Catheter Site Insertion Plug for Leakage Prevention
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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
Engineering 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
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.
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.
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
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.
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.
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
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.
4Reliability
If traditional securement methods are used, then the catheter can be attached to skin, but additional adhesives are required and removal becomes complicated
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.
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
Data Source
Figure 1A
Figure 1B
Figure 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.