Safety Needle Caps for Integrated Fill and Inject
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Solution Overview
Problem
Safety needle devices often require manual assembly for post-injection needle shielding, which can lead to accidental needle sticks and misuse, especially when in a fill state, as the passive safety feature may not activate during injection, necessitating a solution for integrated filling and injection without interfering with passive safety features.
Innovation Solution
Caps for safety needle devices with an access opening in fluid communication with the needle cannula, featuring a fill feature that engages with the safety feature to maintain the device in a fill state, allowing for integrated filling and injection without activating the passive safety feature, and are designed to prevent misuse by making it difficult to inject when in the fill state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual assembly of needle shields is used for post-injection safety, then needle shielding can be achieved, but the risk of accidental needle sticks increases due to the need for manual assembly
Solution Approach 1:
The safety needle device employs passive safety features that automatically activate after injection without requiring manual assembly. The device self-shields the needle through mechanical structures that engage automatically when the syringe barrel is detached or when specific movement occurs, eliminating the need for healthcare workers to manually assemble needle shields.
Solution Approach 2:
The needle shielding structure is pre-positioned and pre-configured within the device assembly before use. The safety feature is prepared in advance to automatically engage and cover the needle cannula after injection, so that the shielding action occurs automatically without requiring subsequent manual intervention.
2Ease of operation
If passive safety features are activated automatically, then needle shielding is achieved without manual intervention, but there is a risk that injection may occur in fill state causing the safety feature to fail to activate
Solution Approach 1:
The device incorporates state-detecting mechanisms that provide feedback about whether the device is in fill state or injection state. Sensors or mechanical indicators detect the operational mode and ensure that the passive safety feature is only deactivated when properly in injection state, preventing premature activation or failure to activate.
Solution Approach 2:
The safety feature employs dynamic state transitions that adapt based on the operational phase. The device dynamically adjusts the engagement state of the safety mechanism - remaining engaged during filling operations and automatically disengaging only when injection is confirmed, thereby ensuring reliable activation timing.
3Adaptability or versatility
If the device allows multiple fills without activating safety features, then the device can be reused for multiple fills, but there is increased risk of misuse by injecting in fill state
Solution Approach 1:
The device employs different local properties at different operational stages. The access protrusion or filling mechanism has characteristics that are suitable for fluid transfer but unsuitable for injection into tissue - such as a blunt tip or specific geometry that prevents proper injection. This local quality difference creates an inherent barrier against misuse while allowing legitimate multiple fills.
Solution Approach 2:
The cap structure acts as an intermediary element that mediates between the fill function and injection function. The cap with its specific design (spike cap or blunt fill needle cap) enables fluid access for filling but physically prevents or makes injection difficult, serving as a protective intermediary that allows multiple fills while blocking misuse.
4Adaptability or versatility
If a cap with access opening is used for integrated filling and injection, then both functions can be performed with one device, but the cap must not interfere with passive safety features
Solution Approach 1:
The cap is designed as a multi-functional component that serves both as a protective cover and as an access mechanism for fluid filling. The same cap structure that protects the needle cannula also provides controlled access for filling operations, eliminating the need for separate components and simplifying the overall device while enabling integrated fill and inject functions.
Data Source
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AI summary
Drug delivery safety devices comprise a safety needle device comprising a needle hub, a needle cannula, and a safety feature; and a cap comprising a cap body having a proximal end attached to the safety needle device and a distal end having an access opening that is in fluid communication with the needle cannula. The safety needle device allow for an integrated device for both filling and injection that do not interfere with passive safety features. The caps may have a fill feature that engages with a safety feature of the safety needle device to keep it in a fill state.