Implantable prosthesis

Abstract

An implantable prosthesis for preventing, reinforcing and / or repairing anatomical defects, including parastomal hernia that may occur after forming a stoma or an ostomy opening, such as parastomal hernia formed in conjunction with ileostomy or colostomy. The prosthesis may include a body made of a biocompatible material having a preformed three-dimensional channel configured to receive a portion of a lateral intestinal tract created in conjunction with parastomal hernia repair or ostomy. An anti-adhesion barrier may be located on the inner side of the channel to isolate the portion of the lateral intestinal tract from the tissue permeable surface of the body to reduce or eliminate potential adhesion between the body and the lateral intestinal tract. A portion of the channel may include a flared section extending inwardly from the outer periphery to reduce pressure of the portion of the lateral intestinal tract at the open end of the channel.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. application no. 63 / 357,152, filed on June 30, 2022, and U.S. application no. 63 / 357,175, filed on June 30, 2022, both of which are incorporated herein by reference in their entirety. 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 using implantable prostheses that are configured to cover and / or fill the defect.

[0005] For some procedures, an implantable repair fabric, such as a mesh fabric, is sutured, stapled, tacked, or otherwise temporarily anchored in place over, under, or within the defect. Tissue fusion to 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. Examples of implantable fabrics that have been successfully used in soft tissue and muscle wall repair include BARD Soft Mesh, BARD Mesh, PHASIX Mesh, and PHASIX ST Mesh available from Davol, a Becton Dickinson company. Such fabrics are made of monofilaments that are woven into a mesh with holes or gaps that promote tissue ingrowth and fusion with the fabric. Some fabrics have anti-adhesion properties.

[0007] A parastomal hernia is an incisional hernia that occurs at or near the stoma. It is a complication associated with ileostomy, colostomy, or ileal conduit stoma. A parastomal hernia can be repaired using a variety of techniques, including the Sugarbaker technique. The repair involves the surgeon performing an open procedure, such as a laparotomy, or a minimally invasive procedure, such as a laparoscopic or robotic procedure. After hernia reduction, cystectomy, and trephine reduction, the ostomy opening is covered with a prosthetic mesh placed intraperitoneally and sutured to the fascia. The intestine is lateralized and secured between the mesh and the peritoneum, thereby lateralizing the forces that press the intestine ventrally against the abdominal wall so that instead of pushing upward toward the defect, these forces press ventrally against the intact abdominal wall.

[0008] It is an object of the present invention to provide a prosthesis and method for preventing and / or repairing defects in soft tissue and muscle wall including parastomal hernias. Summary of the invention

[0009] The present disclosure relates to an implantable prosthesis and method for augmenting, preventing and / or repairing anatomical defects, such as tissue or muscle wall defects including parastomal hernias.

[0010] According to one aspect, an implantable prosthesis includes a body made of an implantable biocompatible material, a preformed channel on the body, and an anti-adhesion barrier. The body has a preformed three-dimensional configuration and includes a first surface and a second surface opposite to the first surface. The first surface is tissue permeable and the second surface is anti-adhesion. The channel has a three-dimensional configuration to receive a portion of a lateralized intestinal tract and includes an inner side formed by a portion of the first surface and an outer side formed by a portion of the second surface. The anti-adhesion barrier is located on the inner side of the channel to isolate the portion of the lateralized intestinal tract from the first surface.

[0011] According to another aspect, an implantable prosthesis includes a body made of an implantable biocompatible material, a channel located on the body, and an anti-adhesion barrier. The body has a circular configuration and includes a first surface and a second surface opposite to the first surface. The first surface is tissue permeable and the second surface is anti-adhesion. The channel is configured to receive a portion of a lateralized intestinal tract and includes an inner side formed by a portion of the first surface and an outer side formed by a portion of the second surface. The anti-adhesion barrier is located on the inner side of the channel to isolate the portion of the lateralized intestinal tract from the first surface.

[0012] According to another aspect, a method for reinforcing a stoma, repairing a parastomal hernia, or preventing a parastomal hernia is provided. The method comprises the following actions: (a) placing a prosthesis intra-abdominally on the stoma. The prosthesis comprises a body made of an implantable, biocompatible material and a preformed channel on the body. The channel has a three-dimensional configuration to accommodate a portion of a lateralized intestine. The body comprises a first surface and a second surface opposite to the first surface. The first surface is tissue permeable and the second surface is anti-adhesion. The channel comprises an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface. An anti-adhesion barrier is positioned on the inner portion of the channel. The method further comprises the following actions: (b) placing the preformed channel on a portion of the lateralized intestine extending from the stoma, wherein the anti-adhesion barrier isolates the portion of the lateralized intestine from the inner portion of the channel, and fixing the prosthesis to the fascia.

[0013] According to another aspect, a method for reinforcing a stoma, repairing a parastomal hernia, or preventing a parastomal hernia is provided. The method comprises the following actions: (a) placing a prosthesis intra-abdominally on the stoma. The prosthesis comprises a body made of an implantable, biocompatible material and a preformed channel on the body. The channel is configured to receive a portion of a lateralized intestinal tract. The body has a circular configuration and comprises a first surface and a second surface opposite to the first surface. The first surface is tissue permeable and the second surface is anti-adhesion. The channel comprises an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface. An anti-adhesion barrier is positioned on the inner portion of the channel. The method further comprises the following actions: (b) placing the channel on a portion of the lateralized intestinal tract extending from the stoma, wherein the anti-adhesion barrier isolates the portion of the lateralized intestinal tract from the inner portion of the channel, and fixing the prosthesis to the fascia.

[0014] According to another aspect, an implantable prosthesis includes a body made of an implantable, biocompatible material and a channel preformed on the body. The body has a preformed three-dimensional configuration and includes a first surface and a second surface opposite the first surface. The body also includes an outer periphery. The channel is preformed on the body and has a three-dimensional configuration to accommodate a portion of a lateralized intestine. The channel includes an inner side formed by a portion of the first surface and an outer side formed by a portion of the second surface. The channel extends from the outer periphery to an interior region of the body and includes an open end located at the outer periphery and a closed end located at the interior region. A portion of the channel includes a flared section extending from the outer periphery toward the closed end.

[0015] According to another aspect, an implantable prosthesis includes a body made of an implantable, biocompatible material and includes a first surface and a second surface opposite to the first surface. The body includes an outer portion and an inner portion extending from the outer portion, and also includes an outer periphery. The implantable prosthesis also includes a channel preformed on the outer portion of the body. The channel has a three-dimensional configuration to accommodate a portion of the lateralized intestine. The channel includes an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface. The channel extends from the outer periphery to an interior region of the body and includes an open end located at the outer periphery and a closed end located at the interior region. The outer portion is configured to be placed at a stoma site to prevent and / or repair parastomal hernia, and the inner portion is configured to be placed at a midline abdominal incision when the outer portion is placed at the stoma site.

[0016] The foregoing is a non-limiting summary of the present disclosure, which is defined by the appended claims.Other aspects, embodiments and / or features will become apparent from the following description.

