Non-thermal effect nanosecond pulse system and working method

Abstract

The non-thermal effect nanosecond pulse system comprises a pulse electric field generation module, a double-net type expansion type ablation electrode module and a pulse electric field ablation planning module, and is characterized in that the pulse electric field ablation planning module comprises a blood vessel 3D model reconstruction module and an electric field simulation calculation module; a blood vessel 3D model is constructed through the blood vessel 3D model reconstruction module, an electric field intensity cloud picture is constructed through the electric field simulation calculation module, the pulsed electric field ablation planning module accurately plans an ablation area through the blood vessel 3D model reconstruction module and the electric field simulation calculation module, and the ablation area comprises a catheter path marked in the blood vessel 3D model and an ablation point sequence. The tip of the catheter is electromagnetically positioned, the real-time position of the blood vessel is mapped to the blood vessel 3D model, and after the pulsed electric field generation module supplies power to the double-net type expansion type ablation electrode module, the double-net type expansion type ablation electrode module conducts ablation according to a catheter path and an ablation point sequence marked in the blood vessel 3D model.

Description

Technical Field

[0001] The present invention relates to the technical field of nanosecond pulses, in particular to a system and a working method of a non-thermal effect nanosecond pulse. Background Art

[0002] While traditional energy ablation techniques (such as radiofrequency and laser) can ablate hyperplastic tissue through thermal effects, high temperatures can easily lead to irreversible damage to the vascular endothelium, collagen degeneration, and secondary inflammatory responses, exacerbating neointimal hyperplasia and restenosis. Traditional ablation systems are unable to construct 3D models of blood vessels, nor can they generate ablation paths and ablation areas based on these 3D models. This leads to technical issues such as inaccurate ablation processes and poor ablation outcomes. Furthermore, dynamic model optimization is also impossible, resulting in inaccurate ablation processes and irreversible damage to the vascular endothelium. This has led to extensive research into this issue. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a system and a working method for non-thermal effect nanosecond pulses, which can solve the above-mentioned problems in the existing technology.

[0004] The present invention is achieved through the following technical solutions: A non-thermal effect nanosecond pulse ablation system of the present invention includes a pulse electric field generating module, a dual-grid expandable ablation electrode module and a pulse electric field ablation planning module, characterized in that the pulse electric field ablation planning module includes a blood vessel 3D model reconstruction module and an electric field simulation calculation module, a blood vessel 3D model is constructed by the blood vessel 3D model reconstruction module, and an electric field strength cloud map is constructed by the electric field simulation calculation module, the pulse electric field ablation planning module accurately plans the ablation area through the blood vessel 3D model reconstruction module and the electric field simulation calculation module, the ablation area includes marking the catheter path and ablation point sequence in the blood vessel 3D model, electromagnetic positioning of the catheter tip, and mapping the real-time position of the blood vessel to the blood vessel 3D model. After the pulse electric field generating module supplies power to the dual-grid expandable ablation electrode module, the dual-grid expandable ablation electrode module performs ablation according to the catheter path and ablation point sequence marked in the blood vessel 3D model.

[0005] Further technical solutions, the vascular 3D model reconstruction module includes multimodal image data fusion, vascular segmentation and centerline extraction, three-dimensional model reconstruction and dynamic model optimization. Multimodal image data fusion includes data source and data source alignment and fusion, vascular segmentation and centerline extraction include deep learning segmentation and centerline generation, three-dimensional model reconstruction includes surface mesh generation and stent / plaque modeling, and dynamic model optimization includes respiratory and heartbeat motion compensation.

[0006] For further technical solutions, the data source includes multimodal imaging data such as macrovascular topology, dynamic blood flow information, and vascular wall microstructure; data source registration and fusion include aligning different modal imaging data to a unified coordinate system through feature point matching or deep learning algorithms.

[0007] Further technical solutions include deep learning segmentation, which includes using U-Net or nnUNet to segment the vascular cavity, wall, and branch structure images; centerline generation includes extracting the vascular centerline through a centerline extraction algorithm and constructing a topological connection relationship.

[0008] Further technical solutions include surface mesh generation, which includes generating a smooth blood vessel surface mesh based on the segmentation results; and stent / plaque modeling, which includes reconstructing the stent and neointimal structure by integrating the blood vessel wall microstructure data if in-stent restenosis exists.

