Dual-Layer Balloon Catheter Film for Stenosis Wall Contact
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Solution Overview
Problem
Conventional balloon catheters struggle to effectively contact and dilate stenosis in complex vascular lumens due to insufficient adherence of the balloon to the inner wall.
Innovation Solution
A balloon catheter design featuring a dual-layer balloon film with varying stiffnesses, where a first layer with lower Shore D hardness and a second layer with higher Shore D hardness are alternately arranged, allowing the balloon to conform to the inner wall of stenosis, enhancing dilation efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single-material balloon is used to improve ease of insertion, then the balloon can be reduced in diameter, but the balloon cannot sufficiently contact the inner wall of complex stenosis
Solution Approach 1:
The balloon is constructed with a composite structure comprising an inner layer made of a soft material and an outer layer made of a hard material. This composite material approach allows the balloon to maintain both flexibility for insertion and rigidity for effective contact with the stenosis inner wall during dilation.
Solution Approach 2:
Different portions of the balloon wall have different material properties: the inner layer provides flexibility and conformability to the vessel shape, while the outer layer provides rigidity and structural support. This local differentiation of material qualities enables the balloon to simultaneously achieve ease of insertion and reliable contact with the stenosis.
2Reliability
If protrusions with greater rigidity are provided to enhance dilation function, then dilation performance improves, but the balloon cannot adequately follow complex inner lumen shapes
Solution Approach 1:
The balloon employs a composite material structure where the inner soft layer enables the balloon to conform to complex inner lumen shapes and the outer hard layer provides the rigidity needed for effective dilation. This composite approach resolves the contradiction between adaptability and dilation performance.
Solution Approach 2:
The balloon structure locally differentiates material properties across its wall thickness, with the inner layer providing conformability to follow the vessel's inner wall shape and the outer layer providing rigidity for dilation. This spatial differentiation of material qualities allows the balloon to simultaneously adapt to complex geometries and deliver effective dilation force.
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 dual-layer balloon design improves dilation performance by ensuring better contact with the stenosis, maintaining rigidity, and enhancing pressure resistance.
Implementation Method 1
a balloon film (20M) including a first layer (20a) and a second layer (20b) composed of a material having a Shore D hardness higher than that of the first layer
Data Source
AI summary
A balloon for a balloon catheter that is more likely to follow the inner wall of the stenosis and readily come into contact with the inner wall, thereby improving the performance of dilation of the stenosis, is provided. The balloon includes a balloon film including a first layer and a second layer having a Shore D hardness higher than that of the first layer, and the second layer is located outside the first layer. A variation rate ((|Tx−Ta|/Ta)×100) of a film thickness Tx of the balloon film with respect to an average film thickness Ta is 15% or less, an average film thickness T1a of the first layer is 2 μm or more, and a variation rate ((|T1x−T1a|/T1a)×100) of a film thickness T1x of the first layer with respect to the average film thickness T1a is 20% or more.