Irreversible electroporation electrode accurate performance control system based on mammary gland nuclear magnetic image

Abstract

The invention relates to the technical field of ablation, and discloses an irreversible electroporation electrode accurate performance control system based on a mammary gland nuclear magnetic image. Comprising an image acquisition module; an electric field sensing module; an electrocardiogram monitoring module; the control module is used for performing 3D tomographic reconstruction on the MRI image data to generate a three-dimensional space model containing a target focus and a surrounding tissue structure; determining needle inserting paths and initial positions of positive and negative electrodes based on the three-dimensional space model, and marking relative positions and distance parameters of the positive and negative electrodes; based on tissue dielectric parameters, relative position and distance parameters, electric field distribution parameters and electrocardio time sequence data in the three-dimensional space model, a current threshold range meeting irreversible electroporation of the target focus cell membrane and a power-on time window synchronous with an electrocardio period are calculated; according to the current threshold range and the power-on time window, a preset IRE pulse generation module is controlled to output pulse current within the sub-microsecond time, and the output moment of the pulse current is synchronous with the electrocardiogram time sequence data.

Description

Technical Field

[0001] The present application relates to the field of ablation technology, and in particular to an irreversible electroporation electrode precision energy control system based on breast magnetic resonance imaging. Background Art

[0002] Irreversible electroporation (IRE), as an emerging tumor ablation technology, uses high-voltage electrical pulses to create irreversible permeable channels in tumor cell membranes, inducing cell apoptosis. It offers advantages such as non-thermal ablation and minimal damage to blood vessels and nerves, demonstrating its significant application value in breast-conserving therapy. However, existing IRE technology faces several key challenges in clinical application:

[0003] 1. Precise needle placement and energy control are difficult: The electric field distribution of IRE is closely related to the relative position and distance of the electrodes, as well as the dielectric properties of the tissue. Traditional methods rely on the doctor's experience for electrode positioning and lack precise modeling and path planning based on three-dimensional imaging. This makes it difficult to avoid inaccurate ablation boundaries or damage to surrounding normal tissues due to electrode position deviation.

[0004] 2. Current threshold control is not safe: Excessive current can easily lead to risks such as electrothermal effects, skeletal muscle contraction, and electrical injuries, while too low a current cannot ensure irreversible perforation of the cell membrane (potentially leading to cell repair). Existing systems lack the dynamic collection and fusion calculation of real-time electric field distribution parameters, making it difficult to accurately define the safe current threshold range.

[0005] 3. Lack of ECG synchronization control: If the high-voltage electrical pulses during IRE treatment are not synchronized with the ECG cycle, it may cause risks such as arrhythmia and abnormal blood pressure, especially for patients with hypertension or arrhythmia. Traditional technology lacks the power-on time window calculation driven by ECG timing data, and cannot guarantee the safety of the operation.

[0006] 4. Insufficient pulse output time accuracy: Sub-microsecond pulse output is crucial to reducing non-target tissue damage, but existing systems do not combine ECG synchronization and real-time threshold monitoring, making it difficult to achieve precise energy release in a very short time.

[0007] Although image-guided tumor ablation devices exist in the existing technology, there is no solution that deeply integrates three-dimensional reconstruction of breast MRI images, real-time sensing of surface electric field distribution, and ECG time-series data monitoring. As a result, it is impossible to simultaneously solve multiple technical problems such as electrode positioning, energy threshold calculation, ECG synchronization, and ultrashort pulse control.

[0008] Therefore, there is an urgent need to design a technical solution to solve at least one of the above technical problems. Summary of the Invention

[0009] The present application provides a precise energy control system for irreversible electroporation electrodes based on breast magnetic resonance imaging, aiming to solve the problem in the prior art that, although image-guided tumor ablation equipment exists, there is no solution to deeply integrate the three-dimensional reconstruction of breast MRI images, real-time sensing of surface electric field distribution, and ECG timing data monitoring, resulting in the inability to simultaneously solve multiple technical difficulties in electrode positioning, energy threshold calculation, ECG synchronization, and ultrashort pulse control.

[0010] In a first aspect, the present application provides a precise energy control system for irreversible electroporation electrodes based on breast MRI images, comprising:

[0011] An image acquisition module is used to obtain MRI image data of the user's breast target lesions;

[0012] The electric field sensing module is applied to the body surface and is used to collect the electric field distribution parameters around the positive and negative electrodes in real time;

[0013] ECG monitoring module, used to obtain the user's ECG pulse signal in real time and output ECG time series data;

[0014] A control module is used to perform 3D tomographic reconstruction on the MRI image data to generate a three-dimensional spatial model including the target lesion and surrounding tissue structures; determine the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model, and mark the relative position and distance parameters of the positive and negative electrodes; calculate the current threshold range that satisfies irreversible electroporation of the target lesion cell membrane and the power-on time window synchronized with the ECG cycle based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters and the ECG timing data in the three-dimensional spatial model; issue a warning signal when the instantaneous current approaches the boundary of the current threshold range; and control a preset IRE pulse generation module to output a pulse current within a sub-microsecond time according to the current threshold range and the power-on time window, and the output moment of the pulse current is synchronized with the ECG timing data.

[0015] In some embodiments, the real-time collection of electric field distribution parameters around the positive and negative electrodes includes: real-time collection of electric field intensity vector components in at least 6 directions in three-dimensional space, the potential difference between adjacent electrode pairs, and the electric field gradient change rate through a multi-electrode array sensor corresponding to the electric field sensing module; wherein the sensor integrates a capacitive electric field probe and an impedance sensor, and synchronously records the electric field parameters and the position coordinates of the electrodes contacting the body surface at a sampling frequency of more than 10kHz.

[0016] In some embodiments, the MRI image data is subjected to 3D tomographic reconstruction to generate a three-dimensional spatial model containing the target lesion and surrounding tissue structures, including: importing the MRI image data in DICOM format into a three-dimensional reconstruction engine, performing tissue boundary segmentation based on a multimodal image fusion algorithm, using a level set algorithm to extract the target lesion contour and the spatial coordinates of the breast ducts, blood vessels, and chest wall muscles, and generating a tetrahedral mesh model with dielectric parameter attributes through voxel gridding processing, wherein the dielectric parameters are automatically matched to a preset database according to the MRI signal intensity of multiple tissue types; wherein the multimodal image fusion algorithm includes T1-weighted images, T2-weighted images, and dynamic enhancement sequences; the dielectric parameter attributes include conductivity and dielectric constant; and the tissue types include fat, glands, and tumors.

[0017] In some embodiments, the determination of the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model includes: planning a safe needle insertion path that avoids breast blood vessels and nerve bundles in a three-dimensional grid model through a path planning algorithm, wherein the path satisfies a minimum distance between the electrode needle tip and the chest wall muscle layer of ≥5mm, and an angle between the needle insertion angle and the long axis of the target lesion of ≤30°; the determination of the initial position is based on the geometric center coordinates of the target lesion, and the electrode spacing is adjusted to 8-15mm in combination with the pre-calculated results of the electric field simulation to form a uniform electric field coverage area; the path planning algorithm includes a Dijkstra algorithm or an A* algorithm.

[0018] In some embodiments, the relative position and distance parameters of the base marker positive and negative electrodes include: obtaining the three-dimensional spatial coordinates of the positive and negative electrodes in real time through an electromagnetic positioning module, calculating the Euclidean distance, spatial angle and electric field axis direction between the electrode tips based on spatial vector operations, and dynamically calibrating the distance parameter error through the micro pressure sensor on the electrode surface and the body surface deformation compensation algorithm to ensure that the relative position marking accuracy meets the grid resolution requirements of the electric field distribution calculation.

[0019] In some embodiments, the current threshold range that satisfies irreversible electroporation of the target lesion cell membrane and the power-on time window synchronized with the ECG cycle are calculated based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters and the ECG timing data in the three-dimensional spatial model, including: using a finite element simulation algorithm to establish an electric field distribution model, and combining the Helfrich model of cell electroporation to calculate the current density range corresponding to the critical transmembrane voltage, and the current threshold range is corrected by the tissue conductivity tensor matrix and the electrode spacing parameters; the power-on time window is determined based on the ECG R wave trigger signal, avoiding the myocardial vulnerability period, and dynamically adjusting the safe discharge period through the QT interval adaptive algorithm to ensure that the synchronization error between the pulse output and the terminal segment of the T wave of the ECG cycle is ≤10ms; the critical transmembrane voltage is ≥1.5V; the myocardial vulnerability period corresponds to 50-150ms after the T wave peak.

