Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Muscle
Reexamination Certificate
1999-05-10
2001-07-10
Smith, Jeffrey A. (Department: 3732)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Muscle
C623S011110, C606S151000
Reexamination Certificate
active
06258124
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a prosthetic repair fabric and, more particularly, to an adhesion resistant fabric for use in soft tissue repair and reconstruction.
DISCUSSION OF RELATED ART
Various prosthetic mesh materials have been proposed to reinforce the abdominal wall and to close abdominal wall defects. In certain procedures, the prosthetic mesh may come into contact with sensitive tissue or organs potentially leading to postoperative adhesions between the mesh and the sensitive tissue or organs. There has been a suggestion that, in an inguinal hernia repair, the prosthetic mesh may come into direct contact with the spermatic cord. Postoperative adhesions between the mesh and the spermatic cord and/or erosion of the mesh into the cord, were they to occur, could potentially affect spermatic cord structure and function.
Inguinal hernias are commonly repaired using a sheet of mesh fabric, such as BARD MESH, which may be trimmed, as necessary, to match the particular size and shape of the inguinal floor. A slit is preformed or made by the surgeon from the lateral end of the mesh opposite the medial corner of the inguinal canal toward the medial end of the mesh to form a pair of lateral tails that are separated to receive the spermatic cord therebetween. The tails may then be overlapped to encircle the cord and reinforce the internal ring. A preshaped mesh may be provided with the slit and a keyhole at the end of the slit for receiving the cord therein.
Uzzo et al., “The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures: A Preliminary Report in a Canine Model”, The Journal of Urology, Vol. 161, April 1999, pp. 1344-1349, reports that prosthetic mesh in direct contact with the spermatic cord may adversely affect spermatic cord structure and function. The article suggests that the interposition of autologous fat between the mesh and the cord during open inguinal repair may prove beneficial.
Various approaches to reducing the incidence of postoperative adhesions arising from the use of prosthetic mesh materials have been proposed by the prior art. It had been proposed in U.S. Pat. No. 5,593,441, assigned to C. R. Bard, Inc., also the assignee of the present application, to repair ventral hernias and/or reconstruct chest walls using a prosthesis that is covered with an adhesion resistant barrier, such as a sheet of expanded PTFE. In the repair of ventral hernias and in chest wall reconstruction, the composite is positioned with the barrier relative to the region of potential adhesion, such as the abdominal viscera.
International Publication No. WO 97/35533 proposed a universal composite prosthesis in which one side of a layer of mesh material is completely covered with a layer of barrier material. The mesh material promotes biological tissue ingrowth while the barrier material retards biological tissue adherence thereto. The prosthesis may be utilized for various surgical procedures, including ventral hernia repair and inguinal hernia repair in which the barrier material is positioned adjacent the sensitive tissue. For an inguinal hernia, the barrier material is positioned adjacent the spermatic cord to retard adhesions thereto and the mesh material is positioned adjacent muscle tissue to promote tissue adhesion thereto.
It is an object of the present invention to provide an improved method and prosthesis for the repair of inguinal hernias.
SUMMARY OF THE INVENTION
The present invention is a composite prosthetic repair fabric and method for reinforcing and repairing a tissue or wall defect by promoting enhanced tissue ingrowth thereto, while limiting the incidence of postoperative adhesions between the mesh and sensitive tissue or organs. The composite is formed of a biologically compatible, flexible implantable fabric suitable for reinforcing tissue and closing tissue defects, and a barrier for physically isolating the reinforcing fabric from areas likely to form adhesions. The barrier and implantable fabric may be attached by stitching, an adhesive, fusion or insert molding in a manner which preserves sufficient openings in the fabric for tissue ingrowth.
The prosthetic repair fabric is particularly suited for repairing a tissue or muscle wall defect located in the inguinal canal near the spermatic cord, the inguinal canal having a medial corner and a lateral end. The prosthetic repair fabric comprises a layer of mesh fabric with a plurality of interstices that are constructed and arranged to allow tissue ingrowth, the mesh fabric being susceptible to the formation of adhesions with sensitive tissue and organs. The mesh fabric includes a medial section and a lateral section that are configured to be positioned adjacent the medial corner and the lateral end of the inguinal canal, respectively, when the prosthetic repair fabric is placed in the inguinal canal. The prosthetic repair fabric further comprises at least one barrier layer that inhibits the formation of adhesions with sensitive tissue and organs, the barrier layer being disposed on at least one side of the layer of mesh fabric to inhibit the formation of adhesions between the spermatic cord and the mesh fabric.
In one embodiment of the invention, the barrier layer covers at least a portion of the medial section that is to be positioned adjacent the spermatic cord when the prosthetic repair fabric is placed in the inguinal canal. At least a portion of the lateral section of the mesh fabric is free of the barrier layer on both sides thereof to promote enhanced tissue ingrowth therein.
In another embodiment of the invention, the barrier layer includes at least one flap constructed and arranged to be folded through the mesh fabric to isolate the spermatic cord from internal edges of the mesh fabric when the spermatic cord is routed through the prosthesis.
Other objects and features of the present invention will become apparent from the following detailed description when taken in connection with the accompanying drawings. It is to be understood that the drawings are designed for the purpose of illustration only and are not intended as a definition of the limits of the invention.
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paten
Cherok Dennis
Darois Roger E.
Eldridge Stephen N.
Greene Ronald L.
C. R. Bard Inc.
Smith Jeffrey A.
Wolf Greenfield & Sacks P.C.
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