COLLAGEN PRODUCTS AND METHODS FOR PRODUCING COLLAGEN PRODUCTS

• US 20080260794A1
• Filed: 02/12/2008
• Published: 10/23/2008
• Est. Priority Date: 02/12/2007
• Status: Abandoned Application

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Shimp, Lawrence A., Lauritzen, Nels J., Mitchell, Brent
• Application Number:
  US12/030,188
• Publication Number:
  US 20080260794A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61L 15/32 Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin A61L15/225 takes precedence
• CPC Class Codes: A61L 15/40 containing ingredients of undetermined constitution or reaction products thereof , e.g. plant or animal extracts
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Medical implants and methods for forming a medical implant blends a dispersion of human collagen fibers and/or threads and optionally a volume between about 2 to about 15% of an alcohol and forms medical implants by removing a liquid component of the collagen dispersion. Medical implants formed include collagen films, coatings, threads, patches, tubes, plugs, scaffolds, injectable collagen, and collagen for in vitro applications.

Claims

1. Human-derived collagen product fibers and/or threads having a preserved amount of native constituents.

2. The human-derived collagen product of claim 1, wherein the native constituents comprise one or more of non-collagenous proteins, growth factors, cells, and extracellular matrix.

3. The human-derived collagen product of claim 1, wherein the collagen product fibers and/or threads comprise a length of about 10 cm to about 50 microns.

4. The human-derived collagen product of claim 1, wherein the collagen product fibers and/or threads are ground collagen fibers.

5. The human-derived collagen product of claim 1, wherein the collagen product fibers and/or threads are milled collagen fibers and/or threads.

6. The human-derived collagen product of claim 1, wherein the collagen product fibers and/or threads comprises fibrillar collagen.

7. The human-derived collagen product of claim 1, wherein the collagen product fibers and/or threads is derived from fascia.

8. The human-derived collagen product of claim 7, wherein the fascia is tensor fascia lata.

9. The human-derived collagen product of claim 1, wherein the collagen fibers and/or threads is a hemostat.

10. The human-derived collagen product of claim 1, wherein the collagen product fibers and/or threads is a collagen product strand.

11. The human-derived collagen product of claim 10, wherein the collagen strand comprises a diameter of about 50 microns to about 3 millimeters.

12. The human-derived collagen product of claim 11, wherein the collagen strand is an extruded monofilament having a diameter of about 50 microns to about 200 microns.

13. The human-derived collagen product of claim 11, wherein the collagen strand is formed by electrostatic spinning and comprises a diameter of about 50 nanometers to about 400 nanometers.

14. The human-derived collagen product of claim 10, wherein the collagen strand is a collagen rope formed from a plurality of the collagen strands, wherein the collagen rope comprises a diameter of between about 200 microns to about 3 millimeters.

15. An intermediate collagen product comprising human or human-like collagen fibers and/or threads dispersed in a volume of water, wherein the human collagen comprises a preserved amount of its native constituents.

16. An intermediate collagen product comprising a foam containing at least human collagen fibers and/or threads and a leveling agent, wherein the human collagen in the foam comprises a preserved amount of native constituents.

17. The intermediate collagen product of claim 16, wherein the leveling agent is an alcohol, wherein the volume of the alcohol comprises between about 2% to about 15% and has a purity of about 70% to about 99%.

18. The intermediate collagen product of claim 16, wherein the collagen fibers and/or threads is derived from human fascia.

19. The intermediate collagen product of claim 18, wherein the fascia is tensor fascia lata.

20. An intermediate collagen product comprising human-derived collagen fibers and/or threads dispersed in a volume of water and an alcohol, wherein the volume of alcohol comprises between about 2% to about 15% and has a purity of about 70% to about 99%, and wherein the human-derived collagen comprises a preserved amount of native constituents.

21. The intermediate collagen product of claim 20, wherein the collagen fibers and/or threads is derived from human fascia.

22. The intermediate collagen product of claim 21, wherein the fascia is tensor fascia lata.

23. A collagen product implant produced from human collagen having a preserved amount of native constituents, said collagen implant comprising elasticity and plasticity performance characteristics that causes the implant to generally return to its original shape when manipulated.

24. The collagen product implant of claim 23, wherein the collagen implant is a collagen scaffold, said collagen scaffold comprising flexibility and resistivity to cracking performance characteristics that causes the implant to generally conform to an implant area when implanted.

25. The collagen product implant of claim 23, wherein the collagen is derived from human fascia.

26. The collagen product implant of claim 25, wherein the fascia is tensor fascia lata.

79. The collagen product implant of claim 23, wherein the collagen implant is a compressed collagen scaffold, said compressed collagen scaffold that is drapeable and/or resistant to suture pullout.

80. The collagen product implant of claim 23, wherein the collagen implant is a compressed collagen scaffold, said compressed collagen scaffold configured to form a seal with an implant area.

27. A method for preparing a human or human-like derived collagen product, comprising:

treating harvested human or human-like tissue with an enzyme to form a collagen product;

deactivating the enzyme with a non-alkaline enzyme deactivation solution; and

collecting the collagen product resulting from the enzyme treatment, the collected collagen product having a preserved amount of its natural collagen constituents.

