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    • 专利摘要:
    The present invention relates to a new composition based on triblock copolymers of the ABA type, comprising two styrene thermoplastic end blocks and a central elastomer block B which is a saturated olefin, comprising at least one resin chosen from aromatic resins which can be used in particular for the realization of an interface dressing with armature or support or self-supporting, preferably self-supporting. The present invention relates to a self-supporting interface dressing which has a facilitated handling because it has a good tear resistance.
    公开号:FR3068975A1
    申请号:FR1756589
    申请日:2017-07-12
    公开日:2019-01-18
    发明作者:Nadege Meyer
    申请人:Urgo Recherche Innovation et Developpement；
    IPC主号:
    专利说明:

    COMPOSITION FOR INTERFACE DRESSING
    ABSTRACT
    The present invention relates to a new composition based on triblock copolymers of the ABA type, comprising two thermoplastic end blocks A styrene and an elastomer central block B which is a saturated olefin, and at least one resin chosen from aromatic resins, usable in particular for the production of an interface dressing comprising a frame or a support, or a self-supporting, preferably self-supporting, interface dressing.
    The present invention also relates to a self-supporting interface dressing which has easier handling because it has good tear resistance.
    STATE OF THE PRIOR ART
    It has been known for a long time for wounds to be treated with dressings designated by the term “interface dressings”, intended to be brought into contact with the wound by providing an interface between the wound and an absorbent pad which is deposited on the dressing to absorb the exudates.
    The URGOTUL® dressing marketed since 2000 by the company Laboratoires URGO is an illustrative example of an interface dressing. The URGOTUL® product consists of a frame made of an open mesh fabric, the threads of which are coated with a cohesive gel, so as to leave the meshes essentially non-closed. This gel is formed from a composition consisting of an elastomeric matrix based on triblock copolymers of the ABA (styrene-saturated olefin-styrene) type, highly plasticized and containing in dispersion a small amount of hydrophilic particles of a hydrocolloid. This dressing and its composition are described in Example 1 of patent application WO 00/16725. The qualitative and quantitative composition of the elastomeric matrix of this dressing gives it remarkable properties with regard to promoting the healing process and in particular the proliferation of fibroblasts.
    The URGOTUL® product nevertheless has the drawback, in cases where it is desired to apply it to wounds which are difficult to recover, for example because of their location, of lacking conformability, because of the rigidity of its frame.
    To solve this problem, self-supporting interface dressings (without reinforcement) have been described in patent application FR 2 936 158. The products described in this application have both good elasticity and sufficient cohesion to be able to be handled. However, the self-supporting interface dressings described in this document use different constituents of triblock polymers of the ABA type used in the URGOTUL® dressing so that the healing and proliferation properties of fibroblasts are not preserved.
    In addition, in a logic of economic profitability, it would be desirable for the applicant to be able to manufacture a self-supporting interface dressing from compounds of the same nature, or even identical, to those used for the manufacture of the URGOTUL® dressing and its variations, than it already produces.
    In addition to the economic aspect, this would also present a non-negligible advantage in the case where it is wished to incorporate into the composition of the self-supporting interface dressing active compounds, that is to say, compounds which have an action on the process. wound healing or treatment of the wound, such as for example antibacterials, such as silver salts, or inhibitors of MMP (Matrix metalloproteases) such as potassium salt of sucrose octasulfate. Indeed, the incorporation of active ingredients in this type of composition is always delicate and complex, each compound of the composition being able to interact with the others, to modify the rheological and physico-chemical properties of the composition, or else to affect the stability or the solubility of assets.
    By using compounds of the same nature as those already used for the manufacture of the URGOTUL® dressing, the chances of developing new compositions having the desired advantages are therefore optimized.
    Finally, the use of compounds of the same nature or even identical to those used for the manufacture of the URGOTUL® dressing would make it possible to preserve the remarkable properties of the URGOTUL® product on the proliferation of fibroblasts and on the healing process.
    It would therefore be desirable to have an interface dressing composition made up of compounds of the same nature or identical to those used in the URGOTUL® product, making it possible to prepare interface dressings having good conformability and good tear resistance, even without reinforcement. .
    SUMMARY OF THE INVENTION
    Thus, the present invention has made it possible to develop a specific composition based on triblock copolymers of the ABA type, comprising two thermoplastic end blocks A styrene and a central elastomer block B which is a saturated olefin, allowing the preparation of an elastomeric matrix likely to be implemented in a dressing, which, preferably, is self-supporting, said matrix having a very good resistance to tearing.
    More specifically, it has been discovered, and this constitutes the basis of the present invention, that compositions comprising at least two specific triblock copolymers (elastomers) of the styrene - saturated olefin - styrene type, and at least one aromatic resin present within the composition in a predetermined weight quantity, make it possible to make dressings which have improved mechanical properties. Indeed, the dressings obtained with the elastomeric matrices of the invention are easy to handle, and the risk of tearing at the time of application or at the time of removal of the dressing by the nursing staff is reduced. Once applied, the dressings obtained with these elastomeric matrices have improved conformability, contact with the wound bed is therefore encouraged. Because of its improved elasticity, the dressing better follows the patient's movements, and the strengthening of its mechanical properties makes it possible to prevent the dressing from disintegrating in the wound, even after contact with the exudates of the wound over a prolonged period .
    The addition of specific resins reduces the viscosity of the elastomeric mixture and mechanically reinforces the elastomeric matrix. This is particularly advantageous in the process for manufacturing the elastomeric matrix. The composition, due to its reduced viscosity, can be coated more easily on a frame. In the case of a self-supporting dressing, improving the cohesion of the elastomeric matrix allows better molding and demolding of the latter. In addition, because of the specific resins used, the manufacturing temperature of the composition can be reduced by approximately 10 ° C., which makes it possible to introduce into the mixture components sensitive to thermal treatments, such as active agents for example. According to a preferred embodiment, the dressing according to the invention does not adhere to surgical latex gloves.
