# US 2018/0021169 A1 · Phase Change Material For Thermal Therapy And Delivery Of Active Ingredients

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- Number: US 2018/0021169 A1
- Document ID: US20180021169A1
- Status: Published application
- Kind: A1
- Application number: 15/656,564
- Filed: 2017-07-21
- Published: 2018-01-25
- Earliest claimed: 2015-01-22
- Assignees: Alps South, LLC
- Applicants: Alps South, LLC
- Inventors: Aldo Laghi
- Web page: https://patentgrep.com/patent/US20180021169A1

## CPC

- A61F 7/02: Compresses or poultices for effecting heating or cooling
- A61F 7/00: Heating or cooling appliances for medical or therapeutic treatment of the human body (hyperthermia using electric or magnetic fields or ultrasound A61N)
- A61F 13/00063: {comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic (drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00)}
- A61F 13/08: Elastic stockings; for contracting aneurisms
- A61F 13/12: specially adapted for the head or neck
- A61M 35/10: {Wearable devices, e.g. garments, glasses or masks}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 31/04: Antibacterial agents
- A61P 39/06: Free radical scavengers or antioxidants
- A61F 2007/0003: {Face}
- A61F 2007/0004: {Eyes or part of the face surrounding the eyes}
- A61F 2007/001: {Throat only}
- A61F 2007/0052: {for treatment of skin or hair}
- A61F 2007/0228: {with belt or strap, e.g. with buckle}
- A61F 2007/0231: {hook and loop-type fastener}
- A61F 2007/0244: {with layers}
- A61F 2007/0261: {medicated}
- A61F 2007/0292: {using latent heat produced or absorbed during phase change of materials, e.g. of super-cooled solutions}
- C08L 9/06: Copolymers with styrene
- 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 (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

A soft thermoformable elastomer with a phase change material exhibiting high latent heat of fusion. The compound provides elasticity, softness, formability, and heat over an extended duration and to facilitate prolonged skin contact at elevated temperatures. Used in combination with active ingredients the increased temperature and formability provides enhanced transdermal delivery through the skin. Thermoplastic elastomers may be manufactured by mixing together plasticizing oil, a triblock copolymer, a paraffinic substance and one or more additives, e.g., an antioxidant, an antimicrobial agent, and/or other additives to form a mixture which melted then cooled into the thermoplastic elastomer. During cooling, the thermoplastic elastomer may be molded or otherwise formed into any number of articles including, but not limited to, prosthetic liners, prosthetic sleeves, external breast prostheses, breast enhancement bladders, masks, wound dressing sheets, wound dressing pads, socks, gloves, malleolus pads, metatarsal pads, shoe insoles, urinary catheters, vascular catheters, and balloons for medical catheters both vascular as well as urinary. Active ingredients are preferably added to the cooling thermoplastic elastomer when the temperature is below 100° F. to prevent heat degradation and/or breakdown of vital proteins.

## Claims

### Claim 1

A treatment garment for treatment of a surface comprising:
a thermoformable composite further comprising a thermoplastic elastomer gel layer comprising a styrenic triblock copolymer where the triblock copolymer is a selected amount of one or more of hydrogenated poly(styrene-b-isoprene), hydrogenated poly(styrene-b-isoprene-b-styrene), hydrogenated poly(styrene-b-butadiene-b-styrene), hydrogenated poly(styrene-b-isoprene/butadiene-b-styrene), or polyethylene, a plasticizing agent, a high latent heat of fusion agent comprising at least one paraffin, and an additive, arranged on the thermoformable composite arranged between an outer layer, the thermoformable composite configured to be heated to a glass transition temperature of the thermoplastic elastomer gel layer such that the thermoformable composite can be shaped to conform to contours of the surface.

### Claim 2 (depends on 1)

The treatment garment of claim 1 further comprising a series of holes in the inner and outer layer shaped to receive orifices.

### Claim 3 (depends on 1)

The treatment garment of claim 1 further comprising at least one strap configured to secure around a user's head to hold the treatment garment in place having a first end and a second end with a hook and loop fastener at the first end for securing the strap to the treatment garment.

### Claim 4 (depends on 1)

The treatment garment of claim 1, wherein the thermoplastic elastomer experiences a solid-solid phase transition whenever the thermal capacity agent melts into liquid form.

### Claim 5 (depends on 1)

The treatment garment of claim 1, wherein the thermoformable assembly is configured to be heated to a temperature of no more than 80° F. above the glass transition temperature of the thermoplastic elastomer gel layer.

### Claim 6 (depends on 1)

The treatment garment of claim 1, wherein the outer layer is continuous.

### Claim 7 (depends on 4)

The treatment garment of claim 4, wherein the outer layer has multidirectional stretch.

### Claim 8 (depends on 1)

The treatment garment of claim 1, wherein the thermoplastic elastomer gel layer is removable from the thermoformable assembly.

### Claim 9 (depends on 1)

The treatment garment of claim 1, wherein the thermoplastic elastomer gel layer is from 0.1 to 0.625 inches in thickness.

