EP3082676A1 - Matériau composite de remplissage des plaies cavitaires - Google Patents

Matériau composite de remplissage des plaies cavitaires

Info

Publication number
EP3082676A1
EP3082676A1 EP14830838.0A EP14830838A EP3082676A1 EP 3082676 A1 EP3082676 A1 EP 3082676A1 EP 14830838 A EP14830838 A EP 14830838A EP 3082676 A1 EP3082676 A1 EP 3082676A1
Authority
EP
European Patent Office
Prior art keywords
wound
materials
envelope
fibers
porous
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP14830838.0A
Other languages
German (de)
English (en)
French (fr)
Inventor
Jean-Marc Pernot
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Urgo Recherche Innovation et Developpement
Original Assignee
Laboratoires Urgo SAS
HCP Healthcare Asia Pte Ltd
Vivatech Co
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 SAS, HCP Healthcare Asia Pte Ltd, Vivatech Co filed Critical Laboratoires Urgo SAS
Publication of EP3082676A1 publication Critical patent/EP3082676A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—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
    • 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01021—Non-adhesive bandages or dressings characterised by the structure of the dressing
    • 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01021—Non-adhesive bandages or dressings characterised by the structure of the dressing
    • A61F13/01029—Non-adhesive bandages or dressings characterised by the structure of the dressing made of multiple layers
    • 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01034—Non-adhesive bandages or dressings characterised by a property
    • A61F13/01042—Absorbency
    • 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
    • A61M1/915—Constructional details of the pressure distribution manifold
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00119—Wound bandages elastic

