Medical Balloon Dual-Layer Texturing Retention

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Solution Overview

Problem

Medical balloons with smooth outer surfaces tend to lose texturing when inflated due to stretching, compromising their ability to prevent slippage during procedures, and adding texturing elements can compromise foldability and flexibility.

Innovation Solution

A medical balloon with a dual-layer structure, where an underlying layer with a lower softening temperature fills recesses in the outer layer, maintaining texturing and preventing stretching during inflation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a balloon with a smooth outer surface is used, then the balloon maintains good foldability and wrappability, but the balloon experiences slippage in vessels or across valve openings and loses its ability to prevent slippage during procedures

Engineering Contradiction:
Improvefoldability and wrappabilityVSAvoidgrip prevention capability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The balloon surface is divided into two distinct layers with different properties: an outer layer providing smooth texture for foldability, and an inner layer providing rough texture for grip. This local differentiation allows different regions of the balloon wall to serve different functions - the outer surface maintains smoothness for ease of handling while the inner surface provides roughness for preventing slippage during inflation procedures

Inventive Principle:
Principle #3Local quality

2Reliability

If texturing elements are formed from solid material to prevent slippage, then the balloon grip is improved, but the foldability and wrappability of the balloon are compromised

Engineering Contradiction:
Improvegrip prevention capabilityVSAvoidfoldability and wrappability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

Instead of using rigid solid texturing elements, the invention employs a flexible inner layer made of elastomeric material that can deform and flex. This thin film approach provides the necessary rough texture for grip while maintaining the overall flexibility and thin-wall characteristics needed for foldability and wrappability

Inventive Principle:
Principle #30Flexible shells and thin films

3Power

If the balloon is inflated to high pressure to break through vessel plaque or deploy devices, then the therapeutic effect is achieved, but the outer balloon surface becomes virtually smooth due to stretching

Engineering Contradiction:
Improveinflation pressure capabilityVSAvoidsurface texturing retention
Core Design Contradiction:
PowerVSReliability

Solution Approach 1:

The balloon wall is segmented into two functional layers: the outer layer handles the mechanical stress of high-pressure inflation and maintains its smooth surface, while the inner layer is specifically designed to maintain its rough texture under inflation pressure. This segmentation allows each layer to specialize in its primary function without compromising the other

Inventive Principle:
Principle #1Segmentation

4Reliability

If attachment mechanisms are used to add texturing elements to the balloon, then the grip is improved, but the device complexity increases due to additional components

Engineering Contradiction:
Improvegrip prevention capabilityVSAvoidnumber of components
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention merges the texturing function directly into the balloon wall structure by forming an integrated inner layer with rough texture. This eliminates the need for separate attachment mechanisms, components, or assemblies, as the texturing is inherently part of the balloon construction itself, thereby reducing overall device complexity

Inventive Principle:
Principle #5Merging (Combining)

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 dual-layer structure retains the texturing of the balloon even when inflated, enhancing grip and preventing slippage without compromising foldability or flexibility.

Implementation Method 1

the heat causes melting or softening of the underlying layer, whereupon the material of the underlying layer flows into any recesses or cavities in the overlying layer

Methodology Applied
Scientific EffectMelting: Melting

Implementation Method 2

the underlying layer will support the outer layer during subsequent inflation of the balloon and prevent stretching of the outer layer

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP2944347B1Medical balloon assembly and method of making a medical balloon
Publication Date: 2019.06.19 COOK MEDICAL TECHNOLOGIES LLC
  • EP2944347B1 patent drawingFigure 1~2B
  • EP2944347B1 patent drawingFigure 3A~4
  • EP2944347B1 patent drawingFigure 5~6

AI summary

A medical balloon (200) includes an outer layer (202) and an inner layer (204). The outer layer (202) has a surface texture or formation such as a scoring element (206). The inner layer (204) is made of a reflow material which during production of the balloon (200) from a raw tubing (60) will soften and flow into internal recesses in the outer layer (202), thereby filling these recesses and providing support to the outer layer formations so as to avoid flattening of these formations (206) during use of the balloon. The balloon (200) can be manufactured in a single formation step from a raw tubing (60) having the outer and inner reflow layer coextruded.