Smart adaptive ablation system for the duodenum, ablation catheter and method

Abstract

The application discloses an intelligent self-adaptive ablation system, an ablation catheter and a method for type 2 diabetes treatment, and belongs to the technical field of medical devices. The system comprises an intelligent control host and an electrode unit library. The intelligent control host integrates a main control processor, a motion prediction decision unit, an intelligent driving control module and an intelligent energy control module. The electrode unit library comprises a plurality of electrode units with different structures. The main control processor and the motion prediction decision unit automatically select an optimal electrode unit based on the duodenal cavity tract anatomical form obtained by a sensing component. The intelligent driving control module receives instructions to drive the selected electrode unit to adapt to the cavity environment. The intelligent energy control module provides controlled ablation energy to the electrode unit. Through the "sensing-decision-execution" closed loop, the application realizes self-adaptive and precise ablation treatment in the duodenal dynamic environment, thereby solving the problems of passive control strategy and lack of prospective compensation in the prior art which depend on a single electrode form.

Description

Technical Field

[0001] This invention belongs to the field of medical device and intelligent control technology, specifically relating to an intelligent adaptive ablation system, ablation catheter and method for the duodenum. Background Technology

[0002] Currently, duodenal mucosal ablation (DMR) offers a new approach to the treatment of type 2 diabetes (T2D). Its success hinges on precise energy delivery within the complex and dynamic environment of the duodenum. The organ's anatomy features both significant "straight segments" (such as the descending part) and "sharp curved segments" (such as the ascending and descending curves), posing almost contradictory requirements for the ablation catheter: it must provide efficient and stable adhesion in the straight segments while ensuring safe and smooth passage in the curved segments. Furthermore, the organ's own peristalsis, respiration, and heartbeat make the target tissue a continuously shifting "dynamic target."

[0003] To address these challenges, existing technologies have developed ablation catheters of various shapes, such as basket-type and balloon-type, and are attempting to introduce more intelligent control schemes. For example, patent document CN121015305A discloses a duodenal mucosal modulation system and method based on pulsed electric field ablation. This system includes an intelligent control host and an adjustable catheter, which can adaptively adjust pulse energy parameters by monitoring data such as impedance in real time. The distal end of the catheter adopts a structure combining a spindle-shaped flexible support (such as a balloon) with a spiral arrangement of ring electrodes, aiming to uniformly cover the mucosal folds and achieve selective cell ablation.

[0004] However, the applicant has found that even in such advanced prior art, the core architecture still has fundamental limitations and fails to systematically resolve the aforementioned contradictions and dynamic challenges. Specifically: First, the system still relies on a single, fixed-shape electrode support structure as the execution terminal. This design attempts to "adapt one structure to all shapes," but in dealing with the conflicting needs of efficient attachment for straight segments and safe passage for curved segments, it is essentially a compromise. It cannot intelligently switch to the most suitable heterogeneous electrode unit (such as a basket or balloon) based on the real-time anatomical shape of the cavity (straight or curved), and the selection of the optimal electrode still highly depends on the surgeon's experience.

[0005] Secondly, its "intelligence" is mainly reflected in the closed-loop feedback of energy parameters, lacking a top-level decision-making layer based on real-time morphological perception. The system cannot automatically identify "where it is located," and therefore cannot automatically decide "which electrode to activate," leading to a decoupling of hardware (morphology) and software (control) at the strategy level. Furthermore, its control strategy is essentially a passive "monitor-response" adjustment, lacking an active prediction and compensation mechanism for organ physiological movements (such as peristalsis), making it difficult to accurately hit the "dynamic target point" of continuous displacement. Finally, its hardware configuration is fixed, failing to support personalized customization of electrode unit libraries (such as type, size, and layout) based on individual patient anatomical characteristics, as well as automatic adaptation with the system.

[0006] In summary, the core deficiency of existing technologies—including the solution represented by CN121015305A—lies in their outdated "system architecture." They generally lack a top-level intelligent decision-making system capable of deeply integrating real-time environmental perception, intelligent resource (electrode) scheduling, and predictive execution compensation. Therefore, a long-standing and urgent technical problem in this field is: how to provide an intelligent ablation system that can automatically select the optimal electrode unit through real-time perception of anatomical morphology, dynamically configure energy strategies based on real-time feedback, and proactively compensate for tissue movement, thereby transforming the ablation process from a highly experience-dependent craft into an objective, repeatable, precise, and controllable scientific technology. Summary of the Invention

[0007] The present invention aims to solve the problems of the prior art mentioned above, and proposes an intelligent adaptive ablation system, ablation catheter and method for the duodenum.

[0008] The objective of this invention is achieved through the following technical solution: an intelligent adaptive ablation system for the duodenum, comprising:

[0009] The intelligent control host integrates a main control processor, a motion prediction and decision-making unit, an intelligent drive control module, and an intelligent energy control module;

[0010] Sensing components are used to sense the anatomical morphology of the duodenal cavity in real time;

[0011] And an electrode unit library, including several electrode units with different structures;

[0012] The main control processor and motion prediction decision unit are configured to automatically select the optimal electrode unit from the electrode unit library based on the anatomical morphology of the duodenal cavity perceived by the sensing components.

[0013] The intelligent drive control module is configured to receive electrode unit selection instructions from the main control processor and the motion prediction decision unit, and drive the selected electrode unit to change its shape to adapt to the cavity environment.

[0014] The intelligent energy control module is configured to provide controlled ablation energy to the driven and adapted electrode unit.

[0015] Further description: the electrode unit library includes basket electrode units and balloon electrode units;

[0016] The intelligent drive control module includes:

[0017] The balloon pressure control system is used to realize the automatic inflation, deflation and pressure regulation of the balloon electrode unit;

[0018] The basket deformation control system is used to automatically control the opening degree of the basket electrode units.

[0019] Furthermore, the configuration of the electrode unit library can be personalized and customized according to the individual characteristics of the patient; the intelligent control host is configured to recognize the personalized configuration and automatically load the corresponding control parameters.

