DE102013014295A1 - Surgical implant - Google Patents

Abstract

A surgical implant (10) comprises a flat, flexible, porous base structure (12) having a first side and a second side. At least one resorbable colored film piece (20) is attached to the base structure (12) and has a plurality of solid ridges protruding from the colored film piece (20) in a direction away from the base structure (12). The at least one colored film piece (20) is arranged in a mold structure that is asymmetric in the area of the base structure (12) ("E"). Optionally, the implant (10) further comprises an adhesion barrier layer (16).

Description

The invention relates to a surgical implant, in particular a tissue-reinforcing implant for the repair (reconstruction) of inguinal hernias (inguinal hernias) and / or abdominal hernias (abdominal hernias) / scar fractures (incisional hernias).

Hernia reconstruction is one of the most common surgical procedures, with approximately 6.4 million surgeries performed annually worldwide. Annually, approximately 3.1 million hernias (48%) are reconstructed using flat nets.

The surgical implant mesh reinforces the area of the hernia. To achieve a secure fixation, the mesh may be sutured to the body tissue near the hernia. However, the suturing step extends the surgical procedure and may result in postoperative pain in the patient, e.g. B. because of nerve damage.

The WO 2011/026987 A discloses a prosthetic tissue (mesh) having an array of sutures and barbs that extend outwardly with respect to one side of the tissue. The barbs, which serve as a fixation aid, may be formed of threads, or made of a biocompatible material as hooks and attached to the tissue. The other side of the fabric has a microporous layer made of a bioabsorbable material. The barbs are generally sharp as a result of a cutting process. To reduce the tendency of this product to adhere to itself, e.g. When folded for transport through a trocar sleeve, the barbs are covered with a coating made of a water-soluble material that dissolves during the surgical procedure. Handling the product can still be difficult.

With low weight and large pore networks and with small holding increases on one side, it is often difficult to identify the correct side for placement. Especially with nets having a transparent adhesion barrier film attached to one side, orientation may be difficult and incorrect placement could be dangerous.

It is known to provide a surgical mesh with markings to facilitate the placement of the mesh in a surgical procedure.

For example, the EP 1 439 796 B1 a planar implant with a net-like base structure and a mark in the central area. Through this central marker runs a marker line.

The WO 2011/159700 A1 discloses a composite implant including an anisotropic surgical mesh that is more extensible along a first axis and less extensible along a second axis that is transverse to the first axis. Over one side of the anisotropic mesh is an alignment mark extending along the first axis. The mesh and alignment mark are sandwiched between two absorbable anti-adhesion films.

The EP 2 593 038 A1 relates to a surgical prosthesis comprising a base tissue and information means provided to guide the surgeon to implant the prosthesis in a particular position. The informational agents include a patch of a color different from that of the base tissue. The patch has barbs that protrude from one of its surfaces and it can be fixed by the barbs at a particular position on the surface of the base fabric.

Object of the present invention was to provide a surgical implant, z. For hernia reconstruction, which reduces the need for suturing and which can be handled easily, quickly and safely during a surgical procedure.

This object is achieved by a surgical implant according to claim 1. Claim 18 is directed to a method of making such a surgical implant. Advantageous embodiments of the invention will become apparent from the dependent claims.

The surgical implant according to the invention comprises a flat, flexible, porous base structure having a first side and a second side. Further, the implant includes at least one absorbable colored film piece (film piece) attached to the base structure (eg, on the first side thereof) and having a plurality of solid protrusions formed from the colored film piece in one direction sticking out of the base structure. The at least one colored film piece is arranged in a mold structure that is asymmetric in the region of the base structure.

The basic structure is flat, ie it is generally flat. It is not necessarily flat because, in principle, it could also be curved in a third dimension. In addition, the basic structure is flexible and porous. In advantageous embodiments, it is made of a polymeric material and comprises a net-like structure with pores (eg with a size of at least 1 mm), eg. As a surgical mesh or a porous film. The pores allow the ingrowth of body tissue. Such structures are generally well known in the art.

The surgical implant further comprises at least one colored film piece. Its color is generally well visible in optical contrast with the base structure or possible other components of the implant. The at least one colored piece of film is arranged in an asymmetrical manner. This means that when the surgical implant is flipped about an axis that is generally in the plane of the base structure and viewed from the same position as before, the at least one colored piece of film will look different, usually as a mirror image.

The at least one colored film piece may include only a single colored film piece, or a plurality of colored film pieces.

If there is only one colored piece of film, it has an associated asymmetric shape structure, i. H. that its shape in the area of the basic structure is asymmetric. In this case, the colored film piece may extend over a larger part of the area of the base structure, e.g. B. including the edge or part thereof, for. B. in a strip-like arrangement. Because the colored film piece locally forms an additional layer fixed to the base structure, the rigidity of the implant is generally increased by such a construction. It can also be imagined that the surgical implant has several connected asymmetrical shape structures.

When providing a plurality of colored film pieces, the asymmetrical shape structure is preferably formed by a plurality of individual colored film pieces arranged in an asymmetric pattern. In this case, each colored film piece may have a symmetrical shape, but the overall arrangement is in a pattern that is asymmetric. When the colored film pieces are comparatively small, the flexibility behavior of the base structure as a whole is not much influenced by the presence of the colored film pieces.

The inventive surgical implant can, for. B. constructed as a hernia implant, as pelvic mesh, as a breast implant support or as a reconstruction patch for the dura mater. Particularly preferred is the use as a tissue-reinforcing implant for the repair (reconstruction) of inguinal hernias (inguinal hernias) and / or abdominal hernias (abdominal hernias) / incisional hernias (incisional hernias).

The plurality of solid ridges protruding from the at least one colored film piece in a direction away from the base structure imparts a self-fixing effect to the implant. The elevations mechanically engage in soft tissue, resulting in increased resistance to shear forces as well as peel forces. This reduces the need for additional fixation during the surgical procedure, e.g. By suturing, and is expected to lower the risk of pain for the patients and to increase the speed of the surgical procedure. In general, the inventive surgical implant attaches to body tissue, but it may nevertheless be repositioned during the surgical procedure. In addition, when folded, the surgical implant does not adhere to itself, which makes handling much easier. In general, the implant can be easily made and handled during surgery. After the period of tissue integration, the implant is securely held in place and network migration is prevented. Because the at least one colored piece of film is made of resorbable material, it is absorbed after some time, so that ultimately no bumps or barbs remain in the body tissue.

Another advantage of the surgical implant according to the invention is derived from the at least one colored piece of film. Because of its arrangement in an asymmetrical shape structure, the at least one colored piece of film provides an optical indication of the correct placement of the implant in open and laparoscopic operations. Furthermore, the orientation of the implant (the first side of the base structure points in the direction of the surgeon or pointing in the opposite direction) is easily recognized by means of the asymmetrical shape structure. This is important because the elevations must point in the right direction and an optional adhesion-preventing layer of the implant (see below) must also point to the right side. Without the visual aid, by means of the at least one colored piece of film, it would be difficult to properly place the implant, especially if gloves are worn and the implant is lightweight.

Thus, the at least one colored piece of film has a dual function: it improves attachment to body tissue (by means of the elevations) and promotes correct placement of the implant (because it is colored and easily visible, and because of its asymmetric arrangement). This double effect leads to a lower consumption of material, which is advantageous for the patient, because no additional markings are necessary to indicate the correct position of the implant.

In advantageous embodiments of the invention, the asymmetric shape structure of the at least one colored film piece defines at least one symbol or a sequence of symbols. For example, a plurality of colored film pieces may be arranged as the letters of a word, e.g. A brand. Alternatively, a word may be represented in reverse (negative), e.g. B. with only one colored piece of film, the parts are missing, representing the letters of the word. Accordingly, one can also imagine sequences of words or combinations of such positives and negatives. In general, a sequence of symbols provides the necessary asymmetry. If the sequence has a meaning, it is immediately clear whether it occurs in the correct orientation or in mirror image form.

In advantageous embodiments of the surgical implant according to the invention, second film pieces (preferably resorbable) are applied to the base structure (eg on its first side) in addition to the at least one colored film piece, each of the second film pieces having at least one protrusion consisting of respective second film piece protrudes in a direction away from the base structure. The second pieces of film are not colored or otherwise colored compared to the at least one colored piece of film. The second pieces of film (this includes the case of only a single second piece of film) are helpful when additional mounting surface is necessary. Because of their different color, the at least one colored piece of film can be distinguished well from the second piece of film.

