Methods and compositions for articular resurfacing

• US 20030055502A1
• Filed: 05/28/2002
• Published: 03/20/2003
• Est. Priority Date: 05/25/2001
• Status: Abandoned Application

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Lang, Philipp, Steines, Daniel, Linder, Barry
• Application Number:
  US10/160,667
• Publication Number:
  US 20030055502A1
• Time in Patent Office: Days
• US Class Current: 623/16.11
• CPC Class Codes: A61B 17/1662 for particular parts of the body
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4514 Cartilage
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• 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 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/3097 using laser
• CPC Class Codes: A61F 2002/4631 the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• 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 2310/00047 : Aluminium or Al-based alloys
• CPC Class Codes: A61F 2310/00065 : Manganese or Mn-based alloys
• CPC Class Codes: A61F 2310/00071 : Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00077 : Copper or Cu-based alloys
• CPC Class Codes: A61F 2310/00083 : Zinc or Zn-based alloys
• CPC Class Codes: A61F 2310/00107 : Palladium or Pd-based alloys
• CPC Class Codes: A61F 2310/00113 : Silver or Ag-based alloys
• CPC Class Codes: A61F 2310/00119 : Tin or Sn-based alloys
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00149 : Platinum or Pt-based alloys
• CPC Class Codes: A61F 2310/00155 : Gold or Au-based alloys
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00383 : Gelatin
• CPC Class Codes: A61F 2310/00395 : Coating or prosthesis-covering structure made of metals or of alloys
• CPC Class Codes: A61F 2310/00592 : Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: G06F 18/00 : Pattern recognition
• CPC Class Codes: G06F 30/00 : Computer-aided design [CAD]
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture

Abstract

Disclosed herein are methods and compositions for producing articular repair materials and for repairing an articular surface. In particular, methods for providing articular replacement material, the method comprising the step of producing articular replacement material of selected size, curvature and/or thickness are provided. Also provided are articular surface repair systems designed to replace a selected area cartilage, for example, a system comprising at least one solid, non-pliable component and an external surface having near anatomic alignment to the surrounding structures.

Claims

1. A method for providing articular replacement material, the method comprising the step of producing articular replacement material of selected dimensions.

2. The method of claim 1, wherein the dimensions comprise thickness and curvature.

3. The method of claim 1, wherein the dimensions comprise size and curvature.

4. The method of claim 1, wherein the dimensions comprise size, thickness and curvature.

5. The method of claim 1, wherein the articular replacement material replaces cartilage and wherein said material is non-pliable.

6. The method of claim 1, wherein the dimensions of the articular replacement material are selected following intraoperative measurements.

7. The method of claim 6, wherein said measurements are made using imaging techniques.

8. The method of claim 7, wherein said imaging techniques are selected from the group consisting of ultrasound, MRI, CT scan, x-ray imaging obtained with x-ray dye and fluoroscopic imaging.

9. The method of claim 6, wherein said measurements are made using a mechanical probe.

10. The method of claim 9, wherein said measurements are made using an ultrasound probe, a laser, an optical probe and a deformable material.

11. The method of claim 1, wherein said producing step comprises growing or hardening the articular replacement material.

12. The method of claim 1, wherein said producing step comprises shaping the articular replacement material to the selected dimensions.

13. The method of claim 12, wherein said shaping is selected from the group consisting of mechanical abrasion, laser ablation, radiofrequency ablation, cryoablation and enzymatic digestion.

14. The method of claim 12, wherein said shaping is performed manually.

15. The method of claim 12, wherein said shaping is performed by machine.

16. The method of claim 15, wherein said shaping is automated.

17. The method of claim 1, wherein said articular replacement material is produced postoperatively.

18. The method of claim 1, wherein said articular replacement material is selected from a library of pre-existing repair systems.

19. The method of claim 1, wherein said articular replacement material comprises synthetic materials.

20. The method of claim 19, wherein the synthetic materials comprise metals, polymers or combinations thereof.

21. The method of claim 5, wherein said cartilage replacement material comprises biological materials.

22. The method of claim 21, wherein said biological materials comprise cells.

23. The method of claim 22, wherein said cells are stem cells, fetal cells or chondrocyte cells.

39. A method of repairing a cartilage in a subject, the method of comprising the step of implantating cartilage repair material prepared according to the method of claim 1, into the subject.

24. A method of making cartilage repair material, the method comprising the steps of

(a) measuring the dimensions of the intended implantation site or the dimensions of the area surrounding the intended implantation site;

and

(b) providing cartilage replacement material that conforms to the measurements obtained in step (a).

25. The method of claim 24, wherein the step (a) comprises measuring the thickness of the cartilage surrounding the intended implantation site and measuring the curvature of the cartilage surrounding the intended implantation site.

26. The method of claim 24, wherein the step (a) comprises measuring the size of the intended implantation site and measuring the curvature of the cartilage surrounding the intended implantation site.

27. The method of claim 24, wherein the step (a) comprises measuring the thickness of the cartilage surrounding the intended implantation site, measuring the size of the intended implantation site, and measuring the curvature of the cartilage surrounding the intended implantation site.

28. The method of claim 24, wherein step (a) comprises obtaining and analyzing an image of the cartilage.

29. The method of claim 28, wherein said image is obtained intraoperatively.

30. The method of claim 24, wherein step (a) comprises using a mechanical probe intraoperatively to measure the dimensions.