[0020] Furthermore, the sensing components include at least one of an inertial measurement unit (IMU), a contact force sensor, and a tissue impedance measurement unit.

[0021] In this invention, the sensing component includes:

[0022] An inertial measurement unit (IMU) installed in the electrode unit library is used to sense motion posture;

[0023] Contact force sensors disposed on the surface of the balloon electrode unit and / or on the support nodes of the basket electrode unit are used to measure the contact force between the electrode and the tissue.

[0024] The electrode units in the electrode unit library can be used as the tissue impedance measurement unit.

[0025] The intelligent energy control module includes:

[0026] The multi-channel switch matrix, composed of high-voltage and high-speed electronic switches, is controlled by the instructions of the main control processor and is used to route the energy generated by the pulse generator to the designated electrode unit channel.

[0027] A high-speed data acquisition circuit, including a current sensor and a high-precision analog-to-digital converter, is used to sample the pulse current of each channel in real time and convert it into a digital signal;

[0028] The high-speed safety monitoring circuit includes an analog comparator, which compares the signal sampled by the current sensor with a preset safe current threshold and directly shuts off the energy output when the threshold is exceeded.

[0029] The catheter identification unit is used to identify and read the configuration information of the connected catheter.

[0030] The main control processor and motion prediction decision unit are configured to predict the motion state of the duodenal cavity and implement dynamic compensation based on the prediction results.

[0031] A composite ablation catheter for an intelligent adaptive ablation system, the catheter comprising:

[0032] Guide shaft;

[0033] The first electrode unit, which is located at the distal end of the catheter rod, is an inflatable and deflated balloon electrode unit.

[0034] The second electrode unit, which is spaced apart from the first electrode unit along the axial direction of the conduit rod, is an expandable and retractable basket electrode unit;

[0035] The balloon electrode unit and the basket electrode unit have different structures and are used for selection and driving by the intelligent adaptive ablation system to adapt to different anatomical cavities of the duodenum.

[0036] The basket electrode unit is woven from alloy wire, and the alloy wire contains basket electrode wire and a wire-like contact force sensor.

[0037] An adaptive ablation method includes the following steps:

[0038] Step S1, system initialization and catheter identification steps;

[0039] Step S2, Real-time morphological perception and segment judgment step, based on real-time data from the sensor, automatically determines whether the segment of the duodenal cavity where the catheter tip is located is a straight segment or a curved segment.

[0040] Step S3, intelligent electrode unit selection step: based on the segment judgment result, automatically select and activate the corresponding balloon electrode unit, basket electrode unit or a combination of the two.

[0041] Step S4, Energy Mode Adaptive Configuration Step, dynamically configures the parameters and modes of energy release based on the real-time electrode-tissue contact state;

[0042] Step S5, predictive ablation execution step, performs temporal or physical compensation for ablation execution based on motion prediction;

[0043] Step S6, closed-loop monitoring and iteration steps, automatically determine the ablation endpoint based on objective physiological indicators, and iterate to the next ablation point.

[0044] Step S2 includes:

[0045] Acquire real-time motion data from the inertial measurement unit (IMU);

[0046] Calculate the variance of the motion data to quantify the motion intensity;

[0047] The motion intensity is compared with a preset threshold to automatically determine whether the end of the catheter is in a straight section with low motion intensity or a curved section with high motion intensity.

[0048] The execution logic of step S3 includes:

[0049] If it is determined to be a straight section, then select and expand the basket electrode unit;

[0050] If it is determined to be a curved section, then select and inflate the balloon electrode unit;

[0051] If the area is determined to be a mixed transition zone or requires rapid coverage, the basket electrode unit and the balloon electrode unit are activated simultaneously to form a composite electrode array for synergistic ablation.

[0052] Further, step S4 includes:

[0053] The contact quality score (CQS) is calculated based on real-time measurements of contact force and tissue resistance.

[0054] Based on whether the contact quality score (CQS) reaches a preset threshold, a decision is made to adopt a unipolar energy release mode or switch to a bipolar energy release mode.

[0055] Further, step S5 includes:

[0056] By integrating endoscopic visual data with catheter IMU data, tissue displacement can be predicted.

[0057] Based on the prediction results, one or a combination of the following compensations may be selectively performed.

[0058] Timing compensation adjusts the timing of ablation energy release;

[0059] Physical compensation involves dynamically adjusting the balloon pressure to track deformation when the balloon electrode unit is activated.

[0060] This invention, through the aforementioned technical solution, constructs a system-level solution integrating real-time perception, intelligent decision-making, precise execution, and closed-loop security. This solution, through its innovative architecture and collaborative working mechanism, achieves multi-dimensional improvements in technical efficiency and clinical value, producing the following significant beneficial effects:

[0061] 1. The system achieves intelligent and automated surgical decision-making, reducing operational difficulty and human uncertainty. Through a closed loop of "morphological perception - electrode selection - energy adaptation," the system can automatically complete complex decisions that previously relied on the surgeon's experience. Specifically, the system first automatically selects the optimal electrode unit (basket, balloon, or a combination thereof) based on the cavity morphology perceived by the inertial measurement unit (IMU), solving the electrode adaptation problem; then, based on contact quality scoring (CQS), it dynamically configures the energy release mode and parameters, solving the problem of precise energy delivery, transforming the surgeon from a manual operator to a process supervisor.

[0062] 2. Adaptive full-coverage ablation of complex anatomical structures has been achieved. The system overcomes the limitations of single-electrode morphology, intelligently selecting and driving basket electrode units, balloon electrode units, or composite electrode arrays composed of both based on the cavity morphology (straight segments, curved segments, or transitional segments). This collaborative working mode eliminates the coverage blind spots of traditional single electrodes in morphological transition areas. Combined with motion prediction-based temporal and physical compensation mechanisms, it can actively track tissue movement, ensuring that ablation energy is released at the correct time and location, thereby improving the continuity, uniformity, and predictability of the ablation line and treatment effect.

