Pulsed-Field Ablation Control for Target Lesion Size
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Solution Overview
Problem
Existing pulsed-field ablation (PFA) technologies lack effective lesion size control, leading to inconsistent therapeutic outcomes and potential irreversible thermal damage to tissue.
Innovation Solution
A readable storage medium with a computer program that calculates theoretical ablation lesion size based on electric field energy and resistance, adjusting energy application to match a predetermined target size, and includes sensors to monitor contact force and circuit integrity for precise control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pulsed energy is applied to achieve larger ablation lesion size, then therapeutic effect is improved, but risk of irreversible thermal damage increases
Solution Approach 1:
The system continuously monitors resistance changes during ablation and uses this feedback to calculate real-time ablation lesion size. When the calculated size reaches the predetermined target size, the system automatically stops energy delivery, creating a closed-loop control that prevents over-ablation and thermal damage while ensuring adequate therapeutic effect.
Solution Approach 2:
The system changes the monitoring parameter from direct temperature measurement (which is difficult and slow) to electrical resistance measurement (which is rapid and continuous). Resistance changes correlate with tissue impedance changes during ablation, allowing real-time estimation of lesion size and enabling precise control to avoid thermal damage.
2Reliability
If ablation energy is increased to ensure complete tissue destruction, then ablation efficacy is improved, but lesion size control precision deteriorates
Solution Approach 1:
The system employs real-time feedback by continuously measuring resistance changes during energy delivery and calculating the resulting ablation lesion size. This allows dynamic adjustment of energy delivery to achieve the predetermined target size with high precision, ensuring both complete tissue destruction and accurate lesion boundaries.
Solution Approach 2:
The system pre-establishes the target ablation lesion size before treatment begins and uses this predetermined value as a stopping criterion. By planning the treatment parameters in advance based on the desired lesion size, the system ensures both adequate tissue destruction and precise size control.
3Manufacturing precision
If real-time monitoring of ablation lesion size is implemented, then treatment precision is improved, but system complexity increases
Solution Approach 1:
The system uses electrical resistance as an intermediary parameter to indirectly measure ablation lesion size. Instead of requiring complex direct imaging or temperature mapping systems, the patent leverages the readily measurable resistance change that occurs during ablation to estimate lesion dimensions, significantly reducing system complexity while maintaining precision.
Solution Approach 2:
The system replaces complex mechanical or imaging-based monitoring systems with an electrical measurement approach. By substituting direct physical measurement of lesion size with electrical resistance measurement and calculation, the system achieves precise monitoring with simpler, more integrated circuitry that is already present in ablation devices.
4Reliability
If continuous energy delivery is used to ensure complete ablation, then treatment effectiveness is improved, but treatment time increases
Solution Approach 1:
The system uses periodic or pulsed energy delivery rather than continuous energy application. By delivering energy in controlled pulses and monitoring resistance changes between pulses, the system achieves complete ablation effectiveness while allowing brief intervals that prevent excessive heat accumulation and enable real-time assessment of progress toward the target lesion size.
Solution Approach 2:
The real-time resistance monitoring provides continuous feedback on ablation progress, allowing the system to stop energy delivery as soon as the predetermined target size is achieved. This prevents unnecessary continuation of treatment beyond the required effectiveness threshold, thereby reducing overall treatment time while ensuring adequate ablation.
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 the success rate of PFA procedures by accurately predicting lesion size and preventing thermal damage, ensuring precise and safe tissue ablation.
Implementation Method 1
PFA employs trains of high voltage in very short duration electrical pulses to injure tissue by the mechanism of irreversible electroporation
Implementation Method 2
pressure sensor may be provided at a distal end of the ablation catheter, wherein the pressure sensor is configured to detect a magnitude and a direction of a contact force
Implementation Method 3
determining electric field energy and a resistance during an ablation process
Data Source
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AI summary
The present invention provides a readable storage medium, an ablation system and an electronic device. The readable storage medium having a computer program stored thereon, when the computer program is executed by a processor to perform the steps of: controlling an ablation catheter to apply pulsed energy to target tissue and determining electric field energy and resistance during ablation process; calculating a theoretical ablation lesion size according to the electric field energy and the resistance; determining whether the difference between the theoretical ablation lesion size and a target ablation lesion size is within a first predetermined range; if so, controlling the ablation catheter to stop applying pulsed energy to the target tissue; and if not, controlling the ablation catheter to continue applying pulsed energy to the target tissue, until the difference between theoretical and target ablation lesion sizes is within the first predetermined range. The present invention enables prediction of PFA efficacy, which can effectively enhance the success rate of a PFA procedure and avoid irreversible thermal damage from being caused to tissue.