WO2022093784A1 - Matériau à changement de phase pour thérapie thermique et administration de principes actifs - Google Patents

Matériau à changement de phase pour thérapie thermique et administration de principes actifs Download PDF

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Publication number
WO2022093784A1
WO2022093784A1 PCT/US2021/056599 US2021056599W WO2022093784A1 WO 2022093784 A1 WO2022093784 A1 WO 2022093784A1 US 2021056599 W US2021056599 W US 2021056599W WO 2022093784 A1 WO2022093784 A1 WO 2022093784A1
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Prior art keywords
elastomer
mixture
manufacturing
therapeutic material
plasticizing oil
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PCT/US2021/056599
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English (en)
Inventor
Aldo Laghi
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Alps South, LLC
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Priority claimed from US17/083,454 external-priority patent/US11707556B2/en
Application filed by Alps South, LLC filed Critical Alps South, LLC
Publication of WO2022093784A1 publication Critical patent/WO2022093784A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/24—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0002—Head or parts thereof
    • A61F2007/0003—Face
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0002—Head or parts thereof
    • A61F2007/0004—Eyes or part of the face surrounding the eyes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0039—Leg or parts thereof
    • A61F2007/0042—Knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0051—Stumps after amputation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0203—Cataplasms, poultices or compresses, characterised by their contents; Bags therefor
    • A61F2007/0215—Cataplasms, poultices or compresses, characterised by their contents; Bags therefor containing liquids other than water
    • A61F2007/0219—Gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

  • the present invention relates to a field of thermal therapy articles employing a thermoplastic elastomer and more particularly to a thermoplastic elastomer composite having a high latent heat of fusion for the delivery of fat soluble active substances through the skin into the bloodstream.
  • post-surgical garments are currently used to treat surgical sites in an attempt to reduce bruising, swelling, and edema sometime associated with surgery.
  • most post-surgical garments e.g., compression garments
  • most post-surgical garments utilize only fabric and/or hydrogels, which are used in an attempt to reduce and/or prevent postsurgical bruising, swelling, and edema.
  • Post-surgical garments that incorporate thermal therapy devices often utilize hydrogels because they are relatively inexpensive, easy to manufacture, and may be easily adapted for the purposes of compression therapy, thermal therapy, cold compression therapy, or any combination thereof.
  • hydrogels often lack durability because of the high water content within these materials. Specifically, these hydrogels lack tear strength due to high water content, which makes them prone to tearing during handling and application. Hydrogels also tend to desiccate very quickly during usage. Thus, for at least the above discussed reasons, hydrogels and hydrogel garments (including hydrogel compression garments) have very short lifespans for usage coupled with undesirable treatment results.
  • thermoplastic A well-known characteristic of thermoplastics is that they become soft and formable when heated. The majority of commonly used thermoplastics require higher temperatures than would be acceptable for contact with human skin, specifically the facial skin. To take advantage of the latent heat of fusion plastics must, at a minimum, reach the glass transition temperature which is far higher than what is acceptable for human skin contact. At the glass transition temperature, the plastic is able to utilize the latent heat of fusion and thermoplastics formability feature.
  • phase change material of this invention is a salt and is encapsulated by one of variously described materials. The compound is then used in combination with a
  • Patent US 9,249,303 discloses an invention that is a thermoplastic elastomer with phase change characteristics for providing heat to or absorbing heat from a body.
  • An embodiment of this invention includes a percentage of a plasticizing oil in an amount of less than or equal to 45 percent by weight. It has been found that amounts greater than 45 percent by weight of the plasticizing oil are necessary to control the rate of delivery through the dermis. To maintain a higher percentage of fat soluble active ingredients a higher percentage of plasticizing oil must also be present.
  • TTS transdermal therapeutic systems
  • styrenic triblock copolymers such as a hydrogenated poly(styrene-b-isoprene), a hydrogenated poly(styrene-b-isoprene-b- styrene), a hydrogenated poly(styrene-b-butadiene-b-styrene), or combinations thereof.
  • elastomeric articles of the present invention comprised any of polystyrene- b-poly(ethylene/propylene) (SEP), polystyrene-b-poly(ethylene/propylene)-b-polystyrene
  • Suitable plasticizing agents 30 included plasticizing oils such as paraffinic oils, naphtenic petroleum oils, mineral oils, and synthetic liquid oligomers of polybutene, polypropylene, polyterpene, etc..
  • plasticizing oils such as paraffinic oils, naphtenic petroleum oils, mineral oils, and synthetic liquid oligomers of polybutene, polypropylene, polyterpene, etc.
  • a seeding of the oil was also effected, with an insoluble fine powder such as talc.
  • 300 to 1000 parts by weight of the plasticizing oil was used, more preferably between about 500 and 700 parts per hundred
  • the oil 30 or other plasticizing agent (also referred to herein as a plasticizer) was added to the triblock copolymer 40 in order to provide desired mechanical properties, such as elasticity, softness (or hardness), and elongation, tear and tensile strength characteristics of the resulting elastomer.
  • suitable mechanical properties of the resulting elastomer included: (a) hardness between approximately 10 to 70 durometer on the Shore 00 scale, more preferably about 25 durometer on the Shore 00 scale; (b) ultimate elongation of approximately 300 to 2000 percent, more preferably about 1500 percent; and/or (c) tensile modulus at 300 percent elongation of between about 5 to 300 psi, more preferably about 30 psi.
  • One or more other additives 20 were also included, that precipitated out of a molten mixture of the polymer, plasticizing oil, and additive, upon cooling, thereby forming microcraters on the surface of the resulting thermoplastic elastomer.
  • the surface microcraters had an average radius of between about 0.001 mm and 0.07 mm, more preferably between about 0.0067 mm and 0.0433 mm, and an average depth between about 0.0183 mm and 0.1434 mm, for example to provide a desired tactile feel, and/or to optimize surface characteristics, mechanical properties or other characteristics of the resulting thermoplastic elastomer.
  • the additive was a compound that has lower solubility in the mixture of polymer and plasticizing oil when cooled to room temperature (e.g., about
  • additives 20 comprised one or more antioxidants and/or antimicrobial agents.
