Medical Balloon Textured Outer Layer Inflation Anchoring

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Solution Overview

Problem

Medical balloons with smooth exterior surfaces tend to migrate during procedures due to lack of anchoring, leading to ineffective procedures and potential organ damage, as previous attempts to roughen the surface have been unsuccessful due to inflation causing flattening of the surface features.

Innovation Solution

A medical balloon with two layers, where the inner layer is integral and less compliant to support the outer layer with a textured surface, preventing flattening upon inflation, achieved through coextrusion and a manufacturing process involving a mold with a textured surface to shape the softer outer layer while keeping the inner layer smooth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the balloon surface is roughened to improve anchoring, then the anchoring capability is improved, but the surface texturing is flattened during inflation

Engineering Contradiction:
Improveanchoring capabilityVSAvoidsurface texturing
Core Design Contradiction:
ReliabilityVSShape

Solution Approach 1:

The balloon is divided into two distinct layers: an inner layer that maintains structural integrity and a smooth outer layer that can be textured without flattening. This segmentation allows each layer to perform its specific function independently, resolving the contradiction between maintaining surface texture and withstanding inflation pressure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The balloon uses a composite structure with two different materials having different compliance characteristics. The inner layer material provides structural support while the outer layer material allows for surface texturing. This composite approach enables both the smooth inner surface and textured outer surface to coexist, solving the flattening problem during inflation.

Inventive Principle:
Principle #40Composite materials

2Ease of manufacture

If the balloon surface is kept smooth for easy manufacture, then manufacturing simplicity is improved, but the anchoring capability deteriorates

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidanchoring capability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

By separating the balloon into two layers with different surface characteristics, the invention achieves both smooth manufacturing (inner layer) and effective anchoring (textured outer layer). The segmentation allows each layer to be optimized for its specific purpose without compromising the other.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The balloon applies different surface qualities to different locations/layers: the inner layer remains smooth for manufacturing ease, while the outer layer is textured for anchoring. This local differentiation of properties resolves the contradiction between manufacturing simplicity and anchoring effectiveness.

Inventive Principle:
Principle #3Local quality

3Shape

If the outer layer is made more compliant to accommodate texturing, then the surface texturing is improved, but the structural support capability deteriorates

Engineering Contradiction:
Improvesurface texturingVSAvoidstructural support
Core Design Contradiction:
ShapeVSStrength

Solution Approach 1:

The structural support function is segregated to the inner layer, while the outer layer is free to be highly compliant and textured. This functional segmentation allows the outer layer to achieve surface texturing without compromising overall structural integrity, as the inner layer bears the structural load.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The composite structure combines a stiff inner layer material for structural support with a compliant outer layer material for surface texturing. This material differentiation allows the outer layer to be highly compliant without sacrificing structural strength, as each material is selected for its specific mechanical properties.

Inventive Principle:
Principle #40Composite materials

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 effectively maintains the textured surface of the balloon during inflation, enhancing its anchoring within vessels or valves, reducing migration and ensuring the integrity of medical procedures.

Implementation Method 1

the first balloon layer has a first compliance and the second balloon layer has a second compliance, the first compliance being less than the second compliance

Methodology Applied
Scientific EffectCompliance difference: Elasticity

Implementation Method 2

inflating and heating the raw tubing so as to cause it to inflate, wherein said heating causes said second material to soften or melt

Methodology Applied
Scientific EffectSoftening or melting: Melting

Data Source

PatentEP2644171B1Method of manufacture of a medical balloon with textured or roughened outer layer
Publication Date: 2021.03.03 COOK MEDICAL TECHNOLOGIES LLC
  • EP2644171B1 patent drawingFigure 1
  • EP2644171B1 patent drawingFigure 2~3
  • EP2644171B1 patent drawingFigure 4~6

AI summary

A medical balloon (30) of a balloon catheter (10) has at least first and second layers (44, 46) in which the second, outer, layer (46) is made of a material having a lower melting or softening temperature than the inner layer (44). The outer layer (46) is provided with texturing or roughening (54) on its outer surface, thereby to provide a textured roughened medical balloon (30). The inner layer (44) supports the outer layer (46) and in particular the texture or roughening of the outer surface of the outer layer (46). This support prevents or substantially reduces any flattening of any texture or roughening on the outside surface of the balloon (320) when inflated.