Secure Reconstitution Device with Latch-Actuated Vial Release
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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 steps, and lack secure access control for toxic or valuable drugs.
Innovation Solution
A secure fluid transfer system with a vial socket and cartridge assembly that minimizes access to components, using a housing with latches to securely retain the vial and cartridge, and a needle hub with piercing ends to facilitate controlled mixing and dispensing without manual needle handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional reconstitution processes are used with multiple separate components and manual needle handling, then flexibility and ease of manufacture are improved, but error rates increase, needle stick injuries occur, and access control is compromised
Solution Approach 1:
The patent combines multiple separate components (vial, cartridge, needle hub, latches) into an integrated secure reconstitution system where all elements are housed within a single protective housing. This merging eliminates manual needle handling while maintaining operational functionality, directly resolving the contradiction between manual flexibility and safety reliability.
Solution Approach 2:
The patent employs a nested structure where the vial is retained within the vial socket, the cartridge is positioned within the housing, and the needle hub connects both components. This nesting arrangement allows compact integration of multiple functional elements while maintaining individual component integrity and access control.
2Reliability
If access to vial and cartridge components is minimized through secure housing and latches, then tampering is prevented and reliability is improved, but device complexity increases
Solution Approach 1:
The patent divides the secure housing into distinct functional segments: a vial socket portion for securing the vial, a cartridge portion for holding the cartridge, and interconnecting latch mechanisms. This segmentation allows each component to perform its specific security function independently, reducing overall system complexity while maintaining comprehensive access control.
Solution Approach 2:
The latch mechanisms serve as intermediary elements that mediate between the housing structure and the components (vial and cartridge). These latches provide controlled access by mechanically interfacing with the components without requiring direct manual manipulation of the components themselves, thus simplifying the access control mechanism.
3Reliability
If the vial is non-removably retained in the vial socket with latches, then access control is improved and tampering is prevented, but ease of manufacture and adaptability decrease
Solution Approach 1:
The patent employs dynamic latch mechanisms that can transition between locked and unlocked states. The latches are designed to securely retain the vial during the reconstitution process, yet can be released to allow vial removal after use. This dynamic behavior provides both secure retention during operation and adaptability for component replacement.
Data Source
AI summary
A reconstitution device comprising a cartridge (212) containing a first substance, the cartridge having a plunger (238) at one end and a piercable septum (222) at a second end, a vial (218) containing a second substance, the vial having a piercable septum (224), a housing (210), a cartridge needle hub (226), the cartridge needle hub (226) having a needle (228) protruding therefrom, a vial needle hub (229), the vial needle hub having a needle (222) protruding therefrom, the vial needle hub (229) and the cartridge needle hub (226) being releasably securable together, cartridge latches (240) holding the cartridge needle hub (226) within the housing, vial needle hub latches (231) extending to engage the housing, and a plunger rod (232), the plunger rod having an inner portion (234) engageable with the plunger (238) of the cartridge, the plunger rod (232) having an outer portion (236) which is adapted to engage the vial needle hub latches (240) to release the vial needle hub (229) from engagement with the cartridge needle hub (226), whereby the vial (218) and the vial needle hub (229) may be released from the housing.