  • Table 1 included examples of suitable antioxidant additives.
  • Pentaerythritol Tetrakis (3-(3,5-di-tert-butyl-4- hydroxphenyl)propionate) [e.g., IRGANOX 1010, Ciba Chemicals,
  • the tris (2,4-ditert-butylphenyl) phosphate as listed in Table I is a white crystalline powder, commonly used as a phosphate processing stabilizer for polycarbonate and polyolefins. It was used in combination with phenolic antioxidants and acts for synergistical color stability and polymer viscosity.
  • the butanedionic acid as listed in Table I is a white crystalline powder, commonly used as a phosphate processing stabilizer for polycarbonate and polyolefins. It was used in combination with phenolic antioxidants and acts for synergistical color stability and polymer viscosity.
  • the butanedionic acid as listed in Table I is a white crystalline powder, commonly used as a phosphate processing stabilizer for polycarbonate and polyolefins. It was used in combination with phenolic antioxidants and acts for synergistical color stability and polymer viscosity.
  • the butanedionic acid as listed in Table I is a
  • succinic acid is a dicarboxylic acid with four carbon atoms, occurs naturally in plant and animal tissues and can play a role in intermediary metabolism (Krebs cycle). It is a colorless crystalline solid with a melting point of 185-187° C., soluble in water, slightly dissolved in ethanol, ether, acetone and glycerine, but not dissolved in benzene, carbon sulfide, carbon tetrachloride and oil ether.
  • a common method of synthesis of succinic acid is the catalytic hydrogenation of maleic acid or its anhydride.
  • Succinic acid has uses in certain drug compounds, in agricultural and food production, and in perfume esters.
  • pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4- hydroxphenyl)propionate) was the additive used.
  • Using a percent may be more preferably to parts, or PPH, as the ratio of oil to polymer can change considerably.
  • the additives were solid at room temperature (25° C.) and soluble in the molten mixture.
  • the additives had higher solubility in the triblock copolymer elastomers at higher temperatures than at room temperature.
  • the addition of such additives were in a predetermined proportion that exceeds the solubility of the additives 20 in the elastomer at room temperature.
  • the addition of such additives to the mixture 50 of polymers 40 and plasticizing oil 30 was made either prior to the melting of the mixture in a heated vessel or when the mixture was in its molten state.
  • suitable antimicrobial agent additives included but were not limited to silver zeolite, silver zirconium phosphate, silver nitrate, silver thiosulfate, silver sulphadiazine, silver fusidate, and quaternary ammonium compounds (QAC).
  • silver-based antimicrobial agents for example a silver acetate, a silver bromide, a silver carbonate, a silver chlorate, a silver chloride, a silver citrate, a silver fluoride, a silver iodate, a silver lactate, a silver nitrate, a silver nitrite, a silver perchlorate or a silver sulfide.
  • One or more other antimicrobial agents were used in conjunction with or instead of such silver-based antimicrobial agents or other additive.
  • the force required for 0% elongation is 0, values increase in substantially linear relation as force is applied to any given material. Accordingly, the higher the modulus the stiffer the material. The modulus is inversely proportional to the amount of plasticizing oil in the composition of the elastomeric gel.
  • a method of making a thermoplastic elastomer included mixing additive 20, plasticizing oil 30 and polymer 40 to form a mixture 50.
  • One or more additives such as antioxidant or hydroxyl scavenger additives, e.g., such as one or more of those additives listed in Table I above, were used to create a powder-like precipitate that diffused to the surface of the elastomer during and/or after formation to create surface microcraters that reduced tackiness of the elastomer where such surface characteristics were desired.
  • Plasticizing oil 30 was heated prior to the addition of polymer 40 and/or additive 20.
  • Mixture 50 was melted, for example in an extruder, a molding machine or other suitable heated vessel so that the additives became soluble in molten mixture 50 and remained in stable solution in the molten mixture 50.
  • Molten mixture 50 was then molded 60 or otherwise shaped into any desired shape or form 70, for example into a prosthetic sleeve or liner configured to receive the residual limb on an amputee (e.g., of an arm or leg) or a front or rear prosthetic breast skin, or a mask.
  • an amputee e.g., of an arm or leg
  • a front or rear prosthetic breast skin or a mask.
  • the additives began to diffuse to the surface of elastomer 80 upon completion of the solidification process. Precipitation optionally was initiated by seeding the surface of elastomer 80 with fine powder 90 such as talcum powder, for example during the cooling process. Elastomer 80 was then cooled to make solidified elastomer 100, whereby additive
  • solidified elastomer 100 optionally precipitated to the surface of solidified elastomer 100, e.g., in the form of a dry powder.
  • An additive 20 was then be mixed in the plasticizing oil, optionally with seed, for a defined time, e.g., approximately 5 to 15 minutes, more preferably about 10 minutes, at a temperature of approximately 130 to 165° F.
  • One or more additives 20 was optionally also added to the plasticizing oil 30 with or after the addition of the polymer 40.
  • a polymer 40 or mixture of polymers was added to the plasticizing oil 30 or to the mixture of plasticizing oil and additives for a desired period of time, for example 20-40 minutes, more preferably about
  • suitable polymers included any triblock copolymer, including for example styrenic triblock copolymers such as SEP, SEPS, SEES or SEEPS.
  • styrenic triblock copolymers such as SEP, SEPS, SEES or SEEPS.
  • 100 parts by weight of one or a mixture of two or more of a hydrogenated styrene/isoprene/butadiene block copolymer were used.
  • the mixture containing the plasticizing oil, the additive and the polymer was melted in an extruder, a reciprocating screw molding machine, or a heated vessel at about 400 to 460° F., more preferably between about 415° F., as an example in our prior invention.
  • the additive was added to the mixture of polymers and plasticizing oils either prior to the melting of the mixture or in the melt phase.
  • the mixture was maintained at an elevated temperature, with or without mixing, for an amount of time necessary to ensure adequate dissolution and dispersion of the additives in the mixture. The time required to effect an adequate mixture was function of the triblock copolymer used and the equipment used to melt the mixture.
