WO2016166463A1 - Materiau lamellaire non tisse pour son utilisation dans la cicatrisation des plaies par pression negative - Google Patents

Materiau lamellaire non tisse pour son utilisation dans la cicatrisation des plaies par pression negative Download PDF

Info

Publication number
WO2016166463A1
WO2016166463A1 PCT/FR2016/050841 FR2016050841W WO2016166463A1 WO 2016166463 A1 WO2016166463 A1 WO 2016166463A1 FR 2016050841 W FR2016050841 W FR 2016050841W WO 2016166463 A1 WO2016166463 A1 WO 2016166463A1
Authority
WO
WIPO (PCT)
Prior art keywords
wound
nonwoven
core
bark
fibers
Prior art date
Application number
PCT/FR2016/050841
Other languages
English (en)
French (fr)
Inventor
Jean-Marc Pernot
Laurent Apert
Laurent PASQUINET
Original Assignee
Laboratoires Urgo
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Laboratoires Urgo filed Critical Laboratoires Urgo
Publication of WO2016166463A1 publication Critical patent/WO2016166463A1/fr

Links

Classifications

    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/54—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties by welding together the fibres, e.g. by partially melting or dissolving
    • D04H1/541—Composite fibres, e.g. sheath-core, sea-island or side-by-side; Mixed fibres
    • D04H1/5412—Composite fibres, e.g. sheath-core, sea-island or side-by-side; Mixed fibres sheath-core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/425—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/225—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/42—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties characterised by the use of certain kinds of fibres insofar as this use has no preponderant influence on the consolidation of the fleece
    • D04H1/4282—Addition polymers
    • D04H1/43—Acrylonitrile series
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/54—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties by welding together the fibres, e.g. by partially melting or dissolving
    • D04H1/541—Composite fibres, e.g. sheath-core, sea-island or side-by-side; Mixed fibres
    • D04H1/5418—Mixed fibres, e.g. at least two chemically different fibres or fibre blends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00727—Plasters means for wound humidity control
    • A61F2013/00748—Plasters means for wound humidity control with hydrocolloids or superabsorbers

