Balloon Catheter Layered Hardness for Stenosis Contact
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Solution Overview
Problem
Conventional balloon catheters face issues with insufficient contact with the inner wall of stenosed sites and longitudinal axis displacement during angioplasty, leading to reduced efficacy and safety.
Innovation Solution
A balloon catheter design featuring a first layer with lower Shore D hardness and a second layer with higher Shore D hardness, arranged in specific configurations to enhance flexibility and rigidity, allowing better contact with the stenosed site and preventing longitudinal displacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the balloon is made of a single material throughout, then the structure is simple and ease of manufacture is improved, but the ability to contact the inner wall of the stenosis is insufficient and longitudinal displacement occurs
Solution Approach 1:
The balloon is divided into multiple layers with different material properties: a first layer (softer material) and a second layer (harder material). This segmentation allows each layer to perform its specific function - the softer first layer provides flexibility and contact capability while the harder second layer provides structural support and prevents displacement, resolving the contradiction between manufacturing simplicity and functional reliability.
Solution Approach 2:
The balloon employs composite material construction by combining at least two different materials with complementary properties. The first layer uses a softer material for flexibility and conformability to the stenosis inner wall, while the second layer uses a harder material for rigidity and displacement prevention. This composite approach achieves both adequate contact capability and displacement prevention that a single material cannot provide.
2Adaptability or versatility
If the balloon wall is made softer to improve flexibility and contact ability, then the ability to conform to the stenosed site is improved, but the structural integrity and pressure resistance are reduced
Solution Approach 1:
The balloon structure is segmented into functional zones: the first layer (softer material) handles flexibility and conformability to the stenosis, while the second layer (harder material) handles structural integrity and pressure resistance. This segmentation allows the softer first layer to adapt to complex lumen shapes without compromising the overall structural strength provided by the harder second layer.
Solution Approach 2:
The composite material structure combines a softer first layer with a harder second layer, where the softer material provides adaptability to the stenosed site geometry while the harder material provides the necessary structural integrity and pressure resistance. Together, they achieve both flexibility for contact and strength for withstanding inflation pressures.
3Productivity
If protrusions are added to the balloon to improve dilating function, then the ability to dilate the stenosed site is improved, but the complexity of the balloon structure increases
Solution Approach 1:
Instead of adding separate protrusion structures, the invention applies local quality differentiation by making the second layer (harder material) extend over specific portions of the first layer in the circumferential direction. This creates localized regions of enhanced rigidity that function as protrusions for dilation while maintaining a simpler overall structure compared to adding separate protrusion components.
Data Source
AI summary
A balloon for a balloon catheter that, when inflated at a stenosed site, can easily contact the inner wall of the stenosis to improve the ability to dilate the stenosis and prevent displacement of the balloon in the longitudinal axis direction, thereby enhancing safety, is provided. The balloon includes a first layer disposed over the entire 360° in the circumferential direction and a second layer having a Shore D hardness higher than that of the first layer. The balloon includes, in a cross-section perpendicular to the longitudinal axis direction, a first part including the first layer where the second layer is not disposed on an outer side of the first layer in the radial direction, and a second part including the first layer and the second layer where the second layer is disposed on the outer side of the first layer in the radial direction.