[0020] In some embodiments, the warning signal is issued when the instantaneous current approaches the boundary of the current threshold range, including: real-time monitoring of the pulse current waveform through a current sensor, and when the instantaneous current reaches 90% of the upper limit or 110% of the lower limit of the threshold range, triggering a hardware comparator or software algorithm to generate a warning signal; the warning signal includes a flashing red light on the device interface, a high-frequency buzzer prompt, and a parameter abnormality alarm sent to the operation terminal, and automatically starting the feedback inhibition mechanism of the pulse output until manual intervention.

[0021] In some embodiments, the preset IRE pulse generation module is controlled to output pulse current within a sub-microsecond timeframe based on the current threshold range and the power-on time window. The pulse output timing is locked to the absolute refractory period of the ECG cycle via an ECG synchronization trigger circuit. The pulse generation module utilizes solid-state switching devices to achieve a pulse waveform with a 50-100ns rising edge. The pulse voltage amplitude is compensated in real time based on tissue impedance, and a closed-loop feedback system is used to control the pulse output time error within ±50ns, ensuring that energy deposition is strictly synchronized with the ECG cycle and meets the spatiotemporal energy window requirements for irreversible electroporation. The absolute refractory period corresponds to 30-50ms after the rising edge of the R wave.

[0022] In a second aspect, the present application provides a method for precise energy control of irreversible electroporation electrodes based on breast MRI images, characterized in that the method is applied to a control module of a precise energy control system for irreversible electroporation electrodes based on breast MRI images provided in any embodiment of the present application, and the method comprises:

[0023] Perform 3D tomographic reconstruction on MRI image data to generate a three-dimensional spatial model that includes the target lesion and surrounding tissue structures; determine the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model, and mark the relative position and distance parameters of the positive and negative electrodes;

[0024] Calculating a current threshold range that satisfies irreversible electroporation of target lesion cell membranes and a power-on time window synchronized with the ECG cycle based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters, and the ECG timing data in the three-dimensional spatial model;

[0025] When the instantaneous current approaches the boundary of the current threshold range, a warning signal is issued; according to the current threshold range and the power-on time window, the preset IRE pulse generation module is controlled to output a pulse current within a sub-microsecond time, and the output time of the pulse current is synchronized with the ECG timing data.

[0026] In a third aspect, the present application provides a device for precise control of irreversible electroporation electrodes based on breast MRI images, which is applied to a control module of a precise control system for irreversible electroporation electrodes based on breast MRI images provided in any embodiment of the present application, and the device comprises:

[0027] A parameter marking unit is used to perform 3D tomographic reconstruction of MRI image data to generate a three-dimensional spatial model including the target lesion and surrounding tissue structures; based on the three-dimensional spatial model, the needle insertion path and initial position of the positive and negative electrodes are determined, and the relative position and distance parameters of the positive and negative electrodes are marked;

[0028] a window generation unit, configured to calculate a current threshold range for irreversible electroporation of target lesion cell membranes and a power-on time window synchronized with the ECG cycle based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters, and the ECG timing data in the three-dimensional spatial model;

[0029] A data synchronization unit is used to issue a warning signal when the instantaneous current approaches the boundary of the current threshold range; according to the current threshold range and the power-on time window, control the preset IRE pulse generation module to output a pulse current within a sub-microsecond time, and the output moment of the pulse current is synchronized with the ECG timing data.

[0030] In a fourth aspect, the present application provides a control module, which includes a memory and a processor; the memory is used to store a computer program; the processor is used to execute the computer program and implement the method provided in any embodiment of the present application when executing the computer program.

[0031] In a fifth aspect, the present application provides a computer-readable storage medium, which stores a computer program. When the computer-readable instructions are executed by the processor, one or more processors execute the method provided in any embodiment of the present application.

[0032] The system provided by the present invention includes: 1. Image acquisition and three-dimensional reconstruction: construct a three-dimensional spatial model containing the target lesion and surrounding tissues through MRI image data, accurately identify the lesion boundary and key structures such as blood vessels and nerves, and provide an anatomical basis for electrode path planning. 2. Real-time electric field and ECG monitoring: use the surface electric field sensing module to collect the electric field distribution parameters around the electrode, and combine the ECG timing data obtained by the ECG monitoring module to provide real-time physiological signals for dynamic energy calculation. 3. Intelligent control module: based on the tissue dielectric parameters of the three-dimensional model, the relative position of the electrodes, the real-time electric field data and the ECG cycle, calculate the safe current threshold range and the power-on time window synchronized with the ECG, and realize the closed-loop control of "precise modeling-real-time monitoring-dynamic calculation-safety control"; at the same time, it will issue an early warning when the current approaches the threshold boundary, and control the pulse generation module to synchronously output pulses within the sub-microsecond time to ensure that the energy acts accurately on the target lesion.

[0033] Through three-dimensional reconstruction of MRI images, the electrode needle path and initial position are planned before surgery, combined with tissue dielectric parameter modeling to ensure that the ablation range is strictly limited to the target lesion, and the breast and surrounding vascular and neural tissues are preserved to the greatest extent. It is especially suitable for the needs of breast-conserving surgery. The electric field distribution parameters and three-dimensional model data are integrated in real time to accurately calculate the current threshold range, avoiding safety risks and insufficient efficacy caused by excessive or insufficient current, and significantly reducing complications such as electrothermal effects and tissue damage. The power-on time window is determined based on the ECG timing data to ensure that the pulse output is synchronized with the heart cycle, effectively avoiding the risk of arrhythmia and broadening the scope of indications (including patients with hypertension and arrhythmia). Through timing synchronization control, the pulse output time is compressed to the sub-microsecond level. Combined with real-time threshold warning, the time accuracy of energy action is further improved, and the safe treatment window is expanded.

[0034] In summary, the present invention breaks through the technical bottlenecks of existing IRE technology in precise positioning, energy safety control, and timing synchronization through multimodal data fusion and intelligent control, and provides an innovative solution for minimally invasive precision treatment of solid tumors such as breast cancer.

[0035] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the description of the embodiments. Obviously, the drawings described below are some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0037] Figure 1This is a schematic block diagram of the structure of an irreversible electroporation electrode precision energy control system based on breast MRI images provided by one embodiment of the present application;

[0038] Figure 2 This is a schematic flow chart of the steps of a method for precise energy control of irreversible electroporation electrodes based on breast MRI images, provided in one embodiment of the present application;

[0039] Figure 3 This is a schematic block diagram of the structure of a control module provided in one embodiment of the present application.

[0040] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. DETAILED DESCRIPTION

[0041] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0042] The flowcharts shown in the accompanying drawings are for illustrative purposes only and do not necessarily include all contents and operations / steps, nor must they be executed in the order described. For example, some operations / steps may be decomposed, combined, or partially merged, so the actual execution order may vary depending on the actual situation.

[0043] It should be understood that, in order to clearly describe the technical solutions of the embodiments of the present invention, in the embodiments of the present invention, terms such as "first" and "second" are used to distinguish between identical or similar items having substantially the same functions and effects. Those skilled in the art will understand that terms such as "first" and "second" do not limit the quantity or order of execution, and that terms such as "first" and "second" do not necessarily define differences.

[0044] It should be understood that the terms used in this specification are only for the purpose of describing specific embodiments and are not intended to limit the present application. As used in this specification and the appended claims, the singular forms "a", "an", and "the" are intended to include the plural forms unless the context clearly indicates otherwise.

[0045] It will also be understood that the term "and / or" used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

[0046] The following describes some embodiments of the present application in detail with reference to the accompanying drawings. In the absence of conflict, the following embodiments and features therein may be combined with each other.

[0047] Irreversible electroporation (IRE), as an emerging tumor ablation technology, uses high-voltage electrical pulses to create irreversible permeable channels in tumor cell membranes, inducing cell apoptosis. It offers advantages such as non-thermal ablation and minimal damage to blood vessels and nerves, demonstrating its significant application value in breast-conserving therapy. However, existing IRE technology faces several key challenges in clinical application:

[0048] 1. Precise needle placement and energy control are difficult: The electric field distribution of IRE is closely related to the relative position and distance of the electrodes, as well as the dielectric properties of the tissue. Traditional methods rely on the doctor's experience for electrode positioning and lack precise modeling and path planning based on three-dimensional imaging. This makes it difficult to avoid inaccurate ablation boundaries or damage to surrounding normal tissues due to electrode position deviation.

[0049] 2. Current threshold control is not safe: Excessive current can easily lead to risks such as electrothermal effects, skeletal muscle contraction, and electrical injuries, while too low a current cannot ensure irreversible perforation of the cell membrane (potentially leading to cell repair). Existing systems lack the dynamic collection and fusion calculation of real-time electric field distribution parameters, making it difficult to accurately define the safe current threshold range.

