Moldable Adhesive Wafer for Ostomy Pouch Customization
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Solution Overview
Problem
Existing ostomy wafer designs, particularly those for 1-piece ostomy pouches with integral adhesive wafers, lack the ability to be molded to fit the size and shape of a stoma effectively, leading to potential leakage and discomfort.
Innovation Solution
A moldable adhesive structure comprising multiple adhesive layers and a thin, flexible elastic film that can be rolled or folded to create a counteracting force, allowing the adhesive to return to its original size and shape for a snug fit around the stoma, and can be integrated with a wafer unit or used as an adhesive base for an ostomy pouch faceplate.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size adhesive wafer is used in a 1-piece ostomy pouch, then the device complexity is reduced, but the adaptability to different stoma sizes and shapes is poor
Solution Approach 1:
The adhesive wafer is designed with a dynamic structure that allows it to change shape and size through rolling or folding. The wafer transitions from a larger initial configuration to a customized smaller configuration that fits the stoma, enabling adaptability without requiring multiple fixed-size options.
Solution Approach 2:
The adhesive wafer can be rolled or folded into a compact nested structure that fits within the 1-piece pouch assembly. This nesting capability allows the wafer to be integrated into the pouch while maintaining the ability to unfold and customize its shape and size as needed.
2Reliability
If the adhesive wafer is made moldable and customizable, then the seal quality and leakage prevention are improved, but the ease of operation during application becomes more difficult
Solution Approach 1:
The adhesive wafer is pre-configured in a larger, more manageable size that simplifies initial handling and positioning. The rolling or folding action is then performed to customize the fit, combining the benefits of easy initial application with a customized final seal configuration.
Solution Approach 2:
The rolling or folding mechanism allows the user to easily customize the wafer size and shape through simple manual manipulation. The design enables self-service customization without requiring complex tools or procedures, maintaining ease of operation while achieving a reliable customized seal.
3Adaptability or versatility
If multiple adhesive layers with elastic film are used to create a moldable structure, then the adaptability and seal quality are improved, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The adhesive wafer incorporates thin flexible elastic film layers that enable the structure to be rolled or folded without compromising adhesive integrity. These flexible films allow the multi-layer structure to be manufactured in a standardized manner while still achieving custom moldability through simple rolling or folding actions.
Solution Approach 2:
The adhesive wafer uses a composite structure with multiple adhesive layers and elastic film layers. This composite design allows each layer to perform its specific function (adhesion, flexibility, elasticity) while the overall structure remains manufacturable through standardized layering processes followed by simple rolling or folding.
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 solution provides a secure, customizable seal around the stoma, reducing leakage and enhancing comfort by allowing the adhesive to be molded to match the individual stoma size and shape, while maintaining flexibility and security for attaching medical devices.
Implementation Method 1
at least one layer of thin, flexible, elastic film between two adjacent adhesive layers to form a composite adhesive structure, wherein the moldable adhesive is formed by rolling or folding the composite adhesive structure onto itself such that the inner surface of the composite structure upon rolling provides a counteracting force to allow the edge of the rolled composite adhesive structure to partially return to its original size and shape
Data Source
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Figure 3A~3G
AI summary
Disclosed herein are methods and devices for coupling and securing a medical device appliance. In particular, one piece moldable adhesive structures are disclosed which allow customization of an attachment wafer to the size and shape of, for example, a stoma, while allowing flexibility and security for attaching a medical device, such as an ostomy pouch or other device to the subject.