Duodenal ablation system and method incorporating three-dimensional reconstruction

Abstract

The application provides a duodenum ablation system and method combined with three-dimensional reconstruction. The duodenum ablation system combined with three-dimensional reconstruction comprises a master control unit, a three-dimensional reconstruction module, an intelligent ablation planning module, a nerve function mapping module, an ablation execution device and a real-time monitoring and feedback control module. By integrating intraluminal electrical stimulation mapping technology, the nerve excitability of the target region can be functionally evaluated and mapped before ablation, and the "high-risk nerve area" can be intuitively marked on the three-dimensional mucosa model. When the system automatically plans the path, it can actively avoid these areas or use verified safe energy parameters in these areas, thereby maximizing the protection of important intestinal nerve function and reducing the risk of nerve damage-related complications from the source. The purposes of intelligent navigation and automatic planning, individualized adaptive control and functional nerve protection are achieved.

Description

Technical Field

[0001] This invention belongs to the field of medical technology, and in particular relates to a duodenal ablation system and method that combines three-dimensional reconstruction. Background Technology

[0002] In recent years, duodenal mucosal thermal ablation has become a new and effective interventional treatment for type 2 diabetes in the biomedical engineering industry. Its principle is to ablate the surface layer of the duodenal mucosa with controlled energy, promoting mucosal regeneration and thereby improving insulin resistance and blood glucose regulation.

[0003] The existing duodenal ablation equipment and related technologies are as follows:

[0004] Balloon catheter thermal ablation system: It uses an expandable balloon to fit the intestinal wall and performs uniform ablation by injecting hot saline or steam. However, it relies on two-dimensional X-ray positioning and cannot achieve three-dimensional structural perception and individualized navigation.

[0005] Multi-electrode radiofrequency ablation system: It performs point-by-point ablation through a deployable electrode array and monitors changes in tissue impedance, but it still lacks real-time three-dimensional guidance and adaptive path planning capabilities.

[0006] Pulsed electric field ablation (PFA) and cryoablation: Although each has its own characteristics, they still have significant shortcomings in terms of real-time visualization, precise control and immediate assessment during the procedure.

[0007] The existing technology has the following main limitations:

[0008] Low visualization dimension: Relying on two-dimensional X-rays or direct endoscopic visualization, lacking three-dimensional spatial information, it is difficult to judge the fit between the ablation head and complex mucosal folds, which can easily lead to ablation omissions or overlaps.

[0009] The control strategy is rigid: it mostly uses preset energy parameters and time. Although some systems introduce impedance feedback, they do not combine real-time three-dimensional anatomical information to carry out individualized path planning and dynamic energy adjustment.

[0010] Lack of real-time intraoperative assessment: The ablation effect usually depends on endoscopic follow-up several weeks after the operation. It is impossible to judge the ablation coverage and uniformity in real time during the operation, which may lead to insufficient efficacy or the need for a second operation.

[0011] Operational dependence on experience: The selection of ablation points and the path depend on the surgeon's experience, making it difficult to standardize and repeat.

[0012] Furthermore, existing ablation techniques have blind spots in terms of neuroprotection: the duodenal wall is rich in a complex enteric nervous system (ENS) and exogenous nerve endings (such as the vagus nerve), which are crucial for intestinal motility, secretion, and sensory functions. Current ablation techniques, whether based on temperature, impedance, or pre-defined anatomical pathways, lack the ability to identify and locate functional neural structures in real time during the procedure. Ablation energy may inadvertently damage these nerves, leading to postoperative complications such as intestinal motility disorders and delayed gastric emptying. Summary of the Invention

[0013] To address the aforementioned problems in the existing technology, this invention provides a duodenal ablation system and method that combines three-dimensional reconstruction.

[0014] In a first aspect, embodiments of this disclosure provide a duodenal ablation system incorporating three-dimensional reconstruction, comprising:

[0015] The system comprises a main control unit, a 3D reconstruction module, an intelligent ablation planning module, a neural function mapping module, an ablation execution device, and a real-time monitoring and feedback control module.

[0016] The three-dimensional reconstruction module, intelligent ablation planning module, neural function mapping module, ablation execution device, and real-time monitoring and feedback control module are all electrically connected to the main control unit.

[0017] The three-dimensional reconstruction module is used to generate and update the three-dimensional mucosal model of the duodenal lumen in real time based on the acquired data;

[0018] The intelligent ablation planning module is used to automatically plan the position and movement path of the ablation point based on the three-dimensional mucosal model, and obtain a preliminary ablation path.

[0019] The neural function mapping module includes a neural stimulation unit, a neural response detection unit, a neural atlas generation unit, and a safe path planning and optimization unit.