  • a typical time for processing the mixture was, for example, 10 to 30 minutes in a reciprocating screw type injection molding machine or an extruder, and 4 to 16 hours in a melting pot or vat.
  • a typical time for processing the mixture was, for example, 10 to 30 minutes in a reciprocating screw type injection molding machine or an extruder, and 4 to 16 hours in a melting pot or vat.
  • a typical time for processing the mixture was, for example, 10 to 30 minutes in a reciprocating screw type injection molding machine or an extruder, and 4 to 16 hours in a melting pot or vat.
  • a typical time for processing the mixture was, for example,
  • the size of the particles of the precipitated phase was a function of the time temperature profile maintained during the cooling period and of the mechanical stress to which the elastomer was subjected. More particularly, the particles increased in size as the cooling rate decreased and as the amount of mechanical deformation decreased. A faster cooling rate (e.g., under refrigeration instead of room temperature) and greater mechanical deformation can produce smaller particle sizes.
  • the diffusion rate of precipitate to the surface of the liner also increased as the stress to strain ratio decreased, i.e., the diffusion rate increased as the modulus of the elastomer, or elastic limit stress, decreased.
  • Molding, casting or extruding of the molten mixture was conducted at a mold temperature of, for example, 95-130° F. for 5-10 minutes. The molded elastomer was removed from the mold after the expiration of such period of time. Although stretching was not required, stretching of the elastomer by about 50% improved the diffusion rate.
  • step of aging at a controlled temperature profile was also performed in the prior invention. For example, such aging was accomplished at a temperature of 20-32°
  • FIG. 5 of the prior invention shows a photograph of an elastomer before (left) and after (right) aging at room temperature, e.g., approximately 25° C. for 24 hours.
  • the precipitated phase can diffuse to the surface of the elastomer and collect as a powder on its surface as shown in the right photo of FIG. 5. After optional removal of the surface powder, by wiping, washing (e.g., using a washing machine), or the like, additional powder can migrate to the surface of the elastomer. The process can be repeated until the saturation level at room temperature of the precipitate phase in the elastomer is reached. The process of diffusion to the surface may then stop.
  • the diffusion had several advantageous characteristics.
  • the diffused precipitated phase modified the surface characteristics of elastomer 100 by creating micro-craters 120 on elastomer surface 110.
  • the average number of microcraters per unit varied depending upon, for example, by the amount of antioxidant additives that are used, the speed of cooling, and/or by imparting mechanical stresses on the elastomeric material during the cooling process.
  • the microcraters were more numerous, smaller and more packed.
  • the microcraters were larger and more spaced. If the process of precipitation of the hydroxyl scavengers occurred too slowly, the scavengers coagulated together to form crystals on the surface of the elastomer. The crystals and/or the resulting microcraters made the surface rough and were undesirable for use in skin contact applications.
  • the depth of the microcraters varied with the number and size of particles that emerged from the precipitation.
  • the precipitated and migrated particles stacked on top of each other at the surface of the elastomer, forming a variable depth.
  • the range of depth of surfaces having desirable characteristics were, for example, 0.005 mm to 0.2 mm, more preferably between about 0.018 mm and 0.143 mm.
  • the diffusion had several advantageous characteristics.
  • the diffused precipitated phase modified the surface characteristics of the elastomers by creating microcraters on the surface as seen in the photographs of FIGS. 6-12.
  • FIG. 6 a cross sectional photograph at 60 x magnification shows elastomer 80 with precipitated hydroxyl scavenger additives 770 forming in the gel medium, and microcraters 780 at the surface
  • FIG. 7 shows the surface of a cooled elastomer 80 that was formed according to the present invention and which includes hydroxyl scavengers tightly packed and relatively small in diameter. As stated above, the size of the scavenger precipitation spots is equal to the size of the craters.
  • FIG. 8 is a similar top-view photograph of another elastomer 80 formed as described above, showing hydroxyl scavengers having larger diameters and more spaces in between.
  • microcraters in each of the formed elastomers 80 was measured using a computer software as shown in FIG. 9. (Microscope: Skope by Boreal,
  • FIG. 10 shows a top view photograph of an elastomer 80 formed as described above, but where the process of precipitation of the hydroxyl scavengers was allowed to occurred slowly as no seeding, stretching, or other manipulations to facilitate precipitation were performed.
  • the scavengers coagulated together to form crystals on the surface of the elastomer.
  • the ciystals made the surface rough, which is undesirable for use in some skin contact applications.
  • the scavenger particle sizes in this example were 3 to 19 times larger than those on a more desirable surface, such as those shown in FIGS. 7-9.
  • Such size measurements were performed, for example, using a computer program to draw an a circle, ellipse, or other shape around the outline of each crystal or crater, and to calculate the area, perimeter and radius of the defined area.
  • the mean measured depth was 0.0634 mm
  • maximum depth was 0.143 mm
  • minimum depth was 0.0183
  • standard deviation of depth measurements was
  • tissue target 150 having tissue surface 160 abutted elastomer surface 110 wherein therapeutic compound 170 embedded in micro-craters 120 migrated through tissue surface 160 to deliver compound 170 to tissue target 150.
  • Therapeutic compounds were applied to molded surface 110 and retained by the micro-craters 120 for contact with tissue target 150.
  • Such compounds included, but were not limited to, vitamins, nutrients, antibiotics, antimicrobials, fungicides, cancer chemotherapeutics, and other dmgs.
  • the elastomers of the prior art invention were able to be molded or extruded or thermoformed into various shapes and items such as prosthetic liners and sleeves, external breast prostheses, seals for CPAP (Continuous Positive Air Pressure) masks or other masks, headbands, bum treatment dressings, other wound care dressing sheets and pads, scar reduction pads, socks for diabetic feet, malleolus pads, metatarsal pads, shoe insoles, other orthotics, garments, catheters and balloons for catheters, temporary implantations, and applications of cosmetics.
  • the thermoplastic elastomers of the prior art invention included antioxidants and hydroxyl scavengers as additives, and are formed into useful articles for wound healing applications.
  • thermoplastic elastomer included one or more antioxidant and/or hydroxyl scavenger additives, for example,
  • Irganox 1010 and/or other additives such as those listed in Table 1 above.
