Transplantable prosthesis for repairing soft tissue defects

Abstract

A transplantable prosthesis for covering a peritoneal defect. The prosthesis includes a body (22) of a transplantable biocompatible material having a first surface (24) and a second surface (26). The first surface is tissue-permeable and the second surface has adhesion resistance. The body includes a grip region adjacent to the outer periphery of the body having tissue grips (28) projecting outwardly away from the second surface. The prosthesis may be disposed between the peritoneum and a separate hernia repair fabric located within the preperitoneal pocket to repair tissue or muscular wall defects such as abdominal wall hernias.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Application No. 63 / 357,500, filed Jun. 30, 2022, and U.S. Application No. 63 / 357,491, filed Jun. 30, 2022, both of which are hereby incorporated by reference in their entirety.

[0002] The present invention relates to implantable prostheses, and more particularly, to prostheses for repairing soft tissue and muscular wall defects and weaknesses.

Background Art

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

[0004] In some procedures, an implantable repair fabric, such as a mesh fabric, is temporarily secured in a position over, under, or within the defect by suturing, stapling, tacking, or other means. The repair is ultimately completed when the tissue integrates with the fabric, such as by growing inwards into and / or along the mesh fabric.

[0005] A variety of repair fabrics are known and used for repairing soft tissue and muscular wall defects. Examples of implantable fabrics that have been effectively used for soft tissue and muscular wall repair include BARD SoftMesh, BARD Mesh, and VISILEX, available from Davol, a division of Becton Dickinson. Such fabrics are made from mesh - woven polypropylene monofilaments having pores or gaps that promote ingrowth and integration of tissue.

[0006] Abdominal wall hernias can be repaired using a technique called robotic transabdominal preperitoneal repair (rTAPP). This repair involves creating a preperitoneal pocket for the surgeon to place a repair mesh inside the patient's body. Since the mesh is completely covered by the patient's peritoneum and not exposed to the internal organs in the abdominal cavity, it often does not require an anti-adhesion barrier or coating. A potential problem can occur when one or more small holes open in the peritoneum during dissection by the surgeon when forming the preperitoneal pocket. Such holes are often closed by the surgeon using sutures.

[0007] An object of the present invention is to provide a prosthesis and a method for covering and / or repairing defects in soft tissues and muscular walls including the peritoneum.

Summary of the Invention

[0008] The present disclosure relates to a transplantable prosthesis and method for covering and / or repairing anatomical defects such as tissue or muscular wall defects including peritoneal defects.

[0009] According to one aspect, a transplantable prosthesis comprises a body of a transplantable biocompatible material. The body has a first surface and a second surface opposite the first surface. The first surface is tissue-permeable, and the second surface has adhesion resistance. The body includes an outer periphery and a grip region adjacent to the outer periphery. A plurality of tissue grips are located within the grip region of the body and project outwardly away from the second surface.

[0010] According to another aspect, a transplantable prosthesis comprises a body of a transplantable biocompatible material. The body has a first surface and a second surface opposite the first surface. The first surface is tissue-permeable, and the second surface is resistant to tissue penetration. The body has a maximum width of 5 cm or less.

[0011] According to another aspect, a method of covering a peritoneal defect is provided. The method includes an act (a) of forming a preperitoneal pocket between the peritoneum and a tissue or muscle layer, and an act (b) of placing at least one first implantable prosthesis into the preperitoneal pocket. The first implantable prosthesis includes a body of biocompatible material including a first surface and a second surface. The first surface is tissue-penetrable, and the second surface has adhesion resistance. A plurality of tissue grips project outwardly away from the second surface. The method further includes an act (c) of positioning at least one first implantable prosthesis over at least one peritoneal defect such that the first surface faces away from the peritoneum and the second surface faces the peritoneum by engaging the plurality of tissue grips with a region of the peritoneum adjacent to the peritoneal defect to maintain the at least one first implantable prosthesis in an appropriate position relative to the peritoneal defect.

[0012] According to another aspect, a method of repairing a hernia defect is provided. The method includes an act (a) of forming a preperitoneal pocket between the peritoneum and a tissue or muscle layer having the hernia defect, and an act (b) of placing at least one first implantable prosthesis into the preperitoneal pocket. The first implantable prosthesis includes a body of biocompatible material including a first surface and a second surface, the second surface having adhesion resistance. The method further includes an act (c) of placing a second implantable prosthesis into the preperitoneal pocket. The second implantable prosthesis includes a body of biocompatible material that is tissue-penetrable for repairing the hernia defect. The method further includes an act (d) of positioning at least one first implantable prosthesis over at least one peritoneal defect such that the first surface faces away from the peritoneum and the second surface faces the peritoneum, and an act (e) of positioning the second implantable prosthesis over the hernia defect of the tissue or muscle layer.

