Tracheostomy Tube Flange Overmoulded Silicone Inserts
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Solution Overview
Problem
Tracheostomy tube mounting flanges made of soft silicone materials face issues with strength and abrasion resistance, leading to potential decannulation and infection risks due to separation of reinforcement members and bacterial harboring, especially when using hook and loop fasteners or sutures.
Innovation Solution
The flange is overmoulded with heat-cured silicone rubber inserts of similar hardness, providing a secure bond and enhanced abrasion resistance without compromising the soft and conformable nature of the silicone material, eliminating the need for priming and reducing the risk of separation or bacterial accumulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the flange is made of soft silicone material to ensure conformability and comfort, then the patient comfort and conformability are improved, but the abrasion resistance and strength are worsened
Solution Approach 1:
The flange is constructed as a composite structure combining soft silicone material for conformability with heat-cured silicone rubber inserts for abrasion resistance. The heat-cured inserts are integrated into the flange at strategic locations (openings and periphery) to provide reinforcement while the main body remains soft for patient comfort.
2Strength
If reinforcement members are added to improve strength and abrasion resistance, then the abrasion resistance is improved, but the risk of separation and bacterial harboring is worsened
Solution Approach 1:
The invention changes the material parameters of the reinforcement inserts by using heat-cured silicone rubber with specific durometer (20-40 Shore A) that provides both strength and biocompatibility. The curing process creates a durable bond between the insert and flange material, reducing separation risk.
Solution Approach 2:
Reinforcement is applied locally only where needed (at the openings and periphery of the flange) rather than throughout the entire flange. This localized reinforcement maintains the overall softness and conformability of the flange while providing strength exactly where the neck strap applies force.
3Strength
If harder plastics reinforcement members are used to improve abrasion resistance, then the abrasion resistance is improved, but the compatibility with autoclave cleaning is worsened
Solution Approach 1:
The reinforcement inserts are made from heat-cured silicone rubber that has been treated to withstand autoclave temperatures. The material parameters are specifically selected to maintain structural integrity and abrasion resistance after exposure to high-temperature sterilization processes.
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 ensures a strong, durable, and bacteria-resistant tracheostomy tube flange that maintains conformability and withstands prolonged use and flexing, preventing decannulation and infection risks while being suitable for autoclave cleaning.
Implementation Method 1
The mounting flange is of a soft plastics material overmoulded on two reinforcement inserts at respective ones of the openings
Implementation Method 2
Mounting flanges made of some silicone materials, such as liquid silicone rubber have a poor abrasion resistance, particularly to abrasion by ties of a relatively stiff material
Implementation Method 3
the flange is of a first silicone material overmoulded on two reinforcement inserts... providing a secure bond and enhanced abrasion resistance without compromising the soft and conformable nature of the silicone material
Implementation Method 4
Certain materials used to reinforce the flange openings might be damaged by elevated temperatures, thereby making the entire tube unsuitable for autoclave cleaning
Data Source
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AI summary
A tracheostomy tube flange (13) of a liquid silicone material has openings (14) towards opposite ends for receiving ends of a neck strap. The openings (14) are reinforced with overmoulded inserts (137, 138) of a heat cured silicone material having a similar hardness to that of the flange material. The inserts (137, 138) have an outwardly-projecting ledge (144) between their ends.