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    • 专利摘要:
    surgical implant. The present invention relates to a surgical implant (100) comprising a flexible, mesh-like basic structure (104) having a central area and an outer periphery (120), the outer periphery (120) having a polygonal shape. with n corners (122), n being at least 3. the implant (100) may comprise at least two pockets (124), each pocket (124) extending from a peripheral line connecting two corners (122) of the outer periphery (120) of the basic frame (104) towards the central area of the basic frame (104). the central area of the basic structure (104) may be marked by a central marking (130), with directional indicators (132) pointing from the central marking (130) to at least two corners (122) of the outer periphery (120) ) of the basic structure (104).
    公开号:BR112015022927B1
    申请号:R112015022927-1
    申请日:2014-02-21
    公开日:2022-01-11
    发明作者:Volker Harms；Susan Cooper；Dajana Kaiser；Christoph Walther
    申请人:Johnson & Johnson Medical Gmbh；
    IPC主号:
    专利说明:

    [001] The invention relates to a surgical implant, in particular, a surgical implant that has a basic area shape and that comprises a flexible, mesh-like basic structure. The implant can be applied, for example, as a ventral hernia device in the intraperitoneal space, but it can also be useful for other indications of ventral hernia anomalies (such as umbilical hernia anomalies, incisional hernia anomalies), to prevent hernia and to repair an abnormality of the muscle wall or tissue, in general.
    [002] EP 2 032 073 A discloses an implantable medical device comprising a tissue repair material that has two sides (faces) and an outer perimeter (periphery) with at least one side adapted for ingrowth of cells . A hem is formed from the outer perimeter to overlap one side of the tissue repair material, creating an opening between the hem and the tissue repair material. The sheath forms an attachment area on the outer edge of the device for use in attaching the device to a patient's tissue.
    [003] US patent 2008/0147099 A shows a double layer hernia repair patch device that includes a first and a second layer. The first layer is cut to form locating flakes. The edges of the first layer and the second layer are connected to form a pocket. The second layer further comprises an auxiliary layer. The patch can be attached to a cavity of the peritoneum to repair a hernia.
    [004] US patent 2011/0118851 A discloses an implantable prosthesis for repairing or augmenting fragilities or anatomic anomalies, and is particularly suitable for repairing soft tissue and muscle wall openings. The prosthesis includes a repair tissue that is constructed and arranged to allow tissue ingrowth and is susceptible to erosion and the formation of adhesions to tissue and organs. One or more regions of the prosthesis may be configured to inhibit erosion and/or adhesion formation. The prosthesis may include an erosion resistant edge, which may be provided along an opening that is adapted to receive a tube-like structure such as the esophagus.
    [005] Pocket-shaped implants, which are currently available on the market, show some disadvantages. Pockets are formed by placing several layers of material one on top of the other, followed by, for example, a suture connection at the edges. Support rings are also sometimes included in the edge areas. Implant fixation is only allowed within these edge connections. This leads to unfixed edge material, which can result in edge areas with bumps and/or creases. In addition, rigid materials, eg support rings, tend to fail (by bending or breaking). Problems relating to tissue ingrowth, such as irritation or injury to organs, can result in the disadvantages mentioned above. As a consequence of the assembly process (laying layers of different materials on top of each other), the outer edges of some pocket-shaped implants are not covered with non-adhesive materials and present a potential risk for adhesions.
    [006] Currently, the fixation of such implants in the shape of a pocket is often performed with staplers or splicers. Due to the shape of current IPOM (IntraPeritoneal Onlay-Mesh Techniques) open devices (oval, circular or rectangular, with significantly rounded edges), preset positions of the first attachment points cannot be found.
    [007] Furthermore, a correct positioning in terms of orientation and centering of the implant after insertion into the abdominal cavity is always difficult.
    [008] WO 2011/159700 A describes a composite implant that can be used for hernia repair, specifically incisional hernias, particularly for intraperitoneal applications. This implant includes an alignment marker that is asymmetrical and is tailored to show the center of the implant and the preferred placement direction for the implant.
    [009] WO 2003/037215 A presents an area implant that has a basic mesh-like structure and a marking in a central region that indicates the center of the implant. A marker line passes through the center marker. The center marking and marking line can be used to align the implant in relation to a surgical opening to reinforce tissue.
    [010] These implants can provide an indication of implant orientation. However, they do not clearly inform the surgeon about the actual position of the implant periphery, which may be hidden by body tissue. Such information is important because, in general, the implant is attached to body tissue in its peripheral area.
    [011] The aim of the invention is to provide a surgical implant, in particular useful for hernia repair, that can be easily manipulated and that facilitates the surgical procedure.
    [012] This objective is achieved by a surgical implant having the features according to claim 1. Advantageous versions of the implant comprise the dependent claims.
