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    FAST THERAPEUTIC ABSORBENCY TISSUE REPAIR DEVICE.The present invention relates to innovative implantable medical tissue repair devices. The devices have a central tissue member that has anti-adhesion films on both opposite sides. The films have pores, and are arranged so that the pores in the opposite films are deflected. The devices are useful in hernia repair procedures.
    公开号:BR112013025206A2
    申请号:R112013025206-5
    申请日:2012-03-30
    公开日:2020-10-20
    发明作者:Joerg PRIEWE
    申请人:Ethicon, Inc.；
    IPC主号:
    专利说明:

    Invention Patent Descriptive Report for "RAPID THERAPEUTIC ABSORBING TISSUE REPAIR DEVICES".
    FIELD OF THE INVENTION The present invention relates to soft tissue repair devices capable of minimizing tissue adhesion between adjacent and opposite tissue surfaces, more particularly such soft tissue repair devices capable of rapidly absorbing agents assets in an operating room environment prior to implementation.
    BACKGROUND OF THE INVENTION Tissue repair or reinforcement implants, such as nets, can be designed to enable internal tissue growth on one side (for example, having open pores or interstices) and resist internal tissue growth on the opposite side (for example, having a smooth surface like a film or non-porous layer, conventionally called in this technique of adhesion barrier). This is important when mesh implants are used or implanted in the abdominal area, for example in hernia repair procedures, where adhesion of the peritoneum (ie, internal tissue growth) to the implant is desired while internal tissue growth or adhesions on the visceral side are undesirable (ie, anti-adhesion). Various conventional products are known in the art and are commercially available which basically have a soft side that is an adhesion barrier and a porous or rough side for internal tissue growth. Products can be completely absorbable, completely non-absorbable or partially absorbable and partially non-absorbable. The products can be composites of multiple layers of network and barriers resistant to adhesion. Certain implants are ready for use as soon as they come out of the package (for example, Proceed® Hernia Net, Gore DualMesh® and Bard Composix® Mesh) and other mesh implants need to be pre-soaked for several minutes in water or saline prior to delivery. implantation, to swell the adhesion barrier and make the implant soft enough for implantation and placement in the patient (for example, Composite
    Sepramesh®; Parietex®). In certain surgical applications, it is desirable that these implants deliver a dose of therapeutic agent or active agent to the tissues surrounding or adjacent to the implant.
    To achieve this, the implant can be preloaded by coating or otherwise impregnated with the active agent desired by the manufacturer before packaging.
    However, preloading an implant with an active agent can be difficult.
    In addition, the amount of active agent that can be added to the implant is limited, unless the active agent is applied with controlled release by the implant to controlled release to adjacent tissues.
    To enable the release of the active agent stored on both sides of an implant, the reservoir of the active agent in the implant must have fluid communication with each side of the implant.
    In the case of an implant consisting of a mesh of mesh contained between opposite layers of external film, this may be possible by including pores in the films on both sides of the mesh.
    However, providing such pores can allow tissue-to-tissue contact through the pores located in the films in the areas where the films are laminated with each other and the pores are in alignment.
    Fabric-to-fabric contact will encourage or allow unwanted adhesions to the fabric.
    If the pores are present in only one layer of the implant film, the therapeutic fluid may not be effectively exposed to the side without pores.
    It is also believed that having pores on only one side will limit the flow of tissue fluids between the two sides of the implant.
    This can result in the formation of seroma.
    A conventional way of applying active agents in conjunction with implanted medical devices is for the surgeon or assistant to immerse or soak the medical device in an active agent solution prior to implantation.
    As an example, immersing surgical mesh film for hernia in active agent solutions is important to provide a network loaded with active ingredient that can also be put in contact with the viscera to prevent adhesions.
    In other applications, there may be a need to place the tissue in contact with the vaginal wall (for example, a pelvic net) or in contact with the urethra, as with the TVT system
    GYNECARE® by Ethicon, Inc., where a set of perforated film could be beneficial to prevent erosion of structures such as the bladder, vaginal wall, etc. by the implant.
    Products currently available on the market and commercially available that are coated with collagen films (eg Parietex®Composite (PCO) MESH) have to be incubated for 5 to 10 minutes in an active agent solution, which is a relatively time-consuming task to perform in the operating room (OR) and while the patient is under anesthesia during a procedure.
    An additional disadvantage of products currently available for commercialization is that active agent coatings are very sensitive to mechanical forces during handling in the operating room, and using forceps to manipulate or place implants can easily destroy these coatings and can lead to product disintegration.
    Certain commercially available mesh composite implants, such as the Composix® mesh, have a polypropylene mesh with an ePTFE layer on one side of the mesh.
    As both polypropylene and ePTFE do not accept hydrophilic liquids very well, it is expected that the application of such networks together with a solution for coating the active ingredient through a trocar to the surgical site will be difficult.
