Single-Use Delivery Device Primer Element for Air Bubble Removal
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Solution Overview
Problem
Current vascular access devices face issues with air reflux and occlusion due to incomplete priming of pre-filled saline flush syringes, leading to contamination and inefficiency in fluid delivery during maintenance procedures.
Innovation Solution
A single-use pre-filled delivery device with a manually deformable container and a primer element that removes air bubbles, featuring a collapsible design and one-way valve to prevent reflux, ensuring a secure and sterile connection with vascular access devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a pre-filled delivery device is used to maintain vascular access devices, then fluid delivery efficiency is improved, but air bubbles may remain in the chamber causing incomplete priming and potential contamination
Solution Approach 1:
The device includes a collapsible priming chamber that is pre-configured to force air bubbles out of the fluid pathway before fluid delivery begins. The collapsible design allows the chamber to be compressed, actively expelling air bubbles from the inner chamber and fluid pathway, ensuring complete priming before the device is connected to the vascular access device.
2Ease of operation
If conventional syringes with elastomeric stoppers are used for flushing, then ease of operation is improved, but the stopper expansion causes blood reflux into the catheter
Solution Approach 1:
The delivery device is segmented into distinct functional zones: a fluid storage chamber, a collapsible priming chamber separated by a partition, and a fluid pathway. This segmentation allows the priming chamber to be collapsed independently to remove air bubbles without affecting the main fluid supply, and prevents backflow into the catheter by maintaining positive pressure through the one-way valve mechanism.
Solution Approach 2:
The one-way valve acts as an intermediary element between the fluid pathway and the catheter connection. It allows fluid to flow in one direction (from the device to the catheter) but prevents backward flow (reflux) even when the collapsible chamber is compressed during priming, thereby eliminating the harmful effect of blood reflux while maintaining ease of operation.
3Reliability
If the container is sealed during manufacturing, then sterility is improved, but air bubbles are trapped inside requiring additional priming steps
Solution Approach 1:
The device is pre-configured with a collapsible priming chamber and partition structure during manufacturing that enables automatic air bubble removal. The partition separates the priming chamber from the main fluid chamber, and the collapsible design allows air bubbles to be forced out through designated pathways before fluid delivery, eliminating the need for complex external priming procedures while maintaining sterility.
4Device complexity
If manual deformation of the container is used to deliver fluid, then device simplicity is improved, but incomplete air removal may occur
Solution Approach 1:
The simple manually deformable container is segmented into a fluid storage chamber and a collapsible priming chamber separated by a partition. This segmentation allows the priming chamber to be independently collapsed through manual deformation to force air bubbles out, while the rest of the container remains simple and easy to manipulate. The partition ensures that air bubbles are directed to the priming chamber outlet rather than being trapped in the main fluid pathway.
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 device effectively primes the container, reducing the risk of contamination and reflux, providing a secure and efficient delivery of sterile solutions to vascular access devices, thereby maintaining their functionality and preventing occlusions.
Implementation Method 1
applying force to deform the container so that a solution located in the chamber flows through the one-way valve into the vascular access device
Implementation Method 2
a one-way valve disposed between the tip and the deformable container, the one-way valve in fluid communication with the inner chamber of the container, said one-way valve permitting air or fluid evacuation from the inner chamber but preventing air or fluid intake into the inner chamber when the container is manually deformed and released
Implementation Method 3
a primer element for removing one or more air bubbles from the chamber
Data Source
AI summary
A single use delivery device is disclosed having a manually deformable liquid container defining an inner chamber, the container having a distal end, a body, a proximal end, and an outlet on the distal end; a tip projecting from the outlet on the distal end of the container, the tip in fluid communication with the inner chamber of the container; a primer element for removing one or more air bubbles from the chamber, said primer element being attached to and in fluid communication with the deformable container, the container, the tip and the primer element being collapsible to minimize dead space in the delivery device; and two or more one-way valves. A method of administering a fluid to or flushing a vascular access device using a single use pre-filled delivery device as described herein is also disclosed.