Method and apparatus for manufacturing an implant

• US 8,407,067 B2
• Filed: 08/31/2010
• Issued: 03/26/2013
• Est. Priority Date: 04/17/2007
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Uthgenannt, Brian A., Metzger, Robert, Belcher, Nathan E., Catanzarite, Joshua B.
• Primary Examiner(s): NGUYEN, HIEP VAN
• Application Number:
  US12/872,663
• Publication Number:
  US 20100324692A1
• Time in Patent Office: 938 Days
• Field of Search: 700/117, 705/2
• US Class Current: 705/2
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 90/96 using barcodes
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• 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 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/30708 Means for distinguishing between left-sided and right-sided devices, Sets comprising both left-sided and right-sided prosthetic parts
• CPC Class Codes: A61F 2002/3071 Identification means; Administration of patients
• CPC Class Codes: A61F 2002/30884 Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• 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 2002/30953 using a remote computer network, e.g. Internet
• CPC Class Codes: A61F 2002/3096 trimmed or cut to a customised size
• CPC Class Codes: A61F 2002/30962 using stereolithography
• CPC Class Codes: A61F 2002/3863 : Condyles fitted on an anchored base
• CPC Class Codes: A61F 2002/4633 : for selection of endoprosthetic joints or for pre-operative planning
• CPC Class Codes: A61F 2250/0084 : Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts
• CPC Class Codes: A61F 2250/0085 : Identification means; Administration of patients
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia
• CPC Class Codes: B33Y 50/00 : Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• 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
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture

Abstract

An orthopedic device includes a femoral implant having a non-custom internal bone engagement surface. The femoral implant includes at least nine parameters adjusted preoperatively to correspond to a specific patient. The parameters can include patient-specific lengths, such as, for example, medial and lateral condyle widths and notch height, and patient-specific medial and lateral angles.

Claims

1. An orthopedic device manufacturing method comprising:

preparing pre-operatively a three-dimensional image of a patient'"'"'s joint from imaging scans of the patient using computer modeling;

selecting pre-operatively a non-custom femoral implant closely matching the joint and having a plurality of planar surfaces corresponding to planned planar resections of a femoral bone of the joint, the planned resections including an anterior cut plane, anterior chamfer plane, distal cut plane, posterior chamfer plane and posterior cut plane;

manufacturing pre-operatively a customized femoral implant by a machining operation, the machining operation modifying at least six angles of the plurality of planar surfaces of the femoral implant to be patient-specific as determined from the three-dimensional image of the patient'"'"'s joint, each patient-specific angle defined between a central plane perpendicular to a medial-lateral width of the femoral implant and lines connecting medial end points at medial edges between the planar resections and lateral points at lateral edges between the planar resections;

manufacturing a patient-specific femoral alignment guide;

coupling a removable tracking tag to the patient-specific femoral alignment guide for tracking the alignment guide from manufacture to surgery, the tracking tag including patient-specific information and configured to be removed prior to a corresponding surgical procedure; and

preparing a surgical kit including the femoral implant and a patient-specific alignment guide for the surgical procedure.

2. The method of claim 1, wherein the six angles include three medial angles and three lateral angles of the implant.

3. The method of claim 1, further comprising machining at least three lengths of the implant to be patient specific, as determined from the three-dimensional image of the patient'"'"'s joint.

4. The method of claim 3, wherein machining at least three lengths of the implant to be patient specific includes machining a medial condyle width of the femoral implant.

5. The method of claim 3, wherein machining at least three lengths of the implant to be patient specific includes machining a lateral condyle width of the femoral implant.

6. The method of claim 3, wherein machining at least three lengths of the implant to be patient specific includes machining a notch height width of the femoral implant.

7. The method of claim 1, further comprising tracking the patient information from manufacture to implant procedure.

8. The method of claim 1, wherein the surgical kit includes additional surgeon-selected instruments.

9. The method of claim 1, wherein the surgical kit is designed to be disposable.

10. The method of claim 1, wherein the tracking tag is inserted in a pocket formed in an extension of the alignment guide.

11. The method of claim 10, wherein the extension is frangible.