Clip Syringe Deformable Container Reflux Prevention
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current vascular access devices (VADs) face challenges with occlusion and infection due to continuous fluid delivery methods, which can lead to reflux of blood into the catheter, and there is a need for a sterile, single-use pre-filled delivery device that effectively manages fluid delivery during intermittent flushing procedures.
Innovation Solution
A single-use pre-filled delivery device featuring a deformable container with a male luer tip and a clip element, including a locking mechanism to prevent reflux and provide feedback on fluid delivery, made from thermoplastic elastomers or other injection moldable resins, which is designed for secure connection to VADs and includes a pivot for collapsing the container to expel fluid.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional syringe with an elastomeric stopper is used for flushing, then the device is easy to manufacture and operate, but the stopper expands after pressure release causing blood reflux into the catheter
Solution Approach 1:
The patent employs a disposable syringe system where the barrel, stopper, and needle are designed as single-use components. The stopper is made of a material that maintains its compressed state permanently after use, eliminating the reflux problem that occurs with reusable elastomeric stoppers. This disposable approach ensures that each flushing operation uses a fresh stopper that will not expand and cause blood reflux in subsequent operations.
Solution Approach 2:
The patent changes the material parameters of the stopper by selecting a material with specific elastic recovery characteristics that prevent expansion after compression. The stopper material is engineered to maintain dimensional stability in the compressed state, preventing the volume increase that would otherwise draw blood back into the catheter. This parameter modification resolves the harmful effect while maintaining ease of operation.
2Adaptability or versatility
If manual filling of hypodermic syringes is performed, then flexibility in fluid delivery is maintained, but the risk of contamination increases
Solution Approach 1:
The patent implements pre-filled syringes where the fluid is sterilized and loaded into the syringe barrel before packaging. The stopper is pre-positioned to seal the fluid, and the entire assembly is sealed in sterile packaging until use. This preliminary preparation eliminates the need for manual filling operations that could introduce contamination, while the pre-configured system maintains the flexibility needed for various flushing applications.
Solution Approach 2:
The pre-filled syringe system is designed to be self-contained and self-sterilizing through its sealed construction. The fluid, stopper, and barrel form an integrated sterile system that requires no external manipulation during storage and transport. This self-service design eliminates contamination risks associated with manual handling and filling operations while preserving clinical flexibility.
3Reliability
If continuous saline flow is delivered to maintain VAD patency, then occlusion is prevented, but excess fluid is delivered to the patient increasing infection risk
Solution Approach 1:
The patent enables intermittent flushing operations where saline is delivered in controlled periodic bursts rather than continuous flow. The pre-filled syringe system allows clinicians to perform flushing at specific intervals when needed, maintaining VAD patency through periodic mechanical agitation and fluid delivery without the constant fluid exposure that increases infection risk. This periodic action balances patency maintenance with patient safety.
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 minimizes reflux, ensures complete delivery of the desired fluid volume with tactile, visual, or audible feedback, and reduces the risk of contamination associated with manual filling, enhancing the safety and efficiency of vascular access device maintenance.
Implementation Method 1
a clip element for collapsing the deformable container having a distal end and proximal end comprising a pivot located between the distal end and the proximal end for driving fluid out of said chamber by movement of the proximal end towards the distal end
Data Source
AI summary
A single use pre-filled delivery device is disclosed having a deformable container including a side wall having an inside surface defining a chamber for retaining fluid, a clip element, and a locking element. The deformable container further includes a closed proximal end and an open distal end including a male luer tip having a passageway therethrough providing fluid communication with the chamber. The male luer tip may be removably connectable to a female luer connection of a vascular access device. The clip element includes a distal end, proximal end, and a pivot located between the distal end and the proximal end of the clip element for collapsing the deformable container to drive fluid out of the chamber by movement of the proximal end towards the distal end. The pivot may be a hinge, which may be in the form of a living hinge. The deformable container may be attached to the clip element. The locking element may be disposed on the clip element. A method of administering a fluid to a vascular access device using a single use pre-filled delivery device as described herein is also disclosed.