For example, every other piece of film may have a size that is equal to or greater than the size of a pore of a net-like base structure. A second piece of film may be shaped, e.g. Hexagon, rounded hexagon, triangle, rounded triangle, rectangle, rounded rectangle, square, rounded square, circle or ellipse, or may be the shape of a cross, serpentine, or spiral. The second film pieces may be arranged in a regular pattern. A second piece of film may be surrounded by a surface of the base structure which is free of other pieces of film, this area having a width in the range of e.g. B. 1 mm to 10 mm can have. It is also possible that second film pieces are connected to each other via struts, z. As pairs (eg with a strut between the members of a pair), in smaller groups or in larger groups. Such struts can be made of the same material as the film pieces. If the strips are relatively narrow, they form connectors that are not rigid and do not degrade the flexibility characteristics of the implant.

The total area of all film pieces (ie, the at least one colored film piece and the second film pieces) is preferably less than 50% of the area of the first side of the base structure (eg, less than a value selected from the following list: 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%). A total area of all film pieces of about 5% of the area of the first side of the basic structure may already be sufficient to achieve the desired self-fixing effect by means of the elevations.

The film pieces (i.e., the at least one colored film piece and the second film pieces) may have a thickness of e.g. B. in the range of 5 microns to 250 microns or in the range of 10 microns to 200 microns. This is the thickness of the film in an area between elevations. In general, the thickness may vary and may be substantially less than the thickness of the original planar film layer used to make the film pieces including bumps (see examples below) because in the manufacturing process, a portion of the material will transfer the original film layer into the bumps can be.

In advantageous embodiments of the invention, at least one elevation is rod-shaped, columnar or mushroom-shaped. A shape defined by a respective body and a respective head, with the body protruding from the film piece and terminating in the head, and the head extending sideways with respect to the body is a kind of mushroom shape, but somehow more general. Such mushroom-like elevations may show a particularly effective self-fixation effect.

Preferably, the ridges have a respective longitudinal axis which protrudes from the associated film piece at an angle with respect to the surface of the film piece in the range of 40 ° to 90 ° or in the range of 70 ° to 90 °. The ridges may have a wide variety of dimensions, e.g. B. measured along the longitudinal axis of an increase, in the range of 20 microns to 5000 microns or in the range of 100 microns to 500 microns or from 20 microns to 400 microns. Typically, the areal density of the elevations is in the range of 0.5 elevations / mm ² to 5 elevations / mm ² or increases / mm ² to 4 elevations / mm ² . Of course, the implant may have protrusions of different shapes or sizes, or protrusions provided in different areal densities on respective pieces of film. The film pieces and the corresponding ridges may be made in one piece, see the following examples of manufacturing methods.

Also on the second side of the base structure, a film may be attached. This movie can have different properties. For example it may be provided as a single piece, for example as a continuous film covering part or all of the second side of the base structure; or it may be provided as a plurality of film pieces, similar to the second film pieces. In addition, the film on the second side may be resorbable or non-absorbable. It may have elevations to achieve a self-fixation effect, or it may be more or less smooth, with no elevations. If the film has barrier properties, body tissues can be prevented from growing into the pores of the base structure. Adhesion barrier films can be transparent, so it is generally difficult to find out which side of the surgical implant is the first side and which side is the second side. The inventive asymmetrical arrangement of the at least one colored film piece provides a clear marking and thus solves this problem.

In a further advantageous embodiment of the invention, the effect of raised film pieces on both sides (first side and second side) of the base structure is achieved by a layer of film pieces. In this case, the at least one colored film piece extends into the pores present in the base structure, with protrusions protruding from the at least one colored film piece in both directions, away from the first side of the base structure and away from the second side of the base structure. The second pieces of film or a portion thereof may or may be constructed in a similar manner.

In particularly advantageous embodiments of the surgical implant according to the invention, at least two strip-like shaped structures, each comprising at least one colored film piece and each defining a sequence of symbols, are attached to the base structure (eg its first side). Uncolored or otherwise colored second film pieces having ridges may optionally be attached to the base structure (eg, on its first side), in an area between the strip-like mold structures, if a greater self-fixing effect is desired. For example, the sequence of symbols may indicate to the surgeon a mark or clue, including repetitions, such that the marking effect produced by the asymmetry is very evident and a relatively large area is provided which exhibits a self-fixation effect. The positioning of the strip-like mold structures can also provide information about the actual position of the implant. As already mentioned, the sequence of symbols can be represented as positive (which almost does not affect the flexibility of the implant), or as negative (which generally reduces the flexibility of the implant because of the overall greater thickness of material).

In general, the film pieces are resorbable because some time after the surgical operation, the self-fixation effect is no longer necessary. If the film pieces have decomposed or been absorbed at this time, tissue growth on the base structure and the healing process can be improved. If the base structure is also resorbable, the film pieces are preferably more rapidly absorbable than the base structure.

Suitable materials for the resorbable film pieces (i.e., colored film pieces as well as resorbable second film pieces) are well known in the art. The selection of the film material depends z. B. from the absorption time. Considering manufacturing methods of this invention may also depend on the melting temperature of the film material as compared to the material of the base structure (see below). For example, the film pieces may be poly-p-dioxanone ("PDS"), copolymers of glycolide and ε-caprolactone (eg, "Monocryl" from Johnson & Johnson Medical GmbH) and / or copolymers of glycolide and lactide (especially in the ratio of 90 : 10, "Vicryl" from Johnson & Johnson Medical GmbH). In general, a wide variety of synthetic bioabsorbable polymeric materials can be used, e.g. Polyhydroxy acids (eg, polylactides, polyglycolides, polyhydroxybutyrates, polyhydroxyvalerates), copolymers of lactide and trimethylene carbonate, copolymers of glycolide, lactide and trimethylene carbonate, polycaprolactones, polydioxanones, synthetic (but also natural) oligo- and polyamino acids, polyphosphazenes, polyanhydrides, Polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers. However, naturally occurring materials such as collagens and gelatin or naturally derived materials such as bioabsorbable gel sheets crosslinked with omega-3 fatty acids or oxidized regenerated cellulose (ORC) are also possible.

Suitable materials for the base structure are also well known in the art. Absorbable or very slowly resorbable substances include, for. Polyalkenes (e.g., polypropylene or polyethylene), fluorinated polyolefins (e.g., polytetrafluoroethylene (PTFE) or polyvinylidene fluoride), polyamides, polyurethanes, polyisoprenes, polystyrenes, polysilicones, polycarbonates, polyaryletherketones (PEEKs), polymethacrylic acid esters, polyacrylic acid esters, aromatic polyesters , Polyimides as well as mixtures and / or copolymers of these substances. Other advantageous materials, many of which are resorbable, include polyhydroxy acids, polylactides, polyglycolides, copolymers of lactide and trimethylene carbonate, copolymers of glycolide, lactide and trimethylene carbonate, polyhydroxybutyrates, polyhydroxyvalerates, Polycaprolactones, polydioxanones, poly-p-dioxanone, synthetic and natural oligo- and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers, cellulose, bacterial cellulose, polyamides, aliphatic polyesters, aromatic polyesters, copolymers of polymerizable Substances thereof, and absorbable glasses. Particularly advantageous materials include polypropylene (non-resorbable), blends of polyvinylidene fluoride with copolymers of vinylidene fluoride and hexafluoropropene (non-resorbable, eg, "Pronova" from Johnson & Johnson Medical GmbH), PTFE (non-absorbable, including ePTFE and cPTFE), Polysiloxanes (non-resorbable), poly-p-dioxanone ("PDS", resorbable), copolymers of glycolide and lactide (absorbable), in particular 90:10 copolymers of glycolide and lactide ("Vicryl", resorbable), copolymers of glycolide and ε-caprolactone (absorbable "monocryl"). Biological materials such as allograft types and xenograft types are also possible. In general, materials suitable for the base structure are also conceivable as materials for an adhesion barrier film (see above).

In summary, the inventive surgical implant has a number of advantages. Self-fixation properties result in improved comfort for the patient due to a reduced risk of chronic pain that may be associated with suture fixation. The basic structure, z. A surgical mesh, is securely held in place during the period of integration in the tissue so that network migration is prevented. Thereafter, the film pieces including the bumps can be absorbed.

