Deformable articulating templates

• US 10,052,206 B2
• Filed: 09/13/2016
• Issued: 08/21/2018
• Est. Priority Date: 02/25/2009
• Status: Active Grant

• Current Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Mahfouz, Mohamed Rashwan
• Primary Examiner(s): Tabatabai, Abolfazl
• Application Number:
  US15/264,434
• Publication Number:
  US 20170000614A1
• Time in Patent Office: 707 Days
• Field of Search: 382128-134, 604116
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• 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: A61B 8/4245 involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• 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 2/3601 for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices non-prosthetic internal fixation devices for the femoral head or neck A61B17/74
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/4003 Replacing only the epiphyseal or metaphyseal parts of the humerus, i.e. endoprosthesis not comprising an entire humeral shaft replacing only the epiphyseal or metaphyseal parts of the femur A61F2/3601
• 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 2002/3863 Condyles fitted on an anchored base
• CPC Class Codes: A61F 2002/3895 unicompartimental
• CPC Class Codes: G06F 17/18 for evaluating statistical data , e.g. average values, frequency distributions, probability functions, regression analysis forecasting specially adapted for a specific administrative, business or logistic context G06Q10/04
• CPC Class Codes: G06T 19/00 Manipulating 3D models or images for computer graphics
• CPC Class Codes: G06T 2210/41 Medical
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A method of generating a patient specific prosthetic implant is described, which includes: generating a three dimensional electronic representation of a human anatomical feature of a unique patient; identifying one or more representative surface curvature features on the three dimensional electronic representation; and associating the three dimensional electronic representation with a virtual implant template of the human anatomical feature selected from a database of virtual implant templates, and comparing fit of the identified representative surface curvature features of the three dimensional electronic representation with corresponding surface curvature features of the virtual implant template. The virtual implant template is selected to have the most similar corresponding surface curvature features.

Claims

1. A method of generating a patient-specific prosthetic implant, the method comprising:

generating a three-dimensional electronic representation of a human anatomical feature of a unique patient;

identifying one or more representative surface curvature features on the three-dimensional electronic representation;

selecting a virtual implant template of the human anatomical feature from a database of virtual implant templates,

virtually test-fitting the identified one or more representative surface curvature features of the three-dimensional electronic representation with one or more corresponding surface curvature features of the selected virtual implant template of the human anatomical feature;

associating the three-dimensional electronic representation with the selected virtual implant template, and

generating the patient-specific prosthetic implant based on the selected virtual implant template, the patient-specific prosthetic implant having surface curvature features that imitate those of the human anatomical feature and that are specific to the unique patient.

2. The method of claim 1, further comprising forming the database of the virtual implant templates by generating a series of the virtual implant templates, including:

obtaining a plurality of electronic three-dimensional models representing said human anatomical feature across a population of humans;

grouping the plurality of models in a database;

associating with each of the plurality of models in the database at least one characteristic selected from the group consisting of;

age, race, and gender; and

designing said plurality of virtual implant templates, where each of the plurality of virtual implant templates corresponds to at least a portion of the population of humans for which electronic three-dimensional models were generated.

3. The method of claim 2, wherein designing said plurality of virtual implant templates includes, for each of at least a portion of the plurality of virtual implant templates, incorporating a size and/or a contour that approximates a mean size and/or a mean contour, respectively, of at least the corresponding portion of the population of humans.

4. The method of claim 2, further comprising virtually test fitting at least one of the plurality of virtual implant templates to at least one of the plurality of electronic three-dimensional models.

5. The method of claim 2, further comprising measuring, for at least two of the plurality of electronic three-dimensional models, at least one topography selected from the group consisting of:

a medial condyle camming surface topography, a lateral condyle surface topography, and a trochlear groove topography.

6. The method of claim 1, wherein the human anatomical feature is a femur, and identifying one or more representative surface curvature features on the three-dimensional electronic representation further comprises:

generating a shell of the femur from bone mapping,

generating profiles/points from the shell by sweeping around the bone every ten degrees,

generating a curve from the profiles/points, and

matching at least four radii to the curve.

7. The method of claim 1, wherein the one or more representative surface curvature features include one or more radii of curvature on an outer surface of the human anatomical feature.

8. The method of claim 1, wherein generating the three dimensional electronic representation of the human anatomical feature of said unique patient further comprises:

imaging at least a portion of the human anatomical feature, and creating a plurality of 2D image slices of the human anatomical feature taken orthogonal to an axis extending through the at least a portion of the human anatomical feature, where each of the plurality of 2D image slices includes a bone segment comprising an enclosed boundary corresponding to an exterior of the patient'"'"'s bone; and

constructing a 3D image bone shell of the at least a portion of the human anatomical feature for which the plurality of 2D image slices were taken.

