Implants and methods for repair, replacement and treatment of disease

• US 8,480,757 B2
• Filed: 08/28/2006
• Issued: 07/09/2013
• Est. Priority Date: 08/26/2005
• Status: Expired due to Fees

• Current Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Gage, Gary, Adkisson, H. Davis IV, Blanchard, Cheryl R.
• Primary Examiner(s): Sweet, Thomas
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/063,291
• Publication Number:
  US 20090143867A1
• Time in Patent Office: 2,507 Days
• Field of Search: 623 2355- 2359, 623 2312- 2314, 623/11.11, 623/16.11, 424/499
• US Class Current: 623/23.55
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/3021 frustoconical
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30276 frustopyramidal
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30762 Means for culturing cartilage
• CPC Class Codes: A61F 2002/30764 Cartilage harvest sites
• CPC Class Codes: A61F 2002/30797 internally-threaded
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30929 : having at least two superposed coatings
• CPC Class Codes: A61F 2002/30934 : Special articulating surfaces
• CPC Class Codes: A61F 2002/30968 : Sintering
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/365 : Connections of heads to necks
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0086 : Pyramidal, tetrahedral, or wedge-shaped
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00059 : Chromium or Cr-based alloys
• CPC Class Codes: A61F 2310/00095 : Niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00395 : Coating or prosthesis-covering structure made of metals or of alloys
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00964 : Coating or prosthesis-covering structure made of cartilage
• CPC Class Codes: A61F 2310/00982 : Coating made of collagen
• CPC Class Codes: A61F 2310/00988 : Coating made of fibrin
• CPC Class Codes: A61L 27/306 : Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/3612 : Cartilage, synovial fluid
• 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 27/3645 : Connective tissue
• CPC Class Codes: A61L 27/3817 : Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3843 : Connective tissue
• 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 27/56 : Porous materials, e.g. foams or sponges

Abstract

Implants comprising cartilage and trabecular metal, and methods of making the implants are disclosed. Further disclosed are therapeutic uses of the implants, which include methods of treatment or repair of an chondral or osteochondral defect, such as a chondral or osteochondral injury, lesion or disease. An implant comprises cartilage or chondrocytes and a subchondral base comprising trabecular metal. An implant can comprise a geometric shape such as a cylinder or an anatomical shape such as a condyle, and can be used in conjunction with a positioning structure.

Claims

1. An implant for administering to a patient in need of treatment for joint disease, defect or injury, the implant comprising:

minced juvenile cartilage tissue from a human cadaveric donor; and

a subchondral base comprising at least one trabecular metal.

2. The implant of claim 1 wherein the cartilage tissue comprises articular cartilage.

3. The implant of claim 2 wherein the cartilage tissue and the subchondral base are attached.

4. The implant of claim 1, wherein the subchondral base further comprises at least one porous surface layer and a porous core, the at least one porous surface layer comprising a plurality of pores of median diameter from about 3 microns to about 800 microns wherein the median diameter of the plurality of pores of the at least one porous surface layer is different from that of the plurality of pores of the core of the subchondral base.

5. The implant of claim 1, wherein the subchondral base comprises at least two surfaces, wherein a first surface comprises trabecular metal comprising a plurality of pores having a median pore diameter of from about 100 microns to about 800 microns, and a second surface which is a cartilage-adherent surface.

6. The implant of claim 5, wherein the cartilage-adherent surface comprises a plurality of pores of median diameter from about 3 microns to about 800 microns.

7. The implant of claim 5, wherein the cartilage-adherent surface comprises a cartilage adhesive.

8. The implant of claim 7, wherein the cartilage adhesive comprises a hydrogel.

9. The implant of claim 7, wherein the cartilage-adhesive comprises trans-glutaminase, hyaluronic acid, collagen, fibrin, albumin, elastin or silk.

10. The implant of claim 9, wherein the cartilage adhesive comprises fibrin.

11. The implant of claim 1 wherein the trabecular metal comprises tantalum, niobium, stainless steel, chromium-cobalt alloy or titanium.

12. The implant of claim 11 wherein the trabecular metal comprises tantalum.

13. The implant of claim 1 wherein the subchondral base is cylindrical.

14. The implant of claim 1 wherein the subchondral base approximates the anatomical shape of a human condyle, hemi-condyle, acetabulum or femoral head.

