Implantable prosthesis for repairing soft tissue defects

Abstract

An implantable prosthesis for covering a defect in the peritoneum. The prosthesis may include a body (22) of implantable biocompatible material having a first surface (24) and a second surface (26). The first surface is tissue permeable and the second surface is adhesion resistant. The body includes a clip region adjacent an outer perimeter thereof having tissue clips (28) protruding in an outward direction away from the second surface. The prosthesis may be positioned between the peritoneum and a separate hernia repair fabric located in the anterior peritoneal pocket for repairing tissue or muscle wall defects, such as abdominal hernia.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Application No. 63 / 357,500, filed on June 30, 2022, and U.S. Application No. 63 / 357,491, filed on June 30, 2022, both of which are hereby incorporated by reference in their entireties. Technical Field

[0003] The present invention relates to implantable prostheses and, more particularly, to prostheses for repairing defects and weaknesses in soft tissue and muscle walls. Background Art

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

[0005] For some procedures, an implantable repair fabric (e.g., a mesh fabric) is sutured, stapled, stapled, or otherwise temporarily anchored in place above, below, or within the defect. Integration of tissue with the fabric, such as tissue ingrowth into and / or along the mesh fabric, ultimately completes the repair.

[0006] A variety of repair fabrics are known and used to repair soft tissue and muscle wall defects. Some examples of implantable fabrics that have been successfully used for soft tissue and muscle wall repair include BARD Soft Mesh, BARD Mesh, and VISILEX available from Davol, a division of Becton Dickinson. Such fabrics are made of polypropylene monofilaments that are knitted into a mesh with holes or voids that promote tissue ingrowth and integration with the fabric.

[0007] Ventral hernias can be repaired using a technique called robotic transabdominal preperitoneal repair (rTAPP). This repair involves the surgeon creating a preperitoneal pocket in the patient for placement of a repair mesh. The mesh typically does not contain any anti-adhesion barrier or covering because it will be completely covered by the patient's peritoneum and will not be exposed to the internal organs in the abdominal cavity. When a preperitoneal pocket is formed, a potential disadvantage may be the creation of one or more small holes in the peritoneum during dissection by the surgeon. Such holes are typically closed by the surgeon using sutures.

[0008] It is an object of the present invention to provide prostheses and methods for covering and / or repairing defects in soft tissue and muscle walls, including the peritoneum. Summary of the invention

[0009] The present disclosure relates to implantable prostheses and methods for covering and / or repairing anatomical defects, such as tissue or muscle wall defects, including defects in the peritoneum.

[0010] According to one aspect, an implantable prosthesis includes a body of an implantable biocompatible material. The body includes a first surface and a second surface opposite the first surface. The first surface is tissue permeable and the second surface is adhesion resistant. The body includes an outer perimeter and a clamp region adjacent to the outer perimeter. A plurality of tissue clamps are located within the clamp region of the body and protrude in an outward direction away from the second surface.

[0011] According to another aspect, an implantable prosthesis comprises a body of an implantable biocompatible material. The body comprises 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 maximum width of the body is 5 cm or less.

[0012] According to another aspect, a method for covering a defect in the peritoneum is provided. The method includes the following actions: (a) forming a preperitoneal pocket between the peritoneum and a tissue layer or a muscle layer; and (b) placing at least one first implantable prosthesis in the preperitoneal pocket. The first implantable prosthesis includes a body of a biocompatible material, wherein the body includes a first surface and a second surface. The first surface is tissue permeable and the second surface is adhesion resistant. A plurality of tissue clamps protrude in an outward direction away from the second surface. The method also includes the following actions: (c) positioning at least one first implantable prosthesis on at least one defect in the peritoneum, wherein the first surface is facing away from the peritoneum, the second surface is facing the peritoneum, and the plurality of tissue clamps are engaged with a peritoneal region adjacent to at least one peritoneal defect to maintain the first implantable prosthesis in a position relative to the peritoneal defect.

[0013] According to another aspect, a method for repairing a hernia defect is provided. The method includes the following actions: (a) forming a preperitoneal pocket between the peritoneum and a tissue layer or muscle layer having a hernia defect; and (b) placing at least one first implantable prosthesis in the preperitoneal pocket. The first implantable prosthesis comprises a body of a biocompatible material, the body comprising a first surface and a second surface, wherein the second surface is adhesion-resistant. The method also includes the following actions: (c) placing a second implantable prosthesis in the preperitoneal pocket. The second implantable prosthesis comprises a body of a biocompatible material, the body being tissue permeable for repairing a hernia defect. The method also includes the following actions: (d) positioning at least one first implantable prosthesis on at least one defect in the peritoneum, wherein the first surface is facing away from the peritoneum and the second surface is facing the peritoneum; and (e) positioning the second implantable prosthesis on the hernia defect in the tissue layer or muscle layer.

[0014] The foregoing is a non-limiting summary of the present disclosure as defined by the appended claims.Further aspects, embodiments and / or features will become apparent from the following description.

