Temporarily Stiffened Mesh Prostheses

• US 20070198040A1
• Filed: 02/08/2007
• Published: 08/23/2007
• Est. Priority Date: 02/08/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: TYRX Pharma, Inc. (Medtronic Plc)
• Inventors: Pulapura, Satish, Buevich, Fatima, Moses, Arikha, Edelman, William, Diamond, Mason, Do, Frank, McJames, William, Timothy, Shari
• Granted Patent: US 8,636,753 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 23/02 Local anaesthetics
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics

Abstract

The present invention relates to medical prostheses and methods of manufacturing those devices. In particular, the prostheses are temporarily stiffened meshes with particular coatings to provide initial stiffness and thereby permit easier surgical handling for treatment or reconstruction of soft tissue defects. Preferred embodiments include surgical meshes coated with one or more biodegradable polymers that can act as a stiffening agent by coating the filaments or fibers of the mesh to temporarily immobilize the contact points of those filaments or fibers and/or by increasing the stiffness of the mesh by at least 1.1 times its original stiffness. The devices of the invention can also provide relief from various post-operative complications associated with their implantation, insertion or surgical use. By including biologically active agents and/or drugs in the coating, the devices provide prophylaxis for and can alleviate side effects or complications associated with the surgery or use of prostheses in general.

Claims

1. A medical prosthesis comprising a mesh and one or more coating which temporarily stiffens the mesh to at least 1.1 times its original stiffness.

2. The medical prosthesis of claim 1, wherein said coating does not substantially alter the porosity of said mesh.

3. The medical prosthesis of claim 1 or 2, wherein said mesh has a three-dimensional shape maintained by said coating.

25. The medical prosthesis of any one of claims 1, 4, 16 or 20 wherein said mesh comprises woven polypropylene.

26. The medical prosthesis of claim 25, wherein said mesh has a backing of expanded polytetrafluoroethylene (ePTFE).

27. The medical prosthesis of any one of claims 1, 4, 16 or 20, wherein said mesh is capable of substantially reverting to its original stiffness under conditions of use.

28. The medical prosthesis of any one of claims 1, 4, 16 or 20, wherein said mesh retains its stiffness for about one week after surgical implantation.

29. The medical prosthesis of any one of claims 1, 4, 16 or 20, wherein at least one of said coatings further comprises one or more drugs.

30. The medical prosthesis of any one of claim 29, wherein said one or more drugs is selected from the group consisting of antimicrobial agents, anesthetics, analgesics, anti-inflammatory agents, anti-scarring agents, anti-fibrotic agents and leukotriene inhibitors.

31. The medical prosthesis of claim 30, wherein said drug is an anesthetic.

32. The medical prosthesis of claim 30, wherein said anesthetic is bupivacaine HCl.

33. The medical prosthesis of claim 30, wherein said drug is an antimicrobial agent.

34. The medical prosthesis of claim 33, wherein said antimicrobial agent is selected from the group consisting of rifampin, minocycline, silver/chlorhexidine, vancomycin, a cephalosporin, gentamycin, triclosan and combinations thereof.

35. The medical prosthesis of claim 29, wherein at least one of said coatings comprises rifampin in combination with another antimicrobial agent.

36. The medical prosthesis of claim 35, wherein said another antimicrobial agent is minocycline HCl.

37. The medical prosthesis of claim 35, wherein said another antimicrobial agent is gentamycin.

38. The medical prosthesis of claim 35, wherein said another antimicrobial agent is vancomycin.

39. The medical prosthesis of claim 30, wherein at least one of said coatings comprises a cephalosporin in combination with another antimicrobial agent.

40. The medical prosthesis of claim 30, wherein ate least one of said coatings comprises an anti-inflammatory agent selected from non-selective cox-1 and cox-2 inhibitors

41. The medical prosthesis of claim 30 wherein at least one of said coatings comprises an anti-inflammatory agent selected from selective cox-1 or cox-2 inhibitors.

4. A medical prosthesis comprising a mesh and one or more coatings, wherein said one or more coatings comprise a stiffening agent which coats filaments or fibers of said mesh to temporarily immobilize contact points of the filaments or fibers of said mesh.

5. The medical prosthesis of claim 4, wherein said mesh remains porous when coated with said agent.

6. The medical prosthesis of claim 5, wherein the porosity of the mesh is substantially unchanged by the stiffening agent.

7. The medical prosthesis of claim 4, wherein said agent selectively and/or partially coats said filaments or said fibers.

8. The medical prosthesis of claim 7, wherein said coating is positioned on said mesh in a templated pattern or in an array.

