Prefillable Cannula Closure Assembly for Thin Needle Sterility
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Solution Overview
Problem
Existing pre-filled disposable syringes with pre-attached needles face challenges in manufacturing thin cannulas (31 G to 34 G) due to injection molding limitations, leading to increased contamination risks, complex production, and reduced shelf life, especially for pharmaceutical preparations.
Innovation Solution
A prefillable container system with a cannula assembly and sealing element, sealed by a closure cap, allows for secure attachment of thin cannulas without disassembly, ensuring sterility and long-term storage up to three years, using commercially available components and Luer-Lock connections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If injection molding is used to manufacture pre-filled syringes with thin cannulas (31G to 34G), then production can be automated, but manufacturing precision and reliability deteriorate due to molding limitations
Solution Approach 1:
The device is divided into separate components: the syringe body and the cannula assembly are manufactured independently and then connected through a Luer-Lock interface. This segmentation allows each component to be optimized separately - the syringe can be injection molded while the thin cannula (31G-34G) can be precisely manufactured and attached to a connector using alternative methods that preserve its integrity.
Solution Approach 2:
A Luer-Lock connector serves as an intermediary component between the syringe body and the thin cannula. This mediator allows the cannula to be securely attached without direct injection molding into the syringe barrel, enabling precise attachment of fragile thin-walled cannulas while maintaining automation benefits.
2Productivity
If pre-filled syringes with pre-attached needles are manufactured using conventional methods, then productivity increases, but contamination risks increase due to complex production processes
Solution Approach 1:
The cannula assembly is pre-assembled with the Luer-Lock connector in a controlled environment, then the entire assembly is sterilized together with the syringe body. This preliminary assembly approach allows for streamlined production while maintaining sterility, as the components are joined before final sterilization rather than requiring complex post-assembly sterilization processes.
Solution Approach 2:
The invention employs a disposable pre-filled syringe system where the entire assembly (syringe body, cannula, and connector) is designed for single use. This approach simplifies production by eliminating the need for complex re-sterilization and reassembly processes, thereby reducing contamination risks while maintaining high productivity through efficient manufacturing of disposable units.
3Manufacturing precision
If additional adhesives are used to attach cannulas to syringes, then manufacturing precision improves, but reliability deteriorates due to potential contamination and reduced shelf life
Solution Approach 1:
The invention replaces chemical bonding (adhesives) with a mechanical Luer-Lock connection system. The cannula assembly is attached to the syringe body through threaded mechanical engagement, providing precise and reliable attachment without introducing adhesive materials that could contaminate the pharmaceutical preparation or compromise shelf life.
4Ease of operation
If thin cannulas (31G to 34G) are manufactured with pre-attached needles, then ease of operation improves, but device complexity increases due to production challenges
Solution Approach 1:
The device is segmented into modular components: a standard syringe body, a Luer-Lock connector, and a thin cannula assembly. This modular design simplifies production by allowing each component to be manufactured using appropriate processes, then assembled through straightforward mechanical connection, reducing overall production complexity while maintaining ease of operation.
Solution Approach 2:
The Luer-Lock connector serves as a universal interface that can accommodate various thin cannula sizes (31G to 34G) and connect to standard syringe bodies. This universal design simplifies production by using a common connector type across different product variations, reducing the need for specialized manufacturing equipment while providing ready-to-use convenience for different applications.
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 enables cost-effective, sterile storage and application of pharmaceutical preparations with thin cannulas, reducing contamination risks and simplifying production by allowing modular assembly and long-term storage without additional adhesives, while maintaining leak-proof connections.
Implementation Method 1
wherein the chamber is fluid-tightly closed by compression of the sealing element
Implementation Method 2
an outer channel opening of the cannula projects into a sealing elastomeric inner area of the closure cap and the latter seals the channel opening
Data Source
Figure 1
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AI summary
To provide a container for storing and applying a fluid, in particular a pharmaceutical or cosmetic preparation, that is flexible with respect to the dimensions of the container and the cannula, pre-assembled or pre-assemblable, pre-fillable or pre-filled, and which can be stored for a longer period of time, it comprises a container, in particular a syringe, with a syringe body, a cartridge or an injection device, with a chamber for receiving the fluid, furthermore a cannula assembly, wherein the cannula assembly has a cannula and a sealing element and the cannula assembly can be attached to the container, and a cap, wherein an outer channel opening of the cannula projects into a sealing, preferably elastomeric, inner area of the cap and the latter seals the channel opening.wherein the chamber is fluid-tightly sealed by radial and/or axial compression of the sealing element and by sealing the channel opening using the closure cap.