    Thus according to a first aspect, the subject of the present invention is a composition, in particular useful for the manufacture of dressings, comprising:
    - 5 to 20% of a mixture of 2 triblock copolymers of the styrene - saturated olefin - styrene type, the first having a viscosity of between 0.01 and 1 Pa.s as measured in a 5% solution (mass / mass) in toluene and a second which has a viscosity between 0.01 and 0.5 Pa.s measured in a 15% solution (mass / mass) in toluene
    - 50 to 80% by weight of at least one plasticizer,
    - 5 to 20% of at least one alpha-methyl styrene type resin whose softening point is between 80 and 125 ° C, preferably between 90 and 110 ° C, it being understood that:
    when the content of triblock copolymers is between 5 and 10% by weight, the resin content is between 15 and 20% by weight, relative to the total weight of the composition and
    - When the content of triblock copolymers is greater than 10% by weight, the resin content is between 5 and 20% by weight, based on the total weight of the composition, the percentages being based on the total weight of the composition.
    According to a second aspect, the present invention relates to an elastomeric matrix obtained from such a composition and an interface dressing, with support or self-supporting comprising said elastomeric matrix.
    DETAILED DESCRIPTION
    elastomer
    The composition according to the invention comprises a mixture of 2 triblock copolymers of the ABA type.
    In particular, this mixture of two copolymers will comprise at least one copolymer which has a viscosity between 0.01 and 1 Pa.s measured in a 5% w / w solution in toluene and at least one copolymer having a viscosity between 0.01 and 0.5 Pa.s measured in a 15% solution (mass / mass) in toluene.
    The block copolymers used in the context of the invention are triblock copolymers of the ABA type comprising two thermoplastic end blocks A styrene and a central elastomer block B which is a saturated olefin. The B sequences of saturated olefins are, for example, ethylene-butylene, ethylene-propylene or ethylene-ethylene-propylene sequences.
    For the sake of simplicity, in the present description, the polymer blocks constituting the abovementioned copolymers are designated by the nature of their recurring units. Thus, the expression "block" or "styrene block A" denotes a poly (styrene) block and the expression "block" or "saturated olefin block" denotes a poly (saturated olefin block).
    Triblock copolymers with a saturated central block are well known to those skilled in the art and are for example marketed:
    - by the company KRATON under the name KRATON® G, and in particular the grades KRATON® G1651, KRATON® G1654, KRATON® G 1657, KRATON® G1652 or KRATON® G1650 and by the company KURARAY under the names SEPTON® and in particular grades 8006 or 8004 for poly (styrene-ethylene-butylene-styrene) block copolymers (abbreviated SEBS);
    -by the company KURARAY under the name SEPTON® for poly (styrene-ethylene-propylene-styrene) block copolymers (abbreviated SEPS) and in particular the grades 2005,2006 or 2063 and for poly (styrene-ethylene- ethylene-propylene-styrene) (abbreviated as SEEPS) and in particular grades 4033,4044, 4055, 4077 or 4099.
    In the context of the present invention, the triblock copolymers SEBS, SEPS or SEEPS having a styrene content of between 25 and 45% by weight relative to the weight of said SEBS, SEPS or SEEPS copolymer are preferred.
    Among the copolymers which have a viscosity of between 0.01 and 1 Pa.s measured in a 5% solution (mass / mass) in toluene, mention may be made of the copolymers marketed by the company Kraton under the grades Kraton® G 1651 and KRATON® G 1654 and the copolymers marketed by the company KURARAY under the grades SEPTON® 2005, 2006, 8006, 4055, 4077, 4044 or 4099.
    Among the copolymers which have a viscosity of between 0.01 and 0.5 Pa.s measured in a 15% solution (mass / mass) in toluene, mention may be made of the copolymers marketed by the company Kraton under the grades Kraton® G 1650, KRATON® G 1657 and KRATON® G 1652 and the copolymers marketed by the company KURARAY under the grades SEPTON® 2063 or 4033.
    These viscosities are measured at 30 ° C. using a Brookfield model LVI viscometer in a solution in toluene at 5% or 15% w / w depending on the molecular weight of the copolymer.
    Generally, the amount of copolymers in the final composition may be between 5 and 20% by weight, preferably between 7 and 15% by weight, based on the total weight of the composition.
    In the context of the present invention, the use of two SEBS block copolymers is particularly preferred, and in particular the combination of the KRATON® G 1654 and KRATON® G 1650 copolymers in which the KRATON® G 1654 is present in an amount of 5 to 10% by weight, based on the total weight of the composition and the KRATON® G 1650 is present in an amount of 2 to 5% by weight, based on the total weight of the composition.
    Preferably, this mixture of two copolymers will therefore comprise at least 5 to 10% by weight of a copolymer which has a viscosity of between 0.01 and 1 Pa.s measured in a solution at 5% mass / mass in toluene and at least 2 to 5% of a copolymer having a viscosity of between 0.01 and 0.5 Pa.s measured in a 15% solution (mass / mass) in toluene, relative to the total weight of the composition.
    Resins
    The resins used in the composition according to the invention are aromatic hydrocarbon resins, that is to say based on aromatic monomers only. They are distinguished from aliphatic resins, based on aliphatic monomers only, or aliphatic / aromatic resins based on aliphatic and aromatic monomers. Without wishing to be bound by any theory, it seems that these resins have good solubility in block A of ABA copolymers and reinforce this styrene block, which improves the cohesion of the final elastomeric matrix obtained.
    In particular, the aromatic monomer is alpha-methyl styrene. Thus, according to a particularly preferred embodiment, the aromatic hydrocarbon resin is chosen from resins of homopolymers and copolymers of alpha-methyl-styrene.