Definitions

  • the present invention relates to a composite material for wound filling ("wound packing" in Anglo-Saxon terminology), including cavity wounds, which can be used in topical treatment of wounds using negative pressure devices.
  • TPN 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 increased blood flow and faster tissue granulation.
  • Topical treatments of wounds using negative pressure devices can treat different types of wounds, from small lesions to larger cavitary wounds or burns of any size. These wounds can also be deep and therefore have a large volume.
  • the lesion should heal deeply in the beginning and then close again by joining the edges of the wound in a uniform manner.
  • the wound does not close at the surface before deep healing is completed, to avoid the formation of cavities in the flesh which would become sites favorable to infections.
  • the wound is usually filled with soft or compressible porous material, and has properties to withstand the pressure differential created within the wound. relative to the atmospheric pressure room. The purpose of the material is to keep the edges of the wound sufficiently far apart so that they can not grow and join together to form an undesired cavity.
  • the material must also provide fluid flow channels to allow effective suction of exudates out of the wound, usually in a waste receptacle, also called reservoir, associated with the suction conduit.
  • the materials used in the TPN systems are distinguished from conventional multilayer lamellar dressings which are intended to provide a superficial protection for small and substantially planar lesions, and are not configured to be introduced into a patient's body. wound, but simply to be positioned on the surface of the latter, so as to isolate it from the external environment the time of healing.
  • lamellar dressings do not form fluid flow channels to allow effective drainage of exudates.
  • the materials constituting these lamellar dressings, in particular constituting the outer layer of these dressings have a certain adhesion to the tissues, and are not intended to be brought into contact with the wound. Use in a cavitary wound would inevitably cause contact between the outer layer material of the dressing and the wound tissues, which would result in an unacceptable tearing of the tissue buds during removal of the dressing.
  • porous materials of this type have the disadvantage of promoting tissue growth in their pores, tissue growth that clings to said pores, which, upon removal of the material, can damage newly formed granulation tissue and to be painful for the patient.
  • porous materials may also leave the exudates in contact with the wound, causing an accumulation of bacteria leading to infection.
  • the subject of the present invention is thus a composite wound-filling material comprising an envelope enclosing a material or a set of materials forming fluid flow channels, said envelope consisting of a nonwoven material formed from a mixture of two-component superabsorbent fibers and non-absorbing thermoling fibers, said two-component superabsorbent fibers being of the core / bark type, said core being made of polyacrylonitrile and the bark being of polyacrylate.
  • composite wound filling material is understood to mean a core / shell structure, the core being constituted by a material or a set of materials forming fluid flow channels, the bark, also called envelope, consisting of a non-woven material formed of a mixture of two-component superabsorbent fibers and non-absorbent thermoling fibers.
  • FIGS. 1A and B are diagrams illustrating two embodiments of a wound filling material according to the invention comprising a casing containing a material (FIG. 1A) or a set of materials (FIG. fluid flow (the flow of the exudates being materialized, in a purely illustrative manner, by arrows in the figures).
  • Figure 2 is a photograph of the assembly of the device used to perform the strength test implemented in the examples according to the invention.
  • Figure 3 is a photograph of the mounted device used to perform the strength test implemented in the examples according to the invention.
  • Figure 4 is a photograph of the product Algosteril® in the hydrated state after "1 cycle" of mechanical strength test.
  • FIGS. 6, 7 A and B and 8A and B are photographs of the envelope of the composite material according to various embodiments of the invention in the hydrated state, after "1 or 5 cycles", as the case may be, mechanical strength test.
  • Non-woven casing made of a blend of superabsorbent fibers and non-absorbent, heat-absorbing fibers
  • the composite wound filling material according to the invention comprises a casing made of a nonwoven material formed of a mixture of two-component superabsorbent fibers and non-absorbing thermoling fibers, said two-component superabsorbent fibers being of the core / bark type, said core being polyacrylonitrile and the bark being polyacrylate.
  • said nonwoven may consist of a mixture of superabsorbent fibers, two-component core / bark, said core being polyacrylonitrile and the bark being polyacrylate, and non-absorbent thermoling fibers, all of the fibers being preferably thermolated.
  • the nonwoven material is in particular non-adherent to human tissues, and more particularly to the wound. Thus during its removal, in a dry or wet environment, but preferably in a moist environment, said nonwoven can be removed without the structure of the wound or perilesional skin being altered.
  • 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 water per gram, and more preferably greater than 30 g water per gram.
  • the superabsorbent fibers consist of two different materials. These materials may be distributed in a side-by-side configuration, or preferably in a core-shell configuration.
  • the first material intended to form an outer part of the fiber preferably the bark, must be able to form a gel with the exudates of the wound and will advantageously be formed of one or more crosslinked and / or partially crosslinked polymers.
  • This first material 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 material to ensure the stability of the fiber after gel formation by the first material. It can be formed of any type of polymer stable in aqueous medium and compatible with the material of the bark to lead to a stable two-component fiber.
  • This second material is formed of polyacrylonitrile.
  • the superabsorbent fibers advantageously have a decitex of between 2 and 6 dtex.
  • 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 thermoling fibers capable of reinforcing and stabilizing the three-dimensional structure of the nonwoven 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.
  • thermobonding fibers of the heart-bark type in which the core is formed of a polyester such as 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 constituting the envelope of the composite 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 constituting the envelope of the composite material according to the invention can 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 fabric after absorption, by creating anchoring points between the nonwoven fibers. It is necessary to enhance the cohesion of the nonwoven to allow removal of the used composite material without tearing it.
