Cryoablation System with Multi-Sensor Temperature Feedback
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Solution Overview
Problem
Current methods for assessing lesion formation during cryoablation procedures lack real-time temperature and occlusion feedback, leading to incomplete or suboptimal lesion creation, which can result in recurrent atrial fibrillation and potential damage to non-target tissue.
Innovation Solution
A cryoablation system with multiple temperature sensors positioned within and outside the cryoballoon, along with a coolant circulation control mechanism, provides real-time temperature measurements correlated to reference data to ensure complete occlusion and optimal lesion formation without damaging non-target tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If cryoablation is performed without real-time temperature feedback, then the procedure can be performed with simpler equipment, but lesion formation quality cannot be assessed in real-time leading to incomplete or suboptimal lesions
Solution Approach 1:
The patent implements real-time temperature feedback by placing temperature sensors within the cryoballoon and target tissue to continuously monitor temperature during cryoablation. This feedback is used to adjust coolant flow and ablation duration to achieve optimal lesion formation. The system provides continuous temperature data to guide the procedure, ensuring complete occlusion and adequate lesion depth without requiring complex post-procedural imaging.
Solution Approach 2:
The patent replaces complex mechanical imaging systems and post-procedural assessment methods with direct thermal sensing and temperature-based control. Instead of using imaging techniques to assess lesion formation after the procedure, the system uses temperature sensors to directly measure and control the thermal parameters that determine lesion quality, simplifying the overall system while improving measurement precision.
2Reliability
If cryoballoon temperature is reduced to create permanent lesions, then lesion formation is improved, but risk of damage to non-target tissue increases
Solution Approach 1:
The patent uses real-time temperature feedback from sensors positioned in the cryoballoon and target tissue to monitor the ablation process. When the temperature reaches predetermined thresholds indicating adequate lesion formation, the system automatically adjusts or terminates coolant flow to prevent excessive cooling that could damage non-target tissue. This feedback control ensures reliable lesion creation while minimizing harmful effects.
Solution Approach 2:
The patent employs dynamic adjustment of ablation parameters including coolant flow rate, balloon inflation pressure, and ablation duration based on real-time temperature measurements. By changing these parameters in response to temperature feedback, the system optimizes lesion formation reliability while preventing damage to surrounding healthy tissue through controlled parameter modification.
3Loss of information
If standard imaging techniques are used to assess lesion formation, then anatomical visualization is achieved, but the procedure must be interrupted and real-time assessment is not provided
Solution Approach 1:
The patent provides continuous real-time temperature feedback during the cryoablation procedure, eliminating the need to interrupt the procedure for imaging assessments. Temperature sensors continuously monitor the ablation process and provide immediate information about lesion formation, allowing the procedure to proceed without interruption while still achieving complete lesion assessment.
Solution Approach 2:
The patent replaces imaging-based assessment methods with direct temperature measurement and monitoring. Instead of using imaging techniques that require procedure interruption, the system uses temperature sensors to continuously assess lesion formation in real-time, eliminating information loss and procedure time loss associated with imaging interruptions.
4Measurement precision
If temperature sensors are placed within target tissue to measure temperature, then accurate temperature measurement is achieved, but invasive measurement increases procedure complexity and risk
Solution Approach 1:
The patent divides the temperature measurement function into multiple segments by placing temperature sensors at different locations: within the cryoballoon, in the target tissue, and potentially in surrounding structures. This segmentation allows comprehensive temperature monitoring to assess both the cooling effect and the resulting lesion formation, achieving high measurement precision through distributed sensing rather than a single complex measurement system.
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
Enables the creation of permanent lesions in target tissue while preventing damage to surrounding tissues by adjusting coolant circulation based on real-time temperature feedback, ensuring effective electrical isolation and reducing the risk of procedure-related complications.
Implementation Method 1
coolant circulation within the occlusion element causing the occlusion element to reach temperatures sufficient to ablate tissue
Implementation Method 2
a first temperature sensor located distal of the occlusion element, and a second temperature sensor located within the occlusion element
Data Source
AI summary
A method and system for creating permanent lesions in an area of target tissue, such as tissue at or proximate a junction between a pulmonary vein and the left atrium. The method may generally include positioning a medical device in contact with a pulmonary vein ostium, ablating the tissue, and recording a plurality of temperature measurements from one or more of three temperature sensors. The device may include an occlusion element in communication with a coolant source, a first sensor located distal of the occlusion element, a second sensor located proximal of the occlusion element, and a third sensor located in the occlusion element. One or more temperature measurements may be compared with each other to assess occlusion of the pulmonary vein, and/or may be compared with a set of reference temperatures to predict a real-time temperature within the target tissue.