Self-lubricating Polyurethane Resin for Medical Articles

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Solution Overview

Problem

Current medical devices, such as catheters and infusion therapy equipment, face challenges with surface lubrication, antimicrobial properties, and thrombogenicity due to the need for additional coatings that complicate manufacturing, increase costs, and pose environmental and health risks, while also being prone to agent migration and loss of properties over time.

Innovation Solution

A polyurethane-based resin is developed with a diisocyanate, diol chain extender, and modifying oligomer, which includes fluoroether or silicone moieties, forming a self-lubricating and anti-fouling surface without the need for separate coatings, achieved through a one-step copolymerization process without solvents or catalysts, enhancing soft segment concentration and phase separation for improved surface properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If separate coatings (silicone, fluorocarbon, PVP) are applied to medical device surfaces for lubrication, then surface lubricity is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:
Improvesurface lubricityVSAvoidmanufacturing process complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent combines multiple functions (lubrication, anti-fouling, mechanical strength) into a single polymeric material system. The segmented polyurethane copolymer integrates the polyol matrix providing mechanical properties with lubricious additive segments, eliminating the need for separate coating layers and simplifying manufacturing while maintaining surface lubricity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention creates a composite polymeric material system consisting of a polyol matrix combined with lubricious additive segments. This composite approach allows the material to exhibit both structural integrity from the polyol and surface lubricity from the additive segments, replacing multiple separate materials (base polymer + separate coatings) with a single integrated composite material.

Inventive Principle:
Principle #40Composite materials

2Reliability

If separate coatings are applied for antimicrobial and non-thrombogenic properties, then biological performance is improved, but manufacturing complexity and cost increase

Engineering Contradiction:
Improveantimicrobial and non-thrombogenic propertiesVSAvoidnumber of coating steps
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The polymeric material system is designed to provide multiple functions simultaneously: mechanical strength from the polyol matrix, surface lubricity from additive segments, and biological performance (antimicrobial and non-thrombogenic properties) through the integrated segmented structure. This multi-functional material eliminates the need for separate specialized coatings for each function.

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

Solution Approach 2:

The invention merges biological performance characteristics directly into the polymeric material system through the segmented structure. The additive segments are incorporated during polymer synthesis, creating an integrated material that provides both mechanical and biological functions in a single step, rather than requiring separate antimicrobial and non-thrombogenic coating steps.

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If external coatings are used for surface properties, then initial performance is improved, but agent migration and property loss occur over time

Engineering Contradiction:
Improvesurface propertiesVSAvoidproperty stability over time
Core Design Contradiction:
Ease of operationVSDuration of action of stationary object

Solution Approach 1:

The lubricious additive segments are incorporated into the polymeric material system during the polymer synthesis process itself, before the final product is manufactured. This preliminary incorporation ensures that the surface-modifying components are permanently integrated into the material structure, preventing migration and property loss that would occur with post-manufacturing coatings.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The polymeric material system is self-sufficient, with the lubricious and functional properties arising from its own internal segmented structure rather than requiring external coatings. The additive segments are part of the material itself, providing self-lubrication and self-anti-fouling properties that are inherently stable and do not migrate or degrade over time.

Inventive Principle:
Principle #25Self-service

4Ease of manufacture

If organic solvents are used in coating processes, then coating application is facilitated, but environmental and health risks increase

Engineering Contradiction:
Improvecoating applicationVSAvoidenvironmental and health risks
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The invention extracts and eliminates the harmful organic solvent step from the manufacturing process. By incorporating the lubricious additive segments directly into the polyol matrix during polymer synthesis through a solvent-free polyaddition reaction, the process removes the need for separate coating applications that would require organic solvents, thereby eliminating associated environmental and health risks.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The polymeric material system is manufactured through a self-sufficient polyaddition process that does not require external solvents or catalysts. The reaction between the polyol and diisocyanate proceeds without harmful additives, creating a solvent-free manufacturing process that is inherently safer for the environment and worker health while still achieving the desired material properties.

Inventive Principle:
Principle #25Self-service

5Device complexity

If secondary coating steps are eliminated, then manufacturing cost and complexity are reduced, but surface property achievement becomes more challenging

Engineering Contradiction:
Improvemanufacturing process simplicityVSAvoidsurface property achievement
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The invention creates a composite polymeric material where the polyol matrix provides mechanical properties and the integrated lubricious additive segments provide surface properties. This composite structure allows both bulk and surface requirements to be met within a single material system, eliminating the need for secondary coating steps while achieving the desired surface characteristics.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The segmented polyurethane copolymer structure creates local variations in properties: the polyol matrix regions provide mechanical strength and structural integrity, while the lubricious additive segments concentrate at or near the surface to provide surface lubricity and anti-fouling properties. This local differentiation of properties within a single material allows elimination of secondary coatings while maintaining both bulk and surface performance.

Inventive Principle:
Principle #3Local quality

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 resulting medical articles exhibit reduced bacterial biofilm formation, lower thrombosis risk, and improved lubricity, eliminating the need for external coatings and reducing manufacturing complexity and costs, while maintaining mechanical integrity and environmental safety.

Implementation Method 1

One improved characteristic is phase separation, which concentrates a soft segment of the resin towards a surface of a medical article formed therefrom

Methodology Applied
Scientific EffectPhase separation:

Implementation Method 2

The resulting surface of the medical article provides advantages including being self-lubricating

Methodology Applied
Scientific EffectLubrication: Lubrication

Data Source

PatentUS12252657B2Self-lubricating medical articles
Publication Date: 2025.03.18 BECTON DICKINSON & CO
  • US12252657B2 patent drawing
  • US12252657B2 patent drawing
  • US12252657B2 patent drawing

AI summary

Medical articles formed from a polyurethane-based resin including a modifying oligomer provide enhanced properties. A modifying oligomer incorporated into a backbone, as a side chain, or both of the polyurethane-based resin formed by a diisocyanate, a polyglycol, and a diol chain extender has at least one, preferably two, alcohol moieties (C—OH) and a functional moiety. Exemplary modifying oligomers are: a diol-containing perfluoropolyether incorporated into the backbone, a monofunctional polysiloxane (e.g., monodialcohol-terminated polydimethylsiloxane) incorporated as the side chain, and combinations thereof. Medical articles herein are self-lubricating and/or anti-fouling.