[0017] Various embodiments of the present disclosure may provide certain advantages and may overcome certain disadvantages of previous prostheses. Embodiments of the present disclosure may not share the same advantages, and embodiments that share the same advantages may not share the same advantages in all cases. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Aspects of the present disclosure are described below by way of example with reference to the accompanying drawings, in which like reference numerals refer to like elements, and in which:

[0019] Figure 1 is a top perspective view of an implantable prosthesis according to one embodiment;

[0020] Figure 2 yes Figure 1 A bottom-up stereoscopic view of an implantable prosthesis;

[0021] Figure 3 yes Figure 1 to Figure 2 A top plan view of an implantable prosthesis;

[0022] Figure 4 yes Figures 1 to 3 A side elevation view of an implantable prosthesis illustrating an open end of a channel;

[0023] Figure 5 It is along Figure 3 A cross-sectional view taken along section line 5-5 of FIG. 5 , which illustrates the length of the channel of the prosthesis;

[0024] Figure 6 is located over the ostomy opening and lateralized intestinal Figures 1 to 5 Schematic diagram of an implantable prosthesis for parastomal hernia repair;

[0025] Figure 7 Is adopted Figures 1 to 5 Schematic cross-sectional view of parastomal hernia repair with an implantable prosthesis;

[0026] Figure 8 is a top perspective view of an implantable prosthesis according to one embodiment;

[0027] Fig. 9 yes Figure 8 A top plan view of an implantable prosthesis;

[0028] Fig.10 yes Figures 8 to 9 A side elevation view of an implantable prosthesis;

[0029] Fig.11 According to one embodiment Figure 8 An exploded view of an implantable prosthesis;

[0030] Fig.12 According to another embodiment Figure 8 An exploded view of an implantable prosthesis;

[0031] Fig.13 is a top perspective view of an implantable prosthesis according to one embodiment;

[0032] Fig.14 yes Fig.13 A top plan view of an implantable prosthesis;

[0033] Fig.15 yes Figure 13 to Figure 14 A side elevation view of an implantable prosthesis; and

[0034] Fig.16 According to one embodiment Fig.13 Exploded view of an implantable prosthesis. DETAILED DESCRIPTION

[0035] It should be understood that aspects of the present disclosure are described herein with reference to the accompanying drawings, which show illustrative embodiments according to aspects of the present disclosure. The illustrative embodiments described herein are not necessarily intended to show all aspects of the present disclosure, but are used to describe one or more illustrative embodiments. Therefore, in view of the illustrative embodiments, the various aspects of the present disclosure are not intended to be interpreted narrowly. Therefore, it should be understood that the various 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. In addition, it should be understood that aspects of the present disclosure can be used alone or in any suitable combination with other aspects of the present disclosure.

[0036] The present invention relates to an implantable prosthesis for preventing, reinforcing and / or repairing anatomical defects, and is particularly suitable for preventing, reinforcing and / or repairing defects and weak points in soft tissue and muscle walls or other anatomical areas. The phrase "repairing defects" includes the act of repairing, enhancing and / or reconstructing defects and / or potential defects. For ease of understanding, and without limiting the scope of the present invention, the prosthesis described below is particularly useful for parastomal hernias, which may potentially occur after the formation of a stoma or ostomy opening, such as in combination with an ileostomy, a colostomy or an ileal conduit stoma. However, it should be understood that the prosthesis is not limited thereto and can be used for other anatomical procedures, which should be obvious to those skilled in the art. For example, but not limited to, the prosthesis can be used for abdominal hernia repair, 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 of which may contribute to these properties independently or in combination.

[0037] The present disclosure more particularly relates to a prosthesis that includes a body made of a biocompatible material, such as a repair fabric, configured to cover or extend across a defect opening or weakness when the body is placed against the defect. The prosthesis can take the form of a patch, but it should be apparent to those skilled in the art that the prosthesis can also take other configurations. The patch can have a planar or non-planar configuration suitable for the particular surgery used to repair the defect.

[0038] The prosthesis can include a body having a preformed three-dimensional configuration with a preformed channel configured to receive a portion of lateralized intestine formed in conjunction with a parastomal hernia repair. The preformed channel can allow the surgeon to suture or staple the prosthesis along the edge of the channel without compressing the lateralized intestine and while achieving a snug fit, which eliminates potential gaps that could allow additional intestine to enter and / or inadvertent enterotomy to occur.

[0039] The body may include a first surface and a second surface opposite the first surface, wherein the first surface is tissue permeable and the second surface is anti-adhesion. The channel may include an inner side formed by a portion of the first surface and an outer side formed by a portion of the second surface. The anti-adhesion barrier may be located on the inner side of the channel to isolate a portion of the lateralized intestinal tract from the first surface. In this way, the barrier layer can reduce potential adhesions between the body and the lateralized intestinal tract, even if it cannot eliminate potential adhesions between the body and the lateralized intestinal tract.

[0040] The body may include an outer periphery, wherein the passage extends from the outer periphery to an interior region of the body. The passage may include an open end located at the outer periphery and a closed end located at the interior region of the body opposite the open end. The open end of the passage may include a flared section configured to minimize pressure along the outer periphery that could otherwise potentially cause erosion of the body into the intestine. The flared section may be configured to reduce sharp angulation or kinking of the intestine along the outer periphery that could otherwise potentially cause intestinal obstruction.

[0041] In one embodiment, the body of the prosthesis can be configured to have a circular shape, wherein the channel extends from the outer periphery in a radial direction to the center of the body. The channel can have a partially tubular configuration, which has a semicircular shape in a plane transverse to the length of the channel. The closed end of the channel can have a partially hemispherical shape and be close to the center of the body. However, the prosthesis can adopt a body with any suitable shape for a specific application. For example, but not limited to, the body can be configured to have a quadrilateral shape such as a square or rectangle, a triangular shape, a polygonal shape, an oval shape, or an elliptical shape. The portion of the body other than the channel can have a planar configuration, or a curved configuration such as a concave shape or a convex shape relative to the channel.

[0042] In one embodiment, the body of the prosthesis can include an inner portion and an outer portion extending from the inner portion. The outer portion can be configured to cover the site of the stoma and include a preformed channel for receiving a lateralized intestinal tract. The inner portion can be configured to support a midline laparotomy incision, such as an incision through the linea alba created during open surgery, for example to repair an abdominal hernia. The outer portion can have a circular shape, and the inner portion can have a quadrilateral shape, such as a rectangular shape, which can be aligned with the incision.

[0043] According to one aspect, the body and / or the passage barrier may be formed of a bioabsorbable material. However, it should be understood that the prosthesis may be formed of a non-absorbable material or a combination of absorbable and non-absorbable materials.

[0044] According to one aspect, the body and / or barrier can be formed of a material having translucent or transparent properties to facilitate viewing of the intestine and soft tissue behind the prosthesis during fixation. For example, but not limited to, translucent fibers and / or knits with appropriate pore sizes can be used to achieve translucency to allow visualization through a mesh, such as the VISILEX mesh available from Davol. If desired, different transparent or translucent components can be colored with different hues to provide contrast in the surgical field and facilitate visualization of these components without sacrificing translucency or visibility of tissue behind the prosthesis.

