Disinfecting Cap With Multi-Zone Thread For Needleless Injection Sites
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Solution Overview
Problem
Current methods for preventing bloodstream infections caused by microorganisms entering through intravascular catheters are inadequate, as impregnated catheters show limited effectiveness and antimicrobial resistance issues, and existing disinfecting solutions fail to provide a secure and consistent fit for needleless injection sites.
Innovation Solution
A female-disinfecting cap with a unique thread design and piloting zone that securely fits needleless injection sites, featuring a piloting counter bore, free running zone, transition zone, and main bore to ensure interference fit without being difficult to install, and optionally includes an absorbent antiseptic pad for disinfection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a thread design with interference fit is used to secure the cap, then the reliability of the connection is improved, but the difficulty of installation increases
Solution Approach 1:
The cap's internal surface is segmented into distinct zones: a piloting zone for initial alignment, a free-running zone for easy threading engagement, and an interference-fit zone for secure locking. This segmentation allows the cap to progress through installation stages, providing ease of initial installation while achieving reliable securement in the final position.
Solution Approach 2:
Different regions of the cap's internal surface have different diameters and surface properties. The piloting zone has a larger diameter for alignment, the free-running zone has matching threads for engagement, and the interference-fit zone has a smaller diameter for secure locking. This local variation in geometry provides both easy installation and reliable connection.
2Object-affected harmful factors
If impregnated catheters with antimicrobial agents are used, then infection prevention is improved, but antimicrobial resistance develops reducing effectiveness
Solution Approach 1:
The cap serves as an intermediary barrier between the external environment and the catheter connection site. It physically blocks microorganisms from entering the bloodstream through the needleless injection site, eliminating the need for antimicrobial agents that can develop resistance. The cap can be optionally impregnated with antiseptic agents for additional protection during the capping period.
Solution Approach 2:
The cap provides preliminary protection by being applied to the needleless injection site before connection to infusion equipment. This preliminary barrier prevents microorganism contamination at the critical moment of potential exposure, addressing the infection risk before it can manifest.
3Reliability
If a secure interference fit is provided to maintain sterility, then reliability of sterility protection is improved, but the cap becomes difficult to install
Solution Approach 1:
The cap's internal surface is segmented into distinct zones: a piloting zone for initial alignment, a free-running zone for easy threading engagement, and an interference-fit zone for secure locking. This segmentation allows the cap to progress through installation stages, providing ease of initial installation while achieving reliable securement in the final position.
Solution Approach 2:
The piloting zone and free-running zone perform preliminary alignment and engagement actions, guiding the cap onto the needleless injection site before the interference-fit zone engages. This preliminary action reduces the force and difficulty required for final securement, making installation easier while maintaining reliable sterility protection.
4Object-affected harmful factors
If existing disinfecting caps are used, then some level of protection is provided, but they fail to provide consistent secure fit for various needleless injection site dimensions
Solution Approach 1:
The cap design with its multi-zone structure (piloting, free-running, and interference-fit zones) provides universal compatibility with various needleless injection site dimensions and thread specifications. The progressive engagement zones accommodate dimensional variations while maintaining secure fit and sterility protection across different catheter types.
Solution Approach 2:
The cap's internal geometry parameters (diameters of different zones, thread pitch, engagement depth) are optimized to accommodate variations in needleless injection site dimensions. By designing the interference-fit zone with appropriate clearance and engagement characteristics, the cap adapts to different catheter sizes while maintaining consistent securement and sterility protection.
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 cap effectively prevents contamination and infection by providing a secure, interference-fit seal that maintains sterility and reduces the need for pre-connection disinfection, while accommodating various needleless injection site dimensions and preventing damage to septums.
Implementation Method 1
The cap also includes an absorbent material for holding the antiseptic agent disposed in the chamber
Data Source
AI summary
A female-disinfecting cap and a method for applying the female-disinfecting cap. The cap threadingly accepts a needleless injection site, and applies an antiseptic agent to the needleless injection site. The cap includes a cap body with an opening for accepting the needleless injection site. The cap has an absorbent material that holds an antiseptic agent.