Lockable Vial Sleeve for Blinded Clinical Trials
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Solution Overview
Problem
Conventional label exposure on cryogenic vials poses challenges, particularly in blinded clinical trials where drug details need to be obscured, and there is a need for secure labeling of cryogenically stored vials containing autologous and allogeneic cell therapies.
Innovation Solution
A lockable vial sleeve assembly with a locking member that rotatably locks with the vial sleeve, allowing the vial to be securely housed and preventing label exposure, featuring a recess entrance, channel, and lock mechanism, along with a locking plate with tabs that engage with elongated channels to prevent vial removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If a label is adhered to the side wall of the cylindrical body for identification, then the product can be identified, but the label may be exposed to view which is undesirable in blinded studies
Solution Approach 1:
The system segments the identification function into two parts: a permanent label on the vial and a controllable sleeve that can be rotated to either expose or hide the label. This allows the label information to be separated from the viewing mechanism, enabling selective visibility.
Solution Approach 2:
The sleeve is designed to be rotatable relative to the vial, transitioning between static positions that either expose or conceal the label. This dynamic capability allows the same system to serve both identification and blinding functions depending on the rotational position.
2Loss of information
If a lockable sleeve is used to hide the label, then label exposure is prevented, but the device complexity increases
Solution Approach 1:
The locking mechanism and the label-hiding function are merged into a single integrated system. The same rotational motion that positions the sleeve to hide the label also engages the locking features, eliminating the need for separate locking and concealing mechanisms.
Solution Approach 2:
The locking mechanism is designed to be self-actuating through the rotational motion itself. As the sleeve is rotated into the blind position, the locking features automatically engage without requiring additional steps or components, making the system self-servicing.
3Reliability
If the locking member rotatably locks with the vial sleeve, then the vial is securely locked, but the ease of operation for insertion and removal decreases
Solution Approach 1:
The system is designed so that the locking action occurs automatically as a preliminary result of the rotational insertion process. The locking features engage before the vial is fully inserted, providing security upfront without requiring a separate locking step.
Solution Approach 2:
Instead of requiring separate actions for insertion and then locking, the system inverts the sequence by achieving both insertion and locking through a single rotational motion. The locking is embedded within the insertion process itself, simplifying the overall operation.
Data Source
AI summary
A lockable vial sleeve assembly includes a sleeve configured to house a vial, the sleeve defining a body and a first opening provided at one end of the body, the first opening configured to receive the vial therethrough. A locking member is configured to pivotably lock to the sleeve adjacent the one end. The vial is insertable into the body through the first opening, and in response to the locking member being pivotably locked to the sleeve, the locking member at least partially closes the first opening to restrict withdrawal of the vial through the first opening.