[0063] 3. Supports personalized and precise treatment based on individual patient characteristics. The system's electrode unit library can be customized based on the patient's preoperative imaging data (such as the size, number, and layout of the balloon and basket). The system automatically identifies and loads the control parameters of the corresponding catheter through the catheter identification module, achieving seamless integration between "preoperative planning" and "intraoperative execution," making personalized treatment feasible for large-scale application.

[0064] 4. A multi-layered, closed-loop proactive safety protection system has been constructed. The system employs multiple safety mechanisms, including real-time contact quality scoring (CQS) assessment, hardware-level microsecond overcurrent protection, and predictive motion pause, forming a proactive safety closed loop of "perception-judgment-intervention." Simultaneously, the system automatically determines the ablation endpoint using objective physiological indicators such as impedance drop curves and iterates to the next point, replacing subjective experience-based judgment. This ensures the uniformity and thoroughness of ablation throughout the treatment area and avoids efficacy fluctuations caused by operational differences. Attached Figure Description

[0065] The accompanying drawings of this invention are described below:

[0066] Figure 1 This invention provides a preferred embodiment of the system's intelligent control architecture and data flow diagram;

[0067] Figure 2 This is a block diagram of the overall structure of the intelligent adaptive ablation system;

[0068] Figure 3This is a schematic diagram of the composite ablation catheter structure;

[0069] Figure 4 for Figure 3 The diagram shows the working state of the composite ablation catheter.

[0070] Figure 5 This is a schematic diagram of the control handle structure;

[0071] Figure 6 This is a schematic diagram of the second structure of the composite ablation catheter (with the basket-balloon sequence reversed).

[0072] Figure 7 This is a schematic diagram of the third structure of the composite ablation catheter (double balloon configuration).

[0073] Figure 8 This is a flowchart of the system's intelligent control process;

[0074] Figure 9 This is a schematic diagram showing the working state of the catheter in the curved section of the duodenum;

[0075] Figure 10 yes Figure 9 A schematic diagram showing the working state of the catheter in the straight section of the duodenum;

[0076] Figure 11 This is a schematic diagram illustrating the principles of motion prediction and compensation.

[0077] Figure 12 This is a schematic diagram illustrating the timing compensation principle of ablation energy release.

[0078] Figure 13 A schematic diagram illustrating organizational displacement prediction and contact risk;

[0079] Figure 14 This is a schematic diagram illustrating the physical compensation principle of dynamic adjustment of balloon pressure.

[0080] The components are: 1-catheter rod body, 2-balloon, 3-balloon electrode, 4-contact force sensor, 5-basket electrode unit, 6-steel wire; 7-connection status indicator light, 8-handle handle body, 9-basket control mechanism interface, 10-balloon fluid passage interface, 11-main power connector and signal interface. Detailed Implementation

[0081] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings. However, the present invention is not limited to these embodiments. Any improvements or substitutions based on the basic spirit of these embodiments shall still fall within the scope of protection claimed by the claims of the present invention.

[0082] Example 1

[0083] This embodiment corresponds to Figures 1 and 2. It aims to clearly explain the intelligent control logic and physical implementation of the intelligent adaptive ablation system through textual analysis of the two core block diagrams. It focuses on revealing the complete closed-loop data flow and control flow of "perception-decision-execution-feedback", providing specific and detailed technical support for the system's technical features.

[0084] 1.1 System Intelligent Control Architecture

[0085] Figure 1 defines the core logical architecture of the intelligent adaptive ablation system, clarifying the hierarchical relationship of each functional module, the data interaction path, and the flow of control commands. It is the logical core of the system to realize intelligent adaptive ablation, and its components and working mechanisms are as follows:

[0086] 1.1.1 Core Functional Modules

[0087] The main control processor and motion prediction decision unit are located at the center of the architecture and serve as the computational and decision-making hub of the intelligent adaptive ablation system. Figure 1 The "main control processor" and "decision-making unit" shown in the diagram define the functional modules. Core functions include receiving multi-source sensor data, executing intelligent decision-making algorithms, automatically selecting the optimal electrode unit from the electrode unit library based on the perceived anatomical morphology of the duodenal cavity, predicting the motion state of the duodenal cavity, implementing dynamic compensation based on the prediction results, and coordinating the collaborative work of all modules in the intelligent adaptive ablation system.

[0088] Human-computer interaction interface: As a two-way interaction interface between the intelligent adaptive ablation system and the operator, it receives operation instructions such as start-up, parameter adjustment, and treatment mode selection input by the operator on the one hand, and displays information such as system operation status, sensor feedback data, ablation progress, and fault alarms to the operator in real time on the other hand, ensuring the operator's real-time monitoring and intervention of the treatment process.

[0089] Catheter identification unit: As a system-level logical functional unit, it establishes bidirectional communication with the main control processor and motion prediction decision unit. On the one hand, it receives raw configuration data read from the catheter identification interface, verifies and parses it, and provides the main control processor and motion prediction decision unit with valid catheter personalized parameters (such as electrode unit type, quantity, size, layout, etc.). On the other hand, it can send authentication commands to the interface and receive authentication status feedback to ensure that the system only establishes working connections with catheters that have passed authentication, thereby realizing the automatic identification of personalized configurations and loading of control parameters.

[0090] Customizable electrode unit library: As the functional resource pool of the intelligent adaptive ablation system, it encapsulates two core sub-modules and forms the hardware foundation for achieving multi-scenario cavity adaptation.

[0091] The composite catheter sensing module integrates an inertial measurement unit (IMU), a contact force sensor, and an impedance measurement electrode. It is responsible for collecting multi-dimensional sensor data such as the morphology of the duodenal cavity (IMU motion data), the contact state between the electrode and the tissue (contact force data), and the electrical properties of the tissue (impedance data). The collected raw data is uploaded in real time to the main control processor and the motion prediction and decision-making unit to provide data support for intelligent decision-making.

