Balloon Dilation Catheter with Segmented Semi-Compliant Design
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Solution Overview
Problem
Current airway balloon dilation procedures face challenges such as difficulty in maintaining balloon position during dilation, limited inflation pressure, and inability to permanently dilate the airway, especially in cases of mild subglottic stenosis and areas distal to proximal narrowing.
Innovation Solution
A balloon dilation catheter with a high-pressure, semi-compliant balloon that inflates in a dumbbell shape, with the proximal and distal portions inflating first to secure the balloon in place and then the central section expanding to achieve uniform dilation, allowing for increased pressure and preventing slippage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional balloon is used for airway dilation, then the procedure can be performed, but the balloon cannot be securely positioned and slips during inflation
Solution Approach 1:
The balloon is divided into three distinct segments: proximal hub, central working portion, and distal hub. The proximal and distal hubs are designed to inflate first and engage with the airway walls to secure the balloon position, while the central working portion inflates later to perform the dilation. This segmentation allows the balloon to be anchored firmly before dilation occurs.
Solution Approach 2:
The proximal and distal portions of the balloon inflate in advance of the central section to establish secure positioning within the airway. This preliminary inflation of the hub portions creates anchoring engagement with the airway walls before the central dilation portion is inflated, ensuring the balloon remains stationary during the dilation process.
2Reliability
If high inflation pressure is applied to achieve permanent dilation, then effective treatment is achieved, but excessive trauma is caused to the airway
Solution Approach 1:
The balloon applies different pressures to different regions of the airway through its segmented design. The proximal and distal hubs engage with the airway walls at lower pressures to secure positioning, while the central working portion delivers controlled high pressure for dilation. This localized pressure application achieves effective dilation while minimizing trauma by distributing forces appropriately across different anatomical regions.
Solution Approach 2:
The balloon material and design are optimized to enable controlled pressure delivery. The semi-compliant material allows the balloon to deliver high inflation pressures (up to 2-3 atmospheres) when needed for effective dilation, while the segmented structure and controlled inflation sequence ensure that pressure is applied progressively and locally, reducing the risk of excessive trauma to the airway tissues.
3Device complexity
If the balloon inflates uniformly from start to finish, then the inflation process is simple, but the balloon cannot be securely positioned during dilation
Solution Approach 1:
The balloon is divided into three distinct segments with different inflation characteristics: proximal hub, central working portion, and distal hub. This segmentation enables controlled sequential inflation where the proximal and distal hubs inflate first to secure positioning, followed by inflation of the central portion for dilation. The segmented design provides inherent control over the inflation sequence without requiring complex external control mechanisms.
Solution Approach 2:
The balloon incorporates dynamic inflation characteristics through its segmented structure and material properties. The proximal and distal portions are designed to inflate more readily and engage with the airway walls first, creating a dynamic sequence where positioning occurs before dilation. This dynamic behavior ensures reliable positioning while maintaining relative simplicity in the overall device design.
4Adaptability or versatility
If the balloon is made highly compliant to conform to airway shape, then it adapts to the anatomy, but it cannot generate sufficient pressure for permanent dilation
Solution Approach 1:
The balloon exhibits different compliance characteristics in different regions. The proximal and distal hubs are designed to be more compliant to conform to and engage with the airway walls for secure positioning. The central working portion is designed with different material or structural properties to provide the rigidity and pressure generation capability needed for permanent dilation. This local differentiation of compliance allows the balloon to adapt to airway shape while generating sufficient pressure for effective treatment.
Solution Approach 2:
The balloon may incorporate composite material construction or composite structural design that combines materials with different compliance properties. This allows different regions of the balloon to exhibit appropriate compliance characteristics: more compliant regions for anchoring and adaptation to airway shape, and less compliant regions for generating and maintaining high inflation pressures to achieve permanent dilation.
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 ensures safe and effective balloon dilation with improved positioning and increased pressure, enabling effective treatment of stenosis without causing excessive trauma, and allows for the deployment of a stent at the stenosis site.
Implementation Method 1
a high pressure balloon attached to the distal end of the catheter. The high pressure balloon is made from a semi-compliant material exhibiting a dumbbell-shaped outer periphery when inflated to a first atmospheric pressure and a substantially linear outer periphery when inflated to a second atmospheric pressure
Data Source
AI summary
An apparatus for performing a balloon dilation procedure at the site of a stenosis or for deploying a stent in a patient, the apparatus including a single lumen catheter having a proximal end and a distal end, and a high pressure balloon attached to the distal end of the catheter. The high pressure balloon is fabricated from a semi-compliant material that has an average rated burst pressure of between about 15 and about 27 atmospheres of pressure and exhibits a dumbbell-shaped outer periphery when inflated to a first atmospheric pressure and a substantially linear outer periphery when inflated to a second atmospheric pressure.