Furthermore, the efficiency during the surgical operation is improved in terms of time. In particular, the surgical implant can be made and handled more easily during the operation. In general, because of the construction of the ridges, the implant does not tend to stick to itself when rolled up or folded. Thus, the implant is well suited for laparoscopic placement. It can be brought to the surgical site through a trocar sleeve and then easily unrolled or unfolded without sticking to itself. Moreover, it is possible to reposition the implant because it is generally possible to detach it from body tissue and reposition it at a different or displaced location, although the implant is self-fixating. If its design is versatile enough, the implant will adhere well to anatomical structures, even if they are not even. Because it is generally not necessary to fix the implant by suturing, the surgical procedure may tend to be shorter. If it is still desired, the implant can additionally by z. B. sewing can be fixed.

The clear mark provided by the asymmetrical shape structure of the at least one colored piece of film represents a further advantage of the surgical implant according to the invention. It allows reliable, quick and easy determination of the right side to point in a particular direction.

When the surgical implant is constructed as a soft tissue implant, e.g. A hernia implant adapted to fix itself at least partially to soft tissue such as muscle or fat, the friction between the surgical implant and the soft tissue may be reversed in at least one direction (measured substantially in the plane of the implant) be increased by a factor of 2 or more compared to a corresponding implant without elevations.

In general, one can also use the technology of attached colored film pieces with ridges in other medical devices that have more pronounced three-dimensional configurations, e.g. Hoses, stents, vascular grafts, hip implants, etc. For example, the base structure (including the film pieces and any additional layers attached thereto) may be formed into a three-dimensional configuration with the surgical graft e.g. B. in the form of a tube, vascular graft, stents, breast implant, orthopedic implant, etc. is constructed.

A surgical implant according to the invention may be manufactured using the following steps: providing a mold containing a panel of wells, each well having the form of an elevation; Filling the mold with a liquid material which forms the at least one colored film piece and the protrusions according to a pattern defining the shape structure of the at least one colored film piece; Hardening the liquid material; Attaching the at least one colored film piece to a base structure, the elevations pointing away from the base structure; Removing the mold.

The order of these steps listed above need not necessarily represent the sequence in which the steps are carried out when the manufacturing method according to the invention is carried out, which is described in more detail below.

The mold is preferably flexible and comprises e.g. As silicone, polyurethane, natural rubber or synthetic rubber. Silicone is z. B. very flexible and thermostable. The mold is substantially planar and provides a surface for forming the film pieces. Starting from this surface are cavities, each having the shape of an elevation. For example, a silicone mold may be made by using, for example, a mechanically prepared master (a positive of the array of prominences) of metal or polymer as a master mold filled with silicone precursor materials and allowed to react. Because of the high elasticity of silicone, the master mold can be taken out after the reaction is complete, and with the use of the mold, the mold can be separated from the ridges formed by the mold, even in the case of laterally extending parts of the ridges.

In advantageous embodiments of the method, the pattern defining the shape structure of the at least one colored film piece is determined by a mask placed between the base structure and the material to be filled in the mold.

The steps of filling the mold with a liquid material forming film pieces including the ridges, curing the liquid material, and attaching the film pieces to a base structure, particularly a surgical mesh, may be performed substantially simultaneously, e.g. In the following way:
In this advantageous embodiment, the method employs a layered structure comprising in the following order: the mold, a surgical mesh (e.g., polypropylene) as the base structure, the mask, a sheet of material (e.g., purple poly p-dioxanone) for the at least one colored film piece having a lower melting point than the surgical mesh, and a flexible plate device having a closed surface. The layer of material is heated to a temperature above its melting point and below the melting point of the surgical mesh so that the layer becomes fluid. Then, the mold and the plate device are pressed together, the plate device serving as a counterpart or a kind of die, whereby the material for the at least one film piece is transferred through the mask into the mold and at the same time embeds into the surgical mesh. After lowering the temperature, the liquid material solidifies (this is the above-mentioned hardening step), so that the mold can be removed because of its high elasticity. In this way, the asymmetric shape structure of the at least one colored piece of film is formed by the mask and fixedly connected to the surgical mesh, and the elevations are formed, with all steps taking place substantially simultaneously.

In a variant of the latter embodiment, the initial positions of the surgical mesh and the layer of material for the at least one colored piece of film are interchanged. In this case, the material for the colored piece (s) of film is transferred to the mold and embedded in the surgical mesh in those areas not covered by the mask.

The flexible disk device may have a closed surface. Alternatively, it may be formed as a second shape which is flexible and contains a field of cavities, each cavity being in the form of an elevation. This second shape is similar to the other shape and can be used to make elevations on the second side of the mesh to make a surgical mesh implant with elevations on both sides.

In order to make second pieces of film and attach them to the surgical mesh in areas free of the at least one colored piece of film, slightly modified methods can be used. For this, sheet material for producing the second film pieces is placed side by side with sheet material used for producing the at least one colored film piece so that the respective sheets do not overlap. Otherwise, the methods are as described above. The mask also defines the shapes and positions of the second film pieces.

Depending on the materials used and the details of the process, the curing step may be by evaporation of a solvent, by cooling (as in the above examples), or by reaction of reactants forming the film and the bumps.

Hereinafter, some aspects of the invention, in addition to those associated with the marking effect of the at least one colored film piece, will be further described generally.

Examples of applications

• (a) Bauch- und Inguinalhernien treten auf, wenn ein Gewebe, eine Struktur oder ein Teil eines Organs durch eine abnorme Öffnung im Körper vorragt. Dies hängt zumeist mit dem Vorragen des Darms durch eine Schwachstelle in der Bauchdecke zusammen. Vorrichtungen zur Reparatur von Hernien könnten in verschiedenen Gestalten und aus verschiedenen Materialen, in Form von flachen Vorrichtungen, grundsätzlich flachen aber gekrümmten Vorrichtungen, Beuteln, Säcken hergestellt oder zu Stopfen (flugs) gefaltet werden.
• (b) Chirurgische Netze, Bänder oder Schlingen kommen bei Beckenstörungen wie Stressharninkontinenz oder Beckenorganvorfall zum Einsatz. Bei diesen Anwendungen muss der Stoff möglicherweise mit der Scheidenwand (z. B. ein Beckennetz) in Kontakt gebracht werden oder mit der Harnröhre, z. B. mit dem GYNECARE^® TVT-System von Ethicon, Inc., in Kontakt gebracht werden, wobei die erfindungsgemäße Baugruppe die Arretierung in bestimmten Regionen des Bandes oder Netzes unterstützen kann.
• (c) Durapatches werden nach einer Gehirnoperation zum Abdecken und Schließen der Dura mater verwendet. Die Dura mater ist die harte, unflexible Faserhülle, die die äußerste von drei Lagen ist, die das Gehirn und das Rückenmark umgeben. Handelsübliche Transplantate werden entweder aus biologischem (inklusive Xenotransplantate und Allotransplantate) oder synthetischem Material gebildet. Die erfindungsgemäßen Patches mit Mikrovorsprüngen in bestimmten Bereichen auf einer der beiden Seiten können dabei behilflich sein, das Implantat an seinem Platz zu halten.
• (d) Rotatorenmanschettenverstärkungs-Transplantate werden zumeist in solchen Fällen verwendet, bei denen vorhandenes Gewebe nicht mehr verwendet oder behandelt werden kann, um die Funktionen der Rotatorenmanschetten zu unterstützen.
• (e) Absorptionsfähige Beutel kommen in der Unfallchirurgie als Leberkompressionsvorrichtung zum Einsatz, um Blutungen zu verringern (wie ”Vicryl-Netzbeutel A”).
• (f) Im Bereich der Brustrekonstruktion werden Transplantate mit dem ”TRAM-Flap”-Verfahren verwendet, bei dem eine autogene Geweberekonstruktion der Brust mit dem TRAM-(transverse rectus abdominis myocutaneous)-Lappen vom Brustkorb durchgeführt wird. Am Bauchdecken-Spendeort für den Muskellappen entsteht möglicherweise eine Bauchdeckenschwachstelle, Wölbung und Hernie. Zur Vermeidung einer Hernie verwenden die meisten Chirurgen ein synthetisches Netz zum Schließen des Abdomens. Stoffe wie absorptionsfähige Netze wie Vicryl^®-Netz oder TiGr-Matrix^®, werden ebenfalls zur Brustvergrößerung oder -rekonstruktion, d. h. in der onkoplastischen Chirurgie, verwendet, die als eine Kombination von Tumorexzision, mit einem Lumpektomie oder Mastektomie beinhaltenden angemessenen Spielraum, und sofortiger Rekonstruktion der Brust definiert ist ( Koo et al. 2011 ”Results from Over One Year of Follow-Up for Absorbable Mesh Insertion in Partial Mastectomy ”Yonsei Med J 52(5): 803-808, 2011 ). Die erfindungsgemäßen Vorrichtungen sind dabei behilflich, Nähte, Stifte oder Klebstoffe zu minimieren.
• (g) Vorrichtungen für die Weichgewebereparatur werden als Füllstoff verwendet, um Gewebe z. B. in der kosmetischen Chirurgie aufzubauen, um Falten zu entfernen oder um in der Fistelchirurgie die Fistelkanäle zu füllen. Je nach der beabsichtigten Verwendung können absorptionsfähige Materialien verwendet werden.

