Transdermal Catheter Antimicrobial Insert for Lumen Infection Control

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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 leaking into 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 that displaces fluid, creating a saturated solution to disinfect the connector and deposit antimicrobial agents on the catheter threads, combined with physical barriers to prevent microbial incursion.

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 uses the patient's own blood to activate and deliver antimicrobial agents through blood-activated switching mechanisms and blood-flow-dependent release systems, allowing the system to self-regulate and maintain effectiveness without external intervention or degrading coatings

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent employs dynamic delivery mechanisms including blood-flow-dependent release systems that adjust antimicrobial agent release based on blood flow conditions, and switchable mechanisms that activate antimicrobial protection only when needed, preventing the static degradation issues of traditional coatings

Inventive Principle:

Principle #15Dynamics

2Reliability

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

Engineering Contradiction:

Improveinfection preventionVSAvoidantimicrobial leakage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies antimicrobial agents locally at specific sites within the catheter system using targeted delivery mechanisms, including localized coatings on internal surfaces and site-specific release mechanisms that confine agents to where they are needed most, reducing systemic exposure

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent uses blood itself as an intermediary to trigger and control antimicrobial agent release, where blood components activate the release mechanism and simultaneously serve as the delivery medium, ensuring agents are released only when blood is present and directing them away from vascular exposure

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If the proximal end of the catheter is disassembled for maintenance, then cleaning access is improved, but microbial contamination risk increases

Engineering Contradiction:

Improvecleaning accessVSAvoidmicrobial contamination

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent applies antimicrobial agents to the proximal end components and connector surfaces before assembly, creating a protective barrier in advance that prevents microbial contamination during subsequent disassembly and cleaning operations

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent maintains continuous antimicrobial protection on the proximal end components through persistent coatings and sustained-release mechanisms that remain effective throughout repeated assembly, disassembly, and cleaning cycles, ensuring uninterrupted protection despite maintenance activities

Inventive Principle:

Principle #20Continuity of useful action

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 significantly reduces the incidence of bloodstream infections by maintaining a consistent antimicrobial presence on the catheter, preventing microbial growth, and minimizing the risk of antimicrobial agents entering the bloodstream, thereby reducing infection rates and adverse reactions.

Implementation Method 1

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 EffectFluid displacement: Displacement

Implementation Method 2

creating a saturated solution to disinfect the connector and deposit antimicrobial agents on the catheter threads

Methodology Applied

Scientific EffectSaturation: Supersaturation

Implementation Method 3

combined with physical barriers to prevent microbial incursion

Methodology Applied

Scientific EffectPhysical barrier: Physical Containment

Data Source

PatentUS11389634B2Device for delivery of antimicrobial agent into trans-dermal catheter

Publication Date: 2022.07.19 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. In the alternative an antimicrobial agent can be placed on an interior surface of a retaining ring.