[0045] Figures 1 to 3 One embodiment of a prosthesis is illustrated for covering, reinforcing and / or repairing tissue and muscle wall defects, including but not limited to peritoneal defects that may form during preperitoneal hernia repair surgery. Prosthesis 20 may include a body 22 made of an implantable, biocompatible material and a channel 24 preformed with the body. In this manner, the prosthesis may have a preformed three-dimensional configuration.

[0046] In one embodiment, the body 22 may include a repair fabric that is relatively flexible, thin, and lightweight and that has the performance and physical properties required to cover, reinforce, and / or repair soft tissue and muscle wall defects. The body 22 may be configured to have a size and / or shape suitable for covering or extending across an opening or weak point in tissue and / or muscle when the body is placed against a tissue and / or muscle wall having a defect.

[0047] The body may include a first surface 26 ( Figure 2 ) and a second surface 28 ( Figure 1In one embodiment, the first surface 26 can be tissue permeable and the second surface 28 can be adhesion resistant. In this manner, but not limited to, the prosthesis can be positioned at a repair site with the first surface 26 facing the soft tissue and / or muscle to accommodate tissue ingrowth and the second surface 28 facing the viscera or other organs, tissues and / or muscles to avoid tissue adhesion to the body.

[0048] In one embodiment, passage 24 can be configured to receive a portion of lateralized intestinal tract formed in conjunction with a parastomal hernia repair, such as formed using the Sugarbaker technique. Passage 24 can include an inner portion formed by a portion of first surface 26 and an outer portion formed by a portion of second surface 28.

[0049] For some applications, it may be desirable to reduce the incidence of adhesions between the prosthesis and the intestine received in the passage. In one embodiment, the prosthesis may include an anti-adhesion barrier 30 located on the inner side of the passage to isolate a portion of the lateralized intestine from the first surface 26. In this manner, the barrier layer 30 may reduce, if not eliminate, the potential for adhesions between the body and the lateralized intestine.

[0050] exist Figures 1 to 3 In one embodiment illustrated in FIG. 1 , the passage 24 can be arranged to extend from the outer periphery 32 to the interior area of ​​the body. The passage can include an open end 34 located at the outer periphery and a closed end 36 opposite the open end. The closed end 36 of the passage can be constructed and arranged to cover an ostomy opening for passage of the intestine. Figure 4 As illustrated in , the channel 24 can have a partial tubular configuration having a semicircular shape in a plane oriented perpendicular to the length of the channel. The closed end 36 of the channel can be configured to have a partial hemispherical shape and be near the center 38 of the body.

[0051] exist Figures 1 to 3 In one embodiment illustrated in FIG. , the body 22 of the prosthesis can be configured to have a circular shape. However, it should be understood that the prosthesis can adopt a body having any suitable shape for a particular application. For example, but not limited to, the body can be configured to have a quadrilateral shape such as a square or a rectangle, a triangular shape, a polygonal shape, an oval shape, or an elliptical shape.

[0052] like Figures 1 to 3As illustrated in , the preformed channel 24 can extend from the outer periphery of the body in a radial direction to the center. The closed end 36 of the channel can be formed around the center of the body. As illustrated, the channel can be configured to extend linearly from the open end 34 to the closed end 36. However, it should be understood that the channel can be preformed to have any suitable configuration, which should be obvious to those skilled in the art.

[0053] As will be appreciated by those skilled in the art, the body and passage can be configured to have any shape and / or size suitable for a particular application and / or to accommodate lateralized intestinal tracts of various sizes. In one embodiment, the body can have a maximum width W1 of about 5.5 inches (14 cm) to about 9.8 inches (25 cm), depending on the size of the intestinal tract covered by the prosthesis. Similarly, the linear passage can have a length of about 2.7 inches (6.9 cm) to about 4.9 inches (12.5 cm). The passage can have a radius of curvature R1 of about 0.59 inches (1.5 cm) to about 1.8 inches (4.5 cm) about its longitudinal axis and a total radius of curvature of about 0.59 inches (1.5 cm) to about 1.8 inches (4.5 cm) about the center of the body to form a closed end of the passage.

[0054] For a body having a circular shape, the maximum width corresponds to the diameter.

[0055] In one embodiment for the small intestine, the body can have a diameter of about 5.9 inches (15 cm) to about 7.9 inches (20 cm) and a linear channel along its longitudinal axis from the outer periphery 32 to the center 38 of the body with a length LI of about 3.0 inches (7.6 cm) to about 4.0 inches (10 cm). The channel can have a radius of curvature R1 of about 0.59 inches (1.5 cm) about its longitudinal axis and a full radius of about 0.59 inches (1.5 cm) about the center of the body to form a closed end of the channel. In one embodiment, the body can have a diameter of about 6.0 inches (15.2 cm) and the channel can have a length L1 of about 3.0 inches (7.6 cm).

[0056] In one embodiment for the large intestine, the body can have a diameter of about 7.1 inches (18 cm) to about 8.7 inches (22 cm) and a linear channel along its longitudinal axis from the outer periphery 32 to the center 38 of the body, with a length LI of about 3.5 inches (9 cm) to about 4.0 inches (11 cm). The channel can have a radius of curvature R1 of about 1.18 inches (3.0 cm) about its longitudinal axis and a total radius of curvature of about 1.18 inches (3.0 cm) about the center of the body to form a closed end of the channel.

[0057] In one embodiment for the cecum, the body can have a diameter of about 8.2 inches (21 cm) to about 9.8 inches (25 cm) and a linear channel along its longitudinal axis from the outer periphery 32 to the center 38 of the body, with a length L1 of about 4.1 inches (10.5 cm) to about 4.9 inches (12.5 cm). The channel can have a radius of curvature R1 of about 1.77 inches (4.5 cm) about its longitudinal axis and a total radius of curvature of about 1.77 inches (4.5 cm) about the center of the body to form a closed end of the channel.

[0058] In one embodiment, the portion of the body 22 other than the passage 24 can have a planar configuration prior to implantation. The body can have sufficient flexibility to adapt to the anatomical structure adjacent to the stoma when implanted to repair the hernia defect. In other embodiments, the portion of the body extending outward from the passage can have a non-planar configuration, such as a preformed curved configuration, including a concave shape or a convex shape relative to the passage, which can also have a desired degree of flexibility.

[0059] Preformed channel 24 can be formed in the body using vacuum thermoforming technology. In this way, a mold or forming tool can be used to compress the sheet of the body material by applying heat and vacuum, so that the sheet is thermally deformed and / or plastically deformed and forms a channel of the desired shape and size defined by the mold or forming tool. Heat and vacuum can be applied directly or indirectly to the sheet of material, for example, by placing the sheet of the body material between a forming tool and a heated elastic material sheet, such as rubber. Vacuum removes air and stretches the elastic material and the body material onto or into the forming tool. The process can be repeated in a gradually increasing form to achieve the final geometry of other features of the channel and the body. If necessary, the body can also be preformed in a similar manner to have a non-planar configuration. It should be understood that other manufacturing processes, such as cold forming using a rigid mold, can be used to preform the channel and / or non-planar body, which should be obvious to those skilled in the art.