[0092] Actuator assembly: Integrating balloon inflation mechanism, basket deployment mechanism, and ablation electrode, it serves as a physical action execution terminal. It receives action commands from the main control processor and motion prediction decision unit to realize the morphological switching of the electrode unit (balloon inflation / deflation, basket deployment / contraction) and the release of ablation energy, thereby completing the precise attachment and ablation operation to the target tissue.

[0093] Intelligent Energy Control Module: Located at the bottom layer of the architecture, it is responsible for the precise control of ablation energy. Internally, it is divided into three functional areas: multi-channel control, real-time monitoring, and safety protection. Its core components and functions are as follows:

[0094] Multi-channel switch matrix: Composed of high-voltage and high-speed electronic switches, controlled by the main control processor and motion prediction decision unit, used to route the energy generated by the pulse generator to the designated electrode unit channel;

[0095] High-speed data acquisition circuit: including current sensor and high-precision analog-to-digital converter, used to sample the pulse current of each channel in real time and convert it into digital signal, which is used by the main control processor and motion prediction decision unit to calculate tissue impedance;

[0096] High-speed safety monitoring circuit: includes an analog comparator, which compares the signal sampled by the current sensor with a preset safe current threshold, and directly shuts off the energy output when the threshold is exceeded, forming hardware-level safety protection;

[0097] Catheter identification interface: Serving as the physical communication interface between the intelligent energy control module and the catheter handle of the composite ablation catheter, it works in conjunction with the system-level catheter identification unit. It connects directly to the catheter identification module (memory chip) inside the handle, responsible for performing low-level hardware connections, signal transmission, and communication protocol parsing to complete the physical reading of configuration information.

[0098] 1.1.2 Critical Data Flow and Control Flow

[0099] This architecture constructs a complete intelligent closed loop of "perception-decision-execution-feedback" through seven clearly defined instructions and data flows, ensuring that all modules of the system work together efficiently.

[0100] Two-way user interaction flow: The two-way data transmission between the main control processor, the motion prediction decision unit, and the human-computer interaction interface realizes user command input (the operator issues operation commands to the intelligent adaptive ablation system) and system status output (the intelligent adaptive ablation system provides feedback on operation information to the operator), ensuring the real-time performance and effectiveness of human-computer interaction.

[0101] Identity recognition and configuration reading stream: The bidirectional interaction between the main control processor, the motion prediction decision unit, and the catheter identity recognition unit completes the reading of catheter configuration information (the main control processor and the motion prediction decision unit obtain personalized catheter parameters) and the feedback of identity verification status (the catheter identity recognition unit feeds back the legality verification result to the main control processor and the motion prediction decision unit), thereby realizing the function of "identifying personalized configuration and automatically loading corresponding control parameters".

[0102] Uplink of sensor data: The composite catheter sensing module transmits sensor data (IMU motion data, contact force data, impedance data) uplink to the main control processor and motion prediction decision unit to realize the function of "real-time sensing of the anatomical morphology of the duodenal cavity" and provide raw data support for intelligent decision-making.

[0103] Intelligent decision-making downlink: The main control processor and motion prediction decision unit send action commands downlink to the actuator components. The command types include single activation (activating the balloon electrode unit or the basket electrode unit separately) or coordinated activation (activating two types of electrode units simultaneously to form a composite electrode array), realizing the functions of "automatically selecting the optimal electrode unit based on the anatomical morphology of the cavity" and "driving the selected electrode unit to change its shape to adapt to the cavity environment".

[0104] Energy control command flow: The main control processor and motion prediction decision unit send energy control commands to the intelligent energy control module, specifying the energy release channel selection (specifying the electrode channel to be activated), parameter configuration (voltage, pulse width, frequency, etc.), and triggering timing, so as to realize the function of "providing controlled ablation energy to the electrode unit after drive adaptation".

[0105] Safety monitoring feedback flow: The intelligent energy control module provides real-time safety monitoring status information to the main control processor and motion prediction decision unit, including the output current of each electrode channel, tissue impedance data, and fault alarm signals (such as overcurrent, short circuit, poor contact, etc.). Real-time monitoring and abnormal response are achieved through the high-speed safety monitoring circuit, forming a safety closed loop for energy control.

[0106] Final energy delivery flow: The intelligent energy control module delivers high-voltage pulse energy to the actuator component. After intelligent decision-making and safety verification by the main control processor and motion prediction decision unit, the controlled ablation energy is precisely delivered to the selected electrode unit to ensure that the energy acts on the target tissue efficiently and safely.

[0107] 1.2 System Physical Implementation

[0108] Figure 2 illustrates the physical hardware carrier and the connection relationships of the components of the logical architecture described in Figure 1, clarifying the physical structure and signal transmission path of the intelligent adaptive ablation system, and enabling the technical features of the intelligent adaptive ablation system to be implemented through physical hardware.

[0109] 1.2.1 Core Physical Components

[0110] Intelligent control host: As the central processing and control unit of the intelligent adaptive ablation system, it is the physical carrier of the main control processor, motion prediction and decision unit, intelligent drive control module, intelligent energy control module and human-machine interface in the logical architecture. It integrates a high-frequency pulse electric field generator, a multi-channel switch matrix, a main control processor (including motion prediction and decision unit) and human-machine interface. It undertakes core functions such as data operation, instruction generation, ablation energy generation and control, and human-machine interaction. It is the "control center" of the intelligent adaptive ablation system.

[0111] The basket-balloon hybrid ablation catheter serves as the execution terminal and sensing front end of the intelligent adaptive ablation system. It is the physical implementation of the customizable electrode unit library in the logical architecture. It integrates all the hardware of the hybrid catheter sensing module (inertial measurement unit IMU, contact force sensor, impedance measurement electrode) and the actuator components (balloon inflation mechanism, basket deployment mechanism, ablation electrode). It establishes a communication and energy transmission link with the intelligent control host through a dedicated connection cable. It is the core device that directly contacts the target area in the patient's body and performs ablation operations.

