WO2008056090A1 - Device for regenerating human skin and method for manufacturing said device - Google Patents
Device for regenerating human skin and method for manufacturing said device Download PDFInfo
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- WO2008056090A1 WO2008056090A1 PCT/FR2007/052323 FR2007052323W WO2008056090A1 WO 2008056090 A1 WO2008056090 A1 WO 2008056090A1 FR 2007052323 W FR2007052323 W FR 2007052323W WO 2008056090 A1 WO2008056090 A1 WO 2008056090A1
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- textile web
- transparent support
- dermis
- textile
- resorbable
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Classifications
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- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/10—Hair or skin implants
- A61F2/105—Skin implants, e.g. artificial skin
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
- A61L27/24—Collagen
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/60—Materials for use in artificial skin
Definitions
- the invention relates to a device for the regeneration of the human dermis. It also relates to a method for the manufacture of such a device.
- the regeneration of the human dermis by means of collagen matrix or equivalent followed by an epidermal graft is one of the most used techniques to reform the skin. Third degree burns are one of the major indications of this technique. Regeneration of the dermis is also required in reconstructive surgery for the treatment of keloids, retractile bridles, scarred wardrobes, hypertrophic scars, cutaneous necrosis following failure of a skin graft, nevi. Dermal regeneration is also required after cutaneous tumor excision, for the treatment of chronic or acute wounds when the dermis needs to be regenerated as well as in reconstructive trauma surgery.
- the complex is thus in the form of three distinct layers, respectively: a resorbable polymeric matrix, a textile web, - a transparent permeable layer, in practice in the form of a silicone film.
- the surgeon proceeds as follows. First and if necessary, the nonviable burnt dermis parts are excised, so as to obtain a viable underlying tissue.
- the multilayer complex is positioned so that the resorbable polymeric matrix is in contact with the muscle or the subcutaneous tissue, the device is then fixed on the muscle or cutaneous tissue, by means of staples or by suture, so as to prevent it from moving during the regeneration phase of the dermis and to seal the wound.
- the dermis is regenerated, which can take about three weeks, remove the double layer transparent film / textile web, then, in a final step, we proceed to an epidermis graft on the dermis thus regenerated.
- tearing of the film / textile web assembly causes at least partial tearing of the dermis formed due to the colonization of the textile by the host cells. It follows possible bleeding and irregularity of the dermis.
- the epidermis graft is then performed on a non-homogeneous dermis with the risk of persistence of skin defects after reconstruction.
- the film can separate from the sheet, so that it remains fixed in the dermis during training.
- the epidermis graft will be performed on a dermis containing a non-resorbable and useless material, with risks of loss of functionality of the skin in terms of flexibility, elasticity and aesthetics due to the persistence of the textile structure.
- Another disadvantage of the device of the prior art is to cause tear formation within the transparent sheet and the collagen matrix, at the time of fixing by stapling and during the regeneration of the dermis. The tearing of the matrix of collagen then leaves a hole that will be filled by the formation of a designated tissue
- a third disadvantage is that the permeable sheet, in view of its small thickness, manages to tear near the attachment points, under the effect of the movements of the patient.
- the subcutaneous tissue or the muscle is no longer isolated from the ambient air, open to a significant risk of contamination.
- a fourth disadvantage is that the textile web provides a certain rigidity to the device. The latter may then not adapt to the wound to be treated in certain regions of the body with a pronounced relief such as the fingers, the face.
- the contact between the polymeric material and the wound bed is essential for good dermal reconstruction.
- the transparency of the permeable film can be affected by the presence of the textile web.
- transparency is essential for the follow-up of wounds and in particular the verification of the absence of infection or hematomas which can lead to the failure of the dermal regeneration.
- Transparency also makes it possible to check the progress of regeneration of the dermis for the planning of the epidermal graft.
- the Applicant has developed a new device in which the textile web is integrated in the mass of the transparent layer.
- the transparent layer thus reinforced allows the certain removal, not only of the transparent sheet, but also that of the textile material when the dermis is formed definitively, just before the grafting of the epidermis. Furthermore, the Applicant has conducted experiments showing that the layer reinforced in this way, was not subject to widening of the holes formed by the staples, thus preventing any risk of contamination or unsatisfactory reconstruction.
- EP 0 943 298 discloses a surgical plate also composed of a multilayer complex comprising two layers, respectively a macroporous textile knitted or nonwoven coated on one side by a non-adherent film.
- the problem posed in this document concerns the difficulty of manufacturing such a device by producing a very thin continuous and smooth non-stick silicone film applied to a macroporous fabric (paragraph 23).
- the process used corresponding to that of Figure 2 of the document, consists of dipping a composite glass + tefion sheet in a silicone solution.
- the silicone-coated composite sheet is then applied to a porous textile, the assembly then being fired at a temperature of about 150 ° C. in order to allow the silicone to be polymerized.
- the glass + tefion composite sheet is then removed to leave the silicone film on the porous textile.
- the surgical plate described in EP 943 298 as used on the patient consists only of a biocompatible textile layer covered on one of its faces with a thin silicone film.
- EP 305 052 discloses a method of manufacturing artificial skin, the problem being based essentially on the combination of the biodegradable regeneration material with the release film.
- the silicone film partially covers the synthetic biodegradable polymer.
- the subject of the invention is therefore a device intended for the regeneration of the human dermis in the form of a multilayer complex associating a resizable colonizable polymeric internal matrix able to induce, by contact with the muscle or the subcutaneous tissue, the regeneration of the dermis, a non-resorbable openwork textile sheet, a transparent external support.
- This device is characterized in that the openwork textile web is contained entirely in the mass of the transparent support thus constituting a reinforced transparent support.
- openwork textile web is meant a woven, a knit, a nonwoven, the textile being openwork.
- the device comprises, between said support and the matrix, an adhesive layer, advantageously a silicone adhesive.
- the resorbable polymeric material may consist of collagen, polysaccharides (cellulose, alginate, agarose, chitosan), glycosaminoglycans (hyaluronic acid, chondroitin sulfate, heparin), glycoproteins (fibronectin, laminin, chondronectin), proteins of structure (for example elastin, gelatin) or resorbable synthetic polymers (polylactic gly colic ...), alone or in combination.
- Other compounds may be added to the absorbable polymeric material such as for example growth factor, antiseptics, antibiotics.
- the polymeric material may be crosslinked before being applied to the transparent support depending on its nature.
- the crosslinking agent is glutaraldehyde, formaldehyde, N-hydroxysuccinimide, ethyl 3-dimethylaminopropylcarbodiimide, a polysaccharide functionalized to react with collagen.
- the crosslinking can also be carried out by physical treatment such as vacuum heat treatment, irradiation.
- the material in the case where the material consists of collagen, it may be native collagen, fibrous, atelocollagen or partially or completely denatured collagen.
- the resorbable polymeric material consists exclusively of collagen, which is crosslinked before association with the reinforced transparent support.
- the perforated textile web With regard to the perforated textile web, it must be sufficiently dense to allow effective reinforcement of the support, and therefore avoid the risk of tearing, at the point of contact with the staples, while not affecting the transparency of the support, essential to the visualization of the formation of the dermis by the surgeon, and its conformability essential for its adaptation to the site to be treated.
