Implantable prosthesis with self-fixing grip

Abstract

An implantable prosthesis for repairing a tissue defect site includes a layer of repair fabric and a plurality of micro-textured grip segments attached to the repair fabric. The grip segments include a pattern of perforations on the surface facing the tissue to promote in-growth of the tissue.

Description

【Technical Field】 【0001】 Related Applications 【0001】 This application claims the benefit of U.S. Patent Application No. 63 / 357,116, filed on June 30, 2022, and U.S. Patent Application No. 63 / 357,127, filed on June 30, 2022, both of which are hereby incorporated by reference in their entirety. 【0002】 Field 【0002】 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】 【0003】 Background 【0003】 Defects in muscle or tissue walls, such as hernias, are generally repaired using implantable prostheses configured to cover and / or fill the defect. 【0004】 【0004】 In some procedures, an implantable repair fabric, such as a mesh cloth, is sutured, stapled, tacked, or otherwise temporarily anchored in place over, under, or within the defect. The repair is ultimately completed by tissue ingrowth into and / or along the fabric, such as tissue ingrowth into the mesh fabric. 【0005】 【0005】 A variety of repair fabrics are known and used for repairing defects in soft tissue and muscle walls. Examples of implantable fabrics that have been well used for repairing soft tissue and muscle walls include BARD Soft Mesh, BARD Mesh, and VISILEX available from C. R. Bard. Such fabrics are woven into a mesh having pores or gaps that are made of polypropylene monofilaments and that promote tissue ingrowth and integration with the fabric. 【0006】 【0006】 Depending on the treatment, it may be desirable to employ an implantable prosthesis configured to conform to the shape of the anatomical region of the defect. In some cases, such prostheses can be positioned and maintained in place with little or no temporary fixation relative to the defect. Examples of implantable prostheses that have been well used for the repair of soft tissue and muscle walls include 3DMAX Light Mesh and 3DMAX Mesh available from C. R. Bard. Such prostheses are manufactured from a mesh fabric formed in a curved three-dimensional shape that conforms to the anatomical shape of the defect region, such as the anatomical structure of the groin. These prostheses have proven to be useful and are established in the practice of repairing the muscles or tissue walls of the groin and thigh. 【Summary of the Invention】 【Problems to be Solved by the Invention】 【0007】 【0007】 An object of the present disclosure is to provide a prosthesis for repairing defects in soft tissue and muscle walls. 【Means for Solving the Problems】 【0008】 Summary 【0008】 Provided is an implantable prosthesis comprising a layer of biocompatible repair fabric and a plurality of grip segments integrated with the layer of repair fabric. Each of the plurality of grip segments includes a plurality of grips and a plurality of perforations extending through each of the plurality of grip segments. 【0009】 【0009】 Provided is an implantable prosthesis comprising a layer of biocompatible repair fabric and a plurality of microtextured grip segments integrated with the layer of repair fabric. Each of the plurality of microtextured grip segments includes a plurality of perforations extending therethrough. 【0010】 An implantable prosthesis is provided that includes a biologically compatible repair fabric layer and a plurality of grip segments integrated with the repair fabric layer. Each of the plurality of grip segments includes a substrate and a plurality of grips extending from the surface of the substrate, and each of the plurality of grips includes at least one hook structure. 【0011】 A grip segment for an implantable prosthesis is provided. The grip segment includes a substrate of a biologically compatible material attachable to a layer of repair fabric and a plurality of microstructured grips extending from the surface of the substrate. Each of the plurality of microstructured grips includes at least one hook structure. The grip segment also includes a plurality of perforations extending through the substrate. 【0012】 A method of manufacturing an implantable prosthesis is provided. The method includes providing a layer of biologically compatible repair fabric and attaching a plurality of grip segments to the surface of the layer of repair fabric. Each of the grip segments includes a plurality of grips and a plurality of perforations extending through each of the grip segments. 【0013】 An implantable prosthesis is provided that includes a layer of biologically compatible repair fabric having a pre-formed three-dimensional configuration with a vertex and a rounded ridge extending from the vertex to the outer periphery of the layer of repair fabric. The implantable prosthesis also includes a plurality of grip segments integrated with the layer of biologically compatible repair fabric, and at least a portion of at least one of the plurality of grip segments extends beyond the rounded ridge. 【0014】 It should be understood that the foregoing concepts, as well as additional concepts discussed below, may be arranged in any suitable combination since the present disclosure is not limited in this respect. Further, 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 figures. 【0015】 【0015】 If this specification and the documents incorporated by reference contain conflicting and / or contradictory disclosures, this specification shall prevail. If two or more documents incorporated by reference contain conflicting and / or contradictory disclosures with respect to each other, the document with the later effective date shall prevail. 【0016】 Brief Description of the Drawings 【0016】 The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or substantially identical component shown in various figures may be represented by similar numbers. For clarity, not all components are labeled in all of the drawings. 【Brief Description of the Drawings】 【0017】 【Figure 1】 【0017】 An embodiment of an implantable prosthesis according to one embodiment. 【Figure 2】 【0018】 An embodiment of a layer of repair fabric that can be pre-formed into a configuration for use as a prosthesis. 【Figure 3A】 【0019】 A top view of one embodiment of a grip segment. 【Figure 3B】 【0020】 A top view of one embodiment of a grip segment. 【Figure 4A】 【0021】 A schematic view of the perforation of the grip segment of FIG. 3A according to one embodiment. 【Figure 4B】 【0022】 A schematic view of the perforation of the grip segment of FIG. 3B according to one embodiment. 【Figure 5A】 【0023】 A top perspective view of one embodiment of a micro-textured film. 【Figure 5B】 【0024】}A top view of the micro-textured film of FIG. 5A. 【Figure 5C】 【0025】It is an enlarged view of section 5C of FIG. 5B. 【Figure 5D】 【0026】 It is a side view of the micro-texture processing film of FIG. 5A. 【Figure 5E】 【0027】 It is an enlarged view of section 5E of FIG. 5D. 【Figure 5F】 【0028】 It is a side view of one embodiment of the micro-texture processing film. 【Figure 5G】 【0029】 It is one embodiment of the hook of the micro-texture processing film. 【Figure 6】 【0030】 It is one embodiment of a prosthesis. 【Figure 7】 【0031】 It is one embodiment of a prosthesis. 【Figure 8】 【0032】 It is one embodiment of a prosthesis. 【Figure 9】 【0033】 It is one embodiment of a prosthesis. 【Figure 10】 【0034】 It is one embodiment of a prosthesis. 【Figure 11】 【0035】 It is one embodiment of a prosthesis. 【Figure 12】 【0036】 It is a schematic side view of a main body part according to one embodiment. 【Figure 13A】 【0037】 It is one embodiment of a prosthesis. 【Figure 13B】 【0038】 It is one embodiment of a prosthesis. 