Tracheostoma Sealing Device With Weakness Line
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Solution Overview
Problem
Current methods for sealing a tracheostoma after decannulation are inadequate, leading to air leakage, infection risks, and hindered healing due to the use of bandages that are either airtight and difficult to manage or absorbing but not effective in maintaining positive air pressure, and they require frequent changes, which can cause skin irritation and delay healing.
Innovation Solution
A device comprising a disc with a predetermined line of weakness and attached threads that can be pulled to form a seal against the tracheostoma and later removed through it, using a combination of threads and an external cover with a constant-force spring to maintain tension and facilitate controlled removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a bandage is used to cover the stoma, then the stoma is protected from infection, but air leakage occurs during speaking and coughing which prevents effective coughing and may cause atelectasis
Solution Approach 1:
The device is divided into two functional parts: an external occlusive element that seals the stoma from the outside, and an internal balloon element that can be inflated to maintain positive air pressure. This segmentation allows each part to perform its specific function optimally without the compromises of a single-bandage solution.
Solution Approach 2:
The balloon acts as an intermediary element between the external occlusive dressing and the tracheal airway. When inflated, it transmits the occlusive force internally while maintaining air pressure, mediating between the external seal and the internal respiratory needs.
2Reliability
If an occlusive bandage is used to seal the stoma, then air leakage is reduced, but the bandage requires frequent changes which causes skin irritation and delays healing
Solution Approach 1:
The device incorporates a dynamic balloon element that can be inflated and deflated as needed, allowing the occlusive properties to be activated only when required for speaking or coughing. This dynamic adjustment reduces the need for frequent complete bandage changes while maintaining effective sealing when needed.
3Ease of operation
If a finger is used to occlude the stoma for speaking, then speech is enabled, but the patient loses the ability to generate necessary air pressure for effective coughing and breathing
Solution Approach 1:
The balloon is designed to be self-inflating through the patient's own respiratory effort. When the patient exhales against the occluded stoma, the generated pressure automatically inflates the balloon, creating positive air pressure without requiring external assistance or manual intervention.
4Speed
If the stoma is left open for breathing, then air flow is maintained, but air passes in and out during normal breathing which reduces the chance of stoma closure
Solution Approach 1:
The occlusive device is designed to be applied periodically rather than continuously - activated during speaking or coughing maneuvers and relaxed during normal breathing. This periodic application allows the stoma to remain open for normal respiratory function while receiving occlusive treatment during specific therapeutic maneuvers that promote closure.
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 effectively seals the tracheostoma to promote healing by preventing air leakage, reduces infection risk, and allows for controlled removal, enabling patients to regain the ability to generate necessary air pressures for effective coughing and breathing, thus aiding in the closure of the stoma without surgical intervention.
Implementation Method 1
an external cover with a constant-force spring to maintain tension
Implementation Method 2
a seal member for insertion through the tracheostoma to the trachea, which in a first configuration can form a seal by being pulled against the tracheostoma
Data Source
AI summary
A device for sealing a tracheostoma in a patient includes a seal member for insertion through the tracheostoma to a trachea. The seal member includes a disc having a predetermined line of weakness. In a first configuration, the seal member forms a seal by being pulled against the tracheostoma. In a second configuration, the seal member is removed from the trachea through the tracheostoma by breaking along the line of weakness.