Method and apparatus for manufacturing an implant

• US 8,473,305 B2
• Filed: 06/12/2009
• Issued: 06/25/2013
• 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: Belcher, Nathan E., Metzger, Robert, Catanzarite, Joshua B.
• Primary Examiner(s): NGUYEN, HIEP VAN
• Application Number:
  US12/483,807
• Publication Number:
  US 20090254367A1
• Time in Patent Office: 1,474 Days
• Field of Search: 705/2
• US Class Current: 705/2
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• 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 2/3859 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 2002/30948 using computerized tomography, i.e. CT scans
• 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 2002/4633 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: G06Q 30/0601 Electronic shopping [e-shopping]
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 30/20 : for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders

Abstract

An orthopedic implant manufacturing method. The method includes preparing a pre-operative surgical plan for a specific patient, the surgical plan including a three-dimensional image of a patient'"'"'s joint indicating at least one resection plane, communicating the surgical plan to a surgeon of the patient, and receiving approval of the surgical plan and the resection plane by the surgeon. The method also includes providing automated osteophyte/protrusion removal control for surgeon manipulation, receiving a modified three-dimensional image of a patient'"'"'s joint indicating an osteophyte/protrusion removal and a recommendation for a corresponding selected orthopedic implant from the surgeon, and requesting manufacture of the selected orthopedic implant.

Claims

1. A method for manufacturing an implant for a specific patient, comprising:

accessing a data file including a pre-operative plan of the patient with a handheld device, the pre-operative plan including a three-dimensional image of the patient'"'"'s un-resected distal femoral bone reconstructed from two-dimensional medical imaging scans of the patient'"'"'s knee joint and including a planned resection plane corresponding to a planned femoral knee implant location for the femoral bone of the patient;

viewing on the display of the handheld device the three-dimensional image of the patient'"'"'s distal femoral bone with the planned resection plane;

modifying the image of the femoral bone on the display of the handheld device by removing from the image of the distal femoral bone a portion of a bone protrusion associated with an edge of the planned resection plane by providing inputs to the handheld device;

moving on the image of the distal femoral bone a visual slider associated with the edge of the planned resection plane to control removal of the image of the protrusion by providing inputs to the handheld device;

selecting on the display a femoral knee implant corresponding to the modified image of the femoral bone;

saving an edited pre-operative plan associated with the provided inputs to the handheld device and the modified image of the femoral bone;

transmitting the edited pre-operative plan to an implant manufacturer; and

requesting manufacture of the femoral knee implant according to the edited preoperative plan and the modified image of the distal femoral bone.

2. The method of claim 1, further comprising:

generating the pre-operative plan at a service provider; and

transmitting the edited pre-operative plan to the service provider.

3. The method of claim 1, further comprising:

receiving the femoral knee implant; and

forwarding the femoral knee implant for implantation.

4. The method of claim 3, wherein generating the pre-operative plan includes at least one of determining a substantially anatomical orientation of the patient and selecting resections and implants to achieve the determined substantially anatomical orientation after performing the operative procedure based on the pre-operative plan.

5. The method of claim 1, further comprising:

acquiring image data of the patient;

determining a healthy anatomical orientation of the patient; and

selecting the resection plane and associated implants to achieve the determined substantially anatomical orientation after performing the operative procedure based on the pre-operative plan.

6. The method of claim 1, wherein accessing a data file includes copying the data file to the handheld device and executing a program to process the data file for viewing with the handheld device.

7. The method of claim 6 wherein editing the pre-operative plan includes:

executing a program with the handheld device based on the provided inputs.

8. The method of claim 1, wherein accessing a data file includes:

communicating with a main processor to transmit information regarding an image to the handheld device; and

viewing the image on the handheld device.

9. The method of claim 8, wherein editing the pre-operative plan includes:

transmitting the provided inputs with the handheld device to the main processor; and

executing a program only with the main processor to change the pre-operative plan to the edited pre-operative plan;

wherein saving an edited pre-operative plan includes saving the edited pre-operative plan at a location separate from the handheld device.

10. The method of claim 1, wherein accessing the pre-operative plan includes:

downloading the pre-operative plan to a handheld device.

11. The method of claim 10, wherein downloading the pre-operative file includes transmitting the data file wirelessly via a cellular or mobile phone data network.

12. The method of claim 10, wherein downloading includes transmitting wirelessly to the handheld device via a local access wireless transmission data protocol.

13. The method of claim 10, wherein downloading includes transmitting to the handheld device via a cable connection or physical connection to a main processor and main storage system.

14. The method of claim 10, wherein viewing the pre-operative plan includes viewing a cropped portion of an image of the pre-operative plan.

15. The method of claim 14, further comprising:

zooming into the cropped portion of the image of the pre-operative plan to view in detail a portion of the cropped portion of the pre-operative plan.

16. The method of claim 15, further comprising editing only the cropped portion of the image of the pre-operative plan.

17. The method of claim 16, wherein saving the edited pre-operative plan includes saving the edited pre-operative plan in a storage system of the handheld device.

18. The method of claim 10, further comprising executing a program on the handheld device to edit the pre-operative plan on the handheld device.

19. The method of claim 1, wherein accessing the pre-operative plan includes wirelessly accessing the pre-operative plan with a selected wireless communication system and protocol.

20. The method of claim 19, wherein the selected wireless data system and protocol includes a cellular or mobile wireless data system.

21. The method of claim 19, further comprising:

transmitting to the main processor via the wireless transmission system, the provided inputs from the handheld device;

wherein editing the pre-operative plan includes executing a program with the main processor to edit the pre-operative plan to generate the edited pre-operative plan.

22. The method of claim 21, wherein saving the edited pre-operative plan includes saving the edited pre-operative plan at the main storage system associated with the main processor separate from the handheld device.

23. The method of claim 21, further comprising:

changing at least one parameter of the pre-operative plan data file based on the provided inputs.

24. The method of claim 1, further comprising:

displaying a plurality of depth contours associated with the bone protrusion on the display;

selecting one of the depth contours by the surgeon using the bone removal tool on the display; and

displaying the image of the bone with the bone protrusion removed to the selected depth contour on the display.

25. The method of claim 24, wherein the protrusion is an osteophyte of the bone.