WO2002045697A2 - Matiere composite servant a neutraliser un oedeme - Google Patents

Matiere composite servant a neutraliser un oedeme Download PDF

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Publication number
WO2002045697A2
WO2002045697A2 PCT/BE2001/000205 BE0100205W WO0245697A2 WO 2002045697 A2 WO2002045697 A2 WO 2002045697A2 BE 0100205 W BE0100205 W BE 0100205W WO 0245697 A2 WO0245697 A2 WO 0245697A2
Authority
WO
WIPO (PCT)
Prior art keywords
fabric
silicone
composite material
edema
counteracting
Prior art date
Application number
PCT/BE2001/000205
Other languages
English (en)
Other versions
WO2002045697A3 (fr
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
Application filed by Den Heede Marie Therese Van, Bernard Hoste filed Critical Den Heede Marie Therese Van
Priority to AU2002215713A priority Critical patent/AU2002215713A1/en
Publication of WO2002045697A2 publication Critical patent/WO2002045697A2/fr
Publication of WO2002045697A3 publication Critical patent/WO2002045697A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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

Definitions

  • COMPOSITE MATERIAL FOR COUNTERACTING EDEMA COMPOSITE MATERIAL FOR COUNTERACTING EDEMA.
  • the present invention relates to a therapeutic composite material for reducing edema, including lymphedema.
  • Edema may result from a number of causes e.g. due to increased extracellular fluid volume by fluid retention when a person has difficulty excreting fluids for whatever reason and by blockage of lymphatic vessels as often occurs after a radical mastectomy (breast removal, usually because of cancer).
  • a radical mastectomy nearby lymph nodes are removed with the breast tissue. Edema occurs in the arm on the same side because lymph drainage is blocked. The accumulated lymph fluid produces subcutaneous tissue swelling.
  • Edema is counteracted by means of elastic pressure stockings.
  • the arm or the leg Before taking the measures for the stockings to be made the arm or the leg has to be reduced in thickness by applying a bandage for several days. Once the measures are known it takes another couple of weeks to make the stockings so that the patient has to remain with the bandages on.
  • the existing self-adhering bandages for single use are expensive and of limited length so that several are needed to cover e.g. an entire leg. Moreover experienced people are needed to correctly apply the bandages. Because this technique for making the correct stockings is expensive and time consuming it is often not applied and too wide or too tight stockings are used with unsatisfactory effect on the edema.
  • the present invention provides a composite material for counteracting edema comprising a carrier material carrying on both surfaces silicone coatings characterised in that said carrier material is an elastic fabric and carries on one surface thereof a tacky coating of a silicone gel elastomer and on the other surface a non-tacky fully cured silicone coating.
  • the material of the present invention has self adherent properties and can be easily applied as a bandage by the patient.
  • the pressure can be corrected to the appropriate degree by adapting the tension.
  • the material Upon use the material will loose partly its adherent character by adsorption of body exudates such as sweat and other dirt but this can be regained by washing in cold or hot water.
  • the bandages of the invention can be used in combination with pressure stockings as referred to hereinbefore e.g. when the pressure stockings themselves become insufficiently effective.
  • Silicones, dressings and the like having one or more silicone coatings are known for use in medical, paramedical and cosmetic applications.
  • silicone gels in the form of sheets, dressing and the like have been used in the management of new scar tissue. When the gels are positioned against scar tissue and pressure is applied thereto hypertrophic scar tissue can be reduced.
  • a composite material for use in medical, paramedical, cosmetic and sports applications.
  • Said material comprises a silicone layer on at least one side of an elastic carrier and exerts an evenly spread pressure on the skin to which it is applied.
  • a wound dressing is described that comprises an apertured carrier material coated with a tacky silicone gel or a non-tacky silicone elastomer or coated on one surface with a tacky silicone gel and on the other surface with a non-tacky silicone elastomer.
  • the fibres of the carrier material are to be effectively encapsulated by the gel so that loss of fibres in the wound is eliminated.
  • the apertures in the material e.g. cotton gauze are not to be occluded by the silicone gel.
  • a bandage in the form of reinforced silicone gel sheet for the treatment of scar tissue is disclosed.
  • the bandage consists of a first layer of silicone adapted to adhere to the skin, a second layer of a perforated polyester mesh fabric with a plurality of holes therethrough which contacts the first layer and a third layer of silicone.
  • the third layer provides a non adherent surface sealing the second layer which enables the bandage to be worn underneath clothing.
  • the elastic carrier material of the composite material according to the present invention is 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 carrier material 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 coatings of the composite material according to the present invention consist on the one hand of a tacky silicone gel on the surface intended for contact with the skin and on the other hand of a non-tacky cured silicone on the exterior surface.
  • Silicones suitable for coatings in the material of the invention are well known and commercially available. Reference can be made to USP5919476 and EP 0251810 referred to hereinbefore.
  • 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 0.05 and 2 mm, most preferably between 0.1 and 1 mm.
  • the coating of non-tacky cured silicone is not critical ; it preferably has a thickness between 0.05 and 1 mm.
  • One way of manufacturing the elastic composite material 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.
  • a coating station for depositing a layer of tacky silicone gel.
  • Several coating techniques can be used: knife 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 reverse side of the fabric is then coated with the non-tacky silicone and this is followed by curing.
  • a suitable coating technique there can also be referred to EP 0507760.
  • the fabric is chosen and the silicone layers are coated such as to avoid that the silicone coatings substantially penetrate the fabric.
  • the number of threads in both directions of the fabric is preferably such so as to obtain apertures of at most 0.1 mm 2 and most preferably at most 0.05 mm 2 .
  • the silicone layers especially the tacky silicone layer are applied at such a degree of curing that they form a coherent layer that does not permeate the fabric.
  • the thicknesses of the coatings and the thickness and elasticity of the fabric are preferably chosen so as to obtain a silicone coated fabric that has a so-called short to medium elasticity i.e. an elasticity in the longitudinal direction of at most 100 %, preferably at most 70 %, and most preferably at most 30 %.
  • the silicone coatings can be obtained by coating two or more layers over each other.
  • the packaging 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 store his product.
  • 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.
  • 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.
  • MED for a silicone polyaddition product FA557 MED for a silicone polyaddition product FA557.
  • the first component known as part A containing a mixture of polymethylvinyl, polymethylhydrogenosiloxanes and silica was intimately mixed at roomtemperature in a ratio of 100 to 10 by weight with the second component know as part B, containing a mixture of polymethylvinylsiloxanes, silica and platinum.
  • Liquid part A has a viscosity at 25°C of 40.000 mPas whereas liquid part B has a viscosity at 25°C of 20.000 mPas.
  • the mixture was coated at a ratio of 340 g per sq.m. at the free side of the elastic polyamide fabric and fully cured.
  • the temporary support was removed.
  • the % of elasticity in the longitudinal direction of the composite material formed was 75 %.
  • a bandage made from the composite material was wound around the arm of a patient having lymphedema and left applied thereto. In this way the lymphedema could be managed.
  • a constant pressure can be exerted on a determined part of the body by means of the material of the invention applied under tension.
  • the windings once applied do not shift relative to each other and remain in place under tension and no external fastening means is necessary.
  • the windings adhering at least partly over each other can be easily loosened and the self adherent elastic composite material can be removed from the body part to which it is applied as often as desireable e.g. for washing.
  • the composite material withstands multiple reuses and cleaning without degradation.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une matière composite permettant de neutraliser efficacement un oedème, notamment un lymphoedème, cette matière comprenant un tissu élastique pourvu d'une couche d'élastomère silicone non collant sur la surface extérieure. Par ailleurs, cette matière, qui est auto-adhésive, peut être lavée et convient pour des utilisations répétées.
PCT/BE2001/000205 2000-12-04 2001-12-04 Matiere composite servant a neutraliser un oedeme WO2002045697A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002215713A AU2002215713A1 (en) 2000-12-04 2001-12-04 Composite material for counteracting edema

