Compliant Balloon with Liquid Injection for Pulmonary Vein Occlusion
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Solution Overview
Problem
Current cardiac arrhythmia treatment methods, such as pulmonary vein ablation, require multiple differently sized catheters to accommodate varying ostial sizes, leading to inefficiencies and increased costs due to the need for trial-and-error with non-reusable catheters.
Innovation Solution
A medical device with an adjustable treatment element comprising a first inflatable balloon and a second expandable balloon, where the second balloon can be expanded to accommodate varying ostial sizes using fluid injection and pressure sensors to ensure complete occlusion of the pulmonary vein, allowing for precise fitting and effective ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple differently sized catheters are used to accommodate varying ostial sizes, then the ability to treat different pulmonary vein sizes is improved, but the device complexity and procedural time increase due to the need for trial-and-error with non-reusable catheters
Solution Approach 1:
The balloon catheter incorporates a expandable framework that allows the balloon diameter to be dynamically adjusted during the procedure. The framework includes expandable elements that can be inflated to different diameters to match the specific size of the pulmonary vein ostium, eliminating the need for multiple fixed-size catheters.
Solution Approach 2:
The invention changes the parameter of balloon diameter from fixed to variable. By controlling the inflation of the expandable framework elements, the balloon diameter can be adjusted to match different ostial sizes, providing versatility while using a single catheter design.
2Adaptability or versatility
If multiple differently sized catheters are used to accommodate varying ostial sizes, then the ability to treat different pulmonary vein sizes is improved, but the procedural time and cost increase due to trial-and-error with non-reusable catheters
Solution Approach 1:
The balloon catheter incorporates a expandable framework that allows the balloon diameter to be dynamically adjusted during the procedure. The framework includes expandable elements that can be inflated to different diameters to match the specific size of the pulmonary vein ostium, eliminating the need for multiple fixed-size catheters.
Solution Approach 2:
The system includes sensors that detect the size of the pulmonary vein ostium and provide feedback to control the expansion of the framework. This feedback mechanism ensures the balloon is expanded to the correct diameter without requiring trial-and-error, reducing procedural time.
3Device complexity
If a fixed-size balloon catheter is used, then the device complexity is reduced, but the ability to achieve complete occlusion of varying sized pulmonary veins is compromised
Solution Approach 1:
The balloon catheter incorporates a expandable framework that allows the balloon diameter to be dynamically adjusted during the procedure. The framework includes expandable elements that can be inflated to different diameters to match the specific size of the pulmonary vein ostium, eliminating the need for multiple fixed-size catheters.
Solution Approach 2:
The invention changes the parameter of balloon diameter from fixed to variable. By controlling the inflation of the expandable framework elements, the balloon diameter can be adjusted to match different ostial sizes, providing versatility while using a single catheter design.
4Adaptability or versatility
If the balloon is made compliant to accommodate varying sizes, then the adaptability is improved, but the precision of occlusion for specific ostial sizes may be compromised
Solution Approach 1:
The balloon catheter incorporates a expandable framework that allows the balloon diameter to be dynamically adjusted during the procedure. The framework includes expandable elements that can be inflated to different diameters to match the specific size of the pulmonary vein ostium, eliminating the need for multiple fixed-size catheters.
Solution Approach 2:
The system includes sensors that detect the size of the pulmonary vein ostium and provide feedback to control the expansion of the framework. This feedback mechanism ensures the balloon is expanded to the correct diameter without requiring trial-and-error, reducing procedural time.
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 adjustable device enables precise occlusion of pulmonary veins of varying sizes, reducing the need for multiple catheters, improving procedural efficiency and cost-effectiveness by ensuring complete contact and effective treatment.
Implementation Method 1
The first balloon may be inflatable to a first diameter by fluid delivered to the chamber from the first fluid reservoir through the first fluid injection lumen
Implementation Method 2
the second balloon being expandable to a second diameter by liquid delivered to the interstitial space by the second fluid reservoir through second fluid injection lumen, the second diameter being greater than the first diameter
Implementation Method 3
one or more sensors on the treatment element, such as pressure sensors, and the second diameter may correspond to a diameter of a pulmonic vein ostium within the patient's heart, with the diameter of the pulmonic vein ostium being determined at least in part by signals from the one or more pressure sensors
Data Source
AI summary
A system and method for occluding a pulmonary vein. The device includes a treatment device comprising an inner balloon, an outer balloon, and a space therebetween. Delivery of fluid to the inner balloon inflates the treatment element to a first diameter. If a greater treatment element diameter is required to completely occlude a pulmonary vein, fluid is delivered to the space between the first and second balloons, which expands the second balloon and causes the treatment element to have a second diameter that is greater than the first diameter. The fluid delivered to the inner balloon and fluid delivered to the space between the balloons may be from different sources and may be delivered and exhausted independently. Once the treatment element is caused to have a diameter sufficient to completely occlude the pulmonary vein, the treatment element is activated to cool or heat ostial tissue.