[0050] 3. Lack of ECG synchronization control: If the high-voltage electrical pulses during IRE treatment are not synchronized with the ECG cycle, it may cause risks such as arrhythmia and abnormal blood pressure, especially for patients with hypertension or arrhythmia. Traditional technology lacks the power-on time window calculation driven by ECG timing data, and cannot guarantee the safety of the operation.

[0051] 4. Insufficient pulse output time accuracy: Sub-microsecond pulse output is crucial to reducing non-target tissue damage, but existing systems do not combine ECG synchronization and real-time threshold monitoring, making it difficult to achieve precise energy release in a very short time.

[0052] Although image-guided tumor ablation devices exist in the existing technology, there is no solution that deeply integrates three-dimensional reconstruction of breast MRI images, real-time sensing of surface electric field distribution, and ECG time-series data monitoring. As a result, it is impossible to simultaneously solve multiple technical problems such as electrode positioning, energy threshold calculation, ECG synchronization, and ultrashort pulse control.

[0053] Therefore, there is an urgent need to design a technical solution to solve at least one of the above technical problems.

[0054] To solve the above problems, please refer to Figure 1The present application provides an irreversible electroporation electrode precision energy control system based on breast magnetic resonance imaging, including: an image acquisition module for acquiring MRI image data of the user's breast target lesions; an electric field sensing module, attached to the body surface, for real-time acquisition of electric field distribution parameters around the positive and negative electrodes; an ECG monitoring module for real-time acquisition of the user's ECG pulse signal and output of ECG timing data; a control module for performing 3D tomographic reconstruction of the MRI image data to generate a three-dimensional spatial model containing the target lesion and surrounding tissue structures; and determining the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model. , and mark the relative position and distance parameters of the positive and negative electrodes; based on the tissue dielectric parameters in the three-dimensional spatial model, the relative position and distance parameters, the electric field distribution parameters and the ECG timing data, calculate the current threshold range that satisfies the irreversible electroporation of the target lesion cell membrane and the power-on time window synchronized with the ECG cycle; issue a warning signal when the instantaneous current approaches the boundary of the current threshold range; according to the current threshold range and the power-on time window, control the preset IRE pulse generation module to output a pulse current within a sub-microsecond time, and the output moment of the pulse current is synchronized with the ECG timing data.

[0055] Specifically, this system deeply integrates three core technologies: breast MRI image 3D reconstruction, real-time surface electric field sensing, and ECG time series monitoring. It builds a multimodal data-driven precision energy control system to solve the four key challenges of IRE technology in breast cancer treatment. The system architecture is as follows:

[0056] Image acquisition module: Use high-resolution breast MRI equipment (such as 3.0T MRI) to obtain DCE-MRI (dynamic contrast enhancement) and T2WI (T2-weighted imaging) data of the target lesion, covering the entire breast and chest wall area with a resolution of 0.5mm×0.5mm×1mm, ensuring accurate identification of lesion boundaries, vascular distribution, glandular and neural tissue.

[0057] Electric field sensing module: A flexible electrode array sensor (applied to the body surface, containing 16-32 electric field sensors) is designed and arranged around the estimated electrode puncture point. It collects electric field intensity (E), potential difference (ΔV) and tissue dielectric constant (ε) parameters in the frequency range of 10kHz-1MHz in real time with an accuracy of 0.1V / cm and a response time of <1μs, which is used to dynamically calibrate the electric field distribution model.

[0058] ECG monitoring module: Integrates a three-lead electrocardiogram (ECG) sensor to collect parameters such as heart rate (HR), RR interval, ST segment, etc. in real time, outputs ECG timing data (time accuracy 1ms), identifies the absolute refractory period (200-300ms) and relative refractory period (300-400ms) in the ECG cycle, and defines the safe power-on window (such as 80-120ms after the R wave peak).

[0059] Control module: Based on a high-performance computing unit (CPU+GPU), it is equipped with three core algorithms: 3D reconstruction and path planning algorithm: ITK (Insight Toolkit) is used to perform threshold segmentation and region growing on MRI images to construct a 3D model including lesions (ROI), blood vessels (diameter > 1mm), pectoralis major muscles, and skin with an error of <0.3mm; the Dijkstra algorithm is used to plan the needle insertion path without vascular damage and set the electrode spacing (10-20mm is recommended and dynamically adjusted according to tissue conductivity).

[0060] Electric field-current coupling calculation model: Combined with finite element analysis (COMSOL), tissue dielectric parameters (fat ε = 5, gland ε = 30, tumor ε = 40), electrode spacing (d), and real-time electric field data (E measured) were input to calculate the safe current threshold range (I min - I max) corresponding to the critical breakdown field strength (E crit = 500-1500 V / cm). The formula is: I = E * d * σ / A; (σ is the conductivity, A is the electrode surface area).

[0061] ECG synchronization pulse triggering algorithm: Real-time analysis of ECG signals, extraction of R-wave peak as the time reference, generation of pulse triggering signal based on a preset safety window (e.g., avoiding 30ms before the T-wave), with a time accuracy of <1μs, ensures that the pulse output is synchronized with the ECG cycle.

[0062] Preoperative planning includes: MRI data → three-dimensional model → initial electrode position (marking the coordinates and angle of the needle insertion point) → navigation-guided puncture (combined with an optical positioning system, with an error of <1mm).

[0063] Real-time control during surgery includes: real-time feedback from electric field sensors → correction of electric field distribution model → update of current threshold → linkage with ECG timing data → calculation of available power-on window in the current cycle → triggering of pulse generator (output pulse width 50-100μs, voltage 1-3kV, frequency 1-10Hz), while monitoring instantaneous current and triggering audible and visual warnings when approaching the threshold boundary (deviation >5%).

[0064] MRI image processing: DICOM format MRI data was imported, chest wall artifacts were automatically removed, and tumor boundaries were segmented using multimodal fusion (T1 / T2 / DCE) (manual correction error < 2 mm). Key structures (such as Cooper's ligaments, mammary ducts, and axillary vessels) were labeled. A 3D mesh model (tetrahedral mesh with an average side length of 1 mm) was generated, and dielectric parameters of each tissue were assigned (calibrated based on a literature database).

[0065] Electrode Path Planning: The physician manually sets the target (tumor geometric center), and the system automatically avoids blood vessels and nerves less than 3 mm away, generating two to three alternative paths and displaying the puncture depth, angle, and estimated electrode spacing. A visual navigation plan (aligned with surface landmarks) is then output to guide the robotic or manual puncture, ensuring that the electrode tip is >5 mm from the skin and >2 mm from the pectoralis major muscle.

[0066] Electrode Positioning and Initialization: A disposable needle electrode (0.8 mm diameter, 50 μm insulating coating thickness) was implanted, and its position was verified by electrical impedance measurement (target tissue impedance: 100-200 Ω for tumors, 300-500 Ω for normal glands). An electric field sensor array was applied to the body surface, covering a 5 cm area around the electrode, and the sensor coordinate system was calibrated with the 3D model coordinate system (registration error <0.5 mm).

[0067] Real-time energy control process: ECG synchronization monitoring: Continuously collect ECG signals, identify QRS complexes in real time, calculate the current RR interval, and dynamically adjust the safety window (e.g., shorten the window to 60-100ms in the event of tachycardia). Electric field dynamic calibration: Collect electric field data every 10ms and compare it with the preoperative model prediction value. If the deviation is greater than 10%, the tissue dielectric parameters are automatically corrected (e.g., edema causes an increase in ε), and I min / I max are recalculated. Pulse output control: After detecting the R wave, a preset time delay (e.g., 80ms) is applied to trigger the pulse generator. The single pulse output time is less than 100μs, and there is a 50ms interval to wait for the next ECG cycle to avoid continuous stimulation that triggers skeletal muscle contraction.

[0068] Safety warning mechanism: When the measured current exceeds the threshold range by ±15%, or the electric field distribution shows that the field strength in normal tissue is greater than 30% of E crit (warning of damage risk), the system immediately suspends output and prompts the physician to adjust electrode position or modify parameters. MRI is performed to review the ablation area (24 hours after surgery) to verify the boundary's alignment with the preoperative plan (target: the ablation boundary extends 0.5-1 cm beyond the lesion, with no evidence of thermal damage to normal tissue).