Definitions

  • the present invention relates to a non-woven material of superabsorbent and non-absorbent fibers and a medical device implementing such a material, such as a dressing, for use in a method of negative pressure therapy (TPN).
  • TPN negative pressure therapy
  • NPT negative pressure therapy
  • TPN treatments The basic principle of TPN treatments is to create a closed cavity on the wound by means of a thin, flexible sealing film, and glued to the skin of the patient surrounding the wound.
  • the cavity also makes it possible to admit one end of a suction duct, the duct being, for example, sealed to the sealing film and connected at its other end to a vacuum pump capable of creating a vacuum.
  • cavity a pressure lower than the ambient atmospheric pressure which surrounds the wound.
  • the depression created inside the cavity provides many beneficial therapeutic effects for healing, such as an increase in blood circulation, faster tissue granulation.
  • Topical wound treatments using negative pressure devices can treat different types of wounds, from the smallest lesions to the largest exudative or cavitary wounds or burns of any size. These wounds produce exudates that should be evacuated as effectively as possible to improve healing. It has been observed that the drainage of the exudates allowed to promote the tissue growth, thus improving the cicatrization.
  • such a device comprises an interface material affixed in contact with the wound, a porous material optionally absorbing directly disposed on the upper surface of the interface material and capable of sensing the liquid secretions generated by the wound to isolate them from the cutaneous zone to be protected.
  • an adhesive layer or sealing film
  • the gelling and possibly absorbing properties of the interface material brought into contact with the wound can generate a phenomenon called "gel blocking" in English terminology, ie the material swells in the presence of fluids containing water. water to form a compact gel tight exudates no longer allowing the absorption and dissemination thereof.
  • gel blocking in English terminology
  • the subject of the present invention is, according to a first aspect, a nonwoven lamellar material comprising a mixture of superabsorbent bicomponent fibers of the core / bark type, said core being made of polyacrylonitrile and the bark being made of polyacrylate and non-absorbing heat-binding fibers, for use in a method of treating wounds by negative pressure.
  • the invention also relates, according to a second aspect, to a negative pressure wound treatment device comprising such a material, said device preferably being a dressing.
  • the subject of the invention is said device for its use in a method of treating wounds by negative pressure.
  • the material of the invention has the advantage of being cohesive and not tearing when subjected to a negative pressure.
  • Nonwoven material comprising a mixture of two-component superabsorbent fibers and non-absorbent thermoling fibers
  • the nonwoven material according to the invention is in the form of a flat, lamellar sheet, and is distinguished in particular from cavity filling materials of three-dimensional structure consisting of an envelope containing a material capable of forming channels of flow of fluids, said three-dimensional structure for filling cavitary wounds.
  • the nonwoven lamellar material according to the invention does not contain any material or a set of materials capable of forming or forming fluid flow channels.
  • Such materials may be porous or non-porous, compressible or non-compressible, deformable or non-deformable, resilient or non-resilient, provided that they fulfill their function of forming, intrinsically and / or by their arrangement with respect to each other, fluid flow channels.
  • porous material in the sense of the present application, any material whose structure has cavities that can form fluid flow channels.
  • compressible material means any material whose volume decreases and whose shape is modified under the effect of external physical stress.
  • deformable material is meant any material whose shape is modified under the effect of an external physical constraint but whose volume remains constant.
  • Resilient material means any compressible or deformable material having the property of recovering its initial volume and / or its initial shape once the external physical stress has been lifted.
  • the nonwoven lamellar material according to the invention does not contain any material or a set of materials capable of forming or forming fluid flow channels such as those described in the application filed under the number FR 13 63156.
  • the nonwoven material according to the invention consists of a mixture of superabsorbent fibers, two-component core / bark, said core being polyacrylonitrile and the bark being polyacrylate, and non-absorbing heat-binding fibers, all fibers being preferably fused.
  • the nonwoven material is in particular non-adherent to human tissues, and more particularly to the wound.
  • said nonwoven can be removed without the structure of the wound or perilesional skin is impaired.