    WO2003041613 A1 describes networks that have two synthetic polymer films on each side, where the films are glued or welded to the pores of the network; perforated films containing pores on both sides and films containing displaced pores are not described.
    EP1237588 B1 describes a non-absorbable mesh implant covered on one side with an absorbable film produced from natural materials (hyaluronic acid) or derivatives of natural products (CMC) that may have pores, and between an adhesive such as a polylactide copolymer.
    A drug can be incorporated into any portion of the prosthesis to provide controlled release of the drug to the body.
    WO2003099160 A1 describes films with protrusions that may be present on both sides of a tissue implant, where both films may have holes that are arranged in a pattern.
    It is taught to fill the lumps with an active agent, however, immersion or filling of the area outside the lumps is not indicated. EP1541183 A1 describes a network having absorbable polymeric films with two different absorption times. US20030017775 A1 describes an intraluminal composite prosthesis which is preferably used as a vascular prosthesis and includes an ePTFE layer and a textile material layer, which are joined by an elastomeric bonding agent. The ePTFE layer includes a porous microstructure defined by nodes interconnected by fibrils. The adhesive bonding agent is preferably applied in solution so that the bonding agent enters the pores of the ePTFE microstructure. There is a need in this technique for tissue implantation devices that offer advantages over prior art tissue devices, including providing a device that allows rapid absorption of active agents while providing tissue separation at least for a certain period of time. In particular, tissue implants that are suitable for rapid immersion coating processes are needed to provide active implants with effective amounts of active agents quickly and efficiently, particularly for immersion in the operating room. Dip-fast and laminated mesh implants are also necessary, suitable for an in-line process (through a coating bath), in which the time of impregnation of the active agent in the mesh implant is reduced.
    SUMMARY OF THE INVENTION Consequently, innovative medical devices for tissue repair implantation are revealed. The medical tissue implant device of the present invention has a tissue repair member that has a plurality of limb openings or pores and is preferably a tissue like a mesh. The repair member has opposite and second sides. A first polymeric film, having pores from the first film, is mounted on the first side of the member. A second polymeric film, having the pores of the second film, is mounted on the second side of the member. The pores of the first film are not in alignment with the pores of the second film, that is, the pores are displaced, so that fabric contact is substantially avoided. Another aspect of the present invention is a method of repairing a tissue defect, using the above described tissue repair implant devices. Yet another aspect of the present invention is a combination of the aforementioned tissue repair implant device and an active agent. The tissue repair devices of the present invention have many advantages. An advantage of the devices of the present invention is to allow an active agent containing liquid to impregnate the repair tissue and films in a short period of time, while not exposing the tissue directly or adjacent to direct contact when implanted, thus minimizing the possibility of adhesions to the fabric. The devices of this invention are particularly suitable for immersion in active agent solutions, either in a batch process (such as in an operating room environment) or through a manufacturing process, and demonstrate rapid absorption of liquids.
    BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of an embodiment of a tissue repair device of the present invention. FIG. 2 illustrates an enlarged partial cross section of the tissue repair device of FIG. 1 along line of sight 2-2. FIG. 3 is an illustration of a section of one embodiment of a tissue repair device of the present invention made in accordance with Example 1 showing the relationship between the upper pores of the film in the upper porous film and the lower pores of the film in the lower porous film and the central network. FIG. 4 is an enlarged illustration of a pore in a film according to an embodiment of the present invention made in accordance with
    Example 1.
    DETAILED DESCRIPTION OF THE INVENTION The implantable medical tissue repair devices of the present invention as described herein consist of a composite of a repair tissue member and porous adhesion barrier films mounted on opposite external sides of the tissue repair tissue. Both films have pores, so that tissue repair devices can be easily and quickly immersed, regardless of the size of the device and the way in which it is placed in the immersion bath, that is, horizontally or vertically. Due to the non-overlapping or unaligned orientation of the pores in the opposite films of the devices of the present invention (i.e., displaced pores), the devices can be placed in contact with the viscera with little concern, since the aforementioned pore orientation it completely or substantially prevents fabric-to-fabric contact and at the same time allows fabric to contact the mesh on both sides (good internal growth). In addition, less seroma formation (and therefore less infection) is expected due to the improved fluid flow through the implant. Surgical repair fabrics suitable for use as the middle layer or middle layer of the tissue repair devices of the present invention include conventional mesh, woven fabrics and tapes for surgical applications. Other fabrics or materials include perforated or condensed films and non-woven ePTFE materials having pore sizes of at least one millimeter. The tissues will have open pores with a size of at least 1 mm. "Open pores" means openings that extend from one side of the fabric to the opposite side, providing a route through the fabric. Depending on the intended use of the tissue repair device, a long-term, stable biocompatible polymer can be used to manufacture a repair tissue member. Long-term stable polymer means a biocompatible, non-resorbable polymer, or a bioabsorbable polymer that absorbs or degrades slowly, for example, that can
    at least 50% of its resistance to original rupture in vivo 60 days after implantation.
