Balloon Catheter Protrusion Roughness Gradient for Stenosis Grip
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Solution Overview
Problem
Conventional balloon catheters struggle to effectively penetrate and dilate stenotic areas hardened by calcification or ISR lesions due to insufficient engagement of the protrusion parts, leading to inefficiency and potential displacement during dilation.
Innovation Solution
A balloon catheter with a protrusion part having a surface roughness gradient, where the base region is smoother than the tip region, allowing easier penetration into stenotic areas and reducing frictional resistance, while the tip region maintains grip on slippery lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the protrusion part has a uniform rough surface, then it can grip onto slippery ISR lesions, but it causes excessive frictional resistance that prevents sufficient penetration into hardened calcified lesions
Solution Approach 1:
The protrusion part is designed with non-uniform surface roughness distribution: the tip region has high surface roughness to grip slippery ISR lesions, while the base region has low surface roughness to reduce frictional resistance during penetration into calcified lesions. This local differentiation resolves the contradiction between needing high grip stability and low penetration resistance.
2Reliability
If the protrusion part is made with high surface roughness throughout, then it can effectively bite into stenotic areas, but it causes difficulty in inserting the balloon catheter through the delivery system
Solution Approach 1:
The surface roughness is localized to specific regions of the protrusion part rather than being uniform. The base region maintains smoothness for easy insertion through the delivery system, while only the tip region that contacts the stenotic area has high roughness for effective biting and incision.
3Manufacturing precision
If conventional balloons with protrusions are used, then they can contact the stenotic area, but they fail to sufficiently penetrate hardened calcified lesions or slippery ISR lesions
Solution Approach 1:
The surface roughness parameter is varied across different regions of the protrusion part. By changing the surface roughness parameter from the base to the tip, the balloon achieves both reliable contact with the stenotic area and sufficient penetration capability into hardened or slippery lesions.
Data Source
AI summary
Disclosed is a balloon for a balloon catheter in which the protrusion part provided on the balloon can easily bite into the stenosis, thereby efficiently dilating the stenosis. A balloon (2) for a balloon catheter having a balloon body (20) and a protrusion part (28) that projects outward from the outer surface of the balloon body (20) in the radial direction (y1) and extends in the longitudinal axis direction (x1); the protrusion part (28) having a tip region (28t) including an outer end (28T) and a base region (28b) located inward from the tip region (28t), the balloon body (20) and the protrusion part (28) being composed of the same material, and the surface roughness of the base region (28b) is smaller than that of the tip region (28t) where the surface roughness if measured for a reference length in a direction perpendicular to the longitudinal axis direction (x1).