    [013] The surgical implant, according to the invention, comprises a flexible mesh-like basic structure that has a central area and an outer periphery. The outer periphery comprises a polygonal shape that has N corners, with N being at least 3. The term "corner" also includes something like rounded shapes. Preferably, the surgical implant has a hexagonal or octagonal shape, i.e. N=6 or N=8.
    [014] A polygonal-shaped implant has a compact and well-defined shape, in general, helping the surgeon to estimate the contours of the implant, which is often not straightforward, because part of the implant may be hidden by body tissue.
    [015] In advantageous embodiments, according to a main aspect of the invention, the surgical implant comprises at least two pockets, with each pocket (or bag) extending from a peripheral line or edge line (which connects two corners of the outer periphery of the basic frame) towards the central area of the basic frame. Preferably, the implant comprises N pockets.
    [016] The pockets can be manufactured separately and be fixed to the basic structure. In advantageous embodiments, however, the basic mesh structure and pockets are folded around fold lines from a common blank, the fold lines being located on the outer periphery of the basic structure. Pockets are accessible via respective edges opposite the fold lines. In this terminology, the common blank is made of mesh-like material and comprises the base frame material plus the material from the pocket flaps folded back toward the base frame along the fold lines; and one face of a pocket is formed from the flap of the pocket, while the opposite face of the pocket is part of the basic structure.
    [017] When the surgical implant according to the invention is used, for example, for hernia repair, the face that includes the pocket flaps (parietal side, fixation layer) is pointing towards the surgeon, while the opposite side (visceral side, repair layer) of the implant, faces the inside of the patient.
    [018] In advantageous embodiments of the invention, material from a given pocket overlaps material from an adjacent pocket in a respective overlap area, whereby material from the overlap area of adjacent pockets is connected to each other. The overlapping areas can be designed, for example, strip-like, curved, zigzag-shaped, asymmetrical, or diamond-shaped. In areas of overlap, material from adjacent pockets can be connected, for example, by welding, gluing or suturing. A material used for bonding (eg, a film material) or suturing (eg, a thread material) can be permanent (non-absorbable), absorbable (resorbable), or partially absorbable.
    [019] Material from a pocket flap can also be connected to the base frame outside of an overlap area. This can be advantageous if the edge of the pocket flap, through which the pocket is accessible, is relatively long, because it stabilizes the pocket when used to secure the implant to body tissue. For example, such a connection may be tip-like, and it is advantageous when a directional indicator (see below) points to such a tip-like connection area.
    [020] On the other hand, it is also conceivable that adjacent pockets are not secured together in the overlapping areas or even that the pocket flaps are formed in such a way that there is no overlap between adjacent pockets. In such cases, however, the shape of the pockets may be rigid enough to allow the function of a fixation layer for the implant.
    [021] In advantageous embodiments of the invention, an anti-adhesive film (or, more generally, anti-adhesive layer) is located on the face of the basic structure facing away from the pockets, that is, on the visceral side of the implant. The anti-adhesive layer resists and prevents the ingrowth of body tissue into the mesh-like basic structure and acts as an anti-adhesive. Preferably, the anti-adhesive film/coat is absorbable so that it exhibits its effect during the initial curing period, when this is important. The release film/layer can cover the area of the base frame and also extend beyond the outer periphery of the base frame, where the film/release layer is folded back together with the material (flaps) of the pockets. Preferably, less than 50% of the material area of the pocket area is covered by the anti-adhesive layer. In this way, the edges of the surgical implant are also protected against generally unwanted adhesion to body tissue.
    [022] Suitable materials for the anti-adhesive film/layer are, for example, poly-p-dioxanone (PDS), ε-caprolactone, copolymers of glycolide and ε-caprolactone (e.g. MONOCRYL™ film from Ethicon), regenerated cellulose oxygenated (ORC), collagens or combinations thereof, but other anti-adhesive and biocompatible materials known in the art may also be considered. The anti-adhesive film can be of any thickness in the range, for example, 2 μm to 1000 μm. Typical thicknesses are in the ranges of 5 μm to 100 μm and preferably 8 μm to 30 μm.
    [023] The film or anti-adhesive layer can be connected to the material of the basic structure over the entire surface of the film or anti-adhesive layer or over part of the surface of the film or anti-adhesive layer, for example, by laminating, welding, gluing, and /or suturing (e.g. laminating a double layer film comprising a MONOCRYL film and a PDS film). Additional material used for laminating, bonding and/or suturing can be permanent (non-absorbable), absorbable or partially absorbable.
    [024] In another main aspect of the invention, the surgical implant provides the surgeon with clear indications as to its location and orientation, even if the contours of the implant are hidden by body tissue. For this purpose, the central area of the mesh-like basic structure is marked by a central marking, and directional indicators point from the central marking to at least two corners of the outer periphery of the basic structure. Preferably, the directional indicators point from the central marking to all corners of the outer periphery of the basic structure. The center marking may be a marking indicative of a particular point, such as the center of gravity of the implant, for example a cross, but it may also be an extended marking arrangement, which marks the central area of the implant in a different way, however. unambiguously. Such central marking and directional indicators can also be used with the basic mesh-like structures without pockets.
