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WO2008012443A2 - Device for protection and/or healing - Google Patents

Device for protection and/or healing Download PDF

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Publication number
WO2008012443A2
WO2008012443A2 PCT/FR2007/001291 FR2007001291W WO2008012443A2 WO 2008012443 A2 WO2008012443 A2 WO 2008012443A2 FR 2007001291 W FR2007001291 W FR 2007001291W WO 2008012443 A2 WO2008012443 A2 WO 2008012443A2
Authority
WO
WIPO (PCT)
Prior art keywords
layer
film
textile
dressing
obtaining
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/FR2007/001291
Other languages
French (fr)
Other versions
WO2008012443A3 (en
Inventor
Daniel Bourgeois
Jean-Jacques Mongold
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to DE112007001732T priority Critical patent/DE112007001732T5/en
Publication of WO2008012443A2 publication Critical patent/WO2008012443A2/en
Publication of WO2008012443A3 publication Critical patent/WO2008012443A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
    • A61F13/0253—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the adhesive material
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/06—Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings
    • A61F13/08—Elastic stockings; for contracting aneurisms
    • 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
    • A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00119—Wound bandages elastic
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00519—Plasters use for treating burn
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00519—Plasters use for treating burn
    • A61F2013/00523—Plasters use for treating burn with hydrogel
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00655—Plasters adhesive
    • A61F2013/00676—Plasters adhesive hydrogel

