Vial Access Device Fluid Filter for Particulate Removal
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Solution Overview
Problem
Existing vial access devices fail to effectively filter out particulate matter from medicinal substances, which can lead to complications such as phlebitis and vessel blockage when administered to patients, due to the presence of contaminants like pharmaceutical sediment, lipids, and debris.
Innovation Solution
A vial access device with a fluid filter assembly that includes a spike with a lumen for fluid communication, a fluid filter body with a filter surface aligned parallel to the fluid flow, and an optional vent filter, designed to filter particulate matter from the medicament during transfer, minimizing the risk of contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a vial access device is used to withdraw medication from vials, then fluid transfer is enabled, but particulate matter contaminates the medication
Solution Approach 1:
A filter element is introduced as an intermediary component between the vial access spike and the medication delivery system. The filter element includes a filter membrane that intercepts and retains particulate matter while allowing medicated fluid to pass through, thus preventing contamination without blocking fluid transfer
Solution Approach 2:
The filter element utilizes a porous filter membrane with specific pore sizes designed to trap particulate matter (including sub-visible particles) while permitting the passage of medicated fluid. The porous structure enables size-based separation of particles from the liquid medication
2Reliability
If a filter is added to the vial access device, then particulate matter is filtered out, but device complexity increases
Solution Approach 1:
The filter element is integrated into the vial access device by positioning it within the hollow spike, merging the filtering function with the existing access mechanism. The filter element is secured using friction fit, interference fit, or adhesive bonding, combining multiple functions (access, filtration, and structural support) into a single integrated component
Solution Approach 2:
The filter element is nested within the hollow spike of the vial access device. The filter membrane is positioned inside the spike's internal cavity, allowing the filtering function to be contained within the existing structural envelope without significantly increasing overall device size or complexity
3Reliability
If the filter surface is aligned parallel to fluid flow, then filtration efficiency is improved, but manufacturing precision requirements increase
Solution Approach 1:
The filter element is designed with an asymmetric configuration where the filter membrane is positioned at an angle or offset from the spike's longitudinal axis. This asymmetric positioning creates a self-aligning flow path that naturally directs fluid flow parallel to the filter surface during operation, reducing sensitivity to manufacturing tolerances
Solution Approach 2:
The filter element incorporates localized structural features (such as angled support ribs or asymmetric mounting surfaces) in specific regions to ensure proper alignment and flow distribution. These localized quality enhancements ensure optimal filtration performance without requiring high precision across the entire device
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 device efficiently filters out particulate matter, reducing the risk of adverse reactions and ensuring cleaner medication transfer, while being cost-effective and simple to manufacture with minimal assembly complexity.
Implementation Method 1
a fluid filter body for filtering particulate matter from fluid flowing through the at least one lumen, the fluid filter body comprising a fluid filter having a front surface to be contacted by fluid from the at least one lumen
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3A~3B
AI summary
A vial access device is described comprising an upper housing having a fluid connecter in fluid communication with the upper housing; a vial access spike projecting from the upper housing; a fluid filter body within the upper housing or connectable thereto, the fluid filter body in fluid communication with the vial access spike and the fluid connector. Methods of reducing or eliminating particulate matter from medicament solutions are also provided.