[0060] The body 22 may include a mesh fabric and may be knitted to provide openings or holes to allow tissue penetration to fit into the prosthesis. If desired, the body 22 may be a warp knitted mesh to allow trimming of adjacent passages or areas relative to the passages to optimize support for lateralized intestinal tract and ostomy trephine. The repair fabric may also be flexible enough to facilitate easy reduction in size for entry into the subject. In this manner, the tough fabric may be telescoping into an elongated configuration, such as a roll, which may be supported in a narrow vacuum cannula and advanced through the cannula for use in laparoscopic or robotic surgery.

[0061] In one embodiment, the body 22 of the prosthesis can be formed by a layer of PHASIX ST mesh (available from Davol), which is an absorbable repair fabric having a first surface 26 and a second surface 28, wherein the first surface 26 supports functional healing via tissue ingrowth, and the second surface 28 has a hydrogel barrier that is anti-adhesion to minimize tissue attachment. After implantation, the mesh promotes rapid ingrowth of tissue or muscle into and around the mesh structure while minimizing potential attachment to adjacent viscera. The body will eventually be absorbed, at which point the prosthesis is no longer needed to separate the viscera on one side of the prosthesis from the abdominal wall on the opposite side of the prosthesis. For example, but not limited to, the body may not be absorbed until the para-hernia repair is sufficiently healed that it is no longer prone to adhesion to the viscera. It should be understood that any suitable repair fabric that provides tissue ingrowth and anti-adhesion can be used for the body, as will be understood by those skilled in the art.

[0062] In another embodiment, the body 22 of the prosthesis can be formed from a layer of softer or more elastic P4HB fabric, such as GalaflexLite. A softer texture may be desired so as to be gentler on any intestinal tract that the prosthesis may contact. In addition, the greater elasticity of the material can allow the prosthesis to closely support the lateralized bowel and ostomy trephine while avoiding excessive contraction.

[0063] In one embodiment, the channel barrier layer 30 can be formed by a layer of SEPRAFILM (available from Baxter Advanced Surgery), which is an absorbable, translucent and hydrophilic adhesion barrier that reduces the incidence of adhesions. It is composed of modified sodium hyaluronate (HA) and carboxymethyl cellulose (CMC). The barrier layer will eventually be absorbed, and it is no longer necessary to separate the lateralized intestine on one side of the barrier from the repair fabric on the opposite side of the barrier. For example, but not limited to, the barrier layer may not be absorbed until the repair fabric has been absorbed and / or is no longer prone to adhesion to the intestine. It should be understood that any suitable barrier material can be used for the channel barrier, as will be understood by those skilled in the art.

[0064] For some applications, the prosthesis 20 can be formed of two or more layers of biocompatible materials. For example, but not limited to, the body 22 of the prosthesis can include a first or ingrowth layer of a knitted mesh fabric and a second or barrier layer of an anti-adhesion material covering the surface of the mesh fabric. The barrier layer can be separate from the fabric layer and can be attached to the fabric layer using any suitable fastening technique, which should be apparent to those skilled in the art. For example, but not limited to, the mesh fabric and the barrier layer can be joined together by any one or more of suturing, sewing, in-situ polymerization, solvent welding, ultrasonic welding, lamination and / or overmolding.

[0065] Examples of absorbable surgical materials and / or fabrics that can be used as a first or ingrowth layer and are suitable for tissue or muscle augmentation and defect correction include, but are not limited to, poly-4-hydroxybutyrate (P4HB), such as PHASIX mesh (available from Davol), polyglactin (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 but not limited to polypropylene, such as BARD Mesh (available from Davol), BARD Soft Mesh (available from Davol), SURGIPRO (available from US Surgical); TRELEX (available from Meadox Medical); PROLENE (available from Ethicon); polyester, such as MERSILENE (available from Ethicon); microporous ePTFE, such as SOFT TISSUE PATCH (available from WL Gore & Associates); and other mesh materials (e.g., available from Atrium Medical) may be suitable for applications involving permanent correction of tissue or muscle defects. It is also contemplated that the mesh fabric may be made of multifilament yarns and that the mesh material may be formed by any suitable method, such as knitting, braiding, plaiting, molding, etc.

[0066] For some embodiments employing a separate second layer that can be attached to the first or ingrowth layer, the second layer can be formed by a reabsorbable SEPRAFILM layer. Representative and non-limiting examples of other suitable barrier materials include: sheets of expanded polytetrafluoroethylene (ePTFE), such as GORETEX available from WL Gore & Associates, which have pore sizes (submicron) that prevent tissue ingrowth and adhesion; silicone elastomers, such as SILASTIC Rx medical grade sheets (platinum cured) distributed by Dow Corning Corporation; TEFLON mesh; and microporous polypropylene sheets (CELGARD). Autologous tissue, allogeneic tissue, and xenogeneic tissue are also envisioned, including, for example, pericardium and small intestinal submucosa. Certain applications may employ absorbable materials, such as oxidized regenerated cellulose (Interceed (TC7)). It should be understood that any suitable anti-adhesion material can be used, which should be obvious to those skilled in the art.

[0067] As indicated above, the prosthesis may be suitable for use during hernia repair procedures including parastomal hernia repair. Figure 6 to Figure 7 In one embodiment illustrated in FIG. , the repair surgery involves repairing a parastomal hernia using the Sugarbaker technique. Figure 6 As shown in the figure, after hernia reduction, cystectomy and / or stomal trephine are reduced to the appropriate size, if necessary, the prosthesis 20 is placed intraperitoneally on the ostomy opening and fixed to the fascia. When the prosthesis is placed on the ostomy opening, the intestine is lateralized, and the preformed channel 24 of the prosthesis is placed on a portion of the lateralized intestine 40. The prosthesis can be fastened to the fascia including the peritoneum and / or the tissue covering the peritoneum. In this way, the intestine 40 is fixed between the prosthesis 20 and the peritoneum, so that the force pressing the intestine ventrally to the abdominal wall is lateralized, thereby making the force not push upward toward the defect, but making these forces ventrally press against the complete abdominal wall. If necessary and not limited to, one or more sutures 46 or other suitable fasteners can be placed along the length of the channel to fix the lateralized intestine in the channel. The preformed shape of the channel can help avoid compression of the intestine, which may occur with a flat prosthesis placed on the lateralized intestine and fastened along the side of the intestine.

[0068] like Figure 6 and Figure 7 As shown in , the prosthesis 20 can be placed intraperitoneally in the abdominal cavity via open surgery or minimally invasive surgery, such as laparoscopy or robotic surgery, and positioned over the ostomy opening, wherein the barrier surface 26 faces the viscera 42 in the abdominal cavity to minimize tissue adhesion. The tissue ingrowth surface 24 of the prosthesis faces the peritoneum 44 and engages with the peritoneum 44 to support functional healing of the hernia via tissue ingrowth. Figure 7 As illustrated in , the lateralized portion of the intestine 40 located within the channel 24 is isolated from the tissue ingrowth surface of the prosthesis by a barrier layer 30 lining the inner surface of the channel facing the intestine to minimize tissue attachment between the prosthesis and the intestine.

