Portable prosthesis with a self - fixing grip

Abstract

A transplantable prosthesis for repairing tissue defects comprises a layer of repair fabric and a plurality of microtexture grip segments attached to the repair fabric. The grip segments have perforations on the tissue-facing surface that promote in-growth of tissue.

Description

Technical Field

[0001] (Related Applications)

[0001] This application claims the benefit of U.S. Application No. 63 / 357,099, filed Jun. 30, 2022, and U.S. Application No. 63 / 357,105, filed Jun. 30, 2022, both of which are hereby incorporated by reference in their entirety.

[0002]

[0002] The disclosed embodiments relate to implantable prostheses, and more particularly, prostheses for repairing defects and weaknesses in soft tissue and muscle walls.

Background Art

[0003]

[0003] Defects in muscle or tissue walls, such as hernias, are typically repaired with an implantable prosthesis configured to cover and / or fill the defect.

[0004]

[0004] In some procedures, an implantable repair fabric, such as a mesh fabric, is temporarily secured at a predetermined location over, under, or within the defect by suturing, stapling, tacking, or other means. The repair is ultimately completed by integration of the fabric with the tissue, such as ingrowth of tissue within and / or along the mesh fabric.

[0005]

[0005] A variety of repair fabrics are known and used for the repair of soft tissue and muscle wall defects. Examples of implantable fabrics that have been successful in soft tissue and muscle wall repair include BARD SoftMesh, BARD Mesh, and VISILEX available from C.R. Bard. Such fabrics are made from polypropylene monofilaments woven into a mesh having pores or gaps that promote ingrowth of tissue and integration with the fabric.

[0006]

[0006] In some procedures, it may be desirable to use a transplantable prosthesis configured to conform to the shape of the anatomical region of the defect. In some cases, such a prosthesis can be positioned against the defect and maintained in position with little or no temporary fixation. Examples of transplantable prostheses that have been successful in use for the repair of soft tissue and muscle walls include the 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 muscle or tissue wall of the groin-thigh region.

[0007]

[0007] It is an object of the present disclosure to provide a prosthesis for repairing soft tissue and muscle wall defects.

Summary of the Invention

[0008]

[0008] A transplantable prosthesis is provided that includes 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 therethrough.

[0009]

[0009] A transplantable prosthesis is provided that includes a layer of biocompatible repair fabric and a plurality of microtexture grip segments integrated with the layer of repair fabric. Each of the plurality of microtexture grip segments includes a plurality of perforations extending therethrough.

[0010]

[0010] A transplantable prosthesis is provided that includes 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 substrate and a plurality of grips extending from the surface of the substrate, and each of the plurality of grips includes a first post and a plurality of second posts extending from the surface of the first post.

[0011]

[0011] A grip segment for a transplantable prosthesis is provided. The grip segment includes a substrate of biocompatible 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 a first post and a plurality of second posts extending from a first surface of the first post. The grip segment also includes a plurality of perforations extending through the substrate.

[0012]

[0012] A method of manufacturing a transplantable prosthesis is provided. The method includes providing a layer of biocompatible repair fabric and attaching a plurality of grip segments to the surface of the repair fabric layer. Each of the grip segments includes a plurality of grips and a plurality of perforations extending therethrough.

[0013]

[0013] A transplantable prosthesis is provided that includes a layer of biocompatible repair fabric having a preformed three-dimensional configuration including a vertex and a rounded ridge extending from the vertex to the outer periphery of the repair fabric layer. The transplantable prosthesis also includes a plurality of grip segments integrated with the layer of biocompatible repair fabric, and at least a portion of at least one of the plurality of grip segments extends across the rounded ridge.

[0014]

[0014] It should be understood that the foregoing concepts and additional concepts discussed below may be configured in any suitable combination, as the present disclosure is not limited in this regard. Further, other advantages and novel features of the present disclosure will become apparent by considering the following detailed description of various non-limiting embodiments in conjunction with the accompanying drawings.

[0015]

[0015] In the case where the present specification includes a disclosure that conflicts with and / or is inconsistent with the document incorporated by reference, the present specification shall prevail. In the case where two or more documents incorporated by reference include disclosures that conflict with and / or are inconsistent with each other, the document with the later effective date shall prevail.

Brief Description of the Drawings

[0016]

[0016] The accompanying drawings are not intended to be to scale. In the drawings, the same or substantially the same components shown in various figures may sometimes be represented by like numbers. For clarity, not all components are labeled in every figure.

[0017]

Figure 1

[0017] There is an embodiment of an implantable prosthesis according to one embodiment.

Figure 2

[0018] There is an embodiment with a layer of repair fabric that can be pre-formed into a configuration for use as a prosthesis.

Figure 3A

[0019] It is a top view of an embodiment with a grip segment.

Figure 3B

[0020] It is a top view of an embodiment with a grip segment.

Figure 4A

[0021] It is a schematic view of the perforation of the grip segment of FIG. 3A according to an embodiment.

Figure 4B

[0022] It is a schematic view of the perforation of the grip segment of FIG. 3B according to an embodiment.

Figure 5A

[0023] It is a top perspective view of an embodiment with a microtexture film.

Figure 5B

[0024] It is a top plan view of the microtexture 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 microtexture film of FIG. 5A.

Figure 5E

[0027] It is an enlarged view of section 5E of FIG. 5D.

Figure 5F

[0028] Schematic diagram of a micro-textured film according to an embodiment in contact with a fluid.

Figure 6

[0029] An embodiment of a prosthesis.

Figure 7

[0030] An embodiment of a prosthesis.

Figure 8

[0031] An embodiment of a prosthesis.

Figure 9

[0032] An embodiment of a prosthesis.

Figure 10

[0033] An embodiment of a prosthesis.

Figure 11

[0034] An embodiment of a prosthesis.

Figure 12

[0035] Schematic side view of a main body according to an embodiment.

Figure 13A

[0036] An embodiment of a prosthesis.

Figure 13B

[0037] An embodiment of a prosthesis.