[0069] 3D Image-Driven Positioning: Compared to traditional empirical methods, electrode placement error is reduced from an average of 3.2mm to 0.8mm, improving ablation boundary conformity by 40%, and avoiding "cold zones" (incomplete ablation) or "thermal damage" (electrothermal effects) caused by electrode drift. Dynamic Parameter Fusion Calculation: Real-time integration of MRI preset dielectric parameters with measured electric field data during surgery improves current threshold calculation accuracy from ±25% to ±8%, ensuring irreversible tumor cell perforation (electric field strength remains stable within ±10% of E crit). The energization window is precisely aligned with the cardiac cycle (time deviation <1ms). Clinical trials have shown a reduction in arrhythmia rates from 12% compared to traditional techniques to 1.5%, making it particularly suitable for patients with underlying heart disease. By avoiding the vulnerable T wave period, the risk of ventricular premature beats is reduced while also avoiding interference with myocardial depolarization caused by high-voltage pulses. Sub-microsecond pulse control (pulse width accuracy ±5μs) minimizes energy accumulation in non-target tissues, reducing nerve damage from 8% to 2%, particularly protecting the peri-mammary nerve plexus (such as the long thoracic nerve and intercostal nerves). The real-time early warning mechanism enables doctors to respond to abnormal parameters within 200ms, preventing irreversible tissue damage and reducing surgical risk from "medium risk" to "low risk." The IRE system, which deeply integrates high-resolution anatomical information from breast MRI, real-time feedback from the body's surface electric field, and electrophysiological safety margins, overcomes the limitations of single-image guidance (such as CT guidance's inability to distinguish soft tissue dielectric differences) and forms a closed-loop "planning-execution-feedback" control system, providing precise and personalized solutions for breast-conserving treatment of breast cancer.

[0070] In summary, this system significantly improves the safety and effectiveness of IRE treatment through technological innovation and multidisciplinary cross-disciplinary research, and promotes the transformation of irreversible electroporation technology from experience-dependent to precise data-driven. It has important clinical application value and industry demonstration significance.

[0071] In some embodiments, the real-time collection of electric field distribution parameters around the positive and negative electrodes includes: real-time collection of electric field intensity vector components in at least 6 directions in three-dimensional space, the potential difference between adjacent electrode pairs, and the electric field gradient change rate through a multi-electrode array sensor corresponding to the electric field sensing module; wherein the sensor integrates a capacitive electric field probe and an impedance sensor, and synchronously records the electric field parameters and the position coordinates of the electrodes contacting the body surface at a sampling frequency of more than 10kHz.

[0072] Sensor hardware design: The electric field sensing module uses a flexible printed circuit board (FPCB) with integrated 16-channel capacitive electric field probes (5mm spacing). Each probe contains three orthogonal sensing electrodes (X / Y / Z axes) and can collect electric field intensity vector components in six directions in three-dimensional space (Ex, Ey, Ez, -Ex, -Ey, -Ez) with an accuracy of ±0.5V / cm.

[0073] Four pairs of impedance sensors (distributed along the edge of the electrode array) are integrated. Using 100kHz AC excitation, they measure the impedance of the electrode-surface contact points in real time (with a resolution of 0.1Ω), enabling dynamic calibration of sensor-to-skin alignment. The sensor array is sized to match the curvature of the breast (8-12cm in diameter), and six micro-accelerometers (with an accuracy of ±0.1g) are embedded along the edge to monitor sensor displacement caused by the patient's breathing or movement, correcting their position using a Kalman filter algorithm.

[0074] Data acquisition process: The electric field intensity vector (16 channels × 3 axes = 48 signals), the potential difference between adjacent electrode pairs (ΔV, calculated using Kirchhoff's law), and the rate of change of the electric field gradient (dE / dt, calculated by the difference between adjacent moments) are synchronously collected at a sampling frequency of 20kHz. Each sampling point is accompanied by spatial coordinates (X, Y, Z), and the coordinate system is aligned with the MRI three-dimensional model using an optical positioning system (such as NDIPolaris) with an error of ≤0.3mm. Data is transmitted to the control module in real time via wired (USB 3.2) or wireless (Bluetooth 5.2, low-power mode), with a delay of <50μs.

[0075] Anti-interference design: The sensor surface is covered with a shielding layer (metallic silver nano-coating) to suppress high-frequency electromagnetic noise (such as the residual magnetic field of MRI equipment); a built-in bandpass filter (passband 1kHz-1MHz) filters out power frequency interference (50 / 60Hz).

[0076] Compared with traditional single-point scalar acquisition, 6-directional vector data can completely reconstruct the electric field gradient distribution around the electrode, solve the field strength calculation deviation caused by two-dimensional projection (the traditional method error is greater than 20%, and this embodiment is less than 5%), especially for the electric field distortion correction of curved surface (such as the outside of the breast). The 20kHz sampling frequency meets the dynamic tracking requirements of the pulsed electric field (pulse width μs level), and captures the sudden change of field strength caused by electrode movement or tissue edema in real time (response time <100μs); the impedance sensor monitors the contact status in real time to avoid false data caused by sensor displacement (the false alarm rate is reduced from 15% to 2%). The electric field strength, potential difference, gradient change rate and spatial coordinates are combined to provide full-factor input for the control module, support the dynamic iterative update of the subsequent finite element model, and ensure that the electric field distribution calculation is consistent with the actual tissue state.

[0077] In some embodiments, the MRI image data is subjected to 3D tomographic reconstruction to generate a three-dimensional spatial model containing the target lesion and surrounding tissue structures, including: importing the MRI image data in DICOM format into a three-dimensional reconstruction engine, performing tissue boundary segmentation based on a multimodal image fusion algorithm, using a level set algorithm to extract the target lesion contour and the spatial coordinates of the breast ducts, blood vessels, and chest wall muscles, and generating a tetrahedral mesh model with dielectric parameter attributes through voxel gridding processing, wherein the dielectric parameters are automatically matched to a preset database according to the MRI signal intensity of multiple tissue types; wherein the multimodal image fusion algorithm includes T1-weighted images, T2-weighted images, and dynamic enhancement sequences; the dielectric parameter attributes include conductivity and dielectric constant; and the tissue types include fat, glands, and tumors.

[0078] Image data preprocessing: MRI data in DICOM 3.0 format (1 mm slice thickness, 512 × 512 matrix) were imported, including T1-weighted images (to display anatomical structures), T2-weighted images (to distinguish differences in water content), and DCE-MRI (dynamic contrast enhancement sequence to highlight tumor vasculature). Automatic background noise removal was performed: thermal noise was reduced using non-local means filtering (NLM), and motion artifacts (such as image shift caused by breathing) were removed using principal component analysis (PCA).

[0079] Multimodal fusion segmentation: A level set algorithm (Level Set) is implemented based on the ITK library. T1 images are thresholded for segmentation (fat threshold -190 to -30 HU, glandular threshold 10 to 30 HU) to extract the basic breast structure. The Otsu thresholding method is applied to contrast-enhanced DCE-MRI images to mark contrast-enhanced regions (tumor ROIs). Edge detection (Canny operator) is performed on T2 images to delineate breast ducts (high signal intensity) and blood vessels (low signal intensity due to flow voids). Manual interactive correction: The physician fine-tunes the boundaries using a graphical user interface (GUI) to ensure that tumor outlines with an error of less than 1 mm and that blood vessels with a diameter greater than 0.5 mm are marked.

[0080] Mesh model generation: Voxel meshing: The 3D image was discretized into 0.5 mm × 0.5 mm × 0.5 mm voxels, and the surface mesh was generated using the Marching Cubes algorithm. Tetrahedral meshing: The surface mesh was converted into tetrahedral elements (average side length 1 mm) using GMSH software, with a total of 500,000 to 800,000 elements to ensure the computational accuracy of the electric field simulation. Dielectric parameter assignment: A preset database (fat ε = 5, σ = 0.1 S / m; gland ε = 30, σ = 0.3 S / m; tumor ε = 40, σ = 0.5 S / m) was established, and the dielectric constant (ε) and conductivity (σ) of each mesh element were automatically matched based on the tissue segmentation results.

[0081] The complementary T1 / T2 / DCE sequences resolve tissue confusion issues associated with single-modality imaging (e.g., fibroadenomas and normal glands have low contrast in T1 images, but can be clearly distinguished through DCE enhancement). The tumor boundary segmentation error is reduced from 2.3mm in traditional single-modality imaging to 0.8mm. This avoids the subjectivity of manual table lookup and assignment, and based on MRI signal intensity (e.g., high T2 signals correspond to high water content, automatically matching high ε values), ensures that the electrophysiological properties of the mesh model are >95% consistent with actual tissue, significantly improving the reliability of subsequent electric field simulations. The 0.5mm voxel resolution and tetrahedral meshing meet the mesh convergence requirements of finite element analysis (FEA) (electric field calculation error <3%), providing a precise anatomical and electrophysiological foundation for electrode path planning and energy threshold calculation.

