Automated Systems for manufacturing patient-specific orthopedic implants and instrumentation

• US 9,495,483 B2
• Filed: 07/30/2012
• Issued: 11/15/2016
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Steines, Daniel, Zhuravlev, Alexey, Slamin, John, Lang, Philipp
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US13/561,696
• Publication Number:
  US 20130197870A1
• Time in Patent Office: 1,569 Days
• Field of Search: 606/86.R, 606 87- 89, 703 1- 3, 700/117, 700/98
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1662 for particular parts of the body
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• 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 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30943 using mathematical models
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/3895 unicompartimental
• CPC Class Codes: G06F 30/00 Computer-aided design [CAD]

Abstract

Disclosed herein are devices, systems and methods for the automated design and manufacture of patient-specific/patient-matched orthopedic implants. While the embodiments described herein specifically pertain to unicompartmental resurfacing implants for the knee, the principles described are applicable to other types of knee implants (including, without limitation, other resurfacing implants and joint replacement implants) as well as implants for other joints and other patient-specific orthopedic applications.

Claims

1. A method of designing a patient-specific implant using a computer system for repairing a diseased or damaged knee joint of a patient, comprising:

obtaining image data of at least a portion of the patient'"'"'s knee joint including a femoral condyle;

creating a virtual model of at least a portion of the femoral condyle from the image data;

processing the virtual model to design a patient-specific implant based at least in part on the virtual model,

wherein the patient-specific implant includes one or more planar bone-facing portions, and

wherein at least a portion of the femoral condyle portion of the implant is adapted based on a dimension of the femoral condyle.

2. The method of claim 1, wherein processing the virtual model is automated without human intervention.

3. The method of claim 1, further comprising checking the design to determine whether the parameters of the design meet predetermined specifications.

4. The method of claim 1, wherein the virtual model is processed predominately without human intervention.

5. The method of claim 1, wherein the step of processing further comprises identifying anatomic landmarks to generate an implant design.

6. The method of claim 5, wherein identifying anatomic landmarks includes locating maxima or minima on the curvature of a surface portion of the virtual model.

7. The method of claim 1, wherein the step of process further comprises:

identifying anatomic landmarks; and

merging information regarding the anatomic landmarks with a generic model to create an implant design.

8. The method of claim 4, further comprising automatically determining an optimal viewpoint to allow a user to perform a design step.

9. The method of claim 1, further comprising combining a virtual template with the virtual model to design the patient-specific implant.

10. The method of claim 9, wherein the template may be adjusted by a user.

11. The method of claim 9, wherein the template is three dimensional.

12. The method of claim 1, wherein the one or more planar bone-facing portions are configured to accommodate one or more corresponding bone cuts of the femoral condyle.

13. The method of claim 12, wherein the position of each bone cut is automatically determined.

14. The method of claim 12, wherein the position of each bone cut is automatically determined using anatomical landmarks.

15. The method of claim 1, wherein the computer system is configured to automatically design attachment features.

16. The method of claim 15, wherein the attachment features are at least one of pegs and anchors.

17. The method of claim 1, wherein the coronal curvature of the femoral condyle portion of the patient-specific implant is constant.

18. The method of claim 1, wherein the coronal curvature of the femoral condyle portion of the patient-specific implant is derived from the patient'"'"'s image data.

19. The method of claim 12, wherein the position of at least one bone cut is automatically determined.

20. The method of claim 12, wherein the position of at least one bone cut is automatically determined using anatomical landmarks.

21. A method of designing a patient-specific implant using a computer system for repairing a diseased or damaged knee joint of a patient, comprising:

obtaining image data of the diseased or damaged knee joint including a femoral condyle;

creating a virtual model of at least a portion of the femoral condyle from the image data;

processing the virtual model to design a patient-specific implant based at least in part on the virtual model in two or more planes,

wherein the patient-specific implant includes one or more planar bone-facing portions, and

wherein at least a portion of a sagittal curvature of the femoral condyle portion of the implant is adapted based on a shape of the femoral condyle in two or more dimensions.

22. The method of claim 21, further comprising producing the patient-specific implant from the design.

23. The method of claim 21, wherein the step of processes further comprises:

identifying anatomic landmarks; and

merging information regarding the anatomic landmarks with a generic model containing to create an instrument design.

24. The method of claim 21, wherein the coronal curvature of the femoral condyle portion of the patient-specific implant is constant.

25. The method of claim 21, wherein the coronal curvature of the femoral condyle portion of the patient-specific implant is derived from the patient'"'"'s image data.

26. The method of claim 21, wherein the one or more planar bone-facing portions are configured to accommodate one or more corresponding bone cuts of the femoral condyle.

27. The method of claim 26, wherein the position of at least one bone cut is automatically determined.

28. The method of claim 26, wherein the position of at least one bone cut is automatically determined using anatomical landmarks.