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

• US 20050113938A1
• Filed: 09/30/2004
• Published: 05/26/2005
• Est. Priority Date: 03/07/2003
• Status: Active Grant

• Current Assignee: Dennis D. Jamiolkowski, Iksoo Chun, Kelly R. Brown, Mora Carolynne Melican
• Original Assignee: Dennis D. Jamiolkowski, Iksoo Chun, Kelly R. Brown, Mora Carolynne Melican
• Inventors: Melican, Mora Carolynne, Brown, Kelly R., Chun, Iksoo, Jamiolkowski, Dennis D.
• Granted Patent: US 8,197,837 B2
• Time in Patent Office: Days
• US Class Current: 623/23.740
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• 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, consists of a biocompatible polymeric foam. The tissue implant also includes a biocompatible reinforcement member. The polymeric foam and the reinforcement member are soluble in a lyophilizing solvent. The reinforcement may be annealed and/or coated.

Claims

1. A tissue implant, comprising:

a biocompatible polymeric foam, said foam soluble in a lyophilizing solvent;

a biocompatible polymeric reinforcement member, said reinforcement member soluble in the lyophilizing solvent; and

,

a polymeric coating having a thickness applied to the reinforcement member, said coating comprising a coating polymer, wherein said coating polymer is substantially insoluble in said lyophilizing 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 yarn 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 15, wherein the mesh has a mesh density of about 20% to about 88%.

25. The implant of claim 15, 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(alpha-hydroxy acids), poly(amino acids), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, polyorthoesters, polyoxaesters, polyamidoesters, polylactides, and copolymers and 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. The implant of claim 1, wherein the coating comprises a polymer selected from the group consisting of polydioxanone, and its copolymers with L(−

)-lactide, D(+)-lactide, meso- lactide, trimethylene carbonate, epsilon-caprolactone, or glycolide, or combinations thereof, with the provision that polymerized dioxanone is at least 50 weight percent.

33. The implant of claim 1, wherin the coating comprises poly(p-dioxanone).

34. The implant of claim 1, wherein the thickness of the coating is sufficient to effectively prevent the lyophilizing solvent from contacting the reinforcement member.

35. The implant of claim 1, wherein the thickness of the coating is greater than about_—

1.0_mil.

36. The implant of claim 1, wherein the lyophilizing solvent is selected from the group consisting of p(dioxane) and trioxane.

37. The implant of claim 1, wherein the lyophilizing solvent comprises p(dioxane)

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

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

providing a biocompatible polymeric reinforcement member, said reinforcement member comprising a polymer that is soluble in the lypophilizing solvent, and, a biocompatible polymeric coating having a thickness applied to said member, wherein said polymeric coating comprises a coating polymer that is substantially insoluble in the lyophilizing solvent;

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;

and,

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

39. The method of claim 38 comprising the additional step of orienting the reinforcement member in the cavity of the mold in a particular configuration.

40. The method of claim 38, wherein the reinforcement member is annealed prior to placement in the cavity of the mold.

41. The method of claim 38, wherein the reinforcement member is placed under tension prior to placement in the cavity of the mold.

42. The method of claim 38, 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.

43. The method of claim 38, wherein a solid that does not react with the foam forming polymer or the solvent is added to the solution.

44. The method of claim 43, wherein the solid comprises a particle selected from the group consisting of demineralized bone, calcium phosphate, calcium sulfate, and calcium carbonate.

45. The method of claim 43, 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.

46. The method of claim 43, wherein the solid comprises a member selected from the group consisting of stainless steel, cobalt chrome, titanium, titanium alloys, alumina, and zirconia.

47. The method of claim 43, 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.

48. The method of claim 38, wherein the polymeric foam comprises a bioabsorbable polymer.

49. The method of claim 38, 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.

50. The method of claim 38, wherein the polymeric reinforcement member comprises a bioabsorbable polymer.

51. The method of claim 38, wherein the reinforcement member comprises a polymer selected from the group consisting of aliphatic polyesters, poly(alpha-hydroxy acids), poly(amino acids), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, polyorthoesters, polyoxaesters, polyamidoesters, polylactides, and copolymers and blends thereof.

52. The method of claim 38, wherein the reinforcement member comprises comprising a copolymer of polymerized lactide and glycolide.

53. The method of claim 38, wherein the coating comprises a polymer selected from the group consisting of polydioxanone, and its copolymers with L(−

)-lactide, D(+)-lactide, meso- lactide, trimethylene carbonate, epsilon-caprolactone, or glycolide, or combinations thereof, with the provision that polymerized dioxanone is at least 50 weight percent.

54. The method of claim 38, wherein the coating comprises poly(p-dioxanone).

55. The method of claim 38, wherein the thickness of the coating is sufficient to effectively prevent the lyophilizing solvent from contaicting sid reinforcement member.

56. The method of claim 38, wherein the thickness of the coating is greater than about 1.0 mil.

57. The method of claim 38, wherein the lyophilizing solvent is selected from the group consisting of p(dioxane) and trioxane.

58. The method of claim 38, wherein the lyophilizing solvent comprises p(dioxane)

73. The method of claim 38, 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 above the freezing point of the solution prior to adding the solution to the cavity of the mold.

59. A method of repairing damaged tissue, comprising:

providing a biocompatible tissue implant comprising;

a biocompatible polymeric foam, said foam soluble in a lyophilizing solvent;

a biocompatible polymeric reinforcement member, said reinforcement member soluble in the lyophilizing solvent; and

, a polymeric coating having a thickness applied to the reinforcement member, said coating comprising a coating polymer, wherein said coating polymer is substantially insoluble in said lyophilizing solvent; and

,

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

60. The method of claim 59, wherein the implant is placed within a lesion that constitutes the tissue injury

61. The method of claim 60, wherein the implant is over the lesion.

62. The method of claim 60, wherein the implant is of a size and shape such that it matches a geometry and dimension of the lesion.

63. The method of claim 60, wherein the implant is placed within the lesion in an interference fit.

64. The method of claim 59, wherein the implant is placed adjacent to a lesion that constitutes tear such that the implant reinforces the tissue.

65. The method of claim 59, wherein the implant is wrapped around tissue having a lesion.

66. The method of claim 59, wherein the foamed polymer and the polymeric reinforcement member comprise bioabsorbable polymers.

67. The method of claim 59, wherein the implant is affixed to the site by suturing.

68. The method of claim 59, wherein the implant is affixed to the site by stapling.

69. The method of claim 59, wherein the implant is affixed to the site by using a glue.

70. The method of claim 59, wherein the implant is affixed to the site by using a device selected from the group consisting of suture anchors, tissue tacks, darts, screws, arrows, and combinations thereof.

71. The method of claim 69, 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.

72. The method of claim 59 wherein the tissue comprises soft tissue.