Inflatable Medical Balloon With S-Shaped Fiber Reinforcement for Shape Control
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Solution Overview
Problem
Existing fiber-reinforced medical balloons face challenges in manufacturing complexity, high cost, and inadequate shape control, puncture resistance, and tear properties, while also requiring precise shape control and high pressure resistance.
Innovation Solution
A fiber-reinforced inflatable balloon design with S-shaped fibers that maintain their configuration during inflation, combining longitudinal and hoop fibers with an S-shape to enhance tear resistance and trackability, and using an automated application process for efficient manufacturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If traditional high-compliance medical balloons are used, then the balloon can easily expand in volume, but the balloon cannot reach high pressures and provides insufficient force
Solution Approach 1:
The balloon incorporates a composite structure combining a compliant balloon body with an embedded fiber reinforcement layer. The fiber layer (made of materials like polyester, nylon, or PTFE) provides high tensile strength and pressure resistance, while the compliant balloon material (such as Pebax, polyurethane, or silicone) maintains expandability. This composite construction allows the balloon to withstand high pressures up to 20-30 atm while delivering sufficient radial force for medical procedures.
2Shape
If traditional high-compliance medical balloons are used, then the balloon can expand easily, but the balloon has poor shape control
Solution Approach 1:
The fiber reinforcement layer is configured with specific patterns (longitudinal fibers, circumferential fibers, or helical fibers) that provide shape control while maintaining compliance. The fibers are embedded within or on the surface of the balloon wall, creating a composite structure that guides expansion along desired axes while preventing unwanted deformations, thus achieving precise shape control without excessive structural complexity.
Solution Approach 2:
Different fiber orientations and densities are applied to different regions of the balloon to achieve localized shape control. For example, higher fiber density in specific zones can control expansion in those areas, while other regions maintain higher compliance. This allows the balloon to assume specific three-dimensional shapes during inflation to match anatomical structures.
3Strength
If PET balloons are used, then the balloon is stronger and can be made thin, but the balloon is fragile and prone to tears
Solution Approach 1:
The fiber reinforcement layer uses materials specifically selected for high tear and puncture resistance, such as polyester, nylon, or PTFE fibers. These fibers are embedded in the balloon wall to create a composite structure where the fiber network distributes stress and prevents tear propagation. The fiber layer acts as a reinforcement mesh that significantly improves puncture and tear resistance compared to homogeneous polymer balloons.
4Reliability
If fiber-reinforced composite balloons are used, then the balloon can sustain high pressures, but the manufacturing process is complicated and expensive
Solution Approach 1:
The fiber reinforcement layer is pre-formed or pre-positioned on a mandrel or form before the balloon material is applied. This preliminary arrangement of fibers ensures proper orientation and distribution, simplifying the subsequent manufacturing steps. The pre-formed fiber structure allows for more straightforward assembly and reduces the need for complex in-process fiber alignment procedures.
Solution Approach 2:
The manufacturing process merges the fiber layer application with the balloon forming process itself. Fibers are embedded within or on the surface of the balloon wall during a single integrated manufacturing step, rather than requiring separate fiber attachment operations. This consolidation of steps reduces manufacturing complexity and cost while maintaining the high-pressure resistance benefits of fiber reinforcement.
Data Source
AI summary
A fiber-reinforced device (100), such as an inflatable medical balloon, includes a cylindrical central portion. The balloon includes (100) first and second tapered portions connected to the cylindrical central portion along a longitudinal axis extending from a first end of the balloon to a second end of the balloon. The balloon includes at least one fiber (134, 142) having a fixed, S-shaped portion in a plan view, the fixed S-shaped portion remaining intact when the inflatable balloon is fully inflated.