EP3700592A1 - Implant partie molle biocompatible - Google Patents

Implant partie molle biocompatible

Info

Publication number
EP3700592A1
EP3700592A1 EP18795509.1A EP18795509A EP3700592A1 EP 3700592 A1 EP3700592 A1 EP 3700592A1 EP 18795509 A EP18795509 A EP 18795509A EP 3700592 A1 EP3700592 A1 EP 3700592A1
Authority
EP
European Patent Office
Prior art keywords
soft tissue
tissue implant
layer
textile fabric
fibers
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Withdrawn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
EP18795509.1A
Other languages
German (de)
English (en)
Inventor
Karl-Heinz HEFFELS
Denis Reibel
Dirk Grafahrend
Guenter Germann
Oliver Boegershausen
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.)
Carl Freudenberg KG
Original Assignee
Carl Freudenberg KG
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 Carl Freudenberg KG filed Critical Carl Freudenberg KG
Publication of EP3700592A1 publication Critical patent/EP3700592A1/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Withdrawn legal-status Critical Current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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/20—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/34—Macromolecular materials
    • A—HUMAN NECESSITIES
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/044—Proteins; Polypeptides; Degradation products thereof
    • A61L29/045—Collagen
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/044—Proteins; Polypeptides; Degradation products thereof
    • A61L29/046—Gelatin
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/044—Proteins; Polypeptides; Degradation products thereof
    • A61L29/048—Other specific proteins or polypeptides not covered by A61L29/045 - A61L29/047
    • A—HUMAN NECESSITIES
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    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
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    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
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    • A61L29/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
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    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
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Definitions

