Slit-Leaflet Catheter Valves for Blood Loss and Leak Control

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing catheter systems face issues with accidental disconnection leading to potential life-threatening blood loss and exposure, unsanitary conditions, and increased infection risk due to uncontrolled fluid flow and loose connections during catheter insertion and removal.

Innovation Solution

A valve assembly with a barrier layer and slits forming leaflets that open upon insertion of a male luer, allowing controlled fluid flow and minimizing blood exposure, featuring a flange for secure engagement and a recessed design to accommodate the luer without interference.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a catheter connection port is left open during insertion and removal procedures, then ease of operation is improved, but blood loss and infection risk increase

Engineering Contradiction:

Improvecatheter insertion and removalVSAvoidblood loss and infection risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The valve is pre-positioned in a closed state within the catheter hub before any procedures begin. This preliminary closed state prevents blood loss and contamination during the periods between catheter insertions and removals, while still allowing rapid access when needed.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The valve assembly acts as an intermediary component between the catheter lumen and the external environment. It mediates between the need for open access during procedures and the need for closed protection during idle periods, allowing controlled flow only when a male luer is inserted.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If a valve assembly is added to control fluid flow, then safety is improved, but device complexity increases

Engineering Contradiction:

Improvefluid flow control and connection securityVSAvoidvalve assembly structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The valve incorporates a flexible barrier layer with integrated slits that form leaflets. This thin-film structure provides effective flow control while minimizing the overall complexity and bulk of the valve assembly. The flexible nature allows simple actuation by the male luer insertion without complex mechanical components.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The valve assembly merges multiple functions into a single integrated component: the barrier layer provides both sealing and flow control, the slits form the valve mechanism, and the flange provides both structural support and connection functionality. This consolidation improves reliability while managing complexity.

Inventive Principle:

Principle #5Merging (Combining)

3Object-affected harmful factors

If the valve closes rapidly upon luer removal, then blood loss is reduced, but ease of operation may be affected

Engineering Contradiction:

Improveblood lossVSAvoidconnection and disconnection

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The valve mechanism is self-actuating through the mechanical action of male luer insertion and removal. The slits open automatically when the luer is inserted and close automatically when removed, without requiring additional user actions. This self-service mechanism ensures rapid closure to minimize blood loss while maintaining ease of operation.

Inventive Principle:

Principle #25Self-service

Data Source

PatentUS20250281732A1Methods and devices for vascular access

Publication Date: 2025.09.11 IV ACCESS TECHNOLOGY INC

AI summary

Valve assemblies having improved ability to selectively control flow of fluids through the catheter and prevent leakage of fluids from the proximal end of a catheter that is positioned within a patient. Such improved catheter valve assemblies also prevent leakage of fluids after repeated insertion and removal of medical instruments through the valve.