Catheter Site Insertion Plug for Leakage Prevention

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Infusion catheters face issues with securement and leakage at the skin puncture site, leading to potential crimping, kinking, and increased risk of infection due to inadequate sealing and adhesion methods.

Innovation Solution

A catheter site insertion plug with a protruding portion and passageway designed to receive the catheter, featuring a foam or composite base with a skin-compatible adhesive for stabilization and a beveled opening for easy catheter insertion, along with notches for securement, to prevent leakage and secure the catheter in place.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If catheters are sutured to the skin or secured by adhesive tape, then the catheter can be secured in position, but the results are inconsistent and can result in movement, leakage, kinking, and increased infection risk

Engineering Contradiction:
Improvecatheter securement reliabilityVSAvoidleakage and infection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device segments the securement function into distinct components: the insertion plug seals the puncture site while the retention flange prevents catheter movement. This segmentation allows each component to optimize its specific function without the compromises of traditional single-method securement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The insertion plug acts as an intermediary element between the catheter and the skin puncture site. It provides a reliable seal and mechanical anchor point, eliminating the need for direct adhesion to skin and thereby reducing leakage and infection risks associated with adhesive tape.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If the skin puncture site diameter is greater than the catheter diameter, then the catheter can be inserted, but fluid leakage occurs along the catheter to the opening

Engineering Contradiction:
Improvecatheter insertion easeVSAvoidfluid delivery reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The insertion plug is pre-formed with a tapered configuration that matches the puncture site geometry. This preliminary preparation allows the plug to be inserted first to create a precise seal, followed by the catheter, ensuring both easy insertion and leak-free fluid delivery.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The insertion plug changes the effective diameter parameter at the puncture site by providing a tapered seal surface. This allows the catheter to maintain its original diameter for easy insertion while the plug creates a tighter sealing interface that prevents fluid leakage.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If medical adhesive is used to seal the skin puncture site, then leakage may be reduced, but the adhesive may not seal completely and complicates catheter removal

Engineering Contradiction:
Improvepuncture site sealing reliabilityVSAvoidcatheter removal ease
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The invention replaces the chemical adhesion mechanism of medical adhesive with a mechanical sealing system. The tapered insertion plug creates a physical seal through friction and geometric interlocking, providing reliable sealing without the complications of adhesive removal and ensuring complete seal integrity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Reliability

If traditional securement methods are used, then the catheter can be attached to skin, but additional adhesives are required and removal becomes complicated

Engineering Contradiction:
Improvecatheter securement reliabilityVSAvoidsecurement system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device merges the sealing function and the securement function into a single integrated insertion plug assembly. The tapered plug provides the seal while the retention flange provides mechanical attachment, eliminating the need for separate adhesive applications and simplifying both application and removal procedures.

Inventive Principle:
Principle #5Merging (Combining)

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 solution effectively secures the catheter, reduces fluid leakage, and minimizes the risk of infection by providing a stable and adhesive-free method for maintaining catheter position, thus reducing the need for additional adhesives and minimizing complications during removal.

Implementation Method 1

The base may include a skin contacting portion that may further include a skin-compatible adhesive

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentEP3089782B1Catheter site insertion plug
Publication Date: 2023.01.04 AVENT INC
  • EP3089782B1 patent drawingFigure 1A
  • EP3089782B1 patent drawingFigure 1B
  • EP3089782B1 patent drawingFigure 2A~2D

AI summary

The present invention provides a catheter site insertion plug composed of a body that includes an upper surface, a lower surface and a protruding portion extending from the lower surface. The protruding portion of the body forms a frustum having a terminus and defines a passageway extending from an opening at the upper surface to an exit orifice at the terminus of the frustum. The passageway is configured to receive a catheter therethrough. The lower surface may include a second protruding portion in the form of an annular ring around the first protruding portion. The first protruding portion may include an end section that extends radially outward to provide an inflection point generally adjacent the terminus of the frustum. The end section may extend outward to provide at least one radial edge. The present invention also provides a catheter system composed of a flexible catheter and catheter site insertion plug.