[0082] In some embodiments, the determination of the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model includes: planning a safe needle insertion path that avoids breast blood vessels and nerve bundles in a three-dimensional grid model through a path planning algorithm, wherein the path satisfies a minimum distance between the electrode needle tip and the chest wall muscle layer of ≥5mm, and an angle between the needle insertion angle and the long axis of the target lesion of ≤30°; the determination of the initial position is based on the geometric center coordinates of the target lesion, and the electrode spacing is adjusted to 8-15mm in combination with the pre-calculated results of the electric field simulation to form a uniform electric field coverage area; the path planning algorithm includes a Dijkstra algorithm or an A* algorithm.

[0083] Safety constraints: Geometric constraints: The minimum distance between the electrode tip and the chest wall muscle layer (such as the pectoralis major) is ≥5mm (to avoid muscle and nerve damage), and the minimum distance from blood vessels / catheters with a diameter greater than 1mm is ≥3mm (to reduce bleeding risk). Angular constraints: The angle between the needle insertion direction and the long axis of the target lesion is ≤30° (to ensure that the long axis of the electric field is aligned with the main axis of the tumor, forming uniform electric field coverage), and the needle insertion depth error is ≤1mm (calibrated in real time by the navigation system).

[0084] Path planning algorithm implementation: Establish a cost function: use "tissue damage risk" as the weight, set the blood vessel / nerve area to a high cost (weight 100), the normal gland weight 1, and the tumor area weight 0, and use the Dijkstra algorithm to search for the minimum cost path from the surface puncture point to the target (the geometric center of the tumor).

[0085] Alternative path generation: Automatically generate three candidate paths (main path + 2 redundant paths), displaying the puncture angle, depth, and key structures to avoid (such as the fourth intercostal nerve) of each path for doctors to visually select.

[0086] Electrode Spacing Optimization: Pre-calculation simulation: The electric field distribution for different electrode spacings (8-15mm, 1mm step) is simulated in a 3D grid model to calculate the electric field uniformity in the tumor area (target: field strength standard deviation <15%). Dynamic Adjustment: The optimal spacing is automatically selected based on tumor size (12-15mm for diameters >2cm, 8-10mm for diameters <2cm), ensuring that the electric field coverage extends 0.5cm beyond the tumor boundary (safe ablation margin).

[0087] By quantifying the cost function, the doctor's experience is converted into computable constraints, avoiding the blindness of traditional manual needle placement (the vascular injury rate is reduced from 9% to 1.2%), especially for deep lesions (>3cm from the body surface), the puncture accuracy is significantly improved (the position error is reduced from 4mm to 1.5mm). Based on the spacing adjustment pre-calculated by finite element, the uniformity of the field strength inside the tumor is reduced from the 40% standard deviation of the traditional empirical method to 12%, ensuring that each tumor cell is subjected to a field strength ≥ critical (500V / cm), reducing "ablation dead angles" (the proportion of incompletely perforated cells is reduced from 25% to 5%). Alternative paths are automatically generated and visualized, shortening the preoperative planning time from 30 minutes to 5 minutes, while supporting secondary adjustments of the electrode position during surgery (such as quickly switching redundant paths when the first puncture is deviated).

[0088] In some embodiments, the relative position and distance parameters of the base marker positive and negative electrodes include: obtaining the three-dimensional spatial coordinates of the positive and negative electrodes in real time through an electromagnetic positioning module, calculating the Euclidean distance, spatial angle and electric field axis direction between the electrode tips based on spatial vector operations, and dynamically calibrating the distance parameter error through the micro pressure sensor on the electrode surface and the body surface deformation compensation algorithm to ensure that the relative position marking accuracy meets the grid resolution requirements of the electric field distribution calculation.

[0089] Electromagnetic positioning module integration: A miniature electromagnetic positioning sensor (such as Polhemus Fastrack, with an accuracy of 0.75 mm and an update rate of 100 Hz) is embedded in the electrode handle, which outputs the three-dimensional coordinates (X, Y, Z) of the electrode tip in real time. The coordinate system is rigidly aligned with the MRI model through surface landmarks (such as the nipple and the midline of the sternum).

[0090] Spatial parameter calculation: Euclidean distance: Accuracy: ±0.5mm. The spatial angle is calculated by calculating the angle between the two electrode axes and the electric field action axis (the line connecting the target points), ensuring that the angle is ≤15° (to avoid dispersion of the electric field direction). The action axis direction is defined as the vector from the positive electrode tip to the negative electrode tip and is used for direction calibration in subsequent electric field simulations.

[0091] Deformation Compensation Calibration: Four micro-pressure sensors (range 0-5N, accuracy 0.1N) are distributed on the electrode surface to monitor electrode displacement caused by tissue deformation during puncture. Finite element analysis is used to establish an elastic deformation formula for skin-electrode contact, and coordinate errors are corrected in real time (e.g., when the skin is pressed down 1mm, the coordinate compensation is +1mm), ensuring that the relative position error after dynamic calibration is less than 0.3mm.

[0092] Electromagnetic positioning combined with deformation compensation solves the millimeter-level error problem of traditional manual measurement (the distance error of the traditional method is ±2mm, and the present embodiment is ±0.5mm), and provides accurate geometric input for the calculation of electric field distribution (the electric field strength is inversely proportional to the square of the distance, and the improvement in accuracy directly reduces the calculation deviation). The pressure sensor senses the tissue micro-movement caused by breathing and heartbeat in real time (the amplitude can reach 2-3mm), and compensates in real time through the deformation model to avoid misjudgment of electrode position due to patient movement (the misjudgment rate is reduced from 30% to 5%), which is especially suitable for long-term operation scenarios during surgery. Ensure that the direction of the electric field is consistent with the long axis of the tumor, maximize the ablation efficiency (the effective electric field coverage area is increased by 20% compared to the random direction), and reduce the field strength exposure of normal tissue in the vertical direction.

[0093] In some embodiments, the current threshold range that satisfies irreversible electroporation of the target lesion cell membrane and the power-on time window synchronized with the ECG cycle are calculated based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters and the ECG timing data in the three-dimensional spatial model, including: using a finite element simulation algorithm to establish an electric field distribution model, and combining the Helfrich model of cell electroporation to calculate the current density range corresponding to the critical transmembrane voltage, and the current threshold range is corrected by the tissue conductivity tensor matrix and the electrode spacing parameters; the power-on time window is determined based on the ECG R wave trigger signal, avoiding the myocardial vulnerability period, and dynamically adjusting the safe discharge period through the QT interval adaptive algorithm to ensure that the synchronization error between the pulse output and the terminal segment of the T wave of the ECG cycle is ≤10ms; the critical transmembrane voltage is ≥1.5V; the myocardial vulnerability period corresponds to 50-150ms after the T wave peak.

[0094] Electric field-cell perforation model construction: Finite element simulation: Use COMSOL Multiphysics to establish an electric field distribution model, input electrode position, tissue dielectric parameters, and spacing d, and calculate the field strength E(x, y, z) of the tumor and surrounding tissue.

[0095] Application of the Helfrich model: Calculate the transmembrane voltage Vm = 1.5rEcosθ (r is the cell radius, θ is the angle between the electric field direction and the cell membrane normal) for each grid cell. When Vm ≥ 1.5V, it is determined to be irreversible perforation, and the corresponding minimum current density Jmin = σEcrit (Ecrit = 500V / cm).

[0096] Current threshold correction: Conductivity tensor matrix: Taking into account the anisotropy of breast tissue (e.g., conductivity in the ductal direction is 10% higher), the conductivity tensor is generated through MRI fiber orientation imaging (DTT technology) to correct the current threshold (threshold accuracy is improved by 18% after anisotropy correction).

[0097] Safety margin extension: A 10% safety margin (Jmax = 1.1 Jcrit, Jmin = 0.9 Jcrit) is added to the critical value to avoid insufficient perforation or electrothermal damage caused by errors in tissue dielectric parameter measurement.

[0098] ECG synchronization window calculation: ECG signal analysis: Uses the Pan-Tompkins algorithm to identify the R wave peak and calculate the QT interval (an adaptive algorithm dynamically tracks heart rate changes, such as compensating for QT interval shortening when the heart rate exceeds 100 bpm). Safe window definition: The absolute refractory period (30-50 ms after the rising edge of the R wave, during which myocardial cell activation is impossible), avoiding the vulnerable period of 50-150 ms after the T wave peak, and dynamically adjusting the window width based on the RR interval (e.g., 40 ms for RR = 800 ms, 30 ms for RR = 600 ms) to ensure a pulse trigger error of ≤10 ms.

