Method for design and production of a custom-fit prosthesis

• US 20050133955A1
• Filed: 09/30/2004
• Published: 06/23/2005
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: 3D Systems, Inc. (3D Systems Corporation)
• Original Assignee: Medical Modeling, LLC
• Inventors: Christensen, Andrew M.
• Granted Patent: US 8,086,336 B2
• Time in Patent Office: Days
• US Class Current: 264/219
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61C 9/0046 Data acquisition means or methods
• CPC Class Codes: A61F 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• 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 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2310/00353 Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: G05B 19/4097 characterised by using design data to control NC machines, e.g. CAD/CAM G05B19/4093 takes precedence
• CPC Class Codes: G05B 2219/45168 Bone prosthesis
• CPC Class Codes: G05B 2219/45204 Die, mould making
• CPC Class Codes: G05B 2219/49013 Deposit layers, cured by scanning laser, stereo lithography SLA, prototyping
• 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 50/50 for simulation or modelling of medical disorders

Abstract

Systems and methods are provided for designing and producing a custom-fit prosthesis. According to one embodiment, a mold is produced from which a custom-fit implant may be directly or indirectly manufactured. Medical image data representing surrounding portions of a patient'"'"'s anatomy to be repaired by surgical implantation of the custom-fit implant are received. Then, three-dimensional surface reconstruction is performed based on the medical image data. Next, the custom-fit implant is designed based on the three-dimensional surface reconstruction and a positive or negative representation of a two-part mold is created with a void in the shape of the custom-fit implant by subtracting a representation of the custom-fit implant from a representation of a mold. Finally, the two-part mold is output from which the custom-fit implant may be directly manufactured; or an implant is directly output. Alternatively, an intermediate mold is created from which a two-part mold may be directly manufactured.

Claims

1. A method, the method comprising:

receiving medical image data representing surrounding portions of a patient'"'"'s anatomy to be repaired by surgical implantation of the custom-fit implant;

performing three-dimensional surface reconstruction based on the medical image data;

designing a custom-fit implant based on the three-dimensional surface reconstruction;

modeling a two-part mold with a void in the shape of the custom-fit implant by subtracting a representation of the custom-fit implant from a representation of a simple block; and

outputting the two-part mold from which the custom-fit implant may be manufactured.

2. The method of claim 1, the method further comprising:

generating a lower intermediate mold with a void in the shape of a bottom portion of the two-part mold by subtracting a representation of the bottom portion of the two-part mold from a lower intermediate block model;

generating an upper intermediate mold with a void in the shape of a top portion of the two-part mold by subtracting a representation of the top portion of the two-part mold from an upper intermediate block model; and

pouring a mold material into the upper intermediate mold and the lower intermediate mold to form a new top portion of a final two-part mold and a new bottom portion of a final two-part mold.

3. The method of claim 2, wherein said outputting the two-part mold comprises removing the new top portion of the final two-part mold from the upper intermediate mold and removing the new bottom portion of the final two-part mold from the lower intermediate mold.

4. The method of claim 1, wherein said outputting the two-part mold comprises creating the two-part mold with a Solid Freeform Fabrication method.

5. The method of claim 1, wherein said outputting the two-part mold comprises creating a data file containing three-dimensional coordinates, the three-dimensional coordinates defining the shape of the two-part mold.

6. The method of claim 5, wherein said outputting the two-part mold further comprises sending the data file to an implant manufacturer.

7. The method of claim 1, wherein the medical image data comprises computed tomography scan data.

8. The method of claim 1, wherein said performing three-dimensional surface reconstruction comprises outputting a three-dimensional representation of the patient'"'"'s anatomy in a stereolithography file format.

9. The method of claim 1, the method further comprising forming within the two-part mold at least one hole to allow insertion of mold material into the two-part mold.

10. A method, the method comprising:

receiving medical image data representing surrounding portions of a patient'"'"'s anatomy;

performing three-dimensional surface reconstruction based on the medical image data;

designing a custom-fit implant based on the three-dimensional surface reconstruction;

creating a representation of a two-part mold with a void in the shape of the custom-fit implant by subtracting a representation of the custom-fit implant from a simple block model;

creating a representation of a lower intermediate mold with a void in the shape of a bottom half of the two-part mold by subtracting a representation of the bottom half of the two-part mold from a lower intermediate block model;

creating a representation of an upper intermediate mold with a void in the shape of a top half of the two-part mold by subtracting a representation of the top half of the two-part mold from an upper intermediate block model; and

outputting the upper and lower intermediate molds from which the custom-fit implant mold may be manufactured.

11. The method of claim 10, wherein outputting the upper and lower intermediate molds comprises creating the upper and lower intermediate molds with a Solid Freeform Fabrication method.

12. A method, the method comprising:

receiving medical image data representing portions of a patient'"'"'s anatomy;

performing three-dimensional surface reconstruction based on the medical image data;

designing a custom-fit implant based on the three-dimensional surface reconstruction; and

outputting the custom-fit implant using a Solid Freeform Fabrication method.

13. The method of claim 12, wherein the custom-fit implant is a mock custom-fit implant.

14. The method of claim 12, wherein said outputting the custom-fit implant using a Solid Freeform Fabrication method comprises outputting a data file instructing how to make the custom-fit implant in three dimensions using Solid Freeform Fabrication.

15. The method of claim 12, wherein said outputting the custom-fit implant using a Solid Freeform Fabrication method comprises outputting a tangible three-dimensional instance of the custom-fit implant.

16. A system for producing a two-part mold from which a custom-fit implant may be directly manufactured, the system comprising:

a memory device having stored therein medical image data representing portions of a patient'"'"'s anatomy; and

a computer system configured to read the medical image data from the memory device, create a three-dimensional surface reconstruction of the patient'"'"'s anatomy based on the medical image data, generate a model of the custom-fit implant based on the three-dimensional surface reconstruction, produce a model of the two-part mold based on the model of the custom-fit implant, store the model of the two-part mold, and output the model to a Solid Freeform Fabrication device.

17. The system of claim 16, further comprising a Solid Freeform Fabrication device configured to create the two-part mold based on the model of the two-part mold.

18. A system for producing an intermediate mold from which a custom-fit implant mold may be directly manufactured, the system comprising:

a memory device having stored therein medical image data representing portions of a patient'"'"'s anatomy; and

a computer system configured to read the medical image data from the memory device, create a three-dimensional surface reconstruction of the patient'"'"'s anatomy based on the medical image data, generate a model of the custom-fit implant based on the three-dimensional surface reconstruction, produce a model of the two-part mold based on the model of the custom-fit implant, produce a model of an intermediate mold based on the model of the two-part mold, store the model of the intermediate mold, and output the model of the intermediate mold to a Solid Freeform Fabrication device.

19. The system of claim 18 further comprising a Solid Freeform Fabrication device configured to create the intermediate mold based on the model of the intermediate mold.

20. A system for producing a custom-fit implant, the system comprising:

a memory device having stored therein medical image data representing portions of a patient'"'"'s anatomy; and

a computer system configured to read the medical image data from the memory device, create a three-dimensional surface reconstruction of the patient'"'"'s anatomy based on the medical image data and generate a model of the custom-fit implant based on the three-dimensional surface reconstruction.

21. The system of claim 20 further comprising a Solid Freeform Fabrication device configured to output the custom-fit implant based on the model of the custom-fit implant.