Tracheostoma Holder Flange Segmentation for Sunken Stoma Adhesion

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Solution Overview

Problem

Existing tracheostoma device holders are inadequate for patients with sunken stomas, as they struggle with adhesion, deformation, and application due to limited adhesive area, stiffness, and uniform plasticity, leading to poor holding and increased risk of loosening under speech pressure.

Innovation Solution

A tracheostoma device holder with a tubular portion and a flange that includes a skin-adhesive proximal side and a reinforced distal side, featuring bracing means that provide higher resistance in the caudal/cranial direction to prevent flipping, and non-adhesive covering sheets for improved application and skin contact, allowing for secure attachment to sunken stomas without cutting the sternocleidomastoid muscles.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the adhesive area is increased to improve holding, then the device adheres better to the skin, but the device deforms under speech pressure

Engineering Contradiction:
Improveholding stabilityVSAvoiddevice shape stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The flange is divided into multiple segments (first flange segment, second flange segment, third flange segment) that can independently deform. This segmentation allows the adhesive areas to maintain contact with the skin while accommodating shape changes, resolving the contradiction between needing large adhesive area for stability and maintaining device shape under pressure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the flange have different adhesive properties - the first and second flange segments have adhesive areas while the third flange segment has a non-adhesive covering sheet. This local differentiation allows specific areas to adhere to the skin for stability while other areas remain flexible to prevent deformation under speech pressure.

Inventive Principle:
Principle #3Local quality

2Strength

If the device is made stiffer to resist deformation, then the device maintains its shape, but it becomes difficult to apply to sunken stomas

Engineering Contradiction:
Improveresistance to deformationVSAvoidapplication ease
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The flange is designed with dynamic characteristics - it has sufficient stiffness to resist deformation under speech pressure but contains flexible segments that allow it to conform to sunken stoma geometries during application. The covering sheet can be removed to expose adhesive areas only when needed, allowing the device to transition between flexible (during application) and stiff (during use) states.

Inventive Principle:
Principle #15Dynamics

3Reliability

If the adhesive area is increased to improve holding, then the device adheres better, but the application process becomes more difficult

Engineering Contradiction:
Improveadhesion strengthVSAvoidapplication difficulty
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The third flange segment is pre-covered with a non-adhesive covering sheet that protects the adhesive areas during application. The covering sheet is removed only when the device is positioned correctly, exposing the adhesive areas for bonding. This preliminary protection simplifies the application process by preventing premature adhesion while still providing strong holding once applied.

Inventive Principle:
Principle #10Preliminary action

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 device securely holds tracheostoma devices on sunken stomas, reducing the risk of loosening and deformation, facilitating easy application, and ensuring effective airflow control with improved resistance to speech pressure, accommodating various stoma configurations without the need for muscle cutting.

Implementation Method 1

at least a part of said proximal side being skin adhesive

Methodology Applied
Scientific EffectAdhesive: Adhesive

Data Source

PatentUS9814852B2Tracheostoma plaster
Publication Date: 2017.11.14 COLOPLAST AS
  • US9814852B2 patent drawing
  • US9814852B2 patent drawing
  • US9814852B2 patent drawing

AI summary

A device for holding a tracheostoma device over a tracheostoma of a patient including a passage having a distal and a proximal opening for receiving the tracheostoma device at the distal opening thereof. A flange may extend laterally, caudially, and cranially from the passage. The flange may have a proximal side facing the tracheostoma of the patient and a distal side facing outwardly from the patient. At least a part of said proximal side may include skin adhesive. The flange may have a higher moment of resistance in the caudal/cranial direction than in the lateral/medial direction for said device by having a higher moment of resistance in the caudal/cranial direction than in the lateral/medial direction for at least a part of said flange.