Definitions

  • the present invention relates generally to a dressing, having a composite structure and having great flexibility and elasticity, to protect and / or effectively treat any area, including the human body, regardless of its area and location .
  • the invention relates to a dressing comprising at least one layer intended to cover said zone, directly, and to adhere to it, that said layer is said to be proximal and provides both the protection and / or the treatment of said zone and the adhesion to said zone, and at least one layer intended to protect and / or maintain the proximal layer, this layer is said to be distal.
  • the effectiveness of currently commercially available dressings may vary during use, even to zero, depending on the thickness of the proximal layer, the location and extent of the area to be protected and treated. .
  • the dressing is applied on the heel or toe, its permanent or repeated contact with a part of the shoe may cause its movement by creep of the adhesive, and thus clear the area to be protected from the dressing, may cause worsening of the wound.
  • One solution may be the application of wide strips of dressing to securely maintain said area in contact with the proximal layer; however, it leads to often uncomfortable and unsightly protection.
  • US2003 / 040691 discloses a wound protection device comprising from the distal zone to the proximal zone:
  • non-elastic and breathable layer which may consist of a non-woven strip on which is fixed an air-permeable film, made of polyurethane for example,
  • an elastomer layer for example consisting of filaments obtained by hot extrusion, and
  • a layer of a non-elastic and absorbent nonwoven which may be in laminated form.
  • an occlusive and compressive device consisting of the following layers: an elastic fabric, an adhesive layer of a treating hydrocolloidal composition, interacting with the biological fluids, and optionally, a thin layer of latex reinforcing the cohesion between the elastic fabric and the adhesive layer, and a removable protective layer of the adhesive layer.
  • This device is obtained by coating the elastic fabric with latex, on the one hand, and preparing the layer and applying the protective layer, on the other hand, and then laminating the assembly.
  • This dressing is more intended for the bandaging of areas to be treated and compress ulcerated leg type, and is not used as a dressing for the protection of an area, in that it has no protective layer and cohesion the adhesive layer which can flow through the elastic fabric.
  • a device comprising a polyurethane-based distal film, a textile intermediate layer and a proximal layer of silicone gel. It is obtained by successive stratification of the different materials, starting with the constituent polymer of the distal film which is first deposited, in the liquid state, on a cardboard support, then the textile layer is glued on the distal film, by calendering to obtain, mechanically, a complete impregnation of the textile in the distal film. Then, the silicone of the proximal layer is applied to the textile layer.
  • the resulting dressing does not disadvantageously have the expected elasticity, that is to say that of the textile fabric because the latter is actually embedded in the polyurethane of the distal film and can then confer a very limited elasticity to the dressing .
  • This dressing has a certain extensibility, but it is not reversible, and as soon as the elongation force is too great, white marks appear on the surface of the polyurethane film, characteristics of the damaging separation of the textile layer of the film .
  • the method of manufacturing this dressing consists of successive stratification steps of the different layers, and under these manufacturing conditions, the polyurethane of the film passes through the textile layer and pollutes the silicone on contact, modifying its properties, particularly its stability.
  • the invention provides a solution, with a protective and / or healing device, flexible, having elasticity close to that of the layer textile, and having a layer for holding, cohesion and protection of the adhesive adhesive layer.
  • a device which is the subject of the present invention comprises at least one distal elastic film based on a filmable polymer and a proximal elastic adhesive layer based on a gel and comprising two longitudinal portions, one of which is said to be superior. directed towards said film and the lower one intended to be in contact with the area to be protected and / or treated, said device comprising an extensible textile intermediate layer located between the distal film and the proximal layer and fixed in points on said film, the upper longitudinal portion of the layer passing through said textile layer, between the attachment points.
  • the device resulting from the combination according to the invention of these three elements, distal film, intermediate layer and proximal layer, allows protection and / or treatment of the area to be treated, sustainable whatever the zone and whatever the typical constraints. Shear applied, and reusable. Indeed, this combination gives the device an elasticity that ensures both ease of placement, even in areas difficult to access and its perfect hold in place on the area, in use. Even over wide areas, the device provides a contention of said zone, the elasticity being obtained in the longitudinal, transverse and diagonal directions, regardless of the thickness of the distal protective layer and / or treatment. After removal and cleaning the device, it can be reused.
  • the applications of a device of the invention are numerous and varied, such as in the fields of phlebology, the treatment of burns, in the prevention or protection of bedsores, the prevention or reduction of keloids, and of course in the prevention, protection and treatment of more or less deep skin lesions.
  • the method of attachment between the distal film and the intermediate layer allows the proximal layer to mechanically catch in the device of the invention, without risk of pollution of the materials by each other. Indeed, when the gel of the proximal layer is applied to the film and the textile, the gel of the upper longitudinal portion of the proximal layer passes through the interstices between the fibers constituting the textile and comes to rest between the attachment points of the textile layer to the distal film, without chemical interaction and therefore without risk of diminishing the properties of the materials of each of the film and layers.
  • the attachment points of the proximal layer to the distal film are also distributed or not, and are preferably 0.5 to 1 mm apart.
  • the distal film and the proximal layer of a device of the invention advantageously have an elasticity, identical or different, but which is greater than that of the textile layer.
  • the device according to the invention has an elasticity which is generally not more than 10% less than that of the textile layer.
  • the gel of the proximal layer will make it possible to obtain an occlusive treatment device. It is known that the closure of an area of the skin causes a defense mechanism of the body, by bringing blood and oxygen to said area, which will promote the strengthening of cellular tissue and healing. We therefore choose a gel that allows at least partial closure, or even the entire area to be treated. It is advantageously chosen from compounds which, in addition to their mechanical action above promoting healing, intrinsically participate in healing.
  • the gel is selected from silicones, hydrocolloid gels, caprolactone-based gels, and mixtures thereof.
  • the gel of the layer may comprise at least one active principle, for example bactericidal, virucidal, fungicidal and / or antiseptic.
  • This is preferably associated with a vehicle, resulting in the gradual release of said active ingredient, especially to the lesion, promoting the disinfection of the wound to be treated.
  • a gel may be a silicone as described in FR-A-2768615.
  • a silicone having an adhesion strength of at least 500 g / cm 2 is chosen.
  • the gel may also include any other ingredient contributing to the protection and / or treatment of the zone, this ingredient being associated or not with the active principle (s) above. It may for example be an agent promoting cell reinforcement of the skin, such as vitamin A.
  • the constituent polymer of the adhesive layer at least for the portion intended to cover the skin, must be stable, having a blocked chemical structure, to prevent any uncontrolled and undesirable release of molecules, eg oil molecules, that would cross the skin barrier. It is preferably permeable to oxygen.
  • the adhesive layer has a variable thickness which is determined according to the application of the device.
  • the adhesive layer comprises in the longitudinal direction, two parts, a portion directed towards the film which is designated by the upper longitudinal portion, and a portion directed towards the area to be protected and / or treated that the is designated lower longitudinal portion. So that the proximal layer is adhesive, it is preferable that said lower portion does not include fibers of the textile layer, the upper longitudinal portion corresponding to the portion of the adhesive layer in which the textile layer is embedded.
  • the thickness of the lower longitudinal portion of the adhesive layer may vary from 0.5 to 4 mm, the thickness of the upper longitudinal portion may vary from 0.05 to 0.1 mm.
  • the consistency of the gel which is determined during gel production is fixed in relation to the destination of the device, for example protection of an area subjected to friction or shear or protection / treatment of an area where the support of the body is concentrated.
  • the consistency of the gel will be higher, thus allowing the support pressures to be distributed over the entire surface of the device.
  • the distribution of the gel in the layer is also adaptable to use, it is generally at least 700 g / m 2 .
  • Silicone is a polymer which combines all the aforementioned preferential qualities and is therefore the preferred polymer according to the invention for constituting the proximal layer.
  • the polymer of the distal film is preferably selected to be liquid-tight, tear-resistant, friction-resistant, shear-resistant. It is also advantageously microaerated. For this purpose, it may be chosen from polyurethanes, polyvinyl chloride, polyethylenes, and mixtures thereof.
  • the thickness of the distal film can vary between 15 and 25 microns, depending on the use, particularly depending on the constraints that will be submitted.
  • the gel is a silicone and the film is a polyurethane film.
  • the elasticity of the device is maintained even for large thicknesses of the proximal layer. This elasticity that it can be expressed as a percentage of elongation with respect to the device not subjected to stretching, can thus reach 250%, and this without the properties of the device are affected.
  • textile of the intermediate layer a material consisting of synthetic fibers and / or natural, having elastic properties.
  • This textile may be woven or non-woven, it is preferably of fibers selected from polyamide fibers, polyester fibers, mixtures thereof.
  • the textile may thus be a Lycra ®, whose elasticity is chosen according to the application of the device according to the invention, as said earlier.
  • the device of the invention may comprise a removable protective layer of the adhesive layer, before use, paper, cardboard, other material or composite.
  • this layer advantageously comprises a layer of polyethylene which is in contact with the gel, on a cardboard sheet.
  • the polyethylene is preferably embossed.
  • the cardboard sheet of the protective layer has a basis weight of the order of 150 to 200 g / m 2 .
  • Yet another advantage derived from the elasticity of the device of the invention lies in a mode of removal of this removable layer.
  • the layer is advantageously precut for shrinkage, the shrinkage taking place by simple stretching of the device which leads to the separation of the pre-separated parts of the removable layer.
  • a device of the invention can adopt various presentations, for example in the form of strips to cut, roll, or individual dressings of varying sizes and shapes. These presentations can be obtained by simply cutting a device of the invention to the desired size and shape.
  • a device of the invention can be used as a dressing or protection device and / or treatment of burns, as a dressing or device for protecting and / or preventing bedsores, for example pressure ulcers of the heels, elbows, cheeks, sacrum, as a dressing or device for protecting and / or treating skin lesions, for example foot lesions, such as ampoules, as a dressing or device for preventing or reducing keloids, cartilage-poor areas, or any other cutaneous lesion such as varicose origin.
  • the proximal layer of said device is covered with a textile layer, expandable.
  • a device finds particular interest for obtaining a plantar pad or for obtaining a sleeve for covering a stump, including tibial or femoral.
  • the device is cut into shape, and said textile layer advantageously only partially covers the proximal layer, the zone of contact with the arch is not covered as well as holding zones on the foot by adhesion of and others of said device.
  • the device of the invention promotes lymphatic drainage of the stump, while allowing a distribution of the supports. This device can also be used as a bandage for restraint purposes.
  • a device for distributing the pressing pressures it is possible to obtain, by superposition of two devices described above, a device for distributing the pressing pressures. More specifically, this device has a sandwich structure superimposing a first protection / treatment device of the invention and a second protection / treatment device of the invention, said second device being identical to or different from said first device, the two devices implementing common their layer (3), respectively.
  • This support pressure distribution device is not necessarily obtained by superposition of said first and second devices, and, according to an advantageous variant, it comprises only one and the same layer (3).
  • Such a support pressure distribution device has various applications, in particular in any pathology or any situation in which the support pressures of an area affected by this pathology or situation are restricted, which can cause or cause pain.
  • a device can be used to obtain a footpad, or to obtain a sleeve for covering a stump, including tibial stump or femoral stump.
  • the plantar foot is a zone under the soles of the foot strongly solicited, by the standing, the sport, and its wear causes pain, the distribution of the pressures being reduced, as in the case of the stump whose contact with the prosthesis can be painful for the same reasons.
  • a device according to the invention makes it possible to restore a distribution of pressures and to relieve pain, and to maintain lymphatic drainage.
  • the elasticity of the device gives the latter a shape memory that will make it reusable, and in the In the case of the stump sleeve, this device makes it possible to provide restraint, facilitating its formation and guaranteeing lymphatic drainage.
  • the device is cut according to the desired application, and in particular size and shape.
  • the invention also relates to a method for obtaining a protection and treatment device as described above; it includes the following steps:
  • Glue dots are deposited on the distal film
  • the textile layer is pressed onto the distal film to fix the textile layer on the distal film by point.
  • the polymer of the proximal layer is applied to the textile layer, by topping.
  • the method according to the invention which is not a stratification of the different layers, allows each material to retain its original properties, the interactions between each of them being very restricted.
  • FIGS. 1 and 2 respectively, showing a sectional view of devices of the invention.
  • Figure 1 illustrates a device 1 for protection and / or healing. It comprises a distal film 2 of a fumable polymer, a proximal layer 3 having an upper longitudinal portion 6 directed towards the film 2 and a lower longitudinal portion 7 intended to be applied to the area to be protected and / or treated, and a layer 4 textile. The latter is embedded in the part 6 of the layer 3 and is fixed in points to the film 2. This figure perfectly illustrates the mode of attachment of the layer 4 to the film 2, leading to the indirect fixation of the layer 3 in the device 1 Part 7 of layer 3 is free of textile fibers.
  • a removable protective layer 8 covers the layer 3.
  • FIG. 2 illustrates a device 9 for distributing the pressing pressures. It responds to a sandwich structure whose core consists of a layer 10 of a polymer chosen polymers suitable for obtaining the distal layer 3 of the device 1 shown in Figure 1.
  • the device On each longitudinal side of the heart, the device comprises a layer 11, identical or different, then a film 12, identical or different, on which the layer 11 is fixed by points 5.
  • the layer 10 comprises two longitudinal peripheral portions 13 directed towards the film 12, passing through the textile layer and a central longitudinal part 14.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Hematology (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to a flexible device (1) for protecting and/or healing a zone that is to be protected and/or treated, comprising at least one distal elastic film (2) based on film-forming polymer and a proximal elastic adhesive layer (3) based on a gel and comprising two longitudinal parts, an upper part (6) directed towards said film and a lower part (7) intended to be in contact with the zone that is to be protected and/or treated, said device (1) comprising an intermediate textile stretchable layer (4) which is located between the distal film (2) and the proximal layer (3) and is fixed at points (5) to said film (2), the upper longitudinal part (6) of the layer (3) passing through said textile layer (4) between the fixing points (5). The invention also relates to a process for obtaining a device of this type and to its uses.