Implants such as surgical meshes for the repair of soft tissue are mainly used when there is a defect or weakness in soft tissue, or when a tissue hole needs to be filled or covered:

• (a) Abdominal and inguinal hernias occur when a tissue, structure or part of an organ protrudes through an abnormal opening in the body. This mostly depends on the protrusion of the intestine through a weak spot in the abdominal wall. Devices for repairing hernias could be made in different shapes and made of different materials, in the form of flat devices, basically flat but curved devices, bags, bags are made or folded into plugs (flugs).
• (b) Surgical nets, ligaments or slings are used in pelvic disorders such as stress urinary incontinence or pelvic organ prolapse. In these applications, the substance may need to be brought into contact with the vaginal wall (eg a pelvic mesh) or with the urethra, e.g. B. with the GYNECARE ^® TVT system from Ethicon, Inc., in which the assembly according to the invention can support the locking in certain regions of the belt or network.
• (c) Durapatches are used after brain surgery to cover and close the dura mater. The dura mater is the hard, inflexible fibrous sheath that is the outermost of three layers that surround the brain and spinal cord. Commercially available grafts are formed from either biological (including xenografts and allografts) or synthetic material. The patches according to the invention with micro projections in certain areas on one of the two sides can help to hold the implant in place.
• (d) Rotator cuff reinforcement grafts are mostly used in cases where existing tissue can no longer be used or treated to support the functions of the rotator cuffs.
• (e) Absorbent bags are used in trauma surgery as a liver compression device to reduce bleeding (such as "Vicryl Net Bag A").
• (f) In the area of breast reconstruction, transplants are used with the "TRAM flap" method, in which an autogenous tissue reconstruction of the breast is performed with the TRAM (transverse rectus abdominis myocutaneous) flap from the thorax. At the abdominal donation site for the muscle flap may develop an abdominal wall weakness, camber and hernia. To avoid herniation, most surgeons use a synthetic mesh to close the abdomen. Materials such as absorbent networks such as Vicryl ^® -Netz or TIGR Matrix ^®, are also used for breast augmentation or reconstruction, ie, used in the onkoplastischen surgery,-containing as a combination of tumor excision, with a lumpectomy or mastectomy adequate clearance and immediate reconstruction the breast is defined ( Koo et al. 2011 "Results from Over One Year of Follow-Up on Absorbable Mesh Insertion in Partial Mastectomy" Yonsei Med J 52 (5): 803-808, 2011 ). The devices of the invention help to minimize sutures, pins or adhesives.
• (g) Soft tissue repair devices are used as a filler to seal tissue e.g. B. in cosmetic surgery to remove wrinkles or to fill the fistula in fistula surgery. Depending on the intended use, absorbent materials may be used.

Film piece size and shape

Film pieces are preferably in the millimeter range of 1 mm to 10 mm, which gives the base structure little rigidity, and have a thickness of 5 microns to 500 microns. The film pieces may take any form, e.g. Circle, oval, triangle, rectangle, square, pentagon, hexagon, cross, star.

The stiffness, shape, and overall thickness of the film piece, and the edges of the film piece, can be used in addition to the micro-increments to provide additional features such as handleability to facilitate orientation.

Film piece pattern and spacing

Depending on the intended use of the implant, the film pieces can be arranged on the edge, centrally or over the entire surface. Preferably, the total film area is less than 50%, preferably less than 25%, of the total surface area compared to the implant side surface. For implants with only central area or edge-foil patterns, the total film area can be further reduced for geometrical reasons. The film piece pattern can be used to adjust parameters such as buckling stiffness in different directions. Preferably, the film piece pattern does not impart rigidity to the implant to allow nesting even on uneven structures, and does not adversely affect features such as curling and unrolling, or folding or unfolding in laparoscopic surgery.

Connection of the film piece to the basic structure

The film pieces may be joined together, in the case of a sandwiched placement, and / or with the base structure in a variety of different conventional manners, e.g. Quilted, embroidered, bonded (including by thermal means), or thermally fused, including ultrasonic melts. More generally, the melting technique may also include thermal deformation of at least one of the films (below the melting point of the film). An absorbable hot melt adhesive, such as polydioxanone, as a relatively low melting rate, bioabsorbable polymer can be used as an adhesive for other film piece materials. Other soluble polymers such as polylactide, polycaprolactone or Copolymers thereof can be used as solvent adhesives. Reactive adhesives such as cyanoacrylates or isocyanates or oxiranes can also be used if they are biocompatible.

Particularly preferred is a one-step process of producing micro-increases and bonding to a porous tissue reconstruction structure (base structure). In the case of large pore nets, the film pieces preferably extend over at least part of the pore edges.

The micro-raised film pieces preferably enclose / at least partially surround the base structure. This helps to secure the film piece elements themselves to weakly adherent surfaces such as PTFE or polypropylene without any surface pretreatment.

Micro-increases of the film pieces

The micro-elevations (i.e., the elevations) are solid and preferably in the range of 20 microns to 800 microns, preferably 50 microns to 500 microns, more preferably 250 microns to 350 microns, out of the film piece surface out.

The micro-elevations alter the attachment to mammalian or human soft tissue during implant placement and / or ingrowth.

Microbubbles preferably extend 45 ° to 90 ° from the surface of the film pieces and may have a complex structure, such as mushroom, curved rod, etc.

Preferred microfungi having a density of about 288 increments per cm ² piece of film were prepared. For example, mushrooms were determined by scanning electron microscopy with a height of 288 μm, a caliper of 410 μm in diameter, a narrower middle portion of 177 μm in diameter, and a head portion of 410 μm diameter with a lip thickness of the mushroom head of about 12 μm.

Active ingredients

It may, for example, be advantageous to provide an implant according to the invention which has at least one biologically active or therapeutic ingredient which, if appropriate, can be released locally after implantation. Substances which are useful as active or therapeutic agents may be naturally occurring or synthetic, and include, for example: Including, but not limited to, antibiotics, antimicrobials, antibacterial agents, antiseptics, chemotherapeutics, cytostatics, metastasis inhibitors, antidiabetics, antifungals, gynecological agents, urological agents, antiallergics, sex hormones, sex hormone inhibitors, hemostyptics, hormones, peptide hormones, antidepressants , Vitamins such as vitamin C, antihistamines, naked DNA, plasmid DNA, cationic DNA complexes, RNA, cell components, vaccines, naturally occurring cells in the body, or genetically modified cells. The active or therapeutic agent may be in various forms, including in encapsulated form or in adsorbed form. Such active agents may improve patient outcome or induce a therapeutic effect (eg, better wound healing or anti-inflammatory or reduction).

