Two-Way Stoma Plug Valve for Ostomy Reflux and Output Control
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Solution Overview
Problem
Current ostomy devices lack self-control mechanisms for managing liquid or semi-liquid waste, leading to continuous expulsion of biological fluids, which causes physical, psychological, and economic challenges for ostomized patients.
Innovation Solution
A stoma plug with a two-way valve system that includes a tube with openings and a plug, allowing controlled fluid flow through a passive or spring-actuated mechanism, enabling self-regulation of fluid output and reusable design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a collection bag is used to collect fecal or urinary material, then the biological fluids are contained, but the patient experiences continuous expulsion of biological fluids requiring frequent bag changes
Solution Approach 1:
The stoma plug incorporates a two-way valve system with a spring mechanism that automatically opens to allow fluid expulsion when the collection bag is full, and automatically closes to prevent refilling. This self-regulating mechanism eliminates the need for manual operation or frequent device changes, allowing the patient to maintain control over fluid output without continuous intervention.
Solution Approach 2:
The spring mechanism provides automatic feedback by detecting when the collection bag is full and triggering valve opening to expel fluids, then automatically closing to prevent further filling. This feedback loop ensures reliable control over fluid output and eliminates the need for frequent manual checks or device changes.
2Ease of operation
If a reusable stoma plug with two-way valve system is used, then self-control over fluid output is achieved, but the device complexity increases
Solution Approach 1:
The two-way valve system is designed to be self-regulating through an automatic spring mechanism that opens and closes without manual intervention. The spring automatically opens the valve when the collection bag is full and closes it afterward, providing self-control over fluid output while minimizing the operational burden on the patient.
Solution Approach 2:
The complex control functionality is extracted into a separate, dedicated two-way valve system with spring mechanism, while the main stoma plug body remains simple. This allows the self-control mechanism to be isolated and optimized independently, reducing the overall complexity burden on the patient's daily life.
3Device complexity
If manual operation of the valve is required, then device complexity is reduced, but the patient experiences physical and psychological challenges from continuous fluid expulsion
Solution Approach 1:
The spring mechanism provides automatic self-service by detecting when the collection bag is full and triggering valve opening to expel fluids without requiring any manual operation from the patient. This eliminates the physical and psychological challenges associated with continuous fluid expulsion and manual valve operation.
Solution Approach 2:
The spring mechanism automatically provides feedback by opening the valve when the collection bag is full and closing it afterward, creating a self-regulating system that prevents continuous fluid expulsion without requiring patient intervention or complex manual operation.
4Device complexity
If frequent device changes are required, then the valve mechanism remains simple, but economic costs and loss of time increase
Solution Approach 1:
The automatic spring mechanism enables the stoma plug to serve itself by automatically opening to expel fluids when full and closing to prevent refilling. This self-regulating capability eliminates the need for frequent manual device changes, reducing economic costs and time loss while maintaining a relatively simple valve mechanism.
Solution Approach 2:
The spring mechanism ensures continuous useful action by automatically managing valve opening and closing throughout the fluid expulsion cycle. This continuous automatic operation eliminates interruptions for manual device changes, maximizing productivity and minimizing economic and time losses.
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
Provides self-control over stool continence, enhances user confidence, reduces the need for frequent device changes, and offers a cost-effective solution with painless insertion.
Implementation Method 1
the two-way valve system (20) further comprises a spring (27) and a plug stopper (29) comprising at least one opening (21), the base element (22) configured to be slidably receivable by the spring (27), wherein the two-way valve system (20) is configured to passively remain closed such that the spring (27) is configured to press the plug (24) against the plug stopper (29) and close the at least one opening (21) of the two-way valve system (20)
Data Source
AI summary
A stoma plug suitable for controlling the output of biological fluids from a colon, ileum and/or ureter through a stoma created by a colostomy, ileostomy or urostomy, respectively. The stoma plug includes a tube comprising an opening in a proximal portion and at least one opening in a distal portion, a two-way valve system including a base element and a plug, the two-way valve system connected to the tube through the base element, the two-way valve system configured to control the fluid flow through the opening of the proximal portion of the tube, and a cap configured to cover the two-way valve system and the stoma, the cap including an opening to directly access the two-way valve system from the outside. The tube is configured to be inserted into the colon, ileum and/or ureter through its distal portion, and the two-way valve system is configured to passively remain closed and to be opened when the plug is displaced from the at least one opening