Secure Reconstitution Device with Integrated Needle Hub
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Solution Overview
Problem
Conventional pharmaceutical reconstitution processes are prone to errors, tampering, and needle stick injuries due to the handling of multiple components and open needles, and lack secure access control, especially when dealing with toxic substances.
Innovation Solution
A secure fluid transfer system comprising a vial socket, housing, needle hub, and cartridge with a plunger and septum, designed to minimize access to components until reconstitution is complete, using a tamper-evident and non-removable design to prevent misuse and reduce needle handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional reconstitution processes use multiple separate components and open needles, then ease of operation is improved, but safety and reliability deteriorate due to tampering risks and needle stick injuries
Solution Approach 1:
The patent combines multiple separate components (vial, cartridge, needle hub, latches) into a single integrated secure reconstitution device. The housing unifies these elements, preventing tampering while maintaining operational functionality. The needle hub integrates both the cartridge needle and vial needle components, reducing the number of separate handling elements.
Solution Approach 2:
The device is segmented into distinct functional modules (vial socket, cartridge housing, needle hub, latch mechanisms) that are releasably connected. This allows the device to maintain security during storage and transport, then be easily separated into functional components during operation, balancing safety with ease of use.
2Reliability
If the vial is non-removably retained in the vial socket, then reliability is improved by preventing tampering, but ease of operation worsens due to restricted access
Solution Approach 1:
The vial retention system transitions from a static locked state to a dynamic released state through the latch mechanism. The latches engage with the vial neck to secure it during storage and transport, then can be actuated to release the vial when needed, providing conditional access control that adapts to operational requirements.
Solution Approach 2:
The latch mechanism serves as an intermediary between the secure locked state and the accessible released state. It mediates access to the vial by requiring specific action (actuating the latch) to transition from secured to accessible, preventing unauthorized removal while allowing legitimate access.
3Reliability
If the housing surrounds the latches to prevent access, then reliability is improved by preventing tampering, but ease of repair worsens due to reduced accessibility
Solution Approach 1:
The housing acts as an intermediary protective structure that surrounds and secures the latch mechanisms during normal operation and storage. When repair or maintenance is needed, the housing can be opened or accessed through designated access points, allowing service while maintaining security during use.
Data Source
AI summary
A reconstitution device comprising a cartridge containing a first substance having a plunger at one end and a pierceable septum at a second end, a vial containing a second substance having a pierceable septum, a housing, a cartridge needle hub) having a needle protruding therefrom, a vial needle hub having a needle protruding therefrom, the vial needle hub and the cartridge needle hub being releasably securable together, cartridge holder latches holding the cartridge needle hub within the housing, vial needle hub latches extending to engage the housing, and a plunger rod having an inner portion engageable with the plunger of the cartridge and having an outer portion adapted to engage the vial socket latches to release the vial needle hub from engagement with the cartridge needle hub, whereby the vial and the vial needle hub are releasable from the housing.