    [025] In advantageous embodiments of the invention, the directional indicators are provided as line marks (e.g. solid lines or dashed lines, etc.) extending from the central marking to the respective corner of the outer periphery of the basic structure, the which tends to maximize the desired effect of a clear indication of implant position and orientation during surgery.
    [026] The central marking and/or the directional indicators can be formed from a film structure connected to the basic structure. They can also be formed from a threaded structure connected to the base structure, for example embroidered on the base structure or sewn onto the base structure. It is also conceivable that the center marking and/or directional indicators are produced in one piece with the basic structure; for example, embedded in a warp-entanglement process. Preferably, the central marking and/or directional indicators are dyed, but they could also be undyed, as long as there is good contrast to the rest of the surgical implant. The center marking and/or directional indicators can be produced from absorbable or non-absorbable materials.
    [027] Advantageous materials for the backbone include, for example, polypropylene, fluorinated polyolefins, blends of polyvinylidene fluoride and copolymers of vinylidene fluoride and hexafluoropropene (for example PRONOVA™ Poly(Hexafluoropropylene-VDF) material from Ethicon), which are all non-absorbable, or poly-p-dioxanone (PDS), glycolide lactide copolymers, 90:10 ratio glycolide lactide copolymers (e.g. VICRYL™ (polyglactin 910) absorbable synthetic filaments from Ethicon), copolymers of glycolide and ε-caprolactone (eg, Ethicon's MONO-CRYL absorbable material), which are all absorbable. Other biocompatible materials for the backbone, as commonly known in the art, are also conceivable. Furthermore, the basic structure may comprise a mixture of different materials, including a mixture of absorbable and non-absorbable materials.
    [028] In advantageous embodiments, the basic structure is microporous, eg having a pore size of at least 1 mm. Preferably, it is a lightweight construction that has a weight of less than 50 g/m2, but could also be heavier. The basic structure may comprise, for example, a woven-woven, weft-woven, crocheted-braided film, a woven and/or perforated cloth. If it includes filaments, the filaments may be bioabsorbable or non-absorbable, and the filaments may comprise monofilaments and/or multifilaments (including multifilaments produced from different materials). Tape strands and/or pulled film tapes are also conceivable.
    [029] In summary, the surgical implant comprising pockets, in particular when designed as a Ventral Hernia Device (VHD) with tissue separation properties (anti-adhesive film), offers a plurality of advantages compared to to the prior technique. Unlike implants that are currently available on the market, the repair layer and the fixation layer (pocket) of the VHD can be formed by just bending a flexible raw block. In this context, the attachment layer consists of several folded tabs that can overlap adjacent tabs at the edges. Fusing these folds of material, preferably strip-like, leads to palpable areas that are oriented towards the corners of the implants. Therefore, the cast strips allow for better tactile control and guidance to corners, which leads to optimized intra-operational handling of the device. Furthermore, the formation of the bag (pocket) from just one flexible block, allows for attachment to the outermost positions of the edges and corners of the device. Unfixed edge areas, with disadvantageous consequences, are avoided. VHD can be covered on the visceral side (repair layer) with an anti-adhesive, resorbable layer that extends to the parietal side (attachment layer). Covered edges provide additional protection despite adhesion formation.
    [030] Folding the surgical implant from a flexible raw block results in a significant reduction of material and an increase in the area available for tissue ingrowth, because seams along the periphery of the basic structure can be avoided. The stiffness of the fastening layer can be influenced by the shape of the pockets' overlapping areas and the type of connection in the overlapping areas.
    [031] Furthermore, the repair layer can contain a marking guide (central marking and directional indicators), which is linked to the external shape of the implant and indicates the center of the implant and the position of the corners. This marking guide helps the surgeon discover the current position and orientation of the implant, allows for controlled fixation with evenly positioned staples, and offers the possibility of a standardized fixation approach during surgery (first fixation points are predefined and can be contracted intuitively by following the markup guide).
    [032] A surgical implant comprising a central marking and directional indicators, in accordance with the invention, may be useful in pocketless designs as well.