Description

DISPOSITIF DE PROTECTION ET/OU DE CICATRISATION DEVICE FOR PROTECTING AND / OR HEALING

La présente invention se rapporte de manière générale à un pansement, ayant une structure composite et possédant une grande flexibilité et une grande élasticité, permettant de protéger et/ou traiter efficacement toute zone, notamment du corps humain, quelles que soient sa superficie et sa localisation.The present invention relates generally to a dressing, having a composite structure and having great flexibility and elasticity, to protect and / or effectively treat any area, including the human body, regardless of its area and location .

Plus particulièrement, l'invention concerne un pansement comprenant au moins une couche destinée à recouvrir ladite zone, directement, et y adhérer, celle couche est dite proximale et assure à fois la protection et/ou le traitement de ladite zone et l'adhérence sur ladite zone, et au moins une couche destinée à protéger et/ou assurer le maintien de la couche proximale, cette couche est dite distale.More particularly, the invention relates to a dressing comprising at least one layer intended to cover said zone, directly, and to adhere to it, that said layer is said to be proximal and provides both the protection and / or the treatment of said zone and the adhesion to said zone, and at least one layer intended to protect and / or maintain the proximal layer, this layer is said to be distal.

L'efficacité des pansements actuellement disponibles dans le commerce, peut varier en cours d'utilisation, jusqu'à même devenir nulle, en fonction de l'épaisseur de la couche proximale, la localisation et l'étendue de la zone à protéger et traiter. A titre d'exemple, si le pansement est appliqué sur le talon ou un orteil, son contact permanent ou répété avec une partie de la chaussure peut provoquer son déplacement par fluage de l'adhésif, et ainsi dégager la zone à protéger du pansement, pouvant entraîner une aggravation de la plaie. Une solution peut consister en l'application de larges bandes de pansement afin de maintenir de manière sûre ladite zone au contact de la couche proximale ; elle conduit cependant à une protection souvent inconfortable et inesthétique.The effectiveness of currently commercially available dressings may vary during use, even to zero, depending on the thickness of the proximal layer, the location and extent of the area to be protected and treated. . By way of example, if the dressing is applied on the heel or toe, its permanent or repeated contact with a part of the shoe may cause its movement by creep of the adhesive, and thus clear the area to be protected from the dressing, may cause worsening of the wound. One solution may be the application of wide strips of dressing to securely maintain said area in contact with the proximal layer; however, it leads to often uncomfortable and unsightly protection.

US2003/040691 décrit un dispositif de protection d'une blessure comprenant de la zone distale à la zone proximale :US2003 / 040691 discloses a wound protection device comprising from the distal zone to the proximal zone:

- une couche non élastique et perméable à l'air, qui peut consister en une bande de non-tissé sur laquelle est fixé un film perméable à l'air, en polyuréthane par exemple,a non-elastic and breathable layer, which may consist of a non-woven strip on which is fixed an air-permeable film, made of polyurethane for example,

- une couche élastomère par exemple constituée par des filaments obtenus par extrusion à chaud, etan elastomer layer, for example consisting of filaments obtained by hot extrusion, and

- une couche d'un non-tissé non élastique et absorbant, pouvant se présenter sous forme stratifiée.a layer of a non-elastic and absorbent nonwoven, which may be in laminated form.

Le dispositif décrit ne possède aucune propriété élastique. Selon le document, EP-B1 -370789, on connaît un dispositif occlusif et compressif, constitué par les couches suivantes: un tissu élastique, une couche adhésive d'une composition hydrocolloïdale traitante, interagissant avec les fluides biologiques, et éventuellement, une couche fine de latex renforçant la cohésion entre le tissu élastique et la couche adhésive, et une couche amovible de protection de la couche adhésive.The described device has no elastic property. According to the document EP-B1 -370789, an occlusive and compressive device consisting of the following layers is known: an elastic fabric, an adhesive layer of a treating hydrocolloidal composition, interacting with the biological fluids, and optionally, a thin layer of latex reinforcing the cohesion between the elastic fabric and the adhesive layer, and a removable protective layer of the adhesive layer.

Ce dispositif est obtenu par revêtement du tissu élastique par du latex, d'une part, et préparation de la couche et application de la couche de protection, d'autre part, puis stratification de l'ensemble.This device is obtained by coating the elastic fabric with latex, on the one hand, and preparing the layer and applying the protective layer, on the other hand, and then laminating the assembly.

Ce pansement est davantage destiné au bandage de zones à traiter et comprimer du type jambe ulcérée, et n'est pas utilisable en tant que pansement pour la protection d'une zone, en ce qu'il ne comporte aucune couche de protection et de cohésion de la couche adhésive qui peut fluer au travers du tissu élastique.This dressing is more intended for the bandaging of areas to be treated and compress ulcerated leg type, and is not used as a dressing for the protection of an area, in that it has no protective layer and cohesion the adhesive layer which can flow through the elastic fabric.

Selon W02005/048911A, on connaît un dispositif comprenant un film distal à base de polyuréthane, une couche intermédiaire textile et une couche proximale de gel de silicone. Il est obtenu par stratification successive des différents matériaux, en commençant par le polymère constitutif du film distal qui est d'abord déposé, à l'état liquide, sur un support cartonné, puis la couche textile est collée sur le film distal, par calandrage pour obtenir, mécaniquement, une complète imprégnation du textile dans le film distal. Ensuite, la silicone de la couche proximale est appliquée sur la couche textile.According to WO2005 / 048911A, there is known a device comprising a polyurethane-based distal film, a textile intermediate layer and a proximal layer of silicone gel. It is obtained by successive stratification of the different materials, starting with the constituent polymer of the distal film which is first deposited, in the liquid state, on a cardboard support, then the textile layer is glued on the distal film, by calendering to obtain, mechanically, a complete impregnation of the textile in the distal film. Then, the silicone of the proximal layer is applied to the textile layer.

Le pansement résultant ne présente désavantageusement pas l'élasticité attendue, c'est-à-dire celle du tissu textile car ce dernier se trouve en fait noyé dans le polyuréthane du film distal et ne peut alors conférer qu'une élasticité très limitée au pansement. Ce pansement possède une certaine extensibilité, mais elle n'est pas réversible, et dès que la force d'allongement est trop importante, des traces blanches apparaissent à la surface du film de polyuréthane, caractéristiques de la séparation dommageable de la couche textile du film. Ces inconvénients empêchent la réutilisation de ce pansement d'une part, et en limitent son application, par exemple à la contention, d'autre part. Enfin, le procédé de fabrication de ce pansement consiste en des étapes de stratifications successives des différentes couches, et dans ces conditions de fabrication, le polyuréthane du film traverse la couche textile et vient polluer la silicone à son contact, modifiant ses propriétés, notamment sa stabilité. L'invention apporte une solution, avec un dispositif de protection et/ou de cicatrisation, flexible, possédant une élasticité proche de celle de la couche textile, et comportant une couche de maintien, de cohésion et de protection de la couche adhésive traitante.The resulting dressing does not disadvantageously have the expected elasticity, that is to say that of the textile fabric because the latter is actually embedded in the polyurethane of the distal film and can then confer a very limited elasticity to the dressing . This dressing has a certain extensibility, but it is not reversible, and as soon as the elongation force is too great, white marks appear on the surface of the polyurethane film, characteristics of the damaging separation of the textile layer of the film . These disadvantages prevent the reuse of this dressing on the one hand, and limit its application, for example to the restraint, on the other hand. Finally, the method of manufacturing this dressing consists of successive stratification steps of the different layers, and under these manufacturing conditions, the polyurethane of the film passes through the textile layer and pollutes the silicone on contact, modifying its properties, particularly its stability. The invention provides a solution, with a protective and / or healing device, flexible, having elasticity close to that of the layer textile, and having a layer for holding, cohesion and protection of the adhesive adhesive layer.

