Integral Balloon Dilation Elements for Hardened Stenosis Cracking
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Solution Overview
Problem
Conventional balloon catheters face challenges in effectively dilating hardened and calcified stenosed regions due to limitations in securing and material properties of dilation elements, leading to potential detachment and reduced efficacy.
Innovation Solution
The development of a balloon catheter with integral dilation elements made from the same material as the balloon wall, featuring specific cross-sectional shapes such as trizoid, trapezoid, and triangle designs that enhance the area and polar moment of inertia, improving resistance to bending and torsion, and manufacturing through co-extrusion processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If separate dilation wires or beads are attached to the balloon surface using adhesives, then dilation pressure can be focused on hardened stenosis regions, but the dilation elements may detach from the balloon surface during expansion
Solution Approach 1:
The patent merges the dilation elements with the balloon wall by forming them as integral structures during the balloon manufacturing process. This eliminates the need for separate attachment mechanisms and ensures the dilation elements remain firmly attached to the balloon surface during expansion, resolving the contradiction between achieving focused dilation and maintaining attachment reliability.
Solution Approach 2:
The patent employs composite material structures where the balloon wall incorporates dilation elements made from materials with different mechanical properties. The balloon wall and dilation elements are formed as a unified composite structure that provides both the flexibility needed for balloon expansion and the rigidity required for effective dilation of hardened stenosis.
2Ease of operation
If conventional balloon materials are used, then the balloon maintains flexibility and compliance, but the balloon cannot effectively dilate hardened and calcified stenosed regions
Solution Approach 1:
The patent applies local quality by creating regions of different mechanical properties within the balloon structure. The balloon wall incorporates localized dilation elements with higher rigidity and strength at specific positions, while the rest of the balloon wall maintains its flexibility and compliance. This allows the balloon to remain easy to operate while achieving effective dilation of hardened stenosis at targeted locations.
Solution Approach 2:
The patent uses composite materials to combine the flexibility of compliant balloon materials with the strength of rigid dilation elements. The composite structure allows the balloon to exhibit both compliant behavior during delivery and expansion, and localized rigid behavior when contacting hardened stenosis regions, resolving the contradiction between flexibility and dilation capability.
3Adaptability or versatility
If the balloon is made compliant to navigate vasculature, then the balloon can be delivered through the body, but the balloon material stretches during expansion causing adhesive detachment
Solution Approach 1:
The patent merges the dilation elements with the balloon wall structure itself, eliminating the need for separate adhesive bonding. The integral formation ensures that as the compliant balloon material stretches during expansion, the dilation elements move and deform with the material, preventing any relative motion that would cause adhesive detachment and maintaining bond stability.
4Strength
If separate dilation elements are used, then focused pressure can be applied to crack hardened stenosis, but the device complexity increases due to attachment requirements
Solution Approach 1:
The patent combines the dilation elements and balloon wall into a single integrated structure formed during manufacturing. This eliminates the need for separate attachment mechanisms, reducing device complexity while maintaining the capability to apply focused pressure for cracking hardened stenosis. The integral structure simplifies both the device design and manufacturing process.
Data Source
AI summary
A balloon catheter is provided for dilating hardened stenoses. The balloon catheter has dilation elements integrally formed on the outer surface of the balloon. The dilation elements have cross-sectional shapes that improve the performance of the balloon catheter.