- the density of the textile ply is between 0.6 and 60 g / m 2 , advantageously between 15 and 20 g / m 2 .
- the constituent yarn of the web has a dtex value of between 10 and 30, advantageously between 20 and 25 dtex.
- the web contains between 3 and 100, advantageously between 10 and 60 threads and as many picks per centimeter.
- the material constituting the textile web consists of synthetic fibers (polyester, polypropylene) or natural fibers (silk, cellulose), or cotton, in the form of single or multi-strand wire.
- the transparent support advantageously has a permeability to water vapor, identical to that of the epidermis.
- it is preferably in the form of a film of silicone, polyurethane (PU), or polyolefin (polyethylene (PE), polyethylene terephthalate copolysester (PETG), polyvinyl chloride (PVC)) transparent and non-absorbable on time of dermal reconstruction.
- the transparent support is present in the form of a sandwich comprising two silicone films applied on either side of the textile web.
- the thickness of the reinforced transparent support is between 20 and 1000 microns, advantageously between 200 and 300 microns.
- the transparent support assembly - perforated textile sheet of the device of the invention is provided with orifices distributed over all or part of the surface.
- the orifices are calibrated and distributed so as to allow a satisfactory extraction of exudates and a homogeneous distribution of pressures on the treated area.
- the orifices are through, that is to say that the orifices present in the transparent support communicate with the orifices provided in the textile.
- the orifices may correspond to the previously mentioned openings or to orifices created in the thickness of the textile.
- the invention also relates to the method of manufacturing the device described above.
- an adhesive layer is sprayed on the surface of a transparent support having in its mass, a perforated textile web, - the polymeric resorbable matrix, possibly crosslinked, is applied to the bonded surface of the transparent support.
- the transparent support is formed by application on both sides of the textile web of two silicone films.
- the films may be bonded together by thermofusion or hot or cold pressing, optionally followed by heat treatment.
- the presence of the textile web in the support also allows to have a perfectly flat surface, not deformed, adapted to receive the adhesive layer by spraying.
- the polymeric resorbable matrix is obtained from collagen or other materials alone or as a mixture, as previously described.
- the resorbable matrix consists entirely of collagen.
- the collagen is crosslinked and forms a porous dry structure applied directly to the surface of the reinforced transparent layer in the form of a sheet.
- the device thus produced is optionally cut and then conditioned before being sterilized.
- the orifices are formed in the support assembly - textile web before its association with the resorbable matrix.
- the matrix has the advantage of keeping all its integrity, without any defects on the surface in contact with the support or at the level of holes.
- the perforations can be performed by any technique known to those skilled in the art, in particular laser or mechanically
- the invention also relates to a dermal regeneration method consisting of: - beforehand and if necessary, to excise the non-viable or scarred dermis parts,
- the device of the invention applying to the subcutaneous tissue or the muscle, the device of the invention, so that the resorbable polymeric matrix is in contact with the said muscle or subcutaneous tissue, to fix the said device on the muscle or tissue cutaneous by fastening means such as stapling or suturing,
- grafting the epidermis by means of an autograft, a sheet of cultured keratinocytes, a keratinocyte spray or another epidermal regeneration technique.
- FIG. 1 is an exploded schematic representation of the device of the invention.
- FIG. 2 is a photograph of the dermal reconstruction carried out by means of the device of the invention compared with that of a device of the trade.
- the device of the invention comprises a first layer in the form of a resorbable polymeric matrix (1) made in practice of 100% collagen.
- the starting collagen is native collagen of bovine dermis, in particular veal, milled and then transformed into gel before being lyophilized, and then cross-linked using glutaraldehyde.
- the product formed is in the form of a dry sheet, which can be glued directly onto the reinforced transparent support.
- the excess crosslinking agent is removed by washing or chemical reduction.
- the reinforced transparent support (2) comprises a textile ply (3) consisting of single-strand polyester threads, whose texture corresponds to 36 threads and 36 picks per centimeter, while the density is 17 g / cm.sup.2. m 2 .
- This textile web (3) is sandwiched between two silicone films (4.1, 4.2), each of thickness about 100 microns.
- the two silicone films are previously applied to each of the surfaces of the textile web to form the reinforced transparent support.
- the joining of the assembly is obtained by cold pressing followed by a heat treatment.
- On one of the surfaces of this layer is then applied, by spraying or other coating technique, a silicone adhesive, and then comes to apply the collagen matrix previously prepared.
- FIG. 2 is a photograph of the dermal reconstruction (just before the epidermal grafting) carried out by means of the device of the invention (right part (5)) applied on the back of a patient initially burned in the 3 rd degree and presenting a scar patch that has been excised. The product was applied directly to the muscle and compared to the INTEGRA® DRT product (left side of the image (6)).
- the surgeon after excising the rest of the dermis, applies the device so that the face provided with collagen is in contact with the muscle.
- the size of the device is chosen according to the size of the burn.
- the device is then stapled on the adjacent cutaneous tissue or on another device of the same nature.
- the device is removed as already said by tearing of the only reinforced support.
- a thin epidermal dermo graft is then performed on the regenerated dermis.
- Figure 2 shows the reconstructed dermis in the device after three weeks.
- the reconstructed dermis in the INTEGRA® DRT device shows granulation tissue budding at stitches (8), indicating poor dermal regeneration. These buds are the result of the holes formed by the staples in the INTEGRA DRT product, holes that expanded during the neoderm formation period.
- the device of the invention (5) has not torn at the holes formed by the staples and this, thanks to the presence of the textile web in the thickness of the transparent layer.
- the reconstructed dermis in the device according to the invention does not show any granulation of granulation tissue at the point of stapling (7).
- the presence of the textile web inside the transparent layer has also completely avoided the colonization of the textile by the neoderm, the surface of the neoderm after removal of the transparent layer is smooth and free of bleeding. Removal of the transparent layer could be achieved without any partial excision of the newly formed dermis.
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Abstract
The invention relates to a device for regenerating human skin in the form of a multi-layered complex that comprises a resorptive polymer inner matrix (1) capable of inducing skin regeneration by contact with the muscle or the subcutaneous tissues (3), a non-resorptive net-like textile ply, and a transparent outer carrier, characterised in that the net-like textile ply is entirely contained in the mass of the transparent carrier (4.1, 4.2).
Description
DISPOSITIF DESTINE A LA REGENERATION DU DERME HUMAIN ET DEVICE FOR REGENERATING HUMAN DERMA AND
PROCEDE DE FABRICATION DUDIT DISPOSITIFMETHOD OF MANUFACTURING THE SAID DEVICE
L'invention a pour objet un dispositif destiné à la régénération du derme humain. Elle concerne également un procédé pour la fabrication d'un tel dispositif.The invention relates to a device for the regeneration of the human dermis. It also relates to a method for the manufacture of such a device.
