Targeted ablation system, control method, device, medium, and electronic device

Abstract

The present invention discloses a targeted ablation system, a control method, a device, a medium, and an electronic device, in which a navigation control device constructs a virtual model based on regional image information of a target intervention area, morphological attribute information of an interventional assembly, motion position information, and intervention position information, to obtain a navigation three-dimensional model and a three-dimensional model of an operation object, the navigation three-dimensional model representing the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the interventional assembly, and spatial position information between the ablation object, the interventional assembly, and the target intervention area, the navigation control device further determines target ablation parameters corresponding to the ablation object, and controls the ablation device to operate based on the target ablation parameters, so that the interventional assembly performs ablation treatment on the ablation object. The application of the targeted ablation system of the present invention can improve surgical accuracy, efficiency, therapeutic effect, and safety.

Description

[Technical Field]

[0001] The present invention relates to the technical field of medical devices, and in particular to targeted ablation systems, control methods, devices, media and electronic equipment. [Background technology]

[0002] Conventional ablation techniques primarily involve thermal ablation, such as radiofrequency ablation, microwave ablation, cryoablation, and focused ultrasound ablation. The basic principle of radiofrequency ablation is hyperthermia using high-frequency electromagnetic waves (375 kHz–500 kHz) consisting of alternating electric and magnetic fields. Energy generated by radiofrequency waves (375 kHz–500 kHz) forms a closed circuit within the human body, passing from the radiator to the negative electrode plate and then to the treatment electrode needle. Ions around the electrode needle are excited by the alternating current, colliding and rubbing together to generate heat. When the heat exceeds the tumor tissue's tolerance level, tumor cells undergo coagulation necrosis, and small blood vessels around the tumor are thermally damaged and occluded, cutting off the tumor's blood supply. During surgery, the tumor tissue undergoes rapid and widespread coagulation necrosis, resulting in a complete blurring of the lesion boundary under real-time ultrasound imaging. Therefore, determining complete ablation is difficult, leading to complications such as skin ecchymosis, skin burns, muscle burns, secondary fat necrosis, and wound infection.

[0003] There are two main methods of microwave ablation: focused microwave phased array thermotherapy (FMPA) and percutaneous microwave coagulation therapy (PMC). In FMPA, microwaves generate dielectric heat through the rapid movement of water molecules within tissues and cells, causing thermal coagulation necrosis. In PMC, a probe capable of emitting microwave energy is inserted directly into the tumor, generating high temperatures that quickly induce protein denaturation or cell coagulation necrosis. The main mechanism of action is that cancer cells have a higher water content than normal cells, so they generate more heat under the action of microwaves, causing cell coagulation necrosis. However, thermal damage still occurs in the surrounding tissues due to the burned skin.

[0004] Laser ablation mainly involves inserting a tip laser fiber into the tumor, raising the temperature of the tissue through the thermal effect of the laser photons and the tissue, and forming a thermal ablation area, but it may cause permanent damage to surrounding blood vessels and nerve tissue, as well as causing the phenomenon of incomplete ablation or excessive ablation.

[0005] High-intensity focused ultrasound ablation (HIFU) is a non-invasive ablation technique that does not require minimally invasive surgery to place a catheter or probe at the tumor site. In HIFU, high-energy ultrasound is focused, resulting in extremely high ultrasound intensity at the focal point. This energy is rapidly absorbed by tumor tissue and converted into thermal energy, instantly raising the local temperature to over 65°C. Proteins in the target area denature, resulting in coagulation and necrosis of cells. Damage to normal tissues and tissues surrounding the target area is minimal or unaffected. However, during HIFU treatment, tissues in the target area must be kept as still and motionless as possible; otherwise, off-target effects may occur, resulting in incomplete ablation. While curative treatment can be achieved by ablation of an extended area around the tumor margin, the extended ablation area also increases the risk of internal tissue damage.

[0006] Cryoablation involves placing a cryoprobe at the center of a tumor and rapidly lowering the temperature of tumor cells to below freezing. The repeated freezing and thawing process ruptures tumor cell membranes, damages organelles, and ultimately leads to tumor cell death. However, cells that do not die from direct cryoinjury may undergo secondary apoptosis. Cryoablation can also induce localized microvascular destruction, leading to blood stasis.

[0007] The above-mentioned ablation principle, as seen in, for example, US 14023328, US 15099665, and CN 202011501204.5, primarily aims to achieve the goal of necrosing tissue cells by changing the temperature surrounding the tissue. However, due to the heat sink effect, thermal ablation technology is prone to damaging healthy tissues such as nerves, lymphatics, and blood vessels in the ablation area. For example, some manufacturers use radiofrequency ablation technology to ablate lung diseases, such as chronic bronchitis, by ablating the smooth muscle surrounding the tracheal cartilage, thereby achieving tracheal dilation and increasing ventilation. However, this method, which is also a thermal ablation technology, achieves tissue necrosis by denaturing cellular proteins with high temperatures, making it difficult to control the ablation area and prone to damaging healthy tissues such as blood vessels and nerves. Furthermore, because the trachea is primarily supported by cartilage and smooth muscle, excessive ablation of smooth muscle can cause the cartilage to lose its support, potentially leading to tracheal collapse and more serious consequences.

[0008] Pulsed electric field ablation, a non-thermal ablation technique based on the theory of irreversible electroporation, has gradually gained attention in clinical applications. Pulsed electric field ablation generates high-voltage pulsed electric fields with pulse widths on the order of milliseconds, microseconds, or even nanoseconds, releasing extremely high energy in a short period of time. This generates a large number of irreversible micropores in cell membranes and intracellular organelles, such as the endoplasmic reticulum, mitochondria, and nucleus, thereby inducing apoptosis of diseased cells and achieving the desired therapeutic goal. In the treatment of chronic obstructive pulmonary disease (COPD), pulsed electric field ablation selectively targets pulmonary inflammatory cells without affecting other non-target tissues. It also provides thorough, accurate, and rapid full-thickness ablation, protecting blood vessels, nerves, and cartilage. Furthermore, because pulsed electric field ablation is not subject to the heat sink effect, it allows for multiple repeated ablation procedures, thereby significantly increasing the ablation depth.

[0009] Current ablation treatments involve surgical incision of surrounding tissues to fully expose the tumor, followed by puncture ablation and resection. However, this approach results in significant wound damage, prolonged incision healing, and the risk of wound infection. Therefore, minimally invasive interventional procedures have become the standard surgical method in the medical community. When performing interventional biopsies or lesion ablation of target lesions, determining the position of the interventional device within the patient's body is crucial for accurate surgery. Conventional methods for determining the precise position of an interventional device within the patient's body include endoscopic observation and fluoroscopic recognition. In actual use, for example, in treating lung lesions, the anatomical structure of the pulmonary bronchi exhibits multiple levels of branching, making it impossible to recognize and record the precise intrabronchial position of the interventional device using bronchial endoscopy alone. Furthermore, due to the limited outer diameter of the bronchoscope, the endoscope cannot reach the smaller bronchial branches, making it impossible to provide image support for the interventional device. During surgery, fluoroscopic observation cannot be routinely performed due to the potential harm caused to the human body. Because the images of the lung bronchi formed by fluoroscopy are not clear, it is not possible to determine the three-dimensional position of interventional instruments within the image. In interventional treatment of complex areas such as the lung bronchi, surgeons tend to get lost in the complexly branched lung bronchi when operating interventional instruments, which affects the accuracy and efficiency of surgery and increases the surgeon's workload.

[0010] In conventional lung disease treatments, for example, CN201810310511.1 requires the use of CT imaging to guide the ablation head through the bronchial bifurcation to reach the tumor, resulting in significant radiation exposure for both the patient and surgeon. CN201580060018.3 requires marking the tissue near the target and then combining fluoroscopic and CT images for localization, which is complex and inaccurate. Therefore, a microwave ablation device is used for ablation treatment. CN202010113062.9 requires the use of a fusion localization method combining a depth camera and a magnetic localization device to determine the ablation needle position, which results in poor real-time localization and poor visibility. CN109788979A uses pulsed electric field ablation technology, but during the intervention and energy delivery process, the exact position of the interventional device within the treatment area cannot be determined, and control parameters can only be modified based on feedback from the status of the area that has already been treated, resulting in problems such as low accuracy and real-time ablation using pulsed energy and insufficient targeting of the lesion area.In US13538947, CN201711006154.1, etc., a probe ablation head is provided to treat tissue in a narrow lung area, but the probe ablation head cannot properly abut the lesion tissue, resulting in a small ablation area.

[0011] Most conventional interventional devices have large volume, poor connection reliability, poor bending flexibility, and are unable to reach the more distant and narrower bronchial branches, and are unable to properly abut the diseased tissue, which significantly affects the accuracy, efficiency, and therapeutic effect of surgery and is prone to injuring the patient.

[0012] In view of the shortcomings of the prior art, there is a need to provide an integrated system that uses minimally invasive interventional treatment methods to navigate and determine the precise position of an interventional device within a complex treatment area, allowing the interventional device to accurately reach the treatment area and uniformly abut the diseased tissue, and that uses pulsed electric field ablation technology to generate more precise pulse energy to target and treat the diseased tissue. Summary of the Invention [Problem to be solved by the invention]

[0013] In order to solve the problems of the targeted ablation system in the prior art, which involves navigating an interventional device in a complex area, making it impossible for the interventional device to accurately reach the target treatment position and uniformly abut the diseased tissue, and making it impossible to control the tissue ablation range caused by the ablation energy delivered from the ablation device, which is prone to damaging healthy tissue and affecting the accuracy, efficiency and therapeutic effect of the surgery, the present application provides a targeted ablation system, a control method, an apparatus, a medium and an electronic device. [Means for solving the problem]

[0014] In one aspect, the present application provides a targeted ablation system comprising an interventional device, a navigation control device, a first position acquisition device, and an ablation device, the interventional device comprising a second position acquisition device and an interventional assembly, the first position acquisition device, the second position acquisition device, the interventional assembly, and the ablation device being communicatively coupled to the navigation control device; The first position acquisition device acquires the movement position information of the subject and transmits it to the navigation control device; The second position acquisition device acquires intervention position information of the intervention assembly within a target intervention area and transmits it to the navigation control device, and the target intervention area belongs to the subject; The navigation control device constructs a virtual model based on the area image information of the target intervention area, the shape attribute information of the intervention assembly, the motion position information, and the intervention position information to obtain a navigation three-dimensional model and an operation object three-dimensional model, the navigation three-dimensional model representing the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the intervention assembly, and the spatial position information between the ablation object, the intervention assembly, and the target intervention area, and the operation object three-dimensional model representing the three-dimensional spatial characteristics of the ablation object; The navigation control device further determines target ablation parameters corresponding to the ablation target based on the navigation three-dimensional model, the three-dimensional model of the operation target, and the object attribute information of the ablation target, and controls the ablation device to operate based on the target ablation parameters, thereby causing the interventional assembly to perform an ablation process on the ablation target.

[0015] Furthermore, the navigation control device an intervention area sub-model construction module that performs image recognition processing on area image information of the target intervention area to obtain an image recognition result, and performs image reconstruction based on the image recognition result to obtain an intervention area sub-model that represents three-dimensional spatial features of the target intervention area and the operation target three-dimensional model; an intervention assembly sub-model construction module that constructs a virtual model based on the shape attribute information of the intervention assembly to obtain an intervention assembly sub-model representing three-dimensional spatial characteristics of the intervention assembly; and a fusion module that performs spatial fusion processing on the intervention area sub-model, the operation object 3D model, and the intervention assembly sub-model based on the intervention position information and the movement position information to obtain the navigation 3D model.

[0016] Additionally, the navigation control device further includes a navigation planning module communicatively connected to the navigation three-dimensional model; The navigation planning module performs navigation planning based on the intervention area sub-model and the three-dimensional model of the operation object to obtain a navigation path for the intervention assembly within the intervention area sub-model, and the navigation path indicates a driving path required for the intervention assembly to reach the ablation object within the target intervention area.

[0017] Furthermore, the navigation planning module further determines intervention trajectory information of the intervention assembly based on the intervention position information of the intervention assembly and the movement position information during the process of the intervention assembly moving within the target intervention area, and if the intervention trajectory information and the path trajectory information corresponding to the navigation path satisfy a predetermined deviation condition, corrects the intervention position of the intervention assembly within the target intervention area until the updated intervention trajectory information of the intervention assembly matches the path trajectory information.

[0018] In addition, the navigation control device further includes an initial parameter acquisition module and a target parameter determination module; The initial parameter acquisition module acquires initial ablation parameters corresponding to object attribute information of the ablation object, impedance data of the ablation object, contact parameters of the interventional assembly, and a dielectric constant of the ablation object, wherein the initial ablation parameters include at least one of a pulse voltage, a pulse width, a number of pulses, and a number of pulse groups; The target parameter determination module performs ablation effect evaluation based on the navigation three-dimensional model, the operation object three-dimensional model, object attribute information of the ablation object, initial ablation parameters corresponding to the object attribute information of the ablation object, impedance data of the ablation object, contact parameters of the interventional assembly, and the dielectric constant of the ablation object, to obtain ablation effect data corresponding to the initial ablation parameters, and if the ablation effect data meets the target ablation conditions, determines the initial ablation parameters as the target ablation parameters.

[0019] Furthermore, the interventional device includes a contact detection device and a dielectric constant detection device, and the contact detection device and the dielectric constant detection device are each communicatively connected to the navigation control device; the contact detection device detects impedance data of the ablation target and contact parameters of the interventional assembly, and sends them to the initial parameter acquisition module, the impedance data indicating a load of the interventional assembly, and the contact parameters indicating a degree of contact between the interventional assembly and the ablation target; The dielectric constant detection device detects the dielectric constant of the object to be ablated.

[0020] Furthermore, the target parameter determination module includes a simulation ablation model building unit; The simulation ablation model construction unit performs an ablation effect simulation using the object attribute information, the initial ablation parameters, the impedance data, the contact parameters, the dielectric constant, the three-dimensional model of the operated object, and the three-dimensional navigation model as inputs of an ablation evaluation model to obtain a simulation ablation model corresponding to the initial ablation parameters, and the simulation ablation model represents ablation effect data corresponding to the initial ablation parameters.

[0021] Furthermore, the navigation control device further includes an ablation three-dimensional model generation module; The ablation three-dimensional model generation module acquires ablation trajectory information and ablation data of the interventional assembly after the interventional assembly performs ablation processing on the ablation target, and generates an ablation three-dimensional model based on the ablation trajectory information, the ablation data and the target ablation parameters, wherein the ablation data includes an ablated ablation area and ablation position information of the ablation area, and the ablation three-dimensional model represents the three-dimensional spatial characteristics of the ablation target after ablation.

[0022] The navigation control device further includes a pulsed energy generation module; The pulsed energy generation module generates energy generation control signals based on the target ablation parameters to control the ablation device to operate.

[0023] Further, the control circuit of the ablation device includes a switching circuit, which includes at least two branch circuits connected in parallel, full bridge, half bridge, or series, each branch circuit including an input end switching module and an output end switching module, and the switching circuit controls the corresponding input end switching module and output end switching module to conduct in response to an energy generation control signal of the pulse energy generating module, thereby generating pulse energy.

[0024] Furthermore, the branch circuit includes a filtering module, and the filtering module includes a plurality of filtering units, and the filtering units include a plurality of filters and a filter selector that selects a filter to perform filtering processing.

[0025] further comprising: the interventional instrument including a mandrel and a steering control tube assembly, the mandrel electrically connected to the interventional assembly and the ablation instrument, respectively; the second position acquisition device is provided on the mandrel and / or the intervention assembly; The interventional assembly includes at least one ablation electrode, the at least one ablation electrode being mesh-like and arranged in sequence along the mandrel, the steering control tube assembly being fitted to the outside of the mandrel, and the steering control tube assembly being movable relative to the mandrel to expand or contract the ablation electrode.

[0026] Furthermore, the contact detection device and the permittivity detection device are both provided on the intervention assembly and communicatively connected to the navigation control device.

[0027] Furthermore, the interventional device includes a fixed sleeve, and internal tooth structures are provided along the circumferential direction at both ends of the sleeve body of the fixed sleeve, and the internal tooth structures at both ends are both provided inclined from the end face of the sleeve body toward the inside of the end face.

[0028] Furthermore, the second position acquisition device is provided between the two internal tooth structures of the fixed sleeve.

[0029] Additionally, the steering control tube assembly includes at least one steering control tube connected to the ablation electrode.

[0030] Additionally, at least one of the ablation electrodes can be configured as a monopolar electrode or a bipolar electrode.

[0031] Furthermore, the maximum extendable distances of the ablation electrodes arranged in sequence along the mandrel increase in sequence along the direction from the distal end to the proximal end of the mandrel.

[0032] Furthermore, the ablation electrode includes a plurality of electrode wires, which are cross-woven to form the mesh-like ablation electrode.

[0033] Furthermore, the ablation electrode has an elliptical, fusiform, polygonal or umbrella-shaped axial cross section after expansion.

[0034] The targeted ablation system further includes a control handle having a passageway therethrough for passage of the mandrel and the control tube assembly.

[0035] Further, the operating handle is provided with an operating control assembly, which is slidably or rotatably connected to the operating handle and controls at least one of the operating control tubes to move.

[0036] In another aspect, a medical intervention device according to the present application includes an inner core tube, a steering and control outer tube, an electrode guide wire, and an ablation electrode, the electrode guide wire being removably inserted into the inner core tube, and the steering and control outer tube being fitted over the outside of the inner core tube; The ablation electrode has a distal end fixedly connected to the distal end of the inner core tube and a proximal end fixedly connected to the outer wall of the operating control outer tube, and the operating control outer tube is movable along the inner core tube to expand or contract the ablation electrode.

[0037] Furthermore, the inner core tube is a penetration tube, and the distal end of the electrode guidewire can pass through the distal end of the inner core tube to contact diseased tissue.

[0038] Additionally, both the electrode guidewire and the ablation electrode are electrically connected to an ablation device.

[0039] Furthermore, the ablation electrode includes a plurality of electrode wires, which are woven in a cross-mesh pattern.

[0040] Additionally, the distal ends of the plurality of electrode wires are fixedly connected to the outer wall of the distal end of the inner core tube.

[0041] In another aspect, the present disclosure provides an energy delivery device comprising a guide tube, an expandable structure, an interventional assembly, and a handle, the guide tube having one end connected to the handle and another end connected to the expandable structure; a cooling medium passage formed within the guide tube, the cooling medium passage having one end communicating with a cooling medium source and the other end communicating with the expandable structure; The interventional assembly includes a delivery wire and an ablation electrode, the delivery wire having one end connected to the ablation electrode and the other end connected to an ablation device, the ablation electrode being mesh-like and covering the expandable structure.

[0042] Additionally, a second position acquisition device is provided at the end of the guide tube remote from the handle.

[0043] Furthermore, the guide tube includes an outer tube and an inner tube, and a cooling medium passage is formed between the outer tube and the inner tube.

[0044] Furthermore, one end of the expandable structure adjacent to the handle is connected to the outer tube, and the other end of the expandable structure is connected to the inner tube.

[0045] Furthermore, the ablation electrode has a square mesh-like structure.

[0046] Additionally, the ablation electrodes may be manufactured by cutting, knitting, or electroforming.

[0047] Furthermore, both ends of the ablation electrode are connected to both ends of the expandable structure via connecting members, respectively.

[0048] Furthermore, the ablation electrode is expandable with the expansion of the expandable structure and contractable with the contraction of the expandable structure.

[0049] Furthermore, the handle is provided with communication portions which communicate with the cooling medium source and the cooling medium passage, respectively.

[0050] Furthermore, the second position acquisition device is communicatively connected to a navigation control device.

[0051] In another aspect, a guide tube with adjustable curvature according to the present application includes an operation control section, a first layer tube and a second layer tube, the proximal ends of which are connected to the operation control section, the second layer tube being provided within the first layer tube and communicating with an interior of the operation control section; a second position acquisition device is provided at one end of the second layer tube away from the operation control unit, and the second position acquisition device is provided on an outer wall of the second layer tube; The operation control section is provided with a curvature adjustment control member and an adjustment wire, one end of the adjustment wire is connected to the curvature adjustment control member and the other end is fixedly connected to the curvature adjustment segment of the second layer tube.

[0052] Furthermore, the first layer tube and the second layer tube have a gradually decreasing diameter from the proximal end to the distal end.

[0053] Furthermore, the bend-adjustable guide tube includes a lead wire, and the second position acquisition device is connected to a navigation control device via the lead wire.

[0054] Furthermore, the bend-adjusting segment is provided on the second layer tube, and the distance from the bend-adjusting segment to the distal end of the second layer tube is 2 cm to 5 cm.

[0055] Furthermore, a connection structure is provided on the outside of the curvature adjustment segment, and the curvature adjustment segment is connected to the adjustment wire through the connection structure.

[0056] Furthermore, the curvature adjustment control member is slidably or rotatably connected to the operation control section.

[0057] Furthermore, the bending adjustment control member pulls and bends the second layer tube with the adjustment wire to an angle of 0 to 180°.

[0058] Furthermore, the adjusting wire is a round wire rope or a flat wire rope made of a single-core or multi-core wire.

[0059] Furthermore, a bending wire passage is fitted around the outside of the adjustment wire, and the bending wire passage is provided along the axial direction of the second layer tube and is connected to the operation control section.

[0060] In another aspect, a medical biopsy sampling device according to the present application includes an adjustment section, a guide tube, a sampling member, and a bending adjustment member, the guide tube being fitted into the sampling member, the guide tube being connected to the adjustment section, and the adjustment section being provided with a first adjustment member and a second adjustment member; The sampling member has one end connected to the first adjustment member and the other end having a sampling head, the curvature adjustment member has one end connected to the second adjustment member and the other end connected to the curvature adjustment portion of the guide tube, and the curvature adjustment member is capable of pulling and curving the guide tube using the curvature adjustment portion.

[0061] Furthermore, a second position acquisition device is provided on the sampling member, and the second position acquisition device is provided in the vicinity of the sampling head, and acquires position information of the sampling head and transmits it to a navigation control device.

[0062] Furthermore, the curvature adjustment portion is provided on the guide tube adjacent to the distal end of the guide tube.

[0063] Furthermore, the bending adjustment member includes an adjustment control wire, one end of which is connected to the second adjustment member and the other end of which is connected to the bending adjustment section.

[0064] Furthermore, the curvature adjustment member includes an adjustment tube, which is fitted onto the adjustment control wire and connected to the guide tube.

[0065] Furthermore, a connecting and fixing member is provided on the bending adjustment portion of the guide tube, and the adjustment control wire is connected to the bending adjustment portion via the connecting and fixing member.