【Mode for Carrying Out the Invention】 【0018】 Detailed Description 【0039】The present disclosure is directed to an implantable prosthesis for repairing anatomical defects, and is particularly suitable for repairing defects and their vulnerable parts in soft tissue and muscle walls or other anatomical regions. The phrase "repairing a defect" includes the act of repairing, strengthening, and / or reconstructing a defect and / or a potential defect. For ease of understanding, without limiting the scope of the present disclosure, hereinafter, particularly but not limited to, it will be described in connection with a prosthesis for repairing an inguinal defect, including one or more of indirect inguinal hernia (external inguinal hernia), direct inguinal hernia (internal inguinal hernia), femoral hernia, and / or other vulnerable parts or ruptures of the anatomical structure of the inguinal region. However, it should be understood that the prosthesis is not so limited and can be employed in other anatomical procedures, as will be apparent to those skilled in the art. For example, without limitation, the prosthesis can be employed for abdominal wall hernia, reconstruction of the chest wall or abdominal wall, or large defects that may occur in obese patients. The prosthesis can include one or more features that contribute to such attributes, either independently or in combination. 【0019】 【0040】 More particularly, the present disclosure is directed to a prosthesis including a repair fabric having a body portion, the body portion being configured to cover or extend across an opening or vulnerable part of a defect when the body portion is disposed in contact with the defect. The prosthesis may be in the form of a patch, but other configurations may be employed as will be apparent to those skilled in the art. The patch can have a planar or non-planar configuration suitable for a particular procedure employed to repair the defect. 【0020】 【0041】The prosthesis can be configured to have a self - gripping arrangement having features that help maintain the position of the prosthesis relative to the defect. The self - gripping arrangement can reduce, if not eliminate, separation, sliding, twisting, bending and / or other movements between the prosthesis and adjacent tissue, depending on the desired likelihood. Such an arrangement can also reduce, if not eliminate, the need for a surgeon to temporarily tether the prosthesis in place by suturing, stapling, tacking or other means while waiting for tissue integration. 【0021】 【0042】 The prosthesis can include one or more grip segments integrated with a layer of the prosthesis' repair fabric. In some embodiments, the grip segments can be integrated with the repair fabric by attaching the grip segments to the surface of a body portion configured to engage adjacent tissue. In some embodiments, the grip segments can be formed from patches of film of various shapes and sizes. More particularly, the grip segments can include a micro - structure arrangement of grips that project from the surface of the grip segments configured to engage adjacent tissue. The grips can be configured to grip through the tissue when the prosthesis is placed in contact with and / or pressed against the tissue. Thus, the grips can project a defined distance from the surfaces of the grip segments and the body portion and be configured to penetrate a sufficient depth of tissue to provide a desired amount of grip. The grips can be arranged on the grip segments in any suitable configuration to provide the desired amount of grip. For example, without limitation, the grips can be dispersed across the grip segments in a uniform, non - uniform or random array and / or any suitable combination of arrays. 【0022】 【0043】The gripper can include a grip head located at an end of the grip body opposite the base, and this grip head is configured to be inserted into tissue while providing a sufficient amount of tissue gripping to reduce, if not eliminate, inadvertent release from the tissue. The grip head can also be configured to minimize, if not eliminate, potential entanglement with prostheses such as mesh repair fabrics while providing the desired tissue gripping. For example, without limitation, the grip head can include one or more hook mechanisms of any suitable configuration, which should be apparent to those skilled in the art. The grip head can include hook mechanisms having different configurations relative to each other. Examples of the configuration of the grip head include, but are not limited to, a hook shape, a barb shape, a crescent shape, a plurality of prongs arranged in a V-shape, and a claw shape. Other grip head shapes are also contemplated. 【0023】 【0044】 The grip segments can be arranged on the body portion in any suitable configuration to provide the desired amount of gripping, which should be apparent to those skilled in the art. For example, without limitation, the grip segments can be arranged in a uniform, non-uniform, or random array and / or in any suitable combination of arrays, and dispersed over the body portion. The grip segments can be dispersed over the entire body portion or arranged in one or more selected regions of the body portion. For example, without limitation, the grip segments can be arranged in one or more selected regions adjacent to one or more segments of the outer periphery of the body portion and / or in one or more selected regions located inwardly within the inner region of the body portion away from the outer periphery. Each selected region can include one or more grip segments arranged in any suitable pattern within that region. 【0024】 【0045】According to one aspect, the grip segment can be manufactured independently of the body portion of the prosthesis and attached to the body portion. In this way, the grip segment can be formed from a material different from that of the body portion. For example, without limitation, the grip segment can be formed of a bioabsorbable material, and the body portion can be formed of a non-absorbable material. Such an arrangement can provide temporary gripping characteristics to the prosthesis during the period of 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 formed of a bioabsorbable material that may be absorbed at a slower rate than the grip segment material. 【0025】 【0046】 Manufacturing the grip segment independently can also provide flexibility in configuring the prosthesis. For example, without limitation, the prosthesis can include grip segments having the same or different grip segment configurations and / or arrangements depending on the particular use of the prosthesis. For example, without limitation, the prosthesis can include grip segments having the same shape but attached to the body portion in different orientations relative to each other. The prosthesis can include grip segments having one or more different shapes in one or more regions of the body portion. In this way, various gripping characteristics based on the particular orientation and / or shape of the grip segments can be provided to the prosthesis, individually and as a whole. 【0026】 【0047】In some embodiments, the grip segment can include a plurality of perforations to allow for ingrowth of tissue into and through the grip segment. The perforations can be configured in various patterns, sizes, and shapes depending on the desired amount of tissue ingrowth while maintaining the structural integrity of the grip segment. For example, the perforations can be distributed across the grip segment in a uniform, non-uniform, or random array, and / or in any suitable combination of arrays. The perforations can be distributed throughout the grip segment or located in one or more selected regions of the grip segment. Each selected region can include one or more perforations arranged in any suitable pattern within that region. 【0027】 【0048】 In some embodiments, the grip segment can be integrated with the body portion of the prosthesis by using one or more sutures to secure the grip segment to the body portion. In some embodiments, attaching the grip segment to the body portion can include the application of suturing along the periphery of the grip segment with a non-absorbable monofilament such as polypropylene or ePTFE, or an absorbable monofilament. In some embodiments, the grip segment can be attached to the body portion using an adhesive, bonding, ultrasonic or thermal welding, or overmolding. In some embodiments, the grip segment can include one or more protrusions extending from the surface of the grip segment adjacent to the body portion. In a non-limiting example, the protrusions can include hooks or other engaging structures configured to be at least partially inserted into the surface of the body portion when the grip is pressed against the body portion to secure the grip segment to the body portion. 