[0015] Various embodiments of the present disclosure may provide certain advantages and may overcome certain disadvantages of existing prostheses.Some embodiments of the present disclosure may not share the same advantages, and those embodiments that share the same advantages may not share them in all cases. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Some aspects of the present disclosure are described below by way of example with reference to the accompanying drawings, wherein like numerals refer to like elements, and wherein:

[0017] Figure 1 is a front view of an implantable prosthesis according to one embodiment;

[0018] Figure 2 yes Figure 1 Posterior view of the implantable prosthesis;

[0019] Figure 3 is along Figure 2 An enlarged cross-sectional view taken along section line 3-3 of FIG. 1 , showing a tissue clamp positioned along a peripheral region of the prosthesis;

[0020] Figure 4 is a schematic diagram of the human body showing the area of ​​the preperitoneal pouch formed around an abdominal hernia;

[0021] Figure 5 is an illustration of the peritoneum with multiple holes created during the formation of the peritoneal pouch;

[0022] Figure 6 yes Figure 6 Diagram of the peritoneum, where Figures 1 to 3 The implantable prosthesis is positioned over the hole; and

[0023] Figure 7 Is adopted Figures 1 to 3 Schematic diagram of an implantable prosthesis for ventral hernia repair. DETAILED DESCRIPTION

[0024] It should be understood that some aspects of the present disclosure are described herein with reference to the accompanying drawings showing illustrative embodiments according to some aspects of the present disclosure. The illustrative embodiments described herein are not necessarily intended to illustrate all aspects of the present disclosure, but are used to describe some illustrative embodiments. Therefore, it is not intended to narrowly explain some aspects of the present disclosure based on the illustrative embodiments. It should then be understood that the multiple concepts and embodiments discussed herein can be implemented in any of a variety of ways, because the disclosed concepts and embodiments are not limited to any specific implementation. It should also be understood that some aspects of the present disclosure can be used alone or in any suitable combination with other aspects of the present disclosure.

[0025] The present disclosure relates to implantable prostheses that are used to cover and / or repair anatomical defects and are particularly suitable for covering and / or repairing defects and weaknesses in soft tissue and muscle walls or other anatomical regions. The phrase "repairing a defect" includes the act of repairing, enlarging and / or reconstructing a defect and / or a potential defect. For ease of understanding, and without limiting the scope of the invention, the following describes a prosthesis that is particularly useful for connecting to a defect in the peritoneum, which may occur during the formation of a preperitoneal pocket associated with a ventral hernia repair, including but not limited to one or more of an umbilical hernia, an incisional hernia and / or other weaknesses or ruptures in the abdomen. However, it should be understood that the prosthesis is not limited thereto and can be used for other anatomical operations, as should be apparent to those skilled in the art. For example, but not limited to, the prosthesis can be used for inguinal hernia, chest wall or abdominal wall reconstruction or large defects, such as those that may occur in obese patients. The prosthesis may include one or more features (each independently or in combination) to contribute to such properties.

[0026] The present disclosure relates more particularly to prostheses that include a body of a biocompatible material (e.g., a repair fabric) configured to cover or extend through a defect opening or weakness when the body is placed against the defect. The prosthesis can be in the form of a patch, but the prosthesis can also take other configurations, as should be apparent to one skilled in the art. The patch can have a planar configuration or a non-planar configuration suitable for a particular operation used to repair the defect.

[0027] The prosthesis may be configured with a self-gripping arrangement having features that help maintain the position of the prosthesis relative to the defect. The self-gripping arrangement may reduce, if not eliminate, separation, sliding, twisting, folding, and / or other movement between the prosthesis and adjacent tissue, as may be desired. Such an arrangement may also reduce, if not eliminate, the need for the surgeon to suture, staple, staple, or otherwise temporarily anchor the prosthesis in place prior to tissue integration.

[0028] The prosthesis may include a plurality of clamps positioned on a body. More particularly, the clamps may be located on a surface of a body configured to be placed against adjacent muscles and / or tissues.

[0029] For some applications, the clamp may include a microstructure arrangement that can grip materials with low coefficients of friction without causing damage to the materials, including tissue and / or muscle. In some embodiments, the microstructure arrangement can be configured to grip tissue using fluid mechanics. For example, the microstructure texture of the clamp can allow fluid to penetrate into the microstructure, thereby providing high solid-fluid adhesion and high contact angle hysteresis.

[0030] For some applications, the clamp can be configured to penetrate and grasp tissue when the prosthesis is placed and / or pressed against the tissue. In some embodiments, the clamp can be configured to protrude a defined distance from the surface of the body portion to grasp and / or penetrate a depth of tissue sufficient to provide a desired amount of grasp. For example, the clamp can be configured as a barb, hook, or other suitable structure, as should be apparent to one skilled in the art.

[0031] The clamps may be arranged on the body in any suitable configuration to provide the desired amount of gripping, as should be apparent to one skilled in the art. For example, but not limited to, the clamps may be distributed on the body in a uniform, non-uniform or random array and / or any suitable combination of arrays. The clamps may be distributed throughout the body, or may be located at one or more selected areas of the body. For example, but not limited to, the clamps may be located at one or more selected areas adjacent to one or more portions of the outer perimeter of the body, and / or at one or more selected areas within an interior area of ​​the body positioned inwardly away from the outer perimeter. Each selected area may include one or more clamps arranged in any suitable pattern within the area. One or more of the selected areas may adopt the same or different gripping arrangements relative to one or more other selected areas of the clamps.

[0032] According to one aspect, the clamps may be located within a peripheral clamp region of the body, which is located adjacent to and extends inwardly from its outer perimeter. An interior region of the body may be free of clamps. In this manner, the clamp region may be configured and arranged to provide an adequate amount of grip with minimal coverage of the prosthesis body. According to one aspect, the area of ​​the clamp region may be proportional to the size of the body.