    [033] Next, the invention is described in more detail by means of the modalities. The drawings show in
    [034] Figure 1, in parts (a) to (d), several views of a first modality of the surgical implant according to the invention, that is, in part (a) an exploded view of the implant components, in part ( b) an isometric view of the partially finished implant, in part (c) a plan view of the implant and in part (d) an isometric view of the implant,
    [035] Figure 2, in parts (a) to (f), several views of a second modality of the surgical implant according to the invention, that is, in part (a) an isometric view of a raw block for the implant, in part (b) an exploded view of the blank and an anti-adhesive film, in part (c) a plan view of the blank with an anti-adhesive film illustrating areas bonded by fusion, in part (d) an isometric view of the partially finished implant, in the part (e) a plan view of the implant and part (f) an isometric view of the implant,
    [036] Figure 3, in parts (a) to (e), several views of a third modality of the surgical implant according to the invention, that is, in part (a) an isometric view of a raw block for the implant, in part (b) an exploded view of the blank block and an anti-adhesive film, in part (c) an isometric view of the partially finished implant, in part (d) a plan view of the implant and in part (e) an isometric view of the implant,
    [037] Figure 4, in parts (a) to (e), several views of a fourth modality of the surgical implant according to the invention, that is, in part (a) an isometric view of a blank block for the implant, in part (b) an exploded view of the various layers used in the assembly of the implant, in part (c) an isometric view of the partially finished implant, in part (d) a plan view of the implant and in part (e) an isometric view of the implant,
    [038] Figure 5, a schematic plan view of an illustrative embodiment of the surgical implant, according to the invention, showing various designs for connecting the overlapping areas between adjacent flaps, and
    [039] Figure 6, in parts (a) to (c) various schematic representations as examples for the arrangement of central markings and directional indicators in surgical implants, according to the invention.
    [040] Figure 1 illustrates a first embodiment of a surgical implant, which is designated by the reference number 100, as well as a manufacturing process for the implant 100.
    [041] As shown in the exploded view of Figure 1(a), the implant 100 consists of three parts. One part is a blank block 102, which consists of a mesh-like material, in one embodiment an interwoven mesh, of undyed monofilament polypropylene (PROLENE™ polypropylene mesh from Ethicon; non-absorbable) comprising a filament thickness of 89 µm. The blank block 102 defines a basic structure 104 of the implant 100 plus six tabs 106.
    [042] On top of the blank 102, Figure 1(a) shows a marking layer 108 composed of a dyed (violet) film of poly-p-dioxanone (PDS) having a thickness of 50 μm (absorbable) and comprising a total of eight openings 110. The openings 110 may be perforated or cut, for example by laser cutting.
    [043] The third part visible in Figure 1(a) is the blank of the anti-adhesive film 112. In the embodiment, the anti-adhesive film 112 is a 20 μm thick (undyed) MONOCRYL film. MONOCRYL material (Ethicon) is an absorbable copolymer of glycolide and ε-caprolactone and has anti-adhesive properties.
    [044] The three layers 102, 108 and 112 are placed one on top of the other and laminated by heat. In that step, the poly-p-dioxanone of layer 108 melts or becomes very soft and penetrates through the pores of the blank 102, so that it attaches well to the blank 102 and additionally sticks the anti-adhesive film 112 to the blank. 102, so that part of the area of the anti-adhesive film 112 adheres to the blank block 102.
    [045] Thereafter, as shown in Figure 1(b), the flaps 106 are folded over respective fold lines 114, which pass through the edge areas of the anti-adhesive film 112, so that the zones 116 of the anti-adhesive film are formed 112 which are folded, as well as covering, but not completely, the flaps 106.
    [046] Adjacent flaps 106 overlap at their common edge zones so that overlapping areas 118 are provided. In the overlapping areas 118, the material of adjacent tabs 106 is connected to each other, in the fused mode by ultrasonic welding in a strip-like format.
    [047] Figure 1(c) illustrates the finished implant 100 in a top plan view. Fold lines 114 define an outer periphery 120 of base frame 104. In one embodiment, base structure 104, i.e., finished implant 100, has a hexagonal shape that includes six corners 122. Six pockets 124 are formed by flaps 106 and the opposite material of the base frame 104. These pockets are accessible via edges 126 defined by part of the outer edge of the original blank 102.
    [048] The marking layer 108 provides a central marking 130, six directional indicators 132 that point to and extend to corners 122, and additionally a midline indicator 134 that also extends to the outer periphery 120 of the implant 100. In Figure 1(c), the overlap areas 118 are hatched, but as the mesh material of the blank block 102 is translucent, the directional indicators 132 and also the midline indicator 134 are clearly visible through the tabs 106 when the implant 100 is viewed from its upper side shown in Figure 1(c).
    [049] Figure 1(d) is an isometric view of the implant 100 from the top.
    [050] The surgical implant 100 is flexible and comprises a mesh-like area structure. The central marking 130 and the directional indicators 132 allow some assessment of the position and orientation of the implant 100, even if its outer periphery 120 is not visible or completely visible. In the overlap areas 118, the material is double thick, which provides a tactile response, thus facilitating the surgical procedure. Furthermore, the hexagonal shape of the implant 100 with six well-defined corners 122 (which, however, can be somewhat rounded in an atraumatic manner) further optimizes the handling properties of the implant 100.
