Flexible High-Pressure Balloon Segmentation
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Solution Overview
Problem
Conventional angioplasty balloons lose flexibility when inflated, leading to stress and strain on stents and arteries, particularly in curved vessels, which can cause inflammation and recurrent narrowing due to their stiffened configuration.
Innovation Solution
Incorporating a supporting structure such as a braid, wrap, or mesh made from inelastic fibers around the balloon, which allows the balloon to maintain flexibility by reconfiguring and shortening as it inflates, reducing longitudinally-directed tension and enabling curvature even at high pressures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional angioplasty balloons are constructed of low-compliance materials to withstand high inflation pressures, then the balloon can tolerate high pressures and attain uniform predictable diameters, but the balloon loses flexibility when inflated and becomes stiff and biased into a straightened configuration
Solution Approach 1:
The balloon is divided into multiple segments separated by grooves or hinges, allowing each segment to move independently. This segmentation enables the balloon to maintain its pressure-containing integrity while allowing flexibility through relative movement between segments, resolving the contradiction between strength and ease of operation.
Solution Approach 2:
The balloon incorporates composite construction combining low-compliance materials for pressure resistance with flexible hinge regions or segmented structures. This composite approach allows different parts of the balloon to have different mechanical properties - strong and stiff where needed for pressure containment, and flexible where needed for bending capability.
2Force
If the balloon is inflated to high pressures to treat calcified arteries, then the balloon can expand stents and open narrowed arteries, but the balloon straightens and imposes straightened cylindrical configuration on stents, creating stresses and strains
Solution Approach 1:
The segmented design with flexible hinges allows the balloon to maintain curvature during high-pressure inflation, preventing the transmission of straightening forces to the stent and artery. Each segment can accommodate pressure-induced expansion while the hinges absorb longitudinal stresses, eliminating the harmful straightening effect.
Solution Approach 2:
The balloon design changes its mechanical parameters under pressure - while maintaining radial expansion capability for stent deployment, the segmented structure with hinges allows longitudinal compression and curvature maintenance, changing the stress distribution pattern to avoid straightening forces.
3Manufacturing precision
If segmented balloons are inflated enough to eliminate inter-segment gaps for complete stent expansion, then the stent can be fully expanded, but adjacent segments interfere with one another hindering flexibility
Solution Approach 1:
The hinge regions are designed to remain dynamically flexible even when segments are closely spaced. The hinges can accommodate small relative movements between adjacent segments, maintaining flexibility while allowing the segments to be positioned close together for complete stent expansion. This dynamic capability resolves the contradiction between manufacturing precision and ease of operation.
Data Source
AI summary
Flexible high-pressure angioplasty balloons are disclosed herein which utilize an inflatable balloon positioned upon the catheter and a supporting structure secured over or along the catheter at a first location proximal to the balloon and at a second location distal to the balloon. Inflation of the balloon reconfigures the supporting structure to urge the first location and the second location towards one another thereby inhibiting longitudinal elongation of the balloon relative to the catheter. The supporting structure may surround, support, or otherwise extend over the entire length of the balloon and allows for the balloon to retain increased flexibility which enables the balloon to bend or curve even at relatively high inflation pressures.


