A method for selecting design parameters of a pulse ablation catheter based on finite element analysis

Abstract

This invention discloses a method for selecting design parameters for pulse ablation catheters based on finite element analysis, relating to the field of medical device technology. The method includes: obtaining a registered and aligned DICOM format image dataset through high-resolution CT and DTI multimodal imaging of the patient's skull base; obtaining the optimal combination of pulse voltage parameters through gradient optimization under geometric constraints based on a high-fidelity simulation model; generating a catheter manufacturing and treatment plan through catheter 3D printing and intraoperative treatment planning; and constructing a catheter tip with electrode slots and an optimized 3D printing file based on the catheter manufacturing and treatment plan to obtain the pulse ablation catheter design parameters. This invention also achieves realistic simulation of electric field conduction along the axonal direction in finite element simulation by constructing a composite neural tissue model incorporating nerve fiber pathways and defining anisotropic conductivity, thus obtaining precise catheter design parameters that combine anatomical adaptability and electrophysiological targeting.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a method for selecting design parameters for pulse ablation catheters based on finite element analysis. Background Technology

[0002] Pulsed electric field ablation technology has been applied to the minimally invasive treatment of trigeminal neuralgia in recent years. It involves applying high-energy electrical pulses to the ganglion via catheter electrodes to achieve selective ablation. Current methods typically design catheter structural parameters based on general anatomical models or empirical parameters, and combine this with finite element analysis to conduct a preliminary assessment of the electric field distribution to guide electrode placement and pulse parameter settings.

[0003] However, conventional methods often fail to fully integrate the individualized Meckel cavity bony geometric constraints and the electrophysiological anisotropy of trigeminal nerve fibers during the selection of catheter design parameters. This makes it difficult for finite element models to accurately reflect the conduction behavior of electric fields in the direction of nerve axons, thereby affecting the accuracy of catheter parameters and the targeting of ablation. Summary of the Invention

[0004] In view of the aforementioned existing problems, the present invention is proposed.

[0005] Therefore, this invention provides a method for selecting design parameters of pulse ablation catheters based on finite element analysis to solve the problems of inaccurate catheter parameter selection and insufficient electric field targeting.

[0006] To solve the above-mentioned technical problems, the present invention provides the following technical solution:

[0007] This invention provides a method for selecting design parameters of pulse ablation catheters based on finite element analysis, which includes obtaining a registered and aligned DICOM format image dataset through high-resolution CT and DTI multimodal image scanning of the patient's skull base;

[0008] Based on the DICOM format image dataset, the spatial trajectory of the point cloud of the Meckel cavity inner wall of the catheter tip is segmented and extracted to generate the adaptive three-dimensional curvature trajectory of the catheter tip.

[0009] Based on the adaptive three-dimensional curvature trajectory of the catheter tip, combined with the trigeminal ganglion structure segmented by 3D-CISS, a composite neural tissue model is generated.

[0010] By performing finite element analysis on the composite neural tissue model, defining the neural tissue properties, a high-fidelity simulation model with individualized anatomical and electrophysiological characteristics is obtained.

[0011] Based on a high-fidelity simulation model, the optimal combination of pulse voltage parameters is obtained through gradient optimization under geometric constraints. Then, a catheter manufacturing and treatment plan is generated through catheter 3D printing and intraoperative treatment.

[0012] Based on the catheter manufacturing treatment plan, a catheter tip with electrode slots was constructed and optimized 3D printing files were created to obtain the design parameters of the pulse ablation catheter.

[0013] As a preferred embodiment of the method for selecting design parameters of pulse ablation catheters based on finite element analysis described in this invention, the specific steps for obtaining a registered and aligned DICOM format image dataset through high-resolution CT and DTI multimodal image scanning of the patient's skull base are as follows:

[0014] Based on the patient's skull base region, CT image data is obtained by acquiring bony structures;

[0015] Diffusion tensor imaging was used to perform multi-directional diffusion-weighted scanning of the skull base region of the same patient to obtain raw DTI data containing information on the direction of nerve fibers.

[0016] The CT image data and the original DTI data are registered and aligned using an image registration method to obtain a registered and aligned DICOM format image dataset.

[0017] As a preferred embodiment of the method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in this invention, the steps of segmenting and extracting the spatial trajectory of the catheter tip from the Meckel cavity inner wall point cloud based on the DICOM format image dataset, and generating an adaptive three-dimensional curvature trajectory of the catheter tip, are as follows.

[0018] Based on the DICOM format image dataset, the point cloud of the Meckel cavity inner wall was processed by segmentation extraction to obtain a preliminary three-dimensional mask of the Meckel cavity.

[0019] Based on the preliminary 3D mask of the Meckel cavity, the geometry of the surface of the inner wall of the Meckel cavity is converted into point cloud data by point cloud extraction, and the original point cloud dataset describing the geometry of the inner wall of the cavity is obtained.

[0020] The original point cloud dataset is denoised and feature points are extracted. An adaptive three-dimensional curvature trajectory of the duct tip centerline is generated by spatial curve fitting.

[0021] As a preferred embodiment of the method for selecting design parameters of pulse ablation catheters based on finite element analysis described in this invention, the specific steps for generating a composite neural tissue model based on the adaptive three-dimensional curvature trajectory of the catheter tip and the trigeminal ganglion structure segmented by 3D-CISS are as follows.

[0022] Based on the adaptive three-dimensional curvature trajectory of the catheter tip, the geometric data of the trigeminal ganglion structure are obtained by finely delineating the trigeminal ganglion and surrounding key anatomical structures.

[0023] Based on the geometric data of the trigeminal ganglion structure, spatial registration and fusion were performed using the nerve fiber orientation information reconstructed by DTI to obtain composite neural tissue data of nerve fiber orientation.

