Polyurethane Based Medical Articles

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Solution Overview

Problem

Existing medical devices, such as infusion therapy devices, face challenges with infection and thrombosis due to microbial colonization and blood coagulation, and current antimicrobial and antithrombogenic coatings complicate manufacturing and increase costs.

Innovation Solution

A polyurethane-based resin incorporating an anionic modifier, such as 2,2-bis(hydroxymethyl)butyric acid or bis-1,4-((2-hydroxypropoxy)-2-propoxy)-butane sulfonate sodium salt, is used to create medical articles with inherent antimicrobial and anti-fouling properties or to easily bond cationic agents, eliminating the need for separate coating processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If catheters are impregnated with antimicrobial agents, then antimicrobial efficacy is improved, but manufacturing complexity increases and regulatory concerns arise

Engineering Contradiction:
Improveantimicrobial efficacyVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the antimicrobial agent directly into the polyurethane polymer matrix during synthesis, merging the active agent with the structural material. This integration eliminates separate impregnation or coating steps, reducing manufacturing complexity while maintaining antimicrobial efficacy through the polyol component that provides both structural integrity and biological activity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention creates a composite polyurethane material where the polyol component serves dual functions: providing the polymer matrix structure and delivering antimicrobial activity. This composite approach integrates multiple functions (structural support and antimicrobial protection) into a single material system, avoiding the need for separate coatings or impregnations.

Inventive Principle:
Principle #40Composite materials

2Reliability

If surface coating techniques are used to bond antimicrobial agents, then chemical bonding is achieved, but manufacturing steps increase and costs significantly rise

Engineering Contradiction:
Improvechemical bonding stabilityVSAvoidmanufacturing efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent incorporates the antimicrobial polyol component during the initial polymer synthesis step, performing the antimicrobial agent integration action before any subsequent processing or coating steps. This preliminary incorporation ensures chemical bonding stability is built into the material structure itself, eliminating the need for later coating operations and significantly improving manufacturing efficiency.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If heparin is attached to polymeric surfaces, then anti-thrombogenicity is improved, but heparin-induced thrombocytopenia risk increases

Engineering Contradiction:
Improveanti-thrombogenicityVSAvoidthrombocytopenia risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a polyol component that provides anti-thrombogenic properties through its inherent chemical structure rather than through heparin attachment. This approach uses a stable, non-leaching polymer-based mechanism that avoids the immunogenic issues associated with heparin, effectively replacing the need for heparin while maintaining anti-thrombogenic protection.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Reliability

If multiple surface coating steps are performed, then antimicrobial and anti-fouling properties are improved, but manufacturing time and costs increase

Engineering Contradiction:
Improveanti-fouling propertiesVSAvoidmanufacturing time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent uses a polyol component that simultaneously provides multiple functions: structural polymer matrix formation, antimicrobial activity, and anti-fouling properties. This multi-functional approach consolidates what would traditionally require multiple separate coating steps into a single integrated material synthesis process, dramatically reducing manufacturing time while maintaining comprehensive protective properties.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 resin provides effective antimicrobial and anti-fouling characteristics, reducing thrombus and bacterial biofilm formation, and simplifies manufacturing by integrating antimicrobial agents without the need for additional coating steps.

Implementation Method 1

the polyurethane-based resin having inherent antimicrobial and/or anti-fouling characteristics

Methodology Applied
Scientific EffectAntimicrobial activity:

Implementation Method 2

the polyurethane-based resin having inherent antimicrobial and/or anti-fouling characteristics

Methodology Applied
Scientific EffectAnti-fouling properties:

Implementation Method 3

can easily bond cationic active agents to provide desirable material properties, including antimicrobial, anti-fouling, and/or radiopacity

Methodology Applied
Scientific EffectIonic bonding: Ion Repulsion/Attraction

Data Source

PatentUS20250213754A1Polyurethane Based Medical Articles
Publication Date: 2025.07.03 BECTON DICKINSON & CO
  • US20250213754A1 patent drawing
  • US20250213754A1 patent drawing
  • US20250213754A1 patent drawing

AI summary

Medical articles formed from a polyurethane-based resin including an ionically-charged modifier provide enhanced properties. The polyurethane-based resin is a reaction product of ingredients comprising: a diisocyanate; a diol chain extender; a polyglycol; and an anionic modifier incorporated into a backbone, as a side chain, or both of the polyurethane-based resin. Exemplary anionic modifier includes 2,2-bis(hydroxymethyl)butyric acid (BHMBA) and/or bis-1,4-((2-hydroxypropoxy)-2-propoxy)-butane sulfonate sodium salt (SULFADIOLĀ®-7Q). Medical articles herein either have inherent antimicrobial and/or anti-fouling characteristics or can easily bond cationic active agents to provide desirable material properties, including antimicrobial, anti-fouling, and/or radiopacity.