Fiber-Reinforced Medical Balloon for Pressure and Shape Control
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Solution Overview
Problem
Existing medical balloons, particularly those used for procedures like transcatheter aortic-valve implantation, face challenges with high-compliance materials that lack sufficient pressure, shape control, and puncture resistance, while low-compliance materials like PET are fragile and difficult to shape.
Innovation Solution
A composite fiber-reinforced medical balloon with reinforcement fibers oriented parallel to the longitudinal axis, featuring a fiber and polymeric matrix outer wall, and a design that minimizes radial distension and shearing load, enhancing strength and shape control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If high-compliance materials (urethane, latex, silicone, PVC, Pebax) are used for medical balloons, then the balloon can easily expand and return to original shape, but the balloon cannot reach high pressures and has poor puncture and tear resistance
Solution Approach 1:
The patent uses composite materials consisting of a polymer matrix combined with reinforcement fibers (such as polyester, nylon, or other high-strength fibers) to create a balloon wall structure that simultaneously provides the elasticity needed for expansion and recovery, as well as the strength required for high pressure and puncture resistance. The composite structure combines the beneficial properties of both materials.
Solution Approach 2:
The patent applies reinforcement fibers selectively in specific regions of the balloon wall where strength is most needed, such as areas prone to puncture or high stress concentrations. This allows the balloon to maintain high compliance in less critical areas while providing enhanced strength where required.
2Strength
If low-compliance material (PET) is used for high pressure balloons, then the balloon can withstand high pressures, but the balloon is fragile, prone to tears, and difficult to pack or fold
Solution Approach 1:
The patent combines PET or other low-compliance materials with reinforcement fibers to create a composite structure that maintains the high pressure resistance of the base material while the fiber reinforcement prevents tear propagation and improves overall toughness, making the balloon less fragile and more manageable during procedures.
3Adaptability or versatility
If high-compliance medical balloons are used, then the balloon can expand several times in volume, but the balloon has poor shape control and assumes shape dictated by environment rather than clinical goals
Solution Approach 1:
The patent employs reinforcement fibers with specific orientations (such as circumferential, longitudinal, or angled patterns) in different regions of the balloon to control shape in specific directions while allowing expansion in others. This directional reinforcement enables the balloon to maintain clinically desired shapes during expansion.
Solution Approach 2:
The composite structure of polymer matrix with strategically oriented reinforcement fibers provides both the compliance needed for volume expansion and the shape memory or shape control required to maintain clinically appropriate geometries during the procedure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The balloon achieves high pressure resistance, precise shape control, and improved puncture and tear resistance, ensuring reliable performance in medical procedures.
Implementation Method 1
the wall comprises reinforcement fibers; wherein the reinforcement fibers are oriented substantially parallel with the longitudinal axis of the device
Implementation Method 2
High-compliance medical balloons are often composed of urethane, latex, silicone, PVC, Pebax, and other elastomers. As the pressure in a high-compliant balloon is increased, the balloon dimensions expand. Once the pressure is reduced, the high-compliance medical balloon may return to its original shape
Data Source
AI summary
Inflatable medical devices and methods for making and using the same are disclosed. The devices can be medical invasive balloons, such as those used for transcutaneous heart valve implantation, such as balloons used for transcatheter aortic-valve implantation. The balloons can have high strength, fiber-reinforced walls.