Deformable articulating templates

• US 10,213,311 B2
• Filed: 09/13/2016
• Issued: 02/26/2019
• 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): Johns, Andrew W
• Application Number:
  US15/264,488
• Publication Number:
  US 20170000615A1
• Time in Patent Office: 896 Days
• 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: G06F 18/00 Pattern recognition
• 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 system for generating a patient-specific implant is described which includes a means for generating a three dimensional electronic representation of a human anatomical feature including size and curvature features matching the human anatomical feature, a means for selecting a prosthetic implant template from a database of prosthetic implant templates, the database being formed of the prosthetic implant templates by a means for generating a series of the virtual implant templates, a means for designing the patient-specific implant to imitate the size and curvature features based at least in part on the selected prosthetic implant template, and a means for virtually testing fit of the patient-specific implant using the three dimensional electronic representation of the human anatomical feature.

Claims

1. A system for generating a patient-specific implant, the system comprising:

a means for generating a three-dimensional electronic representation of a human anatomical feature including size and curvature features matching the human anatomical feature;

a means for selecting a virtual implant template from a database of virtual implant templates generated by a means for generating a series of the virtual implant templates;

a means for designing a patient-specific prosthetic implant to imitate the size and curvature features based at least in part on the selected virtual implant template; and

a means for virtually testing fit of the patient-specific prosthetic implant using the three-dimensional electronic representation of the human anatomical feature.

2. The system of claim 1, further comprising the means for generating the series of the virtual implant templates, where the means for generating the series of the virtual implant templates further comprises:

a means for generating a plurality of electronic three-dimensional models representing said human anatomical feature across a population of humans, the plurality of electronic three-dimensional models in the database being grouped together;

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

age, race, and gender; and

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

3. The system of claim 2, wherein the means for designing includes a means for incorporating a size and/or a contour that approximates a mean size and/or a mean contour, respectively, of at least a portion of the population of humans.

4. The system of claim 2, further comprising a means for 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 system of claim 2, further comprising a means for 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 system of claim 2, further comprising a means for sweeping the selected virtual implant template, after associating each of the plurality of models in the database with the at least one characteristic, to create a smooth articulating surface template.

7. The system of claim 6, further comprising a means for generating a virtual template cutting guide representing cuts to be made to a human bone to adapt the human bone to accept the patient-specific prosthetic implant.

8. The system of claim 7, further comprising a means for 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.

9. The system of claim 7, wherein the means for generating the virtual template cutting guide automatically measures an anterior-to-posterior height and a medial-to-lateral width of the three-dimensional electronic representation of the human anatomical feature.

10. The system of claim 9, further comprising a means for merging the virtual template cutting guide and the smooth articulating surface template to generate a patient-specific virtual model for use by the means for designing to generate the patient-specific prosthetic implant.

11. The system of claim 1, wherein the human anatomical feature is a femur, and the system further comprises:

a means for generating a shell of the femur from bone mapping,

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

a means for generating a curve from the profiles/points, and

a means for matching at least four radii to the curve.

12. The system of claim 1, wherein the size and curvature features include one or more radii of curvature on an outer surface of the human anatomical feature.

13. The system of claim 1, wherein the means for generating the three-dimensional electronic representation of the human anatomical feature further comprises:

a means for imaging at least a portion of the human anatomical feature, and

a means for creating a plurality of 2D image slices of the human anatomical feature taken orthogonal to an axis extending through 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

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

14. The system of claim 13, wherein the means for virtually constructing a 3D image bone shell includes software configured to recognize the enclosed boundary of each bone segment by using a template 3D image bone shell that is not patient-specific, wherein the 3D image bone shell depicts a current state of the patient'"'"'s human anatomical feature.

15. The system of claim 13, wherein the means for imaging comprises a magnetic resonance imaging device and/or a computed tomography device.

16. The system of claim 13, wherein the human anatomical feature comprises at least one bone selected from the group consisting of:

a femur, a tibia, and a humerus.

17. The system of claim 13, further comprising means for generating a 3D image surgical jig configured to mate with the 3D image bone shell, wherein the 3D image surgical jig includes topographical features customized to the exterior features of the 3D image bone shell, and the means for generating a 3D image surgical jig includes a software component.

18. The system of claim 17, wherein the software component is configured to output an instruction file for fabricating a surgical jig having tangible topographical features of the 3D image surgical jig.

19. The system of claim 13, further comprising a means for virtually 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 human anatomical feature, wherein the means for virtually constructing the 3D image cartilage shell includes software configured to recognize an outline of cartilage appearing in a 2D image slice.

20. The system of claim 1, wherein the human anatomical feature is a bone and the curvature features include a camming surface of bone, the system further comprising a means for identifying a plurality of radii of curvature on the camming surface of the bone.

21. The system of claim 20, wherein the bone is a femoral component of a knee joint, the camming surface includes an anterior-to-distal-to-posterior surface of the medial or lateral condyle, and the means for identifying is configured to identify 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.

22. The system of claim 20, 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.

23. The system of claim 20, 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.

24. The system of claim 1, further comprising a means for physically forming the patient-specific prosthetic implant using the selected one of the virtual implant templates.