Valved Catheter Assembly with Dynamic Flap for Controlled Fluid Access
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Solution Overview
Problem
Current IV catheter systems face challenges in controlling fluid flow and preventing blood exposure during placement and use, with existing solutions often leading to uncontrolled fluid flow or requiring awkward manual pressure to maintain vein occlusion.
Innovation Solution
A valved catheter assembly with a valve opener mechanism that obstructs or restricts fluid flow, featuring a valve with slits and flaps that can be opened and closed to facilitate controlled fluid access, and a needle guard for safety, addressing issues of fluid control and needle protection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a septum actuator is advanced through a slit of the septum to provide a fluid pathway, then fluid flow is enabled, but the septum actuator becomes lodged within the slit and cannot return to its initial position, resulting in uncontrolled fluid flow
Solution Approach 1:
The valve flap is designed as a dynamic component that can transition between closed and open states. The flap is initially closed to block fluid flow, and when the actuator is advanced, the flap dynamically opens to allow fluid passage. The flap's ability to return to its closed position after opening ensures controlled fluid flow and prevents the actuator from becoming permanently lodged.
Solution Approach 2:
The valve is segmented into distinct functional components: a valve body with a slit, a movable valve flap, and an actuator. This segmentation allows the flap to independently control fluid flow through the slit while the actuator provides mechanical activation. The separated design enables the flap to open and close the fluid pathway without the actuator becoming trapped.
2Object-affected harmful factors
If the clinician manually occludes the vein to prevent blood exposure, then blood exposure is prevented, but the clinician must awkwardly maintain pressure on the vein while simultaneously coupling the catheter adapter and IV tubing
Solution Approach 1:
The valve is pre-configured in a closed state before catheter insertion, automatically preventing blood exposure without requiring manual vein occlusion. After successful venipuncture and blood flashback confirmation, the valve can be opened via the actuator to allow fluid flow. This preliminary closure eliminates the need for continuous manual pressure during the coupling process.
Solution Approach 2:
The valve system provides self-service blood exposure prevention through its automatic closed position and self-sealing capability. When the actuator is not engaged, the valve flap automatically blocks the fluid pathway, preventing blood from leaking out. This self-service mechanism frees the clinician's hands to perform coupling operations without maintaining manual vein occlusion.
3Ease of operation
If the valve flap is opened to allow fluid flow, then fluid access is facilitated, but the valve must reliably close to prevent uncontrolled flow
Solution Approach 1:
The valve flap is designed as a dynamic component that responds to pressure differentials and actuator movement. When the actuator pushes the flap open, fluid can flow through the slit. When the actuator is released, the flap dynamically returns to its closed position under elastic recovery or pressure differential, reliably restricting fluid flow again.
Solution Approach 2:
The valve flap's state is changed by varying the mechanical parameter of actuator position. In the retracted position, the flap is closed; when the actuator is advanced, the flap opens. The flap's material properties (elasticity, flexibility) are selected to ensure it can reliably change state between open and closed positions, providing controlled fluid access when needed and reliable restriction when the actuator is not engaged.
Data Source
AI summary
Catheter assemblies are described having a catheter hub with a catheter tube and a needle hub with a needle projecting through the catheter tube. The catheter hub has a valve or a septum for stopping or slowing down the flow of fluid in or out of the catheter hub when the valve or septum is closed. The valve has features formed thereon to facilitate venting, opening, closing, or combinations thereof.