Resilient Tube with Female Luer Lock Fitting for Contamination-Free Extraction
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Solution Overview
Problem
Current methods for extracting pharmaceutical products for parenteral use from glass ampoules and vials are cumbersome, involve the risk of contamination, and require multiple handling steps and hypodermic needles, including the potential introduction of unsterile air and glass splinters.
Innovation Solution
A tube with a resilient container and a female Luer Lock fitting that allows for airtight sealing with a needle-less syringe, featuring a tamper-evident closure that opens with pressure from the syringe, enabling easy extraction without hypodermic needles and reducing contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If glass ampoules are used for storage, then product stability is improved, but device complexity and handling time increase due to multiple opening and extraction steps
Solution Approach 1:
The ampoule is divided into two functional parts: a breakable glass ampoule body for stable storage and a separate plastic ampoule head with Luer lock fitting for easy connection to syringes. This segmentation allows the stable glass container to be combined with a convenient plastic closure system, eliminating the need for complex opening and needle insertion procedures.
Solution Approach 2:
The invention merges the breakable glass ampoule body with a plastic ampoule head that includes a female Luer lock fitting. This combination integrates the storage function of glass with the connectivity function of plastic, allowing direct attachment of syringes without additional needles or complex procedures.
2Ease of operation
If hypodermic needles are used for extraction, then product extraction is enabled, but contamination risk increases due to exposure to unsterile air
Solution Approach 1:
The harmful hypodermic needle is extracted from the system and replaced by a sterile Luer lock fitting that is pre-sterilized as part of the ampoule head. This eliminates the need to pierce through rubber stoppers with non-sterile needles, thereby removing the contamination pathway while maintaining extraction capability through direct syringe connection.
Solution Approach 2:
The plastic ampoule head with Luer lock fitting is designed as a disposable sterile component that is discarded after single use, eliminating the need to sterilize and reuse hypodermic needles. This single-use sterile barrier prevents contamination while enabling easy product extraction.
3Quantity of substance
If glass vials with rubber stoppers are used, then product storage is enabled, but harmful factors increase due to rubber particle contamination
Solution Approach 1:
The rubber stopper is extracted from the system and replaced by a plastic ampoule head with a breakable seal. This eliminates the source of rubber particle contamination while maintaining the storage capability through the glass ampoule body and the sealed plastic head.
4Ease of operation
If multiple handling steps are used for extraction, then product transfer is enabled, but loss of time increases due to complex procedures
Solution Approach 1:
The invention merges the storage container, closure system, and connection interface into a single integrated ampoule with a plastic head containing a female Luer lock fitting. This integration combines multiple functions (storage, sealing, and syringe connection) into one component, eliminating the need for separate opening, needle attachment, and product transfer steps.
Solution Approach 2:
The ampoule head is pre-sterilized and pre-assembled with the female Luer lock fitting during manufacturing. This preliminary preparation eliminates the need for on-site sterilization and assembly steps, allowing immediate connection to syringes and rapid product extraction.
Data Source
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AI summary
The invention relates to tube with a tube head (4) and a container (5) made of resilient material, wherein the tube head (4) is connected to the container (5), wherein the tube head (4) comprises a female Luer lock fitting (7) with a flow passage (17), the female Luer lock fitting (7) being designed for sealingly receiving a male Luer lock fitting (9) of a syringe (2), wherein a tamper-evident closure (11; 12, 13, 14) is arranged at the inner surface of the female Luer lock fitting (7) such that it closes the flow passage (17) in a closed state of the tube (1).