Multi-layered Medical Balloon with Fiber-Reinforced Wall
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Solution Overview
Problem
Current medical balloons, particularly high-compliance and low-compliance balloons, face issues such as inadequate pressure resistance, poor shape control, and compatibility with medical procedures due to material limitations, leading to potential complications and inefficiencies in medical procedures.
Innovation Solution
A medical inflatable device with a balloon structure featuring a multi-layered wall composition, including an inner leak-proof layer, a middle layer with fibers, and an outer MMA-resistant layer, designed to provide high burst pressure, precise shape control, and resistance to degradation from bone cement, while maintaining a thin profile for minimally invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a single-layer balloon material is used, then the device complexity is reduced, but the burst pressure resistance and shape control are insufficient
Solution Approach 1:
The balloon wall is constructed as a composite structure with an inner layer made of a first material providing burst pressure resistance, and an outer layer made of a second material providing shape control. This composite material approach allows each layer to contribute its specific functional properties, achieving both high burst pressure resistance and precise shape control simultaneously.
Solution Approach 2:
The balloon wall is divided into distinct functional layers: an inner layer for burst pressure resistance and an outer layer for shape control. This segmentation allows each layer to be optimized independently for its specific function, with the inner layer material selected for tensile strength and the outer layer material selected for rigidity and dimensional stability.
2Ease of operation
If the balloon wall is made thinner for minimally invasive procedures, then the ease of operation is improved, but the burst pressure resistance deteriorates
Solution Approach 1:
The composite balloon wall structure enables thin overall wall thickness suitable for minimally invasive procedures while maintaining burst pressure resistance. The inner layer, though thin, is made of high-strength material specifically selected for burst pressure resistance, allowing the balloon to withstand high expansion pressures despite the reduced overall wall thickness.
Solution Approach 2:
Different regions of the balloon wall have different material properties optimized for their specific functions. The inner layer is localized for burst pressure resistance with high tensile strength material, while the outer layer is localized for shape control and thin profile. This local quality differentiation allows the balloon to achieve both thin wall thickness and high burst pressure resistance.
3Ease of operation
If high-compliance balloon material is used, then the ease of operation is improved, but the shape control deteriorates
Solution Approach 1:
The balloon is segmented into two functional layers: the inner layer uses high-compliance material for ease of operation and expansion, while the outer layer uses low-compliance material for shape control. This segmentation allows the inner layer to expand readily in response to pressure changes while the outer layer maintains the desired geometric shape and dimensional stability.
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 device achieves a high burst pressure of over 150 psi, maintains shape integrity, and resists degradation, enhancing the safety and efficacy of medical procedures by providing reliable and controlled expansion within the body.
Implementation Method 1
The inner layer can be thinner than about 0.05 mm (0.002 in.)... providing high burst pressure
Implementation Method 2
The first middle layer can have a fiber
Implementation Method 3
The outer layer can have a melt or decomposition temperature greater than about 200° Celsius... resistance to degradation from bone cement
Data Source
AI summary
Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.