Patient-adapted and improved orthopedic implants, designs, and related tools

• US 8,771,365 B2
• Filed: 06/23/2010
• Issued: 07/08/2014
• Est. Priority Date: 02/25/2009
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Bojarski, Raymond A., Lang, Philipp, Chao, Nam, Fitz, Wolfgang, Slamin, John, Steines, Daniel, Minas, Thomas
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/821,301
• Publication Number:
  US 20110029091A1
• Time in Patent Office: 1,476 Days
• Field of Search: 623/20.21, 623/20.32, 623/20.33, 623/20.34, 623/20.3, 623/13.11, 623/13.14, 606/86.R
• US Class Current: 623/20.32
• 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: 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 2/3886 for stabilising knees against anterior or lateral dislocations
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 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 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: B33Y 70/00 Materials specially adapted for additive manufacturing
• 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 tibial implant for a knee arthroplasty in a patient, the tibial implant comprising:

(a) a tibial tray sized and shaped generally for placement on a proximal surface of a tibia of the patient and having at least one insert locking mechanism;

(b) a first insert comprising a first reciprocal locking mechanism, a first bottom surface for engaging a surface of the tibial tray, a first articular surface portion generally opposite the first bottom surface, and a first thickness extending in a generally perpendicular direction between the first bottom surface and the first articular surface portion; and

(c) a second insert comprising a second reciprocal locking mechanism, a second bottom surface for engaging a surface of the tibial tray, a second articular surface portion generally opposite the second bottom surface, and a second thickness extending in a generally perpendicular direction between the second bottom surface and the second articular surface portion;

wherein the first thickness is greater than the second thickness, wherein the first articular surface portion or the second articular surface portion, or both, includes patient-adapted sagittal radii or curvature.

2. The tibial tray of claim 1, wherein the first and second thicknesses are measured from geographic centers of the first and second contact areas of the first and second articular surface portions, respectively.

3. The tibial tray of claim 1, wherein the first and second thicknesses are measured from corresponding edges of first and second contact areas of the first and second articular surface portions, respectively.

4. The tibial tray of claim 1, wherein the first and second thicknesses are measured from central points of the first and second articular surface portions, respectively.

5. The tibial tray of claim 1, wherein the first and second thicknesses are measured from the point of the first and second articular surfaces that are closest to the first and second bottom surface portions, respectively.

6. The tibial tray of claim 1, wherein the first and second thicknesses are measured from the point of the first and second articular surfaces that are furthest from the first and second bottom surface portions, respectively.

7. The tibial tray of claim 1, wherein the first and second thicknesses are average thicknesses of the first and second inserts, respectively.

8. The tibial tray of claim 1, wherein the first thickness is substantially greater than the second thickness.

9. The tibial tray of claim 1, wherein a difference in the thickness of the first and second thicknesses is a statistically significant difference.

10. The tibial tray of claim 1, wherein a difference in the thickness of the first and second thicknesses is a clinically significant difference.

11. The tibial tray of claim 1, wherein a difference in the thickness of the first and second thicknesses is sufficient to induce a clinical effect.

12. The tibial tray of claim 11, wherein the clinical effect is an alignment of at least a portion of the knee.

13. The tibial tray of claim 11, wherein the clinical effect is a balancing of at least a portion of the knee.

14. The tibial tray of claim 1, wherein the first and second inserts have different curvatures on respective articular surface portions.

15. The tibial tray of claim 1, wherein the first and second inserts have different slopes on respective articular surface portions.

16. A tibial implant for knee arthroplasty in a patient, the tibial implant comprising:

(a) a medial tibial insert comprising (i) a substantially planar inner surface for engaging a medial tibial tray face and (ii) an articular surface comprising an articular surface plateau and disposed therein a curved portion for opposing an articular surface of a medial femoral condyle; and

(b) a lateral tibial insert comprising (i) a substantially planar inner surface for engaging a lateral tibial tray face and (ii) an articular surface comprising an articular surface plateau and disposed therein a curved portion for opposing an articular surface of a lateral femoral condyle;

wherein the distance from the inner surface to the articular surface of the medial tibial insert is different from the distance from the inner surface to the articular surface of the lateral tibial insert, and wherein the articular surface of the medical tibial insert, or the articular surface of the lateral tibial insert, or both, includes patient-adapted sagittal radii or curvature.

17. The tibial implant of claim 16, wherein the minimum distance from the inner surface to the articular surface of the medial tibial insert is different from the minimum distance from the inner surface to the articular surface of the lateral tibial insert.

18. The tibial implant of claim 16, wherein the maximum distance from the inner surface to the articular surface of the medial tibial insert is different from the maximum distance from the inner surface to the articular surface of the lateral tibial insert.

19. The tibial implant of claim 16, wherein the average distance from the inner surface to the articular surface of the medial tibial insert is different from the average distance from the inner surface to the articular surface of the lateral tibial insert.

20. The tibial implant of claim 16, wherein the distance from the inner surface to the articular surface of the medial tibial insert is substantially different from the distance from the inner surface to the articular surface of the lateral tibial insert.

21. The tibial implant of claim 16, wherein the distance from the inner surface to the articular surface of the medial tibial insert is significantly different from the distance from the inner surface to the articular surface of the lateral tibial insert.

22. The tibial implant of claim 16, wherein the distance from the inner surface to a central point of the articular surface of the medial tibial insert is different from the distance from the inner surface to a central point of the articular surface of the lateral tibial insert.

23. The tibial implant of claim 16, wherein the distance from the inner surface to a central point of a contact area of the articular surface of the medial tibial insert is different from the distance from the inner surface to a central point of a contact area of the articular surface of the lateral tibial insert.