    Among the aromatic resins tested, a number of them were not entirely satisfactory. Indeed, certain grades of resin, because of their high softening point, require to be heated to high temperatures (above 140 ° C.) to produce the composition of the invention. By working at such temperatures, there is a risk of evaporation of the plasticizer. When hydrocolloids (such as carboxymethylcellulose) or active ingredients are added to the composition, they risk being degraded.
    Thus, the resins used in the compositions according to the invention are resins of the alpha-methyl styrene type, the softening point of which is between 80 and 125 ° C, preferably between 90 and 110 ° C.
    These resins give the best results in terms of manufacturing process, breaking strength and elongation at break. The addition of such resins makes it possible to reduce the viscosity of the mixture and to mechanically reinforce the composition, thus facilitating its transformation into a polymer matrix resistant to tearing.
    The softening point is measured according to ISO 4625 (Ring and Bail method).
    Preferably, the resin according to the invention is an alpha-methyl styrene resin having a softening point located between 95 and 105 ° C or between 115 and 125 ° C or a poly (styrene-co-alpha-methyl styrene) resin having a softening point between 95 ° C and 115 ° C.
    The above preferred resins are well known to those skilled in the art and are available commercially, for example sold under the following trade names:
    - Sylvares SA 100 and Sylvares SA 120 of Arizona Chemical: alpha-methyl styrene resins having a softening point between 95 and 105 ° C or between 115 and 125 ° C respectively,
    - Cleartack W90 or Norsolene W90 resin from Cray Valley: poly resin (styrene-co-alpha-methylstyrene) with a softening point between 85 and 95 ° C,
    - Kristalex 3100LV, Kristalex F100, Kristalex 3105 SD and Kristalex Fl 15 resins from Eastman: poly (styrene-co-alpha-methylstyrene) resins with a softening point of 100 ° C, or between 96 and 104 ° C or 105 ° C, or between 114 and 120 ° C respectively.
    In the context of the present invention, the resin is preferably present in an amount of 5 to 20%, preferably 5 to 15% by weight, based on the total weight of the composition.
    In the context of the present invention:
    when the content of triblock copolymers is between 5 and 10% by weight, the resin content is between 15 and 20% by weight, relative to the total weight of the composition and
    - When the content of triblock copolymers is greater than 10% by weight, the resin content is between 5 and 20% by weight, based on the total weight of the composition, the percentages being based on the total weight of the composition.
    In the context of the present invention, the content of triblock copolymers and of resin represents 16 to 40% by weight, preferably from 20 to 35% by weight, relative to the total weight of the composition.
    The plasticizer
    In order to produce interface dressings, the mixture of copolymers and the resin present in the composition according to the invention are combined with one (or more) plasticizer compound (s).
    The plasticizers which can be used are well known and intended to improve the stretching, flexibility, extrudability or processing properties of the copolymers. One or more plasticizers can be used for this purpose if necessary.
    In general, as plasticizers, liquid compounds are preferred which are compatible with the saturated olefin central block of the abovementioned block copolymers.
    Among the plasticizing compounds which may be used for this purpose, particular mention will be made of plasticizing mineral oils.
    Alternatively, one can also use synthetic products based on liquid mixtures of saturated hydrocarbons such as for example the products sold by the company TOTAL under the name GEMSEAL® and in particular the product GEMSEAL® 60 which is an isoparaffinic mixture derived from a fully hydrogenated petroleum cut.
    In the context of the present invention, use will preferably be made of plasticizing oils and in particular mineral oils formed from paraffinic or naphthenic compounds, or mixtures thereof, in variable proportions.
    Particularly preferred plasticizing mineral oils are formed from mixtures of compounds of paraffinic and naphthenic nature, and in particular of such mixtures in which the proportion of compounds of paraffinic nature is predominant.
    Among the plasticizing oils which are particularly suitable, mention may be made of the products sold by the company SHELL under the names ONDINA® and in particular ONDINA® 919 or the oil sold by the company PETRO CANADA under the reference PURETOL® 9D or the oil BLANDOL sold by Sonneborn or the Pionier 2076P oil sold by Hansen & Rosenthal.
    In addition to oils, the plasticizer may include petroleum jelly. The petrolatum used in the compositions of the invention is a petrolatum conforming to the French Pharmacopoeia available commercially.
    In the context of the present invention, petrolatum is present in an amount of 1 to 30%, preferably 5 to 25% by weight, based on the total weight of the composition.
    In the context of the present invention, the plasticizer is present in an amount of 50 to 80%, preferably 60 to 70% by weight, based on the total weight of the composition.
    Preferably, the plasticizer consists of a mixture of mineral oil and petroleum jelly, the mineral oil being present in an amount ranging from 45 to 60% by weight relative to the total weight of the composition, the petroleum jelly being present in a amount ranging from 5 to 20% by weight relative to the total weight of the composition.
    Based on the tests described in the examples of the present application, an elastomeric weft having a breaking strength of 1.5 to 2.5 N / cm and an elongation at break of 640% to 900%, preferably 700 % to 900% will have the best mechanical properties. Compared with an identical formulation without resin, the breaking strength is improved by at least 40%.
    To obtain this result, it has been determined that the composition according to the invention preferably comprises:
    -5 to 20% by weight of a mixture of two copolymers comprising at least one copolymer which has a viscosity of between 0.01 and 1 Pa.s measured in a solution at 5% mass / mass in toluene and at least one copolymer having a viscosity between 0.01 and 0.5 Pa.s measured in a 15% solution (mass / mass) in toluene.
    -50 to 80% by weight of a mixture of oil and petrolatum,
    -5 to 20% by weight of a resin chosen from alpha-methyl styrene resins having a softening point between 95 and 105 ° C or between 115 and 125 ° C or a poly (styrene-co-alpha-methyl resin) styrene) with a softening point between 95 ° C and 115 ° C.
    These compositions are also useful for the preparation of dressings with or without reinforcement.
