Patient-adapted and improved articular implants, designs and related guide tools

• US 20110029093A1
• Filed: 02/25/2010
• Published: 02/03/2011
• Est. Priority Date: 05/25/2001
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Lang, Philipp, Steines, Daniel, Chao, Nam, Bojarski, Ray, Slamin, John, Fitz, Wolfgang
• Granted Patent: US 8,480,754 B2
• Time in Patent Office: Days
• US Class Current: 623/20.35
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• 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 2/384 hinged, i.e. with transverse axle restricting the movement
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/3886 for stabilising knees against anterior or lateral dislocations
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/5046 for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30327 differing in diameter
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/3895 unicompartimental
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Methods and devices are disclosed relating improved articular models, implant components, and related guide tools and procedures. In addition, methods and devices are disclosed relating articular models, implant components, and/or related guide tools and procedures that include one or more features derived from patient-data, for example, images of the patient'"'"'s joint. The data can be used to create a model for analyzing a patient'"'"'s joint and to devise and evaluate a course of corrective action. The data also can be used to create patient-adapted implant components and related tools and procedures.

Claims

1. A pre-primary articular implant component comprising:

(a) an outer, joint-facing surface comprising a bearing surface portion; and

(b) an inner, bone-facing surface comprising one or more patient-engineered bone cuts selected and/or designed from patient-specific data.

2. The pre-primary articular implant component of claim 1, wherein the one or more patient-engineered bone cuts are selected and/or designed from patient-specific data to minimize the amount of bone resected in one or more corresponding predetermined resection cuts.

3. The pre-primary articular implant component of claim 1, wherein the one or more patient-engineered bone cuts substantially negatively-match one or more predetermined resection cuts.

4. The pre-primary articular implant component of claim 3, wherein the predetermined resection cuts are at a first depth that allows, in a subsequent procedure, removal of additional bone to a second depth required for a traditional primary implant component.

5. The pre-primary articular implant component of claim 1, wherein the pre-primary articular implant component is selected from the group consisting of a knee joint implant component, a hip joint implant component, a shoulder joint implant component, and a spinal implant component.

6. The pre-primary articular implant component of claim 1, wherein the pre-primary articular implant component is a knee joint implant component.

7. The pre-primary articular implant component of claim 1, wherein the pre-primary articular implant component is a femoral implant component.

8. The pre-primary articular implant component of claim 1, further comprising six or more patient-engineered bone cuts.

9. The pre-primary articular implant component of claim 1, further comprising an implant component thickness in one or more regions that is selected and/or designed from patient-specific data to minimize the amount of bone resected.

10. The pre-primary articular implant component of claim 9, wherein the one or more regions comprises the implant component thickness perpendicular to a planar bone cut and between the planar bone cut and the joint-surface of the implant component.

16. The method of any preceding claim, wherein the implant component features in step (c) include one or more of the features selected from the group consisting of implant thickness, bone cut number, bone cut angles, and/or bone cut orientations.

11. A method for minimizing resected bone from a single patient in need of an articular implant replacement procedure, the method comprising:

(a) identifying unwanted tissue from one or more images of the patient'"'"'s joint;

(b) identifying a combination of resection cuts and implant component features that remove the unwanted tissue and also provide maximum bone preservation; and

(c) selecting and/or designing for the patient a combination of resection cuts and implant component features that provide removal of the unwanted tissue and maximum bone preservation.

13. The method of claim 11 or 12, wherein the unwanted tissue is diseased tissue or deformed tissue.

14. The method of claim 11 or 12, wherein step (c) comprises designing for the single patient a combination of resection cuts and implant component features that provide removal of the unwanted tissue and maximum bone preservation.

15. The method of claim 14, wherein designing comprises manufacturing.

17. The method of claim 11 or 12, wherein a bone preservation measurement is selected from the group consisting of total volume of bone resected, volume of bone resected from one or more resection cuts, volume of bone resected to fit one or more implant component bone cuts, average thickness of bone resected, average thickness of bone resected from one or more resection cuts, average thickness of bone resected to fit one or more implant component bone cuts, maximum thickness of bone resected, maximum thickness of bone resected from one or more resection cuts, maximum thickness of bone resected to fit one or more implant component bone cuts.

18. The method of claim 11 or 12, wherein step (a) also includes identifying a minimum implant component thickness for the single patient.

