Multi-layer Balloon Sealing Under Cyclical Pressure
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Solution Overview
Problem
Existing balloon-like structures used in catheters for sealing and tamponading internal spaces face challenges in maintaining efficient sealing under cyclical pressure fluctuations, particularly in organs like the trachea and esophagus, where internal pressure changes due to breathing can lead to loss of seal and increased fluid passage.
Innovation Solution
A multi-layer balloon foil material is developed, comprising elastically deformable polyurethane (PUR) and non-elastic polyvinyl chloride (PVC) layers, produced by coextrusion, which reduces the formation of secretion-conducting channels and maintains a stable seal even under fluctuating pressures by counteracting the elastic properties of the PUR layer with the PVC layer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a thin-walled elastic PUR balloon is used to enable low-pressure sealing and maintain perfusion, then tissue compatibility and perfusion maintenance are improved, but sealing reliability deteriorates under cyclical pressure fluctuations
Solution Approach 1:
The patent applies composite materials by combining an inner PUR layer (5-20 μm) that provides elasticity and low-pressure sealing with an outer PVC layer (10-30 μm) that provides dimensional stability and resistance to cyclical pressure fluctuations. This composite structure resolves the contradiction by integrating the advantages of both materials: the elastic PUR layer maintains perfusion at low pressures while the stable PVC layer prevents channel formation during pressure fluctuations.
Solution Approach 2:
The patent changes the material parameter from single-material elastic PUR to a composite PUR-PVC structure with specific thickness ratios. This parameter change transforms the balloon's mechanical properties, allowing it to maintain both the low-pressure sealing capability (through the thin PUR layer) and the stability under cyclical pressure (through the outer PVC layer), thereby resolving the reliability-tissue compatibility contradiction.
2Reliability
If the balloon circumference exceeds the lumen circumference to enable invagination sealing, then sealing efficiency is improved, but channel formation deteriorates under pressure fluctuations
Solution Approach 1:
The outer PVC layer in the composite structure counteracts the elastic expansion tendency of the inner PUR layer during pressure fluctuations. This prevents the invaginated balloon walls from opening up and forming channels, while still allowing the initial invagination to occur for effective sealing. The composite material thus resolves the contradiction between sealing efficiency and channel prevention.
3Object-affected harmful factors
If a single-layer elastic PUR balloon is used to achieve low-pressure sealing, then tissue perfusion is maintained, but sealing consistency deteriorates under cyclical pressure changes
Solution Approach 1:
The patent uses a composite PUR-PVC structure where the inner PUR layer (5-20 μm) maintains tissue perfusion through its elasticity and low-pressure characteristics, while the outer PVC layer (10-30 μm) provides dimensional stability that ensures consistent sealing performance. This composite approach resolves the contradiction by allowing the balloon to simultaneously maintain perfusion and provide consistent sealing under cyclical pressure changes.
Solution Approach 2:
The patent applies local quality by assigning different functional properties to different layers: the inner PUR layer is optimized for tissue interaction and perfusion maintenance, while the outer PVC layer is optimized for structural stability and sealing consistency. This localized functional differentiation resolves the contradiction between perfusion maintenance and sealing consistency.
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 multi-layer structure ensures a more consistent and efficient sealing performance across a wider range of pressures, reducing the cross-sectional area of secretion-conducting channels and maintaining a reliable seal during cyclical pressure changes, thereby preventing fluid leakage and maintaining perfusion of adjacent tissues.
Implementation Method 1
at least one layer (2) consisting of an elastically deforming polyurethane (PUR)
Implementation Method 2
counteracting the elastic properties of the PUR layer with the PVC layer
Implementation Method 3
reducing the cross-sectional area of secretion-conducting channels
Data Source
Figure 1~2b
Figure 3~6
AI summary
The invention relates to a multi-layer balloon film material in which one or more layers of an elastically deforming material is/are combined with one or more layers of a plastically deforming non-elastic material, wherein the non-elastic layer counteracts the straightening properties of the elastic layer in the case of planar folds or bends in the balloon film material. In particular, the cross-sectional area of eyelet- or channel-shaped structures which conducts secretions or fluids, which structures typically occur in the area of wrinkle-like invaginations of a residually sized balloon film in an organ lumen or a body cavity, can be reduced and, particularly in the case of cyclically changing filling pressures of the balloon, can be stabilized in such a way that an optimally sealing closure or tamponade effect is achieved across the largest possible filling pressure amplitudes.