A real-time monitoring system and device for ablation therapy based on a single-needle multipolar electrode needle

Abstract

The present invention is applicable to the field of smart medical treatment of medical devices, and provides a real-time monitoring system and device for ablation treatment based on a single-needle multi-polar electrode needle. In this embodiment, important tissues and organs are first marked on the preoperative image. When performing the needle advancement and withdrawal operation, the electrode needle path and relative position can be monitored in real time through the preoperative image and the ultrasonic image of the area around the ablation electrode needle, and an early warning is issued when the distance to the important tissue is too close, which realizes the real-time monitoring of the needle advancement and withdrawal operation process. During the pulse treatment process, the ablation range can be displayed in real time through ultrasonic images, and then it is judged whether the expectation is achieved based on the ablation range, and whether it is necessary to adjust the treatment parameters or end the ablation treatment, which realizes the real-time monitoring of the electric field ablation process. Through this application, the precision and accuracy of needle advancement and withdrawal and electric field ablation during the ablation treatment operation can be improved, thereby improving the safety of the operation.

Description

Technical Field

[0001] The present application relates to the field of smart medical treatment of medical devices, and in particular to a real-time monitoring system and device for ablation treatment based on a single-needle multipolar electrode needle. Background Art

[0002] Electric field ablation is a medical technology that uses electric fields to perform non-thermal ablation of biological tissues. This technology has attracted attention since the end of the 20th century. With the in-depth study of cell electrophysiology and electroporation effects, electric field ablation has gradually developed into an effective medical method. Compared with traditional thermal ablation technology, electric field ablation can more accurately control the ablation area and reduce damage to surrounding normal tissues.

[0003] The single-needle multipolar pulsed electric field ablation probe is an innovative medical device. Taking a single-needle bipolar electrode needle as an example, it generates a bipolar electric field through a single probe to achieve ablation of specific tissues. This design utilizes the nonlinear characteristics of the electric field. By precisely controlling the intensity and pulse parameters of the electric field, the target tissue can be ablated without damaging the surrounding normal tissue.

[0004] However, when the electrode needle is moved in and out, the operator needs to operate the ultrasound probe with one hand and perform puncture with the other hand, which is difficult. At present, transcutaneous ultrasound has a certain impact on imaging precision and accuracy due to factors such as angle and depth. Summary of the invention

[0005] In view of this, the present application provides a real-time monitoring system and device for ablation therapy based on a single-needle multi-polar electrode needle, which makes the needle advancement and withdrawal operations in ablation therapy surgery faster, more precise and safer, and after pulsed electric field ablation therapy, the ablation range can be accurately displayed immediately through ultrasonic imaging, thereby realizing real-time monitoring of electric field ablation.

[0006] In a first aspect, the present application provides a real-time monitoring system for ablation therapy based on a single-needle multipolar electrode needle, the system comprising a treatment parameter control module, a pulse electric field generation module, an ultrasound monitoring module, a data storage processing module, a multi-mode image data fusion module, a single-needle multipolar visualization electrode needle module, and a needle advancement and retreat module;

[0007] The treatment parameter control module is used to obtain the treatment parameters of the preoperative ablation plan, adjust the treatment parameters according to the treatment effect of the pulsed electric field ablation treatment determined by the ultrasound monitoring module, and send the treatment parameters to the pulsed electric field generation module;

[0008] The pulse electric field generating module is used to perform pulse electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module;

[0009] The ultrasound monitoring module is used to perform ultrasound imaging of the surrounding area of ​​the ablation electrode needle when the ablation electrode needle performs needle advancement and withdrawal operations and performs pulsed electric field ablation treatment, thereby obtaining real-time ultrasound images during the operation and sending them to the multi-mode image data fusion module;

[0010] Monitor the insertion path of the ablation electrode needle according to the fusion image generated by the multi-mode image data fusion module, accurately locate the position and depth of the ablation electrode needle, and monitor the treatment effect of the pulsed electric field ablation treatment and send it to the treatment parameter control module;

[0011] The multi-modal image data fusion module is used to fuse the preoperative image with the intraoperative real-time ultrasound image to generate a fused image;

[0012] The single-needle multipolar visualized electrode needle module comprises an ablation electrode needle having an electrode head and at least one electrode ring, and is used to discharge through the electrode head and the electrode ring to form a high-voltage pulse electric field required for ablation treatment;

[0013] The needle advancing and withdrawing module is used to determine the advancing and withdrawing path of the ablation electrode needle according to the fused image, and to issue an alarm message when it is determined that the distance between the ablation electrode needle and a predetermined protective tissue reaches a threshold during the needle advancing and withdrawing operation.