  • 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 constituting the envelope of the composite material according to the invention can be manufactured according to the process described in the document GB 2401879.
  • Contact layer
  • the nonwoven envelope may be partially covered with a contact layer on the face of the envelope intended for come into contact with the wound, said layer comprising openings allowing the passage of exudates from the wound.
  • 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 secure the dressing using other means of fixation, e.g. covering the dressing with a restraining means or tape.
  • 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. with a dynamometer at a pulling speed of 100 mm / min at an angle of 90 °.
  • 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 hydrocolloids 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 the face of the envelope intended to come into contact with the wound.
  • the contact layer preferably has a basis weight ranging from 110 to 500 g / m, 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 in the removal of the composite wound filling material. By maintaining a moist environment on the surface of the wound while avoiding contact with the nonwoven envelope, it improves healing.
  • the incorporation of hydrocolloids gives the elastomer composition a hydrophilic character and promotes the vectorization of active agents that can promote the treatment of the wound.
  • the composition comprises one or more elastomers selected from poly (styrene-olefin-styrene) block polymers.
  • the block copolymers used in the context of the invention are advantageously triblock copolymers of the ABA type comprising two styrene thermoplastic end blocks and a central elastomer block B which is an olefin, optionally combined with AB type diblock copolymers comprising a thermoplastic block.
  • a styrene and an elastomer block B which is an olefin.
  • the olefin blocks 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.
  • Examples of poly (styrene-isoprene-styrene) (abbreviated to SIS ) can be cited products sold under the names KRATON D1107 or KRATON ® DU 19 BT or the products sold by the company EXXON MOBIL
  • VECTOR 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.
  • SIS 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).
  • compositions of the present invention triblock block copolymers and in particular the product sold by the company Kraton Polymers under the name KRATON ® Dl 119 BT.
  • the saturated central block triblock copolymers are also well known to those skilled in the art and are for example marketed:
  • SEPS poly (styrene-ethylene-propylene-styrene)
  • KRATON POLYMERS under the name KRATON ® G 1651;
  • copolymers will be preferred SEBS triblocks or
  • SEPS having a styrene content of between 25 and 45% by weight relative to the weight of said SEBS or SEPS.
  • the elastomer will be used in suitable amounts depending on the saturated or unsaturated nature of the olefin core sequence 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 exudates.
  • 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 strong absorption capacity of the hydrocolloids causes swelling of the contact layer, so that the holes of the mesh can become clogged.
  • the nonwoven does not absorb directly the exudates but absorbs the exudates present in the hydrocolloid absorbent layer which decreases the absorption capacity of the composite material and creates maceration problems.
  • 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 intended to improve their stretching, flexibility, extrudability or implementation.
  • 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.
  • Polybutenes can also be mentioned, such as, for example, the products marketed by BP Chemicals under the name NAPVIS®, or else phthalate derivatives such as dioctylphthalate or dioctyladipate, when the central block is unsaturated.
  • 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 from a fully 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 mixtures thereof in variable proportions.
  • plasticizing oils that are particularly suitable, mention may be made of: the products marketed by SHELL under the names ONDINA and RISELLA which consist of mixtures based on naphthenic and paraffinic compounds;
  • 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 “tackifying" compounds such as those conventionally used by those skilled in the art in the preparation of pressure sensitive adhesives based on elastomers.
  • tackifying compounds such as those conventionally 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 (are) incorporated into the elastomeric matrix in a proportion of about 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-adherence power for the envelope.
  • 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.
  • tackifying products 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 may 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 86 which is a synthetic resin formed of C5 / C9 or WINGTACK copolymers which is a synthetic polyterpene resin;
  • KRISTALEX 3085 which is a resin based on alpha-methylstyrene.
  • tackifying resins Escorez ® 5000 series and particularly the resin ESCOREZ ® 5380.
  • the tackifying resins may be used alone or in admixture with other tackifiers products, preferably in a proportion of 10 to 50% by weight, and more particularly from 15 to 40% by weight, based on the total weight of the composition.
  • polyisobutylenes which may be used as tackifying products
  • 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.
  • Such contact layers are for example illustrated in the application FR2973223.
  • Non-woven envelopes formed of a mixture of superabsorbent fibers and non-absorbent thermolating fibers, partially covered with a contact layer on the face of the envelope intended to come into contact with the wound are sold especially under the name Urgoclean by Urgo.
  • the composite wound-filling material according to the present invention comprises a casing as described above, enclosing a material or a set of materials forming fluid flow channels, more particularly exuded wounds.
  • the materials introduced into the envelope of the composite material according to the invention 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 or by their arrangement relative 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 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.
  • resilient material means a shape memory material.