【0028】 【0049】The prosthesis can be used to repair defects in the soft tissue and muscular wall using a variety of surgical techniques, including open, laparoscopic, hybrid (e.g., Kugel method), and robotic techniques. During open surgery, the prosthesis can be placed through a relatively large incision made in the abdominal wall and tissue layers, after which the defect is filled or covered with a repair fabric. In laparoscopic and hybrid surgeries, the prosthesis can be collapsed into a reduced form, such as by rolling or folding, to enter the subject's body directly through a relatively small incision or through an elongated laparoscopic cannula placed through the incision. The prosthesis can be particularly applied to robotic surgery that achieves placement of the prosthesis using a surgical robotic tool that can pass the prosthesis through a relatively small cannula (e.g., 8 mm) compared to cannulas typically employed in more common laparoscopic techniques (e.g., 10 - 12 mm). 【0029】 【0050】 With reference to the figures, specific non - limiting embodiments will be described in further detail. Since the present disclosure is not limited to only the specific embodiments described herein, it should be understood that the various systems, components, features, and methods described in connection with these embodiments can be used individually and / or in any desired combination. 【0030】 【0051】Figure 1 shows one embodiment of a prosthesis for repairing tissue such as a hernia defect and a defect in the muscular wall. This prosthesis includes an implantable biologically compatible material repair cloth. In one embodiment, the repair cloth can include a mesh cloth that is relatively flexible, thin, and lightweight and meets the performance and physical properties for repairing defects in soft tissue and the muscular wall. Prosthesis 10 can include a body portion 100, which is configured to have a size and / or shape suitable to cover or extend across the opening or vulnerable portion of the defect when the body portion is disposed in contact with the defect. The body portion 100 may be a pre-formed non-planar patch having a three-dimensional curved shape. The body portion can include a first region 101 and a second region 103, which are joined 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 extends in a direction from the first outer edge 109 and the second outer edge 111 toward the first region 101 and can intersect at an angle at a vertex 113 disposed near a central region 105 of the body portion between the first region 101 and the second region 103. The vertex 113 can form the highest point of the body portion relative to a plane formed by a peripheral edge 112 (see also Figure 12). In one embodiment, the height H of the prosthesis from the plane defined by the peripheral edge 112 and the vertex 113 is about 21 mm. In some embodiments, the height H of the prosthesis defined by the peripheral edge 112 and the vertex 113 is about 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 about 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 about 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 to define the second region of the body portion. 【0031】 【0052】As shown in FIG. 12, the first region 101 and the second region 103 can have a substantially spherical shape to improve the conformity to a specific anatomical shape. In one exemplary embodiment, the radius of curvature of the first region is smaller than that of the second region, forming a surface of the second region with a steeper slope relative to the first region. Returning to FIG. 1, the second region can be shaped to form a recess 115 in the surface of the body portion, and the recess 115 is configured to receive the external iliac vessels, for example, when the prosthesis is employed for inguinal hernia repair. The recess extends inwardly from the peripheral edge 112 between the first outer edge 109 and the second outer edge 111 towards the apex 113. 【0032】 【0053】 As shown in FIG. 1, the prosthesis 10 can include one or more grip segments 102, 104, 106 attached to the 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 grip segments can be a plurality of grips protruding from the surface of the grip segment, configured to grip and engage the tissue when the prosthesis is placed in contact with and / or pressed against the adjacent tissue. For example, the grip segment can include a substrate having a plurality of microstructures (i.e., grips), and a hook mechanism can extend from the substrate in a micro - pattern design to form a micro - textured surface (see FIGS. 5A - 5F). 【0033】 【0054】In some embodiments, the grip segments 102, 104, 106 can be located in one or more grip regions of the body portion 100. Such an arrangement may be suitable for placing the grip segments in selected regions of the body portion 100 to correspond to specific anatomical sites. For example, as would be apparent to those skilled in the art, it may be desirable to avoid providing grip segments in regions of the body portion 100 that may contact blood vessels, nerves, or other parts of the anatomical structure at the defect site. Depending on the position of the grip segments, it is possible to facilitate rounding and / or folding of the prosthesis for delivery to the site of soft tissue repair. In some embodiments, the grip segments can include one or more perforations 108 to allow for ingrowth of tissue into the body portion 100 through the grip segments after implantation. 【0034】 【0055】 As shown in FIG. 1, according to some embodiments, the prosthesis 10 includes a first grip segment 102 and a second grip segment 104 positioned near the peripheral edge 112 in a first region 101 of the body portion 100. The grip segments 102, 104 can be arranged such that each segment is positioned on opposite sides of the apex 113. The grip segments 102, 104 may be configured in an elliptical shape and may or may not have the same shape or size. A third grip segment 106 can be substantially positioned near the peripheral edge 112 in a second region 103 of the body portion 100. The third grip segment 106 can have an L-shape, and a first portion 130 of the grip segment can extend at least partially into the first region over a rounded ridge 107 along the peripheral edge 112 of the second region 103. A second portion 132 of the grip segment 106 can extend upwardly into the first region 101 over the rounded ridge 107 along the peripheral edge 112. 【0035】 【0056】As shown in FIG. 1, the grip segments can be positioned on the body portion 100 adjacent to the peripheral edge 112 such that there are no grip segments in the central region 105 of the prosthesis. The grip segments 102, 104, 106 can be disposed near the peripheral edge 112 so that a user (e.g., a surgeon, a physician, etc.) can view through the prosthesis when the prosthesis is implanted over the defect in the patient's body. Additionally, such an arrangement can reduce or prevent the possibility that the grip segments, when implanted, contact nerves or other potentially sensitive sites and cause pain to the patient. For example, the L-shape of the third grip segment 106 can be positioned to avoid nerves, blood vessels, or other tissues when implanted in the defect site. 【0036】 【0057】 The size, shape, and position of the grip segments can be configured and arranged to balance the gripping force, the potential for ingrowth into tissue, and the flexibility of the prosthesis. For example, the grip segments can increase the gripping force while reducing the exposed mesh surface necessary for rapid ingrowth into tissue. In this way, the grip segments can act as a barrier to rapid ingrowth into tissue until the grip segments degrade. By providing one or more perforations in the grip segments, rapid ingrowth into tissue can be enabled before the grip segments degrade. The grip segments may also potentially reduce the flexibility of the prosthesis, which may be necessary to roll up to fit within a thin cannula or trocar to reach the target site during the procedure. The configuration and arrangement of the grip segments 102, 104, 106 shown in FIG. 1 allow the prosthesis to maintain sufficient flexibility while still providing a sufficient surface area including a gripping portion to securely adhere to the tissue. 