Ainsi, un dispositif objet de la présente invention, comprend au moins un film distal, élastique, à base de polymère filmable et une couche proximale, élastique, adhésive, à base d'un gel et comportant deux parties longitudinales, l'une dite supérieure dirigée vers ledit film et l'autre inférieure destinée à être en contact avec la zone à protéger et/ou traiter, ledit dispositif comprenant une couche intermédiaire, textile, extensible, située entre le film distal et la couche proximale et fixée par points sur ledit film, la partie longitudinale supérieure de la couche traversant ladite couche textile, entre les points de fixation.Thus, a device which is the subject of the present invention comprises at least one distal elastic film based on a filmable polymer and a proximal elastic adhesive layer based on a gel and comprising two longitudinal portions, one of which is said to be superior. directed towards said film and the lower one intended to be in contact with the area to be protected and / or treated, said device comprising an extensible textile intermediate layer located between the distal film and the proximal layer and fixed in points on said film, the upper longitudinal portion of the layer passing through said textile layer, between the attachment points.

On utilisera au cours de la description indifféremment les termes traitement et cicatrisation.In the course of the description, the terms treatment and cicatrization will be used interchangeably.

Le dispositif résultant de la combinaison selon l'invention de ces trois éléments, film distal, couche intermédiaire et couche proximale, permet une protection et/ou traitement de la zone à traiter, durable quelle que soit la zone et quelles que soient les contraintes type cisaillement appliquées, et réutilisable. En effet, cette combinaison confère au dispositif une élasticité qui assure à la fois une facilité de placement, même sur des zones difficiles d'accès et son parfait maintien en place sur la zone, en cours d'utilisation. Même sur des zones larges, le dispositif assure une contention de ladite zone, l'élasticité étant obtenue dans les sens longitudinal, transversal et diagonal, quelle que soit l'épaisseur de la couche distale de protection et/ou de traitement. Après retrait et nettoyage du dispositif, celui-ci peut être réutilisé.The device resulting from the combination according to the invention of these three elements, distal film, intermediate layer and proximal layer, allows protection and / or treatment of the area to be treated, sustainable whatever the zone and whatever the typical constraints. Shear applied, and reusable. Indeed, this combination gives the device an elasticity that ensures both ease of placement, even in areas difficult to access and its perfect hold in place on the area, in use. Even over wide areas, the device provides a contention of said zone, the elasticity being obtained in the longitudinal, transverse and diagonal directions, regardless of the thickness of the distal protective layer and / or treatment. After removal and cleaning the device, it can be reused.

En cela, les applications d'un dispositif de l'invention sont nombreuses et variées, telles que dans les domaines de la phlébologie, du traitement des brûlés, dans la prévention ou la protection des escarres, la prévention ou la réduction des chéloïdes, et bien sûr dans la prévention, la protection et le traitement de lésions cutanées plus ou moins profondes.In this, the applications of a device of the invention are numerous and varied, such as in the fields of phlebology, the treatment of burns, in the prevention or protection of bedsores, the prevention or reduction of keloids, and of course in the prevention, protection and treatment of more or less deep skin lesions.

Le mode de fixation entre le film distal et la couche intermédiaire permet à la couche proximale de s'accrocher mécaniquement dans le dispositif de l'invention, sans risque de pollution des matériaux les uns par les autres. En effet, lorsque le gel de la couche proximale est appliqué sur le film et le textile, le gel de la partie longitudinale supérieure de la couche proximale traverse les interstices entre les fibres constitutives du textile et vient se poser entre les points de fixation de la couche textile au film distal, sans interaction chimique et donc sans risque d'amoindrir les propriétés des matériaux de chacun des film et couches.The method of attachment between the distal film and the intermediate layer allows the proximal layer to mechanically catch in the device of the invention, without risk of pollution of the materials by each other. Indeed, when the gel of the proximal layer is applied to the film and the textile, the gel of the upper longitudinal portion of the proximal layer passes through the interstices between the fibers constituting the textile and comes to rest between the attachment points of the textile layer to the distal film, without chemical interaction and therefore without risk of diminishing the properties of the materials of each of the film and layers.

Les points de fixation de la couche proximale au film distal sont également répartis ou non, et sont de préférence distants de 0,5 à 1 mm. Pour atteindre les objectifs décrits ci-dessus, le film distal et la couche proximale d'un dispositif de l'invention ont avantageusement une élasticité, identique ou différente, mais qui est supérieure à celle de la couche textile. Le dispositif selon l'invention présente une élasticité qui n'est généralement pas inférieure de plus de 10% à celle de la couche textile. Ainsi, en fonction de la destination du dispositif, l'homme du métier sait sélectionner le textile d'élasticité appropriée pour fabriquer ledit dispositif.The attachment points of the proximal layer to the distal film are also distributed or not, and are preferably 0.5 to 1 mm apart. To achieve the objectives described above, the distal film and the proximal layer of a device of the invention advantageously have an elasticity, identical or different, but which is greater than that of the textile layer. The device according to the invention has an elasticity which is generally not more than 10% less than that of the textile layer. Thus, depending on the destination of the device, the skilled person knows to select the appropriate elastic textile to manufacture said device.

Le gel de la couche proximale va permettre d'obtenir un dispositif de traitement occlusif. On sait que l'obturation d'une zone de la peau provoque un mécanisme de défense de l'organisme, par apport de sang et d'oxygène sur ladite zone, ce qui va favoriser le renforcement des tissus cellulaires et la cicatrisation. On choisit donc un gel qui permet une obturation au moins partielle, voire totale de la zone à traiter. Il est avantageusement choisi parmi les composés qui, en complément de leur action mécanique ci-dessus favorisant la cicatrisation, participent intrinsèquement à la cicatrisation. De préférence, le gel est sélectionné parmi les silicones, les gels hydrocolloïdaux, les gels à base de caprolactone, et leurs mélanges.The gel of the proximal layer will make it possible to obtain an occlusive treatment device. It is known that the closure of an area of the skin causes a defense mechanism of the body, by bringing blood and oxygen to said area, which will promote the strengthening of cellular tissue and healing. We therefore choose a gel that allows at least partial closure, or even the entire area to be treated. It is advantageously chosen from compounds which, in addition to their mechanical action above promoting healing, intrinsically participate in healing. Preferably, the gel is selected from silicones, hydrocolloid gels, caprolactone-based gels, and mixtures thereof.

Pour compléter et améliorer le traitement de la zone, le gel de la couche peut comprendre au moins un principe actif, par exemple bactéricide, virucide, fongicide et/ou antiseptique. Celui-ci est de préférence associé à un véhicule, entraînant le relargage progressif dudit principe actif, notamment vers la lésion, favorisant la désinfection de la plaie à traiter. A titre d'illustration, un tel gel peut être une silicone comme décrit dans FR-A-2768615. De préférence, on choisit une silicone possédant une force d'adhésion d'au moins 500 g/cm2. Le gel peut aussi comprendre tout autre ingrédient concourant à la protection et/ou traitement de la zone, cet ingrédient étant associé ou non à ou aux principe(s) actif(s) ci-dessus. Il peut par exemple s'agir d'un agent favorisant le renforcement cellulaire de la peau, tel que la vitamine A.To complete and improve the treatment of the zone, the gel of the layer may comprise at least one active principle, for example bactericidal, virucidal, fungicidal and / or antiseptic. This is preferably associated with a vehicle, resulting in the gradual release of said active ingredient, especially to the lesion, promoting the disinfection of the wound to be treated. By way of illustration, such a gel may be a silicone as described in FR-A-2768615. Preferably, a silicone having an adhesion strength of at least 500 g / cm 2 is chosen. The gel may also include any other ingredient contributing to the protection and / or treatment of the zone, this ingredient being associated or not with the active principle (s) above. It may for example be an agent promoting cell reinforcement of the skin, such as vitamin A.