  • the superabsorbent fibers which have a very high capacity for absorbing liquids, preferably greater than or equal to 10 g of water (or saline such as physiological saline) per gram more preferably greater than 20 g of water per gram.
  • the superabsorbent fibers consist of two different components. These components may, for example, be distributed in a side-by-side configuration, or preferably in a core-shell configuration.
  • the first component for forming an outer portion of the fiber preferably the bark, should be able to absorb the exudates from the wound and can be formed of one or more polymers.
  • This first component is formed of polyacrylate.
  • the second component which will preferably form the core of the superabsorbent fibers, will preferably be non-gelling and compatible with the first component to ensure stability of the fiber after absorption of the exudates by the first component. It can be formed of any type of polymer stable in aqueous medium and compatible with the component of the bark to lead to a stable two-component fiber.
  • This second component is formed of polyacrylonitrile.
  • the superabsorbent fibers advantageously have a length of the order of 10 to 100 mm, preferably 30 to 60 mm.
  • Superabsorbent fibers that can be used in the context of the invention are for example sold by the company TOYOBO CO LTD under the name LANSEAL® F.
  • the non-absorbent fibers are heat-binding fibers capable of reinforcing and stabilizing the three-dimensional structure of the nonwoven material by forming a reinforcement resulting from the binding of these fibers together and / or of these fibers with the superabsorbent fibers.
  • These second fibers may consist of a single thermoplastic material such as a polyethylene, a polypropylene or a low melting point polyester.
  • these second fibers will also consist of two different materials distributed in a side-by-side or preferably heart-shell configuration.
  • the length of these fibers may be of the order of 10 to 100 mm, preferably 25 to 75 mm.
  • the diameter of these fibers is preferably equal to that of the superabsorbent fibers.
  • non-absorbent two-component heat-binding fibers of heart-bark type in which the core is formed of a polyester as in particularly polyethylene terephthalate, and the bark is formed of polyethylene, are particularly preferred.
  • the mass ratio between the superabsorbent fibers and the heat-absorbing non-absorbent fibers may be between 20/80 and 80/20, preferably between 60/40 and 80/20.
  • the nonwoven material according to the invention will be obtained from mixtures incorporating more than 50% by weight, preferably more than 60% by weight, of superabsorbent fibers.
  • This nonwoven material according to the invention may in particular be obtained by thermobonding, or by needling and heat-sealing the fiber mixture.
  • thermobonding operation makes it possible to improve the tear resistance of the nonwoven after absorption of the exudates, by creating anchoring points between the nonwoven fibers. It is necessary to strengthen the cohesion of the nonwoven material so that it can be implemented in negative pressure wound treatment devices without tearing.
  • the assembly of the fibers will be carried out under conditions making it possible to obtain a nonwoven having a thickness of between 0.3 and 3 mm, preferably of 2 mm, and a basis weight of between 30 and 400 g / m 2 , preferably of the order of 100 g / m 2 .
  • the nonwoven material according to the invention can be manufactured according to the process described in GB 2401879.
  • the nonwoven may be partially covered with a contact layer on the face intended to come into contact. with the wound, said layer comprising openings allowing the passage of exudates from the wound.
  • the nonwoven material according to the invention comprises, and preferably consists of:
  • a mixture of two-component superabsorbent fibers of core / bark type said core being made of polyacrylonitrile and the bark being of polyacrylate as described previously, and non-absorbing heat-binding fibers, all the fibers being preferably thermo-bonded and optionally a contact layer.
  • the contact layer is said micro-adherent, that is to say, it allows to temporarily fix said nonwoven coated on the wound.
  • the assembly can then be removed without the structure of the wound or perilesional skin is altered, so that the set is repositionable and facilitates nursing.
  • This temporary fixation may also help the caregiver or user to temporarily fix the dressing.
  • the contact layer may be chosen so that it has an adhesive strength on a steel plate of between 0.5 and 100 cN / cm, preferably between 5 and 40 cN / cm.
  • This adhesive power is measured according to the method EN 1939 in which a contact layer sample of 20 mm wide and 150 mm long is placed on a steel plate and in which the adhesive power is measured after 10 minutes.
  • the contact layer may preferably be formed of a composition comprising an elastomeric matrix and hydrocolloids, and in particular an elastomeric matrix in which hydrocolloids are preferably dispersed homogeneously.
  • the proportion of hydrocoUoids is preferably between 2 and 20% by weight of the weight of said composition.
