Device for facilitating implantation of a surgical mesh

Abstract

The present invention relates to a device (10) for facilitating the implantation of a surgical mesh (1) having at least one barbed face (2), said device comprising: - said surgical mesh (1); - at least one biocompatible membrane (11, 11a, 11b) shaped and sized to at least partially cover said barbed face (2); - at least one cable (12) arranged to removably attach said membrane (11, 11a, 11b) to said barbed face (2) of said mesh (1).

Description

[0001] This invention relates to a device for facilitating the implantation of a surgical mesh into a patient, wherein barbs are provided on at least one side of the surgical mesh. Such meshes can be used to produce tissue-reinforced prostheses for treating hernias. The device of this invention is particularly useful in the treatment of inguinal hernias, wherein the mesh is preferably introduced into the patient via classic open surgery.

[0002] Tissue-reinforcing prostheses (e.g., prostheses used to reinforce the abdominal wall) are widely used in the surgical field. These prostheses are designed to treat hernias by temporarily or permanently reinforcing or filling tissue defects. These prostheses are typically made of biocompatible surgical mesh and can come in various shapes, such as rectangular, round, or oval, depending on the anatomy to which they are to be adapted. The surgical mesh can be made of non-biodegradable yarn, or it can be made of biodegradable yarn, or it can be made of a combination of non-biodegradable and biodegradable yarn, depending on whether the surgical mesh is intended to remain permanently in the patient or, conversely, disappear after the reinforcing effect of the surgical mesh has been achieved, during cell colonization and tissue healing.

[0003] Surgical meshes may include arrangements of yarns, such as knitted, woven, or nonwoven fabrics. Surgical meshes may further include barbs projecting outward from one side (sometimes from both sides): these barbs form hooks that are capable of securing themselves to another mesh, whether belonging to or not of the same prosthesis, or directly to biological tissue (e.g., the abdominal wall).

[0004] Having barbs on at least one face of the mesh offers several advantages. Due to the presence of barbs, the mesh can directly grip and attach to biological tissue without the need for conventional attachment devices such as pins, U-bolts, sutures, or adhesives. In fact, conventional attachment devices such as pins, U-bolts, sutures, and adhesives can cause trauma to biological tissue and are a source of chronic pain. Pins, U-bolts, and sutures can also cause tension in biological tissue and / or tearing in the mesh. When a barbed mesh is attached to biological tissue, optimal force distribution is achieved across the entire surface of the mesh because the barbs are typically located across the entire face of the mesh. This is an advantage over attaching a barbed mesh without pins, U-bolts, or sutures, where force is concentrated at the fixation point, potentially leading to tearing of the mesh and potential patient discomfort.

[0005] Although barbed meshes have advantages, surgical meshes with at least one barbed side may leave surgeons with some negative impressions, making such surgical meshes difficult to implant.

[0006] In practice, when a surgical mesh with at least one barbed side is delivered to the implantation site, the barbs may stick to adjacent tissue, making it difficult to deliver the surgical mesh to the implantation site without damaging adjacent tissue and / or the surgical mesh itself. Therefore, the introduction phase of the surgical mesh can be uncomfortable for the surgeon.

[0007] Another drawback of barbed surgical meshes is that the barbs make them difficult to reposition once implanted. In fact, once the surgical mesh has been advanced to the implantation site, the surgeon may want to experiment with various positions and / or orientations of the mesh relative to the surrounding tissue to ensure its proper function once secured. The fact that the barbs make it difficult to detach and reattach the mesh to biological tissue can make this positioning step challenging for the surgeon.

[0008] In addition, when the mesh is folded, the barbs may grip the mesh itself, thus hindering its subsequent deployment and positioning.

[0009] Therefore, there is still a need for a device for facilitating the implantation of a surgical mesh having at least one barbed surface, wherein such a device would allow the surgical mesh to be introduced without damaging the barbs and / or surrounding biological tissue, and once the mesh has reached the implantation site, such a device would further enable the positioning and repositioning of the surgical mesh.

[0010] A first aspect of the invention is a device for facilitating the implantation of a surgical mesh having at least one barbed surface, the device comprising:

[0011] -The surgical mesh,

[0012] - At least one biocompatible membrane, the shape and size of which are determined to at least partially cover the barbed surface.

[0013] - At least one cable is arranged to removably attach the membrane to the barbed surface of the mesh.

[0014] In the device of the present invention, a biocompatible membrane covers most of the barbs present on the barbed surface of the mesh, and in some embodiments, covers all the barbs. When the surgical mesh is delivered to the implantation site, the surrounding biological tissue is thus protected from the barbs because the barbs primarily contact the surface of the biocompatible membrane, which is smooth and non-invasive. Therefore, the surgeon does not have to deal with the surgical mesh becoming entangled in the surrounding tissue and causing damage to such tissue.