[0009] Further technical solutions include compensation for respiratory and cardiac motion, building a dynamic vascular model through four-dimensional computed tomography or electrocardiogram gating, and simulating vascular displacement.

[0010] As a further technical solution, the electric field simulation calculation module simulates the distribution of the pulsed electric field and predicts the range and intensity of the ablation area, including tissue electrical characteristics modeling, electrode configuration and pulse parameter input, electric field distribution simulation, thermal effect and safety boundary assessment.

[0011] Further technical solutions, thermal effect and safety boundary assessment include Joule heat calculation and vascular protection mechanism. Joule heat calculation includes evaluating the heat deposition of pulse energy in tissue to ensure that the temperature rise does not exceed the safety threshold; vascular protection mechanism includes setting electric field strength attenuation zone or shielding strategy according to the position of the 3D model of the blood vessel.

[0012] A non-thermal nanosecond pulse ablation system operates as follows: The first step is to establish a 3D model of the blood vessels, integrate dynamic blood flow information and blood vessel wall microstructure data to reconstruct the in-stent restenosis data, and construct a three-dimensional blood vessel model.

[0013] The second step is electric field distribution prediction: input the electrode type double tennis ball capsule, position and pulse parameters to generate the electric field intensity cloud map.

[0014] The third step is to output the navigation plan: mark the catheter path and ablation point sequence in the 3D model to form an ablation path map.

[0015] The fourth step is equipment linkage: the PFA generator is connected to the ablation catheter, and the pulsed electric field ablation system is connected to the PFA generator.

[0016] The fifth step is catheter navigation: real-time registration, electromagnetic positioning of the catheter tip, mapping the real-time position of the blood vessel to the 3D model of the blood vessel; breathing / heartbeat compensation, real-time update of blood vessel displacement through intracavitary ultrasound (ICE).

[0017] Step 6: Pulse energy release and monitoring.

[0018] Further technical solutions, pulse energy release and monitoring include, in the first step, the dual-net expandable electrode pulse ablation system applies a test pulse V1, and the dual-net expandable ablation electrode module performs impedance detection; when the impedance drops > 20, the dual-net expandable electrode pulse ablation system releases a full-pressure pulse V2, V1 <V2,V1和V2的范围为500-15000V,并且实时监测电场分布,若覆盖靶区,则移至下一点消融,若没有覆盖靶区,则调整导管位置,使阻抗下降> 20% and determine whether the target area is covered; in the second step, when the impedance drops ≤ 20%, it is also necessary to adjust the catheter position so that the impedance drops > 20% and determine whether the target area is covered.

[0019] The beneficial effects of the present invention are: 1. By performing 3D modeling on blood vessels, various data information are integrated in the modeling process to feedback the authenticity of the 3D modeling, and in the process of non-thermal effect nanosecond pulses, the real-time position of the blood vessels is monitored and fed back and matched with the 3D modeling. Combined with the electric field simulation calculation module, the distribution of the pulsed electric field is simulated, and the range and intensity of the ablation area are predicted, including tissue electrical characteristics modeling, electrode configuration and pulse parameter input, electric field distribution simulation, thermal effect and safety boundary evaluation, so as to achieve accurate, efficient and safe ablation.

[0020] 2. The pulsed electric field ablation planning module accurately plans the ablation area through the vascular 3D model reconstruction module and the electric field simulation calculation module, achieving precise ablation while avoiding tissue damage.

[0021] 3. The vascular 3D model reconstruction module includes multimodal image data fusion, vascular segmentation and centerline extraction, three-dimensional model reconstruction and dynamic model optimization. Multimodal image data fusion includes data source and data source alignment and fusion. Vascular segmentation and centerline extraction include deep learning segmentation and centerline generation. Three-dimensional model reconstruction includes surface mesh generation and stent / plaque modeling. Dynamic model optimization includes respiratory and heartbeat motion compensation. Through the above data processing methods, an accurate vascular 3D model can be built and matched with the real-time vascular position. It also has dynamic model optimization function to further avoid tissue damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] For ease of explanation, the present invention is described in detail with reference to the following specific embodiments and accompanying drawings.