    Hydrocolloids
    According to an embodiment of the invention which is particularly preferred in the context of the production of self-supporting interface dressings, with support or with reinforcement for wound healing, the compositions according to the invention comprise hydrophilic particles of a hydrocolloid (or particles hydrocolloid).
    These particles allow the painless removal of an interface dressing and the maintenance of a moist environment at the level of the wound in order to promote healing.
    For this purpose, a small amount of hydrophilic particles of a hydrocolloid is thus either placed on the surface of the elastomeric matrix once it has formed or, preferably, dispersed homogeneously within the composition according to the invention.
    The term “hydrocolloid” or “hydrocolloid particles” is intended to denote here any compound usually used by those skilled in the art for its ability to absorb aqueous liquids such as water, physiological saline or exudates from a wound.
    As suitable hydrocolloids, mention may be made, for example, of pectin, alginates, natural vegetable gums such as in particular Karaya gum, cellulose derivatives such as carboxymethylcelluloses and their alkali metal salts such as sodium or calcium, as well than synthetic polymers based on acrylic acid salts, known under the name superabsorbents, such as for example the products sold by the company CIBA Specialty Chemicals under the name SALCARE® SC91 as well as mixtures of these compounds.
    Some of these superabsorbents qualified as “microcolloids” because they have a particle size of less than 10 micrometers can of course also be used.
    The hydrocolloids preferred in the context of the present invention are the alkali metal salts of carboxymethylcellulose, and in particular sodium carboxymethylcellulose (CMC).
    The size of the hydrocolloid particles is generally between 50 and 100 microns, advantageously of the order of 80 microns.
    In general, the quantity of hydrocolloid particles incorporated in the composition according to the invention will advantageously be less than or equal to 25% by weight, advantageously of the order of 2 to 20% by weight, preferably 5 to 18% by weight, more preferably from 10 to 15% by weight, based on the total weight of said composition.
    If the hydrocolloid particles are placed on the surface of the elastomeric matrix once it has formed, their quantity will preferably be of the order of 1 to 10% and more particularly of 2 to 5% by weight, based on the total weight of said elastomeric matrix.
    The choice of a quantity of hydrocolloid particles included in these ranges of values is important for the production of an interface dressing, and in particular a ventilated, self-supporting interface dressing, in order to prevent the gelation of the composition from causing closing the through holes when absorbing exudates.
    Antioxidants
    The composition according to the invention can also comprise antioxidant agents.
    The term “antioxidant agents” is intended to denote here the compounds commonly used by those skilled in the art to ensure the stability of the compounds used in the formulation of the compositions, in particular with respect to oxygen, heat, ozone or ultraviolet radiation.
    As examples of suitable antioxidant agents, mention may in particular be made of phenolic antioxidants such as in particular the products sold by the company BASF under the names IRGANOX® 1010, IRGANOX® 565, IRGANOX® 1076.
    In general, these antioxidant agents can be used alone or in combination in an amount of the order of 0.05 to 1% by weight, preferably from 0.05 to 0.2% by weight, based on the total weight. of the composition.
    In the context of the present invention, the use of the product IRGANOX® 1010 is preferred in an amount of between 0.05 and 0.2% by weight, relative to the total weight of the composition.
    Additional assets
    In addition to the antioxidant agents, the composition according to the invention may comprise one (or more) other active substance (s) making it possible to induce or accelerate healing or which may have a favorable role in the treatment of 'a wound.
    Among these active substances, there may be mentioned, in particular, as examples:
    - healing agents such as retinol, vitamin A, vitamin E, N-Acetyl Hydroxyproline, Centella Asiatica extracts, papain, silicone, essential oils of thyme, niaouli, rosemary, sage, l hyaluronic acid, sucrose potassium octasulfate, sucralfate, allantoin, metformin
    - antibacterial agents such as silver salts or complexes (such as silver sulphates, silver nitrates, silver sulphonamides or even silver-based zeolites), zinc or copper salts , metronidazole, neomycin, penicillins, clavulanic acid, tetracyclines, mynocycline, chlorotetracycline, aminoglycosides, amikacin, gentamicin, probiotics;
    - antiseptics such as chlorhexidine, trichlosan, biguanide, hexamidine, thymol, lugol, povidone iodine, benzalkonium and benzethonium chloride;
    - painkillers such as paracetamol, codeine, dextropropoxyphene, tramadol, morphine and its derivatives, corticoids and their derivatives;
    - local anesthetics such as lidocaine, benzocaine, dibucaine, pramoxine hydrochloride, bupivacaine, mepivacaine, prilocaine, etidocaine;
    - anti-inflammatory drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or acetylsalicylic acid, ibuprofen, ketoprofen, flurbiprofen, diclofenac, aceclophenac, ketorolac, meloxicam, piroxicam, tenoxicam, naproxen, indomethacin, naproxcinod, nimesulid, celecoxib, etoricoxib, parecoxib, rofecoxib, valdecoxib, phenylbutazone, niflumic acid, mefenamic acid;
    These active agents may be used in an amount of the order of 0.01 to 20% by weight, preferably from 1 to 15% by weight, and more preferably from 2 to 10% by weight, based on the total weight of the composition.
    The presence of hydrocolloids within the composition will promote the release of these active agents.
    Of course, the composition according to the invention can also comprise one or more other compounds known for their action in the detersion phase, for example:
    - enzymes;
    - urea.
    admixtures
    As adjuvants which may be used in the compositions according to the invention, mention may be made of compounds known to promote the release of active agents, such as for example the products Montanox® 80 or Sepinov® EMT 10 which are commonly used in URGOTUL® products which incorporate active agents.
    These adjuvants may be used in an amount of the order of 1 to 15% by weight, based on the total weight of the composition.
    Obviously, the particular embodiments which have just been described can be implemented separately or according to any one of their combinations.
    The compositions according to the invention make it possible in particular to produce self-supporting interface dressings or interface dressings having a frame or a support.