[0015] Once the surgical mesh has reached the implantation site, the surgeon can easily manipulate it to try various positions because the biocompatible membrane linked to the barbed side still covers most of the barbs, thus continuing to protect the surrounding biological tissue. When a portion of the barbed side of the surgical mesh is uncovered, the surgeon can use this uncovered portion to create a fixation point from which the surgeon can try various positions / orientations of the mesh.

[0016] Once the surgeon is comfortable with the position of the surgical mesh, the surgeon can decide to remove the cables attaching the biocompatible membrane to the surgical mesh. Once these cables are removed, the surgeon can then remove the biocompatible membrane. As can be seen from this specification, the biocompatible membrane and the barbed cables that removably attach the biocompatible membrane to the surgical mesh are not intended to remain in the patient's body. Once the surgical mesh is properly positioned, the biocompatible membrane and cables are removed. Once the biocompatible membrane and cables are removed, the barbs are allowed to grip surrounding biological tissue and perform their fixation function.

[0017] Therefore, the device of the present invention allows for improved handling of meshes because the meshes can be folded without creating problems such as barbs becoming entangled within the mesh. The device of the present invention further allows for the repositioning of surgical meshes without compromising their gripping properties, because the barbs are neither damaged during transport of the mesh to the implantation site nor by the biocompatible membrane itself.

[0018] Furthermore, the device of the present invention further allows for the protection of surrounding biological tissue during the insertion of the mesh into the patient up to the implantation site. Additionally, since all components of the device except the mesh are removed from the patient's body once implanted, the device of the present invention does not introduce foreign substances intended to remain in the patient's body.

[0019] As can be seen from the above, the device of the present invention allows the surgeon to choose the moment when he / she wants to engage the barbs in the surrounding tissue, thereby securing the mesh. If necessary, the surgeon can also decide to completely remove and reintroduce the device before removing the cables and membrane. With the device of the present invention, there is no limitation on when the surgeon decides to initiate the barb engagement by removing the membrane from the mesh.

[0020] The device of the present invention includes a surgical mesh having at least one barbed facet. The surgical mesh is typically made of an arrangement of biocompatible yarns, which can be, for example, knitted, woven, or nonwoven fabrics, the arrangement of the yarns defining two opposing faces of the mesh. The barbs are present on at least one facet of the mesh, particularly on the facet intended to be secured to surrounding biological tissue when the mesh is implanted. In embodiments, the barbs may be present on both faces of the mesh.

[0021] Once the mesh is correctly positioned at the implantation site, the barbs are designed to grip the mesh to the surrounding biological tissue. Thus, the barbs typically protrude outwards from the barbed side of the mesh, for example, substantially perpendicular to the mesh surface. To achieve uniform fixation, where force is distributed across the entire surface of the mesh, the barbs are preferably positioned in a more or less regular manner across the entire surface of the barbed side of the mesh.

[0022] The surgical mesh yarns and barbs of the device of the present invention are made of biocompatible materials, which may be biodegradable or non-biodegradable.

[0023] In this application, "biocompatibility" is understood to mean that a material with this property can be implanted into the body of a human or animal.

[0024] All biocompatible materials can be synthetic or natural, biodegradable, non-biodegradable, or a combination of both. As used herein, the term "biodegradable" is defined to include both bioabsorbable and bioresorbable materials. Biodegradable means that a material decomposes or loses its structural integrity under in vivo conditions (e.g., enzymatic degradation or hydrolysis) or breaks down under physiological conditions in vivo (physical or chemical), such that the degradation products can be excreted or absorbed by the body.

[0025] The biodegradable materials suitable for the surgical mesh of the present invention can be selected from polylactic acid (PLA), polyglycolic acid (PGA), oxidized cellulose, polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoate (PHA), poly(glycolic acid-caprolactone-lactide-trimethylene carbonate), copolymers thereof, and mixtures thereof. The non-biodegradable materials suitable for the surgical mesh of the present invention can be selected from polyethylene terephthalate (PET), polyamide, aromatic polyamide, expanded polytetrafluoroethylene, polyurethane, polyvinylidene fluoride (PVDF), butyl ester polymers, polyetheretherketone (PEEK), polyolefins (such as polyethylene or polypropylene), polyethers, copper alloys, silver or platinum alloys, medical-grade steel (such as medical-grade stainless steel), and combinations thereof.

[0026] Barbs can be obtained by melting loops created from hot-melt monofilament yarns used to construct meshes. The generation of barbs from primary loops made of hot-melt monofilament yarns is known and described, for example, in document WO01 / 81667.

[0027] Mesh can be displayed in any shape, such as rectangular, circular, or elliptical, depending on the anatomical structure to which the mesh is intended to be fitted.

