3D-Printed Cranial Remodeling Shell for Accurate Clinic Fitting
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Solution Overview
Problem
Existing methods for manufacturing custom cranial remodeling devices are prone to errors and inaccuracies due to multiple manufacturing steps, require shipment from a manufacturing facility to a clinic, and involve the use of a foam layer that may not evenly compress, leading to potential misfitting and inefficiencies.
Innovation Solution
Implementing a point-of-service manufacturing process using an additive manufacturing device at the clinic, which processes three-dimensional digital data to directly produce a custom cranial remodeling device with multiple layers, including electronic sensors for fit confirmation and pressure monitoring, without a foam layer, and integrating alignment marks for precise fitting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If traditional multi-step manufacturing process is used, then device can be manufactured with foam liner, but manufacturing precision deteriorates due to accumulation of errors from multiple steps
Solution Approach 1:
The patent combines multiple separate manufacturing steps (3D scanning, digital modeling, foam liner attachment, plastic molding, trimming) into a single integrated additive manufacturing process. The 3D printer directly fabricates the final device geometry in one continuous process, eliminating the need for sequential operations and the associated error accumulation from each step.
Solution Approach 2:
The patent extracts and eliminates the foam liner component from the manufacturing process. By removing this intermediate layer that caused conformance issues and spring back problems, the device can be manufactured directly in its final shape using additive manufacturing, thereby improving both manufacturing simplicity and precision.
2Ease of manufacture
If clinic and manufacturing location are physically separated, then specialized manufacturing equipment can be used, but time delay increases due to shipping the device
Solution Approach 1:
The patent enables the clinic to perform manufacturing itself by acquiring an additive manufacturing device. The clinic captures the patient's head geometry, processes the data, and manufactures the custom device on-site, eliminating the need to ship devices between locations and reducing delivery time to near-zero.
Solution Approach 2:
The patent transitions the manufacturing capability from a centralized external facility to a distributed on-site capability. By placing the additive manufacturing device at the clinic location, the system changes the spatial dimension of manufacturing from remote to local, eliminating transportation time and enabling immediate device production.
3Duration of action of stationary object
If foam liner is added to extend product life, then device can accommodate patient growth, but reliability deteriorates due to spring back and loss of conformance
Solution Approach 1:
The patent removes the foam liner component entirely from the device structure. By manufacturing the device directly in its final geometry using additive manufacturing, the problematic foam layer that caused spring back and conformance loss is eliminated, while device longevity is maintained through the inherent accuracy and durability of the 3D printed structure.
Data Source
AI summary
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.