Implant device and method for manufacture

• US 8,617,242 B2
• Filed: 02/14/2008
• Issued: 12/31/2013
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Philipp, Lang
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/031,239
• Publication Number:
  US 20080195216A1
• Time in Patent Office: 2,147 Days
• Field of Search: 623/22.11, 623/20.14, 623/19.11, 623/18.11, 623/23.63, 623/23.53, 623/11.11, 623/20.35, 623/23.29, 623/23.37, 219/121.35, 219/121.38, 219/121.72, 216/83, 216/53, 216/96, 216/103, 216/106, 216/108, 216/109, 427/2.24, 427/2.26, 428/615, 428/610
• US Class Current: 623/16.11
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• 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 2/32 for the hip
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3804 for elbows
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/4225 for feet, e.g. toes
• CPC Class Codes: A61F 2/4241 for hands, e.g. fingers
• CPC Class Codes: A61F 2/4261 for wrists
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30892 parallel
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/3097 using laser
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• 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 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00161 : Carbon; Graphite
• CPC Class Codes: A61F 2310/00167 : Diamond or diamond-like carbon
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2
• CPC Class Codes: B23P 19/04 : for assembling or disassembling parts
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: G06F 30/00 : Computer-aided design [CAD]
• CPC Class Codes: Y10T 29/49995 : Shaping one-piece blank by removing material

Abstract

A knee implant includes a femoral component having first and second femoral component surfaces. The first femoral component surface is for securing to a surgically prepared compartment of a distal end of a femur. The second femoral component surface is configured to replicate the femoral condyle. The knee implant further includes a tibial component having first and second tibial component surfaces. The first tibial component surface is for contacting a proximal surface of the tibia that is substantially uncut subchondral bone. At least a portion of the first tibial component surface is a mirror image of the proximal tibial surface. The second tibial component surface articulates with the second femoral component surface.

Claims

1. A method for making an implant suitable for repairing an articular surface of a joint, the method comprising:

a. determining a desired dimension selected from the group consisting of width, length, curvature, thickness, and any combination thereof, of an articular implant based on an articular shape derived from image data of the joint;

b. providing a blank with at least one corresponding dimension larger than the desired dimension of the articular implant; and

c. cutting the blank to obtain the desired dimension of the articular implant.

2. The method according to claim 1, wherein the blank is made of a material selected from the group consisting of a polymer, a metal, a cross-linked polymer, a ceramic, a ceramic-metal composite, an alloy, and any combination thereof.

3. The method according to claim 1, wherein providing the blank includes forming the blank by casting, milling, forging, compression molding, extruding or injection molding.

4. The method according to claim 1, wherein cutting the blank includes cutting the blank such that at least a portion of one surface of the implant is substantially a negative of at least a portion of the articular surface of the joint.

5. The method according to claim 1, further comprising obtaining the image data of the joint by an imaging technique selected from the group consisting of MRI, CT, ultrasound, digital tomosynthesis, optical coherence tomography, and any combination thereof.

6. The method according to claim 1, wherein the implant includes one of a cartilage repair implant, a unicompartmental knee implant, a bicompartmental knee implant, a total knee replacement implant, a hip implant, and a shoulder implant.

7. The method according to claim 1, wherein the implant is an interpositional joint implant.

8. The method according to claim 1, wherein the interpositional joint implant is associated with one of a knee, hip and shoulder.

9. The method of claim 1, further comprising selecting the blank from a library of pre-made implants.

10. The method of claim 1, wherein the joint is a knee joint, wherein the articular implant includes a surface configured to substantially replicate at least a portion of a femoral condyle of the knee joint.

11. The method of claim 1, wherein the articular implant includes a surface configured to substantially replicate at least a portion of articular curvature of the joint.

12. The method of claim 1, wherein the articular implant includes a surface that substantially replicates a cartilage surface of the joint.

13. The method of claim 1, wherein the articular implant includes a surface that substantially replicates a subchondral bone surface of the joint.

14. A method for making an implant suitable for repairing an articular surface of a joint, the method comprising:

a. determining a desired dimension of an articular implant based on image data of the joint;

b. providing a blank with at least one dimension smaller than the desired dimension of the articular implant; and

c. adding material to the blank so as to obtain the desired dimension of the articular implant.

15. The method according to claim 14, wherein adding material to the blank includes laser sintering and/or electron beam melting.

16. The method according to claim 14, wherein adding material to the blank includes adding a material selected from the group consisting of a ceramic, a metal, a ceramic-metal composite, and any combination thereof.

17. The method according to claim 14, further comprising, after adding material, polishing the material added to the blank.

18. The method according to claim 14, wherein the blank is made of a material selected from the group consisting of a polymer, a metal, a cross-linked polymer, a ceramic, a ceramic-metal composite, an alloy, and any combination thereof.

19. The method according to claim 14, wherein providing the blank includes forming the blank casting, milling, forging, compression molding, extruding or injection molding.

20. The method according to claim 14, wherein material is added to the blank such that at least a portion of one surface of the implant is substantially a negative of at least a portion of the articular surface of the joint.

21. The method according to claim 14, further comprising obtaining the image data of the joint by an imaging technique selected from the group consisting of MRI, CT, ultrasound, digital tomosynthesis, optical coherence tomography, and any combination thereof.

22. The method according to claim 14, wherein the implant includes one of a cartilage repair implant, a unicompartmental knee implant, a bicompartmental knee implant, a total knee replacement implant, a hip implant, and a shoulder implant.

23. The method according to claim 14, wherein the implant is an interpositional joint implant.

24. The method according to claim 23, wherein the interpositional joint implant is associated with one of a knee, hip and shoulder.

25. The method of claim 14, further comprising selecting the blank from a library of pre-made implants.

26. A method for making an implant suitable for a joint, the method comprising:

a. determining a desired dimension selected from the group consisting of width, length, curvature, and any combination thereof, of an articular surface of the implant based on image data of the joint;

b. providing a blank having at least a corresponding dimension that is different from the desired dimension of the articular surface of the implant; and

c. modifying the blank to obtain the desired dimension of the surface of the articular implant.

27. The method according to claim 26, wherein providing the blank includes providing a blank having at least one dimension that is larger than the desired dimension of the articular surface of the implant, and wherein modifying the blank includes cutting the blank with the laser.

28. The method according to claim 27, wherein modifying the blank includes polishing surfaces cut by the laser.

29. The method according to claim 26, wherein providing the blank includes providing a blank that has at least one dimension that is smaller than the desired dimension of the articular surface of the implant, and wherein modifying the blank includes adding material by one of laser sintering and electron beam melting.

30. The method according to claim 29, wherein modifying the blank includes polishing the added material.

31. The method according to claim 26, wherein the blank is made of a material selected from the group consisting of a polymer, a metal, a cross-linked polymer, a ceramic, a ceramic-metal composite, an alloy, and any combination thereof.

32. The method according to claim 26, wherein providing the blank includes forming the blank by casting, milling, forging, compression molding, extruding or injection molding.

33. The method according to claim 26, wherein the blank is modified such that at least a portion of one surface of the implant is substantially a negative of at least a portion of the articular surface of the joint.

34. The method according to claim 26, further comprising obtaining the image data of the joint by an imaging technique selected from the group consisting of MRI, CT, ultrasound, digital tomosynthesis, optical coherence, and any combination thereof.

35. The method of claim 26, further comprising selecting the blank from a library of pre-made implants.

36. The method of claim 26, wherein the joint is a knee joint, wherein the articular implant includes a surface configured to substantially replicate at least a portion of a femoral condyle of the knee joint.