Balloon Shape Adjustment for Cryoablation Cooling
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Solution Overview
Problem
Cryoablation devices face challenges in maintaining cooling uniformity and efficiency, particularly in circulating coolant at high pressures and flow rates, which can be dangerous and impair catheter flexibility, and existing balloon shapes may increase the risk of vascular damage during procedures.
Innovation Solution
A cryoablation device with a cooling chamber and coolant distribution element, such as a membrane or secondary balloon, that guides coolant efficiently and allows for shape adjustment to optimize coolant delivery and occlusion, featuring a movable shaft to change the balloon's shape from an occlusion mode to an ablation mode.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If high flow rates and pressures are used to circulate coolant through the catheter, then cooling efficiency is improved, but patient safety risks and catheter structural integrity deteriorate
Solution Approach 1:
The cooling chamber is divided into multiple segments or zones with internal partitions that create multiple flow paths for the coolant. This segmentation allows the coolant to distribute more evenly across the treatment element surface, improving cooling efficiency without requiring excessively high flow rates or pressures that would compromise catheter safety.
2Productivity
If a teardrop-shaped balloon is used for optimal occlusion, then occlusion effectiveness is improved, but the risk of pulmonary vein stenosis and vascular damage increases
Solution Approach 1:
The balloon treatment element is designed with a movable shaft that enables dynamic shape adjustment between different configurations (e.g., teardrop shape for occlusion and spherical shape for ablation). This dynamic reconfigurability allows the device to optimize occlusion effectiveness when needed while minimizing vascular damage risk during ablation procedures by adopting a more uniform spherical shape that applies pressure more evenly.
3Device complexity
If a single balloon shape is used for both occlusion and ablation, then device simplicity is improved, but the risk of vascular damage increases
Solution Approach 1:
The balloon is equipped with a movable shaft mechanism that allows it to dynamically change its shape configuration. In occlusion mode, the balloon adopts a teardrop shape that effectively blocks blood flow. In ablation mode, the balloon transitions to a spherical shape that distributes pressure more evenly against the tissue, reducing the risk of vascular damage while maintaining ablation effectiveness.
4Productivity
If the distal neck of the balloon is withdrawn to allow spherical contact with the posterior wall, then ablation contact is improved, but the complexity of positioning and control increases
Solution Approach 1:
The movable shaft mechanism enables dynamic repositioning of the distal neck and adjustment of the balloon's overall shape. This allows the operator to optimize the balloon's contact with the posterior wall by adjusting the shaft position, achieving effective spherical contact for ablation while maintaining manageable positioning and control through a single actuation mechanism.
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
Enhances cooling uniformity and efficiency by reducing the need for high pressures and flow rates, while allowing the device to serve multiple purposes and minimize vascular risks through shape adjustment, ensuring effective tissue ablation and occlusion.
Implementation Method 1
The temperature of phase-change coolants is lowered via the Joule-Thomson effect, which occurs when the coolant expands within the treatment element.
Implementation Method 2
the membrane meters transit of coolant from the first portion to the second portion, and may be at least one of: gas permeable; liquid permeable; and combination thereof
Data Source
AI summary
A device, system, and method for enhancing cooling uniformity and efficiency of cryogenic fluids and providing a treatment element the shape of which can be adjusted for multiple purposes. The device may include a balloon catheter and fluid dispersion element, the fluid dispersion element directing the flow of coolant from a fluid injection element the interior wall of the balloon. The method of changing the shape of the treatment element may include retracting and extending a shaft to which the distal neck of a balloon is coupled, so that the balloon goes from a first shape to a second shape.