Ostomy Skin Barrier Passages Kept Open for Leak-Resistant Adhesion
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Solution Overview
Problem
Ostomy appliances often experience adhesive failure due to stomal output entering between the base plate and the skin, leading to leakage incidents, which are embarrassing and reduce quality of life, and existing devices do not adequately address this issue.
Innovation Solution
A skin-engageable element for ostomy appliances featuring a carrier sheet with a first adhesive layer and a protective element with discrete projections that support through-going passages, preserving adhesive functionality during storage and use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional adhesive layer is used without protective structures, then the device structure is simple, but the adhesive integrity deteriorates due to contamination from stomal output
Solution Approach 1:
The adhesive layer is segmented into multiple functional zones: a first adhesive layer for skin attachment, through-going passages for fluid drainage, and a second adhesive layer for additional sealing. This segmentation allows each zone to perform its specific function while maintaining overall adhesive integrity despite exposure to stomal output.
Solution Approach 2:
A protective element is introduced as an intermediary component between the adhesive layers and the stomal output. This protective element prevents direct contact between the adhesive material and contaminants, thereby maintaining adhesive integrity without requiring the adhesive itself to be chemically resistant to all body fluids.
2Ease of operation
If through-going passages are provided in the adhesive layer, then fluid drainage is enabled, but the passages may close and adhesive functionality is lost
Solution Approach 1:
The through-going passages are pre-formed and reinforced during manufacturing with structures that prevent collapse. The passages are designed with sufficient rigidity and dimensional stability to maintain openness during storage and use, preventing closure that would block fluid drainage or compromise adhesive functionality.
3Ease of manufacture
If the adhesive layer is exposed to stomal output during storage, then the device is easy to manufacture, but the adhesive deteriorates and leakage occurs
Solution Approach 1:
A protective element serves as a mediator during both manufacturing and use. This element shields the adhesive layers from exposure to stomal output and other contaminants during storage and handling, preventing deterioration while allowing the adhesive to maintain its bonding properties throughout the device's service life.
Solution Approach 2:
The protective element is implemented as a flexible barrier layer or film that covers the adhesive surfaces. This thin film structure provides effective protection against contamination while maintaining flexibility and not interfering with the adhesive's ability to bond to the skin when the protective element is removed.
4Reliability
If the base plate is tightly attached to the skin, then leakage is prevented, but adhesive failure occurs due to stress from skin movement and folds
Solution Approach 1:
The adhesive system employs different material properties in different locations: the first adhesive layer provides initial skin attachment, while the second adhesive layer provides enhanced sealing and stress distribution. This local differentiation of adhesive qualities allows the system to accommodate skin movement and folds without compromising overall bond strength or causing leakage.
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 system maintains adhesive integrity by preventing passage closure and protecting the adhesive from contamination, reducing the risk of sudden leakage and ensuring reliable wear time.
Implementation Method 1
a first layer of adhesive material, which is configured for adhesion of the skin-engageable element to a peristomal skin portion of the user
Data Source
Figure 1
Figure 2
Figure 3a~3b
AI summary
A system for preserving functionality of a skin-engageable element for attachment to a skin portion of a user during storage including a skin-engageable element including one or more electrodes and a protective element having discrete portions projecting therefrom. The discrete portions are adapted to engage with through-going passages in an adhesive layer of the skin-engageable element, and ensure that the passages are open and passable when the protective element is removed before use of the skin-engageable element.