Tracheostomy Tube Flange Inserts for Tear-Resistant Tie Openings

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Solution Overview

Problem

Tracheostomy tubes with flanges made of soft plastics materials face issues of insufficient strength, leading to potential damage from neck straps or sutures, and risk of reinforcement members separating and being inhaled.

Innovation Solution

Incorporating hollow inserts of harder plastics materials with radially-enlarged heads into the flange openings, where the inserts have a smooth patient-facing surface and a passage for neck ties or sutures, securely retained with a radially-extending head to prevent separation and ensure strength.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the flange is moulded from a soft plastics material to allow flexing and conformity to the patient's neck, then the comfort and adaptability are improved, but the strength and resistance to tearing from neck straps or sutures deteriorates

Engineering Contradiction:
Improveflange conformabilityVSAvoidflange strength
Core Design Contradiction:
Adaptability or versatilityVSStrength

Solution Approach 1:

The invention combines a soft flange material (silicone or soft plastic) with harder plastic inserts to create a composite structure. The soft flange provides comfort and conformability to the patient's neck, while the harder plastic inserts embedded within the flange provide the necessary strength and resistance to tearing from neck straps or sutures.

Inventive Principle:
Principle #40Composite materials

2Strength

If an additional reinforcement member is added around the neck strap openings to increase strength, then the resistance to tearing is improved, but the risk of the reinforcement member separating and being inhaled increases

Engineering Contradiction:
Improveopening reinforcementVSAvoidinhalation risk
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The harder plastic inserts are nested within the soft flange material, with the inserts being completely enclosed by the flange. This nesting arrangement provides reinforcement at the opening while eliminating the risk of the reinforcement member separating and being inhaled, as the hard insert is permanently housed within the soft flange structure.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Ease of manufacture

If the flange is made as a one-piece component with the shaft, then the manufacturing simplicity is improved, but the ability to provide localized reinforcement at openings deteriorates

Engineering Contradiction:
Improvemoulding simplicityVSAvoidlocalized reinforcement
Core Design Contradiction:
Ease of manufactureVSStrength

Solution Approach 1:

The invention segments the flange structure by incorporating separate harder plastic inserts within the soft flange material. This segmentation allows the majority of the flange to be moulded as a simple one-piece component for ease of manufacture, while specific localized areas (at the openings) receive additional reinforcement from the embedded inserts.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP4138966B1Tracheostomy tubes and their manufacture
Publication Date: 2024.01.31 ICU MEDICAL INTERNATIONAL LTD
  • EP4138966B1 patent drawingFigure 1
  • EP4138966B1 patent drawingFigure 2~3
  • EP4138966B1 patent drawingFigure 4~5

AI summary

The neck flange 3 of a tracheostomy tube is of a soft plastics such as silicone and has neck tie or suture openings 35 at opposite ends reinforced to prevent damage to the flange. The openings are reinforced by tubular inserts 38 of a harder plastics. The patient end of each insert has an enlarged, radially extending head 41 sitting flush in an enlarged recess 43 around the patient end of each opening. The opposite end of each insert also has an enlarged head 42 overlapping the flange but formed after the insert has been inserted in the flange. The opposite end head 42 may be heat formed from the end of the insert or may be a separate component clipped onto the end of the insert.