[0020] The neural stimulation unit is used to apply diagnostic electrical stimulation to the duodenal wall;

[0021] The neural response detection unit is used to detect intestinal wall microfeedback signals induced by electrical stimulation;

[0022] The neural atlas generation unit is used to generate a neural excitability heatmap on the three-dimensional mucosal model based on the coordinates of each electrical stimulation point and its corresponding neural response threshold and amplitude.

[0023] The safety path planning optimization unit is used to optimize the preliminary ablation path planned by the intelligent ablation planning module based on the neural excitability heatmap.

[0024] The ablation execution device is used to perform ablation operations under optimized path guidance;

[0025] The real-time monitoring and feedback control module is electrically connected to the ablation execution device and is used to collect ablation parameters in real time and dynamically adjust the ablation energy output.

[0026] Optionally, it also includes a multimodal image fusion and navigation module and a display and interaction unit, both of which are electrically connected to the main control unit.

[0027] The multimodal image fusion and navigation module is used to register the three-dimensional mucosal model with real-time medical images to generate an augmented reality navigation interface.

[0028] The display and interaction unit is used to display the augmented reality navigation interface, ablation path, neural excitability heatmap, and real-time monitoring parameters.

[0029] Optionally, the three-dimensional reconstruction module includes:

[0030] The preoperative image import unit is used to import and reconstruct CT or MRI images to generate a priori model of the duodenal anatomy.

[0031] The intraoperative real-time acquisition unit, integrated into the catheter tip, includes a structured light / laser scanning component, an electromagnetic or impedance positioning unit, and a vision unit, used to acquire dense point cloud data within the lumen, catheter position information, and endoscopic video stream;

[0032] The multi-source data fusion unit is used to fuse the prior model, point cloud data, duct location information and video stream in a unified coordinate system to generate a real-time updated three-dimensional mucosal model.

[0033] Optionally, the safe path planning optimization unit is configured to perform one or more of the following operations:

[0034] The ablation path was redesigned to bypass the highly excitable core region marked in the aforementioned neuroexcitability thermogram;

[0035] In the area of ​​high neural excitability, it automatically switches to a preset safe ablation mode with energy parameters below the set value;

[0036] Before performing ablation on the highly neurologically active area, a mandatory secondary confirmation prompt message is issued.

[0037] Optionally, the real-time monitoring and feedback control module includes:

[0038] A multi-parameter sensing unit is used to acquire at least one of the following in real time: contact force, tissue impedance, local temperature, image features, intracavitary pressure waveform, and electrophysiological signal;

[0039] An adaptive energy control unit is used to dynamically adjust the ablation energy and time based on the data collected by the multi-parameter sensing unit and the morphological characteristics of the three-dimensional mucosal model.

[0040] The ablation boundary prediction unit is used to predict the ablation range and depth in real time on the three-dimensional mucosal model based on the data and energy parameters collected by the multi-parameter sensing unit and in combination with the pre-established energy, depth and range mapping model.

[0041] Optionally, the ablation execution device includes: an intelligent ablation catheter and a robot-assisted drive unit;

[0042] The head of the intelligent ablation catheter integrates an ablation energy generator, a contact force sensor, a temperature sensor, and an optical scanning element, wherein the ablation energy generator is at least one of a radio frequency electrode, a pulsed electric field electrode, a laser unit, and a hot steam unit.

[0043] The robot-assisted drive unit is electrically connected to the intelligent ablation catheter to achieve automatic positioning and stable fitting of the catheter.

[0044] Secondly, embodiments of this disclosure also provide a method for duodenal ablation combined with three-dimensional reconstruction, based on the system described in any one of the first aspects, comprising:

[0045] Data acquisition and 3D model construction steps: Import preoperative images, insert the ablation catheter into the target segment of the duodenum, and use the scanning component and vision module at the catheter tip to generate and update the 3D mucosal model of the duodenal lumen in real time.

[0046] Multimodal image registration and navigation preparation steps: Register the three-dimensional mucosal model with the intraoperative medical images to generate and display an augmented reality navigation interface that integrates the real-time catheter position and the preliminary planned path;

[0047] Personalized ablation path planning steps: Based on the three-dimensional mucosal model, the target ablation intestinal segment is automatically identified, and the preliminary ablation point location, sequence, and catheter movement path are planned to obtain the preliminary ablation path;

[0048] Functional neuromapping and safety boundary calibration steps: The guiding catheter performs neurofunctional mapping on the planned ablation area, diagnostic electrical stimulation is applied at the mapping points, and changes in intracavitary pressure and electrical signals are monitored simultaneously. The spatial coordinates of each mapping point and the stimulation threshold that elicits a positive neurological response are recorded. All mapping point data are integrated, and a neuroexcitability thermogram is generated and displayed on the three-dimensional mucosal model. Based on the neuroexcitability thermogram, the preliminary ablation path is optimized to generate a safe ablation path.