[0069] As indicated above, the prosthesis may take the form of a body having any shape suitable for a particular application. Figure 6 In one embodiment illustrated in FIG. 8 , the body may have a quadrilateral shape, such as a square or a rectangle.

[0070] For some applications, it may be desirable to configure the passage to reduce pressure on the lateralized intestine and / or reduce sharp angulation or kinking of the lateralized intestine exiting the passage along the outer periphery of the body. Excessive pressure on the intestine exiting the passage may potentially result in erosion of the body into the intestine. Angulation or kinking of the intestine exiting the passage may potentially result in intestinal obstruction.

[0071] exist Figure 8 In one illustrative embodiment shown in , the passage 24 can include a flared section 50 at its open end 34. As illustrated, the flared section 50 provides a relatively larger opening compared to the remainder of the passage. The flared section tapers in size in a direction toward the closed end of the passage to merge with the main portion 56 of the passage. In one embodiment, the flared section 50 can present a relatively large surface area for engaging the intestine exiting the passage. The flared section can be configured to position its outer periphery 58 at an angle relative to the passage to reduce the likelihood of excessive pressure or angulation of the lateralized intestine and the outer periphery, which could result in potential erosion and / or obstruction of the intestine. In Figures 8 to 10 In one embodiment shown in FIG. 5 , the flared section 50 may be configured to position its outer periphery 58 in a plane perpendicular to the longitudinal axis of the passage.

[0072] As indicated above, and as will be appreciated by those skilled in the art, the body and passageway may be configured to have any shape and / or size suitable for a particular application and / or to accommodate lateralized intestinal tracts of various sizes. Figures 8 to 10 In one embodiment illustrated in FIG. 1 , the body 22 can have a circular configuration having a diameter D1 of about 5.5 inches (14 cm) to about 9.8 inches (25 cm), depending on the size of the intestine covered by the prosthesis. Similarly, the linear channel 24 can have a length L2 of about 2.7 inches (6.9 cm) to about 4.9 inches (12.5 cm). The channel can have a radius of curvature R1 ( R2 ) of about 0.6 inches (1.5 cm) to about 1.8 inches (4.5 cm) about its longitudinal axis. Figure 4 ) and a total radius of curvature of about 0.6 inches (1.5 cm) to about 1.8 inches (4.5 cm) about the center of the body to form a closed end of the channel. The flared section 50 of the channel can have a radius of curvature R2 of about 0.6 inches (1.5 cm) to about 1.8 inches (4.5 cm). The longitudinal side of the channel can be located at a distance X1 of about 1.6 inches (4 cm) to about 3.2 inches (8.1 cm) away from the outer periphery. The closed end 36 of the channel can be located at a distance Y1 along its longitudinal axis from the outer periphery of about 1.6 inches (4 cm) to about 3.2 inches (8.1 cm).

[0073] As indicated above, the prosthesis 20 may be formed from multiple layers of material to provide desired performance and physical properties for covering, reinforcing, and / or repairing soft tissue and muscle wall defects.

[0074] exist Fig.11In one illustrative embodiment shown in , the body 22 may include a first layer or ingrowth layer 52, such as a knitted mesh fabric, and a second layer or barrier layer 54 of anti-adhesion material, which covers the surface 28 of the ingrowth layer 52 intended to face the viscera or other organs, tissues and / or muscles to prevent tissue adhesion to the ingrowth layer. The body may also include a third layer or channel barrier layer 30, which is configured to line the inner surface 26 of the preformed channel 24 to isolate a portion of the lateralized intestinal tract from the ingrowth layer 52.

[0075] The barrier layer 30, 54 may be separate from and preformed to correspond to the shape of the channel 24 preformed in the ingrowth layer. As illustrated, each layer 30, 52, 54 may include a corresponding flared section 50a, 50b, 50c as described above to provide a relatively large entrance to the channel.

[0076] Any suitable fastening technique may be used to attach the barrier layer 30, 54 to the ingrowth layer 52, as should be apparent to one skilled in the art. For example, and without limitation, the ingrowth layer and the barrier layer may be joined together by any one or more of stitching, sewing, in-situ polymerization, solvent welding, ultrasonic welding, lamination, and / or overmolding.

[0077] It is also contemplated that the prosthesis may be placed in other planes within the body. For example, but not limited to, the prosthesis may be used for preperitoneal, retrorectal, and / or retromuscular placement. For such applications, it may be desirable that both the first and second surfaces 24, 26 of the body are tissue permeable, and that the anti-adhesion barrier layer 30 is disposed only on the inner surface of the passageway. In this manner, tissue ingrowth may also occur on the visceral surface of the prosthesis.

[0078] exist Fig.12 In one embodiment illustrated in , the prosthesis 20 may include a body 22 made of an implantable biocompatible material, and a preformed channel 24. The body 22 may include a first layer or ingrowth layer 52, such as a knitted mesh fabric, which may be relatively flexible, thin and lightweight, and meet the performance and physical properties for covering, reinforcing and / or repairing soft tissue and muscle wall defects. The body may include a first surface 26 and a second surface 28 opposite the first surface, and the first surface 26 and the second surface 28 are both tissue permeable. In this manner, but not limited to, the prosthesis can be positioned at a repair site, wherein the first surface 26 and the second surface 28 face the soft tissue and / or muscle for receiving tissue ingrowth.

[0079] It may be desirable to reduce the incidence of adhesions between the prosthesis and the intestine received in the passage. In one embodiment, the prosthesis may include an anti-adhesion barrier 30 to cover the inner surface of the passage and isolate a portion of the lateralized intestine from the first surface 26. In this manner, the barrier layer 30 may reduce, if not eliminate, potential adhesions between the body and the lateralized intestine.

[0080] The barrier layer 30 may be separate from the preformed channel 24 in the ingrowth layer 52 and preformed to correspond to the shape of the channel 24. As illustrated, each layer 30, 52 may include a corresponding flared section 50a, 50c as described above to provide a relatively large entrance to the channel. As described above, the barrier layer 30 may be attached to the ingrowth layer 52 using any suitable fastening technique, which should be apparent to those skilled in the art.

[0081] For some applications, it may be necessary to implant the prosthesis using an open surgical procedure, during which the surgeon may create an abdominal incision. Thus, in addition to covering the stoma site to repair and / or reduce the incidence of parastomal hernias, it may be necessary to support the incision. For example, but not limited to, the prosthesis may be used in conjunction with an abdominal hernia repair, which is accessed through the patient's linea alba via a midline laparotomy incision, which is typically the site of an abdominal hernia, which may occur alone or in conjunction with a parastomal hernia.

[0082] exist Figures 13 to 15 In one embodiment illustrated in FIG. 1 , the body 70 of the prosthesis may include an outer portion 72 and an inner portion 74 extending from the outer portion. The outer portion 72 may be configured to cover the site of the stoma and include a preformed channel 76 for receiving a lateralized intestinal tract. In this manner, the outer portion is similar to the above-described and Figures 1 to 12 The medial portion 74 may be configured to support a midline laparotomy incision created during open surgery, such as an incision through the linea alba.