[0013] The foregoing is a non-limiting summary of the present disclosure as defined by the appended claims. Other aspects, embodiments and / or features will become apparent from the following description.

[0014] Various embodiments of the present disclosure can provide certain advantages of conventional prostheses and overcome certain disadvantages. Embodiments of the present disclosure may not share the same advantages, and even if they do share the same advantages, they may not share the same advantages in all situations.

Brief Description of the Drawings

[0015] As an example, aspects of the present disclosure will be described below with reference to the accompanying drawings in which like reference numerals refer to like elements.

[0016]

Figure 1

Figure 2

Figure 3

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Figure 7

Modes for Carrying Out the Invention

[0017] Aspects of the present disclosure are to be understood as being described herein with reference to the figures showing exemplary embodiments according to aspects of the present disclosure. The exemplary embodiments described herein are not necessarily for showing all aspects of the present disclosure and are used for explaining the exemplary embodiments. Therefore, one aspect of the present disclosure is not to be construed as being limited to the exemplary embodiments. Since the disclosed concepts and embodiments are not limited to a specific implementation method, it should be understood that the various concepts and embodiments discussed herein can be implemented by any of a number of means. Also, it should be understood that aspects of the present disclosure can be used alone or in appropriate combination with other aspects of the present disclosure.

[0018] The present disclosure relates to implantable prostheses for covering and / or repairing anatomical defects, and is particularly suitable for covering and / or repairing defects and weaknesses in soft tissues and muscular walls, or other anatomical regions. The expression "repairing a defect" includes the act of improving, enlarging, and / or reconstructing a defect and / or a potential defect. Without limiting the scope of the present invention, for ease of understanding, the prosthesis is not limited to one or more of umbilical hernia, incisional hernia, and / or other weaknesses or ruptures in the abdomen, but includes these and is particularly employed in connection with peritoneal defects that may occur during the formation of a preperitoneal pocket in association with ventral hernia repair. However, the prosthesis is not so limited and it should be understood that it can also 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 large defects such as inguinal hernia, chest wall or abdominal wall reconstruction, or those 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] The present disclosure is directed to a prosthesis, and more particularly to a prosthesis that includes a body of a biocompatible material, such as a repair cloth, configured to cover or extend across an opening or weakness in a defect when the body is pressed against the defect. The prosthesis may be in the form of a patch, although other configurations may be employed as will be apparent to those skilled in the art. The patch may have a planar or non-planar configuration suitable for a particular procedure employed to repair the defect.

[0020] The prosthesis may be configured by a self-grip arrangement having features that help maintain the position of the prosthesis relative to the defect. The self-grip arrangement can reduce, if not eliminate, separation, sliding, twisting, folding, and / or other movement between the prosthesis and adjacent tissue, as desired. Such an arrangement can also reduce, if not eliminate, the need for the surgeon to temporarily secure the prosthesis by suturing, stapling, tacking, or other means until tissue integration is complete.

[0021] The prosthesis may include a plurality of grips located on the body. More particularly, the grips may be located on a surface of the body configured to be pressed against adjacent muscle and / or tissue.

[0022] In some applications, the grips may include a microstructured arrangement that can grip a low-friction coefficient material without damaging the material, including tissue and / or muscle. In some embodiments, the microstructured arrangement may be configured to grip tissue using hydrodynamics. For example, the microstructured texture of the grip may allow fluid to penetrate into microstructures that provide high solid-fluid adhesion and high contact angle hysteresis.

[0023] In some applications, the grip may be configured to penetrate and grip tissue when the prosthesis is pressed against and / or onto the tissue. In some embodiments, the grip may be configured to project a defined distance from the surface of the body portion to grip and / or penetrate tissue to a depth sufficient to provide a desired amount of grip. For example, as will be apparent to those skilled in the art, the grip may be configured as barbs, hooks, or other suitable structures.

