Multilayer Balloon Segmentation for Compliance and Flexibility
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Solution Overview
Problem
Catheter balloons face challenges in achieving low compliance while maintaining high flexibility and softness to navigate tortuous vasculature and cross lesions effectively, with existing designs often compromising on compliance due to material limitations and manufacturing constraints.
Innovation Solution
A multilayer balloon design featuring layers with varying Shore durometer hardness, where inner layers are highly oriented to maximize blow-up-ratio and outer layers are softer, allowing for controlled radial expansion and reduced compliance, while maintaining high flexibility and softness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a single-layer balloon is made with high durometer material to reduce compliance, then compliance is reduced, but flexibility and softness deteriorate
Solution Approach 1:
The balloon is divided into multiple layers with different durometer values. The inner layer has a first durometer value providing flexibility and softness for vessel navigation, while the outer layer has a second durometer value providing compliance control during inflation. This segmentation allows each layer to perform its specific function without compromising the other.
Solution Approach 2:
Different regions of the balloon (inner vs outer layers) have different material properties tailored to their specific functions. The inner layer is designed with softer material to interact with the vessel wall and provide flexibility, while the outer layer uses stiffer material to control overall balloon expansion and compliance.
2Adaptability or versatility
If the blow-up-ratio is increased to improve balloon expansion, then radial expansion capability is improved, but manufacturing stability deteriorates due to polymer rupture
Solution Approach 1:
The balloon structure is segmented into multiple layers, each with different maximum blow-up-ratios. The inner layer can be expanded to a higher BUR without rupturing, while the outer layer is expanded to a lower BUR. This segmentation allows the overall balloon to achieve high expansion capability through the inner layer while the outer layer provides structural stability and prevents manufacturing defects.
Solution Approach 2:
The balloon uses composite material construction with at least two different polymeric materials having different mechanical properties and maximum BURs. This composite structure enables the balloon to achieve expansion ratios that would be impossible with a single material, as each layer contributes its specific expansion characteristics without compromising overall structural integrity.
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 multilayer balloon achieves very low compliance with improved flexibility and softness, enabling controlled expansion and reduced trauma to blood vessels, outperforming single-layer balloons in terms of compliance and rupture pressure.
Implementation Method 1
The balloon is formed by radially expanding a multilayered tube in a balloon mold so that radially expanding the tube to the mold inner diameter radially expands each layer substantially to the maximum blow-up-ratio of the polymeric material forming the layer
Implementation Method 2
The starting dimensions of the polymer tube and the finished dimensions of the blow-molded balloon within the mold are a measure of the degree to which the polymeric material has been stretched and oriented during balloon blowing
Data Source
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AI summary
A balloon catheter (10) having a multi-layered balloon (14) which has a first layer (30) and at least a second layer (31), and which has noncompliant limited radial expansion beyond the nominal diameter of the balloon. By selecting the polymeric materials forming the balloon layers, and arranging and radially expanding the multiple layers of the balloon in accordance with the invention, a balloon is provided having an improved low compliance, preferably in combination with high flexibility and softness.