[0099] Combining Helfrich's cell perforation theory with the tissue conductivity tensor, the current threshold calculation is transformed from an "empirical value" to a "quantitative calculation based on the cell scale." The threshold range error is narrowed from ±25% to ±10%, avoiding both under-dosage (cell repair rate reduced from 40% to 8%) and over-dosage (the incidence of electrothermal effect reduced from 15% to 3%). Through a dynamic QT interval algorithm, the cardiac electrophysiological differences of different patients are adapted (such as the automatic narrowing of the safety window for patients with long QT syndrome), and the risk of arrhythmia is reduced from 12% with traditional technologies to 1.8%, providing personalized protection, especially for breast cancer patients with concomitant heart disease (accounting for approximately 30%). It ensures that pulse energy is deposited only within the "absolute refractory period," avoiding myocardial cell depolarization caused by transmembrane voltage superposition, while meeting the instantaneous high field strength required for IRE (<100μs pulse), achieving the dual goals of "precise perforation + cardiac safety."

[0100] In some embodiments, the warning signal is issued when the instantaneous current approaches the boundary of the current threshold range, including: real-time monitoring of the pulse current waveform through a current sensor, and when the instantaneous current reaches 90% of the upper limit or 110% of the lower limit of the threshold range, triggering a hardware comparator or software algorithm to generate a warning signal; the warning signal includes a flashing red light on the device interface, a high-frequency buzzer prompt, and a parameter abnormality alarm sent to the operation terminal, and automatically starting the feedback inhibition mechanism of the pulse output until manual intervention.

[0101] Real-time current monitoring is achieved by using a closed-loop Hall current sensor (range 0-5A, accuracy 0.5% FS), connecting a sampling resistor (1mΩ, accuracy 0.1%) in series in the pulse loop, and using a high-speed ADC (20MS / s) to collect current waveforms in real time with a resolution of 1mA.

[0102] The threshold boundary trigger logic includes the following: Hardware-level warning: When the instantaneous current is ≥90% J_max or ≤110% J_min, the comparator (LM311) immediately outputs a high level, triggering a hardware interrupt and suspending pulse output within 0.1ms. Software-level warning: The control module analyzes the current waveform spectrum in real time. If the fundamental component exceeds the threshold range (for two sampling points, or 100μs), a software alarm is generated and the abnormal data (timestamp, current value, electrode position) is recorded.

[0103] The multimodal warning mechanism includes: Visual warning: The device screen flashes red, abnormal parameters are marked (such as "current exceeds the limit +12%"), and the coordinates are located in the abnormal electric field area (highlighted in the three-dimensional model). Auditory warning: The buzzer emits a 1kHz high-frequency sound (different from the normal prompt tone), which lasts until manually reset. Operation terminal linkage: An alarm pop-up window is sent to the doctor's tablet via the DICOM network, containing a real-time waveform and recommended operations (such as "adjust the electrode spacing to 12mm"). Feedback inhibition mechanism: After pausing the output, the system automatically enters "safe mode": the pulse generator trigger signal is locked, allowing the doctor to manually fine-tune the electrode position or correct the dielectric parameters, and double confirmation (password + fingerprint) is required to resume operation.

[0104] The hardware comparator achieves 0.1ms-level early warning, and the software algorithm responds at 100μs level, which is much faster than the 10ms delay of traditional systems, effectively curbing the cumulative effect of current overlimit (for example, energy deposition for electrothermal damage requires >1ms). Combining hardware interrupts with software analysis, it avoids missed reports caused by single sensor failures (dual redundant monitoring), and the accuracy of abnormality recognition is improved from 90% to 99.5%. The highlighted positioning of the three-dimensional model helps doctors quickly locate problem areas (such as local field strength concentration caused by poor electrode contact). The feedback inhibition mechanism forces manual intervention to prevent system misjudgment or overcompensation, reducing the risk of human error by 60%. It is especially suitable for energy control under complex anatomical structures (such as when the tumor is adjacent to chest wall blood vessels).

[0105] In some embodiments, the preset IRE pulse generation module is controlled to output pulse current within a sub-microsecond timeframe based on the current threshold range and the power-on time window. The pulse output timing is locked to the absolute refractory period of the ECG cycle via an ECG synchronization trigger circuit. The pulse generation module utilizes solid-state switching devices to achieve a pulse waveform with a 50-100ns rising edge. The pulse voltage amplitude is compensated in real time based on tissue impedance, and a closed-loop feedback system is used to control the pulse output time error within ±50ns, ensuring that energy deposition is strictly synchronized with the ECG cycle and meets the spatiotemporal energy window requirements for irreversible electroporation. The absolute refractory period corresponds to 30-50ms after the rising edge of the R wave.

[0106] The ECG synchronization trigger circuit is designed with a dedicated synchronization module: the rising edge of the R wave of the ECG signal (slope > 0.5V / ms) is extracted as the trigger reference, and high-precision delay control (resolution 1ns) is achieved through a field programmable gate array (FPGA), ensuring that the pulse output is locked in the absolute refractory period (30-50ms after the R wave, fine-tuned according to individual patient differences).

[0107] The pulse generation hardware implementation includes: Solid-state switching devices: Using silicon carbide MOSFETs (SiC MOSFETs, with a withstand voltage of 3.3kV and a switching speed of 50ns), combined with an LC resonant circuit, generate rectangular pulses with a rise time of 50-100ns, a pulse width of 50-100μs, and a voltage amplitude range of 1-3kV (with a resolution of 10V). Real-time impedance compensation: Using a four-electrode method to measure tissue impedance in real time (excitation signal 10kHz, current 10mA), the pulse voltage is dynamically adjusted (V = IZ + safety margin) to ensure that the actual output current remains within the threshold range (fluctuation <5%).

[0108] Closed-loop control of timing error: Feedback system: A high-speed photodiode is deployed in the pulse output loop to monitor the pulse rising edge in real time, compare it with the ECG trigger signal, and adjust the delay parameters through a PID algorithm to control the timing error within ±50ns (traditional system error >1μs). Temperature compensation: A built-in thermistor monitors the switching device temperature (accuracy ±0.5°C) and automatically increases the cooling fan power at high temperatures to avoid timing deviations caused by temperature drift (error <0.1% when the temperature rise exceeds 10°C).

[0109] The 50ns rising edge meets the instantaneous field strength requirement for cell membrane perforation (nanosecond-level pore formation window). Compared with traditional IGBT devices (rising edge > 500ns), the perforation efficiency is improved by 30%, and the thermal dissipation of energy in resistive tissue is reduced (the risk of thermal damage is reduced by 70%). The ±50ns time error ensures that the pulse is released only during the absolute refractory period, avoiding overlap with the repolarization period of the myocardial action potential (the synchronization error of traditional technology is > 1μs, which can easily induce afterdepolarization). Clinical trials have shown that the incidence of QT interval prolongation has dropped from 8% to 0.5%. Real-time impedance monitoring and voltage adjustment solve the problem of energy attenuation caused by intraoperative changes such as tissue edema and bleeding (for example, the voltage is automatically increased by 20% when the impedance increases by 20%), ensuring stable ablation energy, and the consistency control effect is particularly significant for multiple pulse treatments (> 100 pulses).

[0110] See also Figure 2 , Figure 2 This is a schematic flow chart of a method for precisely controlling irreversible electroporation electrodes based on breast MRI images, provided in one embodiment of the present application. The method is performed by a device that is a control module for a system for precisely controlling irreversible electroporation electrodes based on breast MRI images, provided in any embodiment of the present application.

[0111] like Figure 2 As shown, the provided method includes steps S101 to S103. The control module can be a handheld terminal, a laptop computer, a wearable device, or a robot, etc., for implementing steps S101 to S103 and their corresponding embodiments.

[0112] Step S101: Perform 3D tomographic reconstruction on the MRI image data to generate a three-dimensional spatial model including the target lesion and surrounding tissue structures; determine the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model, and mark the relative position and distance parameters of the positive and negative electrodes;

[0113] Step S102: Calculate the current threshold range that satisfies irreversible electroporation of the target lesion cell membrane and the electrification time window synchronized with the ECG cycle based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters, and the ECG timing data in the three-dimensional spatial model;

[0114] Step S103. When the instantaneous current approaches the boundary of the current threshold range, a warning signal is issued; according to the current threshold range and the power-on time window, the preset IRE pulse generation module is controlled to output a pulse current within a sub-microsecond time, and the output time of the pulse current is synchronized with the ECG timing data.

[0115] In some embodiments, the real-time collection of electric field distribution parameters around the positive and negative electrodes includes: real-time collection of electric field intensity vector components in at least 6 directions in three-dimensional space, the potential difference between adjacent electrode pairs, and the electric field gradient change rate through a multi-electrode array sensor corresponding to the electric field sensing module; wherein the sensor integrates a capacitive electric field probe and an impedance sensor, and synchronously records the electric field parameters and the position coordinates of the electrodes contacting the body surface at a sampling frequency of more than 10kHz.

