Temporarily stiffened mesh prostheses

• US 9,457,129 B2
• Filed: 09/23/2013
• Issued: 10/04/2016
• Est. Priority Date: 02/08/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: TYRX, INC. (Medtronic Plc)
• Inventors: Pulapura, Satish, Buevich, Fatima, Do, Frank, McJames, William, Edelman, William, Moses, Arikha, Diamond, Mason, Timothy, Shari
• Primary Examiner(s): Tran, Susan
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US14/033,979
• Publication Number:
  US 20140046350A1
• Time in Patent Office: 1,107 Days
• Field of Search: None
• US Class Current: 1/1
• 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 porous surgical mesh with one or more biodegradable or resorbable polymer coatings, wherein said one or more biodegradable or resorbable polymer coatings have been applied to said mesh without substantially altering a porosity of said porous surgical mesh, and wherein said medical prosthesis ameliorates or mitigates a soft tissue defect,

wherein said one or more biodegradable or resorbable polymer coatings comprise one or more tyrosine-derived dipghenol monomer units.

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

3. The medical prosthesis of claim 1, wherein said porous surgical mesh comprises woven polypropylene.

4. The medical prosthesis of claim 3, wherein said porous surgical mesh has a backing of expanded polytetrafluoroethylene (ePTFE).

5. The medical prosthesis of claim 1, wherein said porous surgical mesh retains its stiffness for about one week after surgical implantation.

6. The medical prosthesis of claim 1, wherein said one or more biodegradable or resorbable polymer coatings comprise one or more drugs selected from the group consisting of antimicrobial agents, anesthetics, analgesics, anti-inflammatory agents, anti-scarring agents, anti-fibrotic agents and leukotriene inhibitors.

7. The medical prosthesis of claim 6, wherein said one or more drubs is an anesthetic.

8. The medical prosthesis of claim 6, wherein said anesthetic is bupivacaine HCI.

9. The medical prosthesis of claim 6, wherein said one or more drugs is an antimicrobial agent.

10. The medical prosthesis of claim 9, wherein said antimicrobial agent is selected from the group consisting of rifampin, minocycline, silver/chlorhexidine, vancomycin, a cephalosporin, gentamycin, triclosan and combinations thereof.

11. The medical prosthesis of claim 6, wherein said one or more biodegradable or resorbable polymer coatings comprise rifampin in combination with another antimicrobial agent.

12. The medical prosthesis of claim 11, wherein said another antimicrobial agent is minocycline HCI.

13. The medical prosthesis of claim 11, wherein said another antimicrobial agent is gentamycin.

14. The medical prosthesis of claim 11, wherein said another antimicrobial agent is vancomycm.

15. The medical prosthesis of claim 6, wherein said one or more biodegradable or resorbable polymer coatings comprise a cephalosporin in combination with another antimicrobial agent.

16. The medical prosthesis of claim 6, wherein said one or more biodegradable or resorbable polymer coatings comprise an anti-inflammatory agent selected from non-selective cox-1 and cox-2 inhibitors.

17. The medical prosthesis of claim 6 wherein said one or more biodegradable or resorbable polymer coatings comprise an anti-inflammatory agent selected from selective cox-1 or cox-2 inhibitors.

18. The mesh of claim 6, wherein said one or more drugs is a combination of rifampin and minocycline.

19. The mesh of claim 6, wherein said one or more drugs is a combination of rifampin, minocycline, and an anesthetic or analgesic agent.

20. The medical prosthesis of claim 1, wherein said prosthesis is configured to reconstruct, reinforce, bridge, replace, repair, support, stabilize, position, or strengthen said soft tissue defect.

21. The mesh of claim 20, wherein said soft tissue defect is a hernia.

22. The mesh of claim 1, wherein said porous surgical mesh is sufficiently porous to permit tissue ingrowth into said mesh prosthesis.

23. The mesh of claim 1, wherein said one or more coatings temporarily stiffen said porous mesh to at least 1.1 times its original stiffness.

24. The medical prosthesis of claim 1, wherein said one or more tyrosine-derived diphenol monomer units comprise DT-DTE succinate having from about 1% DT to about 30% DT.

25. The medical prosthesis of claim 24, wherein said one or more biodegradable or resorbable polymer coatings comprise rifampin and minocycline.

43. The medical prosthesis of claim 24, wherein said polymer from said P22-xx family of polymers is P22-10.

26. 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,

wherein said stiffening agent comprises one or more biodegradable polymers, said one or more biodegradable polymers comprising one or more tyrosine-derived diphenol monomer units.

27. The medical prosthesis of claim 26, wherein said mesh remains porous when coated with said stiffening agent.

28. The medical prosthesis of claim 27, wherein the porosity of the mesh is substantially unchanged by the stiffening agent.

29. The medical prosthesis of claim 26, wherein said stiffening agent selectively and/or partially coats said filaments or said fibers.

30. The medical prosthesis of claim 29, wherein said one or more coatings are positioned on said mesh in a templated pattern or in an array.

31. The medical prosthesis of claim 26, wherein said contact points comprise the knots in a woven mesh.

32. The medical prosthesis of claim 26, wherein said one or more coatings are on one side or both sides of said mesh.

33. The medical prosthesis of claim 26, wherein said mesh has a three-dimensional shape maintained by said one or more coatings.

34. The medical prosthesis of claim 33, wherein said mesh was flat or substantially flat before coating.

35. The medical prosthesis of claim 26, wherein said one or more coatings increases stiffness of said mesh by at least 1.1 to about 4.5 times its uncoated stiffness.

36. The medical prosthesis of claim 26, wherein said one or more coatings increase stiffness of said mesh from about 1.25 to about 2 times its uncoated stiffness.

37. The medical prosthesis of claim 26, wherein said one or more biodegradable polymers are a polyarylate, polycarbonate, polyiminocarbonate or a polyphosphonate.

38. The medical prosthesis of claim 37, wherein said one or more biodegradable polymers are a polyarylate.

39. The medical prosthesis of claim 38, wherein said polyarylate is DT-DTE succinate having from about 1% DT to about 30% DT.

40. The medical prosthesis of claim 38, 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.

41. The medical prosthesis of claim 38, 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.

42. A porous surgical mesh comprising one or more biodegradable or resorbable polymer coatings, wherein said one or more biodegradable or resorbable polymer coatings have been applied to said porous surgical mesh without substantially altering a porosity of said porous surgical mesh, said one or more biodegradable or resorbable polymer coatings comprising a polymer from a P22-xx family of polymers having from 5-50% DT, said one or more biodegradable or resorbable polymer coatings further comprising rifampin and minocycline.