Concentric Needle Dilator Assembly with Self-Sealing Valve
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Solution Overview
Problem
Conventional catheterization methods pose risks to healthcare workers and patients due to the need for large needles, which cause trauma and potential vascular damage, and suffer from fluid leakage issues after catheter insertion.
Innovation Solution
The use of axially concentric needle and dilator assemblies with retraction mechanisms and improved valves, allowing for the insertion of catheters using smaller needles, reducing pain and vascular damage risk, and incorporating a one-way blood control valve to minimize leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a large needle is used for catheter insertion, then the catheter can be introduced into the vessel, but the patient experiences trauma and vascular damage
Solution Approach 1:
The catheter is nested within the introducer needle assembly, allowing the catheter to be guided through the needle into the vessel. This nesting arrangement enables the use of a smaller needle while still accommodating the catheter, thereby reducing vascular trauma while maintaining catheter insertion capability
Solution Approach 2:
The introducer assembly is segmented into multiple components including the needle, dilator, and catheter that can be independently manipulated. This segmentation allows the needle to be removed after vessel access is established, leaving only the smaller catheter in place, thus reducing ongoing vascular trauma
2Reliability
If a needle is used for catheterization, then the catheter can be inserted into the vessel, but fluid or blood leakage occurs from the proximal end
Solution Approach 1:
The valve mechanism is designed to automatically seal the proximal end of the catheter when the connector is not attached, without requiring active control or additional components. The valve self-activates based on the presence or absence of the connector, providing reliable leakage prevention while maintaining relatively simple device architecture
Solution Approach 2:
The valve acts as an intermediary component between the catheter lumen and the external environment, controlling fluid flow passively. It provides a reliable seal when the connector is detached while allowing seamless fluid connection when the connector is attached, thus preventing leakage without adding significant complexity to the overall system
3Object-affected harmful factors
If a needle is left exposed after catheter insertion, then the catheter can be positioned in the vessel, but the needle poses a risk to healthcare workers
Solution Approach 1:
The needle retraction mechanism is pre-configured to automatically retract the needle upon catheter insertion or connector attachment. This preliminary action eliminates the need for manual needle retraction, thereby protecting healthcare workers from needlestick injuries while maintaining ease of operation through automated safety features
Solution Approach 2:
The safety mechanism is designed to self-activate based on the insertion state or connector presence, automatically retracting the needle without requiring additional manual intervention. This self-service approach ensures healthcare worker safety while maintaining operational simplicity, as the system autonomously manages the needle retraction process
Data Source
AI summary
Methods and devices to facilitate positioning of a catheter into a vessel. Devices include axially concentric assemblies of a piercing needle and a dilator that guides an outer catheter into a vessel, such as a blood vessel. The assemblies described herein can include retraction mechanisms and/or lock mechanisms to control needle positioning during catheterization processes as well as improved valves that prevent leakage of fluid from the proximal end of the devices. The devices and method include the use of novel valves to prevent undesired leakage of fluids through the proximal end of the catheter.