Point of service manufacturing method for custom cranial remodeling device

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;
• utilizing said predetermined reference points to generate an upper peripheral edge;
• locating an anterior superior point of said reference points at a point of curvature on a sagittal midline above frontal bones of said head, utilizing said anterior superior point as a location of an anterior superior upper peripheral edge portion of said upper peripheral edge;
• identifying a posterior superior point of curvature on a sagittal plane above Occipital bones of said head as a height location of a posterior edge portion of said upper peripheral edge;
• determining an anterior corner front starting point of a portion of said upper peripheral edge from a standard offset of said sagittal plane;
• determining an anterior corner lateral starting point of said upper peripheral edge in the coronal direction utilizing curvatures associated with a coronal suture;
• determining a posterior corner back starting point of a portion of said upper peripheral edge in the sagittal direction by calculating a standard offset of a mathematically derived sagittal plane;
• determining a posterior corner lateral starting point for a portion of said upper peripheral edge in the coronal direction using curvatures associated with said coronal plane;
• automatically generating a modified head shape data file for said head;
• utilizing said modified head shape data file to generate a device shape for said custom cranial remodeling device, said device shape having an interior surface to contact said head and an outer surface;
• and
• utilizing said upper peripheral edge 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.

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;
• utilizing said predetermined reference points to generate a peripheral edge for said cranial remodeling device;
• mathematically defining corresponding first ear and second ear bottom ear points;
• generating a neck inflection portion of said peripheral edge;
• determining a location of said neck inflection portion by using a mathematically defined neck inflection point and said first and second ear bottom points and calculating a weighted average between said mathematically defined neck inflection point and said first and second ear bottom points;
• identifying a chin point and determining a guideline connecting said neck inflection point to said chin point and utilizing said guideline to determine an angle of said neck inflection portion of said peripheral edge;
• automatically generating a modified head shape data file for said head;
• utilizing said modified head shape data file to generate a device shape for said custom cranial remodeling device, said device shape having an interior surface to contact said head and an outer surface;
• utilizing said peripheral edge 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.