Hard-Packaged Safety Needle Enclosure for Low-Waste Sterility
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Solution Overview
Problem
Existing safety needle devices incorporate bulky and complex safety shields that increase manufacturing costs and material usage, while the needle shields provide limited protection and are discarded post-use, necessitating a need for a cost-effective and efficient safety mechanism that maintains sterility and reduces waste.
Innovation Solution
A safety needle device with a removable collar and two-piece hinged cap in a clamshell configuration, along with a hard needle enclosure, that provides both needle and safety shield features, allowing for interference fits and snap connections to reduce manufacturing complexity and waste, while maintaining sterility without the need for blister packaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional safety shield mechanism is used, then needle protection and sterility are ensured, but manufacturing cost and device complexity increase
Solution Approach 1:
The patent combines the needle shield and safety shield functions into a single integrated component. The shield assembly includes a shield body that covers the needle cannula and a hub portion that interfaces with the needle hub, eliminating the need for separate safety shield mechanisms. This merging reduces device complexity while maintaining both needle protection and sterility barrier functions.
Solution Approach 2:
The shield assembly serves multiple functions simultaneously: it acts as a sterility barrier during storage and transport, provides needle protection during use, and includes a safety mechanism through the hinged cap that prevents reuse. The collar with attachment points and the hinged cap work together to provide both protective and safety features in a single integrated design.
2Strength
If a thick-walled needle shield is used, then needle protection is ensured, but material usage and cost increase
Solution Approach 1:
The shield assembly is divided into separate functional components: a shield body for needle protection, a hub portion for interface with the needle hub, and a hinged cap for safety. This segmentation allows each component to be optimized for its specific function, using material only where needed rather than uniformly thick walls throughout the entire structure.
Solution Approach 2:
The shield body can be constructed as a thin-walled structure that provides adequate protection, replacing the need for thick-walled shields. The flexible nature of the shield body allows it to conform to the needle hub while maintaining protective functions, reducing material usage while preserving strength where required.
3Reliability
If a blister pack is used for packaging, then sterility is maintained, but packaging complexity and waste increase
Solution Approach 1:
The shield assembly integrates the packaging function directly into the device structure. The shield body acts as a protective enclosure that maintains sterility without requiring separate blister pack packaging. The hinged cap provides an additional barrier when closed, eliminating the need for external packaging while maintaining sterility protection.
Solution Approach 2:
The device itself provides the sterility barrier function through its design. The shield assembly and hinged cap work together to create a self-contained sterile enclosure that protects the needle during storage and use, eliminating the need for separate packaging materials and reducing waste.
4Reliability
If a safety shield is added to the needle hub, then worker safety is improved, but hub complexity and manufacturing difficulty increase
Solution Approach 1:
The safety features are segmented into separate components: the shield body, the hinged cap, and the collar with attachment points. This allows the needle hub to remain a simple, easily manufactured component while the safety functions are distributed across separate parts that can be assembled afterward, reducing manufacturing difficulty.
Solution Approach 2:
The hinged cap provides a dynamic safety mechanism that can be opened and closed, allowing the needle to be accessed during use and then secured afterward. This dynamic feature provides worker safety without requiring complex modifications to the hub structure itself, as the hinged cap interfaces with the hub through simple attachment points on the collar.
Data Source
AI summary
A hard-packaged safety needle device comprises a needle hub having a needle cannula extending therefrom and a hard needle enclosure including a needle cover and a cap. The needle cover has an elongated body and a ribbed surface configured to create an interference fit with a proximal portion of the hub. The cap includes a body having an open distal end, a closed proximal end, and a cavity defined by the open distal end and the closed proximal end, the open distal end of the cap abutting an open proximal end of the needle cover.