[0028] In one embodiment, the surgical mesh of the device of the present invention has an overall elliptical shape defining a longitudinal axis and two opposing ends of the barbed surface. The two opposing ends are substantially aligned along the longitudinal axis. Such an elliptical mesh can be particularly used for the treatment of hernias.

[0029] In this implementation, the surgical mesh is intended to treat an inguinal hernia. Therefore, the mesh may have an overall elliptical shape defining a longitudinal axis and two opposite ends of the barbed face, and is also provided with slits to allow the spermatic cord to pass through. Such surgical meshes are known: they are typically elliptical, and the slits extend upwards from a point substantially located at the center of the mesh (at a point substantially located in the middle of one of the long sides of the mesh) to the edge of the mesh.

[0030] In other embodiments, the mesh may further be provided with flaps extending from the edge of the slit, which, once the mesh is implanted, serve to close the mesh around the spermatic cord. Such flaps can further be used to maintain the mesh in a closed configuration. For example, such flaps may themselves be provided with barbs on one face, preferably on the barbless face of such flaps facing the mesh. Membranes provided with slits and flaps and intended for the treatment of inguinal hernias are known and will not be described further herein. In such meshes, the barbed face is preferably the face of the mesh without flaps.

[0031] The device of the present invention further includes a biocompatible membrane. The shape and size of the biocompatible membrane are determined to at least partially cover the barbed surface of the surgical mesh.

[0032] As described above, the membrane is designed to cover most of the barbs during the delivery of the surgical mesh to the implantation site in the patient and during the unfolding and positioning of the mesh at the implantation site.

[0033] The membrane is preferably non-porous. This allows for perfect coverage of the barbs and thus provides optimal protection relative to the surrounding biological tissue during insertion of the mesh into the patient. The smooth and glossy surface of the membrane allows it to slide over the biological tissue and facilitates removal from the patient at the end of the implantation procedure.

[0034] The membrane is preferably thin. As an indication, the membrane thickness can be shown as approximately 15 μm to approximately 25 μm. The thin membrane allows for protection against overloading of the mesh. It also allows for good contact between the mesh and barbs through the surgeon's fingertips.

[0035] The membrane preferably exhibits sufficient strength to prevent tearing during the introduction and delivery of the surgical mesh into the patient. The membrane must also exhibit sufficient strength so that the surgeon can pull it at the end of the implantation procedure to remove it from the implantation site without tearing it.

[0036] The membrane is made of biocompatible materials. The membrane can be made from the biodegradable materials listed above, non-biodegradable materials, or a combination of biodegradable and non-biodegradable materials. The membrane is preferably obtained by laminating biocompatible materials. Such lamination processes are well known and will not be described further herein.

[0037] In the embodiments, the membrane is made only of biodegradable materials. This limits the potential negative consequences of some portions of the membrane remaining in the patient's body after the mesh is implanted. For example, the membrane is made of poly(glycolic acid-caprolactone-lactide-trimethylene carbonate). The preparation of poly(glycolic acid-caprolactone-lactide-trimethylene carbonate) copolymer compositions suitable for forming the membrane of the device of the present invention is described in US 6,235,869.

[0038] In one implementation, the shape and size of the membrane can be determined to cover the entire surface of the barbed side of the mesh. In such cases, all barbs present on the barbed side are covered by the membrane.

[0039] In an embodiment where the mesh has an overall elliptical shape with two opposing ends of a barbed face defining a longitudinal axis, the shape and size of the membrane are determined such that at least a portion of one of the ends of the barbed face is uncovered. Once the mesh is in place at the implantation site, the uncovered portion of the end of the barbed face allows the surgeon to create a first fixation point in the biological tissue by attaching the barbs present on the uncovered end to the surrounding biological tissue. This first fixation point allows the surgeon to experiment with different positions and / or orientations for the mesh while the membrane is still attached to the barbed face before determining the final position. The presence of the membrane on the barbed face and its uncovered end allows for easy handling of the mesh and smooth, convenient movement of the mesh within the biological tissue as the surgeon changes the position / or orientation of the mesh. This first fixation point can be determined if the surgeon has reached a position / or orientation of the mesh that he finds comfortable. Alternatively, since the uncovered portion of the barbed face has a limited surface area, with only a few barbs present on that limited surface, the first fixation point can be temporary if the surgeon ultimately decides to detach the barbs of the uncovered portion of the barbed face from the biological tissue and reattach them to a different location. To attach / detach and / or reattach the barbs of the uncovered portion of the barbed face to / from the surrounding biological tissue, the surgeon only needs to push or pull on the barbless side of the mesh in the region of the uncovered portion of the barbed face.