[0083] The body may include a first surface 78 ( Fig.15 ) and a second surface 80 ( Fig.13 ). In one embodiment, the first surface 78 can be tissue permeable and the second surface 80 can be anti-adhesion. In this manner, but not limited to, the prosthesis can be positioned at a repair site with the first surface 78 facing the soft tissue and / or muscle to accommodate tissue ingrowth and the second surface 80 facing the viscera or other organs, tissues and / or muscles to avoid tissue adhesion to the body.

[0084] In one embodiment, the passage 76 can be configured to receive a portion of lateralized intestinal tract formed in conjunction with a parastomal hernia repair, such as that formed using the Sugarbaker technique. The passage 76 can include an inner portion formed by a portion of the first surface 78 and an outer portion formed by a portion of the second surface 80. The passage can include a flared section 77, such as described above, to reduce pressure on the lateralized intestinal tract and / or reduce sharp angles or kinks of the lateralized intestinal tract exiting the passage along the outer periphery of the body.

[0085] For some applications, it may be desirable to reduce the incidence of adhesions between the prosthesis and the intestine received in the passage. In one embodiment, the prosthesis may include an anti-adhesion barrier 84 ( ) located on the inner side of the passage to isolate a portion of the lateralized intestine from the first surface 26. Fig.16 ). In this way, the barrier layer 84 can reduce, if not eliminate, potential adhesions between the body and the lateralized intestinal tract.

[0086] In one embodiment, the outer portion 70 can have a circular shape, while the inner portion 72 can have a quadrilateral shape, such as a rectangular shape, which can be aligned with the cutout. The inner portion 72 can be configured to have a length X2 in a direction perpendicular to the longitudinal axis of the channel 24, and the length X2 is greater than the diameter D1 of the outer portion 70. However, it should be understood that the outer portion 70 and / or the inner portion 72 can take any shape and / or size suitable for a particular application, as will be understood by those skilled in the art.

[0087] exist Figures 13 to 15 In one embodiment illustrated in , the outer portion 72 can have a generally circular configuration having a diameter D1 of about 5.5 inches (14 cm) to about 9.8 inches (25 cm), depending on the size of the intestine covered by the prosthesis. The longitudinal sides of the passage can be located at a distance XI of about 1.6 inches (4 cm) to about 3.2 inches (8.1 cm) away from the outer periphery. The closed end 36 of the passage can be located at a distance Y1 along its longitudinal axis from the outer periphery of about 1.6 inches (4 cm) to about 3.2 inches (8.1 cm).

[0088] The channel 76 can be configured to have a length L2 of about 2.7 inches (6.9 cm) to about 4.9 inches (12.5 cm). The channel can have a radius of curvature R1 (about 0.6 inches (1.5 cm) to about 1.8 inches (4.5 cm) about its longitudinal axis. Figure 4) and a total radius of curvature of about 0.6 inches (1.5 cm) to about 1.8 inches (4.5 cm) about the center of the body to form a closed end of the channel. The flared section 50 of the channel can have a radius of curvature R2 of about 0.2 inches (0.5 cm) to about 1.8 inches (4.5 cm).

[0089] The inner portion 74 may have a quadrilateral shape having a length X2 of about 5.5 inches (14 cm) to about 11.8 inches (30 cm), and a width Y2 of about 3.1 inches (7.9 cm) to about 11.8 inches (30 cm). The closed end of the channel may be spaced a distance Y3 of about 1.6 inches (4 cm) to about 6.3 inches (16 cm) from the centerline Y4 of the inner portion.

[0090] As indicated above, body 70 and passageway 76 may be configured to have any shape and / or size suitable for a particular application and / or to accommodate various sizes of lateralized intestines and / or abdominal incisions, as will be appreciated by those skilled in the art.

[0091] As indicated above, the prosthesis 20 may be formed from multiple layers of material to provide desired performance and physical properties for covering, reinforcing, and / or repairing soft tissue and muscle wall defects.

[0092] exist Fig.16 In one illustrative embodiment shown in , the body 70 may include a first layer or ingrowth layer 82, such as a knitted mesh fabric, and a second layer or barrier layer 84 of anti-adhesion material, which covers the surface of the ingrowth layer 82 intended to face the viscera or other organs, tissues and / or muscles to prevent tissue adhesion to the ingrowth layer. The body may also include a third layer or channel barrier layer 86, which is configured to line the inner surface of the preformed channel 76 to isolate a portion of the lateralized intestinal tract from the ingrowth layer 52.

[0093] Barrier layers 84, 86 may be separate from and preformed to correspond to the shape of channels 76 preformed in the ingrowth layer. As illustrated, each layer 82, 84, 86 may include a corresponding flared section 77a, 77b, 77c as described above to provide a relatively large entrance to the channel.

[0094] Any suitable fastening technique may be used to attach the barrier layers 84, 86 to the ingrowth layer 82, as should be apparent to one skilled in the art. For example, but not limited to, the ingrowth layer and the barrier layer may be joined together by any one or more of stitching, sewing, in-situ polymerization, solvent welding, ultrasonic welding, lamination, and / or overmolding.

[0095] For purposes of this patent application and any patent issued therefrom, the expressions "a" and "an", as used herein in the specification and claims, shall be understood to mean "at least one", unless expressly indicated to the contrary. The phrase "and / or", as used herein in the specification and claims, shall be understood to mean "one or both" of the elements so combined, i.e., elements present in combination in some cases and separately in other cases. Multiple elements listed with "and / or" shall be interpreted in the same manner, i.e., "one or more elements" of the elements so combined. In addition to the elements explicitly identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to the explicitly identified elements.

[0096] As used herein, "including," "comprising," "having," "containing," "involving," and / or variations thereof, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0097] 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 in which the method steps or actions are described unless explicitly stated to the contrary.

[0098] The foregoing description of various embodiments is intended to be illustrative of the present invention only and other embodiments, modifications and equivalents are within the scope of the present invention as recited in the following claims.

Claims

1. An implantable prosthesis comprising: a body made of an implantable, biocompatible material, the body having a preformed three-dimensional configuration, 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 anti-adhesion; a channel preformed on the body, the channel having a three-dimensional configuration to receive a portion of a lateralized intestinal tract, the channel comprising an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface; as well as An anti-adhesion barrier is located on the inner side of the passage to isolate the portion of the lateralized intestine from the first surface.

2. The implantable prosthesis according to claim 1, wherein: The body includes an outer periphery, and the channel extends from the outer periphery to an interior region of the body.

3. The implantable prosthesis according to claim 2, wherein: The channel includes an open end at the outer periphery and a closed end opposite the open end.

4. Implantable prosthesis according to one of claims 1 to 3, wherein: The body has a maximum width of about 5.9 inches to about 9.8 inches.

5. The implantable prosthesis according to claim 4, wherein: The body has a circular shape having an outer diameter, and the maximum width corresponds to the outer diameter.