Le polymère constitutif de la couche adhésive, au moins pour la partie destinée à recouvrir la peau, doit être stable, avoir une structure chimique bloquée, pour empêcher toute libération non contrôlée et non souhaitable de molécules, par exemple molécules d'huile, qui traverserait la barrière de la peau. Il est de préférence perméable à l'oxygène.The constituent polymer of the adhesive layer, at least for the portion intended to cover the skin, must be stable, having a blocked chemical structure, to prevent any uncontrolled and undesirable release of molecules, eg oil molecules, that would cross the skin barrier. It is preferably permeable to oxygen.

La couche adhésive a une épaisseur variable qui est déterminée en fonction de l'application du dispositif. Comme dit précédemment, la couche adhésive comporte dans le sens de la longueur, deux parties, une partie dirigée vers le film que l'on désigne par partie longitudinale supérieure, et une partie dirigée vers la zone à protéger et/ou traiter que l'on désigne par partie longitudinale inférieure. Afin que la couche proximale soit adhésive, il est préférable que ladite partie inférieure n'inclue pas de fibres de la couche textile, la partie longitudinale supérieure correspondant à la partie de la couche adhésive dans laquelle est noyée la couche textile.The adhesive layer has a variable thickness which is determined according to the application of the device. As stated above, the adhesive layer comprises in the longitudinal direction, two parts, a portion directed towards the film which is designated by the upper longitudinal portion, and a portion directed towards the area to be protected and / or treated that the is designated lower longitudinal portion. So that the proximal layer is adhesive, it is preferable that said lower portion does not include fibers of the textile layer, the upper longitudinal portion corresponding to the portion of the adhesive layer in which the textile layer is embedded.

L'épaisseur de la partie longitudinale inférieure de la couche adhésive peut varier de 0,5 à 4 mm, l'épaisseur de la partie longitudinale supérieure pouvant varier 0,05 à 0,1 mm. De même, la consistance du gel qui est déterminée au cours de la fabrication du gel, est fixée en relation avec la destination du dispositif, par exemple protection d'une zone soumise à un frottement ou un cisaillement ou protection/traitement d'une zone où l'appui du corps est concentré. Ainsi, dans le traitement de l'hallux valgus ou la prévention d'escarres du sacrum, la consistance du gel sera plus élevée, permettant ainsi de répartir les pressions d'appui sur toute la surface du dispositif.The thickness of the lower longitudinal portion of the adhesive layer may vary from 0.5 to 4 mm, the thickness of the upper longitudinal portion may vary from 0.05 to 0.1 mm. Likewise, the consistency of the gel which is determined during gel production is fixed in relation to the destination of the device, for example protection of an area subjected to friction or shear or protection / treatment of an area where the support of the body is concentrated. Thus, in the treatment of hallux valgus or the prevention of sacrum ulcers, the consistency of the gel will be higher, thus allowing the support pressures to be distributed over the entire surface of the device.

La répartition du gel dans la couche est aussi adaptable à l'utilisation, elle est généralement d'au moins 700 g/m2.The distribution of the gel in the layer is also adaptable to use, it is generally at least 700 g / m 2 .

La silicone est un polymère qui réunit toutes les qualités préférentielles précitées et est donc le polymère préféré selon l'invention pour constituer la couche proximale.Silicone is a polymer which combines all the aforementioned preferential qualities and is therefore the preferred polymer according to the invention for constituting the proximal layer.

Le polymère du film distal est choisi de préférence pour être étanche aux liquides, résistant au déchirement, aux frottements, au cisaillement. Il est aussi avantageusement microaéré. A cet effet, il peut être choisi parmi les polyuréthanes, le polychlorure de vinyle, les polyéthylènes, et leurs mélanges. L'épaisseur du film distal peut varier entre 15 et 25 μm, en fonction de l'utilisation, en particulier en fonction des contraintes qui lui seront soumises.The polymer of the distal film is preferably selected to be liquid-tight, tear-resistant, friction-resistant, shear-resistant. It is also advantageously microaerated. For this purpose, it may be chosen from polyurethanes, polyvinyl chloride, polyethylenes, and mixtures thereof. The thickness of the distal film can vary between 15 and 25 microns, depending on the use, particularly depending on the constraints that will be submitted.

Selon une variante particulièrement préférée de l'invention, le gel est une silicone et le film est un film de polyuréthane. Comme dit précédemment, l'élasticité du dispositif est conservée, même pour des épaisseurs importantes de la couche proximale. Cette élasticité que l'on peut exprimer en pourcentage d'allongement par rapport au dispositif non soumis à un étirement, peut ainsi atteindre 250%, et ceci sans que les propriétés du dispositif ne soient affectées.According to a particularly preferred variant of the invention, the gel is a silicone and the film is a polyurethane film. As said above, the elasticity of the device is maintained even for large thicknesses of the proximal layer. This elasticity that it can be expressed as a percentage of elongation with respect to the device not subjected to stretching, can thus reach 250%, and this without the properties of the device are affected.

Selon l'invention, on entend par textile de la couche intermédiaire, un matériau constitué de fibres synthétiques et/ou naturelles, ayant des propriétés élastiques. Ce textile peut être tissé ou non tissé, il est de préférence en fibres choisies parmi les fibres polyamide, les fibres polyester, leurs mélanges. Le textile peut ainsi être un Lycra®, dont l'élasticité est choisie en fonction de l'application du dispositif selon l'invention, comme dit précédemment. Dans une variante préférentielle, le dispositif de l'invention peut comprendre une couche amovible de protection de la couche adhésive, avant emploi, en papier, cartonnée, autre matériau ou composite. Ainsi, cette couche comprend avantageusement une couche de polyéthylène qui est en contact avec le gel, sur une feuille cartonnée. Pour faciliter le retrait de cette couche de protection lors de l'application du dispositif, le polyéthylène est de préférence gaufré. La feuille cartonnée de la couche de protection a un grammage de l'ordre de 150 à 200 g/m2.According to the invention, textile of the intermediate layer, a material consisting of synthetic fibers and / or natural, having elastic properties. This textile may be woven or non-woven, it is preferably of fibers selected from polyamide fibers, polyester fibers, mixtures thereof. The textile may thus be a Lycra ®, whose elasticity is chosen according to the application of the device according to the invention, as said earlier. In a preferred embodiment, the device of the invention may comprise a removable protective layer of the adhesive layer, before use, paper, cardboard, other material or composite. Thus, this layer advantageously comprises a layer of polyethylene which is in contact with the gel, on a cardboard sheet. To facilitate the removal of this protective layer during the application of the device, the polyethylene is preferably embossed. The cardboard sheet of the protective layer has a basis weight of the order of 150 to 200 g / m 2 .

Encore un autre avantage tiré de l'élasticité du dispositif de l'invention réside dans un mode de retrait de cette couche amovible. La couche est avantageusement, prédécoupée pour le retrait, le retrait s'effectuant par simple étirement du dispositif qui conduit à la séparation des parties préséparées de la couche amovible.Yet another advantage derived from the elasticity of the device of the invention lies in a mode of removal of this removable layer. The layer is advantageously precut for shrinkage, the shrinkage taking place by simple stretching of the device which leads to the separation of the pre-separated parts of the removable layer.

