PRE-FORMED PARASTOMAL HERNIA REINFORCEMENT MESH

Abstract

A mesh for repair/prevention of a parastomal hernia during ostomy treatment is disclosed. More specifically, a pre-molded mesh having a unique shape to provide support to the abdominal wall adjacent a stoma formed during an ostomy procedure to prevent/repair formation of a parastomal hernia is disclosed which also provides a clearance channel through which the bowel can pass in a manner that prevents collapse or obstruction of the exposed segment of the bowel.

Claims

1. A preformed parastomal hernia reinforcement, comprising: a repair prosthetic formed from a bio implantable mesh, said repair prosthetic including: a raised clearance channel configured to be positioned about a lateralized bowel segment; and a margin region about a periphery of said clearance channel, the margin region to be positioned adjacent and fastened to an abdominal wall, wherein said repair prosthetic reinforces a herniated region of said abdominal wall while providing clearance for uncompressed passage of said bowel through a stomal opening in said abdominal wall.

2. The preformed parastomal hernia reinforcement of claim 1, further comprising: openings positioned about a periphery of said margin region and at a transition between said margin region and said raised clearance channel to facilitate installation of fastening means.

3. The preformed parastomal hernia reinforcement of claim 1, wherein said margin region has a width of 2.5 cm or greater.

4. The preformed parastomal hernia reinforcement of claim 1, wherein said raised clearance channel has a length of between 5 cm and 10 cm.

5. The preformed parastomal hernia reinforcement of claim 1, wherein said raised clearance channel is formed in said bio implantable mesh during manufacture thereof.

6. The preformed parastomal hernia reinforcement of claim 1, wherein said raised clearance channel is formed in said bio implantable mesh by heat molding.

7. The preformed parastomal hernia reinforcement of claim 1, wherein said raised clearance channel is formed in said bio implantable mesh prior to an implantation procedure.

8. The preformed parastomal hernia reinforcement of claim 1, wherein said mesh is a synthetic mesh material.

9. The preformed parastomal hernia reinforcement of claim 1, wherein said mesh is a bio sourced mesh material.

10. The preformed parastomal hernia reinforcement of claim 1, wherein said mesh is selected from the group consisting of: synthetic mesh, composite mesh, polypropylene, polyester, ePTFE, bioabsorbable mesh, bio-sourced tissue and combinations thereof.

11. The preformed parastomal hernia reinforcement of claim 1, wherein said mesh is coated with a material selected from the group consisting of: absorbable fatty acids, cellulose or collagen and combinations thereof.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0016] In the drawings which illustrate the best mode presently contemplated for carrying out the present invention:

[0017] FIG. 1 is a proximal view of a mesh repair prosthesis in accordance with the present disclosure;

[0018] FIG. 2 is a proximal view of a mesh repair prosthesis positioned over the lateralized bowel adjacent the stomal opening in accordance with the present disclosure;

[0019] FIG. 3 is a lateral perspective view of a mesh repair prosthesis positioned over the lateralized bowel adjacent the stomal opening in accordance with the present disclosure; and

[0020] FIG. 4 is a partial cross-sectional view of a mesh repair prosthesis positioned over the lateralized bowel adjacent the stomal opening in accordance with the present disclosure.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0021] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the device and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present disclosure is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. Further, in the present disclosure, like-numbered components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-numbered component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Further, to the extent that directional terms like top, bottom, up, or down are used, they are not intended to limit the systems, devices, and methods disclosed herein. A person skilled in the art will recognize that these terms are merely relative to the system and device being discussed and are not universal.

[0022] Now referring to the drawings, the preformed prosthetic repair mesh for a parastomal hernia repair is shown and generally illustrated in the figures. As can be seen in FIG. 1, a preformed mesh prosthetic 10 is disclosed for repair/prevention of a parastomal hernia during ostomy treatment. More specifically, the preformed mesh prosthetic 10 has a unique shape including blunted or rounded edges to improve placement and increase the biocompatibility of the preformed mesh prosthetic 10. The includes a margin region 12 that is preferably greater than or equal to 2.5 cm in width to provide support to the abdominal wall adjacent a stoma formed during an ostomy procedure to prevent/repair formation of a parastomal hernia and to provide sufficient overlap onto the adjacent fascia to provide effective repair and prevent formation of additional hernias.