A preferred class of active agents are antibiotics which include agents such as gentamicin or ZEVTERA ^™ (ceftobiprole medocaril) brand antibiotic (available from Basilea Pharmaceutica Ltd., Basel, Switzerland). Other useful active agents are highly effective broad spectrum antimicrobial agent against various bacteria and yeast (even in the presence of body fluids), such as octenidine, octenidine dihydrochloride (available as active ingredient in disinfectants Octenisept ^® from Schulke & Mayr, Norderstedt, Germany), polyhexamethylene biguanide (PHMB) (available as the active ingredient in Lavasept ^® Braun, Switzerland), triclosan, copper (Cu), silver (Ag), nano silver, gold (Au), selenium (Se), gallium (Ga), taurolidine, N-chlorotaurine, antiseptic alcohol-based as Listerine ^® -Mundspülung, Na-lauryl-L-arginine ethyl ester (LAE), myristamidopropyl dimethylamine (MAPD, available as the active ingredient in SCHERCODINE ^® M), oleamidopropyl dimethylamine (OAPD, available as the active ingredient in SCHERCODINE ^® O) (and stearamidopropyl SAPD, available as the active ingredient in SCHERCODINE ^® S), and most preferably Fettsäuremonoester Octenidindihydroc hlorid (hereinafter referred to as octenidine), taurolidine and PHMB.

A preferred class of active agents are local anesthetics, e.g. The following agents include: ambucaine, benzocaine, butacaine, procaine / benzocaine, chloroprocaine, cocaine, cyclomethycaine, dimethocaine / larocaine, etidocaine, hydroxyprocaine, hexylcain, isobucaine, paraethoxycain, piperocaine, procainamide, propoxycaine, procaine / novocaine, proparacaine, tetracaine / Amethocaine, lidocaine, articaine, bupivacaine, dibucaine, cinchocaine / dibucaine, etidocaine, levobupivacaine, lidocaine / lignocaine, mepivacaine, metabutoxycain, piridocaine, prilocaine, propoxycaine, pyrrocain, ropivacaine, tetracaine, trimecain, tolycaine, combinations thereof, e.g. Lidocaine / prilocaine (EMLA) or naturally derived local anesthetics such as saxitoxin, tetrodotoxin, menthol, eugenol and prodrugs or derivatives thereof.

In addition, a contrast agent may be included in the devices of the invention. Such contrast agents may be a gas or a gas-generating substance for ultrasound contrast or MRI contrast be as metal complexes such as GdDTPA or superparamagnetic nanoparticles (Resovist ^® or Endorem ^®), as in the EP 1 324 783 B1 which is incorporated by reference. It can be included radiopaque substances, as in the EP 1 251 794 B1 (including by reference), including pure zirconia, stabilized zirconia, zirconium nitride, zirconium carbide, tantalum, tantalum pentoxide, barium sulfate, silver, silver iodide, gold, platinum, palladium, iridium, copper, iron oxides, non-magnetic implant steels, non-magnetic implant steels, titanium, Alkali iodides, iodinated aromatic compounds, iodinated aliphatic compounds, iodinated oligomers, iodinated polymers, alloys of such substances that can be alloyed. The contrast agents can be incorporated in or on a net, or in or on the film pieces.

base structure

In advantageous embodiments of the invention, the basic structure comprises a net-like structure with pores. The term "net-like structure" is to be understood quite generally and includes a porous flexible layer in general, and in particular z. Nets (surgical nets), tapes, perforated films (foils), nonwoven fabrics, fibrous webs, knitted sheets, knitted ribbons, braided sheets, braided ribbons, collagen bundle sheets, mesh bags or net plugs. In mesh bags or net plugs, a net is folded or rolled and optionally fixed to itself at individual points or areas, or a corresponding structure is provided from multiple pieces of mesh. Another example of porous base structures are foams or sponges.

For example, the base structure may comprise a surgical mesh with pores, the first side of which is formed from one side of the surgical mesh. In this case, the implant can be used, for example, for hernia reconstruction. It is also possible, the inventive surgical implant z. B. to use as a pelvic or breast implant. In such cases, the basic structure of the implant is adapted for the desired purpose. In general, it is not necessary that resorbable film pieces be applied over the entire side of the net-like structure or, more generally, the base structure.

A reticular base structure for the first layer is preferably macroporous with typical pore dimensions greater than 0.5 mm, which assists in good tissue integration. However, other pore sizes are possible. As indicated above, any type of mesh or net-like basic structure known in the art may be provided, e.g. Knitting or crocheting or weaving. A construction as a perforated film or foil is also possible. Depending on the material, all filaments of the mesh may be bioabsorbable or nonabsorbable. The mesh may therefore be absorbable (absorbable), nonabsorbable or partially absorbable. A network constructed as a perforated layer is also possible. The filaments can be constructed as monofilaments or as multifilaments. Ribbon yarns and stretched film strips are also conceivable. Any mixtures, mixtures or combinations of materials and embodiments are also possible. In addition, the filaments can be coated. A network constructed as a perforated layer is also possible. In general, the reticulated structure is flexible and has a planar basic shape. It may for example be based on a commercial network for hernia repair.

Depending on the intended application of the tissue repair device, a biocompatible, long-term stable polymer may be used to prepare the soft tissue textil repair element (base structure). By long-term stable polymer is meant a non-absorbable biocompatible polymer, or a bioabsorbable polymer which is slowly absorbed or decomposed, e.g. For example, one that has at least 50% of its original tear strength 60 days after implantation in vivo. The latter group includes substances such as polyamides, which are generally considered stable because they are not constructed as resorbable materials, but are attacked by body tissue and tissue fluids over time. Preferred materials for the textile repair element include polyhydroxy acids, polylactides, polyglycolides, polyhydroxybutyrates, polyhydroxyvalerates, polycaprolactones, polydioxanones, synthetic and natural oligo- and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers, cellulose, bacterial cellulose, polyamides , aliphatic polyesters, aromatic polyesters, copolymers of polymerizable substances thereof, and absorbable glasses. Particularly preferred materials for the tissue reconstruction element include polypropylene and blends of polyvinylidene fluoride with copolymers of vinylidene fluoride and hexafluoropropene, PTFE, ePTFE and cPTFE, silicone, but other conventional biocompatible materials are also useful. The tissue reconstruction element may be composed of monofilaments and / or multifilaments or combinations thereof. The tissue reconstruction element may include, in addition to a long-term stable polymer, an absorbable polymer (ie, bioabsorbable or biodegradable). contain. The resorbable and long-term stable polymer preferably contain monofilaments and / or multifilaments. The terms resorbable polymers and bioabsorbable polymers can be used interchangeably. The term bioabsorbable is defined as having its conventional meaning.

When only a short-term tissue carrier is needed, such as for fistula plugs, the tissue reconstruction element can be made of bioabsorbable polymer or bioabsorbable polymers without any long-term stable polymers.

Optionally, the base structure may be made of a biological material such as allograft, xenograft.

Additional location or locations

Tissue reconstruction or reinforcement implants, such as nets, may be constructed to permit tissue ingrowth on one side (eg, they may have open pores or spaces) and resist ingrowth of tissue on the opposite side (e.g. By having a smooth surface such as a film (a film) or a non-porous layer, conventionally referred to in the art as an adhesion barrier). This is important when using or implanting the abdominal area mesh implants, eg In hernia repair procedures where adhesion of the peritoneum (ie tissue ingrowth) of the implant is desired while tissue ingrowth or adhesions on the visceral side are undesirable (ie, non-adherent). Several conventional products are known in the art and are commercially available and have a virtually smooth side, which is an adhesion barrier, and a porous or rough side for tissue ingrowth. The products may be completely absorbable, completely nonabsorbable, or partially absorbable and partially nonabsorbable. The products may be composites of multiple network layers and adhesion resisting barriers. Certain implants are out of the package ready for use (eg. B. Proceed ^® -Herniennetz, PhysioMesh ^®, Gore DualMesh ^® and Bard Composix ^® mesh), and other mesh implants have to several minutes of pre-soaking prior to implantation in water or saline to the swell adhesion barrier and make the implant soft enough for implantation and placement in the patient (eg. as Sepramesh ^®, Parietex ^® -Verbund).

Additional layer (s) may be added to the surgical implant, either between multi-elevation film pieces and the base structure, or on the opposite side, or both, resulting in the following arrangements:
Pieces of film + additional layer + basic structure or
Film pieces + basic structure + additional layer or
Film pieces + additional layer + base structure + additional layer.

The additional layer (or layers) may (or may have) different effects on the tissue repair implant, such as imparting stiffness or enhancing tissue regeneration or ingrowth.

