Method of preparation of bioabsorbable porous reinforced tissue implants and implants thereof

• US 20040175408A1
• Filed: 03/07/2003
• Published: 09/09/2004
• Est. Priority Date: 03/07/2003
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Chun, Iksoo, Binette, Francois, Hwang, Julia, Melican, Mora Carolynne, Brown, Kelly R., Jamiolkowski, Dennis D.
• Granted Patent: US 7,368,124 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/446 with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A biocompatible tissue implant. The tissue implant may be bioabsorbable, and is made from a biocompatible polymeric foam. The tissue implant also includes a biocompatible reinforcement member. The polymeric foam and the reinforcement member are soluble in a common solvent.

Claims

1. A tissue implant, comprising a biocompatible polymeric foam and a biocompatible polymeric reinforcement member, wherein the foam and the reinforcement member are soluble in a common solvent.

2. The implant of claim 1, wherein the polymeric foam is bioabsorbable.

3. The implant of claim 1, wherein the polymeric foam comprises a polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, polyorthoesters, polyoxaesters, polyamidoesters, and copolymers and blends thereof.

4. The implant of claim 1, wherein the polymeric foam comprises poly(lactide-co-caprolactone) having a mole ratio of between about 70/30 and about 55/45.

5. The implant of claim 1, wherein the polymeric foam comprises poly(lactide-co-caprolactone) having a mole ratio of about 60/40.

6. The implant of claim 1, wherein the polymeric foam comprises poly(glycolide-co-caprolactone) having a mole ratio of between 35/65 and 65/35.

7. The implant of claim 1, wherein the polymeric foam comprises poly(glycolide-co-caprolactone) having a mole ratio of about 65/35.

8. The implant of claim 1, wherein the polymeric foam comprises a blend of poly(lactide-co-caprolactone) having a mole ratio of about 60/40 and poly(glycolide-co-caprolactone) having a mole ratio of about 65/35.

9. The implant of claim 1, wherein the polymeric reinforcement member comprises a plurality of particles.

10. The implant of claim 1, wherein the polymeric reinforcement member comprises at least one sheet.

11. The implant of claim 1, wherein the polymeric reinforcement member comprises at least one fiber.

12. The implant of claim 11, wherein the fiber comprises a monofilament.

13. The implant of claim 11, wherein the fiber comprises a multifilament yarn.

14. The implant of claim 13, wherein the yam comprises at least two filaments.

15. The implant of claim 11, wherein the fiber comprises a mesh.

16. The implant of claim 11, wherein the fiber comprises a braid.

17. The implant of claim 11, wherein the fiber comprises a surgical suture.

18. The implant of claim 11, wherein the fiber comprises a weave.

19. The implant of claim 11, wherein the fiber comprises a knit.

20. The implant of claim 11, wherein the fiber comprises a non-woven.

21. The implant of claim 15 wherein the mesh comprises a monofilament.

22. The implant of claim 16, wherein the braid comprises a monofilament.

23. The implant of claim 12, wherein the monofilament has a diameter between about 50 and about 2000 micron.

24. The implant of claim 14, wherein the mesh has a mesh density of about 20% to about 88%.

25. The implant of claim 14, wherein the mesh has a mesh density of about 20% to about 55%.

26. The implant of claim 1, wherein the polymeric reinforcement member comprises a bioabsorbable polymer.

27. The implant of claim 1, wherein the polymeric reinforcement member comprises a polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, polyorthoesters, polyoxaesters, polyamidoesters, and copolymers blends thereof.

28. The implant of claim 1, wherein the polymeric reinforcement member comprises a mesh, said mesh comprising a copolymer of polymerized lactide and glycolide.

29. The implant of claim 1, wherein the polymeric reinforcement member comprises a mesh, said mesh comprising poly(lactide-co-glycolide) at a 95/5 mole ratio.

30. The implant of claim 1, wherein the foam comprises an open cell structure.

31. The implant of claim 1 wherein the foam comprises a closed cell structure.

32. A method of manufacturing a biocompatible tissue implant, comprising:

providing a solution comprising a foam forming, biocompatible polymer in a solvent, said solvent having a freezing point;

providing a biocompatible polymeric reinforcement member;

placing the polymeric reinforcement member in a cavity of a suitable mold;

adding the solution to the cavity of the mold such that at least a part of the cavity is filled with the solution and at least part of the reinforcing member is in contact with the solution;

quenching the reinforcement member and solution to below the freezing point of the solvent, and lyophilizing.

