Medical Device Resin Layer Visibility Adhesion

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Solution Overview

Problem

Medical devices like guide wires used in percutaneous transluminal coronary angioplasty face challenges in visibility and identifiability, especially when their color matches the operating room background, and existing coatings with organic pigments can suffer from discoloration and adhesion issues during high-temperature baking.

Innovation Solution

A medical device with a resin layer comprising a first layer of fluororesin, organic pigment, and titanium oxide, and a second layer of fluororesin, applied in a specific configuration to enhance visibility, identifiability, and adhesion properties, while maintaining color brightness and mechanical strength.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If a green inorganic pigment is used to color the guide wire, then visibility is improved, but the medical device becomes difficult to recognize against green or blue surgical drapes

Engineering Contradiction:
ImprovevisibilityVSAvoididentifiability against background
Core Design Contradiction:
Illumination intensityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent applies color changes by using red organic pigment instead of traditional green inorganic pigment to color the fluororesin coating on the guide wire. This color selection provides high contrast against green or blue surgical drapes, solving the visibility problem while maintaining identifiability. The red color is specifically chosen because it belongs to a different color group than the typical surgical drape colors, ensuring the medical device remains distinguishable.

Inventive Principle:
Principle #32Color changes

2Strength

If high-temperature baking is performed to form the fluororesin layer, then adhesion is improved, but organic pigment discoloration occurs

Engineering Contradiction:
ImproveadhesionVSAvoidcolor stability
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent applies parameter changes by modifying the baking temperature parameter to a range of 200°C to 400°C, which is lower than conventional high-temperature baking. This temperature range is optimized to prevent discoloration of the red organic pigment while still achieving sufficient adhesion of the fluororesin layer. The specific temperature parameter adjustment allows simultaneous achievement of both adhesion and color stability.

Inventive Principle:
Principle #35Parameter changes

3Illumination intensity

If organic pigment content is increased to enhance color brightness, then visibility is improved, but adhesion property deteriorates

Engineering Contradiction:
Improvecolor brightnessVSAvoidadhesion property
Core Design Contradiction:
Illumination intensityVSStrength

Solution Approach 1:

The patent applies parameter changes by optimizing the organic pigment content to a specific range of 1-50 parts by weight relative to 100 parts by weight of fluororesin. This optimized parameter range achieves a balance between color brightness and adhesion property, preventing the adhesion deterioration that occurs with excessive pigment content while maintaining sufficient visibility.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies composite materials by combining fluororesin with red organic pigment and optional inorganic pigments in a specific composition ratio. This composite coating material integrates the adhesive properties of fluororesin with the coloring properties of organic pigment, achieving both good adhesion and high color brightness through proper material combination rather than relying solely on increased pigment content.

Inventive Principle:
Principle #40Composite materials

4Stability of the object's composition

If dispersant content is increased to improve pigment dispersion, then color uniformity is improved, but adhesion property and coating strength deteriorate

Engineering Contradiction:
Improvecolor uniformityVSAvoidadhesion property
Core Design Contradiction:
Stability of the object's compositionVSStrength

Solution Approach 1:

The patent applies parameter changes by limiting the dispersant content to a maximum of 10 parts by weight relative to 100 parts by weight of fluororesin. This controlled dispersant parameter achieves sufficient pigment dispersion and color uniformity without excessive dispersant that would compromise adhesion property and coating strength. The optimized dispersant parameter prevents over-dispersion damage to the coating system.

Inventive Principle:
Principle #35Parameter changes

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 provides high visibility and identifiability of the medical device on green or blue backgrounds, maintains color brightness, and ensures strong adhesion and mechanical strength, even with reduced organic pigment content, thus improving operational efficiency and device reliability.

Implementation Method 1

The fluororesin layer on an outer surface of the core member (elongated body) of the guide wire is generally formed by coating the coating solution containing the fluororesin dispersed in a solvent on the core member and then performing baking.

Methodology Applied
Scientific EffectMelting: Melting

Implementation Method 2

the visibility of a guide wire is increased by including a green inorganic pigment such as chromium oxide, cobalt green, or the like contained in a resin layer to impart coloration to the guide wire

Methodology Applied
Scientific EffectAbsorption (EM radiation): Absorption (EM radiation)

Data Source

PatentUS11471569B2Medical device
Publication Date: 2022.10.18 TERUMO KK
  • US11471569B2 patent drawing
  • US11471569B2 patent drawing

AI summary

The disclosed medical device has high visibility on non-woven fabric having a color such as green, blue, or the like, excellent identifiability from other medical devices having colors such as green, blue, or the like, and also a high adhesion property and strength of a coating. The medical device comprises an elongated body and a resin layer covering at least a proximal portion of the elongated body. The resin layer is comprised of a first layer which includes a first fluororesin, an organic pigment and titanium oxide, and a second layer which is formed on the first layer and includes a second fluororesin.