19. The method of claim 18, wherein step (b) also includes identifying a combination of resection cuts and/or implant component features that provide a minimum implant thickness determined for the single patient.

20. The method of claim 18, wherein step (c) includes selecting and/or designing the combination of resection cuts and/or implant component features that provides at least a minimum implant thickness for the single patient.

21. The method of claim 18, wherein the minimum implant component thickness is based on one or more of femur and/or condyle size or patient weight.

22. The method of claim 11 or 12, wherein the articular implant component is a femoral implant component.

12. A method for making an articular implant component for a single patient in need of an articular implant replacement procedure, the method comprising:

(a) identifying unwanted tissue from one or more images of the patient'"'"'s joint;

(b) identifying a combination of resection cuts and implant component features that remove the unwanted tissue and also provide maximum bone preservation; and

(c) selecting and/or designing a combination of resection cuts and/or implant component features that provide removal of the unwanted tissue and maximum bone preservation.

23. A femoral implant component comprising:

(a) a joint-facing surface comprising a bearing surface portion, and (b) a bone-facing surface comprising six or more bone cuts.

24. A femoral implant component comprising:

(a) a joint-facing surface comprising a bearing surface portion, and (b) a bone-facing surface comprising a distal bone cut having two or more planar facets or portions that are non-coplanar with each other.

25. The femoral implant component of claim 24, wherein the two or more facets or portions are non-parallel with each other.

26. The femoral implant component of claim 24, wherein a first of the two or more facets or portions is on a lateral condyle bone-facing surface and the second is on a medial condyle bone-facing surface.

27. A femoral implant component comprising:

(a) a joint-facing surface comprising a bearing surface portion, and (b) a bone-facing surface comprising an anterior bone cut having two or more planar facets or portions that are non-coplanar with each other.

28. The femoral implant component of claim 27, wherein the two or more planar facets or portions are non-parallel with each other.

29. A femoral implant component comprising:

(a) a joint-facing surface comprising a bearing surface portion, and (b) a bone-facing surface comprising a posterior bone cut having two or more facets or portions that are non-parallel with each other.

30. The femoral implant component of claim 29, wherein a first of the two or more facets or portions is on a lateral condyle bone-facing surface and the second is on a medial condyle bone-facing surface.

31. A femoral implant component comprising:

(a) a joint-facing surface comprising a bearing surface portion, and (b) a bone-facing surface comprising an anterior chamfer bone cut having two or more planar facets or portions that are non-coplanar with each other.

32. The femoral implant component of claim 31, wherein the two or more planar facets or portions are non-parallel with each other.

33. The femoral implant component of claim 31, wherein a first of the two or more facets or portions is on a lateral condyle bone-facing surface and the second is on a medial condyle bone-facing surface.

34. A femoral implant component comprising:

(a) a joint-facing surface comprising a bearing surface portion, and (b) a bone-facing surface comprising a posterior chamfer bone cut having two or more facets or portions that are non-parallel with each other.

35. The femoral implant component of claim 34, wherein a first of the two or more facets or portions is on a lateral condyle bone-facing surface and the second is on a medial condyle bone-facing surface.

36. A femoral implant component comprising:

(a) a joint-facing surface comprising lateral and medial condylar surface portions, and (b) a bone-facing surface comprising an anterior bone cut, wherein the distance between the anterior bone cut and the lateral condylar surface portion is different from the distance between the anterior bone cut and the medial condylar surface portion.

37. The femoral implant component of claim 36, wherein the two or more facets or portions are substantially non-parallel.

38. A femoral implant component comprising:

(a) lateral and medial condylar portions, and (b) a bone-facing surface comprising a distal bone cut facet that is asymmetric about its center line in a sagittal plane.

39. The femoral implant component of claim 38, wherein the asymmetric distal bone cut facet lies on the bone-facing surface of the lateral condyle.

40. The femoral implant component of claim 38, wherein the asymmetric distal bone cut facet lies on the bone-facing surface of the medial condyle.

41. A femoral implant component having a bone-facing surface comprising one or more bone cuts, wherein at least one of the one or more bone cuts comprises two planar bone cut facets separated by at least one step cut.

42. The femoral implant component of claim 41, wherein the step cut is substantially perpendicular to at least one of the bone cut facets.

43. The femoral implant component of claim 41, wherein the step cut rises or falls at about 30 degrees or more from at least one of the bone cut facet planes.