La régénération du derme humain au moyen de matrice de collagène ou équivalent suivie d'une greffe d'épiderme est une des techniques les plus usitées pour reformer la peau. Les brûlures du troisième degré constituent l'une des indications majeures de cette technique. La régénération du derme est également requise en chirurgie réparatrice pour le traitement des chéloïdes, brides rétractiles, placards cicatriciels, cicatrices hypertrophiques, nécrose cutanée consécutive à l'échec d'une greffe de peau, naevus. La régénération dermique est aussi requise après excision de tumeur cutanée, pour le traitement des plaies chroniques ou aiguë quand le derme à besoin d'être régénéré de même qu'en chirurgie reconstructrice en traumatologie.The regeneration of the human dermis by means of collagen matrix or equivalent followed by an epidermal graft is one of the most used techniques to reform the skin. Third degree burns are one of the major indications of this technique. Regeneration of the dermis is also required in reconstructive surgery for the treatment of keloids, retractile bridles, scarred wardrobes, hypertrophic scars, cutaneous necrosis following failure of a skin graft, nevi. Dermal regeneration is also required after cutaneous tumor excision, for the treatment of chronic or acute wounds when the dermis needs to be regenerated as well as in reconstructive trauma surgery.
Le document US-A-4 060 081 décrit un dispositif pour la régénération du derme du type de celui de l'invention se présentant sous la forme d'un complexe multicouches associant successivement : - une matrice polymérique résorbable, destinée à être en contact, en fonction de l'indication, avec le muscle ou le tissu sous-cutané,The document US Pat. No. 4,060,081 describes a device for the regeneration of the derm of the type of that of the invention in the form of a multilayer complex successively associating: a resorbable polymeric matrix, intended to be in contact, depending on the indication, with the muscle or the subcutaneous tissue,
- une nappe textile de caractéristiques non spécifiées appliquée sur la face de la matrice, non en contact avec le muscle ou le tissu sous-cutané, un film perméable faisant office de pseudo épiderme temporaire, appliqué à la lame, directement sur la nappe textile.a textile web of unspecified characteristics applied on the face of the matrix, not in contact with the muscle or the subcutaneous tissue, a permeable film acting as a temporary pseudo epidermis, applied to the blade, directly on the textile web.
Le complexe se présente donc sous la forme de trois couches distinctes, respectivement : une matrice polymérique résorbable, une nappe textile, - une couche perméable transparente, en pratique sous la forme d'un film de silicone.The complex is thus in the form of three distinct layers, respectively: a resorbable polymeric matrix, a textile web, - a transparent permeable layer, in practice in the form of a silicone film.
Lorsque ces complexes multicouches sont utilisés pour la régénération du derme, en particulier chez les grands brûlés, le chirurgien procède de la manière suivante.
D'abord et si nécessaire, on excise les parties du derme brûlées non viables, de manière à obtenir un tissu sous jacent viable.When these multilayer complexes are used for the regeneration of the dermis, particularly in burn victims, the surgeon proceeds as follows. First and if necessary, the nonviable burnt dermis parts are excised, so as to obtain a viable underlying tissue.
Directement sur le muscle, ou selon les cas, sur le tissu sous-cutané : - on positionne le complexe multicouche de sorte à ce que la matrice polymérique résorbable soit en contact avec le muscle ou le tissu sous-cutané, on fixe ensuite le dispositif sur le muscle ou le tissu cutané, au moyen d'agrafes ou par suture, de manière à éviter qu'il ne bouge pendant la phase de régénération du derme et pour assurer l'étanchéité de la plaie. - lorsque le derme est régénéré, ce qui peut prendre environ trois semaines, on retire la double couche film transparent / nappe textile, puis, dans une dernière étape, on procède à une greffe d'épiderme sur le derme ainsi régénéré.Directly on the muscle, or depending on the case, on the subcutaneous tissue: the multilayer complex is positioned so that the resorbable polymeric matrix is in contact with the muscle or the subcutaneous tissue, the device is then fixed on the muscle or cutaneous tissue, by means of staples or by suture, so as to prevent it from moving during the regeneration phase of the dermis and to seal the wound. - When the dermis is regenerated, which can take about three weeks, remove the double layer transparent film / textile web, then, in a final step, we proceed to an epidermis graft on the dermis thus regenerated.
L'un des inconvénients majeurs du dispositif décrit dans le document US-A-4 060 081 est de présenter un contact direct entre le derme en cours de formation et la nappe textile. En effet, au moment de l'arrachage de la double couche film perméable / nappe textile, deux situations peuvent se produire.One of the major drawbacks of the device described in document US Pat. No. 4,060,081 is that it presents a direct contact between the dermis during formation and the textile web. Indeed, at the time of tearing of the double layer permeable film / textile web, two situations can occur.
Dans certains cas, l'arrachage de l'ensemble film / nappe textile engendre l'arrachage au moins partiel du derme formé du fait de la colonisation du textile par les cellules hôtes. Il s'ensuit des possibles saignements ainsi qu'une irrégularité du derme. La greffe d'épiderme est alors effectuée sur un derme non homogène avec donc des risques de persistance de défaut cutanée après reconstruction.In some cases, tearing of the film / textile web assembly causes at least partial tearing of the dermis formed due to the colonization of the textile by the host cells. It follows possible bleeding and irregularity of the dermis. The epidermis graft is then performed on a non-homogeneous dermis with the risk of persistence of skin defects after reconstruction.
Dans d'autres cas, le film peut se désolidariser de la nappe, de sorte que celle-ci reste fixée dans le derme en cours de formation. Dans cette hypothèse, la greffe d'épiderme sera effectuée sur un derme contenant une matière non résorbable et inutile, avec des risques de perte de fonctionnalité de la peau en termes de souplesse, d'élasticité et d'esthétique du fait de la persistance de la structure textile.In other cases, the film can separate from the sheet, so that it remains fixed in the dermis during training. In this hypothesis, the epidermis graft will be performed on a dermis containing a non-resorbable and useless material, with risks of loss of functionality of the skin in terms of flexibility, elasticity and aesthetics due to the persistence of the textile structure.
Un autre inconvénient du dispositif de l'art antérieur est de provoquer la formation de déchirement au sein de la feuille transparente et de la matrice de collagène, au moment de la fixation par agrafage et lors de la régénération du derme. Le déchirement de la matrice
de collagène laisse alors un trou qui va être comblé par la formation d'un tissu désignéAnother disadvantage of the device of the prior art is to cause tear formation within the transparent sheet and the collagen matrix, at the time of fixing by stapling and during the regeneration of the dermis. The tearing of the matrix of collagen then leaves a hole that will be filled by the formation of a designated tissue
"tissu de granulation", signe d'une mauvaise reconstruction de derme."granulation tissue", a sign of poor dermal reconstruction.
Un troisième inconvénient réside en ce que la feuille perméable, eu égard à sa faible épaisseur, parvient à se déchirer à proximité des points de fixation, sous l'effet des mouvements du patient. Dans cette hypothèse, le tissu sous-cutané ou le muscle n'est plus isolé de l'air ambiant, porte ouverte à un risque important de contaminationA third disadvantage is that the permeable sheet, in view of its small thickness, manages to tear near the attachment points, under the effect of the movements of the patient. In this hypothesis, the subcutaneous tissue or the muscle is no longer isolated from the ambient air, open to a significant risk of contamination.
