Transplantable prosthesis
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- DAVOL INC
- Filing Date
- 2023-06-29
- Publication Date
- 2026-06-30
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 357,152, filed Jun. 30, 2022, and U.S. Provisional Patent Application No. 63 / 357,175, filed Jun. 30, 2022, and incorporates those applications herein by reference in their entirety.
[0002] Field 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
[0003] Background Defects in muscle or tissue walls, such as hernias, are typically repaired by implantable prostheses configured to cover and / or fill the defect.
[0004] In some procedures, an implantable repair fabric, such as a mesh fabric, is sutured, stapled, tacked, or otherwise temporarily fixed in place under or within the defect to cover the defect. Integration of the fabric with the tissue, such as ingrowth of tissue into and / or along the mesh fabric, ultimately completes the repair.
[0005] A variety of repair fabrics are known and are used for repairing defects in soft tissue and muscle walls. Examples of implantable fabrics that have been successfully used for soft tissue and muscle wall repair include BARD Soft Mesh, BARD Mesh, PHASIX Mesh, and PHASIX ST Mesh, available from Davol, a division of Becton Dickinson. Such fabrics are made from monofilaments and are woven into a mesh with pores or gaps that promote ingrowth of tissue and integration with the fabric. Some fabrics are adhesion - resistant.
[0006] Parastomal hernia is a type of incisional hernia that occurs at or adjacent to the stoma, i.e., the fistula. It is a complication associated with creating an ileostomy, colostomy, or ileal conduit stoma. Parastomal hernias can be repaired using various techniques, such as the Sugarbaker technique. This repair involves the surgeon performing an open procedure, such as laparotomy, or a minimally invasive procedure, such as laparoscopy or robotic surgery. Following hernia repair, sac excision, and reduction of the stoma trephine, the ostomy opening is covered by a prosthetic mesh placed intraperitoneally, which is sutured to the fascia. The bowel is lateralized and fixed between the mesh and the peritoneum, thereby shifting the forces that push the bowel ventrally against the abdominal wall laterally and redirecting those forces upward and toward the defect, such that these forces compress the intact abdominal wall ventrally. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION
[0007] An object of the present invention is to provide a prosthesis and method for preventing and / or repairing defects in soft tissue and muscle walls, including parastomal hernias. MEANS FOR SOLVING THE PROBLEMS
[0008] SUMMARY The present disclosure relates to implantable prostheses and methods for reinforcing, preventing, and / or repairing anatomical defects, such as defects in tissue or muscle walls, including parastomal hernias.
[0009] According to one aspect, a transplantable prosthesis includes a body of a transplantable biocompatible material, a channel preformed in the body, and an adhesion-resistant barrier. The body has a preformed three-dimensional shape that includes a first surface and a second surface opposite the first surface. The first surface is tissue-infiltratable and the second surface is adhesion-resistant. The channel has a three-dimensional shape configured to receive a portion of the intestine moved outwardly and includes an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface. The adhesion-resistant barrier is located on the inner surface of the channel to isolate a portion of the intestine moved outwardly from the first surface.
[0010] According to another aspect, a transplantable prosthesis includes a body of a transplantable biocompatible material, a channel on the body, and an adhesion-resistant barrier. The body has a circular shape and includes a first surface and a second surface opposite the first surface. The first surface is tissue-infiltratable and the second surface is adhesion-resistant. The channel is configured to receive a portion of the intestine moved outwardly and includes an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface. The adhesion-resistant barrier is located on the inner surface of the channel to isolate a portion of the intestine moved outwardly from the first surface.
[0011] According to another aspect, a method is provided for reinforcing a stoma, repairing a parastomal hernia, or preventing a parastomal hernia. The method includes: (a) placing a prosthesis into the abdominal cavity so as to cover the stoma. The prosthesis includes a body of a transplantable biologically compatible material and a channel preformed in the body. The channel has a three-dimensional shape configured to receive a portion of the intestine that has been moved outwardly. The body includes a first surface and a second surface opposite the first surface. The first surface is tissue-infiltratable and the second surface is adhesion-resistant. The channel includes an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface. An adhesion-resistant barrier is located on the inner surface of the channel. The method further includes: (b) placing the preformed channel so as to cover a portion of the intestine that has been moved outwardly and extends from the stoma, such that the adhesion-resistant barrier isolates the portion of the intestine that has been moved outwardly from the inner surface of the channel, and securing the prosthesis to the fascia.
[0012] According to another aspect, a method is provided for reinforcing a stoma, repairing a parastomal hernia, or preventing a parastomal hernia. The method includes: (a) placing a prosthesis into the abdominal cavity so as to cover the stoma. The prosthesis includes a body of a transplantable biologically compatible material and a channel preformed in the body. The channel is configured to receive a portion of the intestine that has been moved outwardly. The body has a circular shape and includes a first surface and a second surface opposite the first surface. The first surface is tissue-infiltratable and the second surface is adhesion-resistant. The channel includes an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface. An adhesion-resistant barrier is located on the inner surface of the channel. The method further includes: (b) placing the channel so as to cover a portion of the intestine that has been moved outwardly and extends from the stoma, such that the adhesion-resistant barrier isolates the portion of the intestine that has been moved outwardly from the inner surface of the channel, and securing the prosthesis to the fascia.
[0013] According to another aspect, a transplantable prosthesis includes a body of a transplantable biocompatible material and a channel preformed in the body. The body has a preformed three-dimensional shape and includes a first surface and a second surface opposite the first surface. The body also includes an outer perimeter. The channel is preformed in the body and has a three-dimensional shape to receive a portion of the intestine moved outward. The channel includes an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface. The channel extends from the outer perimeter of the body to an inner region and includes an open end at the outer perimeter and a closed end at the inner region. A portion of the channel includes a flared segment extending from the outer perimeter toward the closed end.
[0014] According to another aspect, a transplantable prosthesis includes a body of a transplantable biocompatible material and includes a first surface and a second surface opposite the first surface. The body includes an outer portion and an inner portion extending from the outer portion and further includes an outer perimeter. The transplantable prosthesis further includes a channel preformed in the outer portion of the body. The channel has a three-dimensional shape to receive a portion of the intestine moved outward. The channel includes an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface. The channel extends from the outer perimeter of the body to an inner region and includes an open end at the outer perimeter and a closed end at the inner region. The outer portion is configured to be placed at the stoma site to prevent and / or repair a parastomal hernia, and the inner portion is configured to be placed at the midline abdominal incision when the outer portion is placed at the stoma site.