[0112] Surface circuit electrode: As an auxiliary component of the unipolar energy release mode, it is connected to the high-frequency pulse electric field generator of the intelligent control host through an independent cable, and forms a complete current loop with the ablation electrode on the basket-balloon composite ablation catheter, providing a return path for the current in the unipolar ablation mode, and ensuring the integrity and safety of energy transmission.

[0113] 1.2.2 Physical Connections and Functional Mapping

[0114] Connection between the host and the catheter: The basket-balloon composite ablation catheter is bidirectionally connected to the intelligent control host via a dedicated connecting cable. This cable performs dual functions: downlink transmission (transmitting control signals generated by the intelligent control host, including electrode mode switching instructions, energy parameter instructions, and ablation energy, to the catheter); and uplink transmission (feeding back sensor data collected by various sensors on the catheter to the intelligent control host), realizing a closed-loop physical link of "perception-decision-execution" in the logical architecture and ensuring that all modules work together.

[0115] Connection of surface circuit electrode: The surface circuit electrode is connected to the high-frequency pulse electric field generator of the intelligent control host through an independent cable. It is only activated in unipolar energy release mode. Its core function is to provide a return path for the ablation current, so that the current can flow out from the active electrode on the catheter, pass through the target tissue, and return to the intelligent control host through the surface circuit electrode to form a complete current loop, ensuring the construction of multi-channel control and energy loop.

[0116] Human-machine interaction connection: The human-machine interface is integrated on the surface of the intelligent control host and is connected to the main control processor and motion prediction decision unit through an internal bus, realizing direct interaction between the operator and the system. The operator can issue operation commands (such as starting the system, selecting the treatment mode, and adjusting parameters) through input devices such as buttons and touch screens on the interface. The system can provide feedback on the operating status (such as ablation progress, sensor data, and fault alarms) through output devices such as displays and indicator lights on the interface, realizing the human-machine interaction function of the intelligent control host.

[0117] Example 2

[0118] This embodiment provides a composite ablation catheter for the aforementioned intelligent adaptive ablation system, the structure of which corresponds to the attached... Figure 3 (Conveying status) Figure 4 (Work status) Figure 5 (Control handle) Figure 6 (Sequence change variation) Figure 7 (Double ball configuration variation) Figure 9 (Working on the curved section) and Figure 10 (Straight section operation). This conduit specifically embodies the physical structure of the "electrode unit library" described in the claims.

[0119] like Figure 3 and Figure 4 As shown, the core structure of the composite ablation catheter includes the catheter shaft (1), the first electrode unit (balloon electrode unit), the second electrode unit (basket electrode unit, 5), and the control handle. The composition, position, and connection relationship of each component are as follows:

[0120] 2.1 Guide rod body 1

[0121] The catheter shaft 1 serves as the main support structure for the entire catheter. It is made of biocompatible polymer materials (such as polyurethane and polyamide) and possesses excellent flexibility and kink resistance. Internally, it integrates multi-lumen cables for ablation energy transmission, sensor signal transmission, balloon inflation fluid delivery, and basket drive control, providing mounting carriers and transmission channels for various media for each functional component, ensuring coordinated operation of all units.

[0122] 2.2 First Electrode Unit (Balloon Electrode Unit)

[0123] The first electrode unit is an inflatable and deflated balloon electrode unit, disposed at the distal end of the catheter shaft 1, and specifically includes:

[0124] Balloon 2: Made of biocompatible materials with good compliance (such as TPU, silicone), it is connected to the balloon fluid passage interface 10 of the proximal control handle through a dedicated inflation cavity inside the catheter shaft 1, and can achieve automatic inflation, deflation and dynamic pressure adjustment under the control of the intelligent drive control module.

[0125] Balloon electrode 3: Made of medical metal material with excellent conductivity (such as platinum-iridium alloy, stainless steel), it is distributed on the balloon 2 and connected to the main electrical connector and signal interface 11 of the control handle through the energy transmission cable inside the catheter rod 1, and is used to receive the ablation energy output by the intelligent energy control module.

[0126] Contact force sensor 4: A miniature fiber optic or piezoresistive sensor is distributed in an array on the surface of the balloon 2 and connected to the main control processor through a dedicated signal cable to collect contact force data in real time.

[0127] 2.3 Second electrode unit (basket electrode unit, 5)

[0128] The second electrode unit is an expandable and retractable basket electrode unit 5, which is spaced apart from the first electrode unit along the axial direction of the guide rod 1, and specifically includes:

[0129] Main structure: A basket-like structure woven from shape memory alloy wires (such as nickel-titanium alloy wires), which has good elasticity and shape recovery ability.

[0130] Electrode and sensor integration: The alloy wire of the basket electrode unit 5 is internally woven with basket electrode wires and filamentous contact force sensors (such as fiber Bragg grating sensors), realizing the integration of electrode and sensing functions. The basket electrode wires are used to transmit ablation energy, and the filamentous contact force sensors are distributed at key support nodes of the basket, collecting contact force data in real time and feeding it back to the main control processor.

[0131] Drive connection: A control steel wire 6 is inserted into a dedicated control cavity inside the guide rod body 1. One end of the wire is connected to the basket electrode unit 5, and the other end extends to the control handle and docks with the basket control mechanism interface 9. It is used to transmit push and pull actions from the intelligent drive control module to control the expansion and contraction of the basket electrode unit 5.

[0132] 2.4 Control Handle

[0133] As shown in Figure 5, the control handle is provided at the proximal end of the catheter, specifically including:

[0134] Handle body 8: Made of biocompatible engineering plastic injection molding, with an internal isolation cavity for laying electrical cables, fluid pipelines and identification chips.

[0135] Connection status indicator 7: Located on the surface of the handle body 8, it is connected to the main control processor and is used to provide real-time feedback on the tube connection status.

[0136] Net basket control mechanism interface 9: Located on the side of the handle body 8, connected to the control wire 6, and used to interface with the net basket deformation control system in the intelligent drive control module.

[0137] Balloon fluid passage interface 10: It adopts a quick self-sealing connector, which is located on the side of the handle body 8 and communicates with the balloon 2 through the inflation cavity, for connecting with the balloon pressure control system in the intelligent drive control module.