[0033] According to one aspect, the prosthesis body can be configured in a circular shape and the fixture area can be configured in an annular shape located adjacent to the outer perimeter of the body. The annular shape of the fixture area can be configured to extend around the defect and not cover the defect when the body is positioned on the defect. According to one aspect, the fixture area can be configured to surround the defect and have an inner perimeter that is larger than the size of the defect. In this way, the fixture area can be configured to avoid direct engagement with any portion of the defect. However, it should be understood that the body and / or fixture area can adopt any configuration and / or size suitable for a particular repair, as should be apparent to those skilled in the art.

[0034] According to one aspect, the clamp can be manufactured independently of the body of the prosthesis and mounted to the body of the prosthesis. In this way, the clamp can be formed of a material different from the body. For example, but not limited to, both the clamp and the body can be formed of a bioabsorbable material, wherein the clamp has the same or different degradation time relative to the body. For example, but not limited to, the clamp can be formed of a material that is absorbed faster than the body of the prosthesis. For some applications, the clamp can be formed of a bioabsorbable material and the body can be formed of a non-absorbable material. Such an arrangement can provide a temporary gripping property to the prosthesis during tissue integration while reducing the amount of foreign material remaining in the patient's body and maintaining the long-term strength of the prosthesis.

[0035] The independent manufacture of the clamps may also provide flexibility in configuring the prosthesis. For example, but not limited to, the prosthesis may include clamps having the same or different gripping configurations and / or arrangements, depending on the specific application of the prosthesis. For example, but not limited to, the prosthesis may include clamps having the same shape but mounted on the body at different orientations relative to each other. The prosthesis may include clamps having one or more different shapes in one or more areas of the body. In this way, a variety of gripping features may be provided for the prosthesis based on the specific orientation and / or shape of the clamps individually and as a whole.

[0036] The gripper may be mounted directly or indirectly to the body of the prosthesis. According to one aspect, the prosthesis may include a gripper section including a plurality of grippers disposed on a common base. For example, but not limited to, each gripper may include a gripper body extending from a material base including, but not limited to, a film material. The base may be mounted to the body, wherein the gripper body protrudes from a surface of the body and is configured to engage and grip tissue. The gripper section may be molded with the gripper and the base to form a single unitary structure.

[0037] In one aspect, the clamp may be molded or embossed directly onto the body. For example, but not limited to, the clamp may be insert molded into a preformed mesh fabric placed in a mold that receives the clamp material and forms the desired clamp shape directly onto the body. Alternatively, the clamp may be embossed directly onto the material of the repair fabric, or onto a layer of material attached to the repair fabric. For example, but not limited to, the repair fabric may include a covering layer or layer of material (e.g., an adhesion resistant material) onto which the clamp may be embossed. This arrangement would reduce the need for additional components and processing steps.

[0038] In one aspect, the clamp can be mechanically mounted to the body. For example, but not limited to, the clamp can be mounted using a mechanical assembly or arrangement attached to the body. For example, but not limited to, the body can include a repair fabric layer, and the clamp can be independently formed and secured to the fabric layer. As described above, the clamp can be disposed on a clamp section that includes a base material that is subsequently secured to the repair fabric layer. Such an indirect mounting arrangement can reduce the likelihood of potential degradation of the strength, tissue penetration characteristics, and / or adhesion resistance characteristics of the repair fabric layer.

[0039] In one embodiment, the clamp may be formed on a layer of membrane material attached to the repair fabric layer. The clamp may be integrated as part of the membrane layer by molding or embossing the clamp on the membrane.

[0040] Prostheses can be used to cover and / or repair soft tissue and muscle wall defects using a variety of surgical techniques, including open surgery, laparoscopic surgery, hybrid surgery (e.g., Kugel surgery), and robotics. During open surgery, the prosthesis can be placed through a relatively large incision made in the abdominal wall and tissue layers, and the defect can then be filled or covered with a repair fabric. During laparoscopic and hybrid surgery, the prosthesis can be collapsed into a reduced configuration, such as by rolling or folding, for entry into a subject directly through a relatively small incision or through an elongated laparoscopic cannula placed through the incision.

[0041] The prosthesis may be particularly suitable for robotic surgery, where surgical robotic tools are used to achieve placement of the prosthesis, which may involve passing the prosthesis through a relatively small cannula (e.g., 8 mm) compared to the cannula (e.g., 10 to 12 mm) typically used for more conventional laparoscopic techniques. The prosthesis may be particularly suitable for rTAPP surgery, where one or more holes may be formed in the peritoneum during the creation of a preperitoneal pocket. In this regard, the prosthesis may be used to cover the holes formed in the peritoneum to separate the viscera located on one side of the peritoneum from the exposed tissue repair fabric (e.g., hernia repair mesh) or tissue located on the opposite side of the peritoneum. For example, but not limited to, the prosthesis may be used to prevent direct contact between the viscera and the exposed mesh fabric within the preperitoneal pocket for repairing a hernia or other tissue defect.

[0042] Figures 1 to 3 One embodiment of a prosthesis for covering and / or repairing tissue and muscle wall defects is shown, including but not limited to defects in the peritoneum that may be formed during preperitoneal hernia repair surgery. Prosthesis 20 may include a body 22 of an implantable biocompatible material. In one embodiment, body 22 may include a repair fabric that is relatively flexible, thin, and lightweight and that meets the performance and physical properties for covering and / or repairing soft tissue and muscle wall defects.