[0024] As will be apparent to those skilled in the art, the grip may be disposed on the body in any suitable configuration to provide a desired amount of grip. For example, but not limited to, the grip may be distributed on the body in a uniform, non-uniform or random array, and / or any suitable combination of these arrays. The grip may be distributed throughout the body or located in one or more selected regions of the body. For example, but not limited to, the grip may be located in one or more selected regions adjacent to one or more portions of the outer periphery of the body and / or in one or more selected regions in the inner region of the body that is inside the outer periphery of the body. Each selected region may include one or more grips arranged in any suitable pattern within that region. One or more selected regions may employ the same or different grip arrangements relative to one or more other selected regions of the grip.

[0025] According to one aspect, the grip can be located adjacent to and extending inwardly from the outer periphery of the body in a peripheral grip region of the body. The inner region of the body may be grip-free. Thus, the grip region may be configured and arranged to provide a sufficient amount of grip while minimizing the coverage area of the prosthesis body. According to one aspect, the area of the grip region may be proportional to the size of the body.

[0026] According to one aspect, the artificial organ body may be configured in a circular shape, and the grip region may be configured in an annular shape that is adjacent to the outer periphery of the body. The annular shape of the grip region may be configured to extend around and not cover the defect when the body is positioned over the defect. According to one aspect, the grip region may be configured to surround the defect and have an inner circumference larger than the size of the defect. In this way, the grip region may be configured not to directly engage any part of the defect. However, as will be apparent to those skilled in the art, it should be understood that the body and / or the grip region may adopt any configuration and / or size suitable for a particular repair.

[0027] According to one aspect, the grip may be manufactured independently of the body of the prosthesis and attached to the body of the prosthesis. In this way, the grip may be formed from a material different from that of the body. For example, but not limited to, both the grip and the body may be formed of a bioabsorbable material, and the grip may have the same or a different degradation time relative to the body. For example, but not limited to, the grip may be formed of a material that is absorbed faster than the body of the prosthesis. In some applications, the grip may be formed of a bioabsorbable material and the body may be formed of a non-absorbable material. Such an arrangement can reduce the amount of foreign matter remaining in the patient's body and provide temporary grip characteristics to the prosthesis during the period of tissue integration while maintaining the long-term strength of the prosthesis.

[0028] Manufacturing the grip independently can also provide flexibility in the configuration of the prosthesis. For example, but not limited to, the prosthesis may include grips having the same or different grip configurations and / or arrangements according to the particular application of the prosthesis. For example, but not limited to, the prosthesis may include grips that are of the same shape and attached to the body in different orientations relative to each other. The prosthesis may include grips of one or more different shapes in one or more regions of the body. In this way, various grip characteristics can be provided to the prosthesis based on the particular orientation and / or shape of the grip, both individually and as a whole.

[0029] The grip may be attached directly or indirectly to the prosthesis body. According to one aspect, the prosthesis may include a grip segment including a plurality of grips provided on a common base. For example, but not limited to, each grip may include a grip body extending from a base of material, which is not limited to film material but includes these. The base may be attached to a body having a grip body protruding away from the surface of the body and configured to engage and grip tissue. The grip segment may be molded to form the grip and the base as a single integral structure.

[0030] In one aspect, the grip may be directly molded or imprinted on the body. For example, but not limited to, the grip may be insert molded into a prefabricated mesh fabric placed in a mold that receives grip material and directly forms the desired shape of the grip on the body. Alternatively, the grip may be directly imprinted on the material of the repair fabric or on a layer of material attached to the repair fabric. For example, but not limited to, the repair fabric may include a coating or layer of material such as an adhesion-resistant material on which the grip is imprinted. Such an arrangement reduces the need for separate parts and processing steps.

[0031] In one aspect, the grip may be mechanically attached to the body. For example, but not limited to, the grip may be attached using mechanical parts or arrangements attached to the body. For example, but not limited to, the body includes a layer of repair fabric and the grip may be formed independently and fixed to the fabric layer. As described above, the grip may be provided in a grip segment including a base material that is later fixed to the layer of repair fabric. Such an indirect attachment arrangement can reduce the potential for a potential decrease in the strength, tissue penetration characteristics, and / or adhesion resistance characteristics of the layer of repair fabric.

[0032] In one embodiment, the grip may be formed in a layer of film material attached to a layer of repair fabric. The grip may be integrated as part of the film layer by molding or imprinting the grip onto the film.