[0015] The foregoing is a non-limiting summary of the present disclosure as defined in the appended claims. Other aspects, embodiments and / or features will become apparent from the following description.
[0016] Various embodiments of the present disclosure may provide several advantages and may overcome some disadvantages of conventional prostheses. Embodiments of the present disclosure need not share the same advantages, and those that are shared need not be shared in all situations.
[0017] Aspects of the present disclosure will be described below by way of example with reference to the accompanying drawings, in which like reference numerals refer to like elements.
Brief Description of the Drawings
[0018] Brief Description of the Drawings
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DETAILED DESCRIPTION
[0019] DETAILED DESCRIPTION Reference is made to the drawings to describe the aspects of the present disclosure in this specification, and it should be understood that the drawings show embodiments useful in the description of the aspects of the present disclosure. The embodiments useful in the description described herein are not necessarily intended to show all aspects of the present disclosure and are used to describe one or more embodiments useful in the description. Therefore, the aspects of the present disclosure are not intended to be construed narrowly in view of the embodiments useful in the description. Therefore, it should be understood that the various concepts and embodiments described herein may be implemented in any of a number of ways since the concepts and embodiments of the present disclosure are not limited to any particular implementation method. Further, it should be understood that the aspects of the present disclosure may be used alone or in any suitable combination with other aspects of the present disclosure.
[0020] The present disclosure relates to implantable prostheses for preventing, reinforcing, and / or repairing anatomical defects, and in particular, is suitable for preventing, reinforcing, and / or repairing defects and vulnerable portions of soft tissue and muscle walls or other anatomical regions. The phrase "repairing a defect" includes the act of restoring, augmenting, and / or reconstructing a defect and / or potential defect. For ease of understanding, without limiting the scope of the present invention, the prosthesis will hereinafter be described as being particularly used in connection with parastomal hernias that may occur after the formation of an opening for a stoma or ostomy, such as formed with an ileostomy, colostomy, or ileal conduit stoma. However, as will be apparent to those skilled in the art, it should be understood that the prosthesis is not so limited and may be used in other anatomical procedures. For example, without limitation, the prosthesis may be used with large defects such as abdominal wall hernia repair, inguinal hernia, chest and abdominal wall reconstruction, or those that may occur in obese patients. The prosthesis may include one or more features, each independently or in combination, contributing to such properties.
[0021] More particularly, the present disclosure relates to a prosthesis comprising a biologically compatible material, such as a body of a repair fabric, the body being configured to cover or extend across an opening or vulnerable portion of a defect when the body is placed against the defect. The prosthesis may be in the form of a patch, but as will be apparent to those skilled in the art, the prosthesis may be used in other forms. The patch may have a planar or non-planar form suitable for a particular procedure used to repair a defect.
[0022] The prosthesis may include a body having a preformed three-dimensional shape provided with a preformed channel configured to receive a portion of the intestine that has been moved outward and shaped simultaneously with para-stomal hernia repair. The preformed channel may achieve a snug fit that eliminates potential gaps that would allow additional intestine to enter and / or allow the surgeon to suture or staple the prosthesis along the edge of the channel without compressing the intestine that has been moved outward and without accidental enterotomy.
[0023] The body may include a first face and a second face opposite the first face, the first face being tissue-infiltratable and the second face being adhesion-resistant. The channel may include an inner face formed by a portion of the first face and an outer face formed by a portion of the second face. An adhesion-resistant barrier is located on the inner face of the channel to isolate a portion of the intestine that has been moved outward from the first face. In this way, the barrier layer can reduce potential adhesion between the body and the intestine that has been moved outward, if not eliminate it.
[0024] The body may include an outer perimeter, and the channel extends from the outer perimeter of the body to an inner region. The channel may include an open end at the outer perimeter and a closed end at the inner region of the body, opposite the open end. The open end of the channel may include a flared segment configured to minimize pressure along the outer perimeter, which pressure could otherwise lead to erosion of the body into the intestine. The flared segment may be configured to reduce sharp angulation or kinking of the intestine along the outer perimeter, which could otherwise lead to intestinal obstruction.
[0025] In one embodiment, the prosthesis body may be configured to have a circular shape, and the channel extends radially from the outer periphery to the center of the body. The channel may have a partially tubular form and include a semi-circular shape in a plane perpendicular to the length of the channel. The closed end of the channel may have a partially hemispherical shape and may be located closest to the center of the body. However, the prosthesis may use a body having any suitable shape for a particular application. For example, without limitation, the body may be configured to include a quadrilateral, such as a square or a rectangle, a triangle, a polygon, an oval, or an ellipse. The portion of the body excluding the channel may have a planar form or a curved form, such as a concave or convex shape with respect to the channel.
[0026] In one embodiment, the prosthesis body may include an inner portion and an outer portion extending from the inner portion. The outer portion may be configured to cover the stoma site and include a preformed channel for receiving the intestine moved outward. The inner portion may be configured to support, for example, a midline laparotomy incision, such as an incision through the linea alba, made during a surgical procedure under direct vision for repairing an abdominal wall hernia. The outer portion may have a circular shape, and the inner portion may have a quadrilateral shape, such as a rectangle, which may be aligned with the incision.
[0027] According to one aspect, the body and / or the channel barrier may be formed of a bioresorbable material. However, it should be understood that the prosthesis may be formed of a non-resorbable material or a combination of a resorbable material and a non-resorbable material.
[0028] According to one aspect, the body and / or barrier may be formed of a material having a translucent or transparent nature to facilitate visualization of the intestine and soft tissue behind the prosthesis during fixation. For example, without limitation, translucency may be achieved using transparent fibers and / or knits having an appropriate pore size that allows visualization through a mesh such as the VISILEX mesh available from Davol, Inc. Optionally, different transparent or translucent components may be colored with different shades to provide contrast in the surgical field and facilitate visualization of those components without sacrificing translucency or visibility of the tissue behind the prosthesis.
[0029] Figures 1 - 3 illustrate one embodiment of a prosthesis for covering, reinforcing, and / or repairing tissue and muscle wall defects, including, but not limited to, defects in the peritoneum, that may be formed during a preperitoneal hernia repair procedure. Prosthesis 20 may include a body 22 of a transplantable biologically compatible material and a channel 24 preformed with the body. In this way, the prosthesis may have a preformed three-dimensional shape.