  • the present invention relates to a soft tissue implant for implantation in a human body.
  • the invention further relates to a method for producing the soft tissue implant.
  • Biocompatibility refers to the property of materials in a biological environment adapted to the situation
  • An implant is a material that is implanted in the body and is intended to remain in the human body permanently or for a period of a few days to 10 years. Medical implants have the task of supporting body functions or replace, while in plastic implants the shape, if necessary
  • breast implants are used as implants for soft tissue, for breast reconstruction or breast augmentation.
  • Calf muscles or cheek, nose, buttock, testis or humerus implants Calf muscles or cheek, nose, buttock, testis or humerus implants.
  • the silicone often used in implants is basically silicone
  • the immune system of the host body is activated after implantation and tries to resorb the foreign material. If the immune cells do not resorb due to the foreign material properties, the body begins to surround the implant with a fibrous sheath and thereby separate from the surrounding tissue. This separation is at least then of concern when the capsule of scar tissue hardens and to
  • biocompatible materials for the surface of implants that can interact with the host body. These can be bioresorbable materials that can be decomposed and metabolized by the body's own cells. Be this Materials designed as support structures, cells can migrate into these structures to build new, endogenous tissue.
  • Supporting structure material is meanwhile absorbed (US 6,638,308 B2
  • the invention is based on the object
  • Soft tissue implant in particular to provide a breast implant for introduction into a human body, which has the aforementioned disadvantages
  • a biocompatible soft tissue implant in particular breast implant for introduction into a human body comprising at least one layer comprising an elastomeric material, and at least one arranged on this layer and the surface of the
  • the connection between the textile fabric and the elastomeric material can be communicated via the bioresorbing fibers, which are at least partially embedded in the layer of elastomeric material.
  • This embedding can be obtained, for example, that the textile fabric on an elastomeric precursor material, for example an unvulcanized silicone layer is applied and pressed into this. The impressions have the purpose of introducing the fibers of the textile fabric into the precursor layer. Subsequently, the composite, for example by vulcanization of the precursor to form the
  • elastomeric material can be a stable composite material with high
  • Layer adhesion can be obtained.
  • a high layer adhesion is to be understood that the soft tissue implant can be handled in the usual way and, for example, can be introduced into the human body, without the adhesion between elastomeric material and textile
  • the soft tissue implant according to the invention offers the following advantages
  • the soft tissue implant it is advantageous for the soft tissue implant to have a surface which is formed from a textile material which has bioresorbable fibers, since biocompatibility-enhancing interaction with the surrounding tissue is possible as a result.
  • Textile fabrics have a three-dimensional structure due to their fiber structure. As explained above, structured surfaces can reduce the frequency of occurrence of
  • Nonwovens are particularly preferred since the fibers are present there as a random knit and have a strong three-dimensional structuring.
  • One possible measure of the extent of the three-dimensional structuring of the surface is the average pore size of the textile fabric.
  • the textile fabric has a mean pore size of 50 ⁇ to 300 ⁇ , preferably from 70 to 250 ⁇ , more preferably from 100 to 200 ⁇ on.
  • the pore size is measured before introduction into the elastomeric material. It is measured according to ASTM E 1294 (1989).
  • the bioresorbable fibers may be resorbed after being introduced into the body over time. It is advantageous that the bioresorbable fibers are also present within the elastomeric layer, as in bioresorption
  • the layer of elastomeric material is thus provided with cavities.
  • the formation of the cavities takes place continuously, with preferably more than half, more preferably more than 75% by weight, in particular more than 90% by weight, of the textile fabric being absorbed after 60 days.
  • the layer of elastomeric material is successively to the surface layer of
  • the soft tissue implant according to the invention allows ingrowth of body tissue and consequently a stepwise replacement of the textile
  • a further advantage of the soft tissue implant according to the invention is that, at least in the first time after introduction into the body, the surface of the elastomeric material is absorbed by the bioresorbable coating Body can be separated from the tissue, which increases its acceptance and tissue compatibility after implantation.
  • the soft tissue implant according to the invention is characterized in that it can have excellent elasticity due to the use of an elastomeric material. As a result, a good adaptation to deforming forces outside and inside the body can be ensured.
  • the high elasticity is particularly advantageous if the soft tissue implant, for example, as a breast implant to be introduced by the smallest possible body opening in the body. Its high elasticity allows the soft tissue implant to deform severely, for example, to be lengthened to pass through the small
  • the soft tissue implant is characterized by an elasticity measured according to DIN 53504 S2 at a rate of 200 mm / min from 50% to 500%, preferably from 200% to 500%, more preferably from 400% to 500%. It was surprising for the person skilled in the art that the soft tissue implant according to the invention can have such a high elasticity. In particular, it was expected that at
  • the proportion of the textile Area at the surface of the soft tissue implant more than 50%, more preferably more than 70%, more preferably more than 90% and in particular 100%.
  • the above values refer to the state before introduction into the human body.
  • the bioresorbable fibers may comprise a wide variety of fiber materials.
  • the fibers comprise bioresorbable fiber materials selected from the group consisting of natural polymers, proteins, peptides, sugars, chitosan, chitin, gelatin, collagen, polyvinyl alcohol, polyvinylpyrrolidone, dextran, pullulan, hyaluronic acid, polycapolactones, polylactides, polyglycolides, polyhydroxyalkanolates, polydioxanones,
  • the fiber material consists entirely of the abovementioned materials, with customary auxiliaries, for example catalyst residues, also being present in the fiber material.
