Expandable Hydrogel Plug for Trans-Dermal Catheter Infection Prevention

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Solution Overview

Problem

Long-term hemodialysis catheters are prone to infection due to colonization of infectious organisms within the catheter lumen, leading to elevated mortality rates and healthcare costs, with existing solutions like antimicrobial coatings and locking solutions facing issues of resistance and spillage into the bloodstream.

Innovation Solution

A radially expandable plug made of hydrogel or other materials, incorporating antimicrobial agents, is inserted into the catheter lumen to create a physical barrier and maintain a consistent antimicrobial presence, reducing infection risk by preventing blood from entering the catheter and minimizing the exchange of antimicrobial agents with blood.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If antimicrobial coatings are applied to the catheter, then infection prevention is improved, but bacterial resistance develops over time

Engineering Contradiction:
Improveinfection preventionVSAvoidbacterial resistance
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the delivery mechanism from passive coating to active controlled release, maintaining effective antimicrobial concentration while reducing total exposure time and amount, thereby delaying resistance development

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system provides periodic pulses of antimicrobial agent through the expandable plug, creating intermittent high-concentration exposure that is more effective at preventing biofilm formation and reducing resistance compared to continuous low-level exposure

Inventive Principle:
Principle #19Periodic action

2Reliability

If locking solutions are used to prevent infection, then antimicrobial presence is maintained, but spillage into the bloodstream occurs

Engineering Contradiction:
Improveantimicrobial presenceVSAvoidspillage into bloodstream
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The expandable plug is nested within the catheter lumen, creating a contained internal chamber that holds the antimicrobial solution and prevents it from leaking into the bloodstream while still delivering the agent to the catheter wall

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The system creates a localized high-concentration antimicrobial environment within the catheter lumen at the site of potential infection, while the rest of the bloodstream remains unaffected by the antimicrobial agent

Inventive Principle:
Principle #3Local quality

3Reliability

If the catheter lumen is periodically scrubbed to remove biofilm, then infection prevention is improved, but device complexity increases

Engineering Contradiction:
Improveinfection preventionVSAvoidscrubbing mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The expandable plug incorporates a rough or abrasive surface that mechanically scrubs the catheter wall during insertion and removal, physically disrupting and removing biofilm through friction rather than requiring complex scrubbing mechanisms

Inventive Principle:
Principle #18Mechanical vibration

Solution Approach 2:

The plug performs multiple functions during a single insertion-removal cycle: it delivers antimicrobial agent, mechanically scrubs the catheter wall to remove biofilm, and creates a temporary physical barrier, all without requiring external power or complex mechanisms

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS9072868B2Device for delivery of antimicrobial agent into trans-dermal catheter
Publication Date: 2015.07.07 ICU MEDICAL INC
  • US9072868B2 patent drawing
  • US9072868B2 patent drawing
  • US9072868B2 patent drawing

AI summary

A system for delivering an antimicrobial agent into the lumen of a trans-dermal catheter. In an embodiment, the system comprises an elongate member configured for insertion into a lumen of a catheter; an expandable portion of the elongate member, said expandable portion configured to increase in diameter upon exposure to an aqueous fluid; and an antimicrobial composition positioned to be delivered into the catheter. In another embodiment, the system comprises an elongate member configured for insertion into a lumen of a trans-dermal catheter, said elongate member comprising a hydrogel; and an antimicrobial composition positioned to be delivered into the catheter; wherein the elongate member defines a volume of liquid that is at least substantially contained within the lumen of the trans-dermal catheter.