WO2002045698A2 - Silicone gel sheet for treatment of scar tissue - Google Patents

Silicone gel sheet for treatment of scar tissue Download PDF

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Publication number
WO2002045698A2
WO2002045698A2 PCT/BE2001/000206 BE0100206W WO0245698A2 WO 2002045698 A2 WO2002045698 A2 WO 2002045698A2 BE 0100206 W BE0100206 W BE 0100206W WO 0245698 A2 WO0245698 A2 WO 0245698A2
Authority
WO
WIPO (PCT)
Prior art keywords
fabric
coating
silicone
silicone gel
sheet
Prior art date
Application number
PCT/BE2001/000206
Other languages
French (fr)
Other versions
WO2002045698A3 (en
Inventor
Marie-Thérèse VAN DEN HEEDE
Bernard Hoste
Original Assignee
Den Heede Marie Therese Van
Bernard Hoste
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
Priority to EP00204326 priority Critical
Priority to EP00204326.3 priority
Priority to EP01200035.2 priority
Priority to EP01200035 priority
Application filed by Den Heede Marie Therese Van, Bernard Hoste filed Critical Den Heede Marie Therese Van
Publication of WO2002045698A2 publication Critical patent/WO2002045698A2/en
Publication of WO2002045698A3 publication Critical patent/WO2002045698A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug

Abstract

A silicone gel sheet for treatment of scar tissue comprises an elastic fabric carrying on the surface for contacting the skin a coating of a tacky silicone gel elastomer that does not permeate the fabric and being uncoated at the exterior surface. The sheet is in particular suitable for use as facial mask.

Description

SILICONE GEL SHEET FOR TREATMENT OF SCAR TISSUE.

The present invention relates to a therapeutic elastic composite material having a silicone coating particularly suitable for treatment and rehabilitation of scar tissue.

Silicone gels in the form of sheets and bandages with fibre nets embedded in the gels have been used in the management of scar tissue in particular hypertrophic and keloid scarring resulting from cuts or burns. Gel sheets of the type that utilize silicone are tacky to the touch both on the inner body contacting surface and the exterior surface. While this is advantageous and desirable for the body contacting surface it is not for the exterior surface because of the tendency of clothing adhering thereto and of more quickly soiling.

In US 5919746 this problem is solved by layering a polyester mesh fabric on top of a silicone gel sheet and covering the mesh fabric with a layer of silicone projecting through the holes of the fabric in order to seal the fabric and to laminate the fabric between the two silicone layers. In this way a non adherent exterior silicone surface for the gel sheet is formed.

It is an object of the present invention to provide novel silicone gel sheets having a tacky surface for contact with the body and a non tacky exterior surface without need of an exterior silicone coating.

It is another object of the present invention to provide novel silicone gel sheets having elastic properties which will allow to reach difficult facial areas and follow the gestures made by expressions on the face.

It is a further object of the present invention to provide novel elastic silicone gel sheets particularly suitable for use as masks covering the face or parts thereof and providing a comfortable solution compared to the products existing on the market .

Further objects will become apparent from the description hereinafter. According to the present invention a silicone gel sheet for scar treatment is provided said sheet comprising a fabric carrying on one surface thereof a coating of silicone gel elastomer that is tacky to the touch characterised in that said fabric is elastic, said silicone gel coating forms a coating not permeating the fabric, and that the other surface of the fabric is free from silicone coating.

The elastic fabric of the silicone gel sheet according to the present invention is e.g. an elastic woven fabric which is made as is known by providing elastomeric threads in between the natural or synthetic fibres of the fabric. The elastic fabric has an elasticity in the longitudinal and an elasticity in the transverse direction which are the same or different and which can be chosen according to the particular use intended. A particularly preferred fabric is a polyamide fabric. The fabric can be coloured or can have designs printed on it so that it obtains a less clinical look.

The silicone coating of the composite sheet material according to the present invention consists of a tacky silicone gel elastomer on the surface intended for contact with the skin. Silicones suitable for forming the coating in the material of the invention are well known and commercially available e.g. from known companies like Rhone-Poulenc, Dow Corning, Bayer, Wacker Chemie, Applied Silicone Corporation, Polymer Systems Technology Ltd., etc. Reference can also be made to USP5919476 and EP 0251810. The coating of tacky silicone gel is flexible so that it can follow in use all irregularities of the skin. Its adherence to the skin is such that it is not too high so as to cause pain or irritations upon long time use and not too low to avoid becoming loose e.g. by body sweat. The tacky coating preferably has a thickness between 0.5 and 4 mm, most preferably between 1 and 2 mm. The fabric is chosen and the silicone gel is coated such as to avoid that the silicone coating substantially penetrates the fabric and makes the other side tacky. For example the number of threads in both directions of the fabric is preferably such so as to obtain apertures of at most 0.1 mm2 and most preferably at most 0.05 mm2.