[0024] A composite neural tissue model is generated by spatially registering and fusing composite neural tissue data with the adaptive three-dimensional curvature trajectory of the catheter tip.

[0025] As a preferred embodiment of the method for selecting design parameters of pulse ablation catheters based on finite element analysis according to the present invention, the specific steps for defining the neural tissue properties by performing finite element analysis on the composite neural tissue model are as follows.

[0026] Based on the complex neural tissue model, the trigeminal ganglion and surrounding key anatomical structures are discretized into a mesh using finite element analysis to obtain a computational mesh for individualized anatomical morphology.

[0027] Based on the computational grid of individualized anatomical morphology, the material properties of neural tissue are defined using an anisotropic conductivity assignment method, thereby obtaining the properties of neural tissue.

[0028] As a preferred embodiment of the method for selecting design parameters of pulse ablation catheters based on finite element analysis according to the present invention, the specific steps for obtaining a high-fidelity simulation model of individualized anatomical and electrophysiological characteristics are as follows:

[0029] Based on the properties of neural tissue, the electrode positions are arranged using the geometric path of the adaptive three-dimensional curvature trajectory of the catheter tip in three-dimensional space, resulting in an electrode array spatial configuration distributed along the Meckel cavity.

[0030] Based on the spatial configuration of the electrode array and combined with the point-by-point nerve fiber direction information in the composite neural tissue model, the electrical properties of the neural tissue region are defined by the anisotropic conductivity assignment method, thereby obtaining a high-fidelity simulation model of individualized anatomical and electrophysiological characteristics.

[0031] As a preferred embodiment of the method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in this invention, the optimal combination of pulse voltage parameters is obtained through gradient optimization under geometric constraints based on a high-fidelity simulation model. The specific steps are as follows:

[0032] Based on the high-fidelity simulation model, the electric field distribution in the trigeminal ganglion region is analyzed by projection to obtain the cumulative intensity distribution of the electric field along the nerve fiber direction;

[0033] Based on the cumulative intensity distribution, the gradient optimization method is used to coordinately adjust the electrode spacing, electrode length, and pulse voltage under the geometric constraints limited by the adaptive curvature of the catheter, so as to obtain the optimal combination of pulse voltage parameters that meets the requirements of targeted ablation and safety boundaries.

[0034] As a preferred embodiment of the method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in this invention, the specific steps for generating a catheter manufacturing and treatment plan through catheter 3D printing and intraoperative treatment planning are as follows.

[0035] Based on the optimal combination of pulse voltage parameters, the electrode arrangement scheme including the number of electrodes, spacing and spatial coordinates is obtained by marking the electrode position on the adaptive three-dimensional curvature trajectory of the catheter tip.

[0036] Based on the catheter electrode arrangement scheme and the slot opening and insulation layer layout according to the geometry of the catheter tip, a solid file of the catheter tip for 3D printing and the corresponding pulse therapy parameters are obtained, and a catheter manufacturing treatment plan is generated.

[0037] As a preferred embodiment of the method for selecting design parameters of a pulse ablation catheter based on finite element analysis according to the present invention, the specific steps for obtaining the pulse ablation catheter design parameters are as follows: [The steps involve constructing a catheter tip containing electrode slots and optimizing a 3D printing file based on the catheter manufacturing treatment plan.]

[0038] According to the catheter manufacturing treatment plan, electrode slots are embedded in the three-dimensional curvature trajectory of the adaptive catheter tip to obtain the solid structural parameters of the catheter tip, including the electrode position and orientation.

[0039] Based on the solid structural parameters of the catheter tip, the geometric features of the electrode groove and the outer contour of the catheter are adapted to the manufacturing process using a format conversion method. This generates a 3D printing file of the catheter tip that meets the manufacturing requirements, along with a matching pulse therapy guidance document, thus obtaining the design parameters for the pulse ablation catheter.

[0040] As a preferred embodiment of the method for selecting design parameters of pulse ablation catheters based on finite element analysis as described in this invention, the step of embedding electrode slots into the three-dimensional curvature trajectory of the adaptive catheter tip according to the catheter manufacturing treatment plan to obtain the solid structural parameters of the catheter tip including electrode position and orientation is as follows.

[0041] Based on the catheter manufacturing and treatment plan, the electrode centerline is located by the three-dimensional curvature trajectory of the adaptive catheter tip. Using the electrode axial arrangement reference distributed along the catheter bending path, the solid structural parameters of the catheter tip containing the precise electrode position and orientation are obtained.

[0042] The beneficial effects of this invention are as follows: By generating an adaptive three-dimensional curvature trajectory at the tip of the catheter, precise matching between the catheter geometry and the individualized anatomy of the Meckel cavity is achieved, ensuring that the electrode array is laid out along the natural direction of the ganglion, providing a spatial basis for efficient energy transfer; by constructing a composite neural tissue model that integrates the direction of nerve fibers and defining anisotropic conductivity, the electric field is realistically simulated along the axonal direction in finite element simulation, allowing parameter optimization to focus on the target area of ​​nerve function, and obtaining precise catheter design parameters that combine anatomical adaptability and electrophysiological targeting. Attached Figure Description

[0043] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0044] Figure 1 This is a flowchart illustrating the method for selecting design parameters for pulse ablation catheters based on finite element analysis.

[0045] Figure 2 Flowchart for registration and alignment of multimodal image data.

[0046] Figure 3 Flowchart for generating the three-dimensional curvature trajectory of the catheter tip.

[0047] Figure 4 Flowchart for constructing a composite neural tissue model. Detailed Implementation

[0048] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0049] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0050] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in one embodiment" appearing in different places in this specification does not necessarily refer to the same embodiment, nor is it a single or selective embodiment that is mutually exclusive with other embodiments.