[0043] The body 22 can be configured to have a size and / or shape suitable for covering or extending across an opening or weakness in the tissue and / or muscle when the body is placed against a tissue and / or muscle wall having a defect. The body can include a first surface 24 and a second surface 26 opposite the first surface. In one embodiment, the first surface 24 can be tissue permeable and the second surface 26 can be adhesion resistant. In this manner, but not limited to, the prosthesis can be positioned at a repair site with the first surface facing the soft tissue and / or muscle to receive tissue ingrowth, and with the second surface facing the viscera or other organs, tissues and / or muscles to avoid tissue adhesion to the body.

[0044] The prosthesis may also include a plurality of clamps 28 on the surface of the body to provide a self-gripping arrangement for maintaining the position of the prosthesis relative to the defect. In one embodiment, the clamps 28 may be disposed on the second surface 26 of the body for engaging adjacent tissue, such as the peritoneum. In this manner, when the prosthesis is implanted in a preperitoneal pocket to cover one or more holes in the peritoneum, the clamps may be disposed on the adhesion-resistant surface of the body to grip the peritoneum, wherein the adhesion-resistant surface faces the viscera on the opposite side of the peritoneum. However, it should be understood that, if desired, the clamps may be disposed on the tissue-permeable surface of the prosthesis for other applications.

[0045] When the prosthesis is placed and / or pressed against the tissue, the clamp 28 can be configured to grip the tissue. In this way, the clamp can be configured to protrude from the surface of the body to fully engage and / or interact with the tissue, thereby providing a desired amount of grip. In one embodiment, the clamp 28 may include a microstructure arrangement configured to grip a material with a low coefficient of friction without causing damage to the material (including tissue and / or muscle). The microstructure arrangement can be configured to grip the tissue using fluid mechanics. For example, and without being bound by theory, the microstructure texture of the clamp can allow fluid to penetrate into the microstructure to provide high solid-fluid adhesion and high contact angle hysteresis.

[0046] exist Figure 3In one embodiment shown in FIG. 1 , the microstructure arrangement may include a plurality of clamps 28 protruding outwardly from a base 30 to form a clamp section. Each clamp 28 may include a first or primary pillar 32 protruding from the base 30, wherein the distal end 34 of the primary pillar is spaced apart from the base. Each clamp 28 may also include a plurality of second pillars or secondary pillars 36 protruding from the surface of the primary pillar 32. As shown, the secondary pillars 34 may extend from the distal end of the primary pillar. The clamp section including the clamps and the base may be made of a membrane material.

[0047] In such Figure 3 In one illustrative embodiment shown in FIG. 1 , each main column 32 may have a cylindrical shape. In some embodiments, the main columns may have a diameter D1 of about 0.09 inches to about 0.11 inches and may be spaced apart at a pitch P1 of about 0.18 inches to about 0.22 inches. The height H1 of the main columns may be about 0.045 inches to about 0.055 inches. The axis angle of the main columns is about 3° to about 7°.

[0048] In an illustrative embodiment, the secondary pillars 36 may also have a cylindrical shape and extend from the surface of the primary pillar in a substantially vertical direction. In some embodiments, the diameter D2 of the secondary pillars may be about 0.009 inches to about 0.011 inches, and may be spaced apart at a pitch P2 of about 0.018 inches to about 0.022 inches. The height H2 of the secondary pillars may be about 0.018 inches to about 0.022 inches.

[0049] It should be understood that other cross-sectional shapes (e.g., square, oval, orthogonal, etc.), sizes, and styles for the primary and / or secondary posts are also contemplated, as the present disclosure is not limited thereto. It should also be understood that the secondary posts may extend from any suitable surface of the primary post and / or at an angle that is not perpendicular to that surface. Although Figure 3 The section shown in FIG. 1 contains three clamps, but it should be understood that this is for illustrative purposes only and that the clamp section may contain any number and density of clamps suitable for a particular application.

[0050] According to one aspect, the clamp 28 can be located at one or more clamp regions of the body. Such an arrangement can be suitable for placing the clamp in selected areas of the body to accommodate specific anatomical regions. For example, it may be desirable to avoid providing clamps on areas of the body portion that could potentially contact a defect, blood vessel, nerve, or other portion of the anatomical structure at the defect site, as should be apparent to one skilled in the art.

[0051] like Figures 1 to 2, the prosthesis may include a circular body with the clamp located within an annular clamp region 38 adjacent to the outer perimeter 40 of the body 22. In one embodiment, the clamp region may extend continuously around the entire perimeter of the body. However, it should be understood that the clamp may be located in two or more areas of the body. In this regard, multiple clamp sections may be located at desired locations of the body. Furthermore, it should be understood that the prosthesis may employ a body and / or clamp region having any shape suitable for a particular application.

[0052] The body 22 can have any size suitable for the particular repair and size of the hole in the peritoneum. In one embodiment, particularly one suitable for covering a hole in the peritoneum, the width of the body can be 1 cm to 5 cm. In some embodiments, the maximum width of the body can be 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, and 4 cm or more. For a circular body, it should be understood that its maximum width corresponds to the outer diameter.

