Antimicrobial Catheter Insert and Cap for Lumen Infection Blocking

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Solution Overview

Problem

Long-term hemodialysis catheters are prone to infections, leading to elevated mortality rates and significant healthcare costs, due to the inability of existing technologies to effectively prevent infectious organisms from entering and occupying the catheter lumen.

Innovation Solution

A device and method for delivering an antimicrobial agent into the lumen and near the entry region of catheters, using an elongate member with an antimicrobial composition that is delivered into the catheter upon insertion, and a capping member with an antimicrobial composition on its interior, to physically block and kill organisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional catheters are used without antimicrobial delivery systems, then the device structure remains simple, but infection rates increase significantly

Engineering Contradiction:

Improveinfection preventionVSAvoidcatheter structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The catheter is pre-filled with antimicrobial lock solution before use, and the delivery device is pre-assembled with the elongate member containing antimicrobial composition. This preliminary preparation ensures that antimicrobial protection is immediately available when the catheter is installed, preventing infections before they can establish themselves in the catheter lumen.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The delivery device acts as an intermediary system between the antimicrobial composition and the catheter lumen. It includes a delivery catheter with an elongate member that transfers the antimicrobial solution from the lock chamber into the catheter, ensuring controlled and effective delivery without direct contact between the user and the antimicrobial agents.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If antimicrobial agents are delivered into the catheter lumen, then infection prevention improves, but the risk of organisms developing resistance increases

Engineering Contradiction:

Improveinfection preventionVSAvoidantimicrobial resistance

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system employs multiple different antimicrobial agents (e.g., heparin, sodium citrate, taurolidine) that can be selected and rotated based on clinical needs and resistance patterns. By changing the chemical parameters and types of antimicrobials used, the system maintains effectiveness against resistant organisms while preventing the development of broad-spectrum resistance.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The catheter lock solution is replaced periodically according to a scheduled regimen, and different antimicrobial agents can be alternated between sessions. This periodic replacement prevents continuous exposure to a single antimicrobial agent, reducing the selective pressure that leads to resistance development while maintaining effective infection prevention.

Inventive Principle:

Principle #19Periodic action

3Reliability

If the catheter is filled with lock solution to prevent infections, then antimicrobial effectiveness increases, but fluid spillage into the bloodstream occurs

Engineering Contradiction:

Improveinfection preventionVSAvoidfluid spillage

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The delivery device extracts and contains the antimicrobial lock solution in a separate lock chamber before delivery. The elongate member is inserted through the catheter hub and delivers the solution directly to the catheter lumen, separating the storage and delivery functions from the catheter itself. This extraction and controlled delivery system prevents accidental spillage into the bloodstream while ensuring the antimicrobial solution reaches its intended destination.

Inventive Principle:

Principle #2Taking out (Extraction)

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 reduces the number of organisms reaching the bloodstream by physically blocking migration, killing organisms with antimicrobials, and preventing biofilm formation, thereby decreasing infection rates and associated mortality and healthcare costs.

Implementation Method 1

an antimicrobial composition positioned to be delivered into the catheter. At least a portion of the antimicrobial composition is delivered to the exterior of the proximal end of the catheter upon insertion of the elongate member into the proximal end of the catheter

Methodology Applied

Scientific EffectAntimicrobial action:

Implementation Method 2

inserting an elongate member into the proximal end of the transdermal catheter such that the elongate member sufficiently displaces lock solution so as to have the lock solution flow from the proximal end of the catheter

Methodology Applied

Scientific EffectMechanical displacement:

Implementation Method 3

a capping member configured for placement over the proximal end of a catheter; to physically block and kill organisms

Methodology Applied

Scientific EffectPhysical blocking: Physical Containment

Data Source

PatentUS20250121174A1Device for delivery of antimicrobial agent into a medical device

Publication Date: 2025.04.17 ICU MEDICAL INC

AI summary

A system, method, and article for delivering an antimicrobial agent into the lumen of a trans-dermal catheter are disclosed. In an embodiment, the system comprises an elongate member configured for insertion into a lumen of a catheter, and the elongate member containing an antimicrobial. An antimicrobial agent can be placed on an interior surface of a retaining ring.