  • the contact layer may in particular cover between 55 and 65% of the face of the nonwoven intended to come into contact with the wound.
  • the contact layer preferably has a basis weight ranging from 110 to 500 g / m 2 , preferably from 150 to 200 g / m 2 .
  • the contact layer advantageously makes it possible not to adhere to the wound and to avoid any pain during its removal. By maintaining a moist environment on the wound surface while avoiding contact with the nonwoven material, it improves healing.
  • the incorporation of hydrocoUoids gives the elastomeric composition a hydrophilic character and promotes the vectorization of active agents that can promote the treatment of the wound.
  • Said composition comprises one or more elastomers chosen from poly (styrene-olefin-styrene) block polymers.
  • Block copolymers used in the context of the invention are advantageously triblock copolymers of the ABA type comprising two styrene thermoplastic end blocks and an elastomeric central block B which is an olefin, optionally combined with AB type diblock copolymers comprising a styrene thermoplastic block and an elastomer block B which is an olefin.
  • the B olefin sequences of these copolymers may consist of unsaturated olefins such as isoprene or butadiene or saturated olefins such as ethylene-butylene or ethylene-propylene.
  • the triblock unsaturated central block are well known to the skilled person and are especially sold by the company Kraton Polymers under the name KRATON ® D.
  • poly (styrene-isoprene-styrene) (abbreviated to SIS ) can be cited products sold under the names KRATON ® D1 107 or KRATON ® Dl 119 BT or the products sold by the company EXXON MOBIL CHEMICAL under the name VECTOR ® such as the product marketed under the name VECTOR ® 4113.
  • poly (styrene-butadiene-styrene) the product sold under the name KRATON Dl 102 ®.
  • All these copolymers based on isoprene or butadiene generally have a styrene content of between 10 and 52% by weight, based on the total weight of said copolymer.
  • triblock block copolymers poly (styrene-isoprene-styrene) (abbreviated SIS) having a styrene content of between 14 and 52% and preferably between 14 and 30% by weight reported the weight of said poly (SIS).
  • SIS poly (styrene-isoprene-styrene)
  • SIS triblock block copolymers
  • the saturated central block triblock copolymers are also well known to those skilled in the art and are for example marketed:
  • triblock SEBS such as in particular the product sold by the company Kraton Polymers under the name KRATON ® G 1651;
  • styrene-olefin such as in particular poly (styrene-ethylene-propylene), sold by the company Kraton Polymers under the trademark KRATON ® G1702.
  • SEBS or SEPS triblock copolymers having a styrene content of between 25 and 45% by weight relative to the weight of said SEBS or SEPS.
  • triblock block copolymers and in particular the products sold by the company Kraton Polymers under the names KRATON ® G1651 and Kraton G1654 ®.
  • the elastomer will be used in amounts that are adapted according to the saturated or unsaturated nature of the olefin central block of the block copolymer.
  • an unsaturated central block triblock copolymer it will be used in an amount of the order of 10 to 30% by weight, preferably 10 to 20% by weight, relative to the total weight of the composition.
  • a saturated central block triblock copolymer it will be used in an amount of the order of 3 to 10% by weight, preferably 4 to 7% by weight, based on the total weight of the composition.
  • hydrocolloid or hydrocolloid particles is meant here any compound usually used by those skilled in the art for its ability to absorb aqueous liquids such as water, saline or wound exudants.
  • Suitable hydrocolloids include, for example, 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, and that synthetic polymers based on salts of acrylic acid, known under the name "superabsorbents", such as the products sold by BASF under the name LUQUASORB ® 1003 or by the company Ciba Specialty Chemicals under the trademark Salcare ® SC91 as well as mixtures of these compounds.
  • superabsorbents such as the products sold by BASF under the name LUQUASORB ® 1003 or by the company Ciba Specialty Chemicals under the trademark Salcare ® SC91 as well as mixtures of these compounds.
  • microcolloids Some of these superabsorbents qualified as "microcolloids" because they have a particle size of less than 10 micrometers can of course be used in the context of the production of the composition.
  • 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 for example between 50 and 100 microns, in particular of the order of 80 microns.
  • the amount of hydrocolloids incorporated in the elastomeric composition will advantageously be of the order of 2 to 20% by weight, preferably 5 to 18% by weight, more preferably 8 to 18% by weight, more preferably 12 to 18% by weight. at 16% by weight, based on the total weight of the elastomer composition.
  • Hydrocolloids introduced in excessive amounts into a perforated contact layer decrease the absorption capacity of a nonwoven based on superabsorbent fibers as the gel is formed.