[0030] In one embodiment, body 22 may include a repair fabric that is relatively flexible, thin, lightweight, and meets the performance and physical properties for covering, reinforcing, and / or repairing soft tissue and muscle wall defects. Body 22 may be configured in a size and / or shape suitable to cover or extend across tissue and / or muscle openings or vulnerable portions when the body is placed in contact with the tissue and / or muscle wall having the defect.
[0031] The body may include a first surface 26 (FIG. 2) and a second surface 28 (FIG. 1) opposite the first surface. In one embodiment, the first surface 26 may be tissue-infiltratable and the second surface 28 may be adhesively resistant. In this way, but not limited to, the prosthesis is positioned at the repair site such that the first surface 26 faces the soft tissue and / or muscle to accept ingrowth of the tissue, and the second surface 28 faces the viscera, or other organs, tissues and / or muscle to avoid tissue adhesion to the body.
[0032] In one embodiment, the channel 24 may be configured to receive a portion of the intestine that has been moved outward, formed simultaneously with parastomal hernia repair, for example by the Sugarbaker technique. The channel 24 may include an inner surface 26 formed by a portion of the first surface and an outer surface 28 formed by a portion of the second surface.
[0033] In some applications, it may be desirable to reduce the incidence of adhesion between the prosthesis and the intestine received in the channel. In one embodiment, the prosthesis may include an adhesion-resistant barrier 30 located on the inner surface of the channel to isolate a portion of the intestine that has been moved outward from the first surface 26. In this way, the barrier layer 30 can reduce potential adhesion between the body and the intestine that has been moved outward, if not eliminate it.
[0034] In one embodiment shown in FIGS. 1-3, the channel 24 may be arranged to extend from the outer periphery 32 of the body to the inner region. The channel may include an open end 34 at the outer periphery and a closed end 36 opposite the open end. The closed end 36 of the channel may be configured and arranged to lie over the opening of the stoma through which the intestine passes. As shown in FIG. 4, the channel 24 may have a partial tubular form, with the semi-circular shape in the plane being oriented perpendicular to the length of the channel. The closed end 36 of the channel may be configured to comprise a partial hemispherical shape and may be located closest to the center 38 of the body.
[0035] In one embodiment shown in FIGS. 1-3, the prosthesis body 22 can be configured to have a circular shape. However, it should be understood that the prosthesis may use 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 rectangle, a triangle, a polygon, an oval, or an ellipse.
[0036] As shown in FIGS. 1-3, the preformed channel 24 can extend radially from the outer periphery of the body to the center. The closed end 36 of the channel can be formed around the center of the body. As shown, 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 form, as will be understood by those skilled in the art.
[0037] As should be understood by those skilled in the art, the body and the channel can be configured to have any shape and / or size suitable for a particular application and / or to accommodate intestines moved to the outside of various sizes. In one embodiment, the maximum width W1 of the body can be approximately 5.5 inches (14 cm) to approximately 9.8 inches (25 cm), depending on the size of the intestine covered by the prosthesis. Similarly, the length of the linear channel can be approximately 2.7 inches (6.9 cm) to approximately 4.9 inches (12.5 cm). The channel can have a radius of curvature R1 around its longitudinal axis of approximately 0.59 inches (1.5 cm) to approximately 1.8 inches (4.5 cm), and a full radius of curvature around the center of the body of approximately 0.59 inches (1.5 cm) to approximately 1.8 inches (4.5 cm) to form the closed end of the channel.
[0038] In a circular body, the maximum width corresponds to the diameter.
[0039] In one embodiment related to the small intestine, the body may have a linear channel with a diameter of approximately 5.9 inches (15 cm) to approximately 7.9 inches (20 cm) and a length L1 of approximately 3.0 inches (7.6 cm) to approximately 4.0 inches (10 cm) along its longitudinal axis from the outer periphery 32 to the center 38 of the body. The channel may have a radius of curvature R1 of approximately 0.59 inches (1.5 cm) around its longitudinal axis and may have an overall radius of approximately 0.59 inches (1.5 cm) around the center of the body to form the closed end of the channel. In one embodiment, the diameter of the body may be approximately 6.0 inches (15.2 cm) and the length L1 of the channel may be approximately 3.0 inches (7.6 cm).
[0040] In one embodiment related to the large intestine, the body may have a linear channel with a diameter of approximately 7.1 inches (18 cm) to approximately 8.7 inches (22 cm) and a length L1 of approximately 3.5 inches (9 cm) to approximately 4.0 inches (11 cm) along its longitudinal axis from the outer periphery 32 to the center 38 of the body. The channel may have a radius of curvature R1 of approximately 1.18 inches (3.0 cm) around its longitudinal axis and may have an overall radius of approximately 1.18 inches (3.0 cm) around the center of the body to form the closed end of the channel.
[0041] In one embodiment related to the cecum, the body may have a linear channel with a diameter of approximately 8.2 inches (21 cm) to approximately 9.8 inches (25 cm) and a length L1 of approximately 4.1 inches (10.5 cm) to approximately 4.9 inches (12.5 cm) along its longitudinal axis from the outer periphery 32 to the center 38 of the body. The channel may have a radius of curvature R1 of approximately 1.77 inches (4.5 cm) around its longitudinal axis and may have an overall radius of approximately 1.77 inches (4.5 cm) around the center of the body to form the closed end of the channel.
[0042] In one embodiment, the portion of the body 22 excluding the channel 24 may have a planar form prior to implantation. The body may have sufficient flexibility to conform to the anatomical structures adjacent to the stoma when implanted to repair the hernia defect. In other embodiments, the portion of the body extending outwardly from the channel may have a preformed curved form, including a non-planar form, such as a concave or convex shape relative to the channel, and may also have a desired amount of flexibility.
[0043] The preformed channel 24 can be formed in the body using vacuum thermoforming techniques. In this way, a sheet of body material is compressed using a mold or forming tool by applying heat and vacuum to thermally and / or plastically deform the sheet to form a channel of the desired shape and size defined by the mold or forming tool. The heat and vacuum can be applied directly to the sheet of material or indirectly, for example, by placing the sheet of body material between a forming tool and a heated sheet of an elastic material such as rubber. By applying a vacuum, air is removed and the elastic material and the body material are expanded and contracted to cover or enter into the forming tool. This process may be repeated using progressively larger forms to achieve the final geometric shape for the channel and other features of the body. Optionally, the body may also be preformed in a similar manner to have a non-planar form. As will be apparent to those skilled in the art, it should be understood that other manufacturing processes, such as cold forming using a rigid mold, may be used to preform the channel and / or non-planar body.