[0049] Real-time precise ablation steps guided by neural function: Under the guidance of an augmented reality navigation interface that integrates neural excitability thermograms, the ablation operation is performed along the safe ablation path, and the parameters are monitored in real time and the ablation energy is dynamically adjusted during the ablation operation.

[0050] Intraoperative real-time assessment and supplementary ablation steps: After ablation, the target area is scanned a second time. The three-dimensional mucosal model after ablation is compared with the three-dimensional mucosal model before ablation. The ablation coverage rate is automatically calculated and the missed areas are marked. Safe ablation paths are planned for the missed areas and supplementary ablation is performed.

[0051] Optionally, in the intraoperative real-time assessment and supplementary ablation steps, the intraoperative real-time assessment includes:

[0052] For ablation methods that can cause color / texture changes, directly compare the color and texture changes of the three-dimensional mucosal model before and after ablation;

[0053] For ablation methods that do not cause obvious color changes, after spraying the dye, the target area is scanned a second time and compared with the three-dimensional mucosal model.

[0054] Optionally, in the functional neuromapping and safety boundary calibration step, recording the spatial coordinates of each mapping point and the stimulation threshold that elicits a positive neural response includes:

[0055] By using wavelet analysis or lock-in amplification techniques, weak intracavitary pressure and electrical signals induced by stimuli can be extracted from background noise to determine whether a positive neural response is elicited.

[0056] Optionally, in the functional neural mapping and safety boundary calibration step, the preliminary ablation path is optimized to generate a safe ablation path, including:

[0057] The safe ablation path is generated using a multi-objective optimization algorithm. The optimization objectives include maximizing the coverage of the ablation area, minimizing the catheter movement path, and maximizing the avoidance of highly neurologically excitable areas.

[0058] The duodenal ablation system combined with 3D reconstruction provided by this invention automatically plans the optimal ablation path based on 3D anatomical features, achieving standardized operation with full coverage and no overlap, reducing reliance on operator experience. It dynamically adjusts ablation parameters to achieve "precise dose delivery," ensuring efficacy while maximizing the protection of deep tissues. By integrating intraluminal electrical stimulation mapping technology, it can perform functional assessment and mapping of the nerve excitability of the target area before ablation, visually marking "high-risk nerve areas" on the 3D mucosal model. During automatic path planning, the system can actively avoid these areas or use validated safe energy parameters in these areas, thereby maximizing the protection of important intestinal nerve function and reducing the risk of nerve damage-related complications from the source. This achieves the goals of intelligent navigation and automatic planning, individualized adaptive control, and functional neuroprotection. Attached Figure Description

[0059] The above and other objects, features and advantages of this disclosure will become more apparent from the accompanying drawings, in which like reference numerals generally denote like parts.

[0060] Figure 1 A schematic diagram of the principle of the duodenal ablation system combined with three-dimensional reconstruction provided in the embodiments of this disclosure;

[0061] Figure 2 A flowchart of multi-source data fusion provided in this embodiment of the disclosure;

[0062] Figure 3 A flowchart illustrating the spatial alignment of feature points between a 3D model and a real-time X-ray fluoroscopic image provided in the embodiments of this disclosure;

[0063] Figure 4 This is a schematic diagram of the ablation catheter head structure provided in an embodiment of this disclosure;

[0064] Figure 5 A flowchart of state-adjusted ablation energy and time provided in embodiments of this disclosure;

[0065] Figure 6 A flowchart of duodenal ablation combined with three-dimensional reconstruction provided in this embodiment of the disclosure;

[0066] The components include: 1. Mapping / ablation / stimulation electrodes; 2. Pressure sensor; 3. Magnetic / electric sensor; 4. Temperature sensor; 5. CMOS camera; and 6. Structured light projector. Detailed Implementation

[0067] The embodiments of this disclosure will now be described in detail with reference to the accompanying drawings.

[0068] It should be understood that the following specific examples illustrate the implementation of this disclosure, and those skilled in the art can easily understand other advantages and effects of this disclosure from the content disclosed in this specification. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. This disclosure can also be implemented or applied through other different specific implementation methods, and the details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of this disclosure. It should be noted that, in the absence of conflict, the following embodiments and features in the embodiments can be combined with each other. Based on the embodiments in this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0069] It should be noted that the aspects described herein can be embodied in a wide variety of forms, and any particular structure and / or function described herein is merely illustrative. Based on this disclosure, those skilled in the art will understand that one aspect described herein can be implemented independently of any other aspect, and two or more of these aspects can be combined in various ways. For example, any number of aspects set forth herein can be used to implement the device and / or practice method. Furthermore, this device and / or practice method can be implemented using other structures and / or functionalities besides one or more of the aspects set forth herein.

