Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Tissue
Reexamination Certificate
2000-06-09
2001-08-07
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Tissue
C623S023760, C623S926000, C606S213000, C600S037000
Reexamination Certificate
active
06270530
ABSTRACT:
FIELD OF INVENTION
The present invention relates to a prosthetic repair fabric and, more particularly, to an adhesion resistant, dual layer knitted fabric for use in soft tissue repair and reconstruction.
BACKGROUND OF THE INVENTION
Various prosthetic repair materials have been proposed for mending inguinal hernias and for reconstructing the abdominal and chest wall, MARLEX mesh, a single bar warp knit, dual course Atlas polypropylene monofilament fabric, is exemplary of an implant material that has been successfully used in soft tissue reinforcement and defect closure.
A concern had been raised that MARLEX mesh may form postoperative adhesions with the abdominal viscera, such as the intestines, when used in the repair of inguinal hernias and other abdominal wall defects. Similarly, there was a suggestion that intra-thoracic viscera (i.e. heart and lungs) could adhere to the porous prosthetic repair material after chest wall reconstruction. To alleviate these concerns, 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 cover the MARLEX fabric (or other tissue infiltratable material) with an adhesion resistant barrier, such as a sheet of expanded PTFE. The composite prosthesis is surgically placed so that the barrier isolates the sensitive viscera from the porous fabric, preventing the formation of postoperative adhesions.
One method of forming the composite is to laminate the mesh and adhesion resistant cover together. Preliminary investigation, however, suggests that fusing a sheet of MARLEX to a barrier layer of ePTFE may detrimentally affect the tissue infiltratability of the prosthesis. With one surface of the porous fabric covered by the ePTFE, the ingrowing tissue may be unable to completely incorporate the mesh.
Accordingly, there is a need for an improved laminate prosthesis for the repair of tissue or muscle wall defects that exhibits acceptable tissue ingrowth properties.
SUMMARY OF THE INVENTION
The present invention is a prosthetic repair fabric for reinforcing or repairing a damaged muscle or tissue wall and includes a first sheet of porous and tissue infiltratable material, an adhesion resistant, microporous barrier sheet for isolating the first sheet from sensitive tissue and organs after implantation, and a second sheet that is united with the porous and tissue infiltratable first sheet and which also is fused to the barrier sheet to form a laminate composite construction. Preferably, the second sheet also is porous and tissue infiltratable and at least a surface portion of the lower melting temperature porous second sheet melts during lamination and flows into the microporous structure of the adhesion resistant covering, encapsulating the void network of the barrier upon solidification to form a strong mechanical fixation between the two materials. Degradation of physical properties of the composite implant is avoided since only one of the fabric sheets, the fabric panel adjacent the barrier, is melted during assembly of the prosthesis, allowing the other porous panel to retain its full tissue ingrowth potential and strength.
In one embodiment, the laminate includes two united sheets of warp knitted polypropylene monofilament, preferably having a 2 course Atlas pattern, that are bonded to a sheet of submicron porous expanded PTFE. The two tissue ingrowth panels may be simultaneously knitted on a double needle bed machine and then joined together by intermittent or continuous machine direction, but laterally spaced, stitches. Where the stitches arc intermittent, the connecting yarn may be laid in between the fabric panels. Preferably, the sheets are knitted together as the panels are formed on the knitting machine. Alternatively, the dual layers may be tacked together after the fabric panels have been removed from the knitting device. The dual layer, porous polypropylene fabric is laminated to the sheet of expanded PTFE by a combination of heat and pressure. The top mesh layer becomes fused to the expanded PTFE while the lower mesh layer, which is not melted, retains its shape and physical characteristics.
Another important embodiment of the invention involves a method of limiting the incidence of postoperative adhesions arising from the repair of an opening in a tissue or muscle wall. The method includes the steps of providing a composite prosthesis including first and second sheets of tissue infiltratable fabric and an adhesion resistant barrier sheet that is fused to the first fabric sheet, and then positioning the composite prosthesis with the second tissue infiltratable fabric sheet filling or covering, thereby occluding, the tissue or muscle wall opening and with the barrier sheet facing away from the tissue or muscle wall opening and extending between a region of potential postoperative adhesion and the porous fabric sheets. The method has particular applicability in the repair of ventral hernias and in the reconstruction of the chest wall.
In another important embodiment, a dual layer implantable fabric is provided including a pair of waip knit sheets having interstices constructed and arranged for tissue ingrowth so that the fabric becomes secured in place after implantation, wherein the two sheets are united by intermittent stitches of a connecting yarn that is laid in between the intermittent stitches.
It is a general object of the invention to provide a laminated adhesion resistant, composite 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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Eldridge Stephen N.
Titone Milo A.
C.R. Bard Inc.
Isabella David J.
Koh Choon P.
Wolf Greenfield & Sacks P.C.
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