Inflatable Imbibed Polymer Devices for Bladderless Balloon Catheters
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Solution Overview
Problem
Existing balloon catheters require a separate bladder that increases the profile and can lead to leaks due to inadequate adhesion and stress concentrations, necessitating a solution for a low-profile, bladderless balloon that maintains watertightness under pressure strain.
Innovation Solution
A stretchable material comprising a reinforcing polymer with a porous matrix and a sealing material that infiltrates and forms a surface coating, allowing the balloon to expand without leaking, using a composite film with anisotropic properties for directional strain and controlled porosity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a separate bladder is used in traditional balloon catheters, then the balloon can be pressure-expanded, but the profile of the balloon increases and leakage risk increases due to inadequate adhesion and stress concentrations
Solution Approach 1:
The patent merges the bladder function and the balloon wall into a single integrated structure. The elastomeric material forms both the structural balloon wall and the pressure-containing bladder, eliminating the need for a separate bladder component. This integration reduces the overall profile while maintaining pressure containment capability and eliminating adhesion-related leakage risks.
Solution Approach 2:
The patent employs a composite material system consisting of an elastomeric matrix reinforced with non-elastomeric filaments. This composite structure provides both the flexibility needed for pressure expansion and the strength required for pressure containment, replacing the traditional separate bladder construction with a unified composite balloon wall.
2Ease of manufacture
If traditional fluoropolymer matrix with coating is used, then the balloon can be formed, but the coating pulls away from the matrix causing holes and weeping due to inadequate adhesion strength
Solution Approach 1:
The patent changes the fundamental material parameters by transitioning from a fluoropolymer matrix with separate coating to an elastomeric matrix with integrated non-elastomeric reinforcement. This parameter change eliminates the coating-matrix adhesion interface problem by creating a unified composite structure where the non-elastomeric filaments are embedded within the elastomeric matrix, providing both structural integrity and pressure containment without coating delamination.
3Device complexity
If the balloon is wrapped at low angle, then the profile is reduced, but the material must withstand excessive strain perpendicular to the wrap direction during inflation
Solution Approach 1:
The patent applies local quality by using non-uniform wrapping angles in different circumferential zones of the balloon. The wrapping angle varies from zone to zone, with tighter wrapping in regions experiencing higher circumferential stress and looser wrapping in regions with lower stress. This localized variation in wrapping density optimizes both the low-profile requirement and the strain resistance capability in different areas of the balloon.
Solution Approach 2:
The composite material system of elastomeric matrix with non-elastomeric filaments provides the necessary strength to withstand the excessive strain perpendicular to the wrap direction. The non-elastomeric reinforcement filaments carry the tensile loads that would otherwise exceed the capacity of the elastomeric material alone, enabling the use of low wrapping angles for reduced profile while maintaining structural integrity during inflation.
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 solution enables balloons to expand significantly without inducing holes or compromising sealing, providing a reduced profile and improved strength, suitable for medical devices, with enhanced durability and radial symmetry upon inflation.
Implementation Method 1
A stretchable material comprises a reinforcing polymer having a porous matrix with void spaces and a sealing material imbibed into the reinforcing polymer substantially sealing the porous matrix void spaces
Implementation Method 2
The imbibed polymer is stretched in one direction such that strain is transferred to the wrap direction. The anisotropic material properties of the imbibed polymer allow for this directional strain
Data Source
AI summary
The present invention provides a stretchable material suitable for use in an inflatable medical device. The stretchable material has at least one reinforcing polymer layer with a top and bottom side forming a porous matrix which is imbibed with a sealing material to infiltrate and substantially seal spaces of the porous matrix and extend beyond the reinforcing polymer layer to form a surface coating.