Un quatrième inconvénient réside en ce que la nappe textile apporte une certaine rigidité au dispositif. Ce dernier peut alors ne plus s'adapter sur la plaie à traiter dans certaines régions du corps présentant un relief prononcé comme par exemple les doigts, le visage. Or, le contact entre le matériau polymérique et le lit de la plaie est indispensable à une bonne reconstruction dermique.A fourth disadvantage is that the textile web provides a certain rigidity to the device. The latter may then not adapt to the wound to be treated in certain regions of the body with a pronounced relief such as the fingers, the face. However, the contact between the polymeric material and the wound bed is essential for good dermal reconstruction.
Enfin, la transparence du film perméable peut être affectée par la présence de la nappe textile. Or, la transparence est indispensable pour le suivi des plaies et notamment la vérification de l'absence d'infection ou d'hématomes qui peuvent conduire à l'échec de la régénération dermique. La transparence permet aussi de vérifier l'avancement de la régénération du derme pour la planification de la greffe épidermique.Finally, the transparency of the permeable film can be affected by the presence of the textile web. However, transparency is essential for the follow-up of wounds and in particular the verification of the absence of infection or hematomas which can lead to the failure of the dermal regeneration. Transparency also makes it possible to check the progress of regeneration of the dermis for the planning of the epidermal graft.
Pour résoudre l'ensemble de ces problèmes, le Demandeur a développé un nouveau dispositif dans lequel la nappe textile est intégrée dans la masse de la couche transparente.To solve all these problems, the Applicant has developed a new device in which the textile web is integrated in the mass of the transparent layer.
La couche transparente ainsi renforcée permet le retrait certain, non seulement de la feuille transparente, mais également celui du matériau textile lorsque le derme est formé de manière définitive, juste avant la greffe de l'épiderme. Par ailleurs, le Demandeur a conduit des expériences montrant que la couche renforcée de cette manière, n'était pas sujet à l'élargissement des trous formés par les agrafes, interdisant ainsi tout risque de contamination ou de reconstruction non satisfaisante.The transparent layer thus reinforced allows the certain removal, not only of the transparent sheet, but also that of the textile material when the dermis is formed definitively, just before the grafting of the epidermis. Furthermore, the Applicant has conducted experiments showing that the layer reinforced in this way, was not subject to widening of the holes formed by the staples, thus preventing any risk of contamination or unsatisfactory reconstruction.
Par ailleurs, le Demandeur a constaté que la transparence de la couche renforcée avec la nappe textile était meilleure que la transparence de la couche et de la nappe textile superposées.
Le document EP 0 943 298 décrit une plaque chirurgicale composée également d'un complexe multicouches comprenant deux couches, respectivement un textile macroporeux tissé tricoté ou non tissé revêtu sur une de ses faces par un film non adhérent.Furthermore, the Applicant has found that the transparency of the layer reinforced with the textile web was better than the transparency of the superimposed layer and textile web. EP 0 943 298 discloses a surgical plate also composed of a multilayer complex comprising two layers, respectively a macroporous textile knitted or nonwoven coated on one side by a non-adherent film.
Le problème posé dans ce document concerne la difficulté à fabriquer un tel dispositif en réalisant un film de silicone très fin continu et lisse anti-adhérent appliqué sur un tissu macroporeux (paragraphe 23). Pour ce faire, le procédé employé, correspondant à celui de la figure 2 du document, consiste à tremper une feuille composite verre + téfion dans une solution de silicone. La feuille composite enduite de silicone est ensuite appliquée sur un textile poreux, l'ensemble étant ensuite cuit à une température d'environ 1500C pour permettre de polymériser le silicone. Comme mentionné dans le document, la feuille composite verre + téfion est ensuite retirée afin de laisser le film de silicone sur le textile poreux. En d'autres termes, la plaque chirurgicale décrite dans le document EP 943 298 telle qu'elle est utilisée sur le patient est constituée uniquement d'une couche textile biocompatible recouverte sur une de ses faces d'un film de silicone de faible épaisseur.The problem posed in this document concerns the difficulty of manufacturing such a device by producing a very thin continuous and smooth non-stick silicone film applied to a macroporous fabric (paragraph 23). To do this, the process used, corresponding to that of Figure 2 of the document, consists of dipping a composite glass + tefion sheet in a silicone solution. The silicone-coated composite sheet is then applied to a porous textile, the assembly then being fired at a temperature of about 150 ° C. in order to allow the silicone to be polymerized. As mentioned in the document, the glass + tefion composite sheet is then removed to leave the silicone film on the porous textile. In other words, the surgical plate described in EP 943 298 as used on the patient consists only of a biocompatible textile layer covered on one of its faces with a thin silicone film.
Le document EP 305 052 décrit un procédé de fabrication de peau artificielle, le problème reposant essentiellement sur l'association du matériau de régénération biodégradable avec le film anti-adhérent. Dans le produit final, et notamment à l'appui de la figure 1, le film de silicone couvre partiellement le polymère biodégradable synthétique. Il n'est nullement question dans ce document d'incorporer dans le complexe un élément de renfort sous forme d'une nappe textile. Le matériau fibreux dont il est question ne s'apparente pas au textile de renfort de l'invention non résorbable, mais est au contraire destiné à être colonisé par les cellules hôtes.EP 305 052 discloses a method of manufacturing artificial skin, the problem being based essentially on the combination of the biodegradable regeneration material with the release film. In the final product, and particularly in support of Figure 1, the silicone film partially covers the synthetic biodegradable polymer. There is no question in this document to incorporate in the complex a reinforcing element in the form of a textile web. The fibrous material in question is not related to the reinforcing textile of the nonabsorbable invention, but is instead intended to be colonized by the host cells.
L'invention a donc pour objet un dispositif destiné à la régénération du derme humain se présentant sous la forme d'un complexe multicouches associant une matrice interne polymérique résorbable colonisable apte à induire, par contact avec le muscle ou le tissu sous-cutané, la régénération du derme, une nappe textile ajourée non résorbable, un support externe transparent.The subject of the invention is therefore a device intended for the regeneration of the human dermis in the form of a multilayer complex associating a resizable colonizable polymeric internal matrix able to induce, by contact with the muscle or the subcutaneous tissue, the regeneration of the dermis, a non-resorbable openwork textile sheet, a transparent external support.
Ce dispositif se caractérise en ce que la nappe textile ajourée est contenue en totalité dans la masse du support transparent constituant ainsi un support transparent renforcé.
Par l'expression « nappe textile ajourée » on désigne un tissé, un tricot, un non tissé, le textile étant ajouré.This device is characterized in that the openwork textile web is contained entirely in the mass of the transparent support thus constituting a reinforced transparent support. By the expression "openwork textile web" is meant a woven, a knit, a nonwoven, the textile being openwork.
Pour favoriser la solidarisation du support transparent renforcé, par le matériau textile, avec la matrice polymérique résorbable, le dispositif comporte, entre ledit support et la matrice, une couche adhésive, avantageusement une colle silicone.To promote the joining of the reinforced transparent support, by the textile material, with the resorbable polymeric matrix, the device comprises, between said support and the matrix, an adhesive layer, advantageously a silicone adhesive.