    The latter group includes substances such as polyamides, which are generally considered to be resistant, as they are not designed as resorbable materials, but are attacked over time by body tissue and tissue fluids.
    Preferred materials for the repair tissue limb include polyhydroxy acids, polylactides, polyglycolides, polyhydroxy butyrates, polyhydroxy valerates, polycaprolactones, polydioxanones, oligo and natural and synthetic polyamino acids, polyanhydrides, polyoxides, polyphosphates, polyphosphates, polyphosphates , polyalcohols, polysaccharides, polyethers, polyamides, aliphatic polyesters, aromatic polyesters, copolymers of polymerizable substances and resorbable glasses.
    Particularly preferred materials for the repair tissue member include polypropylene and mixtures of polyvinylidene fluoride and copolymers of vinylidene fluoride and hexafluorpropene, PTFE, ePTFE and cPTFE, however other conventional biocompatible materials are also useful.
    Tissue repair members can be constructed from monofilaments, multifilaments or combinations thereof.
    The repair tissue member may contain, in addition to a long-term stable polymer, a resorbable polymer (ie, bioabsorbable or biodegradable). The resorbable polymer and the long-term stable polymer preferably contain monofilaments and / or multifilaments.
    The terms resorbable polymers and bioabsorbable polymers are used interchangeably in the present invention.
    The term bioabsorbable is defined to have its conventional meaning.
    Although not preferred, the repair tissue member can be made of bioabsorbable polymers without any long-term stable polymers.
    The films that are used to manufacture tissue repair implant devices of the present invention will have a thickness that will be sufficient to effectively prevent the formation of adhesions.
    The thickness will typically be in the range of about 1 µm to about 500 µm, and preferably about 5 µm to about 50 µm.
    Films suitable for use as first and second films of the tissue repair devices of the present invention include bioabsorbable and non-absorbable films.
    Films are preferably polymer based and can be produced from several conventional biocompatible polymers.
    Non-resorbable or very slowly resorbable substances include polyalkenes (for example, polypropylene or polyethylene), fluorinated polyolefins (for example, polytetrafluorethylene or polyvinylidene fluoride), polyamides, polyurethanes, polyisoprene, polystyrene, polysilicon polycarbonates, polyarylethylketones (PEEKs), esters of polymethacrylic acids, esters of polyacrylic acids, aromatic polyesters, polyimides, as well as mixtures and / or copolymers of these substances.
    Also useful are synthetic bioabsorbable polymer materials, for example, polyhydroxy acids (for example polylactides, polyglycolides, polyhydroxybutyrates, polyhydroxyvalerates), polycaprolactones, polypropylanones, synthetic oligo- and polyamino acids and natural, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers.
    However, naturally occurring materials such as collagen, gelatin or materials derived from natural products such as bioabsorbable cross-linked Omega 3 fatty gel or oxygenated regenerated cellulose (ORC) can also be used.
    The films used in the tissue repair devices of the present invention can cover the entire outer surfaces of the repair limb tissue or a part of it.
    In some cases, it is beneficial to have films overlapping the limits of the repair tissue.
    The term limit used in the present invention means a peripheral border or central border if there is an orifice in the network, for example, to receive an anatomical structure like the intestine for treatment or prevention of parastomal hernia or spermatic cord.
    The porous films used to build the devices of the present invention will have open pores.
    Perforated or porous films can be prepared using conventional processes such as mechanical cutting or puncture, by applying energy such as laser, ultrasound, microwave, heat or corona / plasma.
    Engraving processes by chemical corrosion or injection molding can also be used.
    Conventional processes
    Foaming agents, including lyophilization can also be used to create the open porous structure.
    The pores in the films may be made in the form of multiple slits or incisions without cutting or removing material from the film, or they may be of a certain length and width or diameter resulting from the removal of material from the film, or they may be openings resulting from absence of polymeric material in locations in the film.
    The pores can have several geometrical configurations including circular, oval, rectangular, lozenge, square, tri-angular, polygonal, irregular, combinations thereof and the like.
    It is particularly preferable that the pores are holes extending through the film having a circular cross section.
    The films can be perforated before or after the device is assembled, or the films can be manufactured in a way that contains pores.
    However, it will be understood by those skilled in the art that precautions must be taken to avoid injury to the tissue limb or the second film when drilling a mounted device.
    For ease of fabrication during assembly and a desired wettability with aqueous coatings (ie, liquid must enter / air must escape), perforation / pore size should typically be at least 0.2 mm to 5 cm, preferably 0.5 to 7 mm, with a maximum preference of 1 to 5 mm in at least one direction.