[0070] It should also be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of this disclosure. The illustrations only show the components related to this disclosure and are not drawn according to the number, shape and size of the components in actual implementation. In actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.

[0071] Furthermore, specific details are provided in the following description to facilitate a thorough understanding of the examples. However, those skilled in the art will understand that the described aspects can be practiced without these specific details.

[0072] This embodiment solves the technical problems in the field of duodenal ablation where real-time visualization and dynamic updates are not possible during the procedure, and the lack of protection of functional neural structures prevents real-time intraoperative assessment and supplementary ablation of the ablation effect.

[0073] Based on existing technologies, there is an urgent need for an intelligent ablation system that can construct a three-dimensional model in real time during surgery and achieve precise navigation and adaptive control in order to improve the safety, effectiveness and standardization of the surgery.

[0074] This embodiment describes a duodenal mucosal ablation system and method for the treatment of metabolic diseases such as type 2 diabetes. The system integrates real-time 3D reconstruction, multimodal image navigation, intelligent path planning, and adaptive energy control to achieve full-process visualization, precision, and personalized operation during the procedure.

[0075] The ablation system and method of this embodiment address the problems existing in the prior art, such as lack of three-dimensional visualization, reliance on experience for path planning, inaccurate energy control, and difficulty in intraoperative assessment, thereby achieving intelligent, precise, and personalized ablation surgery.

[0076] like Figure 1 As shown, the present invention provides a duodenal ablation system combining three-dimensional reconstruction, comprising:

[0077] (1) Main control unit: includes a high-performance processor and memory, used for system control, data fusion, algorithm execution and user interaction.

[0078] (2) Three-dimensional reconstruction module: used to construct a three-dimensional duodenal mucosa model that is updated in real time during surgery, supporting multi-source data fusion:

[0079] 3D reconstruction module: includes preoperative image import unit, intraoperative real-time acquisition unit and multi-source data fusion unit;

[0080] Preoperative image import unit: Supports the import and 3D reconstruction of images such as CT and MRI, and provides prior knowledge of anatomical structures.

[0081] Intraoperative real-time acquisition unit: includes structured light / laser scanning components, electromagnetic or impedance positioning unit (hereinafter referred to as positioning unit) and vision unit;

[0082] Structured light / laser scanning component: integrated into the catheter tip, used for high-precision optical scanning of the inner surface of the duodenum to acquire dense point cloud data.

[0083] Electromagnetic or impedance positioning unit: Acquires catheter position information in real time through electrodes on the catheter surface to assist in modeling and tracking.

[0084] Visual unit: Based on the endoscope video stream, it estimates lens motion in real time and incrementally updates the 3D mucosal model.

[0085] Multi-source data fusion unit: This unit fuses data from the preoperative image import unit and the intraoperative real-time acquisition unit in a unified coordinate system to generate a high-precision, real-time updated three-dimensional duodenal mucosal model. The fusion process is as follows: Figure 2 As shown:

[0086] After the fusion begins, a globally unified coordinate system is first established. Establishing a globally unified coordinate system specifically includes:

[0087] 1. Coordinate system anchoring: Select the patient's anatomical feature points as fixed anchor points and define the x / y / z axes;

[0088] 2. Coordinate transformation relationship calibration: Establish the transformation matrix from the local coordinate system to the global coordinate system for each device.

[0089] 3. Preoperative CT / MRI image coordinate registration: The coordinate transformation matrix is ​​obtained by registering anatomical feature points.

[0090] After establishing a globally unified coordinate system, multi-source data preprocessing is performed to eliminate data noise and bias. Then, hierarchical multi-source data fusion is carried out, including coarse fusion and fine fusion.

[0091] Coarse fusion: Rigid registration of preoperative model and intraoperative positioning to construct a global anatomical framework model.

[0092] The fine fusion process includes: 1. Constructing an initial fine point cloud based on structured light point clouds; 2. Incrementally supplementing the point cloud in blind spots of the field of view using endoscopic video; 3. Applying motion constraints to localization data to avoid splicing misalignments; 4. Cross-validating multiple datasets, using the structured light point cloud as a benchmark to correct deviations. The model is then updated and optimized in real time based on the fused data.

[0093] (3) Multimodal image fusion and navigation module:

[0094] Image registration unit: Aligns the 3D mucosal model with real-time X-ray fluoroscopic images in terms of feature points and space. The alignment process is as follows: Figure 3 As shown. This implementation can also utilize other medical images besides X-rays.

[0095] The alignment process includes: dual coordinate system calibration, feature point extraction, and spatial alignment and registration.

[0096] Dual coordinate system calibration includes: 1. X-ray equipment calibration, establishing the projection matrix; 2. Global coordinate system anchor point mapping (3D coordinates to 2D pixel coordinates); 3. Solving for the transformation matrix from the global coordinate system to the X-ray imaging coordinate system.