[0014] Optionally, the monitoring of the therapeutic effect of pulsed electric field ablation therapy includes:

[0015] Setting a treatment cycle according to the preoperative ablation plan, wherein the treatment cycle includes a group of treatment pulses and a group of ultrasound imaging pulses, and the treatment pulses include a plurality of electronic pulses;

[0016] The ablation range after several treatment cycles is determined by real-time ultrasound imaging, the ablation range is compared with the ablation range preset in the preoperative planning, and the treatment effect of the pulsed electric field is determined based on the comparison result.

[0017] Optionally, the protected tissue includes target tissues and organs manually or automatically outlined based on preoperative images.

[0018] Optionally, before the pulse electric field generating module performs pulse electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module, the method further includes:

[0019] Conduct pulse electric field simulation to determine the simulated pulse electric field ablation area;

[0020] The simulated pulsed electric field ablation area is compared with the ablation range preset in the preoperative planning. When the repetition rate of the preset ablation range and the simulated pulsed electric field ablation area exceeds the preset value, the step of performing pulsed electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module is executed.

[0021] Optionally, the performing pulse electric field simulation to determine the simulated pulse electric field ablation area includes:

[0022] Through the equation ,and Determine the electric field strength E, where is the conductivity, U is the potential, the positive electrode boundary potential of U is a preset value U0, and the negative electrode boundary potential of U is grounded 0V;

[0023] Will The area is determined as the simulated pulse electric field ablation area, where are radial, axial and tangential coordinates respectively, is the time parameter, is the ablation threshold field strength.

[0024] The second aspect of the present application provides a real-time monitoring device for ablation therapy based on a single-needle multipolar electrode needle, the device comprising:

[0025] An ultrasound imaging unit, used to perform ultrasound imaging of the surrounding area of ​​the ablation electrode needle when performing needle advancement and withdrawal operations and ablation treatment, and to generate real-time ultrasound images during the operation;

[0026] An image fusion unit, used to fuse preoperative images with real-time intraoperative ultrasound images to generate a fused image;

[0027] A needle advancement and withdrawal monitoring unit is used to locate the position and depth of the ablation electrode needle in real time according to the fused image when performing the needle advancement and withdrawal operation, and to issue an alarm message when determining that the distance between the ablation electrode needle and a predetermined protective tissue reaches a threshold;

[0028] The treatment effect determination unit is used to monitor the treatment effect of the pulsed electric field according to the fused image during pulsed electric field ablation treatment, and determine to adjust the treatment parameters or end the pulsed electric field ablation treatment according to the treatment effect.

[0029] Optionally, the monitoring of the treatment effect of the pulsed electric field ablation treatment in the treatment effect determination unit includes:

[0030] Setting a treatment cycle according to the preoperative ablation plan, wherein the treatment cycle includes a group of treatment pulses and a group of ultrasound imaging pulses, and the treatment pulses include a plurality of electronic pulses;

[0031] The ablation range after several treatment cycles is determined by real-time ultrasound imaging, the ablation range is compared with the ablation range preset in the preoperative planning, and the treatment effect of the pulsed electric field is determined based on the comparison result.

[0032] Optionally, the protected tissue in the needle advancement and withdrawal monitoring unit includes target tissues and organs manually or automatically outlined based on preoperative images.

[0033] Optionally, the device further comprises:

[0034] A simulation calculation unit is used to perform pulse electric field simulation and determine a simulated pulse electric field ablation area before performing pulse electric field ablation treatment;

[0035] The simulated pulse electric field ablation area is compared with the ablation range preset in the preoperative planning, and when the repetition rate of the preset ablation range and the simulated pulse electric field ablation area exceeds a preset value, the step of performing pulse electric field ablation treatment is executed.