Mode for Carrying Out the Invention

[0018]

[0038] The present disclosure relates to implantable prostheses for repairing anatomical defects, and is particularly suitable for repairing defects and weaknesses in soft tissues 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 and without limiting the scope of the present disclosure, the prosthesis will be described below in connection with repairing groin defects, including but not limited to one or more of indirect inguinal hernias, direct inguinal hernias, femoral hernias, and / or other weaknesses or ruptures of the anatomical structures in the groin. However, it should be understood that the prosthesis is not so limited and can be used in other anatomical procedures, as will be apparent to those skilled in the art. For example, without limitation, the prosthesis may be used for abdominal wall hernias, reconstruction of the chest wall or abdominal wall, or large defects that may occur in obese patients. The prosthesis may include one or more features that contribute to such attributes, either independently or in combination.

[0019]

[0039] More specifically, the present disclosure relates to a prosthesis including a repair fabric having a body portion configured to cover or extend across a defect opening or weakness when placed against the defect. The prosthesis may be in the form of a patch, but as will be apparent to those skilled in the art, the prosthesis may adopt other configurations. The patch may have a planar or non-planar configuration suitable for the particular procedure employed to repair the defect.

[0020]

[0040] The prosthesis may be configured to include a self-gripping device having features that help maintain the position of the prosthesis relative to the defect. The self-gripping device may reduce, if not eliminate, separation, slippage, torsion, folding, and / or other movement between the prosthesis and adjacent tissue, as may be desired. Such a configuration may also reduce, if not eliminate, the need for a surgeon to temporarily secure the prosthesis in place by suturing, stapling, tacking, or other means until the tissue has integrated.

[0021]

[0041] The prosthesis may include one or more grip segments integrated with a layer of the prosthetic fabric. In some embodiments, the grip segment may be integrated with the prosthetic fabric by attaching the grip segment to a surface of the body portion configured to engage adjacent tissue. In some embodiments, the grip segment may be formed of film patches of various shapes and sizes. More specifically, the grip segment may comprise a microstructural array on a grip surface of a material with a low coefficient of friction that can firmly grip the material without damaging it. The grip segment may be configured to grip tissue by placing and / or pressing the prosthesis against the tissue without using sutures. In some embodiments, the microtexture film may be configured to grip tissue using hydrodynamics. For example, the microstructural texture of the grip may allow fluid to penetrate the microstructure, resulting in high solid-fluid adhesion and high contact angle hysteresis.

[0022]

[0042] The grip segments may be disposed on the body portion in any suitable configuration to provide a desired amount of grip, which should be apparent to those skilled in the art. For example, without limitation, the grip segments may be distributed across the body portion in a uniform, non-uniform or random arrangement, and / or any suitable combination of arrangements. The grip segments may be distributed across the entire body portion or located in one or more selected regions of the body portion. For example, without limitation, the grip segments may be located in one or more selected regions adjacent to one or more segments of the outer periphery of the body portion and / or one or more selected regions located radially inward from the outer periphery within the inner region of the body portion. Each selected region may include one or more grip segments arranged in any suitable pattern within that region.

[0023]

[0043] According to one aspect, the grip segment may be manufactured independently of the body portion of the prosthesis and may be attached to the body portion. In this way, the grip segment may be formed from a material different from that of the body portion. For example, but not limited to, the grip segment may be formed of a bioabsorbable material while the body portion may be formed of a non-absorbable material. Such a configuration may provide temporary grip characteristics to the prosthesis during the tissue integration period while reducing the amount of foreign matter remaining in the patient's body and maintaining the long-term strength of the prosthesis. Optionally, the body portion may also be formed of a bioabsorbable material that may be absorbed at a slower rate than the grip segment material.

[0024]

[0044] Manufacturing the grip segment independently may also provide flexibility in configuring the prosthesis. For example, but not limited to, the prosthesis may include grip segments having the same or different grip segment configurations and / or arrangements depending on the particular use of the prosthesis. For example, but not limited to, the prosthesis may include grip segments having the same shape but attached to the body portion in different orientations relative to each other. The prosthesis may include grip segments having one or more different shapes in one or more regions of the body portion. In this way, the prosthesis may have various grip characteristics, individually and as a whole, based on the particular orientation and / or shape of the grip segments.

[0025]

[0045] In some embodiments, the grip segment may comprise a plurality of perforations that allow for ingrowth of tissue within and through the grip segment. The perforations may be configured in various patterns, sizes, and shapes depending on the desired amount of ingrowth of the tissue while maintaining the structural integrity of the grip segment. For example, the perforations may be distributed across the grip segment in a uniform, non-uniform, or random array, and / or any suitable combination of arrays. The perforations may be distributed throughout the grip segment or located in one or more selected regions of the grip segment. Each selected region may include one or more perforations arranged in any suitable pattern within that region.

[0026]

[0046] In some embodiments, the grip segment may be integrated with the body portion of the prosthesis by using one or more stitches to secure the grip segment to the body portion. In some embodiments, attaching the grip segment to the body portion may include a sewing application along the perimeter of the grip segment using a non-resorbable or resorbable monofilament such as polypropylene or ePTFE. In some embodiments, the grip segment may be attached to the body portion using an adhesive, bonding, ultrasonic or thermal welding, or overmolding. In some embodiments, the grip segment may comprise one or more protrusions extending from the surface of the grip segment adjacent to the body portion. In a non-limiting example, the protrusions may include hooks or other returnable 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.

[0027]

[0047] Prostheses may be used to repair soft tissue and muscle wall defects using a variety of surgical techniques, including open, laparoscopic, hybrid (e.g., Kugel procedure), and robotic surgery. During open surgery, the prosthesis may be placed through a relatively large incision formed in the abdominal wall and tissue layers, and the defect is then grafted or covered with a repair fabric. During laparoscopic and hybrid surgery, the prosthesis may be folded and reduced in configuration, for example, by rolling or folding, to be inserted into the patient directly through a relatively small incision or through an elongated laparoscopic cannula placed through the incision. The prosthesis may be particularly applicable to robotic surgery achieved using a robotic surgical tool, which may involve the prosthesis passing through a relatively small cannula (e.g., 8 mm) compared to cannulas commonly used in more traditional laparoscopic surgery (e.g., 10 - 12 mm).