【0037】 【0058】The number, shape, size, and position of the grip segments 102, 104, 106 can be changed according to a particular procedure, and those shown in the figures are merely non-limiting examples since the present disclosure is not so limited. For example, the grip segments can take on any symmetric or asymmetric shape, including but not limited to circular, polygonal, arched, elliptical, or any freeform shape. In some embodiments, the grip segments may be positioned along the periphery of the prosthesis, but in some embodiments, the grip segments may be positioned near the central region of the prosthesis, or disposed to cover a fairly large surface 110 of the prosthesis, as needed. Alternatively, fewer than three or more than three grip segments may be used. For example, four elliptical-shaped grip segments may be disposed around the periphery of the body portion, or two L-shaped grip segments may be positioned to face each other in the first region 101 and the second region 103. Any suitable number of grip segments can be used to achieve the desired gripping force and flexibility. 【0038】 【0059】 In some embodiments, the body portion 100 can be a pre-formed non-planar patch having a three-dimensional curved shape. In one embodiment, the body portion 100 is available from Davol and can have a shape corresponding to 3DMAX MID, 3DMAX Light Mesh, or 3DMAX Mesh, as described in one or more of U.S. Patent Nos. 6,723,133, 6,740,122, and 6,740,122. As such, the prosthesis may be particularly suitable for conforming to and repairing a defect to the anatomical structure of the groin. However, it should be understood that the prosthesis can adopt other configurations, as would be apparent to those skilled in the art. For example, without limitation, the body portion can have a planar or other non-planar configuration suitable for a particular procedure employed to repair the defect. Further, the prosthesis can be provided as a planar sheet of self-gripping repair fabric that can be selectively trimmed by the surgeon to any desired size and shape for a particular procedure. 【0039】 【0060】 In some embodiments, the length of the body portion can be 5.25 inches, 5.5 inches, 5.75 inches, 6.0 inches, 6.25 inches, and / or any other suitable length or greater. In some embodiments, the length can be 6.25 inches, 6.5 inches, 6.75 inches, 7 inches, and / or any other suitable width or less. For example, combinations of the foregoing are contemplated, including a length between or equal to 5.5 inches and 6.65 inches, and / or any other suitable combination of the foregoing. In some embodiments, the width of the body portion can be 3.25 inches, 3.5 inches, 3.75 inches, 4.0 inches, 4.25 inches, and / or any other suitable width or greater. In some embodiments, the width can be 4.5 inches, 4.75 inches, 5.0 inches, 5.25 inches, and / or any other suitable width or less. For example, combinations of the foregoing are contemplated, including 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 applied above, it should be understood that the present disclosure is not so limited, and both ranges larger and smaller than those described above are also contemplated. 【0040】 【0061】Figure 2 shows an embodiment of a layer of repair fabric that can be pre-formed into a configuration for use as a prosthesis or selectively trimmed to a desired configuration for use as a prosthesis or part of a prosthesis. The repair fabric can employ a knit structure that provides openings or pores to allow for ingrowth within the tissue for integrating the prosthesis. When implanted, the mesh promotes rapid ingrowth of tissue or muscle within and around the mesh structure. Examples of surgical materials that can be utilized in those layers and are suitable for tissue or muscle reinforcement and defect correction include, but are not limited to, BARD Mesh (available from Davol, Inc.), BARD Soft Mesh (available from Davol, Inc.), SOFT TISSUE Mesh (available from Davol, Inc.), SOFT TISSUE Mesh (available from Davol, Inc.), SOFT TISSUE PATCH (microporous ePTFE available from W.L. Gore & Associates, Inc.), SURGIPRO (available from US Surgical, Inc.), TRELEX (available from Meadox Medical), PROLENE and MERSILENE (available from Ethicon, Inc.), and other mesh materials (e.g., available from Atrium Medical Corporation). Absorbable or resorbable materials, including PHASIX Mesh (available from Davol, Inc.), polyglactin (VICRYL available from Ethicon, Inc.), and polyglycolic acid (DEXON available from US Surgical, Inc.), may be suitable for applications involving temporary correction of tissue or muscle defects. Collagen materials such as COOK SURGISIS available from Cook Biomedical, Inc. can also be used. It is also contemplated that the mesh fabric may be formed from multifilament yarns and any suitable method such as knitting, weaving, braiding, molding, etc. may be employed to form the mesh material. 【0041】 【0062】The repair cloth can also have sufficient flexibility to facilitate easy size reduction for entry into the body of the subject. Thus, the flexible cloth can be collapsed into an elongated form, such as a roll, that can be supported and advanced through a thin laparoscope cannula for use in laparoscopic or robotic procedures. 【0042】 【0063】 Figures 3A and 3B each show an embodiment of the L-shaped grip segment 120 and the elliptical grip segment 124. One or more of the L-shaped grip segment 120 and / or the elliptical grip segment 124 can be positioned on the surface of the body portion of the prosthesis. 【0043】 【0064】 In some embodiments, the length L of the L-shaped grip segment 120 can be about 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 grip segment 120 is about 5.4 inches. In some embodiments, the width W of the shaped grip segment 120 can be about 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 grip segment 120 can be about 155 μm, 165 μm, 175 μm, and / or any other suitable thickness. Combinations of the foregoing are contemplated, including lengths that are between or equal to 5.25 inches and 5.5 inches, widths that are between 2.0 inches and 2.2 inches, and / or any other suitable combination of the foregoing. 【0044】 【0065】In some embodiments, the length L of the elliptical grip segment 124 can be about 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 elliptical grip segment 124 is about 2.7 inches. In some embodiments, the width W of the elliptical grip segment 124 can be about 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 elliptical grip segment 124 is 1.0 inch. In some embodiments, the thickness of the elliptical grip segment 124 can be about 150 μm, 155 μm, 165 μm, 175 μm, and / or any other suitable thickness. For example, combinations of the foregoing are contemplated, including lengths that are between and including 2.5 inches and 2.7 inches, widths that are between 1.8 inches and 1.1 inches, and / or any other suitable combination of the foregoing. Although specific ranges of dimensions of the grip segment are provided above, it should be understood that the present disclosure is not so limited, and both ranges larger and smaller than those described above are also contemplated. 【0045】 【0066】As shown in FIGS. 3A and 3B, in some embodiments, the grip segments 120, 124 can include a plurality of perforations that allow for in-growth within the tissue to integrate the prosthesis. When implanted, the porous grip segments promote rapid in-growth of tissue or muscle into and around the grip segments and the body portion. The perforations 122 may extend through the entire thickness of the grip segment or only partially. The perforations can be included in various patterns in the grip segment. For example, in the embodiment of FIG. 3A, the L-shaped grip segment 120 includes a single array of 18 perforations along the length of the grip segment. In the embodiment of FIG. 3B, the oval-shaped grip segment 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 suitable combination of arrays. The perforations may be dispersed throughout the grip segment. 【0046】 【0067】 The perforations provided in the grip segment can be of various shapes and sizes to optimize in-growth within the tissue and maintain the integrity of the components for prosthesis insertion. In some embodiments, the perforations can occupy about 4%, 6%, 8%, 10% or 12% or more of the grip segment surface. In some embodiments, the perforations may occupy about 25%, 22%, 20% or 17% or less of the grip segment surface. Any suitable combination of the above-described ranges is also possible. In one embodiment, the perforations may occupy 6% or more and 20% or less of the grip segment surface. 