[0138] Main power connector and signal interface 11: Located at the tail of the handle body 8, it is the core connection interface between the catheter and the intelligent control host, realizing energy transmission and signal communication; the handle integrates a catheter identification module (such as an EEPROM storage chip). When the main power connector and signal interface 11 is connected to the host, the catheter identification interface in the host will read the information in the module, which will be processed by the system-level catheter identification unit to automatically load the corresponding parameters.

[0139] 2.5 Customized variations and work scenario adaptation of the electrode unit library

[0140] The first electrode unit (balloon electrode unit) and the second electrode unit (basket electrode unit, 5) have different structures and together constitute an electrode unit library that can be selected by the intelligent adaptive ablation system.

[0141] Customized variations: such as Figure 6 As shown, the basket electrode unit 5 can be positioned at the farthest end of the catheter shaft 1, while the balloon electrode unit can be positioned at its proximal end. Figure 7As shown, a dual-balloon configuration can be used, i.e., two balloon electrode units are installed at the distal end of the catheter shaft 1. These variations all support system recognition and adaptation via the catheter identification module.

[0142] Work scenario adaptation: such as Figure 9 As shown, in the duodenal bend, the system automatically selects and inflates the balloon 2, causing the balloon electrode 3 to adhere to the tissue. Figure 10 As shown, in the straight section of the duodenum, the system automatically selects and deploys the basket electrode unit 5 via the control wire 6, so that it can stably adhere to the tissue over a large area.

[0143] Example 3

[0144] This embodiment corresponds to the attached Figure 8 , Figure 11 , Figure 12 , Figure 13 , Figure 14 The purpose is to clearly demonstrate the complete execution process of the adaptive ablation method and the implementation principle of its core algorithm.

[0145] 3.1 Complete Procedure of Adaptive Ablation Method

[0146] like Figure 8 As shown, the adaptive ablation method uses "initialization-sensing-decision-execution-compensation-closed-loop iteration" as its core logic. Through multi-dimensional intelligent decision-making and dynamic compensation, it achieves precise ablation of the duodenal cavity. The specific steps are as follows:

[0147] 3.1.1 Step S1: System Initialization and Catheter Identification

[0148] Operation: Connect the composite ablation catheter to the intelligent control host through the main power connector and signal interface 11 of the control handle, and power on the system.

[0149] Core operation: The intelligent control host reads the pre-stored catheter configuration information in the catheter identification module (such as an EEPROM storage chip) inside the handle through its catheter identification unit. The configuration information includes, but is not limited to, the composition of the electrode unit library (such as the type, quantity, size, and layout of each electrode unit) and related sensor parameters.

[0150] Based on the read configuration information, the system automatically initializes the intelligent drive control module and the intelligent energy control module, completing channel mapping, loading drive parameters, and algorithm thresholds. The algorithm thresholds include, but are not limited to, pressure-volume curves for balloons of a specific size and deployment angle parameters for net baskets.

[0151] The human-machine interface then displays the catheter model, configuration information, and system readiness status, thus completing the initialization process.

[0152] 3.1.2 Step S2: Real-time morphological perception and segment judgment

[0153] Operation: The catheter is inserted into the target treatment area of ​​the duodenum through the endoscope working channel, and the system initiates multi-sensor data acquisition.

[0154] Core operation: The inertial measurement unit (IMU) in the sensing component acquires motion data (e.g., triaxial acceleration and triaxial angular velocity) in real time. Based on the motion data, the main control processor and motion prediction decision unit calculate indicators reflecting the intensity of motion at the catheter tip.

[0155] Example of motion intensity quantification: In a specific implementation, the system calculates the variance of the resultant acceleration (Var_A) and the variance of the resultant angular velocity (Var_Ω) within a time window (e.g., 100ms). The resultant acceleration A_combined and the resultant angular velocity Ω_combined can be obtained by taking the square root of the sum of the squares of the triaxial accelerations and triaxial angular velocities, respectively, while the variance reflects the fluctuation of motion intensity within this time window.

[0156] Segment judgment logic:

[0157] Flat segment (steady state): When the motion intensity index remains below the first preset threshold, it is determined to be a flat segment. For example, when Var_A < 0.5 m² / s 4 The duration of the state where Var_Ω < 0.8 rad² / s² exceeds 1 second.

[0158] Bending segment (unstable / rotational state): When the motion intensity index exceeds the second preset threshold, or when a continuous and regular periodic change in angular velocity is detected, it is judged as a bending segment. For example, when Var_Ω ≥ 0.8 rad² / s².

[0159] Mixed transition zone: When the motion intensity index is between the judgment thresholds of the straight section and the curved section mentioned above, or when the operator actively selects the "fast coverage mode", it is judged as a mixed transition zone.

[0160] 3.1.3 Step S3: Smart Electrode Unit Selection

[0161] Core decision-making logic: Based on the segment judgment result of step S2, the main control processor and motion prediction decision unit output an electrode unit start command:

[0162] If the segment is determined to be straight, the instruction is "deploy the basket electrode unit". The intelligent drive control module pulls the control wire 6 through the basket deformation control system, causing the basket electrode unit 5 to expand from the contracted state to a preset angle, thereby achieving stable attachment to the duodenal cavity wall.

[0163] If the segment is determined to be curved, the instruction is "Inflate the balloon electrode unit". The intelligent drive control module injects fluid into the balloon 2 through the balloon pressure control system, inflating it to a preset pressure, thereby achieving a smooth fit with the curved cavity wall.

[0164] If the system is identified as a mixed transition zone or a rapid coverage mode is activated, the instruction is "simultaneously activate the basket electrode unit and the balloon electrode unit." These two elements form a composite electrode array, and the system is configured with a specific synergistic ablation sequence to ensure uniform coverage of the ablation area (especially the boundary areas between different electrode units).

[0165] 3.1.4 Step S4: Adaptive Configuration of Energy Mode

[0166] Core operation: The system collects real-time data through a contact force sensor and a tissue impedance measurement unit, and calculates a comprehensive contact quality score (CQS).