[0023] Figure 1This is a structural diagram of the dual-net expandable electrode pulse ablation system of the present invention; Figure 2 for Figure 1 Schematic diagram of the structure of the double-mesh expandable ablation electrode module; Figure 3 Schematic diagram of the blood vessel 3D model reconstruction method of the present invention; Figure 4 Schematic diagram of the operation of the electric field simulation calculation module in the present invention; Figure 5 is a schematic diagram of the 3D model of blood vessels in the present invention; Figure 6 Schematic diagram of the electric field strength of the electrodes in the present invention; Figure 7 This is a schematic diagram of the double-net expandable ablation electrode module during ablation in the present invention; Figure 8 Schematic diagram of the workflow of pulse energy release and detection in the present invention; In the figure, there are a first mesh electrode 1, a second mesh electrode 2, a catheter 3, a protective cover 4, a handle 5 and a high-voltage tail line plug 6. DETAILED DESCRIPTION

[0024] like Figures 1-8 As shown, a system and working method of non-thermal effect nanosecond pulse of the present invention includes a pulse electric field generating module, a dual-mesh expandable ablation electrode module and a pulse electric field ablation planning module. The pulse electric field ablation planning module includes a blood vessel 3D model reconstruction module and an electric field simulation calculation module.

[0025] Advantageously, the pulse electric field generating module is used to generate high-voltage electric pulses required for ablation.

[0026] Beneficially, the dual-mesh expandable ablation electrode module includes a first mesh electrode 1, a second mesh electrode 2, a catheter 3, a protective cover 4, a handle 5 and a high-voltage tail plug 6, which are electrically connected to the pulse electric field generating module through the high-voltage tail plug 6, so that the first mesh electrode 1 and the second mesh electrode 2 can achieve the ablation function. By operating the handle 5, the first mesh electrode 1 and the second mesh electrode 2 can be expanded to form an expandable structure. The handle 5 is electrically connected to the high-voltage tail plug 6. A wire is provided in the catheter 3, and the wire electrically connects the first mesh electrode 1, the second mesh electrode 2 and the handle 5. The protective cover 4 is provided between the handle 5 and the catheter 3.

[0027] Advantageously, the pulsed electric field ablation planning module accurately plans the ablation area through the blood vessel 3D model reconstruction module and the electric field simulation calculation module, thereby achieving precise ablation while avoiding damage to tissues, such as blood vessels.

[0028] Advantageously, the vascular 3D model reconstruction module forms a 3D model by three-dimensionally modeling the vascular. Its construction method includes multimodal image data fusion, vascular segmentation and centerline extraction, 3D model reconstruction and dynamic model optimization.

[0029] Beneficially, multimodal image data fusion includes data sources and data source registration and fusion, where the data sources include multimodal image data such as CT / MRI (macrovascular topology), DSA (dynamic blood flow information), and OCT (vascular wall microstructure); data source registration and fusion include aligning different modal image data to a unified coordinate system through feature point matching (such as vascular bifurcation, calcified plaque) or deep learning algorithms.

[0030] Advantageously, the blood vessel segmentation and centerline extraction include deep learning segmentation and centerline generation. Deep learning segmentation includes using U-Net (a deep learning architecture based on convolutional neural network CNN) or nnUNet (a deep learning framework specifically for medical image segmentation tasks) to segment the blood vessel lumen, wall and branch structure images; centerline generation includes extracting the blood vessel centerline through a centerline extraction algorithm and constructing a topological connection relationship.

[0031] Advantageously, the three-dimensional model reconstruction includes surface mesh generation and stent / plaque modeling. The surface mesh generation includes generating a smooth vascular surface mesh based on the segmentation results, and the algorithm used may be the Marching Cubes algorithm. The stent / plaque modeling includes, if in-stent restenosis exists, fusing OCT data to reconstruct the stent and neointimal structure.

[0032] Advantageously, the dynamic model optimization includes compensation for respiratory and cardiac motion, and a dynamic vascular model is constructed through four-dimensional computed tomography or electrocardiogram gating technology to simulate vascular displacement.

[0033] Advantageously, the electric field simulation calculation module refers to simulating the distribution of pulsed electric fields in biological tissues and predicting the range and intensity of ablation areas, including tissue electrical property modeling, electrode configuration and pulse parameter input, electric field distribution simulation, thermal effect and safety boundary assessment.

