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 model for manufacturing a custom cranial remodeling orthosis device for an infant's deformed head includes the steps of receiving a head shape digital file corresponding to the deformed head and 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 at least one growth area where head growth is to occur. The method includes processing the modified shape digital file to produce an extra growth room shape data file comprising extra growth room contiguous to the growth area and utilizing the extra growth room shape data file to manufacture the model.

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 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 head model for thermoforming a cranial remodeling orthosis device to shape an infant's deformed head shape as the infant's head grows comprises a head shape surface used to define the inner surface of the cranial remodeling orthosis device. The head shape surface is derived from a three-dimensional data file representing the deformed head shape modified to a modified head shape. The head shape surface has first areas corresponding to hold areas of the cranial remodeling orthosis device where growth of the infant's head is held or restrained. The head shape surface has one or more second’ areas where the cranial remodeling orthosis device is to provide growth room for the infant's head. The one or more second areas extend radially outward from the modified head shape to provide 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 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: 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 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 cranial remodeling orthosis (CRO) device comprises an outer portion comprising an outer surface and an inner surface and an inner layer carried on the outer portion inner surface and having an inner surface adapted to contact the head of a patient in first predetermined areas and spaced apart from the head of the patient in other predetermined areas. A sensor is carried by the CRO device. The sensor comprises a sensor memory and is operable to capture specific condition parameters and to store corresponding parameter data in the sensor memory at periodic intervals. The parameter data stored in the sensor memory is readable by an external electronic device. The parameter data is utilizable by a processor to determine wear time periods for the CRO device.

Abstract: A system for determining cranial remodeling orthosis (CRO) device wearing time comprises a CRO device comprising at least one sensor device having a sensor memory. The system further comprises an electronic device external to the CRO device. The at least one sensor device is operable to capture specific condition parameters and to store corresponding parameter data in the sensor memory at periodic intervals. The parameter data stored in the sensor memory may be accessed and the system further comprises a software program stored in a non-transient memory and comprising instructions executable to analyze the parameter data to determine wear times for the CRO 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 yet further comprises utilizing the headwear data file to generate a shape for a desired headwear, the shape having an interior configured to restrain growth of the head in first predetermined areas. Still further, the method comprises generating 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. Still further the method includes utilizing the modified head shape data file to generate a shape for a desired custom cranial remodeling device and restricting growth of the head in first areas.

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. Still further the method includes utilizing the modified head shape data file to generate a shape for a desired custom cranial remodeling device and restricting growth of the head in first areas.

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 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 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.