[0097] Feature point extraction includes: extracting anatomical feature points and preprocessing (enhancement / denoising) + extracting homologous feature points, and outputting two-dimensional pixel coordinates.

[0098] Spatial alignment and registration includes coarse registration and fine registration; coarse registration: based on the transformation matrix, the 3D mucosal model is projected onto the X-ray image and roughly aligned; fine registration: least squares method / ICP correction of the transformation matrix.

[0099] Augmented reality navigation interface: The display unit integrates and displays a 3D mucosal model, real-time catheter position, planned path, ablation area and predicted ablation boundary, and supports 3D perspective, cross-sectional view and panoramic view.

[0100] (4) Intelligent ablation planning module:

[0101] Target area identification unit: Automatically identifies ablation target areas (such as the bulb and upper descending part) based on a three-dimensional mucosal model.

[0102] Path planning algorithm: Using surface rasterization or graph search algorithm, a sequence of ablation points with full coverage, no overlap and shortest path is planned on the surface of the three-dimensional mucosa model.

[0103] (5) Ablation actuator:

[0104] like Figure 4 As shown, the intelligent ablation catheter integrates an ablation energy generator (such as a radio frequency electrode, a pulsed electric field electrode, a laser or thermal steam unit), a contact force sensor, a temperature sensor, and an optical scanning element at its head.

[0105] Robot-assisted drive unit: enables automatic positioning and stable fitting of the catheter.

[0106] (6) Neurofunctional mapping module:

[0107] This module works in conjunction with the intelligent ablation catheter and the main control unit to perform functional neuromapping of the duodenal wall before ablation, identifying and marking nerve-sensitive areas that need to be avoided.

[0108] Neurostimulation unit: Integrated into the tip of the ablation catheter, it can output safe and controllable low-frequency electrical stimulation pulses using one or more sets of dedicated electrodes. Stimulation parameters (waveform, frequency, pulse width, current intensity) are precisely controlled by the main control unit and follow safe electrophysiological stimulation protocols.

[0109] Neural response detection unit:

[0110] Intraluminal pressure / motion sensor: A high-sensitivity sensor used to detect localized micro-contractions of the intestinal wall (motor nerve response) induced by electrical stimulation.

[0111] Intracavitary electrophysiological recording electrodes: used to synchronously record stimulation-induced smooth muscle compound action potentials (direct electrophysiological responses).

[0112] The neural atlas generation unit can be located within the main control unit. This unit receives the spatial coordinates of each mapping point (from the positioning unit) and its corresponding neural stimulation threshold (the minimum current required to elicit a detectable response) and response amplitude. Through algorithmic processing, a superimposed neural excitability heatmap is generated on an existing 3D duodenal mucosa model. This map uses color coding (e.g., dark red represents low threshold / high excitability, dark blue represents high threshold / low excitability) to visually display the distribution of neural function. The entire algorithm flow follows the logic of "data preprocessing → spatial interpolation → excitability quantization → color coding → 3D texture mapping → rendering output".

[0113] Safety Path Planning Optimization Unit: This unit works in conjunction with the "Intelligent Ablation Planning Module". After obtaining the neural excitability heatmap, this unit automatically optimizes the initially planned ablation path, employing one or more of the following strategies for areas with high neural excitability.

[0114] Proactive avoidance: Replan the route to bypass the core high-risk area.

[0115] Parameter downgrade: Automatically switch to a pre-validated, safer ablation energy mode or parameter set (such as lower energy or shorter duration) in this area.

[0116] Key confirmation: Before performing ablation in this area, issue a mandatory secondary confirmation prompt to the operator.

[0117] (7) Real-time monitoring and feedback control module:

[0118] Multi-parameter sensing unit: Real-time acquisition of contact force, tissue impedance, local temperature, image features, as well as intracavitary pressure waveforms and electrophysiological signals during neuromapping.

[0119] Adaptive energy control unit: Based on sensor data and 3D mucosal model characteristics, it dynamically adjusts the ablation energy and time. Specifically, as follows... Figure 5 As shown:

[0120] After ablation is initiated; initial energy parameters are set; energy output begins; real-time data acquisition includes contact force, power, and impedance; characteristic change rate and predicted depth are calculated; comparison is made with target and safety thresholds; it is determined whether adjustment is needed. If so, new energy parameters are calculated and energy output is updated; otherwise, it is determined whether termination conditions have been met. If not, the loop continues; if so, energy output is stopped.