[0053] The body can be configured to include a clamping area 38 sufficient to provide the desired amount of tissue clamping to maintain the prosthesis in position relative to the defect. In one embodiment, the clamping area can be configured to occupy about 10% to about 20% of the total area of ​​the first surface 24 of the body. For a circular body with a diameter of 1 cm to 5 cm, the clamping area can be configured to occupy about 0.1 cm of the body area. 2 To about 3.92cm 2 .

[0054] As described above, the clamp 28 can be arranged in an annular clamp area 38 adjacent to the outer perimeter 40 of the body. The inner diameter D3 of the annular clamp area can be about 0.90 cm to 0.95 cm for a body with a diameter of 1 cm, about 1.79 cm to 1.90 cm for a body with a diameter of 2 cm, about 2.68 cm to 2.85 cm for a body with a diameter of 3 cm, about 3.58 cm to 3.80 cm for a body with a diameter of 4 cm, and about 4.47 cm to 4.75 cm for a body with a diameter of 5 cm. It should be understood that the clamp area can be configured to have any suitable shape and / or size relative to the body, as should be apparent to those skilled in the art.

[0055] The body 22 may comprise a mesh fabric and may be of knitted construction providing openings or holes to allow tissue infiltration to incorporate the prosthesis. The repair fabric may also be sufficiently flexible to facilitate easy reduction in size to enter the subject. In this manner, the flexible fabric may be collapsed into an elongated configuration, such as a roll, which may be supported in and advanced through a narrow laparoscopic cannula for laparoscopic or robotic surgery.

[0056] In one embodiment, the body 22 of the prosthesis can be formed from a layer of PHASIX ST mesh (available from Davol, Inc.), which is an absorbable repair fabric having a first surface 24 that supports functional healing by tissue ingrowth and a second surface 26 of a hydrogel barrier that is adhesion resistant to minimize tissue attachment. Upon implantation, the mesh promotes rapid ingrowth of tissue or muscle into and around the mesh structure while minimizing potential attachment to adjacent viscera. The prosthesis is eventually absorbed, at which point the prosthesis no longer needs to separate the viscera 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 no longer be absorbed until such a time that the hernia repair mesh has integrated with the tissue and / or has been absorbed by itself so as to no longer be susceptible to adhesion to the viscera.

[0057] like Figure 3 As shown in the figure, the individual clamp sections can be mounted on the second surface 26 of the body, wherein the base 30 of the clamp section is attached to the body. However, it should be understood that the clamp can be integrated with the body, such as by molding or stamping the clamp on the body, as will be understood by those skilled in the art.

[0058] For some applications, the prosthesis 20 may be formed of two or more layers of biocompatible material. For example, but not limited to, the body 22 of the prosthesis may include a first layer or ingrowth layer 42 of a knitted mesh fabric and a second layer or barrier layer 44 of an adhesion-resistant material covering the surface of the mesh fabric. The barrier layer may be separate from the fabric layer and attached to the fabric layer using any suitable fastening technique, as should be apparent to one skilled in the art. For example, but not limited to, the mesh fabric and the barrier layer may be connected together by suturing, ultrasonic welding, lamination, and / or overmolding.

[0059] like Figure 3 As shown in FIG. 1 , the clamp segments may cover and be mounted on the barrier layer. However, for some applications, the barrier layer may be smaller than the ingrowth layer, with the clamp segments being mounted on the ingrowth layer.

[0060] Some examples of absorbable surgical materials that can be used for the mesh fabric layer and are suitable for tissue or muscle augmentation and defect correction include, but are not limited to, PHASIX Mesh (available from Davol, Inc.), polyglactin (VICRYL—available from Ethicon, Inc.), and polyethylene glycol acid (DEXON—available from US Surgical, Inc.). Collagen materials such as COOK SURGISIS available from Cook Biomedical, Inc. can also be used. Non-absorbable materials may be suitable for applications involving permanent correction of tissue or muscle defects, including: BARD Mesh (available from Davol, Inc.), BARD SoftMesh (available from Davol, Inc.), SOFT TISSUE PATCH (microporous ePTFE-available from WL Gore & Associates, Inc.); SURGIPRO (available from US Surgical, Inc.); TRELEX (available from Meadox Medical); PROLENE and MERSILENE (available from Ethicon, Inc.); and other mesh materials (e.g., available from Atrium Medical Corporation). It is also contemplated that the mesh fabric may be formed from multifilament yarns, and that any suitable method, such as knitting, weaving, braiding, molding, etc., may be used to form the mesh material.

[0061] For some embodiments employing a separate barrier layer that can be attached to the mesh fabric layer, the barrier can be formed from an expanded polytetrafluoroethylene (ePTFE) sheet, such as GORETEX available from WL Gore & Associates, Inc., which has a pore size (submicron) that hinders tissue ingrowth and adhesion. Exemplary and non-limiting sampling of other suitable barrier materials include silicone elastomers (e.g., SILASTIC Rx medical grade sheet (platinum cured) distributed by Dow Corning Corporation), TEFLON mesh, and microporous polypropylene sheet (CELGARD). Autologous, allogeneic, and xenogeneic tissues are also contemplated, including, for example, the pericardium and the submucosa of the small intestine. Absorbable materials, such as oxidized regenerated cellulose (Intercede (TC7)), can be used for some applications. It should be understood that any suitable adhesion-resistant material can be used, as should be apparent to those skilled in the art.