  • the contact layer may comprise one or more elastomers chosen from poly (styrene-olefin-styrene) block polymers in combination with one or more plasticizer compounds to improve their stretching, flexibility, extrudability or processing properties.
  • plasticizer compounds that may be used for this purpose, mention may be made in particular of mineralizing plastic oils, whatever the nature of the central block. Mention may also be polybutenes - as for example the products marketed by the company BP Chemicals under the trade name NAPVIS ® 10 -or phthalate derivatives such as dioctyl phthalate or dioctyl adipate, as the core sequence is unsaturated.
  • saturated-based liquid hydrocarbon mixtures synthetic products such as the products marketed by the company TOTAL under the name Gemseal ® and in particular the product Gemseal ® 60 which is an isoparaffinic mixture derived from a completely hydrogenated petroleum cut. These products will preferably be used with a triblock copolymer comprising a saturated central block.
  • plasticizing oils and in particular mineral oils formed of compounds of paraffinic, naphthenic or aromatic nature or of their mixtures in variable proportions.
  • plasticizing oils that are particularly suitable, mention may be made of:
  • a mineral plasticizing oil selected from the products sold under the names ONDINA ® 933 and ONDINA ® 919.
  • plasticizer compounds may be used in an amount of about 20 to 65% by weight, preferably 30 to 50% by weight, based on the total weight of the hydrocolloid elastomer composition.
  • these compositions are said to be adherent: they have the property of adhering to the skin without adhering to the wound. They comprise one or more so-called “tackifiers” such as those customarily used by those skilled in the art in the preparation of pressure sensitive adhesives based on elastomers.
  • tackifiers such as those customarily used by those skilled in the art in the preparation of pressure sensitive adhesives based on elastomers.
  • one (or more) tackifying product (s) may be used which will be incorporated into the elastomeric matrix in a proportion of the order of 1 to 50% by weight. relative to the total weight of the hydrocolloid elastomer composition, which will be determined according to the nature and the relative proportion of the other constituents of the latter, to achieve the desired micro-adhesion power for the nonwoven.
  • the tackifying product (s) will represent (represent) from 10 to 45% by weight, and more preferably from 15 to 40% by weight of the total weight of the hydrocolloid elastomer composition.
  • the tackifiers that may be used in the context of the present invention may be chosen from tackifying resins, polyisobutylenes of low molecular weight, or mixtures thereof.
  • tackifying resins that can be used according to the invention, mention may be made of modified polyterpene or terpenes resins, rosin resins, hydrocarbon resins, mixtures of cyclic, aromatic and aliphatic resins, or mixtures of these resins.
  • WINGTACK ® particularly WINGTACK ® 86, which is a synthetic resin formed of copolymers C5 / C9 or WINGTACK ® 10 which is a synthetic polyterpene-based resin
  • KRISTALEX ® a synthetic resin formed of copolymers C5 / C9
  • KRISTALEX ® a synthetic polyterpene-based resin
  • KRISTALEX ® 3085 which is a resin based on alpha-methylstyrene.
  • the use of hydrogenated resins will be preferred, in particular with saturated central block triblock copolymers because they are much more compatible with them than the resins.
  • unsaturated WINGTACK type which is used essentially with unsaturated central block triblock copolymers.
  • the tackifying resins may be used alone or in admixture with other tackifiers, preferably in a proportion of 10 to 50% by weight, and more particularly from 15 to 40% by weight, relative to the total weight of the composition.
  • polyisobutylenes which may be used as tackifiers
  • polyisobutylenes may be used alone or in admixture with other tackifiers in combination with triblock copolymers with unsaturated central block. Their proportion may vary in this case between 5 to 30% by weight, and more particularly from 8 to 15% by weight, based on the total weight of the composition.
  • the nonwoven materials formed of a mixture of superabsorbent fibers and non-absorbing heat-binding fibers, partially covered with a contact layer, preferably discontinuous, on the face of the nonwoven intended to come into contact with the wound are especially marketed under the name Urgoclean by the company Urgo.
  • Various compounds may also be added to the lamellar material which is the subject of the present invention and / or to the partially overlapping contact layer, such as, in particular, active agents or adjuvants commonly used in the field of wound treatment or in the field pharmacological.
  • the material may contain active ingredients having a favorable role in the treatment of the wound. These active ingredients may preferably induce or promote the healing of the wound.
  • Other active agents may also be used in the context of the invention, such as, for example, bactericidal or bacteriostatic agents, antiseptics, anti-pain agents or local anesthetics, anti-inflammatory agents, antipruritic agents, soothing agents, moisturizing agents, antioxidants, depigmenting agents and mixtures thereof.