[0033] The prosthesis can be used to cover and / or repair soft tissue and muscular wall defects using various surgical techniques such as open surgery, laparoscopic surgery, hybrid surgery (e.g., Kugel procedure), and robotic surgery. During an open procedure, after placing the prosthesis through a relatively large incision made in the abdominal wall and tissue layers, the defect can be filled or covered with a repair fabric. During laparoscopic and hybrid procedures, for insertion into the subject, the prosthesis can be housed in a reduced configuration by being rolled or folded, directly or indirectly, through an elongated laparoscopic cannula inserted through a relatively small incision or incision, for example, a prosthesis can pass through a relatively small cannula (e.g., 8 mm) compared to cannulas commonly used in conventional laparoscopic surgery (e.g., 10 - 12 mm). The placement of the prosthesis can be particularly applied in robotic procedures achieved using robotic surgical tools. The prosthesis can be particularly suitable for use in rTAPP procedures where one or more holes can be formed in the peritoneum, particularly when creating a preperitoneal pocket. In this regard, the prosthesis may be employed to cover the holes formed in the peritoneum and isolate the organs located on one side of the peritoneum from the exposed tissue repair fabric such as a hernia repair mesh or the tissue located on the other side of the peritoneum. For example, but not limited to, the prosthesis can be employed to prevent direct contact between the exposed mesh fabric used to repair a hernia or other tissue defect in the preperitoneal pocket and the organs.

[0034] The prosthesis can be particularly applied in robotic procedures where the placement of the prosthesis includes the prosthesis passing through a relatively small cannula (e.g., 8 mm) compared to cannulas commonly used in conventional laparoscopic surgery (e.g., 10 - 12 mm). The prosthesis can be particularly suitable for use in rTAPP procedures where one or more holes can be formed in the peritoneum, particularly when creating a preperitoneal pocket. In this regard, the prosthesis may be employed to cover the holes formed in the peritoneum and isolate the organs located on one side of the peritoneum from the exposed tissue repair fabric such as a hernia repair mesh or the tissue located on the other side of the peritoneum. For example, but not limited to, the prosthesis can be employed to prevent direct contact between the exposed mesh fabric used to repair a hernia or other tissue defect in the preperitoneal pocket and the organs.

[0035] Figures 1 through 3 show one embodiment of a prosthesis for covering and / or repairing tissue and muscular wall defects, including but not limited to peritoneal defects that may be formed during preperitoneal hernia repair procedures. Prosthesis 20 may include a body 22 of implantable biocompatible material. In one embodiment, body 22 may include a repair fabric that is relatively flexible, thin, and lightweight and meets the performance and physical properties for covering and / or repairing soft tissue and muscular wall defects.

[0036] Body 22 may be configured in a size and / or shape suitable to cover or extend across an opening or weakness in the tissue and / or muscle when the body is pressed against the tissue and / or muscular wall having the defect. The body may include a first surface 24 and a second surface 26 opposite the first surface. In one embodiment, the first surface 24 may be tissue-permeable and the second surface 26 may have adhesion resistance. Thus, by way of non-limiting example, the prosthesis may be positioned at the repair site such that the first surface faces the soft tissue and / or muscle to receive ingrowth of the tissue and the second surface faces the viscera or other organs, tissues, and / or muscle to avoid adhesion of the tissue to the body of the prosthesis.

[0037] The prosthesis may also include a plurality of grips 28 on the surface of the body to provide a self-grip arrangement for maintaining the position of the prosthesis relative to the defect. In one embodiment, grips 28 may be provided on the second surface 26 of the body for engaging adjacent tissue such as the peritoneum. Thus, the grips may be provided on the adhesion-resistant surface of the body to grip the peritoneum with an adhesion-resistant surface facing the organ on the opposite side of the peritoneum when the prosthesis is implanted within the preperitoneal pocket to cover one or more holes in the peritoneum. However, it should be understood that in other applications, grips may be provided on the tissue-permeable surface of the prosthesis, if desired.

[0038] The grip 28 may be configured to grip tissue when the prosthesis is pressed against and / or onto the tissue. In this way, the grip may be configured to project from the surface of the body to engage and / or interact with the tissue sufficient to provide a desired amount of grip. In one embodiment, the grip 28 may include a microstructural arrangement configured to grip materials with a low coefficient of friction without damaging materials including tissue and / or muscle. The microstructural arrangement may be configured to grip tissue using hydrodynamics. For example, without being bound by theory, the microstructural texture of the grip may be capable of infiltrating fluid into the microstructure to provide high solid-fluid adhesion and high contact angle hysteresis.