    As previously mentioned, the pores can be of different sizes and shapes.
    In addition, depending on the manufacturing technique, the edges of the film pores can be smooth or rough.
    In addition, the pore edges can be embossed and rounded or chamfered.
    The films can be joined in several conventional ways, for example by sewing, gluing, welding and laminating.
    The union / connection can be around the periphery, in the central region or in the entire assembly as a linear point or general connection, making sure that the upper and lower pores are substantially displaced.
    The films can be connected to each other and / or to the repair fabric member in several conventional ways, for example, by sewing, embroidering, binding (including thermal means) in partial regions (for example, in stitches or along lines or strips, such as the peripheral edge), or thermally welded, including by ultrasonic means.
    Welding techniques also include, in the broadest sense, thermal deformation of at least one of the films (below the melting point of a film). The implant can optionally have embroidered structures designed as reinforcement, for example, structures similar to ribs.
    Particularly preferred for the devices of the present invention is a film-to-film connection with the use of hot lamination techniques, optionally with the use of an additional biocompatible melt glue such as polydioxanone as a relatively low melting bioabsorbable polymer.
    Other soluble polymers such as polylactide, polycaprolactone or copolymers thereof can be used as solvent adhesives.
    Reactive adhesives such as cyanoacrylates or isocyanates or oxirans can also be used if biocompatible.
    Now with reference to Figures 1 and 2, a tissue repair implant device 1 of the present invention is observed.
    Device 1 is seen to have a central or intermediate tissue member 20. Member 20 is seen to have a substantially flat web woven from fibers 22. Member 20 is seen to have a plurality of mesh openings or pores of mesh 25 formed between fibers 22. Member 20 has opposite outer sides 28. Device 1 is also seen as having first and second porous adhesion barrier films 10 and 30 mounted, respectively, to the fabric member 20 on the sides opposites 28. In this embodiment of the tissue repair device of the present invention, films 10 and 30 are connected together through mesh openings or mesh pores 25. The first film 10 is seen as having pores of film 12 extending through the same, while the second film 30 has pores of film 32 that extend through it.
    Pores 12 and pores 32 are arranged to be displaced so that they are not in alignment, thus not providing a direct route between opposing pores 12 and 32. The term active agents includes, but is not limited to, thermal agents
    pharmaceuticals.
    The selection of active agents that can be used in combination with the medical devices of the present invention depends on the benefit desired by the patient.
    For example, it may be advantageous to provide an implant according to the present invention that has at least one biologically active or therapeutic ingredient that can optionally be released locally after implantation.
    Substances that are suitable as active or therapeutic agents can be naturally occurring or synthetic and include, but are not limited to, for example, antibiotics, antimicrobials, antibacterials, antiseptics, chemotherapy, cytostatics, metastasis inhibitors, antidiabetics, antimycotics , gynecological agents, urological agents, antiallergic agents, sex hormones, sex hormone inhibitors, hemostiptics, hormones, peptide hormones, antidepressants, vitamins such as vitamin C, antihistamines, naked DNA, plasmid DNA, cationic DNA complexes, RNA, constituent cells, vaccines, naturally occurring cells in the body or genetically modified cells.
    The active or therapeutic agent can be present in various forms including in an encapsulated or adsorbed form.
    With such active agents, the patient's outcome can be enhanced or a therapeutic effect can be provided (for example, better wound healing, inhibition or reduction of inflammation). A preferred class of active agents is antibiotics, which include such agents as gentamicin or antibiotic brand ZEVTERA ™ (ceftobiprole medocaril) (available from Basilea Pharmaceutica Ltd., Basel, Switzerland). Other active agents that can be used are highly effective, with a wide spectrum of antimicrobials against different bacteria and yeasts (even in the presence of body fluids) such as octenidine, octenidine dihydrochloride (available as an active ingredient in the Octenisept® disinfectant from Schülke & Mayr , Norderstedt, Germany as), polyhexamethylene biguanide (PHMB) (available as an active ingredient in Lava-sept® from Braun, Switzerland), triclosan, copper (Cu), silver (Ag), nanoparticulate silver, gold (Au ), selenium (Se), gallium (Ga), taurolidine, N-chlorotaurine, alcohol-based antiseptics such as the Listerine mouthwash (R), N α-lauryl-L-
    arginine ethyl ester (LAE), myristamidopropyl dimethylamine (MAPD, available as an active ingredient in SCHERCODINE ™ M), oleamidopropyl dimethylamine (OAPD, available as an active ingredient in SCHERCODINE ™ O) and propyl dimethylamine (SAPD, available as an active ingredient in SCHERCODINE ™ S), fatty acid monoesters and most preferably octenidine dihydrochloride (later in this document called octenidine), taureolidine and PHMB.