[0066] Furthermore, the first adjustment member and the second adjustment member are each slidably or rotatably connected to the adjustment portion.

[0067] Furthermore, the curvature adjustment member pulls and bends the guide tube to an angle of 0° to 120°.

[0068] Furthermore, the second position acquisition device is connected to a navigation control device via a signal line.

[0069] In another aspect, the method for controlling targeted ablation of the present application comprises: receiving motion position information of the subject acquired by a first position acquisition device and intervention position information of an intervention assembly within a target intervention area acquired by a second position acquisition device, wherein the target intervention area belongs to the subject; A step of constructing a virtual model based on the area image information of the target intervention area, the shape attribute information of the intervention assembly, the motion position information and the intervention position information to obtain a navigation three-dimensional model and a manipulation object three-dimensional model, wherein the navigation three-dimensional model represents the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the intervention assembly, and the spatial position information between the ablation object, the intervention assembly and the target intervention area, and the manipulation object three-dimensional model represents the three-dimensional spatial characteristics of the ablation object; determining target ablation parameters corresponding to the ablation target based on the navigation three-dimensional model, the operation target three-dimensional model, and target attribute information of the ablation target; and controlling the ablation device to operate based on the target ablation parameters, thereby causing the interventional assembly to perform an ablation process on the ablation target.

[0070] In another aspect, the present application provides a targeted ablation control device comprising: an information receiving module for receiving motion position information of the subject acquired by a first position acquisition device and intervention position information of the intervention assembly within a target intervention area acquired by a second position acquisition device, wherein the target intervention area belongs to the subject; a model construction module that constructs a virtual model based on area image information of a target intervention area, shape attribute information of an intervention assembly, the motion position information, and the intervention position information to obtain a navigation three-dimensional model and an operation object three-dimensional model, wherein the navigation three-dimensional model represents the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the intervention assembly, and spatial position information between the ablation object, the intervention assembly, and the target intervention area, and the operation object three-dimensional model represents the three-dimensional spatial characteristics of the ablation object; a parameter determination module for determining target ablation parameters corresponding to the ablation target based on the navigation three-dimensional model, the operation target three-dimensional model, and target attribute information of the ablation target; and a subject control module that controls an ablation device to operate based on the target ablation parameters, thereby causing the interventional assembly to perform an ablation process on the ablation subject.

[0071] In another aspect, the present application provides a method for evaluating pulse ablation effect, the method comprising: performing mapping modeling on the current tissue at the ablation catheter to obtain a three-dimensional model of the current tissue; acquiring evaluation data including sensing data acquired by the ablation catheter, ablation parameters of the ablation device, and basket status data; a step of inputting the evaluation target data into a pre-trained ablation condition evaluation model to obtain an ablation condition evaluation result, wherein the ablation condition evaluation model calculates the ablation condition evaluation result corresponding to the evaluation target data based on the evaluation target data and a correspondence relationship between the evaluation target data and the ablation condition; and displaying the ablation status assessment results in the three-dimensional model of the current tissue.

[0072] Furthermore, after inputting the evaluation target data into a pre-trained ablation state evaluation model to obtain an ablation state evaluation result, the pulse ablation effect evaluation method includes: a step of saving the evaluation target data and the ablation state evaluation result in sample data and acquiring updated sample data; and training and updating the ablation condition assessment model based on the updated sample data.

[0073] Furthermore, before inputting the evaluation target data into a pre-trained ablation state evaluation model, the pulse ablation effect evaluation method includes: obtaining sample data; The method includes the steps of training a pre-constructed machine learning model using the sample data, adjusting parameters of the machine learning model during the training process until the ablation condition assessment result output from the machine learning model meets requirements, and saving the machine learning model as the ablation condition assessment model.

[0074] Further, the step of displaying the ablation status evaluation result in the three-dimensional model of the current tissue includes: determining a display color corresponding to the ablation state evaluation result based on the ablation state evaluation result and a correspondence relationship between the ablation state evaluation result and a display color; The method includes a step of displaying the ablation status evaluation result and / or a display color corresponding to the ablation status in the three-dimensional model of the current tissue, wherein the ablation status evaluation result includes an ablation range and an ablation depth.

[0075] Furthermore, the detection data includes an impedance signal, and the step of acquiring the evaluation target data includes: applying a first signal having a frequency range within a first predetermined frequency range to an electrode of the ablation catheter; acquiring a backhaul signal after applying the first signal to an electrode; and performing a filtering process on the backhaul signal to convert the backhaul signal into the impedance signal.

[0076] Furthermore, the detection data includes a permittivity signal, and the step of acquiring the evaluation target data includes: applying a sinusoidal excitation signal having a frequency range within a second predetermined frequency range to the current tissue via an electrode of the ablation catheter; and obtaining backhauled complex impedance electrical signals after applying sinusoidal excitation signals of different frequencies to the current tissue, and the complex impedance electrical signals being the permittivity signals.

[0077] Furthermore, the basket status data includes basket expansion status data and a contact area between the basket and the current tissue, and the basket expansion status data and the contact area are used to determine the thickness of the ablation target region.

[0078] In another aspect, the pulse ablation effect evaluation device according to the present application comprises: a model construction module that performs mapping modeling on the current tissue at the ablation catheter to obtain a three-dimensional model of the current tissue; a data acquisition module for acquiring evaluation target data including detection data acquired by the ablation catheter, ablation parameters of the ablation device, and basket status data; a condition evaluation module that inputs the evaluation target data into a pre-trained ablation condition evaluation model to obtain an ablation condition evaluation result, wherein the ablation condition evaluation model calculates the ablation condition evaluation result corresponding to the evaluation target data based on the evaluation target data and a correspondence relationship between the evaluation target data and the ablation condition; and a result display module for displaying the ablation status assessment result in the three-dimensional model of the current tissue.

[0079] In another aspect, a computer-readable storage medium according to the present application has at least one instruction or at least one program stored in the storage medium, the at least one instruction or the at least one program being loaded and executed by a processor to implement the above-described target ablation control method and the above-described pulse ablation effect evaluation method.

[0080] In another aspect, the electronic device of the present application includes a processor and a memory, wherein at least one instruction or at least one program is stored in the memory, and the at least one instruction or the at least one program is loaded and executed by the processor to realize the above-mentioned target ablation control method and pulse ablation effect evaluation method. [Effects of the Invention]

[0081] By practicing embodiments of the present invention, the following beneficial effects are achieved.

[0082] The targeted ablation system of the present application constructs a virtual model of a complex target intervention area based on regional image information of the target intervention area to obtain a navigation three-dimensional model and a manipulation object three-dimensional model. The navigation three-dimensional model represents the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the interventional assembly, and the spatial position information between the ablation object, the interventional assembly, and the target intervention area. The navigation three-dimensional model can perform navigation positioning for the interventional assembly, providing important visual support for determining the position of the interventional assembly during surgery, thereby allowing the interventional assembly to reach more distant and narrow lesion locations, allowing the interventional device to accurately reach the treatment area and uniformly abut the lesion tissue, and significantly optimizing the ablation effect.

[0083] In the present application, by constructing a simulation ablation model before ablation, the surgeon can visually observe the ablation range and ablation effect due to the pulse energy generated based on the initial ablation parameters, and visually assist the surgeon in determining whether the initial ablation parameters need to be adjusted, and further optimize the initial ablation parameters and the number of ablation attempts to obtain the target ablation parameters and generate more accurate pulse energy.

[0084] The switching circuit of the ablation device of the present application can realize several combinations of pulse energy amplitude, pulse width, interval, number, or direction by connecting different branch circuits and controlling the corresponding input and output switching modules of the different branch circuits. By controlling the corresponding input and output switching modules of the different branch circuits and combining them with a filtering module, pulse energy output of different frequencies and forms can be realized. The switching circuit of the present application enables the ablation device to generate more directional pulse energy by varying the voltage amplitude, frequency, and pulse form of a set of pulse energy, thereby improving the therapeutic effect and reducing the risk of irritation during ablation treatment, which is advantageous for improving treatment safety.

[0085] The navigation control device of the present application further includes an ablation 3D model generation module that records ablation trajectory information and ablation data within the target intervention area of ​​the interventional assembly. The ablation 3D model allows the surgeon to check and observe the ablation trajectory information and ablation data of the interventional assembly at any time, providing crucial data support for the surgeon's determination of which areas have been ablated and which areas have not yet been ablated, effectively improving surgical efficiency and reducing the possibility of repeated ablation during surgery.

[0086] The targeted ablation system of the present application combines navigation control devices, ablation devices, and interventional devices to improve surgical accuracy, efficiency, therapeutic efficacy, and safety.

[0087] The interventional assembly of the present invention includes at least one mesh-like ablation electrode, which has a compact structure, high supportability, uniform energy distribution, better contact with the lesion tissue, a larger contact area, and more uniform ablation. Both ends of the ablation electrode are fixed by a fixing sleeve with an internal tooth structure, improving coaxiality and significantly reducing the coaxiality problem caused by the distal end of the ablation electrode bending and twisting after being fixed to the mandrel. This ensures a reliable connection and effectively prevents the distal end of the ablation electrode from falling off or cracking during surgery, improving the reliability of the interventional device and shortening treatment time.

[0088] The targeted ablation system of the present application combines a navigation control device, an ablation device, and an interventional device to improve surgical accuracy, efficiency, therapeutic efficacy, and safety.

[0089] By removably inserting an electrode guide wire into the inner core tube of the medical intervention device of the present application, if the diseased tissue is in the narrower trachea, the inner core tube can transport the electrode guide wire into the narrower bronchi to reach the diseased tissue, allowing ablation treatment to be performed on a narrower area.

[0090] In the energy delivery device of the present application, the ablation electrode is mesh-like and covers the surface of the expandable structure, resulting in a compact structure with higher tensile performance and structural stability. After controlling the expansion of the expandable structure, the contact area between the mesh-like ablation electrode and the target area is larger and more uniform, resulting in a better therapeutic effect. The guide tube is a double-layer catheter with a cooling medium passage and a lead passage, resulting in a more compact structure and avoiding the redundancy of exposed leads. The energy delivery device can be combined with a second position acquisition device and a navigation control device to guide the expandable structure and interventional assembly to accurately reach the target area.

[0091] The present invention provides an adjustable-curvature guide tube with a second position acquisition device at its distal end, allowing the guide tube to be positioned and navigated. The guide tube further includes a curvature adjustment control member and an adjustment wire, which control the guide tube to bend. The combination of the second position acquisition device with the curvature adjustment control member and the adjustment wire for controlling the guide tube to bend allows for more accurate localization of lesions, allowing the distal end of the guide tube to accurately reach more distant and narrow lesion locations, thereby significantly improving the accuracy of diagnosis and treatment and effectively reducing trauma caused by diagnosis and treatment. The adjustable-curvature guide tube has a simple structure, is easy to operate, and can be combined with other interventional instruments to perform accurate examinations or treatments, such as sampling, microwave inspection, ablation, and radiation therapy. It is highly practical and convenient for widespread use and production. The medical biopsy sampling device of the present application integrates a first adjustment member for controlling the sampling member and a second adjustment member for controlling the curvature adjustment member into the adjustment unit, and they are adjusted using different adjustment paths, making operation more convenient. The curvature adjustment member controls the distal end of the guide tube to adjust the curvature and increase the curvature, improving the flexibility of the curvature of the sampling member via the guide tube and allowing fine adjustment, allowing for more accurate access to and sampling of the lesion area. The sampling device is also provided with a second position acquisition device, which positions and navigates the guide tube and sampling head, guiding the sampling head to more accurately reach the lesion area and improving sampling accuracy.

[0092] The pulsed ablation effect evaluation method and apparatus of the present application combine three-dimensional mapping modeling technology and pulsed electric field ablation technology to realize ablation status evaluation, and can further improve the effectiveness of lung treatment with pulsed electric field ablation based on the ablation status evaluation results. [Brief explanation of the drawings]

[0093] In order to more clearly explain the technical means of the present invention, the following briefly describes the drawings that need to be used in the description of the embodiments or prior art. Obviously, the drawings in the following description are only some embodiments of the present invention, and those skilled in the art can also obtain other drawings based on these drawings without creative efforts.

[0094] [Figure 1] 1 is a schematic diagram of a targeted ablation system according to the present application. [Figure 2] 1 is a schematic diagram of an interventional device according to the present invention; [Figure 3] 1 is a schematic diagram of an ablation electrode provided with a position limiting structure of an interventional device of the present application. [Figure 4] 1 is a schematic diagram of an interventional device of the present application, including two ablation electrodes and two steering control tubes. [Figure 5] 1 is a schematic diagram of an interventional assembly including multiple ablation electrodes of an interventional device of the present application. [Figure 6] 1 is a cross-sectional view of an operating handle of an interventional instrument of the present application. [Figure 7] 1 is a schematic diagram of a fixing sleeve of an interventional device according to the present invention; [Figure 8] 1 is a schematic diagram of one embodiment of an ablation electrode of an interventional device of the present application. [Figure 9] 1 is a schematic diagram of another embodiment of an ablation electrode of an interventional device of the present application. [Figure 10] 1 is a schematic diagram of an interventional device according to the present invention when the ablation electrode is deployed in an umbrella shape. [Figure 11] 1 is a schematic diagram of an interventional assembly of an interventional device of the present application, the interventional assembly including multiple cylindrical ablation electrodes. [Figure 12] 1 is a schematic diagram of a medical intervention device according to the present invention; [Figure 13] 1 is a cross-sectional view of the inner core tube, steering control outer tube, and electrode guidewire of the present medical interventional device. [Figure 14]1 is a schematic diagram showing a state in which the medical intervention device of the present application is inserted into the trachea. [Figure 15] FIG. 1 is a top view of an energy delivery device of the present application. [Figure 16] 1 is a schematic diagram of an energy delivery device according to the present application. [Figure 17] FIG. 1 is a schematic diagram of details of the expandable structure and interventional assembly of the energy delivery device of the present application. [Figure 18] FIG. 1 is a cross-sectional view of a guide tube of the energy delivery device of the present application. [Figure 19] 1 is a schematic diagram of a guide tube of the present application that can be adjusted to bend; [Figure 20] 1 is a schematic diagram of a second position acquisition device and a distal end of a second layer tube of a guide tube with adjustable curvature according to the present application. [Figure 21] 10 is a schematic diagram showing the connection between the adjustment wire and the bend adjustment segment of the bend-adjustable guide tube of the present application. FIG. [Figure 22] 1 is a schematic diagram of a medical biopsy sampling device according to the present invention; [Figure 23] 2 is a schematic diagram illustrating the configuration of a sampling head and a second position acquisition device of the sampling device of the present application. FIG. [Figure 24] 1 is a schematic diagram illustrating the connection between a curvature adjustment member and a curvature adjustment segment of a sampling device according to the present invention. [Figure 25] 10 is a schematic diagram showing the connection between a curvature adjustment member and a curvature adjustment segment in another embodiment of the sampling device of the present application. FIG. [Figure 26] FIG. 1 is a schematic diagram of a navigation control device for the targeted ablation system of the present application. [Figure 27] FIG. 1 is a schematic block diagram of a target parameter determination module of the targeted ablation system of the present application. [Figure 28] FIG. 1 is a diagram illustrating the principle of simulation, evaluation, and display of the lung ablation effect using pulse energy according to the present invention. [Figure 29] FIG. 1 is a diagram showing the relationship between the contact length between the interventional assembly and the bronchus and the inner diameter of the bronchus, as simulated in this application. [Figure 30] FIG. 10 is a diagram of the relationship between contact length and field strength with increasing number of bronchial levels, as simulated in this application. [Figure 31] FIG. 10 is a diagram showing the relationship between contact length and electric field strength as the bronchial wall thickness increases, as simulated in this application. [Figure 32] FIG. 10 is a diagram showing the ablation effect on lung tissue caused by pulse energy in a simulated ablation model when the pulse voltage amplitude is set to 1500 V in the present application. [Figure 33] FIG. 1 shows the pathological structure of the bronchial tissue of the present application. [Figure 34] 1 is a predicted ablation effect of the bronchial tissue mucosal layer by pulse energies generated using different initial ablation parameters in the present application. FIG. [Figure 35] 1 is a schematic diagram of a module of the control circuit of the ablation device of the present application. [Figure 36] 1 is a schematic diagram of a module of a branch circuit of the ablation device of the present application. [Figure 37] 1 is a flowchart of the present method for controlling targeted ablation. [Figure 38] 1 is a flowchart of a pulse ablation effect evaluation method according to the present invention. [Figure 39] 1 is a connection block diagram of a pulse ablation effect evaluation system according to the present invention. [Figure 40] 1 is a block diagram showing the principle of a pulse ablation effect evaluation method according to the present invention; [Figure 41] 1 is an example of an ablation state evaluation model according to the present application. [Figure 42] 1 is a structural block diagram of a pulse ablation effect evaluation device according to the present application. [Figure 43] FIG. 2 is a schematic configuration diagram of a server according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0095] Hereinafter, the technical means in the embodiments of the present application will be described clearly and completely with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and are not all of the embodiments, and all other embodiments that a person skilled in the art can obtain based on the embodiments of the present application without making any creative efforts are all within the scope of protection of the present application.

[0096] It should be noted that the terms "first," "second," etc. in the specification, claims, and drawings of this application are used to distinguish between similar objects and do not necessarily describe a particular order or priority. It should be understood that the data used in this manner may be interchanged as appropriate, so that the embodiments of this application described herein may be practiced in orders other than those shown or described herein. Furthermore, the terms "comprise," "have," and any variations thereof are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus comprising a series of steps or units is not limited to the explicitly shown steps or units, but may include other steps or units that are not explicitly shown or inherent in such process, method, product, or apparatus.

[0097] The present application provides a targeted ablation system that uses a navigation and localization function to control an interventional device so that it accurately enters a target intervention area such as a tumor, lumen, or organ and makes good contact with the diseased tissue, and that performs ablation effect evaluation based on ablation effect data before ablation, thereby generating and delivering more accurate and more directional pulse energy to the diseased tissue to perform ablation treatment.

[0098] The targeted ablation system of the present application can be used to treat pulmonary tracheal and endobronchial diseases, such as chronic bronchitis, chronic obstructive pulmonary disease, and asthma. The structure of pulmonary bronchial tissue mainly includes epithelial cells, the lamina propria, and the submucosa. The epithelial cells are ciliated pseudostratified cells, with goblet cells sandwiched between the pseudostratified cells, which secrete a small amount of mucus. The submucosa mainly comprises smooth muscle and connective tissue, with mucus glands in the connective tissue secreting the majority of the mucus. Long-term excessive mucus production and accumulation in the lungs is a major cause of many pulmonary diseases. The targeted ablation system of the present application uses pulsed energy to destroy and remove goblet cells in the epithelial cells and mucus glands in the submucosa, thereby reducing mucus secretion in the bronchial lumen. The pulsed energy also kills ineffective ciliated pseudostratified cells, allowing the new epithelial cells to be generated, helping to cough up tracheal mucus and preventing mucus accumulation. The targeted ablation system of the present application can improve surgical accuracy, efficiency, therapeutic efficacy and safety.

[0099] In the case of treating a pulmonary endobronchial disease, the target intervention region in the present application is the pulmonary bronchial region of the subject, and the manipulation object is the diseased tissue region within the pulmonary bronchial region that is the target of ablation.

[0100] 1 to 11 , the present application provides a targeted ablation system including an interventional device 1, a navigation control device 2, a first position acquisition device 3, and an ablation device 4. The interventional device 1 includes a second position acquisition device 11 and an interventional assembly 12. The first position acquisition device 3, the second position acquisition device 11, the interventional assembly 12, and the ablation device 4 are each communicatively connected to the navigation control device 2.

[0101] Specifically, the interventional device 1 delivers pulsed energy and intervenes within the subject's body to perform ablation on an ablation target. In this application, the interventional device 1 includes a mandrel 13, an operation control tube assembly 14, a second position acquisition device 11, and an interventional assembly 12. The mandrel 13 is electrically connected to the interventional assembly 12 and the ablation device 4, respectively.

[0102] The second position acquisition device 11 is provided on the mandrel 13 and / or on the intervention assembly 12 .

[0103] The interventional assembly 12 includes at least one ablation electrode 121, which is mesh-like and arranged in sequence along the mandrel 13, and the operating control tube assembly 14 is fitted into the mandrel 13, and the operating control tube assembly 14 is movable relative to the mandrel 13 to expand or contract the ablation electrode 121.

[0104] In some embodiments, the second position acquisition device 11 may be installed at any position on the mandrel 13 or the interventional assembly 12, and the number of second position acquisition devices 11 is not limited. The more second position acquisition devices 11 there are, the more comprehensively the interventional device 1 can be located in real time, the more real-time changes in the trachea of ​​the interventional device 1 can be displayed, and the position of the interventional device in the trachea can be expressed in different dimensions. Preferably, the second position acquisition device 11 is installed at the distal end of the mandrel 13 or the interventional assembly 12. The second position acquisition device 11 acquires intervention position information of the interventional assembly 12 within the target intervention area and transmits it to the navigation control device 2 via a signal line. The target intervention area belongs to the subject. In some possible embodiments, the second position acquisition device 11 may be a magnetic induction sensor, which is able to acquire intervention position information within the target intervention area of ​​the intervention assembly 12 by means of a magnetic field, while in other possible embodiments, the second position acquisition device 11 may be an electric induction sensor, which is able to acquire intervention position information within the target intervention area of ​​the intervention assembly 12 by means of an electric field. Preferably, the second position acquisition device 11 includes at least one 5-DOF or 6-DOF magnetic orientation sensor.

[0105] In some embodiments, the mandrel 13 may be an electrode wire connected to the ablation device 4 and the interventional assembly 12, respectively, to transmit ablation energy to the interventional assembly 12. In other embodiments, the mandrel 13 may be a stainless steel spring tube, hypotube, or spiral tube, and the electrode wire connected to the ablation device 4 and the interventional assembly 12, respectively, is disposed within the mandrel 13. The electrode wire may be single-core or multi-core, may have a wire diameter of 0.05 mm to 1 mm, and is made of a conductive metal material. In some embodiments, the mandrel 13 has an outer layer with or without a polytetrafluoroethylene coating.