    [051] As the material of the marking layer 108 is also present in the area of the fold lines 114, the outer periphery 120 of the implant 100 is also clearly visible (unless it is hidden by body tissue).
    [052] Preferably, the implant 100 is attached to body tissue by introducing a stapling instrument into the pockets 124 and expelling the staples so that they penetrate only the flaps 106, which point in the opposite direction to the basic structure 104. This procedure can be carried out in a well-defined manner, for example, a clip can be positioned in the area of each corner 122 so that it penetrates the material of the tabs 106 in the overlapping areas 118, which are stronger because of the thickness. pair.
    [053] A second embodiment of the surgical implant, designated by the reference number 200, is illustrated in Figure 2. The implant 200 is similar to the implant 100. For this reason, the parts and components of the implant 200 will not be explained again in detail. Next, only the differences between implants 100 and 200 will be pointed out. In Figure 2, the respective associated reference numbers of Figure 1 have been increased by 100.
    [054] The blank 202 is cut from an interlaced, partially absorbable mesh material produced from undyed polypropylene monofilaments (89 μm thick; PROLENE polypropylene) and dyed (violet) poly-p-dioxanone monofilaments (81 μm thick; PDS).
    [055] In the implant 200, a central marking 230 and directional indicators 232 are not provided via a film-like marking layer, but by filaments 208 of absorbable violet-colored poly-p-dioxanone monofilaments (109 μm thick; PDS) , which are sewn to the blank 202 to form the center marking 230, six directional indicators 232, a midline indicator 234, as well as a hexagonal line along the outer periphery 220 of the implant 200, see Figure 2(a).
    [056] The flexible blank 202 and an absorbable anti-adhesive layer 212 (see Figure 2(b)), in the embodiment a 20 μm thick undyed Monocryl film, are partially connected in the area of the sewn marking threads. 208 of PDS and in zones 216, see Figure 2(c). For this purpose, the assembly is heated in the pre-selected areas (hatched in Figure 2(c)) so that the PDS material from the raw block 202 and the marking threads 208, fuse in these areas and act as a molten glue. , similar to the first modality. In the overlap areas 218, the folded tabs 206 are fused by ultrasonic welding into a strip-like format, see Figure 2(d). Figures 2(e) and 2(f) show the finished implant 200.
    [057] A third modality of the surgical implant, designated by the reference number 300, is illustrated in Figure 3. The implant 300 is similar to the implant 200. Again, the respective associated reference numbers have been increased by 100. In the implant 300, the material for the blank block 302 and sewn marker threads 308, respectively, is the same as the implant 200.
    [058] Unlike implant 200, anti-adhesive film 312 (again undyed MONOCRYL film) is only 10 μm thick and is connected across its entire surface to block 302. To achieve this, during the lamination process, the heat is controlled to sufficiently soften or melt the PDS filaments in the block 302 as opposed to the anti-adhesive film 312 and not just the marking threads 308. In the overlap areas 318, the folded tabs 306 are fused by ultrasonic welding into a strip, as in the other modalities.
    [059] Figure 3(a) shows the block 302 with the marking wires 308, Figure 3(b) additionally the anti-adhesive film 312, Figure 3(c) the partially finished implant 300 and Figures 3(d) and 3(e) show the finished implant 300.
    [060] Figure 4 illustrates a fourth surgical implant modality, designated by the reference number 400. Because of similarity with the other modalities, the respective associated reference numbers have again been increased by 100.
    [061] Block 402 is produced from an 89 μm thick interlaced mesh of polypropylene monofilaments (PROLENE Polypropylene; dyed and undyed), which includes in the central area a marking guide 408 sewn with polypropylene monofilaments. dyed fabrics (89 μm thick; PROLENE Polypropylene), see Figure 4(a).
    [062] Flexible blank 402 and an anti-adhesive resorbable layer 412 of oxidized regenerated cellulose (ORC; undyed) are connected through the use of an intermediate layer 411 produced from 20 μm thick undyed PDS film. and an additional layer 413 made of a 5 μm thick undyed absorbable PDS film as a hot melt adhesive, see Figure 4(b). In the overlap areas 418, the folded tabs 406 are fused by ultrasonic welding into a strip-like format, as in the other embodiments. Figure 4(c) shows the partially finished implant 400, and Figures 4(d) and 4(e) show the finished implant 400.
    [063] Figure 5 illustrates various shapes of overlapping areas 518 (hatched), in which adjacent flaps 506 of a surgical implant 500 are connected together. By designing the size and shape of the overlap areas 518, the properties of the pockets 524 (in particular in terms of flexibility) can be influenced. Usually, the shape will be the same for all overlapping areas on a given implant, as in surgical implants 100, 200, 300 and 400, but assemblies such as Figure 5 are also conceivable, in particular when symmetrical with respect to the axes of symmetry. .
