Mouldable Inner Adhesive Layer for Ostomy Base Plate Sealing
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Solution Overview
Problem
Ostomy base plates face challenges in providing a tight seal around the stoma due to skin irritation and adhesive erosion from stomal effluent, especially when scarred peristomal areas complicate the attachment, leading to leakage and detachment issues.
Innovation Solution
A base plate design featuring a mouldable inner adhesive layer surrounded by a non-tacky backing layer that can be radially extended to fit the stoma, protecting the adhesive from direct contact with stomal output and providing a secure seal by shaping to the stoma's size and shape, while the backing layer prevents garment adherence and enhances tear resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If the mouldable adhesive is left uncovered by the backing layer, then it can be easily moulded radially towards the stoma to provide a tight fit, but it becomes exposed and easily eroded by stomal output
Solution Approach 1:
The adhesive system is divided into two distinct layers: an inner mouldable adhesive layer that contacts the stoma and provides sealing, and an outer non-mouldable adhesive layer that protects the inner layer from erosion. This segmentation allows each layer to perform its specific function optimally without compromising the other.
Solution Approach 2:
The inner mouldable adhesive layer is nested within the outer non-mouldable adhesive layer. The outer layer completely surrounds and protects the inner layer, while the inner layer maintains direct contact with the stoma for sealing. This nested structure enables the inner layer to be moulded without direct exposure to erosive output.
2Reliability
If a separate sealing member is added to the base plate, then sealing around the stoma is improved, but the device complexity increases
Solution Approach 1:
The sealing function and adhesive attachment function are merged into a single integrated adhesive system. The inner mouldable adhesive layer provides sealing around the stoma while the outer non-mouldable adhesive layer provides attachment to the skin. This eliminates the need for separate sealing members and reduces device complexity.
Solution Approach 2:
The adhesive system performs multiple functions simultaneously: the inner layer provides sealing around the stoma, the outer layer provides skin attachment and protection, and together they create a unified bonding interface. This multi-functionality eliminates the need for separate specialized components.
3Adaptability or versatility
If the adhesive is made mouldable to adapt to scarred peristomal areas, then sealing is improved, but the adhesive becomes more susceptible to erosion and deterioration
Solution Approach 1:
The adhesive system segments the adaptation function from the protection function. The inner mouldable layer adapts to scarred peristomal areas and irregular skin surfaces, while the outer non-mouldable layer provides durability and resistance to erosion from stomal output, thereby extending wear time.
Solution Approach 2:
Different regions of the adhesive system have different properties tailored to their specific functions. The inner layer has mouldable properties for adapting to irregular skin topography, while the outer layer has non-mouldable, erosion-resistant properties for protection and durability. Each layer's local quality optimizes its specific role.
Data Source
AI summary
The current invention relates to a base plate (1) for an ostomy collection device, the base plate comprises at least one backing layer (3) whereon an outer adhesive layer (4) is disposed on the proximal side of said backing layer, wherein the outer adhesive layer encircles an inner adhesive layer (7) also disposed on the proximal side of at least one backing layer, said inner adhesive layer encircles a through-going hole (5) of the base plate defining a central axis A-A, wherein at least a part of the backing layer whereon the inner adhesive layer is disposed is extendable in a radial direction in respect to the central axis A-A. By allowing the backing layer to be radially extendable with the inner adhesive layer, the backing layer functions as a barrier to output from the stoma. Thus, output from the stoma will not come in direct contact with the distal side of the inner adhesive layer, which is shielded by the backing layer and thus extends the wear time of the ostomy appliance and reduces the risk that leakage may occur.