Needle Assembly Sterile Seal via Welded Closure
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Solution Overview
Problem
Existing needle assemblies for prefilled injection syringes often face challenges in maintaining a sterile seal during production and handling, with known systems either being complex or risking microbiological contamination due to releasable connections.
Innovation Solution
A non-releasable sterile barrier is created between the closure element and the needle shielding sheath using bonding or welding techniques, such as ultrasonic or laser welding, ensuring a secure and tamper-proof seal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a releasable connector is used between closure element and needle shielding sheath, then assembly and disassembly is simplified, but sterile seal reliability deteriorates due to risk of loosening during shipment or handling
Solution Approach 1:
The closure element is pre-assembled with the needle shielding sheath in a sterile environment before final product assembly. This preliminary assembly ensures the sterile barrier is established early and maintained throughout subsequent handling and shipping processes, eliminating the risk of contamination from later connection operations.
Solution Approach 2:
A sterile barrier (such as a sterile drape or seal) is introduced as an intermediary between the closure element and needle shielding sheath during assembly. This barrier maintains sterility during the connection process and can be designed to remain in place during shipping, preventing contamination while allowing controlled access when needed.
2Ease of manufacture
If a snap-action connector is used to achieve releasable connection, then assembly is simplified, but sterile seal reliability deteriorates because the connector cannot assure microbiological shield
Solution Approach 1:
The closure element and needle shielding sheath are assembled in a sterile environment before final product assembly, establishing the sterile barrier early. This preliminary action ensures that the connection is made under controlled sterile conditions, preventing microbiological contamination while maintaining assembly simplicity.
Solution Approach 2:
A disposable sterile barrier or seal is used between the closure element and needle shielding sheath. This single-use component ensures sterility during assembly and shipping, then is discarded or activated when the product is ready for use, eliminating the need for complex reusable sterile mechanisms.
3Stability of the object's composition
If axially staggered ribs are used to connect housing and needle hub, then secure location is achieved, but sterile seal reliability deteriorates as microbiological seal is not assured
Solution Approach 1:
The connection between housing and needle hub is established in a sterile environment before final assembly, with the sterile barrier already in place. This preliminary action ensures that the mechanical connection (via axially staggered ribs) does not compromise sterility, as the barrier is already sealed during the connection process.
Solution Approach 2:
A sterile barrier is introduced as an intermediary between the housing and needle hub connection points. This barrier allows the axially staggered ribs to provide secure mechanical location while the barrier itself maintains the sterile seal, preventing microbiological contamination despite the mechanical connection design.
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 ensures the needle remains sterile from sterilization to use, simplifies production and assembly, and provides a cost-effective, tamper-proof sterile seal for the needle assembly.
Implementation Method 1
The closure connection between the closure element and the needle shielding sheath being configured as a non-releasable and sterile barrier produced by means of a bonding or welding technique. Advantageous further embodiments of the invention read from the sub-claims. Thus, the sterile barrier is preferably a closure connection produced by ultrasonic or laser welding.
Implementation Method 2
Thus, the sterile barrier is preferably a closure connection produced by ultrasonic or laser welding.
Implementation Method 3
Where a bonded connection finds application it is recommended to use non-toxic, acrylic-based adhesives for curing by means of UV light or at room temperature, such as e.g. adhesive type LOCTITE® 3011
Data Source
AI summary
A needle assembly (10; 210) for a prefilled injection syringe is described. A needle holder (12; 212) has a needle (14; 214) secured to it and is adapted to be secured to a syringe barrel of the injection syringe. A needle sheath (16; 216) has a distal end forming a releasable sterile seal with the needle holder (12; 212), and surrounds and shields the needle (14; 214). A needle seal (18; 218) surmounts the needle tip and is arranged at least in part in the proximal end of the needle sheath (16; 216) and closed off by a closure element (20; 220). A closure connection between the closure element (20; 220) and the needle sheath (16; 216) is configured as a non-releasable and sterile barrier (54; 254) produced by means of bonding or welding.