[0106] Specifically, the steering control tube assembly 14 includes at least one steering control tube 141 connected to the ablation electrode 121. In some possible embodiments, the interventional assembly 12 includes one ablation electrode 121, and the steering control tube assembly 14 includes one steering control tube 141, with the ablation electrode 121 having a distal end connected to the distal end of the mandrel 13 and a proximal end fixedly connected to the outer wall of the steering control tube 141, and the distal end of the steering control tube 141 being spaced apart from the distal end of the mandrel 13. In another possible embodiment, the interventional assembly 12 includes a first ablation electrode 122 and a second ablation electrode 123, the first ablation electrode 122 and the second ablation electrode 123 being arranged in sequence along the mandrel 13, the steering control tube assembly 14 including a first steering control tube 142 and a second steering control tube 143 arranged in sequence, the first ablation electrode 122 having a distal end connected to the distal end of the mandrel 13 and a proximal end fixedly connected to the outer wall of the first steering control tube 142 and movable along the first steering control tube 142. The first ablation electrode can be controlled to expand or contract by controlling the first operating control tube 142, the distal end of the first operating control tube 142 is spaced apart from the distal end of the first ablation electrode 122, the second ablation electrode 123 has its distal end connected to the outer wall of the first operating control tube a certain distance away from the distal end of the first operating control tube and its proximal end fixedly connected to the outer wall of the second operating control tube 143, and the second ablation electrode can be controlled to expand or contract by controlling the second operating control tube to move.

[0107] As shown in FIG. 5 , in some possible embodiments, the interventional assembly 12 includes multiple ablation electrodes 121, and the maximum extendable distances of the multiple ablation electrodes 121 are the same. As shown in FIG. 11 , in other possible embodiments, the maximum extendable distances of the multiple ablation electrodes 121 arranged sequentially along the mandrel 13 increase sequentially from the distal end to the proximal end of the mandrel 13. Therefore, depending on the change in the tracheal inner diameter, the ablation electrodes 121 with different diameters can be controlled to expand using the operating control tube assembly, thereby adapting to tracheal diameters of different sizes. Specifically, at least one ablation electrode 121 can be configured as a monopolar electrode or a bipolar electrode. In some possible embodiments, the at least one ablation electrode 121 emits monopolar pulses, and a negative electrode plate is attached to the subject's body surface. The negative electrode plate is coupled to a product to form a circuit inside the body, thereby applying pulse energy to the treatment area. In another possible embodiment, different ablation electrodes 121 form positive and negative poles inside the subject's body, and energy is transmitted between the positive and negative poles to form a closed-loop treatment area by the positive and negative poles and the energy range within them. By controlling the circuits of the ablation electrodes 121 at the two ends to be conductive, a wider range of ablation area can be obtained, and by controlling the circuits of two adjacent ablation electrodes 121 to be conductive, the ablation range can be controlled between the two adjacent ablation electrodes 121, thereby making the treatment range more precise and reducing irritation.

[0108] In some possible embodiments, the interventional assembly 12 includes one ablation electrode 121, which is electrically connected to connection ports in the ablation device via multiple electrode wires, including one negative port and seven positive ports. The negative port is connected to a negative electrode plate attached to the subject's body surface, and the other seven positive ports are connected to different electrode wires, which are connected to the ablation electrodes 121. For example, the first electrode wire is connected to the first port, the second electrode wire is connected to the second port, the third electrode wire is connected to the third port, the fourth electrode wire is connected to the fourth port, the fifth electrode wire is connected to the fifth port, the sixth electrode wire is connected to the sixth port, and the seventh electrode wire is connected to the seventh port. Each electrode connection port can be individually controlled by user settings, allowing the circuit to be turned on or off depending on the region and scope of ablation.

[0109] In some embodiments, the ablation electrode 121 includes a plurality of electrode wires that are cross-woven to form a mesh-like ablation electrode 121. Preferably, the ablation electrode 121 is formed by weaving conductive wire, and the wire material is preferably a material with good electrical conductivity, such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. The longitudinal cross section of the wire may be elliptical, circular, or polygonal, thereby allowing the weaved ablation electrode 121 to more fully contact the target location. The mesh-like ablation electrode 121 is easily shape-changeable, expandable, and contractible, and has higher mesh density, tensile strength, and structural stability, allowing for better contact with the target location, a larger and more uniform contact area, and a more effective treatment effect.

[0110] 8 to 11, the expanded axial cross section of ablation electrode 121 may be spindle-shaped, polygonal, elliptical, or umbrella-shaped. When the proximal end of ablation electrode 121 moves away from its distal end, ablation electrode 121 contracts to become a cylindrical body coaxial with mandrel 13 to facilitate movement within narrow passages. When the proximal end of ablation electrode 121 is driven by the operating control tube to move closer to the distal end of ablation electrode 121, ablation electrode 121 expands to become a mesh-like body with an elliptical, spindle-shaped, polygonal, or umbrella-shaped axial cross section to increase the contact area with bronchi of different inner diameters and ablation targets of special shapes. In some possible embodiments, the multiple ablation electrodes 121 are arranged in sequence along the mandrel 13, with the maximum expandable diameter of the multiple ablation electrodes 121 increasing in sequence along the direction from the distal end to the proximal end of the mandrel 13, and depending on the inner diameter of the trachea they enter, the ablation electrodes 121 of different diameters can be controlled to expand to accommodate different inner diameter dimensions. If the trachea is particularly narrow, it is only necessary to control the ablation electrode 121 with the smallest diameter at the farthest end to expand, and a cylindrical structure with a rectangular axial cross section is more suitable for trachea with a smooth passage.

[0111] In some embodiments, the exterior of the ablation electrode 121 is provided with an insulating layer to improve the insulating performance of the ablation electrode 121 .

[0112] In some embodiments, the manipulation control tube 141 may be an extruded tube such as PI (polyimide), PET (polyethylene terephthalate), Pebax (block polyetheramide resin), or PTFE (polytetrafluoroethylene), or a PI / PTFE composite tube. The manipulation control tube 141 preferably has an outer diameter of 0.5 mm to 5 mm, a wall thickness of 0.025 mm to 0.5 mm, and a length of 40 cm to 80 cm.

[0113] In some embodiments, as shown in FIG. 3 , a position limiting structure 124 is provided within the ablation electrode 121 and spaced apart from the distal end of the steering control tube 141. In some possible embodiments, the position limiting structure may be a position limiting tube provided within the ablation electrode 121, which is spaced apart from the distal end of the steering control tube 141. When the distal end of the steering control tube 141 abuts against the position limiting tube, the ablation electrode 121 is maximally expanded. In some possible embodiments, when the abutment point between the position limiting structure 124 and the distal end of the steering control tube 141 is at an intermediate position between the ablation electrode 121 and the maximally expanded position, the ablation electrode 121 is more stable overall and can better abut against the trachea. In the present application, the maximum radial expansion distance of the ablation electrode 121 can be adjusted by adjusting the length of the position limiting tube. In some possible embodiments, the position limiting structure 124 can limit the direction of expansion of the ablation electrode 121 when the ablation electrode 121 expands. Generally, when the position limiting structure 124 approaches the distal end of the ablation electrode 121, the ablation electrode 121 expands in an umbrella shape, and the opening direction of the expansion may also be toward the distal end, so that when the ablation electrode 121 is in a short trachea, the contact area with the trachea can be increased by such expansion method, and such an umbrella structure can also fit into a narrow trachea, and the radial supporting force is too large, so that the expansion width of the ablation electrode 121 is not too large, which will damage the inner wall of the trachea.

[0114] Specifically, the interventional device 1 further includes a fixing sleeve 15 fixedly connected to the end of the ablation electrode 121 to fix the end of the ablation electrode 121. Internal tooth structures 151 are provided along the circumferential direction at both ends of the sleeve body of the fixing sleeve 15, and the internal tooth structures 151 at both ends are inclined inward from the end surface of the sleeve body. In some possible embodiments, the tooth shape of the internal tooth structures 151 may be wavy, triangular, spur, trapezoidal, or the like. Both ends of the ablation electrode 121 are fixedly connected to the mandrel 13 or the operation control tube assembly 14 via the fixing sleeve 15. The internal tooth structures 151 of the fixing sleeve 15 can better fix the mesh-like ablation electrode 121. The provision of the internal tooth structures 151 reduces the openings at both ends of the fixing sleeve 15, improving coaxiality and significantly reducing coaxiality problems caused by bending and twisting after the distal end of the ablation electrode 121 and the mandrel 13 are fixed. In some possible embodiments, the second position acquisition device 11 may be disposed between two internal tooth structures (151) of the fixing sleeve 15 so as to reduce the space required for mounting the second position acquisition device 11. Fixing both ends of the ablation electrode 121 with the fixing sleeve 15 improves the coaxiality and connection reliability of both ends of the ablation electrode 121, prevents the ablation electrode 121 from falling off during surgery, improves the reliability of the interventional equipment, shortens the treatment time, and ensures space for disposing the second position acquisition device 11.

[0115] Specifically, the interventional device 1 further includes an operating handle 16, which has a passage 161 through which the mandrel 13 and the operating control tube assembly 14 pass. The operating handle 16 is a control handle for the interventional device, and the mandrel 13 and signal lines of the interventional device may be integrated and drawn out through the passage 161 of the operating handle 16, thereby achieving a compact structure and avoiding redundancy due to the signal lines being exposed to the outside. In some possible embodiments, a fixed locking port 162 is provided at the proximal end of the passage 161, and the fixed locking port 162 is connected to the proximal end of the mandrel 13 to secure the mandrel 13 in place. A seal ring 163 may be provided inside the fixed locking port 162 to improve the sealing and electrical safety of the operating handle 16. In some embodiments, the operating handle 16 may be 3D printed or injection molded from a material such as plastic, nylon, or silicone. The operating handle 16 is provided with an operating control assembly 17, one end of which is slidably or rotatably connected to the operating handle 16 and the other end of which is fixedly connected to the proximal end of the operating control tube assembly 14. In some possible embodiments, the operating control assembly 17 is configured as a slider having one end slidably connected to the outer wall of the operating handle 16 and the other end as a plunger portion slidably connected to the inner wall of the operating handle 16, the plunger portion being fixedly connected to the proximal end of the operating control tube assembly 14. In other possible examples, the operating control assembly 17 may be configured as a knob, the inner ring of which is threadedly engaged with the operating control tube assembly 14, so that rotation of the knob can drive the operating control tube assembly to move axially. In the present application, the operating control assembly 17 can control the movement of the operating control tube assembly 14 relative to the mandrel 13 to control the degree of expansion of the interventional assembly 12.

[0116] Specifically, the interventional device 1 further includes a contact detection device and a dielectric constant detection device, which are communicatively connected to the navigation control device 2, respectively. The contact detection device detects impedance data of the ablation target and contact parameters of the interventional assembly 12 and transmits them to the initial parameter acquisition module 025, where the impedance data indicates the load of the interventional assembly 12 and the contact parameters indicate the degree of contact between the interventional assembly 12 and the ablation target. The dielectric constant detection device detects the dielectric constant of the ablation target. In some embodiments, the contact detection device and the dielectric constant detection device may be provided on the outer wall of the interventional assembly 12.

[0117] In this application, the steps of treating intrapulmonary bronchial diseases using the above interventional device are as follows: the mandrel 13 and the operation control tube assembly are controlled by the operating handle 16 to feed the contracted interventional assembly 12 into the trachea; when the interventional assembly reaches the target diseased tissue area, the operation control assembly 17 controls the expansion degree of the ablation electrode 121 according to the inner diameter of the trachea so that the ablation electrode 121 uniformly abuts the diseased tissue; the ablation device connected to the mandrel 13 delivers ablation energy, and the ablation electrode 121 emits the ablation energy to perform ablation treatment on the diseased tissue; the time and number of ablation treatments are controlled and operated according to the lesion types of different target areas, different treatment plans, and the amount and type of ablation energy delivered.

[0118] The targeted ablation system of the present application further includes a first position acquisition device 3 that acquires the subject's motion position information and transmits it to the navigation control device 2. Specifically, the subject's motion position information of the present application may be the subject's respiratory status information, and the first position acquisition device 3 may be magnetic localization electrodes placed on or around the subject's body to acquire chest activity information during breathing. In some possible embodiments, the first position acquisition device 3 includes three or six electrodes with unique configurations incorporating magnetic localization sensors and is placed on the patient's anterior chest and / or back. The first position acquisition device 3 moves upward with the subject's chest when the subject inhales and moves downward with the subject's chest when the subject exhales. The subject's chest movement in the magnetic localization signal field is captured by the first position acquisition device 3, and the subject's movement position information provided by the first position acquisition device 3 can be used to perform respiratory interference compensation calculations on the intervention position information within the target intervention area of ​​the intervention assembly 12 provided by the second position acquisition device 11, and the compensation calculations can remove the respiratory interference experienced by the second position acquisition device 11 during movement to obtain more accurate intervention position information.

[0119] The targeted ablation system of the present application further includes a localization generating device communicatively connected to the navigation control device, which generates a multi-dimensional localization signal field within the working area, and can acquire corresponding three-dimensional spatial position information when the first and second position acquisition devices move within the localization signal field.

[0120] In some embodiments, as shown in Figures 12 to 14, the interventional device of the present application may be a medical intervention device, which similarly accurately enters a target intervention area such as a tumor, a lumen, or an organ, closely contacts the diseased tissue, and is connected to a navigation control device and an ablation device, and delivers and applies ablation energy generated by the ablation device to the diseased tissue to achieve ablation treatment.

[0121] The medical intervention device includes an inner core tube 100, an operating and controlling outer tube 101, an electrode guide wire 102 and the above-mentioned ablation electrode 121, wherein the electrode guide wire 102 is removably inserted into the inner core tube 100, the operating and controlling outer tube 101 is fitted on the outside of the inner core tube 100, the distal end of the ablation electrode 121 is fixedly connected to the distal end of the inner core tube 100 and the proximal end is fixedly connected to the outer wall of the operating and controlling outer tube 101, and the operating and controlling outer tube 101 can move along the inner core tube 100 to expand or contract the ablation electrode 121.

[0122] Specifically, both the electrode guidewire 102 and the ablation electrode 121 are electrically connected to the ablation device 4. In some embodiments, the inner core tube 100 may be a tubular structure such as a spring tube, hypotube, or spiral tube. An electrode wire is inserted into the inner core tube 100, and the ablation electrode 121 is electrically connected to the ablation device via the electrode wire, transmitting ablation energy to the ablation electrode 121. The electrode wire may be single-core or multi-core, may have a wire diameter of 0.05 mm to 1 mm, and may be made of a conductive metal material. In some possible embodiments, when the ablation electrode 121 is inserted into the trachea to perform ablation treatment, when the target lesion tissue is found, the operation-controlled outer tube 101 can be pressed according to the inner diameter of the trachea to control the ablation electrode 121 to expand and evenly abut against the lesion tissue.

[0123] In some embodiments, the inner core tube 100 is a penetration tube, and the distal end of the electrode guide wire 102 can pass through the distal end of the inner core tube 100 to contact the diseased tissue. Preferably, the electrode guide wire may be a conductive wire, and the material of the wire is preferably a material with good electrical conductivity, such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. When performing ablation treatment on a narrow trachea, the electrode guide wire 102 is inserted from the end of the control handle and pulled out from the distal end of the inner core tube 100 to reach the target diseased tissue, and ablation treatment is performed on the diseased tissue.

[0124] Specifically, the ablation electrode 121 includes a plurality of electrode wires, which are interwoven in a mesh pattern. Preferably, the electrode wires are conductive wires, preferably made of a material with good electrical conductivity, such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. The longitudinal cross section of the wires may be elliptical, circular, or polygonal, thereby allowing the woven ablation electrode 121 to more fully contact the diseased tissue. The mesh-shaped ablation electrode 121 is easily shape-changeable, expandable, and contractible, and has higher mesh density, tensile strength, and structural stability, allowing for better contact with the diseased tissue, a larger and more uniform contact area, and a more effective treatment effect. The axial cross section of the ablation electrode 121 after expansion may be elliptical, spindle-shaped, polygonal, or umbrella-shaped. When the proximal end of the ablation electrode 121 moves away from the distal end of the ablation electrode 121, the ablation electrode 121 contracts to become a cylindrical body coaxial with the inner core tube 100 to facilitate movement within narrow passages, and when the proximal end of the ablation electrode 121 is driven by the operating control outer tube 101 to move in a direction approaching the distal end of the ablation electrode 121, the ablation electrode 121 expands to become a mesh-like body with an elliptical, spindle-shaped, polygonal or umbrella-shaped axial cross section to increase the contact area with bronchi of different inner diameters and diseased tissue of special shapes.

[0125] In some embodiments, the electrode wires of the ablation electrodes 121 are electrically connected to connection ports of the ablation device. For example, in some possible embodiments, the connection ports include one negative port and multiple positive ports. The negative port is connected to a negative electrode plate attached to the subject's body surface, one end of the electrode guide wire 102 is connected to the negative port, and the other positive ports are each connected to a different electrode wire. Each electrode connection port can be individually controlled by user settings, allowing the circuit to be turned on and off depending on the region and scope of ablation.

[0126] In some embodiments, the ablation electrode 121 includes multiple electrode wires that are expandable into a lantern-like structure that can contact bronchi of different diameters and diseased tissue of special shapes.

[0127] Specifically, the distal ends of the plurality of electrode wires are fixedly connected to the outer wall of the distal end of the inner core tube 100. In some possible embodiments, the distal ends of the plurality of electrode wires may be fixedly connected to the outer wall of the distal end of the inner core tube 100 by methods such as welding, hot melting, or adhesive bonding.

[0128] Specifically, the interventional device further includes a fixing member 103 for fixing the proximal end of the ablation electrode 121. Internally toothed structures are provided along the circumferential direction on both ends of the sleeve body of the fixing member 103, and the internally toothed structures at both ends are inclined inward from the end surface of the sleeve body. The tooth shape of the internally toothed structures may be wavy, triangular, spur, or trapezoidal. The internally toothed structures can better fix the mesh-shaped ablation electrode 121, and providing the internally toothed structures reduces the openings at both ends of the sleeve body of the fixing member 103, improving coaxiality. In some possible embodiments, a second position acquisition device 11 is provided between the internally toothed structures at both ends of the fixing member 103. The second position acquisition device 11 acquires intervention position information of the ablation electrode 121 within the target intervention area and transmits it to the external navigation control device 2 via a signal line. By providing the second position acquisition device 11 inside the fixing member 103, the space required for installing the second position acquisition device 11 can be significantly reduced. In the present application, fixing the ablation electrode 121 with the fixing member 103 improves the connection reliability of the ablation electrode 121, prevents the ablation electrode 121 from falling off during surgery, improves the reliability of the interventional device, shortens treatment time, and ensures space for arranging the second position acquisition device. In some embodiments, the second position acquisition device may be installed at any position on the inner core tube 100 or the ablation electrode 121, and the number of second position acquisition devices is not limited. The more second position acquisition devices there are, the more comprehensively the interventional device can be positioned in real time, the more real-time changes in the trachea of ​​the interventional device can be displayed, and the position of the interventional device in the trachea can be expressed in different dimensions.

[0129] In some embodiments, the exterior of the ablation electrode 121 is provided with an insulating layer to improve the insulating performance of the ablation electrode 121 .

[0130] In some embodiments, the operation control outer tube 101 may be an extruded tube such as PI, PET, Pebax, or PTFE, or a PI / PTFE composite tube. The operation control outer tube 101 preferably has an outer diameter of 0.5 mm to 5 mm, a wall thickness of 0.025 mm to 0.5 mm, and a length of 40 cm to 80 cm.

[0131] Specifically, the interventional device of the present application further includes an operating handle 104, which has a passageway for the inner core tube 100 and the operation control outer tube 101 to pass through. The inner core tube 100, the electrode guide wire 102, and the signal line of the interventional device may be integrated and led out of the operating handle 104, thereby achieving a compact structure and avoiding the redundancy of the signal line being exposed to the outside. In some embodiments, a fixed locking port is provided at the proximal end of the passageway, and the fixed locking port is connected to the proximal end of the inner core tube 100 to secure the inner core tube 100. A seal ring may be provided inside the fixed locking port to improve the sealing and electrical safety of the operating handle 104. In some embodiments, the operating handle 104 may be 3D printed or injection molded from a material such as plastic, nylon, or silicone.

[0132] Specifically, the operating handle 104 is provided with an operating control member 105, which is slidably or rotatably connected to the operating handle 104 and controls the operating control outer tube 101 to move. In some possible embodiments, one end of the operating control member 105 is slidably or rotatably connected to the operating handle 104, and the other end is fixedly connected to the proximal end of the operating control outer tube 101. In some possible embodiments, the operating control member 105 is configured as a slider whose one end is slidably connected to the outer wall of the operating handle 104, and the other end is configured as a plunger portion slidably connected to the inner wall of the operating handle 104, and the plunger portion is fixedly connected to the proximal end of the operating control outer tube 101. In another possible example, the operating control member 105 may be configured as a knob, and an inner ring of the knob is threadedly engaged with the operating handle 104, so that rotation of the knob can drive the operating control outer tube 101 to move in the axial direction. The steering control member 105 allows for controlled movement of the steering control outer tube 101 relative to the inner core tube 100 to control the degree of expansion of the expandable electrode 3 .

[0133] In this application, the steps of using the interventional device are as follows: using the operating handle 104, the inner core tube 100 and the operating control outer tube 101 are controlled to feed the contracted ablation electrode 121 into the trachea; when the ablation electrode 121 reaches the target diseased tissue area, the operating control member 105 controls the degree of expansion of the ablation electrode 121 according to the inner diameter of the trachea so that the ablation electrode 121 uniformly abuts on the diseased tissue; when the diseased tissue is in a narrower trachea, the ablation electrode 121 is first contracted to reach the smallest accessible bronchus, and then the electrode guide wire 102 is moved by the operating handle. The electrode guide wire 102 is inserted into the inner core tube 100 at the end of the handle 104 and pulled out from the distal end of the inner core tube 100, transported through the smaller bronchi to reach the diseased tissue, and ablation energy is delivered by an ablation device electrically connected to the electrode guide wire 102 and the ablation electrode 121, which then emits ablation energy to perform ablation treatment on the diseased tissue, and the time and number of ablation treatments are controlled and manipulated according to the lesion types in different target areas, different treatment plans, and the amount and type of ablation energy to be delivered.

[0134] In some embodiments, as shown in Figures 15 to 18, the interventional device of the present application may be an energy delivery device, which accurately enters a tissue region such as a tumor, lumen, or organ, and closely abuts the target region, is connected to a navigation control device and an ablation device, and works in cooperation with the navigation control device to perform navigation and accurate positioning, and applies pulsed energy to the target region via the ablation device and interventional assembly, thereby achieving pulsed ablation without damaging surrounding normal tissue.

[0135] The energy delivery device of the present application includes a guide tube 20, an expandable structure 21, an interventional assembly 12, and a handle 22. The guide tube 20 is connected at one end to the handle 22 and at the other end to the expandable structure 21. The guide tube 20 connects the handle 22 and the expandable structure 21. A cooling medium passage 201 is formed within the guide tube 20, and the cooling medium passage 201 is connected at one end to a cooling medium source and at the other end to the expandable structure 21.