[0044] The body 22 may include a mesh fabric and may use a knitted fabric that provides openings or pores to enable tissue infiltration for incorporating the prosthesis. Optionally, the body 22 may use a warp-knitted mesh so that areas adjacent to or opposite the channels can be trimmed to optimize support for the displaced intestine and ostomy trephine. The repair fabric also has sufficient flexibility to be easily sized down for insertion into the subject. In this way, the flexible fabric may be collapsed into a slender form, such as a roll, which can be supported and advanced through a thin vacuumopic cannula for use in laparoscopic or robotic procedures.
[0045] In one embodiment, the body 22 of the prosthesis may be formed from a layer of PHASIX ST Mesh (available from Davol, Inc.), which is a resorbable repair fabric having a first side 26 that aids in functional healing by ingrowth of tissue and a second side 28 with a hydrogel barrier that is adhesion-resistant to minimize tissue adhesion. When implanted, the mesh promotes rapid ingrowth of tissue or muscle into and around the mesh structure while minimizing potential adhesion to adjacent viscera. The body is ultimately resorbed, at which point the prosthesis no longer needs 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 resorbed until the parastomal hernia repair is sufficiently healed such that it is no longer affected by adhesion to the viscera. It should be understood that any suitable repair fabric that provides ingrowth of tissue and adhesion resistance may be used for the body.
[0046] In another embodiment, the body 22 of the prosthesis may be formed from a layer of a softer or more elastic P4HB fabric, such as Galaflex Lite. The softer texture may be desirable to be gentler on any intestine that the prosthesis may contact. Further, the high elasticity of the material may enable the prosthesis to snugly support the intestine moved outward and the stoma perforation while avoiding excessive stenosis.
[0047] In one embodiment, the channel barrier layer 30 may be formed from a layer of SEPRAFILM (available from Baxter Advanced Surgery), which is a resorbable, translucent, hydrophilic adhesion barrier that reduces the incidence of adhesions. It is composed of modified sodium hyaluronate (HA) and carboxymethylcellulose (CMC). The barrier layer is ultimately resorbed, at which point there is no longer a need to separate the intestine moved outward 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 resorbed until the repair fabric has been resorbed and / or otherwise is no longer affected by adhesion to the intestine. As should be understood by those skilled in the art, it is understood that any suitable barrier material may be used for the channel barrier.
[0048] In some applications, the prosthesis 20 may be formed from two or more layers of biocompatible materials. For example, but not limited to, the body 22 of the prosthesis may include a first or inner growth layer of a knitted mesh fabric and a second or barrier layer of an adhesion-resistant material that overlays the surface of the mesh fabric. The barrier layer is separate from the fabric layer and may be attached thereto using any suitable fastening technique as will be apparent to those skilled in the art. For example, but not limited to, the mesh fabric and the barrier layer may be joined by any one or more of stitching, suturing, in-situ polymerization, solvent welding, ultrasonic welding, lamination, and / or overmolding.
[0049] It may be used for the first or inner growth layer, and examples of resorbable surgical materials and / or fabrics suitable for reinforcing tissues and muscles and correcting defects include, but are not limited to, poly-4-hydroxybutyrate (P4HB), such as PHASIX Mesh (available from Davol, Inc.), polyglactin (VICRYL--available from Ethicon, Inc.), and polyglycolic acid (DEXON--available from US Surgical, Inc.). Collagen materials such as COOK SURGISIS available from Cook Biomedical, Inc. may also be used. Non-resorbable materials including, but not limited to, polypropylene, such as BARD Mesh (available from Davol, Inc.), BARD Soft Mesh (available from Davol, Inc.), SURGIPRO (available from US Surgical, Inc.); TRELEX (available from Meadox Medical); PROLENE (available from Ethicon, Inc.); polyester, such as MERSILENE (available from Ethicon, Inc.); microporous ePTFE, such as SOFT TISSUE PATCH (available from W.L.Gore & Associates, Inc.); and other mesh materials (e.g., available from Atrium Medical Corporation) may be suitable for applications including permanent correction of tissue or muscle defects. 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.
[0050] In some embodiments using a separate second layer that can be attached to the first or inner growth layer, the second layer may be formed from the resorbable layer of SEPRAFILM. Representative non-limiting samples of other suitable barrier materials include expanded polytetrafluoroethylene (ePTFE) having a pore size (submicron) that inhibits ingrowth and adhesion of tissue, such as a sheet of GORETEX available from W.L.Gore & Associates, Inc., silicone elastomers such as SILASTIC Rx Medical Grade Sheeting (Platinum Cured) distributed by Dow Corning Corporation, TEFLON mesh, and microporous polypropylene sheet (CELGARD). Autologous, heterologous, and xenogeneic tissues, such as pericardium and submucosal tissue of the small intestine, are also contemplated. An absorbent material, such as oxidized regenerated cellulose (Interceed (TC7)), may be used in some applications. As will be apparent to those skilled in the art, it should be understood that any suitable adhesion-resistant material may be used.
[0051] As described above, the prosthesis may be suitable for use during hernia repair procedures, including parastomal hernia repair. In one embodiment shown in FIGS. 6-7, the repair procedure includes repair of a parastomal hernia using the Sugarbaker technique. As shown in FIG. 6, following hernia reduction, sac excision and / or reduction of the stoma aperture to an appropriate size, if necessary, the prosthesis 20 is placed intraperitoneally to cover the ostomy opening and secured to the fascia. By placing the prosthesis to cover the ostomy opening, the intestine is moved outwardly and the preformed channel 24 of the prosthesis is positioned to cover a portion of the intestine 40 that has been moved outwardly. The prosthesis is secured to a membrane that includes the peritoneum and / or tissue that overlaps the peritoneum. In this way, the intestine 40 is fixed between the prosthesis 20 and the peritoneum, thereby moving the forces that push the intestine ventrally up against the abdominal wall outwardly and shifting those forces away from the defect and toward the intact abdominal wall ventral to the defect, such that those forces compress the intact abdominal wall ventrally. Optionally, but not limited to, one or more sutures 46 or other suitable fasteners may be placed along the length of the channel to secure the intestine that has been moved outwardly within the channel. The preformed shape of the channel may help avoid compression of the intestine, or otherwise may occur using a flat prosthesis that is placed to cover the intestine that has been moved outwardly and secured along the side of the intestine.