  • Such additives acted as effective scavengers of free radicals and hydroxyl groups, and had beneficial effects on the skin, including for example, wound healing.
  • Antioxidant additives such as
  • Irganox 1010 were previously used in thermoplastic polymers to scavenge oxygen and other free radicals that may degrade the polymers when they are in a molten state for molding and extrusion.
  • an excessive amount of such antioxidants were utilized; for example in an amount beyond the solubility of the antioxidant in the thermoplastic elastomer. In the polymer at room temperature, this excess, over time, precipitated out of the bulk of the polymer.
  • Irganox 1010 was added in excess of its room temperature solubility in the gel, precipitated in the build of the polymer, then migrated to the surface of the gel.
  • the mineral oil also migrated to the surface of the gel and included the additive (e.g., Irganox 1010) dissolved within the oil.
  • thermoplastic elastomers as described in the prior invention were used, for example, as liners or sleeves in prosthetic devices, as bandages, patches, pads, wound dressings, or in any other applications involving prolonged contact of an elastomer with the skin of a user, and in particular where healing of a wound is desired.
  • the patient or user included human or non-human mammals, e.g., primate, dog, cat, mouse, cow, etc.
  • the precipitated additives comprised antioxidants or free radical scavengers that are useful in treating different types of wounds, e.g., lesions due to bums, trauma, surgery, diabetic lesions or ulcers, pressure ulcers, etc.
  • a therapeutic article such as a sleeve, liner, bandage, dressing, pad, malleolus pad, scar patch, insole or other article included a thermoplastic elastomer with one or more additives.
  • a fabric or other backing was integrated within or bonded to the article. The fabric was stitched or woven, and in some embodiments was elastic in one or more directions and in other embodiments was substantially inelastic in one or more directions.
  • thermoplastic elastomer lining examples include prosthetic liners, a prosthetic sleeve, a prosthetic skin, a bum dressing, a scar reduction pad, a wound care dressings, goggle frames, a mask, a headband, an orthotic device, a garment, a catheter, a temporary implantation, and a cosmetic application.
  • thermoplastic elastomers of the present invention were particularly suitable for use as liners, sleeves or other skin contact points in a prosthetic device.
  • a prosthetic liner 540 was configured to receive and fit against a residual limb of an amputee patient, and to hold a prosthetic limb against the residual limb.
  • liner 540 included a thermoplastic elastomer 570 with a fabric backing 580 attached to one side.
  • An inner surface 590 of the thermoplastic elastomer preferably had microcraters as described and included antioxidants, hydroxyl scavengers, antimicrobials, lubricants or other agents or substances that were applied to surface 590 or precipitated from elastomer 570.
  • An open end 550 was configured to receive the residual limb of the patient and a closed end 560 was configured to attach to a prosthetic limb or other device.
  • An umbrella 600 or other device for securing the prosthetic limb was attached to or integrated within the liner 540.
  • the fabric 580 of liner 540 included any suitable fabric and may be stitched or woven. Fabric 580 preferably allowed stretching in a radial direction (e.g., radial stretching of up to 50%) and resisted elongation (e.g., relatively inelastic in a longitudinal or axial direction to support the weight of a prosthetic limb).
  • a radial direction e.g., radial stretching of up to 50%
  • elongation e.g., relatively inelastic in a longitudinal or axial direction to support the weight of a prosthetic limb.
  • a prosthetic sleeve 610 comprised a thermoplastic elastomer 570 surrounded by a sleeve fabric 580.
  • the sleeve preferably was substantially cylindrical or conical in shape, and included a central passage 620 through which a limb or other body part was placed.
  • inner surface 590 contacted against the skin of the user.
  • therapeutic agents were included in elastomer
  • such agents were transferred, e.g., by direct contact with the skin or through absorption of oil in the elastomer (e.g., where the therapeutic agent was carried by the oil).
  • such sleeves or liners were used to treat various types of wounds and/or infections, depending upon the additives in the composition of the thermoplastic elastomer.
  • thermoplastic elastomers of the prior invention could be employed in various arrangements of known prosthetic devices.
  • FIG. 19 illustrated the same principle but with a prosthetic socket 740 engaging leg 720 by liner 610 coated with thermoplastic elastomer on the inner surface of the fabric of the liner, in contact with wound 730.
  • thermoplastic elastomer had all the properties of a prosthetic liner an additional advantage of the prior invention was to prevent, stem or cure infections caused by previously ill-fitted prosthetic devices.
  • the disclosed garments may include a post-surgical treatment mask including a thermoformable assembly configured to be heated to a transition temperature of the thermoplastic elastomer such that the thermoformable assembly can be shaped to conform to contours of a user’s face, and a styrene-based polymeric gel layer arranged on the inner fabric layer.
  • This thermoplastic elastomer should be configured to form a rigid structure that is capable of supporting and applying pressure to the gel when secured to the wearer.
  • thermoplastic elastomers of the present invention may be manufactured by mixing together oil, a polymer and one or more additives, e.g., an antioxidant, an antimicrobial agent, and/or other active ingredients, to form a mixture which is melted then cooled into the thermoplastic elastomer.
  • additives e.g., an antioxidant, an antimicrobial agent, and/or other active ingredients.
  • the additives may be added to the mixture after the mixture is melted or during the cooling process.
  • thermoplastic elastomers according to the present invention comprises a polymer that is a hydrogenated poly(styrene-b-isoprene), a hydrogenated poly(styrene-b-isoprene-b- styrene), a hydrogenated poly(styrene-b-butadiene-b-styrene), a hydrogenated poly(styrene-b-isoprene/butadiene-b-styrene), or combinations thereof.
  • the thermoplastic article comprises any of polystyrene-b- poly(ethyleneZpropylene) (SEP), polystyrene-b-poly(ethylene/propylene)-b-polystyrene
  • a thermoplastic elastomer comprises one or more additives, such as antioxidants or hydroxyl scavengers, that optimize the surface characteristic of the elastomer.
  • additives may be in a stable solution with a mixture of polymer and plasticizing oil when the mixture is in its molten state.