[0136] In some embodiments, a cooling medium passage 201 is formed inside the guide tube 20, and the cooling medium enters the expandable structure 21 through the cooling medium passage 201 inside the guide tube 20. As shown in Fig. 18, the guide tube 20 includes an outer tube 202 and an inner tube 203, and the cooling medium passage 201 is formed between the outer tube 202 and the inner tube 203. A wire passage 204 is formed in the inner tube 203. The guide tube 20 is configured as a double-layer catheter, and the inner tube 203 is hollow and has the cooling medium passage 201 and the wire passage 204 formed therein, resulting in a more compact structure.

[0137] Specifically, one end of the expandable structure 21 adjacent to the handle 22 is connected to the outer tube 202, and the other end of the expandable structure 21 is connected to the inner tube 203. The length of the inner tube 203 is longer than that of the outer tube 202, and one end of the expandable structure 21 adjacent to the handle 22 is connected to the outer tube 202 and the other end is connected to the inner tube 203. The cooling medium flows into the expandable structure 21 through the end connected to the outer tube, and the end of the expandable structure 21 connected to the inner tube 203 is closed, preventing the cooling medium from flowing out. The cooling medium enters the expandable structure 21 through a cooling medium passage 201 located between the outer tube 202 and the inner tube 203, circulates, and then returns along the original path through the cooling medium passage 201. By using the same passage for both the inlet and outlet of the cooling medium in the present invention, it is possible to simplify the structure and to accurately control the volume of the cooling medium flowing into the expandable structure 21, thereby advantageously controlling the degree of expansion of the expandable structure 21. The expandable structure 21 expands as the cooling medium flows in and contracts as the cooling medium flows out, allowing the energy delivery assembly to better contact or separate from the target area.

[0138] In some embodiments, the guide tube 20 may be a sheath. Specifically, it may be a PEBAX tube or a nylon tube. The outer layer 202 of the guide tube 20 has an outer diameter of 1 mm to 5 mm, a wall thickness of 0.025 mm to 0.5 mm, and a length of at least 40 cm. The inner layer 203 has an inner diameter of 0.5 mm to 3 mm, a wall thickness of 0.025 mm to 0.5 mm, and a length of at least 40 cm. For example, the outer layer 202 has an outer diameter of 4 mm, a wall thickness of 0.2 mm, and a length of 60 cm, while the inner layer 203 has an inner diameter of 1.6 mm, a wall thickness of 0.2 mm, and a length of 68 cm. In other embodiments, the guide tube 20 is sufficiently long after being connected to the expandable structure 21 and the interventional assembly so that it can extend from outside the body to a target area for pulsed ablation therapy. Preferably, the length of the guide tube 20 may be at least 50 cm, 60 cm, 70 cm, 80 cm, 90 cm, 100 cm, 110 cm, 120 cm, 130 cm, 140 cm, or any range therebetween. The guide tube 20 has excellent bending resistance and can better adapt to the complex and curvature requirements of the human body. The inner wall of the guide tube 20 is smooth and has low friction resistance.

[0139] The cooling medium source supplies the cooling medium to the cooling medium passage 201 and may be a cooling medium injector or a cooling medium supplier. In some embodiments, the cooling medium source can control the volume and pressure of the cooling medium supplied into the expandable structure 21. In the present application, the expandable structure 21 is controlled to expand by supplying the cooling medium, and the expandable structure 21 is controlled to contract by controlling the cooling medium to flow out. The cooling medium may include, but is not limited to, one or more of water, sodium chloride solution, glucose solution, sodium lactate and complex sodium chloride solution, sodium bicarbonate and isotonic salt solution, etc., or a combination thereof. In some embodiments, the cooling medium cools the surface of the expandable structure by absorbing heat.

[0140] Specifically, the expandable structure 21 is configured as a balloon that is expandable with the supply of a cooling medium. In some embodiments, the expandable structure 21 may expand to one of a spherical balloon, an elliptical balloon, a conical balloon, a dumbbell-shaped balloon, or a cylindrical balloon. In some embodiments, the expandable structure 21 may be made of a material such as PU, PEBAX, or nylon. The length of the expandable structure 21 is at least 5 mm. Preferably, the length of the expandable structure 21 may be 6 mm, 7 mm, 8 mm, 10 mm, 12 mm, 15 mm, 16 mm, 18 mm, 20 mm, or any range therebetween. Preferably, the outer diameter range of the expandable structure 21 is 4 mm to 10 mm.

[0141] Specifically, the handle 22 is an operating handle that controls the guide tube 20 to deliver the expandable structure 21 and the interventional assembly 12 to the target area for treatment. One end of the guide tube 20 is inserted into the handle 22 and may be attached to the handle 22 with an adhesive, such as a quick-drying adhesive, a UV adhesive, or an epoxy adhesive. In some embodiments, the handle 22 may be 3D printed or injection molded from a material such as plastic, nylon, or silicone. In the present application, the handle 22 is provided with a communication portion 221, which is connected to the cooling medium source and the cooling medium passage 201. In some embodiments, the communication portion 221 may be a communication hole provided in the handle 22, and the cooling medium source is connected to the cooling medium passage 201 through the communication hole. In some embodiments, the communication portion 221 may be a connecting tube provided in the handle 22, and the cooling medium source is connected to the cooling medium passage 201 through the connecting tube. In some embodiments, the connecting tube is integrally molded with the handle 22.

[0142] 17, the interventional assembly 12 includes a delivery wire 120 and an ablation electrode 121, with the delivery wire 210 connected at one end to the ablation electrode 121 and at the other end to an energy delivery device, i.e., an ablation instrument. The ablation electrode 121 is mesh-like and covers the expandable structure 21.

[0143] Specifically, both ends of the ablation electrode 121 are connected to both ends of the expandable structure 21 via connecting members 23. In some embodiments, the connecting members 23 may be connecting cannulas, preferably cold-shrinkable tubing or heat-shrinkable tubing. Both ends of the ablation electrode 121 of the present application may be fixedly connected to both ends of the expandable structure 21 via heat-shrinkable tubing. The ablation electrode 121 can expand as the expandable structure 21 expands and contract as the expandable structure 21 contracts. When the expandable structure 21 contracts, the ablation electrode 121 can enter the human body along with the expandable structure 21 via the guide tube 20. After the expandable structure 21 expands, the ablation electrode 121 abuts against the surface of the expandable structure 21. The surface of the ablation electrode 121 uniformly abuts against the target area. Pulse discharge is achieved by controlling the delivery wire 120 to transmit pulse energy to the ablation electrode 121.

[0144] Specifically, the delivery wire 120 may be a stainless steel wire, a copper wire, or an enameled wire. The diameter of the delivery wire 120 is 0.05 mm to 0.5 mm. In some embodiments, a PTFE heat shrink tube, a PET heat shrink tube, or a PI sheath is fitted over the outer layer of the delivery wire 120. In other embodiments, a PTFE coating is further provided over the outer layer of the delivery wire 120. The delivery wire 120 is for transmitting pulse energy to the ablation electrode 121.

[0145] Specifically, the ablation electrode 121 may have a rectangular mesh structure. In some embodiments, the ablation electrode 121 may have a parallelogram mesh structure. Preferably, the ablation electrode 121 may have a diamond mesh structure. Because a rectangular mesh is unstable and prone to shape changes, a rectangular mesh structure provides a denser mesh, higher tensile strength, and structural stability, allowing for better contact with the surface of the expandable structure 21 and allowing for expansion and contraction along with the expandable structure 21. The contact area between the mesh ablation electrode 121 and the target area is larger and more uniform, resulting in a more effective treatment. In some embodiments, the ablation electrode 121 may be manufactured by cutting, knitting, or electroforming. The ablation electrode 121 may be made of a material with good electrical conductivity, such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. The wire diameter of the mesh ablation electrode 121 is 0.05 mm to 0.30 mm. The length of the ablation electrode 121 is greater than the length of the expandable structure 21, and the length of the ablation electrode 121 is at least 5 mm. Preferably, the length of the ablation electrode 121 may be 6 mm, 8 mm, 10 mm, 15 mm, 18 mm, 20 mm, or a range therebetween.

[0146] Specifically, a second position acquisition device 11 is further provided at one end of the guide tube 20 remote from the handle 22. The second position acquisition device 11 may be connected to the inner tube 203 of the guide tube 20. In some embodiments, the second position acquisition device 11 may be adhered to the guide tube 20 by an adhesive such as a quick-drying adhesive, a UV adhesive, or an epoxy adhesive. In other embodiments, the second position acquisition device 11 may be connected to the guide tube 20 via a heat-shrinkable tube made of PU, PET, PTFE, PEEK, or the like.

[0147] Specifically, the second position acquisition device 11 includes at least one multi-degree-of-freedom magnetic orientation sensor. In one embodiment, the second position acquisition device 11 includes at least one five-degree-of-freedom or six-degree-of-freedom magnetic orientation sensor. The second position acquisition device 11 is communicatively connected to an external detection device. In some embodiments, the second position acquisition device 11 is connected to the external detection device via a conductor 24, which transmits acquired information such as position and direction to the external detection device. As shown in FIG. 18 , the conductor 24 is inserted into the conductor passage 204 and pulled out from the handle 22, thereby achieving a more compact structure and avoiding the redundancy of externally exposed conductors. In another embodiment, the second position acquisition device 11 may be wirelessly connected to the external detection device.

[0148] Specifically, the second position acquisition device 11 of the present application is connected to a navigation control device, which is an extracorporeal detection device, and the second position acquisition device 11 acquires and positions in real time the movement position and direction coordinates of one end of the guide tube 20 that is away from the handle 22 in an electromagnetic positioning system within a magnetic field space, and transmits the position information of the guide tube 20 to the navigation control device 2.

[0149] In this application, the steps of using the above energy delivery device are as follows: use the handle 22 to control the guide tube 20 to send the expandable structure 21 and the interventional assembly 12 in a deflated state to the target area in the body; use the second position acquisition device 11 to perform navigation and accurate positioning; use the cooling medium source to supply cooling medium to the expandable structure 21 through the cooling medium passage 201; after the expandable structure 21 expands, the ablation electrode 121 expands together with the expandable structure 21 and uniformly abuts the diseased tissue; use the ablation device to control the pulse energy to be released, and perform pulse therapy on the target area; during the process of multiple pulse therapy, the supply and outflow of cooling medium can be controlled to control the expandable structure and absorb and discharge heat caused by the therapy; the time and number of pulse therapy can be controlled and manipulated according to the lesion types of different target areas, different treatment plans, and the amount of pulse energy to be delivered.

[0150] The ablation electrode 121 of the present application is mesh-shaped and covers the surface of the expandable structure, resulting in a denser structure with higher tensile strength and structural stability. The contact area between the mesh-shaped ablation electrode 121 and the diseased tissue is larger and more uniform, resulting in a better treatment effect. The guide tube is a double-layer catheter with a cooling medium passage and a lead passage, resulting in a compact structure and avoiding the redundancy of exposed leads. The energy delivery device of the present application can guide the expandable structure and interventional assembly to accurately reach the target area through the positioning and navigation of the second position acquisition device, resulting in a simple structure, simple operation steps, low cost, convenient for popularization and production, and advantageous for reducing the economic burden on patients.

[0151] In some embodiments, as shown in FIGS. 19 to 21 , the interventional device of the present application may be an adjustable-bend guide tube. The guide tube may be used in combination with an endoscope or alone to reach more distant lesion locations. A second position acquisition device 11 is provided at the distal end of the guide tube, and the second position acquisition device 11 is externally connected to a navigation control device 2. The navigation control device 2 tracks the position of the distal end of the guide tube using the second position acquisition device 11, thereby achieving navigation. The guide tube may be combined with an interventional instrument, such as a biopsy forceps or an ablation catheter, to perform precise examinations or treatments, such as sampling, microwave examinations, ablation, and radiation therapy.

[0152] 19 is a schematic diagram of a guide tube whose bending is adjustable. The guide tube whose bending is adjustable according to the present application includes an operation control section 30, a first layer tube 31 and a second layer tube 32 whose proximal ends are connected to the operation control section 30, and the second layer tube 32 is provided inside the first layer tube 31 and communicates with the inside of the operation control section 30.

[0153] Specifically, the operation control unit 30 may be a hollow adjustment handle or adjustment rod. The operation control unit 30 may be 3D printed or injection molded from materials such as plastic, nylon, or silicone. The proximal ends of the first and second layer tubes 31 and 32 may be bonded to the operation control unit 30 with adhesives such as quick-drying adhesives, UV adhesives, and epoxy adhesives. The first layer tube 31 is fitted over the second layer tube 32, which may be configured as a single-lumen sheath or a multi-lumen sheath depending on actual needs. In some embodiments, the guide tube may be an extruded tube made of PI / PET / PEBAX / PTFE, a PI / PTFE composite tube, a tube braided with PEBAX and stainless steel wire, or a multi-layer tube. The second layer tube 32 may have a diameter of 0.5 mm to 5 mm and a wall thickness of 0.025 mm to 0.5 mm. In some embodiments, the length of the second layer tube 32 is equal to or greater than the length of the first layer tube 31, and the distal end of the second layer tube 32 is flush with or protrudes beyond the distal end of the first layer tube 31. In some embodiments, the length of the second layer tube 32 is at least 60 cm. Preferably, the length of the second layer tube 32 may be at least 60 cm, 70 cm, 80 cm, 90 cm, 100 cm, 110 cm, 120 cm, or any range therebetween. In some embodiments, the diameters of the first layer tube 31 and the second layer tube 32 do not change from the proximal end to the distal end. In other embodiments, the diameters of the first layer tube 31 and the second layer tube 32 gradually decrease from the proximal end to the distal end. Preferably, the second layer tube 32 has a diameter of 2 mm to 5 mm at the proximal end and a diameter of 0.5 mm to 3 mm at the distal end. The gradual reduction in diameter of the first layer tube 31 and the second layer tube 32 is advantageous in improving the flexibility of the distal end of the guide tube, making it easier for the guide tube to bend along the direction of travel, and minimizing injury to the human body.

[0154] Specifically, the hollow channel of the second-layer tube 32 can function as a working channel for interventional instruments such as biopsy forceps and ablation catheters, or external therapeutic agents such as drugs, to enter the human body. By transporting interventional instruments such as biopsy forceps and ablation catheters through the hollow channel inside the guide tube, frictional damage to the human body can be avoided.

[0155] Specifically, a second position acquisition device 11 connected to the outer wall of the second layer tube 32 is provided at the distal end of the second layer tube 32 away from the operation control unit 30 .

[0156] In some embodiments, the distance from the second position acquisition device 11 to the distal end of the second layer tube 32 is 0 to 2 cm. Preferably, the distance from the second position acquisition device 11 to the distal end of the second layer tube 32 may be 0, 0.5 cm, 1 cm, 2 cm, or any range therebetween. The fact that the second position acquisition device 11 is connected to the outer wall of the second layer tube 32 and does not occupy the space of the hollow tube of the second layer tube 32 is advantageous for operation in combination with interventional instruments for sampling, ablation, etc. The shorter the distance from the second position acquisition device 11 to the distal end of the second layer tube 32, the more accurate the position and direction information of the distal end of the second layer tube 32 acquired by the second position acquisition device 11. In some embodiments, the second position acquisition device 11 may be glued to the outer wall of the second layer tube 32. In other embodiments, the second position acquisition device 11 may be connected to the second layer tube 32 by heat shrinking via a heat shrink tube made of PU, PET, PTFE, PEEK, or the like.

[0157] In some embodiments, the second position acquisition device 11 is connected to a conductor 33 for external connection to the navigation control device 2. Specifically, one end of the conductor 33 is connected to the second position acquisition device 11, and the other end is communicatively connected to the navigation control device 2. Specifically, the conductor 33 may be welded to the second position acquisition device 11 by laser welding, soldering, or other methods. The conductor 33 may be drawn through the hollow conduit of the second layer tube 32, or may be drawn along the gap between the second layer tube 32 and the first layer tube 31. The conductor 33 is a single-core or multi-core enameled wire with a wire diameter of 0.05 mm to 0.3 mm. The conductor 33 is used to transmit information such as the position and direction of the guide tube acquired by the second position acquisition device 11 to the navigation control device 2 outside the body.

[0158] Specifically, the second position acquisition device 11 includes at least one multi-degree-of-freedom magnetic orientation sensor connected to the outer wall of the second layer tube 32. In some embodiments, the second position acquisition device 11 includes at least one five-degree-of-freedom or six-degree-of-freedom magnetic orientation sensor. The second position acquisition device 11 of the present application acquires the movement position and direction coordinates of the distal end of the guide tube and transmits the position information of the guide tube to the navigation control device 2, thereby enabling navigation and orientation of the guide tube.

[0159] Specifically, the operation control unit 30 is provided with a curvature adjustment control member 34 and an adjustment wire 35. One end of the adjustment wire 35 is connected to the curvature adjustment control member 34, and the other end is fixedly connected to a curvature adjustment segment 321 of the second-layer tube 32. The curvature adjustment segment 321 of the present application is provided on the second-layer tube 32 in close proximity to the distal end of the second-layer tube 32. In some embodiments, the distance from the curvature adjustment segment 321 to the distal end of the second-layer tube 32 is 2 cm to 5 cm. Preferably, the distance from the curvature adjustment segment 321 to the distal end of the second-layer tube 32 is 2 cm, 3 cm, 4 cm, 5 cm, or any range therebetween. The curvature adjustment control member 34 pulls and bends the second-layer tube 32. If the distance from the curvature adjustment segment 321 to the distal end of the second-layer tube 32 is too large or too small, the flexibility and accuracy of the bending of the second-layer tube 32 by the adjustment wire 35 will be affected.

[0160] Specifically, the curvature adjustment control member 34 is slidably or rotatably connected to the operation control unit 30. In some embodiments, the curvature adjustment control member 34 may be configured as a slider structure slidably connected to the operation control unit 30. The slider structure may be 3D printed or injection molded from a material such as plastic, nylon, or silicone. The operation control unit 30 is provided with a rail 36, and the curvature adjustment control member 34 slides along the rail 36 to pull the curvature adjustment segment 321 of the second-layer tube 32 with the adjustment wire 35, thereby bending the second-layer tube 32 and controlling the direction of the distal end of the second-layer tube 32 to more accurately reach the lesion area. Specifically, the rail 36 may be a guide rail chute. In other embodiments, the curvature adjustment control member 34 is configured as a rotating wheel structure connected to the operation control unit 30. The curvature adjustment control member 34 rotates to pull and move the adjustment wire 35, thereby bending the second-layer tube 32. The curvature adjustment structure of the present application is simple and easy to implement.

[0161] Specifically, the curvature adjustment control member 34 pulls the second-layer tube 32 with the adjustment wire 35 to bend it to a curvature of 0 to 180°. Preferably, the maximum curvature of the second-layer tube 32 may be 100°, 110°, 120°, 150°, 160°, 180°, or a range therebetween. The curvature adjustment control member 34 pulls the second-layer tube 32 with the adjustment wire 35 to bend it to a large curvature, improving the flexibility of the distal end of the second-layer tube 32 and enabling it to reach hard-to-reach lesion locations. Both the first-layer tube 31 and the second-layer tube 32 of the present invention have a certain degree of flexibility. The first-layer tube 31 is fitted around the outside of the second-layer tube 32, and when the second-layer tube 32 is bent, the first-layer tube 31 bends along with the second-layer tube 32.

[0162] Specifically, a connecting structure 37 is provided on the outside of the curvature adjusting segment 321, and the curvature adjusting segment 321 is connected to the adjusting wire 35 via the connecting structure 37. The connecting structure 37 connects the adjusting wire 35 and the curvature adjusting segment 321. In some embodiments, the connecting structure 37 may be configured as a connecting tube or a connecting clip fixed to the adjusting segment 321, and the adjusting wire 35 is welded to the connecting structure 37. In other embodiments, the connecting structure 37 may be a heat-shrinkable connecting tube or a cold-shrinkable connecting tube, which is fitted around the outside of the curvature adjusting segment 321 and the adjusting wire 35, and when the connecting structure 37 shrinks, the adjusting wire 35 and the adjusting wire 321 are tightly attached to each other.

[0163] Specifically, the adjustment wire 35 is a round wire rope or a flat wire rope made of a single-core or multi-core wire. The outer diameter of the adjustment wire 35 may be 0.05 mm to 0.3 mm. In practical application, the guide tube can be controlled to bend by pulling the adjustment control wire 431 connected to the curvature adjustment segment 321.

[0164] Specifically, a bending wire passage 38 is fitted around the adjustment wire 35, and is arranged along the axial direction of the second-layer tube 32 and connected to the operation control unit 30. Specifically, the bending wire passage 38 is fitted around the adjustment wire 35 and connected to the second-layer tube 32. One end of the bending wire passage 38 may be connected to the operation control unit 30, and the other end may be welded to the outer wall of the second-layer tube 32. The distance from one end of the bending wire passage 38 adjacent to the bend adjustment segment 321 to the distal end of the second-layer tube 32 is 2.5 cm to 5.5 cm. The bending wire passage 38 may be a PTFE or nylon tube and has a diameter of 0.15 mm to 0.35 mm. The bending wire passage 38 is a passage through which the adjustment wire 35 moves, and prevents the adjustment wire 35 from running out of control or bending excessively when pulled by force, which could affect the accuracy of adjustment to the distal end of the guide tube.

[0165] In this application, the method for using the adjustable curvature guide tube is as follows: the guide tube is placed in the working channel of the endoscope, and then it is brought to the lung together with the endoscope, pulled out from the exit of the channel, and navigated and guided by the second position acquisition device to accurately locate and reach the diseased tissue. During this process, the distal end of the guide tube can be controlled by the curvature adjustment control member and the adjustment wire to bend and aim at the lesion location, and an interventional instrument such as a biopsy forceps or an ablation interventional assembly is then fed through the guide tube to perform precise examination or treatment such as sampling, microwave examination, ablation or radiation therapy.

[0166] The present invention provides a guide tube with adjustable curvature, which is provided at its end with a second position acquisition device for positioning and navigating the guide tube. The guide tube further includes a curvature adjustment control member and an adjustment wire, which control the guide tube to bend. By combining the second position acquisition device with the curvature adjustment control member and the adjustment wire, which control the guide tube to bend, diseased tissue can be more accurately located, allowing the distal end of the guide tube to accurately reach more distant and narrower lesion locations, thereby significantly improving the accuracy of diagnosis and treatment and effectively reducing injuries caused by diagnosis and treatment. The present invention provides a guide tube with an adjustable curvature that is simple in structure, easy to operate, low in cost, highly practical, and convenient for widespread use and production.

