Method and Apparatus for Manufacturing an Implant

• US 20100324692A1
• Filed: 08/31/2010
• Published: 12/23/2010
• 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: Catanzarite, Joshua B., Metzger, Robert, Uthgenannt, Brian A., Belcher, Nathan E.
• Granted Patent: US 8,407,067 B2
• Time in Patent Office: Days
• US Class Current: 623/20.35
• 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 adjusted preoperatively to correspond to a specific patient.

2. The orthopedic device of claim 1, wherein the parameters include three patient-specific lengths.

3. The orthopedic device of claim 2, wherein the patient-specific lengths include a medial condyle width.

4. The orthopedic device of claim 2, wherein the patient-specific lengths include a lateral condyle width.

5. The orthopedic device of claim 2, wherein the patient-specific lengths include a notch height.

6. The orthopedic device of claim 1, wherein the parameters include six patient-specific angles.

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

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

10. The orthopedic device of claim 8, wherein the surgical kit includes a drill guide and a cutting block.

11. The orthopedic device of claim 8, wherein the surgical kit includes a tracking tag.

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

9. The orthopedic device of claim 9, wherein the surgical kit includes reusable instruments.

13. An orthopedic device comprising:

a femoral implant having a non-custom internal engagement surface, the femoral implant further including three patient-specific lengths, 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.

14. The orthopedic device of claim 13, wherein the patient specific lengths include a medial condyle width, a lateral condyle width and a notch height.

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

16. The orthopedic device of claim 13, further comprising a disposable instrument kit including only disposable instruments.

17. The orthopedic device of claim 16, wherein the instrument kit includes disposable patient-specific alignment guides.

18. An orthopedic device manufacturing method comprising:

preparing a three-dimensional image of a patient'"'"'s joint;

selecting a non-custom implant closely matching the joint; and

modifying at least six angles of the implant to be patient-specific.

19. The method of claim 18, wherein the six angles include three medial angles and three lateral angles of the implant.

20. The method of claim 18, further comprising modifying at least three lengths of the implant to be patient specific.

21. The method of claim 20, wherein modifying at least three lengths of the implant to be patient specific includes modifying a medial condyle width.

22. The method of claim 20, wherein modifying at least three lengths of the implant to be patient specific includes modifying a lateral condyle width.

23. The method of claim 20, wherein modifying at least three lengths of the implant to be patient specific includes modifying a notch height.

24. The method of claim 18, further comprising preparing a surgical kit including the femoral implant and a patient-specific alignment guide.

25. The method of claim 24, further comprising including a removable tracking tag including patient-specific information in the patient-specific alignment guide.

26. The method of claim 25, further comprising tracking the patient information from manufacture to implant procedure.

27. An orthopedic device manufacturing method comprising:

preparing a three-dimensional image of a patient'"'"'s joint;

selecting a non-custom femoral implant closely matching the joint; and

modifying at least three lengths and six angles of the femoral implant to be patient-specific.

28. The method of claim 27, wherein the six angles include three medial angles and three lateral angles of the implant.

29. The method of claim 27, wherein modifying at least three lengths of the implant to be patient specific includes modifying a medial condyle width.

30. The method of claim 29, wherein modifying at least three lengths of the implant to be patient specific includes modifying a lateral condyle width.

31. The method of claim 29, wherein modifying at least three lengths of the implant to be patient specific includes modifying a notch height.

32. The method of claim 27, further comprising preparing a surgical kit including the femoral implant and a patient-specific alignment guide.

33. The method of claim 27, further comprising tracking the surgical kit during stocking of the surgical kit.

34. The method of claim 32, further comprising attaching a tracking tag with patient-specific information to the patient-specific alignment guide and tracking the information from manufacture to implant procedure.

35. The method of claim 27, further comprising preparing a surgical kit including surgeon-selected instruments.

36. The method of claim 35, wherein the surgical kit is designed to be disposable.