  • the composite material of the present invention consists of a "shell enclosing a material or set of materials", i.e. it is in the form of a heart / bark structure, the core being a material or set of materials forming fluid flow channels, the shell, also called shell, consisting of a nonwoven material formed from a mixture of two-component superabsorbent fibers and non-absorbent fibers thermolating, for example in the form of nonwoven alone or optionally associated with the contact layer described above.
  • the bark completely encloses the material or set of materials forming fluid flow channels.
  • the material or materials forming channels flow of fluids may have a greater or lesser mobility within the envelope.
  • Such structures are schematized in FIGS. 1A and B.
  • the envelope contains a (single) material forming fluid flow channels.
  • the material is porous, compressible and resilient.
  • the porosity of the material gives it the property of forming fluid flow channels intrinsically, because of the properties and the nature of the material used, having in its structure fluid flow channels.
  • the envelope may contain a (single) material combining various properties, that is to say can be porous or non-porous, compressible or non-compressible, deformable or non-deformable, resilient or non-resilient, as long as it fulfills its function of forming intrinsically fluid flow channels.
  • FIG. 1A This first embodiment is viewable in FIG. 1A, in which the fluid flow channels pass the exudates as illustrated in a schematic and purely illustrative manner by arrows in the figure.
  • the envelope contains a set of materials forming fluid flow channels.
  • the materials are distinct from each other inside the envelope and separated by one or more interstices that can constitute fluid flow channels.
  • the materials may, in a first preferred aspect, be porous, compressible and resilient.
  • the fluid flow channels can then be formed both by the intrinsic porosity of the materials constituting the assembly, and by the interstices present between the different materials.
  • the materials being compressible and resilient, and able to move relative to each other within the envelope, all of these materials is also compressible and resilient.
  • the materials may, according to a second preferred aspect, be non-porous, non-compressible and non-deformable.
  • the fluid flow channels are then formed solely by the interstices present between the different materials.
  • the fluid flow channels pass the exudates as illustrated diagrammatically and purely illustratively by arrows in Figure 1 B.
  • the non-compressible and non-deformable materials can move relative to each other. other inside the envelope, giving all of these materials a deformable character.
  • This second embodiment can be viewed in FIG. 1B.
  • porous or non-porous, compressible or non-compressible, resilient or non-resilient and deformable or non-deformable materials then constituting a set of materials forming fluid flow channels.
  • the intrinsic properties of each porous material having, by its structure, inherent fluid flow channels, and the properties conferred by a set of materials, porous or not, are of course preserved in this type of association.
  • fluid flow channels can both be formed by the intrinsic porosity of a material, but also by the interstices separating different materials arranged in an assembly, especially if the latter are able to move relative to each other. other.
  • the porous, compressible and resilient fill material of the envelope may, for example, comprise one or more foams, or gauzes, but any other suitable material having the required physical characteristics may be used as the envelope filling material.
  • porous, compressible and resilient material for filling the envelope mention may be made of polyurethane foams, foams based on poly (vinyl alcohol), or based on cellulose or on starch, or many different textile products, based on synthetic or natural fibers chosen from the nonlimiting list of compounds consisting in particular of cotton, linen, wool, silk, chlorofibres, polyester, polyolefins, preferably polyethylene, or polyacrylic or polyamide fibers and in any form whatsoever, yarn, fiber, knit, woven, nonwoven, or fabric, etc.
  • This envelope filling material must be both compressible, and also hard enough to move skin tissue away from the wound bed, without being too aggressive to the tissue.
  • the porous filling material of the envelope may thus have a hardness ranging from 5 to 100 Shore A and preferably 20 to 100 Shore A.
  • the non-porous, non-compressible and non-deformable materials for filling the envelope may, for example, be chosen from PMMA (poly (methyl methacrylate)), glass, polystyrene, PVC, acrylonitrile butadiene styrene (ABS), silicone, SAN (styrene acrylonitrile), polyurethane, polyvinyl alcohol, cellulose, polyester, polyolefins, polyethylene, or a mixture of these materials.
  • the non-porous, non-compressible and non-deformable materials for filling the envelope may be chosen from glass, polystyrene or silicone beads, or polyethylene.
  • Various compounds may further be added in the casing and / or in the filling material of the composite materials of the present invention, such as, in particular, active agents or adjuvants commonly used in the field of wound treatment or in the treatment of wounds. pharmacological field.
  • the composite material may contain active ingredients having a favorable role in the treatment of the wound. These active ingredients can in particular induce or accelerate 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, antiprurigines, agents soothing agents, moisturizers, 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), CoUageneer (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
  • 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;
  • anti-pain agents 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;
  • 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),
  • 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, glycyrrhébénénique acid, tanactine (CPN), Calmiskin (Silab),
  • the active agents that can be introduced into the envelope and / or into the filling material of the composite materials according to the present invention are preferably selected from the assets promoting healing, anti-inflammatory and their mixture.
  • heating promoting active agent any active agent capable of favorably intervening at any stage of the cicatricial process and via any type of interaction whatsoever, that is to say by any interaction of a biological nature. chemical or physical with the wound in contact with which said asset is dispensed.
  • the active agents that can be introduced into the envelope and / or into the filling material of the composite materials according to the present invention are preferably chosen from metformin, the synthetic polysulfated oligosaccharides having 1 to 4 unsaturated units, such as in particular the potassium salt of sucrose octasulfate, aspirin, silver sulfate, silver sulfadiazine and mixtures thereof.
  • the composite materials according to the present invention may comprise active agents in the envelope and / or in the filling material in an amount of 0.01 to 20% by weight, preferably 1 to 15% by weight. by weight and more preferably from 2 to 10% by weight, based on the total weight of the casing and / or filling material containing them.