[0039] In one embodiment shown in FIG. 3, the microstructural arrangement may include a plurality of grips 28 projecting outwardly from the base 30, forming grip segments. Each grip 28 may include a first or primary pillar 32 projecting from the base 30, and the tip 34 of the primary pillar may be spaced from the base. Also, each grip 28 may include a plurality of second or secondary pillars 36 projecting from the surface of the primary pillar 32. As shown, the secondary pillars 34 may extend from the tip of the primary pillar. The grip segment including the grip and the base may be fabricated from a film material.

[0040] In an exemplary embodiment shown in FIG. 3, each primary pillar 32 may be cylindrical. In some embodiments, the primary pillar may have a diameter D1 of approximately 0.09 inches to approximately 0.11 inches and may be spaced by a pitch P1 of approximately 0.18 inches to approximately 0.22 inches. The primary pillar may have a height H1 of approximately 0.045 inches to approximately 0.055 inches. The primary pillar may have an axis angle of approximately 3° to approximately 7°.

[0041] In one exemplary embodiment, the secondary pillar 36 may also be cylindrical and may extend substantially perpendicular to the surface of the primary pillar. In some embodiments, the secondary pillar may have a diameter D2 of approximately 0.009 inches to approximately 0.011 inches and a pitch P2 that may be spaced apart by approximately 0.018 inches to approximately 0.022 inches. The secondary pillar may have a height H2 of approximately 0.018 inches to approximately 0.022 inches.

[0042] It should be understood that the present disclosure is not limited thereto, and other cross-sectional shapes (e.g., square, elliptical, orthogonal, etc.), dimensions, and patterns of the primary and / or secondary pillars are also contemplated. It should also be understood that the secondary pillar may extend from any suitable surface of the primary pillar and / or at an angle that is not perpendicular to the surface. The segment shown in FIG. 3 includes three grips, which is shown illustratively, and it should be understood that the grip segment may include any number and density of grips suitable for a particular application.

[0043] According to one aspect, the grip 28 may be located in one or more grip regions of the body. Such an arrangement may be suitable for placing grips in selected regions of the body in accordance with a particular anatomical region. For example, as will be apparent to those skilled in the art, in regions of the body part that may come into contact with these parts of the anatomy of a defect, blood vessel, nerve, or other part of the anatomical structure of the defect site, it may be desirable not to provide a grip.

[0044] As shown in FIGS. 1 to 2, the prosthesis may include a circular body in which the grips are located within an annular grip region 38 adjacent to the outer periphery 40 of the body 22. In one embodiment, the grip region may extend continuously around the entire circumference of the body. However, it should be understood that the grips may be located in two or more regions of the body. In this regard, a plurality of grip segments may be located at desired locations on the body. It should also be understood that the prosthesis may employ a body and / or grip region of any shape suitable for a particular application.

[0045] The main body 22 may be of any size suitable for a particular repair and the size of the peritoneal hole. In one embodiment, it is particularly suitable for covering the peritoneal hole that the main body has a width in the range of 1 cm to 5 cm. In some embodiments, the main body may have a maximum width of 5 cm or less, 4 cm or less, 3 cm or less, 2 cm or less, 1 cm or more, 2 cm or more, 3 cm or more, 4 cm or more. It should be understood that for a circular main body, the maximum width corresponds to the outer diameter.

[0046] The main body may be configured to include a grip region 38 sufficient to provide a desired amount of tissue grip to maintain the prosthesis in a predetermined position relative to the defect. In one embodiment, the grip region may be configured to occupy approximately 10% to approximately 20% of the total area of the first surface 24 of the main body. For a circular main body with a diameter in the range of 1 cm to 5 cm, the grip region is approximately 0.1 cm 2 to approximately 3.92 cm 2 of the main body area.

[0047] As described above, the grip 28 may be disposed in an annular grip region 38 adjacent to the outer periphery 40 of the main body. The inner diameter D3 of the annular grip region may be about 0.90 cm to about 0.95 cm for a 1 cm diameter body, about 1.79 cm to about 1.90 cm for a 2 cm diameter body, about 2.68 cm to about 2.85 cm for a 3 cm diameter body, about 3.58 cm to about 3.80 cm for a 4 cm diameter body, and about 4.47 cm to about 4.75 cm for a 5 cm diameter body. It should be understood that the grip region may be configured to have any suitable shape and / or size with respect to the main body, as will be apparent to those skilled in the art.

