Custom Stoma Insert via 3D Scanning and Additive Manufacturing
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Solution Overview
Problem
Conventional stoma systems often experience leakage, odor escape, and excessive inflammation due to poor fit and compatibility with the body, leading to discomfort and mobility issues for patients.
Innovation Solution
A custom stoma insert is manufactured using 3D scanning and additive manufacturing to create a precise mold mirroring the stoma and surrounding skin, allowing for a snug fit and inclusion of antimicrobial, anti-inflammatory, and deodorant compounds to enhance comfort and hygiene.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional stoma systems are used, then manufacturing simplicity is maintained, but fit precision and patient comfort deteriorate due to poor customization
Solution Approach 1:
The patent applies preliminary action by performing 3D scanning of the patient's stoma area before manufacturing to capture precise anatomical data. This pre-measurement enables the subsequent additive manufacturing process to create a perfectly fitted insert, resolving the contradiction between fit precision and manufacturing complexity by preparing all measurement data in advance.
Solution Approach 2:
The patent utilizes parameter changes by transitioning from conventional standardized stoma systems to custom-fitted inserts manufactured through additive manufacturing. The manufacturing parameters (layer height, infill density, material selection) are optimized to achieve precise fit while managing complexity, allowing the system to produce highly accurate medical devices with controlled manufacturing complexity.
2Ease of operation
If custom-fitted inserts are manufactured using 3D scanning and additive manufacturing, then fit precision and comfort improve, but manufacturing complexity and cost increase
Solution Approach 1:
The patent applies self-service by enabling the manufacturing system to automatically process 3D scan data through digital modeling and additive manufacturing without requiring manual intervention for measurements or custom fitting. The system self-adjusts to patient anatomy through automated data processing, improving comfort while managing manufacturing complexity through automation rather than manual customization.
Solution Approach 2:
The patent uses copying by creating a digital 3D model (copy) of the patient's stoma anatomy from scan data. This digital replica serves as the basis for manufacturing the custom insert, allowing precise reproduction of anatomical features without requiring complex manual measurement and fabrication processes, thus improving comfort while controlling manufacturing complexity.
3Reliability
If conventional stoma systems are used, then device simplicity is maintained, but reliability deteriorates due to leakage and odor escape
Solution Approach 1:
The patent applies segmentation by dividing the stoma management system into distinct functional components: a custom-fitted insert with precise contours that interfaces directly with the stoma, and an ostomy pouch that attaches to the insert. The segmented design with precise interfaces between components prevents leakage and odor escape while managing system complexity through modular architecture.
Solution Approach 2:
The patent utilizes local quality by creating an insert with locally optimized features: a central aperture sized and shaped to match the specific stoma, peripheral flanges with specific geometries for pouch attachment, and surface textures for secure adhesion. These locally tailored features prevent leakage and improve reliability without requiring complex overall system design.
4Object-affected harmful factors
If standard stoma inserts are used, then manufacturing cost is reduced, but harmful effects increase due to inflammation and skin irritation
Solution Approach 1:
The patent applies inversion by reversing the conventional approach: instead of fitting standard inserts to various stoma shapes, the system creates custom inserts by inverting the 3D scan data to generate complementary toolpaths for additive manufacturing. This inverted approach ensures precise fit that prevents skin inflammation and harmful effects while maintaining manufacturing precision.
Data Source
Figure 1A~1B
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AI summary
The invention relates to method of manufacturing a custom stoma insert for a patient having a stoma, as well as to a stoma made using the method of the invention. The method comprises the steps of scanning the stoma and surrounding skin area to generate a three-dimensional scan of the area for which the stoma insert is to be manufactured; manipulating scan data obtained from the three- dimensional scan to render a three-dimensional model of the stoma and surrounding skin contours, such that the scan data is suitable for use in an additive manufacturing environment; creating a custom mould for the stoma insert using additive manufacturing such that the mould provides a complementary surface closely mirroring the contours of the stoma and surrounding skin area; and producing the stoma insert by casting a physiologically acceptable mouldable material into the custom mould.