Abstract: A cranial remodeling orthosis (CRO) device for shaping an infant's deformed head shape as the infant's head grows includes an interior surface configuration based upon a modified shape derived from the deformed head shape. The interior surface comprises hold areas to restrain growth of said infant's head. The hold locations and amounts are determined from the modified shape. The interior surface also comprises one or more second areas providing growth room for the infant's head. The second areas are determined from the modified shape. At least one of the second areas is configured to provide extra growth room for the infant's head. Trimlines are provided and the trimlines are used to define the second areas.

Abstract: A cranial remodeling orthosis (CRO) device for shaping an infant's deformed head shape as the infant's head grows includes an interior surface configuration based upon a modified shape derived from the deformed head shape. The interior surface comprises hold areas to restrain growth of said infant's head. The hold locations and amounts are determined from the modified shape. The interior surface also comprises one or more second areas providing growth room for the infant's head. The second areas are determined from the modified shape. At least one of the second areas is configured to provide extra growth room for the infant's head.

Abstract: A method of manufacturing a custom cranial remodeling orthosis device for an infant's deformed head includes the step of receiving a head shape digital file corresponding to the deformed head. The method also includes processing the head shape digital file to generate a modified shape data file. The modified shape defines hold areas on the deformed head where head growth is to be constrained and growth areas where head growth is to occur. The method further includes processing the modified shape digital file to produce an extra growth room shape data file comprising one or more extra growth room areas contiguous with corresponding one or more of the growth areas and utilizing trim lines to further define the extra growth room.

Abstract: A method of manufacturing a custom cranial remodeling orthosis device for an infant's deformed head includes the step of receiving a head shape digital file corresponding to the deformed head. The method also includes processing the head shape digital file to generate a modified shape data file. The modified shape defines hold areas on the deformed head where head growth is to be constrained and growth areas where head growth is to occur. The method further includes processing the modified shape digital file to produce an extra growth room shape data file comprising one or more extra growth room areas contiguous with corresponding one or more of the growth areas. The method further includes utilizing the extra growth room head shape data file to manufacture a modified shape with extra growth room and utilizing the modified shape with extra growth room to manufacture said custom cranial remodeling orthosis device.

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 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.

Abstract: 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.

Abstract: 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.

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 and determining contour lines on the head; automatically generating a headwear data file. The method further comprises 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. The method yet further comprises 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. Still further, the method comprises 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 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.

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 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.

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 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.

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 and determining contour lines on the head; automatically generating a headwear data file. The method further comprises 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. The method yet further comprises 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. Still further, the method comprises 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 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. Predetermined reference points are identified on the head. The predetermined reference points are utilized to calculate contour lines on the head. A modified head shape data file is generated and juxtaposed with the head represented by the three-dimensional head data file having the contour lines thereon. The modified head shape data file is used 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 contour lines establish peripheral edges for the custom cranial remodeling device.

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: 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 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 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: 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 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.