The additional layers used with surgical implant devices according to the invention should have a thickness sufficient to prevent it from adhering. The thickness is typically in the range of about 1 μm to about 500 μm, and preferably from about 5 μm to about 50 μm. Suitable films for use include both bioabsorbable and nonabsorbable films. The films are preferably polymer-based and can be made from various conventional biocompatible polymers. Non-resorbable or very slowly resorbable substances include polyalkenes (eg, polypropylene or polyethylene), fluorinated polyolefins (eg, polytetrafluoroethylene (PTFE) or polyvinylidene fluoride), polyamides, polyurethanes, polyisoprenes, polystyrenes, polysilicones, polycarbonates, polyaryletherketones (PEEKs). , Polymethacrylic acid esters, polyacrylic acid esters, aromatic polyesters, polyimides as well as mixtures and / or copolymers of these substances. Also useful are synthetic bioabsorbable polymeric materials, e.g. Polyhydroxy acids (eg, polylactides, polyglycolides, polyhydroxybutyrates, polyhydroxyvalerates), polycaprolactones, polydioxanones, synthetic and natural oligo- and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers. Naturally occurring materials such as collagens, gelatin or naturally derived materials such as bioabsorbable omega-3 fatty acid crosslinked gel films or oxygenated regenerated cellulose (ORC) may also be used.

The films used in surgical implant devices according to the invention may cover the entire outer surfaces of the repair fabric element (base structure) or a portion thereof. In some cases it is advantageous for films to overlap the edges of the repair fabric. As used herein, the term "edge" refers to a marginal edge or a central edge when there is a hole in the mesh, for example, to receive an anatomical structure, such as the intestine, for treating or preventing parastomal hernia, or the spermatic cord.

Porous films may be perforated before or after assembly of the device, or porous films may be made to contain pores. However, it will be apparent to those skilled in the art that precautions must be taken to prevent damage to other parts of the implant when perforating a composite device.

The films may be connected together in a variety of conventional ways, e.g. By sewing, gluing, fusing and laminating. The bonding can be on the edge, in the central area or over the entire arrangement, as a point-like, linear or planar connection.

Films may be bonded together and / or to the repair fabric element (base structure) in a variety of different conventional manners, e.g. Stitched, stitched, bonded (including by thermal means) in subregions (eg, at points or along lines or stripes, such as at the outer edge), or thermally welded, including by ultrasonic welding. Welding techniques also broadly include thermoforming of at least one of the films (below the melting point of a film). The implant may optionally have embroidered structures constructed as reinforcements, e.g. B. rib-like structures.

One possible film-film combination uses hot lamination techniques, optionally using additional biocompatible hot melt adhesive such as polydioxanone as a relatively low melting bioabsorbable polymer. Other soluble polymers such as polylactide, polycaprolactone or copolymers thereof can be used as the solvent adhesive. Reactive adhesives such as cyanoacrylates or isocyanates or oxiranes can also be used if they are biocompatible.

In the following, the invention will be described in more detail by means of embodiments. The drawings show in

1 an exploded view of a first embodiment of the surgical implant according to the invention,

2 a plan view of one in the embodiment according to 1 used colored film piece,

3 a schematic plan view of a colored film piece used in another embodiment of the surgical implant according to the invention,

4 in the parts (a) to (h) are three-dimensional representations of different embodiments of increases for film pieces of surgical implants according to the invention,

5 a top view of another embodiment of the surgical implant according to the invention,

6 an enlarged partial plan view of the embodiment according to claim 5, in which also a part of a base structure is shown,

7 an enlarged three-dimensional view of a part of the embodiment according to 5 and

8th a schematic representation of an embodiment of a method for producing a surgical implant according to the invention, ie the embodiment according to 5 ,

1 is a partial exploded view of a first embodiment of a surgical implant, which with 10 is designated.

The implant 10 includes a basic structure 12 as a surgical mesh with pores 14 is constructed, in the embodiment, an "Ultrapro" network of Ethicon. "Ultrapro" is a low molecular weight, partially resorbable surgical monofilament net made of polypropylene (non-resorbable) fibers and "Monocryl" (copolymers of glycolide and ε-caprolactone, resorbable, see above) with a pore size of about 2.27 mm in one direction and a pore width of about 3.17 mm in a direction perpendicular thereto.

A transparent "Monocryl" film with a thickness of 20 μm serves as a visceral adhesion barrier layer 16 , The barrier situation 16 is by means of a colored piece of film 20 fusion-bonded with the basic structure 12 , In the embodiment, the colored film piece is 20 made of a poly-p-dioxanone (PDS) sheet having an original thickness of 150 μm and dyed with the violet dye " D & C Violet No. 1 " 2 ", which is well known in the art. In the view according to 1 is the colored piece of film 20 on the basic structure 12 placed. In the fusion bonding process, the colored film piece becomes 20 Made from PDS soft and melts easily, making the PDS material the top surface of the barrier layer 16 achieved and fixed it with the basic structure 12 combines.

2 shows the colored piece of film 20 detail. The dyed piece of film 20 is connected and arranged as an asymmetric shape structure and includes an edge marking area 22 , a central axis marking area 24 , a short axis marking area 25 and two concentric inner marking areas 26 , The letter "E" becomes an asymmetry 28 reached. If the colored piece of film 20 When viewed in reverse, the letter "E" appears in mirror image. Because of its purple color is the colored film piece 20 clearly visible and provides easily recognizable markings, which in a surgical procedure, the insertion of the implant 10 support. In particular, the position of the edge, the azimuthal angle orientation and the central region of the implant can be determined 10 easy to estimate when looking at the marking areas 20 . 24 / 25 respectively. 26 considered. The letter "E" allows easy control of the correct orientation of the barrier layer 16 that are on the bottom of the implant 10 should be located.

From the dyed piece of film 20 protrudes a plurality of fixed elevations, in the embodiment of all the marking areas 22 . 24 . 25 and 26 , in one direction from the base structure 12 and the adhesion barrier layer 16 away, ie towards the parietal side. Examples of increases are by means of 4 described. In the 1 and 2 the elevations are not shown. These elevations give the implant 10 self-adhesive properties. Because the elevations from all areas of the colored film piece 20 stick out, the implant can 10 be securely attached to body tissue in its peripheral area and in its central area. If necessary, the implant can be removed, repositioned and repositioned after application. General details of the elevations are also described above.

Thus, the colored film piece has 20 a double function: it serves as a marker and it provides self-adhesive properties. Both effects facilitate the surgical procedure for placing the implant 10 very.

The implant 10 can by a method according to the following means 7 Explained be prepared.

3 illustrates a colored piece of film 30 for another implant. The dyed piece of film 30 is also constructed as a contiguous asymmetric shape structure. However, its marking areas are narrower than those of the implant 10 , so that the flexibility of the basic structure due to the presence of the colored piece of film 30 less affected compared with the implant 10 , The markers close a peripheral mark 32 , a central axis marker 34 , a short axis marker 35 and asymmetric inside markings 36 which carry all elevations pointing away from the base structure (not in 3 shown).

4 shows in the parts (a) to (h) various types of fixed elevations, all by reference numerals 40 Marked are. Most of the raises 40 own a shaft 42 (some of them have a shaft with a pronounced foot area 43 ) and a head 44 which is at least partially in relation to the shaft 42 extends sideways, see 4 (a) to 4 (e) and 4 (g) , Some raises close a bit 46 one that is over your head 44 extends, see 4 (c) . 4 (e) and 4 (g) , The elevation of Figure (f) is constructed entirely as a peak. 4 (h) shows an increase that as a bent rod 48 is shaped. A particularly advantageous form is like a mushroom, see 4 (d) ,

In detail: In 4 (a) are the shaft 42 and the head 44 hexagonal, with the head 44 in relation to the shaft 42 extends symmetrically sideways. In 4 (b) are shank 42 and head 44 hexagonal, with the head 44 in relation to the shaft 42 is arranged asymmetrically. In 4 (c) is the increase of 4 (b) similar, but carries a three-sided pyramidal tip. The elevation of Figure (d) is mushroom-like and has a frusto-conical foot portion 43 , a tapered central portion of the shaft 42 and a relatively flat head 44 , In 4 (e) is the increase of 4 (d) similar, but has an additional pyramidal tip. The increase of 4 (f) has a round base section 43 with a diameter that extends to a sharp peak or peak 46 reduced. 4 (g) shows a mushroom-like increase that of 4 (e) is similar, the head 44 includes some cuts. The increase of 4 (h) is as a curved rod 48 shaped, which is composed of three straight areas, which are at an angle to each other, in one variant, it is smoothly curved along its entire length.