    A preferred class of active agents are local anesthetics that include agents such as: Ambucaine, Benzocaine, Butacaine, Procaine / Benzocaine, Chloroprocaine, Cocaine, Cyclomethylcaine, Dimetocaine / Larocaine, Ethidocaine, Hydroxyprocaine, Hexylcaine, Isobucaine, Paraeto- xicaína, Piperocaína, Procainamida, Propoxicaína, Procaína / Novocaína, Proparacaína, Tetracaína / Ametocaína, Lidocaína, Articaína, Bupivacaína, Dibucaína, Cinchocaína / Dibucaína, Etidocaína, Levobupivacaína, Lidocaí- na- poxicaína, Pirrocaína, Ropivacaína, Tetracaína, Trimecaína, Tolicaína, combinations thereof, for example, lidocaine / prilocaine (EMLA) or naturally-derived local anesthetics including Saxitoxin, Tetrodotoxin, Menthol, Eugenol and prodrugs.
    In some cases, the active or therapeutic agent is provided in a solution.
    The solution can comprise any suitable solvent compatible with the selected active ingredient.
    The solution can be water-based and can contain at least one of the following additional conventional ingredients: a surface active agent, a polymer, protein or dye.
    Polymers are used to adjust the release rate.
    Depending on the active agent and the required release, mixtures of polymeric solvent for coatings can be advantageous.
    In addition, a contrast agent can be incorporated into the devices of the present invention.
    This contrast agent can be a biocompatible dye to create a visual marker as described in EP1392198B1, which is incorporated by reference or an agent such as a gas or gas-creating substance for ultrasonic or MRI contrast, such as metal complexes such as GdDTPA or superparamagnetic nanoparticles (Resovist ™ or Endorem ™) as presented in EP 1324783 B1, which is incorporated by reference.
    X-ray visible substances could be included as shown in document 5 EP1251794B1 (incorporated by reference) including pure zirconium dioxide, stabilized zirconium dioxide, zirconium nitrate, zirconium carbide, tantalum, tantalum pentoxide, sulfate barium, silver, silver iodide, gold, platinum, palladium, iridium, copper, ferric oxides, non-magnetic implant steels, non-magnetic implant steels, titanium, alkali iodides, iodized aromatics, iodized aliphatics, iodized oligomers, polymers iodines, alloys of substances thereof capable of being formed into an alloy.
    Contrast agents can be included within or over the network, or within or over the films.
    In addition, swelling or gel-forming substances can be added to the mesh and / or films.
    This has the advantage of improving the absorption of the immersion solution.
    Substances include proteins such as collagen or gelatin, surfactants such as PPO-PEO block copolymers (Pluronics), polysorbates such as polysorbate 20, 40, 60, 65, 80 (Tweens), or spans such as Span 20 (sorbitan monolaurate), Span 40 (sorbitan monopalmitate), Span 60 (sorbitan monostearate), Span 65 (sorbitan tristearate), Span 80 (sorbitan mono-oleate), phospholipids, natural or synthetic hydrophilic polymers such as alginate, dextran, chitosan, carcinene, PEG, PVA, PVP, CMC, HES.
    Hydrogel-forming polymers can be obtained by polymerization, polyaddition or polycondensation containing at least one of the substances selected from the following group: polymerized ethyl hydroxy methacrylate (HEMA); polymerized hydroxypropyl methacrylate (HPMA); polymerized α-methacryloyl-o-methoxy polyethylene glycol; polymerized polyethylene glycol-bisacrylate; A-B-C-B-A resorbable prepolymers with A = acrylic or methacryl groups, B = hydrolytically divisible and containing polymers of lactide, glycolide, 2-hydroxybutyric acid, 2-hydroxyvaleric acid, trimethylene carbonate, poly-polyesters, polyanhydrides, poly-
    phosphates, polyphosphazenes and / or polyamides and / or copolymers thereof, and C = hydrophilic polymers, in particular polyethylene glycol (PEG), polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), poly N-isopropylacrylamide (PNiPAAM). The following examples illustrate the principles and practice of this invention, although I do not limit it.
    Example 1 LAMINATED LIGHT WEIGHT NET BETWEEN TWO POROUS MO- NOCRYL ® FILMS A lightweight polypropylene net having the same weft structure as the Ultrapro® net available from Ethicon, Inc., Somerville, New Jersey, USA, but without absorbable filaments Monocryl® (polyglecaprone 25) was prepared.
    This net was laminated by heat between two layers of film.
    The first film consisted of a 25 µm thick polyglecaprone 25 Monocryl® film that was extruded and laminated with 8 µm thick poly-p-dioxanone film (PDS).
    The pre-laminate was laser cut with 1 mm holes or pores with a 5 mm hole-to-hole distance.