【0047】 【0068】Figures 4A and 4B show enlarged views of the perforations of sections 4A and 4B of FIGS. 3A and 3B. As shown in FIG. 4A, the perforation 126 can be configured to have a round shape. The perforation 126 can have a diameter D1 that is about 0.003 inches, 0.05 inches, 0.075 inches, 0.100 inches, 0.125 inches, and / or any other suitable diameter. As shown in FIG. 4B, the perforation 128 may be configured to have a hexagonal shape. The perforation 128 can have a segment distance D2 that is about 0.025 inches, 0.050 inches, 0.075 inches, and / or any other suitable distance. Although only two perforations are described, it should be noted that any perforation on the grip segment can be of any shape or size depending on the specific requirements. It should also be understood that the grip segment may employ combinations of perforations having different configurations including, but not limited to, different shapes and / or sizes. 【0048】 【0069】 As would be apparent to one of ordinary skill in the art, it should be understood that any suitable grip segment arrangement can be provided on the prosthesis to provide the desired amount of grip. In some embodiments, the prosthesis can include grip segments having the same or different grip configurations and / or arrangements depending on the particular use of the prosthesis. For example, without limitation, the prosthesis can include grip segments having the same shape but attached at different orientations relative to each other in the body portion. The prosthesis can include grip segments having one or more different shapes in one or more regions of the body portion. The grip segments can include perforations in various patterns to promote the desired level of ingrowth while maintaining structural integrity. Thus, different gripping characteristics can be imparted to the prosthesis based on the configuration and / or arrangement of the grip segments, depending on the particular use of the prosthesis. 【0049】 【0070】The grip segment can be fabricated independently of the body portion of the prosthesis and attached to the body portion (e.g., via adhesives, molding, joining, sewing, etc.). By manufacturing the grip segment independently, flexibility in constructing the prosthesis can be provided. In one embodiment, the grip segment can be formed of a bioabsorbable material, while the body portion can be formed of a non-absorbable material. If desired, the body portion may be formed of a bioabsorbable material that may be absorbed at a slower rate than the grip segment material. Such an arrangement can provide temporary gripping characteristics to the prosthesis during the period of tissue integration, while reducing the amount of foreign matter remaining in the patient's body and maintaining the long-term strength of the prosthesis. 【0050】 【0071】In some embodiments, the grip segment can be composed of one or more layers of the film. FIGS. 5A-5E show one embodiment of a grip segment formed from a microtextured film. The microtextured film can be cut to form grip segments of different shapes, including but not limited to L-shaped grip segments and elliptical grip segments. The microtextured film includes a film having a fine pattern of fine structures (e.g., grips) on its surface. As shown in FIG. 5A, the microtextured film 20 includes a substrate 200 and a plurality of fine structure grips 201 on the surface of the substrate. In one embodiment, the film 20 may be single-sided, having the grip 201 on one surface of the substrate as shown, but the present disclosure is not so limited. In one embodiment, the film 20 may be double-sided, having grips provided on and protruding from two opposing surfaces of the substrate. Such an arrangement can position either side of the grip segment towards the body portion and face the opposite side away from the body portion, thereby facilitating the fabrication of the prosthesis. In a non-limiting example, an asymmetric grip segment (e.g., an L-shaped grip segment) made of a double-sided film can be attached to either a left-handed prosthesis or a right-handed prosthesis by flipping the grip segment (i.e., attaching the first side of the grip segment to the right-handed prosthesis and the opposite second side to the left-handed prosthesis). 【0051】 【0072】FIG. 5B is a top view of the film 20, FIG. 5C is an enlarged view of detail 5C of FIG. 5B, FIG. 5D is a side view of the film 20, and FIG. 5E is an enlarged view of detail 5E of FIG. 5D. In some embodiments, the grips 201 may be arranged on the substrate in a uniform pattern, such as an alternating linear array having the offset grips shown in FIGS. 5B and 5C, but the present disclosure is not so limited, and the grips 201 may be arranged on the substrate in any pattern including, but not limited to, a hexagonal, honeycomb, or square lattice. In some embodiments, the grips 201 may be positioned on the substrate in a random pattern. 【0052】 【0073】 In some embodiments, as shown in FIGS. 5C and 5E, the film 20 can include grips 201 arranged in a linear array. The arrays can be spaced apart by a distance D1 of about 0.01 inch, 0.015 inch, 0.02 inch, or 0.025 inch, or any other suitable distance to achieve the gripping level required for a particular procedure. In some embodiments, the arrays may be spaced apart by a distance D1 of 0.016 inch. In some embodiments, the grips 201 can be spaced apart by a distance D2 of about 0.025 inch, 0.05 inch, or any suitable distance to achieve the desired gripping level in each array. In some embodiments, the grips may be spaced apart by a distance D2 of 0.03 inch in each array. In some embodiments, the grips 201 can have a width W1 of about 0.002 inch, 0.004 inch, 0.005 inch, or any other suitable width. 【0053】 【0074】As shown in FIG. 5E, each grip 201 can extend from the surface of the substrate 200. In some embodiments, the substrate 200 can have a height H1 of about 0.001 inches, 0.002 inches, 0.003 inches, or any other suitable height that provides sufficient strength and flexibility. In some embodiments, the film 20 can have a height H2 that includes the substrate 200 and the grip 201 of about 0.010 inches, 0.015 inches, or 0.02 inches, or any other suitable height. In some embodiments, the grip 201 can have a length L1 of about 0.010 inches, 0.015 inches, 0.02 inches, or 0.025 inches, or any other suitable length. In some embodiments, as shown in FIGS. 5D and 5E, the grips in adjacent columns can be offset by a distance D3 equal to the length L1 of the grip so that the grips in adjacent columns do not overlap when viewed from the side. The dimensions and spacing of the grips can be adjusted as needed to provide various patterns and arrangements of grips on the substrate. 【0054】 【0075】 As shown in FIG. 5E, in some embodiments, each grip 201 can include a first post 202 extending from the surface of the substrate 200 and a second post 204 extending from the surface of the first post 202. The cross-sectional area of the first post can be larger than the cross-sectional area of the second post. As shown in FIG. 5C, the first post 202 can have a generally quadrilateral shape. One or more sides 208 of the first post can be angled so that the planar cross-section of the first post increases towards the substrate to form a trapezoidal shape. The angled sides 208 can increase the flexibility of the grip segment to allow it to be folded or rounded to fit within a trocar or other elongate body for medical procedures. 【0055】 【0076】As shown in FIG. 5E, each grip 201 can include one or more hook mechanisms 206 at the free end of the grip on the side opposite the substrate 200, and the hook mechanisms 206 are configured to be inserted into the tissue while providing a sufficient amount of tissue gripping to reduce, if not eliminate, inadvertent release from the tissue. The hook mechanisms 206 can also be configured to minimize, if not eliminate, possible entanglement with prostheses such as mesh repair fabrics while providing the desired tissue gripping. In some embodiments, the grip 201 can include two hook mechanisms 206 that extend from the second post 204 and curve outwardly in opposite directions. In some embodiments, the hook mechanism 206 can have a crescent shape that extends from the second post 204. The hook mechanism 206 is sized to decrease in the direction from the post 204 towards its tip for penetration into the tissue. In one embodiment as shown in FIG. 5E, each grip can have a configuration like a coconut tree. 