Vial Access Spike with Pressure Equalization
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Solution Overview
Problem
Contemporary vial connector assemblies face issues with hazardous aerosol and particle leakage during medicament transfer and coring of vial stoppers, leading to contamination risks and compromised sterility.
Innovation Solution
A vial access device with a spike member having a vent lumen and a fluid lumen, designed with an oval-shaped circumference and chamfered edges to minimize stopper damage and prevent coring, along with a pressure equalization chamber and lubricant coating to ensure safe and efficient medicament transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a sharp metal cannulated needle is used to pierce the elastomeric stopper, then fluid transfer is enabled, but coring occurs and stopper fragments are punched out compromising sterility
Solution Approach 1:
The patent changes the geometric parameters of the spike by providing a rounded leading end with a radius of curvature of at least 0.5mm instead of a sharp point, and specifies dimensional parameters (length 10-20mm, diameter 1-3mm) to optimize penetration while preventing coring. This parameter modification allows the spike to penetrate the stopper effectively without punching out fragments, thus maintaining sterility while enabling fluid transfer.
Solution Approach 2:
The patent employs a composite structure where the spike member is made of a material different from the traditional metal needle - specifically a biocompatible polymer or coated metal that combines penetration capability with stopper-friendly properties. The rounded leading end may also feature a lubricant coating or hydrophilic treatment to reduce friction and prevent coring, creating a composite functional surface that maintains both penetration effectiveness and sterility.
2Productivity
If a hollow pointed spike or needle is used to pierce the vial stopper, then medicament transfer is enabled, but hazardous aerosols and particles may leak into the environment
Solution Approach 1:
The patent incorporates a flexible membrane or seal at the interface between the spike and the receiving container that dynamically seals around the spike during insertion and withdrawal. This flexible sealing mechanism prevents aerosol and particle leakage while allowing the spike to penetrate and transfer medicament efficiently, thus resolving the contradiction between transfer productivity and harmful factor prevention.
Solution Approach 2:
The patent introduces an intermediary sealing component (such as a elastomeric seal or gasket) that mediates between the rigid spike and the container opening. This intermediary element creates a tight seal that prevents hazardous aerosols and particles from escaping into the environment during the medicament transfer process, while not interfering with the efficiency of the transfer itself.
3Strength
If the vial connector spike is large in size, then structural strength is improved, but the stopper is damaged by ripping or tearing
Solution Approach 1:
The patent applies local quality by providing different characteristics at different locations of the spike. The leading end has a rounded shape with large radius of curvature to protect the stopper, while the shaft maintains sufficient diameter and wall thickness for structural strength. The tapered configuration concentrates the protective rounded geometry at the stopper-contact region while preserving overall spike strength through the shaft design, thus resolving the contradiction between strength and stopper protection.
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 solution effectively prevents coring and leakage, reducing contamination risks and maintaining sterility by minimizing stopper damage and using a pressure equalization system to manage air displacement during fluid transfer.
Implementation Method 1
a vial access device with a spike member having a vent lumen and a fluid lumen, designed with an oval-shaped circumference and chamfered edges to minimize stopper damage and prevent coring, along with a pressure equalization chamber and lubricant coating to ensure safe and efficient medicament transfer
Implementation Method 2
The solution effectively prevents coring and leakage, reducing contamination risks and maintaining sterility by minimizing stopper damage and using a pressure equalization system to manage air displacement during fluid transfer
Data Source
AI summary
A vial access device includes a housing having first and second connectors, with the first connector configured to be secured to a first container and the second connector configured to be secured to a second container. The device also includes a spike member extending from the housing and having a proximal end and a distal end. The spike member defines a vent lumen and a fluid lumen spaced from the vent lumen, with each of the vent lumen and the fluid lumen having a distal opening. The distal openings of the vent lumen and the fluid lumen are each defined by a top edge and a bottom edge spaced axially from the top edge. The bottom edge of the fluid lumen is positioned above the distal opening of the vent lumen in a direction extending along a longitudinal axis of the spike member.