Multilayer Balloon Radial Ratio Design for Burst Resistance

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Solution Overview

Problem

Existing medical balloons face challenges in achieving high burst resistance while maintaining a low wall thickness, which is crucial for minimally invasive procedures, as they often require a balance between robustness and deliverability.

Innovation Solution

The development of multilayer balloons with an inner layer and an outer layer coextruded in a specific radial ratio configuration, where the outer layer has a lower maximum radial ratio than the inner layer, utilizing materials with different glass transition temperatures and Shore durometer hardness, resulting in a balloon with enhanced burst pressure and reduced wall thickness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If the wall thickness of the balloon is increased to achieve high burst resistance, then the burst pressure increases, but the deliverability through narrow vasculature decreases

Engineering Contradiction:
Improveburst resistanceVSAvoidwall thickness
Core Design Contradiction:
StrengthVSLength of moving object

Solution Approach 1:

The balloon is divided into multiple functional layers with distinct properties. The inner layer provides burst resistance with high radial expansion capability, while the outer layer provides structural support with lower radial ratio, enabling thin-wall high-burst balloons without compromising deliverability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses composite material structures where the inner layer and outer layer are made from different materials with complementary properties. The inner layer material is selected for high radial ratio and burst resistance, while the outer layer material provides structural integrity, achieving both thin wall thickness and high burst pressure

Inventive Principle:
Principle #40Composite materials

2Strength

If the radial ratio of the balloon layers is optimized for burst resistance, then the burst pressure increases, but the flexibility and conformability to vasculature decreases

Engineering Contradiction:
Improveburst pressureVSAvoidflexibility
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

Different layers of the balloon are assigned different radial ratios tailored to their specific functions. The inner layer has a higher radial ratio optimized for burst resistance, while the outer layer has a lower radial ratio optimized for structural support, allowing each layer to perform its function optimally without compromising overall flexibility

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The balloon structure is designed to be dynamically adaptive, where the inner layer can expand more radially to accommodate burst pressures while the outer layer maintains structural constraints, enabling the balloon to conform to vasculature during delivery and resist bursting during inflation

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP3468653A1Multilayer balloons
Publication Date: 2019.04.17 MEDTRONIC VASCULAR INC

AI summary

In some examples, a medical device includes a balloon inflatable to an inflated configuration. The balloon includes an outer layer coextruded on an inner layer. The outer layer has a maximum radial ratio that is lower than that of the inner layer.