【0056】 【0077】 FIG. 5F shows another embodiment of the microtextured film. As shown, the film includes a substrate 220, and a plurality of grips 221 extend from the surface of the substrate facing the tissue. The grip 221 includes a first post 224 that extends from the substrate 220 and one or more hook mechanisms 226 that extend in a direction opposite to the first post 224. In some embodiments, the grip 221 has a height H3 of about 0.20 mm to 0.70 mm. In some embodiments, the hook mechanism has a span D4 of about 0.20 mm to 0.30 mm. 【0057】 【0078】 In some embodiments, the first post 224 can form a rounded corner with the substrate 220. The rounded corner can have a radius R1 of about 0.09 mm to 0.11 mm. In some embodiments, the hook mechanisms can curve outwardly from each other with a radius R2 of about 0.003 mm to 0.023 mm. In some embodiments, the tip of the hook mechanism 226 can have a radius R3 of about 0.008 mm to 0.038 mm. 【0058】 【0079】 Figure 5G shows another embodiment of the grip 231. As shown in Figure 5G, the grip 231 has one hook mechanism 236 extending from the first post 234. The grip can have a height H4 of about 0.50 mm to 0.75 mm, or any suitable height. 【0059】 【0080】 Figures 6 - 10 show embodiments of prostheses having various grip segment and perforation configurations and arrangements. The number, size, shape, and configuration of the grip segments can be adjusted according to the application and desired use. 【0060】 【0081】 Figure 6 shows an embodiment of a prosthesis 30 having three grip segments disposed on the surface 310 of the body portion 300. The body portion 300 includes a first grip segment 302 and a second grip segment 304 having an oval configuration disposed near the periphery 312 in the first region 301 of the body portion 300. The body portion 300 also includes a third grip segment 306 having an L-shaped configuration disposed near the periphery 312 of the second region 303 and extending into the first region 301 beyond the rounded ridge 307. The grip segments can be disposed below the apex 313 of the body portion so that the grip segments do not cover the apex. In some embodiments, the grip segments may be disposed to cover the apex. 【0061】 【0082】Each of the grip segments 302, 304, 306 can include a plurality of perforations 308. As shown, the perforations 308 for the first grip segment 302 and the second grip segment 304 can be provided in a linear arrangement along the length of the grip segment. The pattern of perforations for the third grip segment can include a plurality of rows of perforations 308 along the length of the grip segment. This pattern can include a bottom row of perforations and successive rows of perforations, and the successive rows of perforations are arranged in a V-shaped, outwardly stepped configuration such that the perforations extend in a lattice pattern along each end of the grip segment. The rows of perforations can be arranged obliquely with respect to the direction along the length of the grip segment. Such a lattice pattern may be for ease of manufacture or may facilitate ingrowth into tissue at a desired location while maintaining the structural integrity and sufficient gripping force of the grip segment. However, as will be apparent to those skilled in the art, it should be understood that the grip segment can employ any suitable arrangement of perforations. 【0062】 【0083】 FIG. 7 shows an embodiment of a prosthesis 30 having three grip segments disposed on a surface 410 of a body portion 300. The body portion 400 includes a first grip segment 402 and a second grip segment 404 disposed near a peripheral edge 412 in a first region 401 of the body portion 400. The body portion also includes a third L-shaped grip segment 406 disposed near the peripheral edge 412 of a second region 403 and extending into the first region 401 beyond a rounded ridge 407. The first grip segment 402 and the second grip segment 404 can have an asymmetric elliptical shape as compared to the grip segments 302, 303 of FIG. 6, and the third grip segment 406 can have a larger surface area and more perforations 408 than the grip segment 306. The grip segment 404 can be positioned to rotate slightly clockwise around the peripheral edge 412 closer to the grip segment 406 than to the grip segment 402. The grip 406 can be positioned to cover the apex 413. 【0063】 【0084】 Each of the grip segments 402, 404, 406 includes a plurality of rows of perforations 408. In some embodiments, the first grip segment 402 and the second grip segment 404 include 15 perforations aligned in three rows along the length of the grip segment. The larger grip segment 406 includes three separate groups of perforations 408, namely, a central region 420 and two end regions 422, 424. The groups of perforations can be arranged in a grid with equal size and spacing, as shown. The distance between adjacent perforations in different groups may be smaller or larger than the distance between perforations in the same group. Alternatively, the perforations may be in a less structured arrangement within each group and may include unequal or random spacing and / or sizes. 【0064】 【0085】 FIG. 8 shows an embodiment of a prosthesis 50 having three grip segments disposed on a surface 510 of a body portion 500. The body portion 300 includes a first grip segment 502 and a second grip segment 504 disposed near a peripheral edge 512 in a first region 501 of the body portion 300. The second grip 504 can be disposed on a side closer to a rounded bulge 517 of the peripheral edge 512. The first grip segment 502 and the second grip segment 504 can be larger than the first and second grip segments of FIGS. 2-7. The first grip segment 502 and the second grip segment 504 can include a pattern of perforations 508 that occupies a fairly large portion of the surface area of the grip segment. The perforations 508 can be arranged in a grid with equal spacing, as shown. 【0065】 【0086】The body portion 500 also includes a third grip segment 506 that is disposed near the peripheral edge 512 of the second region 503 and extends upwardly into the first region 501 beyond the rounded bulge 507. The third grip segment 506 can be shaped such that one end has a greater width than the opposite end. The third grip segment 506 can have perforations 508 of equal spacing and size positioned in three distinct regions of the grip segment. 【0066】 【0087】 FIG. 9 shows an embodiment of a prosthesis 60 having three grip segments 602, 604, 606 that include a plurality of perforations 608 disposed on the surface 610 of the body portion 600. The body portion 600 includes a first grip segment 602 and a second grip segment 604 disposed near the peripheral edge 612 in the first region 601 of the body portion 600. The body portion 600 also includes a third grip segment 606 that is disposed near the peripheral edge 612 of the second region 603 and extends upwardly into the first region 601 beyond the rounded bulge 607. The third grip segment 606 can be sized to have a shorter length relative to the third grip segment of FIG. 8. Comparing FIG. 8 and FIG. 9, the grip segment 506 of FIG. 8 includes a relatively long end portion 509 that extends to the peripheral edge 512 of the body portion, whereas the grip segment 606 of FIG. 9 has a relatively short end portion 609 that terminates in front of the periphery. 【0067】 【0088】As shown in FIG. 10, the prosthesis 70 includes three grip segments disposed on the surface 710 of the body portion 700. The body portion 700 includes a first grip segment and a second grip segment each having 12 perforations 708 arranged in two offset columns of six perforations each. The body portion 700 also includes a third L-shaped grip segment 706 having two groups 720, 722 of perforations 708 separated by an intermediate portion 724 of the grip segment without perforations. The third L-shaped grip portion 706 can be disposed near the peripheral portion 712 in the second region 703 of the body portion, and a part of the grip portion 706 can extend into the first region 701 beyond the rounded ridge 707. 