Micro-thin Polyurethane Balloon Tamponade for Sinus Cavities
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Solution Overview
Problem
Conventional tamponades for nasal and sinus cavities face issues such as pain and bleeding during removal, encrustation, incomplete wound surface coverage, pressure spikes that hinder healing, and blockage of nasal breathing, due to inadequate fit and inhomogeneous pressure distribution.
Innovation Solution
The use of micro-thin polyurethane balloon sheaths with residual dimensions that fold into the balloon interior, allowing for a shell-like coverage of complex surfaces, adjustable length and diameter, and a tapered design to ensure homogeneous pressure application, maintaining nasal breathing and facilitating ventilation and rinsing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stress or pressure
If conventional balloon tamponades are used to fill sinus cavities, then the cavity can be tamponaded, but the balloon cannot rest flat against the individual shape of the sinus surface, leading to inhomogeneous pressure distribution and pressure spikes
Solution Approach 1:
The patent employs a micro-thin balloon sheath made of polyurethane material that can flex and conform to the complex three-dimensional surface of the sinus cavity. The thin film structure allows the balloon to adapt to individual anatomical variations while maintaining uniform pressure distribution across the wound surface, eliminating pressure spikes that occur with conventional rigid or thick-walled balloons.
2Duration of action of stationary object
If tamponade material is left in place for up to a week to prevent stenosis recurrence, then the ostium remains protected, but the material becomes encrusted and anchored to the wound area, causing pain and bleeding during removal
Solution Approach 1:
The micro-thin polyurethane balloon sheath maintains a smooth surface that does not encrust or anchor to the wound tissue during the dwell period. This non-adherent surface allows the tamponade to be removed easily after up to a week without causing pain or bleeding, while still effectively preventing ostium stenosis recurrence.
Solution Approach 2:
The tamponade system is designed as a disposable single-use device that can be safely left in place for the required dwell time and then discarded after removal. The material is engineered to perform its function during the dwell period without becoming contaminated or adhering to tissue, making it suitable for single-use application.
3Shape
If the balloon sheath is made elastic to conform to the cavity shape, then it can adapt to the sinus surface, but it cannot prevent pressure spikes on prominent structures that interrupt blood flow
Solution Approach 1:
The micro-thin polyurethane sheath provides a unique combination of flexibility and pressure distribution characteristics. While elastic enough to conform to the cavity shape, its thin film structure allows it to flex around prominent structures without creating localized pressure spikes that would interrupt blood flow, thus maintaining both adaptability and hemodynamic safety.
4Stress or pressure
If the tamponade is designed to completely fill the sinus cavity for effective tamponading, then wound healing is promoted, but nasal breathing is completely blocked
Solution Approach 1:
The balloon tamponade is designed with differentiated functionality: the distal portion fills the sinus cavity to provide effective tamponading and promote wound healing, while the proximal portion maintains a smaller profile that allows nasal breathing. This local differentiation of tamponade intensity enables both effective treatment and patient comfort.
Data Source
AI summary
A tamponade for nasal cavities or sinus cavities for tamponading a cavity of the nasal tract in the region of an ostium leading to the cavity with uniform force, comprising a thin-walled balloon which is made from a soft foil-like, only slightly expandable, smoothly folding polyurethane material, with a wall thickness in the range of 5 to 50 μm, which is already completely shaped with the required tamponade dimensions or greater at the time of production, and can therefore be expanded without application of filling pressure, and said balloon occupies the respective, generally irregular-shaped cavity and the ostium of same when in the filled condition, through the development of forces that are as uniform as possible on the structures exposed to the balloon in such a way that a distal segment of the balloon is located inside the cavity where a tamponade is to be applied, a proximal segment of the balloon is located upstream of the cavity and a transostial segment of the balloon extends through the ostium and connects the distal segment of the balloon to the proximal segment of the balloon, wherein the transostial segment of the balloon is tapered relative to the proximal and distal segments of the balloon in the deployed state of the balloon, and the nasal cavity or sinus cavity tamponade is anchored in the transition region and reliably secured in position.