Backflow Prevention Valve for Delayed Drug Delivery Paths
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Solution Overview
Problem
Drug delivery devices can experience occlusions and clot formation in the fluid path, leading to delayed or incomplete drug delivery, particularly in devices with delayed activation mechanisms.
Innovation Solution
A drug delivery device with a backflow prevention mechanism featuring a valve that moves between first and second positions to restrict and permit fluid flow, including a valve pin septum and pin to prevent ingress of bodily fluids and reduce clot formation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a delayed delivery mechanism is used to enhance therapeutic efficacy and reduce side effects, then drug delivery timing is improved, but the risk of occlusion and clot formation in the fluid path increases
Solution Approach 1:
The fluid path is pre-filled (primed) with medicament or saline solution before the delayed delivery period begins. This preliminary action ensures that the fluid path remains filled with compatible fluid throughout the delay period, preventing occlusion and clot formation while maintaining the ability to deliver the drug at the intended time.
Solution Approach 2:
A backflow prevention valve is positioned in the fluid path to actively prevent bodily fluids from flowing backward into the device during the delayed delivery period. This preliminary protective action counteracts the harmful backflow that would otherwise cause clot formation and occlusion before drug administration.
2Device complexity
If the fluid path is left non-primed to simplify device structure, then device complexity is reduced, but backflow of bodily fluids occurs leading to clot formation
Solution Approach 1:
The fluid path is pre-filled (primed) with medicament or saline solution before the delayed delivery period begins. This preliminary action ensures that the fluid path remains filled with compatible fluid throughout the delay period, preventing occlusion and clot formation while maintaining the ability to deliver the drug at the intended time.
Solution Approach 2:
A backflow prevention valve is positioned in the fluid path to actively prevent bodily fluids from flowing backward into the device during the delayed delivery period. This preliminary protective action counteracts the harmful backflow that would otherwise cause clot formation and occlusion before drug administration.
3Productivity
If pressure is increased to push drug through a clot, then drug delivery may be restored, but the drive force capability of the device is exceeded causing the device to stall
Solution Approach 1:
A backflow prevention valve is positioned in the fluid path to actively prevent bodily fluids from flowing backward into the device during the delayed delivery period. This preliminary protective action counteracts the harmful backflow that would otherwise cause clot formation and occlusion before drug administration, eliminating the need to exceed drive force capabilities to clear clots.
Solution Approach 2:
The fluid path is pre-filled (primed) with medicament or saline solution before the delayed delivery period begins. This preliminary action ensures that the fluid path remains filled with compatible fluid throughout the delay period, preventing occlusion and clot formation while maintaining the ability to deliver the drug at the intended time.
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 mechanism effectively prevents backflow and clot formation, ensuring reliable and timely drug delivery, especially in non-primed fluid paths, and is applicable to wearable and handheld drug delivery devices.
Implementation Method 1
The valve pin is movably disposed within the second throughbore. When the valve is in the first position, the valve pin is positioned within the first throughbore to restrict the medicament from flowing therethrough. When the valve is in the second position, the valve pin is positioned to permit the medicament to flow through the first throughbore.
Data Source
AI summary
A drug delivery device includes a housing, a container disposed in the housing, an activation mechanism, a needle insertion mechanism, a fluid flow connection, and a valve in fluid communication with the fluid flow connection and the needle insertion mechanism. The container has an inner volume to contain a medicament which is urged out of the container by the activation mechanism. The needle insertion mechanism is adapted to insert a needle and/or a cannula to deliver the medicament from the container via the fluid flow connection. The valve is in fluid communication with the fluid flow connection and needle insertion mechanism, and is movable between first and second positions. Upon insertion of the needle and/or the cannula, the valve remains in the first position whereby fluid flow is restricted. At a later time, the valve is urged to the second position whereby fluid may flow through the needle or cannula.