[0034] Advantageously, tissue electrical property modeling includes conductivity and dielectric constant and anisotropy modeling. Conductivity and dielectric constant include establishing conductivity and dielectric constant models based on the electrophysiological properties of different tissues (such as myocardium, vascular wall, fat, etc.), taking into account dispersion characteristics (frequency dependence); anisotropy modeling includes the anisotropy of electric field propagation caused by the directionality of myocardial fibers, which needs to be combined with diffusion tensor imaging (DTI) or histological data modeling.

[0035] Advantageously, the electrode configuration and pulse parameter input include the electrode geometry and position and pulse parameters. The electrode geometry and position include defining the electrode shape (such as needle, balloon), spacing and contact status with the tissue of the ablation catheter; the pulse parameters include setting the pulse amplitude (kV level), pulse width (nanosecond to microsecond level), frequency and sequence (monophasic / biphasic pulse).

[0036] Advantageously, the electric field distribution simulation includes numerical methods and dynamic tissue response. The numerical method includes solving Maxwell's equations using the finite element method (FEM) or the boundary element method (BEM) to calculate the spatial distribution of the electric field intensity (E-field); the dynamic tissue response includes simulating the electric field-induced cell membrane electroporation threshold (usually 500-1000 V / cm) and marking the ablation area (the area where the electric field exceeds the threshold).

[0037] Beneficially, thermal effect and safety boundary assessments include Joule heat calculations and vascular protection mechanisms. Joule heat calculations involve evaluating the thermal deposition of pulse energy in tissues to ensure that the temperature rise does not exceed a safety threshold (to avoid thermal damage). Vascular protection mechanisms involve setting electric field intensity attenuation zones or shielding strategies based on the location of the 3D model of the blood vessel to prevent endothelial damage.

[0038] The method and process of using the system and method are as follows: The first step is the vascular 3D model reconstruction module, which integrates dynamic blood flow information and vascular wall microstructure data to reconstruct in-stent restenosis data and build a three-dimensional vascular model.

[0039] Step 2: Electric field distribution prediction: Input electrode type, double tennis ball capsule, position and pulse parameters, and solve Poisson's equation , generate the electric field intensity cloud map.

[0040] The third step is to output the navigation plan: mark the catheter path and ablation point sequence in the 3D model to form an ablation path map. The following are parameter recommendations. The fourth step is equipment linkage: the PFA generator is connected to the ablation catheter, and the pulsed electric field ablation system is connected to the PFA generator.

[0041] The fifth step is catheter navigation: real-time registration, electromagnetic positioning of the catheter tip, mapping the real-time position of the blood vessel to the 3D model of the blood vessel; breathing / heartbeat compensation, real-time update of blood vessel displacement through intracavitary ultrasound (ICE).

[0042] Step 6: Pulse energy release and monitoring: At the beginning, the dual-net expandable electrode pulse ablation system applies a test pulse V1, and the dual-net expandable ablation electrode module performs impedance detection; when the impedance drops > 20, the dual-net expandable electrode pulse ablation system releases a full-pressure pulse V2, V1 <V2,V1和V2的范围为500-15000V,并且实时监测电场分布,若覆盖靶区,则移至下一点消融,若没有覆盖靶区,则调整导管位置,使阻抗下降> When the impedance drops by ≤20%, the catheter position needs to be adjusted to make the impedance drop by >20% and determine whether the target area is covered. The impedance change refers to the impedance drop after cell electroporation (normal myocardium: 90-110Ω, after electroporation: 70-80Ω).

[0043] The above is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited to this. Any changes or substitutions that are not conceived through creative work should be included in the scope of protection of the present invention; therefore, the scope of protection of the present invention should be based on the scope of protection defined in the claims.

Claims

1. A non-thermal nanosecond pulse system, comprising a pulse electric field generation module, a dual-net expandable ablation electrode module and a pulse electric field ablation planning module, characterized in that: The pulsed electric field ablation planning module includes a vascular 3D model reconstruction module and an electric field simulation calculation module. The vascular 3D model is constructed by the vascular 3D model reconstruction module, and the electric field strength cloud map is constructed by the electric field simulation calculation module. The pulsed electric field ablation planning module accurately plans the ablation area through the vascular 3D model reconstruction module and the electric field simulation calculation module. The ablation area includes marking the catheter path and ablation point sequence in the vascular 3D model, electromagnetically positioning the catheter tip, and mapping the real-time position of the blood vessel to the vascular 3D model. After the pulsed electric field generating module supplies power to the dual-mesh expandable ablation electrode module, the dual-mesh expandable ablation electrode module performs ablation according to the catheter path and ablation point sequence marked in the vascular 3D model.

