Point-of-Service 3D Printed Cranial Remodeling Device
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Solution Overview
Problem
The existing methods for manufacturing custom cranial remodeling devices are prone to errors and inaccuracies due to multiple steps, and the physical separation between clinics and manufacturing facilities leads to time delays in delivery, while the foam liners used in these devices often fail to maintain conformance due to spring back, necessitating frequent replacements and adjustments for growth.
Innovation Solution
Implementing point-of-service additive manufacturing at clinics using three-dimensional digital data capture and processing to directly manufacture custom cranial remodeling devices, eliminating the need for foam liners by using multiple layers with varying strength and material properties, and incorporating electronic sensors for real-time adjustments and fitting confirmation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional multi-step manufacturing process is used, then manufacturing precision can be maintained through multiple quality checks, but the number of manufacturing steps increases leading to more opportunities for error and inaccuracy
Solution Approach 1:
The patent combines multiple manufacturing steps into a single additive manufacturing process. The 3D printer manufactures the entire cranial remodeling device including integrated foam liner and shell in one continuous operation, eliminating the need for separate vacuum thermo-forming steps and reducing the number of components that need to be assembled and aligned.
Solution Approach 2:
The patent uses composite materials approach by integrating the foam liner and hard shell as unified structures within the additive manufacturing process. The device comprises a foam liner layer and a shell layer manufactured together, creating an integrated composite structure that eliminates the need for separate manufacturing and assembly of these components.
2Manufacturing precision
If custom cranial remodeling devices are manufactured at a separate facility, then specialized manufacturing equipment can be used, but physical separation causes time delays in delivery measured in days
Solution Approach 1:
The patent enables clinics to manufacture their own custom cranial remodeling devices using portable additive manufacturing equipment. The clinic performs the manufacturing in-house after capturing the patient's head geometry, eliminating the need to ship devices between facilities and reducing delivery time from days to hours or minutes.
Solution Approach 2:
The patent transitions from centralized off-site manufacturing to distributed on-site manufacturing by bringing additive manufacturing equipment into the clinic environment. This dimensional shift in manufacturing location enables immediate production at the point of care, eliminating transportation time and logistics delays.
3Duration of action of stationary object
If foam liner is added to extend product life, then the device can accommodate patient growth, but the foam liner does not compress evenly under vacuum and springs back resulting in loss of conformance
Solution Approach 1:
The patent pre-compresses the foam liner during the additive manufacturing process before the device is used on the patient. The 3D printer compresses the foam material layer by layer as it builds the device, eliminating the need for post-manufacturing vacuum compression and preventing spring back that would otherwise occur during fitting.
Solution Approach 2:
The patent replaces the traditional vacuum compression system with an additive manufacturing process that inherently compresses and shapes the foam liner during deposition. The mechanical vacuum system is substituted by the controlled layer-by-layer material deposition and compression inherent to 3D printing, achieving both compression and conformance in one process.
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 reduces manufacturing steps, eliminates time delays, ensures precise and accurate production, extends the device's lifespan by accommodating growth, and enhances fitting accuracy through real-time adjustments and pressure monitoring.
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
Implementation Method 2
vacuum thermo-forming a foam liner onto the life size model, vacuum thermo-forming a hard plastic onto the foam liner
Data Source
AI summary
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.