[0051] Reference Figures 1-4This is one embodiment of the present invention, which provides a method for selecting design parameters of a pulse ablation catheter based on finite element analysis, including the following steps:

[0052] S1. Obtain a registered and aligned DICOM format image dataset through high-resolution CT and DTI multimodal image scanning of the patient's skull base.

[0053] Based on the patient's skull base region, CT image data is obtained by acquiring bony structures;

[0054] Furthermore, a computed tomography scan of the patient's skull base was performed. The scanned images of the patient's skull base region were reconstructed using a bone window sequence to obtain high-resolution images. The scan covered the Meckel's cavity and surrounding bony anatomical structures. Based on the image acquisition equipment, CT image data containing bony structural information was obtained.

[0055] Diffusion tensor imaging was used to perform multi-directional diffusion-weighted scanning of the same region to obtain raw DTI data containing information on the direction of nerve fibers.

[0056] Furthermore, diffusion tensor imaging was used to perform multi-directional diffusion-weighted scanning of the same region. Multiple non-collinear diffusion-sensitive gradient directions were used to apply magnetic resonance pulse sequences to the patient's skull base region to collect diffusion response signals of water molecules in different directions. By calculating the diffusion tensor of each voxel, raw DTI data containing nerve fiber orientation information was obtained.

[0057] It should be noted that in this invention, the diffusion tensor is calculated based on the original diffusion tensor imaging data. Tensor fitting is performed on multi-directional diffusion-weighted images acquired from the same skull base region. The diffusion tensor value of water molecule diffusion within each voxel is used to perform eigenvalue decomposition to extract the principal feature vector. The principal feature vector represents the direction of local nerve fibers, which is used for spatial registration and fusion of the trigeminal ganglion structural geometric data.

[0058] The CT image data and the original DTI data are registered and aligned using image registration methods to obtain a registered and aligned DICOM format image dataset.

[0059] Furthermore, the CT image data and the original DTI data are registered and aligned using image registration methods. The spatial coordinates of the bony anatomical structures in the CT image data are aligned with the spatial positions of the nerve fibers in the original DTI data, so that the two achieve anatomical consistency in three-dimensional space and obtain a registered and aligned DICOM format image dataset.

[0060] It should be noted that, in this invention, the image registration method spatially aligns CT image data with the raw DTI data obtained from diffusion tensor imaging, using skull base bony landmarks or common anatomical features as a reference, so that the Meckel cavity bony structures in the CT image data and the nerve fiber orientation information in the raw DTI data correspond precisely in a unified coordinate system, thereby obtaining a registered and aligned DICOM format image dataset.

[0061] S2. Based on the DICOM format image dataset, segment and extract the spatial trajectory of the point cloud of the Meckel cavity inner wall of the catheter tip, and generate the adaptive three-dimensional curvature trajectory of the catheter tip.

[0062] Based on a DICOM format image dataset, segmentation extraction was used to process the point cloud of the Meckel cavity inner wall to obtain a preliminary 3D mask of the Meckel cavity.

[0063] Furthermore, based on CT image data in the DICOM format image dataset, by utilizing the difference in grayscale values ​​between bone tissue and surrounding soft tissue, the Meckel cavity inner wall region is three-dimensionally segmented. Voxels belonging to the bony boundary of the Meckel cavity are marked as foreground, and the remaining areas are marked as background. The segmentation results are extracted to obtain a preliminary three-dimensional mask of the Meckel cavity.

[0064] Based on the preliminary 3D mask of the Meckel cavity, the geometry of the surface of the Meckel cavity inner wall is converted into point cloud data by point cloud extraction, and the original point cloud dataset describing the geometry of the cavity inner wall is obtained.

[0065] Furthermore, based on the preliminary Meckel cavity 3D mask, the inner surface of the Meckel cavity 3D mask is sampled using point cloud processing. The vertices of the triangular mesh on the mask surface and the equidistant sampling points are extracted. The resulting geometric shape is converted into point cloud data through the Meckel cavity 3D mask. Dense point sampling is performed on the point cloud data of the Meckel cavity 3D mask to obtain the original point cloud dataset describing the geometry of the cavity inner wall.

[0066] It should be noted that in this invention, point cloudification processing involves uniformly or adaptively extracting a large number of discrete spatial points on the inner wall surface of the closed surface geometry represented by the initial Meckel cavity 3D mask through a surface sampling algorithm. Each point records the x, y, and z position information in the 3D coordinate system, converting the continuous surface representation into a point cloud dataset composed of a finite number of spatial points. The original point cloud dataset can faithfully reflect the geometric shape and local curvature characteristics of the inner wall of the Meckel cavity.

[0067] Denoising and feature point extraction were performed on the original point cloud dataset, and an adaptive three-dimensional curvature trajectory of the duct tip centerline was generated by spatial curve fitting.

[0068] Furthermore, noise points in the original point cloud dataset are filtered out, retaining only the point cloud reflecting the true geometry of the Meckel cavity wall. The curvature changes of the point cloud within a local neighborhood are extracted using feature points. A curve fitting method is then used to smooth and interpolate the extracted point cloud curvature changes, generating a continuous, smooth spatial curve located in the central region of the Meckel cavity. This spatial curve fully characterizes the curvature path that the catheter tip should follow within the patient's individual anatomical structure, obtaining the adaptive three-dimensional curvature trajectory of the catheter tip centerline. It should be noted that in this invention, spatial curve fitting, based on the surface point cloud data of the Meckel cavity wall, after denoising and feature point extraction, generates a continuous, smooth, and accurately reflective three-dimensional centerline by fitting the spatial distribution trend of the point cloud. This three-dimensional centerline is the adaptive three-dimensional curvature trajectory of the catheter tip, used to constrain the subsequent electrode array placement path, ensuring optimal fit of the catheter tip within the individualized anatomical structure. In this invention, point cloud data is obtained by performing point cloudification on the three-dimensional mask of the Meckel cavity initially extracted from the DICOM format image dataset. This is the original point cloud dataset used to describe the geometry of the inner wall of the Meckel cavity. After denoising and feature point extraction, the point cloud data is used to generate an adaptive three-dimensional curvature trajectory of the catheter tip centerline through spatial curve fitting technology, providing a geometric basis for individualized anatomical adaptation of the catheter tip.

