Catheter Lumen Antimicrobial Insert for Replenished Infection Protection

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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 failure of antimicrobial coatings that wear off or become ineffective, and the risk of antimicrobial agents entering the bloodstream.

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, which physically blocks or kills organisms, and a cap system that replenishes the antimicrobial agent with each use, reducing the risk of bloodstream exposure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If antimicrobial coatings are applied to catheters, then infection prevention is improved, but the coatings wear off or become ineffective over time

Engineering Contradiction:
Improveinfection preventionVSAvoidcoating effectiveness
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The catheter system performs self-service by automatically replenishing antimicrobial agent through the lock solution infusion process. The lock solution acts as a carrier that continuously delivers fresh antimicrobial agent to the catheter surface, eliminating the need for manual reapplication and maintaining consistent protective levels without degradation over time.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention changes the delivery mechanism from a static coating to a dynamic replenishment system. By utilizing the lock solution flow parameters (volume, frequency, concentration), the system maintains optimal antimicrobial agent concentration on the catheter surface, transforming a degrading static state into a renewable dynamic state.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If antimicrobial agents are delivered into the catheter lumen, then infection prevention is improved, but there is risk of agents entering the bloodstream

Engineering Contradiction:
Improveinfection preventionVSAvoidbloodstream exposure
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The lock solution serves as an intermediary medium that carries the antimicrobial agent to the catheter surface without direct entry into the bloodstream. The agent is delivered through the luminal space and adheres to the catheter wall, creating a protective barrier while the lock solution itself acts as a controlled delivery vehicle that prevents uncontrolled systemic exposure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The antimicrobial agent is concentrated locally on the catheter surface where it is needed for infection prevention, rather than being distributed systemically. The lock solution delivery ensures high local concentration at the catheter-lumen interface while minimizing systemic circulation, achieving targeted therapy with reduced harmful effects.

Inventive Principle:
Principle #3Local quality

3Reliability

If the proximal end of the catheter is treated with antimicrobial agent, then organism proliferation is prevented, but device complexity increases

Engineering Contradiction:
Improveorganism proliferation preventionVSAvoiddelivery system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system utilizes the existing lock solution infusion procedure to automatically deliver the antimicrobial agent, requiring no additional manual steps or complex delivery devices. The standard lock solution process becomes self-sufficient by also performing antimicrobial replenishment, maintaining simplicity while achieving enhanced protection at the proximal end.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS11826539B2Device for delivery of antimicrobial agent into a medical device
Publication Date: 2023.11.28 ICU MEDICAL INC
  • US11826539B2 patent drawing
  • US11826539B2 patent drawing
  • US11826539B2 patent drawing

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. In the alternative an antimicrobial agent can be placed on an interior surface of a retaining ring.