Additive Cranial Device Manufacturing via Point-of-Service 3D Printing
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Solution Overview
Problem
Current methods for manufacturing custom cranial remodeling devices are prone to errors and require multiple steps, leading to inaccuracies and time delays due to physical separation between data capture and manufacturing locations, and they often rely on foam liners that can compress unevenly and lose conformance, necessitating frequent device changes and adjustments for patient growth.
Innovation Solution
Implementing point-of-service additive manufacturing at the clinic using a processor to generate a device file for a custom cranial remodeling device, which includes removable manufacturing supports and electronic sensors, allowing for on-site production with layers of varying strength and material properties, eliminating the need for foam layers and enabling real-time adjustments for patient growth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional multi-step manufacturing methods are used, then manufacturing capability is achieved, but manufacturing precision deteriorates due to error accumulation across multiple steps
Solution Approach 1:
The patent extracts and eliminates the foam liner intermediate step from the traditional manufacturing process. By using additive manufacturing to directly produce the cranial remodeling device with integrated adjustment mechanisms, the process removes the foam layer that caused uneven compression and conformance loss, thereby improving manufacturing precision while reducing the number of steps.
Solution Approach 2:
The patent replaces the mechanical vacuum thermo-forming process with an additive manufacturing process. This substitution eliminates the need for vacuum formation, foam liners, and manual trimming steps, directly creating the final device structure through digital modeling and layer-by-layer deposition, thus improving precision and reducing complexity.
2Productivity
If physical separation between clinic and manufacturing location is maintained, then specialized manufacturing capability is achieved, but loss of time increases due to shipping delays
Solution Approach 1:
The patent merges the data capture and manufacturing functions into a single integrated system at the clinic location. The 3D scanning apparatus, processing system, and additive manufacturing device are combined in one facility, enabling same-day or real-time device production, thereby eliminating shipping delays and significantly reducing time loss.
Solution Approach 2:
The patent uses digital 3D scanning to create a precise virtual copy of the patient's head, which is then processed and manufactured at the same location. This digital copying approach eliminates the need for physical transport of patient data or device prototypes, enabling rapid local production without time delays.
3Adaptability or versatility
If foam liner is added to extend device life, then adaptability to patient growth is improved, but reliability deteriorates due to uneven compression and spring back
Solution Approach 1:
The patent incorporates dynamic adjustment mechanisms directly into the additive-manufactured device structure. These mechanisms allow the device to adapt to patient growth through controlled modifications, eliminating the need for foam liners while maintaining reliable conformance through the inherent structural integrity of the additively manufactured material.
Solution Approach 2:
The patent uses composite material properties in the additive manufacturing process to create a device that combines rigidity for structural support with flexibility for adaptation. The multi-layered construction allows different regions to have varying material properties, enabling both reliable conformance and adaptability to patient growth without requiring separate foam liners.
Data Source
AI summary
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.