Medical Device Resin Layer Visibility and Smoothness

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Solution Overview

Problem

Medical devices, such as guide wires used in percutaneous transluminal coronary angioplasty, face challenges in visibility and identifiability on operation room backgrounds with green or blue non-woven fabrics, and surface smoothness issues due to titanium oxide aggregation in fluororesin coatings.

Innovation Solution

A medical device with a resin layer comprising a first layer of fluororesin, titanium oxide, and a polymer dispersant, and a second layer of fluororesin, where the titanium oxide content is 30% by weight or more in the first layer, and the dispersant has an acid value of 30 to 80 mgKOH/g, ensuring high visibility, identifiability, and surface smoothness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If a fluororesin coating containing titanium oxide is applied to enhance visibility, then the medical device becomes more visible on green or blue backgrounds, but titanium oxide aggregates form causing surface irregularities and reduced sliding property

Engineering Contradiction:
ImprovevisibilityVSAvoidsurface smoothness
Core Design Contradiction:
Illumination intensityVSManufacturing precision

Solution Approach 1:

A dispersant is introduced as an intermediary substance between titanium oxide particles and fluororesin. The dispersant prevents aggregation of titanium oxide particles while maintaining uniform distribution in the coating, thereby achieving both high visibility and surface smoothness simultaneously

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent optimizes specific parameters including dispersant concentration (0.1-5% by weight relative to fluororesin), titanium oxide content (1-50% by weight), and coating thickness (1-20 μm) to achieve the desired balance between visibility and surface smoothness

Inventive Principle:
Principle #35Parameter changes

2Illumination intensity

If the guide wire is colored with green or blue pigments to match conventional schemes, then it blends with the surgical drape background, but changing to other colors improves visibility against green or blue non-woven fabric

Engineering Contradiction:
ImprovevisibilityVSAvoidcolor compatibility
Core Design Contradiction:
Illumination intensityVSAdaptability or versatility

Solution Approach 1:

The patent employs color theory principles to select coating colors that create maximum contrast against green or blue surgical drapes. Specifically, coatings with yellow, red, or white pigments are used as they provide superior visual contrast against the predominant green/blue backgrounds in operating rooms

Inventive Principle:
Principle #32Color changes

3Adaptability or versatility

If multiple guide wires are used simultaneously for complex procedures, then comprehensive treatment is enabled, but identifying each guide wire becomes difficult without markers

Engineering Contradiction:
Improveprocedural capabilityVSAvoididentifiability
Core Design Contradiction:
Adaptability or versatilityVSDifficulty of detecting and measuring

Solution Approach 1:

Different sections or portions of guide wires are coated with different colored fluororesin coatings to create localized color variations. This allows each guide wire to have unique color identification zones, enabling easy differentiation and tracking of multiple guide wires during complex procedures

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 solution enhances visibility and identifiability of the medical device on green or blue backgrounds while maintaining high surface smoothness by preventing titanium oxide aggregation, thus improving operational efficiency in the operation room.

Implementation Method 1

a resin layer which has a first layer including a first fluororesin, titanium oxide, and a polymer dispersant

Methodology Applied
Scientific EffectDispersion: Dispersion (of waves)

Implementation Method 2

the content of the titanium oxide is 30% by weight or more relative to a solid content of the first layer, an acid value of the dispersant is 30 to 80 mgKOH/g

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentEP3603687B1Medical implement
Publication Date: 2024.08.07 TERUMO KK
  • EP3603687B1 patent drawingFigure 1
  • EP3603687B1 patent drawingFigure 2

AI summary

To provide a medical device which has high visibility on non-woven fabric having a color such as green, blue, or the like, excellent identifiability from other medical devices having a color such as green, blue, or the like, and high surface smoothness. A medical device comprising an elongated body and a resin layer for covering at least a proximal portion of the elongated body, in which the resin layer has a first layer which includes a first fluororesin, titanium oxide, and a dispersant, and a second layer which is formed on the first layer and includes a second fluororesin, the content of the titanium oxide is 30% by weight or more relative to the solid content of the first layer, and an acid value of the dispersant is 20 to 90 mg/KOH.