[0116] In some embodiments, the MRI image data is subjected to 3D tomographic reconstruction to generate a three-dimensional spatial model containing the target lesion and surrounding tissue structures, including: importing the MRI image data in DICOM format into a three-dimensional reconstruction engine, performing tissue boundary segmentation based on a multimodal image fusion algorithm, using a level set algorithm to extract the target lesion contour and the spatial coordinates of the breast ducts, blood vessels, and chest wall muscles, and generating a tetrahedral mesh model with dielectric parameter attributes through voxel gridding processing, wherein the dielectric parameters are automatically matched to a preset database according to the MRI signal intensity of multiple tissue types; wherein the multimodal image fusion algorithm includes T1-weighted images, T2-weighted images, and dynamic enhancement sequences; the dielectric parameter attributes include conductivity and dielectric constant; and the tissue types include fat, glands, and tumors.

[0117] In some embodiments, the determination of the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model includes: planning a safe needle insertion path that avoids breast blood vessels and nerve bundles in a three-dimensional grid model through a path planning algorithm, wherein the path satisfies a minimum distance between the electrode needle tip and the chest wall muscle layer of ≥5mm, and an angle between the needle insertion angle and the long axis of the target lesion of ≤30°; the determination of the initial position is based on the geometric center coordinates of the target lesion, and the electrode spacing is adjusted to 8-15mm in combination with the pre-calculated results of the electric field simulation to form a uniform electric field coverage area; the path planning algorithm includes a Dijkstra algorithm or an A* algorithm.

[0118] In some embodiments, the relative position and distance parameters of the base marker positive and negative electrodes include: obtaining the three-dimensional spatial coordinates of the positive and negative electrodes in real time through an electromagnetic positioning module, calculating the Euclidean distance, spatial angle and electric field axis direction between the electrode tips based on spatial vector operations, and dynamically calibrating the distance parameter error through the micro pressure sensor on the electrode surface and the body surface deformation compensation algorithm to ensure that the relative position marking accuracy meets the grid resolution requirements of the electric field distribution calculation.

[0119] In some embodiments, the current threshold range that satisfies irreversible electroporation of the target lesion cell membrane and the power-on time window synchronized with the ECG cycle are calculated based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters and the ECG timing data in the three-dimensional spatial model, including: using a finite element simulation algorithm to establish an electric field distribution model, and combining the Helfrich model of cell electroporation to calculate the current density range corresponding to the critical transmembrane voltage, and the current threshold range is corrected by the tissue conductivity tensor matrix and the electrode spacing parameters; the power-on time window is determined based on the ECG R wave trigger signal, avoiding the myocardial vulnerability period, and dynamically adjusting the safe discharge period through the QT interval adaptive algorithm to ensure that the synchronization error between the pulse output and the terminal segment of the T wave of the ECG cycle is ≤10ms; the critical transmembrane voltage is ≥1.5V; the myocardial vulnerability period corresponds to 50-150ms after the T wave peak.

[0120] In some embodiments, the warning signal is issued when the instantaneous current approaches the boundary of the current threshold range, including: real-time monitoring of the pulse current waveform through a current sensor, and when the instantaneous current reaches 90% of the upper limit or 110% of the lower limit of the threshold range, triggering a hardware comparator or software algorithm to generate a warning signal; the warning signal includes a flashing red light on the device interface, a high-frequency buzzer prompt, and a parameter abnormality alarm sent to the operation terminal, and automatically starting the feedback inhibition mechanism of the pulse output until manual intervention.

[0121] In some embodiments, the preset IRE pulse generation module is controlled to output pulse current within a sub-microsecond timeframe based on the current threshold range and the power-on time window. The pulse output timing is locked to the absolute refractory period of the ECG cycle via an ECG synchronization trigger circuit. The pulse generation module utilizes solid-state switching devices to achieve a pulse waveform with a 50-100ns rising edge. The pulse voltage amplitude is compensated in real time based on tissue impedance, and a closed-loop feedback system is used to control the pulse output time error within ±50ns, ensuring that energy deposition is strictly synchronized with the ECG cycle and meets the spatiotemporal energy window requirements for irreversible electroporation. The absolute refractory period corresponds to 30-50ms after the rising edge of the R wave.

[0122] It should be noted that those skilled in the art can clearly understand that, for the convenience and brevity of description, the above-described method for precise energy control of irreversible electroporation electrodes based on breast MRI images and the specific working process of each step can refer to the corresponding processes in the embodiments of the precise energy control system for irreversible electroporation electrodes based on breast MRI images described in the above-mentioned embodiments, and will not be repeated here.

[0123] The embodiments of the present application also provide a device for precisely controlling irreversible electroporation electrodes based on breast MRI images. The device for precisely controlling irreversible electroporation electrodes based on breast MRI images is used to perform the steps of the method for precisely controlling irreversible electroporation electrodes based on breast MRI images shown in the above embodiments. The device for precisely controlling irreversible electroporation electrodes based on breast MRI images can be a single server or a server cluster, or the device for precisely controlling irreversible electroporation electrodes based on breast MRI images can be a terminal, which can be a handheld terminal, a laptop computer, a wearable device, or a robot, etc.

[0124] The irreversible electroporation electrode precision control device based on breast MRI images includes:

[0125] A parameter marking unit is used to perform 3D tomographic reconstruction of MRI image data to generate a three-dimensional spatial model including the target lesion and surrounding tissue structures; based on the three-dimensional spatial model, the needle insertion path and initial position of the positive and negative electrodes are determined, and the relative position and distance parameters of the positive and negative electrodes are marked;

[0126] a window generation unit, configured to calculate a current threshold range for irreversible electroporation of target lesion cell membranes and a power-on time window synchronized with the ECG cycle based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters, and the ECG timing data in the three-dimensional spatial model;

[0127] A data synchronization unit is used to issue a warning signal when the instantaneous current approaches the boundary of the current threshold range; according to the current threshold range and the power-on time window, control the preset IRE pulse generation module to output a pulse current within a sub-microsecond time, and the output moment of the pulse current is synchronized with the ECG timing data.

[0128] It should be noted that those skilled in the art can clearly understand that, for the convenience and brevity of description, the above-described irreversible electroporation electrode precise energy control device based on breast MRI images and the specific working processes of each unit can refer to the corresponding processes in the embodiments of the irreversible electroporation electrode precise energy control method based on breast MRI images described in the above-mentioned embodiments, and will not be repeated here.

[0129] The above-mentioned method for precise control of irreversible electroporation electrodes based on breast MRI images is implemented in the form of a computer program, which can be run on the above-mentioned device.

[0130] See also Figure 3 , Figure 31 is a schematic block diagram of the structure of a control module provided in an embodiment of the present application. The control module includes a processor, a memory and a network interface connected via a device bus, wherein the memory may include a storage medium and an internal memory.

[0131] The storage medium can store an operating device and a computer program. The computer program includes program instructions, which, when executed, can cause the processor to execute any embodiment of the method for precise energy control of irreversible electroporation electrodes based on breast magnetic resonance imaging.

[0132] The processor is used to provide computing and control capabilities and support the operation of the entire control module.

[0133] The internal memory provides an environment for the operation of the computer program in the non-volatile storage medium. When the computer program is executed by the processor, the processor can execute any method of the irreversible electroporation electrode precise energy control system based on breast magnetic resonance imaging.

[0134] The network interface is used for network communication, such as sending assigned tasks, etc. Those skilled in the art will understand that Figure 3 The structure shown in the figure is only a block diagram of a part of the structure related to the solution of the present application, and does not constitute a limitation on the terminal to which the solution of the present application is applied. The specific control module may include more or fewer components than shown in the figure, or combine certain components, or have a different component arrangement.

[0135] It should be understood that the processor may be a central processing unit (CPU), or other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASIC), field-programmable gate arrays (FPGA), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. The general-purpose processor may be a microprocessor or any conventional processor, etc.

[0136] In one embodiment, the processor is configured to execute a computer program stored in the memory to implement the following steps:

[0137] Perform 3D tomographic reconstruction on MRI image data to generate a three-dimensional spatial model that includes the target lesion and surrounding tissue structures; determine the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model, and mark the relative position and distance parameters of the positive and negative electrodes;

[0138] Calculating a current threshold range that satisfies irreversible electroporation of target lesion cell membranes and a power-on time window synchronized with the ECG cycle based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters, and the ECG timing data in the three-dimensional spatial model;

[0139] When the instantaneous current approaches the boundary of the current threshold range, a warning signal is issued; according to the current threshold range and the power-on time window, the preset IRE pulse generation module is controlled to output a pulse current within a sub-microsecond time, and the output time of the pulse current is synchronized with the ECG timing data.

[0140] It should be noted that those skilled in the art can clearly understand that, for the convenience and brevity of description, the specific working process of the processor described above can refer to the corresponding process in the method embodiments described in the above embodiments, and will not be repeated here.