[0167] In some embodiments, as shown in Figures 22 to 25, the interventional device of the present application may be a medical biopsy sampling device primarily used for sampling lung lesion tissue in clinical settings. The sampling device can be combined with a bronchoscope to enter the trachea through the patient's nose or mouth, and then reach the lungs via the bronchi to sample peripheral lung lesion tissue or diffuse lung lesion tissue. The sampling device of the present application can be used in combination with a bronchoscope, and can accurately reach the lesion location and obtain the lesion tissue by combining with an external navigation control device using an attached second position acquisition device to perform navigation localization, and adjusting the guide tube and sampling member using a curvature adjustment member.

[0168] FIG. 22 is a schematic diagram of the biopsy sampling device of the present application, which includes an adjustment unit 40, a guide tube 41, a sampling member 42, and a curved adjustment member 43. The guide tube 41 is fitted over the sampling member 42 and connected to the adjustment unit 40. The guide tube 41 includes a proximal end and a distal end, and the proximal end is connected to the adjustment unit 40. In practical applications, the proximal end of the guide tube 41 may be attached to the adjustment unit 40 with an adhesive such as a quick-drying adhesive, a UV adhesive, or an epoxy adhesive. The interior of the guide tube 41 has a hollow structure and serves as a working channel for pushing and retracting the sampling member 42. The guide tube 41 may be a sheath, and may be a single-lumen or multi-lumen sheath depending on actual needs. In some embodiments, the guide tube 41 may be an extruded tube such as PI / PET / PEBAX / PTFE, a PI / PTFE composite tube, or a tube braided with PEBAX and stainless steel wire. The guide tube 41 may have an outer diameter of 0.5 mm to 5 mm and a wall thickness of 0.025 mm to 0.5 mm. The length of the guide tube 41 is at least 40 cm. Preferably, the length of the guide tube 41 may be at least 40 cm, 50 cm, 60 cm, 70 cm, 80 cm, 90 cm, 100 cm, 110 cm, or any range therebetween. In some embodiments, the outer diameter of the guide tube 41 gradually decreases from the proximal end to the distal end. Preferably, the outer diameter of the guide tube 41 is 2 mm to 5 mm at the proximal end and 0.5 mm to 2.5 mm at the distal end. The gradually decreasing outer diameter of the guide tube 41 is advantageous in improving the flexibility of the guide tube, allowing the guide tube to bend easily in the direction of travel of the bronchi and minimizing damage to the bronchi.

[0169] Specifically, the adjustment unit 40 is provided with a first adjustment member 401 and a second adjustment member 402. One end of the sampling member 42 is connected to the first adjustment member 401, and the other end is provided with a sampling head 421. The first adjustment member 401 drives the sampling member 42 and the sampling head 421 so that they are pushed out from the distal end of the guide tube 41 or pulled into the guide tube 41.

[0170] In some embodiments, the sampling member 42 may be a wire or metal tube inserted into the guide tube 41. The material of the sampling member 42 may be a material with good bending properties and corrosion resistance, such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. 304 or 316 stainless steel is preferred. The diameter of the sampling member 42 may be 0.2 mm to 2 mm. The outer layer of the sampling member 42 may be provided with a PTFE coating, and the thickness of the coating may be 0.005 mm to 0.1 mm.

[0171] In some embodiments, the sampling head 421 may be a diamond-shaped cone head, which can puncture and sample a lesion. In other embodiments, the sampling head 421 has at least one barb structure distributed along the axial or circumferential direction, which can puncture and sample diseased tissue. Preferably, the sampling head 421 has two barb structures. In other embodiments, a sampling reservoir is provided at the tip of the sampling head 421, which can perform sampling. The sampling member 42 may be integrally molded with the sampling head 421 or formed by machining, grinding, or wire cutting. Compared to conventional clamp-type sampling heads, the sampling head of the present application is smaller in size, easier to manipulate, easier to reach an accurate position, and causes less trauma during sampling.

[0172] 24 , the biopsy sampling device of the present application includes a curvature adjustment member 43, one end of which is connected to the second adjustment member 402 and the other end of which is connected to a curvature adjustment section 411 of the guide tube 41. The curvature adjustment member 43 can pull and bend the guide tube 41 using the curvature adjustment section 411. The curvature adjustment section 411 is provided on the guide tube 41 in proximity to the distal end of the guide tube 41. In some embodiments, the distance from the curvature adjustment section 411 to the distal end of the guide tube 41 is 0.5 cm to 6 cm. Preferably, the distance from the curvature adjustment section 411 to the distal end of the guide tube 41 is 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, or any range therebetween. Specifically, if the distance from the curvature adjustment portion 411 to the distal end of the guide tube 41 is too large, it will affect the flexibility of the curvature of the guide tube by the curvature adjustment member 43, and if the distance from the curvature adjustment portion 411 to the distal end of the guide tube 41 is too small, it will affect the accuracy of the control of the distal end of the guide tube by the curvature adjustment member 43.

[0173] In some embodiments, the curvature adjustment member 43 includes an adjustment control wire 431, one end of which is connected to the second adjustment member 402 and the other end of which is connected to the curvature adjustment unit 411. The second adjustment member 402 moves the adjustment control wire 431, which causes the adjustment control wire 431 to pull and bend the guide tube 41 via the curvature adjustment unit 411. The adjustment control wire 431 may be a single-core or multi-core stainless steel wire and may have an outer diameter of 0.1 mm to 0.3 mm. In actual application, the length of the guide tube 41 remains unchanged, and the guide tube 41 can be pulled and bent to one side by pulling the adjustment control wire 431, which is fixedly connected to the curvature adjustment unit 411.

[0174] In some embodiments, the curvature adjustment member 43 includes an adjustment tube 432, which is fitted onto the adjustment control wire 431 and connected to the guide tube 41. Specifically, one end of the adjustment tube 432 may be connected to the adjustment unit 40, and the other end may be fixedly connected to the guide tube 41 by a method such as heat welding. The adjustment tube 432 is a sheath through which the adjustment control wire 431 passes, and may be a PTFE or nylon tube, with an outer diameter of 0.15 mm to 0.35 mm. The adjustment tube 432 is a guide passage through which the adjustment control wire 431 moves, and can prevent the adjustment control wire 431 from running out of control or bending excessively when pulled by force, which would affect the accuracy of adjustment to the distal end of the guide tube.

[0175] 24, a connecting and fixing member 44 is provided on the curvature adjustment portion 411 of the guide tube 41, and the adjustment control wire 431 is connected to the curvature adjustment portion 411 via the connecting and fixing member 44. The connecting and fixing member 44 may be a connecting tube or a connecting clip fixed to the curvature adjustment portion 411, and the adjustment control wire 431 is connected to the connecting and fixing member 44 by welding. In another embodiment, as shown in FIG. 25, the connecting and fixing member 44 may be a heat-shrinkable connecting tube or a cold-shrinkable connecting tube, and the connecting and fixing member 44 is fitted around the outside of the curvature adjustment portion 411 and the adjustment control wire 431, and when the connecting and fixing member 44 shrinks, the adjustment control wire 431 and the adjustment portion 411 are brought into close contact with each other.

[0176] The curvature adjustment member 43 of the present application pulls and bends the guide tube 41 to a curvature of 0° to 120°. Preferably, the maximum curvature may be 90°, 100°, 110°, 120°, or a range therebetween. Because the curvature adjustment member 43 of the present application bends the guide tube 41 to a large curvature, the distal end of the guide tube 41 has improved flexibility to move the sampling head 421, enabling fine adjustments, allowing for accurate reach to more distant positions and effective acquisition of diseased tissue. In addition, the structure of the curvature adjustment member 43 is simple and easy to implement.

[0177] In some embodiments, a guide cannula 45 is fitted to the outside of the guide tube 41 and the curvature adjustment member 43, and one end of the guide cannula 45 is connected to the distal end of the guide tube 41 and the other end is connected to the adjustment unit 40. The curvature adjustment operation by the curvature adjustment member 43 to bend the guide tube 41 is performed inside the guide cannula 45.

[0178] Specifically, the first adjustment member 401 and the second adjustment member 402 are each slidably or rotatably connected to the adjustment unit 40. The adjustment member 40 may be an adjustment handle or an adjustment rod. The adjustment member 40 may be 3D printed or injection molded using a material such as plastic, nylon, or silicone. In the present application, the first adjustment member 401, which controls the sampling member 42, and the second adjustment member 402, which controls the curved adjustment member 43, are integrated into the adjustment unit 40 and adjusted using different adjustment paths, respectively, making operation more accurate and convenient. In some embodiments, the first adjustment member 401 and the second adjustment member 402 may be configured as a slider structure. The slider structure may be 3D printed or injection molded using a material such as plastic, nylon, or silicone. The adjustment unit 40 is provided with a first chute and a second chute, and the first adjustment member 401 is slidably connected to the first chute, and the second adjustment member 402 is slidably connected to the second chute. In this embodiment, the first and second chutes are integrated to form a strip-shaped groove extending through the adjustment unit 40, and the first and second adjustment members 401 and 402 are connected to either side of the strip-shaped groove. Controlling the second adjustment member 402 to slide along the second chute pulls and moves the adjustment control wire 431, which then pulls and bends the guide tube 41 via the bending adjustment member 411, thereby controlling the direction of the distal end of the guide tube and enabling the guide tube to more accurately reach the lesion. Controlling the first adjustment member 401 to slide along the first chute pulls and moves the sampling member 42, thereby controlling the sampling head 421 to be pushed or pulled out of the distal end of the guide tube 41 and more accurately capture the diseased tissue. In other embodiments, the first adjustment member 401 and the second adjustment member 402 may be configured as a rotating wheel structure, and the first adjustment member 401 can rotate to move the sampling member 42, thereby controlling the sampling head 421 to be pushed out or retracted from the distal end of the guide tube 41.The second adjustment member 402 rotates to move the adjustment control wire 431, which in turn causes the bending adjustment portion 411 to pull and bend the guide tube 41.

[0179] In some embodiments, the maximum extrusion distance of the sampling head 421 controlled by the first adjustment member 401 to be extruded from the distal end of the guide tube 41 is 10 cm. Preferably, the maximum extrusion distance of the sampling head 421 may be 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, or a range therebetween.

[0180] Specifically, as shown in FIG. 23 , the sampling member 42 is provided with a second position acquisition device 11 disposed adjacent to the sampling head 421. In some embodiments, the distance between the second position acquisition device 11 and the sampling head 421 may be 0 to 3 cm. Preferably, the distance from the second position acquisition device to the sampling head 421 may be 0.5 cm, 1 cm, 2 cm, 3 cm, or a range therebetween. The smaller the distance from the second position acquisition device to the sampling head 421 of the present application, the more accurate the acquired position and orientation information of the sampling head 421. In some embodiments, the second position acquisition device 11 may be bonded to the sampling member 42 with an adhesive such as a quick-drying adhesive, a UV adhesive, or an epoxy adhesive. In some embodiments, the second position acquisition device 11 may be connected to the sampling member 42 via a heat-shrink tube made of PU, PET, PTFE, PEEK, or the like. In some embodiments, the second position acquisition device 11 is retracted into the guide tube together with the sampling head 421.

[0181] In some embodiments, the second position acquisition device 11 is connected to the navigation control device 2 outside the body via a signal line 46. The signal line 46 is inserted into the guide tube 41, pulled out from a through-hole formed in the adjustment unit 40, and connected to the navigation control device outside the body. The signal line 46 may be a single-core or multi-core enameled wire with a wire diameter of 0.05 mm to 0.3 mm. The signal line 46 and the second position acquisition device 11 may be welded and connected by a method such as laser welding or soldering. The signal line 46 is used to transmit information such as position and direction acquired by the second position acquisition device 11 to the navigation control device. Specifically, the second position acquisition device 11 includes at least one multi-degree-of-freedom magnetic orientation sensor. In some embodiments, the second position acquisition device 11 includes at least one five-degree-of-freedom or six-degree-of-freedom magnetic orientation sensor. The second position acquisition device 11 acquires the movement position and direction coordinates of the sampling head 421 in real time, and transmits the position information of the sampling head 421 to the navigation control device 2, and the navigation control device 2 navigates and positions the sampling head 421 based on the acquired position information.

[0182] In this application, the steps for achieving sampling using the above-mentioned biopsy sampling device are as follows: connect the signal line 46 of the second position acquisition device 11 to the external navigation control device 2, retract the sampling head into the guide tube, place the guide tube into the working channel of the bronchoscope, and guide it together with the bronchoscope to the lungs and pull it out from the exit of the channel. Navigate and guide using the second position acquisition device 11 and the external navigation control device to accurately position and reach the lesion area. During this process, use the second adjustment member 402 to pull the bending adjustment member 43 to control the guide tube 41 to bend and aim at the lesion location. Use the first adjustment member 401 to control the sampling head 421 to be pushed out from the distal end of the guide tube to puncture and sample. Use the first adjustment member 401 to control the sampling head 421 after sampling to be retracted into the guide tube. Then, remove the sampling device from the working channel of the bronchoscope and remove the tissue sample.

[0183] In the present application, a first adjustment member for controlling the sampling member and a second adjustment member for controlling the curvature adjustment member are integrated into the adjustment member and adjusted via separate adjustment channels, making operation more convenient. The curvature adjustment member controls the distal end of the guide tube to bend, increasing the curvature, thereby improving the flexibility of the curvature of the sampling member caused by the guide tube and enabling fine adjustment, allowing for more accurate access to and sampling of the lesion area, and allowing for flexible withdrawal after sampling. The sampling device of the present application is equipped with a second position acquisition device, and navigation and positioning are performed using the second position acquisition device and an extracorporeal navigation control device to guide the sampling member to directly reach the lesion area, thereby improving sampling accuracy and effectively avoiding sampling failures and repeated sampling problems. The biopsy sampling device has a simple structure, is easy to operate, low cost, and is convenient for widespread use and production, which is advantageous in reducing the economic burden on patients.

[0184] The navigation control device 2 of the present application constructs a virtual model based on the area image information of the target intervention area, the morphological attribute information of the intervention assembly 12, the movement position information and the intervention position information, to obtain a navigation three-dimensional model and a three-dimensional model of the operation object, the navigation three-dimensional model representing the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the intervention assembly 12 and the spatial position information between the ablation object, the intervention assembly 12 and the target intervention area, and the operation object three-dimensional model representing the three-dimensional spatial characteristics of the ablation object.

[0185] Specifically, as shown in FIG. 26, the navigation control device 2 of the present application includes an intervention area sub-model construction module 021, an intervention assembly sub-model construction module 022, and a fusion module 023.

[0186] The intervention area sub-model construction module 021 performs image recognition processing on the area image information of the target intervention area to obtain the image recognition results, and performs image reconstruction based on the image recognition results to obtain the intervention area sub-model and the three-dimensional model of the operation object, and the intervention area sub-model represents the three-dimensional spatial characteristics of the target intervention area.

[0187] In addition, the regional image information of the target intervention region in the present application may be a CT image or a nuclear magnetic image of the target intervention region. By performing image recognition processing on the CT image or nuclear magnetic image of the target intervention region, three-dimensional data of the target intervention region and three-dimensional data of the operation target object can be extracted, providing data support for constructing a three-dimensional model. When the CT image of the target intervention region is a lung CT image of a subject, by performing image recognition processing on the lung CT image, three-dimensional data of the lung bronchi and three-dimensional data of the diseased tissue region within the lung bronchi can be extracted. Image reconstruction can then be performed based on the three-dimensional data of the lung bronchi and the three-dimensional data of the diseased tissue region within the lung bronchi to obtain a three-dimensional lung bronchi model and a three-dimensional diseased tissue model.

[0188] The intervention assembly sub-model construction module 022 constructs a virtual model based on the shape attribute information of the intervention assembly 12 to obtain an intervention assembly sub-model, which represents the three-dimensional spatial characteristics of the intervention assembly 12. Specifically, the shape attribute information of the intervention assembly includes information such as the model number and specifications of the intervention assembly 12, and constructs a model based on the model number and specification information of the intervention assembly 12 to obtain the intervention assembly sub-model. The intervention assembly sub-model of the present application is a three-dimensional model of the intervention assembly 12.

[0189] The fusion module 023 performs space fusion processing on the intervention area sub-model, the operation object 3D model, and the intervention assembly sub-model based on the intervention position information and the movement position information to obtain a navigation 3D model.

[0190] Specifically, the fusion module 023 first performs dynamic matching with the coordinates of the interventional assembly sub-model based on the intervention position information and motion position information of the interventional assembly 12 acquired in real time to obtain a dynamic interventional assembly sub-model, and then displays the dynamic interventional assembly sub-model in the static intervention area sub-model in real time, i.e., performs spatial fusion processing on the intervention area sub-model, the 3D model of the operation object, and the interventional assembly sub-model to obtain a navigation 3D model. The navigation 3D model of the present application can visually display the dynamic trajectory and real-time position of the interventional assembly 12 within the target intervention area, which provides important assistance for determining the position of the interventional assembly during surgery.

[0191] The navigation control device 2 further includes a navigation planning module 024 communicatively connected to the navigation three-dimensional model.

[0192] The navigation planning module 024 performs navigation planning based on the intervention area sub-model and the three-dimensional model of the operation object to obtain a navigation path within the intervention area sub-model of the intervention assembly 12, where the navigation path indicates the travel path required for the intervention assembly 12 to reach the ablation object within the target intervention area.

[0193] It should be noted that the navigation planning module 024 of the present application can perform navigation planning on a moving path of the interventional assembly 12 to reach the ablation target within the target interventional region based on the intervention region sub-model and the operation object three-dimensional model, obtain a navigation path of the interventional assembly 12 within the intervention region sub-model, generate corresponding two-dimensional data, three-dimensional data and navigation data, and display the planned navigation path from the entrance of the interventional assembly to the ablation target in the navigation three-dimensional model. In some possible embodiments, path key points of the planned navigation path can be highlighted in the navigation three-dimensional model, and the surgeon can control the interventional assembly 12 to move in the navigation three-dimensional model to reach the ablation target based on the displayed navigation path.

[0194] In some embodiments, the navigation planning module 024 further determines intervention trajectory information of the intervention assembly 12 based on the intervention position information and movement position information of the intervention assembly 12 during the process of the intervention assembly 12 moving within the target intervention area, and if the intervention trajectory information and the path trajectory information corresponding to the navigation path satisfy a predetermined deviation condition, corrects the intervention position of the intervention assembly 12 within the target intervention area until the updated intervention trajectory information of the intervention assembly 12 matches the path trajectory information.

[0195] Specifically, during the process of the intervention assembly 12 moving within the target intervention area, real-time intervention trajectory information of the intervention assembly 12 is determined based on the intervention position information and movement position information of the intervention assembly 12, trajectory key points of the intervention trajectory are generated based on the real-time intervention trajectory information of the intervention assembly 12, and a dynamic matching calculation is performed between the trajectory key points and the route key points of the planned navigation route. If the matching degree between the trajectory key points and the route key points of the planned navigation route meets a predetermined deviation condition, the real-time intervention position of the intervention assembly 12 within the target intervention area is corrected until the real-time intervention trajectory information of the intervention assembly 12 matches the route trajectory information. The predetermined deviation condition in this application is whether the deviation between the trajectory key points of the intervention trajectory and the route key points of the planned navigation path exceeds a predetermined deviation threshold. If the deviation between the trajectory key points of the intervention trajectory and the route key points is greater than the predetermined deviation threshold, the real-time intervention position of the intervention assembly 12 within the target intervention area is modified. If the deviation between the trajectory key points of the intervention trajectory and the route key points of the planned navigation path is equal to or less than the predetermined deviation threshold, the intervention assembly 12 is controlled to continue moving along the navigation path. By dynamically matching the real-time intervention trajectory of the intervention assembly 12 with the navigation path, the movement direction of the intervention assembly 12 can be adjusted as needed during its movement within the target intervention area, thereby avoiding the intervention assembly 12 from deviating from the navigation path and causing damage to surrounding healthy tissue and improving navigation accuracy.

[0196] In some possible embodiments, when the navigation path is blurred or blocked in the navigation 3D model, the surgeon can still determine whether the path ahead is a passageway based on the displayed navigation 3D model and whether to continue moving along the planned navigation path. For example, when the navigation 3D model of the lung bronchi is blurred or blocked, it is usually caused by lung mucus in the bronchial passageway. If the surgeon can determine that the blocked bronchus ahead is a passageway based on the displayed navigation 3D model, he can continue searching forward. By utilizing the viscous properties of mucus, when the tip of the interventional assembly 12 encounters mucus, it continues to move forward a certain distance based on the direction of the navigation path to break through the mucus. In this way, the mucus flows along the tracheal wall without adhering to the tip of the interventional assembly 12, thereby solving the problem of blurred and interfering vision and saving surgical time.

[0197] As shown in FIGS. 26 and 27, the navigation control device 2 further includes an initial parameter obtaining module 025 and a target parameter determining module 026.

[0198] The initial parameter acquisition module 025 acquires initial ablation parameters corresponding to object attribute information of the ablation object, impedance data of the ablation object, contact parameters of the interventional assembly 12, and dielectric constant of the ablation object, and the initial ablation parameters include at least one of pulse voltage, pulse width, pulse time, and pulse frequency.

[0199] In addition, the object attribute information of the ablation target in the present application includes, but is not limited to, the lesion type and lesion extent information of the diseased tissue, the impedance data of the ablation target can indicate the current load status of the interventional assembly 12, and the contact parameters of the interventional assembly 12 include, but are not limited to, information such as the contact area and contact length between the interventional assembly 12 and the bronchus.

[0200] The present application can determine the tissue characteristics of the current ablation target based on the dielectric constant of the ablation target. Specifically, different cells have different electroporation thresholds, resulting in different dielectric constants for different tissues. The ratio of the dielectric constants of different tissues can be used to determine the proportion of different tissues and, thereby, the content of different cells in the tissue. In some possible embodiments, the dielectric constant can be detected by using a sinusoidal excitation signal generating multiple frequencies between 5 kHz and 300 MHz to stimulate changes in complex impedance electrical signals corresponding to cellular tissue under signals of different frequencies. These signals can then be converted into frequency-domain signals using a method such as Fourier transform to obtain the dielectric constant of the tissue. The present application can determine changes in the content of different types of cells in the bronchial tissue corresponding to the ablation target based on a comparison of the dielectric constant of the ablation target before and after ablation, thereby helping to evaluate the effectiveness of ablation parameters.