    In the context of the production of an interface dressing, it is preferable to use a composition which comprises compounds (copolymers, mineral oil, petrolatum, antioxidant and hydrocolloids) of the same nature as, or identical to, those used in the URGOTUL® product.
    Elastomeric matrix
    In order to make a dressing, the compositions according to the invention will be formed in a thin layer, with through holes, preferably arranged in a distributed manner in said layer to form an elastomeric matrix.
    Another subject of the invention is therefore, according to another aspect, an elastomeric matrix obtained from a composition according to the invention as described above.
    The through holes can be made by punching or punching a composition according to the invention previously formed in a thin layer, alone or associated with a temporary support or with a protective film usually used for the manufacture of a dressing, or even by coating. screened on a temporary support.
    Alternatively, the polymeric matrices in accordance with the invention can be produced by hot casting of a composition as described above on a plate engraved with the pattern selected to form through holes, followed by cooling and demolding.
    In general, the polymer matrices according to the invention will have a thickness of between 0.4 mm and 2 mm, preferably between 0.5 mm and 1 mm, more preferably of the order of 0.6 to 0.7 mm.
    The through holes can be of any geometry and will for example have a circular, rectangular, trapezoidal or square cross section.
    Their surface will generally be between 1 and 7 mm 2 .
    These holes will be distributed, preferably regularly, with a density such that the total surface of the holes represents between 20 and 70%, and preferably between 30 and 60% of the total surface of the dressing.
    According to a preferred embodiment, the polymer matrix, when it is implemented in an interface dressing, preferably self-supporting, is in the form of an aerated net (or grid) preferably of square mesh having:
    - a thickness of the net between 0.4 and 2 mm;
    - a "wire width" (width of the space between two consecutive holes) between 1 and 10 mm, and preferably between 1 and 5 mm;
    - a grammage between 200 and 1700 g / m 2 , and preferably between 300 and 800 g / m 2 .
    According to a particularly preferred embodiment of the invention, such an elastomeric matrix will be in the form of an aerated square mesh net having:
    - a thickness of the net of approximately 750 microns;
    - a wire width (or mesh size) of the order of 0.8 mm;
    - a grammage of the order of 390 g / m 2 .
    For the production of such elastomeric matrices, reference may be made to patent application FR 2 936 158 for more details.
    It can also be envisaged to use this elastomeric matrix to coat a frame or a support.
    The techniques for manufacturing an interface dressing with reinforcement or with support are also well known to those skilled in the art and reference may for example be made to the methods described in patent applications WO 00 16725 and FR 2 936 159 or WO 2015/018720.
    Pad
    The subject of the invention is therefore, according to a preferred embodiment, an interface dressing characterized in that it comprises an elastomeric matrix previously described.
    According to a currently preferred embodiment, the present application aims to cover a self-supporting interface dressing comprising an elastomeric matrix in the form of a thin layer having through holes to allow the exudates to pass, obtained from a composition comprising :
    - 5 to 20% of a mixture of 2 triblock copolymers of the styrene - saturated olefin - styrene type, the first having a viscosity of between 0.01 and 1 Pa.s as measured in a 5% solution (mass / mass) in toluene and a second which has a viscosity between 0.01 and 0.5 Pa.s measured in a 15% solution (mass / mass) in toluene
    - 50 to 80% by weight of at least one plasticizer,
    - 5 to 20% of at least one alpha-methyl styrene type resin whose softening point is between 80 and 125 ° C, preferably between 90 and 110 ° C, it being understood that:
    when the content of triblock copolymers is between 5 and 10% by weight, the resin content is between 15 and 20% by weight, relative to the total weight of the composition and
    - When the content of triblock copolymers is greater than 10% by weight, the resin content is between 5 and 20% by weight, based on the total weight of the composition, the percentages being based on the total weight of the composition.
    Preferably, the interface dressing according to the present invention does not adhere to latex gloves. To do this, the composition may preferably comprise:
    - per 100 parts by weight of a mixture P of 2 specific triblock copolymers of the styrene - saturated olefin - styrene type, the first having a viscosity of between 0.01 and 1 Pa.s as measured in a 5% solution (mass / mass) in toluene and a second which has a viscosity between 0.01 and 0.5 Pa.s as measured in a 15% solution (mass / mass) in toluene;
    - from 300 to 1000 parts by weight of a plasticizer H, preferably a plasticizer oil; and
    - from 90 to 600 parts by weight of vaseline V;
    being further specified that:
    - The total amount, represented by P + H + V, of mixture of elastomers, plasticizer and petrolatum is between 490 and 1700 parts by weight;
    - The ratio between the total amount of the mixture of elastomers, the plasticizer and petroleum jelly and the quantity of petroleum jelly, represented by P + H + V / V, is less than it;
    said mixture of 2 copolymers comprises at least 20% by weight of the first copolymer, the composition further comprising from 5 to 20% by weight of an alpha-methyl styrene type resin whose softening point is between 80 and 125 ° C, preferably between 90 and 110 ° C, it being understood that:
    when the content of triblock copolymers is between 5 and 10% by weight, the resin content is between 15 and 20% by weight, relative to the total weight of the composition and
    - When the content of triblock copolymers is greater than 10% by weight, the resin content is between 5 and 20% by weight, based on the total weight of the composition, the percentages being based on the total weight of the composition.
    In order to protect the composition from the external environment, the interface dressing may be covered, preferably on each of its faces, by a temporary protective film which will be removed before use by the user.
    In order to further facilitate the handling of the interface dressing, in particular if it is self-supporting, these two temporary protective films may be replaced by a single protector as described in patent application WO 2008/145 884 or in patent application W02015 / 018720 whose particular structure facilitates the application of the dressing to the wound.
    The present invention is illustrated in the nonlimiting examples presented below.
    EXAMPLES
    Preparation of the compositions
    The compositions of Examples 1 to 26 were prepared using the following constituents in the proportions, expressed as a percentage by weight, mentioned in Table 1 below.
