Apparatus provides point of service to manufacture a custom cranial remodeling device for correction of cranial deformity of a subject. The apparatus comprises capture apparatus disposed at a physical location for capturing three dimensional digital data of the head of the subject and generating a three-dimensional digital data file representative of the head and an additive manufacture device located at the physical location. The apparatus further comprises a processor that operates to process the three-dimensional digital data file to produce a device file comprising the shape for the custom cranial remodeling device. The processor provides the device file to the additive manufacture device. The said additive manufacture device operates to utilize the device file to manufacture the custom cranial remodeling device at the physical location.

Apparatus is provided for point of service manufacture of custom headwear for a subject. The apparatus comprises capture apparatus disposed at a physical location for capturing three dimensional digital data of the head of the subject and generating a three-dimensional digital data file representative of said head; an additive manufacture device located at the physical location; and a processor. The processor operates to process the three-dimensional digital data file to produce a device file comprising the shape for the custom headwear and to provide the device file to the additive manufacture device. The additive manufacture device operates to utilize the device file to manufacture the custom headwear at the physical location.

A method for fabricating an article of headwear for a subject is provided. The method comprises: generating a three-dimensional digital data file for the subject at a clinic by capturing a three-dimensional data file representative of the head by utilizing apparatus located at the clinic operating to capture three-dimensional data representative of the head; utilizing a processor to process the three-dimensional digital data file to produce a device file comprising the shape for the article of headwear; and manufacturing the article of headwear at the clinic by utilizing an additive manufacture device located at the clinic to operate with the three-dimensional digital data file.

Custom manufactured headwear for a subject's head is provided. The headwear comprises an inner layer shaped to contact the head of the subject at predetermined areas. The inner layer is deposited by an additive manufacturing device. The headwear further comprises an outer layer deposited by the additive manufacturing device. The inner layer and the outer layer are each formed by the additive manufacture device utilizing a device data file derived from a subject data file. The subject data file is representative of the shape of the head and the device data file determining the shape of the headwear.

A custom cranial remodeling orthosis device to modify the shape of a deformed head of a subject is described. The orthosis device has an inner layer carrying an inner surface shaped to provide modification of the head shape. The inner surface of the device has an inner surface peripheral edge. The orthosis device has an outer layer carrying an outer surface. The outer surface has an outer surface peripheral edge. At least one of the inner surface peripheral edge and the outer surface peripheral edge is determined from one or more of curvatures, features, and anthropometric reference points on the shape of the deformed head. Thed inner surface peripheral edge and the outer surface peripheral edge are offset from each other.

A method for concurrent additive manufacture of a plurality of custom cranial remodeling orthosis devices for a corresponding plurality of subjects is provided. Each cranial remodeling orthosis device is customized for a different subject and each cranial remodeling device orthosis is represented by a corresponding device data file. The method comprises partitioning each corresponding device data file into a plurality of device portion data files. Each device portion data file corresponds to a device portion of a corresponding one cranial remodeling orthosis device. The method further comprises processing each of the plurality of device portion data files into a nested data array corresponding to a nested array of device portions of all of the plurality of cranial remodeling orthosis devices. The nested data array is concurrently manufactured in a production or build chamber of additive manufacture apparatus.

A cranial remodeling orthosis device comprises a plurality of device portions manufactured with additive manufacture material. Adjacent ones of the device portions are connected together edge to edge. Each device portion comprises a plurality of integrally formed connecting portions each disposed along each edge adjacent to another one of the plurality of device portions. Each integrally formed connecting portion on one device portion is in engaging connection with a corresponding integrally formed connection portion on an adjacent one device portion to retain the adjacent portions together.

A method of manufacturing a custom cranial remodeling orthosis device represented by a device data file partitions the device data file into a plurality of device portion data files each corresponding to a portion of the cranial remodeling orthosis device. The plurality of device portion data files are processed to provide a data file array comprising the device portion data files for manufacture by additive manufacturing apparatus to manufacture a corresponding array of a plurality of device portions of said cranial remodeling device.

A custom manufactured cranial remodeling orthosis device for modifying the shape of a subject's head is described. The cranial remodeling orthosis device comprises a plurality of device pieces manufactured with additive manufacture material. Each of the device pieces comprising one or more integral connecting portions. The plurality of device pieces are interconnected together utilizing the one or more integral connecting portions.

A method for fabricating a custom cranial remodeling device for correction of cranial deformities in a subject is described. The method comprises generating a three-dimensional head data file for the subject and determining contour lines on the head. The method further comprises automatically generating a modified head shape data file and juxtaposing the modified head shape with the head represented by the three-dimensional head data file having the contour lines thereon. Still further the method includes utilizing the modified head shape data file to generate a shape for a desired custom cranial remodeling device, the shape having an interior surface to contact the head and an outer surface. The method also includes projecting lines outward from the contour lines to the outer surface and utilizing the projected lines to establish cranial remodeling device contour lines for the custom cranial remodeling device.