  • An elastomer is formed when the molten mixture cools and solidifies. As the mixture cools down the solubility of the additives decreases and the mixture becomes a supersaturated solution. When solidification is complete, the additives begin to precipitate from the elastomer.
  • the additives migrate, for example through a process of diffusion, to the surface of the elastomer where they create microcraters, pits or other imperfections or features on the surface of the elastomer.
  • the migrated additives may also form a dry layer of microscopic powder on the elastomer surface.
  • the microcraters and/or the powdery interface may improve the comfort of the user and enables the elastomer to remain in contact with the user's skin for prolonged periods of time. Even if the surface is wet, the micro-craters may collect small pools of liquid that provide lubricity.
  • the additive is preferably an antioxidant or free radical scavenger.
  • the outer layer fabric is made with a non-low melt polyester yam, a non-low melt nylon yam, a non-low melt polypropylene yam, a non-low melt polyethylene yam, cotton yam, wool yam, polyester, polypropylene, polyethylene, any combinations thereof, and the layer may either be multifilament or monofilament.
  • the thermoplastic elastomer is removable.
  • the preferably styrene- based gel is between 0.050 and 0.625 inches, and more preferably between 0.100 and 0.300 inches in thickness.
  • the gel preferably has a thermal conductivity ranging from 0.05 to
  • the mask preferably includes a strap configured to secure around a user’s head to hold the mask in place on the user’s face.
  • the mask includes hook and loop fasteners for securing the strap to the mask.
  • the mask includes two straps configured to secure around a user’s head to hold the mask in place on the user’s face.
  • the mask is a partial face mask adapted to cover a user’s eyes and the bridge of the nose.
  • the garment may include a post-surgical face mask made from a styrene-based gel shaped to conform to and cover a wearer’s face including a chin, a nose, cheeks, forehead, and ears, the mask having openings at the wearer’s eyes, nose, and mouth, and a strap configured to fasten around the forehead and under the chin to secure the mask in place.
  • a post-surgical face mask made from a styrene-based gel shaped to conform to and cover a wearer’s face including a chin, a nose, cheeks, forehead, and ears, the mask having openings at the wearer’s eyes, nose, and mouth, and a strap configured to fasten around the forehead and under the chin to secure the mask in place.
  • the invention may preferably take the form of a mask for application to a user’s face or an insert for insertion into a user’s ear canal.
  • the mask may or may not include an open or closed loop ring to either directly or indirectly provide a seal on the mask for respiration.
  • thermoplastic elastomers of the present invention may be impermeable to water whereby retention of moisture to a wound and skin is achieved.
  • the soft nature of the elastomer may enable controlled compression of the wound to prevent ischemia.
  • the soft nature of the elastomer also minimizes frictional and shear forces on the skin. As a consequence tissue necrosis may be virtually eliminated.
  • Fig. 1-20C illustrate the prior art elastomer.
  • Fig. 25 is a back view of the treatment garment according to the first embodiment.
  • Fig. 26 is a front view of the treatment garment according to the first embodiment.
  • Fig. 27 is a front view of the treatment garment according to the first embodiment including straps and hook and loop fasteners.
  • Fig. 28 is a back view of the treatment garment according to the first embodiment including straps and hooks and loop fasteners.
  • Fig. 29 is a front view of the mask according to a second embodiment of the invention.
  • Fig. 30(a) and 30(b) shows multiple side views of the mask according to a second embodiment of the invention.
  • Fig. 31 is a garment according to another embodiment including the styrene based gel permanently positioned on an elongate, elastic application to a wearer’s abdominal area.
  • FIG. 32 and 33 show multiple views of a garment according to another embodiment including the styrene based gel permanently positioned on an elongate, plastic bandage and adapted for application to a wearer’s chin.
  • Fig. 34 is another embodiment including the styrene based gel adapted to conform to a wearer’s breast.
  • Fig. 35 is a top view of another embodiment of the treatment garment.
  • Fig. 36 is a perspective view of the treatment garment of Fig. 35.
  • Fig. 37(a) and 37(b) show another embodiment of the post-surgical mask having a thermoformable assembly and the styrene based gel; Fig. 37(b) further shows a cross-section of this embodiment showing the outer layer and thermoplastic elastomer gel layer.
  • Fig. 40 shows a graph depicting the relationship between temperature and blood flow.
  • compositions and methods can be easily compared to the specific examples and embodiments disclosed herein. By performing such a comparison, the relative efficacy of each particular embodiment can be easily determined.
  • Particularly preferred compositions and methods are disclosed in the Examples herein, and it is understood that these compositions and methods, while not necessarily limiting, can be performed with any of the compositions and methods disclosed herein.
  • the disclosed garments include compression garments configured to provide evenly distributed compressive forces (e.g., a high modulus of elasticity).
  • these garments e.g., compression garments
  • Each of the garments include a polymeric gel material, with the proviso that this gel material preferably is not a hydrogel.
  • this gel material preferably is not a hydrogel.
  • water content is highly limited within the gel (e.g., including water amounts of less than 1 wt %, 0.5 wt %, 0.3 wt %, or
  • this gel material is made from a triblock copolymer and plasticizing oil and optionally includes one or more additives. However, to potentially reduce manufacturing costs and in certain preferred aspects, the gel material may only include the disclosed triblock copolymer(s), plasticizing oil, and optionally additives.
  • triblock copolymer is a styrene-based polymer that includes styrene and at least one of ethylene, butadiene, butylene, propylene, or isoprene, for example a styrene-ethylene-ethylene-propylene-styrene, a styrene-ethylene-butylene- styrene, or a styrene-ethylene-propylene-styrene.
  • thermoplastic elastomers according to the present invention comprises a polymer that is a hydrogenated poly(styrene-b-isoprene), a hydrogenated poly(styrene-b-isoprene-b-styrene), a hydrogenated poly(styrene-b-butadiene-b-styrene), a hydrogenated poly(styrene-b- isoprene/butadiene-b-styrene), or combinations thereof.
