Implantable prosthesis with self-securing grip

Abstract

An implantable prosthesis for repairing tissue defects includes a layer made of a repair fabric and a plurality of microtextured gripping sections mounted to the repair fabric. The gripping section includes a pattern of perforations located on the tissue-facing surface to promote tissue ingrowth.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Application No. 63 / 357,116, filed on June 30, 2022, and U.S. Application No. 63 / 357,127, filed on June 30, 2022, the entire contents of both of which are incorporated herein by reference. Technical Field

[0003] The disclosed embodiments relate to implantable prostheses and, more particularly, to prostheses for repairing defects and weaknesses in soft tissue and muscle walls. Background Art

[0004] Defects in muscle or tissue walls, such as hernias, are often repaired with an implantable prosthesis that is configured to cover and / or fill the defect.

[0005] For some surgeries, an implantable repair fabric, such as a mesh fabric, is sutured, stapled, stapled, or otherwise temporarily anchored in place above, below, or within the defect. The repair is ultimately completed by the bonding of tissue to the fabric, such as tissue ingrowth into and / or along the mesh fabric.

[0006] Various repair fabrics are known and used to repair soft tissue and muscle wall defects. Examples of implantable fabrics that have been successfully used for soft tissue and muscle wall repair include BARD SoftMesh, BARD Mesh, and VISILEX available from CRBard. Such fabrics are made of polypropylene monofilaments that are knitted into a mesh with holes or voids that promote tissue ingrowth and bond to the fabric.

[0007] For some surgeries, it may be desirable to employ an implantable prosthesis that is constructed to conform to the shape of the anatomical region of the defect. In some cases, such a prosthesis can be positioned and maintained relative to the defect with little or no temporary fixation. Examples of implantable prostheses that have been successfully used for soft tissue and muscle wall repair include the 3DMAX Light Mesh and 3DMAX Mesh that can be obtained from CRBard. Such a prosthesis is made of a mesh fabric that is formed into a curved three-dimensional shape that conforms to the anatomical shape of the defect region such as the groin anatomy. These prostheses have proven to be useful and have been established in practice for muscle or tissue wall repair in the inguinal femoral region.

[0008] The object of the present invention is to provide a prosthesis for repairing defects in soft tissue and muscle walls. Summary of the invention

[0009] An implantable prosthesis is provided, the implantable prosthesis comprising a layer of biocompatible repair fabric and a plurality of gripping sections integrated with the layer of repair fabric, wherein each of the plurality of gripping sections comprises a plurality of gripping portions and a plurality of perforations extending through the plurality of gripping portions.

[0010] An implantable prosthesis is provided, the implantable prosthesis comprising a layer of biocompatible repair fabric and a plurality of micro-textured gripping sections integrated with the layer of repair fabric, each of the plurality of micro-textured gripping sections comprising a plurality of perforations extending through the micro-textured gripping section.

[0011] An implantable prosthesis is provided, the implantable prosthesis comprising a layer made of a biocompatible repair fabric and a plurality of gripping sections integrated with the layer made of the repair fabric, each of the plurality of gripping sections comprising a base plate and a plurality of gripping portions extending from a surface of the base plate, wherein each of the plurality of gripping portions comprises at least one hook structure.

[0012] A gripping section for an implantable prosthesis is provided. The gripping section includes a substrate made of a biocompatible material that can be attached to a layer made of a repair fabric and a plurality of microstructure gripping portions extending from a surface of the substrate. Each of the plurality of microstructure gripping portions includes at least one hook structure. The gripping section also includes a plurality of perforations extending through the substrate.

[0013] A method for manufacturing an implantable prosthesis is provided. The method includes providing a layer of biocompatible repair fabric and attaching a plurality of gripping sections to a surface of the layer of repair fabric. Each of the gripping sections includes a plurality of gripping portions and a plurality of perforations extending through the plurality of gripping portions.

[0014] An implantable prosthesis is provided, the implantable prosthesis comprising a layer of biocompatible repair fabric, the layer having a preformed three-dimensional configuration, the preformed three-dimensional configuration having an apex and a rounded ridge extending from the apex to the outer periphery of the layer of repair fabric. The implantable prosthesis also comprises a plurality of gripping sections integrated with the layer of biocompatible repair fabric, wherein a portion of at least one of the plurality of gripping sections extends across the rounded ridge.

[0015] It should be understood that the aforementioned concepts and the additional concepts discussed below can be arranged in any suitable combination, as the present disclosure is not limited in this respect. In addition, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings.

[0016] In the event that the present application document and the document incorporated by reference include contradictory and / or inconsistent disclosures, the present application document shall prevail. If two or more documents incorporated by reference include mutually contradictory and / or inconsistent disclosures relative to each other, the document with the later effective date shall prevail. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component illustrated in various figures may be represented by a like reference numeral. For purposes of clarity, not every component is labeled in every drawing. In the drawings:

[0018] Figure 1 is an embodiment of an implantable prosthesis according to one embodiment;

[0019] Figure 2 are embodiments of a repair fabric layer that can be preformed into a configuration for use as a prosthesis;

[0020] Figure 3A is a top view of an embodiment of a gripping section;

[0021] Figure 3B is a top view of an embodiment of a gripping section;

[0022] Figure 4A According to the implementation method Figure 3A A schematic diagram of the perforation of the gripping section;

[0023] Figure 4B According to the implementation method Figure 3B A schematic diagram of the perforation of the gripping section;

[0024] Figure 5A is a top perspective view of an embodiment of a microtextured membrane;

[0025] Figure 5B yes Figure 5A Top view of the micro-textured film;

[0026] Figure 5C yes Figure 5B an enlarged view of section 5C;

[0027] Figure 5D yes Figure 5A Side view of the microtextured film;

[0028] Figure 5E yes Figure 5D an enlarged view of section 5E;

[0029] Fig. 5F is a side view of an embodiment of a microtextured membrane;

[0030] Figure 5G is an embodiment of the hook-shaped portion of the microtextured film;

[0031] Figure 6 is the way the prosthesis is implemented;

[0032] Figure 7 is the way the prosthesis is implemented;

[0033] Figure 8 is the way the prosthesis is implemented;

[0034] Fig. 9 is the way the prosthesis is implemented;

[0035] Fig.10 is the way the prosthesis is implemented;

[0036] Fig.11 is the way the prosthesis is implemented;

[0037] Fig.12 is a schematic side view of a body portion according to one embodiment;

[0038] Fig.13A is an embodiment of the prosthesis; and

[0039] Fig. 13B is an embodiment of the prosthesis. DETAILED DESCRIPTION

[0040] The present disclosure relates to implantable prostheses for repairing anatomical defects and are particularly suitable for repairing defects and weaknesses in soft tissue and muscle walls or other anatomical regions. The phrase "repairing a defect" includes the act of repairing, enlarging and / or reconstructing a defect and / or a potential defect. For ease of understanding, and without limiting the scope of the present disclosure, the prosthesis is described below in particular in conjunction with repairing an inguinal defect, including but not limited to one or more of an inguinal oblique hernia, an inguinal direct hernia, a femoral hernia and / or other weaknesses or hernias of the inguinal anatomical structure. However, it should be understood that the prosthesis is not limited thereto and can be used in other anatomical procedures, which is obvious to those skilled in the art. For example, but not limited to, the prosthesis can be used for abdominal hernia, chest wall or abdominal wall reconstruction, or large defects, such as those that may occur in obese patients. The prosthesis may include one or more feature portions, each of which is independently or in combination configured to contribute to these properties.

[0041] The present disclosure relates more particularly to a prosthesis comprising a repair fabric having a body portion configured to cover or extend across a defect opening or weakness when the body portion is placed against the defect. The prosthesis may be in the form of a patch, although the prosthesis may take other configurations that should be apparent to one skilled in the art. The patch may have a planar configuration or a non-planar configuration suitable for a particular procedure used to repair the defect.

[0042] The prosthesis may be configured with a self-grasping device having features that help maintain the position of the prosthesis relative to the defect. It may be desirable to reduce, if not eliminate, separation, sliding, twisting, folding, and / or other movement between the prosthesis and adjacent tissue. Such a device may also reduce, if not eliminate, the need for the surgeon to suture, staple, staple, or otherwise temporarily anchor the prosthesis in place pending tissue integration.

