bound to a thermoplastic film material having good compatibility with '-, the ge! material, wherein the thermoplastic film materia! further comprises a 5 pressure sensitive adhesive located on a surface of the film material opposite to the surface that is bonded to the gel material.
18. The cushioning device of claim 17, wherein the gel material is a poiyurethane gel material.
10
19. The cushioning device of claim 17, wherein the thermoplastic film material is a poiyurethane material.
20. The cushioning device of claim 17, wherein the gel material is SEBS ge! 15 material.
21. The cushioning device of claim 17, wherein the thermoplastic film material is SEBS material.
2 G 22. The cushioning device of claim 17, wherein the pressure sensitive adhesive comprises acrylic adhesives, methacryiate adhesives. rubber-based adhesives,
23. The cushioning device of claim 17, wherein the pressure sensitive adhesive is an adhesive based on styrene copolymers or silicones and combinations thereof. 5
24. The cushioning device of claim 23, wherein the styrene copolymers comprise styrene-isoprene-styrene (SIS)1 styrene-ethylene-butylene-styrene (SEBS), styrene-butadiene-styrene (SBS) copolymers with at least one tackifier, or combinations thereof.
25. The cushioning device of claim 23S wherein the acrylic adhesive comprises ethylene ethyl acryiate (EEA), ethylene methyi acrylate (EMA) copolymers, or combinations thereof.
~ϊ ~ 26. The cushioning device of claim 17, wherein the pressure sensitive adhesive has a fiiickness of between about 0.0125 mm and about 0,25 mm. i «
27. The cushioning device of claim 17, wherein the gel material has a Shore 00 hardness of between about 10 and about 80
28. The cushioning device of claim 17, wherein the material has a Shore 00 13 hardness of between about 30 and about 60.
29. The cushioning device of claim 17, wherein the material has a Shore 00 hardness of Shore 00 hardness of about 50. 5 30. The cushioning device of claim 17, wherein the gel material has a thickness of between 0.3 and 3 mm.
31. The cushioning device of claim 17, wherein the thermoplastic film material has a Shore A hardness of between about 40 to about 95. C
32. The cushioning device of claim 17, wherein the thermoplastic film material has a thickness of between 0.025 mm and 0.25 mm.
33. The cushioning device of claim 17, wherein the thermoplastic film material 5 has a thickness of at least 0.025 mm,
34. A gel cushioning device comprising a sticky surface, the device comprising a layer of gel material having an upper and Sower surface and two layers of thermoplastic film materia!, each film material comprising upper and lower : surfaces, wherein the upper surface of the gei materia! is bonded with the tower surface of one of said layers of film materia! and the tower surface of the gei material is bonded with the upper surface of the other of said layers of fiim materia!, wherein at teast one of the iayers of film material comprises a pressure sensitive adhesive on a surface opposite the surface bonded to the gei materia!
^ -; thereby providing the sticky surface of the device
5 35. The cushioning device of claim 34, wherein the gef material is a polyurethane ge! material.
36. The cushioning device of claim 34, wherein the thermoplastic film material is a polyurethane material.
37. The cushioning device of claim 34, wherein the gel material is SEBS gel material.
38. The cushioning device of claim 34, wherein the thermoplastic film material is 15 SEBS materia!.
39. The cushioning device of claim 34 wherein the pressure sensitive adhesive comprises acrylic adhesives, methacryiate adhesϊves, rubber-based adhesives,
20 40. The cushioning device of claim 34 wherein the pressure sensitive adhesive is an adhesive based on styrene copolymers or silicones and combinations thereof.
41. The cushioning device of claim 40, wherein the styrene copolymers comprise styrene-isoprene-styrene (SIS), styrene-ethylene-butyiene-styrene (SEBS),
25 styrene-butadiene-styrene (SBS) copolymers with at feast one tackifier, or combinations thereof.
42. The cushioning device of claim 40, wherein the acrylic adhesive comprises ethylene ethyl acryiate (EEA). ethylene methyl acrylate (EMA) copolymers, or
S ": combinations thereof.
43. The cushioning device of claim 34, wherein the pressure sensitive adhesive has a thickness of between about 0,0125 mm and about 0.25 mm.
; 3 44 The cushioning device of datm 34, wherein the gei materia! has a Shore 00 hardness of between about 10 and about 80
45. The cushioning device of claim 34, wherein the gel material has a Shore 00 hardness of between about 30 and about 60.
46. The cushioning device of claim 34, wherein the gel material has a Shore 00 IG hardness of Shore 00 hardness of about 50.
47. The cushioning device of claim 34, wherein the gel material has a thickness of between 0.3 and 3 mm.
15 48. The cushioning device of claim 34, wherein the thermoplastic film material has a Shore A hardness of between about 40 to about 95.
49. The cushioning device of claim 34, wherein the thermoplastic film material has a thickness of between 0.025 mm and 0.25 mm.
2G
50. The cushioning device of claim 34, wherein said thermoplastic film material has a thickness of at least 0.025 mm.
51. A method of constructing a gel cushioning device comprising a sticky surface,
25 which comprises loading gel material into a moid cavity comprising at least one layer of thermoplastic film material, said at least one layer of thermoplastic film material comprising upper and lower surfaces, and curing the gel material to form a solid gel, such that the cured gel material is bonded with the film material and wherein said at least one of the layer of thermoplastic film material comprises a
3 Z pressure sensitive adhesive on a surface opposite the surface bonded to the gei material thereby providing the sticky surface of the device.
52. The method of claim 51 , wherein the moid cavity comprises two layers of thermoplastic film material such that when cured the gel material is bonded with i :, the tower surface of one of said te/ers of film and the upper surface of the other of said layers of film material
53. The method of claim 51 , wherein said loading comprises injecting geϊ material into a mo!d cavity comprising said thermoplastic film material, at least one of said thermoplastic film materials comprising a pressure sensitive adhesive on a surface opposite the surface contacting the injected gel material.
: o
54. The method of claim 51 , wherein said mold cavity further comprises a release Siner material positioned between said pressure sensitive adhesive and said mold form.
15 55. The method of claim 51 , wherein said mold form further comprises a surface treatment that resists bonding of the pressure sensitive adhesive to the mold form.
56. The method of claim 51 , wherein the gel material is a polyurethane gel material.
57. The method of claim 51 , wherein the gel material is SEBS gel materia!.
58. The method of claim 51 , further comprising the steps of removing the cured gel material from the mold cavity and die cutting the material to a desired shape.
25
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