  • Adjuvants which may be mentioned are dyestuffs, fillers, odor absorbers or scavengers, pH regulators, microcapsules or microspheres which may optionally contain active agents, petroleum jelly, polymers or surfactants allowing optimize the rate of gelation, wettability or release of the assets of the composite material.
  • the composite material for filling wounds according to the invention may be in any desired geometric shape, in particular adapted to the shape and depth of the wound.
  • the envelope is preferably closed around the material or a set of filling materials forming fluid flow channels by heat sealing, stitching or one or more nodes at the envelope, preferably by heat sealing
  • one or more porous, compressible and elastic filling materials may be introduced in the same envelope.
  • the set of materials forming fluid flow channels may be in the form of a "pearl necklace", that is to say that several filling materials forming fluid flow channels can be distributed individually in as many cavities of the nonwoven envelope, separated from each other by heat-sealing, by stitching or by one or more nodes at the level of the envelope, preferably by heat sealing said envelope.
  • a metal rod terminated by a polished steel ball, diameter 25.3866 mm and circularity at the equator of 0.0093 mm.
  • a non-woven fabric with a basis weight of 72 g / m according to the present invention comprising bicomponent core / bark superabsorbent fibers, said core being made of polyacrylonitrile and the bark being of polyacrylate.
  • a non-woven fabric 185 g / m 2 according to the present invention comprising bicomponent core / bark superabsorbent fibers, said core being of polyacrylonitrile and the bark being of polyacrylate.
  • a non-woven fabric with a basis weight of 72 g / m 2 according to the present invention comprising bicomponent core / bark superabsorbent fibers, said core being made of polyacrylonitrile and the bark being made of polyacrylate, coated with a contact layer prepared according to the methods described hereinabove; after.
  • a nonwoven having a basis weight of 185 g / m 2 according to the present invention comprising bicomponent core / bark superabsorbent fibers, said core being made of polyacrylonitrile and the bark being made of polyacrylate, coated with a contact layer prepared according to the methods described herein; -after.
  • a contact layer was prepared according to the following protocol:
  • hydrocolloid elastomer composition was prepared by mixing in a MEL G-40 kneader.
  • the elastomer composition expressed as a percentage by weight relative to the total weight of the composition, was as follows:
  • Antioxidant sold under the name IRGANOX® 1010 by CIBA SPECIALTY CHEMICALS: 0.2%
  • the various constituents were introduced at a temperature between 105 and 115 ° C with stirring, so as to obtain a homogeneous mixture. More specifically, the mineral oil, the hydrocolloid and the elastomer were initially introduced, then the antioxidant, the salting agent and finally the tackifier resin.
  • This adhesive was coated on the non-woven material of 72 g / m 2 and the 185 g / m 2 basis weight with a grammage of 180 g / m 2 ⁇ 40 g / m 2 in the form of a net whose mesh is square.
  • the coating is carried out by hot melt transfer on an engraved cylinder.
  • the thickness of the wires is 1.6 mm.
  • TPN systems are most commonly set to vacuum at 125mmHg. This corresponds to exerting a force of 26 N on the composite material for filling the wound.
  • a square sample of 80 mm of side of each of the nonwovens constituting the envelope to be tested was cut out with the aid of a punch.
  • a test solution comprising NaCl (8.298 g + 1-5%) and CaCl 2 (0.368 g + 75%) is prepared in parallel. This solution makes it possible, on the one hand, to simulate the humidity conditions found within a wound and, on the other hand, to simulate the saline concentration of the exudates found at the level of a wound.
  • FIG. 2 illustrates the test device on which the sample of composite material consisting of the foam square and the non-woven layer has been deposited.
  • FIG. 1 illustrates a picture of the device after placement of the collet.
  • the dynamometer is adjusted so that the vertical descent rate of the metal rod terminated by the ball corresponds to (300 + 10) mm / min and so that this descent is stopped when the metal rod ends with the ball exerts a force of 26N after coming into contact with the sample. After contact and exerting the desired pressure with the sample, the metal rod terminated by the ball stops and rises.
  • the resistance of the composite samples is then observed at this first cycle.
  • Figure 4 illustrates the sample using the product "Algostéril®” after a test cycle. This product is completely unstructured due to the pressure exerted by the device simulating the pressure forces exerted on TPN.
  • Figure 5 shows the sample using the product "Aquacel®” after a test cycle. This product is completely unstructured due to the pressure exerted by the device simulating the pressure forces exerted on TPN.
  • FIG. 6 illustrates the sample employing the 72 g / m 2 nonwoven coated by the contact layer according to the invention, that is to say a nonwoven comprising heart-type bicomponent superabsorbent fibers. / bark, said core being polyacrylonitrile and the bark being polyacrylate, the whole coated by the contact layer as defined above, after 5 test cycles. It is noted that the product undergoes only very slight deformations, and in any case does not deconstruct completely or partially.
  • FIG. 7 illustrates the sample employing the nonwoven of grammage 72 g / m 2 according to the invention, that is to say a nonwoven comprising two-component superabsorbent fibers of heart / bark type, said core being polyacrylonitrile and the bark being polyacrylate, after 1 (FIG. 7A) and 5 test cycles (FIG. 7B) respectively. It is noted that the product undergoes only very slight deformations, and in any case does not deconstruct completely or partially.
  • FIG. 8A and B illustrates the sample using the nonwoven (185 g / m 2) according to the invention, that is to say a nonwoven comprising two-component superabsorbent fibers of the core / bark type, said core being polyacrylonitrile and the bark being polyacrylate, after 1 ( Figure 8A) and 5 test cycles (Figure 8A) respectively. Note that the product does not deconstruct completely or partially.
  • the sample using the nonwoven according to the invention is therefore the only one that can be used as a composite material having the desired properties of compressibility and resilience or deformability while ensuring the flow of exudates without adhering to the cells of the wound.
  • said composite material further having the ability to mechanically resist the various mechanical stresses such as pressure or pressure cycles exerted during the TPN, without destructuring. .

