Adhesive Ostomy Wafer with Neutralizer Envelope
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Solution Overview
Problem
Ostomy devices face challenges in preventing skin maceration and adhesive degradation due to aggressive output from the stoma, which can lead to leakage and discomfort, as existing solutions do not effectively neutralize the harmful components of the output at the peristomal gap.
Innovation Solution
An adhesive wafer with a central portion, a peripheral portion, a first adhesive layer, a backing layer, a second skin-facing adhesive layer, and a release layer configured to release a neutralizer from an envelope located between the adhesive layers, which is designed to neutralize the output at the peristomal gap, protecting the skin and adhesive.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a neutralizer is released into the peristomal gap to neutralize harmful components of stoma output, then skin maceration and adhesive degradation are reduced, but device complexity increases due to the envelope structure extending to the edge of the stoma-receiving hole
Solution Approach 1:
The neutralizer-containing envelope is segmented to extend specifically to the edge of the stoma-receiving hole, allowing targeted neutralization in the peristomal gap while maintaining a simpler structure in other areas of the wafer. This segmentation enables the neutralizer to be positioned precisely where it is most needed without requiring complex structures throughout the entire device.
Solution Approach 2:
The envelope acts as an intermediary structure that contains and controls the release of the neutralizer. By using this intermediate containment structure, the patent achieves reliable protection against harmful output components while managing the complexity through a standardized envelope design rather than more complex integrated systems.
2Reliability
If the envelope extends to the edge of the stoma-receiving hole to enable neutralizer release, then neutralization effectiveness is improved, but manufacturing precision requirements increase
Solution Approach 1:
The envelope is pre-formed with its extension to the edge of the stoma-receiving hole before final assembly. This preliminary preparation allows the neutralizer containment structure to be manufactured with standard precision tolerances, and then positioned and sealed to the wafer body in a subsequent step, rather than requiring the entire structure to be manufactured in one high-precision operation.
Solution Approach 2:
The envelope structure exhibits local quality by having different geometric characteristics in different regions: it extends to the edge of the stoma-receiving hole in the central region where neutralization is critical, while having a different configuration in other areas. This localized design approach enables effective neutralization without requiring uniform high precision throughout the entire envelope structure.
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
The release of a neutralizer into the peristomal gap effectively neutralizes the harmful components of the stoma output, reducing the risk of skin maceration and adhesive degradation, thereby preventing leakage and ensuring a secure fit of the wafer, enhancing user comfort and device performance.
Implementation Method 1
a release layer configured to releasing a neutralizer, the release layer adapted to be releasable from at least one envelope located between the first and the second adhesive layer
Data Source
AI summary
An adhesive ostomy wafer includes a first adhesive, a skin-facing adhesive located proximal of the first adhesive, and a neutralizer located in an envelope that is contained by the first adhesive and the skin-facing adhesive. The adhesive ostomy wafer includes a stoma-receiving hole formed through wafer such that the first adhesive, the neutralizer, and the skin-facing adhesive are exposed within the stoma-receiving hole.