Cryoballoon Fiber Sensor for Real-Time Tissue Temperature Monitoring
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Solution Overview
Problem
Current cryoablation systems lack real-time lesion formation assessment and tissue contact quality feedback during procedures, relying on secondary devices that can introduce artifacts and require additional equipment, complicating the monitoring of tissue temperature and balloon strain.
Innovation Solution
A cryoablation system incorporating fiber sensors with singlemode and multimode waveguide segments within an inflatable treatment element, such as a cryoballoon, that transmits light to a processing unit for real-time temperature and strain analysis, allowing for direct contact with tissue and eliminating the need for external thermocouples or light sources.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If thermocouples are used to monitor temperature within the cryoballoon, then temperature of the refrigerant can be measured, but the temperature of the treated tissue cannot be directly monitored
Solution Approach 1:
The patent uses the balloon wall as an intermediary medium to transmit light between the tissue and the optical sensor. The optical fiber sensor positioned within the balloon detects light that has interacted with the tissue through the balloon wall, enabling indirect but accurate tissue temperature measurement without direct contact between the sensor and tissue.
Solution Approach 2:
The patent replaces the electrical thermocouple system with an optical measurement system. Instead of using electrical contacts that can only measure refrigerant temperature, the system uses optical fibers to detect tissue temperature through light interaction, substituting a mechanical/electrical measurement approach with an optical one that provides direct tissue temperature information.
2Measurement precision
If secondary devices are used to monitor tissue temperature, then temperature assessment is possible, but additional equipment is required and artifacts may be introduced
Solution Approach 1:
The patent combines the temperature sensing function directly into the cryoballoon structure itself. The optical fiber sensor is integrated within the balloon, merging the treatment delivery system and the monitoring system into a single unified device, eliminating the need for separate secondary monitoring equipment.
Solution Approach 2:
The cryoballoon performs dual functions: delivering the cryotreatment and simultaneously monitoring the tissue temperature. The integrated optical sensor enables the balloon to self-assess the lesion formation in real-time, providing self-service monitoring capability without requiring external monitoring devices.
3Measurement precision
If FBG sensors are used for temperature measurement, then temperature can be measured, but the wavelength shift is indiscernible between temperature and strain effects
Solution Approach 1:
The patent divides the optical fiber into distinct functional segments: a first optical fiber for temperature measurement and a second optical fiber for strain measurement. This segmentation allows each fiber to be optimized for its specific measurement function and enables independent analysis of temperature and strain effects without cross-interference.
Solution Approach 2:
The patent applies different sensor characteristics to different locations and functions within the system. The temperature-sensitive optical fiber is positioned and configured specifically for temperature detection, while the strain-sensitive fiber is configured for strain detection. Each sensor has localized optimization for its specific measurement purpose, enabling clear discrimination between temperature and strain effects.
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 real-time monitoring of tissue temperature and balloon strain, improving lesion quality assessment and contact accuracy without additional devices, simplifying the system and enhancing procedural efficiency.
Implementation Method 1
at least one fiber sensor, at least a portion of each of the at least one fiber sensor being located within the inflatable treatment element and including at least one singlemode waveguide segment and at least one multimode waveguide segment
Implementation Method 2
the refrigerant vapor, which has absorbed heat from the cryoballoon-tissue interface, is drawn out of the cryoballoon
Implementation Method 3
As the refrigerant is injected into the cryoballoon, it expands into the vapor state and causes a temperature decrease
Data Source
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AI summary
A device, system, and method for identifying an area of ablated tissue and/or assessing contact between a treatment element and tissue and/or assessing occlusion of a body lumen by the treatment element. Specifically, the device, system, and method may include a device having one or more fiber sensors and a processing unit for receiving emitted and/or reflected light from tissue and making one or more determinations based on the received light regarding ablated tissue, tissue contact, and/or occlusion. Each of the fiber sensors may include at least one multi mode waveguide segment and at least one single mode waveguide segment, or each of the fiber sensors may be single mode waveguide including fiber Bragg grating for assessing strain of a treatment element by tissue contact. The processing unit may include a beam processing apparatus and a hyperspectral imaging and analysis apparatus, and may optionally include a light source.