The tacky silicone layer that is applied to the fabric is applied at such a degree of curing that it forms a coherent layer that does not permeate the fabric so that the other side of the fabric remains free and non tacky. The silicone coating can be obtained by coating two or more silicone layers over each other.

One way of manufacturing the elastic silicone gel sheet according to the present invention is as follows:

A temporary and releasable support e.g. of paper or film which may be a PE- film, a PVC-film, a PET-film, etc. is passed through a coating station for depositing a layer of tacky silicone gel. Several coating techniques can be used e.g. knife coating, doctor blade coating, roller coating, calender coating. The silicone layer while partly being cured is contacted with the fabric and the whole is passed through an oven for further curing. The releasable paper support is then removed. To arrive at the desired thickness of silicone coating e.g. between 1 mm and 2 mm, one or more further coatings of silicone gel can be applied. Once the product has been manufactured, sheets of different widths can be provided dependent on the body parts that the product will have to treat.

For use as facial masks covering the face or parts thereof e.g. the surroundings of the mouth, the eyes, the nose, etc it is desirable that the sheets are highly flexible and follow all possible curvatures and movements of the skin. For this purpose it was found advantageous to use a relatively thin polyamide fabric e.g. weighing less than 200 g per sq.m. of high elasticity e.g. a longitudinal elasticity of at least 150 % and a coating of silicone gel elastomer having a thickness between 0.5 and 4 mm, most preferably between 1 mm and 2 mm not permeating the fabric. It was found that such facial masks cannot only be used for the management of scar tissue but also for the management of wrinkles in the face e.g. at the eyes. According to an interesting embodiment the sheet or an area of the sheet of the present invention may have embedded within the silicone coating a plate of a thermoplast that can be modelled around body parts after the sheet has been inserted into hot water to soften the plate. For example a facial mask made of a sheet of composite material according to the present invention for covering cheeks and nose of a patient may have embedded in the silicone coating a thin plate of a thermoplast that is intended for being modelled around the nose. In this way the mask can be positioned after insertion in hot water to the face so that through the help of the thermoplast the tacky silicone coating can contact the entire nose area even in the corners thereof. The sheets according to the present invention can also be used as cushions on parts of the body e.g. elbows, ankles, tail-bone, etc for preventing bedsores.

It is preferred to adapt the packaging to the product so that the packaging has more than advertising or "easy storage" function. The packaging together with the cleaning instructions play a part in the longevity of the product. The patients will be using and reusing the product at different time intervals, patients will take it wherever they go and therefore there is a need for a packaging that will allow the patient to safely handle and store his product. The silicone gel sheet is usually provided with its tacky surface in contact with a temporary release material e.g. plate from which the sheet can be removed and to which it can be reapplied after use. The self adherent elastic silicone gel sheets according to the invention can be removed from the body part to which it is applied as often as desireable e.g. for washing. The sheets withstand multiple reuses and correct cleaning procedures.

The following example illustrates the present invention. Example: 1.carrier material

An elastic polyamide fabric (83 % of polyamide) of 130 g per sq.m. having a longitudinal elasticity of 290 % and a transverse elasticity of 85 % is used. The woven fabric has per cm 68.6 yarns in one direction and 28.7 yarns in the other direction. 2.tacky coating

A mixture was made of components commercially available from MADRIGAL FINANCES S.A., Vinay, France under the trade name DROP-ORTHO for a silicone polyaddition gel adhesive FA 111-00. The first component known as part A containing polyorganic siloxanes was intimately mixed at room temperature in a ratio of 50/50 by weight with the second component known as part B containing polyorganic siloxanes and a dimethylpoly (methylhydrogen) dimethylsiloxane. A vacuum of about 30 to 50 mbar was applied to remove air from the liquid. Both components are liquids having a viscosity of about 54.000 mPas at 20° C. Polymerisation started at roomtemperature from the moment the components were mixed. The mixture was coated at a ratio of 500 g per sq.m. on a temporary paper support and the free surface was contacted with the above fabric. Due to the partial curing before contact and the kind of fabric used, the silicone gel did not penetrate the fabric but adhered very well. The composition was passed through an oven for further curing. The composite material consisting of paper support, silicone gel coating and fabric was tightened at all sides and the paper support was removed. Further silicone gel was applied to the tacky coating at a ratio of 1375 g per sq.m., and spread by a platen provide with silicone oil to avoid sticking. The silicone coating was then cured. The total thickness of the coating was 1.5 mm. 3. use

The sheet of composite material formed was suitable for cutting out facial masks therefrom for use in burn scar management.