[0052] As shown in FIGS. 6 and 7, the prosthesis 20 may be placed intraperitoneally by open surgery or minimally invasive procedures, such as laparoscopic or robotic surgery, and positioned to cover the ostomy opening such that the barrier surface 26 faces the viscera 42 within the peritoneal cavity to minimize tissue adhesion. The inner tissue ingrowth surface 24 of the prosthesis faces and engages the peritoneum 44 to assist in the functional healing of the hernia by tissue ingrowth. As shown in FIG. 7, the portion of the intestine 40 that has been moved outwardly and is located within the channel 24 is separated from the inner tissue ingrowth surface of the prosthesis by a barrier layer 30 that lines the inner surface of the channel facing the intestine to minimize tissue adhesion between the prosthesis and the intestine.
[0053] As described above, the prosthesis may use a body having any suitable shape for a particular application. In one embodiment shown in FIG. 6, the body may have a quadrilateral shape, such as a square or a rectangle.
[0054] In some applications, it may be desirable to configure the channel to reduce the pressure on the intestine that has been moved outward and / or to reduce the sharp corners or kinks of the intestine that has been moved outward along the outer periphery of the body. Excessive pressure on the intestine exiting the channel can potentially lead to erosion of the body into the intestine. The angled or kinked shape of the intestine exiting the channel can potentially lead to intestinal obstruction.
[0055] In one illustrative embodiment shown in FIG. 8, the channel 24 may include a flared segment 50 at its open end 34. As shown, the flared segment 50 provides a relatively large opening as compared to the remainder of the channel. The flared segment tapers in size in a direction towards the closed end of the channel and merges with the main portion 56 of the channel. In one embodiment, the flared segment 50 may present a relatively large surface area for engaging the intestine exiting the channel. The flared segment may be configured to position its outer periphery 58 at an angle to the channel to reduce excessive pressure on the intestine that has been moved outward and its outer periphery, or the potential for their overly angled shape, which could otherwise potentially lead to erosion and / or obstruction of the intestine. In one embodiment shown in FIGS. 8 - 10, the flared segment 50 may be configured to position its outer periphery 58 in a plane perpendicular to the longitudinal axis of the channel.
[0056] As described above, as should be understood by those skilled in the art, the body and the channel can be configured to have any shape and / or size suitable for a particular application and / or to accommodate the intestine moved to the outside in various sizes. In one embodiment shown in FIGS. 8-10, the body 22 may have a circular form with a diameter D1 of approximately 5.5 inches (14 cm) to approximately 9.8 inches (25 cm), depending on the size of the intestine covered by the prosthesis. Similarly, the length L2 of the linear channel 24 can be approximately 2.7 inches (6.9 cm) to approximately 4.9 inches (12.5 cm). The channel may have a radius of curvature R1 (FIG. 4) of approximately 0.6 inches (1.5 cm) to approximately 1.8 inches (4.5 cm) around its longitudinal axis and an overall radius of curvature of approximately 0.6 inches (1.5 cm) to approximately 1.8 inches (4.5 cm) around the center of the body to form the closed end of the channel. The radius of curvature R2 of the flared segment 50 of the channel can be approximately 0.6 inches (1.5 cm) to approximately 1.8 inches (4.5 cm). The longitudinal side surface of the channel can be located at a distance X1 approximately 1.6 inches (4 cm) to approximately 3.2 inches (8.1 cm) away from the outer circumference. The closed end 36 of the channel can be located at a distance Y1 approximately 1.6 inches (4 cm) to approximately 3.2 inches (8.1 cm) away from the outer circumference along its longitudinal axis.
[0057] As described above, the prosthesis 20 can be formed of a plurality of layers of material to provide the desired performance and physical properties for covering, reinforcing, and / or repairing defects in soft tissue and muscle walls.
[0058] In one embodiment useful for the description shown in FIG. 11, the body 22 can include a first or inner growth layer 52, such as a knitted mesh fabric, and a second or barrier layer 54 of adhesion-resistant material that overlays the surface 28 of the inner growth layer 52 and is intended to face the viscera, or other organs, tissues, and / or muscles to avoid tissue adhesion to the inner growth layer. The body can also include a third or channel barrier layer 30 configured to line the inner surface 26 of the preformed channel 24 to isolate a portion of the intestine moved to the outside from the inner growth layer 52.
[0059] The barrier layers 30, 54 are separated from the preformed channels 24 within the inner growth layer and may be preformed to correspond to the shape thereof. As shown, as described above, each of the layers 30, 52, 54 may include corresponding flare-shaped segments 50a, 50b, 50c to provide a relatively large inlet to the channel.
[0060] The barrier layers 30, 54 may be attached to the inner growth layer 52 using any suitable fastening technique apparent to those skilled in the art. For example, without limitation, the inner growth layer and the barrier layer may be joined by any one or more of suturing, stitching, in-situ polymerization, welding, ultrasonic welding, lamination and / or overmolding.
[0061] It is also contemplated that the prosthesis may be placed in other planes within the body. For example, without limitation, the prosthesis may be used for placement preperitoneally, behind the rectus muscle (retrorectus), and / or behind the muscle group (retromuscular). In such applications, it may be desirable for both the first and second surfaces 24, 26 of the body to be tissue-infiltratable with the adhesion-resistant barrier layer 30 provided only on the inner surface of the channel. In this way, in-growth of tissue may also occur on the visceral surface of the prosthesis.
[0062] In one embodiment shown in FIG. 12, the prosthesis 20 may include a body 22 of a transplantable biocompatible material and a preformed channel 24. The body 22 may be relatively flexible, thin, lightweight and include a first or inner growth layer 52 such as a knitted mesh fabric that meets the performance and physical properties for covering, reinforcing, and / or repairing defects in soft tissue and muscle walls. The body may include a first surface 26 and a second surface 28 opposite the first surface, both of which surfaces are tissue-infiltratable. In this way, without limitation, the prosthesis may be positioned at the repair site with the first and second surfaces 26, 28 facing soft tissue and / or muscle to receive in-growth of tissue.
