Pressure-Regulating Vial Adaptor With Controlled Enclosure Expansion
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Solution Overview
Problem
Existing systems for extracting fluids from medicinal vials face issues with pressure differentials leading to fluid leakage, inaccurate measurements, and contamination risks due to exposure to ambient air, particularly for volatile and hazardous drugs.
Innovation Solution
A vial adaptor with a regulator assembly that includes a flexible enclosure and a cover mechanism to control pressure differentials, preventing fluid leakage and contamination by ensuring the flexible enclosure expands only after the cover is partially removed, allowing for controlled fluid injection and withdrawal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the flexible enclosure is allowed to expand freely, then pressure equalization is improved, but premature expansion before cover removal causes contamination and leakage
Solution Approach 1:
The cover is designed with a tear-off mechanism that must be manually activated before the flexible enclosure can expand. This preliminary action ensures that the enclosure expands only after the user is ready and the vial is properly positioned, preventing premature expansion that would cause contamination or leakage.
Solution Approach 2:
The cover acts as an intermediary barrier between the flexible enclosure and the external environment. It controls when the enclosure can expand by requiring manual tear-off, thereby mediating between the pressure equalization function and the contamination risk.
2Ease of operation
If the cover is removed completely, then fluid access is improved, but loss of pressure control leads to leakage
Solution Approach 1:
The cover is segmented into a main body and a tear-off portion. The main body remains in place to maintain pressure control, while the tear-off portion can be manually removed to allow expansion. This segmentation enables selective access without complete removal of the protective cover.
Solution Approach 2:
The cover transitions from a static sealed state to a dynamic tear-off state. The tear-off mechanism allows the cover to change its sealing function based on user action, providing pressure control when needed and access when required.
3Productivity
If the piercing member is inserted first, then fluid extraction is enabled, but pressure differential causes leakage before cover removal
Solution Approach 1:
The piercing member is inserted and the vial is positioned before the cover is removed. This sequence ensures that the piercing member is already in place for fluid extraction, while the cover remains in position to prevent leakage until the user is ready to proceed.
Solution Approach 2:
The system maintains continuous readiness for fluid extraction while preventing leakage through the cover barrier. The piercing member remains in place and the cover stays sealed until the tear-off action is performed, ensuring continuous useful action without interruption.
Data Source
AI summary
A vial adaptor can include a connector interface and/or a piercing member. The vial adaptor can include a regulator assembly. The regulator assembly can include a regulator base, a regulator nest coupled with the regulator base, and/or a storage chamber formed at least partially by one or both of the regulator base and regulator nest. The regulator assembly can include a cover connected to one or both of the regulator base and regulator nest and fitted around a radially outward portion of one or both of the regulator base and regulator nest. In some cases, the regular assembly includes a flexible enclosure connected to the regulator nest and configured to transition between a contracted configuration and an expanded configuration. In some cases, the flexible enclosure is inhibited from transitioning to the expanded configuration prior to removal or modification of the cover from the regulator assembly.