Method And Apparatus For Manufacturing An Implant

• US 20150351778A1
• Filed: 06/15/2015
• Published: 12/10/2015
• Est. Priority Date: 04/16/2008
• 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.
• Granted Patent: US 10,159,498 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 comprising:

a femoral implant having a non-custom internal bone engagement surface, the femoral implant further including at least nine parameters including a medial condyle width, a lateral condyle width, and a notch height located between the medial and lateral condyles that are each adjusted preoperatively to correspond to a specific patient.

2. The orthopedic device of claim 1, wherein the femoral implant includes six patient-specific angles.

3. The orthopedic device of claim 1, wherein the six patient-specific angles include three medial angles and three lateral angles.

4. The orthopedic device of claim 1, further comprising a surgical kit including the femoral implant and a patient-specific alignment guide.

5. The orthopedic device of claim 4, wherein the surgical kit includes reusable instruments.

6. The orthopedic device of claim 4, wherein the surgical kit includes a drill guide and a cutting block.

7. The orthopedic device of claim 4, wherein the surgical kit includes a tracking tag.

8. The orthopedic device of claim 4, wherein the patient-specific alignment guide includes a removable tracking tag.

9. An orthopedic device comprising:

a femoral implant having a non-custom internal engagement surface, the femoral implant further including three patient-specific lengths including a medial condyle width, a lateral condyle width, and a notch height located between the medial and lateral condyles, three patient specific medial angles and three patient-specific lateral angles, wherein the lengths and medial and lateral angles are selected preoperatively based on a three-dimensional image of an anatomy of a patient to match the anatomy of the patient.

10. The orthopedic device of claim 9, further comprising a surgical kit including the femoral implant and a patient-specific alignment guide including a removable tracking tag.

11. The orthopedic device of claim 9, further comprising a disposable instrument kit including only disposable instruments.

12. The orthopedic device of claim 11, wherein the instrument kit includes disposable patient-specific alignment guides.

13. An orthopedic device, comprising:

a semi-custom femoral implant having a central plane, and including a non-patient-specific bone engagement surface and an articulating surface,

wherein the non-patient-specific bone engagement surface includes an anterior planar surface, an anterior chamfer surface, a distal planar surface, a posterior chamfer surface, and a posterior planar surface;

the articulating surface includes a medial condyle and a lateral condyle separated by a notch, the notch being located along the central plane; and

the articulating surface includes plurality of patient-specific features including;

a medial condyle width;

a lateral condyle width;

a notch height defined by a distance between the posterior planar surface and the most anterior point of the notch;

a first medial angle defined by an angle between the central plane and a line connecting medial-most points on an anterior edge of the distal planar surface and on a posterior edge of the distal planar surface;

a second medial angle defined by an angle between the central plane and a line connecting medial-most points on a distal edge of the anterior chamfer surface and the anterior edge of the distal planar surface;

a third medial angle defined by an angle between the central plane and a line connecting medial-most points on the distal edge of the anterior chamfer surface and a proximal edge of the anterior planar surface;

a first lateral angle defined by an angle between the central plane and a line connecting lateral-most points on the anterior edge of the distal planar surface and on the posterior edge of the distal planar surface;

a second lateral angle defined by an angle between the central plane and a line connecting lateral-most points on the distal edge of the anterior chamfer surface and the anterior edge of the distal planar surface;

a third lateral angle defined by an angle between the central plane and a line connecting lateral-most points on the distal edge of the anterior chamfer surface and the proximal edge of the anterior planar surface.

14. The orthopedic device of claim 13, further comprising a surgical kit including the femoral implant and a patient-specific alignment guide.

15. The orthopedic device of claim 14, wherein the surgical kit includes reusable instruments.

16. The orthopedic device of claim 14, wherein the surgical kit includes a drill guide and a cutting block.

17. The orthopedic device of claim 14, wherein the surgical kit includes a tracking tag.

18. The orthopedic device of claim 14, wherein the patient-specific alignment guide includes a removable tracking tag.