[0043] The prosthesis may include one or more gripping sections combined with the repair fabric layer of the prosthesis. In some embodiments, the gripping section can be combined with the repair fabric by mounting the gripping section to the surface of the adjacent tissue that is configured as the body part. In some embodiments, the gripping section can be formed by a membrane patch of various shapes and sizes. More specifically, the gripping section can include a microstructural arrangement of a gripping portion protruding from the surface of the gripping section that is configured to engage the adjacent tissue. The gripping portion can be configured to penetrate and grasp the tissue when the prosthesis is placed and / or pressed against the tissue. In this way, the gripping portion can be configured to protrude a defined distance from the surface of the gripping section and the body part to penetrate the depth of the tissue sufficient to provide the desired gripping amount. The gripping portion can be arranged on the gripping section in any suitable configuration to provide the desired gripping amount. For example, but not limited to, the gripping portion can be distributed on the gripping section in a uniform, uneven or random array and / or any suitable array combination.

[0044] The grip portion may include a grip portion head at an end of the grip portion body opposite the base, the grip portion head being configured to be inserted into the tissue while providing sufficient tissue grip to reduce, if not eliminate, unintentional release from the tissue. The grip portion head may also be configured to minimize, if not eliminate, potential entanglement with a prosthesis, such as a mesh repair fabric, while providing desired tissue grip. For example, but not limited to, the grip portion head may include one or more hook features of any suitable configuration, which will be apparent to those skilled in the art. The grip portion head may include hook features having different configurations relative to each other. Grip portion head configurations may include, but are not limited to, hook-shaped, arrow-shaped, crescent-shaped, multiple forks arranged in a V-shape, and claw-shaped. Other grip portion head configurations may also be envisioned.

[0045] The gripping segments may be arranged on the body portion in any suitable configuration to provide a desired amount of gripping, as will be apparent to one skilled in the art. For example, but not limited to, the gripping segments may be distributed on the body portion in a uniform, non-uniform or random array and / or any suitable array combination. The gripping segments may be distributed throughout the body portion or positioned at one or more selected areas of the body portion. For example, but not limited to, the gripping segments may be positioned at one or more selected areas adjacent to one or more sections of the outer periphery of the body portion, and / or positioned at one or more selected areas within an interior region of the body portion that is inwardly away from the outer periphery. Each selected region may include one or more gripping segments arranged in any suitable pattern within the region.

[0046] According to one aspect, the gripping section can be manufactured independently of the body portion of the prosthesis and mounted to the body portion of the prosthesis. In this way, the gripping section can be formed of a material different from the body portion. For example, but not limited to, the gripping section can be formed of a bioabsorbable material, while the body portion can be formed of a non-absorbable material. This arrangement can provide temporary gripping properties for the prosthesis during tissue integration while reducing the amount of foreign matter remaining in the patient's body and maintaining the long-term strength of the prosthesis. If desired, the body portion can also be made of a bioabsorbable material that can be absorbed at a slower rate than the material of the gripping section.

[0047] Independent fabrication of the gripping segments may also provide flexibility in constructing the prosthesis. For example, but not limited to, depending on the particular application of the prosthesis, the prosthesis may include gripping segments having the same or different gripping segment configurations and / or arrangements. For example, but not limited to, the prosthesis may include gripping segments having the same shape but mounted on the body portion at different orientations relative to each other. The prosthesis may include gripping segments having one or more different shapes in one or more areas of the body portion. In this way, a variety of gripping characteristics may be provided to the prosthesis based on the specific orientation and / or shape of the gripping segments, both individually and as a whole.

[0048] In some embodiments, the gripping segment may include a plurality of perforations to allow tissue to grow inwardly into and through the gripping segment. The perforations may be configured in a variety of patterns, sizes, and shapes depending on the amount of tissue ingrowth desired while maintaining the structural integrity of the gripping segment. For example, the perforations may be distributed over the gripping segment in a uniform, non-uniform, or random array and / or any suitable combination of arrays. The perforations may be distributed over the entire gripping segment or positioned at one or more selected areas of the gripping segment. Each selected area may include one or more perforations arranged in any suitable pattern within the area.

[0049] In some embodiments, the gripping section can be combined with the body portion of the prosthesis by fixing the gripping section to the body portion using one or more sutures. In some embodiments, attaching the gripping section to the body portion can include suture application along the periphery of the gripping section using a non-resorbable material, such as polypropylene or ePTFE or a resorbable monofilament. In some embodiments, the gripping section can be attached to the body portion using an adhesive, bonding, ultrasonic or thermal welding, or overmolding. In some embodiments, the gripping section may include one or more protrusions extending from a surface of the gripping section adjacent to the body portion. In a non-limiting example, the protrusion may include a hook structure or other barbed structure, which is configured to be at least partially inserted into the surface of the body portion when the gripping portion is pressed against the body portion to fix the gripping section to the body portion.

[0050] The prosthesis can be used to repair soft tissue and muscle wall defects using various surgical techniques, including open surgery, laparoscopic surgery, hybrid surgery (e.g., Kugel surgery), and robotics. During open surgery, the prosthesis can be placed through a relatively large incision formed in the abdominal wall and tissue layers, and the defect is then filled or covered by repair fabric. During laparoscopic and hybrid surgery, the prosthesis can be collapsed into a reduced configuration, such as by rolling or folding, to enter the subject directly through a relatively small incision or through an elongated laparoscopic cannula placed through the incision. The prosthesis may be particularly suitable for robotic surgery, in which surgical robotic tools are used to achieve the placement of the prosthesis, which may involve passing the prosthesis through a relatively small cannula (e.g., 8 mm) compared to the cannula (e.g., 10 mm to 12 mm) typically used for more conventional laparoscopic techniques.

[0051] Turning to the drawings, specific non-limiting embodiments are further described in detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments may be used alone and / or in any desired combination, as the present disclosure is not limited to the specific embodiments described herein.

[0052] Figure 1An embodiment of a prosthesis for repairing tissue and muscle wall defects, such as hernia defects, is illustrated. The prosthesis includes a repair fabric made of an implantable biocompatible material. In one embodiment, the repair fabric may include a mesh fabric that is relatively flexible, thin and lightweight and meets the performance and physical properties for repairing soft tissue and muscle wall defects. The prosthesis 10 may include a body portion 100 that is configured to have a size and / or shape suitable for covering or extending across a defect opening or weakness when the body portion is placed against the defect. The body portion 100 may be a preformed non-planar patch with a three-dimensional curved shape. The body portion may include a first region 101 and a second region 103 that are combined at a rounded ridge 107 extending from a first outer edge 109 and a second outer edge 111 of the body portion. The rounded ridge 107 may extend from the first outer edge 109 and the second outer edge 111 in a direction toward the first region 101 and intersect at an angle at an apex 113 disposed near a central region 105 of the body portion between the first region 101 and the second region 103. The apex 113 may be formed as the highest point of the body portion relative to a plane formed by the peripheral edge 112 (see also Fig.12 ). In one embodiment, the height H of the prosthesis from the plane defined by the peripheral edge 112 to the vertex 113 is approximately 21 mm. In some embodiments, the height H of the prosthesis defined by the peripheral edge 112 and the vertex 113 is approximately 0.5 inches, 0.7 inches, 0.9 inches, or 1.1 inches. In some embodiments, the vertex 113 can be positioned at a distance of approximately 2.75 inches, 2.8 inches, 3.0 inches, 3.15 inches, 2.25 inches, or 3.33 inches from the left peripheral edge. In some embodiments, the vertex 113 can be positioned at a distance of approximately 1.25 inches, 1.42 inches, 1.5 inches, 1.69 inches, 1.72 inches, 1.75 inches, or 2 inches from the bottom peripheral edge of the second area defining the body portion.

[0053] like Fig.12 As shown in , the first region 101 and the second region 103 can have a generally spherical shape to enhance conformity to a particular anatomical shape. In one illustrative embodiment, the radius of curvature of the first region is smaller than the radius of curvature of the second region to form a surface in the second region with a steeper slope relative to the first region. Back Figure 1 The second region can be shaped to form a depression 115 in the surface of the body portion, the depression 115 being configured to receive external iliac vessels, for example, when the prosthesis is used for inguinal hernia repair. The depression extends inwardly from the peripheral edge 112 between the first outer edge 109 and the second outer edge 111 toward the apex 113.

