Implantable silk-based tissue prostheses

Abstract

A silk fiber based matrix composition comprising spider silk that can be biodegradable, from the spider species Nephila clavipes (or from genetically engineered bacteria making Nephila clavipes silk), and in the form of a mesh or film.

We claim: 
     
         1 . A tissue prosthesis comprising a matrix of sericin-extracted silkworm fibroin fibers, said fibers being biocompatible and helically organized into fiber bundles, wherein said matrix supports ingrowth of cells around said fibroin fibers and is biodegradable. 
     
     
         2 . The prosthesis as recited in  claim 1 , wherein the silk-fiber based matrix comprises fibroin fibers obtained from  Bombyx mori  silkworm. 
     
     
         3 . The prosthesis as recited in  claim 1 , wherein the matrix comprises a composite of the sericin-extracted fibroin fibers and collagen fibers. 
     
     
         4 . The prosthesis as recited in  claim 1 , wherein the matrix comprises a composite of the sericin-extracted fibroin fibers and one or more silk foams, films, meshes or sponges. 
     
     
         5 . The prosthesis as recited in  claim 1 , wherein the matrix comprises a composite of the sericin-extracted fibroin fibers and one or more degradable polymers selected from group consisting of Collagens, Polylactic acid or its copolymers, Polyglycolic acid or its copolymers, Polyanhydrides, Elastin, Glycosamino glycans, and Polysaccharides. 
     
     
         6 . The prosthesis as recited in  claim 1 , further comprising pluripotent or fibroblast cells seeded on said matrix. 
     
     
         7 . The prosthesis as recited in  claim 6 , wherein said pluripotent or fibroblast cells are autologous. 
     
     
         8 . The prosthesis as recited in  claim 7 , wherein said pluripotent or fibroblast cells are allogeneic. 
     
     
         9 . The prosthesis as recited in  claim 7 , wherein said pluripotent cells are selected from the group consisting of bone marrow stromal cells and adult or embryonic stem cells. 
     
     
         10 . The prosthesis as recited in  claim 7 , wherein said fibroblast cells are mature human ACL fibroblast cells. 
     
     
         11 . The prosthesis as recited in  claim 1  in the shape of a smooth muscle tissue. 
     
     
         12 . The prosthesis of  claim 1 , wherein said matrix comprises an ultimate tensile strength of greater than 2000N and a linear stiffness of between 100-600N/mm. 
     
     
         13 . The prosthesis as recited in  claim 13 , wherein the matrix is in the form of a mesh. 
     
     
         14 . A smooth muscle prosthesis comprising a matrix of sericin-extracted silkworm fibroin fibers, said fibers being biocompatible and helically organized into fiber bundles. 
     
     
         15 . The prosthesis as recited in  claim 14 , wherein the silk-fiber based matrix comprises fibroin fibers obtained from  Bombyx mori  silkworm. 
     
     
         16 . The prosthesis as recited in  claim 14 , wherein the matrix is in the form of a mesh. 
     
     
         17 . The prosthesis as recited in  claim 14 , wherein the matrix comprises a composite of the sericin-extracted fibroin fibers and one or more degradable polymers selected from group consisting of Collagens, Polylactic acid or its copolymers, Polyglycolic acid or its copolymers, Polyanhydrides, Elastin, Glycosamino glycans, and Polysaccharides. 
     
     
         18 . The prosthesis as recited in  claim 14 , further comprising pluripotent or fibroblast cells seeded on said matrix. 
     
     
         19 . An implantable, silk-fiber-based mesh comprising helically organized fiber bundles of sericin-extracted biodegradable silkworm fibroin fibers. 
     
     
         20 . The mesh as recited in  claim 19  having an ultimate tensile strength of greater than 2000N and a linear stiffness of between 100-600N/mm, wherein the fibers are completely free of sericin.