[0048] The body 22 may employ a knit structure that includes a mesh fabric and has openings or pores that allow tissue penetration for incorporating the prosthesis. Also, the repair cloth may have sufficient flexibility to facilitate reduction to a size that is easy to insert into the subject body. Thus, the flexible cloth may be housed in an elongated configuration such as a roll, which is advanced with the aid of a narrow laparoscopic cannula used in laparoscopic or robotic procedures.

[0049] In one embodiment, the body 22 of the prosthesis is an absorbent repair cloth having a first surface 24 that aids in functional healing through ingrowth of tissue and a second surface 26 having an adhesive-resistant hydrogel barrier that minimizes tissue adhesion, formed from a layer of PHASIX ST Mesh (available from Davol), which is a mesh. When the mesh is implanted, it promotes rapid growth of tissue or muscle while minimizing adhesion to adjacent organs within and around the mesh structure. The prosthesis is ultimately absorbed, at which point there is no longer a need for the prosthesis to separate an organ on one side of the peritoneum from the repair mesh and / or tissue on the opposite side of the peritoneum. For example, but not limited to, the prosthesis may not be absorbed until the hernia repair mesh has integrated with the tissue and / or the mesh itself has been absorbed and is no longer affected by adhesion to the organ.

[0050] As shown in FIG. 3, a base 30 of a grip segment may be attached to the body on the second surface 26 of the body, such that a separate grip segment may be attached. However, it should be understood by those skilled in the art that the grip may be integrated with the body, for example, by molding or imprinting the grip onto the body.

[0051] In some applications, the prosthesis 20 may be formed from two or more layers of biomaterial. For example, but not limited to, the body 22 of the prosthesis may include a first or inner growth layer 42 of knit mesh fabric and a second or barrier layer 44 of adhesive-resistant material that overlays the surface of the mesh fabric. The barrier layer may be separated from and attached to the fabric layer using any suitable fastening technique, as will be apparent to those skilled in the art. For example, but not limited to, the mesh fabric and the barrier layer may be joined to each other by stitching, ultrasonic welding, laminating, and / or overmolding.

[0052] As shown in FIG. 3, the grip segment may be attached so as to overlap the barrier layer. However, in some applications, the barrier layer may be smaller than the inner growth layer having the grip segment attached thereto.

[0053] Absorbable surgical materials that can be used for mesh fabric layers and are suitable for enhancing tissue or muscle and repairing defects include, but are not limited to, PHASIX Mesh (available from Davol), Polyglyactin (VICRYL available from Ethicon), and Polyglycolic Acid (DEXON available from US Surgical). Collagen materials such as COOK SURGISIS available from Cook Biomedical may also be used. Non-absorbable materials including 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) may be suitable for use in permanently repairing tissue or muscle defects. Also, 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.

[0054] Regarding several embodiments that employ a separate barrier layer attachable to the mesh fabric layer, the barrier may be formed from a sheet of expanded polytetrafluoroethylene (ePTFE), such as GORE-TEX available from W.L. Gore & Associates, having a pore size (submicron) that prevents in-growth and adhesion of tissue. Representative and non-limiting samples of other suitable barrier materials include silicone elastomers such as Dow Corning's SILASTIC Rx medical grade sheet (platinum cured), TEFLON mesh, and microporous polypropylene sheet (CELGARD), but are not limited thereto. For example, autologous, heterologous, and homologous tissues such as epicardium and small intestinal submucosa tissue are also contemplated. In some applications, absorbent materials such as oxidized regenerated cellulose (Interseed (TC7)) may be employed. As will be apparent to those skilled in the art, it should be understood that any suitable adhesion-resistant material may be used.

[0055] In one embodiment, the grip 28 and the base 30 may be formed of an absorbable material. In this way, the grip provides the desired tissue grip for the placement and positioning of the prosthesis. The grip and the base are ultimately absorbed, at which point the prosthesis is well integrated with the tissue. In some embodiments, the grip 28 and the base 30 can be made from a GMP grade copolymer of PURASORB® PLDL7038, a 70 / 30 molar ratio of L-lactic acid and DL-lactic acid, having an intrinsic viscosity midpoint of 3.8 dl / g. Other absorbable materials that can be used for the grip, but are not limited thereto, include PLG (L-lactic acid / glycolide) or PLA (polylactic acid) polymers. In some applications, it may be desirable to use a non-absorbable grip. Non-absorbable materials that can be used for the grip, but are not limited thereto, include polypropylene. As will be apparent to those skilled in the art, it should be understood that other suitable biomaterials, absorbable or non-absorbable, may be used for the grip and / or grip segments.