[0069] S3. Based on the adaptive three-dimensional curvature trajectory of the duct tip, combined with the trigeminal ganglion structure segmented by 3D-CISS, a composite neural tissue model is generated.

[0070] Based on the adaptive three-dimensional curvature trajectory of the catheter tip, the geometric data of the trigeminal ganglion structure are obtained by finely delineating the trigeminal ganglion and surrounding key anatomical structures.

[0071] Furthermore, based on the adaptive three-dimensional curvature trajectory of the duct tip, the trigeminal ganglion and surrounding key anatomical structures are manually or semi-automatically segmented and delineated using 3D-CISS sequence images. The ganglion boundaries and adjacent brainstem, cavernous sinus, and vascular structures are labeled layer by layer in three-dimensional space using segmentation extraction to obtain the geometric data of the trigeminal ganglion structure.

[0072] It should be noted that, in this invention, the 3D-CISS sequence images are used for high-contrast imaging of the trigeminal ganglion and surrounding key anatomical structures, which can clearly show the interface between cerebrospinal fluid and nerve tissue, providing anatomical basis for fine segmentation of the trigeminal ganglion; the 3D-CISS sequence images are manually corrected or semi-automatically delineated to obtain the geometric data of the trigeminal ganglion structure, which serves as the basic input for generating a composite neural tissue model and is used for spatial registration and fusion with the nerve fiber orientation information.

[0073] Based on the geometric data of the trigeminal ganglion structure, spatial registration and fusion were performed using the nerve fiber orientation information reconstructed by DTI to obtain composite neural tissue data of nerve fiber orientation.

[0074] Furthermore, based on the trigeminal ganglion structural geometric data, spatial registration and fusion are performed using the nerve fiber orientation information reconstructed by diffusion tensor imaging. The image spatial registration method is used to align the trigeminal ganglion structural geometric data and the nerve fiber orientation information reconstructed by diffusion tensor imaging in the same coordinate system, so that each spatial position in the trigeminal ganglion structural geometric data is associated with the corresponding nerve fiber orientation information, thus obtaining composite neural tissue data of nerve fiber orientation.

[0075] It should be noted that in this invention, diffusion tensor imaging reconstruction is used to obtain the orientation information of nerve fibers within the trigeminal ganglion region. The original diffusion tensor imaging data is obtained by performing multi-directional diffusion-weighted scanning on the patient's skull base region. Based on the original diffusion tensor imaging data, the diffusion tensor of each voxel is calculated, and the principal feature vector is extracted as the local nerve fiber orientation to form point-by-point nerve fiber orientation data covering the trigeminal ganglion. The point-by-point nerve fiber orientation data is used to perform spatial registration and fusion with the trigeminal ganglion structure segmented by 3D-CISS to generate a composite neural tissue model containing nerve fiber orientation information.

[0076] A composite neural tissue model is generated by spatially registering and fusing composite neural tissue data with the adaptive three-dimensional curvature trajectory of the catheter tip.

[0077] Furthermore, by spatially registering and fusing the composite neural tissue data with the adaptive three-dimensional curvature trajectory of the catheter tip, the composite neural tissue data formed by the trigeminal ganglion structure geometric data obtained based on 3D-CISS segmentation and the nerve fiber orientation information reconstructed by diffusion tensor imaging is aligned with the adaptive three-dimensional curvature trajectory of the catheter tip generated by the Meckel cavity wall point cloud after denoising, feature point extraction and spatial curve fitting in a unified coordinate system. This ensures that the spatial positional relationship between the nerve fiber orientation and the catheter trajectory is accurately corresponded, thus generating a composite neural tissue model.

[0078] It should be noted that, in this invention, the composite neural tissue model is an integrated data structure generated by spatially registering and fusing the adaptive three-dimensional curvature trajectory of the catheter tip with the geometric data of the trigeminal ganglion structure, and combining it with the nerve fiber direction information reconstructed by DTI. This structure includes the spatial morphology of the trigeminal ganglion and the point-by-point nerve fiber orientation within it. The composite neural tissue model is used to define the anisotropic conductivity properties of neural tissue in finite element analysis, enabling the electric field simulation to realistically reflect the conduction characteristics of current along the nerve axon direction, and providing a high-fidelity computational basis with both anatomical and electrophysiological constraints for the optimization of catheter electrode parameters.

[0079] S4. By performing finite element analysis on the composite neural tissue model, the properties of the neural tissue are defined, and a high-fidelity simulation model of individualized anatomical and electrophysiological characteristics is obtained.

[0080] Based on the complex neural tissue model, the trigeminal ganglion and surrounding key anatomical structures are discretized into a mesh using finite element analysis to obtain a computational mesh for individualized anatomical morphology.

[0081] Furthermore, based on the composite neural tissue model, the trigeminal ganglion and surrounding anatomical structures are discretized into a mesh using finite element analysis. By spatially subdividing the trigeminal ganglion, brainstem, cavernous sinus, and adjacent bony structures in the composite neural tissue model, the unit density is adaptively adjusted according to the curvature of each tissue boundary. The mesh is densified in geometrically complex areas and sparsely divided in flat areas to obtain a computational mesh for individualized anatomical morphology.