En pratique, le matériau polymérique résorbable peut être constitué par du collagène, des polysaccharides (cellulose, alginate, agarose, chitosane), des glycosaminoglycanes (acide hyaluronique, chondroitine sulfate, héparine), des glycoprotéines (fibronectine, laminine, chondronectine), des protéines de structure (par exemple élastine, gélatine) ou des polymères synthétiques résorbables (polylactique gly coliques...), seuls ou en combinaison. D'autres composés peuvent être ajoutés au matériau polymérique résorbable tel que par exemple facteur de croissance, antiseptiques, antibiotiques. De manière connue, le matériau polymérique peut être réticulé avant d'être appliqué sur le support transparent en fonction de sa nature. En pratique, pour le collagène, l'agent réticulant est du glutaraldéhyde, formaldéhyde, du N hydroxysuccinimide, 1 Ethyl 3 dimethylaminopropyl- carbodiimide, un polysaccharide fonctionnalisé pour réagir avec le collagène. La réticulation peut être aussi réalisée par traitement physique tel que traitement thermique sous vide, irradiation.In practice, the resorbable polymeric material may consist of collagen, polysaccharides (cellulose, alginate, agarose, chitosan), glycosaminoglycans (hyaluronic acid, chondroitin sulfate, heparin), glycoproteins (fibronectin, laminin, chondronectin), proteins of structure (for example elastin, gelatin) or resorbable synthetic polymers (polylactic gly colic ...), alone or in combination. Other compounds may be added to the absorbable polymeric material such as for example growth factor, antiseptics, antibiotics. In known manner, the polymeric material may be crosslinked before being applied to the transparent support depending on its nature. In practice, for collagen, the crosslinking agent is glutaraldehyde, formaldehyde, N-hydroxysuccinimide, ethyl 3-dimethylaminopropylcarbodiimide, a polysaccharide functionalized to react with collagen. The crosslinking can also be carried out by physical treatment such as vacuum heat treatment, irradiation.
Dans le cas où le matériau est constitué de collagène, il peut s'agir de collagène natif, fibreux, d'atelocollagène ou de collagène partiellement ou totalement dénaturé.In the case where the material consists of collagen, it may be native collagen, fibrous, atelocollagen or partially or completely denatured collagen.
Dans un mode de réalisation avantageux, le matériau polymérique résorbable est exclusivement constitué par du collagène, lequel est réticulé avant association avec le support transparent renforcé.In an advantageous embodiment, the resorbable polymeric material consists exclusively of collagen, which is crosslinked before association with the reinforced transparent support.
S 'agissant de la nappe textile ajourée, celle-ci doit être suffisamment dense pour permettre un renfort efficace du support, et par conséquent éviter les risques de déchirement, au point de contact avec les agrafes, tout en n'affectant pas la transparence du support, indispensable à la visualisation de la formation du derme par le chirurgien, et sa conformabilité indispensable pour son adaptation au site à traiter.
En pratique, la densité de la nappe textile est comprise entre 0,6 et 60 g/m2, avantageusement entre 15 et 20 g/m2.With regard to the perforated textile web, it must be sufficiently dense to allow effective reinforcement of the support, and therefore avoid the risk of tearing, at the point of contact with the staples, while not affecting the transparency of the support, essential to the visualization of the formation of the dermis by the surgeon, and its conformability essential for its adaptation to the site to be treated. In practice, the density of the textile ply is between 0.6 and 60 g / m 2 , advantageously between 15 and 20 g / m 2 .
Selon une autre caractéristique le fil constitutif de la nappe a une valeur dtex comprise entre 10 et 30, avantageusement entre 20 et 25 dtex.According to another characteristic, the constituent yarn of the web has a dtex value of between 10 and 30, advantageously between 20 and 25 dtex.
Par ailleurs et selon une autre caractéristique, la nappe contient entre 3 et 100, avantageusement entre 10 et 60 fils et autant de duites au centimètre.Moreover and according to another characteristic, the web contains between 3 and 100, advantageously between 10 and 60 threads and as many picks per centimeter.
En pratique, le matériau constitutif de la nappe textile est constituée de fibres synthétiques (du polyester, du polypropylène) ou naturelles (Soie, cellulose), ou du coton, sous forme de fil mono ou multibrins.In practice, the material constituting the textile web consists of synthetic fibers (polyester, polypropylene) or natural fibers (silk, cellulose), or cotton, in the form of single or multi-strand wire.
S 'agissant du support transparent, celui-ci présente avantageusement une perméabilité à la vapeur d'eau, identique à celle de l'épiderme. En pratique, il se présente de préférence sous la forme d'un film de silicone, de polyurethane (PU), ou polyolefine (polethylène (PE), Polyéthylène téréphtalate copolysester (PETG), Polyvinyle chloride (PVC)) transparent et non résorbable le temps de la reconstruction dermique.As regards the transparent support, it advantageously has a permeability to water vapor, identical to that of the epidermis. In practice, it is preferably in the form of a film of silicone, polyurethane (PU), or polyolefin (polyethylene (PE), polyethylene terephthalate copolysester (PETG), polyvinyl chloride (PVC)) transparent and non-absorbable on time of dermal reconstruction.
Pour disposer d'un support transparent dans lequel la nappe textile soit disposée de manière régulière, c'est-à-dire que la distance entre ladite nappe et l'une ou l'autre des surfaces du support soit constante, le support transparent se présente sous la forme d'un sandwich comprenant deux films de silicone appliqués de part et d'autre de la nappe textile.To have a transparent support in which the textile web is arranged in a regular manner, that is to say that the distance between said web and one or the other of the surfaces of the support is constant, the transparent support is present in the form of a sandwich comprising two silicone films applied on either side of the textile web.
En pratique, l'épaisseur du support transparent renforcé est comprise entre 20 et 1000 μm, avantageusement comprise entre 200 et 300μm.In practice, the thickness of the reinforced transparent support is between 20 and 1000 microns, advantageously between 200 and 300 microns.
Il a par ailleurs été démontré que la régénération du derme pouvait être accélérée en mettant la plaie à traiter dans des conditions de pression négative. Plus précisément, l'application d'une pression négative permet d'extraire les exsudats de la plaie et par conséquent, de diminuer l'œdème, d'améliorer la circulation sanguine locale, de favoriser la neovascularisation et de limiter les risques d'infection. La greffe épidermique peut donc être envisagée à un délai plus court. Cet avantage est particulièrement intéressant
lors du traitement de zones mobiles comme les mains qui nécessitent une rééducation dans un délai le plus réduit possible.It has also been shown that the regeneration of the dermis could be accelerated by putting the wound to be treated under negative pressure conditions. More specifically, the application of a negative pressure makes it possible to extract the exudates from the wound and consequently, to reduce the edema, to improve the local blood circulation, to promote the neovascularization and to limit the risks of infection. . Epidermal grafting can therefore be considered at a shorter time. This advantage is particularly interesting when treating mobile areas such as hands that require rehabilitation in the shortest possible time.