  • the fibers exclusively comprise gelatin as bioresorbable fiber material and / or consists of at least 70% by weight, and / or at least 80% by weight, and / or at least 90% by weight, and / or At least 95% by weight of gelatin, in each case based on the total weight of the bioresorbable fibers.
  • Porcine gelatin is preferred according to the invention, since these are not
  • BSE bovine spongiform encephalopathy
  • the bioresorbable fibers usually contain water.
  • the bioresorbable fibers additionally contain at least one hydrophilic additive.
  • the hydrophilic additive is selected from the group consisting of: carbomer [9003-01 -4], ethyl acetate, polymer with 1-ethenyl-2-pyrrolidinone [25086-89-9], 1-ethenyl-2-pyrrolidinone homopolymer [9003- 39-8], cellulose
  • hydroxypropylmethylether [9004-65-3], polycarbophil [9003-97-8], 1-ethylen-2-pyrrolidinone homopolymer [9003-39-8], methylcellulose (E 461), ethylcellulose (E 462), hydroxypropylcellulose (E 463 ), Hydroxypropylmethylcellulose (E 464), methylethylcellulose (E 465), sodium carboxymethylcellulose (E 466),
  • Carboxymethylcellulose cellulose acetate (e.g., available from Chisso, Eastman), cellulose acetate butyrate (e.g., available from Eastman, FMC),
  • Cellulose acetate maleate cellulose acetate phthalate (e.g., available from Eastman, FMC, Parmentier), cellulose acetate trimellitates (e.g., available from Eastman, Parmentier), cellulose fatty acid esters (cellulose dilaurate, cellulose dipalmitate, cellulose distearate, cellulose monopalmitate, cellulose monostearate,
  • pregelatinized starch dextrin [9004-53-9], cellulose, 2-hydroxyethyl ether [9004-62-0], hydroxyethylmethylcellulose [9032-42-2], cellulose, 2-hydroxypropyl ether [9004-64-2], cellulose, 2 Hydroxypropyl ether (low substituted) [9004-64-2], hydroxypropyl starch [1 13894-92-1], ethenol,
  • polyethylene oxide polyethylene glycol.
  • the abovementioned hydrophilic additives are present, for example, in an amount of from 0.1% by weight to 30% by weight, preferably from 0.5% to 20%, more preferably from 1% to 10%, each based on the total weight of the bioresorbable fibers.
  • Particularly preferred according to the invention are sodium hyaluronate,
  • Hyaluronic acid polyethylene oxide and polyethylene glycol.
  • hydrophilic additives are used with them a particularly high initial wettability of, for example, less than 10 seconds, preferably less than 5 seconds, more preferably less than 2 seconds can be achieved.
  • the high initial wettability is advantageous to the fabric before the introduction of the soft tissue implant in the
  • Soft tissue implant in the human body can do it in particular
  • antimicrobials anesthetics, anti-inflammatory agents, and
  • Antinarbensch, antifibrotic agents, chemotherapeutic agents and leukotriene inhibitors are particularly suitable for preventing infection.
  • the bioresorbable fibers may be continuous filaments or staple fibers, continuous filaments being understood to be fibers of theoretically unlimited length and staple fibers are fibers of limited length.
  • the bioresorbable fibers are formed as continuous filaments and / or staple fibers with a minimum length of 5 mm, for example of 5 mm to 10 cm. In practical
  • the textile fabric has a basis weight of from 10 to 300 g / m 2 , preferably from 50 to 200 g / m 2 , more preferably from 70 to 150 g / m 2 . This has proved to be advantageous since a sheet with these basis weights has sufficient stability to be applied wrinkle-free on a variety of layers of elastomeric material three-dimensional geometry can.
  • the textile fabric measured with a width of 20 mm can be given a maximum tensile force of at least 0.5 to 100N, preferably from 1.0 to 50N, more preferably from 2.0 to 30N. This is advantageous because a minimum maximum tensile force for the processing of the textile
  • the period of time within which the textile fabric is absorbed depends on various parameters and, among other things, on the thickness of the textile fabric. Against this background, it has proved to be expedient in most cases the textile fabric, with an average thickness of less than 2 mm, preferably from 5 to 700 nm
  • the textile fabric may in principle comprise one or more fiber layers. Particularly preferably, it comprises only one fiber layer, since adhesion problems, as often occur between multiple fiber layers, can be avoided.
  • the textile fabric can also be used in a wide variety of applications
  • Embodiments are present, for example as a woven, knitted or nonwoven fabric.
  • nonwovens as stated above, according to the invention particularly preferred, in particular in a rotary spinning process produced nonwovens.
  • rotary spinning processes nonwovens can be produced, for example, by using a fiber material
  • containing fluid which as a melt, solution
  • Dispersion or suspension may be present, the fluid spun by rotation spinning, stretched and deposited into a nonwoven. This technique can be used at low temperatures up to 60 ° C. This allows a particularly gentle processing of the biopolymers and active ingredients.
  • Nonwovens which are particularly preferred according to the invention are nonwovens, as described in WO 2008/107126 A1, WO 2009/036958 A1, EP 2 409 718 A1, EP 2 042 199 A1, EP2129339 B1, CA2682190C. The aforementioned
  • the layer of elastomeric material may comprise a wide variety of elastomeric materials. Of these materials, silicone elastomers, particularly medical grade silicone elastomers, are particularly preferred because they are relatively inert and do not react with the body.
  • the layer of elastomeric material preferably comprises at least 70% by weight and / or at least 90% by weight and / or at least 95% by weight of the abovementioned silicone elastomers. Most preferably, the layer of elastomeric material to 100 wt.% Of silicone elastomers medical grade, which may contain conventional additives.
  • the thickness of the layer comprising the elastomeric material may vary depending on the materials used and the intended use. As a rule, have thicknesses in the range of 100 ⁇ to 5000 ⁇ , preferably from 100 ⁇ to 4000 ⁇ more preferably from 100 ⁇ to 3000 ⁇ proven.
  • the layer of elastomeric material may in principle comprise one or more layers
  • the soft tissue implant has a carrier layer. This is preferably arranged on the side of the layer facing away from the textile fabric, comprising the elastomeric material.
  • the carrier layer consists of a biocompatible material, since this can remain in the soft tissue implant and meets the requirements for introduction into the human body. For this reason, the carrier layer preferably consists of an elastomeric material, in particular silicone. It is also conceivable the use of others
  • Carrier layers such as films, plates or impression body.
  • an implant is to be understood as a material implanted in the body which is to remain there permanently or at least for a period of time, for example from a few days to 10 years.
  • Soft tissue implant designed as a breast implant, and has the following