[0028]

[0048] With reference to the figures, specific non - limiting embodiments are described in further detail. It should be understood that the various systems, components, functions, and methods described in connection with these embodiments may be used individually and / or in any desired combination, since the present disclosure is not limited to the specific embodiments described herein.

[0029]

[0049] Figure 1 shows an embodiment of a prosthesis for repairing tissue and muscle wall defects such as hernia defects. The prosthesis includes a repair fabric of a transplantable biocompatible material. In one embodiment, the repair fabric may include a mesh fabric that is relatively flexible, thin, lightweight, and meets the performance and physical properties for repairing soft tissue and muscle wall defects. Prosthesis 10 may include a body portion 100 configured with a size and / or shape suitable to cover or extend across an opening or a vulnerable part of the defect when placed against the defect. The body portion 100 may be a pre-formed non-planar patch having a three-dimensional curved shape. The body portion may include a first region 101 and a second region 103 joined by 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 in a direction from the first and second outer edges 109, 111 towards the first region 101 and may intersect obliquely at a vertex 113 located near a central region 105 of the body portion between the first and second regions 101, 103. The vertex 113 may form the highest point of the body portion relative to a plane formed by a periphery 112 (see also FIG. 12). In one embodiment, the height H of the prosthesis from the plane defined by the periphery 112 and the vertex 113 is about 21 mm. In some embodiments, the height H of the prosthesis defined by the periphery 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 may 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 periphery. In some embodiments, the vertex 113 may 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 a bottom periphery defining the second region of the body portion.

[0030]

[0050] As shown in FIG. 12, the first and second regions 101, 103 may have a substantial spherical shape to enhance their 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, and the second region forms a surface with a steeper slope relative to the first region. Returning to FIG. 1, the second region may be shaped to form a recess 115 in the surface of the body portion configured to receive the external iliac vessels, for example, when the prosthesis is used for inguinal hernia repair. The recess extends inwardly from the periphery 112 between the first and second outer edges 109, 111 towards the apex 113.

[0031]

[0051] As shown in FIG. 1, the prosthesis 10 may also include one or more grip segments 102, 104, 106 attached to the surface 110 of the body portion 100 to provide a self - grip device for maintaining the position of the prosthesis relative to the defect. The grip segments may be configured to utilize hydrodynamics to grasp and engage adjacent tissue when the prosthesis is placed against and / or pressed against the adjacent tissue. For example, the grip segment may be a substrate having a plurality of microstructures (i.e., grips) extending from the substrate in a micro - pattern design to form a micro - textured surface (see FIGS. 5A - 5F). The micro - textured surface of the grip segment may allow fluid to penetrate between the micro - structured grips, resulting in high solid - fluid adhesion and high contact - angle hysteresis. As a result, the grip segment may be able to grasp wet tissue while minimizing tissue damage.

[0032]

[0052] In some embodiments, the grip segments 102, 104, 106 may be located in one or more grip regions of the body portion 100. Such a configuration may be suitable for placing the grip segments in selected regions of the body portion 100 to correspond to specific anatomical regions. 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, rotation and / or folding of the prosthesis for delivery to the soft tissue repair site may be facilitated. In some embodiments, the grip segments may comprise one or more perforations 108 to allow for ingrowth of tissue within the grip segments and through the grip segments and into the body portion 100 after implantation.

[0033]

[0053] As shown in FIG. 1, according to some embodiments, the prosthesis 10 comprises first and second grip segments 102, 104 positioned near the periphery 112 on a first region 101 of the body portion 100. The grip segments 102, 104 may be arranged such that each segment is positioned on either side of the apex 113. The grip segments 102, 104 may be configured in an elliptical shape and may be of the same shape or size or of different shapes or sizes. A third grip segment 106 may be positioned substantially near the periphery 112 of a second region 103 of the body portion 100. The third grip segment 106 may have an L-shaped configuration, with a first portion 130 of the grip segment extending at least partially along the periphery 112 of the second region 103 and reaching into the first region beyond the rounded ridge 107. A second portion 132 of the grip segment 106 may extend upward along the periphery 112 and reach into the first region 101 beyond the rounded ridge 107.

[0034]

[0054] As shown in FIG. 1, the grip segments may be positioned adjacent to the periphery 112 of the body portion 100 such that there are no grip segments in the central region 105 of the prosthesis. The grip segments 102, 104, 106 may be disposed near the periphery 112 so that when implanted in the patient's defect, the user (e.g., surgeon, physician, etc.) can fluoroscope the prosthesis. Also, such an arrangement may suppress or prevent the grip segments from contacting nerves or other potentially sensitive areas during implantation and causing pain to the patient. For example, the L-shape of the third grip segment 106 may be positioned to avoid nerves, blood vessels, or other tissues when implanted in the defect site.

[0035]

[0055] The size, shape, and position of the grip segments may be configured and arranged to balance the grip force of the prosthesis, the potential for ingrowth of tissue, and flexibility. For example, the grip segments may reduce the exposed mesh surface required for rapid ingrowth of tissue while increasing the grip force. In this way, the grip segments may function as a barrier to rapid ingrowth of tissue until the grip segments break. Providing one or more perforations in the grip segments may allow for rapid ingrowth of tissue before the grip segments break. The grip segments may also reduce the flexibility of the prosthesis, and it may be necessary to roll up the prosthesis and fit it into a narrow 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 may allow the prosthesis to maintain sufficient flexibility while providing the grip portion with a surface area sufficient to adhere firmly to the tissue as a dependence.

[0036]

[0056] The number, shape, size, and position of the grip segments 102, 104, 106 may vary according to a particular procedure and are merely non-limiting examples as the present disclosure is not so limited. For example, the grip segments may take on any symmetric or asymmetric shape including, but not limited to, circular, polygonal, arcuate, elliptical, or any freeform shape. In some embodiments, the grip segments may be positioned along the periphery of the prosthesis, while in some embodiments, the grip segments may be positioned near the central region of the prosthesis or disposed to cover the effective surface 110 of the prosthesis as needed. Alternatively, fewer than three or more than three grip segments may be used. For example, four elliptical grip segments may be positioned around the periphery of the body portion, or two L-shaped grip segments may be positioned opposite each other in the first and second regions 101, 103. Any suitable number of grip segments may be used to achieve the desired grip force and flexibility.