[0121] Ablation Boundary Prediction Unit: Based on contact force, energy parameters, and tissue characteristics, this unit uses finite element simulation or empirical models to visualize and predict the ablation range and depth in real time on a three-dimensional mucosal model. Taking the empirical model as an example, an energy-depth-range mapping table is first established using extensive experimental data equipment before actual treatment. During the actual treatment process, data such as contact force, power, and impedance are collected in real time via sensors, and the predicted range and depth are then obtained based on the table lookup.

[0122] (8) Display and interaction unit: Provides a multi-view interface, including a three-dimensional navigation view, real-time endoscopic images, parameter monitoring panel, planning path and ablation process display.

[0123] The main control unit of the fusion system can utilize a high-performance workstation with GPU acceleration. The 3D scanning component can employ a combination of a miniature structured light projector and a CMOS camera, encapsulated within a transparent cover at the catheter tip. Positioning can combine an electromagnetic positioning system with impedance positioning to improve robustness. The ablation electrode can be a multi-polar flexible electrode array, compatible with both high-frequency ablation and low-frequency diagnostic stimulation functions, with a miniature pressure sensor and thermocouple integrated below.

[0124] The 3D reconstruction algorithm can employ real-time TSDF fusion and surface mesh extraction, combined with visual inertial odometry (VIO) for continuous optimization.

[0125] Neural detection algorithms can use wavelet analysis or lock-in amplification techniques to accurately extract weak stimulus-induced pressure signals and electrical signals from background noise.

[0126] Neural atlas generation can employ spatial interpolation algorithms to transform discrete threshold data into continuous heatmaps.

[0127] The safe path planning algorithm integrates multi-objective optimization (such as maximizing coverage, minimizing path length, and minimizing neural risk) to provide surgeons with the optimal trade-off.

[0128] Energy control models can be built based on clinical trial data to establish machine learning models and achieve the mapping of multiple parameter inputs to energy parameters.

[0129] The system operation procedure is as follows:

[0130] The operator first completes preoperative image import and equipment self-check. After the catheter enters the duodenum, automatic scanning and modeling are initiated. The system generates a 3D mucosal model and completes registration within minutes. After the operator confirms the target area, the system automatically plans the path. After the system automatically plans the initial ablation path, the operator can activate the "neuromapping" mode. The catheter will automatically or semi-automatically perform rapid mapping of key areas (usually completed within 1-3 minutes). The operator reviews the generated neural heat map and the system-optimized final path, and after confirming that everything is correct, proceeds with the ablation procedure. During the ablation process, the operator mainly plays a supervisory and confirmatory role, with the system providing visual, auditory, and tactile navigation feedback. After ablation is completed, an evaluation process is initiated. If any omissions are found, the system automatically prompts and plans supplementary paths.

[0131] In addition, such as Figure 6 As shown, this embodiment also discloses a duodenal ablation method combined with three-dimensional reconstruction. The system disclosed in this embodiment includes the following steps:

[0132] S1: Data acquisition and 3D model construction steps: Import preoperative images to obtain gross anatomical information of the duodenum; deliver the ablation catheter to the target segment of the duodenum; use the catheter head scanning component and vision module to generate and continuously update the intraluminal 3D mucosal model in real time.

[0133] S2: Multimodal image registration and navigation preparation steps: Register the three-dimensional mucosal model with intraoperative medical images (such as X-ray images) to generate an augmented reality navigation interface that displays the catheter position and planned path in real time.

[0134] S3: Personalized ablation path planning steps: The system automatically identifies the target ablation segment of the intestine based on a three-dimensional mucosal model, plans the location, sequence, and catheter movement path of the ablation point according to the intestinal lumen diameter and fold morphology, and displays it visually.

[0135] S4: Functional Neuromapping and Safety Boundary Determination Procedures:

[0136] S4.1: After completing the reconstruction of the three-dimensional mucosal model and the preliminary ablation path planning, the system guides the catheter to perform point-by-point or regional scanning neurofunctional mapping of the planned ablation area;

[0137] S4.2: At each mapping point, the system automatically applies a series of low-intensity diagnostic electrical stimuli and simultaneously monitors changes in intracavitary pressure and electrical signals, intelligently determines whether a positive nerve response is elicited, and records the stimulation threshold at that point.

[0138] S4.3: The system integrates data from all survey points, generates and displays a neural excitability heatmap in real time on the 3D navigation interface, and merges it with the anatomical model;

[0139] S4.4: Based on the heat map and preset safety thresholds, the system automatically optimizes the initial ablation path, generates the final safe ablation path, and highlights areas that need to be avoided or specially treated, waiting for the operator's confirmation.

[0140] S5: Real-time precise ablation steps guided by neural function: Ablation is performed under the guidance of an augmented reality navigation interface that incorporates neural heatmaps.

[0141] S5.1: Position the ablation head to the planned point under navigation guidance.

[0142] S5.2: After the system detects that all preparation parameters before ablation meet the standards, it will automatically or prompt the operator to start the ablation.