Un dispositif de l'invention peut adopter diverses présentations, par exemple sous la forme de bandes à découper, de rouleau, ou de pansements individuels de tailles et formes variables. Ces présentations peuvent être obtenues par simple découpage d'un dispositif de l'invention, à la taille et la forme souhaitées.A device of the invention can adopt various presentations, for example in the form of strips to cut, roll, or individual dressings of varying sizes and shapes. These presentations can be obtained by simply cutting a device of the invention to the desired size and shape.

Les applications d'un dispositif de l'invention sont multiples. Ainsi, on peut l'utiliser comme pansement ou dispositif de protection et/ou de traitement des brûlures, comme pansement ou dispositif de protection et/ou de prévention des escarres, par exemple des escarres des talons, coudes, joues, sacrum, comme pansement ou dispositif pour protéger et/ou traiter des lésions cutanées, par exemple des lésions au pied, telles que des ampoules, comme pansement ou dispositif pour prévenir ou réduire des chéloïdes, des zones pauvres en cartilage, ou toute autre lésion cutanée par exemple d'origine variqueuse. Selon une mise en œuvre d'un dispositif de l'invention, la couche proximale dudit dispositif est recouverte d'une couche textile, extensible. Dans cette variante, un dispositif trouve notamment un intérêt pour l'obtention d'un coussinet plantaire ou pour l'obtention d'un manchon destiné à recouvrir un moignon, notamment tibial ou fémoral. Dans la première utilisation, le dispositif est découpé en forme, et ladite couche textile ne recouvre avantageusement que partiellement la couche proximale, la zone de contact avec la voûte plantaire n'étant pas recouverte ainsi que des zones de maintien sur le pied par adhésion de part et d'autres dudit dispositif. Dans la seconde utilisation, le dispositif de l'invention favorise un drainage lymphatique du moignon, tout en permettant une répartition des appuis. Ce dispositif peut aussi être utilisé en bandage, à des fins de contention.The applications of a device of the invention are multiple. Thus, it can be used as a dressing or protection device and / or treatment of burns, as a dressing or device for protecting and / or preventing bedsores, for example pressure ulcers of the heels, elbows, cheeks, sacrum, as a dressing or device for protecting and / or treating skin lesions, for example foot lesions, such as ampoules, as a dressing or device for preventing or reducing keloids, cartilage-poor areas, or any other cutaneous lesion such as varicose origin. According to an implementation of a device of the invention, the proximal layer of said device is covered with a textile layer, expandable. In this variant, a device finds particular interest for obtaining a plantar pad or for obtaining a sleeve for covering a stump, including tibial or femoral. In the first use, the device is cut into shape, and said textile layer advantageously only partially covers the proximal layer, the zone of contact with the arch is not covered as well as holding zones on the foot by adhesion of and others of said device. In the second use, the device of the invention promotes lymphatic drainage of the stump, while allowing a distribution of the supports. This device can also be used as a bandage for restraint purposes.

Selon une autre mise en oeuvre d'un dispositif de l'invention, on peut obtenir, par superposition de deux dispositifs décrits ci-dessus, un dispositif de répartition des pressions d'appui. Plus précisément, ce dispositif a une structure sandwich superposant un premier dispositif de protection/traitement de l'invention et un second dispositif de protection/traitement de l'invention, ledit second dispositif étant identique ou différent dudit premier dispositif, les deux dispositifs mettant en commun leur couche (3), respectivement. Ce dispositif de répartition des pressions d'appui n'est pas nécessairement obtenu par superposition desdits premier et second dispositifs, et, selon une variante avantageuse, il ne comporte qu'une seule et même couche (3).According to another implementation of a device of the invention, it is possible to obtain, by superposition of two devices described above, a device for distributing the pressing pressures. More specifically, this device has a sandwich structure superimposing a first protection / treatment device of the invention and a second protection / treatment device of the invention, said second device being identical to or different from said first device, the two devices implementing common their layer (3), respectively. This support pressure distribution device is not necessarily obtained by superposition of said first and second devices, and, according to an advantageous variant, it comprises only one and the same layer (3).

Un tel dispositif de répartition des pressions d'appui trouve diverses applications, en particulier dans toute pathologie ou toute situation dans laquelle les pressions d'appui d'une zone affectée par cette pathologie ou situation sont restreintes, pouvant causer ou causant une douleur. Ainsi selon des applications préférentielles, un tel dispositif peut être utilisé pour l'obtention d'un coussinet plantaire, ou pour l'obtention d'un manchon destiné à recouvrir un moignon, notamment moignon tibial ou moignon fémoral. Le capiton plantaire est une zone sous la plante de pied fortement sollicitée, par la station debout, le sport, et son usure provoque des douleurs, la répartition des pressions étant réduite, comme dans le cas du moignon dont le contact avec la prothèse peut être douloureux pour les mêmes raisons. Un dispositif selon l'invention, permet de rétablir une distribution des pressions et de soulager les douleurs, et d'entretenir un drainage lymphatique. L'élasticité du dispositif confère à ce dernier une mémoire de forme qui le rendra réutilisable, et dans le cas du manchon pour moignon, ce dispositif permet d'assurer une contention, facilitant sa formation et garantissant un drainage lymphatique.Such a support pressure distribution device has various applications, in particular in any pathology or any situation in which the support pressures of an area affected by this pathology or situation are restricted, which can cause or cause pain. Thus, according to preferred applications, such a device can be used to obtain a footpad, or to obtain a sleeve for covering a stump, including tibial stump or femoral stump. The plantar foot is a zone under the soles of the foot strongly solicited, by the standing, the sport, and its wear causes pain, the distribution of the pressures being reduced, as in the case of the stump whose contact with the prosthesis can be painful for the same reasons. A device according to the invention makes it possible to restore a distribution of pressures and to relieve pain, and to maintain lymphatic drainage. The elasticity of the device gives the latter a shape memory that will make it reusable, and in the In the case of the stump sleeve, this device makes it possible to provide restraint, facilitating its formation and guaranteeing lymphatic drainage.

Le dispositif est découpé en fonction de l'application recherchée, et notamment taille et forme. L'invention concerne aussi un procédé d'obtention d'un dispositif de protection et de traitement tel que décrit ci-dessus ; il comprend les étapes suivantes :The device is cut according to the desired application, and in particular size and shape. The invention also relates to a method for obtaining a protection and treatment device as described above; it includes the following steps:

On dépose des points de colle sur le film distalGlue dots are deposited on the distal film

On presse la couche textile sur le film distal pour fixer par point la couche textile sur le film distal etThe textile layer is pressed onto the distal film to fix the textile layer on the distal film by point.

On applique le polymère de la couche proximale sur la couche textile, par nappage.The polymer of the proximal layer is applied to the textile layer, by topping.

Le procédé selon l'invention qui n'est pas une stratification des différentes couches, permet à chaque matériau de conserver ses propriétés d'origine, les interactions entre chacun d'eux étant très restreintes.The method according to the invention which is not a stratification of the different layers, allows each material to retain its original properties, the interactions between each of them being very restricted.