[0063] It may be desirable to reduce the incidence of adhesion between the prosthesis and the intestine received in the channel. In one embodiment, the prosthesis may include an adhesion-resistant barrier 30 to cover the inner surface of the channel and isolate a portion of the intestine moved outward from the first surface 26. In this way, the barrier layer 30 can reduce potential adhesion between the body and the intestine moved outward, if not eliminating it.
[0064] The barrier layer 30 is separated from the preformed channel 24 in the in-growth layer 52 and may be preformed to correspond to its shape. As shown, as described above, each of the layers 30, 52 may include corresponding flare-shaped segments 50a, 50c to provide a relatively large inlet to the channel. As described above, the barrier layer 30 may be attached to the in-growth layer 52 using any suitable fastening technique apparent to those skilled in the art.
[0065] In some applications, it may be desirable to implant the prosthesis using a surgical procedure under direct vision where the surgeon can make an abdominal incision. Therefore, in addition to covering the stoma location to repair parastomal hernias and / or reduce their incidence, it may be desirable to support the incision. For example, but not limited to, the prosthesis may be used in conjunction with repair of an abdominal wall hernia accessed through a midline laparotomy incision through the linea alba, which is often the site for patients with abdominal wall hernias that may present alone or together with parastomal hernias.
[0066] In one embodiment shown in FIGS. 13 - 15, 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 stoma site and include a preformed channel 76 for receiving the intestine moved outward. In this way, the outer portion corresponds to the body 22 of the prosthesis shown in FIGS. 1 - 12 above. The inner portion 74 may be configured to support a midline laparotomy incision made during a surgical procedure under direct vision, for example, an incision through the linea alba.
[0067] The body may include a first surface 78 (FIG. 15) and a second surface 80 (FIG. 13) opposite the first surface. In one embodiment, the first surface 78 may be tissue-infiltratable and the second surface 80 may be adhesion-resistant. In this way, without limitation, the prosthesis may be positioned at the repair site such that the first surface 78 faces soft tissue and / or muscle to receive ingrowth of tissue, and the second surface 80 faces viscera, or other organs, tissues and / or muscle to avoid tissue adhesion to the body.
[0068] In one embodiment, the channel 76 may be configured to receive a portion of the intestine that has been moved outward, formed simultaneously with parastomal hernia repair, for example, by the Sugarbaker technique. The channel 76 may include an inner surface formed by a portion of the first surface 78 and an outer surface formed by a portion of the second surface 80. The channel includes a flared segment 77 such as described above and may reduce the pressure on the intestine moved outward and / or reduce the sharp angulation or kinking of the intestine moved outward exiting the channel along the outer perimeter of the body.
[0069] In some applications, it may be desirable to reduce the incidence of adhesion between the prosthesis and the intestine received in the channel. In one embodiment, the prosthesis includes an adhesion-resistant barrier 84 (FIG. 16) located on the inner surface of the channel and may isolate a portion of the intestine moved outward from the first surface 26. In this way, the barrier layer 84 may reduce potential adhesion between the body and the intestine moved outward, if not eliminating it.
[0070] In one embodiment, the outer portion 70 may have a circular shape, and the inner portion 72 may have a quadrilateral shape, such as a rectangle, which may be aligned with the incision. The inner portion 72 may be configured to have a length X2 in a direction perpendicular to the longitudinal axis of the channel 24, which is greater than the diameter D1 of the outer portion 70. However, as should be understood by those skilled in the art, it is to be understood that the outer portion 70 and / or the inner portion 72 may use any suitable shape and / or size for a particular application.
[0071] In one embodiment shown in FIGS. 13-15, the outer portion 72 may have a generally circular form with a diameter D1 of approximately 5.5 inches (14 cm) to approximately 9.8 inches (25 cm), depending on the size of the intestine covered by the prosthesis. The longitudinal sides of the channel may be located at a distance X1 of approximately 1.6 inches (4 cm) to approximately 3.2 inches (8.1 cm) from the outer perimeter. The closed end 36 of the channel may be located at a distance Y1 of approximately 1.6 inches (4 cm) to approximately 3.2 inches (8.1 cm) from the outer perimeter along its longitudinal axis.
[0072] The channel 76 may be configured to have a length L2 of approximately 2.7 inches (6.9 cm) to approximately 4.9 inches (12.5 cm). The channel may have a radius of curvature R1 (FIG. 4) of approximately 0.6 inches (1.5 cm) to approximately 1.8 inches (4.5 cm) around its longitudinal axis and a total radius of curvature of approximately 0.6 inches (1.5 cm) to approximately 1.8 inches (4.5 cm) around the center of the body to form the closed end of the channel. The radius of curvature R2 of the flared segment 50 of the channel may be approximately 0.2 inches (0.5 cm) to approximately 1.8 inches (4.5 cm).
[0073] The inner portion 74 may have a quadrilateral shape with a length X2 of approximately 5.5 inches (14 cm) to approximately 11.8 inches (30 cm) and a width Y2 of approximately 3.1 inches (7.9 cm) to approximately 11.8 inches (30 cm). The closed end of the channel may be spaced apart by a distance Y3 of approximately 1.6 inches (4 cm) to approximately 6.3 inches (16 cm) from the centerline Y4 of the inner portion.
[0074] As described above, as should be understood by those skilled in the art, the body 70 and the channel 76 can be configured to have any shape and / or size suitable for a particular application and / or to accommodate the intestine and / or abdominal incision moved to the outside of various sizes.
[0075] As described above, the prosthesis 20 can be formed with a plurality of layers of material to provide the desired performance and physical properties for covering, reinforcing, and / or repairing soft tissue and muscle wall defects.
[0076] In one illustrative embodiment shown in FIG. 16, the body 70 can include a first or inner growth layer 82, such as a knitted mesh fabric, and a second or barrier layer 84 of an adhesion-resistant material that overlays the surface of the inner growth layer 82 and is intended to face the viscera, or other organs, tissues, and / or muscles to avoid tissue adhesion to the inner growth layer. The body can also include a third or channel barrier layer 86 configured to line the inner surface of the preformed channel 76 to isolate a portion of the intestine moved to the outside from the inner growth layer 52.