    A second laminate layer comprising polyglecaprone 25 Monocryl film having a thickness of ____ was laser cut and precut in the same way as the first laminate layer above.
    Both films were placed so that the holes or pores were not in alignment (that is, displaced) and were mounted as opposite external films on the external surfaces of the polypropylene mesh.
    The film netting was laminated in a hot press between several layers of parchment paper and cooled between 2 metal plates (30 seconds, 120 ° C and cooled for about 30 minutes between the metal plates) . An 8x11 cm sample of this laminate was placed horizontally in a dish containing 0.1% (by weight) of aqueous violet crystal antibacterial solution as a model antibacterial solution.
    The laminated mesh, including the mesh and films, was completely impregnated with the solution for 10 seconds.
    A laminate of films having films with no holes or pores of the same size was similarly tested and needed significant time.
    longer to impregnate. The time for impregnating the film laminates without pores or holes was observed to be about 5 to 10 minutes or more. After drying the impregnated coated mesh laminate, 5 it was observed that the film bonding area in the center of the mesh pores is basically free of antibacterial dye and the mesh and mesh surrounding the area between the films is stained (about 30 % to 50% of the total area). An illustration of a section of a modality of a tissue repair device of the present invention made in accordance with this Example 1 is seen in FIG. 3. It shows the relationship of the upper film pores in the upper porous film to the lower film pores in the lower pore film, and a central network. FIG. 4 is an enlarged illustration of a pore in a film according to an embodiment of the present invention made in accordance with this Example 1. Example 2
    HORIZONTAL IMMERSION This example demonstrated the wetting capabilities of the tissue repair devices of the present invention compared to non-porous devices. Various 8x12 cm laminates with films containing pores (pore diameter = 1 mm, pore spacing = 5 mm) were prepared according to Example 1. Various 8x12 cm laminates with non-porous films were prepared according to o Example 1 with the exception that non-porous films were used in place of porous films. The dry weight was determined for porous and non-porous laminates. The laminates were placed horizontally in a flat container containing 500 ml of 0.2% Lavasept solution for 10 seconds (produced from a Lavasept concentrate (20% PHMB), lot 7383M03). The laminates were removed and slightly shaken to remove excess liquid and the weight was determined again. Table 1 contains the results of the horizontal immersion experiments.
    Table 1
    HORIZONTAL IMMERSION EXPERIMENTS Laminated Dry Weight Weight Ume- Au-% Au-% (Before deciding (After ment deviation immersion) 10s of medium standard immersion [grams] are) [heavy weight] (%) 1) Porous 0.7801 2.0006 256 - - 2) Porous 0.7707 1.9505 253 - - 3) Porous 0.8013 2.0184 252 254 2 4) Non-porous 0.9558 1.4962 157 - - 5) No porous 0.9512 1.4995 157 - - 6) Non-porous 0.9604 1.8926 197 170 23 All laminates containing pores were apparently completely moistened, including between films. Non-porous laminates began to wet between films on the periphery (laminate 6 in particular was about a quarter moist between films after 10 seconds). The pore-containing laminates had about 70% more liquid absorption after 10 seconds (170% 254%). The weight gain of non-porous laminates appears to be entirely due to the liquid on top of the films, while the increase in laminates containing pores was also due to the absorption of liquid between the films. Example 3 HORIZONTAL IMMERSION IN THE OPERATION ROOM AND PROPERTIES
    HANDLING The laminates were prepared according to Example 1, but in a size of 18 cmx14 cm. Laminates containing pores and non-porous laminates were placed through a conventional 12 mm trocar inserted into the abdominal cavity of a pig. The implants were easily moved (by sliding) through the intestine and then placed against the abdominal wall. Laminates containing pores and non-porous laminates were removably allowed to the abdominal wall. No instruments were needed to keep them in place. The same handling behavior was observed even 5 in implants pre-moistened for 10 seconds in isotonic saline. With the area weights calculated in Table 1, the test articles had a fixation force to the abdominal wall greater than their own area weight of 20 mg / cm2 in the case of the perforated film dipped (calculated from 2 g of the 8x11 cm of wet implant drilled in flap 1). The devices of this invention were seen as useful for preventing adhesion as a film barrier and potential vehicle for the application of medications in surgical fields such as pelvic, colorectal and plastic surgery. Example 4 POROUS CPTFE SHEET BETWEEN 2 PERFORATED FILMS An Omyra 10x10 cm (B.Braun) mesh was laminated according to Example 1 between the perforated Monocryl® films at 120 ° C for 5 minutes and then cooled between two plates of cold metal for another 30 minutes. The films were laminated stable in the pores of the mesh, the usual handling and flexion of the composite implant did not indicate delamination. The optical control showed no overlap of the film pores, that is, displaced pores. Example 5 FILM LAMINATE PERFORATED WITH OCTENIDINE + COATING
    TO IMMERSION THE POLYMERIC COATING A 16 cm x 16 cm mesh laminate was prepared according to Example 1. 1 kg of a coating solution was prepared containing 1.5 g octenidine dihydrochloride + 9 g polymer for PEDG / PLLA 60 / coating 40 according to Example 5b of the commonly assigned pending patent application, Serial No. 12 / 609,10 1 filed on October 30, 2009 (incorporated by reference) + 889 g acetone + 100 g deionized water.