[0040] In a further embodiment, where the mesh has an overall elliptical shape with two opposing ends of a barbed face defining a longitudinal axis, the shape and size of the membrane are determined such that portions of the two ends of the barbed face are not covered. The uncovered portions of the barbed face at both ends of the mesh allow the surgeon to create initial fixation of the mesh to the surrounding biological tissue before membrane removal. In effect, by pushing the two ends of the mesh in the direction of the biological tissue, the barbs present on the uncovered portions of the barbed face penetrate the biological tissue and perform partial anchoring of the mesh within those tissues. As will become clearer in the following detailed description, this initial anchoring of the mesh in the biological tissue facilitates membrane removal and also facilitates the removal of the cables attached to the barbed face of the mesh.

[0041] In addition, for easy removal from the implantation site, the membrane preferably exhibits good flexibility and good tear resistance. In practice, while membrane strength may help limit creases in the mesh, the membrane should in no way increase the excessive rigidity of the mesh, as the mesh must be easily manipulated and folded. The membrane preferably exhibits flexibility, allowing it to be easily folded when separated from the mesh at the end of the implantation process.

[0042] In one embodiment, the mesh has an overall elliptical shape defining a longitudinal axis and two opposing ends of the barbed face, the mesh further being provided with slits for allowing the spermatic cord to pass through in the treatment of inguinal hernia, the membrane exhibiting flexibility thereby allowing the membrane to fold to pass through the slits when the membrane is separated from the barbed face.

[0043] The membrane exhibiting flexibility and tear resistance suitable for the device of the present invention can be obtained, in particular, by lamination of poly(glycolic acid-caprolactone-lactide-trimethylene carbonate).

[0044] In this embodiment, the membrane is obtained by lamination of poly(glycolic acid-caprolactone-lactide-trimethylene carbonate). The preparation of such membranes is described, for example, in document EP 3 106 185 B1. Such membranes exhibit flexibility, thereby allowing them to be easily folded and facilitating removal from the implantation site.

[0045] In some embodiments, the membrane has pre-cut lines that are substantially aligned on the slits. Such pre-cut lines allow the surgeon to easily separate the membrane into two parts when he wishes to remove it from the implantation site. As will become apparent from the detailed description below, the fact that the pre-cut lines are aligned on the slits of the mesh facilitates the grasping of each part of the membrane through the slits by the surgeon's fingers or by any grasping tool.

[0046] In one implementation, the membrane is formed of two parts, each part of which substantially covers half of the mesh and has a central edge substantially aligned on the slit. In another implementation, the central edge of one part of the membrane overlaps with the central edge of the other part. In this type of implementation, because the membrane is initially in the form of two parts, the surgeon does not need to divide the membrane into two parts. Therefore, this type of implementation facilitates removal of the membrane at the end of the implantation procedure. The fact that the central edge of one part of the membrane overlaps with the central edge of the other part facilitates the surgeon's gripping of each part of the membrane, as the overlap near the slit of the mesh, close to the edge of the membrane, provides a larger surface area for the membrane portion that can be gripped.

[0047] The apparatus of the present invention further includes at least one cable arranged to removably attach the membrane to the barbed surface. The cable can be any flexible and elongated structure capable of removably attaching the membrane to the barbed surface, particularly as described herein. For example, the cable can be selected from wires, ropes, yarns, wires, tubes, and combinations thereof.

[0048] Preferably, the device includes multiple cables arranged to removably attach the membrane to the barbed surface.

[0049] Cables are made of biocompatible materials, which can be biodegradable or non-biodegradable. All biocompatible materials (such as the barbs and yarns described above for surgical mesh) are suitable for manufacturing cables.

[0050] The cable can be a multifilament yarn, a monofilament yarn, or a combination of multifilament and monofilament yarns. In this embodiment, the cable is a monofilament yarn. Monofilament yarn allows for the prevention of all tangling between the cable and the barbs of the mesh. The cable may further be colored: colored cables can be more easily positioned by the surgeon at the implantation site and distinguished from the mesh. In this embodiment, cables of different colors can be used. Such embodiments can be used, if desired, to distinguish some cables from others, for example, to indicate to the surgeon which cable should be removed first.

[0051] In the implementation scheme, the cable is a monofilament yarn made of polyethylene terephthalate (PET).

[0052] By suturing the membrane and mesh together with cables, the membrane is removably attached to the barbed side of the mesh, so that simply pulling on some of the cables will cause the cables to separate from the membrane and mesh. Separation of the cables from the membrane and mesh allows the membrane and mesh to be positioned simply side-by-side, without any attachment devices connecting them. The surgeon will then be able to easily separate the membrane from the mesh.

[0053] In this implementation, each cable is simply passed up and down through the two layers of membrane and mesh once or twice without forming any knots, and the membrane is removably attached to the barbed side of the mesh. Friction between the cable and the membrane and mesh keeps them together without the aid of knots. Therefore, simply pulling each cable to overcome this friction allows the cable to be removed from the two layers of membrane and mesh. The surgeon can remove each cable without cutting or untying any knots.