Typical dimensions and number densities of the ridges are disclosed above.

5 shows a plan view of another embodiment of a surgical implant, which with 50 is designated.

The implant 50 includes a basic structure 52 , of the 5 only represents its peripheral line. At the base structure 52 is a plurality of individual colored film pieces 54 appropriate. In this embodiment, the colored pieces of film are 54 they are arranged in asymmetrical patterns, ie they form several asymmetrical shapes, each one a sequence of symbols 56 is, ie: "ETHICONETHICONETH". Thus, each letter or symbol is a colored piece of film 54 built, except the letter "O", which consists of two colored film pieces, see 5 , The colored film pieces 54 are formed from (violet) colored poly-p-dioxanone material.

In the areas between the consequences of symbols 56 are second film pieces 58 at the base structure 52 appropriate. In the embodiment, each one of the second pieces of film has 58 a hexagonal shape and is made of poly-p-dioxanonmaterial, which is not colored.

6 schematically represents a part of the second film pieces 58 It also shows the pores of the basic structure 52 made from a clear (uncolored) polypropylene net with low weight.

7 illustrates that every single one of the second film pieces 58 a plurality of increases 62 that points in one direction from the base structure 52 sticking out. In the embodiment, the elevations are 62 mushroom-shaped and have a shaft 64 and a head 66 , Other forms, like those in 4 Shown, are also possible. If you look at the terminology of 5 used (which is a "top" view), then show the increases 62 downward. Although sheet material for the second film pieces 58 originally on the "top" side of the base structure 52 is placed in the pores of the base structure during the manufacturing process (see below) 52 pulled, and the elevations form on the "bottom" side. In this way the material becomes the basic structure 52 in the second film pieces 58 embedded.

The colored film pieces 54 are provided with similar mushroom-like elevations (not shown in the figures) which also point to the "down" side and the colored film pieces 54 close the material of the basic structure 52 in a similar way as the second film pieces 58 one.

The flexibility of the surgical implant 50 is mainly due to the flexibility of its basic structure 52 certainly, because the colored film pieces 54 and the second film pieces 58 are relatively small. The consequences 56 Symbols are clearly visible and show the orientation of the implant 50 clearly. Because of the raises 62 at the second film pieces 58 and the increases in the colored film pieces 54 has the implant 50 pronounced self-fastening properties.

8th schematically shows an embodiment of a manufacturing method for a surgical implant, ie, a method for producing the already means 5 to 7 described implant 50 , This method will be explained by the following example.

In a first step became a form 70 containing a panel of pits, each puck being in the form of an elevation, made from a 2-component silicone precursor kit (elastomer kit). In the presentation according to 8th These depressions are over the top of the mold 70 accessible, but they are not in 8th shown. To the form 70 was prepared, a positive mold (master) made of polypropylene, which was used on a surface z. B. 288 mushroom-shaped elevations / cm ² with a total height of about 250 microns, a head diameter of about 375 microns, a shaft diameter of about 200 microns and a foot diameter of about 340 microns had. The liquid silicone elastomer was poured over the polypropylene master and, while maintaining a horizontal position, cured at elevated temperatures (50 ° C to 80 ° C) in an oven for several hours. After cooling to room temperature, the silicone mold became 70 with mushroom-shaped negatives of the elevations taken from the polypropylene master.

The basic structure of the implant was an unstained "prolene" net (Ethicon) (surgical mesh 72 , corresponds to basic structure 52 in 5 ), which is a non-absorbable net containing polypropylene fibers. The net could be fixed in a metal frame shape to prevent movement and shrinkage.

Form 70 was placed in a metal mold with the wells facing up, followed by the surgical mesh 72 , Thereafter, a perforated thin rubber layer was used as a mask 74 served and as in 5 was shaped on the surgical mesh 72 placed. The mask had openings 76 which the consequences 56 of symbols, as well as hexagonal openings 78 showing the hexagonal shapes of the second film pieces 58 represent.

Layers of material 80 (hatched) to produce the consequences 56 of symbols and layers of material 52 for the production of the second film pieces 58 page and page took turns on the mask 74 placed as in 8th is shown. In the example were the layers 80 of (violet) colored poly-p-dioxanone (150 μm thick), and the layers 82 were of undyed poly-p-dioxanone (150 μm thick). Poly-p-dioxanone has a lower melting point than the material of the surgical mesh (polypropylene). Ultimately, a disk device became 84 (in the example a soft foam material with closed cells) on the layers 80 and 82 brought.

This assembly was placed in a heat press and held at a temperature slightly below a pressure of about 5 bar for several minutes heated to 130 ° C. Under these conditions, the poly-p-dioxanone material of the layers became 80 and 82 very soft and penetrated the openings 76 respectively. 82 in the mask 74 and the pores of network 72 and filled the wells in the mold 70 that is, such depressions that are not from the mask 74 were covered, causing colored film pieces 54 were formed (ie several episodes 56 of symbols) or hexagonal pieces of film 58 that works well with the net 72 and raises included by the network 72 point away. After cooling the assembly to ambient temperatures (or a temperature below 50 ° C), the pressure could be released, and the mold 70 , the mask 74 (including the rest of the sheet material 80 . 82 That's not for the movie pieces 54 . 58 was used) and the disk device 84 could be taken away. Because of its high flexibility, the silicone mold could 70 be removed from the elevations without problems.

The DE 10 2013 004 574 and the DE 10 2013 004 573 A disclose further examples that can be easily adapted for the purposes of the present invention. These documents are incorporated by reference herein.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2011/026987 A [0004]
• EP 1439796 B1 [0007]
• WO 2011/159700 A1 [0008]
• EP 2593038 A1 [0009]
• EP 1324783 B1 [0064]
• EP 1251794 B1 [0064]
• DE 102013004574 [0113]
• DE 102013004573 A [0113]

Cited non-patent literature

• Koo et al. 2011 "Results from Over One Year of Follow-Up on Absorbable Mesh Insertion in Partial Mastectomy" Yonsei Med J 52 (5): 803-808, 2011 [0050]

Claims (24)

