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

• US 20110071802A1
• Filed: 04/22/2010
• Published: 03/24/2011
• Est. Priority Date: 02/25/2009
• Status: Abandoned Application

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Lang, Philipp, Steines, Daniel, Chao, Nam, Bojarski, Ray, Slamin, John, Fitz, Wolfgang
• Application Number:
  US12/799,355
• Publication Number:
  US 20110071802A1
• Time in Patent Office: Days
• US Class Current: 703/1
• 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 2/3859 Femoral components
• 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

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 method of designing a patient-specific bone-preserving femoral implant having bone-cut surfaces for engaging corresponding resection cut surfaces on a patient'"'"'s knee, the method comprising the steps of:

determining a size, orientation, and/or position of a set of one or more bone-cut surfaces based at least in part on the shape of a patient'"'"'s knee such that the set of one or more bone-cut surfaces minimizes the amount of bone to be resected from the patient'"'"'s knee during implantation of the femoral implant; and

incorporating the set of one or more bone-cut surfaces into the design of a femoral implant, such that the set of one or more bone-cut surfaces is included on a bone-facing side of the implant.

2. The method of claim 1, wherein the set of one or more bone-cut surfaces includes five bone-cut surfaces.

3. The method of claim 1, wherein the set of one or more bone-cut surfaces includes six bone-cut surfaces.

4. The method of claim 1, wherein the set of one or more bone-cut surfaces includes at least five bone-cut surfaces.

5. The method of claim 1, wherein the set of one or more bone-cut surfaces includes at least six bone-cut surfaces.

6. The method of claim 1, wherein the step of determining the set of one or more bone-cut surfaces further comprises:

specifying at least a portion of a joint line of the femoral implant;

specifying a minimum thickness of the femoral implant corresponding to at least the location of the specified joint line;

basing the determination of the at least one bone cut surface at least in part on the specified joint line and minimum implant thickness.

7. The method of claim 1, wherein the bone-facing side of the femoral implant consists substantially entirely of the set of one or more bone-cut surfaces.

8. The method of claim 7, wherein the set of one or more bone-cut surfaces defines an optimal set of resection cuts for the patient to preserve substantially the largest amount of the patient'"'"'s bone on the femoral condyle possible when using the number of bone-cut surfaces in the set.

9. The method of claim 1, wherein the set of one or more bone-cut surfaces are substantially planar.

10. A method of selecting a bone-preserving femoral implant having bone-cut surfaces for engaging corresponding resection cut surfaces on a patient'"'"'s knee, the method comprising the steps of:

determining a desired implant configuration for a femoral implant based at least in part on image data of at least a portion of a patient'"'"'s knee, wherein the desired implant configuration minimizes a total bone resection volume of femoral bone to be resected from the patient'"'"'s knee during implantation of the femoral implant;

selecting a femoral implant design from a library of femoral implant designs based at least in part on the determined desired implant configuration, wherein the selected femoral implant design includes on its bone-facing side a set of bone-cut surfaces having a configuration that results in an actual bone resection volume that approximates the total bone resection volume.

11. The method of claim 10, wherein the set of bone-cut surfaces includes five bone-cut surfaces.

12. The method of claim 10, wherein the set of bone-cut surfaces includes six bone-cut surfaces.

13. The method of claim 10, wherein the set of bone-cut surfaces includes at least five bone-cut surfaces.

14. The method of claim 10, wherein the set of bone-cut surfaces includes at least six bone-cut surfaces.

15. The method of claim 10, wherein the step of determining a desired implant configuration further comprises:

specifying at least a portion of a joint line of the femoral implant;

specifying a minimum thickness of the femoral implant corresponding to at least the location of the specified joint line;

basing the determination of the set of bone cut-surfaces at least in part on the specified joint line and minimum implant thickness.

16. The method of claim 10, wherein the selected implant design is a subset of a complete implant design to be used to produce a physical implant.

17. The method of claim 10, wherein the selected implant design is a complete implant design to be used to manufacture a physical implant.

18. The method of claim 10, wherein the selected implant design is embodied in a physical implant selected from a library of physical implants having different design specifications.

19. The method of claim 10, wherein the implant design includes a bone-facing side of the femoral implant that consists substantially entirely of the set of bone-cut surfaces.

20. The method of claim 19, wherein the set of bone-cut surfaces define an optimized set of resection cuts to the patient for the number of bone-cut surfaces in the set.