[0077] The barrier layers 84, 86 are separated from the preformed channel 76 in the inner growth layer and can be preformed to correspond to its shape. As shown, as described above, each of the layers 82, 84, 86 can include corresponding flare-shaped segments 77a, 77b, 77c to provide a relatively large inlet to the channel.
[0078] The barrier layers 84, 86 may be attached to the inner growth layer 82 using any suitable fastening technique as will be apparent to those skilled in the art. For example, without limitation, the inner growth layer and the barrier layer may be joined by any one or more of suturing, stapling, in-situ polymerization, welding, ultrasonic welding, lamination, and / or overmolding.
[0079] For the purposes of this patent application and any patent issues related thereto, the indefinite articles "a" and "an" as used herein in the specification and claims are to 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 means "either or both" of the elements so joined, i.e., elements that in some cases coexist conjunctively and in other cases disjunctively. Multiple elements listed using "and / or" are to be construed likewise, i.e., as "one or more" of the elements so joined. Other elements may optionally be present, whether or not related or unrelated to the elements specifically identified, in addition to the elements specifically identified by the "and / or" clause.
[0080] As used herein, the use of "including", "comprising", "having", "containing", "involving" and / or variations thereof means including the items listed before it, their equivalents, and additional items.
[0081] It should be understood that, unless expressly indicated to the contrary, in any method claimed herein that includes two or more steps or acts, the order of the method steps or acts is not necessarily limited to the order of the steps or acts recited.
[0082] The above description of various embodiments is for illustrative purposes only, and other embodiments, modifications, and equivalents are within the scope of the invention as recited in the appended claims.
Claims
1. A body of implantable, biocompatible material, the body having a pre-formed three-dimensional shape, the body comprising a first surface and a second surface opposite to the first surface, the first surface being tissue-penetrating and the second surface being adhesion-resistant; A channel pre-formed in the body, the channel having a three-dimensional shape that receives a portion of the intestine moved outward, the channel including an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface; An adhesion-resistant barrier located on the inner surface of the channel, which isolates the portion of the intestine moved outward from the first surface, A transplantable prosthesis equipped with the following features.
2. The aforementioned body includes the outer circumference, The implantable prosthesis according to claim 1, wherein the channel extends from the outer periphery of the main body to the inner region.
3. The implantable prosthesis according to claim 2, wherein the channel includes an open end on the outer circumference and a closed end on the opposite side of the open end.
4. The implantable prosthesis according to any one of claims 1 to 3, wherein the maximum width of the main body is 5.9 inches to 9.8 inches.
5. The aforementioned body has a circular shape with a certain outer diameter, The implantable prosthesis according to claim 4, wherein the maximum width corresponds to the outer diameter.
6. The implantable prosthesis according to any one of claims 1 to 3, wherein the length of the channel is 2.9 inches to 4.9 inches.
7. The channel extends along its longitudinal axis, The implantable prosthesis according to any one of claims 1 to 3, wherein the radius of the channel is 0.6 inches to 1.8 inches about the longitudinal axis.
8. The main body has a circular shape with a diameter of 5.9 inches to 7.9 inches. The length of the channel is 3.0 inches to 4.0 inches along the longitudinal axis from the outer circumference to the center of the main body. The implantable prosthesis according to claim 3, wherein the radius of the channel is 0.6 inches about the longitudinal axis.
9. The diameter of the main body is 6.0 inches. The implantable prosthesis according to claim 8, wherein the length of the channel is 3.0 inches.
10. The main body has a circular shape with a diameter of 7.1 inches to 8.7 inches. The length of the channel along its longitudinal axis is 3.5 inches to 4.0 inches along the longitudinal axis from the outer circumference to the center of the body. The implantable prosthesis according to claim 3, wherein the radius of the channel is 1.2 inches about the longitudinal axis.
11. The main body has a circular shape with a diameter of 8.2 inches to 9.8 inches. The length of the channel along its longitudinal axis is 4.1 inches to 4.9 inches along the longitudinal axis from the outer circumference to the center of the body. The implantable prosthesis according to claim 3, wherein the radius of the channel is 1.8 inches about the longitudinal axis.
12. The implantable prosthesis according to claim 3, wherein the closed end has a hemispherical shape with a radius of 0.6 inches to 1.8 inches about the longitudinal axis.
13. The channel has a periphery, The implantable prosthesis according to any one of claims 1 to 3, wherein the portion of the main body extending outward from the periphery of the channel has a planar shape.
14. The implantable prosthesis according to any one of claims 1 to 3, wherein the main body is reabsorbable.
15. The implantable prosthesis according to any one of claims 1 to 3, wherein the adhesion-resistant barrier is reabsorbable.
16. A body of implantable, biocompatible material, the body having a circular shape, the body comprising a first surface and a second surface opposite to the first surface, the first surface being tissue-penetrating and the second surface being adhesion-resistant; A channel on the body configured to receive a portion of the intestine moved outward, the channel comprising an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface; An adhesion-resistant barrier located on the inner surface of the channel, which isolates the portion of the intestine moved outward from the first surface, A transplantable prosthesis equipped with the following features.
17. The aforementioned body includes the outer circumference, The implantable prosthesis according to claim 16, wherein the channel extends from the outer circumference of the main body to the inner region.
18. The implantable prosthesis according to claim 17, wherein the channel includes an open end on the outer circumference and a closed end on the opposite side of the open end.
19. The implantable prosthesis according to any one of claims 16 to 18, wherein the diameter of the main body is 5.9 inches to 9.8 inches.
20. The implantable prosthesis according to any one of claims 16 to 18, wherein the length of the channel is 2.9 inches to 4.9 inches.
21. The channel extends along its longitudinal axis, The implantable prosthesis according to any one of claims 16 to 18, wherein the radius of the channel is 0.6 inches to 1.8 inches about the longitudinal axis.
22. The diameter of the main body is 5.9 inches to 7.9 inches. The length of the channel along its longitudinal axis is 3.0 inches to 4.0 inches from the outer circumference to the center of the main body. The implantable prosthesis according to claim 18, wherein the radius of the channel is 0.6 inches about the longitudinal axis.
23. The diameter of the main body is 6.0 inches. The implantable prosthesis according to claim 22, wherein the length of the channel is 3.0 inches.