33. The method of claim 32 comprising the additional step of orienting the reinforcement member in the cavity of the mold in a particular configuration.

34. The method of claim 32, wherein the reinforcement member is annealed prior to placement in the cavity of the mold.

35. The method of claim 32, wherein the reinforcement member is placed under tension prior to placement in the cavity of the mold.

36. The method of claim 32, wherein the mold is cooled to below the freezing point of the solvent prior to placement of the reinforcement member in the cavity of the mold.

37. The method of claim 32, wherein a solid that does not react with the foam forming polymer or the solvent is added to the solution.

38. The method of claim 37, wherein the solid comprises a particle selected from the group consisting of demineralized bone, calcium phosphate, calcium sulfate, and calcium carbonate.

39. The method of claim 37, wherein the solid comprises a member selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, sodium tartrate, sodium citrate, glucose, fructose, dextrose, maltose, lactose sucrose, starch, alginate, chitosan, gelatin and agarose.

40. The method of claim 37, wherein the solid comprises a member selected from the group consisting of stainless steel, cobalt chrome, titanium, titanium alloys, alumina, and zirconia.

41. The method of claim 37, wherein the solid comprises a member selected from the group consisting of polyethylene, polyvinylacetate, polyethylene oxide, polymethylmethacrylate, silicone, polyethylene glycol, polyurethanes, cellulose, chitin, keratin, and fluorinated polymers.

42. The method of claim 32, wherein the polymeric foam comprises a bioabsorbable polymer.

43. The method of claim 32, wherein the polymeric foam comprises a polymer selected from the group consisting aliphatic polyesters, poly(amino acids), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, polyorthoesters, polyoxaesters, polyamidoesters, and copolymers and blends thereof.

44. The method of claim 32, wherein the polymeric reinforcement member comprises a bioabsorbable polymer.

45. The method of claim 32, wherein the reinforcement member comprises a polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, polyorthoesters, polyoxaesters, polyamidoesters, and copolymers blends thereof.

60. The method of claim 32, wherein the mold is cooled to below 25°

C. prior to placement of the reinforcement member in the cavity of the mold, pre-chilling the solution below 25°

C. but about the freezing point of the solution prior to adding the solution to the cavity of the mold.

46. A method of repairing damaged tissue, comprising:

providing a biocompatible tissue implant comprising a biocompatible polymeric foam and a biocompatible reinforcement member, wherein the polymeric foam and the reinforcement member are soluble in the same solvent; and

,

placing the implant in a desired position at a site relative to a tissue injury.

47. The method of claim 46, wherein the implant is placed within a lesion that constitutes the tissue injury

48. The method of claim 47, wherein the implant is over the lesion.

49. The method of claim 47, wherein the implant is of a size and shape such that it matches a geometry and dimension of the lesion.

50. The method of claim 47, wherein the implant is placed within the lesion in an interference fit.

51. The method of claim 47, wherein the implant is placed adjacent to a lesion that constitutes tear such that the implant reinforces the tissue.

52. The method of claim 47, wherein the implant is wrapped around the tissue having the lesion.

53. The method of claim 46, wherein the foamed polymer and the polymeric reinforcement member comprise bioabsorbable polymers.

54. The method of claim 46, wherein the implant is affixed to the damaged site by suturing.

55. The method of claim 46, wherein the implant is affixed to the damaged site by stapling.

56. The method of claim 46, wherein the implant is affixed to the damaged site by using a glue.

57. The method of claim 46, wherein the implant is affixed to the damaged site by using a device selected from the group consisting of suture anchors, tissue tacks, darts, screws, arrows, and combinations thereof.

58. The method of claim 56, wherein the glue is selected from the group consisting of fibrin glues, fibrin clots, platelet rich plasma, platelet poor plasma, blood clots, biologically compatible adhesives, and combinations thereof.

59. The method of claim 46 wherein the damaged tissue comprises soft tissue.