  • the thermoplastic article comprises any of polystyrene-b-poly(ethylene/propylene) (SEP), polystyrene-b-poly(ethylene/propylene)-b-polystyrene (SEPS), polystyrene-b- poly(ethylene/butylene)-b-polystyrene (SEBS), or polystyrene-b-poly(ethylene- ethylene/propylene)-b-polystyrene (SEEPS), or any combination thereof.
  • the amount of triblock copolymer included within the gel material ranges from 50 to 500 parts per hundred, 75 to 300 parts per hundred, 90 to 200 parts per hundred, or 95 to 120 parts per hundred.
  • the triblock copolymer is 100 parts per hundred and all other disclosed components (e.g., plasticizer/plasticizing oil, antioxidant, other additives) are weighed/weighted against the triblock copolymer. For example, if a 1:1.2 ratio of triblock copolymer to plasticizer is desired, this would be measured as 100 parts triblock copolymer and 120 parts plasticizer.
  • the disclosed gels are made with and/or include one or more plasticizing oils that may include, for example, a paraffinic oil, naphtenic oil, a mineral oil, or a synthetic liquid oligomer of a polybutene, a polypropene, or a polyterpene oil.
  • suitable oils include plasticizing oils such as paraffinic oils, naphtenic petroleum oils, petroleum mineral oils, and synthetic liquid oligomers of polybutene, polypropylene, polyterpene, etc. may be used.
  • the plasticizer is petroleum mineral oil with a viscosity of 10 to 20 centistokes, more preferably 11 to 17 centistokes, and most preferably 11 to 14 centistokes.
  • the plasticizing agent used within the gel includes petroleum mineral oil is 12 centistokes.
  • the amount of plasticizer included within the gel ranges from 200 to 1000 parts per hundred, 250 to 750 parts per hundred, preferably 300 to 800 parts per hundred, more preferably 400 to 700 parts per hundred, and most preferably 500 to 650 parts per hundred.
  • the oil may also be seeded with an insoluble fine powder such as talc.
  • the oil or other plasticizing agent can be added to the triblock copolymer in order to obtain the desired mechanical properties, such as elasticity, softness (or hardness), thermal conductivity, and elongation, tear and tensile strength characteristics of the resulting gel.
  • suitable mechanical properties of the resulting gel include: (a) hardness between approximately 10 to 70 durometer on the Shore 00 scale, between 15 to 60 durometer on the Shore 00 scale, and more preferably about 15 to 40 durometer on the Shore 00 scale;
  • the disclosed gels may be manufactured by mixing together the styrene-based polymer, the plasticizing oil(s), and one or more optional additives, e.g., an antioxidant, an antimicrobial agent, and/or other additives, to form a mixture which is melted then cooled into the resulting gel.
  • the additives may include, for example, 0.5 to 20 parts, 1 to 12 parts, or 1.5 to 8.5 parts.
  • the antioxidants may include a phenolic antioxidant.
  • the phenolic antioxidant may include at least one of isobutylenated methylstyrenated phenol, a styrenated phenol, various o-, m-, p-cresols
  • 4-hydrocinnamate)methane 2,2'-methylenebis(4-methyl-6-nonyl) phenol, l,3,5-tris(3,5- di-tert-butyl-4-hy droxybenxyl+ 1 ,3 , 5-triazine-2,4,6 (lH,3H,5H)-trione, or any combination thereof, which may each independently range from 1 to 8 parts per hundred or 2 to 5 parts per hundred or in combination may range from 1 to 8 parts per hundred or 2 to 5 parts per hundred.
  • the antimicrobial agents may include, for example, at least one of silver zeolite, silver zirconium phosphate, silver nitrate, silver thiosulfate, silver sulphadiazine, silver fusidate, and quaternary ammonium compounds (QAC).
  • Other classes of silver-based antimicrobial agents may be used as well, for example a silver acetate, a silver bromide, a silver carbonate, a silver chlorate, a silver chloride, a silver citrate, a silver fluoride, a silver iodate, a silver lactate, a silver nitrate, a silver nitrite, a silver perchlorate or a silver sulfide.
  • one or more other antimicrobial agents may be used in conjunction with or instead of such silver-based antimicrobial agents.
  • the antimicrobial agent may only include from 0.3 to 1 wt % or from 0.5 to 0.9 wt
  • the antimicrobial agent may range from 50 to 200 parts per hundred, preferably 65 to 175 parts per hundred, and most preferably 80 to 150 parts per hundred.
  • These antioxidants and antimicrobial agents may be included within the gel to further enhance the therapeutic purposes of the resulting gel and embodiments disclosed herein.
  • the antioxidants and/or antimicrobial agents may seep out from the gel onto the wearer's skin and/or bandages.
  • the antioxidants and/or antimicrobial agents that seep from the gel may contact the surgical site or areas around the surgical site, thus resulting in beneficial delivery of these antioxidants and/or antimicrobial agents that further aid in improved and expedited healing of the surgical site(s).
  • one or more of the above discussed additives may be added to the mixture after the mixture is melted or during the cooling process. After heating and mixing the mixture of styrene-based polymer, the plasticizing oil(s), and one or more optional additives, these components are melted together in such a manner that a homogeneous, molten mixture is obtained. After obtaining the molten mixture, the molten mixture is extruded via an extruder, molded via a molding machine, or other similar heated vessel into the desired shapes and thickness. In certain aspects and when the disclosed gels are included in the disclosed garments and have a thickness ranging from 0.050 inches to
  • the present invention provides thermal therapy to localized site and does so more effectively due to the heat available during the latent heat of fusion.
  • the thermoplastic elastomer utilizes a plasticizing oil that is able propagate the active ingredients, that are soluble in the oil phase, through the dermis of a localized area. When the material is heated to the phase change temperature and placed on a localized site, the formability of the material, in conjunction with the heat, allows for a greater efficacy of the active ingredients therein.
  • Table n includes examples of suitable active ingredients but broadly include nonpolar substances used in treatment of disease.
  • a process of making an elastomer incorporating active ingredients used for the treatment of diseases includes combining an antimicrobial agent
  • Plasticizing oil 640 may be heated prior to or after the addition of the antimicrobial agent 630 and polymer 650.