    [064] In different surgical implant modalities, adjacent flaps are not connected in the areas of overlap or do not overlap at all.
    [065] Figure 6 displays some schematic representations of basic structure shapes and central markings and directional indicators for surgical implant modalities.
    [066] In Figure 6(a), a preferred orientation of polygonal implants with three to six corners with respect to the anatomical environment is indicated.
    [067] Figure 6(b) shows examples of equilateral polygons, in which the central marking 630 is of the tip type and indicates the center of gravity of the respective implant. Directional indicators 632 extend to the corners of the implant. Additional marking lines 636 are provided along the periphery of the implant.
    [068] The implants in the examples in Figure 6(c) have a hexagonal shape like implants 100, 200, 300 and 400. In two cases, marking lines 636 are included along the periphery of the implant. In other cases, there are no such lines of marking. In all cases, the 632 directional indicators extend to the corners. In one case, the corners are additionally marked by extended points 638. However, the directional indicators will be useful even if they do not reach the corners. In some cases, additional midline indicators 634 are provided. It is evident from Figure 1(c) that the central area of each implant is easily assessable, even if a central marking 630 is not dot-like. Many other examples for the arrangement of redlines are conceivable as well.
    [069] The modalities described above illustrate the general concept of the surgical implant according to the invention, when designated as Ventral Hernia Device (VHD) in preferred variants. In summary:
    [070] The Ventral Hernia Device (VHD) is a pocket-shaped device with tissue separation properties for the reinforcement and closure of the abdominal wall in the repair of ventral, incisional and major umbilical hernias, using a technique of intraperitoneal mesh overlay.
    [071] VHD comprises a flexible polygonal basic structure with a central area (repair layer) and peripheral flaps (fixation layer). The flaps form flaps, but do not extend to the geometric center of the fastening layer so that the fastening layer has a central opening and the pockets form a bag type that is easily accessible through that central opening. The folding of the flaps and merging in overlapping areas leads to a duplication, preferably strip-like, of the fixing layer in such a way that the strips are oriented towards the corners; Duplication areas can cover between 1% and 50% of the area of the anchor layer, preferably 1% to 20%. The cast strips allow for better tactile control and guidance to corners, which leads to optimized intra-operational handling of the device.
    [072] The central opening in the fixation layer allows the entry of a finger or surgical instrument, such as a stapler, into the space created between the visceral and parietal sides, that is, in the pockets. The formation of the pocket by bending only a flexible raw block allows for a fixation in the outermost position of the periphery and corners of the implant, which results in a fully expanded implant. Unfixed edge material (as in the case of products with support rings or seams to connect different layers) is avoided so that unfixed edge material does not dilate or bend.
    [073] On the visceral side (repair layer), the implant is covered with a non-adhesive absorbable layer, which is fixed to the basic structure from one side and also covers the edges at the periphery of the implant, where it extends from the visceral side to parietal side, which leads to a partially covered attachment layer. Preferably, less than 50% of the anchor layer is covered by the absorbable layer, which allows for very good tissue ingrowth. Furthermore, such an extended absorbable layer provided additional edge protection despite adhesion formation.
    [074] The surgical implant that has mesh pockets can be used in the so-called IPOM-open technique for the repair of ventral hernias. For fixing mesh pockets, it has been found to be advantageous to start fixing the mesh pockets on the cranial/caudal axis, then fixing the other apexes, and then completing the fixing according to the usual known techniques. In this procedure, which starts with fixation in the cranial/caudal axis, it was observed that the tendency to form folds in the implant, which is caused by non-uniform fixation of the mesh pockets in the relatively soft abdominal wall, is greatly reduced, and the implants are significantly better integrated (tissue ingrowth) into the abdominal wall.
    [075] A marking guide (central marking and directional indicators) in the repair layer, which is linked to the external shape of the implant and indicates the center of the implant and the position of the corners, helps the surgeon to know the real position and orientation of the implant. device without additional lifting of body tissue or manipulation of the implant, and allows for controlled fixation with evenly positioned clamps or clips. This also offers the surgeon the possibility of a standardized fixation approach (eg initial fixation points are predefined and can be found intuitively by following the marking guide). The shape of the mesh pockets and better visualization of mesh edges/corners improve intra-op handling considerably.
    [076] The marking guide (central marking and directional indicators) is also very useful in surgical area implants (in particular mesh-like structures) without pockets.
    [077] In general, the contour or external shape of implant meshes, according to the previous technique, does not provide a reference for the surgeon to consider direction-dependent properties of the repair mesh, such as obtaining a certain coverage or overlap. of the abnormality, the elongation properties of the mesh, the orientation during fixation, a guide for the first fixation points or a clear identification of the area where to fix. On the other hand, correct positioning in terms of orientation and centering of the implant over the abnormality is crucial for a successful repair. And creasing and flexing of the implant during fixation, leads to crease cavities (and, consequently, seroma formation), which results in poor integration of the implant into the abdominal wall.