Surgical implant, comprising - a flat, flexible, porous base structure ( 12 ; 52 ) having a first side and a second side, - at least one resorbable colored film piece ( 20 ; 30 ; 54 ) attached to the basic structure ( 12 ; 52 ) and that a plurality of fixed elevations ( 40 ; 62 ), which consists of the colored film piece ( 20 ; 30 ; 54 ) in one direction from the base structure ( 12 ; 52 ) protrude away, - wherein the at least one colored piece of film ( 20 ; 30 ; 54 ) is arranged to a mold structure which is in the surface of the basic structure ( 12 ; 52 ) is asymmetric. Surgical implant according to claim 1, characterized in that the at least one colored film piece ( 20 ; 30 ) has a contiguous asymmetric shape structure. A surgical implant according to claim 1, characterized in that the asymmetrical shape structure is defined by a plurality of individual colored film pieces ( 54 ) formed in an asymmetrical pattern ( 56 ) are arranged. Surgical implant according to one of claims 1 to 3, characterized in that in addition to the at least one colored piece of film ( 54 ) second film pieces ( 58 ) at the base structure ( 52 ), each of the second pieces of film ( 54 ) at least one increase ( 62 ), which from the respective second film piece ( 54 ) in one direction from the base structure ( 52 ) protrudes away, the second film pieces ( 58 ) are not colored or otherwise colored compared to the at least one colored film piece ( 54 ). Surgical implant according to one of claims 1 to 4, characterized in that the asymmetrical shape structure ( 20 ; 56 ) at least one symbol ("E"; 54 ) Are defined. Surgical implant according to claim 5, characterized in that the asymmetrical shape structure ( 56 ) defines a sequence of symbols. Surgical implant according to one of claims 1 to 6, characterized in that at least one elevation ( 40 ; 62 ) has a property selected from the following list: is rod-shaped, is columnar, is mushroom-shaped, has a shape defined by a corresponding body ( 42 . 43 ) and a corresponding head ( 44 ), where the body ( 42 . 43 ) protrudes from the film piece and in the head ( 44 ) ends, and the head ( 44 ) in relation to the body ( 42 ) extends sideways. Surgical implant according to one of claims 1 to 7, characterized in that a film ( 16 ) on the second side of the basic structure ( 12 ), the film ( 16 ) has a feature from each of the following groups of features: provided as a single piece, provided as a plurality of pieces of film; is absorbable, non-absorbable; has elevations, no elevations; has barrier properties, has no barrier properties. Surgical implant according to claim 8, characterized in that a film ( 16 ) with barrier properties on the second side of the basic structure ( 12 ), this film ( 16 ) comprises at least one of the materials selected from the following list: polyalkenes, polypropylene, polyethylene, fluorinated polyolefins, polytetrafluoroethylene, PTFE, ePTFE, cPTFE, polyvinylidene fluoride, blends of polyvinylidene fluoride with copolymers of vinylidene fluoride and hexafluoropropene, polyamides, polyurethanes, polyisoprenes, polystyrenes, polysilicones , Polycarbonates, polyaryletherketones, polymethacrylic acid esters, polyacrylic acid esters, aromatic polyesters, polyamides, polyhydroxy acids, polylactides, polyglycolides, copolymers of glycolide and lactide, copolymers of glycolide and lactide in the ratio 90:10, copolymers of lactide and trimethylene carbonate, copolymers of glycolide, lactide and trimethylene carbonate , Polyhydroxybutyrates, polyhydroxyvalerates, polycaprolactones, copolymers of glycolide and ε-caprolactone, polydioxanones, poly-p-dioxanone, synthetic and natural oligo- and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonate e, polyalcohols, polysaccharides, polyethers, polyamides, aliphatic polyesters, aromatic polyesters, polyurethanes, copolymers of polymerizable substances thereof, resorbable glasses, cellulose, bacterial cellulose, allograft, xenograft, collagen, gelatin and silk. A surgical implant according to any one of claims 1 to 7, characterized in that the at least one colored piece of film extends into pores of the base structure, wherein protrusions as defined in claim 1 protrude from the at least one colored piece of film in both directions, from the first side of the Base structure away and away from the second side of the base structure. Surgical implant according to one of claims 1 to 10, characterized in that at least two strip-like shaped structures, each comprising at least one colored film piece ( 54 ) and each having a sequence of symbols ( 56 ) at the base structure ( 52 ) and where appropriate second film pieces ( 58 ) as defined in claim 4 in a range between the strip-like shaped structures on the base structure ( 52 ) are mounted. Surgical implant according to one of claims 1 to 11, characterized in that the surgical implant ( 10 ; 50 ) is adapted to be rolled up or folded for laparoscopic placement, moved through a trocar sleeve to a surgical site and, without it sticking to itself, unrolled or unfolded. Surgical implant according to one of claims 1 to 12, characterized in that the surgical implant ( 10 ; 50 ) is designed as a soft tissue implant, preferably as a hernia implant, and is adapted to at least partially fix itself in soft tissue such as muscle or fat, whereby the friction between the surgical implant ( 10 ; 50 ) and the soft tissue is increased in at least one direction by a factor of at least 2 or more compared to a corresponding implant without elevations. Surgical implant according to one of claims 1 to 13, characterized in that the at least one colored film piece ( 20 ; 30 ; 54 ) comprises a material selected from the following list: synthetic bioabsorbable polymer materials, polyhydroxy acids, polylactides, polyglycolides, copolymers of glycolide and lactide, copolymers of glycolide and lactide in the ratio of 90:10, copolymers of lactide and trimethylene carbonate, copolymers of glycolide, lactide and Trimethylene carbonate, polyhydroxybutyrates, polyhydroxyvalerates, polycaprolactones, copolymers of glycolide and ε-caprolactone, polydioxanones, poly-p-dioxanone, synthetic and natural oligo- and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, polyethers, collagen, Gelatin, bioabsorbable gel films, crosslinked with omega-3 fatty acids, and oxidized regenerated cellulose. Surgical implant according to one of claims 1 to 14, characterized in that the basic structure ( 12 ; 52 ) comprises at least one of the materials selected from the following list: polyalkenes, polypropylene, polyethylene, fluorinated polyolefins, polytetrafluoroethylene, PTFE, ePTFE, cPTFE, polyvinylidene fluoride, blends of polyvinylidene fluoride with copolymers of vinylidene fluoride and hexafluoropropene, polyamides, polyurethanes, polyisoprenes, polystyrenes, polysilicones , Polycarbonates, polyaryletherketones, polymethacrylic acid esters, polyacrylic acid esters, aromatic polyesters, polyimides, polyhydroxy acids, polylactides, polyglycolides, copolymers of glycolide and lactide, copolymers of glycolide and lactide in the ratio 90:10, copolymers of lactide and trimethylene carbonate, copolymers of glycolide, lactide and trimethylene carbonate , Polyhydroxybutyrates, polyhydroxyvalerates, polycaprolactones, copolymers of glycolide and ε-caprolactone, polydioxanones, poly-p-dioxanone, synthetic and natural oligo- and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonate e, polyalcohols, polysaccharides, polyethers, polyamides, aliphatic polyesters, aromatic polyesters, polyurethanes, copolymers of polymerizable substances thereof, resorbable glasses, cellulose, bacterial cellulose, allograft, xenograft, collagen, gelatin and silk. Surgical implant according to one of claims 1 to 15, characterized in that the at least one colored film piece ( 20 ; 30 ; 54 ) and the resulting increases ( 40 ; 62 ) are made in one piece. A surgical implant according to any one of claims 1 to 16, characterized in that the base structure is formed into a three-dimensional array, the surgical implant preferably being constructed in a form selected from the following: tubing, vascular grafts, stents, breast implants and orthopedic implants. Process for producing a surgical implant according to claim 1, characterized by the following steps: - providing a mold ( 70 ) containing a field of pits, each puck being in the form of an elevation, - filling the mold ( 70 ) with a liquid material ( 80 ) comprising the at least one colored film piece and the elevations according to a pattern ( 74 ), which defines the shape structure of the at least one colored film piece, - hardening of the liquid material ( 80 ), - attaching the at least one colored piece of film to a base structure ( 72 ), whereby the elevations of the basic structure ( 72 ) pointing away, - removing the form ( 70 ). Method according to claim 18, characterized in that the shape ( 70 ) is flexible and has at least one of the following materials: flexible material, silicone, polyurethane, natural rubbers, synthetic rubbers. A method according to claim 18 or 19, characterized in that the pattern defining the shape structure of the at least one colored film piece is covered by a mask ( 74 ) defined between the basic structure ( 72 ) and in the form ( 70 ) material to be filled ( 80 ) is placed. Method according to claim 20, characterized by the steps: Providing a layer arrangement comprising in the order named: the form ( 70 ), a surgical mesh ( 72 ) as the basic structure, the mask ( 74 ) a layer of material ( 80 ) for the at least one colored piece of film having a lower melting point than the surgical mesh ( 72 ), a flexible disk device ( 84 ), - heating the layer of material ( 80 ) to a temperature above its melting point and below the melting point of the surgical mesh ( 72 ), - pressing the mold ( 70 ) and the disk device ( 84 ), whereby the material ( 80 ) for the at least one film piece through the mask ( 74 ) into the mold ( 70 ) and enters the surgical network ( 72 ), - lowering the temperature and removing the mold ( 70 ). Method according to claim 20, characterized by the steps: Providing a layer assembly comprising, in said order: the shape, a layer of material for the at least one colored film piece having a lower melting point than the surgical mesh, the mask, a surgical mesh as the base structure, a flexible plate device, Heating the layer of material to a temperature above its melting point and below the melting point of the surgical mesh, Pressing the mold and the plate device toward one another, whereby the material for the at least one colored film piece is transferred into the mold and embedded in the surgical mesh in those areas which are not covered by the mask, - Lower the temperature and remove the mold. A method according to claim 21 or 22, characterized in that the flexible disk device ( 84 ) has one of the following properties: has a closed surface; is constructed as a second mold that is flexible and contains a panel of pits, each puck being in the form of an elevation. Method according to one of claims 21 to 23, characterized in that second film pieces according to claim 4 of layer material ( 82 ), placed side by side to sheet material ( 80 ) used to prepare the at least one colored film piece.

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