Microfluidic Pressure Switch Catheter Flush Line

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Solution Overview

Problem

Catheter-associated infections, particularly those related to biofilm contamination, pose a significant threat in medical settings, as existing catheters often allow contaminated fluids to enter the bloodstream during cleaning, risking further infection and complicating the separation of wash solutions from blood streams.

Innovation Solution

A catheter design featuring a microfluidic pressure switch that connects and disconnects the flushing line from the central line, allowing for safe introduction and removal of cleaning solutions without direct contact with the bloodstream, utilizing a kit with specific cleaning reagents like trypsin, calcium deficient buffers, and ethanol to effectively remove biofilms without contaminating the blood stream.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If a catheter is designed to be reusable and cleaned, then the useful life of the catheter is extended, but contaminated cleaning solutions may enter the bloodstream during cleaning, increasing infection risk

Engineering Contradiction:
Improveuseful life of catheterVSAvoidinfection risk
Core Design Contradiction:
Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The catheter is divided into separate functional channels: a central line for medication delivery and a flushing line for cleaning. This segmentation allows independent operation of each line, enabling cleaning of the catheter without introducing contaminants into the bloodstream, thus extending reusable life while maintaining safety.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A microfluidic pressure switch acts as an intermediary mechanism between the flushing line and central line. It controls the connection state, allowing flushing solutions to be introduced into the central line only when needed for cleaning, while preventing contaminated fluids from entering the bloodstream during normal operation, thereby resolving the contradiction between reusability and infection risk.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If cleaning solutions are introduced into the catheter to remove biofilm, then biofilm contamination is reduced, but the separation of wash solutions from blood stream becomes difficult

Engineering Contradiction:
Improvebiofilm contaminationVSAvoidseparation of wash solutions from blood stream
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The catheter structure separates the cleaning function into a dedicated flushing line that is distinct from the central line used for blood access. This physical segmentation maintains clear separation between wash solutions and bloodstream, simplifying the separation problem while still enabling effective biofilm removal through the flushing line.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The microfluidic pressure switch serves as a controlled intermediary that manages the connection between flushing line and central line. It allows precise control over when cleaning solutions are introduced, maintaining separation during normal operation while enabling controlled mixing during cleaning cycles, thus resolving the complexity of separation.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If a microfluidic pressure switch is added to control fluid flow, then safe introduction and removal of cleaning solutions is enabled, but device complexity increases

Engineering Contradiction:
Improvesafe introduction and removal of cleaning solutionsVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The microfluidic pressure switch is designed to be actuated by fluid pressure differences inherent in the cleaning process itself. The switching action is automatically triggered by the flow dynamics of the cleaning solutions, eliminating the need for external control mechanisms and reducing overall device complexity while maintaining reliable control.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces complex mechanical valve systems with a microfluidic pressure switch that utilizes fluid pressure and flow dynamics to control connectivity. This substitution reduces mechanical complexity while achieving more reliable and controllable fluid management, resolving the contradiction between reliability and complexity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

This design effectively prevents bloodstream infections by ensuring that cleaning solutions do not enter the bloodstream, extends the useful life of catheters, and provides a safer, more efficient method for cleaning and disinfecting catheters, reducing the risk of biofilm-related infections.

Implementation Method 1

The valve comprises a microfluidic movable pressure switch configured to move between the distal end and the flushing line

Methodology Applied
Scientific EffectPressure switch:

Implementation Method 2

a) digestive enzyme solution, b) calcium deficient buffer with high ion concentration, c) a solution comprising 70% ethanol

Methodology Applied
Scientific EffectEnzymatic digestion: Enzyme

Implementation Method 3

cleaning reagents may then be used to eliminate any biofilm which may have developed in the catheter central line or flushing line

Methodology Applied
Scientific EffectChemical cleaning:

Implementation Method 4

A tip of said microfluidic movable pressure switch is configured to block a narrowed portion of said central line on a tip of said catheter

Methodology Applied
Scientific EffectMechanical blockage:

Data Source

PatentEP2996746B1Flushable catheter affixed to a wash line activated by a microfluidic pressure switch
Publication Date: 2020.09.30 OUYANG YANNAN
  • EP2996746B1 patent drawingFigure 1A~1C
  • EP2996746B1 patent drawingFigure 2A~2B
  • EP2996746B1 patent drawingFigure 3A~3C

AI summary

This invention relates to systems for delivering medical devices, as well as related systems and methods. The invention also relates to methods of prevention and treatment of biofilm related contamination of systems or devices for medication delivery and methods of treating medical devices, such as catheters, to prevent infection from said device.