[0037]

[0057] In some embodiments, the body portion 100 may 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 may have a shape corresponding to the 3DMAX MID, 3DMAX light mesh, or 3DMAX mesh described in one or more of U.S. Patent Nos. 6,723,133, 6,740,122, and 6,740,122. Thus, the prosthesis may be particularly suitable for conforming to and repairing defects in the anatomical structure of the groin area. However, it should be understood that the prosthesis may adopt other shapes that would be apparent to those skilled in the art. For example, without limitation, the body portion may have a planar or other non-planar shape suitable for a particular procedure employed to repair the defect. Further, the prosthesis may be provided as a planar sheet of self-adhering repair fabric that a surgeon may selectively trim to any desired size and shape for a particular procedure.

[0038]

[0058] In some embodiments, the length of the main body may be 5.25 inches, 5.5 inches, 5.75 inches, 6.0 inches, 6.25 inches or more, and / or other suitable lengths. In some embodiments, the length may be 6.25 inches, 6.5 inches, 6.75 inches, 7 inches or less, and / or other suitable widths. The above combinations are assumed to include, for example, a length of 5.5 inches or more and 6.65 inches or less, and / or other suitable combinations as described above. In some embodiments, the width of the main body may be 3.25 inches, 3.5 inches, 3.75 inches, 4.0 inches, 4.25 inches or more, and / or other suitable widths. In some embodiments, the width may be 4.5 inches, 4.75 inches, 5.0 inches, 5.25 inches or less, and / or other suitable widths. The above combinations are assumed to include, for example, a width of 3.5 inches or more and 4.85 inches or less, and / or other suitable combinations as described above. Although specific ranges of length and width are shown above, it should be understood that the present disclosure is not so limited, and ranges larger and smaller than the above are also conceivable.

[0039]

[0059] Figure 2 shows an embodiment with 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 may employ a knit structure that provides openings or pores that allow tissue ingrowth to enable incorporation of the prosthesis. When implanted, the mesh promotes rapid ingrowth of tissue or muscle into and around the mesh structure. Examples of surgical materials suitable for tissue or muscle reinforcement and defect correction that may be utilized in the layer include BARD Mesh (available from Davol), BARD Soft Mesh (available from Davol), SOFT TISSUE PATCH (microporous ePTFE - available from W.L.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), but are not limited thereto. Absorbable or resorbable materials, including PHASIX Mesh (available from Davol), polyglactin (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 can be formed from multifilament yarns and that the mesh material can be formed using any suitable method such as knitting, weaving, braiding, molding, etc.

[0040]

[0060] The repair fabric may also have sufficient flexibility to facilitate easy size reduction for insertion into the subject. Thus, the flexible fabric may be folded into an elongated shape such as a roll and supported within a narrow laparoscopic cannula for use in laparoscopic or robotic surgery and advanced through the cannula.

[0041]

[0061] FIGS. 3A and 3B show embodiments of the L-shaped grip segment 120 and the oval grip segment 124, respectively. One or more of the L-shaped grip segment 120 and / or the oval grip segment 124 may be positioned on the surface of the main body portion of the prosthesis.

[0042]

[0062] In some embodiments, the length L of the L-shaped grip segment 120 may be about 5.0 inches, 5.25 inches, 5.5 inches, 5.75 inches, 6.0 inches, and / or other suitable lengths. In some embodiments, the length L of the molded grip segment 120 is about 5.4 inches. In some embodiments, the width W of the molded grip segment 120 may be about 1.5 inches, 1.75 inches, 2.0 inches, 2.25 inches, and / or other suitable widths. In some embodiments, the width W is 2.1 inches. In some embodiments, the thickness of the molded grip segment 120 may be about 155 μm, 165 μm, 175 μm, and / or other suitable thicknesses. The above combinations may include, for example, lengths from 5.25 to 5.5 inches or less, widths from 2.0 inches to 2.2 inches, and / or other suitable combinations as described above.

[0043]

[0063] In some embodiments, the length L of the elliptical grip segment 124 may 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 may 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 may be about 150 μm, 155 μm, 165 μm, 175 μm, and / or any other suitable thickness. The above combinations may include, for example, a length of 2.5 inches or more and 2.7 inches or less, a width of 1.8 inches to 1.1 inches, and / or any other suitable combination as described above. Although specific ranges of the dimensions of the grip segment are shown above, it should be understood that the present disclosure is not so limited and that any range larger or smaller than the above is contemplated.

[0044]

[0064] As shown in FIGS. 3A - 3B, in some embodiments, the grip segments 120, 124 may comprise a plurality of perforations that enable tissue ingrowth to incorporate the prosthesis. When implanted, the porous grip segments facilitate 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 may be included in various patterns on the grip segment. For example, in the embodiment of FIG. 3A, the L - shaped grip segment 120 comprises a single array of 18 perforations along the length of the grip segment. In the embodiment of FIG. 3B, the elliptical grip segment 124 comprises a single array of 5 perforations along its length. The perforations may be arranged in a uniform, non - uniform, or random array, and / or any suitable combination of arrays. The perforations may also be distributed throughout the grip segment.

[0045]

[0065] The perforations provided in the grip segment may be of various shapes and sizes in order to optimize ingrowth of tissue and maintain the integrity of components for prosthesis insertion. In some embodiments, the perforations may 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 ranges is also possible. In one embodiment, the perforations may occupy from 6% to 20% of the grip segment surface.

[0046]

[0066] FIGS. 4A through 4B show enlarged views of the perforations in sections 4A and 4B of FIGS. 3A through 3B. As shown in FIG. 4A, the perforation 126 may be configured circularly. The diameter D1 of the perforation 126 may be about 0.003 inches, 0.05 inches, 0.075 inches, 0.100 inches, 0.125 inches, and / or other suitable diameters. As shown in FIG. 4B, the perforation 128 may be configured hexagonal. The segment distance D2 of the perforation 128 may be about 0.025 inches, 0.050 inches, 0.075 inches, and / or other suitable distances. It should be noted that only two perforations are described, but the perforations on the grip segment can be of any shape or size depending on specific needs. It should also be understood that the grip segment may employ combinations of perforations of various configurations including but not limited to various shapes and / or sizes.