[0036] Optionally, the simulation calculation unit performs pulse electric field simulation to determine the simulated pulse electric field ablation area, including:

[0037] Through the equation ,and Determine the electric field strength E, where is the conductivity, U is the potential, the positive electrode boundary potential of U is a preset value U0, and the negative electrode boundary potential of U is grounded 0V;

[0038] Will The area is determined as the simulated pulse electric field ablation area, where are radial, axial and tangential coordinates respectively, is the time parameter, is the ablation threshold field strength.

[0039] In the embodiments provided in the present application, firstly, important tissues and organs are marked on the preoperative images. When performing the needle advancement and withdrawal operation, the path and relative position of the electrode needle can be monitored in real time through the preoperative images and the ultrasound images of the area around the ablation electrode needle, and an early warning can be issued when the distance to important tissues is too close, which realizes the real-time monitoring of the needle advancement and withdrawal operation process. During the pulse treatment process, the ablation range can be displayed in real time through ultrasound images, and then it can be judged whether the expectation is achieved based on the ablation range, and whether it is necessary to adjust the treatment parameters or end the ablation treatment, which realizes the real-time monitoring of the electric field ablation process. Through this application, the precision and accuracy of needle advancement and withdrawal and electric field ablation during the ablation treatment operation can be improved, thereby improving the safety of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 A system module diagram provided for an embodiment of the present application;

[0041] Figure 2 A timing diagram of a treatment cycle provided in an embodiment of the present application;

[0042] Figure 3 A schematic diagram of the structure of a single-needle multipolar electrode needle provided in an embodiment of the present application;

[0043] Figure 4 A structural diagram of a device provided in an embodiment of the present application;

[0044] Figure 5 A schematic diagram of the internal structure of a computer device provided in an embodiment of the present application. DETAILED DESCRIPTION

[0045] Exemplary embodiments will be described in detail herein, examples of which are shown in the accompanying drawings. When the following description refers to the drawings, the same numbers in different drawings represent the same or similar elements unless otherwise indicated. The implementations described in the following exemplary embodiments do not represent all implementations consistent with the present application. Instead, they are merely examples of devices and methods consistent with some aspects of the present application as detailed in the appended claims.

[0046] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms of "a", "said" and "the" used in this application and the appended claims are also intended to include plural forms unless the context clearly indicates other meanings. It should also be understood that the term "and / or" used herein refers to and includes any or all possible combinations of one or more associated listed items.

[0047] It should be understood that although the terms first, second, third, etc. may be used in the present application to describe various information, these information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of the present application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Depending on the context, the word "if" as used herein may be interpreted as "at the time of" or "when" or "in response to determining".

[0048] The present application provides a real-time monitoring system for ablation therapy based on a single-needle multipolar electrode needle to improve the safety of ablation therapy surgery.

[0049] The technical solution of the present application is described in detail with specific embodiments below. These specific embodiments can be combined with each other, and the same or similar concepts or processes may not be described in detail in some embodiments.

[0050] like Figure 1 As shown, this is a module diagram of a real-time monitoring system for ablation treatment based on a single-needle multi-polar electrode needle provided by the present application. The system includes a treatment parameter control module, a pulse electric field generation module, an ultrasound monitoring module, a data storage and processing module, a multi-mode image data fusion module, a single-needle multi-polar visualization electrode needle module, and a needle advancement and retraction module.

[0051] The functions of each module are described below:

[0052] 1. Treatment parameter control module: This module is used to obtain the treatment parameters of the preoperative ablation plan, adjust the treatment parameters according to the treatment effect of the pulsed electric field ablation treatment determined by the ultrasound monitoring module, and send the treatment parameters to the pulsed electric field generation module.

[0053] In this module, the doctor determines the patient's preoperative ablation plan based on the patient's preoperative information, such as preoperative MRI or CT images, preoperative diagnosis, etc. The plan records the patient's treatment parameters such as pulse electric field strength, pulse frequency, pulse width, etc. When the patient is given the first ablation treatment, pulse electric field ablation treatment is performed using the above treatment parameters. After the first ablation treatment, the treatment parameters such as pulse electric field strength, pulse frequency, and pulse width need to be adjusted based on the patient's treatment effect. For example, when the ablation area of ​​the first ablation treatment reaches or exceeds the expected value, it is necessary to reduce the treatment parameters such as pulse electric field strength, pulse frequency, and pulse width; if it does not reach the expected value, it is necessary to increase the above treatment parameters.