9. The method of claim 8, wherein constructing the 3D image bone shell includes using software to recognize the enclosed boundary of each bone segment by using a template 3D image bone shell that is not patient-specific, and the 3D image bone shell depicts a current state of the patient'"'"'s human anatomical feature.

10. The method of claim 8, wherein the imaging comprises magnetic resonance imaging and/or computed tomography.

11. The method of claim 8, wherein the patient'"'"'s bone comprises at least one bone selected from the group consisting of:

a femur, a tibia, and a humerus.

12. The method of claim 8, further comprising generating, by a software component, a 3D image surgical jig configured to mate with the 3D image bone shell, where the 3D image surgical jig includes topographical features customized to the exterior features of the 3D image bone shell.

13. The method of claim 12, wherein the software component is operative to output an instruction file for fabricating a surgical jig having tangible topographical features of the 3D image surgical jig.

14. The method of claim 8, further comprising constructing a 3D image cartilage shell representing at least a portion of a patient'"'"'s cartilage using the plurality of 2D image slices of the at least a portion of the human anatomical feature, where constructing the 3D image cartilage shell includes using software to recognize an outline of cartilage appearing in a 2D image slice.

15. The method of claim 1, further comprising sweeping the selected virtual implant template, after the step of associating, to create a smooth articulating surface template.

16. The method of claim 15, further comprising generating a virtual template cutting guide representing cuts to be made to a human bone to adapt the human bone to accept a patient-specific prosthetic implant corresponding to the selected virtual implant template and/or the smooth articulating surface template.

17. The method of claim 16, further comprising merging the virtual template cutting guide and the smooth articulating surface template to generate a patient-specific virtual model, wherein the patient-specific virtual model is used to generate the patient-specific prosthetic implant.

18. The method of claim 16, wherein generating a virtual template cutting guide includes automatically measuring an anterior-to-posterior height and a medial-to-lateral width of the three-dimensional electronic representation of the human anatomical feature.

19. The method of claim 16, wherein generating a virtual template cutting guide includes automatically measuring an anterior-to-posterior height and a medial-to-lateral width of the three dimensional electronic representation of the human anatomical feature.

20. The method of claim 19, further comprising merging the virtual template cutting guide and the smooth articulating surface template to generate a patient-specific virtual model used to generate the patient specific prosthetic implant.

21. The method of claim 19, wherein generating a virtual template cutting guide includes automatically measuring an anterior-to-posterior height and a medial-to-lateral width of the three dimensional electronic representation of the human anatomical feature.

22. The method of claim 1, wherein the human anatomical feature is a bone, the identified one or more representative surface curvature features include a camming surface of bone, and the method further comprises identifying a plurality of radii of curvature on the camming surface of the bone.

23. The method of claim 22, wherein the bone is a femoral component of a knee joint, the camming surface including an anterior-to-distal-to-posterior surface of the medial or lateral condyle, and the method further comprises identifying at least three radii of curvature on the camming surface of the femoral component that are obliquely angled to a medial-lateral direction of the femoral component.

24. The method of claim 22, wherein the bone is a femoral component of a knee joint having a trochlear groove surface that includes an anterior-to-distal surface incorporating at least two radii of curvature obtusely angled to a medial-lateral direction of the femoral component.

25. The method of claim 22, wherein the bone is a femoral component of a knee joint having a trochlear groove surface that includes a medial-to-lateral surface incorporating at least two radii of curvature parallel to a medial-lateral direction of the femoral component.

26. The method of claim 1, further comprising generating the patient specific prosthetic implant using the selected one of the virtual implant templates.

27. A method of generating a patient-specific prosthetic implant, the method comprising:

generating a three-dimensional electronic representation of a human anatomical feature of a unique patient;

identifying one or more representative surface curvature features on the three-dimensional electronic representation;

associating the three-dimensional electronic representation with a virtual implant template of the human anatomical feature, including selecting the virtual implant template from a database of virtual implant templates, and comparing fit of the identified one or more representative surface curvature features of the three-dimensional electronic representation with corresponding surface curvature features of the selected virtual implant template, the selected virtual implant template selected to have the most similar corresponding surface curvature features; and

generating the patient-specific prosthetic implant having surface curvature features that imitate those of the human anatomical feature and that are specific to the unique patient.