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP00204326.3 2000-12-04
EP00204326 2000-12-04

Publications (2)

Publication Number Publication Date
WO2002045697A2 true WO2002045697A2 (fr) 2002-06-13
WO2002045697A3 WO2002045697A3 (fr) 2002-07-25

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BE2001/000205 WO2002045697A2 (fr) 2000-12-04 2001-12-04 Matiere composite servant a neutraliser un oedeme

Country Status (2)

Country Link
AU (1) AU2002215713A1 (fr)
WO (1) WO2002045697A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8366696B2 (en) 2006-12-27 2013-02-05 Daio Paper Corporation Absorbent article
US8764689B2 (en) 2006-01-13 2014-07-01 Swelling Solutions, Inc. Device, system and method for compression treatment of a body part
FR3049825A1 (fr) * 2016-04-07 2017-10-13 Elodie Vlamynck Vetement therapeutique avec revetement antiderapant
US10071012B2 (en) 2004-10-11 2018-09-11 Swelling Solutions, Inc. Electro active compression bandage
WO2022023622A1 (fr) * 2020-07-30 2022-02-03 Elkem Silicones France Sas Procede d'enduction d'un support textile

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 (fr) * 1995-11-13 1997-05-22 Bio Med Sciences, Inc. Vetements medicaux therapeutiques pour les cicatrices et procede afferent
WO1997030700A2 (fr) * 1996-02-21 1997-08-28 Den Heede Marie Therese Van Materiau composite destine a des applications medicales, cosmetiques et sportives et ses procedes de preparation
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 (fr) * 1995-11-13 1997-05-22 Bio Med Sciences, Inc. Vetements medicaux therapeutiques pour les cicatrices et procede afferent
WO1997030700A2 (fr) * 1996-02-21 1997-08-28 Den Heede Marie Therese Van Materiau composite destine a des applications medicales, cosmetiques et sportives et ses procedes de preparation
US5919476A (en) * 1997-09-29 1999-07-06 Pmt Corporation Reinforced gel sheeting for scar treatment

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10071012B2 (en) 2004-10-11 2018-09-11 Swelling Solutions, Inc. Electro active compression bandage
US8764689B2 (en) 2006-01-13 2014-07-01 Swelling Solutions, Inc. Device, system and method for compression treatment of a body part
US9248074B2 (en) 2006-01-13 2016-02-02 Swelling Solutions, Inc. Device, system and method for compression treatment of a body part
US10828220B2 (en) 2006-01-13 2020-11-10 Tactile Systems Technology Inc. Device, system and method for compression treatment of a body part
US8366696B2 (en) 2006-12-27 2013-02-05 Daio Paper Corporation Absorbent article
FR3049825A1 (fr) * 2016-04-07 2017-10-13 Elodie Vlamynck Vetement therapeutique avec revetement antiderapant
WO2022023622A1 (fr) * 2020-07-30 2022-02-03 Elkem Silicones France Sas Procede d'enduction d'un support textile

Also Published As

Publication number Publication date
WO2002045697A3 (fr) 2002-07-25
AU2002215713A1 (en) 2002-06-18

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