Custom Cranial Remodeling Device via Point-of-Service 3D Printing
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Solution Overview
Problem
The existing manufacturing process for custom cranial remodeling devices is complex and prone to errors, requiring multiple steps and physical separation between data capture and manufacturing, leading to delays and potential inaccuracies in device fit and longevity.
Innovation Solution
Implementing a point-of-service manufacturing system that uses three-dimensional digital data capture and additive manufacturing to produce custom cranial remodeling devices directly at the clinic, reducing the number of manufacturing steps and eliminating the need for a foam liner by selecting layers with specific material and strength properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional multi-step manufacturing process is used, then device can be manufactured with existing equipment, but manufacturing precision and time efficiency deteriorate due to multiple steps and physical separation between data capture and manufacturing
Solution Approach 1:
The patent combines the data capture station and additive manufacturing device into a single integrated system located at the same physical facility. The 3D scanning apparatus and 3D printer are co-located and connected through a shared digital infrastructure, allowing seamless transfer of head geometry data from scanning to manufacturing without physical shipment or intermediate handling steps.
Solution Approach 2:
The patent replaces the traditional mechanical manufacturing process (vacuum thermo-forming of foam and plastic layers) with additive manufacturing technology. The 3D printer directly deposits material layer-by-layer to create the custom cranial device, eliminating the need for physical molds, foam liners, and manual trimming operations.
2Adaptability or versatility
If traditional manufacturing process with foam liner is used, then device can be adjusted for patient growth, but device complexity and manufacturing steps increase
Solution Approach 1:
The patent designs the cranial device with dynamic adjustment capabilities through integrated growth plates and adjustable fastening mechanisms. These features allow the device to accommodate patient growth without requiring complete replacement or addition of foam liners, maintaining adaptability while simplifying the overall structure.
Solution Approach 2:
The patent extracts and eliminates the foam liner component from the device structure entirely. The additive manufacturing process creates the final device geometry directly, removing the intermediate foam layer that was previously used for customization and adjustment, thereby reducing device complexity and manufacturing steps.
3Reliability
If multiple manufacturing steps are used, then device can be manufactured with conventional methods, but reliability and accuracy deteriorate due to potential introduction of error at each step
Solution Approach 1:
The patent replaces the complex multi-step mechanical manufacturing process with a single additive manufacturing operation. The 3D printer directly creates the custom device from digital models, eliminating intermediate steps such as foam layering, vacuum forming, trimming, and assembly, thereby improving reliability while maintaining ease of manufacture through digital automation.
Solution Approach 2:
The patent uses digital copying of the patient's head geometry through 3D scanning to create an accurate digital model. This digital replica is then used to generate the manufacturing file for the additive printer, ensuring high fidelity and accuracy without the error-prone manual measurements and physical model-making steps of traditional methods.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach enables faster, more accurate, and cost-effective production of custom cranial remodeling devices, allowing for frequent updates and adjustments to accommodate patient growth, while ensuring precise fit and extended product life without the need for a foam liner.
Implementation Method 1
an additive manufacture device located at the same physical location... The additive manufacture device operates to utilize the device file to manufacture the custom cranial remodeling device at the physical location
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. 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.