[0054] like Figure 1 As shown in , the prosthesis 10 may also include one or more gripping sections 102, 104, 106 mounted to a surface 110 of the body portion 100 to provide a self-gripping arrangement for maintaining the position of the prosthesis relative to the defect. The gripping section may be a plurality of gripping portions protruding from a surface of the gripping section, the plurality of gripping portions being configured to grip and engage adjacent tissue when the prosthesis is positioned and / or pressed against the adjacent tissue. For example, the gripping section may include a substrate having a plurality of microstructures (i.e., gripping portions) having hook features extending from the substrate in a microscopic pattern design to form a microscopic textured surface (see FIG. 5A to FIG. 5F ).

[0055] In some embodiments, the gripping sections 102, 104, 106 can be positioned at one or more gripping areas of the body portion 100. This arrangement can be suitable for placing the gripping sections in selected areas of the body portion 100 to accommodate specific anatomical regions. For example, it may be desirable to avoid providing gripping sections on the following areas of the body portion 100: these areas may potentially contact blood vessels, nerves or other parts of the anatomical structure at the defect site, which will be obvious to those skilled in the art. The location of the gripping sections may facilitate the rolling and / or folding of the prosthesis for delivery to the soft tissue repair site. In some embodiments, the gripping sections may include one or more perforations 108 to allow tissue to grow inward after being implanted into the gripping sections and through the gripping sections and into the body portion 100.

[0056] like Figure 1 As shown in, according to some embodiments, the prosthesis 10 includes a first gripping section 102 and a second gripping section 104 positioned near the peripheral edge 112 on the first area 101 of the body portion 100. The gripping sections 102, 104 can be arranged so that each section is positioned on either side of the vertex 113. The gripping sections 102, 104 can be configured to have an elliptical shape and may or may not be the same shape or size. The third gripping section 106 can be positioned approximately near the peripheral edge 112 on the second area 103 of the body portion 100. The third gripping section 106 can have an L-shaped configuration, and the first portion 130 of the gripping section can extend at least partially along the peripheral edge 112 of the second area 103 and over the rounded ridge 107 into the first area. The second portion 132 of the gripping section 106 can extend upward along the peripheral edge 112 over the rounded ridge 107 into the first area 101.

[0057] like Figure 1As shown in , the gripping sections can be positioned on the body portion 100 near the peripheral edge 112 so that the central region 105 of the prosthesis is free of gripping sections. The gripping sections 102, 104, 106 can be positioned near the peripheral edge 112 so that a user (e.g., a surgeon, a physician, etc.) can see through the prosthesis when the prosthesis is implanted over a defect in a patient. In addition, such placement can reduce or prevent the gripping sections from contacting nerves or other potentially sensitive areas that may cause pain to the patient when implanted. For example, the L-shaped third gripping section 106 can be positioned so that it avoids nerves, blood vessels, or other tissues when implanted at the defect site.

[0058] The size, shape, and position of the gripping segment can be constructed and arranged to balance the gripping force, the potential for tissue ingrowth, and the flexibility of the prosthesis. For example, the gripping segment can increase the gripping force while reducing the exposed mesh surface required for rapid tissue ingrowth. In this way, the gripping segment can act as a barrier to rapid tissue ingrowth until the gripping segment ruptures. Providing one or more perforations in the gripping segment can allow tissue to grow rapidly inward before the gripping segment ruptures. The gripping segment may also reduce the flexibility of the prosthesis, and the prosthesis may need to be rolled up during surgery to fit into a narrow cannula or trocar in order to reach the target site. Figure 1 The configuration and arrangement of the gripping sections 102, 104, 106 illustrated in FIG. 1 may allow the prosthesis to remain sufficiently flexible while still providing sufficient surface area with gripping portions to adhere securely to tissue.

[0059] The number, shape, size and position of the gripping segments 102, 104, 106 may vary depending on the particular surgery, and those numbers, shapes, sizes and positions shown in the figures are only non-limiting examples, as the present disclosure is not limited thereto. For example, the gripping segments may take on any symmetrical or asymmetrical shape, including but not limited to circular, polygonal, arched, elliptical or any free form. In some embodiments, the gripping segments may be positioned along the periphery of the prosthesis, but in some embodiments, the gripping segments may be positioned near the central region of the prosthesis, or may be arranged to cover the significant surface 110 of the prosthesis as desired. Alternatively, less than or more than three gripping segments may be used. For example, four elliptical gripping segments may be positioned around the periphery of the body portion, or two L-shaped gripping segments may be positioned opposite each other in the first region 101 and the second region 103. Any suitable number of gripping segments may be used to achieve the desired gripping force and flexibility.

[0060] In some embodiments, the body portion 100 can be a preformed non-planar patch with a three-dimensional curved shape. In one embodiment, the body portion 100 can have a shape corresponding to 3DMAX MID, 3DMAXLight Mesh or 3DMAX Mesh that can be obtained from Davol, and described in one or more of U.S. Patents No. 6,723,133, No. 6,740,122 and No. 6,740,122. In this way, the prosthesis can be particularly suitable for repairing and mending the defects of the groin anatomical structure. However, it should be understood that the prosthesis can adopt other configurations, which should be obvious to those skilled in the art. For example, but not limited to, the body portion can have a plane or other non-planar configuration suitable for a specific operation for repairing a defect. In addition, the prosthesis can be set to a plane sheet with a self-gripping repair fabric, which can be selectively trimmed by a surgeon into any desired size and shape for a specific operation.

[0061] In some embodiments, the length of the body portion can be greater than or equal to 5.25 inches, 5.5 inches, 5.75 inches, 6.0 inches, 6.25 inches, and / or any other suitable length. In some embodiments, the length can be less than or equal to 6.25 inches, 6.5 inches, 6.75 inches, 7 inches, and / or any other suitable width. It is contemplated that the aforementioned combination includes, for example, a length between 5.5 inches and 6.65 inches or equal to 5.5 inches and 6.65 inches, and / or any other suitable combination of the aforementioned. In some embodiments, the width of the body portion can be greater than or equal to 3.25 inches, 3.5 inches, 3.75 inches, 4.0 inches, 4.25 inches, and / or any other suitable width. In some embodiments, the width can be less than or equal to 4.5 inches, 4.75 inches, 5.0 inches, 5.25 inches, and / or any other suitable width. Combinations of the foregoing are contemplated including, for example, a width between or equal to 3.5 inches and 4.85 inches, and / or any other suitable combination of the foregoing. While specific ranges for length and width are provided above, it should be understood that ranges greater than and less than the foregoing ranges are also contemplated, as the present disclosure is not limited thereto.

[0062] Figure 2An embodiment of a repair fabric layer is illustrated, which can be preformed into a configuration for use as a prosthesis, or can be selectively trimmed into a desired configuration for use as a prosthesis or a portion of a prosthesis. The repair fabric can be knitted, providing openings or holes to allow tissue infiltration and prosthesis. When implanted, the mesh promotes rapid ingrowth of tissue or muscle into and around the mesh structure. Examples of surgical materials that can be used for these layers and are suitable for tissue or muscle augmentation and defect correction include, but are not limited to: BARD Mesh (available from Davol), BARDSoft Mesh (available from Davol), soft tissue patch (microporous ePTFE - available from WL Gore & Associates), SURGIPRO (available from US Surgical); TRELEX (available from Meadox Medical); PROLENE and MERSILENE (available from Ethicon) and other mesh materials (e.g., available from Atrium Medical Corporation). Absorbable or resorbable materials including PHASIX Mesh (available from Davol), polylactic acid (VICRYL - available from Ethicon), and polyglycolic acid (DEXON - available from US Surgical) may be suitable for applications involving temporary correction of tissue or muscle defects. Collagen materials such as COOK SURGISIS available from Cook Biomedical may also be used. It is also contemplated that the mesh fabric may be formed from multifilament yarns, and that any suitable method may be used to form the mesh material, such as knitting, weaving, braiding, molding, etc.

[0063] The repair fabric can also be flexible enough to be easily reduced in size to enter a subject. In this way, the flexible fabric can be folded into an elongated configuration, such as a roll, which can be supported in and advanced through a narrow laparoscope cannula for laparoscopic or robotic surgery.