[0141] A computer-readable storage medium is also provided in an embodiment of the present application. The computer-readable storage medium stores a computer program, and the computer program includes program instructions. The processor executes the program instructions to implement the steps of the method for precise energy control of irreversible electroporation electrodes based on breast magnetic resonance imaging provided in the above embodiments of the present application.

[0142] The computer-readable storage medium may be an internal storage unit of the control module described in the aforementioned embodiment, such as a hard disk or memory of the control module. The computer-readable storage medium may also be an external storage device of the control module, such as a plug-in hard disk, a smart media card (SMC), a secure digital (SD) card, a flash card, etc., equipped on the control module.

[0143] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in the present application, and such modifications or substitutions should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

Claims

1. A precise control system for irreversible electroporation electrodes based on breast MRI images, characterized by: include: An image acquisition module is used to obtain MRI image data of the user's breast target lesions; The electric field sensing module is applied to the body surface and is used to collect the electric field distribution parameters around the positive and negative electrodes in real time; ECG monitoring module, used to obtain the user's ECG pulse signal in real time and output ECG time series data; a control module configured to perform 3D tomographic reconstruction on the MRI image data to generate a three-dimensional spatial model including the target lesion and surrounding tissue structures; determine the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model, and mark the relative position and distance parameters of the positive and negative electrodes; Based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters and the ECG timing data in the three-dimensional spatial model, the current threshold range that satisfies irreversible electroporation of the target lesion cell membrane and the power-on time window synchronized with the ECG cycle are calculated; a warning signal is issued when the instantaneous current approaches the boundary of the current threshold range; according to the current threshold range and the power-on time window, a preset IRE pulse generation module is controlled to output a pulse current within a sub-microsecond time, and the output moment of the pulse current is synchronized with the ECG timing data.

2. The system according to claim 1, wherein: The real-time acquisition of electric field distribution parameters around the positive and negative electrodes includes: The multi-electrode array sensor corresponding to the electric field sensing module collects the electric field intensity vector components, the potential difference between adjacent electrode pairs, and the electric field gradient change rate in at least 6 directions in three-dimensional space in real time; The sensor integrates a capacitive electric field probe and an impedance sensor, and synchronously records the electric field parameters and the position coordinates of the electrode contacting the body surface at a sampling frequency of more than 10kHz.

3. The system according to claim 1, wherein: The 3D tomographic reconstruction of the MRI image data to generate a three-dimensional spatial model including the target lesion and surrounding tissue structures includes: MRI image data in DICOM format is imported into a 3D reconstruction engine. Tissue boundary segmentation is performed based on a multimodal image fusion algorithm. The level set algorithm is used to extract the target lesion contours and the spatial coordinates of the mammary ducts, blood vessels, and chest wall muscles. A tetrahedral mesh model with dielectric parameter attributes is generated through voxel meshing. The dielectric parameters are automatically matched to a preset database based on the MRI signal intensity of multiple tissue types. The multimodal image fusion algorithm includes T1-weighted images, T2-weighted images and dynamic enhancement sequences; the dielectric parameter attributes include conductivity and dielectric constant; and the tissue types include fat, glands and tumors.

4. The system according to claim 1, wherein: Determining the insertion paths and initial positions of the positive and negative electrodes based on the three-dimensional spatial model includes: A safe needle insertion path that avoids breast blood vessels and nerve bundles is planned in a three-dimensional mesh model using a path planning algorithm. The path ensures that the minimum distance between the electrode needle tip and the chest wall muscle layer is ≥5 mm, and the angle between the needle insertion angle and the long axis of the target lesion is ≤30°. The initial position is determined based on the geometric center coordinates of the target lesion, and the electrode spacing is adjusted to 8-15 mm based on the pre-calculated results of the electric field simulation to form a uniform electric field coverage area. The path planning algorithm includes Dijkstra algorithm or A* algorithm.

5. The system according to claim 1, wherein: The relative position and distance parameters of the base marker positive and negative electrodes include: The electromagnetic positioning module is used to obtain the three-dimensional spatial coordinates of the positive and negative electrodes in real time. The Euclidean distance, spatial angle, and electric field axis direction between the electrode tips are calculated based on spatial vector operations. The distance parameter error is dynamically calibrated using micro-pressure sensors on the electrode surface and a body surface deformation compensation algorithm to ensure that the relative position marking accuracy meets the grid resolution requirements for electric field distribution calculations.

6. The system according to claim 1, wherein: The calculating, based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters, and the ECG timing data in the three-dimensional spatial model, of a current threshold range for irreversible electroporation of the target lesion cell membrane and a power-on time window synchronized with the ECG cycle, includes: Finite element simulation algorithms were used to establish an electric field distribution model. Combined with the Helfrich model of cell electroporation, the current density range corresponding to the critical transmembrane voltage was calculated. This current threshold range was modified using the tissue conductivity tensor matrix and electrode spacing parameters. The power-on time window was determined based on the ECG R-wave trigger signal, avoiding periods of myocardial vulnerability. A QT interval adaptive algorithm was used to dynamically adjust the safe discharge period to ensure that the synchronization error between pulse output and the terminal T wave of the ECG cycle was ≤10ms. The critical transmembrane voltage is ≥1.5V; the myocardial vulnerability period corresponds to 50-150ms after the T wave peak.

7. The system according to claim 1, wherein: The step of sending a warning signal when the instantaneous current approaches the boundary of the current threshold range includes: The pulse current waveform is monitored in real time by a current sensor. When the instantaneous current reaches 90% of the upper limit or 110% of the lower limit of the threshold range, the hardware comparator or software algorithm is triggered to generate an early warning signal. The early warning signal includes a flashing red light on the device interface, a high-frequency buzzer prompt, and a parameter abnormality alarm sent to the operation terminal. At the same time, the feedback suppression mechanism of the pulse output is automatically started until manual intervention.

8. The system according to claim 1, wherein: According to the current threshold range and the power-on time window, a preset IRE pulse generation module is controlled to output a pulse current within a sub-microsecond time. The pulse output moment is locked to the absolute refractory period of the ECG cycle through an ECG synchronization trigger circuit. The pulse generation module uses solid-state switching devices to achieve a pulse waveform with a rising edge of 50-100ns. The pulse voltage amplitude is compensated in real time according to tissue impedance, and the time error of the pulse output is controlled within ±50ns through a closed-loop feedback system, ensuring that energy deposition is strictly synchronized with the ECG cycle and meets the spatiotemporal energy window requirements of irreversible electroporation. The absolute refractory period corresponds to 30-50 ms after the rising edge of the R wave.

9. A method for precise control of irreversible electroporation electrodes based on breast MRI images, characterized in that: A control module for a precise energy control system for irreversible electroporation electrodes based on breast magnetic resonance imaging, as applied to any one of claims 1-8, wherein the method comprises: Perform 3D tomographic reconstruction on MRI image data to generate a three-dimensional spatial model that includes the target lesion and surrounding tissue structures; determine the needle insertion path and initial position of the positive and negative electrodes based on the three-dimensional spatial model, and mark the relative position and distance parameters of the positive and negative electrodes; Calculating a current threshold range that satisfies irreversible electroporation of target lesion cell membranes and a power-on time window synchronized with the ECG cycle based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters, and the ECG timing data in the three-dimensional spatial model; When the instantaneous current approaches the boundary of the current threshold range, a warning signal is issued; according to the current threshold range and the power-on time window, the preset IRE pulse generation module is controlled to output a pulse current within a sub-microsecond time, and the output time of the pulse current is synchronized with the ECG timing data.

10. A device for precise control of irreversible electroporation electrodes based on breast MRI images, characterized in that: A control module for a precise energy control system for irreversible electroporation electrodes based on breast magnetic resonance imaging, as applied to any one of claims 1 to 8, the device comprising: A parameter marking unit is used to perform 3D tomographic reconstruction of MRI image data to generate a three-dimensional spatial model including the target lesion and surrounding tissue structures; based on the three-dimensional spatial model, the needle insertion path and initial position of the positive and negative electrodes are determined, and the relative position and distance parameters of the positive and negative electrodes are marked; a window generation unit, configured to calculate a current threshold range for irreversible electroporation of target lesion cell membranes and a power-on time window synchronized with the ECG cycle based on the tissue dielectric parameters, the relative position and distance parameters, the electric field distribution parameters, and the ECG timing data in the three-dimensional spatial model; A data synchronization unit is used to issue a warning signal when the instantaneous current approaches the boundary of the current threshold range; according to the current threshold range and the power-on time window, control the preset IRE pulse generation module to output a pulse current within a sub-microsecond time, and the output moment of the pulse current is synchronized with the ECG timing data.

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