Pour permettre l'extraction des exsudats et la mise sous pression négative de l'ensemble du site traité, l'ensemble support transparent - nappe textile ajourée du dispositif de l'invention est pourvu d'orifices répartis sur tout ou partie de la surface. En pratique les orifices sont calibrés et répartis de sorte à permettre une extraction des exsudats satisfaisante et une répartition homogène des pressions sur la zone traitées. De préférence, les orifices sont traversants, c'est-à-dire que les orifices présents dans le support transparent communiquent avec les orifices prévus dans le textile. S 'agissant de la partie textile, les orifices peuvent correspondre aux ajourements précédemment mentionnés ou à des orifices créés dans l'épaisseur du textile.To allow the exudates to be extracted and the entire treated site to be put under negative pressure, the transparent support assembly - perforated textile sheet of the device of the invention is provided with orifices distributed over all or part of the surface. In practice the orifices are calibrated and distributed so as to allow a satisfactory extraction of exudates and a homogeneous distribution of pressures on the treated area. Preferably, the orifices are through, that is to say that the orifices present in the transparent support communicate with the orifices provided in the textile. With regard to the textile part, the orifices may correspond to the previously mentioned openings or to orifices created in the thickness of the textile.
L'invention a également pour objet le procédé de fabrication du dispositif précédemment décrit.The invention also relates to the method of manufacturing the device described above.
Selon ce procédé : on pulvérise une couche adhésive à la surface d'un support transparent présentant dans sa masse, une nappe textile ajourée, - on applique sur la surface encollée du support transparent, la matrice résorbable polymérique, éventuellement réticulée.According to this method: an adhesive layer is sprayed on the surface of a transparent support having in its mass, a perforated textile web, - the polymeric resorbable matrix, possibly crosslinked, is applied to the bonded surface of the transparent support.
En pratique, le support transparent est formé par application de part et d'autre de la nappe textile de deux films de silicone. De manière connue de l'homme du métier, les films peuvent être solidarisés entre eux par thermo fusion ou encore pressage à chaud ou à froid, éventuellement suivi d'un traitement thermique. La présence de la nappe textile dans le support permet en outre de disposer d'une surface parfaitement plane, non déformée, apte à recevoir la couche de colle par pulvérisation.In practice, the transparent support is formed by application on both sides of the textile web of two silicone films. In a manner known to those skilled in the art, the films may be bonded together by thermofusion or hot or cold pressing, optionally followed by heat treatment. The presence of the textile web in the support also allows to have a perfectly flat surface, not deformed, adapted to receive the adhesive layer by spraying.
La matrice résorbable polymérique est obtenue à partir de collagène ou d'autres matériaux seul ou en mélange, tels que précédemment décrits.The polymeric resorbable matrix is obtained from collagen or other materials alone or as a mixture, as previously described.
Dans un mode de réalisation particulier, la matrice résorbable est constituée à 100% par du collagène.
En pratique, le collagène est réticulé et forme une structure sèche poreuse appliquée directement à la surface de la couche transparente renforcée sous la forme d'une feuille.In a particular embodiment, the resorbable matrix consists entirely of collagen. In practice, the collagen is crosslinked and forms a porous dry structure applied directly to the surface of the reinforced transparent layer in the form of a sheet.
Le dispositif ainsi réalisé est éventuellement découpé, puis conditionné avant d'être stérilisé.The device thus produced is optionally cut and then conditioned before being sterilized.
Dans le mode de réalisation dans lequel le dispositif de l'invention présente des trous, les orifices sont formés dans l'ensemble support - nappe textile avant son association avec la matrice résorbable. De la sorte, la matrice présente l'avantage de garder toute son intégrité, sans aucun défaut sur la surface en contact avec le support ou au niveau de trous. Les perforations peuvent être effectuées par toute technique connue de l'homme du métier, en particulier au laser ou mécaniquementIn the embodiment in which the device of the invention has holes, the orifices are formed in the support assembly - textile web before its association with the resorbable matrix. In this way, the matrix has the advantage of keeping all its integrity, without any defects on the surface in contact with the support or at the level of holes. The perforations can be performed by any technique known to those skilled in the art, in particular laser or mechanically
L'invention a également pour objet une méthode de régénération de derme consistant : - au préalable et si nécessaire, à exciser les parties de derme non viables ou cicatricielles,The invention also relates to a dermal regeneration method consisting of: - beforehand and if necessary, to excise the non-viable or scarred dermis parts,
- appliquer sur le tissu sous-cutané ou le muscle, le dispositif de l'invention, de sorte à ce que la matrice polymérique résorbable soit en contact avec ledit muscle ou tissu sous-cutané, - à fixer ledit dispositif sur le muscle ou tissu cutané par des moyens de fixation tels que agrafage ou suture,applying to the subcutaneous tissue or the muscle, the device of the invention, so that the resorbable polymeric matrix is in contact with the said muscle or subcutaneous tissue, to fix the said device on the muscle or tissue cutaneous by fastening means such as stapling or suturing,
- lorsque le derme est régénéré, à retirer les moyens de fixation, puis ensuite le support transparent renforcé,when the dermis is regenerated, to remove the fixing means, then the reinforced transparent support,
- à greffer l'épiderme au moyen d'une autogreffe, feuillet de keratinocytes obtenus par culture, spray de keratinocytes ou autre technique de régénération épidermique.grafting the epidermis by means of an autograft, a sheet of cultured keratinocytes, a keratinocyte spray or another epidermal regeneration technique.
En pratique, avant application du dispositif, celui-ci est hydraté.In practice, before application of the device, it is hydrated.
L'invention et les avantages qui en découlent ressortiront bien de l'exemple de réalisation ci-joint, à l'appui des figures annexées.The invention and the advantages which result therefrom will emerge from the attached exemplary embodiment, with reference to the appended figures.
La figure 1 est une représentation schématique éclatée du dispositif de l'invention.
La figure 2 est une photographie de la reconstruction dermique réalisée au moyen du dispositif de l'invention comparée à celle d'un dispositif du commerce.Figure 1 is an exploded schematic representation of the device of the invention. FIG. 2 is a photograph of the dermal reconstruction carried out by means of the device of the invention compared with that of a device of the trade.
Comme le montre la figure 1, le dispositif de l'invention comprend une première couche sous forme d'une matrice (1) polymérique résorbable constituée en pratique de 100% de collagène.As shown in FIG. 1, the device of the invention comprises a first layer in the form of a resorbable polymeric matrix (1) made in practice of 100% collagen.
Le collagène de départ est du collagène natif de derme de bovin, en particulier de veau, broyé puis transformé en gel avant d'être lyophilisé, puis réticulé au moyen de glutaraldéhyde. Le produit formé se présente sous la forme d'une feuille sèche, susceptible d'être collée directement sur le support transparent renforcé. Préférentiellement l'excès d'agent réticulant est éliminé par lavage ou réduction chimique.The starting collagen is native collagen of bovine dermis, in particular veal, milled and then transformed into gel before being lyophilized, and then cross-linked using glutaraldehyde. The product formed is in the form of a dry sheet, which can be glued directly onto the reinforced transparent support. Preferably, the excess crosslinking agent is removed by washing or chemical reduction.