  • Mixture 660 is melted in an extruder, a molding machine, or other suitable heated vessel so that the antimicrobial agent 630 becomes suspended in the mixture 660 and remains in stable suspension with the mixture 660.
  • the molten mixture 660 is molded 670 into the form of a useful item at an appropriate temperature. While the mixture 660 cooling, and when the temperature is below 100° F or 37° C, the active ingredient 750 is added to the mixture 660. When allowed to cool, e.g., towards room temperature of approximately 77°
  • Another method of adding the active ingredients is to perform the addition of all active ingredients into the mixture 660 prior to heating.
  • the active ingredients are heated along with mixture 660 up to the melting temperature of approximately 350F to
  • the molten suspension is cast into the mold and allowed to cool, in order to form a solid elastomer 690 infused with the active ingredients. This method is acceptable if the active ingredients are known to withstand the melting temperature of the mixture without degradation.
  • Yet another method of adding the active ingredients to the finished elastomer is used when the active ingredients to be used cannot withstand the maximum melting temperature of the elastomer 350F - 400F.
  • the peak temperature is 350F - 400F however, once melted the molten mixture will stay liquefied as it cools down.
  • the active ingredients can be added. This can occur at ranges of 300F down to as low as 200F depending on the composition of the mixture.
  • plasticizing oil 640 is heated before mixing, an appropriate temperature range is about 130° to 165° F.
  • Plasticizing oils such as paraffinic oils, napthenic petroleum oils, mineral oils, and synthetic liquid oligomers of polybutene, polypropylene, polyterpene, and the like may be used. In some embodiments, 300 to 1,200 PPH of the plasticizing oil are used, more preferably between about 500 and 700 PPH.
  • the compound contains 50 to 90 percent by weight of plasticizing oil, 0.5 to 30 percent by weight of active ingredient, and 3 to 50 percent by weight of a paraffinic substance.
  • Paraffinic substances are used in order to take advantage of the latent heat used to cause the phase change.
  • the treatment garment 10 includes a styrene-based polymeric gel layer 290 arranged on the outer layer 490 As depicted in FIG. 23, when in use, gel layer
  • the gel layer 290 of treatment garment 10 is placed on bandage 470, which directly covers flesh and/or post-surgical site 480.
  • the gel layer 290 is configured to directly contact the wearer's skin/flesh.
  • thermoformable resin may be included and comprises at least one of a co-polyester, a poly-caprolactone, nylon, polypropylene, polyethylene, or a combination thereof.
  • the thermoformable resin is a low melt resin configured to begin melting or completely melt at temperatures ranging from 100° degree
  • the inner and outer layer fabric layers may independently be made from, for example, a non-low melt polyester yam, a non-low nylon yam, a non-low polypropylene yam, a non-low melt polyethylene yam, cotton yam, wool yam, any combinations thereof, and these yams may be either multifilament or monofilament.
  • the yams included within the inner and outer layer fabric layers are multifilament having a mass ranging from 110 to 160 grams,
  • the fabric of the inner and outer fabric layers have multidirectional stretch characteristics that aid in further enhancing durability of the thermoformable assembly.
  • the fabric of the inner and outer fabric layers may independently include from 6 to 12 courses per cm 2 , more preferably from 8 to 10 courses per cm 2 and from 9 to 14 wales per cm 2 more preferably
  • the inner and outer fabric layers independently include 9 courses and 11 wales per cm 2 .
  • the fabric of the inner and outer fabric layers independently have an elasticity ranging from 80 to 140%, preferably 100 to 130%, and most preferably 115 to 125% in a vertical direction and from
  • the body made from a co-polyester yam, a poly-caprolactone yam, or a combination thereof and optionally having a polyester fiber may be positioned in between the inner and outer layer fabric layers. After layering this stack, this layered stack is heated to a sufficient temperature to melt the body from a co-polyester yam, a poly-caprolactone yam, or a combination thereof to bond these layers together.
  • thermoformable assembly may be heated to or slightly above the thermoformable resin's glass transition temperature to ensure that the thermoformable assembly may be shaped to the user's contours. It is important that thermoformable resin hardens and becomes rigid after heating to (or beyond) its glass transition temperature. However, it is also important that the thermoformable resin does not become brittle after heating such that the thermoformable assembly is fragile, lacks durability, and may not be re-heated and/or re-shaped. Thus, the disclosed thermoformable assembly may be advantageously repeatedly heated and re-shaped into a rigid structure having desired contours.
  • the styrene-based gel is used in combination with the thermoformable assembly, and in certain aspects, the styrene-based gel is removable from the thermoformable assembly. However, in other aspects, the styrene-based gel is permanently attached to the thermoformable assembly. In each of these aspects, the styrene-based gel has a thickness ranging from 0.05 inches to 0.625 inches, more preferably 0.1 inches to 0.5 inches, and most preferably 0.250 to 0.50 inches to further ensure maximum reduction and/or prevention in post-surgical bruising, swelling, and edema.
  • the mask further includes a strap 360 configured to secure around a user's head to hold the mask in place on the user's face, and the mask includes hook and loop fasteners 370, 380 for securing the strap to the mask.
  • the hook or loop fastener may be attached to one end of the strap and the complimentary hook or loop fastener may be attached on the thermoformable assembly 760 or on another strap.
  • the mask includes two straps 370, 380 configured to secure around a user's head to hold the mask in place on the user's face.
  • the treatment garment 10 may preferably be a partial face mask configured for placement over a user's eyes and the bridge of the nose.
  • the styrene based gel of this partial face mask can be heated and/or cooled to a desired temperature and applied and fastened to the user's face to treat post-surgical bruising, swelling, and edema associated with, for example, rhinoplasty, eyelid surgery, check implantation, or any combination thereof.
  • This treatment garment 10 is preferred over conventional hydrogel masks because unlike hydrogel based masks, this mask exhibits low thermal conductivity and high durability and resiliency coupled with the ability to provide evenly distributed compressive forces (e.g., a high modulus of elasticity).
  • post-surgical mask 10 further includes, for example, fabric or a fabric layer that lines the peripheral edges of mask 10 and conceals one or more layers of the thermoformable assembly.