[0143] S5.3: During the ablation process, parameters such as impedance and temperature are monitored in real time, the output energy is dynamically adjusted, and the ablated area and the predicted boundary are updated on the three-dimensional mucosal model.

[0144] S5.4: Automatically jump to the next planned point and loop until the path is completed.

[0145] S6: Intraoperative immediate assessment and supplementary ablation procedures:

[0146] For energy types that can cause color / texture changes, such as thermal ablation, a second scan is performed after ablation. By comparing the three-dimensional mucosal models before and after ablation, the coverage is automatically calculated and the missed areas are highlighted.

[0147] For ablation methods that do not show obvious color changes (such as PFA), a staining agent (such as indigo carmine) can be sprayed before scanning and comparative analysis.

[0148] For any missed areas, the system can automatically plan supplementary ablation paths and guide the process to completion.

[0149] Compared with the prior art, this embodiment has the following effects:

[0150] (1) Panoramic 3D visualization: Provides a real-scale, real-time updated 3D "map" of the duodenum, realizing "what you see is what you eliminate", significantly improving spatial perception and operational accuracy;

[0151] (2) Intelligent navigation and automatic planning: Based on three-dimensional anatomical features, the optimal ablation path is automatically planned to achieve full coverage and non-overlapping standardized operation, reducing the dependence on the surgeon's experience;

[0152] (3) Individualized adaptive control: Combining real-time contact force, impedance, temperature and three-dimensional morphological characteristics, the ablation parameters are dynamically adjusted to achieve "precise dose delivery" and maximize the protection of deep tissues while ensuring the therapeutic effect;

[0153] (4) Intraoperative quantitative assessment: By comparing three-dimensional scans before and after ablation or by staining enhancement analysis, the ablation coverage and uniformity can be assessed in real time, supporting immediate supplementary ablation and potentially improving the success rate of a single operation.

[0154] (5) Functional neuroprotection: By integrating intracavitary electrical stimulation mapping technology, the excitability of nerves in the target area can be functionally assessed and mapped before ablation, and "high-risk nerve areas" can be visually marked on a three-dimensional mucosal model. During automatic path planning, the system can actively avoid these areas or use validated safe energy parameters in these areas, thereby maximizing the protection of important intestinal nerve functions and reducing the risk of nerve damage-related complications from the source.

[0155] The basic principles of this disclosure have been described above with reference to specific embodiments. However, it should be noted that the advantages, benefits, and effects mentioned in this disclosure are merely examples and not limitations, and should not be considered as essential features of each embodiment of this disclosure. Furthermore, the specific details disclosed above are for illustrative and facilitative purposes only, and are not limitations. These details do not limit the scope of this disclosure to the necessity of employing the aforementioned specific details for implementation.

[0156] In this disclosure, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. The block diagrams of devices, apparatuses, devices, and systems involved in this disclosure are merely illustrative examples and are not intended to require or imply that they must be connected, arranged, or configured in the manner shown in the block diagrams. As those skilled in the art will recognize, these devices, apparatuses, devices, and systems can be connected, arranged, and configured in any manner. Words such as "comprising," "including," "having," etc., are open-ended terms meaning "including but not limited to," and are used interchangeably with them. The terms "or" and "and" as used herein refer to the terms "and / or," and are used interchangeably with them unless the context clearly indicates otherwise. The term "such as" as used herein refers to the phrase "such as but not limited to," and is used interchangeably with it.

[0157] Additionally, as used herein, the "or" used in a list of items beginning with "at least one" indicates a separate list, such that a list of, for example, "at least one of A, B, or C" means A or B or C, or AB or AC or BC, or ABC (i.e., A and B and C). Furthermore, the word "exemplary" does not imply that the described example is preferred or better than other examples.

[0158] It should also be noted that in the systems and methods of this disclosure, the components or steps can be decomposed and / or recombined. These decompositions and / or recombinations should be considered as equivalent solutions to this disclosure.

[0159] Various changes, substitutions, and modifications can be made to the techniques described herein without departing from the teachings defined in this embodiment. Furthermore, the scope of this embodiment is not limited to the specific aspects of the processes, machines, manufacturing processes, events, means, methods, and actions described above. Currently existing or later-developed processes, machines, manufacturing processes, events, means, methods, or actions that perform substantially the same function or achieve substantially the same result as the corresponding aspects described herein can be utilized. Therefore, this embodiment includes such processes, machines, manufacturing processes, events, means, methods, or actions within its scope.

[0160] The above description of the disclosed aspects is provided to enable any person skilled in the art to make or use this disclosure. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects without departing from the scope of this disclosure. Therefore, this disclosure is not intended to be limited to the aspects shown herein, but rather to be carried out within the widest scope consistent with the principles and novel features disclosed herein.