    The coating solution was purged in a thin, tall, vertical and rectangular bath container (length up to 20 cm, height up to 20 cm, width up to 2 cm) and the residence time of the implant sheet was about 5 minutes, then it was removed at a speed of 53 mm / second, allowed to dry (about 30 minutes at room temperature / normal pressure and then overnight in a vacuum chamber evaporated by oil pump), perforated in 1.5 cm circles, packaged and sterilized using a conventional ethylene oxide sterilization process. After sterilization, the disks had a content of 2200 ppm octenidine with a standard deviation of 11% between 3 mesh disks. In an FCS containing a S.aureus assay, the mesh discs showed strong antibacterial activity when incubated for 4 hours in 3 ml of bacteria / serum mixture of at least lg5 compared to the uncoated control. Example 6 SURGICAL PROCEDURE USING IMPLANT DEVICES
    OF TISSUE REPAIR OF THE PRESENT INVENTION A patient with a ventral hernia is prepared for surgery in a conventional manner and anesthetized in a conventional manner. The ventral hernia repair procedure is performed as follows with the use of a tissue repair implant device of the present invention. LVHR (Laparoscopic Repair of Ventral Hernia) After placing the trocars, place the pneumoperitoneum, cleaning the contents of the hernia bag and adhesion lysis, the surgeon identifies the size of the hernia defect. An appropriately sized net (according to the present invention) having a certain overlap to cover the hernia defect is wound tightly and passed through the abdomen through a 10 mm or 12 mm opening. If necessary, the net is dipped for a few seconds in a container containing an active solution such as antibiotic or antiseptic before passing through the trocar to the patient.
    After the trocar is passed, the network unfolds alone or with little assistance from a suitable surgical instrument in the intestine and is moved and positioned in the right location and orientation.
    Then the net is lifted on the abdominal wall to cover the defect and is fixed or self-fixed to the abdominal wall.
    Fixation is done in a conventional manner with the use of sutures or transabdominal staples.
    Although this invention has been shown and described in relation to its detailed modalities, those skilled in the art will understand that various changes in the form and detail of it can be made without deviating from the character and scope of the claimed invention. .
    权利要求:
    Claims (25)
    [1]
    1. Medical tissue implantation device, comprising: a tissue repair member having a plurality of limb pores, the repair member having opposite and first sides 5; a first polymeric film that has first film pores, the first polymeric film being mounted on the first side of the member; and, a second polymer film that has second film pores, the second polymer film being mounted on the second side of the fabric member, where the first film pores are not in alignment with the second film pores .
    [2]
    Medical device according to claim 1, which further comprises an active agent.
    [3]
    3. Medical device according to claim 3, in which the active agent is selected from the group consisting of antibiotics, chemotherapeutics, cytostatics, metastasis inhibitors, antidiabetics, antimycotics, antimicrobials, antibacterials, vitamins, gynecological agents, agents urological, antiallergic agents, sex hormones, sex hormone inhibitors, local anesthetics, hemostiptics, hormones, peptide hormones, vitamins, antidepressants, antihistamines, naked DNA, plasmid DNA, cationic DNA complexes, RNA, cell constituents, vaccines, naturally occurring cells in the body, genetically modified cells and mixtures thereof.
    [4]
    4. Medical device according to claim 3, in which the active agent is an antimicrobial selected from the group consisting of octenidine, PHMB, triclosan, copper, silver, nanoparticulate silver, gold, selenium, gallium, taurolidine, cyclotaurolidine, N-chlorotaurine, alcohol, LAE, MAPD, OAPD, and mixtures thereof.
    [5]
    Medical device according to claim 4, wherein the antimicrobial is triclosan.
    [6]
    A medical device according to claim 4, wherein the antimicrobial is octenidine.
    [7]
    7. Medical device according to claim 4, wherein the antimicrobial is PHMB. 5
    [8]
    8. Medical device according to claim 1, wherein the tissue repair member is a tissue.
    [9]
    9. Medical device according to claim 8, wherein the tissue repair tissue is selected from the group consisting of nets, woven materials, non-woven materials, and tapes.
