Vial Adapter Assembly with Spike and Bladder for Sealed Transfer
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Solution Overview
Problem
Current medical vial systems pose a risk to healthcare providers due to potential leakage or exposure of hazardous drugs during handling, as the seals can fail, allowing drug molecules to escape in vapor form, leading to accidental exposure and safety hazards.
Innovation Solution
A vial adapter assembly with a spike mechanism that penetrates the stopper of a medical vial, allowing for safe transfer of gases/liquids while maintaining a closed system, featuring a bladder for expansion and a seal to prevent leakage, and a vial collar for secure attachment to the vial neck.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a needle is used to inject liquid into the vial, then the vial contents can be reconstituted, but drug molecules can leak or pass around the stopper during needle withdrawal
Solution Approach 1:
The patent introduces a stopper as an intermediary component between the vial contents and the external environment. The stopper is designed to be penetrated by the needle during injection, then seal around the needle to prevent drug vapor leakage during withdrawal. This intermediary element resolves the contradiction by enabling both injection and preventing harmful vapor escape.
Solution Approach 2:
The stopper is pre-designed with properties that enable it to be penetrated by the needle and then automatically seal around the needle. The stopper's material and structural characteristics are prepared in advance to facilitate this two-stage process: initial penetration for injection, then sealing to prevent vapor leakage during needle removal.
2Reliability
If the vial is sealed with a stopper to prevent leakage, then drug safety is improved, but injection and mixing operations become more difficult
Solution Approach 1:
The stopper is designed as a dynamic component that changes its sealing characteristics during operation. Initially, it allows needle penetration for injection. During and after injection, it dynamically seals around the needle to maintain reliability. The stopper's ability to adapt its sealing properties at different stages resolves the contradiction between secure sealing and ease of operation.
3Ease of manufacture
If the vial is opened for liquid injection, then reconstitution can occur, but pressure increase stresses the seal and may cause failure
Solution Approach 1:
The stopper is pre-designed with structural characteristics that cushion and distribute the stress caused by pressure increase during liquid injection. The stopper's material properties and geometric design are prepared in advance to absorb and distribute forces, preventing seal failure even under increased pressure conditions during injection and mixing operations.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The vial adapter assembly effectively prevents drug leakage and exposure by ensuring a secure and controlled transfer of substances, enhancing safety for healthcare personnel handling hazardous medications.
Implementation Method 1
a seal extending across the lumen of the male stem
Implementation Method 2
a bladder extending between the base and the cover
Data Source
AI summary
The present disclosure relates to medical vials pre-attached with a vial adapter assembly for the transfer of gases/liquids/fluid or other substances to/from medical vials.