Single-Use Endoscope Cleaning Valve With Irreversible Flow Blocking
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Solution Overview
Problem
Current medical cleaning valves for endoscopes are prone to reuse and confusion with procedural valves, leading to potential bacterial exposure and incorrect fluid delivery during procedures, and lack distinct features to prevent inadvertent use during procedures.
Innovation Solution
A valve assembly that transitions from a first state to a second state upon utilization, blocking fluid communication and preventing reuse, featuring a valve stem with a lumen and transition deposit that changes state upon exposure to liquid, and a design that differentiates it from procedural valves through linkage mechanisms and materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a single-use valve is designed without distinct features, then it is simpler to manufacture and use, but it may be inadvertently reused or confused with procedural valves
Solution Approach 1:
The valve stem incorporates a colored band or colored material that visually distinguishes the cleaning valve from procedural valves. This color coding system provides an immediate visual cue to operators, preventing confusion and inadvertent reuse while maintaining simple valve construction and operation.
Solution Approach 2:
The valve stem features an asymmetric shape with non-circular cross-section (such as oval or flattened circular) that differs from procedural valves. This asymmetric geometry provides tactile and visual differentiation, ensuring the cleaning valve cannot be mistakenly inserted into procedural valve receptacles and preventing inadvertent reuse.
2Reliability
If a valve assembly includes state transition mechanisms to prevent reuse, then reliability is improved, but device complexity increases
Solution Approach 1:
The valve assembly incorporates a phase change material that transitions from solid to liquid or gel state upon exposure to moisture or heat during the cleaning process. This phase transition permanently alters the valve's internal structure, blocking fluid flow paths and preventing any subsequent reuse, while adding minimal structural complexity to the overall assembly.
Solution Approach 2:
The valve utilizes parameter changes in the form of irreversible deformation or chemical reaction triggered by exposure to cleaning solutions or specific temperature ranges. These parameter changes permanently modify the valve's functional properties, ensuring it cannot be reused, while maintaining a relatively simple assembly structure without complex mechanical components.
3Strength
If the valve stem components are permanently fixed together, then structural integrity is maintained, but the valve cannot transition to a non-reusable state
Solution Approach 1:
The valve stem is divided into multiple segments or components that are initially held together by a temporary bonding mechanism. During the cleaning process, this temporary bond irreversibly breaks or transforms, causing the segments to separate or permanently shift position, thereby transitioning the valve to a non-reusable state while maintaining structural integrity during normal operation.
Solution Approach 2:
The valve stem incorporates dynamic components with reversible and irreversible states. During normal use, components remain firmly assembled providing structural strength. Upon exposure to cleaning conditions, a trigger mechanism causes irreversible structural change such as permanent deformation, separation, or locking, transitioning the valve to a non-functional state while maintaining integrity during the operational phase.
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, prevents bacterial exposure by ensuring the valve cannot be reused, and differentiates it from procedural valves to prevent incorrect use during procedures, enhancing cleaning efficiency and safety.
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
Implementation Method 2
the proximal portion of the valve stem is fixed relative to the distal portion of the valve stem by a molded weak point in the first state
Data Source
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.