Multi-Layer Balloon Design for Burst Pressure and Flexibility
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Solution Overview
Problem
Conventional balloon catheters face limitations in exerting hydraulic force due to radial and axial stress, leading to potential bursting, which can result in debris within the patient and impaired access to certain areas, and existing multi-layer balloons do not effectively optimize inner wall stretch for maximum strength and flexibility.
Innovation Solution
The development of multi-layer balloons with optimized inner wall stretch in each layer, utilizing structural and lubricating layers to enhance strength, flexibility, and reduce friction, allowing for higher pressure ratings and improved folding characteristics, while maintaining equivalent mechanical properties and molecular alignment across layers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If balloon wall thickness is increased to withstand higher pressure, then burst pressure resistance is improved, but balloon flexibility and ability to wrap around catheter shaft deteriorate
Solution Approach 1:
The balloon is divided into multiple layers, each with specific functions. The inner layer provides flexibility and wrapability, while outer layers provide strength and burst pressure resistance. This segmentation allows each layer to be optimized for its specific function rather than requiring a single thick wall.
Solution Approach 2:
The balloon uses composite material construction with multiple layers of different materials or configurations. The combination of layers creates a composite structure that exhibits both flexibility (from thinner inner layers) and high burst pressure resistance (from reinforced outer layers), resolving the contradiction between these opposing requirements.
2Ease of manufacture
If single-layer balloon design is used to simplify construction, then manufacturing complexity is reduced, but ability to optimize inner wall stretch for maximum strength is limited
Solution Approach 1:
The balloon construction is segmented into multiple layers, each independently optimized for specific functions. The inner layer can be specifically designed and manufactured to achieve optimal inner wall stretch characteristics, while outer layers address other requirements. This segmentation enables superior strength optimization despite increased manufacturing steps.
Solution Approach 2:
Different layers of the balloon have different local qualities and properties. The inner layer is specifically engineered with properties optimized for inner wall stretch and flexibility, while outer layers have properties optimized for strength and pressure resistance. This local differentiation allows each region of the balloon to perform its specific function optimally.
3Ease of operation
If balloon diameter is increased to improve access to treatment sites, then ease of operation is improved, but risk of radial bursting increases
Solution Approach 1:
The multi-layer composite construction allows the balloon to achieve larger diameters for better access to treatment sites while maintaining high burst pressure resistance. The composite structure distributes stresses across multiple layers, enabling the balloon to withstand the higher radial forces encountered at larger diameters without increasing single-layer thickness.
Solution Approach 2:
The balloon is segmented into multiple layers that collectively provide the strength needed for larger diameter applications. Each layer contributes to the overall pressure resistance, allowing the balloon to safely operate at larger diameters that improve access to difficult treatment sites while maintaining reliability.
Data Source
AI summary
A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.