[0082] It should be noted that in this invention, finite element analysis is used to discretize the composite neural tissue model into a mesh, generating a computational mesh with individualized anatomical morphology. Based on the computational mesh, an anisotropic conductivity assignment method is used to spatially register and fuse the geometric data of the trigeminal ganglion structure obtained by 3D-CISS segmentation in the composite neural tissue model with the nerve fiber orientation information reconstructed by DTI, resulting in composite neural tissue data containing the direction of nerve fibers at each point. Through the composite neural tissue data, a model that can realistically reflect the conduction behavior of electric field along the direction of nerve fibers is constructed. Finite element analysis further supports the deployment of electrode arrays under the constraint of adaptive three-dimensional curvature trajectory at the catheter tip, calculates the electric field distribution in the trigeminal ganglion region, performs projection analysis of the electric field along the direction of nerve fibers, and drives gradient optimization algorithm to coordinately adjust the electrode spacing, electrode length, and pulse voltage, obtaining a composite neural tissue model that meets the requirements of targeted ablation and safety boundaries, providing a quantitative basis for catheter manufacturing and treatment plans.

[0083] Based on the computational grid of individualized anatomical morphology, the material properties of neural tissue are defined using an anisotropic conductivity assignment method to obtain neural tissue properties;

[0084] Furthermore, based on the nerve fiber orientation information reconstructed by DTI in the composite neural tissue model, the conductivity at each location within the neural tissue is assigned different values ​​according to whether it is parallel to or perpendicular to the local fiber direction. Through finite element analysis, the conductivity relationship dependent on the local fiber direction is mapped to each cell of the computational grid of the individualized anatomical morphology, thereby completing the assignment of anisotropic conductivity values ​​to the neural tissue and obtaining neural tissue properties.

[0085] It should be noted that the anisotropic conductivity assignment method in this invention is based on the nerve fiber orientation information reconstructed from diffusion tensor imaging in a composite neural tissue model. According to the nerve fiber orientation information reconstructed from diffusion tensor imaging, the local nerve fiber unit direction vector corresponding to each spatial location within the trigeminal ganglion region is obtained. Through finite element analysis, a local coordinate system is constructed based on the unit direction vector, with one axis aligned with the nerve fiber direction. High conductivity values ​​are assigned to the conductivity components along the nerve fiber direction in the local coordinate system, while low conductivity values ​​are assigned to the conductivity components in the other two perpendicular directions. Through the tensor material property input function supported by finite element analysis, the direction-related conductivity values ​​are assigned to the corresponding spatial grid cells in the form of conductivity tensors, thus completing the anisotropic conductivity assignment of the neural tissue. High conductivity along the nerve fiber direction... Based on the nerve fiber orientation information associated with each spatial location in the composite neural tissue model, a local coordinate system corresponding to the location is established for conductivity perpendicular to the nerve fiber direction. After the finite element mesh is discretized, for each computational mesh element, the corresponding nerve fiber direction is queried from the composite neural tissue model according to its location. The nerve fiber direction is taken as the principal axis, and the high conductivity value in the parallel direction and the low conductivity value in the perpendicular direction are assigned two different values ​​of conductivity along the nerve fiber direction and perpendicular to the nerve fiber direction, respectively. The two different values ​​of conductivity are input into the finite element analysis to solve the electric field distribution. The direction-dependent characteristics of the conductivity of neural tissue are realistically reflected in the simulation, and the anisotropic conductivity of neural tissue is assigned. The anisotropic conductivity characteristics of nerve fiber orientation that truly reflect the preferential conduction of electric field along nerve axons in the high-fidelity simulation model are obtained.

[0086] It should be noted that the process uses the direction of the nerve fiber as the principal axis, assigns the high conductivity value in the parallel direction and the low conductivity value in the perpendicular direction to the conductivity tensor of the computational grid cell, and uses an anisotropic conductivity assignment method to define the material properties of the nerve tissue.

[0087] Based on the properties of neural tissue, the electrode positions are arranged using the geometric path of the adaptive three-dimensional curvature trajectory of the catheter tip in three-dimensional space, resulting in an electrode array spatial configuration distributed along the Meckel cavity.

[0088] Furthermore, by arranging the electrodes sequentially along the centerline of the adaptive three-dimensional curvature trajectory at the catheter tip, so that the geometric center of each electrode is located on the adaptive three-dimensional curvature trajectory at the catheter tip, and keeping the spacing between adjacent electrodes along the arc length of the trajectory consistent with the position of the electrodes on the geometric path, an electrode array spatial configuration distributed along the Meckel cavity is obtained.

[0089] Based on the spatial configuration of the electrode array and combined with the point-by-point nerve fiber direction information in the composite neural tissue model, the electrical properties of the neural tissue region are defined by the anisotropic conductivity assignment method, thereby obtaining a high-fidelity simulation model of individualized anatomical and electrophysiological characteristics.

[0090] Furthermore, in the finite element analysis, based on the nerve fiber direction information corresponding to each position in the composite neural tissue model, the conductivity of the neural tissue region is set as a tensor with different conductivity along the fiber direction and perpendicular to the fiber direction. By spatially aligning the spatial coordinates of each electrode in the electrode array spatial configuration with the composite neural tissue model, the current distribution during the electric field solution process can truly reflect the electrophysiological characteristics of preferential conduction along the nerve axon. By spatially aligning the electrophysiological characteristics with the individualized anatomical morphology, a high-fidelity simulation model of individualized anatomy and electrophysiological characteristics is obtained.