[0064] FIG. 3A to FIG. 3B Embodiments of an L-shaped gripping section 120 and an oval-shaped gripping section 124 are illustrated, respectively. One or more of the L-shaped gripping section 120 and / or the oval-shaped gripping section 124 may be positioned on a surface of a body portion of the prosthesis.

[0065] In some embodiments, the length L of the L-shaped gripping section 120 can be approximately 5.0 inches, 5.25 inches, 5.5 inches, 5.75 inches, 6.0 inches, and / or any other suitable length. In some embodiments, the length L of the shaped gripping section 120 is approximately 5.4 inches. In some embodiments, the width W of the shaped gripping section 120 can be approximately 1.5 inches, 1.75 inches, 2.0 inches, 2.25 inches, and / or any other suitable width. In some embodiments, the width W is 2.1 inches. In some embodiments, the thickness of the shaped gripping section 120 can be approximately 155 μm, 165 μm, 175 μm, and / or any other suitable thickness. It is contemplated that combinations of the foregoing include, for example, a length between or equal to 5.25 inches and 5.5 inches, a width between 2.0 inches and 2.2 inches, and / or any other suitable combination of the foregoing.

[0066] In some embodiments, the length L of the oval grip section 124 can be approximately 2.25 inches, 2.5 inches, 2.75 inches, 3.0 inches, and / or any other suitable length. In some embodiments, the length L of the oval grip section 124 is approximately 2.7 inches. In some embodiments, the width W of the oval grip section 124 can be approximately 0.5 inches, 0.75 inches, 1.0 inches, 1.25 inches, and / or any other suitable width. In some embodiments, the width W of the oval grip section 124 is 1.0 inches. In some embodiments, the thickness of the oval grip section 124 can be approximately 150 μm, 155 μm, 165 μm, 175 μm, and / or any other suitable thickness. Combinations of the foregoing are contemplated including, for example, a length between or equal to 2.5 inches and 2.7 inches, a width between 1.8 inches and 1.1 inches, and / or any other suitable combination of the foregoing. While specific ranges for dimensions of the gripping section are provided above, it should be understood that ranges greater and less than the aforementioned dimensions are also contemplated, as the present disclosure is not limited in this regard.

[0067] like FIG. 3A to FIG. 3B As shown in , in some embodiments, the gripping sections 120, 124 can include a plurality of perforations to allow tissue infiltration to incorporate the prosthesis. When implanted, the porous gripping sections promote rapid ingrowth of tissue or muscle into and around the gripping sections and the body portion. The perforations 122 can extend through the entire thickness of the gripping sections or can extend only partially through the gripping sections. The perforations can be included on the gripping sections in various patterns. For example, in Figure 3A In the embodiment of the L-shaped gripping section 120, there is a single array of 18 perforations along the length of the gripping section. Figure 3B In the embodiment of the present invention, the oval gripping section 124 includes a single array of 5 perforations along its length. The perforations can be arranged in a uniform, non-uniform or random array and / or any combination of suitable arrays. The perforations can also be distributed throughout the gripping section.

[0068] The perforations provided in the gripping section can be of various shapes and sizes to optimize tissue ingrowth and maintain component integrity for insertion of the prosthesis. In some embodiments, the perforations can occupy greater than or equal to approximately 4%, 6%, 8%, 10%, or 12% of the gripping section surface. In some embodiments, the perforations can occupy less than or equal to approximately 25%, 22%, 20%, or 17% of the gripping section surface. Any suitable combination of the above ranges is also possible. In one embodiment, the perforations can occupy greater than or equal to 6% and less than or equal to 20% of the gripping section surface.

[0069] FIG. 4A to FIG. 4B Shown from FIG. 3A to FIG. 3B An enlarged view of the perforations of sections 4A and 4B in FIG. Figure 4A As shown in , the perforations 126 may be configured as circular shapes. The perforations 126 may have a diameter D1 of approximately 0.003 inches, 0.05 inches, 0.075 inches, 0.100 inches, 0.125 inches, and / or any other suitable diameter. Figure 4B As shown in , the perforations 128 can be configured as a hexagonal shape. The perforations 128 can have a segment diameter D2 of approximately 0.025 inches, 0.050 inches, 0.075 inches, and / or any other suitable segment distance. Although only two perforations are described, it should be noted that any perforation on the gripping segment can be of any shape or size as specifically desired. It should also be understood that the gripping segment can employ a combination of perforations having different configurations, including but not limited to different shapes and / or sizes.

[0070] It should be understood that any suitable arrangement of gripping segments may be provided on the prosthesis to provide the desired amount of gripping, as should be apparent to one skilled in the art. In some embodiments, depending on the specific application of the prosthesis, the prosthesis may include gripping segments having the same or different gripping configurations and / or arrangements. For example, but not limited to, the prosthesis may include gripping segments having the same shape but mounted on the body portion in different orientations relative to each other. The prosthesis may include gripping segments having one or more different shapes in one or more regions of the body portion. The gripping segments may include various patterns of perforations to promote desired levels of tissue ingrowth while maintaining structural integrity. In this way, for a particular application of the prosthesis, the prosthesis may have various gripping characteristics based on the configuration and / or arrangement of the gripping segments.

[0071] The gripping section can be manufactured independently of the body portion of the prosthesis and mounted to the body portion of the prosthesis (e.g., via adhesive, molding, bonding, suturing, etc.). The independent manufacture of the gripping section can provide flexibility for constructing the prosthesis. In one embodiment, the gripping section can be formed of a bioabsorbable material, while the body portion can be formed of a non-absorbable material. If necessary, the body portion can also be made of a bioabsorbable material that can be absorbed at a slower rate than the material of the gripping section. This arrangement can provide temporary gripping properties for the prosthesis during tissue integration while reducing the amount of foreign matter remaining in the patient's body and maintaining the long-term strength of the prosthesis.

[0072] In some embodiments, the grip section can include one or more layers of film. FIG. 5A to FIG. 5E An embodiment of a gripping section formed from a microtextured film is shown. The microtextured film can be cut to form gripping sections of different shapes, including but not limited to L-shaped and oval-shaped gripping sections. The microtextured film includes a film having a microscopic pattern of microstructures (e.g., gripping portions) on the surface. Figure 5A As shown in , the microtextured film 20 includes a substrate 200 and a plurality of microstructure gripping portions 201 located on the surface of the substrate. In one embodiment, the film 20 may be a single-sided film having a gripping portion 201 on one surface of the substrate as shown, but the present disclosure is not limited thereto. In one embodiment, the film 20 may be a double-sided film having gripping portions disposed on and protruding from two opposite surfaces of the substrate. This arrangement may allow either side of the gripping section to be positioned toward the body portion, while the opposite side faces away from the body portion, which may facilitate the manufacture of the prosthesis. In a non-limiting example, an asymmetric gripping segment (e.g., an L-shaped gripping segment) made of a double-sided film may be attached to a left-handed or right-handed prosthesis by flipping the gripping segment (i.e., attaching the first surface of the gripping segment to a right-handed prosthesis, and attaching the opposite second surface to a left-handed prosthesis).

[0073] Figure 5B is a top view of the membrane 20, Figure 5C yes Figure 5B A magnified view of the detail of 5C, Figure 5D is a side view of the membrane 20, and Figure 5E yes Figure 5D In some embodiments, the gripping portion 201 may be arranged in a uniform pattern, such as FIG. 5B to FIG. 5CThe alternate linear rows with offset gripping portions shown in the figure are arranged on the substrate 200, but the present disclosure is not limited thereto, and the gripping portions 201 can be arranged on the substrate in any pattern including but not limited to a hexagonal, honeycomb, or square grid. In some embodiments, the gripping portions 201 can be positioned on the substrate in a random pattern.

[0074] In some embodiments, Figure 5C and Figure 5E As shown in , the membrane 20 may include gripping portions 201 arranged in linear rows. The rows may be spaced apart at a distance D1 of approximately 0.01 inches, 0.015 inches, 0.02 inches, or 0.025 inches, or any other suitable distance, to achieve the level of grip required for a particular surgery. In some embodiments, the rows may be spaced apart at a distance D1 of 0.016 inches. In some embodiments, the gripping portions 201 may be spaced apart at a distance D2 of approximately 0.025 inches, 0.05 inches, or any other suitable distance in each row to achieve the desired level of grip. In some embodiments, the gripping portions may be spaced apart at a distance D2 of 0.03 inches in each row. In some embodiments, the gripping portions 201 may have a width W1 of approximately 0.002 inches, 0.004 inches, 0.005 inches, or any other suitable width.