    [10]
    10. Medical device according to claim 9, wherein the tissue repair member is a mesh.
    [11]
    11. Medical device according to claim 1, wherein the tissue repair member comprises a biocompatible non-absorbable polymer selected from the group consisting of polyalkenes, polypropylene, polyethylene, fluorinated polyolefins, polytetrafluoroethylene, polyvinylidene fluoride, polyamides, polyurethanes, polyisoprene, polystyrene, polysilicones, polycarbonates, polyarylethylketones, polymethacrylates, polyacrylates, aromatic polyesters, polyimides, cellulose, copolymers of polymerizable substances thereof.
    [12]
    A medical device according to claim 1, wherein the tissue repair member comprises a bioabsorbable polymer selected from the group consisting of polyhydroxy acids, polylactides, polyglycolides, polyhydroxybutyrates, polyhydrodorxivalerates, polycaprolactones, polydiaxanones, oligo and natural and synthetic polyamino acids, polyphosphazenes, polyanhydrides, polyesters, polyoxaester, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers, resorbable glasses, copolymers of polymerizable substances thereof.
    [13]
    13. Medical device according to claim 1, wherein the first and second films comprise a biocompatible non-absorbable polymer selected from the group consisting of polyolefins, polyester, nylon, Teflon, polyvinylidene fluoride, and cellulose .
    [14]
    Medical device according to claim 1, wherein the first and second films comprise a biocompatible bioabsorbable polymer selected from the group consisting of polyhydroxy acids, polylactides, polyglycolides, polyhydroxy butyrates, polyhydroxy valeriates, poly-caprolactones, polydioxanones, oligo and natural and synthetic polyamino acids, 5 polyphosphazenes, polyanhydrides, polyiortoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers, polyamides, aliphatic polyester polyester and aromatic polyesters, aromatic polyesters resorbable.
    [15]
    Medical device according to claim 1, wherein the film pores have a size in the range of about 0.1 mm to about 5 mm.
    [16]
    Medical device according to claim 1, wherein the films have a thickness of about 5 µm to about 50 µm.
    [17]
    17. Medical device according to claim 1, wherein the tissue repair member comprises monofilament fibers.
    [18]
    18. Medical device according to claim 1, wherein the tissue repair member comprises multifilament fibers.
    [19]
    19. Medical device according to claim 1, further comprising a polymeric coating.
    [20]
    20. Medical device according to claim 1, wherein the pores have a substantially circular cross section.
    [21]
    21. The medical device of claim 1, wherein the pores comprise slits.
    [22]
    22. Method of repair of a tissue defect, which comprises the steps of: inserting a tissue repair implant device in a position adjacent to a tissue defect, the device comprising: a tissue repair member having a plurality limb pores, the repairing member having opposite first and second sides; a first polymeric film that has first film pores, the first polymeric film being mounted on the first side of the
    bro; and a second polymer film that has second film pores, the second polymer film being mounted on the second side of the fabric member, 5 where the first film pores are not in alignment with the second film pores and, attaching the repair device to the tissue defect.
    [23]
    23. The method of claim 22, which further comprises the step of immersing the device in a solution containing an active agent prior to insertion of the tissue repair device.
    [24]
    24. Combination comprising: a) a medical tissue implantation device, comprising: a tissue repair member that has a plurality of limb poles, with the repair member having first and second sides opposites. a first polymeric film that has first film pores, the first polymeric film being mounted on the first side of the member; and, a second polymer film that has second film pores, the second polymer film being mounted on the second side of the fabric member, where the first film pores are not in alignment with the second film pores and, b) an active agent.
    [25]
    25. The combination of claim 24, wherein the active agent is in solution.
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    同族专利:
    公开号 | 公开日
    CN103442741B|2016-12-07|
    US8579990B2|2013-11-12|
    EP2691124B1|2016-07-06|
    EP2691124A1|2014-02-05|
    KR101952571B1|2019-02-27|
    MX338766B|2016-04-28|
    JP2014514941A|2014-06-26|
    MX2013011344A|2013-12-16|
    CN103442741A|2013-12-11|
    US20120253472A1|2012-10-04|
    CA2831605C|2019-07-02|
    KR20140018318A|2014-02-12|
    IL228556D0|2013-12-31|
    AU2012236308B2|2015-12-10|
    JP5932019B2|2016-06-08|
    IL228556A|2017-07-31|
    WO2012135593A1|2012-10-04|
    AU2012236308A1|2013-10-17|
    CA2831605A1|2012-10-04|
    RU2013148112A|2015-05-10|
    ZA201308109B|2015-11-25|
    ES2594773T3|2016-12-22|
    RU2608461C2|2017-01-18|
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    法律状态:
    2020-10-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-12-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2021-02-09| B11B| Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements|
    2021-11-23| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US13/075,531|2011-03-30|
    US13/075,531|US8579990B2|2011-03-30|2011-03-30|Tissue repair devices of rapid therapeutic absorbency|
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