[0054] In this implementation, multiple cables can be used, each oriented radially from the center of the mesh toward its edge without interacting with other cables. This radial arrangement of the cables allows for perfect flattening of the membrane and attachment to the barbed surface of the mesh. Furthermore, the fact that the cables extend in the direction of the mesh's edge without forming any knots allows the surgeon to trim the mesh as needed, and to cut the distal ends of the cables during this trimming step without damaging the connection between the membrane and the mesh.

[0055] In this document, the distal end of a component should be understood as the end furthest from the user's hand, and the proximal end should be understood as the end closest to the user's hand. In the radial arrangement of the cable as described herein, the proximal end of the cable is the end of the cable located at the center of the mesh, while the distal end of the cable is the end of the cable located in the direction of the edge of the mesh.

[0056] Therefore, the radial arrangement of the cables allows the mesh to be trimmed without losing the connection between the membrane and the barbed surface of the mesh.

[0057] In this implementation, the distal end of each cable terminates on the side of the mesh not covered by the membrane. This allows the membrane's smooth surface to be maintained.

[0058] In this implementation, all proximal ends of the cables converge at a central tail that extends outward from the center of the mesh from the uncovered side of the mesh. The cables may be arranged in a braided form at the proximal end of the central tail to provide an easily gripped element for the surgeon. The surgeon only needs to pull the braid to ensure all cables are removed from the mesh and membrane.

[0059] In an alternative implementation, multiple cables may be used, wherein the cable arrangement differs from that of a radial arrangement: the cables may extend, for example, in various directions on the surface of the mesh, and / or reach linearly from one edge of the mesh, etc.

[0060] The invention and the advantages therefrom will become apparent from the following detailed description given with reference to the accompanying drawings, as follows:

[0061] [ Figure 1 This is a top view of the surgical mesh itself.

[0062] [ Figure 2 [It is intercepted along plane II] Figure 1 Cross-sectional view of the surgical mesh.

[0063] [ Figure 3 [Illustration 1] is a top view of one embodiment of the device of the present invention.

[0064] [ Figure 4 ]yes Figure 3 A bottom view of the device.

[0065] [ Figure 5 [It is intercepted along plane II-II] Figure 3 Cross-sectional view of the device,

[0066] [ Figure 6 ] is to show Figure 3 A cross-sectional view of the device positioned on the muscle to be fixed.

[0067] [ Figure 7 ] is to show Figure 3 A cross-sectional view of the initial anchoring of the device and the removal of the cable.

[0068] [ Figure 8 ] is to show Figure 3 A cross-sectional view of the opening of the mesh flaps of the device.

[0069] [ Figure 9 ] is to show Figure 3 A cross-sectional view of the removal of the first portion of the membrane in the device.

[0070] [ Figure 10 ] is to show Figure 3 A cross-sectional view of the removal of the second part of the membrane in the device.

[0071] [ Figure 11 ] indicates that Figure 3 The mesh of the device is fixed and anchored to the cross-section of the muscle.

[0072] [ Figure 12 [ ] is a partial cross-sectional view of another embodiment of the device of the present invention.

[0073] [ Figure 13 [ ] is a partial cross-sectional view of another embodiment of the device of the present invention.

[0074] refer to Figure 1 and Figure 2 This illustrates a surgical mesh 1 with a shape and size suitable for treating inguinal hernias. The mesh 1 is formed by an arrangement of biocompatible yarns defining two opposing faces: a barbed face 2 and a barbless face 3. The barbed face 2 includes a plurality of barbs 4 regularly distributed on its surface. The barbs 4 are used to penetrate biological tissue, and the mesh 1 is used to secure it to the biological tissue in the patient's body.

[0075] like Figure 1 and Figure 2 As shown, the mesh 1 has an overall elliptical shape defining a longitudinal axis A, two opposite ends (1a, 1b) of the mesh 1, and two opposite side edges (1c, 1d). The shape of the mesh 1 thus further defines the two opposite ends (2a, 2b) of the barbed surface 2.

[0076] The mesh 1 is further provided with a central opening 5 and a slit 6 extending from the central opening 5 to one side edge 1d of the mesh 1. Once the mesh 1 is inserted, the slit 6 serves to allow the spermatic cord to pass through. The mesh 1 is also provided with a wing 7 that extends outward from the edge of the slit 6 from the barbless surface 3 of the mesh. Figure 2As shown, the wing 7 has barbs 4 on its surface facing the barbless mesh 3. Once the mesh 1 is inserted, the wing 7 is used to close the mesh 1 around the spermatic cord. The barbs 4 of the wing 7 can then help maintain the mesh 1 in the closed configuration.

