Method of manufacture of custom cranial remodeling devices by additive manufacturing

1. A method for fabricating a custom cranial remodeling device for correction of cranial deformities in a subject's head, said method comprising:

generating a three-dimensional head data file for a shape of said head;

identifying predetermined reference points on said head shape represented by data in said three-dimensional head data file;

processing said predetermined reference points to automatically calculate one or more contour lines on said head shape represented by said three-dimensional head data file, said contour lines defining peripheral edges of said custom cranial remodeling device;

automatically generating a modified head shape data file for said head;

juxtaposing said modified head shape represented by said modified head shape data file with said head represented by said three-dimensional head data file having said one or more contour lines thereon;

utilizing said modified head shape data file to generate a device shape for a said custom cranial remodeling device, said device shape having an interior surface to contact said head and an outer surface;

projecting lines outward from said one or more contour lines; and

utilizing said projected lines to establish corresponding inner and outer surface peripheral edges on said device shape for said custom cranial remodeling device to provide customized inner and outer surfaces for said custom cranial remodeling device.

2. The method of claim 1 , comprising:

generating a three-dimensional device data file comprising said device shape of said custom cranial modeling device comprising said inner and outer surface peripheral edges.

3. The method of claim 2 , comprising:

providing said three-dimensional device data file to an additive manufacturing device.

4. The method of claim 3 , comprising:

utilizing said additive manufacturing device to manufacture said custom cranial remodeling device from said three-dimensional device data file.

5. The method of claim 3 , comprising:

utilizing a three-dimensional printer as said additive manufacturing device.

6. The method of claim 1 , comprising:

modifying said three-dimensional data file by automatically orienting said three-dimensional head data file to a predetermined plane by first automatically identifying two predetermined physical points on said head shape as represented by data in said three-dimensional head data file and utilizing said two predetermined points to form a horizontal plane to which said head shape is rotated to produce a standardized oriented head data file.

7. The method of claim 1 , comprising:

determining predetermined reference points on said head shape data in said three-dimensional head data file; and

automatically utilizing said predetermined reference points to calculate said contour lines.

8. The method of claim 7 , comprising:

generating a three-dimensional device data file comprising said custom cranial remodeling device shape with said corresponding inner and outer surface peripheral edges.

9. The method of claim 8 , comprising:

providing said three-dimensional device data file to an additive manufacturing device.

10. The method of claim 9 , comprising:

utilizing said additive manufacturing device to manufacture said custom cranial remodeling device from said three-dimensional device data file.

11. The method of claim 9 , comprising:

utilizing a three-dimensional printer as said additive manufacturing device.

12. The method of claim 1 , comprising:

capturing digital data for said three-dimensional head data file from said head.

13. The method of claim 12 , comprising:

generating said three-dimensional head data file by capturing three-dimensional digital head data with one of digital image capture apparatus and scanning apparatus.

14. The method of claim 13 , comprising:

generating a three-dimensional device data file comprising said desired custom cranial remodeling device shape with said corresponding inner and outer surface peripheral edges.

15. The method of claim 14 , comprising:

providing said three-dimensional device data file to an additive manufacturing device; and

utilizing said additive manufacturing device to manufacture said custom cranial remodeling device from said three-dimensional device data file.

16. The method of claim 15 , comprising:

utilizing a three-dimensional printer as said additive manufacturing device.

17. A method for creating a device data file for use by a three-dimensional printer to print a custom cranial remodeling device for correction of a deformed head shape in an infant, said custom cranial remodeling device having a custom inner surface and a custom outer surface said method comprising:

generating a three-dimensional data file of said deformed head shape;

processing said three-dimensional data file to generate a three-dimensional modified data file for a modified head shape for said infant;

utilizing said three-dimensional modified data file to generate a device data file for a shape for said custom cranial remodeling device;

automatically determining predetermined reference points on said three-dimensional data file of said captured deformed head shape;

automatically utilizing said predetermined reference points to calculate contour lines on said three-dimensional data file of said deformed head shape, said contour lines comprising peripheral edges for said custom cranial remodeling device;

projecting lines outward from said contour lines to said outer surface of said custom cranial remodeling device; and

utilizing said projected lines to establish peripheral edges for said inner and outer surfaces of said custom cranial remodeling device in said device file.