Apparatus and method for limiting surgical adhesions
A composite prosthesis and method for limiting the incidence of postoperative adhesions. The composite includes a non-inflammatory or coated mesh and a barrier material which prevents exposure of tissue elsewhere in the body to tissue covered by the composite prosthesis. The barrier material is absorbable which allows tissue through-growth and localization of the composite prosthetic. In use, the composite prosthesis is positioned over the tissue defect and may be positioned with the barrier material oriented against the tissue defect or repair site.
1. A composite prosthesis comprising:
a coated mesh having at least one opening through a first surface and a second surface of the coated mesh;
the coated mesh comprising a mesh, and
a cured biocompatible coating substantially surrounding each filament of the mesh,
wherein the biocompatible coating is a non-absorbable cyanate-terminated hydrophilic prepolymer comprising:
a copolymer comprising polyether monomers and from 5% to 30% of propylene oxide monomers;
from 20 to 40 wt. % of at least one polyisocyanate selected from the group consisting of 2,4-toluene diisocyanate, 2,6-toluene diisoscyanate, and isophorone diisocyanate; and
from 1.0 to 10 wt. % of trimethylolpropane; and
a barrier material comprising a biocompatible membrane constructed and arranged to cover at least one surface of the coated mesh, wherein the barrier material is a bioabsorbable material adhered to the mesh by the cured prepolymer.
2. The composite prosthesis according to claim 1 wherein the mesh comprises a knitted mesh and the barrier material is attached to at least one surface of the coated mesh.
3. The composite prosthesis according to claim 2 wherein the barrier material is attached to the coated mesh by the biocompatible coating.
4. The composite prosthesis according to claim 1 wherein the barrier material is comprised of a bioabsorbable segmented copolymer comprising a first component which is a polyalkylene glycol and a second component which is a polyester formed from an alkylene glycol having from 2 to 8 carbon atoms and a dicarboxylic acid; and the barrier material is selected from the group consisting of a non-porous layer and a porous layer in which essentially all of the pores have a pore size no greater than 3 microns.
5. The composite prosthesis according to claim 1 wherein the barrier material comprises a poly lactide polymer or co-polymer.
6. The composite prosthesis according to claim 1 wherein the biocompatible coating is a hydratable polymer.
7. The composite prosthesis according to claim 1 wherein the prepolymer is tri-functional.
8. The composite prosthesis according to claim 1 wherein the barrier material is glued to the coated mesh.
9. The composite prosthesis according to claim 1 wherein the coated mesh comprising the barrier material is formed by applying the barrier material before the coating applied to the mesh has cured.
10. The composite prosthesis according to claim 1 wherein the prepolymer is a hydrogel.
11. The composite prosthesis according to claim 1 wherein the mesh is a multifilament mesh.
12. The composite prosthesis according to claim 1 wherein the mesh is a monofilament mesh.
13. The composite prosthesis according to claim 1 wherein the mesh is a polypropylene mesh.
14. A composite prosthesis comprising:
a coated mesh having at least one opening through a first surface and a second surface of the coated mesh;
the coated mesh comprising a mesh and a cured biocompatible coating substantially surrounding each filament of the mesh, wherein the biocompatible coating is a non-absorbable cyanate-terminated hydrophilic prepolymer comprising:
a copolymer comprising polyether monomers and from 5% to 30% of propylene oxide monomers;
from 20 to 40 wt. % of at least one polyisocyanate selected from the group consisting of 2,4-toluene diisocyanate, 2,6-toluene diisoscyanate, and isophorone diisocyanate; and
from 1.0 to 10 wt. % of trimethylolpropane; and
a bioabsorbable barrier material comprising a biocompatible membrane constructed and arranged to cover at least one surface of the coated mesh.
15. The composite prosthesis according to claim 14 wherein the prepolymer is tri-functional.
16. The composite prosthesis according to claim 14 wherein the mesh comprises a knitted mesh and the barrier material is attached to at least one surface of the coated mesh.
17. The composite prosthesis according to claim 14 wherein the barrier material is attached to the coated mesh by the biocompatible coating.
18. The composite prosthesis according to claim 14 wherein the barrier material is comprised of a bioabsorbable segmented copolymer comprising a first component which is a polyalkylene glycol and a second component which is a polyester formed from an alkylene glycol having from 2 to 8 carbon atoms and a dicarboxylic acid; and the barrier material is selected from the group consisting of a non-porous layer and a porous layer in which essentially all of the pores have a pore size no greater than 3 microns.
19. The composite prosthesis according to claim 14 wherein the barrier material comprises a poly lactide polymer or co-polymer.
20. The composite prosthesis according to claim 14 wherein the biocompatible coating is a hydratable polymer.
21. The composite prosthesis according to claim 14 wherein the mesh is a multifilament mesh.
22. The composite prosthesis according to claim 14 wherein the mesh is a monofilament mesh.
23. The composite prosthesis according to claim 14 wherein the mesh is a polypropylene mesh.