[0167] CQS calculation logic (preferred embodiment):

[0168] Contact force score (F_score): Calculated based on the measured contact force F_measured. An ideal contact force range is set, within which the score is highest (e.g., 1.0), and the score decreases linearly when deviating from this range. For example, the ideal range can be set to 8 grams to 15 grams.

[0169] Impedance Contact Score (Z_score): Calculated based on the measured tissue baseline impedance Z_measured. An ideal impedance range is set; the score is highest when the measured value is within this range, and decreases linearly when deviating from it. For example, the ideal range can be set to 50Ω to 80Ω.

[0170] Overall score: CQS is the weighted sum of F_score and Z_score, i.e., CQS = w1 * F_score + w2 * Z_score, where the weight coefficients w1 and w2 are adjustable and their sum is 1. In an optimal weight configuration, w1 = 0.7 and w2 = 0.3 can be chosen.

[0171] Energy pattern decision:

[0172] If CQS ≥ preset quality threshold (for example, the threshold can be set to 0.7), the contact quality is determined to be up to standard, and the system's default energy release mode (such as configuring a monopolar mode for the basket electrode or a bipolar mode for the balloon electrode) and corresponding pulse parameters are adopted.

[0173] If CQS < preset quality threshold, the contact quality is deemed substandard, and the system automatically activates a safety strategy: forcibly switching to bipolar energy release mode and / or adjusting pulse parameters (such as reducing voltage or shortening pulse width), while simultaneously triggering an alarm through the human-machine interface.

[0174] 3.1.5 Step S5: Predictive Ablation Execution and Dynamic Compensation

[0175] Motion prediction implementation: The system integrates endoscopic visual data with six-degree-of-freedom motion data from the catheter inertial measurement unit (IMU), and establishes a kinematic model through a prediction algorithm to predict the tissue displacement vector (ΔD). In one specific implementation, the endoscopic vision captures feature points and calculates displacement at a certain frame rate (e.g., 30 frames / second), and the IMU provides triaxial acceleration and angular velocity data; the system uses a data fusion algorithm (e.g., Kalman filter) to analyze motion data over a historical period (e.g., 200ms) and predict the tissue displacement vector ΔD within a future period (e.g., 100-300ms), outputting a high-precision predicted trajectory (e.g., ...). Figure 11 (As shown).

[0176] Dynamic compensation execution:

[0177] Timing compensation: such as Figure 12 As shown, the system calculates the optimal pulse firing timing (e.g., defined as the ideal trigger point T_fire) based on the predicted displacement vector ΔD and the tissue movement velocity. By dynamically adjusting the firing delay, the system matches the peak effect of energy release with the moment when the tissue moves to the target position, thereby offsetting the displacement error.

[0178] Physical compensation: such as Figure 13 As shown, when the balloon electrode unit is activated and the predicted displacement ΔD exceeds a preset displacement threshold, the system triggers physical compensation. Figure 14 As shown, the system dynamically adjusts the pressure inside the balloon through the balloon pressure control system according to the preset displacement-pressure control relationship, so that the balloon undergoes active deformation, thereby tracking tissue movement and maintaining a stable electrode-tissue contact force.

[0179] 3.1.6 Step S6: Closed-loop monitoring and iteration

[0180] Ablation endpoint determination: The system monitors physiological indicators such as tissue impedance in real time through the intelligent energy control module. When preset ablation endpoint determination conditions are met, the system determines that ablation at the current site is complete. For example, the determination conditions may include:

[0181] The real-time impedance decreases relative to the initial value to a first preset ratio (e.g., decreases by ≥30%).

[0182] The impedance value enters a stable plateau period (for example, the impedance fluctuation amplitude is less than the second preset ratio for a continuous period of time).

[0183] And / or, for safety redundancy, the ablation pulse count is forcibly terminated when it reaches the preset maximum safe number of times.

[0184] Safety Iterative Cycle: After ablation at the current site is completed, the system automatically moves to the next ablation site along a preset path (e.g., a zigzag path). Before initiating the next ablation, the system reassesses the contact quality (e.g., recalculates CQS), and only repeats steps S2 to S5 if the contact quality meets the requirements (e.g., CQS ≥ preset threshold). This process iterates until all target areas are ablated (e.g., ablation coverage reaches the preset target) or the operator manually terminates the process. All process data is automatically recorded and a treatment report is generated.

[0185] 3.2 Detailed Explanation of Core Algorithm Principles

[0186] 3.2.1 Principles of Motion Prediction

[0187] like Figure 11 As shown, the motion prediction achieves high-precision trajectory estimation and future displacement prediction through multi-source data fusion, specifically including:

[0188] Data input: Feature point data provided by the endoscopic vision system to provide absolute tissue position information; six-degree-of-freedom motion data (three-axis acceleration, three-axis angular velocity) provided by the inertial measurement unit (IMU) at the catheter tip to provide inertial increments. The two types of data complement each other, reducing the error of a single data source.

[0189] Data fusion and state estimation: A fusion model is constructed using a data fusion algorithm (such as a Kalman filter). The absolute position of the visual data and the inertial increment of the IMU data are used as the "observation vector," and the position and velocity of the duct tip are used as the "state vector." Optimal estimation is performed through a filtering algorithm, resulting in a smooth, low-latency six-degree-of-freedom motion trajectory that effectively eliminates noise interference.

[0190] Displacement prediction: Based on the fused historical motion trajectory, a kinematic model (such as a uniform velocity or uniform acceleration model) is established to extrapolate the tissue displacement vector (ΔD) over a future period. The displacement vector ΔD represents the predicted change in tissue position, providing a precise basis for dynamic compensation. In a specific example, the prediction time range is 100 to 300 milliseconds into the future.