  • the layer of elastomeric material is in the form of a bubble-like sheath
  • the envelope can be filled and / or filled with a liquid to viscous filling material
  • the bioresorbable fibers having textile fabrics is arranged as a coating on the outside of the shell.
  • the entire surface of the coating can be formed, so that the aforementioned advantages are particularly efficient can be exploited.
  • the coating completely covers the outside of the envelope.
  • the soft tissue implant is shaped so that it can fill a cavity in shape and size in the human body.
  • the soft tissue implant according to the invention can in a preferred
  • the first method step comprises providing a carrier layer.
  • the carrier layer preferably consists of an elastomeric material, in particular silicone. It is also conceivable the use of others
  • the second method step comprises the application of a biocompatible elastomeric precursor material, in particular unvulcanized Silicone, on one side of the backing layer.
  • a biocompatible elastomeric precursor material in particular unvulcanized Silicone
  • elastomeric precursor material a wide variety of materials, such as unvulcanized and / or incompletely vulcanized silicone can be used. These materials can be converted into elastomeric materials by crosslinking in the form of vulcanization.
  • the third method step comprises the application of a bioresorbable fibers having textile fabric on the elastomeric precursor material such that the fibers of the fabric at least partially penetrate into the elastomeric precursor material.
  • the penetration of the fibers of the textile fabric into the elastomeric precursor material can be accomplished, for example, by pressurizing the composite of textile fabric and elastomeric precursor material.
  • the elastomeric precursor material preferably has a
  • a textile fabric are preferably the above-mentioned textile
  • Sheets used Particular preference is given to fabrics containing fibers of gelatin.
  • the fourth process step comprises crosslinking the elastomeric precursor material to an elastomeric material.
  • the crosslinking can be easily carried out by heating (vulcanization). It was surprising to the person skilled in the art that the crosslinking also works in the presence of a gelatin-containing textile fabric, since gelatin
  • Soft tissue implant excellent in training as a breast implant excellent in training as a breast implant.
  • this also comprises the breast implant itself.
  • this preferably has a bubble-like sheath of elastomeric material, in particular of silicone, as a layer comprising an elastomeric material, wherein the sheath can be filled with a liquid to viscous filling material and / or filled. If an envelope which has not yet been filled with filling material is used, then it can be filled in a simple manner even after its connection to the textile fabric and subsequently closed.
  • the filling material may comprise a wide variety of materials.
  • the filling material is selected from the group consisting of saline, viscous saline, silicone gel, hydrogel and
  • thermoreversible polymeric gel thermoreversible polymeric gel
  • the implant On the outside of the sheath, the implant has a textile fabric having bioresorbable fibers, the bioabsorbable fibers at least partially penetrating the sheath of elastomeric material.
  • the breast implant is shaped so that it can fill in shape and size a cavity in the human body.
  • the soft tissue implant according to the invention is shaped so that it can fill in shape and size a cavity in the human body.
  • a method comprising the following steps: 1. Providing a bubble-like envelope of elastomeric material, wherein the envelope can be filled and / or filled with a liquid to viscous filling material;
  • Sheet at least partially penetrate into the shell
  • MED-6400A component A
  • MED-6400B component B
  • NuSil technology Components A and B are mixed at a weight ratio of 1: 1 at room temperature. The mixture is further processed bubble-free.
  • the resulting elastomeric precursor material is poured onto the surface of a bubble-like shell as a carrier layer.
  • the envelope coated with elastomeric precursor material is held level for 30 minutes to level and evaporate the solvent.
  • gelatin fleece is placed on the surface of the coated sheath.
  • the composite of gelatin non-woven and silicone-coated shell is produced by crosslinking of the elastomeric precursor. This is done in a programmable oven with the following temperature program: 30 minutes at room temperature, 45 minutes at 75 ° C and 135 minutes at 150 ° C with constant change (programming).
  • Soft tissue implant performed with a tensile tester according to DIN 53504 S2 with top speed of 200 mm / min.
  • Fig. 1 Result tensile test pure silicone layer as a reference
  • Fig.2 Result tensile test of the soft tissue implant of Example 1
  • FIG. 3 Microscopic image of the surface of the soft tissue implant from Example 1 after two weeks storage at 37 ° C. in PBS
  • Fig. 5 Schematic cross-section of a device according to the invention
  • Soft tissue implant in its embodiment as a breast implant.
  • FIG. 1 shows as a reference the result of a tensile test with a pure silicone layer.
  • FIG. 2 shows the result of a tensile test of the soft tissue implant from Example 1.
  • the gelatin nonwoven in the composite causes a high
  • Silicon layer almost doubled at 400% - 500%, presumably because the fibers tear and hold together independently of the elastomer. From 200% elongation, the voltage pickup increases linearly again. In this area, it is believed that the elastomer content increases the applied forces, whereas previously the forces were absorbed by the nonwoven fabric up to 200% elongation.
  • the maximum tensile force (HZK) in this composite with 2.4 to 3 MPa is five times greater than with a pure silicone layer.
  • FIG. 3 shows a micrograph of the surface of the
  • FIG. 4 shows the schematic cross section of a device according to the invention
  • Soft tissue implant (1) comprising a layer (2) made of an elastomeric material, and a textile fabric (3) arranged on said layer (2) and forming the surface of the soft tissue implant, the textile fabric (3) comprising bioresorbable fibers at least partially capable of (2) embedded in elastomeric material.
  • FIG. 5 shows the schematic cross section of a device according to the invention
  • Soft tissue implant (1) in its embodiment as a breast implant.
  • Breast implant has a bubble-like sheath (4) made of elastomeric material, here made of silicone, wherein the sheath (4) with a liquid to viscous
  • the implant On the outside of the sheath (4), the implant has a textile fabric (3) having bioresorbable fibers, the bioabsorbable fibers at least partially penetrating the sheath (4) of elastomeric material.
  • FIG. 6 shows an electron micrograph of the sectional view of a soft tissue implant according to the invention.
  • a gelatin fleece as a textile fabric

