Closed Vial Adapter Structure for Leak-Proof Hazardous Drug Transfer
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Solution Overview
Problem
Healthcare providers are at risk of exposure to hazardous drugs due to insecure connections or inadvertent disconnection of delivery devices during reconstitution, transportation, and administration, leading to potential health hazards.
Innovation Solution
A vial adapter with a piercing member and fluid ports configured to securely attach to a container, featuring a concave end wall and symmetrical longitudinal shape to facilitate safe and leak-proof fluid transfer, combined with a syringe adapter for closed system fluid handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional delivery devices and adapters are used for hazardous drug transfer, then ease of operation is maintained, but reliability deteriorates due to insecure connections and inadvertent disconnection
Solution Approach 1:
The adapter is divided into distinct functional segments: a body portion, a piercing member with fluid ports, and a syringe adapter component. Each segment performs a specific function (piercing, fluid transfer, sealing) and can be independently optimized. The piercing member is separable from the body, allowing for specialized design of each component to enhance overall reliability without excessive complexity.
Solution Approach 2:
The adapter serves as an intermediary device between the hazardous drug container and the delivery system. It includes an intermediary piercing member that creates a secure connection point, and an intermediary body that houses the fluid ports and sealing mechanisms. This intermediary structure ensures reliable fluid transfer while protecting healthcare providers from direct exposure.
2Reliability
If secure attachment mechanisms are added to prevent disconnection, then reliability improves, but ease of operation deteriorates
Solution Approach 1:
The piercing member is pre-configured with fluid ports and sealing surfaces that automatically engage when inserted into the container. The attachment mechanism is designed so that the piercing action itself creates the secure connection, eliminating the need for separate fastening steps. The body and piercing member are positioned and secured in advance during assembly, ensuring reliable connection without complex operations during use.
3Reliability
If membrane sealing is implemented to prevent leakage, then reliability improves, but device complexity increases
Solution Approach 1:
A membrane sealing element is incorporated into the body of the adapter. This thin film membrane flexibly seals the fluid ports and internal cavities, preventing leakage of hazardous drugs. The membrane is integrated into the body structure rather than being a separate complex sealing mechanism, maintaining simplicity while ensuring reliable leak prevention. The membrane can deform to accommodate slight misalignments while maintaining the seal.
4Reliability
If multiple fluid ports are provided for safe fluid transfer, then reliability improves, but manufacturing precision requirements increase
Solution Approach 1:
The fluid ports are positioned asymmetrically relative to the piercing member axis, with at least one fluid port offset from the axial line. This asymmetric arrangement creates inherent alignment features that guide proper positioning during assembly. The asymmetric port placement also prevents accidental disconnection by creating a unique engagement geometry that must be correctly oriented, thereby reducing the precision requirements for manufacturing while maintaining fluid transfer safety.
Data Source
AI summary
A vial adapter, including a body with a first end, a second end opposite the first end, and a lumen therein, wherein the second end is configured to attach to a container; a membrane adjacent the first end of the body sealing at least a portion of the lumen; and a piercing member extending from the body, the piercing member including: a fluid channel therein in fluid communication with the lumen, a concave end wall at an axial end of the fluid channel, and a sidewall with a plurality of fluid ports therein in fluid communication with the fluid channel.