[0056] In one embodiment, the grip may be manufactured using an injection molding method. However, as will be apparent to those skilled in the art, suitable manufacturing processes may be utilized for manufacturing the grip. For example, but not limited to, the grip may be manufactured using an embossing process or a 3D printing process.

[0057] As described above, the prosthesis may be suitably used during a hernia repair procedure including an abdominal wall hernia repair involving the creation of a preperitoneal pocket. Certain procedures may include a robotic transabdominal preperitoneal repair (rTAPP). This repair involves creating a preperitoneal pocket for the surgeon to place a first repair mesh inside the patient's body. Since the mesh is completely covered by the patient's peritoneum and not exposed to the internal organs and viscera within the abdominal cavity, it is often not necessary to apply an anti-adhesion barrier or coating. However, during dissection by the surgeon, one or more small holes may be opened in the peritoneum by forming the preperitoneal pocket.

[0058] The prosthesis 20 may be employed to cover the holes formed in the peritoneum and prevent contact between the hernia repair mesh and the underlying organs through the holes in the peritoneum. In this way, the prosthesis provides a barrier between the organs and the hernia repair mesh when one or more unexpected holes are made in the peritoneum during the repair procedure.

[0059] In one embodiment shown in FIGS. 4 to 7, the repair procedure includes the repair of an umbilical hernia, more specifically, a hernia in the posterior leaf of the rectus sheath. As shown in FIG. 4, as will be apparent to those skilled in the art, a preperitoneal pocket 46 (shown by a dashed line) may be formed in the area of the umbilical hernia 48 using conventional surgical techniques. This includes performing a dissection to create a tissue plane between the peritoneum 50 and the posterior leaf of the rectus sheath 52 as shown in FIG. 7.

[0060] As shown in FIGS. 4 and 5, when the peritoneum 50 is dissected from the posterior leaf of the rectus sheath by forming the pocket 46, one or more holes 54 may be created.

[0061] As shown in FIGS. 6 and 7, the holes formed in the peritoneum may be covered by one or more of the prosthesis 20 according to the present disclosure. More specifically, the prosthesis 20 may be disposed within the preperitoneal pocket 46 and positioned over the hole 54 such that the barrier surface 26 faces the peritoneum and the grip 28 contacts the peritoneum. The tissue ingrowth surface 24 of the prosthesis extends away from the peritoneum 50 and upwardly toward the hernia repair fabric 56 and / or tissue.

[0062] As shown in FIG. 7, the hernia repair mesh 56 is disposed within the preperitoneal pocket 46 and positioned over the hernia defect 60 of the posterior leaf 52 of the rectus sheath. The hernia repair mesh 56 is tissue penetrable to assist in the ingrowth of tissue that repairs the hernia defect 60 within the posterior leaf 52 of the rectus sheath, as will be apparent to those skilled in the art. As shown, the prosthesis 20 is positioned between the hole 54 in the peritoneum and the hernia repair mesh, separating the hernia repair mesh exposed by the hole in the peritoneum from the organ 58.

[0063] The particular order of disposing and positioning one or more prostheses and the hernia repair mesh within the preperitoneal pocket is at the discretion of the surgeon. For example, but not limited to, one or more prostheses 20 may be disposed within the preperitoneal pocket and placed over any holes created in the peritoneum, before, after, or simultaneously with introducing the hernia repair mesh into the preperitoneal pocket and / or positioning it over the hernia defect.

[0064] In this particular repair, the prosthesis 20 is intended to function as a barrier between the mesh fabric 56 for repairing the hernia defect and the organ 58 exposed by the hole 54 in the peritoneum. Thus, the prosthesis may be used as a type of wound dressing or bandage to prevent adhesion of the hernia repair mesh to the organ. However, it should be understood by those skilled in the art that the prosthesis may also be employed as a repair fabric for repairing defects in other applications.

[0065] For the purposes of this patent application and any patent issued thereunder, in this specification and the claims, the indefinite articles "a" and "an" as used herein shall be understood to mean "at least one" unless expressly stated otherwise. In this specification and the claims, the phrase "and / or" as used herein shall be understood to mean "either or both" of the connected elements, i.e., elements that may exist conjunctively in some cases and alternatively in other cases. Multiple elements listed in "and / or" shall be construed in like manner, i.e., as "one or more" of the connected elements. Other elements may optionally exist, whether or not specifically associated with a particular element, other than those specifically identified by the "and / or" clause.