24. The tibial implant of claim 16, wherein the distance from the inner surface to an edge of the articular surface of the medial tibial insert is different from the distance from the inner surface to an edge of the articular surface of the lateral tibial insert.

25. The tibial implant of claim 16, wherein a first tibial tray comprises the medial tibial tray face and a second tibial tray comprises the lateral tibial tray face.

26. The tibial implant of claim 16, wherein the medial and lateral tibial inserts have different curvatures in the respective curved portions.

27. The tibial implant of claim 16, wherein the medial and lateral tibial inserts have different articular surface plateau slopes.

28. The tibial implant of claim 16, wherein the slope for the articular surface plateau of the medial tibial insert is patient-matched to the patient'"'"'s medial tibial plateau slope.

29. The tibial implant of claim 16, wherein the slope for the articular surface plateau of the medial tibial insert is patient-matched to the patient'"'"'s lateral tibial plateau slope.

30. The tibial implant of claim 16, wherein the slope for the articular surface plateau of the lateral tibial insert is patient-matched to the patient'"'"'s lateral tibial plateau slope.

31. The tibial implant of claim 16, wherein the slope for the articular surface plateau of the lateral tibial insert is patient-matched to the patient'"'"'s medial tibial plateau slope.

32. A method for implanting a knee implant in a patient'"'"'s knee joint, the method comprising the steps of:

(a) preparing a proximal end of a tibia to receive an implant including at least one tibial implant; and

(b) inserting the at least one tibial implant onto the prepared proximal end of the tibia such that a first articular surface of the at least one tibial implant engages a first articular surface of a femoral implant and a second articular surface of the at least one tibial implant engages a second articular surface of the femoral implant;

wherein the first articular surface is higher than the second articular surface relative to an anatomical axis of the tibia, wherein the first articular surface, or the second articular surface, or both, includes patient-adapted sagittal radii or curvature.

33. The method of claim 32, wherein the at least one tibial implant comprises a single tibial implant tray.

34. The method of claim 33, further comprising a single tibial insert.

35. The method of claim 33, further comprising dual tibial inserts.

36. The method of claim 32, wherein the at least one tibial implant comprises two tibial implant trays.

37. The method of claim 36, further comprising a single tibial insert for each of the two tibial implant trays.

38. The method of claim 32, further comprising adjusting height of the first articular surface relative to the second articular surface.

39. The method of claim 32, further comprising aligning the patient'"'"'s knee joint.

40. The method of claim 39, further comprising assessing the alignment of the patient'"'"'s knee joint.

41. The method of claim 39, further comprising adjusting alignment of the patient'"'"'s knee joint.

42. The method of claim 32, further comprising adjusting rotational alignment of the patient'"'"'s knee joint.

43. The method of claim 32, further comprising adjusting linear alignment of the patient'"'"'s knee joint.

44. The method of claim 32, further comprising adjusting alignment of the patient'"'"'s femur and tibia.

45. The method of claim 32, further comprising adjusting a biomechanical axis of the patient'"'"'s knee joint.

46. The method of claim 32, further comprising adjusting an anatomical axis of the patient'"'"'s knee joint.

47. The method of claim 32, further comprising balancing a patient'"'"'s knee joint.

48. The method of claim 47, further comprising assessing the balance of the patient'"'"'s knee joint.

49. The method of claim 47, further comprising adjusting the balance of the patient'"'"'s knee joint.

50. The method of claim 47, wherein balancing of the patient'"'"'s knee joint comprises balancing of the patient'"'"'s knee joint in extension.

51. The method of claim 47, wherein balancing of the patient'"'"'s knee joint comprises balancing of the patient'"'"'s knee joint in flexion.

52. The method of claim 32, further comprising planning a surgical procedure based on electronic image data of the patient'"'"'s knee joint.

53. The method of claim 52, further comprising performing the surgical procedure.

54. The method of claim 52, further comprising planning the surgical procedure based on electronic image data of the patient'"'"'s knee in order to achieve a predetermined surgical result.

55. The method of claim 54, wherein step (b) substantially achieves the predetermined surgical result.

56. The method of claim 54, wherein the surgical result includes joint balancing.

57. The method of claim 54, wherein the surgical result includes joint alignment.

58. The method of claim 32, wherein step (b) comprises inserting a first insert.

59. The method of claim 58, further comprising adjusting balance with a second insert.

60. The method of claim 58, further comprising adjusting alignment with a second insert.

61. The method of claim 58, further comprising inserting a second insert.

62. The method of claim 61, further comprising replacing the second insert with a third insert.

63. The method of claim 62, further comprising adjusting balance with the third insert.

64. The method of claim 62, further comprising adjusting alignment with the third insert.

65. A kit for implanting a tibial implant in a patient in need of knee replacement, the kit comprising:

(a) a tibial tray comprising a first surface for affixing the tray to the patient'"'"'s tibia and an opposing second surface for engaging a medial tibial insert; and

(b) two or more medial tibial inserts having different thicknesses from which to select one medial tibial insert for engaging with the tibial tray, wherein the two or more medial tibial inserts include an articular surface that has patient-adapted sagittal radii or curvature.

66. A kit for implanting a tibial implant in a patient in need of knee replacement, the kit comprising:

(a) a tibial tray comprising a first surface for affixing the tray to the patient'"'"'s tibia and an opposing second surface for engaging a lateral tibial insert; and

(b) two or more lateral tibial inserts having different thicknesses from which to select one lateral tibial insert for engaging with the tibial tray, wherein the two or more lateral tibial inserts include an articular surface that has patient-adapted sagittal radii or curvature.