    Elastomer: block copolymer of poly (styrene-ethylene-butylenestyrene) (abbreviated SEBS):
    - KRATON® G 1654 ES viscosity at 5% (mass / mass) in toluene: 0.02Pa.s
    - KRATON® G 1650 E viscosity at 15% (mass / mass) in toluene: 0.2 Pa.s
    Plasticizer: Ondina® 919 mineral oil sold by the company SHELL or Pionier 2076P sold by Hansen & Rosenthal
    Vaseline: Codex® A vaseline sold by the company AIGLON
    Antioxidant: IRGANOX® 1010 sold by the company BASF
    Hydrocolloid: Carboxymethylcellulose sodium CMC BLANOSE®
    7H4XF marketed by ASHLAND,
    Resins:
    - Wingtack 86, C9 modified C5 hydrocarbon resin, with a softening point between 84-90 ° C, marketed by Cray Valley,
    - Norsolene W90 or Cleartack W90, poly (styrene-co-alpha-methyl styrene) resin having a softening point between 85-95 ° C, sold by Cray Valley,
    - Norsolene W140, poly (styrene-co-alpha-methyl styrene) resin having a softening point between 135-145 ° C, sold by Cray Valley,
    - Escorez 5380, cycloaliphatic hydrocarbon resin, with a softening point between 80-90 ° C, sold by Exxon Mobil,
    - YS Resin SX 100, polystyrene resin, having a softening point located at 100 ° C, marketed by YASUHARA CHEMICAL,
    - Sylvares SA 100, alpha-methyl styrene resin with a softening point between 95 and 105 ° C, sold by Arizona Chemical
    - Sylvares SA 120 alpha-methyl styrene having a softening point between 115 and 125 ° C, marketed by Arizona Chemical
    - Kristalex 3100LV, poly (styrene-co-alpha-methyl styrene) resin having a softening point of 100 ° C., marketed by Eastman,
    - Kristalex F100 poly (styrene-co-alpha-methyl styrene) having a softening point between 96 and 104 ° C, marketed by Eastman,
    - Kristalex Fl 15, poly (styrene-co-alpha-methylstyrene) resin having a softening point between 114 and 120 ° C, marketed by Eastman,
    - Kristalex 5140, poly (styrene-co-alpha-methylstyrene) resin having a softening point of 139 ° C., marketed by Eastman,
    - Sukorez SU-400, polycyclopentadiene resin with a softening point between 97 and 107 ° C, marketed by Kolon Industries.
    Composition manufacturing
    In a vertical mixer, the plasticizer, the hydrocolloid and the petroleum jelly were successively introduced at a set temperature of 90 ° C. and the mixture was stirred until a homogeneous mixture was obtained.
    The copolymer (s), the antioxidant, as well as the resin (s) were then introduced with stirring, then the set temperature was brought to 150 ° C. and stirred until a mixture was obtained. homogeneous. The mixer was then placed under vacuum to remove the bubbles present in the mixture.
    It was then allowed to cool, and the mixer was drained.
    Subsequently, polymer matrices were produced from the compositions to be tested, by applying a high pressure using a hydraulic press according to the following protocol:
    We preheated the 2 plates of the hydraulic press. On the lower plate of the press, a non-stick plastic film has been deposited, for example a silicone-fluorinated polyester film (the silicone-fluorine face being disposed opposite the lower plate). About 12 g of one of the compositions described were deposited on this face and the latter was covered with a silicone polyester film (the silicone side being placed in contact with the composition). Two 0.75 mm shims were placed between the two polyester films at the ends of the lower plate of the press and the assembly was subjected to a pressure of 200 bars and a temperature of the order of 90 to 100 ° C. .
    The plates thus produced were allowed to cool and their thicknesses were checked with a micrometer so as to obtain a model the thickness of which is around 650 μm.
    Measurement of the force at break and the elongation at break:
    The conditions for carrying out the test and the models used were as follows.
    The principle of this measurement is to exert traction on a dumbbell test piece (corresponding to an elastomeric die-cut frame) at constant speed V until breaking using a dynamometer.
    This measures the breaking strength and the elongation at break.
    MATERIAL / APPARATUS
    Automatic press + shims,
    Electronic dynamometer (0.1 to 999 mm / min),
    Force sensor (to be adapted according to measured force),
    Dumbbell specimen cookie cutter,
    Material type polyurethane mechanical foam 400 pm Exopack.
    SAMPLING / PACKAGING OF SAMPLES Number of test pieces n> 5.
    Conditioning time T> 24h.
    Temperature T = 23 ° C ± 2 ° C.
    RH hygrometry = 50% ± 15%.
    OPERATING CONDITIONS
    -1 (width of test piece) = 12.7 mm
    - lo (distance between the jaws of the dynamometer) = 90 mm
    - V (traction speed) = 300 mm / min
    OPERATING MODE
    Preparation of test pieces:
    - Remove the composition to be analyzed beforehand,
    - Using the automatic press, prepare plates of elastomeric matrix 650 μm thick from the debubbled composition (wedges of 750 μm),
    - Cut the dumbbell test pieces using the cookie cutter, being careful not to primer.
    MEASURED
    - Place a dumbbell test tube with a width of 12.7 mm in the jaws of the dynamometer distant from lo = 90 mm, by previously covering the 2 ends with mechanical PU foam 400 μηι (to avoid shearing of the test piece at the jaws),
    - Carry out the tensile test until the test piece breaks at the speed V = 300 mm / min,
    - Check that the breaking front occurs in the rectilinear part of the test piece.
    CALCULATIONS / EXPRESSION OF RESULTS
    - Extract from the curve the values of breaking strength and elongation at break associated.
    - Calculate for each sample reference:
    - minimum,
    - the maximum,
    - the average,
    - the standard deviation,
    - leCV.
