Single-Use Endoscope Valve Assembly That Blocks Reuse
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Solution Overview
Problem
Existing medical device valves, particularly those used in endoscopes, face challenges in preventing reuse and differentiation from procedural valves, leading to potential contamination and incorrect fluid delivery during procedures.
Innovation Solution
A valve assembly with a transition mechanism that changes states in response to utilization, blocking fluid communication and preventing reuse, while featuring distinct design elements to differentiate it from procedural valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-use valve is designed to be simple and cost-effective, then it can be discarded after one use, but it risks being inadvertently reused
Solution Approach 1:
The valve assembly automatically transitions to a non-functional state after a single use through pre-programmed mechanical changes. The valve stem portions separate and the lumen becomes blocked before the user can attempt reuse, eliminating the need for complex electronic tracking or identification systems while preventing inadvertent reuse
Solution Approach 2:
The valve is designed as a single-use disposable device with built-in destruction mechanisms. After one use, the valve stem separates into proximal and distal portions and the lumen blocks, rendering the device permanently non-functional. This allows use of simpler, cheaper materials and construction methods compared to reusable valves, while ensuring the device cannot be reused
2Adaptability or versatility
If a cleaning valve is made visually similar to a procedural valve, then it can be used in the same valve cylinder, but it risks being confused and used in place of the procedural valve during a procedure
Solution Approach 1:
The interface member incorporates distinct visual features at specific locations - such as color coding, patterns, or text - that differentiate the cleaning valve from procedural valves. These localized visual qualities allow the valve to maintain mechanical compatibility with the valve cylinder while providing clear visual cues to prevent confusion and incorrect use during procedures
3Reliability
If the valve stem remains intact after use, then it can be easily stored, but it risks being reused which causes contamination
Solution Approach 1:
The valve stem is designed as a two-piece construction with proximal and distal portions that are joined during assembly but automatically separate after use. This segmentation allows the valve to be manufactured using standard molding techniques while ensuring that after a single use, the portions separate and the device becomes non-functional, preventing reuse and contamination
Solution Approach 2:
The valve incorporates a transition deposit or weak point that changes its mechanical properties after exposure to fluid flow or pressure changes during use. This parameter change causes the valve stem portions to separate or the lumen to block, automatically transitioning the valve from a functional to a non-functional state and preventing reuse
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
Ensures single-use functionality and correct fluid delivery by transitioning to a non-functional state upon use, thereby preventing reuse and reducing the risk of contamination.
Implementation Method 1
the lumen includes a transition deposit comprising a material configured to expand and fill a portion of the lumen when the material is exposed to a liquid
Data Source
Figure 1
Figure 2A~2B
Figure 3A~3B
AI summary
The cleaning valves (or valves) of the current disclosure are generally single-use devices (SUDs) and therefore disposable. Reusing SUDs can be disadvantageous, as single-use devices are not designed to be reusable. Accordingly, valves (or valve assemblies) for medical devices, such as endoscopes, disclosed may be configured to transition from a first state to a second state in response to utilization of the valve, e.g., to control fluid flow through a valve well. The transition from the first state to the second state may prevent reuse of valves of the present disclosure. For instance, a lumen between first and second orifices in a valve stem may be blocked or disconnected.