Airless Multi-Dose Container with Luer Adapter
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Solution Overview
Problem
Existing medication storage systems, such as Stechampulle or VIALs, are prone to contamination and incorrect operation during dose removal, leading to potential microbial growth and needlestick injuries.
Innovation Solution
A multi-socket container with an airless design, featuring a stiff outer container and an inner bag that compensates for pressure without air, combined with a disposable valve and luer connection system that ensures secure and contamination-free dose delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a piercing ampoule or vial with rubber stopper is used for storing medication solution, then the medication solution can be stored in a sealed container, but contamination risk increases during repeated dose withdrawals
Solution Approach 1:
The system employs a disposable syringe for each dose withdrawal, eliminating the risk of needle contamination and patient-to-patient transmission. The single-use nature ensures sterility while maintaining cost-effectiveness through standardized manufacturing.
Solution Approach 2:
The patent introduces an intermediary barrier system including a needle-free adapter and controlled access mechanism between the medication container and syringe. This intermediary prevents direct contact between the medication solution and potential contaminants, reducing contamination risk during dose withdrawal.
2Productivity
If the rubber stopper is pierced repeatedly for dose withdrawal, then multiple doses can be obtained from the same container, but the risk of needlestick injury increases
Solution Approach 1:
The patent extracts the hazardous piercing action from the dose withdrawal process by replacing needle penetration with a needle-free adapter system. The adapter interfaces with the container opening without requiring repeated needle punctures, eliminating needlestick injury risk while maintaining multi-dose capability.
Solution Approach 2:
The system uses a disposable adapter that is discarded after single use or a limited number of uses. This disposable component eliminates the accumulation of needlestick risks associated with repeated use of the same needle, while remaining cost-effective through standardized production.
3Ease of operation
If air enters the vial to equalize pressure during withdrawal, then the medication solution can be dispensed smoothly, but air contamination of the medication solution occurs
Solution Approach 1:
The patent introduces an intermediary air barrier system including a filter or membrane that allows pressure equalization while preventing airborne contaminants from entering the medication solution. This intermediary maintains smooth dispensing operation while protecting sterility.
Solution Approach 2:
The system creates an inert or sterile atmosphere within the container by using filtered air intake or nitrogen flushing. This inert environment allows pressure equalization during dispensing while preventing microbial contamination from ambient air.
4Loss of time
If the same needle is used for both withdrawal and administration, then time and cost are reduced, but the risk of cross-contamination and incorrect operation increases
Solution Approach 1:
The patent merges the withdrawal and administration functions into a single integrated disposable syringe unit. The pre-attached needle and syringe combination eliminates the need for separate handling steps, reducing time while maintaining accuracy through standardized design and single-step operation.
Solution Approach 2:
The system uses a disposable syringe-needle assembly that is discarded after single use. This eliminates cross-contamination risks between patients while reducing time through elimination of cleaning and sterilization steps. The low cost of disposable units makes this economically viable.
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 prevents air and microbial contamination, reduces the risk of needlestick injuries, and allows for aseptic bottling of medication solutions, ensuring safe and efficient dose delivery.
Implementation Method 1
The negative pressure created in the multi-dose container when medication solution is dispensed into the disposable syringe is compensated for by air entering the space between the outer container and the contracting inner bag through an opening in the outer container
Implementation Method 2
The one-way valve preferably contains an approximately bell-shaped outer cone, preferably made of a thermoplastic elastomer, which closes the entire internal passage opening of the one-way valve, except for a hole formed in the center of the valve membrane
Implementation Method 3
When the disposable syringe with its Luer connector is inserted into the conically widening outlet channel of the one-way valve and the syringe is drawn up, the suction lifts the elastic outer cone or the elastic valve membrane upward from the valve seat pin
Implementation Method 4
A dead volume within the adapter and the one-way valve can also be coated with antimicrobial material such as silver to ensure that no microbial contamination can reach the medication solution in the multi-dose container
Data Source
Figure 1A~1D
Figure 2
Figure 3~4
AI summary
The system for storing a preferably sterile drug solution in a multi-dose container and for dispensing a dose of the drug solution to a disposable syringe is characterized in that the multi-dose container is an airless container consisting of a rigid outer container and a contracting inner bag into which no air enters for pressure equalization during dispensing of drug solution, that an adapter with a one-way valve and a female Luer connector is attached to the multi-dose container, and that the disposable syringe is provided with a matching male Luer connector with which it can be docked to the adapter in order to receive a dose of the drug solution by drawing up the disposable syringe.