Method and apparatus for manufacturing an implant

• US 10,159,498 B2
• Filed: 06/15/2015
• Issued: 12/25/2018
• 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.
• Primary Examiner(s): Nguyen, Hiep V
• Application Number:
  US14/739,160
• Publication Number:
  US 20150351778A1
• Time in Patent Office: 1,289 Days
• Field of Search: 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 comprising:

a femoral implant having a central plane and an internal bone engagement surface that includes an anterior planar surface, an anterior chamfer surface, a distal planar surface, a posterior chamfer surface, and a posterior planar surface, wherein the internal bone engagement surface is standardized so as to be independent of an anatomy of a specific patient'"'"'s joint and is one of a series of predetermined size increments for the femoral implant, each of the series of predetermined size increments varying by a set distance from others, the femoral implant further including a medial condyle width, a lateral condyle width, a notch height located between the medial and lateral condyles and three medial angles and three lateral angles, each of the medial condyle width, the lateral condyle width, the notch height, the three medial angles and the three lateral angles are configured to be patient-specific based on an image of the specific patient'"'"'s joint, wherein the medial condyle width, the lateral condyle width, the notch height, the three medial angles and the three lateral angles are designed using computer modeling to have a shape dependent upon an anatomy of the specific patient, and wherein one of the three medial angles is 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,

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, or

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.

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

3. The orthopedic device of claim 2, wherein the surgical kit includes reusable instruments.

4. The orthopedic device of claim 2, wherein the surgical kit includes a drill guide and a cutting block.

5. The orthopedic device of claim 2, wherein the surgical kit includes a tracking tag.

6. The orthopedic device of claim 2, wherein the patient-specific alignment guide includes a removable tracking tag.

7. An orthopedic device comprising:

a femoral implant having a central plane and an internal engagement surface that includes an anterior planar surface, an anterior chamfer surface, a distal planar surface, a posterior chamfer surface, and a posterior planar surface, wherein the internal bone engagement surface is standardized so as to be independent of an anatomy of a specific patient'"'"'s joint and is one of a series of predetermined size increments for the femoral implant, each of the series of predetermined size increments varying by a set distance from others, 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 each of the medial condyle width, the lateral condyle width, the notch height, the three medial angles and the three lateral angles are configured to be patient-specific based on an image of the specific patient'"'"'s joint, wherein the medial condyle width, the lateral condyle width, the notch height, the three medial angles and the three lateral angles are designed using computer modeling to have a shape dependent upon an anatomy of the specific patient, and wherein one of the three lateral angles is 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,

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, or

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.

8. The orthopedic device of claim 7, further comprising a surgical kit including the femoral implant and a patient-specific alignment guide including a removable tracking tag.

9. The orthopedic device of claim 7, further comprising a disposable instrument kit including only disposable instruments.

10. The orthopedic device of claim 9, wherein the instrument kit includes disposable patient-specific alignment guides.

11. An orthopedic device, comprising:

a semi-custom femoral implant having a central plane, and including a bone engagement surface that is standardized so as to be independent of an anatomy of a specific patient'"'"'s joint and is one of a series of predetermined size increments for the femoral implant, each of the series of predetermined size increments varying by a set distance from others 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 configured to be patient-specific based on an image of the specific patient'"'"'s joint and designed using computer modeling to have a shape dependent upon an anatomy of the specific patient 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.

12. The orthopedic device of claim 11, further comprising a surgical kit including the femoral implant and a patient-specific alignment guide.

13. The orthopedic device of claim 12, wherein the surgical kit includes reusable instruments.

14. The orthopedic device of claim 12, wherein the surgical kit includes a drill guide and a cutting block.

15. The orthopedic device of claim 12, wherein the surgical kit includes a tracking tag.

16. The orthopedic device of claim 12, wherein the patient-specific alignment guide includes a removable tracking tag.