Multi-layered surgical prosthesis

Patent metadata

Field	Value
Publication number	US-9486302-B2
Application number	US-201314059231-A
Country	US
Kind code	B2
Filing date	Oct 21, 2013
Priority date	Feb 11, 2009
Publication date	Nov 8, 2016
Grant date	Nov 8, 2016

Abstract

The present invention generally relates to the field of prostheses for surgical applications, to methods of their manufacturing and to methods of treating a patient by implanting them into a patient. More particularly, the present invention relates to prostheses having a multi-layered sheet structure and their use in hernia repair, the repair of anatomical defects of the abdominal wall, diaphragm, and chest wall, correction of defects in the genitourinary system, and repair of traumatically damaged organs such as the spleen, liver or kidney.

First claim

The invention claimed is:

1. A method of manufacturing a prosthesis having a multi-layered sheet structure, comprising integrally forming at least two continuous polymer film layers with no distinguished filaments or fibers within each layer, wherein the at least two continuous polymer film layers are in continuous contact with each other to produce the multi-layered sheet structure, and wherein the outermost layer of the multi-layered sheet structure is formed by casting the polymer on a roughened mold to obtain a roughed surface, forming the additional layers thereon and, then, mechanically or chemically treating said roughed surface to increase its surface friction and wetting ability.

2. The method according to claim 1 , wherein the at least two layers are formed by at least one method selected from the group consisting of: molding methods; coating methods; solution casting; and an extrusion method.

3. The method according to claim 1 , wherein the mechanical treatment of the roughed surface includes a plasma treatment, a sandblasting treatment, an embossing treatment, or a sizing treatment.

4. The method according to claim 1 , wherein the chemical treatment of the roughed surface comprises an etching treatment or a coating.

5. The method according to claim 1 , wherein pores are made in one or more layers of the multi-layered structure by using a matrix having a pore pattern.

6. The method according to claim 1 , wherein a porous layer is formed in the form of a solid layer as an outermost layer and then the porous structure is formed from this solid layer by means of a mechanical treatment.

7. The method of claim 6 , wherein the mechanical treatment is a grinding process, a laser cutting process, an electrical discharge machining, stamping or a mechanical abrading process.

8. The method according to claim 1 , wherein an anti-adhesion coating layer is formed on at least a part of one or both outer surface(s) of the prosthesis.

9. The method according to claim 8 , wherein the anti-adhesion coating layer comprises a biocompatible or bioresorbable polymer.

10. The method according to claim 8 , wherein the anti-adhesion coating layer comprises an anti-adhesion agent.

11. The method according to claim 1 , wherein the multi-layered structure is made of at least two layers comprising a biocompatible or bioresorbable polymer material.

12. The method according to claim 11 , wherein the biocompatible polymer material is any of polyvinylidene fluoride, polyamide, polyethylene, polypropylene, poly(ethylene terephtalate), polyurethane, polystyrene, polymethacrylate, polytetrafluoroethylene, and polymers or copolymers of p-dioxanone, trimethylene carbonate and alkyl derivatives thereof, valerolactone, butyrolactone, decalactone, hydroxybutyrate, hydroxyvalerate, 1,5-dioxepan-2-one, 1,4-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one or any polymer blend thereof.

13. The method according to claim 11 , wherein the bioresorbable polymer material is any of polyglycolide, polylactide and poly-co-glycolactide, polylactic acid, polyglycolic acid, poly(ethylene glycolide), polyethylene glycol, polycaprolactone like poly(c-caprolactone), polydioxanone, polygluconate, polylactic acid-polyethylene oxide copolymers, polysaccharides, cellulose derivatives, hyaluronic acid based polymers, starch, gelatin, collagen, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(amino acids) or any polymer blends, copolymers, or derivatives.

14. The method according to claim 1 , wherein at least one layer is provided with pores having an average pore size of about 0.5-5 mm.

15. The method according to claim 1 , wherein at least one layer is provided with pores having an average pore size of about 1-4 mm.

16. The method according to claim 1 , wherein at least one layer is provided with pores having a regular or irregular shape.

17. The method according to claim 16 , wherein the pores having a regular shape have a circular, elliptical, oval or polygonal shape such as a triangular, square, pentagonal or rhomb-like shape.

18. The method according to claim 16 , wherein the pores having an irregular shape have a non-circular cross-section or a monosymmetric shape to provide an anisotropic pore structure.

19. The method according to claim 16 , wherein coplanar pores in the multi-layered structure have different pore diameters or pore shapes to provide an anisotropic pore structure.

20. The method according to claim 1 , wherein at least one layer is provided with pores having an anisotropic shape in its cross-section.

21. The method according to claim 20 , wherein the anisotropic shape of the pores tapers from the upper surface of the porous layer to the inner part thereof or the opposite side of the prosthesis.

22. The method according to claim 16 , wherein the anisotropic pore structure or the anisotropic shape of the pores is adapted to the anisotropic anatomical nature of a site at which the prosthesis is to be inserted in a patient.

23. The method according to claim 1 , wherein one, two, or more of the layers of the multi-layered structure like the porous layer or the anti-adhesion coating layer are made as drug-releasing layers by adding one or more compounds selected from the group consisting of: releasable drugs, therapeutic agents, and pharmaceutically active substances in the respective layers before molding the layers or by impregnating them into the molded layers.

24. The method according to claim 1 , further comprising the step of forming an additional polymeric drug-releasing layer on one or both outermost layers of the prosthesis, comprising one or more compounds selected from the group consisting of: releasable drugs, therapeutic agents, and pharmaceutically active substances.

25. The method according to claim 1 , wherein two layers in the multi-layered sheet structure are formed to provide a memory effect.

26. The method according to claim 25 , wherein these two layers are formed of a polymeric material as two additional layers providing the memory effect properties in the multi-layered sheet structure of the prosthesis.

27. The method according to claim 1 , wherein the at least two layers are formed by at least one technique selected from the group consisting of: injection molding, compression molding, dip coating, spin coating, blow extrusion, and film extrusion.

28. The method according to claim 1 , wherein the chemical treatment of the roughed surface comprises a plasma polymerization coating or solution coating.

Assignees

• Univ Nanyang Tech

Inventors

• Boey Yin Chiang Freddy
• Wang Zheng
• Tang Joseph

Classifications

• A61L31/048

  obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence) · CPC title

• B32B3/30

  characterised by a layer formed with recesses or projections, e.g. {hollows, grooves, protuberances, ribs (apertured layer B32B3/266; layer with cavities or internal voids B32B3/26)} · CPC title

• B32B27/34

  comprising polyamides · CPC title

• A61F2250/0031

  made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts · CPC title

• B32B2264/10

  Inorganic particles · CPC title