Moisture-Responsive Ostomy Convex Element for Leakage and Skin Irritation

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Solution Overview

Problem

Conventional ostomy appliances with convex base plates are either too stiff, leading to discomfort and skin irritation, or too flexible, resulting in inadequate pressure and increased leakage risks due to their inability to maintain constant contact with the stoma and adapt to individual stoma shapes.

Innovation Solution

A base plate with a convex element made from a material that reacts to moisture, maintaining convexity and providing a customizable, flexible fit while reducing the risk of skin irritation, by softening or swelling when exposed to mucus or output, thus enhancing the seal and reducing leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a stiff pre-cast or moulded convex unit is used, then the ability to maintain constant pressure against peristomal skin and prevent leakage is improved, but the comfort and skin health deteriorate due to pressure wound ulceration, bruises and irritation

Engineering Contradiction:

Improveleakage preventionVSAvoidskin damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by using a material that changes its physical properties in response to moisture exposure. The convex element starts in a relatively stiff state to provide structural support and pressure, then transitions to a softer state when exposed to moisture from the stoma, thereby maintaining leakage prevention while reducing skin damage risk

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs composite materials by combining the convex element made from moisture-reactive material with the adhesive wafer and backing layer. This composite structure allows the convex element to provide initial structural support while the moisture-reactive properties enable adaptive softening, creating a system that balances support and comfort

Inventive Principle:

Principle #40Composite materials

2Force

If a stiff pre-cast or moulded convex unit is used, then the ability to provide reactive force for stoma protrusion is improved, but the adaptability to individual stoma shapes and movements deteriorates

Engineering Contradiction:

Improvereactive forceVSAvoidadaptability to stoma shape

Core Design Contradiction:

ForceVSAdaptability or versatility

Solution Approach 1:

The patent applies dynamics by creating a convex element that transitions from a static stiff structure to a dynamic moisture-responsive structure. The element adapts its properties based on environmental conditions (moisture exposure), allowing it to provide reactive force initially and then adapt to the stoma's shape and movements as it softens

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent uses parameter changes by leveraging the moisture-induced physical transformation of the convex element material. This transformation allows the element to maintain its shape-providing capability while becoming more adaptable to individual stoma geometries and peristomal skin movements

Inventive Principle:

Principle #35Parameter changes

3Strength

If a stiff pre-cast or moulded convex unit is used, then the ability to withhold peristomal skin from collapsing is improved, but the ease of operation and customization deteriorates due to inability to cut or reshape

Engineering Contradiction:

Improveskin supportVSAvoidcustomization

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

The patent applies parameter changes by using a material that transitions from a relatively rigid state during storage and application to a softer, more formable state when exposed to moisture. This allows the convex element to maintain its structural integrity during handling while becoming more adaptable to customization needs after application

Inventive Principle:

Principle #35Parameter changes

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 higher reactive force to the peristomal skin, maintaining adequate stoma protrusion and significantly reducing leakage by ensuring a secure, customizable fit without causing skin damage, while maintaining structural integrity and comfort.

Implementation Method 1

the innermost edge of the convex element is provided with a lubricating character, in that the material of the convex element changes from a solid state to a semi-liquid state upon exposure to moisture

Methodology Applied

Scientific EffectSwelling:

Implementation Method 2

the material of the convex element changes from a solid state to a semi-liquid state upon exposure to moisture

Methodology Applied

Scientific EffectMoisture absorption: Absorption (physical)

Implementation Method 3

the innermost edge of the convex element is provided with a lubricating character

Methodology Applied

Scientific EffectLubrication: Lubrication

Data Source

PatentUS11484432B2Ostomy appliance having a lubricating edge

Publication Date: 2022.11.01 COLOPLAST AS

AI summary

An ostomy appliance has a base plate and a convex element. The base plate includes a film and an adhesive disposed on a proximal surface of the film, with the convex element attached to a distal surface of the film. A first hole is formed in the base plate and a second hole is formed in the convex element and co-axially aligned with the first hole. The second hole defines an inner perimeter edge that provides a lubricating edge that changes from a solid state to a semi-liquid state when exposed to moisture.