Multi-layer Medical Balloon with Cutting Element
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Solution Overview
Problem
Medical balloons used in procedures like angioplasty often face challenges with defect propagation, such as cracks, which can lead to failure due to uniform material properties and lack of stress distribution, especially when incorporating cutting elements for incising stenosis.
Innovation Solution
A multi-layer medical balloon design featuring layers with significantly different moduli of elasticity, where each layer is formed from materials like Pebax and Nylon, with varying thickness and hardness, to distribute stress and prevent defect propagation, and includes a cutting element for incising stenosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-layer balloon design is used, then the device complexity is low, but the reliability is reduced due to defect propagation and lack of stress distribution
Solution Approach 1:
The balloon is divided into multiple layers (typically 2-5 layers) with each layer having different material properties. This segmentation prevents defect propagation by confining cracks to individual layers and distributes stress more effectively across the multi-layer structure, thereby improving reliability without excessive complexity
Solution Approach 2:
The balloon employs composite material construction where each layer is made from different materials with specific properties (e.g., varying elastomers, polymers, or metals). This composite approach optimizes stress distribution, prevents crack propagation, and enhances overall balloon reliability while maintaining manageable structural complexity through controlled material selection
2Strength
If uniform material properties are used throughout the balloon, then the manufacturing process is simple, but stress distribution is poor leading to defect propagation
Solution Approach 1:
Different regions or layers of the balloon are constructed with materials having different mechanical properties (modulus of elasticity, strength, flexibility). This local quality variation optimizes stress distribution at critical locations, prevents defect propagation, and maintains manufacturing feasibility through established multi-layer fabrication techniques
3Reliability
If the balloon material is made very strong to prevent defect propagation, then the reliability improves, but the balloon becomes less compliant and harder to insert
Solution Approach 1:
The balloon structure is segmented into multiple layers where outer layers can provide strength and defect resistance, while inner layers maintain compliance for easy insertion. This segmentation allows the balloon to be both strong against defects and flexible enough for navigation through vessels
Solution Approach 2:
Composite material construction enables combining strong, defect-resistant materials in outer layers with softer, more compliant materials in inner layers. This composite approach achieves both high reliability against defect propagation and ease of insertion, as each material layer contributes its optimal properties to the overall balloon performance
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 multi-layer design enhances the physical integrity of the balloon by dissipating energy and preventing crack propagation, providing high burst strength and low distention, while allowing for effective incision of stenosis, thus improving the balloon's reliability and performance during medical procedures.
Implementation Method 1
The multi-layer design enhances the physical integrity of the balloon by dissipating energy and preventing crack propagation
Implementation Method 2
A balloon catheter may include an inflatable and deflatable balloon positioned on a long and narrow catheter body... Incising the stenosis can further widen the body vessel and increase the rate of blood flow
Data Source
AI summary
The invention relates to multi-layer medical balloons. In one aspect, a medical device includes an inflatable balloon. The inflatable balloon includes a first layer including a material having a first modulus of elasticity, and a second layer adjacent the first layer, the second layer including a material having a second modulus of elasticity that differs from the first modulus of elasticity by at least about 2,000 psi. A cutting element is carried by the balloon.