Medical Balloon Integral Scoring Elements Amorphous Polymer
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Solution Overview
Problem
Existing medical balloons with separate scoring or cutting blades are complex, costly, and inflexible, making them unsuitable for smaller vessels and tortuous vasculature, with risks of tearing and difficulty in imaging.
Innovation Solution
A medical balloon with elongate elements made of amorphous polymer material, providing increased rigidity and flexibility, which can be formed into a unitary structure without separate stages, reducing the height of scoring or cutting elements for improved performance and easier insertion into small vessels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If separate scoring or cutting blades are fixed to the balloon, then cutting or scoring function is provided, but the manufacturing process becomes more complex, time consuming and costly
Solution Approach 1:
The cutting or scoring elements are integrally formed with the balloon body from the same polymer material, eliminating the need for separate blades and fixation elements. This merging of components simplifies the manufacturing process to a single extrusion operation while reducing structural complexity.
Solution Approach 2:
The balloon body serves multiple functions: it provides the cutting or scoring elements through its integral formation, acts as the dilating element, and maintains structural integrity during the procedure. This multi-functionality eliminates the need for separate components.
2Strength
If fixation elements and adhesives are used to attach blades to the balloon, then the blades are secured to the balloon, but the resultant structure becomes relatively bulky
Solution Approach 1:
The cutting elements are integrally formed with the balloon body, eliminating the need for separate fixation elements and adhesives. This integration removes the bulky components while maintaining the structural strength needed for cutting and dilating functions.
3Strength
If the balloon structure is made rigid to improve cutting efficiency, then cutting or scoring efficiency improves, but the balloon loses flexibility when deflated
Solution Approach 1:
The balloon is made from a polymer material with specific mechanical properties that provide adequate rigidity for cutting efficiency while maintaining flexibility when deflated. The integral formation allows the structure to be sufficiently stiff during inflation for effective cutting but flexible enough when deflated for navigation through tortuous vasculature.
4Ease of operation
If the balloon is made flexible to improve trackability through tortuous vasculature, then trackability improves, but cutting or scoring efficiency reduces
Solution Approach 1:
The polymer material and integral structure are designed to provide the optimal balance between flexibility for trackability and rigidity for cutting efficiency. The balloon maintains adequate structural support for effective cutting while remaining flexible enough for navigation through tortuous vessels.
5Ease of manufacture
If scoring or cutting elements protrude from the balloon wall, then cutting function is provided, but the balloon becomes difficult to fold and wrap to small diameters
Solution Approach 1:
The cutting elements are designed with optimized dimensions and geometry that allow them to protrude sufficiently for effective cutting while maintaining the overall compactness needed for folding and wrapping to small diameters for delivery.
Data Source
Figure 1~2
Figure 3
Figure 9A~9B
AI summary
A medical balloon assembly (10) includes a balloon (20) fitted to a balloon catheter (12). The balloon (20) includes a balloon wall (which is a co-extrusion) with ribs or strengthening elements (40) including amorphous polymer material.