    [078] Such problems can be avoided when the basic mesh-like structure of the implant has a polygonal shape and when the implant comprises a marking guide, that is, a central marking and directional indicators that point from the central marking to the corners. The linkage between the shape and the marking guide helps the surgeon to know the current position and orientation of the implant just by looking at the center of the anomaly, without additional tissue elevation or manipulation of the implant. The implant can be positioned in a better way compared to the previous technique, for example when a corner tip of the implant is placed under bony structures such as the sternum.
    [079] Starting the fixation at the vertices (corner areas) of the implant, following the continuous marking guide with the fixation device from the center of the implant to the vertices, leads to a full spread of the implant with clamps positioned evenly. This offers the surgeon the possibility of a structured and standardized fixation approach, for example, due to the fact that the first fixation points are predefined and can be found intuitively by following the marking guide. A hexagonal shape of the implant is particularly advantageous.
    [080] For example, during implantation for repair of an incisional hernia with a tetragonal mesh (square or rectangular), a marking guide pointing to the vertices or corners "1" and "3", as shown in Figure 6(a). ), may indicate the cranial-caudal direction. For a hexagonal shape, the corners "1" and "4" indicate the cranial-caudal direction. Cranial to caudal orientation can be displayed in a pentagonal mesh format through corner point "1" and the center of the base between corner points 3 and 4.
    权利要求:
    Claims (15)
    [0001]
    1. A surgical implant comprising a flexible mesh-like basic structure (104; 204; 304; 404) having a central area and an outer periphery (120; 220; 320; 420), wherein the outer periphery (120; 220; 320 ; 420) comprises a polygonal shape having N corners (122; 222; 322; 422), N is at least 3; characterized in that the implant comprises at least two pockets (124; 224; 324; 424), each pocket (124; 224; 324; 424) extending from a peripheral line (114; 214; 314; 414) connecting two corners (122; 222; 322; 422) of the outer periphery (120; 220; 320; 420) of the basic frame (104; 204; 304; 404) towards the central area of the basic frame (104; 204; 304; 404).
    [0002]
    2. Surgical implant according to claim 1, characterized by the fact that N is selected from the following set: {6, 8}.
    [0003]
    3. Surgical implant, according to any one of the preceding claims, characterized in that the implant comprises N pockets (124; 224; 324; 424).
    [0004]
    4. Surgical implant according to any one of the preceding claims, characterized in that the mesh-like basic structure (104; 204; 304; 404) and the pockets (124; 224; 324; 424) are folded over fold lines (114; 214; 314; 414) from a common blank (102; 202; 302; 402), the fold lines (114; 214; 314; 414) being located on the outer periphery ( 120; 220; 320; 420) of the basic frame (104; 204; 304; 404) and the pockets (124; 224; 324; 424) are accessible via respective edges (126; 226; 326; 426) opposite the lines of bend (114; 214; 314; 414).
    [0005]
    5. Surgical implant, according to claim 4, characterized by the fact that the material of a given pocket (124; 224; 324; 424) overlaps the material of an adjacent pocket (124; 224; 324; 424 ) in a respective overlapping area (118; 218; 318; 418), whereby in the overlapping area (118; 218; 318; 418) the material of adjacent pockets (124; 224; 324; 424) is connected one to the other. other.
    [0006]
    6. Surgical implant, according to claim 5, characterized by the fact that at least one of the overlapping areas (518) has one of the following formats: strip-like, curved, zigzag-shaped, asymmetrical and diamond-shaped.
    [0007]
    7. Surgical implant, according to claim 5 or 6, characterized in that at least in one of the overlapping areas (118; 218; 318; 418), the material from adjacent pockets (124; 224; 324; 424 ) is connected in at least one of the following ways: welded, glued, sewn; permanent, absorbable, partially absorbable.
    [0008]
    8. Surgical implant according to any one of claims 5 to 7, characterized in that the material of at least one pocket (124; 224; 324; 424) is connected to the basic structure (104; 204; 304). ; 404) outside an overlap area (118; 218; 318; 418).
    [0009]
    9. Surgical implant according to any one of claims 4 to 8, characterized in that an anti-adhesive film (112; 212; 312; 412) situated on the face of the basic structure (104; 204; 304; 404) facing away from the pockets (124; 224; 324; 424); optionally characterized in that the anti-adhesive film (112; 212; 312; 412) covers the area of the basic structure (104; 204; 304; 404) and extends beyond the outer periphery (120; 220; 320; 420). ) of the base frame (104; 204; 304; 404) where the anti-adhesive film (112; 212; 312; 412) is folded back together with the pocket material (124; 224; 324; 424); and/or optionally characterized in that the anti-adhesive film (112; 212; 312; 412) is absorbable and preferably comprises at least one of the following substances: poly-p-dioxanone, ε-caprolactone, glycolide copolymer and ε-caprolactone, oxygenated regenerated cellulose, collagen, combinations thereof..