For better contact of a facial mask in the corners of a nose a thin plate of thermoplast of adapted configuration was adhered at the appropriate place of the tacky silicone coating after removal of the paper support and before the further silicone gel was applied. The embedded thermoplastic plate in the facial mask could be softened by insertion in hot water and perfectly modelled around the nose, and the remaining parts of the facial mask cover the adjacent cheeks.

It may happen, especially with rather thick silicone coatings, that the silicone coating penetrates the fabric in small areas and make the reverse side of the fabric tacky to the touch in those areas. This could be avoided and a coherent layer of completely non-penetrating silicone coating could be realised by proceeding as follows.

The composition consisting of temporary paper support, silicone coating, and fabric is positioned before passing it through an oven with the free surface of the fabric into contact with the surface of a releasable tacky silicone coating on a rigid or flexible material of e.g. textile, film, etc. The latter material with tacky silicone coating functions as a second releasable temporary support. In the same way as described hereinbefore the first releasable support of paper is removed and a further coating of silicone gel is applied to the freed surface of silicone gel adhering to the fabric so as to reach the desired thickness of e.g. 1.5 mm. The composite material is then passed through an oven for curing as described hereinbefore whereupon the second temporary support of rigid or flexible material coated with tacky silicone is removed. What remains is a fabric with tacky silicone coating not permeating the fabric in any area so that the reverse side of the fabric remains non-tacky.

Claims

CLAIMS:
1. A silicone gel sheet for scar tissue treatment comprising a fabric carrying on one surface thereof a tacky coating of silicone gel elastomer characterised in that said fabric is elastic, said silicone gel coating forms a coating not permeating the fabric, and that the other surface of the fabric is free from silicone coating.
2. A sheet according to claim 1 wherein the fabric is a polyamide fabric.
3. A sheet according to claim 1 or 2 wherein the fabric has apertures of at most 0.1 mm2.
4. A sheet according to claim 1 or 2 wherein the fabric has apertures of at most 0.05 mm2.
5. A sheet according to any of claims 1 to 4 wherein the silicone coating has a thickness between 0.5 mm and 4 mm.
6. A sheet according to any of the preceding claims wherein the fabric is a polyamide fabric weighing less than 200 g per sq.m. and having a longitudinal elasticity of at least 150 % and wherein the silicone coating has a thickness between 0.5 mm and 4 mm.
7. A sheet according to any of the preceding claims wherein an area of the sheet has embedded within the silicone coating a plate of a thermoplast.
8. Use of a silicone gel sheet according to any of the preceding claims for scar tissue treatment. Use according to claim 8 wherein said sheet is in the form of a facial mask.
PCT/BE2001/000206 2000-12-04 2001-12-04 Silicone gel sheet for treatment of scar tissue WO2002045698A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP00204326 2000-12-04
EP00204326.3 2000-12-04
EP01200035.2 2001-01-05
EP01200035 2001-01-05

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU1571402A AU1571402A (en) 2000-12-04 2001-12-04 Silicone gel sheet for treatment of scar tissue

Publications (2)

Publication Number Publication Date
WO2002045698A2 true WO2002045698A2 (en) 2002-06-13
WO2002045698A3 WO2002045698A3 (en) 2002-07-25

Family

ID=26072884

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BE2001/000206 WO2002045698A2 (en) 2000-12-04 2001-12-04 Silicone gel sheet for treatment of scar tissue

Country Status (2)

Country Link
AU (1) AU1571402A (en)
WO (1) WO2002045698A2 (en)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004082935A1 (en) * 2003-03-18 2004-09-30 Finden Coatings Limited An adhesive fabric
WO2004105821A1 (en) * 2003-05-30 2004-12-09 Medtrade Products Ltd. Scar management composition comprising silicone
WO2005048911A2 (en) 2003-11-17 2005-06-02 Tricolast Nv Silicone products and methods for making silicone products
EP1741415A1 (en) 2005-07-08 2007-01-10 Bio-Racer Method and accessories for reducing skin friction during physical exercise
EP2027838A1 (en) 2007-08-20 2009-02-25 Bio-Racer Breathing sheet material having an adhesive coating layer and manufacturing method there for
US7683234B2 (en) 2006-08-03 2010-03-23 The Board Of Trustees Of The Leland Stanford Junior University Devices and bandages for the treatment or prevention of scars and/or keloids and methods and kits therefor
US8063263B2 (en) 2003-05-29 2011-11-22 The Board Of Trustees Of The Leland Stanford Junior University Methods for the treatment or prevention of scars and/or keloids
US9248048B2 (en) 2007-08-03 2016-02-02 Neodyne Biosciences, Inc. Wound or skin treatment devices and methods
US9358009B2 (en) 2007-08-03 2016-06-07 Neodyne Biosciences, Inc. Skin straining devices and methods
US9492329B2 (en) 2007-08-03 2016-11-15 Neodyne Biosciences, Inc. Skin treatment devices with locking mechanisms
US10213350B2 (en) 2012-02-08 2019-02-26 Neodyne Biosciences, Inc. Radially tensioned wound or skin treatment devices and methods