6. Implantable prosthesis according to one of claims 1 to 5, wherein: The channel has a length of about 2.9 inches to about 4.9 inches.

7. Implantable prosthesis according to one of claims 1 to 6, wherein: The channel extends along a longitudinal axis, the channel having a radius about the longitudinal axis of about 0.6 inches to about 1.8 inches.

8. The implantable prosthesis according to claim 3, wherein: The body has a circular shape with a diameter of about 5.9 inches to about 7.9 inches, the channel has a length along the longitudinal axis from the outer periphery to the center of the body of about 3.0 inches to about 4.0 inches, and the channel has a radius about the longitudinal axis of about 0.6 inches.

9. The implantable prosthesis according to claim 8, wherein: The body has a diameter of approximately 6.0 inches and the passage has a length of approximately 3.0 inches.

10. The implantable prosthesis according to claim 3, wherein: The body has a circular shape with a diameter of approximately 7.1 inches to approximately 8.7 inches, the channel has a length along the longitudinal axis from the outer periphery to the center of the body along the longitudinal axis of approximately 3.5 inches to approximately 4.0 inches, and the channel has a radius of approximately 1.2 inches about the longitudinal axis.

11. The implantable prosthesis according to claim 3, wherein: The body has a circular shape with a diameter of approximately 8.2 inches to approximately 9.8 inches, the channel has a length along the longitudinal axis from the outer periphery to the center of the body along the longitudinal axis of approximately 4.1 inches to approximately 4.9 inches, and the channel has a radius of approximately 1.8 inches about the longitudinal axis.

12. Implantable prosthesis according to claim 3 and one of claims 4 to 7 as dependent thereon, wherein: The closed end has a hemispherical shape having a radius about the longitudinal axis of about 0.6 inches to about 1.8 inches.

13. An implantable prosthesis according to any one of claims 1 to 12, wherein: The channel has a perimeter, and a portion of the body extending outwardly from the perimeter of the channel has a planar configuration.

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

15. An implantable prosthesis according to any one of claims 1 to 14, wherein: The anti-adhesion barrier is absorbable.

16. A method for reinforcing a stoma, repairing a parastomal hernia or preventing a parastomal hernia, the method comprising the following actions: (a) placing a prosthesis intraperitoneally on a stoma, the prosthesis comprising a body made of an implantable biocompatible material and a preformed channel on the body, the channel having a three-dimensional configuration to receive a portion of a lateralized intestinal tract, the body comprising a first surface and a second surface opposite to the first surface, the first surface being tissue permeable, the second surface being anti-adhesion, the channel comprising an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface, and an anti-adhesion barrier being disposed on the inner portion of the channel; (b) positioning the preformed passageway over a portion of the lateralized intestinal tract extending from the stoma, wherein: The anti-adhesion barrier isolates the portion of the lateralized intestine from the inner portion of the passage; and (c) securing the prosthesis to the fascia.

17. The method of claim 16, further comprising an act (d) of securing the portion of the prosthesis extending along the passageway to the fascia.

18. The method according to any one of claims 16 to 17, wherein: Action (a) includes positioning the first surface facing the fascia and positioning the second surface facing the viscera within the abdominal cavity.

19. The method according to any one of claims 16 to 18, wherein: The body has an outer periphery, the channel includes an open end located at the outer periphery and a closed end opposite the open end, and wherein action (a) includes positioning the closed end of the channel on an ostomy trephine.

20. The method according to any one of claims 16 to 19, wherein: The body has a circular shape with a maximum diameter of about 5.9 inches to about 9.8 inches, the channel has a length along the longitudinal axis of about 2.9 inches to about 4.9 inches, and a radius of curvature about the longitudinal axis of about 0.6 inches to about 1.8 inches, and the closed end of the channel has a full radius of curvature of about 0.6 inches to about 1.8 inches.

21. An implantable prosthesis according to any one of claims 16 to 20, wherein: The body is absorbable.

22. An implantable prosthesis according to any one of claims 16 to 21, wherein: The anti-adhesion barrier is absorbable.

23. An implantable prosthesis comprising: a body made of an implantable, biocompatible material, the body having a circular configuration, the body including a first surface and a second surface opposite the first surface, the first surface being tissue permeable and the second surface being anti-adhesion; a channel on the body, the channel configured to receive a portion of a lateralized intestinal tract, the channel comprising an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface; as well as An anti-adhesion barrier is located on the inner side of the passage to isolate the portion of the lateralized intestine from the first surface.

24. The implantable prosthesis of claim 23, wherein: The body includes an outer periphery, and the channel extends from the outer periphery to an interior region of the body.

25. The implantable prosthesis of claim 24, wherein: The channel includes an open end at the outer periphery and a closed end opposite the open end.

26. Implantable prosthesis according to one of claims 23 to 25, wherein The body has a diameter of about 5.9 inches to about 9.8 inches.

27. Implantable prosthesis according to one of claims 23 to 26, wherein The channel has a length of about 2.9 inches to about 4.9 inches.

28. Implantable prosthesis according to one of claims 23 to 27, wherein The channel extends along a longitudinal axis, the channel having a radius about the longitudinal axis of about 0.6 inches to about 1.8 inches.

29. The implantable prosthesis of claim 25, wherein: The body has a diameter of about 5.9 inches to about 7.9 inches, the passage has a length along the longitudinal axis from the outer periphery to the center of the body of about 3.0 inches to about 4.0 inches, and the passage has a radius about the longitudinal axis of about 0.6 inches.

30. The implantable prosthesis of claim 29, wherein: The body has a diameter of approximately 6.0 inches and the passage has a length of approximately 3.0 inches.

31. The implantable prosthesis of claim 25, wherein: The body has a diameter of approximately 7.1 inches to approximately 8.7 inches, the channel has a length along the longitudinal axis from the outer periphery to the center of the body of approximately 3.5 inches to approximately 4.0 inches along the longitudinal axis, and the channel has a radius of approximately 1.2 inches about the longitudinal axis.

32. The implantable prosthesis of claim 25, wherein: The body has a diameter of approximately 8.2 inches to approximately 9.8 inches, the channel has a length along the longitudinal axis from the outer periphery to the center of the body of approximately 4.1 inches to approximately 4.9 inches along the longitudinal axis, and the channel has a radius of approximately 1.8 inches about the longitudinal axis.

33. Implantable prosthesis according to claim 25 and one of claims 26 to 30 as dependent thereon, wherein: The closed end has a hemispherical shape having a radius about the longitudinal axis of about 0.6 inches to about 1.8 inches.

34. An implantable prosthesis according to any one of claims 23 to 33, wherein: The body is absorbable.

35. An implantable prosthesis according to any one of claims 23 to 34, wherein: The anti-adhesion barrier is absorbable.

36. A method for reinforcing a stoma, repairing a parastomal hernia, or preventing a parastomal hernia, the method comprising the following actions: (a) placing a prosthesis intraperitoneally on a stoma, the prosthesis comprising a body made of an implantable, biocompatible material, and a channel located on the body, the channel being configured to receive a portion of a lateralized intestine, the body having a circular configuration and comprising a first surface and a second surface opposite to the first surface, the first surface being tissue permeable, the second surface being anti-adhesion, the channel comprising an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface, and an anti-adhesion barrier being disposed on the inner portion of the channel; (b) positioning the passage over a portion of the lateralized intestine extending from the stoma, wherein The anti-adhesion barrier isolates the portion of the lateralized intestinal tract from the inner portion of the passage; and (c) securing the prosthesis to the fascia.