[0161] The above description has been given for purposes of illustration and description. Furthermore, this description is not intended to limit the embodiments of this disclosure to the forms disclosed herein. Although numerous exemplary aspects and embodiments have been discussed above, those skilled in the art will recognize certain variations, modifications, alterations, additions, and sub-combinations therein.

Claims

1. A duodenal ablation system incorporating three-dimensional reconstruction, characterized in that, include: The system comprises a main control unit, a 3D reconstruction module, an intelligent ablation planning module, a neural function mapping module, an ablation execution device, and a real-time monitoring and feedback control module. The three-dimensional reconstruction module, intelligent ablation planning module, neural function mapping module, ablation execution device, and real-time monitoring and feedback control module are all electrically connected to the main control unit. The three-dimensional reconstruction module is used to generate and update the three-dimensional mucosal model of the duodenal lumen in real time based on the acquired data; The intelligent ablation planning module is used to automatically plan the position and movement path of the ablation point based on the three-dimensional mucosal model, and obtain a preliminary ablation path. The neural function mapping module includes a neural stimulation unit, a neural response detection unit, a neural atlas generation unit, and a safe path planning and optimization unit. The neural stimulation unit is used to apply diagnostic electrical stimulation to the duodenal wall; The neural response detection unit is used to detect intestinal wall microfeedback signals induced by electrical stimulation; The neural atlas generation unit is used to generate a neural excitability heatmap on the three-dimensional mucosal model based on the coordinates of each electrical stimulation point and its corresponding neural response threshold and amplitude. The safety path planning optimization unit is used to optimize the preliminary ablation path planned by the intelligent ablation planning module based on the neural excitability heatmap. The ablation execution device is used to perform ablation operations under optimized path guidance; The real-time monitoring and feedback control module is electrically connected to the ablation execution device and is used to collect ablation parameters in real time and dynamically adjust the ablation energy output.

2. The duodenal ablation system combined with three-dimensional reconstruction according to claim 1, characterized in that, It also includes a multimodal image fusion and navigation module and a display and interaction unit, both of which are electrically connected to the main control unit. The multimodal image fusion and navigation module is used to register the three-dimensional mucosal model with real-time medical images to generate an augmented reality navigation interface. The display and interaction unit is used to display the augmented reality navigation interface, ablation path, neural excitability heatmap, and real-time monitoring parameters.

3. The duodenal ablation system combined with three-dimensional reconstruction according to claim 1, characterized in that, The three-dimensional reconstruction module includes: The preoperative image import unit is used to import and reconstruct CT or MRI images to generate a priori model of the duodenal anatomy. The intraoperative real-time acquisition unit, integrated into the catheter tip, includes a structured light / laser scanning component, an electromagnetic or impedance positioning unit, and a vision unit, used to acquire dense point cloud data within the lumen, catheter position information, and endoscopic video stream; The multi-source data fusion unit is used to fuse the prior model, point cloud data, duct location information and video stream in a unified coordinate system to generate a real-time updated three-dimensional mucosal model.

4. The duodenal ablation system combined with three-dimensional reconstruction according to claim 1, characterized in that, The safe path planning optimization unit is configured to perform one or more of the following operations: The ablation path was redesigned to bypass the highly excitable core region marked in the aforementioned neuroexcitability thermogram; In the highly excitable core region, the system automatically switches to a preset safe ablation mode with energy parameters below the set value. Before performing ablation on the highly neurologically active core region, a mandatory secondary confirmation prompt message is issued.

5. The duodenal ablation system combined with three-dimensional reconstruction according to claim 1, characterized in that, The real-time monitoring and feedback control module includes: A multi-parameter sensing unit is used to acquire at least one of the following in real time: contact force, tissue impedance, local temperature, image features, intracavitary pressure waveform, and electrophysiological signal; An adaptive energy control unit is used to dynamically adjust the ablation energy and time based on the data collected by the multi-parameter sensing unit and the morphological characteristics of the three-dimensional mucosal model. The ablation boundary prediction unit is used to predict the ablation range and depth in real time on the three-dimensional mucosal model based on the data and energy parameters collected by the multi-parameter sensing unit and in combination with the pre-established energy, depth and range mapping model.

6. The duodenal ablation system combined with three-dimensional reconstruction according to claim 1, characterized in that, The ablation execution device includes: an intelligent ablation catheter and a robot-assisted drive unit; The head of the intelligent ablation catheter integrates an ablation energy generator, a contact force sensor, a temperature sensor, and an optical scanning element, wherein the ablation energy generator is at least one of a radio frequency electrode, a pulsed electric field electrode, a laser unit, and a hot steam unit. The robot-assisted drive unit is electrically connected to the intelligent ablation catheter to achieve automatic positioning and stable fitting of the catheter.

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