Comme il apparaît sur la figure 1, le support transparent renforcé (2) comprend une nappe textile (3) constituée de fils polyester monobrins, dont la texture correspond à 36 fils et 36 duites au centimètre, tandis que la densité est de 17 g/m2.As shown in FIG. 1, the reinforced transparent support (2) comprises a textile ply (3) consisting of single-strand polyester threads, whose texture corresponds to 36 threads and 36 picks per centimeter, while the density is 17 g / cm.sup.2. m 2 .
Cette nappe textile (3) est prise en sandwich entre deux films silicone (4.1, 4.2), d'épaisseurs chacun de 100 μm environ.This textile web (3) is sandwiched between two silicone films (4.1, 4.2), each of thickness about 100 microns.
En pratique, les deux films silicone sont préalablement appliqués sur chacune des surfaces de la nappe textile pour former le support transparent renforcé. La solidarisation de l'ensemble est obtenue par pressage à froid suivi d'un traitement thermique. Sur l'une des surfaces de cette couche, on applique ensuite, par pulvérisation ou une autre technique d'enduction, une colle silicone, puis on vient appliquer la matrice de collagène préalablement préparée.In practice, the two silicone films are previously applied to each of the surfaces of the textile web to form the reinforced transparent support. The joining of the assembly is obtained by cold pressing followed by a heat treatment. On one of the surfaces of this layer is then applied, by spraying or other coating technique, a silicone adhesive, and then comes to apply the collagen matrix previously prepared.
Dans un mode de réalisation non représenté, on perfore l'ensemble support - nappe textile de plusieurs orifices avant son association avec la matrice résorbable. Ce dispositif perfectionné sera plus particulièrement utilisé pour la régénération de derme effectué sous pression négative, permettant ainsi l'extraction des exsudats de manière satisfaisante et une activation de la régénération dermique.
La figure 2 est une photographie de la reconstruction dermique (juste avant la greffe épidermique) réalisée au moyen du dispositif de l'invention (partie droite (5)) appliqué sur le dos d'un patient initialement brûlé au 3eme degré et présentant un placard cicatriciel qui a été excisé. Le produit a été appliqué directement sur le muscle et comparé au produit INTEGRA® DRT (partie gauche de l'image (6)).In a not shown embodiment, the textile web support assembly is perforated with several orifices before being associated with the resorbable matrix. This improved device will be used more particularly for the regeneration of dermis carried out under negative pressure, thus allowing the extraction of exudates satisfactorily and an activation of the dermal regeneration. FIG. 2 is a photograph of the dermal reconstruction (just before the epidermal grafting) carried out by means of the device of the invention (right part (5)) applied on the back of a patient initially burned in the 3 rd degree and presenting a scar patch that has been excised. The product was applied directly to the muscle and compared to the INTEGRA® DRT product (left side of the image (6)).
En pratique, le chirurgien, après avoir excisé le reste du derme, applique le dispositif de sorte à ce que la face munie de collagène soit en contact avec le muscle. La taille du dispositif est choisie en fonction de la taille de la brûlure. Une fois le dispositif appliqué, celui-ci est ensuite agrafé sur le tissu cutané adjacent ou sur un autre dispositif de même nature. Après formation du derme, le dispositif est retiré comme déjà dit par arrachement du seul support renforcé. On effectue ensuite une greffe dermo épidermique fine sur le derme régénéré.In practice, the surgeon, after excising the rest of the dermis, applies the device so that the face provided with collagen is in contact with the muscle. The size of the device is chosen according to the size of the burn. Once the device is applied, it is then stapled on the adjacent cutaneous tissue or on another device of the same nature. After formation of the dermis, the device is removed as already said by tearing of the only reinforced support. A thin epidermal dermo graft is then performed on the regenerated dermis.
La figure 2 représente le derme reconstruit dans le dispositif après trois semaines. Comme le montre cette photographie, le derme reconstruit dans le dispositif INTEGRA® DRT présente des bourgeonnements de tissu de granulation aux points d'agrafage (8) signe d'une mauvaise régénération dermique. Ces bourgeons sont le résultat des trous formés par les agrafes dans le produit INTEGRA DRT, trous qui se sont agrandis pendant la période de formation du néoderme.Figure 2 shows the reconstructed dermis in the device after three weeks. As shown in this photograph, the reconstructed dermis in the INTEGRA® DRT device shows granulation tissue budding at stitches (8), indicating poor dermal regeneration. These buds are the result of the holes formed by the staples in the INTEGRA DRT product, holes that expanded during the neoderm formation period.
A l'inverse le dispositif de l'invention (5) ne s'est pas déchiré au niveau des trous formés par les agrafes et ce, grâce à la présence de la nappe textile dans l'épaisseur de la couche transparente. En conséquence, le derme reconstruit dans le dispositif selon l'invention, ne présente aucun bourgeonnement de tissu de granulation au point d'agrafage (7).Conversely, the device of the invention (5) has not torn at the holes formed by the staples and this, thanks to the presence of the textile web in the thickness of the transparent layer. As a result, the reconstructed dermis in the device according to the invention does not show any granulation of granulation tissue at the point of stapling (7).
La présence de la nappe textile à l'intérieur de la couche transparente a aussi évité totalement la colonisation du textile par le néoderme, la surface du néoderme après retrait de la couche transparente est donc lisse et exempte de saignement. Le retrait de la couche transparente a pu être réalisé sans aucune excision partielle du derme néo formé.The presence of the textile web inside the transparent layer has also completely avoided the colonization of the textile by the neoderm, the surface of the neoderm after removal of the transparent layer is smooth and free of bleeding. Removal of the transparent layer could be achieved without any partial excision of the newly formed dermis.
L'invention et les avantages qui en découlent ressortent bien de la description qui précède. On note, que la bonne tenue du dispositif de l'invention pendant la formation du derme grâce à la présence de la nappe ajourée dans l'épaisseur du film transparent a permis :
" L'absence de contaminationThe invention and the advantages derived therefrom are apparent from the foregoing description. It is noted that the good behavior of the device of the invention during the formation of the dermis by virtue of the presence of the perforated sheet in the thickness of the transparent film has allowed: "The absence of contamination
" D'éviter la formation d'un tissu de granulation aux points de fixations"To avoid the formation of a granulation tissue at the attachment points
" L'absence d'excision du derme néo formé au retrait de la couche transparente et de la nappe textile " L'obtention d'une meilleure transparence
"The absence of excision of the neo-formed dermis to the removal of the transparent layer and the textile web" Obtaining a better transparency
Claims
REVENDICATIONS
1/ Dispositif destiné à la régénération du derme se présentant sous la forme d'un complexe multicouches associant une matrice polymérique résorbable apte à induire, par contact avec le muscle ou le tissu sous-cutané, la régénération du derme, une nappe textile ajourée non résorbable, un support externe transparent caractérisé en ce que la nappe textile ajourée est contenue en totalité dans la masse du support transparent.1 / Device for the regeneration of the dermis in the form of a multilayer complex associating a resorbable polymeric matrix capable of inducing, by contact with the muscle or the subcutaneous tissue, the regeneration of the dermis, a nonwoven textile web resorbable, a transparent outer support characterized in that the openwork textile web is contained entirely in the mass of the transparent support.