### Claim 10 (depends on 1)

The treatment garment of claim 1, wherein the thermoplastic elastomer gel layer has a thermal-conductivity of 0.05 to 3.00 W/mk.

### Claim 11 (depends on 3)

The treatment garment of claim 3, wherein the strap is bifurcated at the first end and the second end.

### Claim 12 (depends on 1)

The treatment garment of claim 1, further comprising two straps configured to secure around a user's head to hold the treatment garment in place on the user's face.

### Claim 13 (depends on 1)

The treatment garment of claim 1, wherein the treatment garment is a partial face mask.

### Claim 14 (depends on 1)

The treatment garment of claim 1, wherein the triblock copolymer is a selected amount of one or more of hydrogenated poly(styrene-b-isoprene), hydrogenated poly(styrene-b-isoprene-b-styrene), hydrogenated poly(styrene-b-butadiene-b-styrene), hydrogenated poly(styrene-b-isoprene/butadiene-b-styrene), or polyethylene.

### Claim 15 (depends on 1)

The treatment garment of claim 1, wherein the plasticizing agent is a plasticizing oil.

### Claim 16 (depends on 1)

The treatment garment of claim 1, wherein the additive is an antioxidant.

### Claim 17 (depends on 1)

The treatment garment of claim 1, wherein the additive is an antimicrobial agent.

### Claim 18 (depends on 1)

The treatment garment of claim 1, wherein the thermoplastic elastomer contains 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 the paraffinic substance.

### Claim 19 (depends on 1)

The treatment garment of claim 1 further comprising a fabric layer bonded to the outer layer.

### Claim 20

A treatment garment comprising:
a garment further comprising a thermoplastic elastomer gel layer inside an outer layer shaped to conform to and cover a wearer's face including a chin, a nose, cheeks, forehead, and ears, the mask having a series of openings after being heated and cooled, the thermoplastic gel layer further comprising a thermoplastic elastomer and a high latent heat of fusion agent comprising at least one paraffin; and
a strap configured to fasten around the forehead and under the chin to secure the garment in place.

### Claim 21 (depends on 20)

The treatment garment of claim 20 further comprising a fabric layer bonded to the outer layer.

### Claim 22

A treatment garment comprising:
a thermoformable assembly comprising a thermoformable body arranged on an outer layer, the thermoformable assembly configured to be heated to a glass transition temperature of the thermoformable body such that the thermoformable assembly can be shaped to conform to contours of a user's face upon heating and cooling; and
a thermoplastic elastomer gel layer arranged within the thermoformable assembly.

### Claim 23 (depends on 22)

The treatment garment of claim 22, wherein the thermoplastic elastomer gel layer is removable.

### Claim 24 (depends on 22)

The treatment garment of claim 22 further comprising a fabric layer bonded to the outer layer.

### Claim 25 (depends on 22)

The treatment garment of claim 22, wherein the thermoplastic elastomer gel layer further comprises a triblock copolymer, a plasticizing agent, a paraffinic substance, and an additive.

### Claim 26 (depends on 25)

The treatment garment of claim 25, wherein the triblock copolymer is a selected amount of one or more of hydrogenated poly(styrene-b-isoprene), hydrogenated poly(styrene-b-isoprene-b-styrene), hydrogenated poly(styrene-b-butadiene-b-styrene), hydrogenated poly(styrene-b-isoprene/butadiene-b-styrene), or polyethylene.

### Claim 27 (depends on 25)

The treatment garment of claim 25, wherein the plasticizing agent is a plasticizing oil.

### Claim 28 (depends on 25)

The treatment garment of claim 25, wherein the additive is an antioxidant.

### Claim 29 (depends on 25)

The treatment garment of claim 25, wherein the additive is an antimicrobial agent.

### Claim 30 (depends on 25)

The treatment garment of claim 25, wherein the thermoplastic elastomer 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 the paraffinic substance.

### Claim 31

A method for the application of additives to a surface of skin comprising:
applying an additive to a treatment garment, the treatment garment further comprising a thermoformable composite further comprising a thermoplastic elastomer gel layer comprising a styrenic triblock copolymer where the triblock copolymer is a selected amount of one or more of hydrogenated poly(styrene-b-isoprene), hydrogenated poly(styrene-b-isoprene-b-styrene), hydrogenated poly(styrene-b-butadiene-b-styrene), hydrogenated poly(styrene-b-isoprene/butadiene-b-styrene), or polyethylene, a plasticizing agent, a low thermal capacity agent comprising at least one paraffin, and an additive, arranged on the thermoformable composite arranged between an outer layer, the thermoformable composite configured to be heated to a glass transition temperature of the thermoplastic elastomer gel layer such that the thermoformable composite can be shaped to conform to contours of a user's face;
heating the treatment garment such that the thermoplastic elastomer gel layer reaches a glass transition temperature;
applying the treatment garment to the surface;
removing the treatment garment from the surface when the thermoplastic elastomer gel layer goes below the glass transition temperature.