Conformal Stoma Plug and Flange Sealing for Tube Leakage
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Solution Overview
Problem
Existing feeding tubes and similar medical devices experience leakage due to friction against the skin at the stoma site, leading to skin irritation, wounds, and potential infections, which current bandages fail to prevent effectively.
Innovation Solution
A stoma site protection device with a plug that conforms to the stoma tract, reducing friction and providing a secure fit, combined with a bumper and bandage system to stabilize the tube and detect leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If a feeding tube is secured with an external retention ring and internal retention feature, then the tube remains in place for several months, but friction against the skin at the stoma site causes leakage, skin irritation, and wounds
Solution Approach 1:
A protective device is introduced as an intermediary component between the feeding tube and the patient's skin. This protective device includes a plug portion that fits within the stoma tract and a flange portion that sits on the external skin surface, creating a barrier that prevents direct friction contact between the feeding tube and skin while maintaining secure tube retention
Solution Approach 2:
The protective device utilizes a flexible, conformable structure that adapts to the contours of the stoma tract and surrounding skin. The plug portion is designed to flexibly fit within the stoma opening, while the flange portion provides a sealing interface against the skin surface, preventing gastric fluid leakage without causing irritation
2Stability of the object's composition
If the external retention ring is used to secure the feeding tube, then the tube stays in position, but the ring slips which breaks the seal at the stomach/intestinal wall and allows gastric fluid to leak
Solution Approach 1:
The protective device is divided into distinct functional segments: a plug portion that interfaces with the stoma tract interior to maintain positioning, and a flange portion that interfaces with the external skin surface to prevent leakage. This segmentation allows each component to optimize its specific function without compromising the other
Solution Approach 2:
The protective device adds a dimensional layer between the feeding tube retention components and the skin/stoma interface. By introducing this intermediate structure, the system maintains tube stability through the plug portion while the flange portion creates a new sealing dimension that prevents gastric fluid leakage even when retention rings slip
3Object-affected harmful factors
If a bandage is applied to protect the stoma site, then some coverage is provided, but it fails to prevent leakage and skin irritation effectively
Solution Approach 1:
Rather than using a bandage as a passive external covering, the protective device acts as an active intermediary barrier that directly addresses the leakage source. The flange portion creates a seal at the stoma opening that actively prevents gastric fluid escape, while the plug portion maintains tube positioning to prevent seal breakdown
Solution Approach 2:
The protective device converts the potential harm of gastric fluid leakage into a beneficial sealed system. By creating a reliable seal at the stoma interface, the device transforms the leakage problem into a controlled environment where gastric fluid is contained, and the tube positioning is stabilized without causing skin damage
Data Source
AI summary
Stoma site protection devices, kits, assemblies and methods are provided that prevent or minimize leakage from a stoma. A stoma site protection device includes a conformal plug that can adapt to the stoma track. Kits and assemblies include additional components such as flexible external bumpers and bandages that provide multiple sealing of the stoma.