Abstract: A method for fabricating a custom cranial remodeling device 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 of the infant by utilizing apparatus operating to capture three-dimensional data representative of the head. The apparatus is located at the clinic. The method further comprises utilizing a processor to process the three-dimensional digital data file to produce a device file comprising the shape for the custom cranial remodeling device and manufacturing the custom cranial remodeling device at the clinic by utilizing an additive manufacture device located at the clinic to operate with the three-dimensional digital data file.

Abstract: A custom cranial remodeling device to correct a deformed head of a subject 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 and 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 representative of the shape of the deformed head, the device data file determining the shape of the cranial remodeling device to correct the shape of the deformed head.

Abstract: 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.

Abstract: Custom manufactured headwear for a subject's head includes 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 includes 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 determines the shape of the headwear.

Abstract: Custom manufactured headwear for a subject's head is provided. The headwear comprises an inner layer 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.

Abstract: 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; identifying predetermined reference points on the head; automatically selective utilizing the predetermined reference points to calculate contour lines on the head; automatically generating a modified head shape data file; juxtaposing the modified head shape with the head represented by the three-dimensional head data file having the contour lines thereon; 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; 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.

Abstract: 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.

Abstract: 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.

Abstract: A method for fabricating a custom headwear for a subject is described. The method comprises generating a three-dimensional head data file for the subject; identifying predetermined reference points on the head; automatically selective utilizing the predetermined reference points to calculate contour lines on the head; automatically generating a headwear data file; juxtaposing the headwear represented by the headwear data file with the head represented by the three-dimensional head data file having the contour lines thereon; utilizing the headwear data file to generate a shape for a desired headwear, the shape having an interior surface to contact the head and an outer surface; projecting lines outward from the contour lines to the outer surface; and utilizing the projected lines to establish headwear contour lines for the custom headwear.

Abstract: A custom cranial remodeling device to correct a deformed head of a subject 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 and 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 representative of the shape of the deformed head, the device data file determining the shape of the cranial remodeling device to correct the shape of the deformed head.

Abstract: 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.

Abstract: 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.

Abstract: A method for fabricating a custom cranial remodeling device 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 of the infant by utilizing apparatus operating to capture three-dimensional data representative of the head. The apparatus is located at the clinic. The method further comprises utilizing a processor to process the three-dimensional digital data file to produce a device file comprising the shape for the custom cranial remodeling device and manufacturing the custom cranial remodeling device at the clinic by utilizing an additive manufacture device located at the clinic to operate with the three-dimensional digital data file.

Abstract: A method for manufacturing a custom cranial remodeling device of a type comprising plastic material is provided. The method includes the steps of: providing a first database of three-dimensional digital surface images of trim lines for cranial remodeling devices of a first type; providing a second database of three-dimensional digital surface images of trim lines for cranial remodeling devices of a second type; providing a first program for creating trim lines for a cranial remodeling device of the first type, the first program utilizing the first database; providing a second program for creating trim lines for a cranial remodeling device of the second type, the second program utilizing the second database; generating a three-dimensional model of a desired head shape; forming the plastic material onto the model; and selecting one of the first or the second programs to generate trim lines for the cranial remodeling device.

Abstract: A method for processing a three-dimensional image file captured directly from a live subject, the file including the cranium of the subject, comprises: providing a vertex point cloud for the three-dimensional image file; determining a median point for the vertex point cloud; determining a point on the cranium; and utilizing the median point and the cranium point to define a z-axis for the three-dimensional image file.

Abstract: A method for processing a three-dimensional image file captured directly from a live subject, the file including the cranium of the subject, comprises: providing a vertex point cloud for the three-dimensional image file; determining a median point for the vertex point cloud; determining a point on the cranium; and utilizing the median point and the cranium point to define a z-axis for the three-dimensional image file.

Abstract: A method for manufacturing a custom cranial remodeling device of a type comprising plastic material is provided. The method includes the steps of: providing a first database of three-dimensional digital surface images of trim lines for cranial remodeling devices of a first type; providing a second database of three-dimensional digital surface images of trim lines for cranial remodeling devices of a second type; providing a first program for creating trim lines for a cranial remodeling device of the first type, the first program utilizing the first database; providing a second program for creating trim lines for a cranial remodeling device of the second type, the second program utilizing the second database; generating a three-dimensional model of a desired head shape; forming the plastic material onto the model; and selecting one of the first or the second programs to generate trim lines for the cranial remodeling device.

Abstract: Apparatus for processing a digital mesh representing a three-dimensional subject automatically filters out portions of a predetermined color to simplify further processing.

Abstract: A method for producing a cranial remodeling device to correct for cranial shape abnormalities is described. One method comprises the steps of: providing cranial remodeling device trim line information; forming device material onto a three-dimensional model of a desired head shape; providing a machine responsive to said trim line information to move a spindle in a plurality of axes over the device material; providing a marking tool carried by the spindle; and operating the machine in response to the trim line information such that the machine moves the marking tool into surface engagement with the device material such that trim lines for the cranial remodeling device are marked onto the device material.

Abstract: A method for manufacturing a custom cranial remodeling device of a type comprising plastic material is provided. The method includes the steps of: providing a first database of three-dimensional digital surface images of trim lines for cranial remodeling devices of a first type; providing a second database of three-dimensional digital surface images of trim lines for cranial remodeling devices of a second type; providing a first program for creating trim lines for a cranial remodeling device of the first type, the first program utilizing the first database; providing a second program for creating trim lines for a cranial remodeling device of the second type, the second program utilizing the second database; generating a three-dimensional model of a desired head shape; forming the plastic material onto the model; and selecting one of the first or the second programs to generate trim lines for the cranial remodeling device.