9. The medical prosthesis of claim 4, wherein said contact points comprise the knots in a woven mesh.

10. The medical prosthesis of claim 4, wherein said one or more coatings are on one side or both sides of said mesh.

11. The medical prosthesis of claim 4, wherein said mesh has a three-dimensional shape maintained by said coating.

12. The medical prosthesis of claim 11, wherein said mesh was flat or substantially flat before coating.

13. The medical prosthesis of claim 4, wherein said one or more coatings increases stiffness of said mesh by at least 1.1 to about 4.5 times its uncoated stiffness.

14. The medical prosthesis of claim 4, wherein said one or more coatings increase stiffness of said mesh from about 1.25 to about 2 times its uncoated stiffness.

15. The medical prosthesis of claim 4, wherein said agent comprises a hydrogel.

16. The medical prosthesis of claim 4, wherein said agent comprises one or more biodegradable polymers.

17. The medical prosthesis of claim 16, wherein said biodegradable polymer is selected from the group consisting of a polylactic acid, polyglycolic acid, poly(L-lactide), poly(D,L-lactide), polyglycolic acid, poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D,L-lactide-co-glycolide), poly(glycolide-co-trimethylene carbonate), poly(D,L-lactide-co-caprolactone), poly(glycolide-co-caprolactone), polyethylene oxide, polyoxaester, polydioxanone, polypropylene fumarate, poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxy-carbonylmethyl glutamate), polycaprolactone, polycaprolactone co-butylacrylate, polyhydroxybutyrate, poly(phosphazene), poly(phosphate ester), poly(amino acid), polydepsipeptide, maleic anhydride copolymer, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)], poly(orthoesters), tyrosine-derived polyarylate, tyrosine-derived polycarbonate, tyrosine-derived polyiminocarbonate, tyrosine-derived polyphosphonate, polyalkylene oxide, hydroxypropylmethylcellulose, polysaccharide, protein, and copolymers, terpolymers and blends of any thereof.

18. The medical prosthesis of claim 16, wherein said biodegradable polymer comprises one or more tyrosine-derived diphenol monomer units.

19. The medical prosthesis of claim 18, wherein said biodegradable polymer is a polyarylate, polycarbonate, polyiminocarbonate or a polyphosphonate.

20. The medical prosthesis of claim 19, wherein said biodegradable polymer is a polyarylate.

21. The medical prosthesis of claim 20, wherein said polyarylate is DT-DTE succinate having from about 1% DT to about 30% DT.

22. The medical prosthesis of claim 20, wherein said polyarylate is a random copolymer of desaminotyrosyl-tyrosine (DT) and an desaminotyrosyl-tyrosyl ester (DT ester), wherein said copolymer comprises from about 0.001% DT to about 80% DT and said ester moiety can be a branched or unbranched alkyl, alkylaryl, or alkylene ether group having up to 18 carbon atoms, any of group of which can, optionally have a polyalkylene oxide therein.

23. The medical prosthesis of claim 20, wherein said polyarylate is a random copolymer of 4-hydroxybenzoyl-tyrosine (BT) and 4-hydroxybenzoyl-tyrosyl ester (BT ester), wherein said copolymer comprises from about 0.001% BT to about 80% BT and said ester moiety can be a branched or unbranched alkyl, alkylaryl, or alkylene ether group having up to 18 carbon atoms, any of group of which can, optionally, have a polyalkylene oxide therein.

24. The medical prosthesis of claim 16, wherein said biodegradable polymer is also a resorbable polymer.

42. A process for coating a mesh with a stiffening agent which coats filaments or fibers of said mesh to temporarily immobilize contact points of the filaments or fibers of said mesh which comprises:

(a) preparing a coating solution comprising a solvent and said stiffening agent;

(b) spraying a mesh one or more times to provide an amount of said solution on said mesh to produce a coating having a thickness and placement sufficient to temporarily immobilize contact points of the filaments or fibers of said mesh that coats filaments or fibers; and

(c) drying said mesh to produce said coating.

43. A method for producing a shaped or three-dimensional medical prosthesis which comprises

(a) forming a mesh into a desired shape or three-dimensional shape;

(b) applying a stiffening agent to said mesh to coat filaments or fibers of said mesh;

(c) allowing said agent to dry, set or cure causing said mesh to temporarily immobilize contact points of the filaments or fibers of said mesh and thereby to retain said shape.

44. The method of claim 43, wherein said shape is formed by affixing said mesh to a mold or framework to created the desired shape, applying said agent to said mesh while so affixed, and removing said mesh from said mold or framework after said agent has dried, set or cured sufficiently to allow said mesh to retain said shape.