Process to design and fabricate a custom-fit implant

• US 8,706,285 B2
• Filed: 12/11/2008
• Issued: 04/22/2014
• Est. Priority Date: 12/11/2007
• Status: Expired due to Fees

• Current Assignee: University of Malaya (Government of Malaysia)
• Original Assignee: University of Malaya (Government of Malaysia)
• Inventors: Narainasamy, Selvanathan, Sankupellay, Mangalam, Seperamaniam, Thyaganathan, Nagappan, Somasundaram, Selvanathan, Senthil K, Devadass, Victor S, Selvanathan, Nanchappan
• Primary Examiner(s): TRINH, MINH N
• Application Number:
  US12/747,075
• Publication Number:
  US 20110016690A1
• Time in Patent Office: 1,958 Days
• Field of Search: 298/961, 700/95, 700/97, 700/98, 700118-120, 623/16.11, 623/17.19, 623/23.51, 623/901
• US Class Current: 700/118
• 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 2240/002 Designing or making customized prostheses
• 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: 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 2219/49008 Making 3-D object with model in computer memory
• CPC Class Codes: G05B 2219/49013 Deposit layers, cured by scanning laser, stereo lithography SLA, prototyping
• CPC Class Codes: G06T 19/20 Editing of 3D images, e.g. changing shapes or colours, aligning objects or positioning parts
• CPC Class Codes: G06T 2207/30052 Implant; Prosthesis
• CPC Class Codes: G06T 2210/41 Medical
• CPC Class Codes: G06T 2219/2016 Rotation, translation, scaling
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A process for designing and fabricating a custom-fit implant, comprising: a) processing medical image data of a patient'"'"'s pathologically defective or anatomically deformed area having a symmetrical part to construct a three-dimensional (3D) digital model; b) forming a mirror image of the left or 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 to form a composite image with a non-overlapping area wherein the implant will be fitted; d) generating a digital implant by cutting off the non-overlapping area of the mirror image; e) designing mounting points between the digital implant and the pathologically defective or anatomically deformed area where the implant is mounted thereon; f) building a positive and a negative mold based on the digital implant to fabricate a custom-fit implant.

Claims

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.