[0191] 3.2.2 Timing Compensation Principle

[0192] like Figure 12 As shown, the timing compensation is achieved through the following steps:

[0193] Motion waveform analysis and ideal trigger point determination: The system analyzes historical motion data to identify periodic tissue motion waveforms caused by physiological activities such as respiration and peristalsis, and determines the "ideal trigger point T_fire" in the waveform, which is the moment when the tissue moves to the target ablation position.

[0194] Delay time calculation: Based on the predicted tissue displacement vector and real-time motion velocity, the system calculates the required "delay time T_delay". Accordingly, the system will trigger the ablation pulse T_delay time earlier than the current time (T_current).

[0195] Real-time adjustment and execution: Through the above calculations, the peak energy release of the ablation pulse is ensured to precisely match the moment when the tissue moves to the T_fire point, thereby offsetting the target displacement error caused by tissue movement. The system continuously updates the motion prediction model and dynamically corrects T_delay to adapt to real-time changes in tissue movement, ensuring the continuous accuracy of timing compensation.

[0196] 3.2.3 Physical Compensation Principle

[0197] like Figure 13 , Figure 14 As shown, the physical compensation is a compensation method specific to the balloon electrode unit. Its core lies in dynamically adjusting the balloon pressure to allow the electrode to actively track tissue movement, thereby maintaining a stable contact state. This process specifically includes:

[0198] Compensation trigger (risk assessment): such as Figure 13 As shown, when the motion prediction results indicate that the tissue displacement vector ΔD exceeds the preset displacement threshold, the system determines that the contact force is at risk of decreasing and triggers the physical compensation mechanism.

[0199] Pressure decision: The system will predict the magnitude and direction of the displacement vector ΔD, convert it into the balloon pressure adjustment amount through a preset displacement-pressure mapping relationship (e.g., through a lookup table or controller algorithm), and calculate the target pressure P_target.

[0200] Closed-loop execution (deformation tracking): such as Figure 14 As shown, the balloon pressure control system rapidly adjusts the intraballoon pressure based on the target pressure P_target through closed-loop control, causing the balloon to undergo controllable active deformation. This deformation tracks the movement trajectory of the mucosa in real time, thereby offsetting the predicted displacement ΔD and maintaining stable electrode-tissue contact force.

[0201] The above technical solutions, through deep collaboration between software and hardware, form an intelligent ablation system that is not only efficient and reliable, but also adaptable to different scenarios and individuals, providing a complete solution for interventional treatment in dynamic and complex environments such as the duodenum.

[0202] The systems, devices, modules, or units described in the above embodiments can be implemented by computer chips or entities, or by products with certain functions.

[0203] It should be noted that the functional modules or units described herein (such as the "catheter identification unit") are named based on the functions they perform. In actual hardware implementation, this function may be performed independently by a single physical component, or it may be implemented collaboratively by multiple sub-components (such as information storage modules, communication interfaces, logic processing units, etc.) distributed in different locations within the system. Those skilled in the art should understand that any hardware or software combination capable of implementing the described functions should fall within the protection scope of the corresponding claims.

[0204] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0205] The above embodiments should be understood as illustrative only and not as limiting the scope of protection of the present invention. After reading the description of the present invention, those skilled in the art can make various alterations or modifications to the present invention, and these equivalent changes and modifications also fall within the scope defined by the claims of the present invention.

Claims

1. An intelligent adaptive ablation system for the duodenum, characterized in that, include: The intelligent control host integrates a main control processor, a motion prediction and decision-making unit, an intelligent drive control module, and an intelligent energy control module; Sensing components are used to sense the anatomical morphology of the duodenal cavity in real time; And an electrode unit library, including several electrode units with different structures; The main control processor and motion prediction decision unit are configured to automatically select the optimal electrode unit from the electrode unit library based on the anatomical morphology of the duodenal cavity perceived by the sensing components. The intelligent drive control module is configured to receive electrode unit selection instructions from the main control processor and the motion prediction decision unit, and drive the selected electrode unit to change its shape to adapt to the cavity environment. The intelligent energy control module is configured to provide controlled ablation energy to the electrode unit after drive adaptation; The electrode unit library includes basket electrode units and balloon electrode units; The intelligent drive control module includes: The balloon pressure control system is used to realize the automatic inflation, deflation and pressure regulation of the balloon electrode unit; The basket deformation control system is used to automatically control the opening degree of the basket electrode units.

2. The intelligent adaptive ablation system for the duodenum according to claim 1, characterized in that, The configuration of the electrode unit library can be personalized according to the individual characteristics of the patient; the intelligent control host is configured to recognize the personalized configuration and automatically load the corresponding control parameters.

3. The intelligent adaptive ablation system for the duodenum according to claim 1, characterized in that, The sensing components include at least one of an inertial measurement unit (IMU), a contact force sensor, and a tissue impedance measurement unit.

4. The intelligent adaptive ablation system for the duodenum according to claim 3, characterized in that, The sensing component includes: An inertial measurement unit (IMU) installed in the electrode unit library is used to sense motion posture; Contact force sensors disposed on the surface of the balloon electrode unit and / or on the support nodes of the basket electrode unit are used to measure the contact force between the electrode and the tissue. The electrode units in the electrode unit library can be used as the tissue impedance measurement unit.

5. The intelligent adaptive ablation system for the duodenum according to claim 1, characterized in that, The intelligent energy control module includes: The multi-channel switch matrix, composed of high-voltage and high-speed electronic switches, is controlled by the instructions of the main control processor and is used to route the energy generated by the pulse generator to the designated electrode unit channel. A high-speed data acquisition circuit, including a current sensor and a high-precision analog-to-digital converter, is used to sample the pulse current of each channel in real time and convert it into a digital signal; The high-speed safety monitoring circuit includes an analog comparator, which compares the signal sampled by the current sensor with a preset safe current threshold and directly shuts off the energy output when the threshold is exceeded. The catheter identification unit is used to identify and read the configuration information of the connected catheter.

6. The intelligent adaptive ablation system for the duodenum according to claim 1, characterized in that, The main control processor and motion prediction decision unit are also configured to predict the motion state of the duodenal cavity and implement dynamic compensation based on the prediction results.

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