Treatment device having multifunctional sensing elements and method of use
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Solution Overview
Problem
Current methods for assessing tissue contact and lesion formation during cardiac ablation procedures are inadequate, leading to challenges in determining transmurality and potential damage to non-target tissues, and methods for evaluating pulmonary vein occlusion are invasive and inaccurate.
Innovation Solution
A medical device with a treatment element and mapping elements, including sensors and a control unit that uses cryogenic fluid to form an ice ball, allowing for real-time evaluation of lesion transmurality and occlusion through impedance and temperature measurements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If impedance measurements are used to monitor tissue contact, then contact status can be assessed, but the results are inconclusive and difficult to accurately measure
Solution Approach 1:
The treatment element is divided into multiple segments with individual sensors at different locations. Each segment independently measures impedance, temperature, and pressure, allowing localized assessment of tissue contact quality rather than relying on a single aggregate measurement that produces inconclusive results.
Solution Approach 2:
The treatment element integrates multiple sensing capabilities (impedance sensors, temperature sensors, pressure sensors) into a single multifunctional device. This universal sensor system provides comprehensive tissue contact assessment through multiple measurement modalities simultaneously, resolving the inconclusiveness of single-method impedance measurements.
2Device complexity
If sensors are placed only at specific locations on the treatment element, then device complexity is reduced, but contact status cannot be evaluated at enough locations to provide complete indication
Solution Approach 1:
The treatment element is segmented into multiple zones with sensors distributed across all segments. This segmentation ensures comprehensive coverage of the treatment surface, preventing information loss about contact status at any location while maintaining manageable device complexity through modular sensor integration.
Solution Approach 2:
Sensors are arranged in multiple dimensions across the treatment element surface rather than at single-point locations. This multi-dimensional sensor distribution provides complete spatial coverage of contact status information without exponentially increasing device complexity, as the segmented modular architecture handles the additional sensing points systematically.
3Measurement precision
If pressure monitoring through guidewire lumen is used, then contact assessment is possible, but the exact location of inadequate tissue contact cannot be pinpointed in real time
Solution Approach 1:
The treatment element is divided into multiple independently monitored segments, each with its own sensors. This segmentation enables location-specific detection of inadequate tissue contact at the precise segment level rather than providing only general pressure monitoring through the guidewire lumen.
Solution Approach 2:
Multiple distributed sensors act as intermediaries between the treatment element and the control system, providing real-time location-specific contact information. These intermediary sensors enable precise pinpointing of inadequate contact locations without requiring complex image processing or indirect measurement methods.
4Measurement precision
If fluoroscopic imaging with contrast medium is used to assess PV occlusion, then occlusion status can be visualized, but patient exposure to contrast medium and radiation increases
Solution Approach 1:
The mechanical/optical imaging system (fluoroscopy with contrast medium) is replaced with an electrical sensing system. Impedance sensors and temperature sensors on the treatment element directly measure PV occlusion status through electrical and thermal properties, eliminating the need for ionizing radiation and contrast medium while maintaining assessment accuracy.
Solution Approach 2:
Impedance sensors serve as intermediaries to detect PV occlusion status by measuring electrical properties of the tissue-balloons interface. This intermediary sensing method provides accurate occlusion assessment without requiring external imaging agents or radiation, directly replacing the harmful fluoroscopic method.
5Measurement precision
If temperature sensors are used to determine ice thickness, then lesion formation can be monitored, but accurate determination is difficult and the method can only be used during injection freeze cycle
Solution Approach 1:
Multiple temperature sensors are distributed across different segments of the treatment element, enabling continuous monitoring of ice formation and thickness at multiple locations. This segmented sensor array provides accurate ice thickness determination throughout the entire treatment process, not just during the injection freeze cycle.
Solution Approach 2:
Temperature sensors provide continuous monitoring of ice ball formation and thawing throughout the entire ablation procedure. This continuous measurement capability maintains measurement precision across all phases of treatment (freezing, holding, and thawing), overcoming the limitation of being able to measure only during the injection freeze cycle.
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 precise determination of lesion transmurality and pulmonary vein occlusion without the need for auxiliary imaging, reducing patient exposure to contrast medium and radiation, and improving the effectiveness of ablation procedures.
Implementation Method 1
circulation of the cryogenic fluid within the treatment element causing formation of an ice ball between the treatment element and the area of tissue
Implementation Method 2
circulation of the cryogenic fluid within the treatment element causing formation of an ice ball
Implementation Method 3
Each of the plurality of mapping elements is configured to record from the area of tissue at least one of unipolar impedance measurements
Implementation Method 4
Each of the plurality of mapping elements includes a corresponding one of the plurality of temperature sensors
Data Source
AI summary
A device, system, and method for treating an area of tissue and evaluating lesion formation and quality. The system may include a medical device having a plurality of mapping electrodes on a treatment element, the plurality of mapping electrodes being configured to record from the area of tissue at least one of unipolar impedance measurements, bipolar impedance measurements, local electrical activity, and pace threshold measurements before, during, and after circulation of the cryogenic fluid within the treatment element. These measurements may be transmitted to a control unit having processing circuitry configured to compare pre-treatment measurements, in-treatment measurements, and/or post-treatment measurements to each other and/or to threshold values to determine occlusion and/or lesion quality, such as lesion transmurality.