[0091] It should be noted that the high-fidelity simulation model in this invention is a computational model constructed based on a composite neural tissue model and through finite element analysis, which simultaneously integrates individualized anatomical morphology and neurophysiological characteristics. The high-fidelity simulation model uses the geometric path of the adaptive three-dimensional curvature trajectory of the catheter tip in three-dimensional space to arrange the electrode positions, forming an electrode array spatial configuration distributed along the Meckel cavity. Combined with the point-by-point nerve fiber direction information in the composite neural tissue model, the anisotropic conductivity assignment method is used to define the electrical properties of the neural tissue region, realistically reflecting the conduction behavior of the electric field along the axonal direction in the trigeminal ganglion, providing a high-precision simulation basis for solving the optimal pulse voltage parameter combination through gradient optimization under geometric constraints.

[0092] S5. Based on a high-fidelity simulation model, the optimal combination of pulse voltage parameters is obtained through gradient optimization under geometric constraints, and a catheter manufacturing and treatment plan is generated through catheter 3D printing manufacturing and intraoperative treatment plan.

[0093] Based on the high-fidelity simulation model, the electric field distribution in the trigeminal ganglion region is analyzed by projection to obtain the cumulative intensity distribution of the electric field along the nerve fiber direction;

[0094] Furthermore, based on the high-fidelity simulation model, the electric field distribution in the trigeminal ganglion region is analyzed by projection. By performing a dot product operation between the electric field vector field calculated in the high-fidelity simulation model and the nerve fiber direction corresponding to each point in the composite neural tissue model, the positive component of the electric field along the nerve fiber direction is extracted, and the volume integral is accumulated along the trigeminal ganglion region to obtain the cumulative intensity distribution of the electric field along the nerve fiber direction.

[0095] Based on the cumulative intensity distribution, the gradient optimization method is used to coordinate the electrode spacing, electrode length and pulse voltage under the geometric constraints limited by the adaptive curvature of the catheter, so as to obtain the optimal combination of pulse voltage parameters that meets the requirements of targeted ablation and safety boundary.

[0096] Furthermore, based on the cumulative intensity distribution of the electric field along the nerve fiber direction obtained by projection analysis of the electric field distribution in the trigeminal ganglion region using a high-fidelity simulation model, the electrode spacing, electrode length, and pulse voltage are coordinated and adjusted using the gradient optimization method under the geometric constraints defined by the adaptive three-dimensional curvature trajectory at the catheter tip. The values ​​of electrode spacing, electrode length, and pulse voltage are iteratively updated based on the spatial gradient of the cumulative intensity distribution, so that the cumulative intensity distribution of the electric field along the nerve fiber direction in the trigeminal ganglion meets the requirements for targeted ablation, while ensuring that the electric field intensity in the adjacent key anatomical structures is within the safety boundary, thus obtaining the optimal combination of pulse voltage parameters that meets the requirements of targeted ablation and safety boundary.

[0097] It should be noted that in this invention, targeted ablation requires that the cumulative intensity distribution of the electric field within the trigeminal ganglion along the nerve fiber direction reach an electric field level sufficient to induce irreversible electroporation, thereby achieving effective ablation of the target nerve tissue. It requires that the projection intensity of the electric field in the direction of the nerve axon be used as the main criterion to ensure that the energy is focused on the nerve functional target area rather than the surrounding non-target area.

[0098] Based on the optimal combination of pulse voltage parameters, the electrode arrangement scheme including the number of electrodes, spacing and spatial coordinates is obtained by marking the electrode position on the adaptive three-dimensional curvature trajectory of the catheter tip.

[0099] Furthermore, based on the spatial geometric path of the adaptive three-dimensional curvature trajectory at the catheter tip, the electrodes are arranged sequentially along the centerline of the adaptive three-dimensional curvature trajectory at the catheter tip. According to the electrode spacing and electrode length optimized in the finite element analysis, the coordinates of the starting and ending points of each electrode are determined on the adaptive three-dimensional curvature trajectory at the catheter tip, thus obtaining a catheter electrode arrangement scheme that includes the number of electrodes, electrode spacing, and the precise coordinates of each electrode in three-dimensional space.

[0100] Based on the catheter electrode arrangement scheme and the slot opening and insulation layer layout according to the geometry of the catheter tip, the solid file of the catheter tip for 3D printing and the corresponding pulse therapy parameters are obtained, and the catheter manufacturing treatment plan is generated.

[0101] Furthermore, based on the number, spacing, and spatial coordinates of the electrodes included in the catheter electrode arrangement scheme, the slot position and contour corresponding to each electrode are determined on the adaptive three-dimensional curvature trajectory of the catheter tip geometry. Slots matching the electrode shape are opened along the outer surface of the catheter, and an insulating area is reserved between adjacent electrode slots to achieve electrical isolation. Based on the number, spacing, and spatial coordinates of the electrodes included in the catheter electrode arrangement scheme, the slot position and contour corresponding to each electrode are located on the adaptive three-dimensional curvature trajectory of the catheter tip geometry. Groove geometric features matching the electrode shape are constructed along the outer surface of the catheter. The groove geometric features are reorganized to form a closed triangular mesh. According to the STL file format specification, the vertex coordinates and normal vector information of all closed triangular meshes are sequentially written into the file to generate an STL format file that meets the input requirements of 3D printing equipment. At the same time, the pulse voltage and electrode polarity in the catheter electrode arrangement scheme are organized into pulse treatment parameters. The two together constitute the catheter manufacturing treatment scheme.

[0102] S6. Based on the catheter manufacturing treatment plan, construct the catheter tip with electrode slots and optimize the 3D printing file to obtain the design parameters of the pulse ablation catheter.

[0103] According to the catheter manufacturing treatment plan, electrode slots are embedded in the three-dimensional curvature trajectory of the adaptive catheter tip to obtain the solid structural parameters of the catheter tip, including the electrode position and orientation.