  • these assets can be chosen from:
  • the active agents promoting healing such as retinol, vitamin A, vitamin E, N-acetyl-hydroxyproline, extracts of Centella Asiatica, papain, silicones, essential oils of thyme, niaouli, rosemary and of sage, hyaluronic acid,, Allantoin, - Hema'tite (gattefossed), Vitamin C, TEGO Pep 4-17 (evonik), Toniskin (silab), Collageneer (Expanscience), Timecode (Seppic), Gatuline skin repair (gattefossé), Panthenol, PhytoCellTec Rose Alp (Mibelle Biochemistry), Erasyal (libragen), Serilesine (Lipotec), Heterosides of Talapetraka (beyer), Stoechiol (codif), macarose (Sensient), Dermaveil (Ichimaru Pharcos), Phycosaccaride AI (Codif), growth
  • antiseptics such as sodium mercurothiolate, eosin, chlorhexidine, phenylmercury borate, hydrogen peroxide, Dakin liquor, triclosan, biguanide, hexamidine, thymol, Lugol, Povidone iodine, Merbromine, Benzalkonium and Benzethonium Chloride, ethanol, isopropanol; pain relievers or local anesthetics such as paracetamol, codeine,
  • Dextropropoxyphene Tramadol, Morphine and its derivatives, Corticosteroids and derivatives; anti-inflammatories such as glucocorticoids, nonsteroidal anti-inflammatory drugs, aspirin, ibuprofen, ketoprofen, flurbiprofen, diclofenac, aceclofenac, ketorolac, meloxicam, piroxicam, tenoxicam, Naproxen, Indomethacin, Naproxcinod, Nimesulide, Celecoxib, Etoricoxib, Parecoxib, Rofecoxib, Valdecoxib, Phenylbutazone, Niflumic acid, Mefenamic acid;
  • anti-inflammatories such as glucocorticoids, nonsteroidal anti-inflammatory drugs, aspirin, ibuprofen, ketoprofen, flurbiprofen, diclofenac, aceclofenac, ketorolac, meloxicam, piroxi
  • depigmenting agents such as kojic acid (Kojic Acid SL®-Quimasso (Sino Lion)), Arbutin (Olevatin®-Quimasso (Sino Lion)), the mixture of palmitoylpropyl of sodium and white water lily extract (Sepicalm) ® - Seppic), undecylenoyl phenylalanine (Sepiwhite® - Seppic); - the antipruriginous: hydrocotisone, enoxolone, diphenyhydramine, antihistamine with local application anti Hl;
  • moisturizing actives such as xpermoist (lipotec), hyaluronic acid, urea, fatty acids, glycerin, waxes, exossin (unipex);
  • UV filters such as Parsol MCX, Parsol 1789; soothing agents such as chamomile, bisabolol, xanthalene, glycyrrhébuze acid, tanactine (CPN), Calmiskin (Silab);
  • antioxidants such as vitamin E.
  • the active agents that can be introduced into the material according to the present invention are preferably chosen from active agents promoting healing, anti-inflammatory agents and their mixture.
  • the material according to the present invention may comprise active agents in an amount of from 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 material containing them.
  • the material of the invention may also contain adjuvants, among which mention may be made of dyestuffs, fillers, odor absorbers or scavengers, pH regulators, microcapsules or microspheres which may optionally contain active agents, petroleum jelly, polymers or surfactants to optimize the rate of gelation, wettability or release of the active material.
  • adjuvants among which mention may be made of dyestuffs, fillers, odor absorbers or scavengers, pH regulators, microcapsules or microspheres which may optionally contain active agents, petroleum jelly, polymers or surfactants to optimize the rate of gelation, wettability or release of the active material.
  • the subject of the invention is also a medical device for the treatment of wounds by negative pressure comprising the absorbent nonwoven material previously described, said device being preferably a dressing.
  • Medical device means equipment used in humans for the prevention, control, treatment or mitigation of disease or injury.
  • negative pressure wound treatment device means any device that makes it possible to create, on the surface of the wound, a pressure that is lower than atmospheric pressure.
  • such a device also comprises an adhesive layer (or sealing film) allowing the device to adhere to the peri-lesional skin zone and to be maintained around this zone.
  • the negative pressure wound treatment device comprises an absorbent nonwoven lamellar material as described above, connected to a source of depression and to a system for collecting exudates.
  • the vacuum source may in particular be a vacuum pump, of any nature whatsoever, manual or electronic.
  • the nonwoven material may be connected to said vacuum source by means of a suction duct, the duct being, for example, sealed to the absorbent material.
  • the subject of the invention is a medical device for the treatment of negative pressure wounds comprising, preferably, a non-woven laminar material as described above, optionally an optionally absorbent porous material, at least partially covering the surface of the non-woven laminar material which is not in contact with the wound, an adhesive layer (also called a sealing film) allowing the device to adhere to the cutaneous zone peri-lesional and to be maintained around this area, and optionally an exudate evacuation duct connected to a source of depression and a system of collection exudists.