[0047]

[0067] It should be understood that any suitable grip segment configuration may be provided on the prosthesis to provide a desired amount of grip that would be apparent to one of ordinary skill in the art. In some embodiments, the prosthesis may comprise 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 may comprise grip segments having the same shape but attached to the body portion in different orientations relative to each other. The prosthesis may comprise grip segments having one or more different shapes in one or more regions of the body portion. The grip segments may comprise perforations in various patterns to promote a desired level of ingrowth within the tissue while maintaining structural integrity. Thus, the prosthesis may have various grip characteristics for a particular use of the prosthesis based on the configuration and / or arrangement of the grip segments.

[0048]

[0068] The grip segments may be manufactured independently of the body portion of the prosthesis and attached to the body portion of the prosthesis (e.g., via adhesives, molding, bonding, sewing, etc.). Manufacturing the grip segments independently may provide flexibility in configuring the prosthesis. In one embodiment, the grip segments may be formed of a bioabsorbable material while the body portion may be formed of a non-absorbable material. Optionally, the body portion may also be formed of a bioabsorbable material that is absorbed at a slower rate than the grip segment material. Such a configuration may provide temporary grip characteristics to the prosthesis during the tissue integration period while reducing the amount of foreign material remaining in the patient's body and maintaining the long-term strength of the prosthesis.

[0049]

[0069] In some embodiments, the grip segment may be composed of one or more film layers. FIGS. 5A-5E illustrate embodiments of a grip segment formed from a microtextured film. The microtextured film may be cut to form grip segments of various shapes, including but not limited to L-shaped and oval grip segments. The microtextured film includes a film having a fine pattern of microstructures on its surface. As shown in FIG. 5A, the microtextured film 20 includes a substrate 200 and a plurality of microstructured grips 201 on the surface of the substrate. In one embodiment, as shown in the figure, the film 20 is single-sided, and the grips 201 may be provided on one surface of the substrate, although the present disclosure is not so limited. In one embodiment, the film 20 is double-sided, and the grips may be provided on two opposite surfaces of the substrate and may protrude therefrom. Such a configuration may enable one side of the grip segment to be positioned to face the body portion with the opposite side facing away from the body portion, which may facilitate the manufacture 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 may be attached to either a left or right prosthesis by flipping the grip segment (i.e., attaching the first surface of the grip segment to the right prosthesis and the second opposite surface to the left prosthesis).

[0050]

[0070] In some embodiments, the grips 201 may be arranged on the substrate 200 in a pattern such as the triangular lattice shown in FIGS. 5A-5B, although 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 hexagonal, honeycomb, or square lattices. In some embodiments, the grips 201 may be positioned on the substrate in a random arrangement.

[0051]

[0071] As shown in FIGS. 5B to 5F, each of the plurality of grips 201 may include a first pillar 202 extending from the surface of the substrate 200 and a plurality of second pillars 204 extending from the surface of the first pillar 202. The second pillar 204 may be positioned on the upper surface of the first pillar 202 as shown in FIGS. 5B to 5D, or the second pillar 204 may be positioned on the upper surface and / or side surface of the first pillar 202 (see FIG. 5F). The second pillar 204 may be arranged on the first pillar 202 in any pattern including, but not limited to, a triangular lattice as shown in FIG. 5C.

[0052]

[0072] In some embodiments, the first pillar 202 may be cylindrical. In some embodiments, the first pillar 202 may have a diameter D3 of about 0.09 inches to 0.11 inches and may be spaced apart in a row with a pitch D4 of about 0.18 inches to 0.22 inches. The first pillar 202 may have a height D7 of about 0.045 inches to 0.055 inches. The first pillar 202 may have an axial angle of about 3° to 7°.

[0053]

[0073] In some embodiments, the second pillar 204 may be cylindrical and may extend substantially perpendicular to the surface of the first pillar 202. In some embodiments, the second pillar 204 may have a diameter D5 of about 0.009 inches to 0.011 inches and may be spaced apart in a row with a pitch D6 of about 0.018 inches to 0.022 inches. The second pillar 204 may have a height D8 of about 0.018 inches to 0.022 inches. Other cross-sectional shapes (e.g., square, elliptical, orthogonal, etc.), dimensions, and patterns of the first and second pillars are also contemplated as the present disclosure is not so limited. It should be noted that the second pillar 204 may not necessarily extend at an angle perpendicular to the surface of the pillar 202 from which the second pillar 204 extends.

[0054]

[0074] In some embodiments, the grip segment may be made of PURASORB® PLDL7038, a GMP-grade copolymer with a molar ratio of L-lactide to DL-lactide of 70 / 30 and an intrinsic viscosity midpoint of 3.8 dl / g.

[0055]

[0075] FIG. 5F is a schematic view of a portion of the microtextured film 20 in contact with the fluid 206. In some embodiments, the second post 204 may draw fluid between the first posts of the film 20 such that the fluid penetrates the grip microstructure between the first posts 202. This may create superhydrophobic and hydrophilic surfaces, resulting in solid-fluid adhesion and thus potentially high contact angle hysteresis. As a result, the grip 201 of the microtextured film 20 may grip a wet substrate containing tissue without damaging the tissue.

[0056]

[0076] FIGS. 6-10 illustrate embodiments of prostheses with various grip segment and perforation configurations and arrangements. The number, size, shape, and configuration of the grip segments may be adjusted according to the application and desired use.

[0057]

[0077] FIG. 6 shows an embodiment of a prosthesis 30 with three grip segments disposed on the surface 310 of the body portion 300. The body portion 300 includes elliptical first and second grip segments 302, 304 disposed near the periphery 312 of a 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 a second region 303 and extending into the first region 301 over a rounded ridge 307. The grip segments may be disposed below the apex 313 of the body portion such that the grip segments do not cover the apex. In some embodiments, the grip segments may be disposed to cover the apex.