[0023] In addition, the preformed mesh prosthetic 10 includes a preformed clearance channel 14 through which the bowel can pass in a manner that prevents collapse or obstruction of the exposed segment of the bowel. The preformed clearance channel 14 is formed in the preformed mesh prosthetic 10 having a size and shape to accommodate the protrusion of the lateralized bowel such that support is provided to the facia adjacent the stoma and yet no pressure is exerted onto the bowel thereby preventing collapsing or obstruction of the bowel that passes therethrough. The extension length of the preformed clearance channel 14 is preferably between 5 cm and 10 cm in length and has a smooth rounded shape and transitions so as to improve placement and increase the biocompatibility of the preformed mesh prosthetic 10.

[0024] Turning now to FIGS. 2-4, in accordance with the present disclosure, the preformed mesh prosthetic 10 is disclosed as a modification for the Sugarbaker repair technique. In the Sugarbaker technique the parastomal hernia repair is performed via a laparotomy. The herniated region adjacent the stomal opening 16 in the abdominal wall 18 is covered with an intraperitoneally placed preformed mesh prosthetic 10 that is attached to the fascial edge using sutures. The preformed mesh prosthetic 10 may include preformed openings 20 to facilitate placement of sutures for fastening to the trephine, further the preformed openings may further include reinforcement to increase the durability of the preformed mesh prosthetic 10. The openings are preferably positioned about the outer margin of the preformed mesh prosthetic 10 and at the transition between the margin region 12 and the preformed clearance channel 14.

[0025] The lateralized bowel 22, passes from the hernia sac between the abdominal wall and the preformed mesh prosthetic 10 into the peritoneal cavity. As stated previously, it is known from incisional hernia repair, that an overlap of 2.5-5 cm between the preformed mesh prosthetic 10 and the adjacent abdominal wall 18 fascia is mandatory to prevent recurrent hernias.

[0026] Given that it is of utmost importance to prevent narrowing of the bowel in the tunnel and angulation of the bowel when entering the abdominal cavity and the hernia sac, the region to be repaired is covered with the preformed mesh prosthetic 10. In the prior art the relatively stiff and rigid mesh is flat and it must be shaped and bent as it is stitched to the trephine to prevent its normally flat nature from compressing the bowel and causing obstruction.

[0027] In accordance with the present disclosure, a preformed mesh prosthetic 10 is provided that is shaped during manufacture or prior to the procedure. The preformed clearance channel 14, in turn, serves to assist in correctly positioning the preformed mesh prosthetic 10 over the lateralized bowel as well as creating the needed clearance for the bowel to pass through the stoma without compression or obstruction thereof.

[0028] The preformed mesh prosthetic 10 of the present disclosure is preferably formed to have a mesh matrix using a material selected from the group consisting of the following materials: synthetic mesh such as polypropylene, polyester, ePTFE; bioabsorbable; bio-sourced tissue or combinations thereof. Further, the mesh may be coated with absorbable fatty acids, cellulose or collagen to prevent adhesions thereto. The unique shape of the preformed mesh prosthetic 10 is preferable performed during the mesh manufacture either by shaping the mesh as it is formed/woven or by heat molding the mesh. Further, the preformed mesh prosthetic 10 may be shaped using heat molding by the surgeon prior to the procedure.

[0029] It can therefore be seen that the present disclosure provides a repair mesh for use in repairing/preventing a parastomal hernia during ostomy treatment. The present disclosure further provides a pre-molded repair mesh for use in repairing/preventing a parastomal hernia during ostomy treatment that resists migration and allows placement without risking collapse or blockage of the extended bowel section. Still further, the present disclosure provides a pre-molded repair mesh for use in repairing/preventing a parastomal hernia during ostomy treatment reduces the time previously needed to form the mesh as it is installed during the procedure that further assists in prosthesis placement without risking collapse or blockage of the extended bowel section. For these reasons, the present disclosure is believed to represent a significant advancement in the art, which has substantial commercial merit.

[0030] While there is shown and described herein certain specific structure embodying the invention, it will be manifest to those skilled in the art that various modifications and rearrangements of the parts may be made without departing from the spirit and scope of the underlying inventive concept and that the same is not limited to the particular forms herein shown and described except insofar as indicated by the scope of the appended claims.