[0201] The target parameter determination module 026 performs ablation effect evaluation based on the navigation three-dimensional model, the operation object three-dimensional model, the object attribute information of the ablation object, the initial ablation parameters corresponding to the object attribute information of the ablation object, the impedance data of the ablation object, the contact parameters of the interventional assembly 12, and the dielectric constant of the ablation object, to obtain ablation effect data corresponding to the initial ablation parameters, and if the ablation effect data meets the target ablation conditions, determines the initial ablation parameters as the target ablation parameters.

[0202] FIG. 28 is a diagram illustrating the principle of simulation, evaluation, and display of the lung ablation effect using pulse energy according to the present invention.

[0203] The impedance data of the present application can be combined with parameters such as pulse voltage, pulse width, pulse time, and pulse frequency to calculate the pulse energy applied to the ablation target. The contact parameters of the interventional assembly 12 can be obtained from the rate of change of impedance to determine the contact quality between the interventional assembly 12 and the ablation target. In some possible embodiments, the contact parameters of the interventional assembly 12 can be used to calculate the inner wall diameter of the bronchus and determine the thickness of the bronchial mucosal layer. Figure 29 shows the relationship between the inner diameter of the bronchus and the contact length. If the model and specifications of the interventional assembly 12 remain unchanged, the contact length between the interventional assembly 12 and the bronchus decreases as the inner diameter of the bronchus increases. Furthermore, based on the impedance data, simulations can be performed to obtain the relationship between the inner diameter of the bronchus, the ablation range, the contact parameters, the pulse parameters, and the thickness of the bronchus and the ablation effect. For example, in some embodiments, as shown in FIG. 30, a point at a central depth of approximately 0.5 mm at the contact point with the inner wall of the bronchus is selected as the marking point representing the ablation effect. When the contact length between the interventional assembly 12 and the bronchus is 5.0 mm, 7.5 mm, 10.0 mm, 12.5 mm, and 15.0 mm, the corresponding electric field strengths are approximately 1220 V / cm, 1120 V / cm, 900 V / cm, 1000 V / cm, and 1125 V / cm, respectively. When the contact length is approximately 11.0 mm, the electric field strength is at a minimum of approximately 900 V / cm. As the number of levels of the bronchus increases and the inner diameter decreases, the contact length between the interventional assembly 12 and the bronchus increases and the electric field strength at the marking point tends to decrease. However, the minimum electric field strength is above 900 V / cm, which meets the threshold electric field strength for achieving a predetermined ablation effect and does not significantly reduce the therapeutic effect.As shown in FIG. 31, the point where the central depth of the contact point with the inner wall of the bronchus is approximately 0.5 mm is selected as the marking point representing the ablation effect. As the wall thickness of the bronchus increases, when the contact length between the interventional assembly 12 and the bronchus is 5.0 mm, 7.5 mm, 10.0 mm, 12.5 mm, and 15.0 mm, the corresponding electric field strengths are approximately 1600 V / cm, 1310 V / cm, 1120 V / cm, 1060 V / cm, 1080 V / cm, and 1200 V / cm, respectively. When the contact length is approximately 10.0 mm, the electric field strength is at its minimum, approximately 1060 V / cm. As the wall thickness of the bronchus increases, the contact length between the interventional assembly 12 and the bronchus increases, and the electric field strength at the marking point tends to decrease. However, the minimum electric field strength is above 1000 V / cm, which satisfies the threshold electric field strength for achieving the desired ablation effect. Obviously, in this application, when the bronchial inner diameter becomes smaller or the bronchial wall thickness increases, the contact length between the interventional assembly 12 and the bronchus increases, which does not significantly affect the ablation effect.

[0204] Specifically, the target parameter determination module 026 includes a simulation ablation model construction unit 0261 .

[0205] The simulation ablation model construction unit 0261 performs an ablation effect simulation using the object attribute information, the initial ablation parameters, the impedance data, the contact parameters, the dielectric constant, the three-dimensional model of the operated object, and the three-dimensional model of the navigation as inputs to the ablation evaluation model, and obtains a simulation ablation model corresponding to the initial ablation parameters, and the simulation ablation model represents the ablation effect data corresponding to the initial ablation parameters.

[0206] The simulation ablation model construction unit 0261 inputs the object attribute information, initial ablation parameters, impedance data, contact parameters, dielectric constant, a three-dimensional model of the manipulated object, and a three-dimensional navigation model into the ablation evaluation model to simulate the ablation effect and obtain a simulated ablation model corresponding to the initial ablation parameters. The ablation evaluation model of the present application may be an ablation evaluation database constructed using pre-simulated data and clinically acquired data. The pre-simulated data includes data relating the bronchial inner diameter, ablation range, contact parameters, pulse parameters, and bronchial thickness to the ablation effect, obtained by simulation based on the impedance data. The present application allows visual observation of the ablation range and ablation effect of lung tissue due to pulse energy generated based on the initial ablation parameters, thereby visually assisting the surgeon in determining whether the initial ablation parameters need to be adjusted. As shown in FIG. 32 , the ablation effect of lung tissue due to pulse energy in the simulated ablation model generated when the pulse voltage width was set to 1500 V shows that most of the intrabronchial area is ablated.

[0207] In some embodiments, the simulation ablation model may use colors to distinguish the ablation range and ablation effect of lung tissue based on different initial ablation parameters, allowing surgeons to adjust the initial ablation parameters based on the simulation ablation model and avoid possible risks. Figure 33 is a diagram showing the pathological structure of bronchial tissue in the present application, and the simulation model shown in Figure 34 shows the ablation effects of surface ablation, partial ablation, and complete ablation of the mucosal layer of bronchial tissue using pulse energies predicted based on different initial ablation parameters.

[0208] If the ablation effect data corresponding to the acquired initial ablation parameters satisfy the target ablation conditions, the initial ablation parameters are determined as the target ablation parameters. In some possible embodiments, the target ablation conditions include: the ablation range and ablation effect of the lung tissue observed by the simulation ablation model achieve the required ablation effect, and the dielectric constant of the ablation object after ablation meets a predetermined condition, i.e., the content of different types of cells in the bronchial tissue after ablation reaches the standard of normal tissue.

[0209] In addition, the present application provides a method for simulating the ablation effect before ablation by inputting object attribute information, initial ablation parameters, impedance data, contact parameters, dielectric constant, a three-dimensional model of the operating object, and a three-dimensional navigation model into an ablation evaluation model to obtain a simulated ablation model. The ablation effect can be predicted before ablation based on the simulated ablation model, and the initial ablation parameters and the number of ablation attempts can be optimized to improve the effectiveness of treatment. In another embodiment, after ablation, the updated object attribute information, ablation parameters, impedance data, contact parameters, dielectric constant, a three-dimensional model of the operating object, and a three-dimensional navigation model can be input into the ablation evaluation model to simulate the effect after ablation, which helps determine whether the ablation is effective. Evaluating the ablation effect after ablation can optimize the ablation evaluation database, which is useful for optimization and learning, thereby improving the quality of the evaluation.

[0210] The navigation control device 2 includes a pulsed energy generation module 027 .

[0211] The pulsed energy generation module 027 generates energy generation control signals based on the target ablation parameters to control the ablation device 4 to operate.

[0212] Specifically, the navigation control device 2 further includes an ablation three-dimensional model generation module 028, which obtains ablation trajectory information and ablation data of the interventional assembly 12 after the interventional assembly 12 performs ablation processing on the ablation target, and generates an ablation three-dimensional model based on the ablation trajectory information, ablation data and target ablation parameters, where the ablation data includes the ablated ablation area and the ablation position information of the ablation area, and the ablation three-dimensional model represents the three-dimensional spatial characteristics of the ablation target after ablation.

[0213] The ablation three-dimensional model of the present application records ablation trajectory information and ablation data within the target intervention region of the interventional assembly 12. In some possible embodiments, the ablation data includes the ablated ablation region and ablation position information of the ablation region. In other possible embodiments, the ablation data further includes information that the interventional assembly 12 is in the ablated ablation region, as well as information such as ablation parameters, ablation time, and ablation status of the ablation region. The ablation three-dimensional model of the present application allows the surgeon to check and observe the ablation trajectory information and ablation data of the interventional assembly 12 at any time. In the complex pulmonary bronchial "maze," this information provides crucial data support for the surgeon to determine which regions have been ablated and which regions have not yet been ablated, thereby effectively improving surgical efficiency and reducing the possibility of repeated ablation during surgery.

[0214] As shown in Figures 35 and 36, the control circuit of the ablation device 4 of the present application includes a pulse power supply 041, a switching circuit 042 and an output interface 043, the pulse power supply 041 is electrically connected to the switching circuit 042, the output interface 043 is electrically connected to the interventional device 1, the switching circuit 042 includes at least two branch circuits 0421 connected in parallel, full bridge, half bridge or series, each branch circuit 0421 includes an input end switching module 4211 and an output end switching module 4212, and the switching circuit 042 controls the corresponding input end switching module 4211 and output end switching module 4212 to conduct in response to the energy generation control signal of the pulse energy generating module 027 to generate pulse energy.

[0215] The branch circuit 0421 further includes a capacitor module 4213, which includes multiple capacitor groups connected in series or parallel. Each capacitor group can include different types and numbers of capacitors for different power outputs. By controlling the activation and deactivation of the input-end switching module 4211 and the output-end switching module 4212 in the branch circuit 0421, the capacitors in the capacitor module 4213 can be charged at the input end, allowing pulse energy of different voltage amplitudes to be output at the output end. In some possible embodiments, the charge and discharge time of the capacitor module 4213 can be controlled to output pulse energy of different voltage amplitudes. In other possible embodiments, by combining multiple controllable branch circuits 0421 and controlling the corresponding input-end switching modules 4211 and output-end switching modules 4212 in different branch circuits 0421, the output of pulse energy and the charging of the capacitor module 4213 can be controlled in a time-division manner, thereby improving the safety, convenience, and efficiency of the circuit.

[0216] Furthermore, the branch circuit 0421 further includes a diode module 4214, which includes a plurality of diodes arranged in a forward direction and a reverse direction. By providing the diode module 4214, during the charging and discharging process of the switching circuit 042, the state of each switch in different branch circuits 0421 can be controlled to charge or discharge a specific capacitor, and during the discharging period, the capacitors in the capacitor group are not reverse-charged, thereby reducing unnecessary energy loss in the capacitors in the capacitor group.

[0217] Furthermore, the branch circuit 0421 further includes a filtering module 4215, which includes a plurality of filtering units, each of which includes a plurality of filters and a filter selector for selecting a filter to perform filtering. In some possible embodiments, the filtering unit includes one or more of a low-pass filter, a high-pass filter, a band-pass filter, a band-stop filter, and an all-pass filter. The energy generating unit of the present application can output pulsed energy of different frequencies and shapes by performing filtering using different filters or combinations of filters. In some possible embodiments, selecting different filters or combinations of filters to perform filtering can output pulsed energy of different waveforms or combinations of waveforms, such as a sine wave, a square wave, a triangular wave, etc.

[0218] In some possible embodiments, the branch circuit 0421 may include, but is not limited to, an input-end switching module 4211, a capacitor module 4213, a diode module 4214, a filtering module 4215, and an output-end switching module 4212.

[0219] The switching circuit of the ablation device of the present application can realize several combinations of pulse energy amplitude, pulse width, interval, number, direction, etc. by connecting multiple branch circuits 0421 and controlling the corresponding input switching modules 4211 and output switching modules 4212 of different branch circuits 0421. By controlling the corresponding input switching modules 4211 and output switching modules 4212 of the branch circuits 0421 and combining them with the filtering module 4215, pulse energy output of different frequencies and forms can be realized. The switching circuit of the present application enables the ablation device to generate more directional pulse energy by varying the voltage amplitude, frequency, and pulse form of a set of pulse energy, thereby improving the therapeutic effect and reducing the problem of irritation during ablation treatment, which is advantageous for improving treatment safety.

[0220] Specifically, the steps of treating pulmonary endobronchial disease using the targeted ablation system of the present application include: delivering the deflated interventional assembly 12 into the pulmonary bronchi by means of the operating handle 16; acquiring the movement position information of the subject and transmitting it to the navigation control device 2; an acquisition device acquiring and transmitting to the navigation control device 2, the intervention position information of the intervention assembly 12 in the pulmonary bronchi; constructing a virtual model based on the lung CT image to obtain a three-dimensional lung and bronchial model and a three-dimensional lesion tissue model; constructing a virtual model based on the morphological attribute information of the interventional assembly 12 to obtain an interventional assembly sub-model; and performing spatial fusion processing on the three-dimensional lung and bronchial model, the three-dimensional lesion tissue model, and the interventional assembly sub-model based on the intervention position information and the motion position information to obtain a navigation three-dimensional model; performing navigation planning based on the three-dimensional lung and bronchial model and the three-dimensional diseased tissue model to obtain a navigation path within the three-dimensional lung and bronchial model of the interventional assembly 12, and generating corresponding two-dimensional navigation data and three-dimensional navigation data; During the process of the interventional assembly 12 moving within the pulmonary bronchus, continuously correcting the real-time intervention position of the interventional assembly 12 within the pulmonary bronchus based on the navigation path until the interventional assembly 12 reaches the diseased tissue region within the pulmonary bronchus; controlling the degree of expansion of the interventional assembly 12 by means of an operating control assembly 17 on the operating handle 16 so that the interventional assembly 12 uniformly abuts the diseased tissue; obtaining initial ablation parameters corresponding to object attribute information of the diseased tissue, impedance data of the diseased tissue, contact parameters of the interventional assembly 12, and dielectric constant of the diseased tissue; performing an ablation effect simulation using the object attribute information, initial ablation parameters, impedance data, contact parameters, dielectric constant, the three-dimensional lesion tissue model, and the three-dimensional navigation model as inputs of an ablation evaluation model to obtain a simulated ablation model corresponding to the initial ablation parameters; determining target ablation parameters based on the simulated ablation model if the ablation effect data corresponding to the initial ablation parameters meets the target ablation conditions; generating energy generation control signals based on target ablation parameters to control the ablation device 4 to operate; the ablation device 4 responding to the energy generation control signal to control the corresponding switching circuit 042 to conduct and generate pulse energy; transmitting pulsed energy to the interventional device 1 for ablating diseased tissue by the interventional assembly 12; acquiring ablation trajectory information and ablation data of the interventional assembly 12, and generating an ablation three-dimensional model based on the ablation trajectory information, ablation data, and target ablation parameters.

[0221] The present application further provides a method for controlling targeted ablation, and FIG. 37 is a flowchart of the method for controlling targeted ablation, which includes the following steps S101 to S104.

[0222] In step S101, the motion position information of the subject acquired by the first position acquisition device and the intervention position information of the intervention assembly within the target intervention area acquired by the second position acquisition device are received, and the target intervention area belongs to the subject.

[0223] In step S102, a virtual model is constructed based on the area image information of the target intervention area, the shape attribute information of the intervention assembly, the movement position information, and the intervention position information to obtain a navigation three-dimensional model and a three-dimensional model of the operation object, where the navigation three-dimensional model represents the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the intervention assembly, and the spatial position information between the ablation object, the intervention assembly, and the target intervention area, and the operation object three-dimensional model represents the three-dimensional spatial characteristics of the ablation object.

[0224] In step S103, target ablation parameters corresponding to the ablation target are determined based on the navigation three-dimensional model, the operation target three-dimensional model, and the target attribute information of the ablation target.

[0225] In step S104, the interventional assembly performs an ablation process on the ablation target by controlling the ablation device to operate based on the target ablation parameters.

[0226] Furthermore, step S102 further includes the following steps S1021 to S1023.

[0227] In step S1021, image recognition processing is performed on the area image information of the target intervention area to obtain the image recognition results, and image reconstruction is performed based on the image recognition results to obtain an intervention area sub-model and a three-dimensional model of the object to be operated that represent the three-dimensional spatial characteristics of the target intervention area.

[0228] In step S1022, a virtual model is constructed based on the shape attribute information of the intervention assembly to obtain an intervention assembly sub-model representing the three-dimensional spatial characteristics of the intervention assembly.

[0229] In step S1023, a space fusion process is performed on the intervention area sub-model, the operation object three-dimensional model, and the intervention assembly sub-model based on the intervention position information and the movement position information to obtain a navigation three-dimensional model.

[0230] Furthermore, step S102 The method further includes step S1024 of performing navigation planning based on the intervention area sub-model and the three-dimensional model of the operation object to obtain a navigation path within the intervention area sub-model of the intervention assembly, wherein the navigation path indicates the travel path required for the intervention assembly to reach the ablation object within the target intervention area.

[0231] Furthermore, step S102 The method further includes step S1025: during the process of the intervention assembly moving within the target intervention area, determining intervention trajectory information of the intervention assembly based on the intervention position information and movement position information of the intervention assembly; if the intervention trajectory information and the path trajectory information corresponding to the navigation path satisfy a predetermined deviation condition, correcting the intervention position of the intervention assembly within the target intervention area until the updated intervention trajectory information of the intervention assembly matches the path trajectory information.

[0232] Furthermore, step S103 further includes steps S1031 and S1032.

[0233] In step S1031, initial ablation parameters corresponding to the object attribute information of the ablation object, impedance data of the ablation object, contact parameters of the interventional assembly, and dielectric constant of the ablation object are obtained, and the initial ablation parameters include at least one of pulse voltage, pulse width, number of pulses, and number of pulse groups.

[0234] In step S1032, an ablation effect evaluation is performed based on the navigation three-dimensional model, the operation object three-dimensional model, the object attribute information of the ablation object, the initial ablation parameters corresponding to the object attribute information of the ablation object, the impedance data of the ablation object, the contact parameters of the interventional assembly, and the dielectric constant of the ablation object to obtain ablation effect data corresponding to the initial ablation parameters. If the ablation effect data meets the target ablation conditions, the initial ablation parameters are determined as the target ablation parameters.

[0235] Furthermore, step S103 The method further includes step S1033 of performing an ablation effect simulation using the object attribute information, initial ablation parameters, impedance data, abutment parameters, dielectric constant, a three-dimensional model of the operated object, and a three-dimensional navigation model as inputs of an ablation evaluation model to obtain a simulated ablation model corresponding to the initial ablation parameters, wherein the simulated ablation model represents ablation effect data corresponding to the initial ablation parameters.

[0236] Further, step 104 Further included is a step S1041 of generating an energy generation control signal based on the target ablation parameters to control the ablation device to operate.

[0237] Furthermore, the method for controlling targeted ablation includes: The method further includes step S105 of obtaining ablation trajectory information and ablation data of the interventional assembly after the interventional assembly performs ablation on the ablation target, and generating a three-dimensional ablation model based on the ablation trajectory information, ablation data and target ablation parameters, wherein the ablation data includes the ablated ablation area and ablation position information of the ablation area, and the ablation three-dimensional model represents the three-dimensional spatial characteristics of the ablation target after ablation.

[0238] The present application further provides a targeted ablation control device, the device comprising: an information receiving module that receives the subject's motion position information acquired by the first position acquisition device and the intervention position information of the intervention assembly within a target intervention area acquired by the second position acquisition device, wherein the target intervention area belongs to the subject; a model construction module that constructs a virtual model based on the area image information of the target intervention area, the shape attribute information of the intervention assembly, the motion position information, and the intervention position information to obtain a navigation three-dimensional model and an operation object three-dimensional model, wherein the navigation three-dimensional model represents the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the intervention assembly, and the spatial position information between the ablation object, the intervention assembly, and the target intervention area, and the operation object three-dimensional model represents the three-dimensional spatial characteristics of the ablation object; a parameter determination module for determining target ablation parameters corresponding to the ablation target based on the navigation three-dimensional model, the operation target three-dimensional model, and the target attribute information of the ablation target; The interventional assembly may include a target control module that controls the ablation device to operate based on the target ablation parameters, thereby performing an ablation process on the ablation target.

[0239] In some embodiments, the model building module: an intervention area sub-model construction module that performs image recognition processing on area image information of the target intervention area, acquires an image recognition result, and performs image reconstruction based on the image recognition result to acquire an intervention area sub-model and an operation target three-dimensional model that represent three-dimensional spatial features of the target intervention area; an intervention assembly sub-model construction module that constructs a virtual model based on the shape attribute information of the intervention assembly to obtain an intervention assembly sub-model that represents three-dimensional spatial characteristics of the intervention assembly; a fusion module for performing spatial fusion processing on the intervention area sub-model, the operation object three-dimensional model, and the intervention assembly sub-model based on the intervention position information and the movement position information to obtain a navigation three-dimensional model.

[0240] Additionally, the model building module further includes a navigation planning module communicatively connected to the navigation three-dimensional model.

[0241] The navigation planning module performs navigation planning based on the intervention area sub-model and the three-dimensional model of the operation object to obtain a navigation path within the intervention area sub-model of the intervention assembly, and the navigation path indicates the travel path required for the intervention assembly to reach the ablation object within the target intervention area.

[0242] Furthermore, the navigation planning module further determines intervention trajectory information of the intervention assembly based on the intervention position information and movement position information of the intervention assembly during the process of the intervention assembly moving within the target intervention area, and if the intervention trajectory information and the path trajectory information corresponding to the navigation path satisfy a predetermined deviation condition, corrects the intervention position of the intervention assembly within the target intervention area until the updated intervention trajectory information of the intervention assembly matches the path trajectory information.

[0243] In some embodiments, the parameter determination module: an initial parameter acquisition module for acquiring initial ablation parameters corresponding to object attribute information of the ablation object, impedance data of the ablation object, contact parameters of the interventional assembly, and a dielectric constant of the ablation object, wherein the initial ablation parameters include at least one of a pulse voltage, a pulse width, a number of pulses, and a number of pulse groups; and a target parameter determination module that performs ablation effect evaluation based on the navigation three-dimensional model, the operation object three-dimensional model, the object attribute information of the ablation object, initial ablation parameters corresponding to the object attribute information of the ablation object, impedance data of the ablation object, contact parameters of the interventional assembly, and the dielectric constant of the ablation object to obtain ablation effect data corresponding to the initial ablation parameters, and determines the initial ablation parameters as target ablation parameters if the ablation effect data meets the target ablation conditions.

[0244] Furthermore, the target parameter determination module The device further includes a simulation ablation model construction unit that performs an ablation effect simulation using the object attribute information, initial ablation parameters, impedance data, contact parameters, dielectric constant, a three-dimensional model of the operated object, and a three-dimensional navigation model as inputs of an ablation evaluation model to obtain a simulation ablation model corresponding to the initial ablation parameters, wherein the simulation ablation model represents ablation effect data corresponding to the initial ablation parameters.

[0245] Furthermore, the object control module A pulsed energy generation module is included that generates energy generation control signals based on target ablation parameters to control the ablation device to operate.