[0104] Furthermore, based on the number, spacing, and spatial coordinate information of electrodes included in the catheter manufacturing treatment plan, the center line of the electrodes is positioned along the three-dimensional curvature trajectory of the adaptive catheter tip. The azimuth angle of each electrode on the circumference of the catheter is determined using the axial arrangement reference of the electrodes distributed along the bending path of the catheter. Using the center line of each electrode as a reference, a groove structure matching the shape of the electrode is generated on the catheter tip entity by stretching. The axial direction of the groove is coordinated with the direction of local nerve fibers, thus obtaining the structural parameters of the catheter tip entity including the position and orientation of the electrodes.

[0105] Based on the solid structure parameters of the catheter tip, the geometric features of the electrode groove and the outer contour of the catheter are adapted to the process using the format conversion method, generating a 3D printing file of the catheter tip that meets the manufacturing requirements and a matching pulse therapy guidance file, thus obtaining the design parameters of the pulse ablation catheter.

[0106] Furthermore, by reconstructing and smoothing the electrode slot spatial coordinates, slot depth, slot width, and outer surface curvature data of the catheter into the solid structural parameters of the catheter tip according to the geometric format supported by the additive manufacturing software, a 3D printing file of the catheter tip required for the printing process is generated. At the same time, the number of electrodes, spatial arrangement, and corresponding pulse voltage parameters are extracted and integrated into a pulse therapy guidance document to obtain the design parameters of the pulse ablation catheter.

[0107] It should be noted that, in this invention, the printing process requirements specifically refer to ensuring that, when converting the solid structural parameters of the catheter tip into a 3D printing file suitable for additive manufacturing, the geometric accuracy of the electrode slots, the surface finish of the catheter's outer contour, and the spatial isolation between the insulation layer and the conductive area meet the electrical safety and mechanical delivery performance requirements of the pulse ablation catheter.

[0108] This embodiment also provides a computer device applicable to the method of selecting design parameters for pulse ablation catheters based on finite element analysis, including: a memory and a processor; the memory is used to store computer-executable instructions, and the processor is used to execute the computer-executable instructions to implement the method of selecting design parameters for pulse ablation catheters based on finite element analysis as proposed in the above embodiment.

[0109] A computer device can be a terminal, and includes a processor, memory, communication interface, display screen, and input devices connected via a system bus. The processor provides computing and control capabilities. The memory includes non-volatile storage media and internal memory. The non-volatile storage media stores the operating system and computer programs. The internal memory provides the environment for the operation of the operating system and computer programs stored in the non-volatile storage media. The communication interface of the computer device is used for wired or wireless communication with external terminals. Wireless communication can be achieved through Wi-Fi, carrier networks, NFC (Near Field Communication), or other technologies. The display screen of the computer device can be an LCD screen or an e-ink screen. The input devices can be a touch layer covering the display screen, buttons, a trackball, or a touchpad on the computer device's casing, or an external keyboard, touchpad, or mouse.

[0110] This embodiment also provides a storage medium on which a computer program is stored. When the program is executed by a processor, it implements the method for selecting design parameters of a pulse ablation catheter based on finite element analysis as proposed in the above embodiment. The storage medium can be implemented by any type of volatile or non-volatile storage device or a combination thereof, such as Static Random Access Memory (SRAM), Electrically Erasable Programmable Read-Only Memory (EEPROM), Erasable Programmable Read-Only Memory (EPROM), Programmable Red-Only Memory (PROM), Read-Only Memory (ROM), magnetic storage, flash memory, magnetic disk, or optical disk.

[0111] In summary, this invention achieves precise matching between catheter geometry and individualized Meckel cavity anatomy by generating an adaptive three-dimensional curvature trajectory at the catheter tip, ensuring that the electrode array is laid out along the natural direction of the ganglion, providing a spatial basis for efficient energy transfer. By constructing a composite neural tissue model that integrates the direction of nerve fibers and defining anisotropic conductivity, it realizes the realistic conduction simulation of the electric field along the axonal direction in finite element simulation, allowing parameter optimization to focus on the neural functional target area, and obtaining precise catheter design parameters that combine anatomical adaptability and electrophysiological targeting.

[0112] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications and substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A method for selecting design parameters of a pulsed ablation catheter based on finite element analysis, the method comprising: include, ​ A registered and aligned DICOM format image dataset was obtained by scanning the patient's skull base with high-resolution CT and DTI multimodal images. Based on the DICOM format image dataset, the spatial trajectory of the point cloud of the Meckel cavity inner wall of the catheter tip is segmented and extracted, and an adaptive three-dimensional curvature trajectory of the catheter tip is generated. Based on the adaptive three-dimensional curvature trajectory of the catheter tip, combined with the trigeminal ganglion structure segmented by 3D-CISS, a composite neural tissue model is generated. By performing finite element analysis on the composite neural tissue model, defining the neural tissue properties, a high-fidelity simulation model with individualized anatomical and electrophysiological characteristics is obtained. Based on a high-fidelity simulation model, the optimal combination of pulse voltage parameters is obtained through gradient optimization under geometric constraints. Then, a catheter manufacturing and treatment plan is generated through catheter 3D printing and intraoperative treatment. Based on the catheter manufacturing treatment plan, a catheter tip containing electrode slots was constructed and the 3D printing file was optimized to obtain the design parameters for the pulse ablation catheter. The specific steps are as follows: According to the catheter manufacturing treatment plan, electrode slots are embedded in the three-dimensional curvature trajectory of the adaptive catheter tip to obtain the solid structural parameters of the catheter tip, including the electrode position and orientation. Based on the solid structural parameters of the catheter tip, the geometric features of the electrode groove and the outer contour of the catheter are adapted to the manufacturing process using a format conversion method. This generates a 3D printing file of the catheter tip that meets the manufacturing requirements, along with a matching pulse therapy guidance document, thus obtaining the design parameters for the pulse ablation catheter.