[0054] In another embodiment, monitoring the therapeutic effect of pulsed electric field ablation therapy includes:

[0055] A treatment cycle is set according to the preoperative ablation plan, wherein the treatment cycle includes a group of treatment pulses and a group of ultrasound imaging pulses, wherein the treatment pulses include a plurality of electronic pulses, such as Figure 2 shown.

[0056] The ablation range after the treatment cycle is determined by real-time ultrasound imaging, the ablation range is compared with the ablation range preset in the preoperative planning, and the treatment effect of the pulsed electric field is determined based on the comparison result.

[0057] In this embodiment, after a group of treatment pulses are performed in each treatment cycle, another group of ultrasound imaging pulses will be performed to generate a real-time ultrasound image of the area around the ablation electrode needle. The actual ablation range of this treatment can be determined through the real-time ultrasound image. The actual ablation range is compared with the estimated ablation range generated by a treatment cycle preset in the preoperative plan to determine the treatment effect. For example, based on the coverage rate of the actual ablation range and the estimated ablation range, when the coverage rate is greater than the first threshold, such as 95%, it is determined that the treatment effect of this ablation treatment is satisfactory. When the coverage rate is less than the second threshold, such as 60%, it is determined that the treatment effect of this ablation treatment is poor, and so on. Then adjust the treatment parameters or stop the electric field ablation treatment according to different treatment effects. Thereby, real-time adjustment during the operation is achieved, which improves the precision and accuracy of electric field ablation.

[0058] 2. Pulsed electric field generation module: This module is used to perform pulsed electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module.

[0059] In this module, the treatment parameters include the treatment parameters determined in the preoperative ablation plan, and also include the treatment parameters that are readjusted during the operation according to the treatment effect.

[0060] In another embodiment, before performing pulse electric field ablation treatment on the target patient according to the treatment parameters, a pulse electric field simulation may be performed to determine a simulated pulse electric field ablation area;

[0061] The simulation method is as follows:

[0062] pass ,and Determine the electric field strength E of the area to be treated, where is the conductivity, which can be expressed as Indicates that conductivity is related to temperature and external ablation electric field, and the specific value can be measured in real time by sensors. U is the electric potential, and the positive electrode boundary potential of U is the preset value U0. U0 can be set to different values ​​according to different ablation devices, and the negative electrode boundary potential is grounded 0V.

[0063] The main parameters to be solved in the above equations, the electric field intensity E and the electric potential U, can be solved by COMSOL finite element software or other similar software.

[0064] After the electric field strength E is determined, the area where the electric field strength is not less than the preset ablation threshold field strength can be determined as the estimated pulse electric field ablation area. The area was determined as the simulated pulse electric field ablation area. is the preset ablation threshold field strength, is the time parameter, It is the three-dimensional spatial parameter of the entire area to be treated.

[0065] After the simulated pulse electric field ablation area is determined, it is compared with the preset ablation range in the preoperative treatment plan. If the repetition rate of the two is less than the preset value, it means that the effect of ablation treatment using the above treatment parameters does not meet expectations and needs to be adjusted and re-estimated and compared. When the repetition rate exceeds the preset value, the step of performing pulse electric field ablation treatment on the target patient according to the treatment parameters is executed.

[0066] In this module, the treatment parameters are simulated before ablation therapy, so that the best treatment parameters can be determined before ablation therapy, thereby improving the accuracy and safety of ablation surgery.

[0067] 3. Ultrasonic monitoring module: This module is used to perform ultrasonic imaging of the surrounding area of ​​the ablation electrode needle when the ablation electrode needle is performing needle advancement and withdrawal operations and performing pulsed electric field ablation treatment, thereby obtaining real-time ultrasonic images during the operation and sending them to the multi-mode image data fusion module.