    Table 1:
    Ex.27 7.8 Tj ce53.5 (NOT this Shout O 2.42 806 X <e Z Tirj this CM this shout rx] 'Z. JJ cx] r-J thisτ O - VS ir. 00 τ3.5 (NOT this Shout O 49 M ci l < thisτ O (NOT 00 • Kthisτ this Cx] this Shout rr- z r i DD Cx |-tj - - O vs r ic ^ > rj c ^ · ©: X cc this rRI this Shout o • z. JJ cx] tj - this - τ tj<N 00 τthis (NOT this (NOTO 'χΓ© 5 M cq l < thisτ O H 00 τ 05 5 © <N x * 00 τthis (NOT this (NOT OM ci l < thisτ O H 00 τ r- <N 05 r * o 00 τthis (NOT this (NOT O 00 M ci l < thisτ Or- /not .z- z 'Z X rx Z Tthis (NOT this Cx] o cx] NOT A WORD - r-J c * , l •not O• z * 00 00 τ τ this(NOT this (NOT O (NOT ’Tt Tj PJ l < this τ O H r- τTj 00 * r ~~ 00 tj this(NOT this (NOT O PJ l < this τ O H r- τ <N 42 3d ' 00 τ S(NOT τ (NOT © 5t < ¢ / - •not - O rj - > - 'Tj _x "n Z > rj Cx] τ CX | this _ NOT A WORD - i < this Ό- - O - 'Z. T not a word r- O thisthis 'rj ol <2; this zT *> rj- - - - -1- tj 'X ©X this r- 'F r-J τ ΓΜ not a word - T) CXJ Ή-O rj O r / ·. > <Cl r-tj tj rRI OC r <r i NOT A WORD - • / S RXI tj - rjO er, rj c <·X - Γ-- '"vs thisthis tj fx] o- r i rf. JU - T) cxj /not - O· //. rj V.X * <rx r- <ζ this rj ΓΊ this Z NOT A WORD - τί H T-O-i- O tj X * r- Ό vs*'· fT T ex] this 3E not a word •not rj T- - VS - - 'Z. ocX r- O Tj cethis tj Cx] cr> z rr_τ rj τ - O• Z. r- > rj r-X r-thisthis rj ex] this ^ 2 JP rj cx] > rj O - -i- © x rj © sX r-J T ex] O ^ q. JU rj rq /not - O T.O rr tj tj X Γ--thisthis irj CX]-r not a word / S Cx] tj- - rj T.- -i- 'Tt 05'Tt (NOT X r- © 5 © 5 this (NOT O thisPJ τ H O H r- thisx ' r-Youthis T ΓΊ this Cx] 'Z. JP rj ΓΊ τ O'Z. eq tj x ' r-> χ © r-J tj CX]• Τ. JP • / S r4 T - O 'rj -1- XVS tj> rj tj CX] r- rr vL JP rj r-i Ό- -o r i o G1654 ES G 1650 E 919 2076P e Codex A lanose 1010 do W90 oc ce 'ri z Z. s SA 100 xF115 s SA 120 'Tl ·'rj X ^ i-O ocz rr _X xFlOO c O ’d-z ruptur is lying (%)Kraton Kraton Ondina Pionier Vaselini CMC B Irganox Norsolè x pCJx z.zZ. Sylvare: Kristale Sylvare: Ov:^ 2 Norsolè FOJ(<* JZZ Kristale p2 zZ Force (N / cm) Elongate
    The matrix obtained in Examples 1 and 15 containing no resin, exhibits poor results in terms of strength and elongation at break.
    The matrix obtained in Examples 2 and 3 (and those of Examples 5 to 14) contains a total content of triblock copolymers of less than 10% by weight and a resin content of less than 15%, which does not make it possible to obtain good strength and elongation results at break. On the contrary, the matrix obtained in Example 4 according to the invention, comprising a total content of triblock copolymers of less than 10% by weight and of resin of 20%, has good results in strength and elongation at break, this which results in good mechanical properties, in particular of tear resistance.
    In addition, the elastomeric matrices obtained in Examples 5, 6, 7, 11, 12, 13 and 14 using resins not in accordance with the present invention do not give good results in terms of strength and elongation at break.
    The elastomeric matrices obtained in Examples 5, 6, 7, 11 and 12 also have a whitish color characteristic of an instability of the mixture, and deceptive from an aesthetic point of view.
    The elastomeric matrices obtained in Examples 16, 17, 18, 20, 21, 22, 25 and 27 in accordance with the invention have good results in terms of strength and elongation at break, which results in good mechanical properties, in particular tear resistance.
    The elastomeric matrix obtained in Examples 19 and 26, using resins not in accordance with the present invention, does not have good strength and elongation at break results.
    The elastomeric matrices of Examples 23 and 24, containing only a single triblock copolymer according to the invention, are also not satisfactory in terms of tear resistance.
    权利要求:
    Claims (10)
    [1" id="c-fr-0001]
    1. Composition including:
    - 5 to 20% of a mixture of 2 triblock copolymers of the styrene - saturated olefin - styrene type, the first having a viscosity of between 0.01 and 1 Pa.s as measured in a 5% solution (mass / mass) in toluene and a second which has a viscosity between 0.01 and 0.5 Pa.s measured in a 15% solution (mass / mass) in toluene
    - 50 to 80% by weight of at least one plasticizer,
    - 5 to 20% of at least one alpha-methyl styrene type resin whose softening point is between 80 and 125 ° C, preferably between 90 and 110 ° C, it being understood that:
    when the content of triblock copolymers is between 5 and 10% by weight, the resin content is between 15 and 20% by weight, relative to the total weight of the composition and
    - When the content of triblock copolymers is greater than 10% by weight, the resin content is between 5 and 20% by weight, based on the total weight of the composition, the percentages being based on the total weight of the composition.
