Reinforced Non-Compliant Balloon Catheter for Controlled Vessel Dilation
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Solution Overview
Problem
Existing balloon catheters lack sufficient non-compliance, leading to potential damage to blood vessels during balloon dilatation procedures due to excessive expansion beyond the intended target shape.
Innovation Solution
A non-compliant medical balloon is designed with a base balloon reinforced by a film reinforcement layer made of high-molecular polymer, such as polyimide, LCP polymer, PET, or PEEK, and optionally a fiber reinforcement layer of high modulus polyethylene fibers, ensuring minimal expansion beyond the nominal pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional balloon catheter is used for balloon dilatation, then the balloon can be inflated to expand blood vessels, but the balloon may expand excessively beyond the target shape causing damage to blood vessels
Solution Approach 1:
The balloon is constructed as a composite structure with a base balloon made of semi-compliant material (such as polyamide) and a film reinforcement layer made of high-molecular polymer (such as polyimide, LCP, PET, or PEEK). This composite construction provides controlled non-compliance, allowing the balloon to expand to a specific diameter while resisting further expansion to prevent vessel damage.
Solution Approach 2:
The patent modifies the mechanical parameters of the balloon by introducing a film reinforcement layer that changes the pressure-diameter relationship. The film layer ensures that when nominal pressure is applied, the balloon expands to the target shape and then maintains constant diameter even as pressure increases toward burst pressure, achieving non-compliance of less than 2% (preferably less than 1%).
2Reliability
If a non-compliant balloon with film reinforcement layer is used, then the balloon maintains its shape and prevents vessel damage, but the structural complexity and manufacturing difficulty increase
Solution Approach 1:
The reinforcement is achieved through a thin film layer made of high-molecular polymer that is wrapped around the base balloon. This film layer provides the necessary mechanical reinforcement to ensure non-compliance while maintaining the flexibility and balloon-like characteristics needed for catheter application.
Solution Approach 2:
An adhesive layer serves as an intermediary between the base balloon and the film reinforcement layer, bonding the two components together. This allows the complex multi-layer structure to be manufactured and assembled in a controlled manner, with the adhesive providing reliable attachment while being thin enough not to compromise the overall balloon performance.
3Strength
If the film reinforcement layer is made thicker to improve non-compliance, then the balloon resistance to expansion increases, but the balloon becomes less flexible and harder to navigate through vessels
Solution Approach 1:
The film reinforcement layer is designed as a thin film (typically 6-25 μm thick) that provides sufficient mechanical reinforcement for non-compliance while maintaining the flexibility required for navigation through blood vessels. The high-molecular polymer materials used have inherent flexibility despite their strength.
Solution Approach 2:
The composite construction combines the flexibility of the semi-compliant base balloon material with the strength of the thin film reinforcement layer. This allows the balloon to be navigated through vessels in its collapsed state while providing the necessary resistance to over-expansion when inflated.
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 reinforced balloon maintains its shape and volume under increased pressure, providing enhanced safety and effectiveness in expanding occluded blood vessels without causing damage, while also incorporating electronic components and visibility markers for improved medical procedures.
Implementation Method 1
the balloon comprises a base balloon and a film reinforcement layer, wherein the film reinforcement layer comprises film made of a high-molecular polymer and surrounds the base balloon at least in sections
Implementation Method 2
The base balloon, which can be made of a semi-compliant material such as polyamide, is reinforced with the aid of the film reinforcement layer so that the medical balloon as a whole is non-compliant
Data Source
AI summary
The invention relates to a non-compliant medical balloon for a balloon catheter having a base balloon and having a film reinforcement layer which comprises film made of a high-molecular polymer, in particular polyimide, LCP polymer, PET and/or PEEK, and surrounds the base balloon at least in sections.