【0068】 【0089】 In some embodiments, the prosthesis can include any number of grip segments. For example, as shown in FIG. 11, the prosthesis 80 can include four grip segments 802, 804, 806, 814 disposed on the surface 810 of the body portion 800 near the peripheral edge 812 in the first region 801. The body portion can also include two grip segments 816, 818 disposed near the peripheral portion in the second region 803 of the body portion. A part of one of the grip segments 816, 818 can extend into the first region 801 beyond the rounded ridge 807. The grip segments can be positioned in pairs, with a small amount of mesh of the body portion 800 exposed between each pair of grip segments of a certain length. This provides greater flexibility of the prosthesis and can minimize the profile of the prosthesis to enable insertion through a trocar. In some embodiments, the prosthesis can fit within an 8 mm trocar. 【0069】 【0090】As shown in FIGS. 13A and 13B, the prosthesis 90 can include four grip segments 902, 904, 906, 914 disposed on the surface 910 of the body portion 900. Each grip segment can include a plurality of perforations 908. The body portion includes three grip segments 902, 904, 906, which can have an elliptical shape and can be disposed near the first peripheral edge 912 in the first region 901 of the body portion 900. As shown, the first region can be located on the first side of the rounded bulge 907. The first grip segment 902 can have a smaller size, such as a shorter length and / or width, etc., compared to the second grip segment 904 and the third grip segment 906. The first grip segment 902 can be disposed along a segment of the first peripheral edge, and the second grip segment 904 and the third grip segment 906 can be disposed along adjacent segments of the first peripheral edge. The fourth grip segment 914 can be disposed in the second region 903 of the body portion 900 located on the second side of the rounded bulge 907 and can extend along the second peripheral edge 912. In some embodiments, the fourth grip segment 914 may be entirely disposed in the second region 903, or a portion of the fourth segment 914 may contact the rounded bulge 907 or partially extend into the first region 901 beyond the rounded bulge 907. As shown in FIG. 13A, the fourth grip segment 914 may contact the rounded bulge 907 on one side of the grip segment, but may not extend beyond the apex 913. As shown in FIG. 13B, the fourth grip segment 914 may extend beyond the rounded bulge 907 and the apex 913 on one side of the grip segment. The fourth grip segment 914 may have an elliptical shape and may be larger, such as having a longer length and / or width, etc., compared to the second grip segment 904 and the third grip segment 906. 【0070】 【0091】In some embodiments, the first grip segment 902 can have a length of about 1.25 inches, 1.50 inches, 1.75 inches, 1.90 inches, or 2.0 inches and a width of about 0.50 inches, 0.70 inches, or 0.80 inches. In some embodiments, the first grip segment 902 can have a length of about 1.89 inches and a width of about 0.689 inches. In some embodiments, the first grip segment 902 can have a length of about 1.51 inches and a width of about 0.614 inches. In some embodiments, the second grip 904 and the third grip 906 can have a length of about 1.75 inches, 2.0 inches, 2.25 inches, or 2.5 inches and a width of about 0.50 inches, 0.60 inches, 0.70 inches, 0.80 inches, or 0.90 inches. In some embodiments, the second grip segment 904 and the third grip segment 906 can have a length of about 2.362 inches and a width of about 0.787 inches. In some embodiments, the second grip segment 904 and the third grip segment 906 can have a length of about 2.047 inches and a width of about 0.632 inches. In some embodiments, the fourth grip segment 914 can have a length of about 3.75 inches, 4.0 inches, 4.50 inches, 4.75 inches, or 5.0 inches and a width of about 0.75 inches, 1.0 inches, or 1.25 inches. In some embodiments, the fourth grip segment 914 can have a length of about 4.762 inches and a width of about 1.00 inches. In some embodiments, the fourth grip segment 914 can have a length of about 4.055 inches and a width of about 0.787 inches. 【0071】 【0092】In some embodiments, the grip segments 902, 904, 906, and 914 can each include a plurality of perforations. The perforations 908 can have a diameter of about 0.10 inches and can be arranged linearly along the longitudinal direction of the grip segment. The perforations can be spaced apart at a pitch of about 0.25 inches to about 0.30 inches. In some embodiments, the perforations 908 can be spaced apart at a pitch of about 0.28 inches. In some embodiments, the first grip segment 902 can include four perforations, the second grip segment 904 and the third grip segment 906 can include six grip segments, and the fourth grip segment can include fifteen perforations. It should be noted that the dimensions and spacing of the grip segments and perforations described with respect to FIGS. 13A and 13B can be included in any of the embodiments described herein. 【0072】 【0093】 The grip segment can be disposed on top of the layer of the repair fabric so as to cover a certain percentage of the surface of the body portion in order to maximize tissue gripping. In some embodiments, the grip segment can be disposed on the body portion so as to cover about 10%, 15%, 20%, or 25% or more of the surface area of the body portion 100. In some embodiments, the grip segment can be disposed on top of the body portion so as to cover about 45%, 40%, 35%, 30%, or 25% or less of the surface area of all sizes of the body portion 100. Any suitable combination of the above-described ranges is also possible. In one embodiment, the grip segment can be disposed on the body portion so as to cover about 20% or more and 30% or less of the surface area of the body portion. 【0073】 【0094】In some embodiments, the grip segments can be made of polylactic acid (PLA), but the present disclosure is not so limited, and the grip segments can be made of other suitable resorbable materials (e.g., P4HB, etc.). In some embodiments, the prosthesis can include four grip segments (see FIGS. 13A and 13B). In such embodiments, the total surface area of the grip segments on the prosthesis can be from 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 from about 17.5 square inches to about 28.4 square inches, depending on the size of the prosthesis. In some embodiments, the grip segments can occupy from about 26% to about 30.2% of the surface area of the body portion. 【0074】 【0095】 It should be understood that all of the grip segments, perforations, and patterns described in each embodiment are non-limiting examples, and in practice, any configuration can be used as needed. It should also be noted that in any prosthesis, any grip segment and configuration from the above-described embodiments can be used. 【Examples】 【0075】 【0096】 The following examples are merely illustrative and are not intended to limit the scope of the invention. The traction force of the microtextured film was evaluated using 2×1 inch samples of films having different grip structures and dimensions as shown in Table 1 below. 【0076】 【Table 1】 【0077】 【Table 2】 【0078】 【0097】As shown in Tables 1 and 2 above, the grip (819) having two opposing hook mechanisms with a height of 0.015 inches had the highest tensile force when tested on muscle, fat, and fascia, compared to grips having a greater height or having only one hook mechanism. 【0079】 【0098】 In this specification, although some embodiments of the present invention have been described and illustrated, those skilled in the art will readily conceive of various other features and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is considered to be within the scope of the present invention. More generally, those skilled in the art will readily recognize 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 be determined by one or more specific applications in which the teachings of the present invention are used. Those skilled in the art will recognize many equivalents to the specific embodiments of the present invention described herein or will be able to ascertain such equivalents without undue experimentation. Accordingly, it should be understood that the foregoing embodiments are presented by way of example only, and that the present invention may be practiced otherwise than as specifically described and claimed within the scope of the appended claims and their equivalents. The present invention is directed to each and every individual feature, system, article, material, kit, and / or method described herein. Additionally, 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 such features, systems, articles, materials, kits, and / or methods do not mutually conflict.