Une description d'un dispositif de protection et/ou de cicatrisation de l'invention et d'un dispositif de répartition des pressions d'appui est ci-après faite en référence aux figures 1 et 2, respectivement, représentant une vue en coupe de dispositifs de l'invention. La figure 1 illustre un dispositif 1 de protection et/ou cicatrisation. Il comprend un film 2 distal d'un polymère fumable, une couche 3 proximale, présentant une partie 6 longitudinale supérieure dirigée vers le film 2 et une partie 7 longitudinale inférieure destinée à être appliquée sur la zone à protéger et/ou traiter, et une couche 4 textile. Cette dernière est noyée dans la partie 6 de la couche 3 et est fixée par points au film 2. Cette figure illustre parfaitement le mode de fixation de la couche 4 au film 2, conduisant à la fixation indirecte de la couche 3 dans le dispositif 1. La partie 7 de la couche 3 est exempte de fibres textile. Une couche 8 amovible de protection couvre la couche 3.A description of a device for protecting and / or healing the invention and a device for distributing the pressing pressures is hereinafter made with reference to FIGS. 1 and 2, respectively, showing a sectional view of devices of the invention. Figure 1 illustrates a device 1 for protection and / or healing. It comprises a distal film 2 of a fumable polymer, a proximal layer 3 having an upper longitudinal portion 6 directed towards the film 2 and a lower longitudinal portion 7 intended to be applied to the area to be protected and / or treated, and a layer 4 textile. The latter is embedded in the part 6 of the layer 3 and is fixed in points to the film 2. This figure perfectly illustrates the mode of attachment of the layer 4 to the film 2, leading to the indirect fixation of the layer 3 in the device 1 Part 7 of layer 3 is free of textile fibers. A removable protective layer 8 covers the layer 3.

La figure 2 illustre un dispositif 9 de répartition des pressions d'appui. Il répond à une structure sandwich dont le cœur est constitué par une couche 10 d'un polymère choisi les polymères appropriés à l'obtention de la couche 3 distale du dispositif 1 représenté à la figure 1. De chaque côté longitudinal du cœur, le dispositif comprend une couche 11 , identique ou différente, puis un film 12, identique ou différent, sur lequel la couche 11 est fixée par points 5. La couche 10 comprend deux parties 13 longitudinales périphériques dirigées vers le film 12, traversant la couche textile et une partie 14 longitudinale centrale. FIG. 2 illustrates a device 9 for distributing the pressing pressures. It responds to a sandwich structure whose core consists of a layer 10 of a polymer chosen polymers suitable for obtaining the distal layer 3 of the device 1 shown in Figure 1. On each longitudinal side of the heart, the device comprises a layer 11, identical or different, then a film 12, identical or different, on which the layer 11 is fixed by points 5. The layer 10 comprises two longitudinal peripheral portions 13 directed towards the film 12, passing through the textile layer and a central longitudinal part 14.