  • the fabric or fabric layer completely lines the peripheral edges of mask 10 and completely conceals the thermoformable assembly such that the thermoformable assembly is not visible to the wearer or another observer.
  • mask 10 is more aesthetically pleasing when the fabric or fabric layer lines the peripheral edges of mask 10.
  • the garment may include a treatment garment 10 including a mask 180 made from a styrene-based gel shaped to conform to and cover a wearer's face including a chin, a nose, cheeks, forehead, and ears, the mask having openings at the wearer's eyes 190, nose 200, mouth 220, and optionally the chin 230; and a mask strap 360 configured to fasten around the forehead and under the chin to secure the mask in place.
  • a treatment garment 10 including a mask 180 made from a styrene-based gel shaped to conform to and cover a wearer's face including a chin, a nose, cheeks, forehead, and ears, the mask having openings at the wearer's eyes 190, nose 200, mouth 220, and optionally the chin 230; and a mask strap 360 configured to fasten around the forehead and under the chin to secure the mask in place.
  • this treatment garment 10 may consist essentially of or consist only of the styrene-based gel, which conforms to and covers a wearer's face including a chin, a nose, cheeks, forehead, and ears, the mask having openings at the wearer's eyes, nose, and mouth, and a strap configured to fasten around the forehead and under the chin to secure the mask in place.
  • the strap includes complimentary hook and look fasteners 370, 380 on opposite ends of the strap.
  • the strap may be bifurcated such that a portion of the bifurcated strap 260 wraps around the chin of a user while a second portion of the bifurcated strap 270 is configured to wrap around the head of the user in such a manner that the mask may be securely fastened to a user with the strap.
  • the strap is an elastic strap configured to stretch and apply compressive forces when securely fastening the mask to the user.
  • the mask strap 360 may be attached to, for example, on the outermost surface of the gel, or in certain aspects, the mask strap
  • the mask strap As further illustrated in FIGS. 35 and 36, in certain aspects, the mask strap
  • the mask strap 360 may have various alternative shapes and configurations.
  • the mask strap may have various alternative shapes and configurations.
  • the mask strap may have various alternative shapes and configurations.
  • the mask strap may have various alternative shapes and configurations.
  • the mask strap may have various alternative shapes and configurations.
  • the mask strap may have various alternative shapes and configurations.
  • the mask strap may have various alternative shapes and configurations.
  • the mask strap may have various alternative shapes and configurations.
  • 360 may be bifurcated at both ends 390, 400, 410, 420. These bifurcated ends 390, 400,
  • the mask strap 360 may include a hole 430 positioned midspan along the length of the mask strap 360 such that portions 440, 450 of the strap are configured to concurrently wrap around a wearer's chin and forehead respectively while not contacting and/or obstructing any of the wearer's nose, eyes, mouth, and combinations thereof.
  • the mask depicted in FIGS. 35 and 36 may also include a styrene based gel mask
  • the styrene based gel mask 190 and the mask strap 360 are two separate components that are not permanently attached to one another.
  • the styrene based gel mask 190 may further include eyeholes 330, a nosehole 340, and mouth hole 350 such that the mask
  • the mask 190 can be placed on, for example, the wearer's face, and then the mask strap 360 including the hole can be positioned over the styrene based gel mask to secure the mask to the wearer.
  • the mask strap 360 may be placed on the wearer such that portions 440, 450 of the strap around the hole 430 secure the forehead and chin portions respectively of the styrene based gel to the wearer and then the strap may be fastened by the hook and loop fasteners positioned on the bifurcated ends 390, 400, 410, 420.
  • the mask 190 can have any number of openings to receive facial orifices.
  • FIGS. 37(a), 37(b), 38(a), and 38(b) depict another embodiment of the treatment garment 10 in which the above discussed thermoformable assembly is included on or within an elongate strap 460 and is configured to apply compression.
  • the elongate strap 460 preferably includes sufficient elasticity to stretch over portions of the wearer's head (e.g., completely around the wearer's head), and the strap further preferably includes hook and loop fasteners 370, 380 positioned at opposite ends of the strap that preferably span the entire width the elongate strap 460.
  • this treatment garment 10 includes an outer fabric layer 490 (i.e., portion of the elongate strap or the entire elongate strap) as disclosed above and a styrene based gel 290 as disclosed above that can be detachably positioned.
  • this treatment mask 10 includes eyeholes 500, a nosehole

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Abstract

L'invention concerne un procédé de fabrication d'un matériau thérapeutique intégrant un élastomère souple thermoformable avec un matériau à changement de phase présentant une chaleur latente de fusion élevée. Le composé amène de l'élasticité, de la souplesse, une aptitude à la déformation, et de la chaleur sur une durée prolongée et facilite un contact prolongé avec la peau à des températures élevées. Utilisées en association avec des principes actifs, la température et l'aptitude à la déformation accrues permettent une administration transdermique améliorée à travers la peau.
PCT/US2021/056599 2020-10-29 2021-10-26 Matériau à changement de phase pour thérapie thermique et administration de principes actifs WO2022093784A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180021169A1 (en) * 2015-01-22 2018-01-25 Alps South, LLC Phase Change Material For Thermal Therapy And Delivery Of Active Ingredients
US20190231598A1 (en) * 2015-01-22 2019-08-01 Alps South, LLC Phase Change Material For Medical And Cosmetic Applications
US20200206354A1 (en) * 2017-07-25 2020-07-02 PK Med SAS Drug delivery composition
US20210100934A1 (en) * 2015-01-22 2021-04-08 Alps South, LLC Phase Change Material for Thermal Therapy and Delivery of Active Ingredients

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180021169A1 (en) * 2015-01-22 2018-01-25 Alps South, LLC Phase Change Material For Thermal Therapy And Delivery Of Active Ingredients
US20190231598A1 (en) * 2015-01-22 2019-08-01 Alps South, LLC Phase Change Material For Medical And Cosmetic Applications
US20210100934A1 (en) * 2015-01-22 2021-04-08 Alps South, LLC Phase Change Material for Thermal Therapy and Delivery of Active Ingredients
US20200206354A1 (en) * 2017-07-25 2020-07-02 PK Med SAS Drug delivery composition

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