Claims

[Claim 1] A layer of biocompatible repair fabric, A plurality of grip segments integrated with the layer of the repair cloth, wherein each of the plurality of grip segments includes a plurality of grips and a plurality of perforations extending through each of the plurality of grip segments, An implantable prosthesis equipped with [features / features]. [Claim 2] The implantable prosthesis according to claim 1, wherein each of the plurality of grips includes at least one hook structure. [Claim 3] The implantable prosthesis according to claim 1, wherein each of the plurality of grips includes two hook mechanisms extending in opposing directions. [Claim 4] The implantable prosthesis according to claim 3, wherein the two hook mechanisms extend over a distance of approximately 0.20 mm to approximately 0.30 mm. [Claim 5] The implantable prosthesis according to claim 1, wherein each of the plurality of grips includes a first column and a second column extending from the surface of the first column, the cross-sectional area of ​​the first column is greater than the cross-sectional area of ​​the second column, and the at least one hook mechanism extends from the second column. [Claim 6] The implantable prosthesis according to claim 5, wherein the first column has a substantially quadrilateral shape. [Claim 7] The implantable prosthesis according to claim 1, wherein each of the plurality of grips has a height of about 0.01 inches to about 0.02 inches. [Claim 8] The implantable prosthesis according to claim 1, wherein the plurality of grips are arranged in a linear row spaced about 0.1 inches to about 0.2 inches apart. [Claim 9] The implantable prosthesis according to claim 1, wherein the plurality of grips are spaced apart at a pitch of approximately 0.3 inches in each row. [Claim 10] The implantable prosthesis according to claim 1, wherein the plurality of grip segments include a plurality of microtextured grip segments. [Claim 11] The implantable prosthesis according to claim 1, wherein the plurality of perforations in at least one of the plurality of grip segments are arranged in at least three separate regions within the grip segment. [Claim 12] The implantable prosthesis according to claim 11, wherein each region includes a group of perforations. [Claim 13] The implantable prosthesis according to claim 11, wherein the distance between regions is greater than the distance between adjacent perforations within a region. [Claim 14] The implantable prosthesis according to claim 12, wherein the perforations in each group are uniformly spaced within each region. [Claim 15] The implantable prosthesis according to claim 1, wherein the layer of the repair cloth has a pre-formed three-dimensional structure having a vertex and a rounded raised portion extending from the vertex to the outer periphery of the layer of the repair cloth, and a portion of at least one of the plurality of grip segments extends beyond the rounded raised portion. [Claim 16] The implantable prosthesis according to claim 15, wherein at least two grip segments are positioned entirely on one side of the rounded protrusion, on top of the layer of the repair cloth. [Claim 17] The implantable prosthesis according to claim 16, wherein the at least two grip segments have an elliptical shape, and the at least two grip segments are positioned such that the longer sides of the grip segments are substantially parallel to a portion of the peripheral area of ​​the repair cloth layer. [Claim 18] The implantable prosthesis according to claim 15, wherein at least one grip segment is positioned on the layer of the repair cloth closer to the periphery of the grip segment than to the rounded protrusion. [Claim 19] The implantable prosthesis according to claim 1, wherein the plurality of grip segments include six or more grip segments integrated with the layer of the repair cloth. [Claim 20] A layer of biocompatible repair fabric, A plurality of microtextured grip segments integrated with the layer of the repair cloth, wherein each of the plurality of microtextured grip segments includes a plurality of perforations extending through it, An implantable prosthesis equipped with [features / features]. [Claim 21] The implantable prosthesis according to claim 1 or claim 20, wherein the plurality of grip segments or the plurality of microtextured grip segments include three or more grip segments integrated with the layer of the repair cloth. [Claim 22] The implantable prosthesis according to claim 1 or claim 20, wherein at least one of the plurality of grip segments or at least one of the plurality of microtextured grip segments has an L-shaped configuration. [Claim 23] The implantable prosthesis according to claim 1 or claim 20, wherein at least one of the plurality of grip segments or at least one of the plurality of microtextured grip segments has an elliptical shape. [Claim 24] The implantable prosthesis according to claim 1 or claim 20, wherein the plurality of grip segments or the plurality of microtextured grip segments are arranged on a layer of the repair cloth such that there are no grip segments or microtextured grip segments in the central part of the repair cloth. [Claim 25] The implantable prosthesis according to claim 20, wherein the layer of the repair cloth has a pre-formed three-dimensional structure having vertices without grip segments or micro-textured grip segments. [Claim 26] The implantable prosthesis according to claim 1 or claim 20, wherein the plurality of perforations in at least one of the plurality of grip segments or at least one of the plurality of microtextured grip segments occupy about 6% to 20% of the grip segment or the microtextured grip segment. [Claim 27] ​​The implantable prosthesis according to claim 1 or claim 20, wherein the plurality of grip segments or the plurality of microtextured grip segments occupy about 20% to about 30% of the surface of the layer of the repair cloth. [Claim 28] The implantable prosthesis according to claim 1 or claim 20, wherein each of the plurality of perforations has a diameter of about 0.10 inches to about 0.11 inches. [Claim 29] The implantable prosthesis according to claim 1 or claim 20, wherein the plurality of perforations are spaced apart at a center-to-center distance of approximately 0.25 inches to approximately 0.30 inches. [Claim 30] The implantable prosthesis according to claim 20, wherein the plurality of perforations in at least one of the plurality of microtextured grip segments are arranged in at least three separate regions in the microtextured grip segment. [Claim 31] The implantable prosthesis according to claim 1 or 20, wherein the plurality of perforations in at least one of the plurality of grip segments or at least one of the plurality of microtextured grip segments are arranged in a two-dimensional pattern at equal intervals. [Claim 32] The implantable prosthesis according to claim 1 or claim 20, wherein the plurality of perforations in at least one of the plurality of grip segments or at least one of the plurality of microtextured grip segments are arranged in an array extending in a direction along the length of the grip segment or the microtextured grip segment. [Claim 33] The implantable prosthesis according to claim 1 or claim 20, wherein the plurality of perforations in at least one of the plurality of grip segments or at least one of the plurality of microtextured segments are arranged in a hexagonal pattern. [Claim 34] A method for manufacturing an implantable prosthesis, To provide a layer of biologically compatible repair fabric, Attaching a plurality of grip segments to the surface of the layer of the repair cloth, wherein each of the grip segments includes a plurality of grips and a plurality of perforations extending through each of the grip segments, A method that includes this. [Claim 35] The method according to claim 34, wherein the plurality of grip segments occupy about 20% to about 30% of the surface of the layer of the repair cloth. [Claim 36] The method according to claim 34, further comprising arranging the plurality of grip segments on a layer of the repair cloth such that there are no grip segments in the central portion of the repair cloth. [Claim 37] The method according to claim 34, further comprising creating the plurality of perforations through the plurality of grip segments. [Claim 38] The method according to claim 34, wherein the perforations occupy about 6% to about 20% of the grip segment. [Claim 39] The method according to claim 34, wherein each of the plurality of holes has a diameter of about 0.10 inches to about 0.11 inches. [Claim 40] The method according to claim 34, wherein the plurality of holes are spaced apart by a center-to-center distance of approximately 0.25 inches to approximately 0.30 inches. [Claim 41] The method according to claim 34, wherein the plurality of perforations in at least one of the plurality of grip segments are arranged in at least three separate regions in the grip segment. [Claim 42] The method according to claim 34, wherein the plurality of perforations in at least one of the plurality of grip segments are arranged in a two-dimensional pattern at equal intervals. [Claim 43] The method according to claim 34, wherein the plurality of perforations in at least one of the plurality of grip segments are arranged in an array extending in a direction along the length of the grip segment. [Claim 44] The method according to claim 34, wherein the plurality of perforations in at least one of the plurality of grip segments are arranged in a hexagonal pattern. [Claim 45] The method according to claim 34, wherein each of the plurality of grips includes at least one hook structure.

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