31. The method of claim 30, wherein the mechanical probe comprises a deformable material.

32. The method of claim 24, wherein step (b) comprises selecting the cartilage replacement material from a library of pre-existing repair systems.

33. The method of claim 24, wherein step (b) comprises growing the cartilage replacement material.

34. The method of claim 24, further comprising shaping the cartilage material.

35. The method of claim 34, wherein said shaping is by machine.

36. The method of claim 34, wherein said shaping is automated.

37. The method of claim 34, wherein said shaping is selected from the group consisting of mechanical abrasion, laser ablation, radiofrequency ablation, cryoablation and enzymatic digestion.

38. The method of claim 24, wherein step (b) comprises growing cartilage replacement material comprising biological substances ex vivo.

40. A method of determining the curvature of an articular surface, the method comprising the step of (a) intraoperatively measuring the curvature of the articular surface using a mechanical probe.

41. The method of claim 40, wherein the articular surface comprises cartilage.

42. The method of claim 40, wherein the articular surface comprises subchondral bone.

43. The method of claim 40, wherein the mechanical probe is selected from the group consisting of an ultrasound probe, a laser, an optical probe and a deformable material.

44. A method of producing an articular replacement material comprising the step of providing an articular replacement material that conforms to the measurements obtained by the method of claim 40.

45. A method of repairing an articular surface in a subject, the method of comprising the step of implanting articular repair material prepared according to the method of claim 40 into the subject.

46. A partial articular prosthesis comprising

a first component comprising a cartilage replacement material;

and

a second component comprising one or more metals, wherein said second component has a curvature similar to subchondral bone, wherein said prosthesis comprises less than about 80% of the articular surface.

47. The prosthesis of claim 46, wherein said first or second components comprise a non-pliable material.

48. The prosthesis of claim 46, wherein said first or second components further comprises a polymeric material.

49. The prosthesis of claim 46, wherein said first component comprises biological materials.

50. The prosthesis of claim 46, wherein said first component exhibits biomechanical properties similar to articular cartilage.

51. The prosthesis of claim 50, wherein said biomechanical properties are elasticity, resistance to axial loading or shear forces.

52. The prosthesis of claim 46, wherein the first and second components comprise two or more metals.

53. The prosthesis of claim 46, wherein the first or second components are bioresorbable.

54. The prosthesis of claim 46, wherein the first or second components are porous or porous coated.

55. The prosthesis of claim 46, wherein the first or second components are smooth.

56. The prosthesis of claim 46, wherein the first or second components are adapted to receive injections.

57. A partial articular prosthesis for use in a human with cartilage disease comprising

an external surface located in the load bearing area of an articular surface, wherein the dimensions of said external surface achieve a near anatomic fit with the adjacent cartilage.

58. The prosthesis of claim 57, further comprising one or more metals or metal alloys.

59. An articular surface repair system comprising

(a) cartilage replacement material, wherein said cartilage replacement material has a curvature similar to surrounding or adjacent cartilage;

and

(b) at least one non-biologic material, wherein said articular surface repair system comprises a portion of the articular surface equal to or smaller than the weight-bearing surface.

60. The articular surface repair system of claim 59, wherein said cartilage replacement material is non-pliable.

61. The articular surface repair system of claim 59, wherein said cartilage replacement material has biomechanical properties similar to that of normal human cartilage.

62. The articular surface repair system of claim 59, wherein said cartilage replacement material has a biochemical composition similar to that of normal human cartilage.

63. An articular surface repair system comprising

a first component comprising a cartilage replacement material, wherein said first component has dimensions similar to that of adjacent or surrounding cartilage;

and

a second component, wherein said second component has a curvature similar to subchondral bone, wherein said articular surface repair system comprises less than about 80% of the articular surface.

64. The repair system of claim 63, wherein said first or said second component comprises a non-pliable material.

65. The articular surface repair system of claim 63, wherein the first component has a curvature and thickness similar to that of adjacent or surrounding cartilage.

66. The articular surface repair system of claim 63, wherein said thickness of said first component is not uniform.

67. A partial articular prosthesis comprising

(a) a metal or metal alloy;

and

(b) an external surface located in the load bearing area of an articular surface, wherein the external surface designed to achieve a near anatomic fit with the adjacent cartilage.

68. The partial articular prosthesis of claim 67, wherein said external surface is comprises a polymeric material attached to said metal or metal alloy.

69. An articular surface repair system comprising a cartilage replacement material, wherein said cartilage replacement material has a curvature similar to surrounding or adjacent cartilage, wherein said articular surface repair system is adapted to receive injections.

70. The articular surface repair system of claim 69, wherein said injections are made through an opening in the external surface of said cartilage replacement material.

71. The articular surface repair system of claims 69, wherein said opening in the external surface terminates in a plurality of openings on the bone surface.

72. The articular surface repair system of claim 69, wherein bone cement is injected through said opening.

73. The articular surface repair system of claim 72, wherein said bone cement is injected under pressure in order to achieve permeation of portions of the marrow space with bone cement.

74. The articular surface repair system of claim 72, wherein said bone cement is combined with a therapeutic drug.