15. A kit for forming the implant of claim 1, the kit comprising:

an amount of the cartilage tissue;

the subchondral base comprising at least one trabecular metal; and

packaging for the cartilage tissue and the subchondral bone.

16. The kit of claim 15 further comprising a cartilage adhesive.

17. The kit of claim 15 wherein the subchondral base is packaged separately from the cartilage tissue and cartilage adhesive.

18. A method of treating joint disease, defect or injury in a patient in need thereof comprising:

introducing into the patient a subchondral base comprising at least one trabecular metal, wherein the subchondral base is configured to receive cartilage tissue; and

applying minced juvenile cartilage tissue from a human cadaveric donor to the subchondral base.

19. The method of claim 18 wherein the cartilage tissue is applied to the subchondral base after introducing the subchondral base into the patient.

20. The method of claim 19, wherein applying comprises attaching the cartilage tissue to a surface of the subchondral base.

21. The method of claim 20, wherein attaching comprises applying a cartilage adhesive to an interface between a surface of the subchondral base and a surface of the cartilage tissue prior to contacting the cartilage tissue with the surface of the subchondral base.

22. The method of claim 18 wherein the cartilage tissue comprises articular cartilage.

23. The method of claim 22, further comprising coupling the subchondral base to a positioning structure.

24. The method of claim 23, wherein the positioning structure comprises a non-trabecular metal.

25. The method of claim 23, wherein the positioning structure comprises a biocompatible polymer.

26. The method of claim 23, wherein the positioning structure comprises a screw, cylinder, plat, rod or washer.

27. The method of claim 18 wherein the subchondral base comprises at least one porous surface layer comprising a plurality of pores of median diameter from about 3 microns to about 800 microns and wherein the median diameter of the plurality of pores of the at least one porous surface layer is different from that of the plurality of pores of the subchondral base.

28. The method of claim 27 wherein the at least one porous surface layer comprises a plurality of pores of median pore diameter of about 100 microns to about 800 microns.

29. The method of claim 18, wherein the subchondral base comprises at least two surfaces, wherein a first surface comprises the trabecular metal having a plurality of pores there through, the pores having a median pore diameter of from about 100 microns to about 800 microns, and a second surface which is a cartilage-adherent surface.

30. The method of claim 18, wherein applying comprises attaching the cartilage tissue to a surface of the subchondral base with a fibrin adhesive.

31. The method of claim 18, wherein the subchondral base is cylindrical.

32. The method of claim 18, wherein the at least one trabecular metal comprises tantalum.

33. A method of forming an implant comprising cartilage and a subchondral base comprising:

obtaining a subchondral base comprising at least one trabecular metal; and

contacting the subchondral base with minced juvenile cartilage tissue from a human cadaveric donor.

34. The method of claim 33, further comprising coupling the cartilage tissue to a surface of the subchondral base.

35. The method of claim 34, wherein coupling comprises applying a cartilage adhesive to an interface between a surface of the subchondral base and a surface of the cartilage tissue prior to contacting the cartilage tissue with the subchondral base.

36. The method of claim 34, wherein coupling comprises attaching the cartilage tissue to a surface of the subchondral base with a fibrin adhesive.

37. The method of claim 33 wherein the implant further comprises at least one porous surface layer comprising a plurality of pores of median diameter from about 3 microns to about 800 microns wherein the median diameter of the plurality of pores of the at least one porous surface layer is different from that of the plurality of pores of the subchondral base.

38. The method of claim 33 wherein the subchondral base comprises at least two surfaces, wherein a first surface comprises trabecular metal comprising a plurality of pores having a median pore diameter of from about 100 microns to about 800 microns, and a second surface which is a cartilage-adherent surface comprising a plurality of pores having a median diameter from about 3 microns to about 20 microns.

39. The method of claim 38 wherein the cartilage-adherent surface comprises a resorbable polymer.

40. The method of claim 33, wherein the cartilage tissue comprises articular cartilage.

41. The method of claim 33, wherein the at least one trabecular metal comprises tantalum.

42. The method of claim 33, wherein the subchondral base is cylindrical.