[0062] In one embodiment, the clamp 28 and base 30 can be formed of an absorbable material. In this way, the clamp provides a desired level of tissue grip for placement and positioning of the prosthesis. The clamp and base will eventually be absorbed, at which point the prosthesis has fully integrated with the tissue. In some embodiments, the clamp 28 and base 30 can be made of PURASORB 7038 is made of PLDL 7038, which is a GMP grade copolymer of L-lactide and DL-lactide in a molar ratio of 70 / 30 and has an intrinsic viscosity midpoint of 3.8 dl / g. Some examples of other absorbable materials that can be used for the clamp include, but are not limited to, PLG (L-lactide / glycolide) or PLA (polylactic acid) polymers. For some applications, it is desirable to use a non-absorbable clamp. An example of a non-absorbable material that can be used for the clamp includes, but is not limited to, polypropylene. It should be understood that other suitable biocompatible materials (absorbable or non-absorbable) can be used for the clamp and / or clamp segments, as should be obvious to those skilled in the art.

[0063] In one embodiment, the fixture can be manufactured using an injection molding process. However, any suitable manufacturing process can be used to manufacture the fixture, as should be apparent to those skilled in the art. For example, but not limited to, the fixture can be manufactured using an embossing or 3D printing process.

[0064] As described above, the prosthesis may be suitable for use during hernia repair surgery, including ventral hernia repair involving the creation of a preperitoneal pocket. One specific surgery may involve a robotic transabdominal preperitoneal repair (rTAPP). This repair involves the surgeon creating a preperitoneal pocket within the patient for placement of a primary repair mesh. The mesh typically does not include any anti-adhesion barrier or covering because it will be completely covered by the patient's peritoneum and will not be exposed to the internal organs or viscera within the abdominal cavity. However, the creation of a preperitoneal pocket may result in one or more small holes being created in the peritoneum during dissection by the surgeon.

[0065] The prosthesis 20 can be used to cover the holes formed in the peritoneum and prevent contact between the hernia repair mesh and the underlying viscera through the holes in the peritoneum. In this way, if one or more holes are accidentally created in the peritoneum during repair surgery, the prosthesis provides a barrier between the viscera and the hernia repair mesh.

[0066] exist Figures 4 to 7 In one embodiment shown in , the repair surgery involves the repair of an umbilical hernia, and more particularly, the repair of a hernia in the posterior rectus muscle sheet. Figure 4 As shown in FIG. 1 , a preperitoneal pocket 46 (shown in phantom) may be formed in the region of the umbilical hernia 48 in accordance with conventional surgical techniques as will be understood by those of ordinary skill in the art. Figure 7As shown in FIG, this involves performing a dissection to create a tissue plane between the peritoneum 50 and the posterior rectus muscle sheet 52.

[0067] As in Figure 4 and Figure 5 As shown in , the formation of the pocket 46 may result in one or more holes 54 being created in the peritoneum 50 when the peritoneum 50 is peeled away from the posterior rectus muscle sheet.

[0068] As in Figure 6 and Figure 7 , a hole formed in the peritoneum can be covered by one or more prostheses 20 according to the present disclosure. More specifically, the prosthesis 20 can be placed in the preperitoneal pocket 46 and positioned over the hole 54, with the barrier surface 26 facing the peritoneum, and the clamp 28 placed in contact with the peritoneum. The tissue ingrowth surface 24 of the prosthesis faces away from the peritoneum 50 toward the covering hernia repair fabric 56 and / or tissue.

[0069] As in Figure 7 , a hernia repair mesh 56 is placed in the preperitoneal bag 46 and positioned over the hernia defect 60 in the posterior rectus sheath 52. The hernia repair mesh 56 is tissue permeable to support tissue ingrowth for repairing the hernia defect 60 in the posterior rectus sheath 52, as will be understood by one of ordinary skill in the art. As shown, the prosthesis 20 is positioned between the hole 54 in the peritoneum and the hernia repair mesh to separate the hernia repair mesh from the viscera 58 exposed by the hole in the peritoneum.

[0070] The specific order in which one or more prostheses and the hernia repair mesh are placed and positioned within the preperitoneal bag is at the discretion of the surgeon. For example, but not limited to, one or more prostheses 20 may be placed within the preperitoneal bag and positioned over any holes created in the peritoneum before, after, or simultaneously with the introduction of the hernia repair mesh into the preperitoneal bag and / or positioning the hernia repair mesh over the hernia defect.

[0071] For this particular repair, the prosthesis 20 is intended to function as a barrier between the mesh fabric 56 used to repair the hernia defect and the viscera 58 exposed by the hole 54 in the peritoneum. In this manner, the prosthesis can be used as a type of wound cover or bandage to prevent adhesions between the hernia repair mesh and the viscera. However, it should be understood that in other applications, the prosthesis can be used as a repair fabric for repairing defects, as should be apparent to those skilled in the art.

[0072] For the purposes of this patent application and any patent issued therefor, unless expressly indicated to the contrary, nouns used herein in the specification and in the claims without quantifier modification should be understood to mean "at least one / kind". The phrase "and / or" as used herein in the specification and in the claims should be understood to mean "either or both" of the elements so connected, i.e., elements that exist jointly in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so connected. Other elements other than the elements specifically indicated by the "and / or" clause may optionally be present, whether or not related to those elements specifically indicated.

[0073] The use of "including," "comprising," "having," "containing," "involving," and / or variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof, as well as additional items.

[0074] It should also be understood that in any method claimed herein that includes more than one step or action, the order of the method steps or actions is not necessarily limited to the order of the method steps or actions as described unless explicitly stated to the contrary.

