Serration Balloon Structure for Controlled Plaque Cleavage
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Solution Overview
Problem
Balloon angioplasty methods often cause unpredictable plaque cleavage and arterial injury due to heterogeneous plaque composition, necessitating improved systems for treating occlusive disease.
Innovation Solution
A serration balloon with longitudinally extending members featuring periodic raised wedges is used, secured to the balloon surface via fiber coating or polymer matrix, allowing controlled plaque tearing during expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard balloon angioplasty is used to treat atherosclerotic plaque, then the blocked blood vessel can be opened, but unpredictable plaque cleavage and arterial injury occur due to heterogeneous plaque composition
Solution Approach 1:
The balloon surface is segmented with multiple longitudinally extending cutting members that have periodic raised wedges. These segmented cutting elements divide the plaque into controlled segments rather than causing unpredictable cleavage, allowing systematic disruption of heterogeneous plaque while minimizing arterial injury.
Solution Approach 2:
The cutting members are positioned at specific locations on the balloon surface with specific orientations (perpendicular to the vessel wall). This local positioning and orientation control ensures that plaque disruption occurs at predetermined locations and angles, improving predictability and reducing harmful effects on the arterial wall.
2Manufacturing precision
If cutting members are added to the balloon surface to improve plaque disruption control, then plaque cleavage predictability improves, but device complexity increases
Solution Approach 1:
The cutting members are pre-positioned and secured to the balloon surface before the procedure. The longitudinally extending members with periodic raised wedges are attached in advance at optimal locations and orientations, eliminating the need for complex real-time adjustments during the procedure while maintaining manufacturing precision.
Solution Approach 2:
The cutting members are designed as thin, flexible structures that can be securely attached to the balloon surface. This allows the complex cutting structure to conform to the balloon's flexible nature, maintaining device simplicity while achieving precise plaque disruption control.
Data Source
AI summary
A serration balloon can have a number of different components and can be made in a number of different manners. One or more longitudinally extending members with periodic raised wedges can be attached to a medical balloon. They can be attached with a fiber coating, a polymer coating, or other methods. A polymer matrix can be used to bond the longitudinally extending member to the surface of the balloon. The fiber coating can be, for example, a thread or mesh that secures the longitudinally extending member to the balloon. The medical balloon can be an angioplasty balloon, such as an off-the-shelf angioplasty balloon.


