Cutting Balloon Pleated Under Scoring Elements
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Solution Overview
Problem
Existing cutting or scoring balloons face challenges with deployment due to the risk of balloon wall damage from cutting elements and require a larger introducer assembly, limiting their use in smaller vessels or heavily stenosed areas, as they are loosely wrapped to protect the balloon wall and conceal the cutting elements until inflation.
Innovation Solution
A pleated and wrapped balloon design where the balloon wall is folded underneath the cutting or scoring elements, keeping them exposed even when the balloon is fully wrapped, allowing for a tighter structure and enhanced trackability and pushability, with pleating elements and a wrapping device to achieve this configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the balloon wall is wrapped loosely to protect it from cutting elements, then the risk of balloon wall damage is reduced, but the delivery footprint (diameter) increases
Solution Approach 1:
The balloon wall is segmented into distinct regions: some portions are wrapped underneath the cutting elements while other portions remain exposed. This segmentation allows the balloon to achieve a compact wrapped configuration without requiring loose wrapping around all cutting elements, thereby reducing delivery footprint while maintaining balloon wall integrity.
Solution Approach 2:
Instead of wrapping the balloon wall around the cutting elements (conventional approach), the invention inverts the arrangement by wrapping portions of the balloon wall underneath the cutting elements. This inversion allows the cutting elements to protrude outward while the balloon wall remains protected in a compact configuration, reducing the delivery footprint.
2Area of stationary object
If the balloon is tightly wrapped to reduce delivery footprint, then the balloon can be deployed in smaller lumens, but the cutting elements may damage the balloon wall
Solution Approach 1:
Different portions of the balloon wall have different wrapping characteristics: some portions are wrapped underneath cutting elements for protection and compactness, while other portions remain exposed to allow the cutting elements to function. This local differentiation of wrapping quality enables the balloon to achieve tight wrapping without compromising balloon wall integrity.
3Reliability
If protective wrapping is provided around cutting elements, then the balloon wall is protected from damage, but the balloon structure becomes more complex
Solution Approach 1:
The invention extracts the protective wrapping function from a complete wrapping configuration and applies it only to specific portions of the balloon wall that need protection. By taking out the wrapping requirement selectively, the balloon structure remains relatively simple while still achieving the necessary protection against cutting element damage.
Data Source
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AI summary
A cutting or scoring balloon (26) is provided with a plurality of cutting or scoring elements (34) and is wrapped onto a balloon catheter (12) such that the cutting or scoring elements (34) overlie the balloon wall (36) with the balloon wall (36) pleated underneath the cutting or scoring elements (34). The cutting or scoring elements (34) remain exposed when the balloon (26) is pleated and wrapped onto the balloon catheter (12) and in a tightly wrapped configuration.