[0246] In some embodiments, the targeted ablation control device comprises: The ablation three-dimensional model generation module further includes an ablation three-dimensional model generation module that acquires ablation trajectory information and ablation data of the interventional assembly after the interventional assembly performs ablation processing on the ablation target, and generates an ablation three-dimensional model based on the ablation trajectory information, ablation data, and target ablation parameters, wherein the ablation data includes an ablated ablation region and ablation position information of the ablation region, and the ablation three-dimensional model represents three-dimensional spatial characteristics of the ablation target after ablation.

[0247] The present application also provides a method and apparatus for evaluating pulse ablation effects applicable to the targeted ablation system, control method, device, medium, and electronic device of the present application. However, the present application is not limited thereto, and the technical means according to the embodiments of the present application can also be used to perform ablation on other body parts, such as the stomach. Hereinafter, the embodiments of the present application will be described taking lung ablation as an example.

[0248] FIG. 38 is a flowchart of a pulse ablation effect evaluation method according to an embodiment of the present application. As shown in FIG. 38, the pulse ablation effect evaluation method according to an embodiment of the present application may include the following steps S110 to S140.

[0249] In S110, mapping modeling is performed on the current tissue in the ablation catheter to obtain a three-dimensional model of the current tissue.

[0250] In an embodiment of the present application, a three-dimensional navigation system and an endoscope are used in combination. By using the three-dimensional navigation system to model the lung bronchi during surgery and constructing a lung model for the current surgery, the surgeon can observe the overall structure and direction of the lung bronchi through the navigation interface. Furthermore, the endoscope can be used to visually observe the position and internal condition of the lung bronchi. In this way, it is possible to observe the overall structure and direction of the lung bronchi, as well as the position and internal condition of the lung bronchi, thereby obtaining a more comprehensive understanding of the lung condition than with conventional techniques.

[0251] In addition, the embodiments of the present application combine prediction and ablation navigation functions, allowing the physician to enter the lungs through a catheter in combination with an endoscope by inputting initial parameters, and the catheter predicts and presents to the physician the depth and range of ablation based on the input parameters and the current tracheal thickness and position, allowing the physician to refer to and adjust the parameters.

[0252] Figure 39 is a connection block diagram of a pulse ablation effect evaluation system according to an embodiment of the present application. As shown in Figure 39, the ablation catheter is connected to a pulsed electric field ablation device via a pulse output circuit and an electrode circuit, the pulsed electric field ablation device is connected to a three-dimensional navigation system via a communication circuit and an electrode circuit, and the ablation catheter and the patient are connected via consumables.

[0253] Figure 40 is a block diagram illustrating the principle of a method for evaluating the effect of pulsed ablation according to an embodiment of the present application. Specifically, as shown in Figure 40, a three-dimensional navigation system acquires data through magnetic localization. The ablation catheter determines the impedance of the current tissue and the abutment state of the catheter through impedance / contact detection, determines the inner wall diameter of the tissue based on the expansion and abutment range of the basket, and obtains the dielectric constant to determine the characteristics of the current tissue. Because different cells have different electroporation thresholds, the information obtained from the dielectric constant can be used to obtain several characteristics of the corresponding tissue, and then evaluate whether the ablation energy meets the requirements.

[0254] The ablation catheter transmits the acquired impedance, permittivity, and basket data to the pulsed electric field ablation system, where the data is input into an ablation status evaluation model along with the ablation parameters set in the pulsed electric field ablation system for calculation. The three-dimensional navigation system can exchange data with the pulsed ablation device and generate a three-dimensional model of the current tissue required for ablation effect evaluation, where the current tissue may be pulmonary bronchial tissue.

[0255] In S120, the evaluation target data is acquired.

[0256] Specifically, the evaluation target data includes detection data acquired by the ablation catheter, ablation parameters of the ablation device, and basket state data; Specifically, the ablation parameters include one or more of a pulse voltage, a pulse width, a number of pulses, and a number of pulse groups.

[0257] Specifically, the basket status data includes basket expansion status data and the contact area between the basket and the current tissue, and the basket expansion status data and the contact area are used to determine the thickness of the ablation target region. The diameter of the bronchial inner wall (not the outer bronchial diameter but the inner bronchial diameter, including those with a cartilage outer bronchial diameter) can be determined based on the basket expansion level and the contact area, and the thickness of the bronchial mucosa layer can be obtained. The ablation target region here is the mucosa layer region.

[0258] In terms of pulmonary bronchial tissue structure, bronchi are mainly divided into epithelial cells (a pseudostratified layer with cilia, with goblet cells sandwiched between the pseudostratified layers, which secrete a small amount of mucus), the lamina propria (a basement membrane and loose connective tissue that, together with the epithelial cells and lamina propria, constitute the mucosa), and the submucosa (smooth muscle and other connective tissue). Mucous glands in the connective tissue are where most of the mucus is secreted, and in situations such as pulmonary ablation, the target of pulse ablation is mainly the mucous glands and goblet cells in the ablated mucosa layer.

[0259] In S130, the evaluation target data is input into a pre-trained ablation condition evaluation model to obtain an ablation condition evaluation result, and the ablation condition evaluation model calculates an ablation condition evaluation result corresponding to the evaluation target data based on the evaluation target data and the correspondence between the evaluation target data and the ablation condition, and the ablation condition evaluation result includes the ablation range, ablation depth, and ablation effectiveness.

[0260] In some possible embodiments, since different cell tissues have different electroporation thresholds, the effectiveness of ablation can be determined by comparing the dielectric constant before and after ablation, and knowing the content of different cell types in bronchial tissue can help evaluate the effectiveness of ablation parameters.

[0261] Since pulmonary ablation is mainly about ablating abnormal tissues (e.g., goblet cells and mucus glands) in the bronchial mucosal layer, the ablation effect can be effectively evaluated by combining simulation data, impedance / contact data, dielectric constant, and currently set ablation parameters and inputting them into the ablation status evaluation model.

[0262] The simulation data is data on the relationship between the bronchial inner diameter, ablation range, contact parameters, pulse parameters, and bronchial thickness and the ablation effect, which is obtained by simulation based on impedance data.

[0263] The evaluation process may be performed before ablation, thus providing a preview of the effect before ablation and allowing the surgeon to understand the parameters and number of ablations. Of course, it may also be performed after ablation, thus helping the surgeon determine whether the ablation was effective. After ablation, a new mapping evaluation can be performed to determine and optimize the extent and effect of the ablation, thereby improving the effectiveness of the treatment.

[0264] In S140, the ablation status evaluation results are displayed in the three-dimensional model of the current tissue.

[0265] When mapping modeling is completed before ablation and evaluation target data is also obtained, in the three-dimensional system, based on the diagram showing the pathological structure of the bronchi shown in Figure 33, the color of the ablation model can be used to distinguish and show the post-ablation evaluation results based on the ablation parameters, and a predicted diagram of the ablation range shown in Figure 34 can be obtained, which the surgeon can understand at a glance based on the model, thereby optimizing the ablation data and avoiding possible risks.

[0266] In one embodiment, after inputting the evaluation target data into a pre-trained ablation condition evaluation model to obtain an ablation condition evaluation result, a step of saving the evaluation target data and the ablation state evaluation result in sample data and acquiring updated sample data; and training and updating the ablation condition assessment model based on the updated sample data.

[0267] Since the feedback operating range, impedance / contact information, dielectric constant and ablation parameters are updated to a certain extent after pulse ablation, the ablation status assessment model undergoes post-ablation optimization and learning for each ablation, thereby optimizing the ablation status assessment model and improving the quality of assessment.

[0268] In one embodiment, before inputting the data to be evaluated into the pre-trained ablation condition evaluation model, a step of acquiring sample data, wherein the sample data may be data obtained in advance by simulation, including evaluation target data, ablation state, and a correspondence relationship between the evaluation target data and the ablation state, or may be clinically acquired data, including evaluation target data, ablation state, and a correspondence relationship between the evaluation target data and the ablation state, or may be a combination of simulation data and clinically acquired data, thereby increasing the number of samples and reducing the workload of acquiring the sample data; The method includes the steps of training a pre-constructed machine learning model using sample data, adjusting the parameters of the machine learning model during the training process until the ablation condition assessment result output from the machine learning model meets requirements, and saving the machine learning model as an ablation condition assessment model.

[0269] Of course, this model training process may be completed simultaneously with the process in which the three-dimensional navigation system performs navigation mapping modeling using a catheter.

[0270] The ablation condition assessment model may be a machine learning model, specifically, a neural network model. FIG. 41 illustrates an example of an ablation condition assessment model according to an embodiment of the present application. As shown in FIG. 41, in one embodiment, the ablation condition assessment model uses a full neural network (e.g., Tensorflow) as its main algorithm, selects Encode and Decode as its neural network machine learning framework, and selects three functions, Sigmold, Relu, and Softmax, as the activation functions of each network layer. A five-layer fully connected neural network is selected as the neural network model. The network structure is divided into four layers: an input layer, a hidden layer, a dropout layer, and an output layer. The entire neural network selects three functions, Sigmold, Relu, and Softmax, as the activation functions of each network layer. The loss function is cross-entropy. There are two parameter optimization methods: Adam Optimizer and Gradient Descent Optimizer, with a learning rate of 1e-4. The input and output of the model are (1*4) and (1*4).

[0271] In one embodiment, the step of displaying the ablation status assessment result in the three-dimensional model of the current tissue comprises: determining a display color corresponding to the ablation state evaluation result based on the ablation state evaluation result and the correspondence between the ablation state evaluation result and the display color, preferably by associating different ablation states with different display colors so that the ablation state of each region is visually reflected, and displaying the correspondence between the ablation state and the display color, preferably as shown in the illustrated example; The method includes a step of displaying an ablation status evaluation result and / or a display color corresponding to the ablation status in a three-dimensional model of the current tissue, wherein the ablation status evaluation result includes the ablation range, ablation depth, and ablation effectiveness.

[0272] As shown in FIG. 32, the ablation effect can be represented by different color shading variations, which allows the physician to visually observe the extent and effect of ablation of the lung tissue and assists in visually determining whether the ablation parameters need to be adjusted.

[0273] Specifically, the detection data includes an impedance signal, and the step of acquiring the evaluation target data includes: applying a first signal to an electrode of the ablation catheter, the first signal having a first predetermined frequency range, preferably between 2 KHz and 200 KHz; acquiring a backhaul signal after applying a first signal to the electrode; and performing a filtering process on the backhaul signal to convert the backhaul signal into an impedance signal.

[0274] The impedance detection method may use one or more of time-division switching detection, fusion-extraction detection, and frequency-division switching detection.

[0275] Here, the impedance signal can indicate the current load situation, and the impedance signal can be used in combination with ablation parameters such as pulse voltage, pulse width, number of pulses, number of pulse groups, etc. to calculate the energy being applied to the tissue. The contact quality and area can be determined by the rate of change of impedance. The size of the contact area can determine the quality of the ablation.

[0276] Specifically, the detection data includes a permittivity signal, and the step of acquiring the evaluation target data includes: applying a sinusoidal excitation signal to the current tissue via an electrode of the ablation catheter, the second predetermined frequency range being preferably between 5 KHz and 300 MHz; and obtaining backhauled complex impedance electrical signals after applying sinusoidal excitation signals of different frequencies to the current tissue, and the complex impedance electrical signals are the permittivity signals.

[0277] To detect the dielectric constant, a sinusoidal excitation signal with multiple frequencies ranging from 5 kHz to 300 MHz is used to stimulate the complex impedance electrical signals corresponding to tissues under different frequency signals. These signals are then converted into frequency-domain signals using methods such as wavelet transform and Fourier transform. Different tissues have different dielectric constants, and the ratio of these can be used to determine the proportion of different tissues and even the cell content. Because different tissues have different electroporation thresholds, determining the content of different cell types in bronchial tissues is useful for assessing the effectiveness of ablation parameters.

[0278] The relationship between the inner diameter of the bronchus and the contact length between the product and the bronchus can be determined by experiment. Based on this data, the correspondence between the evaluation target data and the ablation state can be further obtained by simulation. The correspondence between the evaluation target data and the ablation state is preferably the relationship between the ablation state, contact data, pulse parameters, and bronchial thickness. Specifically, the ablation state includes the ablation range and ablation depth.

[0279] FIG. 42 is a structural block diagram of a pulse ablation effect evaluation device according to an embodiment of the present application. Specifically, as shown in FIG. 42, the pulse ablation effect evaluation device according to an embodiment of the present application includes: a three-dimensional modeling module 210 that performs mapping modeling on the current tissue at the ablation catheter to obtain a three-dimensional model of the current tissue; a data acquisition module 220 for acquiring data to be evaluated, including sensing data acquired by the ablation catheter, ablation parameters of the ablation device, and basket status data; a condition evaluation module 230 that inputs evaluation target data into a pre-trained ablation condition evaluation model to obtain an ablation condition evaluation result, wherein the ablation condition evaluation model calculates an ablation condition evaluation result corresponding to the evaluation target data based on the evaluation target data and a correspondence relationship between the evaluation target data and the ablation condition; and a result display module 240 that displays the ablation status assessment results in a three-dimensional model of the current tissue.

[0280] In one embodiment, the apparatus further includes a feedback module that includes a sample data updating module and a model updating module.

[0281] The sample data update module stores the evaluation target data and the ablation state evaluation result in the sample data, and acquires the updated sample data; The model update module trains and updates the ablation condition assessment model based on the updated sample data.

[0282] In one embodiment, the apparatus further comprises a model training module including a sample data acquisition module and a parameter adjustment module; The sample data acquisition module acquires sample data before inputting the evaluation target data into the pre-trained ablation condition evaluation model; The parameter adjustment module uses sample data to train a pre-constructed machine learning model, and during the training process, adjusts the parameters of the machine learning model until the ablation condition evaluation result output from the machine learning model meets the requirements, and saves the machine learning model as an ablation condition evaluation model.

[0283] In one embodiment, the results display module 240: a display color determination module that determines a display color corresponding to the ablation state evaluation result based on the ablation state evaluation result and a correspondence relationship between the ablation state evaluation result and the display color; and a display module for displaying an ablation status evaluation result and / or a display color corresponding to the ablation status in the three-dimensional model of the current tissue, wherein the ablation status evaluation result includes an ablation range and an ablation depth.

[0284] In one embodiment, the sensed data includes an impedance signal, and the data acquisition module 220 a first signal applying module for applying a first signal having a frequency range within a first predetermined frequency range to an electrode of the ablation catheter; a backhaul signal acquisition module for acquiring a backhaul signal after applying a first signal to the electrode; and a signal conversion module that performs filtering on the backhaul signal to convert the backhaul signal into an impedance signal.

[0285] In one embodiment, the detected data includes a permittivity signal, and the data acquisition module 220 a second signal application module for applying a sinusoidal excitation signal having a frequency range within a second predetermined frequency range to the current tissue via an electrode of the ablation catheter; and a permittivity acquisition module for acquiring backhauled complex impedance electrical signals after applying sinusoidal excitation signals of different frequencies to the current tissue, and using the complex impedance electrical signals as permittivity signals.

[0286] It should be noted that the above device example and method example are based on the same embodiment.

[0287] The navigation control device and ablation device of the targeted ablation system of the present application can operate on a terminal or a server and include a processor and a memory, in which at least one instruction or at least one program is stored, and the at least one instruction or at least one program is loaded and executed by the processor to realize the targeted ablation control method and the pulse ablation effect evaluation method according to the embodiments of the above methods.

[0288] The memory stores software programs and modules, and the processor executes the software programs and modules stored in the memory to perform various functional applications and targeted ablation operations. The memory may primarily include a program storage area capable of storing an operating system, application programs required for functions, etc., and a data storage area capable of storing data generated in accordance with the use of the device. The memory may also include a high-speed random access memory, and may include at least one nonvolatile memory such as a magnetic disk memory device, a flash memory device, or other volatile solid-state memory device. Accordingly, the memory may further include a memory controller to enable the processor to access the memory.

[0289] The method according to the present invention may be implemented in an electronic device such as a mobile terminal, a computer terminal, a server, or a similar computing device. FIG. 43 is a block diagram of the hardware structure of an electronic device that implements the targeted ablation control method according to the present invention. As shown in FIG. 43, the electronic device 1000 may vary significantly due to differences in layout or performance. It may include one or more central processing units (CPUs) 1100 (the central processing unit 1100 may include, but is not limited to, a processing device such as a microprocessor (MCU) or a programmable logic device (FPGA)), a memory 1300 for storing data, and one or more storage media 1200 (e.g., one or more mass storage devices) for storing an application program 1230 or data 1220. The memory 130 and the storage medium 1200 may be temporary or persistent storage devices. The program stored in the storage medium 1200 may include one or more modules, each of which may include a series of instruction operations for the electronic device. Furthermore, central processing unit 1100 may be configured to communicate with storage medium 1200 and execute a series of instructions operating on storage medium 1200 on electronic device 1000. Electronic device 1000 may further include one or more power sources 1600, one or more wired or wireless network interfaces 1500, one or more input / output interfaces 1400, one or more displays 1700, and / or one or more operating systems 1210, such as Windows Server®, Mac OS X®, Unix®, Linux®, FreeBSD®, etc.

[0290] The input / output interface 1400 is for receiving or transmitting data over a network. A specific example of the network may include a wireless network provided by a communication provider of the electronic device 1000. In one example, the input / output interface 1400 includes a network adapter (Network Interface Controller, NIC) that can be connected to other network devices via a base station and communicate with the Internet. In one example, the input / output interface 1400 may be a radio frequency (RF) module that communicates with the Internet wirelessly.

[0291] The display 1700 can display electronic files on a screen via a specific transmission device and reflect them to the human eye. The display 1700 of the present application can be used for interface display, data management display, endoscopic image display, two-dimensional image display, three-dimensional image display, combined display of multiple two-dimensional images and three-dimensional images, multi-dimensional display, etc.

[0292] As will be appreciated by those skilled in the art, the structure shown in Figure 43 is merely exemplary and is not intended to limit the structure of the electronic device. For example, electronic device 1000 may include more or fewer assemblies than those shown in Figure 43 and may have a different arrangement than that shown in Figure 43.

[0293] An embodiment of the present application further provides a computer-readable storage medium, which is provided in an electronic device and can store at least one instruction or at least one program related to realizing the targeted ablation control method in the method embodiment, and the at least one instruction or the at least one program is loaded and executed by the processor to realize the targeted ablation control method and pulse ablation effect evaluation method according to the method embodiment.

[0294] Optionally, in the present application, the storage medium may be located in at least one network server among a plurality of network servers of a computer network. Optionally, in the present application, the storage medium may include various media capable of storing program code, such as, but not limited to, a USB memory, a read-only memory (ROM), a random access memory (RAM), a portable hard disk, a magnetic disk, or an optical disk.

[0295] According to one aspect of the present application, there is provided a computer program product or computer program comprising computer instructions stored on a computer-readable storage medium, the computer instructions being read by a processor of the computer device from the computer-readable storage medium and executed by the computer device to cause the computer device to perform the method according to any of the various embodiments described above.

[0296] The order of the embodiments herein is for illustrative purposes only and does not represent the merits or demerits of the embodiments. Certain embodiments of the present application have been described above. Other embodiments are within the scope of the appended claims. In some cases, the actions or steps recited in the claims may be performed in an order different from the order of the embodiments and still achieve desirable results. Also, processes depicted in the figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In some embodiments, multitasking and parallel processing may also be possible or advantageous.

[0297] Each embodiment in the present application will be described step by step, and the same or similar parts of each embodiment may be referred to each other, and the description of each embodiment will focus on the differences from other embodiments. In particular, the device, apparatus, and storage medium embodiments are basically similar to the method embodiments, so they will be briefly described, and the relevant parts may be referred to the description of the method embodiments.

[0298] Those skilled in the art should understand that all or part of the steps in the above embodiments may be realized by hardware, or may be realized by instructing related hardware by a program.

[0299] Although the preferred embodiments of the present application have been shown and described above, as mentioned above, the present application is not limited to the forms disclosed herein, and should not be considered as excluding other embodiments. It should be understood that the present application can be applied to various other combinations, modifications, and environments, and can be modified by the above teachings or the skill or knowledge of those in the relevant fields within the scope of the inventive concept described herein. Changes and modifications made by those skilled in the art without departing from the spirit and scope of the present application should be within the scope of protection of the claims appended hereto. [Explanation of symbols]

[0300] 1 Intervention device 11 Second position acquisition device 12 Intervention Assembly 120 conveying wire 121 Ablation Electrode 122 First ablation electrode 123 Second ablation electrode 124 Position Restriction Structure 13 Mandrel 14 Operation control tube assembly 141 Operation control tube 142 First operation control tube 143 Second operation control tube 15 Fixed sleeve 151 Internal tooth structure 16 Operating handle 161 Passage 162 Fixed locking port 163 Seal ring 17 Operation Control Assembly 100 Inner Core Tube 101 Operation control outer tube 102 Electrode guide wire 103 Fixing member 104 Operating handle 105 Operation control member 20 Guide tube 201 Cooling medium passage 202 outer tube 203 Inner layer tube 204 Conductor path 21 Inflatable Structure 22 Handle 23 Connecting member 24 Conductor 30 Operation control section 31 First layer tube 32 Second layer tube 321 Curvature Adjustment Segment 33 Conductor 34 Curvature adjustment control member 35 Adjustment wire 36 Rail 37 Connection structure 38 Curved wire passage 40 Adjustment part 401 first adjustment member 402 second adjustment member 41 Guide tube 411 Curvature adjustment part 42 Sampling material 421 Sampling Head 43 Curvature adjustment member 431 Adjustment control wire 432 Adjustment tube 44 Connection fixing member 45 Guide Cannula 46 Signal line 2. Navigation control equipment 021 Intervention Area Submodel Building Module 022 Intervention Assembly Submodel Building Module 023 Fusion Module 024 Navigation Planning Module 025 Initial parameter acquisition module 026 Target parameter determination module 0261 Simulation Ablation Model Construction Unit 027 Ablation 3D model generation module 028 Pulse Energy Generation Module 3 First position acquisition device 4 Ablation devices 041 Pulse power supply 042 Switching circuit 043 Output Interface 0421 Branch circuit 4211 Input Switching Module 4212 Output Switching Module 4213 Capacitor Module 4214 Diode Module 4215 Filtering Module 1000 electronic equipment 1100 Central Processing Unit 1200 Storage medium 1210 Operating System 1220 Data 1230 Application Program 1300 memory 1400 Input / Output Interface 1500 Wired or wireless network interface 1600 power supply 1700 display

Claims

1. The system includes an interventional device (1), a navigation control device (2), a first position acquisition device (3), and an ablation device (4), wherein the interventional device (1) includes a second position acquisition device (11) and an interventional assembly (12), and the first position acquisition device (3), the second position acquisition device (11), the interventional assembly (12), and the ablation device (4) are each communicatively connected to the navigation control device (2); The first position acquisition device (3) acquires the movement position information of the subject and transmits it to the navigation control device (2); The second position acquisition device (11) acquires intervention position information of the intervention assembly (12) within a target intervention area and transmits it to the navigation control device (2), the target intervention area belonging to the subject; The navigation control device (2) constructs a virtual model based on the area image information of the target intervention area, the morphological attribute information of the intervention assembly (12), the motion position information, and the intervention position information, to obtain a navigation three-dimensional model and a manipulation object three-dimensional model, the navigation three-dimensional model representing the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the intervention assembly (12), and spatial position information between the ablation object, the intervention assembly (12), and the target intervention area, and the manipulation object three-dimensional model representing the three-dimensional spatial characteristics of the ablation object; The navigation control device (2) further determines target ablation parameters corresponding to the ablation target based on the navigation three-dimensional model, the operation target three-dimensional model, and the object attribute information of the ablation target, and controls the ablation device (4) to operate based on the target ablation parameters, thereby causing the interventional assembly (12) to perform an ablation process on the ablation target. A targeted ablation system comprising:

2. The navigation control device (2) an intervention area submodel construction module (21) that performs image recognition processing on area image information of the target intervention area, acquires an image recognition result, and performs image reconstruction based on the image recognition result to acquire an intervention area submodel that represents three-dimensional spatial characteristics of the target intervention area and the operation target three-dimensional model; an intervention assembly sub-model construction module (22) for constructing a virtual model based on the morphological attribute information of the intervention assembly (12) to obtain an intervention assembly sub-model representing three-dimensional spatial characteristics of the intervention assembly (12); a fusion module (23) for performing a spatial fusion process on the intervention area sub-model, the operation object three-dimensional model, and the intervention assembly sub-model based on the intervention position information and the movement position information to obtain the navigation three-dimensional model; The targeted ablation system of claim 1 .