24. The diameter of the main body is 7.1 inches to 8.7 inches. The length of the channel along its longitudinal axis is 3.5 inches to 4.0 inches along the longitudinal axis from the outer circumference to the center of the body. The implantable prosthesis according to claim 18, wherein the radius of the channel is 1.2 inches about the longitudinal axis.
25. The diameter of the main body is 8.2 inches to 9.8 inches. The length of the channel along its longitudinal axis is 4.1 inches to 4.9 inches along the longitudinal axis from the outer circumference to the center of the body. The implantable prosthesis according to claim 18, wherein the radius of the channel is 1.8 inches about the longitudinal axis.
26. The implantable prosthesis according to claim 18, wherein the closed end has a hemispherical shape with a radius of 0.6 inches to 1.8 inches about the longitudinal axis.
27. The implantable prosthesis according to any one of claims 16 to 18, wherein the main body is reabsorbable.
28. The implantable prosthesis according to any one of claims 16 to 18, wherein the adhesion-resistant barrier is reabsorbable.
29. A body of implantable, biocompatible material, the body having a preformed three-dimensional shape, the body including a first surface and a second surface opposite to the first surface, the body including an outer periphery; A channel preformed in the body, the channel having a three-dimensional shape that receives a portion of the intestine moved outward, the channel including an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface, the channel extending from the outer periphery of the body to the inner region, the channel including an open end on the outer periphery and a closed end in the inner region, a portion of the channel including a flared segment extending from the outer periphery toward the closed end; A transplantable prosthesis, including one.
30. The implantable prosthesis according to claim 29, wherein the flared segment of the channel is configured to reduce pressure on the outwardly moved portion of the intestine at the open end of the channel.
31. The implantable prosthesis according to claim 29 or 30, wherein the size of the flared segment decreases in the direction from the open end toward the closed end.
32. Furthermore, the implantable prosthesis according to claim 29 or 30, comprising an adhesion-resistant barrier located on the inner surface of the channel, to isolate the outwardly moved portion of the intestine from the first surface.
33. The first surface is capable of tissue infiltration, The implantable prosthesis according to claim 29 or 30, wherein the second surface is resistant to adhesion.
34. The main body comprises a first layer of tissue-penetrating fabric and a second layer of adhesion-resistant material. The first layer forms the first surface of the main body, The implantable prosthesis according to claim 29 or 30, wherein the second layer forms the second surface of the main body.
35. The implantable prosthesis according to claim 29 or 30, wherein the length of the channel is 2.9 inches to 4.9 inches.
36. The channel extends along its longitudinal axis, The implantable prosthesis according to claim 29 or 30, wherein the radius of the channel is 0.6 inches to 1.8 inches about the longitudinal axis.
37. The implantable prosthesis according to claim 29 or 30, wherein the closed end has a hemispherical shape with a radius of 0.6 inches to 1.8 inches about the longitudinal axis.
38. The implantable prosthesis according to claim 29 or 30, wherein the radius of curvature of the flared segment is 0.6 inches to 1.8 inches.
39. The channel has a periphery, The implantable prosthesis according to claim 29 or 30, wherein the portion of the main body extending outward from the periphery of the channel has a planar shape.
40. A body of implantable, biocompatible material, the body comprising a first surface and a second surface opposite to the first surface, the body comprising an outer portion and an inner portion extending from the outer portion, the body comprising an outer periphery; A channel preformed on the outer portion of the main body, the channel having a three-dimensional shape that receives a portion of the intestine moved outward, the channel including an inner surface formed by a portion of the first surface and an outer surface formed by a portion of the second surface, the channel extending from the outer periphery of the main body to the inner region, the channel including an open end on the outer periphery and a closed end in the inner region; A transplantable prosthesis including, The aforementioned outer portion is configured to be placed at the stoma site to prevent and / or repair parastomal hernia, The inner portion of the implantable prosthesis is configured to be placed in the midline abdominal incision when the outer portion is placed in the stoma area.
41. The aforementioned outer portion has a first form, The implantable prosthesis according to claim 40, wherein the inner portion has a second form different from the first form.
42. The implantable prosthesis according to claim 41, wherein at least a portion of the outer circumference along the outer portion has a circular shape.
43. The implantable prosthesis according to claim 41 or 42, wherein the inner portion has a rectangular shape.
44. The implantable prosthesis according to claim 41 or 42, wherein the inner portion has a length of 5.5 inches to 11.8 inches and a width of 3.1 inches to 11.8 inches.
45. The aforementioned inner portion has a center line located at 50% of the aforementioned width, The implantable prosthesis according to claim 44, wherein the closed end of the channel is spaced at a distance of 1.6 inches to 6.3 inches from the center line of the inner portion.
46. The implantable prosthesis according to any one of claims 40 to 42, wherein a portion of the channel includes a flared segment extending from the outer circumference toward the closed end.
47. The implantable prosthesis according to claim 46, wherein the flared segment of the channel is configured at the open end of the channel to reduce pressure on the outwardly moved portion of the intestine.
48. The implantable prosthesis according to claim 46, wherein the size of the flared segment decreases in the direction from the open end toward the closed end.
49. The implantable prosthesis according to claim 46, wherein the radius of curvature of the flared segment is 0.6 inches to 1.8 inches.
50. Furthermore, the implantable prosthesis according to any one of claims 40 to 42 includes an adhesion-resistant barrier located on the inner surface of the channel to isolate the outwardly moved portion of the intestine from the first surface.
51. The first surface is capable of tissue infiltration, The second surface is adhesive-resistant, as described in any one of claims 40 to 42.
52. The main body comprises a first layer of tissue-penetrating fabric and a second layer of adhesion-resistant material. The first layer forms the first surface of the main body, The implantable prosthesis according to any one of claims 40 to 42, wherein the second layer forms the second surface of the main body.
53. The implantable prosthesis according to any one of claims 40 to 42, wherein the length of the channel is 2.9 inches to 4.9 inches.
54. The channel extends along its longitudinal axis, The implantable prosthesis according to any one of claims 40 to 42, wherein the radius of the channel is 0.6 inches to 1.8 inches about the longitudinal axis.
55. The implantable prosthesis according to any one of claims 40 to 42, wherein the closed end has a hemispherical shape with a radius of 0.6 inches to 1.8 inches about the longitudinal axis.
56. The channel has a periphery, The implantable prosthesis according to any one of claims 40 to 42, wherein the portion of the main body extending outward from the periphery of the channel has a planar shape.