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Materials Engineering (AREA)
  • Anesthesiology (AREA)
  • Materials For Medical Uses (AREA)
  • Laminated Bodies (AREA)
  • Medicinal Preparation (AREA)
EP14830838.0A 2013-12-20 2014-12-19 Matériau composite de remplissage des plaies cavitaires Withdrawn EP3082676A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1363156A FR3015226B1 (fr) 2013-12-20 2013-12-20 Materiau composite de remplissage des plaies cavitaires
PCT/FR2014/053445 WO2015092314A1 (fr) 2013-12-20 2014-12-19 Matériau composite de remplissage des plaies cavitaires

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EP3082676A1 true EP3082676A1 (fr) 2016-10-26

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US (1) US20160374862A1 (zh)
EP (1) EP3082676A1 (zh)
JP (1) JP2016540593A (zh)
CN (1) CN106061446A (zh)
BR (1) BR112016014149A2 (zh)
CA (1) CA2933780A1 (zh)
FR (1) FR3015226B1 (zh)
WO (1) WO2015092314A1 (zh)

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FR3034675B1 (fr) * 2015-04-13 2020-02-14 Urgo Recherche Innovation Et Developpement Materiau lamellaire non tisse pour son utilisation dans la cicatrisation des plaies par pression negative
US20180250173A1 (en) * 2017-03-03 2018-09-06 Microcopy Ltd. Dental absorbent pad
FR3087126A1 (fr) 2018-10-16 2020-04-17 Jean Francois Van Cleef Dispositif composite de protection moulant une plaie

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US5643315A (en) * 1994-09-22 1997-07-01 Daneshvar; Yousef Device for wound therapy and prevention of bleeding
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WO2013083800A1 (de) * 2011-12-09 2013-06-13 Birgit Riesinger Set aus wundauflage und wundfüller
CN102600018B (zh) * 2012-03-31 2013-07-03 华南理工大学 具有降温和促进伤口愈合作用的医用敷料及其制备方法

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BR112016014149A2 (pt) 2017-08-08
WO2015092314A1 (fr) 2015-06-25
US20160374862A1 (en) 2016-12-29
CN106061446A (zh) 2016-10-26
FR3015226A1 (fr) 2015-06-26
FR3015226B1 (fr) 2020-04-24
JP2016540593A (ja) 2016-12-28
CA2933780A1 (fr) 2015-06-25

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