Blinding Device With Rotatable Lid For Clinical Trial Container Concealment
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Solution Overview
Problem
Existing blinding measures for clinical study containers are insufficient when preparations in identical containers have visual differences, such as color or consistency, and additional identification like colored sealing caps are used, as they do not completely obscure the container's identity.
Innovation Solution
A blinding device with a rigid, hard-shell cover and a rotatable lid that removes the sealing cap and positions a sampling point for needle access, ensuring the container is completely blinded by rotating the lid to remove the cap and position it laterally, allowing for sampling while maintaining container identity concealment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If an opaque cover is used to blind containers, then visual differentiation between preparations is prevented, but additional identification features like colored sealing caps can still reveal container identity
Solution Approach 1:
The blinding device is segmented into multiple functional components: a blinding cover that obscures the container, a rotatable lid with eccentric axis that provides both sealing and sampling functions, and a gripper mechanism for cap removal. This segmentation allows each component to address specific aspects of the blinding requirement without compromising overall effectiveness.
Solution Approach 2:
The sealing cap is extracted as a separate removable component from the container closure system. The gripper on the lid specifically targets and removes only the cap, leaving the blinding cover intact. This extraction eliminates the visual identification feature while maintaining the blinding effect.
2Loss of information
If a rigid hard-shell cover is used instead of a deformable cover, then container identity concealment is improved, but the ease of operation for sampling may be reduced
Solution Approach 1:
The lid is designed with rotational movement capability around an eccentric axis, transforming the static rigid cover into a dynamic system. This allows the lid to be rotated to different positions: covering the sampling point during storage to maintain blinding, and exposing the sampling point during operation to enable easy access.
Solution Approach 2:
The lid serves multiple functions: it acts as a sealing element, provides a mounting structure for the gripper and sampling point, enables rotational movement for sampling access, and maintains the rigid blinding structure. This multi-functionality resolves the contradiction between rigidity for concealment and operability for sampling.
3Ease of operation
If the lid is rotatable relative to the container with an eccentric axis, then sampling access is enabled while maintaining blinding, but the device complexity increases
Solution Approach 1:
The lid rotates around an eccentric axis rather than a central axis, creating an asymmetric rotation pattern. This asymmetry allows the sampling point to be positioned optimally during rotation while maintaining the blinding cover's effectiveness. The asymmetric design enables sampling access without requiring complex additional mechanisms.
Data Source
AI summary
A blinding cover completely surrounding the container comprises an axially movable and twistable lid that has means for gripping the sealing cap of the container and has a sampling point for a sampling needle. By axially moving and twisting the lid, the sealing cap is removed from the container, and the sampling point is positioned above the open container.