  • the porous material may be a foam or gauze or any other porous material known to those skilled in the art. Such materials are described in particular in application WO 2010/092334 for example.
  • the adhesive layer may be any film known to a person skilled in the art, such as an adhesive-coated polyurethane film, for example such as those described in patent application WO 2008014258.
  • the system for discharging and collecting exudates is for example describes, in turn, in the patent application WO 2012038727.
  • the subject of the invention is said medical device for its use in a method of treating wounds by negative pressure.
  • the invention also relates, in another aspect, to the use of a nonwoven laminar material as described above, comprising a mixture of superabsorbent bicomponent core-bark fibers, said core being made of polyacrylonitrile and the bark. being made of polyacrylate and non-absorbent thermoling fibers, in a method of treating wounds by negative pressure.
  • the invention also relates to the use of a medical device for the treatment of negative pressure wounds comprising a nonwoven lamellar material as described above, comprising a mixture of bicomponent heart-type superabsorbent fibers. bark, said core being polyacrylonitrile and the bark being polyacrylate and non-absorbing thermoling fibers, in a method of treating wounds by negative pressure.
  • the occlusive character was evaluated on the basis of two criteria: the ability to apply the desired pressure to the wound surface, the ability to drain liquids effectively.
  • test plate simulating a wound in which is mounted a syringe pump simulating the exudation of the wound by releasing a mixture of NaCl and CaCl 2 at a constant flow rate of 0.7 ml / h, through a sinter of 6 cm in diameter
  • a liquid collector otherwise called tank, these elements being connected in series and connected to each other through tubes.
  • Two pressure sensors were integrated, one between the pump and the liquid collector and the other under the test plate simulating the wound.
  • the first sensor measures the pressure applied by the pump, and the second sensor measures the pressure exerted on the wound bed.
  • a computer is used to collect the data of interest measured on the "test bench", that is to say the pressure recorded on the two sensors.
  • the volume of exudates recovered in the reservoir is, in turn, measured by graduation on the reservoir.
  • a nonwoven according to the invention previously cut into a square of 8 ⁇ 8 cm, was then placed on the test plate simulating an exudative wound.
  • An adhesive polyurethane film (adhesive layer - sealing film) is applied to cover the assembly sealingly.
  • the polyurethane film is provided with a drainage system in the center.
  • Such a device is illustrated schematically in the figure.
  • the pump is switched on intermittently mode, that is to say to establish cycles of alternating pressure, oscillating for example between a pressure of -125 mmHg for 3 minutes and 0 mmHg for 2 minutes (choosing a minimum duration of 72 hours), and the computer records the pressure measurements of the two sensors.
  • the syringe pump releases a regular flow of 0.7 ml / h NaCl, CaCl 2 with a sufficient volume to simulate the exudation during the 72 hours of the test.
  • a first non-woven fabric (NT1) comprising a blend of two-component superabsorbent fibers of the core / bark type, said core being of polyacrylomtrile and the bark being of polyacrylate and heat-absorbing non-absorbent fibers, said nonwoven having a basis weight of 72 g / m 2 has been tested.
  • a second nonwoven comprising a core / bark type two-component superabsorbent fiber blend, said core being of polyacrylomtrile and the bark being of polyacrylate and heat-binding non-absorbent fibers, said nonwoven having a basis weight of m 2 and being covered with a discontinuous contact layer of grammage 218 g / m 2 was tested.
  • a third nonwoven comprising a blend of two-component superabsorbent core / bark fibers, said core being of polyacrylomtrile and the bark being of polyacrylate and heat-absorbing non-absorbent fibers, said nonwoven having a basis weight of 185 g / m 2 and being covered with a discontinuous contact layer of grammage 180 g / m 2 was tested.
  • a fourth nonwoven fabric (NT4) comprising a core / bark type two-component superabsorbent fiber blend, said core being of polyacrylomtrile and the bark being of polyacrylate and heat-absorbing non-absorbent fibers, said nonwoven having a basis weight of 185 g / m 2 has been tested.
  • the pressure measured under the dressing responds positively to the cycles imposed by the pump, that is to say that pressure cycles reverberate under the wound with a low attenuation which is due to the loss of load caused by the delivery of liquids. There is no loss of pressure due to a phenomenon of gel blocking.
  • the volume of liquid recovered is close to 50 ml, that is to say that almost all the exudates have been removed from the wound (more than 99%), and have passed through the nonwoven object of the invention. .
  • the materials according to the invention have good exudate evacuation properties, without generating occlusion of the wound (blocking gel phenomenon).