Claims

REVENDICATIONS 1. Dispositif (1) de protection et/ou de cicatrisation d'une zone à protéger et/ou à traiter, flexible, comprenant au moins un film (2) distal, élastique, à base de polymère fumable et une couche (3) proximale, élastique, adhésive, à base d'un gel et comportant deux parties longitudinales, supérieure (6) dirigée vers ledit film et inférieure (7) destinée à être en contact avec la zone à protéger et/ou traiter, ledit dispositif (1) étant caractérisé en ce qu'il comprend une couche (4) intermédiaire, textile, extensible, située entre le film (2) distal et la couche (3) proximale et fixée par points (5) sur ledit film (2), la partie (6) longitudinale supérieure de la couche (3) traversant ladite couche (4) textile, entre les points1. Device (1) for protecting and / or healing a zone to be protected and / or treated, flexible, comprising at least one distal elastic film (2) based on a fumable polymer and a layer (3) proximal, elastic, adhesive, gel-based and having two longitudinal portions, upper (6) directed towards said film and lower (7) intended to be in contact with the area to be protected and / or treated, said device (1 ) being characterized in that it comprises an intermediate layer (4), textile, extensible, located between the film (2) distal and the layer (3) proximal and fixed by points (5) on said film (2), the upper longitudinal portion (6) of the layer (3) passing through said textile layer (4) between the points (5) de fixation.(5) fixing. 2. Dispositif selon la revendication 1 , caractérisé en ce que le film (2) distal et la couche (3) proximale ont une élasticité identique ou différente, qui est supérieure à celle de la couche (4) textile.2. Device according to claim 1, characterized in that the film (2) distal and the layer (3) proximal have an identical or different elasticity, which is greater than that of the layer (4) textile. 3. Dispositif selon la revendication 2, caractérisé en ce que son élasticité n'est pas inférieure de plus de 10% à celle de la couche (4) textile.3. Device according to claim 2, characterized in that its elasticity is not more than 10% lower than that of the layer (4) textile. 4. Dispositif selon l'une quelconque des revendications 1 à 3, caractérisé en ce que le gel de la couche (3) est choisi parmi les silicones, les gels hydro colloïdaux, les gels à base de caprolactone, et leurs mélanges.4. Device according to any one of claims 1 to 3, characterized in that the gel of the layer (3) is selected from silicones, hydro colloidal gels, caprolactone-based gels, and mixtures thereof. 5. Dispositif selon l'une quelconque des revendications 1 à 4, caractérisé en ce que le polymère du film (2) est choisi parmi les polyuréthanes, le polychlorure de vinyle, les polyéthylène, et leurs mélanges.5. Device according to any one of claims 1 to 4, characterized in that the polymer of the film (2) is selected from polyurethanes, polyvinyl chloride, polyethylene, and mixtures thereof. 6. Dispositif selon l'une quelconque des revendications 1 à 5, caractérisé en ce que le gel de la couche (3) est une silicone et le polymère du film (2) est un polyuréthane.6. Device according to any one of claims 1 to 5, characterized in that the gel of the layer (3) is a silicone and the polymer of the film (2) is a polyurethane. 7. Dispositif selon l'une quelconque des revendications 1 à 6, caractérisé en ce que la répartition du gel de la couche (3) est d'au moins 700 g/m2.7. Device according to any one of claims 1 to 6, characterized in that the gel distribution of the layer (3) is at least 700 g / m 2 . 8. Dispositif selon l'une quelconque des revendications 1 à 7, caractérisé en ce que le textile de la couche (4) est tissé ou non tissé.8. Device according to any one of claims 1 to 7, characterized in that the textile of the layer (4) is woven or non-woven. 9. Dispositif selon l'une quelconque des revendications 1 à 8, caractérisé en ce que le textile de la couche (4) est en fibres choisies parmi les fibres polyamide, les fibres polyester, et leurs mélanges.9. Device according to any one of claims 1 to 8, characterized in that the textile of the layer (4) is made of fibers selected from polyamide fibers, polyester fibers, and mixtures thereof. 10. Dispositif selon l'une quelconque des revendications 1 à 9, caractérisé en ce que le film (2) est microaéré. 10. Device according to any one of claims 1 to 9, characterized in that the film (2) is microaerated. 11. Dispositif selon l'une quelconque des revendications 1 à 10, caractérisé en ce que le film (2) a une épaisseur variant de 15 à 25 μm.11. Device according to any one of claims 1 to 10, characterized in that the film (2) has a thickness ranging from 15 to 25 microns. 12. Dispositif selon l'une quelconque des revendications 1 à 11 , caractérisé en ce que la couche (3) adhésive est perméable à l'oxygène. 12. Device according to any one of claims 1 to 11, characterized in that the layer (3) adhesive is permeable to oxygen. 13. Dispositif selon l'une quelconque des revendications 1 à 12, caractérisé en ce que la partie (7) longitudinale inférieure de la couche (3) a une épaisseur variant de 0,5 à 4 mm.13. Device according to any one of claims 1 to 12, characterized in that the lower longitudinal portion (7) of the layer (3) has a thickness ranging from 0.5 to 4 mm. 14. Dispositif selon l'une quelconque des revendications 1 à 13, caractérisé en ce que la partie (6) longitudinale supérieure de la couche (3) a une épaisseur variant de 0,05 à 0,1 mm.14. Device according to any one of claims 1 to 13, characterized in that the portion (6) of the upper longitudinal layer (3) has a thickness ranging from 0.05 to 0.1 mm. 15. Dispositif selon l'une quelconque des revendications 1 à 14, caractérisé en ce que la couche (3) comprend au moins un principe actif, par exemple bactéricide, virucide, fongicide et/ou antiseptique.15. Device according to any one of claims 1 to 14, characterized in that the layer (3) comprises at least one active ingredient, for example bactericidal, virucidal, fungicidal and / or antiseptic. 16. Dispositif selon l'une quelconque des revendications 1 à 15, caractérisé en ce que la couche (3) comprend au moins un agent favorisant le renforcement cellulaire de la peau, par exemple la vitamine A.16. Device according to any one of claims 1 to 15, characterized in that the layer (3) comprises at least one agent promoting cell reinforcement of the skin, for example vitamin A. 17. Dispositif selon l'une quelconque des revendications 1 à 16, caractérisé en ce que les points (5) de fixation de la couche (4) au film (2) sont distants de 0,5 à 1 mm. 17. Device according to any one of claims 1 to 16, characterized in that the points (5) for fixing the layer (4) to the film (2) are spaced from 0.5 to 1 mm. 18. Dispositif selon l'une quelconque des revendications 1 à 17, caractérisé en ce qu'il comprend une couche (8) amovible de protection de la couche adhésive, avant emploi.18. Device according to any one of claims 1 to 17, characterized in that it comprises a removable layer (8) for protecting the adhesive layer, before use. 19. Dispositif selon la revendication 18, caractérisé en ce que la couche (6) comprend une couche de polyéthylène en contact avec la couche (3) et déposée sur une feuille cartonnée.19. Device according to claim 18, characterized in that the layer (6) comprises a layer of polyethylene in contact with the layer (3) and deposited on a cardboard sheet. 20. Dispositif selon la revendication 19, caractérisé en ce que le polyéthylène est gaufré.20. Device according to claim 19, characterized in that the polyethylene is embossed. 21. Dispositif selon la revendication 19 ou 20, caractérisé en ce que la feuille cartonnée a un grammage de l'ordre de 150 à 200 g/m2. 21. Device according to claim 19 or 20, characterized in that the cardboard sheet has a basis weight of the order of 150 to 200 g / m 2 . 22. Dispositif selon l'une quelconque des revendications 1 à 21 , caractérisé en ce qu'il se présente sous la forme de bandes à découper, de rouleau, ou de pansements individuels de tailles et formes variables.22. Device according to any one of claims 1 to 21, characterized in that it is in the form of strips to cut, roll, or individual dressings of varying sizes and shapes. 23. Pansement pour protéger et/ou traiter des brûlures, consistant en un dispositif selon l'une quelconque des revendications 1 à 22. 23. A dressing for protecting and / or treating burns, consisting of a device according to any one of claims 1 to 22. 24. Pansement pour protéger et/ou prévenir des escarres, consistant en un dispositif selon l'une quelconque des revendications 1 à 22. 24. A dressing for protecting and / or preventing bedsores, consisting of a device according to any one of claims 1 to 22. 25. Pansement pour protéger et/ou traiter des lésions cutanées, consistant en un dispositif selon l'une quelconque des revendications 1 à 22.25. Dressing for protecting and / or treating skin lesions, consisting of a device according to any one of claims 1 to 22. 26. Pansement pour prévenir ou réduire des chéloïdes, consistant en un dispositif selon l'une quelconque des revendications 1 à 22. 26. Dressing for preventing or reducing keloids, consisting of a device according to any one of claims 1 to 22. 27. Dispositif (9) de répartition des pressions d'appui, caractérisé en ce qu'il a une structure sandwich superposant un premier dispositif selon l'une quelconque des revendications 1 à 22 et un second dispositif selon l'une quelconque des revendications 1 à 22, identique ou différent dudit premier dispositif, les deux dispositifs mettant en commun leur couche (3), respectivement.27. Device (9) for distribution of the pressing pressures, characterized in that it has a sandwich structure superimposing a first device according to any one of claims 1 to 22 and a second device according to any one of claims 1 22, identical or different from said first device, the two devices pooling their layer (3), respectively. 28. Dispositif selon la revendication 27, caractérisé en ce qu'il ne comporte qu'une couche (10).28. Device according to claim 27, characterized in that it comprises only one layer (10). 29. Utilisation d'un dispositif selon l'une quelconque des revendications 1 à 22, pour l'obtention d'un pansement pour la protection et/ou le traitement de brûlures.29. Use of a device according to any one of claims 1 to 22, for obtaining a dressing for the protection and / or treatment of burns. 30. Utilisation d'un dispositif selon l'une quelconque des revendications 1 à 22, pour l'obtention d'un pansement pour la prévention et/ou la protection d'escarres.30. Use of a device according to any one of claims 1 to 22, for obtaining a dressing for the prevention and / or protection of bedsores. 31. Utilisation d'un dispositif selon l'une quelconque des revendications 1 à 22, pour l'obtention d'un pansement pour la protection et/ou le traitement de lésions cutanées.31. Use of a device according to any one of claims 1 to 22, for obtaining a dressing for the protection and / or treatment of skin lesions. 32. Utilisation d'un dispositif selon l'une quelconque des revendications 1 à 22, pour l'obtention d'un pansement pour la prévention ou la réduction de chéloïdes. 32. Use of a device according to any one of claims 1 to 22, for obtaining a dressing for the prevention or reduction of keloids. 33. Utilisation d'un dispositif selon l'une quelconque des revendications33. Use of a device according to any one of the claims 1 à 22, pour l'obtention d'un coussinet plantaire, la couche proximale dudit dispositif est recouverte d'une couche textile, extensible.1 to 22, for obtaining a plantar pad, the proximal layer of said device is covered with a textile layer, extensible. 34. Utilisation d'un dispositif selon l'une quelconque des revendications 1 à 22, pour l'obtention d'un manchon destiné à recouvrir un moignon, notamment tibial ou fémoral, la couche proximale dudit dispositif est recouverte d'une couche textile, extensible.34. Use of a device according to any one of claims 1 to 22, for obtaining a sleeve for covering a stump, in particular tibial or femoral, the proximal layer of said device is covered with a textile layer, extensible. 35. Utilisation d'un dispositif selon la revendication 27 ou 28, pour l'obtention d'un coussinet plantaire.35. Use of a device according to claim 27 or 28, for obtaining a plantar pad. 36. Utilisation d'un dispositif selon la revendication 27 ou 28, pour l'obtention d'un manchon destiné à recouvrir un moignon, notamment tibial ou fémoral. 36. Use of a device according to claim 27 or 28, for obtaining a sleeve for covering a stump, in particular tibial or femoral stump. 37. Procédé d'obtention d'un dispositif selon l'une quelconque des revendications 1 à 22, caractérisé en ce qu'il comprend les étapes suivantes:37. A method for obtaining a device according to any one of claims 1 to 22, characterized in that it comprises the following steps: On dépose des points de colle sur le film distalGlue dots are deposited on the distal film On presse la couche textile sur le film distal pour fixer par point la couche textile sur le film distal etThe textile layer is pressed onto the distal film to fix the textile layer on the distal film by point. On applique le polymère de la couche proximale sur la couche textile, par nappage. The polymer of the proximal layer is applied to the textile layer, by topping.
PCT/FR2007/001291 2006-07-28 2007-07-26 Device for protection and/or healing Ceased WO2008012443A2 (en)

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FR2904214A1 (en) 2008-02-01
DE112007001732T5 (en) 2011-04-28
FR2904214B1 (en) 2009-02-27
WO2008012443A3 (en) 2008-03-27

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