[0075] The foregoing description of various embodiments is intended to be illustrative only and other embodiments, modifications and equivalents are within the scope of the invention as recited in the following claims.

Claims

1. An implantable prosthesis comprising: a body of implantable biocompatible material, the body comprising a first surface and a second surface opposite the first surface, the first surface being tissue permeable and the second surface being adhesion resistant; and A plurality of tissue clamps project in an outward direction away from the second surface.

2. The implantable prosthesis of claim 1, wherein the body comprises an outer perimeter and a clamping region adjacent the outer perimeter, the plurality of tissue clamps being confined within the clamping region.

3. The implantable prosthesis of claim 2, wherein the body has a circular shape and the clamping region has an annular shape.

4. The implantable prosthesis of any one of claims 2 to 3, wherein the first surface has a total surface area, and the clamping area is about 10% to about 20% of the total surface area.

5. The implantable prosthesis according to any one of claims 1 to 4, wherein the maximum width of the body is 5 cm or less.

6. The implantable prosthesis according to any one of claims 1 to 4, wherein the maximum width of the body is 1 cm to 5 cm.

7. The implantable prosthesis according to any one of claims 5 to 6, wherein the body has a circular shape with an outer diameter, the maximum width corresponding to the outer diameter.

8. The implantable prosthesis of any one of claims 1 to 7, wherein the plurality of tissue clamps are independent of the body.

9. The implantable prosthesis of any one of claims 1 to 7, wherein the plurality of tissue clamps are integral with the body.

10. The implantable prosthesis of claim 9, wherein the plurality of tissue clamps are molded to the body.

11. The implantable prosthesis of any one of claims 1 to 10, wherein the plurality of tissue clamps are microstructure clamps.

12. The implantable prosthesis of claim 11, wherein each of the plurality of tissue clamps comprises a first post and a plurality of second posts extending from a surface of the first post.

13. The implantable prosthesis of any one of claims 1 to 12, wherein the plurality of tissue clamps are absorbable.

14. The implantable prosthesis according to any one of claims 1 to 13, wherein the body is absorbable.

15. A method of covering a defect in the peritoneum, the method comprising the following acts: (a) forming a preperitoneal pocket between the peritoneum and the tissue layer or muscle layer; (b) placing at least one first implantable prosthesis within the preperitoneal pocket, the first implantable prosthesis comprising a body of a biocompatible material, the body comprising a first surface and a second surface, the first surface being tissue permeable and the second surface being adhesion resistant, the implantable prosthesis further comprising a plurality of tissue clips projecting in an outward direction away from the second surface; (c) positioning the at least one first implantable prosthesis on at least one defect in the peritoneum, wherein the first surface faces away from the peritoneum and the second surface faces the peritoneum, wherein the plurality of tissue clamps engage with a peritoneal region adjacent to the at least one defect to maintain the at least one first implantable prosthesis in a position relative to the at least one defect.

16. The method of claim 15, wherein act (c) comprises placing the second surface against the peritoneum.

17. A method according to any one of claims 15 to 16, wherein the peritoneum includes multiple defects, wherein action (b) comprises placing a plurality of first implantable prostheses within the preperitoneal pocket, and wherein action (c) comprises positioning each of the plurality of first implantable prostheses over each defect in the peritoneum.

18. The method of any one of claims 15 to 17, further comprising an act (d) of placing a second implantable prosthesis in the preperitoneal pocket, the second implantable prosthesis comprising a body of a biocompatible material, the body being tissue permeable.

19. The method of claim 18, further comprising an act (e) of positioning the second implantable prosthesis at the hernia defect in the tissue layer or muscle layer.

20. The method of any one of claims 18 to 19, wherein act (c) comprises positioning one or more first implantable prostheses over one or more defects in the peritoneum and between the second implantable prosthesis and the peritoneum.

21. The method of any one of claims 15 to 20, wherein the tissue layer or muscle layer is the posterior rectus sheath.

22. The method of any one of claims 15 to 21, wherein the method is a robotic transabdominal preperitoneal repair (rTAPP) procedure.

23. The method of any one of claims 15 to 22, wherein the body has an outer perimeter and a clamping region adjacent the outer perimeter, the plurality of tissue clamps being confined within the clamping region.

24. The method of claim 23, wherein the body has a circular shape and the clamping area has an annular shape.

25. The method of any one of claims 23 to 24, wherein the first surface has a total surface area and the clamping area is about 10% to about 20% of the total surface area.

26. The method of any one of claims 15 to 24, wherein the plurality of tissue clamps protrude in an outward direction relative to the second surface.

27. The method of any one of claims 15 to 26, wherein the maximum width of the body of the first implantable prosthesis is 5 cm or less.

28. The method of claim 27, wherein the maximum width of the body is 4 cm or less.

29. The method of claim 27, wherein the maximum width of the body is 3 cm or less.

30. The method of claim 27, wherein the maximum width of the body is 2 cm or less.

31. The method of claim 27, wherein the maximum width of the body is 1 cm or greater.

32. The method of claim 27, wherein the maximum width of the body is 1 cm to 5 cm.

33. The method of claims 27 to 32, wherein the body has a circular shape having an outer diameter, the maximum width corresponding to the outer diameter.

34. The method of any one of claims 15 to 33, wherein the plurality of fixtures are microstructure fixtures.

35. The method of claim 34, wherein each of the plurality of tissue clamps comprises a first post and a plurality of second posts extending from a surface of the first post.