21. The method of claim 10, wherein the set of bone-cut surfaces are substantially planar.

22. A method of selecting and/or designing for a patient a bone-preserving articular implant having an outer articular surface and an inner bone-facing surface, the method comprising the steps of:

(a) deriving a dimension of the outer articular surface of the articular implant by selecting one or more desired post-implantation distances between one or more patient-specific anatomical landmarks and the outer articular surface of the articular implant;

(b) selecting a desired minimum thickness for the articular implant;

(c) selecting and/or designing one or more surface facets on the inner, bone-facing surface of the articular implant, together with planning one or more corresponding resection cuts to the patient'"'"'s bone, to generate the articular implant having the desired one or more post-implantation distances and having at least the desired minimum thickness.

23. The method of claim 22, wherein the derived dimension of the outer articular surface of the articular implant is selected from the group consisting of a point, a line, a curved line, an area, and a curved area.

24. The method of claim 22, wherein bone preservation is achieved by selecting and/or designing the one or more surface facets on the inner, bone-facing surface of the articular implant to be as close as possible to the outer articular surface while maintaining the one or more desired post-implantation distances and the desired minimum thickness.

25. The method of claim 22, wherein the one or more patient-specific anatomic landmarks in step (a) comprise a cartilage surface.

26. The method of claim 22, wherein the one or more patient-specific anatomic landmarks in step (a) comprise a bone surface.

27. The method of claim 22, wherein a portion of the one or more surface facets and a portion of the one or more corresponding resection cuts are substantially planar.

28. The method of claim 22, wherein a portion of the one or more surface facets substantially negatively-match a portion of the one or more corresponding resection cuts.

29. The method of claim 22, wherein the articular implant is selected from the group consisting of a knee joint implant, a hip joint implant, a shoulder joint implant, and a spinal implant.

30. The method of claim 29, wherein the articular implant is a knee joint implant.

31. The method of claim 30, wherein the articular implant is a femoral implant.

32. The method of claim 30, wherein the articular implant is a tibial implant.

33. The method of claim 22, wherein the one or more surface facets on the inner, bone-facing surface of the articular implant comprise six or more planar surface facets.

34. A method of selecting and/or designing an articular implant for a particular patient, the method including the steps of:

(a) virtually aligning an extremity of the particular patient;

(b) planning one or more resection cuts to one or more of the patient'"'"'s articular surfaces and selecting and/or designing one or more surface facets on the inner, bone-facing surface of the articular implant in order to maintain the virtual alignment and thereby enhance a normal post-implantation mechanical axis for the particular patient;

(c) optimizing a location or orientation of a portion of the one or more surface facets on the inner, bone-facing surface of the articular implant so as to achieve maximum bone preservation.

35. The method of claim 34, wherein step (c) further comprises optimizing the location or orientation of a portion of the one or more surface facets on the inner, bone-facing surface of the articular implant to minimize implant thickness.

36. The method of claim 34, wherein the articular implant is a knee implant.

37. The method of claim 36, wherein the patient'"'"'s articular surface is on the patient'"'"'s femur.

38. The method of claim 36, wherein the patient'"'"'s articular surface is on the patient'"'"'s tibia.

39. The method of claim 34, wherein the articular implant is a hip implant.

40. The method of claim 39, wherein the patient'"'"'s articular surface is on the patient'"'"'s femur.

41. The method of claim 39, wherein the patient'"'"'s articular surface is on the patient'"'"'s acetabulum.

42. A method for making an articular implant 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 features that remove the unwanted tissue and also minimize resected bone; and

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

43. The method of claim 42, wherein the unwanted tissue is cartilage.

44. The method of claim 42, wherein the unwanted tissue is diseased tissue or deformed tissue.

45. The method of claim 42, wherein the implant features in step (c) include one or more of the features selected from the group consisting of implant thickness, number of surface facets on the inner, bone-facing surface of the articular implant, surface facet angles, and/or surface facet orientations.

46. The method of claim 42, 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 surface facets, average thickness of resected bone, average thickness of resected bone from one or more resection cuts, average thickness of resected bone to fit one or more implant surface facets, maximum thickness of resected bone, maximum thickness of resected bone from one or more resection cuts, maximum thickness of resected bone to fit one or more implant resection cuts.

47. A method of revising a total knee replacement implant, the method comprising:

(a) removing a first total-knee replacement implant implanted on the medial condyle and lateral condyles of a patient'"'"'s knee;

(b) preparing the patient'"'"'s knee to receive a primary total knee replacement implant; and

(c) implanting the primary total knee replacement implant on the patients knee such that the primary total knee replacement implant forms medial and lateral condylar articular surfaces and a trochlear articular surface.

48. The method of claim 47, wherein the first total-knee implant is an implant having patient-specific bone-cut surfaces.