Catheter Valve Assembly Slit Leaflets for Leakage Control

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Solution Overview

Problem

Existing valve assemblies for medical devices, particularly catheters, face challenges in controlling fluid flow effectively while preventing leakage and minimizing blood exposure for caregivers, especially during insertion, removal, or changes in catheters.

Innovation Solution

A valve assembly with a barrier layer having slits that form leaflets, which opens upon insertion of a male luer, allowing fluid flow while minimizing blood exposure and preventing leakage. The valve is designed to be used within a catheter hub and can be configured for use in various medical tubing assemblies.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a catheter is inserted into a vessel, then fluid flow control is enabled, but blood leakage and infection risk increase during insertion and removal

Engineering Contradiction:
Improvefluid flow controlVSAvoidblood leakage and infection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The valve is pre-positioned at the insertion site and remains closed during the insertion process. The catheter is inserted through the closed valve, and only after proper positioning is the valve opened to allow fluid flow. This preliminary closing action prevents blood leakage and infection risk during the critical insertion phase.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The valve acts as an intermediary component between the external environment and the vascular system. It provides a controlled interface that allows catheter passage while maintaining hemostasis during insertion, and only permits blood flow when intentionally opened after proper positioning.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the catheter connection is made secure, then accidental disconnection is prevented, but the complexity of the connection increases

Engineering Contradiction:
Improveconnection securityVSAvoidconnection complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The valve assembly integrates multiple functions into a single unified component: it provides the connection interface, maintains hemostasis during insertion, and controls fluid flow. This merging of functions into one integrated assembly reduces overall system complexity while maintaining secure connection.

Inventive Principle:
Principle #5Merging (Combining)

3Object-affected harmful factors

If the valve remains closed during insertion, then blood exposure is minimized, but fluid flow is blocked during the procedure

Engineering Contradiction:
Improveblood exposureVSAvoidfluid flow
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The valve transitions from a static closed state during insertion to a dynamic open state during fluid administration. This dynamic behavior allows the valve to adapt its function based on the procedural phase: closed to minimize blood exposure during insertion, open to allow fluid flow during treatment.

Inventive Principle:
Principle #15Dynamics

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 valve assembly effectively controls fluid flow, reduces the risk of infection, slows blood loss to allow for proper cleaning, and minimizes blood exposure for caregivers, thereby enhancing safety and hygiene during medical procedures.

Implementation Method 1

The valve can be configured for use with a male luer having a distal end, a lateral surface, and a connector portion. Insertion of the male luer into the valve cavity can cause the distal end of the male luer to open the at least one slit to permit fluid flow through the barrier layer.

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS12239814B2Methods and devices for vascular access
Publication Date: 2025.03.04 IV ACCESS TECHNOLOGY INC
  • US12239814B2 patent drawing
  • US12239814B2 patent drawing
  • US12239814B2 patent drawing

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.