Cryoballoon Catheter Pressure Sensing for Stable Tissue Contact
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Solution Overview
Problem
Current cardiac ablation procedures, such as pulmonary vein isolation, face challenges in maintaining consistent contact pressure between the treatment element and cardiac tissue, leading to incomplete lesions, potential complications, and the need for multiple devices due to varying tissue geometries, which increases procedural time and risk.
Innovation Solution
A treatment device with an expandable element and pressure monitoring system that continuously measures contact pressure, providing real-time feedback through contact scores and alerts to ensure adequate tissue contact and prevent undue force during inflation and ablation phases.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple catheters with different treatment element geometries are used to create different ablation patterns, then treatment versatility is improved, but device complexity and procedural time increase
Solution Approach 1:
The treatment element incorporates a shape memory alloy wire that can dynamically change its geometry in response to electrical signals. The wire transitions between different predefined shapes (e.g., circular, figure-eight, D-shaped) by applying specific voltages, allowing a single catheter to perform multiple ablation patterns without physical replacement
Solution Approach 2:
The treatment element's geometric parameters are changed by controlling the phase state and shape of the shape memory alloy wire through electrical actuation. By varying the applied voltage, the wire transforms between different configurations, enabling the same physical treatment element to adapt to different ablation requirements
2Manufacturing precision
If the treatment element is advanced deeper into the pulmonary vein to ensure adequate contact pressure, then contact quality is improved, but risk of complications increases
Solution Approach 1:
A pressure sensor is integrated into the treatment element to provide real-time feedback on the contact force applied to the pulmonary vein ostium. This feedback allows the operator to monitor and adjust the positioning to achieve adequate contact pressure without excessive force that could cause complications
Solution Approach 2:
The pressure sensor provides advance warning before dangerous levels of contact force are reached. By monitoring contact force continuously during positioning, the system alerts the operator to potential hazards before they result in complications such as cardiac tamponade or pulmonary vein stenosis
3Reliability
If the treatment element is inflated to ensure complete occlusion and adequate contact, then treatment efficacy is improved, but risk of undue force and complications increases
Solution Approach 1:
The pressure sensor continuously monitors the contact force during balloon inflation, providing real-time feedback that allows the operator to achieve complete occlusion and adequate contact while stopping before applying undue force. The feedback loop enables precise control of the inflation process
Solution Approach 2:
By monitoring contact force during the inflation process, the system provides preliminary warning of potential hazards before they result in complications. This allows the operator to adjust inflation parameters to achieve complete occlusion without exceeding safe force limits
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 treatment efficacy and patient safety by ensuring consistent balloon-tissue contact, reducing the risk of complications, and allowing a single device to perform multiple ablation patterns without displacement.
Implementation Method 1
a pressure sensor disposed therein. The console is configured to continuously monitor a degree of contact pressure between the balloon element and a target tissue area
Implementation Method 2
The refrigerant is circulated within the expandable treatment element during an ablation phase to reduce a temperature of the target tissue area to a temperature sufficient to cryoablate the target tissue area
Data Source
AI summary
A method of ablating tissue includes positioning a treatment device proximate to a target tissue area. The treatment device has an expandable treatment element. The expandable treatment element is inflated with a refrigerant during an inflation phase such that at least a portion of the expandable treatment element is in contact with the target tissue area. A first pressure measurement of the inflated expandable treatment element is recorded and compared to a predetermined pressure threshold. The refrigerant is circulated within the expandable treatment element during an ablation phase to reduce a temperature of the target tissue area to a temperature sufficient to cryoablate the target tissue area. A second pressure measurement of the expandable treatment element is recorded during the ablation phase and compared to the predetermined pressure threshold.