[0075] like Figure 5E As shown in , each gripping portion 201 may extend from the surface of the substrate 200. In some embodiments, the substrate 200 may have a height H1 of approximately 0.001 inches, 0.002 inches, 0.003 inches, or any other suitable height that provides sufficient strength and flexibility. In some embodiments, the membrane 20 including the substrate 200 and the gripping portion 201 may have a height H2 of approximately 0.010 inches, 0.015 inches, or 0.02 inches, or any other suitable height. In some embodiments, the gripping portion 201 may have a length L1 of approximately 0.010 inches, 0.015 inches, 0.02 inches, or 0.025 inches, or any other suitable length. In some embodiments, as Figure 5D and Figure 5E As shown in , the grips in adjacent rows can be offset by a distance D3, which is equal to the length L1 of the grips, so that the grips in adjacent rows do not overlap when viewed from the side. The size and spacing of the grips can be adjusted to provide grips in various patterns and arrangements on the substrate as needed.

[0076] like Figure 5EAs shown in , in some embodiments, each gripping portion 201 may include a first pillar 202 extending from the surface of the substrate 200 and a second pillar 204 extending from the surface of the first pillar 202. The cross-sectional area of ​​the first pillar may be greater than the cross-sectional area of ​​the second pillar. Figure 5C As shown in , the first strut 202 can have a generally quadrilateral shape. One or more sides 208 of the first strut can be angled so that the planar cross-section of the first strut increases toward the base to form a trapezoidal shape. The angled sides 208 can increase the flexibility of the gripping section to allow the gripping section to be folded or rolled up to fit into a trocar or other elongated body for medical surgery.

[0077] like Figure 5E As shown in , each gripping portion 201 may include one or more hook features 206 located at a free end of the gripping portion opposite the base plate 200, the one or more hook features 206 being configured for insertion into tissue while providing a sufficient amount of tissue grasping to reduce, if not eliminate, inadvertent release from the tissue. The hook features 206 may also be configured to minimize, if not eliminate, potential entanglement with a prosthesis, such as a mesh repair fabric, while providing the desired tissue grasping. In some embodiments, the gripping portion 201 may include two hook features 206 extending from the second pillar 204 and bending outward in opposite directions. In some embodiments, the hook features 206 may have a crescent shape extending from the second pillar 204. The size of the hook features 206 decreases in a direction from the pillar 204 toward its tip to facilitate penetration into the tissue. In such embodiments, the hook features 206 may be configured to minimize, if not eliminate, potential entanglement with a prosthesis, such as a mesh repair fabric, while providing the desired tissue grasping. Figure 5E In one embodiment illustrated in FIG. , each gripping portion may have a palm tree-like configuration.

[0078] Fig. 5F Another embodiment of a microtextured film is shown. As shown, the film includes a substrate 220 having a plurality of grips 221 extending from a tissue-facing surface of the substrate. The grips 221 include a first pillar 224 extending from the substrate 220 and one or more hook features 226 extending in opposite directions from the first pillar 224. In some embodiments, the grips 221 have a height H3 of about 0.20 mm to 0.70 mm. In some embodiments, the hook features have a span D4 of about 0.20 mm to 0.30 mm.

[0079] In some embodiments, the first pillar 224 can form a rounded corner with the base plate 220. The rounded corner can have a radius R1 of about 0.09 mm to 0.11 mm. In some embodiments, the hook features can bend outward from each other with a radius R2 of about 0.003 mm to 0.023 mm. In some embodiments, the tip of the hook feature 226 can have a radius R3 of about 0.008 mm to 0.038 mm.

[0080] Figure 5G Another embodiment of the gripping portion 231 is shown. Figure 5G As shown in FIG. 2 , the grip 231 has a hook feature 236 extending from the first post 234. The grip can have a height H4 of approximately 0.50 mm to 0.75 mm, or any suitable height.

[0081] Figures 6 to 10 Embodiments of prostheses with various gripping segments and perforation configurations and arrangements are shown. The number, size, shape and configuration of the gripping segments can be adjusted depending on the application and desired use.

[0082] Figure 6 An embodiment of a prosthesis 30 is shown having three gripping sections arranged on a surface 310 of a body portion 300. The body portion 300 includes a first gripping section 302 and a second gripping section 304 having an oval configuration arranged near a peripheral edge 312 in a first region 301 of the body portion 300. The body portion 300 also includes a third gripping section 306 having an L-shaped configuration arranged near a peripheral edge 312 of the second region 303 and extending over a rounded ridge 307 into the first region 301. The gripping sections may be arranged below a vertex 313 of the body portion such that the gripping sections do not cover the vertex. In some embodiments, the gripping sections may be arranged to cover the vertex.

[0083] Each of the gripping sections 302, 304, 306 may include a plurality of perforations 308. As illustrated, the perforations 308 for the first gripping section 302 and the second gripping section 304 may be arranged in a linear arrangement along the length of the gripping section. The pattern of the perforations of the third gripping section may include multiple rows of perforations 308 along the length of the gripping section. The pattern may include a row of perforations at the bottom and a row of continuous perforations that step outward in a V-shape so that the perforations extend along each end of the gripping section in a grid-like manner. The rows of perforations may be arranged at an angle to the direction along the length of the gripping section. Such a grid-like pattern may facilitate manufacturing, or may promote tissue ingrowth at a desired location while maintaining the structural integrity and sufficient gripping force of the gripping section. However, it should be understood that the gripping section may adopt any suitable perforation arrangement, which will be apparent to those skilled in the art.

[0084] Figure 7 An embodiment of a prosthesis 30 is shown having three gripping sections arranged on a surface 410 of a body portion 300. The body portion 400 includes a first gripping section 402 and a second gripping section 404 arranged near a peripheral edge 412 in a first region 401 of the body portion 400. The body portion also includes a third gripping section 406 of L-shape, arranged near the peripheral edge 412 of the second region 403 and extending over a rounded ridge 407 into the first region 401. Figure 6 The first grip section 402 and the second grip section 404 may have an asymmetrical oval shape compared to the grip sections 302, 303 of the present invention, and the third grip section 406 may have a larger surface area and a greater number of perforations 408 than the grip section 306. The grip section 404 may be positioned so that it rotates slightly clockwise around the peripheral edge 412 so as to be closer to the grip section 406 than to the grip section 402. The grip portion 406 may be positioned so that it covers the apex 413.

[0085] Each gripping section 402, 404, 406 includes multiple rows of perforations 408. In some embodiments, the first gripping section 402 and the second gripping section 404 include fifteen (15) perforations aligned in three (3) rows along the length of the gripping section. The larger gripping section 406 includes three (3) separate groups of perforations 408: a central region 420 and two end regions 422, 424. The groups of perforations can be arranged in a grid-like manner with equal sizes and spacing as shown. The distance between adjacent perforations of different groups can be less than or greater than the distance between perforations of the same group. Alternatively, the perforations can be arranged in a less structured manner within each group and can include unequal or random spacing and / or sizes.

[0086] Figure 8 50 is a diagram showing an embodiment of a prosthesis 50 having three gripping sections arranged on a surface 510 of a body portion 500. The body portion 300 includes a first gripping section 502 and a second gripping section 504 arranged near a peripheral edge 512 in a first region 501 of the body portion 300. The second gripping section 504 may be arranged near a side of the peripheral edge 512 near a rounded ridge 507. The first gripping section 502 and the second gripping section 504 may be larger than Figures 2 to 7 The first gripping section 502 and the second gripping section 504 may include a pattern of perforations 508 that occupy most of the surface area of ​​the gripping section. The perforations 508 may be arranged in a grid-like manner with equal spacing as shown.

[0087] The body portion 500 also includes a third gripping section 506 disposed proximate the peripheral edge 512 of the second region 503 and extending upwardly past the rounded ridge 507 into the first region 501. The third gripping section 506 can be shaped such that one end has a greater width than the opposite end. The third gripping section 506 can have equally spaced and equally sized perforations 508 positioned in three (3) separate regions on the gripping section.

