Elastomeric Luer Connector Seal for Microorganism Elimination
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Solution Overview
Problem
Medical patient access devices pose a significant risk of microorganism transmission during procedures, leading to clinical bacteremia, severe morbidity, and mortality, due to contamination risks associated with drug mixing and device design flaws, particularly in the use of open piston valves that allow irreversible incubation of bacteria.
Innovation Solution
A biocidal septum and cannula system with a slitted elastomeric design that minimizes contact and uses a solid fluid wave mechanism to eliminate bacteria, combined with a method for testing and optimizing the configuration to reduce residual microorganisms, thereby reducing contamination risks and enhancing sterility during access procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If open piston valves are used for access procedures, then ease of operation is improved, but microorganism transmission risk increases due to crevices allowing bacterial incubation
Solution Approach 1:
The patent removes the problematic piston component entirely, replacing it with a valveless design that eliminates crevices where bacteria can incubate. This extraction of the harmful element (piston/valve mechanism) maintains ease of operation while eliminating the microorganism transmission risk associated with crevices.
Solution Approach 2:
The patent segments the access device into distinct functional components: a hub, a catheter, and a cap, eliminating the integrated piston-valve assembly. This segmentation allows each component to be optimized for its specific function without the compromise of multi-functional valve mechanisms that create crevices.
2Productivity
If conventional access procedures are performed without controlled enclosures, then productivity is improved, but contamination risk increases during drug mixing and access
Solution Approach 1:
The patent incorporates pre-sterilized, pre-assembled components that are ready for use, eliminating the need for bedside drug mixing and preparation procedures. This preliminary preparation maintains productivity while eliminating contamination risks associated with open drug mixing and multiple access steps.
Solution Approach 2:
The patent combines the hub, catheter, and cap into a single integrated access device that requires minimal assembly. This merging of components reduces the number of separate procedures and contact points, maintaining productivity while reducing opportunities for contamination during assembly and use.
3Device complexity
If employee diligence is relied upon to prevent contamination, then device complexity is reduced, but reliability decreases due to uncontrollable human factors
Solution Approach 1:
The patent designs the access device to be self-sterilizing through its valveless, crevice-free structure that prevents bacterial incubation. The device's geometry itself provides the protective function, eliminating reliance on employee diligence for proper cleaning and maintenance, thus improving reliability without adding complexity.
Solution Approach 2:
The patent incorporates design features that preemptively prevent contamination before it can occur. The smooth, crevice-free surfaces and integrated sealing mechanisms are built-in from the start, providing automatic protection against contamination without requiring ongoing human intervention or complex monitoring systems.
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 significantly reduces the risk of microorganism transmission by mechanically eliminating bacteria during insertion and withdrawal, providing a more diligent-independent access procedure that minimizes contamination and irreversible incubation, thereby lowering morbidity and mortality associated with access events.
Implementation Method 1
an elastomeric material configured such that insertion of a male luer connector against the elastomeric material causes enclosed compression of the elastomeric material to produce a predictable fluidic dispersion of the elastomeric material and thereby producing a solid fluid wave against the male luer connector such that the microorganisms are destroyed or displaced
Implementation Method 2
causes enclosed compression of the elastomeric material to produce a predictable fluidic dispersion of the elastomeric material
Implementation Method 3
producing a predictable fluidic dispersion of the elastomeric material and thereby producing a solid fluid wave
Data Source
AI summary
A medical swab pouch is disclosed. The inexpensive elastic pouch contains disinfectant and is configured for protecting and swabbing a wide variety of luer systems to prevent and eliminate bacterial contamination. The pouch has a flattened configuration and can be elastically dilated, as by squeezing the pouch between the thumb and index finger and is readily carried in large numbers in nurse's pockets (in a manner similar to that for conventional alcohol swabs). The pouch covers and protects the luer valve at the discretion of the user and without transmission of torsion or longitudinal force which might loosen the luer valve or otherwise be transmitted to the vein.