Medical Balloon Radial Projections Focused Force Control
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Solution Overview
Problem
Existing balloon dilatation catheters face challenges in navigating tortuous anatomy and applying a focused force to tight lesions, with complex manufacturing processes and limited control over the direction and location of the force provided by external wires.
Innovation Solution
A medical balloon with radial projections, comprising wires embedded between layers of the balloon wall, which are spaced and symmetrical to provide controlled focused force during angioplasty procedures, and can be manufactured in a simpler manner.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If external wires are used to provide focused force, then the ability to crack tight lesions is improved, but the manufacturing complexity increases
Solution Approach 1:
The patent extracts the wire components from the external environment and embeds them within the balloon wall structure. The wires are positioned between the inner and outer layers of the balloon wall, eliminating the need for separate external wire assemblies and their associated complex manufacturing processes while maintaining the focused force capability for lesion cracking
Solution Approach 2:
The patent merges the wire elements with the balloon wall structure by embedding them between the inner and outer layers. This integration combines the force-providing function of the wires with the structural function of the balloon wall, simplifying the overall device architecture and manufacturing process while maintaining controlled focused force delivery
2Ease of operation
If asymmetrical wire locations are used, then the focused force direction is controlled, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The patent applies local quality by positioning wires at specific locations within the balloon wall structure where they are needed to provide focused force in particular directions. The wires can be placed at different radial positions and angles within the wall layers, allowing control over force direction while using a standardized embedding process that remains manufacturable
Solution Approach 2:
The patent employs asymmetry by allowing the wires to be positioned at non-uniform locations within the balloon wall, enabling control over the direction of focused force. The wires can be arranged asymmetrically between the inner and outer layers to target specific lesion orientations while maintaining a symmetric overall balloon structure for ease of manufacture
3Force
If full extension wires are used along the balloon, then focused force is provided, but the control over location and direction of force is reduced
Solution Approach 1:
The patent segments the wire structure into discrete radial projections that extend only partially along the balloon length rather than using full-extension wires. Each wire segment is positioned between the inner and outer balloon wall layers at specific locations, enabling independent control over where and in what direction focused force is applied to different segments of the lesion
Solution Approach 2:
The patent adds dimensional control by positioning wires at multiple radial depths within the balloon wall (between inner and outer layers) and at various angular positions. This multi-dimensional arrangement within the wall structure enables precise control over the location and direction of focused force without requiring full-length wire extensions
Data Source
AI summary
A balloon includes a plurality of radial projections formed in a working surface for use in providing a focused force during the angioplasty procedure. The plurality of radial projections may be formed in a wall of the balloon and spaced apart in a longitudinal direction. The projections for use in connection with such a balloon may comprise wires or wire segments, and may also comprise radiopaque materials to facilitate viewing under fluoroscopy during the procedure. Related methods of manufacturing are also disclosed.