[0077] refer to Figures 3 to 5 The apparatus 10 of the present invention is shown. The apparatus 10 includes... Figures 1 to 2 The mesh 1 and the biocompatible membrane 11 are formed by two parts (11a, 11b) of the membrane, the membrane 11 partially covering the barbed surface 2 of the mesh 1.

[0078] refer to Figure 4 The membrane (11, 11a, 11b) covers most of the barbs 4 present on the barbed surface 2, but the shape and size of the membrane are determined such that some portions (22a, 22b) of the ends (2a, 2b) of the barbed surface 2 are not covered. As will be shown in the description of the implantation procedure below, the uncovered portions 22a and 22b of the barbed surface 2 will allow the surgeon to create initial fixation points when positioning the mesh 1 relative to the biological tissue.

[0079] like Figure 5 As shown, except for the uncovered portion 22b of the first end 2b, the first portion 11b of the membrane 11 substantially covers half of the barbed surface 2, and except for the uncovered portion 22a of the second end 2a, the second portion 11a of the membrane 11 substantially covers the other half of the barbed surface 2. Each portion (11a, 11b) of the membrane 11 has a central edge (111a, 111b) substantially aligned on the slit 6. In any case, as Figure 5 As shown, the central edge 111b of the first portion 11b of the membrane 11 overlaps with the central edge 111a of the second portion 11a of the membrane 11. This overlap provides an important portion of the membrane 11 that can be grasped by the surgeon when removing the membrane 11 from the implantation site.

[0080] exist Figure 12 In the alternative embodiment shown, membrane 11 is made of a single sheet of membrane with pre-cut lines 11c. The pre-cut lines 11c are generally aligned with slit 6. Once the mesh 1 is correctly positioned, the pre-cut lines 11c allow the surgeon to easily separate membrane 11 into two parts (11a, 11b) when ready to remove membrane 11 from the implantation site. The surgeon then removes these parts by passing one part of the membrane through slit 6, one part next to the other.

[0081] exist Figure 13 In another embodiment shown, membrane 11 is made of a single membrane, which the surgeon will remove by passing the membrane through a slit 6 in the mesh 1.

[0082] The membrane 11 is preferably non-porous and may be made solely of biodegradable materials. In addition, the membrane 11 has the flexibility to allow it to fold, so that once the membrane 11 is separated from the mesh 1, when the surgeon wishes to remove the membrane 11 from the implantation site, the surgeon can deliver the membrane 11 through the slits 6 of the mesh 1.

[0083] In the implementation scheme, membrane 11 is obtained by lamination of poly(glycolic acid-caprolactone-lactide-trimethylene carbonate).

[0084] The device 10 of the present invention further includes a set of six cables 12 arranged to removably attach the membrane 11 to the barbed surface 2 of the mesh 1.

[0085] In embodiments not shown, the apparatus may include another number of cables for removably attaching the membrane to the mesh, such as, for example, a single cable, or alternatively a group of four, five, seven, eight or more cables, as long as the membrane remains removably attached to the mesh.

[0086] The cables 12 are radially distributed on the mesh 1: in other words, each cable 12 extends from the center of the mesh 1, for example, from the central opening 5 of the mesh 1 toward the edge of the mesh 1. Furthermore, each cable 12 passes over and over the two layers formed by the membrane 11 and the mesh 1 multiple times without forming any knots. Therefore, the membrane 11 is non-deterministically sewn to the barbed surface 2 of the mesh 1. In effect, the friction between the cable 12 at one end and the membrane 11 and mesh 1 at the other end results in a removable attachment of the membrane 11 to the mesh 1. The radial arrangement of the cables 12 further allows the membrane 11 to be flattened. As a result of sewing the membrane 11 to the mesh 1 as described above, no cable 12 interacts with other cables. Therefore, each cable 12 can be removed simply by pulling the proximal end 12a of the cable with a force capable of overcoming the aforementioned friction between the cable 12 and the membrane 11 and mesh 1.

[0087] like Figure 5 As shown, for each cable 12, its distal end 12b lies on the barbless surface 3 of the mesh 1. This allows the membrane 11 to maintain its smoothness when the device 10 is delivered to the implantation site.

[0088] The proximal ends 12a of the cables 12 are all gathered in a central tail 13, which extends outward from the center of the mesh 1 from the barbless surface 3 of the mesh 1. The cables 12 may be arranged in the form of a braid 14 at the proximal end of the central tail 13. Such a braid 14 provides the surgeon with an easy-to-grip element during the removal of the cables 12.

[0089] Cable 12 is made of a biocompatible material. The cable may be colored so that it can be easily identified by the surgeon at the implantation site. For example, cable 12 may be a PET monofilament yarn.

[0090] Now refer to Figures 6 to 11 A method for implanting a mesh 1 into the groin area of ​​a patient using the device 10 of the present invention is described.