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4838253A (en) * 1986-04-07 1989-06-13 Johnson & Johnson Silicone gel coated permeable wound dressing
WO1997017919A1 (en) * 1995-11-13 1997-05-22 Bio Med Sciences, Inc. Therapeutic medical garments for scars and process
WO1997030700A2 (en) * 1996-02-21 1997-08-28 Den Heede Marie Therese Van Composite material for medical, cosmetic and sports purposes and methods for the preparation thereof
US5919476A (en) * 1997-09-29 1999-07-06 Pmt Corporation Reinforced gel sheeting for scar treatment

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4838253A (en) * 1986-04-07 1989-06-13 Johnson & Johnson Silicone gel coated permeable wound dressing
WO1997017919A1 (en) * 1995-11-13 1997-05-22 Bio Med Sciences, Inc. Therapeutic medical garments for scars and process
WO1997030700A2 (en) * 1996-02-21 1997-08-28 Den Heede Marie Therese Van Composite material for medical, cosmetic and sports purposes and methods for the preparation thereof
US5919476A (en) * 1997-09-29 1999-07-06 Pmt Corporation Reinforced gel sheeting for scar treatment

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004082935A1 (en) * 2003-03-18 2004-09-30 Finden Coatings Limited An adhesive fabric
US8063263B2 (en) 2003-05-29 2011-11-22 The Board Of Trustees Of The Leland Stanford Junior University Methods for the treatment or prevention of scars and/or keloids
US9889046B2 (en) 2003-05-29 2018-02-13 The Board Of Trustees Of The Leland Stanford Junior University Skin treatment devices and methods with pre-stressed configurations
US9248051B2 (en) 2003-05-29 2016-02-02 The Board Of Trustees Of The Leland Stanford Junior University Skin treatment devices and methods with pre-stressed configurations
US9248049B2 (en) 2003-05-29 2016-02-02 The Board Of Trustees Of The Leland Stanford Junior University Skin treatment devices and methods with pre-stressed configurations
WO2004105821A1 (en) * 2003-05-30 2004-12-09 Medtrade Products Ltd. Scar management composition comprising silicone
WO2005048911A2 (en) 2003-11-17 2005-06-02 Tricolast Nv Silicone products and methods for making silicone products
WO2005048911A3 (en) * 2003-11-17 2005-07-07 Tricolast Nv Silicone products and methods for making silicone products
US8580362B2 (en) 2003-11-17 2013-11-12 Tricolast N.V. Silicone products and methods for making silicone products
EP1741415A1 (en) 2005-07-08 2007-01-10 Bio-Racer Method and accessories for reducing skin friction during physical exercise
US7683234B2 (en) 2006-08-03 2010-03-23 The Board Of Trustees Of The Leland Stanford Junior University Devices and bandages for the treatment or prevention of scars and/or keloids and methods and kits therefor
US9649226B2 (en) 2007-08-03 2017-05-16 Neodyne Biosciences, Inc. Skin treatment devices with tensioning features
US9248048B2 (en) 2007-08-03 2016-02-02 Neodyne Biosciences, Inc. Wound or skin treatment devices and methods
US9358009B2 (en) 2007-08-03 2016-06-07 Neodyne Biosciences, Inc. Skin straining devices and methods
US9492329B2 (en) 2007-08-03 2016-11-15 Neodyne Biosciences, Inc. Skin treatment devices with locking mechanisms
US8409699B2 (en) 2007-08-20 2013-04-02 Reskin Medical Nv Breathing sheet material having an adhesive coating layer and manufacturing method therefor
EP2027838A1 (en) 2007-08-20 2009-02-25 Bio-Racer Breathing sheet material having an adhesive coating layer and manufacturing method there for
US9844470B2 (en) 2010-08-11 2017-12-19 Neodyne Biosciences, Inc. Wound or skin treatment devices and methods
US10213350B2 (en) 2012-02-08 2019-02-26 Neodyne Biosciences, Inc. Radially tensioned wound or skin treatment devices and methods

Also Published As

Publication number Publication date
AU1571402A (en) 2002-06-18
WO2002045698A3 (en) 2002-07-25

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