[0068] In this module, ultrasound imaging of the surrounding area of ​​the ablation electrode needle during the needle insertion and withdrawal operation can visualize the needle insertion path, thereby accurately locating the position and depth of the ablation electrode needle during the needle insertion and withdrawal operation. When performing pulsed electric field ablation treatment, ultrasound imaging of the surrounding area of ​​the ablation electrode needle can maximize the ablation range by determining in real time whether the treatment effect and ablation effect meet expectations, and can reduce damage to surrounding normal tissues.

[0069] 4. Multimodal image data fusion module: This module is used to fuse preoperative images, such as preoperative MRI or CT images, with intraoperative real-time ultrasound images to generate fused images.

[0070] In this module, patients need to undergo magnetic resonance imaging (MRI) or CT imaging before surgery to obtain detailed imaging data of the target tissue, which is then reconstructed in three dimensions to form a three-dimensional visualization model. After the ultrasound image is obtained during the operation, it is fused with the ultrasound image based on the three-dimensional visualization model to ensure accurate spatial matching of the two imaging data.

[0071] 5. Single-needle multipolar visualization electrode needle module. This module has an ablation electrode needle, which includes an electrode head, an ultrasound probe and several electrode rings, such as Figure 3 It is used to discharge through the electrode head and the electrode ring to form a high-voltage pulse electric field for ablation treatment.

[0072] This module integrates the ultrasound probe into the ablation electrode needle, making it unnecessary to use a handheld ultrasound probe when performing needle insertion and withdrawal operations, allowing you to focus on needle placement and puncture.

[0073] 6. Needle advancement and withdrawal module. This module is used to determine the path of the ablation electrode needle advancement and withdrawal according to the fusion image, and to issue an alarm message when it is determined that the distance between the ablation electrode needle and the predetermined protective tissue reaches a threshold during the needle advancement and withdrawal operation.

[0074] So far, completed Figure 1 Description of the system modules shown.

[0075] In the above embodiment, important tissues and organs are first marked on the preoperative image. When performing the needle advancement and withdrawal operation, the electrode needle path and relative position can be monitored in real time through the preoperative image and the ultrasonic image of the area around the ablation electrode needle, and an early warning is issued when it is too close to important tissues, which realizes real-time monitoring of the needle advancement and withdrawal operation process. During the pulse treatment process, the ablation range can be displayed in real time through ultrasonic images, and then it is determined whether the expectation is achieved based on the ablation range, and whether it is necessary to adjust the treatment parameters or end the ablation treatment, which realizes real-time monitoring of the electric field ablation process. Through this application, the precision and accuracy of needle advancement and withdrawal and electric field ablation during the ablation treatment operation can be improved, thereby improving the safety of the operation.

[0076] like Figure 4 As shown, the present application also provides a real-time monitoring device for ablation therapy based on a single-needle multipolar electrode needle, the device comprising:

[0077] The ultrasound imaging unit 401 is used to perform ultrasound imaging of the surrounding area of ​​the ablation electrode needle when performing the needle advancement and withdrawal operation and ablation treatment, and generate real-time ultrasound images during the operation;

[0078] An image fusion unit 402 is used to fuse the preoperative image with the intraoperative real-time ultrasound image to generate a fused image;

[0079] The needle advancement and withdrawal monitoring unit 403 is used to locate the position and depth of the ablation electrode needle in real time according to the fused image when performing the needle advancement and withdrawal operation, and to issue an alarm message when determining that the distance between the ablation electrode needle and the predetermined protective tissue reaches a threshold;

[0080] The treatment effect determination unit 404 is used to monitor the treatment effect of the pulsed electric field according to the fused image during the pulsed electric field ablation treatment, and determine to adjust the treatment parameters or end the pulsed electric field ablation treatment according to the treatment effect.

[0081] In another embodiment, monitoring the therapeutic effect of pulsed electric field ablation therapy in the therapeutic effect determination unit includes:

[0082] Setting a plurality of treatment cycles according to the preoperative ablation scheme, wherein the treatment cycle includes a group of treatment pulses and a group of ultrasound imaging pulses, and the group of treatment pulses includes a plurality of pulses;

[0083] The ablation range after several treatment cycles is determined by real-time ultrasound imaging, the ablation range is compared with the ablation range preset in the preoperative planning, and the treatment effect of the pulsed electric field is determined based on the comparison result.