[0091] exist Figures 6 to 11 In this diagram, for the purpose of simplification, the biological tissue to which the mesh 1 is to be fixed is schematically referred to as tissue 20. Tissue 20 may be one of the muscles of the abdominal wall at the groin, such as the psoas muscle of the transverse abdominis, or it may represent the tissue covering the pubis.

[0092] The device 10 of the present invention is as follows: Figure 5 The illustrated configuration is delivered to the implantation site, wherein the membrane 11 covers most of the barbs 4 present on the barbed surface 2 of the mesh 1, with only the barbs 4 present on the uncovered portions (22a, 22b) of the barbed surface 2 remaining free. Additionally, in this configuration, the flaps 7 of the mesh 1 also cover the slits 6, and the membrane 11 is removably attached to the mesh 1 by means of multiple cables 12 that are stitched to the mesh 1 as described above.

[0093] The presence of membrane 11 allows the device 10 to be transported through the surrounding biological tissue without damaging the barbs 4, and therefore without compromising the gripping ability of the barbs. Membrane 11 further allows the surrounding biological tissue to be protected from damage by the barbs 4 during the movement of the device 10.

[0094] refer to Figure 6 The device 10 moves closer to the tissue 20, with the barbed side 2 of the mesh 1, generally covered by the membrane 11, facing the tissue 20. Although not shown in the figure for clarity, the surgeon can open the wing 7 to properly position it around the spermatic cord (not shown). When the surgeon is ready to attempt initial positioning of the mesh 1, he pushes one or both of the uncovered portions (22a, 22b) of the ends (2a, 2b) of the barbed side 2, as... Figure 6As indicated by arrow F1. On these uncovered portions (22a, 22b), the barbs 4 remain free and are able to penetrate the tissue 20 to partially anchor the mesh 1 therein. However, at this stage, the surgeon can still decide to change the position of the mesh 1 and detach the uncovered portions (22a, 22b) from the tissue 20 to attempt a second positioning of the mesh 1 at different locations within the tissue 20. The uncovered portions (22a, 22b) of the barbed face 2 thus allow the surgeon to create initial fixation points until he reaches a comfortable position for the mesh without facing the possibility of the barbs becoming entangled with the mesh or surrounding biological tissue. Therefore, the positioning step is convenient for the surgeon.

[0095] Once the surgeon is satisfied with the positioning of the mesh 1 and the barbs 4 present on the uncovered portion (22a, 22b) of the barbed surface 2 of the mesh are anchored into the tissue 20 (e.g., Figure 7 (as shown in the diagram), then the surgeon can decide to remove elements of device 10 that are not intended to remain in the patient's body.

[0096] In this view, the surgeon grasps the braid 14 located proximal to the central tail 13, and pulls the braid 14 in the direction of arrow F2, as... Figure 7 As shown. Because the cables 12 simply pass through the two layers formed by the membrane 11 and the mesh 1 without forming a knot, and because their distal ends 12b are free, the surgeon can easily apply a pulling force sufficient to overcome the friction between the cables 12 and the membrane 11 and the mesh 1. Therefore, as Figure 8 As shown, the cable 12 is removed from the device 10 and from the implantation site.

[0097] Still referencing Figure 8 Membrane 11 and mesh 1 are now separated from each other and simply positioned one after the other. If necessary, the surgeon can proceed along... Figure 8 The direction indicated by the middle arrow F3 further opens the wing 7 to expose the slit 6 of the mesh 1, making it easier for him to see the central edge 111b of the first part 11b of the membrane 11.

[0098] refer to Figure 9 The surgeon can then grasp the central edge 111b of the first portion 11b of the membrane 11 and pull on it, as indicated by arrow F5, to remove the first portion 11b of the membrane 11 from the implantation site by passing it through the slit 6. The strength and flexibility of the membrane allow it to be folded and passed through the slit 6 without being torn. Simultaneously, the surgeon can apply a force, as indicated by arrow F4, to the half of the mesh 1 released from that portion 11b of the membrane 11. This causes the barbs 4 present on that portion of the barbed surface 2 of the mesh 1 to penetrate the tissue 20.

[0099] Once the first portion 11b of the membrane 11 is removed, the surgeon will be able to see the central edge 111a of the second portion 11a of the membrane 11.

[0100] refer to Figure 10 The surgeon can then grasp the central edge 111a of the second portion 11a of the membrane 11 and pull it in the direction of arrow F7. Due to its flexibility, the second portion 11a of the membrane 11 passes through the slit 6 and is removed from the implantation site without being torn. Simultaneously, the surgeon can apply the force indicated by arrow F6 to the portion of the mesh 1 that is not yet anchored to the tissue 20. When the remaining barbs 4 of the barbed face 2 are released from the second portion 11a of the membrane 1, these remaining barbs penetrate the tissue 20.