[0066] As used herein, the use of "comprising", "including", "having", "containing", "involving", and / or variations thereof shall mean including the items listed thereafter and their equivalents, as well as additional items.

[0067] It should also be understood that in the methods claimed herein, unless otherwise specifically stated, the order of the steps or acts of the method is not necessarily required to be the same as the order of description of the method for a method comprising a plurality of steps or acts.

[0068] The foregoing description of the various embodiments is merely illustrative, and other embodiments, variations, and equivalents are included within the scope of the invention as described in the appended claims.

Claims

1. A body of implantable biocompatible material comprising a first surface and a second surface opposite to the first surface, wherein the first surface is tissue-penetrating and the second surface is adhesion-resistant, Multiple tissue grips that protrude outward away from the second surface, A transplantable prosthesis equipped with the following features.

2. The main body includes an outer circumference and a grip region adjacent to the outer circumference, The implantable prosthesis according to claim 1, wherein the plurality of tissue grips are limited to the grip area.

3. The aforementioned body is circular in shape, The implantable prosthesis according to claim 2, wherein the grip region is annular.

4. The first surface has a total surface area, The implantable prosthesis according to claim 2 or 3, wherein the grip area is approximately 10% to approximately 20% of the total surface area.

5. The main body is an implantable prosthesis according to any one of claims 1 to 3, wherein the maximum width is 5 cm or less.

6. The main body is an implantable prosthesis according to any one of claims 1 to 3, wherein the main body has a maximum width of 1 cm to 5 cm.

7. The aforementioned body is circular in shape and has an outer diameter. The implantable prosthesis according to claim 5, wherein the maximum width corresponds to the outer diameter.

8. The implantable prosthesis according to any one of claims 1 to 3, wherein the plurality of tissue grips are independent of the main body.

9. The implantable prosthesis according to any one of claims 1 to 3, wherein the plurality of tissue grips are integrated with the main body.

10. The implantable prosthesis according to claim 9, wherein the plurality of tissue grips are formed on the main body.

11. The implantable prosthesis according to any one of claims 1 to 3, wherein the plurality of tissue grips are microstructure grips.

12. The implantable prosthesis according to claim 11, wherein each of the plurality of tissue grips includes a first pillar and a plurality of second pillars extending from the surface of the first pillar.

13. The implantable prosthesis according to any one of claims 1 to 3, wherein the plurality of tissue grips are absorbable.

14. The main body is an absorbable, implantable prosthesis according to any one of claims 1 to 3.

15. An implantable prosthesis comprising a body made of an implantable biocompatible material, the body having a first surface and a second surface opposite to the first surface, wherein the first surface is tissue-penetrating and the second surface is resistant to tissue penetration, and the body has a maximum width of 5 cm or less.

16. The implantable prosthesis according to claim 15, wherein the main body has a maximum width of 4 cm or less.

17. The implantable prosthesis according to claim 15, wherein the main body has a maximum width of 3 cm or less.

18. The implantable prosthesis according to claim 15, wherein the main body has a maximum width of 2 cm or less.

19. The implantable prosthesis according to claim 15, wherein the main body has a maximum width of 1 cm to 5 cm.

20. The aforementioned body is circular in shape and has an outer diameter. The implantable prosthesis according to any one of claims 15 to 19, wherein the maximum width corresponds to the outer diameter.

21. The implantable prosthesis according to any one of claims 15 to 19, further comprising a plurality of tissue grips projecting outward away from the second surface of the main body.

22. The main body includes an outer circumference and a grip region adjacent to the outer circumference, The implantable prosthesis according to claim 21, wherein the plurality of tissue grips are limited to the grip area.

23. The aforementioned body is circular in shape, The implantable prosthesis according to claim 22, wherein the grip region is annular.

24. The first surface has a total surface area, The implantable prosthesis according to claim 22, wherein the grip area is approximately 10% to approximately 20% of the total surface area.

25. The implantable prosthesis according to claim 21, wherein the plurality of tissue grips are microstructure grips.

26. The implantable prosthesis according to claim 25, wherein each of the plurality of tissue grips includes a first pillar and a plurality of second pillars extending from the surface of the first pillar.

27. The implantable prosthesis according to any one of claims 15 to 19, wherein the plurality of tissue grips are absorbable.

28. The main body is an absorbable, implantable prosthesis according to any one of claims 15 to 19.

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