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Textile Engineering (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Anesthesiology (AREA)
  • Materials For Medical Uses (AREA)
PCT/FR2016/050841 2015-04-13 2016-04-12 Materiau lamellaire non tisse pour son utilisation dans la cicatrisation des plaies par pression negative WO2016166463A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1553204A FR3034675B1 (fr) 2015-04-13 2015-04-13 Materiau lamellaire non tisse pour son utilisation dans la cicatrisation des plaies par pression negative
FR1553204 2015-04-13

Publications (1)

Publication Number Publication Date
WO2016166463A1 true WO2016166463A1 (fr) 2016-10-20

Family

ID=54329594

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR2016/050841 WO2016166463A1 (fr) 2015-04-13 2016-04-12 Materiau lamellaire non tisse pour son utilisation dans la cicatrisation des plaies par pression negative

Country Status (2)

Country Link
FR (1) FR3034675B1 (pt-PT)
WO (1) WO2016166463A1 (pt-PT)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11331221B2 (en) * 2019-12-27 2022-05-17 Convatec Limited Negative pressure wound dressing

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012131263A1 (fr) * 2011-03-31 2012-10-04 Laboratoires Urgo Pansement absorbant cicatrisant, ses utilisations pour les plaies chroniques
US20140309574A1 (en) * 2011-11-01 2014-10-16 Brightwake Limited Wound dressings, and yarn useful therein
WO2015092314A1 (fr) * 2013-12-20 2015-06-25 Laboratoires Urgo Matériau composite de remplissage des plaies cavitaires

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012131263A1 (fr) * 2011-03-31 2012-10-04 Laboratoires Urgo Pansement absorbant cicatrisant, ses utilisations pour les plaies chroniques
US20140309574A1 (en) * 2011-11-01 2014-10-16 Brightwake Limited Wound dressings, and yarn useful therein
WO2015092314A1 (fr) * 2013-12-20 2015-06-25 Laboratoires Urgo Matériau composite de remplissage des plaies cavitaires

Also Published As

Publication number Publication date
FR3034675B1 (fr) 2020-02-14
FR3034675A1 (fr) 2016-10-14

Similar Documents

Publication Publication Date Title
CA2832885C (fr) Pansement adhesif mince tres absorbant, ses utilisations pour le traitement des plaies chroniques
CA2832883C (fr) Pansement absorbant hydrocellulaire, ses utilisations pour le traitement des plaies chroniques et aigues
CA2831186C (fr) Pansement absorbant cicatrisant, ses utilisations pour les plaies chroniques
CA2878869C (fr) Pansement a liberation prolongee d'actifs
FR3015226A1 (fr) Materiau composite de remplissage des plaies cavitaires
EP3484532A1 (fr) Pansement permettant la liberation controlee et prolongee de la metformine
EP3082887B1 (fr) Materiau composite de remplissage des plaies cavitaires
WO2016166463A1 (fr) Materiau lamellaire non tisse pour son utilisation dans la cicatrisation des plaies par pression negative
EP3233003B1 (fr) Pansement comprenant un support et une matrice elastomerique hydrophobe
EP3191143B1 (fr) Fibre electronegative pour son utilisation dans la cicatrisation des plaies
EP3191142B1 (fr) Fibre electronegative pour son utilisation dans la cicatrisation des plaies
EP3515386B1 (fr) Pansement absorbant comprenant un non-tisse superabsorbant hydrodelitable
CA3087114A1 (fr) Composition presentant une excellente permeabilite a la vapeur d'eau
FR3039409A1 (fr) Pansement comprenant un support et une matrice elastomerique hydrophobe

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16721195

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16721195

Country of ref document: EP

Kind code of ref document: A1