3. The navigation control device (2) further includes a navigation planning module (24) communicatively connected to the navigation three-dimensional model; the navigation planning module (24) performs navigation planning based on the intervention area sub-model and the three-dimensional model of the operation object to obtain a navigation path for the intervention assembly (12) within the intervention area sub-model, the navigation path indicating a travel path required for the intervention assembly (12) to reach the ablation object within the target intervention area. The targeted ablation system of claim 2 .

4. The navigation planning module (24) further determines intervention trajectory information of the intervention assembly (12) based on the intervention position information of the intervention assembly (12) and the movement position information during the process of the intervention assembly (12) moving within the target intervention area, and if the intervention trajectory information and the path trajectory information corresponding to the navigation path satisfy a predetermined deviation condition, corrects the intervention position of the intervention assembly (12) within the target intervention area until the updated intervention trajectory information of the intervention assembly (12) matches the path trajectory information. The targeted ablation system of claim 3 .

5. The navigation control device (2) further includes an initial parameter acquisition module (25) and a target parameter determination module (26); the initial parameter acquisition module (25) acquires initial ablation parameters corresponding to object attribute information of the ablation object, impedance data of the ablation object, contact parameters of the interventional assembly (12), and a dielectric constant of the ablation object, the initial ablation parameters including at least one of a pulse voltage, a pulse width, a number of pulses, and a number of pulse groups; a target parameter determination module (26) performs ablation effect evaluation based on the navigation three-dimensional model, the operation object three-dimensional model, object attribute information of the ablation object, initial ablation parameters corresponding to the object attribute information of the ablation object, impedance data of the ablation object, contact parameters of the interventional assembly (12) and the dielectric constant of the ablation object to obtain ablation effect data corresponding to the initial ablation parameters; and determines the initial ablation parameters as the target ablation parameters if the ablation effect data meets a target ablation condition. The targeted ablation system according to any one of claims 1 to 4.

6. The interventional device (1) includes a contact detection device and a dielectric constant detection device, and the contact detection device and the dielectric constant detection device are each communicatively connected to the navigation control device (2); the contact detection device detects impedance data of the ablation target and contact parameters of the interventional assembly (12) and transmits them to the initial parameter acquisition module (25), the impedance data indicating a load of the interventional assembly (12) and the contact parameters indicating a degree of contact between the interventional assembly (12) and the ablation target; the dielectric constant detection device detects the dielectric constant of the object to be ablated; The targeted ablation system of claim 5 .

7. The target parameter determination module (26) includes a simulation ablation model construction unit (261); the simulation ablation model construction unit (261) performs an ablation effect simulation using the object attribute information, the initial ablation parameters, the impedance data, the contact parameters, the dielectric constant, the operation object three-dimensional model, and the navigation three-dimensional model as inputs of an ablation evaluation model, and obtains a simulation ablation model corresponding to the initial ablation parameters, and the simulation ablation model represents ablation effect data corresponding to the initial ablation parameters; The targeted ablation system of claim 5 .

8. The navigation control device (2) further includes an ablation three-dimensional model generation module (27); the ablation three-dimensional model generation module (27) acquires ablation trajectory information and ablation data of the interventional assembly (12) after the interventional assembly (12) performs ablation processing on the ablation target, and generates an ablation three-dimensional model based on the ablation trajectory information, the ablation data, and the target ablation parameters, wherein the ablation data includes an ablated ablation region and ablation position information of the ablation region, and the ablation three-dimensional model represents three-dimensional spatial characteristics of the ablation target after ablation. The targeted ablation system according to any one of claims 1 to 4.

9. The navigation control device (2) includes a pulsed energy generation module (28); The pulsed energy generation module (28) generates an energy generation control signal based on the target ablation parameters to control the ablation device (4) to operate. The targeted ablation system of claim 7 .

10. The control circuit of the ablation device (4) includes a switching circuit (42), which includes at least two branch circuits (421) connected in parallel, full-bridge, half-bridge, or series, each branch circuit (421) including an input-end switching module (4211) and an output-end switching module (4212), and the switching circuit (42) controls the corresponding input-end switching module (4211) and output-end switching module (4212) to conduct in response to an energy generation control signal of the pulse energy generating module (28), thereby generating pulse energy. The targeted ablation system of claim 9 .

11. The branch circuit (421) includes a filtering module (4215), and the filtering module (4215) includes a plurality of filtering units, and the filtering units include a plurality of filters and a filter selector that selects a filter to perform filtering processing. The targeted ablation system of claim 10 .

12. The interventional device (1) includes a mandrel (13) and a steering control tube assembly (14), the mandrel (13) being electrically connected to the interventional assembly (12) and the ablation device (4), respectively; the second position acquisition device (11) is provided on the mandrel (13) and / or the intervention assembly (12); The interventional assembly (12) includes at least one ablation electrode (121), the at least one ablation electrode (121) being mesh-like and arranged in sequence along the mandrel (13), the operation control tube assembly (14) being fitted to the outside of the mandrel (13), and the operation control tube assembly (14) being movable relative to the mandrel (13) to expand or contract the ablation electrode (121). The targeted ablation system according to any one of claims 1 to 4.

13. The contact detection device and the dielectric constant detection device are both provided on the intervention assembly (12) and communicatively connected to the navigation control device (2). The targeted ablation system according to any one of claims 1 to 4.

14. The interventional device (1) includes a fixing sleeve (15), and internal tooth structures (151) are provided along the circumferential direction at both ends of a sleeve body of the fixing sleeve (15), and the internal tooth structures (151) at both ends are provided inclined from the end surface of the sleeve body toward the inside of the end surface. The targeted ablation system of claim 12 .

15. the second position acquisition device (11) is provided between the two internal tooth structures (151) of the fixing sleeve (15); 15. The targeted ablation system of claim 14.

16. The steering control tube assembly (14) includes at least one steering control tube (141) connected to the ablation electrode (121). The targeted ablation system of claim 12 .

17. At least one of the ablation electrodes (121) can be configured as a monopolar electrode or a bipolar electrode. The targeted ablation system of claim 12 .

18. The maximum extendable distances of the ablation electrodes (121) arranged in sequence along the mandrel (13) increase in sequence along the direction from the distal end to the proximal end of the mandrel (13). The targeted ablation system of claim 12 .

19. The ablation electrode (121) includes a plurality of electrode wires, and the plurality of electrode wires are cross-woven to form the mesh-like ablation electrode (121).

20. The targeted ablation system of claim 18.

20. The ablation electrode (121) has an elliptical, spindle-shaped, polygonal or umbrella-shaped axial cross section after expansion.

20. The targeted ablation system of claim 19.

21. an operating handle (16) having a passageway for the mandrel (13) and the operating control tube assembly (14) to pass through; The targeted ablation system of claim 12 .

22. The operating handle (16) is provided with an operating control assembly (17), which is slidably or rotatably connected to the operating handle (16) and controls at least one operating control tube (141) to move.

22. The targeted ablation system of claim 21.

23. The device comprises an inner core tube (100), an outer operation and control tube (101), an electrode guide wire (102), and an ablation electrode (121), wherein the electrode guide wire (102) is removably inserted into the inner core tube (100), and the outer operation and control tube (101) is fitted onto the outside of the inner core tube (100); The ablation electrode (121) has a distal end fixedly connected to the distal end of the inner core tube (100) and a proximal end fixedly connected to the outer wall of the operation control outer tube (101), and the operation control outer tube (101) is movable along the inner core tube (100) to expand or contract the ablation electrode (121). A medical intervention device characterized by:

24. The inner core tube (100) is a penetration tube, and the distal end of the electrode guide wire (102) can pass through the distal end of the inner core tube (100) and contact diseased tissue.

24. The medical intervention device of claim 23.

25. The electrode guidewire (102) and the ablation electrode (121) are both electrically connected to an ablation device (4).

24. The medical intervention device of claim 23.

26. The ablation electrode (121) includes a plurality of electrode wires, and the plurality of electrode wires are woven in a cross-mesh shape.

24. The medical intervention device of claim 23.

27. The distal ends of the plurality of electrode wires are fixedly connected to the outer wall of the distal end of the inner core tube (100).

27. The medical intervention device of claim 26.

28. a guide tube (20), an inflatable structure (21), an interventional assembly (12), and a handle (22), wherein the guide tube (20) is connected at one end to the handle (22) and at the other end to the inflatable structure (21); A cooling medium passage (201) is formed in the guide tube (20), and one end of the cooling medium passage (201) is connected to a cooling medium source and the other end is connected to the expandable structure (21); The interventional assembly (12) includes a delivery wire (120) and an ablation electrode (121), the delivery wire (120) being connected at one end to the ablation electrode (121) and at the other end to an ablation device (4), the ablation electrode (121) being mesh-like and covering the expandable structure (21); An energy delivery device characterized by:

29. a second position acquisition device (11) is provided at one end of the guide tube (20) remote from the handle (22); 30. The energy delivery device of claim 28.

30. The guide tube (20) includes an outer tube (202) and an inner tube (203), and a cooling medium passage (201) is formed between the outer tube (202) and the inner tube (203).

30. The energy delivery device of claim 28.

31. One end of the inflatable structure (21) adjacent to the handle (22) is connected to the outer tube (202), and the other end of the inflatable structure (21) is connected to the inner tube (203).

31. The energy delivery device of claim 30.

32. The ablation electrode (121) has a square mesh structure.

30. The energy delivery device of claim 28.

33. The ablation electrode (121) is manufactured by cutting, knitting or electroforming.

33. The energy delivery device of claim 32.

34. Both ends of the ablation electrode (121) are connected to both ends of the expandable structure (21) via connecting members (23), respectively.

34. The energy delivery device of claim 33.

35. The ablation electrode (121) is expandable with the expansion of the expandable structure (21) and contractable with the contraction of the expandable structure (21).

35. The energy delivery device of claim 34.

36. a communication portion (221) is provided in the handle (22), and the communication portion (221) is in communication with the cooling medium source and the cooling medium passage (201), respectively; 30. The energy delivery device of claim 28.

37. The second position acquisition device (11) is communicatively connected to a navigation control device (2).

30. The energy delivery device of claim 29.

38. The device includes an operation control unit (30), a first layer tube (31) and a second layer tube (32) whose proximal ends are connected to the operation control unit (30), the second layer tube (32) being provided within the first layer tube (31) and communicating with the interior of the operation control unit (30); a second position acquisition device (11) is provided at one end of the second layer tube (32) away from the operation control unit, and the second position acquisition device (11) is provided on the outer wall of the second layer tube (32); The operation control unit (30) is provided with a curvature adjustment control member (34) and an adjustment wire (35), one end of the adjustment wire (35) is connected to the curvature adjustment control member (34) and the other end is fixedly connected to the curvature adjustment segment (321) of the second layer tube (32). A guide tube with adjustable curvature.

39. The first layer tube (31) and the second layer tube (32) have diameters that gradually decrease from the proximal end to the distal end.

39. The guide tube with adjustable curvature according to claim 38.

40. a conductor (33), and the second position acquisition device (11) is connected to a navigation control device (2) via the conductor (33); 39. The guide tube with adjustable curvature according to claim 38.

41. The curvature adjustment segment (321) is provided on the second layer tube (32), and the distance from the curvature adjustment segment (321) to the distal end of the second layer tube (32) is 2 cm to 5 cm.

39. The guide tube with adjustable curvature according to claim 38.

42. A connection structure (37) is provided on the outside of the curvature adjustment segment (321), and the curvature adjustment segment (321) is connected to the adjustment wire (35) via the connection structure (37).

42. The guide tube with adjustable curvature according to claim 41.

43. The curvature adjustment control member (34) is slidably or rotatably connected to the operation control part (30).

39. The guide tube with adjustable curvature according to claim 38.

44. The curvature adjustment control member (34) pulls and bends the second layer tube (32) by the adjustment wire (35) to a curvature of 0 to 180 degrees.

44. The guide tube with adjustable curvature according to claim 43.

45. The adjusting wire (35) is a round wire rope or a flat wire rope made of a single-core or multi-core wire.

39. The guide tube with adjustable curvature according to claim 38.

46. A bending wire passage (38) is fitted around the outside of the adjustment wire (35), and the bending wire passage (38) is provided along the axial direction of the second layer tube (32) and is connected to the operation control unit (30).

46. ​​The guide tube with adjustable curvature according to claim 45.

47. The apparatus includes an adjustment unit (40), a guide tube (41), a sampling member (42), and a curved adjustment member (43), the guide tube (41) is fitted into the sampling member (42), the guide tube (41) is connected to the adjustment unit (40), and the adjustment unit (40) is provided with a first adjustment member (401) and a second adjustment member (402), The sampling member (42) has one end connected to the first adjustment member (401) and the other end provided with a sampling head (421), the curvature adjustment member (43) has one end connected to the second adjustment member (402) and the other end connected to a curvature adjustment portion (411) of the guide tube (41), and the curvature adjustment member (43) can pull and bend the guide tube (41) by means of the curvature adjustment portion (411). A medical biopsy sampling device characterized by:

48. A second position acquisition device (11) is provided on the sampling member (42), and the second position acquisition device (11) is provided in the vicinity of the sampling head (421), and acquires position information of the sampling head (421) and transmits it to a navigation control device (2).

48. A medical biopsy sampling device according to claim 47.

49. The curvature adjustment portion (411) is provided on the guide tube (41) in the vicinity of the distal end of the guide tube (41).

48. A medical biopsy sampling device according to claim 47.

50. The curvature adjustment member (43) includes an adjustment control wire (431), one end of which is connected to the second adjustment member (402) and the other end of which is connected to the curvature adjustment portion (411).

50. A medical biopsy sampling device as recited in claim 49.

51. The curvature adjustment member (43) includes an adjustment tube (432), which is fitted onto the adjustment control wire (431) and connected to the guide tube (41).

51. A medical biopsy sampling device according to claim 50.

52. a connecting and fixing member (44) is provided on the bending adjustment portion (411) of the guide tube (41), and the adjustment control wire (431) is connected to the bending adjustment portion (411) via the connecting and fixing member (44); 52. A medical biopsy sampling device as recited in claim 51.

53. The first adjustment member (401) and the second adjustment member (402) are each slidably or rotatably connected to the adjustment unit (40).

48. A medical biopsy sampling device according to claim 47.

54. The curvature adjustment member (43) pulls and bends the guide tube (41) to a curvature of 0° to 120°.

48. A medical biopsy sampling device according to claim 47.

55. The second position acquisition device (11) is connected to a navigation control device (2) via a signal line (46).

49. A medical biopsy sampling device according to claim 48.

56. receiving motion position information of the subject acquired by a first position acquisition device (3) and intervention position information of an intervention assembly (12) in a target intervention area acquired by a second position acquisition device (11), the target intervention area belonging to the subject; a step of constructing a virtual model based on the area image information of the target intervention area, the morphological attribute information of the intervention assembly (12), the motion position information, and the intervention position information to obtain a navigation three-dimensional model and a manipulation object three-dimensional model, wherein the navigation three-dimensional model represents the three-dimensional spatial characteristics of the target intervention area, the three-dimensional spatial characteristics of the intervention assembly (12), and spatial position information between the ablation object, the intervention assembly (12), and the target intervention area, and the manipulation object three-dimensional model represents the three-dimensional spatial characteristics of the ablation object; determining target ablation parameters corresponding to the ablation target based on the navigation three-dimensional model, the operation target three-dimensional model, and target attribute information of the ablation target; and controlling an ablation device (4) to operate based on the target ablation parameters, thereby causing the interventional assembly (12) to perform an ablation treatment on the ablation target. A method for controlling targeted ablation.

57. an information receiving module for receiving motion position information of a subject acquired by a first position acquisition device (3) and intervention position information of an intervention assembly (12) in a target intervention area acquired by a second position acquisition device (11), the target intervention area belonging to the subject; a model construction module that constructs a virtual model based on area image information of a target intervention area, shape attribute information of the intervention assembly (12), the motion position information, and the intervention position information to obtain a navigation three-dimensional model and a manipulation object three-dimensional model, wherein the navigation three-dimensional model represents three-dimensional spatial characteristics of the target intervention area, three-dimensional spatial characteristics of the intervention assembly (12), and spatial position information between the ablation object, the intervention assembly (12), and the target intervention area, and the manipulation object three-dimensional model represents three-dimensional spatial characteristics of the ablation object; a parameter determination module for determining target ablation parameters corresponding to the ablation target based on the navigation three-dimensional model, the operation target three-dimensional model, and target attribute information of the ablation target; an object control module that controls an ablation device (4) to operate based on the target ablation parameters, thereby causing the interventional assembly (12) to perform an ablation process on the ablation object. A targeted ablation control device comprising:

58. performing mapping modeling on the current tissue at the ablation catheter to obtain a three-dimensional model of the current tissue; acquiring evaluation data including sensing data acquired by the ablation catheter, ablation parameters of the ablation device, and basket status data; a step of inputting the evaluation target data into a pre-trained ablation condition evaluation model to obtain an ablation condition evaluation result, wherein the ablation condition evaluation model calculates the ablation condition evaluation result corresponding to the evaluation target data based on the evaluation target data and a correspondence relationship between the evaluation target data and the ablation condition; and displaying the ablation status assessment result in the three-dimensional model of the current tissue. A method for evaluating the effect of pulse ablation.

59. The evaluation target data is input into a pre-trained ablation state evaluation model to obtain an ablation state evaluation result, and then: a step of saving the evaluation target data and the ablation state evaluation result in sample data and acquiring updated sample data; training and updating the ablation condition assessment model based on the updated sample data; 59. A method for evaluating pulse ablation effect according to claim 58.

60. before inputting the evaluation target data into a pre-trained ablation condition evaluation model; obtaining sample data; training a pre-constructed machine learning model using the sample data, and adjusting parameters of the machine learning model during the training process until the ablation condition assessment result output from the machine learning model satisfies requirements; and saving the machine learning model as the ablation condition assessment model.

59. A method for evaluating pulse ablation effect according to claim 58.

61. The step of displaying the ablation status evaluation result in the three-dimensional model of the current tissue includes: determining a display color corresponding to the ablation state evaluation result based on the ablation state evaluation result and a correspondence relationship between the ablation state evaluation result and a display color; and displaying the ablation status evaluation result and / or a display color corresponding to the ablation status in the three-dimensional model of the current tissue, wherein the ablation status evaluation result includes an ablation range and an ablation depth.

59. A method for evaluating pulse ablation effect according to claim 58.

62. The detection data includes an impedance signal, and the step of acquiring evaluation target data includes: applying a first signal having a frequency range within a first predetermined frequency range to an electrode of the ablation catheter; acquiring a backhaul signal after applying the first signal to an electrode; and performing a filtering process on the backhaul signal to convert the backhaul signal into the impedance signal.

59. A method for evaluating pulse ablation effect according to claim 58.

63. The detection data includes a permittivity signal, and the step of acquiring evaluation target data includes: applying a sinusoidal excitation signal having a frequency range within a second predetermined frequency range to the current tissue via an electrode of the ablation catheter; and obtaining backhauled complex impedance electrical signals after applying sinusoidal excitation signals of different frequencies to the current tissue, and the complex impedance electrical signals being the permittivity signals.

59. A method for evaluating pulse ablation effect according to claim 58.

64. The basket status data includes basket expansion status data and a contact area between the basket and the current tissue, and the basket expansion status data and the contact area are used to determine a thickness of an ablation target region.

59. A method for evaluating pulse ablation effect according to claim 58.

65. a model construction module that performs mapping modeling on the current tissue at the ablation catheter to obtain a three-dimensional model of the current tissue; a data acquisition module for acquiring evaluation target data including detection data acquired by the ablation catheter, ablation parameters of the ablation device, and basket status data; a condition evaluation module that inputs the evaluation target data into a pre-trained ablation condition evaluation model to obtain an ablation condition evaluation result, wherein the ablation condition evaluation model calculates the ablation condition evaluation result corresponding to the evaluation target data based on the evaluation target data and a correspondence relationship between the evaluation target data and the ablation condition; a result display module for displaying the ablation status evaluation result in the three-dimensional model of the current tissue. A pulse ablation effect evaluation device characterized by:

66. At least one instruction or at least one program is stored, and the at least one instruction or the at least one program is loaded and executed by a processor to realize the target ablation control method according to claim 56 and the pulse ablation effect evaluation method according to any one of claims 58 to 64. A computer-readable storage medium comprising:

67. An electronic device comprising a processor and a memory, wherein at least one instruction or at least one program is stored in the memory, and wherein the at least one instruction or the at least one program is loaded and executed by the processor to realize the targeted ablation control method described in claim 56 and the pulse ablation effect evaluation method described in any one of claims 58 to 64.

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