Integrated Disinfecting Flush Syringe Assembly for Blood Reflux Prevention
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Solution Overview
Problem
Vascular access devices (VADs) are prone to blood reflux and infection due to improper maintenance, leading to bloodstream infections and reduced IV line patency, especially when used by less experienced healthcare workers or patients.
Innovation Solution
A flush syringe assembly with a barrel, plunger rod, cap, sleeve, and disinfecting system, featuring a stopper tip that remains embedded in the VAD after use, and a sleeve that retracts to expose a cap for disinfection, preventing blood reflux and reducing contamination risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the stopper is compressed when contacting the distal end of the syringe barrel, then the flush procedure is completed, but the stopper expands back causing blood to enter the catheter (reflux)
Solution Approach 1:
The syringe assembly is pre-filled with flush solution and the stopper is pre-positioned to maintain constant pressure. The clamp mechanism is pre-configured to automatically maintain positive pressure in the catheter throughout the flush procedure, preventing blood reflux before it can occur.
Solution Approach 2:
A clamp mechanism acts as an intermediary device between the syringe and catheter system. This clamp maintains constant positive pressure in the catheter during flushing, serving as a mediator that prevents blood from refuting into the catheter when the stopper expands.
2Ease of repair
If the stopper is released after flush procedure, then the syringe can be reused, but liquid is withdrawn from the catheter into the syringe barrel causing reflux
Solution Approach 1:
The clamp mechanism is activated before the stopper is released, establishing positive pressure in the catheter in advance. This preliminary action ensures that when the stopper is released and the syringe is withdrawn, blood cannot reflux into the catheter.
Solution Approach 2:
The clamp serves as a protective intermediary that remains in place on the catheter after syringe removal. It continues to maintain positive pressure and prevent blood reflux even after the syringe is withdrawn and reused.
3Productivity
If the VAD is not sterilized before flushing, then the procedure is faster, but the risk of bloodstream infections increases
Solution Approach 1:
The VAD connector is pre-packaged in a sterile barrier pouch that is opened immediately before use. The disinfecting swab is pre-positioned on the syringe assembly, ready to disinfect the connector. These preliminary actions ensure sterilization is performed quickly without compromising the speed of the overall procedure.
Solution Approach 2:
The syringe assembly includes an integrated disinfecting swab that automatically comes into contact with the VAD connector when the barrier pouch is opened. The system performs its own sterilization function without requiring separate manual sterilization steps, maintaining both speed and safety.
4Reliability
If the cap passageway is undercut to retain the stopper tip, then the stopper tip is securely retained, but the device complexity increases
Solution Approach 1:
The cap is divided into distinct functional zones: an undercut portion that retains the stopper tip, a Luer connector portion for attachment, and a cap portion for sealing. This segmentation allows each zone to perform its specific function independently, achieving reliable stopper retention without overly complicating the overall cap design.
Solution Approach 2:
The stopper tip is nested within the undercut portion of the cap, creating a compact integrated structure. The cap components are designed to fit together in a nested arrangement, achieving secure retention functionality while minimizing overall device complexity.
Data Source
AI summary
Embodiments of the invention are directed to flush syringe assemblies comprising an integrated contamination-prevention device integrated with device connector flushing positioned so that the practitioner cannot forget to apply disinfectant. The flush syringe assemblies comprise a barrel with an elongate plunger rod disposed therein and a cap comprising a passageway. The plunger rod includes a stopper of which at least a portion can be embedded in the passageway of the cap to form a plug in the cap. Methods of flushing a vascular access device (VAD) while providing a flush syringe assembly described herein are also disclosed.