Abstract

L'invention concerne un implant de partie molle (1) biocompatible à implanter dans un organisme humain, comprenant au moins une couche (2) comportant un matériau élastomère et, disposée sur cette couche (2), au moins une surface textile (3) formant la surface de l'implant de partie molle (1), la surface textile (3) présentant des fibres biorésorbables qui sont au moins en partie incorporées à la couche (2) en matériau élastomère.
EP18795509.1A 2017-10-26 2018-10-26 Implant partie molle biocompatible Withdrawn EP3700592A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017009989.8A DE102017009989A1 (de) 2017-10-26 2017-10-26 Biokompatibles Verbundmaterial zum Einbringen in einen menschlichen Körper
PCT/EP2018/079407 WO2019081708A1 (fr) 2017-10-26 2018-10-26 Implant partie molle biocompatible

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EP3700592A1 true EP3700592A1 (fr) 2020-09-02

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EP18795509.1A Withdrawn EP3700592A1 (fr) 2017-10-26 2018-10-26 Implant partie molle biocompatible
EP18793653.9A Withdrawn EP3700591A1 (fr) 2017-10-26 2018-10-26 Matériau composite biocompatible à introduire dans un organisme humain

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EP18793653.9A Withdrawn EP3700591A1 (fr) 2017-10-26 2018-10-26 Matériau composite biocompatible à introduire dans un organisme humain

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US (2) US20200289716A1 (fr)
EP (2) EP3700592A1 (fr)
JP (2) JP2021500178A (fr)
CN (2) CN111278474A (fr)
BR (2) BR112020006403A2 (fr)
DE (1) DE102017009989A1 (fr)
RU (2) RU2739357C1 (fr)
WO (2) WO2019081700A1 (fr)

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AU2022218761A1 (en) * 2021-02-09 2023-08-10 Japan Vam & Poval Co., Ltd. Gelatine-containing device

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DE102017009989A1 (de) 2019-05-02
WO2019081708A1 (fr) 2019-05-02
RU2020117044A (ru) 2021-11-26
US20200289716A1 (en) 2020-09-17
EP3700591A1 (fr) 2020-09-02
BR112020006403A2 (pt) 2020-09-24
BR112020006394A2 (pt) 2020-09-24
CN111278474A (zh) 2020-06-12
JP2021500170A (ja) 2021-01-07
RU2739357C1 (ru) 2020-12-23
WO2019081700A1 (fr) 2019-05-02
US20200289715A1 (en) 2020-09-17
RU2020117044A3 (fr) 2021-11-26
JP2021500178A (ja) 2021-01-07

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