2. The athermal nanosecond pulse system according to claim 1, characterized in that: The vascular 3D model reconstruction module includes multimodal image data fusion, vascular segmentation and centerline extraction, three-dimensional model reconstruction and dynamic model optimization. Multimodal image data fusion includes data source and data source alignment and fusion. Vascular segmentation and centerline extraction include deep learning segmentation and centerline generation. Three-dimensional model reconstruction includes surface mesh generation and stent / plaque modeling. Dynamic model optimization includes respiratory and heartbeat motion compensation.

3. The athermal nanosecond pulse system according to claim 2, characterized in that: The data source includes multimodal imaging data such as macrovascular topology, dynamic blood flow information, and vascular wall microstructure; data source registration and fusion include aligning different modal imaging data to a unified coordinate system through feature point matching or deep learning algorithms.

4. The athermal nanosecond pulse system according to claim 2, characterized in that: Deep learning segmentation includes using U-Net or nnUNet to segment vascular lumen, wall and branch structure images; centerline generation includes extracting the vascular centerline through the centerline extraction algorithm and constructing topological connection relationships.

5. The athermal nanosecond pulse system according to claim 2, characterized in that: Surface mesh generation includes generating a smooth blood vessel surface mesh based on the segmentation results; Stent / plaque modeling includes, if in-stent restenosis exists, reconstructing the stent and neointimal structure by integrating the vascular wall microstructure data.

6. The athermal nanosecond pulse system according to claim 2, characterized in that: Respiratory and cardiac motion compensation: construct a dynamic vascular model through 4D computed tomography or ECG gating to simulate vascular displacement.

7. The athermal nanosecond pulse system according to claim 1, characterized in that: The electric field simulation calculation module simulates the distribution of the pulsed electric field and predicts the range and intensity of the ablation area, including tissue electrical characteristics modeling, electrode configuration and pulse parameter input, electric field distribution simulation, thermal effect and safety boundary assessment.

8. The athermal nanosecond pulse system according to claim 7, characterized in that: Thermal effect and safety boundary assessment includes Joule heat calculation and vascular protection mechanism. Joule heat calculation includes evaluating the heat deposition of pulse energy in tissue to ensure that the temperature rise does not exceed the safety threshold; vascular protection mechanism includes setting electric field intensity attenuation zone or shielding strategy according to the position of the 3D model of blood vessels.

9. The operating method of a athermal nanosecond pulse system according to any one of claims 1 to 8, characterized in that: First step: Establish a 3D vascular model, reconstruct in-stent restenosis data by integrating dynamic blood flow information and vascular wall microstructure data, and construct a three-dimensional vascular model. Second step: Prediction of electric field distribution: Input the electrode type (double tennis ball catheter), position, and pulse parameters to generate an electric field intensity cloud map. Third step: Output a navigation plan: Mark the catheter path and ablation point sequence in the 3D model to form an ablation path map. Fourth step: Device linkage: Connect the PFA generator to the ablation catheter, and connect the pulsed electric field ablation system to the PFA generator. Fifth step: Catheter navigation: Real-time registration, electromagnetic positioning of the catheter tip, and mapping the real-time position of the blood vessel to the 3D vascular model; Respiration / heartbeat compensation, real-time update of blood vessel displacement through intravascular ultrasound (ICE). Sixth step: Pulse energy release and monitoring.

10. The operating method of the athermal nanosecond pulse system according to claim 9, characterized in that: Pulse energy release and monitoring include: First step, the double-mesh expandable electrode pulsed ablation system applies a test pulse V1, and the double-mesh expandable ablation electrode module performs impedance detection; when the impedance drops > 20, the double-mesh expandable electrode pulsed ablation system releases a full-pressure pulse V2, where V1 < V2, and the range of V1 and V2 is 500 - 1500V, and the electric field distribution is monitored in real time. If the target area is covered, move to the next ablation point; if the target area is not covered, adjust the catheter position to make the impedance drop > 20% and determine whether the target area is covered; Second step, when the impedance drop ≤ 20%, adjust the catheter position to make the impedance drop > 20% and determine whether the target area is covered.

Images