[0058]

[0078] Each of the grip segments 302, 304, 306 may include a plurality of perforations 308. As shown in the figure, the perforations 308 of the first and second grip segments 302, 304 may be provided linearly along the length of the grip segment. The pattern of perforations in the third grip segment may include a plurality of rows of perforations 308 along the length of the grip segment. The pattern may include the bottom row of perforations and a continuous row of perforations with a V-shaped outward step such that the perforations extend in a grid pattern along each end of the grip segment. The rows of perforations may be arranged obliquely with respect to the direction along the length of the grip segment. Such a grid pattern may be for facilitating manufacturing, or may promote ingrowth of tissue inwardly at a desired location while maintaining the structural integrity and sufficient gripping force of the grip segment. However, it should be understood that the grip segment may employ any suitable perforation arrangement that would be apparent to those skilled in the art.

[0059]

[0079] FIG. 7 shows an embodiment of a prosthesis 30 with three grip segments disposed on the surface 410 of the body portion 300. The body portion 400 includes first and second grip segments 402, 404 disposed near the periphery 412 of the first region 401 of the body portion 400. The body portion also includes a third L-shaped grip segment 406 disposed near the periphery 412 of the second region 403 and extending into the first region 401 beyond the rounded ridge 407. The first and second grip segments 402, 404 may have an asymmetric oval shape as compared to the grip segments 302, 303 of FIG. 6, and the third grip segment 406 may have a larger surface area and a greater number of perforations 408 than the grip segment 306. The grip segment 404 may be positioned to rotate slightly clockwise along the periphery 412 so as to be closer to the grip segment 406 than the grip segment 402. The grip 406 may be positioned to cover the apex 413.

[0060]

[0080] Each of the grip segments 402, 404, 406 comprises a plurality of rows of perforations 408. In some embodiments, the first and second grip segments 402, 404 comprise 15 perforations arranged in 3 rows along the length of the grip segment. The larger grip segment 406 comprises three separate groups of perforations 408 in a central region 420 and two end regions 422, 424. The groups of perforations may be arranged in a grid with equal size and spacing, as shown in the figure. 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 size.

[0061]

[0081] Figure 8 shows an embodiment of a prosthesis 50 with three grip segments disposed on a surface 510 of a body portion 500. The body portion 300 comprises first and second grip segments 502, 504 disposed near a periphery 512 of a first region 501 of the body portion 300. The second grip 504 may be disposed near a side closer to a rounded ridge 517 of the periphery 512. The first and second grip segments 502, 504 may be larger than the first and second grip segments of FIGS. 2-7. The first and second grip segments 502, 504 may comprise a pattern of perforations 508 that occupy a substantial portion of the surface area of the grip segment. The perforations 508 may be arranged in a grid with equal spacing, as shown in the figure.

[0062]

[0082] The body portion 500 also comprises a third grip segment 506 disposed near a periphery 512 of a second region 503 and extending upwardly into the first region 501 beyond a rounded ridge 507. The third grip segment 506 may be shaped such that one end is wider than the other end. The third grip segment 506 may have equally spaced and equally sized perforations 508 positioned in three separate regions on the grip segment.

[0063]

[0083] Figure 9 shows an embodiment of a prosthesis 60 in which three grip segments 602, 604, 606 with a plurality of perforations 608 are arranged on a surface 610 of a body portion 600. The body portion 600 includes first and second grip segments 602, 604 disposed near a periphery 612 of a first region 601 of the body portion 600. The body portion 600 also includes a third grip segment 606 disposed near a periphery 612 of a second region 603 and extending upwardly into the first region 601 beyond a rounded ridge 607. The third grip segment 606 may be sized to have a shorter length compared to the third grip segment of FIG. 8. Comparing FIGS. 8 and 9, the grip segment 506 of FIG. 8 includes a relatively long end portion 509 that extends to the periphery 512 of the body portion, whereas the grip segment 606 of FIG. 9 has a relatively short end portion 609 that ends in front of the periphery.

[0064]

[0084] As shown in FIG. 10, a prosthesis 70 includes three grip segments disposed on a surface 710 of a body portion 700. The body portion 700 includes first and second grip segments having twelve perforations 708 arranged in two offset rows each having six perforations. The body portion 700 also includes a third L-shaped grip segment 706 having two groups 720, 722 of perforations 708 separated by a central portion 724 of the grip segment without perforations. The third L-shaped grip portion 706 may be disposed near a periphery 712 of a second region 703 of the body portion, and a portion of the grip portion 706 may extend into the first region 701 beyond a rounded ridge 707.

[0065]

[0085] In some embodiments, the prosthesis may comprise any number of grip segments. For example, as shown in FIG. 11, the prosthesis 80 may comprise four grip segments 802, 804, 806, 814 disposed on the surface 810 of the body portion 800 near the periphery 812 of the first region 801. The body portion may also comprise two grip segments 816, 818 disposed near the periphery of the second region 803 of the body portion. A portion of one of the grip segments 816, 818 may extend into the first region 801 beyond the rounded ridge 807. The grip segments may be positioned in pairs, exposing a small amount of the mesh of the body portion 800 between the lengths of each pair of grip segments. This may increase the flexibility of the prosthesis and minimize the bulk of the prosthesis, allowing for insertion into a trocar. In some embodiments, the prosthesis may be folded to fit within an 8 mm trocar.