28. The method of claim 27, wherein the harvested tissue-containing collagen is a tendon.

29. The method of claim 27, wherein the harvested tissue-containing collagen is pericardial tissue.

30. The method of claim 27, wherein the harvested tissue-containing collagen is intestinal tissue.

31. The method of claim 27, wherein the harvested tissue-containing collagen is fascia.

32. The method of claim 27, wherein the harvested tissue-containing collagen contains type I collagen.

33. The method of claim 27, wherein the harvested tissue-containing collagen contains type III collagen.

34. The method of claim 27, wherein the harvested tissue-containing collagen contains type V collagen.

35. The method of claim 27, wherein the harvested tissue-containing collagen contains two or more of type I collagen, type III collagen, and type V collagen.

36. The method of claim 27, wherein the enzyme is a hydrolytic enzyme.

37. The method of claim 36, wherein the enzyme is a proteolytic enzyme.

38. The method of claim 27, wherein the collagen product is processed to include a bioactive agent.

39. The method of claim 27, wherein collecting the collagen product comprises:

washing the collagen product; and

drying the collagen product.

40. A collagen product medical implant comprising isolated, enzymatically-treated human derived collagen having a preserved amount of its natural collagen constituents.

41. The medical implant of claim 40, wherein the collagen product is fibrillar collagen.

42. The medical implant of claim 40, wherein the collagen product is particulate collagen.

43. The medical implant of claim 40, wherein said implant comprises a wound repair matrix.

44. The medical implant of claim 40, wherein said implant comprises an absorbent hemostat.

45. The medical implant of claim 40, wherein said implant comprises a medical repair patch.

46. The medical implant of claim 45, wherein the medical repair patch is a woven patch.

47. The medical implant of claim 45, wherein the medical repair match is a non-woven patch.

48. The medical implant of claim 45, wherein the medical repair patch is a braided patch.

49. The medical implant of claim 45, wherein the medical repair patch is a film patch.

50. The medical implant of claim 45, wherein the medical repair patch is a knitted patch.

51. The medical implant of claim 45, wherein the medical repair patch is at least two of a woven, a non-woven, a braided, a film, and a knitted patch.

52. The medical implant of claim 40, wherein said implant comprises a vascular graft.

53. The medical implant of claim 40, wherein said implant comprises a neural graft.

54. The medical implant of claim 40, wherein said implant comprises a cartilage repair structure.

55. The medical implant of claim 40, wherein said implant comprises a sphincter repair matrix.

56. The medical implant of claim 40, wherein said implant comprises a film.

57. The medical implant of claim 40, wherein said implant comprises a prosthetic having a coating of the enzymatically-treated human derived collagen.

58. The medical implant of claim 40, wherein said implant comprises an implantable instrument having a coating of the enzymatically-treated human derived collagen.

59. The medical implant of claim 40, wherein said implant comprises a structural support sling.

60. The medical implant of claim 40, wherein said implant comprises a bioactive agent.

61. The medical implant of claim 40, wherein said implant comprises a plug (is cartilage repair structure from claim 54 sufficient?).

62. The medical implant of claim 40, wherein said implant is for in vitro applications.

63. The medical implant of claim 40, wherein said implant is injectable.

64. The medical implant of claim 40, wherein said implant is reinforced.

65. A method for forming a medical implant, comprising:

dispersing in solution an isolated, enzymatically-treated human derived collagen product having a preserved amount of its natural constituents;

forming the dispersed collagen product into a medical implant; and

removing the liquid component of the collagen product dispersion.

66. The method of claim 65, wherein dispersing human derived collagen product comprises at least suspending the human derived collagen product in a solution.

67. The method of claim 65, wherein said liquid component is removed by evaporating.

68. The method of claim 67, wherein evaporating the liquid component of the collagen product dispersion comprises lyophilizing the collagen product dispersion.

69. The method of claim 68, wherein evaporating the liquid component of the collagen product dispersion comprises freezing and lyophilizing the collagen product dispersion.

70. The method of claim 65, further comprising cross-linking the collagen dispersion.

71. A method for forming a medical implant, comprising:

causing an enzymatically-treated human derived collagen product having a preserved amount of its natural constituents in a solution to react to form a collagen thread; and

forming a collagen fabric from the collagen thread.

72. The method of claim 71, wherein said collagen fabric is a woven collagen fabric.

73. The method of claim 71, wherein said collagen fabric is a non-woven collagen fabric.

74. A method for forming a medical implant, comprising:

depositing a dispersion of an enzymatically-treated human derived collagen product having an amount of its natural constituents preserved in a mold having a predetermined shape; and

evaporating the liquid in the collagen product dispersion.

75. A method for processing a medical implant, comprising:

processing an enzymatically-treated human derived collagen product having an amount of its natural constituents preserved into a gelatin; and

coating the medical implant with the gelatin.

76. A medical implant comprising:

reconstituted human derived collagen,

wherein the human derived collagen product comprises a preserved amount of its native human collagen constituents.

77. A method for providing a medical implant comprising:

reconstituting an isolated human derived collagen product, wherein the human derived collagen product comprises a preserved amount of native human collagen constituents; and

forming a medical implant using the reconstituted human derived collagen product.

78. A human-derived collagen product having a preserved amount of native constituents.