Medical Balloon Dual-Layer Refolding Control
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Solution Overview
Problem
Medical balloons face challenges in refolding back to their original configuration after inflation, resulting in a less desirable profile upon deflation, which complicates their reuse and insertion through vascular systems.
Innovation Solution
A medical balloon design featuring a dual-layer structure with a first layer of constant radial thickness and a second layer with alternating regions of greater and reduced radial thickness, allowing the balloon to fold consistently back into a predetermined pleat configuration during deflation, ensuring a controlled and efficient refolding process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the balloon is made from noncompliant material and folded into pleated configuration for low profile insertion, then the balloon can be easily inserted through introducer and moved through vascular system, but upon deflation the balloon collapses in random manner forming different number of pleats than originally present, resulting in larger or less desirable profile
Solution Approach 1:
The balloon wall is segmented into multiple layers with different properties. The first layer provides structural support while the second layer with varying radial thickness controls the folding behavior. This segmentation allows the balloon to be divided into functional zones that work together to achieve both low-profile insertion and predictable refolding.
Solution Approach 2:
The second layer of the balloon wall has non-uniform radial thickness, with thinner regions strategically positioned to become pleat formation zones during deflation. This local variation in thickness creates specific areas that are more compliant and prone to folding, while other regions maintain structural integrity. The local quality change ensures that pleats form in predetermined locations rather than randomly.
2Stress or pressure
If the balloon is inflated to high pressure to dilate the body lumen, then the balloon effectively dilates the treatment site, but the pleats disappear during inflation and upon deflation the balloon forms random pleats, complicating reuse
Solution Approach 1:
The balloon wall is pre-configured with layers of specific thicknesses before inflation occurs. The second layer is manufactured with predetermined thinner regions that will become pleat formation zones. This preliminary structuring ensures that when the balloon deflates after high-pressure inflation, the pleats reform in the original predetermined pattern rather than randomly, maintaining reliability for reuse.
3Strength
If the balloon wall is made with uniform thickness for structural integrity, then the balloon maintains strength during inflation, but the balloon cannot fold consistently back into original configuration upon deflation
Solution Approach 1:
The balloon wall is constructed as a composite structure with at least two layers having different radial thicknesses. The first layer provides baseline structural strength, while the second layer with varying thickness contributes both strength and controlled flexibility. This composite construction allows the balloon to maintain overall strength during high-pressure inflation while enabling predictable folding behavior during deflation through the thinner regions of the second layer.
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 dual-layer structure enables the balloon to maintain a consistent pleat configuration upon deflation, matching the original folded state, thus facilitating easier insertion and reuse by maintaining a low profile and predictable shape.
Implementation Method 1
The balloon wall is adapted for inflation from a first folded configuration having a first plurality of pleats to an expanded, unpleated configuration and deflation from the expanded, unpleated configuration to a second folded configuration having a second plurality of pleats
Data Source
AI summary
A medical balloon comprises a first end, a second end spaced apart from the first, and a generally cylindrical balloon wall extending therebetween to define an inflation chamber. The balloon wall is adapted for inflation from a first folded configuration having a first plurality of pleats to an expanded, unpleated configuration, and deflation therefrom to a second folded configuration having a second plurality of pleats. The balloon wall includes a first layer formed of a polymer and having a substantially constant radial thickness. A second layer is firmly attached to the first layer and has a plurality of first regions of greater radial thickness interleaved with a plurality of second regions of reduced radial thickness. During deflation from the expanded, unpleated configuration to the second folded configuration, the balloon wall folds along the regions of reduced radial thickness of the second layer to form the second plurality of pleats.