Multilayer Balloon Coextrusion Delamination for Burst Pressure

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Solution Overview

Problem

Manufacturing multilayer balloons with uniform inflation characteristics and high burst pressure is challenging due to difficulties in arranging and inflating nested balloons efficiently, often requiring additional manufacturing steps and introducing air or fluid pockets.

Innovation Solution

A medical device with a balloon structure comprising a non-compliant layer coextruded on an inner layer and an outer layer, where the non-compliant layer delaminates from the inner and outer layers at a predetermined pressure, creating discontinuities or perforations that allow independent movement of the layers, mimicking the behavior of nested balloons without the need for separate nesting steps.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If nested balloons are used to achieve high burst pressure and puncture resistance, then the balloon strength is improved, but the manufacturing complexity increases due to additional nesting steps and potential air or fluid pockets

Engineering Contradiction:
Improveburst pressureVSAvoidmanufacturing complexity
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent combines multiple balloon layers into a single integrated structure manufactured through coextrusion, eliminating the need for separate nesting steps. The multilayer balloon is formed as one continuous component with uniform wall thickness, merging the manufacturing processes into a single operation that produces the same high-strength structure without the complexity of assembling separate nested balloons.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent employs composite material construction with multiple layers coextruded in a single process. Each layer can be made from different materials or compositions optimized for specific functions, creating a composite structure that achieves high burst pressure and puncture resistance while maintaining manufacturing simplicity through the integrated coextrusion process.

Inventive Principle:
Principle #40Composite materials

2Stability of the object's composition

If nested balloons are assembled to achieve uniform inflation characteristics, then the inflation uniformity is improved, but the manufacturing time increases due to additional assembly steps

Engineering Contradiction:
Improveinflation uniformityVSAvoidmanufacturing time
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

The patent performs the layer arrangement and configuration actions during the coextrusion manufacturing process itself, rather than requiring separate post-manufacturing assembly steps. The multilayer structure is pre-configured with uniform wall thickness and proper layer positioning as it is being formed, eliminating the need for subsequent assembly operations that would increase manufacturing time.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent merges the inflation control features into a single integrated balloon structure, combining multiple functional layers into one continuous component. This unified structure ensures uniform inflation characteristics while eliminating the time required to assemble and adjust multiple separate nested balloons.

Inventive Principle:
Principle #5Merging (Combining)

3Strength

If wall thickness is increased to achieve higher burst pressure, then the balloon strength is improved, but the balloon compliance decreases making it harder to inflate

Engineering Contradiction:
Improveburst pressureVSAvoidinflation ease
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The patent segments the balloon wall into multiple distinct layers, each with different thicknesses and material properties. This segmentation allows the overall wall thickness to be sufficient for high burst pressure while distributing the mechanical properties across layers that can inflate more easily, balancing strength requirements with inflation ease through differentiated layer characteristics.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies different material compositions, thicknesses, and mechanical properties to different layers of the multilayer balloon. Each layer can be optimized for specific local functions - some layers for strength and burst pressure resistance, others for compliance and inflation ease - creating a non-uniform but functionally optimized structure that resolves the contradiction between strength and ease of inflation.

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 enables the production of multilayer balloons with enhanced burst pressure and puncture resistance, similar to nested balloons, but from a single coextrusion process, simplifying manufacturing and eliminating the need for additional steps to achieve uniform inflation.

Implementation Method 1

the non-compliant layer is configured to delaminate from the inner layer and the outer layer in the inflated configuration at a predetermined pressure

Methodology Applied
Scientific EffectDelamination:

Implementation Method 2

a non-compliant layer coextruded on an inner layer; and an outer layer coextruded on the non-compliant layer

Methodology Applied
Scientific EffectCoextrusion: Extrusion

Data Source

PatentEP3875138B1Multilayer balloons and method of making the same
Publication Date: 2023.10.25 MEDTRONIC VASCULAR INC
  • EP3875138B1 patent drawingFigure 1~2
  • EP3875138B1 patent drawingFigure 3A~3D
  • EP3875138B1 patent drawingFigure 4

AI summary

An example medical device includes a balloon that is inflatable to an inflated configuration. The balloon includes a non-compliant layer coextruded on an inner layer, and an outer layer coextruded on the non-compliant layer. The non-compliant layer is configured to delaminate from the inner and the outer layers in the inflated configuration. The non-compliant layer may be configured to rupture in the inflated configuration. An example technique includes inflating the balloon to a predetermined pressure sufficient to rupture the non-compliant layer and insufficient to rupture both the inner and outer layers. The example technique further includes deflating the balloon, and introducing the balloon into a vasculature. Another example technique includes coextruding a non-compliant layer on an inner layer, coextruding an outer layer on the non-compliant layer, and forming a balloon from the inner layer, the non-compliant layer, and the outer layer.