2. The method of selecting design parameters for a pulsed ablation catheter based on finite element analysis of claim 1, wherein: The process involves obtaining a registered and aligned DICOM format image dataset through high-resolution CT and DTI multimodal imaging of the patient's skull base. The specific steps are as follows: Based on the patient's skull base region, CT image data is obtained by acquiring bony structures; Diffusion tensor imaging was used to perform multi-directional diffusion-weighted scanning of the skull base region of the same patient to obtain raw DTI data containing information on the direction of nerve fibers. The CT image data and the original DTI data are registered and aligned using an image registration method to obtain a registered and aligned DICOM format image dataset.

3. The method of selecting design parameters for a pulsed ablation catheter based on finite element analysis of claim 2, wherein: The step involves segmenting and extracting the spatial trajectory of the catheter tip from the point cloud of the Meckel cavity inner wall based on the DICOM format image dataset, and generating an adaptive 3D curvature trajectory for the catheter tip. The specific steps are as follows: Based on the DICOM format image dataset, the point cloud of the Meckel cavity inner wall was processed by segmentation extraction to obtain a preliminary three-dimensional mask of the Meckel cavity. Based on the preliminary 3D mask of the Meckel cavity, the geometry of the surface of the inner wall of the Meckel cavity is converted into point cloud data by point cloud extraction, and the original point cloud dataset describing the geometry of the inner wall of the cavity is obtained. The original point cloud dataset is denoised and feature points are extracted. An adaptive three-dimensional curvature trajectory of the duct tip centerline is generated by spatial curve fitting.

4. The method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in claim 3, characterized in that: The process involves generating a composite neural tissue model based on the adaptive three-dimensional curvature trajectory of the duct tip, combined with the trigeminal ganglion structure segmented by 3D-CISS. The specific steps are as follows: Based on the adaptive three-dimensional curvature trajectory of the catheter tip, the geometric data of the trigeminal ganglion structure are obtained by finely delineating the trigeminal ganglion and surrounding key anatomical structures. Based on the geometric data of the trigeminal ganglion structure, spatial registration and fusion were performed using the nerve fiber orientation information reconstructed by DTI to obtain composite neural tissue data of nerve fiber orientation. A composite neural tissue model is generated by spatially registering and fusing composite neural tissue data with the adaptive three-dimensional curvature trajectory of the catheter tip.

5. The method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in claim 4, characterized in that: The process involves defining the neural tissue properties through finite element analysis of the composite neural tissue model. The specific steps are as follows: Based on the complex neural tissue model, the trigeminal ganglion and surrounding key anatomical structures are discretized into a mesh using finite element analysis to obtain a computational mesh for individualized anatomical morphology. Based on the computational grid of individualized anatomical morphology, the material properties of neural tissue are defined using an anisotropic conductivity assignment method, thereby obtaining the properties of neural tissue.

6. The method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in claim 5, characterized in that: The specific steps for obtaining a high-fidelity simulation model of individualized anatomical and electrophysiological characteristics are as follows. Based on the properties of neural tissue, the electrode positions are arranged using the geometric path of the adaptive three-dimensional curvature trajectory of the catheter tip in three-dimensional space, resulting in an electrode array spatial configuration distributed along the Meckel cavity. Based on the spatial configuration of the electrode array and combined with the point-by-point nerve fiber direction information in the composite neural tissue model, the electrical properties of the neural tissue region are defined by the anisotropic conductivity assignment method, thereby obtaining a high-fidelity simulation model of individualized anatomical and electrophysiological characteristics.

7. The method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in claim 6, characterized in that: The optimal combination of pulse voltage parameters is obtained through gradient optimization under geometric constraints based on a high-fidelity simulation model. The specific steps are as follows: Based on the high-fidelity simulation model, the electric field distribution in the trigeminal ganglion region is analyzed by projection to obtain the cumulative intensity distribution of the electric field along the nerve fiber direction; Based on the cumulative intensity distribution, the gradient optimization method is used to coordinately adjust the electrode spacing, electrode length, and pulse voltage under the geometric constraints limited by the adaptive curvature of the catheter, so as to obtain the optimal combination of pulse voltage parameters that meets the requirements of targeted ablation and safety boundaries.

8. The method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in claim 7, characterized in that: The process of generating a catheter manufacturing and treatment plan through 3D printing of catheters and intraoperative treatment planning involves the following specific steps. Based on the optimal combination of pulse voltage parameters, the electrode arrangement scheme including the number of electrodes, spacing and spatial coordinates is obtained by marking the electrode position on the adaptive three-dimensional curvature trajectory of the catheter tip. Based on the catheter electrode arrangement scheme and the slot opening and insulation layer layout according to the geometry of the catheter tip, a solid file of the catheter tip for 3D printing and the corresponding pulse therapy parameters are obtained, and a catheter manufacturing treatment plan is generated.

9. The method for selecting design parameters of a pulse ablation catheter based on finite element analysis as described in claim 1, characterized in that: According to the catheter manufacturing and treatment plan, electrode slots are embedded in the three-dimensional curvature trajectory of the adaptive catheter tip to obtain the solid structural parameters of the catheter tip, including the electrode position and orientation. The specific steps are as follows. Based on the catheter manufacturing and treatment plan, the electrode centerline is located by the three-dimensional curvature trajectory of the adaptive catheter tip. Using the electrode axial arrangement reference distributed along the catheter bending path, the solid structural parameters of the catheter tip containing the precise electrode position and orientation are obtained.

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