[0088] Fig. 9 An embodiment of a prosthesis 60 is shown having three gripping sections 602, 604, 606 including a plurality of perforations 608 disposed on a surface 610 of a body portion 600. The body portion 600 includes a first gripping section 602 and a second gripping section 604 disposed proximate a peripheral edge 612 in a first region 601 of the body portion 600. The body portion 600 also includes a third gripping section 606 disposed proximate a peripheral edge 612 of the second region 603 and extending upwardly over a rounded ridge 607 into the first region 601. The third gripping section 606 may be sized relative to Figure 8 The third gripping section of has a shorter length. Figure 8 and Fig. 9 , Figure 8 The gripping section 506 includes a relatively long end portion 509 extending to a peripheral edge 512 of the body portion, and Fig. 9 The gripping section 606 has a relatively short end portion 609 that terminates before the periphery.

[0089] like Fig.10As shown in , the prosthesis 70 includes three gripping sections arranged on a surface 710 of a body portion 700. The body portion 700 includes a first gripping section and a second gripping section having twelve (12) perforations 708 arranged in two offset rows of six perforations each. The body portion 700 also includes an L-shaped third gripping section 706 having two (2) groups 720, 722 of perforations 708 separated by a middle portion 724 of the gripping section that has no perforations. The L-shaped third gripping portion 706 can be arranged near the periphery 712 in the second region 703 of the body portion, and a portion of the gripping portion 706 can extend beyond the rounded ridge 707 into the first region 701.

[0090] In some embodiments, the prosthesis can include any number of gripping segments. Fig.11 As shown in , the prosthesis 80 may include four (4) gripping sections 802, 804, 806, 814 arranged on a surface 810 of the body portion 800 near the peripheral edge 812 in a first region 801. The body portion may also include two (2) gripping sections 816, 818 arranged near the periphery in a second region 803 of the body portion. A portion of one of the gripping sections 816, 818 may extend beyond the rounded ridge 807 into the first region 801. The gripping sections may be positioned in pairs, with a small amount of the mesh of the body portion 800 exposed between the lengths of each gripping section pair. This may provide greater flexibility to the prosthesis and minimize the bulk of the prosthesis to allow insertion into a trocar. In some embodiments, the prosthesis may fit within an 8 mm trocar.

[0091] like FIG. 13A to FIG. 13BAs shown in , the prosthesis 90 may include four gripping sections 902, 904, 906, 914 arranged on a surface 910 of the body portion 900. Each gripping section may include a plurality of perforations 908. The body portion includes three gripping sections 902, 904, 906 that may have an elliptical shape and may be arranged near a first peripheral edge 912 in a first region 901 of the body portion 900. As illustrated, the first region may be located on a first side of a rounded ridge 907. The first gripping section 902 may have a smaller size, such as a shorter length and / or width, relative to the second gripping section 904 and the third gripping section 906. The first gripping section 902 may be arranged along a section of the first peripheral edge, and the second gripping section 904 and the third gripping section 906 may be arranged along adjacent sections of the first peripheral edge. The fourth gripping section 914 can be disposed in the second region 903 of the body portion 900, the second region 903 being located on a second side of the rounded ridge 907 and extending along the second peripheral edge 912. In some embodiments, the fourth gripping section 914 can be disposed entirely in the second region 903, or a portion of the fourth section 914 can contact or partially extend beyond the rounded ridge 907 into the first region 901. Fig.13A As shown in FIG. 1 , the fourth gripping section 914 may contact the rounded ridge 907 at one side of the gripping section, but does not extend past the apex 913. Fig. 13B As shown in FIG, the fourth gripping section 914 can extend on one side of the gripping section beyond the rounded ridge 907 and the apex 913. The fourth gripping section 914 can be oval in shape and can be larger, such as sized to have a longer length and / or width relative to the second gripping section 904 and the third gripping section 906.

[0092] In some embodiments, the first grip section 902 can have a length of approximately 1.25 inches, 1.50 inches, 1.75 inches, 1.90 inches, or 2.0 inches and a width of approximately 0.50 inches, 0.70 inches, or 0.80 inches. In some embodiments, the first grip section 902 can have a length of approximately 1.89 inches and a width of approximately 0.689 inches. In some embodiments, the first grip section 902 can have a length of approximately 1.51 inches and a width of approximately 0.614 inches. In some embodiments, the second grip section 904 and the third grip section 906 can have a length of approximately 1.75 inches, 2.0 inches, 2.25 inches, or 2.5 inches and a width of approximately 0.50 inches, 0.60 inches, 0.70 inches, 0.80 inches, or 0.90 inches. In some embodiments, the second grip section 904 and the third grip section 906 can have a length of approximately 2.362 inches and a width of approximately 0.787 inches. In some embodiments, the second grip section 904 and the third grip section 906 can have a length of approximately 2.047 inches and a width of approximately 0.632 inches. In some embodiments, the fourth grip section 914 can have a length of approximately 3.75 inches, 4.0 inches, 4.50 inches, 4.75 inches, or 5.0 inches and a width of approximately 0.75 inches, 1.0 inches, or 1.25 inches. In some embodiments, the fourth grip section 914 can have a length of approximately 4.762 inches and a width of approximately 1.00 inches. In some embodiments, the fourth grip section 914 can have a length of approximately 4.055 inches and a width of approximately 0.787 inches.

[0093] In some embodiments, the gripping sections 902, 904, 906, and 914 can each include a plurality of perforations. The perforations 908 can have a diameter of approximately 0.10 inches and can be arranged linearly along the longitudinal direction of the gripping section. The perforations can be spaced apart at intervals of approximately 0.25 inches to approximately 0.30 inches. In some embodiments, the perforations 908 can be spaced apart at intervals of approximately 0.28 inches. In some embodiments, the first gripping section 902 can include four perforations, the second gripping section 904 and the third gripping section 906 can include six perforations, and the fourth gripping section can include fifteen perforations. It should be noted that with reference to FIG. 13A to FIG. 13B The gripping sections and perforations sizes and spacings described may be included in any of the embodiments described herein.

[0094] The gripping sections can be arranged on the layer made of the repair fabric to cover a portion of the surface of the body portion to maximize tissue grip. In some embodiments, the gripping sections can be arranged on the body portion to cover approximately 10%, 15%, 20%, or 25% of the surface area greater than or equal to the body portion 100. In some embodiments, the gripping sections can be arranged on the body portion to cover approximately 45%, 40%, 35%, 30%, or 25% of the surface area of ​​all dimensions less than or equal to the body portion 100. Any suitable combination of the above ranges is also possible. In one embodiment, the gripping sections can be arranged on the body portion to cover approximately 20% greater than or equal to the surface area of ​​the body portion and less than or equal to 30% of the surface area of ​​the body portion.

[0095] In some embodiments, the gripping section may be made of polylactide acid (PLA), but the present disclosure is not limited thereto, and the gripping section may be made of other suitable resorbable materials (e.g., P4HB, etc.). In some embodiments, the prosthesis may include four gripping sections (see Fig.13A and Fig. 13B ). In such an embodiment, the total surface area of ​​the gripping section located on the prosthesis can be about 5.3 square inches to about 7.6 square inches, depending on the size of the prosthesis. The total surface area of ​​the exposed layer of the repair fabric of the body portion can be about 17.5 square inches to about 28.4 square inches, depending on the size of the prosthesis. In some embodiments, the gripping section can occupy about 26% to about 30.2% of the surface area of ​​the body portion.

[0096] It should be understood that all gripping sections, perforations and patterns described in each embodiment are non-limiting examples, and any configuration can be used according to actual needs. It should also be noted that any gripping section and configuration from each of the above embodiments can be used in any prosthesis.

[0097] Example

[0098] The following examples are illustrative only and are not intended to limit the scope of the invention.The traction of the microtextured films was evaluated using 2 x 1 inch samples of the films having different gripping structures and dimensions as listed in Table 1 below.

[0099] Table 1

[0100]

[0101] Table 2

[0102]

[0103] As illustrated in Tables 1 and 2 above, the grip (819) with two opposing hook features of 0.015 inches in height had the highest traction when tested with muscle, fat, and fascia compared to grips with higher heights or with only one hook feature.