37. The method of claim 36, wherein: Action (a) includes positioning the first surface facing the fascia and positioning the second surface facing the viscera within the abdominal cavity.

38. The method according to any one of claims 36 to 37, wherein: The body has an outer periphery, the channel includes an open end located at the outer periphery and a closed end opposite the open end, and wherein action (a) includes positioning the closed end of the channel on an ostomy trephine.

39. The method according to any one of claims 36 to 38, wherein: The body has a maximum diameter of about 5.9 inches to about 9.8 inches, the channel has a length along the longitudinal axis of about 2.9 inches to about 4.9 inches and a radius of curvature about the longitudinal axis of about 0.6 inches to about 1.8 inches, and the closed end of the channel has a total radius of curvature of about 0.6 inches to about 1.8 inches.

40. An implantable prosthesis according to any one of claims 36 to 39, wherein: The body is absorbable.

41. An implantable prosthesis according to any one of claims 36 to 40, wherein: The anti-adhesion barrier is absorbable.

42. An implantable prosthesis comprising: a body made of an implantable, biocompatible material, the body having a preformed three-dimensional configuration, the body comprising a first surface and a second surface opposite the first surface, the body comprising an outer perimeter; and A channel is preformed on the body, the channel having a three-dimensional configuration to receive a portion of a lateralized intestinal tract, the channel including an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface, the channel extending from the outer periphery to an inner region of the body, the channel including an open end located at the outer periphery and a closed end located at the inner region, a portion of the channel including a flared section extending from the outer periphery toward the closed end.

43. The implantable prosthesis of claim 42, wherein: The flared section of the passageway is configured to reduce pressure of the portion of the lateralized intestine at the open end of the passageway.

44. An implantable prosthesis according to any one of claims 42 to 43, wherein: The flared section decreases in size in a direction from the open end toward the closed end.

45. The implantable prosthesis of any one of claims 42 to 44, further comprising an anti-adhesion barrier disposed on the inner side of the channel to isolate the portion of the lateralized intestine from the first surface.

46. ​​An implantable prosthesis according to any one of claims 42 to 45, wherein: The first surface is tissue permeable and the second surface is anti-adhesion.

47. An implantable prosthesis according to any one of claims 42 to 46, wherein: The body includes a first layer formed of a tissue permeable fabric and a second layer formed of an anti-adhesion material, the first layer forming the first surface of the body, and the second layer forming the second surface of the body.

48. An implantable prosthesis according to one of claims 42 to 47, wherein The channel has a length of about 2.9 inches to about 4.9 inches.

49. An implantable prosthesis according to one of claims 42 to 48, wherein The channel extends along a longitudinal axis, the channel having a radius about the longitudinal axis of about 0.6 inches to about 1.8 inches.

50. An implantable prosthesis according to one of claims 42 to 49, wherein The closed end has a hemispherical shape having a radius about the longitudinal axis of about 0.6 inches to about 1.8 inches.

51. An implantable prosthesis according to one of claims 42 to 50, wherein The flared section has a radius of curvature of about 0.6 inches to about 1.8 inches.

52. An implantable prosthesis according to any one of claims 42 to 51, wherein: The channel has a perimeter, and a portion of the body extending outwardly from the perimeter of the channel has a planar configuration.

53. An implantable prosthesis comprising: a body made of an implantable biocompatible material, the body comprising a first surface and a second surface opposite the first surface, the body comprising an outer portion and an inner portion extending from the outer portion, the body comprising an outer perimeter; and a channel preformed on the outer portion of the body, the channel having a three-dimensional configuration to receive a portion of a lateralized intestinal tract, the channel including an inner portion formed by a portion of the first surface and an outer portion formed by a portion of the second surface, the channel extending from the outer periphery to an interior region of the body, the channel including an open end at the outer periphery and a closed end at the interior region, The lateral portion is configured to be positioned at a stoma site to prevent and / or repair a parastomal hernia, and the medial portion is configured to be positioned at a midline abdominal incision when the lateral portion is positioned at the stoma site.

54. The implantable prosthesis of claim 53, wherein: The outer portion has a first configuration and the inner portion has a second configuration different from the first configuration.

55. The implantable prosthesis of claim 54, wherein: At least a portion of the outer periphery along the outer portion has a circular shape.

56. An implantable prosthesis according to any one of claims 54 to 55, wherein: The inner portion has a quadrilateral shape.

57. An implantable prosthesis according to any one of claims 54 to 56, wherein: The inner portion has a length of about 5.5 inches to about 11.8 inches, and a width of about 3.1 inches to about 11.8 inches.

58. The implantable prosthesis of claim 57, wherein: The inner portion has a centerline positioned at 50% of the width, and the closed end of the channel is spaced a distance from about 1.6 inches to about 6.3 inches from the centerline of the inner portion.

59. An implantable prosthesis according to claims 53 to 58, wherein: A portion of the passage includes a flared section extending from the outer periphery toward the closed end.

60. The implantable prosthesis of claim 59, wherein: The flared section of the passageway is configured to reduce pressure of the portion of the lateralized intestine at the open end of the passageway.

61. An implantable prosthesis according to any one of claims 59 to 60, wherein: The flared section decreases in size in a direction from the open end toward the closed end.

62. An implantable prosthesis according to one of claims 59 to 61, wherein The flared section has a radius of curvature of about 0.6 inches to about 1.8 inches.

63. The implantable prosthesis of any one of claims 53 to 62, further comprising an anti-adhesion barrier located on the inner side of the channel to isolate the portion of the lateralized intestine from the first surface.

64. An implantable prosthesis according to any one of claims 53 to 63, wherein: The first surface is tissue permeable and the second surface is anti-adhesion.

65. An implantable prosthesis according to any one of claims 53 to 64, wherein: The body includes a first layer formed of a tissue permeable fabric and a second layer formed of an anti-adhesion material, the first layer forming the first surface of the body and the second layer forming the second surface of the body.

66. An implantable prosthesis according to one of claims 53 to 65, wherein The channel has a length of about 2.9 inches to about 4.9 inches.

67. An implantable prosthesis according to one of claims 53 to 66, wherein The channel extends along a longitudinal axis, the channel having a radius about the longitudinal axis of about 0.6 inches to about 1.8 inches.

68. An implantable prosthesis according to one of claims 53 to 67, wherein The closed end has a hemispherical shape having a radius about the longitudinal axis of about 0.6 inches to about 1.8 inches.

69. An implantable prosthesis according to any one of claims 53 to 68, wherein: The channel has a perimeter, and a portion of the body extending outwardly from the perimeter of the channel has a planar configuration.

Images