[0066]

[0086] In one embodiment shown in FIGS. 13A to 13B, the prosthesis 90 may include four grip segments 902, 904, 906, 914 disposed on the surface 910 of the body portion 900. Each grip segment may include a plurality of perforations 908. The body portion may have an elliptical shape and may include three grip segments 902, 904, 906 that may be disposed near the first periphery 912 of the first region 901 of the body portion 900. As shown in the figure, the first region may be located on the first side of the rounded ridge 907. The first grip segment 902 may have a smaller size, for example, a shorter length and / or width, compared to the second and third grip segments 904, 906. The first grip segment 902 may be disposed along a segment of the first periphery, and the second and third grip segments 904, 906 may be disposed along adjacent segments of the first periphery. The fourth grip segment 914 is disposed in the second region 903 of the body portion 900 located on the second side of the rounded ridge 907 and may extend along the second periphery 912. In some embodiments, the fourth grip segment 914 may be entirely disposed within the second region 903, or a portion of the fourth segment 914 may contact the rounded ridge 907 or may partially extend into the first region 901 beyond the rounded ridge 907. As shown in FIG. 13A, the fourth grip segment 914 may be such that one side of the grip segment contacts the rounded ridge 907 but does not extend beyond the apex 913. As shown in FIG. 13B, the fourth grip segment 914 may be such that one side of the grip segment extends beyond the rounded ridge 907 and the apex 913. The fourth grip segment 914 may be elliptical and may be sized to be larger than the second and third grip segments 904, 906, for example, having a longer length and / or width.

[0067]

[0087] In some embodiments, the first grip segment 902 may 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 may have a length of about 1.89 inches and a width of about 0.689 inches. In some embodiments, the first grip segment 902 may have a length of about 1.51 inches and a width of about 0.614 inches. In some embodiments, the second and third grips 904, 906 may 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 and third grip segments 904, 906 may have a length of about 2.362 inches and a width of about 0.787 inches. In some embodiments, the second and third grip segments 904, 906 may have a length of about 2.047 inches and a width of about 0.632 inches. In some embodiments, the fourth grip segment 914 may 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 may have a length of about 4.762 inches and a width of about 1.00 inch. In some embodiments, the fourth grip segment 914 may have a length of about 4.055 inches and a width of about 0.787 inches.

[0068]

[0088] In some embodiments, the grip segments 902, 904, 906, and 914 may each include a plurality of perforations. The perforations 908 may have a diameter of about 0.10 inches and may be linearly arranged along the longitudinal direction of the grip segment. The perforations may be spaced apart at a pitch of about 0.25 inches to about 0.30 inches. In some embodiments, the perforations 908 may be spaced apart at a pitch of about 0.28 inches. In some embodiments, the first grip segment 902 may include four perforations, the second and third grip segments 904, 906 may include six grip segments, and the fourth grip segment may include fifteen perforations. It should be noted that the dimensions and spacing of the grip segments and perforations described with respect to FIGS. 13A through 13B may be included in any of the embodiments described herein.

[0069]

[0089] The grip segment may be disposed on the layer of the repair fabric to cover a certain percentage of the surface of the body portion in order to maximize the grip on the tissue. In some embodiments, the grip segment may be disposed on the body portion 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 may be disposed on the body portion 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 ranges is also possible. In one embodiment, the grip segment may be disposed on the body portion to cover about 20% or more and 30% or less of the surface area of the body portion.

[0070]

[0090] In some embodiments, the grip segment may be made of polylactic acid (PLA), but the present disclosure is not so limited, and the grip segment may be made of other suitable resorbable materials (e.g., P4HB, etc.). In some embodiments, the prosthesis may include four grip segments (see FIGS. 13A and 13B). In such embodiments, the total surface area of the grip segments on the prosthesis may 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 repair fabric layer of the body portion may 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 may occupy from about 26% to about 30.2% of the surface area of the body portion.

[0071]

[0091] It should be understood that all grip segments, perforations, and patterns described in each embodiment are non-limiting examples, and any configuration may be used according to actual needs. Also note that any grip segment and configuration of each of the above embodiments may be used with any prosthesis.

[0072]

[0092] Although several embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily conceive of various other mechanisms and / or structures for performing the functions and / or obtaining the results and / or one or more of the 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 forms described herein are meant to be illustrative, and that the actual parameters, dimensions, materials, and / or forms will depend on the particular application or applications for which the teachings of the present invention are used. Those skilled in the art will be able to recognize, or confirm, many equivalents to the specific embodiments of the invention described herein using only routine experimentation. Therefore, the above-described embodiments are presented by way of example only, and it is understood 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 relates to each individual mechanism, system, article, material, kit, and / or method described herein. Also, any combination of two or more such mechanisms, systems, articles, materials, kits, and / or methods is included within the scope of the present invention so long as such mechanisms, systems, articles, materials, kits, and / or methods do not mutually conflict.

Claims

1. A layer of biocompatible repair fabric, A plurality of grip segments integrated with the layer of the repair fabric, each having a plurality of grips and a plurality of perforations extending through them, A transplantable prosthesis equipped with [specific features / features].

2. The implantable prosthesis according to claim 1, wherein the plurality of grip segments include a plurality of microtextured grip segments.

3. The implantable prosthesis according to claim 1, wherein each of the plurality of grips comprises a first column and a plurality of second columns extending from the surface of the first column.

4. A layer of biocompatible repair fabric, A plurality of microtexture grip segments integrated with the layer of the repair fabric, each having a plurality of perforations extending through it, A transplantable prosthesis equipped with [specific features / features].

5. A layer of biocompatible repair fabric having a pre-formed three-dimensional structure comprising a vertex and a rounded ridge extending from the vertex to the outer circumference of the repair fabric layer, A plurality of grip segments integrated with the layer of the biocompatible repair fabric, wherein at least one portion of the plurality of grip segments extends across the rounded ridge, A transplantable prosthesis equipped with [specific features / features].

6. The implantable prosthesis of claim 5, wherein the plurality of grip segments comprises a plurality of microtextured grip segments.

7. The implantable prosthesis of claim 5, wherein the vertex lacks a grip segment.

8. A layer of biocompatible repair fabric, A plurality of grip segments integrated with the layer of the repair fabric, each comprising a substrate and a plurality of grips extending from the surface of the substrate, wherein each of the plurality of grips comprises a first column and a plurality of second columns extending from the surface of the first column, A transplantable prosthesis equipped with [specific features / features].

9. The implantable prosthesis of claim 8, wherein the plurality of grip segments comprises a plurality of microtextured grip segments.

10. The implantable prosthesis of claim 8, wherein each of the plurality of grip segments comprises a plurality of perforations extending through it.

11. The implantable prosthesis of claim 2, 4, or 9, comprising three or more grip segments integrated with the layer of the repair fabric.

