Process to design and fabricate a custom-fit implant

1. A process for designing and fabricating a custom-fit implant, comprising the steps of:

a) processing medical image data of a patient's pathologically defective or anatomically deformed area having a symmetrical part to construct a computer-generated original image of a three-dimensional (3D) digital model;

b) forming a mirror image of a left or a right side of the three-dimensional (3D) digital model based on its axis of symmetry depending on which side the pathologically defective or anatomically deformed area is;

c) overlying the mirror image on the original image of the three-dimensional (3D) digital model to form a composite image with a non-overlapping area wherein the custom-fit implant will be fitted;

d) forming a computer-generated digital image of an implant by cutting off the non-overlapping area of the mirror image;

e) designing mounting points between the digital image of the implant and the pathologically defective or anatomically deformed area where the custom-fit implant is to be mounted thereon; and

f) building a positive and a negative mould based on the digital image of the implant to fabricate the custom-fit implant.

2. The process as claimed in claim 1 , further comprising the step of fabricating a physical model and an intermediate physical implant from the three-dimensional (3D) digital model to ensure that the intermediate implant closely fits the anatomically deformed area on the physical model.

3. The process as claimed in claim 2 , wherein the physical model is fabricated by a rapid prototyping process with stereolithography (STL) format.

4. The process as claimed in claim 1 , wherein the medical image data is a computer tomography (CT) or a magnetic resonance imaging (MRI) scan.

5. The process as claimed in claim 1 , wherein the three-dimensional (3D) digital model is constructed by computer-aided design (CAD) software.

6. The process as claimed in claim 1 , wherein the custom-fit implant is fabricated by stamping the moulds with a titanium mesh.

7. A process for designing and fabricating a custom-fit implant, comprising the steps of:

a) processing medical image data of a patient's pathologically defective or anatomically deformed area to construct a computer-generated three-dimensional (3D) digital model;

b) creating a patch representing the pathologically defective or anatomically deformed area of the digital model, wherein the patch is designed according to data obtained from the three-dimensional (3D) digital model or from a reference digital model of another patient;

c) shaping the patch so as to form a computer-generated digital image of an implant;

d) designing mounting points between the digital image of the implant and the pathologically defective or anatomically deformed area where the custom-fit implant is to be mounted thereon; and

e) building a positive and a negative mould based on the digital image of the implant to fabricate the custom-fit implant.

8. The process as claimed in claim 7 , further comprising the step of fabricating a physical model and an intermediate physical implant from the three-dimensional (3D) digital model to ensure that the intermediate implant closely fits the anatomically deformed area on the physical model.

9. The process as claimed in claim 8 , wherein the physical model is fabricated by a rapid prototyping process with stereolithography (STL) format.

10. The process as claimed in claim 7 , wherein the medical image data is a computer tomography (CT) or a magnetic resonance imaging (MRI) scan.

11. The process as claimed in claim 7 , wherein the three-dimensional (3D) digital model is constructed by computer-aided design (CAD) software.

12. The process as claimed in claim 7 , wherein the custom-fit implant is fabricated by stamping the moulds with a titanium mesh.

13. A process for designing and fabricating a custom-fit implant, comprising the steps of:

a) processing medical image data of a patient's pathologically defective or anatomically deformed area to construct a computer-generated three-dimensional (3D) digital model;

b) converting the digital model into a first point cloud, wherein the first point cloud comprises a first set of data points in a three-dimensional coordinate system;

c) filling up the pathologically defective or anatomically deformed area on the digital model to form a second point cloud, wherein the second point cloud comprises a second set of data points in a three-dimensional coordinate system;

d) reverting the second cloud point back into a computer-generated digital image of an implant;

e) designing mounting points between the digital image of the implant and the pathologically defective or anatomically deformed area where the custom-fit implant is to be mounted thereon; and

f) building a positive and a negative mould based on the digital image of the implant to fabricate the custom-fit implant.

14. The process as claimed in claim 13 , further comprising the step of fabricating a physical model and an intermediate physical implant from the three-dimensional (3D) digital model to ensure that the intermediate implant closely fits the anatomically deformed area on the physical model.

15. The process as claimed in claim 14 , wherein the physical model is fabricated by a rapid prototyping process with stereolithography (STL) format.

16. The process as claimed in claim 13 , wherein the medical image data is a computer tomography (CT) or a magnetic resonance imaging (MRI) scan.

17. The process as claimed in claim 13 , wherein the three-dimensional (3D) digital model is constructed by computer-aided design (CAD) software.

18. The process as claimed in claim 13 , wherein the custom-fit implant is fabricated by stamping the moulds with a titanium mesh.