[0104] Although several embodiments of the present invention have been described and illustrated herein, it will be readily apparent to those of ordinary skill in the art that various other features and / or structures for performing functions and / or obtaining one or more of the results and / or advantages described herein will be contemplated, and each of such variations and / or modifications is considered to be within the scope of the present invention. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications for which the teachings of the present invention are used. Those skilled in the art will recognize or be able to determine that many equivalents of the specific embodiments of the present invention described herein can be determined using only routine experiments. Therefore, it should be understood that the foregoing embodiments are given only as examples, and within the scope of the appended claims and their equivalents, the present invention may be implemented in a manner other than specifically described and claimed. The present invention relates to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits and / or methods is included within the scope of the present invention if two or more such features, systems, articles, materials, kits and / or methods are not mutually inconsistent.

Claims

1. An implantable prosthesis comprising: a layer made of a biocompatible repair fabric; as well as A plurality of gripping sections are integrated with the layer of repair fabric, each of the plurality of gripping sections comprising a plurality of gripping portions and a plurality of perforations extending through the plurality of gripping portions.

2. The implantable prosthesis according to claim 1, wherein: Each gripping portion of the plurality of gripping portions includes at least one hook structure.

3. The implantable prosthesis according to claim 1, wherein: Each gripping portion of the plurality of gripping portions includes two hook features extending in opposite directions.

4. The implantable prosthesis according to claim 3, wherein: The two hook features extend a distance of about 0.20 mm to about 0.30 mm.

5. The implantable prosthesis according to claim 1, wherein: Each of the plurality of gripping portions includes a first strut and a second strut extending from a surface of the first strut, wherein a cross-sectional area of ​​the first strut is greater than a cross-sectional area of ​​the second strut, and wherein at least one of the hook features extends from the second strut.

6. The implantable prosthesis according to claim 5, wherein: The first strut has a generally quadrilateral shape.

7. The implantable prosthesis according to claim 1, wherein: Each of the plurality of gripping portions has a height of about 0.01 inches to about 0.02 inches.

8. The implantable prosthesis according to claim 1, wherein: The plurality of grips are arranged in linear rows spaced about 0.1 inches to about 0.2 inches apart.

9. The implantable prosthesis according to claim 1, wherein: The plurality of gripping portions are spaced apart at intervals of approximately 0.3 inches in each row.

10. The implantable prosthesis according to claim 1, wherein: The plurality of gripping sections includes a plurality of microtextured gripping sections.

11. The implantable prosthesis according to claim 1, wherein: The plurality of gripping sections includes three or more gripping sections integrated with the layer of repair fabric.

12. The implantable prosthesis according to claim 1, wherein: At least one gripping section of the plurality of gripping sections has an L-shaped configuration.

13. The implantable prosthesis of claim 1, wherein: At least one gripping section of the plurality of gripping sections has an oval-shaped configuration.

14. The implantable prosthesis of claim 1, wherein: The plurality of gripping sections are arranged on the layer of repair fabric to keep a central portion of the repair fabric free of gripping sections.

15. The implantable prosthesis of claim 1, wherein: The layer of repair fabric has a preformed three-dimensional configuration with vertices devoid of gripping sections.

16. The implantable prosthesis of claim 1, wherein: The plurality of perforations on at least one of the plurality of gripping sections occupy between about 6% and about 20% of the gripping section.

17. The implantable prosthesis of claim 1, wherein: The plurality of gripping sections occupy between about 20% and about 30% of the surface of the layer of repair fabric.

18. The implantable prosthesis of claim 1, wherein: Each of the plurality of perforations has a diameter of about 0.10 inches to about 0.11 inches.

19. The implantable prosthesis of claim 1, wherein: The plurality of perforations are spaced apart at a center distance of about 0.25 inches to about 0.30 inches.

20. The implantable prosthesis of claim 1, wherein: The plurality of perforations for at least one grip section of the plurality of grip sections are arranged in at least three different areas on the grip section.

21. The implantable prosthesis of claim 20, wherein: Each region includes a set of perforations.

22. The implantable prosthesis of claim 20, wherein: The distance between the regions is greater than the distance between adjacent perforations in the regions.

23. The implantable prosthesis of claim 21, wherein: Each set of perforations has uniform spacing within each zone.

24. The implantable prosthesis of claim 1, wherein: The plurality of perforations for at least one gripping section of the plurality of gripping sections are arranged in a two-dimensional pattern with equal spacing.

25. The implantable prosthesis of claim 1, wherein: The plurality of perforations for at least one gripping section of the plurality of gripping sections are arranged in an array extending in a direction along a length of the gripping section.

26. The implantable prosthesis of claim 1, wherein: The plurality of perforations for at least one gripping section of the plurality of gripping sections are arranged in a hexagonal pattern.

27. The implantable prosthesis of claim 1, wherein: The layer of repair fabric has a preformed three-dimensional configuration having an apex and a rounded ridge extending from the apex to an outer periphery of the layer of repair fabric, a portion of at least one of the plurality of gripping sections extending across the rounded ridge.

28. The implantable prosthesis of claim 27, wherein: At least two gripping sections are arranged completely on one side of the rounded ridge on the layer of repair fabric.

29. The implantable prosthesis of claim 28, wherein: The at least two gripping sections have an oval-shaped configuration and wherein the at least two gripping sections are positioned such that the long sides of the gripping sections are substantially parallel to a portion of the periphery of the layer of repair fabric.

30. The implantable prosthesis of claim 27, wherein: At least one gripping section is arranged on the layer of repair fabric closer to a peripheral edge of the gripping section than to the rounded ridge.

31. The implantable prosthesis of claim 1, wherein: The plurality of gripping sections includes six or more gripping sections integrated with the layer of repair fabric.

32. An implantable prosthesis comprising: a layer made of a biocompatible repair fabric; as well as A plurality of micro-textured gripping sections are integrally bonded to the layer of repair fabric, each of the plurality of micro-textured gripping sections comprising a plurality of perforations extending therethrough.

33. The implantable prosthesis of claim 32, wherein: The plurality of micro-textured gripping sections includes three or more gripping sections integrated with the layer of repair fabric.

34. The implantable prosthesis of claim 32, wherein: At least one micro-textured gripping section of the plurality of micro-textured gripping sections has an L-shaped configuration.

35. The implantable prosthesis of claim 32, wherein: At least one micro-textured gripping section of the plurality of micro-textured gripping sections has an oval-shaped configuration.

36. The implantable prosthesis of claim 32, wherein: The plurality of micro-textured gripping sections are arranged on the layer of repair fabric to keep a central portion of the repair fabric free of micro-textured gripping sections.

37. The implantable prosthesis of claim 32, wherein: The layer of repair fabric has a preformed three-dimensional configuration with vertices devoid of micro-textured gripping sections.

38. The implantable prosthesis of claim 32, wherein: The plurality of perforations on at least one micro-textured gripping section of the plurality of micro-textured gripping sections occupy approximately 6% to 20% of the micro-textured gripping section.

39. The implantable prosthesis of claim 32, wherein: The plurality of micro-textured gripping sections occupy between about 20% and about 30% of a surface of the layer of repair fabric.

40. The implantable prosthesis of claim 32, wherein: Each of the plurality of perforations has a diameter of about 0.10 inches to about 0.11 inches.

41. The implantable prosthesis of claim 32, wherein: The plurality of perforations are spaced apart at a center distance of about 0.25 inches to about 0.30 inches.

42. The implantable prosthesis of claim 32, wherein: The plurality of perforations for at least one micro-textured gripping section of the plurality of micro-textured gripping sections are arranged in at least three different areas on the micro-textured gripping section.

43. The implantable prosthesis of claim 32, wherein: The plurality of perforations for at least one micro-textured gripping section of the plurality of micro-textured gripping sections are arranged in a two-dimensional pattern with equal spacing.

44. The implantable prosthesis of claim 32, wherein: The plurality of perforations for at least one micro-textured gripping section of the plurality of micro-textured gripping sections are arranged in an array extending in a direction along a length of the micro-textured gripping section.

45. The implantable prosthesis of claim 32, wherein: The plurality of perforations for at least one of the plurality of micro-textured sections are arranged in a hexagonal pattern.

46. ​​A method of manufacturing an implantable prosthesis, the method comprising: providing a layer made of a biocompatible repair fabric; as well as A plurality of gripping sections are attached to the surface of the layer of repair fabric, wherein each of the gripping sections includes a plurality of gripping portions and a plurality of perforations extending through the plurality of gripping portions.

