Vial Access Device Adapter for Closed Fluid Transfer
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Solution Overview
Problem
Healthcare providers face risks of exposure to hazardous chemotherapy drugs during reconstitution, transportation, and administration due to unintentional release of toxic substances when transferring drugs between containers with pressure differentials, leading to gas or aerosolization.
Innovation Solution
A vial access device with a movable adapter system that accommodates vials of different sizes, providing leak-proof sealing and pressure equalization during cannula engagement and disengagement, using a pressure equalization system with an expandable balloon to maintain balanced pressure within the vial.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a needle is used to transfer solvent from one container to a sealed vial, then the drug can be reconstituted, but drugs may be inadvertently released into the atmosphere in gas form or by aerosolization due to pressure differential
Solution Approach 1:
The patent introduces a specialized transfer device that acts as an intermediary between the solvent container and the sealed vial. This device includes a needle assembly integrated into a housing that maintains closed system transfer, preventing direct atmospheric exposure during the transfer process. The intermediary device ensures that the pressure differential is managed within a controlled environment, eliminating the risk of drug release into the atmosphere.
Solution Approach 2:
The patent extracts the harmful element (atmospheric exposure) from the transfer process by using a closed system. The transfer device is designed to maintain a sealed environment throughout the solvent transfer operation, removing the interface between the drug-containing system and the atmosphere that would otherwise allow for gas form or aerosolization release.
2Adaptability or versatility
If a single vial access device is designed to accommodate multiple vial sizes, then versatility is improved, but device complexity increases
Solution Approach 1:
The patent employs a dynamic adapter system where the adapter can be moved or repositioned within the vial access device housing. This dynamic configuration allows the same basic device structure to accommodate different vial sizes by adjusting the adapter position, rather than requiring completely different devices for each vial size. The movement mechanism enables versatility while maintaining a relatively simple base device architecture.
Solution Approach 2:
The patent uses a nested structure where adapters of different configurations can be inserted into or integrated with the main vial access device housing. The adapter components are designed to nest within the housing structure, allowing multiple adapter types to be stored or integrated within a single device unit. This nesting approach provides multi-size compatibility without requiring a complex array of separate devices.
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 system effectively prevents leakage and exposure to toxic substances by ensuring sealed transfer and balanced pressure, reducing the risk of health hazards for healthcare providers during drug handling.
Implementation Method 1
pressure equalization during engagement of a cannula with a vial, during transfer of a substance from a vial chamber to a barrel chamber via the cannula, and during disengagement of the cannula from the vial
Implementation Method 2
using a pressure equalization system with an expandable balloon to maintain balanced pressure within the vial
Implementation Method 3
The vial access device may be attachable to the first vial such that the spike is in fluid communication with a chamber of the first vial
Data Source
AI summary
A system includes a vial access device including a vial access housing having a wall defining an elongate opening between an opening proximal end and an opening distal end, the vial access housing including a spike and a vial connection element attachable to a first vial defining a first vial size to secure the vial access device to the first vial, and an adapter movable within the elongate opening of the vial access housing. The adapter is transitionable between a first position where the adapter is adjacent the opening distal end of the vial access housing and the adapter is attachable to a second vial defining a second vial size and a second position where the adapter is adjacent the opening proximal end of the vial access housing and the vial connection element of the vial access device is attachable to the first vial.