Flexible Wall CSTD for Multi-Dose Pressure Equilibrium
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Solution Overview
Problem
Existing Closed System Transfer Devices (CSTDs) for hazardous drugs are costly due to complex pressure equilibrium systems, prone to drug leakage and dosing errors, and lack drug-specific graduations and labeling, making them unsafe and inefficient for multi-dose administration.
Innovation Solution
A CSTD with a flexible primary container and a metering pump that maintains pressure equilibrium using a flexible wall, allowing sequential metering of multiple doses without disconnection, and includes a valve system that prevents drug leakage and allows for drug-specific graduations and labeling on the syringe.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex pressure equilibrium systems are used to maintain pressure between the vial and the rigid vial close to equilibrium, then pressure balance is achieved, but manufacturing costs increase significantly
Solution Approach 1:
The patent employs a flexible membrane or diaphragm within the primary container closure system to maintain pressure equilibrium. The flexible element deformable under pressure differential allows the container to equalize pressure with ambient atmosphere during drug withdrawal, eliminating the need for complex mechanical pressure regulation systems while maintaining safety and reducing manufacturing costs
2Productivity
If the syringe is disconnected and reconnected to the vial to draw each additional dose, then multiple doses can be obtained, but the risk of drug exposure and contamination increases
Solution Approach 1:
The patent enables continuous operation by allowing the syringe to remain connected to the primary container throughout the entire multi-dose process. The flexible membrane system maintains pressure equilibrium continuously, enabling sequential dose withdrawals without breaking the sterile barrier or requiring disconnection/reconnection cycles, thereby eliminating exposure risks associated with repeated connector engagement
3Ease of operation
If the syringe is disconnected from the vial after drawing drug, then the syringe can be used for administration, but drug leakage through the pierced septum occurs when the syringe is pressurized
Solution Approach 1:
The patent introduces a needleless connector or adapter as an intermediary component between the syringe and the primary container. This intermediary maintains the closed system architecture, providing a sealed interface that prevents drug leakage from the syringe while enabling safe connection to administration systems, eliminating the need to pierce the septum during normal operation
4Adaptability or versatility
If generic syringes are used without drug-specific graduations and labeling, then versatility is improved, but dosing errors increase
Solution Approach 1:
The patent implements drug-specific graduations, markings, and labeling directly on or associated with the syringe barrel. This local customization provides precise dosing information tailored to the specific medication being administered, while the syringe itself remains a universal component that can be used with different drugs through the standardized connector interface
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 reduces manufacturing costs, minimizes drug exposure risks, prevents leakage, and decreases dosing errors by enabling safe, sequential metering of multiple doses with accurate drug identification and measurement.
Implementation Method 1
a package for storing the beneficial agent comprising at least one flexible wall such that pressure in the primary container is substantially equalized to ambient air pressure
Implementation Method 2
The flexible wall collapses when the beneficial agent is transferred from the primary container to the metering pump
Data Source
Figure 1
Figure 2a~2c
Figure 3
AI summary
A closed transfer system for transferring metered dose of a beneficial agent from a flexible primary container to a second reservoir or to a patient. The system can be configured to transfer multiple doses.