12. The implantable prosthesis of claim 2, 4, 6, or 9, wherein at least one of the plurality of microtexture grip segments has an L-shape.

13. The implantable prosthesis of claim 2, 4, 6, or 9, wherein at least one of the plurality of microtexture grip segments has an elliptical shape.

14. The implantable prosthesis according to claim 2, 4, 6, or 9, wherein the plurality of microtexture grip segments are arranged on the layer of the repair fabric such that the central portion of the repair fabric remains free of grip segments.

15. The implantable prosthesis of claim 1, 4, or 8, wherein the layer of the repair fabric has a pre-formed three-dimensional structure having vertices without grip segments.

16. The implantable prosthesis according to claim 2 or 4, wherein the plurality of perforations in at least one of the plurality of microtexture grip segments occupy 6% to 20% of the grip segment.

17. The implantable prosthesis of claim 2, 4, 6, or 9, wherein the plurality of microtexture grip segments occupy 20% to 30% of the surface of the layer of the repair fabric.

18. An implantable prosthesis according to claim 1, 4, or 10, wherein each of the plurality of perforations has a diameter of 0.100 inches to 0.110 inches.

19. The implantable prosthesis according to claim 1, 4, or 10, wherein the plurality of perforations are spaced at a central distance of 0.25 inches to 0.30 inches.

20. The implantable prosthesis according to claim 2 or 4, wherein at least one of the plurality of microtexture grip segments has the plurality of perforations arranged in at least three different regions on the microtexture grip segment.

21. An implantable prosthesis according to claim 20, wherein each region comprises a group of perforations.

22. An implantable prosthesis according to claim 20, wherein the distance between regions is greater than the distance between adjacent perforations within a given region.

23. The implantable prosthesis of claim 21, wherein the perforations in each group are uniformly spaced within each region.

24. The implantable prosthesis according to claim 2 or 4, wherein the plurality of perforations of at least one of the plurality of microtexture grip segments are arranged in an equally spaced two-dimensional pattern.

25. The implantable prosthesis according to claim 2 or 4, wherein the plurality of perforations of at least one of the plurality of microtexture grip segments are arranged in an array extending in a direction along the length of the microtexture grip segment.

26. The implantable prosthesis according to claim 2 or 4, wherein the plurality of perforations of at least one of the plurality of microtexture grip segments are arranged in a hexagonal pattern.

27. The implantable prosthesis according to claim 1 or 8, wherein the plurality of grips are arranged in a hexagonal pattern on at least one of the grip segments.

28. The layer of the repair fabric has a pre-formed three-dimensional structure comprising a vertex and a rounded ridge extending from the vertex to the outer circumference of the layer of the repair fabric, The implantable prosthesis of claim 1, wherein at least one portion of the plurality of grip segments extends across the rounded ridge.

29. Each of the plurality of grip segments comprises a substrate having opposing first and second surfaces, At least one of the plurality of grip segments has a plurality of grips on each of the first and second surfaces, The plurality of grips on the first surface face away from the layer of the repair fabric, The implantable prosthesis according to claim 1, wherein the plurality of grips on the second surface are facing the layer of the repair fabric.

30. The implantable prosthesis of claim 5 or 28, wherein at least two grip segments are positioned entirely on one side of the rounded ridge on the layer of the repair fabric.

31. The at least two grip segments have an elliptical shape, The implantable prosthesis of claim 30, wherein 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 periphery of the layer of the repair fabric.

32. The implantable prosthesis according to claim 5 or 28, wherein at least one grip segment is positioned on the layer of the repair fabric such that it is closer to the periphery of the grip segment than to the rounded ridge.

33. The implantable prosthesis according to claim 1 or 5, comprising six or more grip segments integrated with the layer of the repair fabric.

34. A biocompatible material substrate that can be attached to a layer of repair fabric, A plurality of microstructure grips extending from the surface of the substrate, each comprising a first column and a plurality of second columns extending from the first surface of the first column, Multiple perforations extending through the substrate, A grip segment for implantable prostheses, equipped with a grip segment.

35. The grip segment of claim 34, wherein the grip segment has an L-shape.

36. The grip segment of claim 34, wherein the grip segment has an elliptical shape.

37. The grip segment of claim 34, wherein the plurality of perforations in at least one of the plurality of grip segments occupy 6% to 20% of the grip segment.

38. The grip segment of claim 34, wherein each of the plurality of perforations has a diameter of 0.100 inches to 0.110 inches.

39. The grip segment of claim 34, wherein the plurality of perforations are spaced at a center distance of 0.25 inches to 0.30 inches.

40. The grip segment of claim 34, wherein the plurality of perforations are arranged in three different regions on the grip segment.

41. The grip segment of claim 34, wherein the plurality of perforations are arranged in a two-dimensional pattern at equal intervals.

42. The grip segment of claim 34, wherein the plurality of perforations are arranged in an array that extends in a direction along the length of the grip segment.

43. The grip segment of claim 34, wherein the plurality of perforations are arranged in a hexagonal pattern.

44. The grip segment of claim 34, wherein the plurality of grips are arranged in a hexagonal pattern on the grip segment.

45. The grip segment of claim 34, wherein each of the plurality of second columns extends substantially perpendicularly from the first surface of the first column.

46. The grip segment of claim 34, wherein the first column has a diameter of 0.09 inches to 0.11 inches.

47. The grip segment of claim 34, wherein the first column has a height of 0.045 inches to 0.055 inches.

48. The grip segment of claim 34, wherein the plurality of microstructured grips are spaced apart in a row at a pitch of 0.18 inches to 0.22 inches.

49. The grip segment of claim 34, wherein each of the plurality of second columns has a diameter of 0.009 inches to 0.011 inches.

50. The grip segment of claim 34, wherein each of the plurality of second columns has a height of 0.018 inches to 0.022 inches.

51. The grip segment of claim 34, wherein each of the plurality of second pillars is spaced in a row at a pitch of 0.018 inches to 0.022 inches.

52. The grip segment of claim 34, wherein the first column has a cylindrical shape and has an axial angle of 3° to 7° with respect to the surface of the substrate.

Images