[0101] refer to Figure 11 All the barbs 4 of the barbed face 2 of the mesh 1 have entered the tissue 20, and the mesh 1 is perfectly anchored to the tissue 20 without the need for additional conventional fixation devices such as U-shaped staples or sutures. Furthermore, since the cables and membranes of the device of the present invention have been removed from the patient's body, no other foreign material is implanted except for the mesh. In the final step (not shown), the surgeon can carefully close the wing 7 around the spermatic cord (not shown) and apply pressure to the wing 7 in the direction of the barbless face 3 of the mesh 1 to grip the barbs of the wing 7 into said face 3, thereby ensuring that the mesh 1 remains in the closed configuration.

[0102] Therefore, the device of the present invention is particularly useful for facilitating the implantation of surgical meshes with barbed surfaces into patients. The device allows the mesh to be inserted into the patient and delivered upwards to the implantation site while maintaining the gripping ability of surrounding biological tissue and the barbs. The device also allows surgeons to easily position and reposition the mesh, and to perform positioning and repositioning multiple times as needed, without damaging the tissue.

Claims

1. A device (10) for facilitating the implantation of a surgical mesh (1) having at least one barbed surface (2), the device comprising: -The surgical mesh (1). - At least one biocompatible membrane (11, 11a, 11b), the shape and size of which are determined to at least partially cover the barbed surface (2). - At least one cable (12) is arranged to removably attach the membrane (11, 11a, 11b) to the barbed surface (2) of the mesh (1).

2. The device (10) according to claim 1, wherein the membrane (11, 11a, 11b) is non-porous.

3. The device (10) according to claim 1 or 2, wherein the membrane (11, 11a, 11b) is made of only biodegradable materials.

4. The device (10) according to claim 1 or 2 includes a plurality of cables (12) arranged to removably attach the membrane (11, 11a, 11b) to the barbed surface (2) of the mesh (1).

5. The device (10) according to claim 1 or 2, wherein the mesh (1) has an overall elliptical shape defining a longitudinal axis and two opposite ends (2a, 2b) of the barbed face (2).

6. The device (10) according to claim 5, wherein the shape and size of the membrane (11, 11a, 11b) are determined such that at least a portion (22a, 22b) of one of the ends (2a, 2b) of the barbed surface (2) is not covered.

7. The device (10) according to claim 6, wherein the shape and size of the membrane (11, 11a, 11b) are determined such that portions (22a, 22b) of the two ends (2a, 2b) of the barbed surface (2) are not covered.

8. The device (10) according to claim 5, wherein the mesh (1) is used to treat inguinal hernia, and the mesh (1) is further provided with slits (6) to allow the spermatic cord to pass through.

9. The device (10) according to claim 8, wherein the mesh (1) is further provided with a wing (7) extending from the edge of the slit (6), the wing (7) serving to close the mesh surrounding the spermatic cord once the mesh (1) is implanted.

10. The device (10) according to claim 8 or 9, wherein the membrane (11, 11a, 11b) exhibits flexibility, thereby allowing the membrane to be folded through the slit (6) as the membrane separates from the barbed surface.

11. The device (10) according to claim 8 or 9, wherein the membrane (11, 11a, 11b) is provided with a pre-cut line (11c) substantially aligned on the slit (6).

12. The device (10) according to claim 8 or 9, wherein the membrane (11) is formed of two portions (11a, 11b) of the membrane, each portion (11a, 11b) substantially covering half of the mesh (1) and having central edges (111a, 111b) substantially aligned on the slit (6).

13. The device (10) according to claim 12, wherein the central edge (111a; 111b) of one portion (11a; 11b) of the membrane overlaps with the central edge (111a; 111b) of another portion (11a; 11b) of the membrane.

14. The apparatus (10) according to claim 1 or 2, wherein the membrane (11, 11a, 11b) is obtained by lamination of poly(glycolic acid-caprolactone-lactide-trimethylene carbonate).

15. The device (10) according to claim 4, wherein the membranes (11, 11a, 11b) are removably attached to the barbed surface (2) of the mesh (1) by means of each cable (12), the cables simply passing over and under the two layers formed by the membranes (11, 11a, 11b) and the mesh (1) once or more without forming any knots.

16. The device (10) according to claim 15, wherein each cable (12) is radially oriented from the center (5) of the mesh (1) toward the edge of the mesh (1) without interacting with other cables (12).

17. The device (10) according to claim 16, wherein the distal end (12b) of each cable (12) terminates on the surface (3) of the mesh (1) that is not covered by the membrane (11, 11a, 11b).

18. The apparatus (10) according to claim 16 or 17, wherein, All the proximal ends (12a) of the cable (12) converge at a central tail (13), which extends outward from the center (5) of the mesh (1) from the surface (3) of the mesh (1) not covered by the membrane (11, 11a, 11b).

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