2/ Dispositif selon la revendication 1, caractérisé en ce que le matériau polymérique résorbable est exclusivement constitué par du collagène réticulé.2 / Apparatus according to claim 1, characterized in that the resorbable polymeric material is exclusively constituted by crosslinked collagen.
3/ Dispositif selon la revendication 1 , caractérisé en ce que la densité de la nappe textile est comprise entre 0,6 et 60 g/m2, avantageusement entre 15 et 20 g/m2.3 / Apparatus according to claim 1, characterized in that the density of the textile web is between 0.6 and 60 g / m 2 , preferably between 15 and 20 g / m 2 .
4/ Dispositif selon la revendication 1, caractérisé en ce que le fil constitutif de la nappe textile a une valeur dtex comprise entre 10 et 30, avantageusement entre 20 et 25.4 / Apparatus according to claim 1, characterized in that the constituent wire of the textile web has a dtex value between 10 and 30, preferably between 20 and 25.
5/ Dispositif selon la revendication 1 , caractérisé en ce que la nappe textile contient entre 3 et 100, avantageusement entre 10 et 60 fils et autant de duites au centimètre.5 / Apparatus according to claim 1, characterized in that the textile web contains between 3 and 100, preferably between 10 and 60 son and as many picks per centimeter.
6/ Dispositif selon la revendication 1 , caractérisé en ce que le matériau constitutif de la nappe textile est du polyester, du polypropylène, ou du coton, sous forme de fil mono ou multibrins.6 / Apparatus according to claim 1, characterized in that the constituent material of the textile web is polyester, polypropylene, or cotton, in the form of single or multi-strand wire.
11 Dispositif selon la revendication 1, caractérisé en ce que le support transparent se présente sous la forme d'un sandwich comprenant deux films de silicone appliqués de part et d'autre de la nappe textile.11 Apparatus according to claim 1, characterized in that the transparent support is in the form of a sandwich comprising two silicone films applied on either side of the textile web.
8/ Dispositif selon la revendication 7, caractérisé en ce que l'épaisseur du support transparent est comprise entre 20 et 1000 μm, avantageusement entre 200 et 300 μm.8 / Apparatus according to claim 7, characterized in that the thickness of the transparent support is between 20 and 1000 microns, preferably between 200 and 300 microns.
9/ Dispositif selon la revendication 1 , caractérisé en ce que le dispositif comporte, entre le support transparent et la matrice polymérique, une couche adhésive.
10/ Dispositif selon la revendication 1, caractérisé en ce que l'ensemble support transparent - nappe textile ajourée est pourvu d'orifices traversants répartis sur toute ou partie de la surface.9 / Apparatus according to claim 1, characterized in that the device comprises, between the transparent support and the polymeric matrix, an adhesive layer. 10 / Apparatus according to claim 1, characterized in that the transparent support assembly - perforated textile web is provided with through holes distributed over all or part of the surface.
11/ Procédé de fabrication du dispositif objet de l'une des revendications 1 à 10, caractérisé en ce que :11 / A method of manufacturing the device according to one of claims 1 to 10, characterized in that:
- on applique une couche adhésive à la surface d'un support transparent renforcé présentant dans sa masse, une nappe textile ajourée, on applique sur la surface collante, la matrice résorbable polymérique.- An adhesive layer is applied to the surface of a reinforced transparent support having in its mass, a perforated textile web is applied to the adhesive surface, the polymeric resorbable matrix.
12/ Procédé selon la revendication 11, caractérisé en ce que le support transparent renforcé est formé par application de part et d'autre de la nappe textile de deux films de silicone.12 / A method according to claim 11, characterized in that the reinforced transparent support is formed by application on both sides of the textile web of two silicone films.
13/ Procédé selon la revendication 11, caractérisé en ce que l'ensemble support transparent - nappe textile ajourée est perforé sur tout ou partie de sa surface, préalablement à l'application sur la matrice polymérique.
13 / A method according to claim 11, characterized in that the transparent support assembly - perforated textile web is perforated on all or part of its surface, prior to application to the polymeric matrix.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07858682A EP2083751A1 (en) | 2006-11-10 | 2007-11-12 | Device for regenerating human skin and method for manufacturing said device |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0654824A FR2908289B1 (en) | 2006-11-10 | 2006-11-10 | DEVICE FOR REGENERATING THE DERME AND METHOD FOR MANUFACTURING THE SAME. |
FR0654824 | 2006-11-10 | ||
FR0753125 | 2007-02-08 | ||
FR0753125A FR2908290B3 (en) | 2006-11-10 | 2007-02-08 | DEVICE FOR REGENERATING HUMAN DERMA AND METHOD OF MANUFACTURING THE SAME |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2008056090A1 true WO2008056090A1 (en) | 2008-05-15 |
Family
ID=39176260
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/FR2007/052323 WO2008056090A1 (en) | 2006-11-10 | 2007-11-12 | Device for regenerating human skin and method for manufacturing said device |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP2083751A1 (en) |
FR (1) | FR2908290B3 (en) |
WO (1) | WO2008056090A1 (en) |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4060081A (en) * | 1975-07-15 | 1977-11-29 | Massachusetts Institute Of Technology | Multilayer membrane useful as synthetic skin |
EP0305052A1 (en) * | 1987-07-30 | 1989-03-01 | Dow Corning Kabushiki Kaisha | Artificial skin and method for its production |
WO1997024089A1 (en) * | 1995-12-27 | 1997-07-10 | Carnaby Ann J | Artificial skin construction |
EP0943298A2 (en) * | 1998-03-20 | 1999-09-22 | Cousin Biotech (S.A.S.) | Surgical patch |
WO2004006808A2 (en) * | 2002-07-17 | 2004-01-22 | Proxy Biomedical Limited | Soft tissue implants and methods for making same |
-
2007
- 2007-02-08 FR FR0753125A patent/FR2908290B3/en not_active Expired - Lifetime
- 2007-11-12 WO PCT/FR2007/052323 patent/WO2008056090A1/en active Application Filing
- 2007-11-12 EP EP07858682A patent/EP2083751A1/en not_active Withdrawn
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4060081A (en) * | 1975-07-15 | 1977-11-29 | Massachusetts Institute Of Technology | Multilayer membrane useful as synthetic skin |
EP0305052A1 (en) * | 1987-07-30 | 1989-03-01 | Dow Corning Kabushiki Kaisha | Artificial skin and method for its production |
WO1997024089A1 (en) * | 1995-12-27 | 1997-07-10 | Carnaby Ann J | Artificial skin construction |
EP0943298A2 (en) * | 1998-03-20 | 1999-09-22 | Cousin Biotech (S.A.S.) | Surgical patch |
WO2004006808A2 (en) * | 2002-07-17 | 2004-01-22 | Proxy Biomedical Limited | Soft tissue implants and methods for making same |
Also Published As
Publication number | Publication date |
---|---|
FR2908290A1 (en) | 2008-05-16 |
EP2083751A1 (en) | 2009-08-05 |
FR2908290B3 (en) | 2009-01-09 |
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