Adhesive Wafer Neutralizer Matrix for Ostomy Skin Protection

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Solution Overview

Problem

Ostomy appliances 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 fail to effectively neutralize the harmful components of the output before they come into contact with the skin or adhesive.

Innovation Solution

An adhesive wafer with a release layer containing a neutralizer matrix on the distal side of the backing layer, which releases neutralizing substances such as AMBERLITE IRA 958 chloride, DEUREX Pure, and trypsin inhibitors into the peristomal gap to neutralize the output, protecting the skin and adhesive from damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional adhesive wafer is used without a neutralizer, then the structure is simple and manufacturing is easy, but the adhesive degrades and skin macerates due to aggressive stoma output

Engineering Contradiction:
Improveadhesive integrityVSAvoidwafer structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The wafer is divided into distinct functional layers: an adhesive layer for skin attachment, a backing layer providing structural support, and a release layer containing the neutralizer matrix. This segmentation allows each layer to perform its specific function optimally while protecting the adhesive from degradation by stoma output.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The release layer acts as an intermediary between the stoma output and the adhesive layer. It contains a neutralizer matrix that releases neutralizing substances to counteract the aggressive components of the output before they can reach and degrade the adhesive, thus protecting the adhesive integrity without requiring fundamental structural changes.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If the release layer is positioned on the proximal side of the adhesive layer, then the neutralizer is closer to the skin, but the release layer may adhere to the skin causing discomfort

Engineering Contradiction:
Improveskin protectionVSAvoidskin comfort
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

Instead of placing the release layer on the proximal (skin-facing) side as might be intuitively expected for maximum skin protection, the release layer is positioned on the distal side of the adhesive layer. This inverted positioning prevents the release layer from adhering to the skin while still allowing the neutralizer to diffuse through the adhesive layer to protect the skin from harmful output components.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The adhesive layer serves as an intermediary medium that allows the neutralizer to diffuse from the distal release layer to the proximal skin surface. This arrangement protects the skin from both the harmful output components and direct contact with the release layer material, maintaining skin comfort while providing protection.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If a neutralizer matrix is incorporated into the wafer, then skin maceration and adhesive degradation are prevented, but the device complexity and manufacturing difficulty increase

Engineering Contradiction:
Improveoutput neutralizationVSAvoidwafer production
Core Design Contradiction:
Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The neutralizer matrix is segregated into a distinct release layer rather than being mixed throughout the entire wafer structure. This segmentation simplifies manufacturing by allowing the neutralizer to be applied as a separate coating or layer on the backing layer, using standard coating or lamination techniques, rather than requiring complex mixing and distribution throughout the adhesive and backing materials.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The neutralizer is concentrated in the release layer at the distal side of the adhesive layer, creating a localized high-concentration zone. This local quality approach ensures effective neutralization where it is most needed (at the interface with stoma output) while minimizing the amount of neutralizer required and simplifying the manufacturing process compared to distributing neutralizer throughout the entire wafer structure.

Inventive Principle:
Principle #3Local quality

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 layer effectively neutralizes the harmful components of the stoma output, preventing skin maceration and adhesive degradation, thereby reducing leakage and discomfort for the user, and maintaining the integrity of the ostomy appliance.

Implementation Method 1

a release layer configured to releasing a neutralizer on the distal side of the backing layer... which releases neutralizing substances such as AMBERLITE IRA 958 chloride, DEUREX Pure, and trypsin inhibitors into the peristomal gap to neutralize the output

Methodology Applied
Scientific EffectNeutralization: Chemical Bonding

Data Source

PatentUS11911310B2Adhesive wafer with a neutralizer matrix
Publication Date: 2024.02.27 COLOPLAST AS
  • US11911310B2 patent drawing
  • US11911310B2 patent drawing
  • US11911310B2 patent drawing

AI summary

An adhesive wafer for an ostomy device, the wafer comprising a skin-facing adhesive layer, a backing layer on the non-skin-facing side of the adhesive layer, and a hole for accommodating a stoma. On the central portion of the backing layer is located a release layer being configured to release a neutralizer. The neutralizer is capable of neutralizing or at least minimizing the level of skin or adhesive aggressiveness of the output.