36. The method of any one of claims 15 to 35, wherein the plurality of tissue clamps are absorbable.

37. The method of any one of claims 15 to 36, wherein the body is absorbable.

38. An implantable prosthesis comprising: A body of implantable biocompatible material, the body comprising a first surface and a second surface opposite the first surface, the first surface being tissue permeable and the second surface being resistant to tissue penetration, the body having a maximum width of 5 cm or less.

39. The implantable prosthesis of claim 38, wherein the maximum width of the body is 4 cm or less.

40. The implantable prosthesis of claim 38, wherein the maximum width of the body is 3 cm or less.

41. The implantable prosthesis of claim 38, wherein the maximum width of the body is 2 cm or less.

42. The implantable prosthesis of claim 38, wherein the maximum width of the body is between 1 cm and 5 cm.

43. The implantable prosthesis of any one of claims 38 to 42, wherein the body has a circular shape having an outer diameter, the maximum width corresponding to the outer diameter.

44. The implantable prosthesis of any one of claims 38 to 43, further comprising a plurality of tissue clips projecting in an outward direction away from the second surface of the body.

45. The implantable prosthesis of claim 44, wherein the body comprises an outer perimeter and a clamping region adjacent the outer perimeter, the plurality of tissue clamps being confined within the clamping region.

46. ​​The implantable prosthesis of claim 45, wherein the body has a circular shape and the clamp region has an annular shape.

47. The implantable prosthesis of any one of claims 45 to 46, wherein the first surface has a total surface area, and the clamping area is about 10% to about 20% of the total surface area.

48. The implantable prosthesis of any one of claims 44 to 47, wherein the plurality of tissue clamps are microstructure clamps.

49. The implantable prosthesis of claim 48, wherein each of the plurality of tissue clamps comprises a first post and a plurality of second posts extending from a surface of the first post.

50. The implantable prosthesis of any one of claims 38 to 49, wherein the plurality of tissue clamps are absorbable.

51. The implantable prosthesis of any one of claims 38 to 50, wherein the body is absorbable.

52. A method of repairing a hernia defect, the method comprising the following actions: (a) A preperitoneal pocket is formed between the peritoneum and the tissue layer or muscle layer containing the hernial defect; (b) placing at least one first implantable prosthesis in the preperitoneal pocket, the first implantable prosthesis comprising a body of a biocompatible material, the body comprising a first surface and a second surface, the second surface being adhesion resistant; (c) placing a second implantable prosthesis in the preperitoneal pocket, the second implantable prosthesis comprising a body of a biocompatible material, the body being tissue permeable for repairing the hernia defect; (d) positioning the at least one first implantable prosthesis over at least one defect in the peritoneum, wherein the first surface faces away from the peritoneum and the second surface faces toward the peritoneum; as well as (e) positioning the second implantable prosthesis over the hernia defect in the tissue layer or muscle layer.

53. The method of claim 52, wherein the at least one first implantable prosthesis further comprises a plurality of tissue clips projecting in an outward direction away from the second surface.

54. The method of claim 53, wherein action (d) comprises engaging the plurality of tissue clamps with a peritoneal region adjacent to at least one defect in the peritoneum to maintain the at least one first implantable prosthesis in a position relative to the defect in the peritoneum.

55. The method of any one of claims 53 to 54, wherein the plurality of fixtures are microstructure fixtures.

56. The method of any one of claims 53 to 55, wherein the body of the at least one first implantable prosthesis has a circular shape having an outer perimeter and includes an annular clamping region adjacent to the outer perimeter, the plurality of clamps being confined within the clamping region.

57. The method of claim 56, wherein the first surface of the body has a total surface area, and the clamping area is about 10% to about 20% of the total surface area.

58. The method of any one of claims 53 to 57, wherein the plurality of tissue clamps protrude in an outward direction relative to the second surface.

59. The method of any one of claims 53 to 58, wherein the plurality of tissue clamps are absorbable.

60. The method of any one of claims 52 to 59, wherein act (b) comprises placing a plurality of first implantable prostheses within the preperitoneal pocket, and act (d) comprises positioning the plurality of first implantable prostheses over a plurality of defects in the peritoneum.

61. The method of any one of claims 52 to 60, wherein at least one of actions (b) and (d) occurs before at least one of actions (c) and (e).

62. The method of any one of claims 52 to 60, wherein at least one of action (c) and action (e) occurs before at least one of action (b) and action (d).

63. The method of any one of claims 52 to 62, wherein act (d) comprises positioning one or more first implantable prostheses between the second implantable prosthesis and the peritoneum.

64. The method of any one of claims 52 to 63, wherein the tissue layer or muscle layer is the posterior rectus sheath.

65. The method of any one of claims 52 to 64, wherein the method is a robotic transabdominal preperitoneal repair (rTAPP) procedure.

66. The method of any one of claims 52 to 65, wherein the maximum width of the body of the at least one first implantable prosthesis is 5 cm or less.

67. The method of claim 66, wherein the maximum width of the body is from 1 cm to 5 cm.

68. The method of claims 66 to 67, wherein the body has a circular shape having an outer diameter, the maximum width corresponding to the outer diameter.

69. The method of any one of claims 52 to 68, wherein the body is absorbable.

70. The method of any one of claims 52 to 69, wherein the first surface of the body is tissue permeable.

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