IP Library Granted Patent US 8,771,365
Granted Patent B2
US 8,771,365 · App. 12/821,301 · Granted Jul 8, 2014

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

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Quick Facts
Patent No.
US 8,771,365
App. No.
12/821,301
Granted
Jul 8, 2014
Kind
B2
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 (80)

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.

Assignments (13)
SECURITY INTEREST Recorded Jun 7, 2024
From: RESTOR3D, INC.; CONFORMIS, INC.; IMATX, INC.
To: TRINITY CAPITAL INC., AS ADMINISTRATIVE AGENT
Reel/Frame 067679/0713 →
RELEASE OF SECURITY INTEREST Recorded Sep 6, 2023
From: MIDCAP FINANCIAL TRUST, AS AGENT FOR LENDERS
To: CONFORMIS, INC.; IMATX, INC.
Reel/Frame 064818/0713 →
RELEASE OF SECURITY INTEREST Recorded Nov 23, 2021
From: CONFORMIS, INC.; IMATX, INC.; CONFORMIS CARES LLC
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
Reel/Frame 058234/0292 →
SECURITY INTEREST Recorded Nov 22, 2021
From: CONFORMIS, INC.; IMATX, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 058219/0346 →
RELEASE OF SECURITY INTEREST Recorded Sep 12, 2019
From: VENTURE LENDING & LEASING V, INC.; VENTURE LENDING & LEASING VI, INC.
To: CONFORMIS, INC.
Reel/Frame 050352/0372 →
RELEASE OF SECURITY INTEREST Recorded Jun 26, 2019
From: OXFORD FINANCE LLC, AS COLLATERAL AGENT
To: CONFORMIS, INC.
Reel/Frame 049599/0084 →
SECURITY INTEREST Recorded Jun 25, 2019
From: CONFORMIS, INC.; IMATX, INC.; CONFORMIS CARES LLC
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP, AS COLLATERAL AGENT
Reel/Frame 049588/0288 →
SECURITY INTEREST Recorded Jul 31, 2018
From: CONFORMIS, INC.
To: OXFORD FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 046676/0152 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT SERIAL NUMBER 13/013466 PREVIOUSLY RECORDED AT REEL: 033460 FRAME: 0396. ASSIGNOR(S) HEREBY CONFIRMS THE RELEASE OF SECURITY INTEREST. Recorded Oct 20, 2016
From: VENTURE LENDING & LEASING V, INC.; VENTURE LENDING & LEASING VI, INC.
To: CONFORMIS, INC.
Reel/Frame 040424/0437 →
RELEASE OF SECURITY INTEREST Recorded Aug 1, 2014
From: VENTURE LENDING & LEASING V, INC. & VENTURE LENDING & LEASING VI, INC.
To: CONFORMIS, INC.
Reel/Frame 033460/0396 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 16, 2014
From: MINAS, THOMAS
To: CONFORMIS, INC.
Reel/Frame 032913/0861 →
SECURITY AGREEMENT Recorded Feb 23, 2011
From: CONFORMIS, INC.
To: VENTURE LENDING & LEASING VI, INC.; VENTURE LENDING & LEASING V, INC.
Reel/Frame 025833/0753 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2010
From: BOJARSKI, RAYMOND A.; LANG, PHILIPP; CHAO, NAM; FITZ, WOLFGANG; SLAMIN, JOHN; STEINES, DANIEL
To: CONFORMIS, INC.
Reel/Frame 024851/0754 →