    [2" id="c-fr-0002]
    2. Composition according to claim 1, characterized in that the resin is chosen from an alpha-methyl styrene resin having a softening point between 95 and 105 ° C or between 115 and 125 ° C or a poly (styrene-co -alpha-methyl styrene) with a softening point between 95 ° C and 115 ° C.
    [3" id="c-fr-0003]
    3. Composition according to one of claims 1 or 2, characterized in that the plasticizer consists of a mixture of mineral oil and petrolatum.
    [4" id="c-fr-0004]
    4. Composition according to one of the preceding claims, characterized in that it comprises hydrocolloid particles in an amount less than or equal to 25% by weight, based on the total weight of the composition.
    [5" id="c-fr-0005]
    5. Composition according to one of the preceding claims, characterized in that it comprises one or more active substance (s) making it possible to induce or accelerate healing or which can have a favorable role in the treatment of wounds, in a amount between 0.01 and 20% by weight, preferably between 1 and 15% by weight, based on the total weight of the composition.
    [6" id="c-fr-0006]
    6. Elastomeric matrix, characterized in that it is obtained from a composition according to one of claims 1 to 5, preferably by forming a thin layer and compression, or by hot casting of said composition.
    [7" id="c-fr-0007]
    7. Elastomeric matrix according to claim 6, characterized in that it comprises a frame or a support, or in that it is self-supporting.
    5
    [8" id="c-fr-0008]
    8. Self-supporting elastomeric matrix according to claim 7, characterized in that it has through holes.
    [9" id="c-fr-0009]
    9. Self-supporting elastomeric matrix according to one of claims 7 or 8, characterized in that it is in the form of an aerated net whose mesh size is of the order of 4mm 2 , the thickness of l '' order of 800 microns and the
    [10" id="c-fr-0010]
    10 grammage of the order of 400 g / m 2 .
    10. Interface dressing, characterized in that it comprises an elastomeric matrix according to one of claims 6 to 9.
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    同族专利:
    公开号 | 公开日
    CN111432759B|2022-02-15|
    US20200190310A1|2020-06-18|
    EP3651707A1|2020-05-20|
    CN111432759A|2020-07-17|
    WO2019012230A1|2019-01-17|
    FR3068975B1|2020-07-17|
    BR112020000726A2|2021-03-23|
    JP2020526631A|2020-08-31|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US20020128345A1|2000-12-29|2002-09-12|Paul Charles W.|Hot melt adhesives for dermal application|
    US20100285129A1|2007-05-25|2010-11-11|Laboratoires Urgo|Novel agent for salting out active principles in dressings containing at least one of fatty substance|
    US20150174285A1|2012-07-17|2015-06-25|Laboratories Urgo|Self-supporting interface dressing|
    WO2016097653A1|2014-12-19|2016-06-23|Laboratoires Urgo|Dressing comprising a support and a hydrophobic elastomeric matrix|
    FR2783412B1|1998-09-18|2000-12-15|Lhd Lab Hygiene Dietetique|NON-ADHERENT STERILE COMPRESS|
    FR2914847B1|2007-04-13|2009-07-10|Urgo Soc Par Actions Simplifie|NEW PROTECTOR FOR DRESSINGS|
    FR2936158A1|2008-09-24|2010-03-26|Plasto|SURGICAL INTERFACE FOR WOUND, WITHOUT SUPPORT|
    FR2936159B1|2008-09-24|2010-10-22|Plasto|SURGICAL INTERFACE FOR WOUND, WITH SUPPORT|
    CN102051018B|2010-11-30|2012-06-13|深圳市盛嘉伦橡塑工业有限公司|Thermoplastic elastomer for being subjected to secondary injection adhesion with PBT material and composite molding product using same|
    FR2993182B1|2012-07-13|2014-10-17|Urgo Lab|DRESSING WITH PROLONGED RELEASE OF ASSETS|
    FR3009188B1|2013-08-05|2017-02-17|Urgo Lab|INTERFACE BANDING APPLICATOR DEVICE|
    EP2995287A1|2014-09-11|2016-03-16|Mölnlycke Health Care AB|Medical dressing|GB201020236D0|2010-11-30|2011-01-12|Convatec Technologies Inc|A composition for detecting biofilms on viable tissues|
    EP2648793B1|2010-12-08|2020-03-11|ConvaTec Technologies Inc.|Integrated system for assessing wound exudates|
    ES2748519T3|2010-12-08|2020-03-17|Convatec Technologies Inc|Wound exudate system accessory|
    GB2497406A|2011-11-29|2013-06-12|Webtec Converting Llc|Dressing with a perforated binder layer|
    WO2018009873A1|2016-07-08|2018-01-11|Convatec Technologies Inc.|Fluid collection apparatus|
    法律状态:
    2019-01-18| PLSC| Publication of the preliminary search report|Effective date: 20190118 |
    2019-07-29| PLFP| Fee payment|Year of fee payment: 3 |
    2020-07-27| PLFP| Fee payment|Year of fee payment: 4 |
    2021-07-26| PLFP| Fee payment|Year of fee payment: 5 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1756589|2017-07-12|
    FR1756589A|FR3068975B1|2017-07-12|2017-07-12|COMPOSITION FOR INTERFACE DRESSING|FR1756589A| FR3068975B1|2017-07-12|2017-07-12|COMPOSITION FOR INTERFACE DRESSING|
    JP2020500856A| JP2020526631A|2017-07-12|2018-07-12|Composition for interface type wound dressing|
    CN201880053057.4A| CN111432759B|2017-07-12|2018-07-12|Composition for interface dressing|
    PCT/FR2018/051759| WO2019012230A1|2017-07-12|2018-07-12|Composition for interface dressing|
    US16/629,141| US20200190310A1|2017-07-12|2018-07-12|Composition for Interface Dressing|
    BR112020000726-9A| BR112020000726A2|2017-07-12|2018-07-12|interface dressing composition|
    EP18749037.0A| EP3651707A1|2017-07-12|2018-07-12|Composition for interface dressing|
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