Methods for Collagen Processing and Products Using Processed Collagen

• US 20080195202A1
• Filed: 02/12/2007
• Published: 08/14/2008
• Est. Priority Date: 02/12/2007
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Shimp, Lawrence A., Lauritzen, Nels J.
• Granted Patent: US 9,056,151 B2
• Time in Patent Office: Days
• US Class Current: 623/11.11
• CPC Class Codes: A61L 15/325 Collagen
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 27/24 Collagen
• 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

Abstract

Purifying human derived collagen from human tissue includes treating harvested human 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, where the collected collagen product includes a preserved amount of its natural collagen constituents. Various medical implants can be formed using the isolated, enzymatically-treated human derived collagen having an amount of its natural collagen constituents preserved, and may include implantable sponges, patches, tubes, structural supports and coatings, and which may be used for repair, barrier, support and/or stabilization purposes.

Claims

1. A method for purifying human derived collagen, comprising:

treating harvested human 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.

2. The method of claim 1, wherein the harvested human tissue is a tendon.

3. The method of claim 1, wherein the harvested human tissue is pericardial tissue.

4. The method of claim 1, wherein the harvested human tissue is intestinal tissue.

5. The method of claim 1, wherein the harvested human tissue is fascia.

6. The method of claim 1, wherein the harvested human tissue contains type I collagen.

7. The method of claim 1, wherein the harvested human tissue contains type III collagen.

8. The method of claim 1, wherein the harvested human tissue contains type V collagen.

9. The method of claim 1, wherein the harvested human tissue contains two or more of type I collagen, type III collagen, and type V collagen.

10. The method of claim 1, wherein the enzyme is a hydrolytic enzyme.

11. The method of claim 10, wherein the enzyme is a proteolytic enzyme.

12. The method of claim 1, wherein the collagen is processed to include a bioactive agent.

13. The method of claim 1, wherein collecting the collagen product comprises:

washing the collagen product; and

drying the collagen product.

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

15. The medical implant of claim 14, wherein the collagen is fibrillar human derived collagen.

16. The medical implant of claim 14, wherein the collagen is particulate human derived collagen.

17. The medical implant of claim 14, wherein said implant comprises a wound repair matrix.

18. The medical implant of claim 14, wherein said implant comprises an absorbent hemostat.

19. The medical implant of claim 14, wherein said implant comprises a medical repair patch.

20. The medical implant of claim 19, wherein the medical repair patch is a woven patch.

21. The medical implant of claim 19, wherein the medical repair match is a non-woven patch.

22. The medical implant of claim 19, wherein the medical repair patch is a braided patch.

23. The medical implant of claim 19, wherein the medical repair patch is a film patch.

24. The medical implant of claim 19, wherein the medical repair patch is a knitted patch.

25. The medical implant of claim 19, wherein the medical repair patch is at least two of a woven, a non-woven, a braided, a film, and a knitted patch.

26. The medical implant of claim 14, wherein said implant comprises a vascular graft.

27. The medical implant of claim 14, wherein said implant comprises a neural graft.

28. The medical implant of claim 14, wherein said implant comprises a cartilage repair structure.

29. The medical implant of claim 14, wherein said implant comprises a sphincter repair matrix.

30. The medical implant of claim 14, wherein said implant comprises a film.

31. The medical implant of claim 14, wherein said implant comprises a prosthetic having a coating of the enzymatically-treated human derived collagen.

32. The medical implant of claim 14, wherein said implant comprises an implantable instrument having a coating of the enzymatically-treated human derived collagen.

33. The medical implant of claim 14, wherein said implant comprises a structural support sling.

34. The medical implant of claim 14, wherein said implant comprises a bioactive agent.

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

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

forming the dispersed collagen into a medical implant; and

removing the liquid component of the collagen dispersion.

36. The method of claim 35, wherein said liquid component is removed by evaporation.

37. The method of claim 36, wherein dispersing human derived collagen comprises at least suspending the human derived collagen in a solution.

38. The method of claim 36, wherein evaporating the liquid component of the collagen dispersion comprises lyophilizing the collagen dispersion.

39. The method of claim 38, wherein evaporating the liquid component of the collagen dispersion comprises freezing and lyophilizing the collagen dispersion.

40. The method of claim 35, further comprising cross-linking the collagen dispersion.

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

causing enzymatically-treated human derived collagen 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.

42. The method of claim 41, wherein said collagen fabric is a woven collagen fabric.

43. The method of claim 41, wherein said collagen fabric is a non-woven collagen fabric.

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

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

evaporating the liquid in the collagen dispersion.

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

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

coating the medical implant with the gelatin.

46. A medical implant comprising:

reconstituted human derived collagen,

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

47. A method for providing a medical implant comprising:

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

forming a medical implant using the reconstituted human derived collagen.