    [0010]
    10. Surgical implant, according to any one of claims 9 or 10, characterized in that the anti-adhesive film (112; 212; 312; 412) has a thickness in one of the following ranges: 2 μm to 1000 μm, 5 μm to 100 μm, 8 μm to 30 μm.
    [0011]
    11. Surgical implant, according to claims 9 or 10, characterized in that the anti-adhesive film (112; 212; 312; 412) is connected to the material of the basic structure (104; 204; 304; 404) in at least one of the following ways: fixing over the entire surface of the anti-adhesive film (312; 412), fixing over part of the surface of the anti-adhesive film (112; 212); laminated, welded, glued, sewn; permanent, absorbable, partially absorbable.
    [0012]
    12. Surgical implant, according to any one of claims 1 to 11, characterized in that the central area of the mesh-like basic structure (104; 204; 304; 404) is marked by a central marking (130; 230; 330 ; 430; 630), with directional indicators (132; 232; 332; 432; 632) pointing from the central marking (130; 230; 330; 430; 630) to at least two corners (122; 222; 322; 422) the outer periphery (120; 220; 320; 420) of the basic structure (104; 204; 304; 404); optionally characterized by the fact that the directional indicators (132; 232; 332; 432; 632) point from the central marking (130; 230; 330; 430; 630) to all corners (122; 222; 322; 422) of the periphery external (120; 220; 320; 420) of the basic structure (104; 204; 304; 404). and/or optionally characterized in that at least part of the directional indicators (132; 232; 332; 432; 632) are provided as line marks extending from the central marking (130; 230; 330; 430; 630) to the respective corner (122; 222; 322; 422) of the outer periphery (120; 220; 320; 420) of the basic frame (104; 204; 304; 404).
    [0013]
    13. Surgical implant, according to claim 12, characterized in that at least one of the central marking (130; 230; 330; 430; 630) and the directional indicators (132; 232; 332; 432; 632) comprises at least one of the following properties: formed from a film structure (108) connected to the base structure (104), formed from a thread structure (208; 308; 408) connected to the base structure (204; 304; 404), embroidered on the basic frame, sewn on the basic frame (204; 304; 404), produced in one piece with the basic frame; dyed (108; 208; 308; 408), undyed; absorbable (108; 208; 308), non-absorbable (408).
    [0014]
    14. Surgical implant, according to any one of claims 1 to 13, characterized in that the basic structure (104; 204; 304; 404) comprises at least one of the materials included in the following list: polypropylene, fluorinated polyolefins, poly -p-dioxanone, copolymers of glycolide and lactide, copolymers of glycolide and lactide in the ratio of 90:10, copolymers of glycolide and ε-caprolactone, mixtures of polyvinylidene fluoride and copolymers of vinylidene fluoride and hexafluoropropene.
    [0015]
    15. Surgical implant, according to any one of claims 1 to 14, characterized in that the basic structure (104; 204; 304; 404) comprises at least one of the following properties included in the following list: being macroporous, having a pore size of at least 1 mm, having a grammage of less than 50 g/m2, comprising a warp knit, comprising a woven knit, comprising a crocheted knit, comprising a woven cloth, comprising a perforated film, comprising bio-absorbable filaments comprising non-absorbable filaments, comprising monofilaments, comprising multifilaments, comprising tape yarns, comprising stretch film tapes.
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    同族专利:
    公开号 | 公开日
    KR102218819B1|2021-02-24|
    BR112015022927A2|2017-07-18|
    IL240534D0|2015-10-29|
    US20140276999A1|2014-09-18|
    MX2015012117A|2016-05-18|
    CA2905549A1|2014-09-18|
    US9795469B2|2017-10-24|
    CN105188602B|2018-05-18|
    AU2014231266B2|2017-11-23|
    CA2905549C|2021-03-23|
    EP2967788B1|2018-12-26|
    DE102013004486A1|2014-09-18|
    JP2016513504A|2016-05-16|
    JP6444900B2|2018-12-26|
    AU2014231266A1|2015-10-29|
    CN105188602A|2015-12-23|
    RU2015143893A|2017-04-20|
    EP2967788A1|2016-01-20|
    KR20150135357A|2015-12-02|
    MX361294B|2018-11-30|
    WO2014139634A1|2014-09-18|
    RU2633282C2|2017-10-11|
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    法律状态:
    2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-02-11| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-10-26| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2022-01-11| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/02/2014, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
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    DE102013004486.3A|DE102013004486A1|2013-03-14|2013-03-14|Surgical implant|
    DE102013004486.3|2013-03-14|
    PCT/EP2014/000467|WO2014139634A1|2013-03-14|2014-02-21|Surgical implant|
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