47. The method of claim 46, wherein: The plurality of gripping sections occupy between about 20% and about 30% of the surface of the layer of repair fabric.

48. The method of claim 46, further comprising arranging the plurality of gripping sections on the layer of repair fabric to maintain a central portion of the repair fabric free of gripping sections.

49. The method of claim 46, further comprising creating the plurality of perforations through the plurality of gripping segments.

50. The method of claim 46, wherein: The perforations occupy between about 6% and about 20% of the gripping section.

51. The method of claim 46, wherein: Each of the plurality of perforations has a diameter of about 0.10 inches to about 0.11 inches.

52. The method of claim 46, wherein: The plurality of perforations are spaced apart at a center distance of about 0.25 inches to about 0.30 inches.

53. The method of claim 46, wherein: The plurality of perforations for at least one grip section of the plurality of grip sections are arranged in at least three different areas on the grip section.

54. The method of claim 46, wherein: The plurality of perforations for at least one gripping section of the plurality of gripping sections are arranged in a two-dimensional pattern with equal spacing.

55. The method of claim 46, wherein: The plurality of perforations for at least one gripping section of the plurality of gripping sections are arranged in an array extending in a direction along a length of the gripping section.

56. The method of claim 46, wherein: The plurality of perforations for at least one gripping section of the plurality of gripping sections are arranged in a hexagonal pattern.

57. The method of claim 46, wherein: Each gripping portion of the plurality of gripping portions includes at least one hook structure.

58. An implantable prosthesis comprising: a layer of biocompatible repair fabric having a preformed three-dimensional configuration having an apex and a rounded ridge extending from the apex to an outer periphery of the layer of repair fabric; as well as A plurality of gripping sections are integrally integrated with the layer of biocompatible repair fabric, wherein each of the plurality of gripping sections comprises at least one hook structure, and wherein a portion of at least one of the plurality of gripping sections extends across the rounded ridge.

59. The implantable prosthesis of claim 58, wherein: At least one gripping section of the plurality of gripping sections has an L-shaped configuration.

60. The implantable prosthesis of claim 58, wherein: At least one gripping section of the plurality of gripping sections has an oval-shaped configuration.

61. The implantable prosthesis of claim 58, wherein: The plurality of gripping sections are arranged on the layer of repair fabric to keep a central portion of the repair fabric free of gripping sections.

62. The implantable prosthesis of claim 58, wherein: The apex has no gripping section.

63. The implantable prosthesis of claim 58, wherein: The plurality of gripping sections occupy between about 20% and about 30% of the surface of the layer of repair fabric.

64. The implantable prosthesis of claim 58, wherein: At least two gripping sections are arranged completely on one side of the rounded ridge on the layer of repair fabric.

65. The implantable prosthesis of claim 58, wherein: The at least two gripping sections have an oval-shaped configuration and wherein the at least two gripping sections are positioned such that the long sides of the gripping sections are substantially parallel to a portion of the periphery of the layer of repair fabric.

66. The implantable prosthesis of claim 58, wherein: At least one gripping section is arranged on the layer of repair fabric closer to a peripheral edge of the gripping section than to the rounded ridge.

67. The implantable prosthesis of claim 58, wherein: The plurality of gripping sections includes six or more gripping sections attached to the layer of repair fabric.

68. An implantable prosthesis comprising: a layer made of a biocompatible repair fabric; as well as A plurality of gripping sections are integrated with the layer of repair fabric, each of the plurality of gripping sections comprising a base plate and a plurality of gripping portions extending from a surface of the base plate, wherein each of the plurality of gripping portions comprises at least one hook structure.

69. The implantable prosthesis of claim 68, wherein: Each gripping portion of the plurality of gripping portions includes two hook features extending in opposite directions.

70. The implantable prosthesis of claim 69, wherein: The two hook features extend a distance of about 0.20 mm to about 0.30 mm.

71. The implantable prosthesis of claim 68, wherein: Each of the plurality of gripping portions includes a first strut and a second strut extending from a surface of the first strut, wherein a cross-sectional area of ​​the first strut is greater than a cross-sectional area of ​​the second strut, and wherein at least one of the hook features extends from the second strut.

72. The implantable prosthesis of claim 71, wherein: The first strut has a generally quadrilateral shape.

73. The implantable prosthesis of claim 68, wherein: Each of the plurality of gripping portions has a height of about 0.01 inches to about 0.02 inches.

74. The implantable prosthesis of claim 68, wherein: The plurality of grips are arranged in linear rows spaced about 0.1 inches to about 0.2 inches apart.

75. The implantable prosthesis of claim 68, wherein: The plurality of gripping portions are spaced apart at intervals of approximately 0.3 inches in each row.

76. The implantable prosthesis of claim 68, wherein: Each gripping section of the plurality of gripping sections includes a plurality of perforations extending therethrough.

77. The implantable prosthesis of claim 68, wherein: The plurality of gripping sections includes three or more gripping sections integrated with the layer of repair fabric.

78. The implantable prosthesis of claim 68, wherein: At least one gripping section of the plurality of gripping sections has an L-shaped configuration.

79. The implantable prosthesis of claim 68, wherein: At least one gripping section of the plurality of gripping sections has an oval-shaped configuration.

80. The implantable prosthesis of claim 68, wherein: The plurality of gripping sections are arranged on the layer of repair fabric to keep a central portion of the repair fabric free of gripping sections.

81. The implantable prosthesis of claim 68, wherein: The layer of repair fabric has a preformed three-dimensional configuration with vertices devoid of gripping sections.

82. The implantable prosthesis of claim 68, wherein: The plurality of gripping sections occupy between about 20% and about 30% of the surface of the layer of repair fabric.

83. A gripping section for an implantable prosthesis, the gripping section comprising: a substrate made of a biocompatible material, said substrate being attachable to the layer made of the repair fabric; a plurality of microstructure gripping portions extending from a surface of the substrate, wherein each microstructure gripping portion of the plurality of microstructure gripping portions comprises at least one hook structure; as well as A plurality of through holes extend through the substrate.

84. The gripping section of claim 83, wherein: The grip section has an L-shaped configuration.

85. The gripping section of claim 83, wherein: The grip section has an oval-shaped configuration.

86. The gripping section of claim 83, wherein: The plurality of perforations on at least one of the plurality of gripping sections occupy between about 6% and about 20% of the gripping section.

87. The gripping section of claim 83, wherein: Each of the plurality of perforations has a diameter of about 0.10 inches to about 0.11 inches.

88. The gripping section of claim 83, wherein: The plurality of perforations are spaced apart at a center distance of about 0.25 inches to about 0.30 inches.

89. The gripping section of claim 83, wherein: The plurality of perforations are arranged in three different areas on the grip section.

90. The gripping section of claim 83, wherein: The plurality of perforations are arranged in a two-dimensional pattern with equal intervals.

91. The gripping section of claim 83, wherein: The plurality of perforations are arranged in an array extending in a direction along the length of the grip section.

92. The gripping section of claim 83, wherein: The plurality of perforations are arranged in a hexagonal pattern.

93. The gripping section of claim 83, wherein: The plurality of microstructure gripping portions are arranged on the gripping section in a plurality of linear rows spaced about 0.1 inches to about 0.2 inches apart.

94. The gripping section of claim 83, wherein: The plurality of microstructure gripping portions are spaced apart in rows at approximately 0.3 inch intervals.

95. The implantable prosthesis of claim 83, wherein: Each microstructure gripping portion of the plurality of microstructure gripping portions includes at least one hook structure.

96. The implantable prosthesis of claim 83, wherein: Each microstructure gripping portion of the plurality of microstructure gripping portions includes two hook features extending in opposite directions.

97. The implantable prosthesis of claim 96, wherein: The two hook features extend a distance of about 0.20 mm to about 0.30 mm.

98. The implantable prosthesis of claim 83, wherein: Each of the plurality of microstructure gripping portions comprises a first strut and a second strut extending from a surface of the first strut, wherein a cross-sectional area of ​​the first strut is greater than a cross-sectional area of ​​the second strut, and wherein at least one of the hook features extends from the second strut.

99. The implantable prosthesis of claim 98, wherein: The first strut has a generally quadrilateral shape.

100. The implantable prosthesis of claim 83, wherein: Each microstructure gripping portion of the plurality of microstructure gripping portions has a height of about 0.01 inches to about 0.02 inches.

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