Segmented Lithotripsy Balloon Structure for Curved Vessel Rupture Prevention
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Solution Overview
Problem
Existing intravascular lithotripsy systems face issues with balloon rupture due to electrodes being positioned in close proximity to the balloon wall when treating curving vessels, leading to potential damage and fluid release into the circulatory system.
Innovation Solution
The system incorporates a segmented balloon design with alternating regions of flexibility and interposed sections to maintain a controlled distance between the inner member and balloon material, preventing positional bias and reducing the risk of rupture during curvature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single balloon design is used, then the structure is simple, but the electrode positioning becomes unstable in curved vessels
Solution Approach 1:
The balloon is divided into multiple segments (first balloon segment, second balloon segment, third balloon segment) with different flexibility characteristics. This segmentation allows each segment to independently respond to vessel curvature while maintaining overall balloon integrity, thereby stabilizing electrode positioning without requiring a completely complex new structure
Solution Approach 2:
Different regions of the balloon are assigned different flexibility properties - the first and third segments have different flexibility than the second segment. This local differentiation enables the balloon to adapt to curved vessel geometry while maintaining proper electrode spacing, resolving the contradiction between simple structure and positioning reliability
2Ease of operation
If the balloon is highly flexible to navigate curved vessels, then the ease of operation improves, but the risk of balloon rupture increases
Solution Approach 1:
The balloon is segmented into multiple sections with alternating flexibility characteristics. The less flexible segments provide structural reinforcement that prevents rupture, while the more flexible segments enable navigation through curved vessels. This segmentation resolves the contradiction by distributing flexibility and strength across different regions
Solution Approach 2:
Specific segments are designed with different flexibility levels - the second balloon segment has different flexibility than the first and third segments. This local quality differentiation allows the balloon to be flexible where needed for navigation while maintaining rupture resistance in other regions, simultaneously achieving ease of operation and reliability
3Productivity
If electrodes are positioned close to the balloon wall, then the treatment efficacy improves, but the risk of electrode damage and fluid release increases
Solution Approach 1:
The segmented balloon structure with alternating flexibility regions maintains a controlled distance between the inner member (electrodes) and the balloon material. This segmentation prevents the electrodes from coming into direct contact with the balloon wall during vessel navigation, thereby reducing the risk of electrode damage and fluid release while preserving treatment efficacy through proper positioning
Solution Approach 2:
The different flexibility characteristics of various balloon segments create localized spacing variations that prevent electrode-balloon contact. This local quality control ensures electrodes remain at a safe distance from the balloon wall, eliminating the harmful effects of electrode damage and fluid release while maintaining treatment effectiveness
Data Source
AI summary
A catheter and segmented balloon system for a lithotripsy system having improved accommodation for curved configurations, which minimizes or prevents damage to the balloon during generation of the lithotripsy shock wave (e.g., resulting from electrical arcing of electrode pairs or use of a laser). Embodiments of the catheter include an elongate member with alternating flexibility regions wherein stiffer regions are configured to support at least one lithotripsy emitter, and wherein more flexible regions are disposed on either side of each stiffer region. This configuration minimizes risk that the section with the lithotripsy emitter(s), will tend to bend in a manner that positions the emitter close to the balloon wall. Embodiments of the segmented balloon system include balloon segments with interposed sections between each of the segmented balloons wherein the outer diameter of an inflated balloon segment is larger than the outer diameter of the interposed section.