[0084] In another embodiment, the protected tissue in the needle advancement and withdrawal monitoring unit includes target tissues and organs manually or automatically outlined based on preoperative images.

[0085] In another embodiment, the apparatus further comprises:

[0086] The simulation calculation unit 405 is used to perform pulse electric field simulation before performing pulse electric field ablation treatment to determine a simulated pulse electric field ablation area;

[0087] The simulated pulse electric field ablation area is compared with the ablation range preset in the preoperative planning, and when the repetition rate of the preset ablation range and the simulated pulse electric field ablation area exceeds a preset value, the step of performing pulse electric field ablation treatment is executed.

[0088] In another embodiment, the simulation calculation unit performs pulse electric field simulation to determine the simulated pulse electric field ablation area, including:

[0089] Through the equation ,and Determine the electric field strength E, where is the conductivity, U is the potential, the positive electrode boundary potential of U is a preset value U0, and the negative electrode boundary potential of U is grounded 0V;

[0090] Will The area is determined as the simulated pulse electric field ablation area, where are radial, axial and tangential coordinates respectively, is the time parameter, is the ablation threshold field strength.

[0091] The above-mentioned embodiment of the present invention provides a real-time monitoring system for ablation therapy based on a single-needle multi-polar electrode needle, and based on the system provides a real-time monitoring device for ablation therapy based on a single-needle multi-polar electrode needle. Through the above-mentioned system and device, the precision and accuracy of the needle advancement and withdrawal operation of the ablation therapy surgery and the ablation therapy can be improved, thereby improving the safety of the ablation therapy surgery.

[0092] This embodiment also discloses a computer device, such as Figure 5As shown, the computer device includes a processor and a memory, wherein the memory stores at least one instruction, and the at least one instruction is loaded and executed by the processor to implement the functions of any of the above-mentioned real-time monitoring systems for ablation therapy based on a single-needle multi-polar electrode needle.

[0093] In addition, in the above-mentioned example implementation of the real-time monitoring device for ablation therapy based on a single-needle multi-polar electrode needle, the logical division of each program module is only an example. In actual application, the above-mentioned functions can be assigned to different program modules as needed, for example, for the convenience of corresponding hardware configuration requirements or software implementation. That is, the internal structure of the real-time monitoring device for ablation therapy based on a single-needle multi-polar electrode needle is divided into different program modules to complete all or part of the functions described above.

[0094] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

Claims

1. A real-time monitoring system for ablation therapy based on a single-needle multipolar electrode needle, characterized in that: The system includes a treatment parameter control module, a pulse electric field generation module, an ultrasound monitoring module, a multi-mode image data fusion module, a single needle multi-polar visualization electrode needle module, and a needle advancement and withdrawal module; The treatment parameter control module is used to obtain the treatment parameters of the preoperative ablation plan, adjust the treatment parameters according to the treatment effect of the pulsed electric field ablation treatment determined by the ultrasound monitoring module, and send the treatment parameters to the pulsed electric field generation module; The pulse electric field generating module is used to perform pulse electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module; The ultrasound monitoring module is used to perform ultrasound imaging of the surrounding area of ​​the ablation electrode needle when the ablation electrode needle performs needle advancement and withdrawal operations and performs pulsed electric field ablation treatment, thereby obtaining real-time ultrasound images during the operation and sending them to the multi-mode image data fusion module; Monitor the insertion path of the ablation electrode needle according to the fusion image generated by the multi-mode image data fusion module, accurately locate the position and depth of the ablation electrode needle, and set a treatment cycle according to the preoperative ablation plan, wherein the treatment cycle includes a group of treatment pulses and a group of ultrasound imaging pulses, and the treatment pulses include a number of electronic pulses; Determine the ablation range after the treatment cycle through real-time ultrasound imaging, compare the ablation range with the ablation range preset in the preoperative planning, determine the treatment effect of the pulsed electric field according to the comparison result and send it to the treatment parameter control module; The multi-modal image data fusion module is used to fuse the preoperative image with the intraoperative real-time ultrasound image to generate a fused image; The single-needle multipolar visualization electrode needle module includes an ablation electrode needle, which includes an electrode head, an ultrasound probe and a plurality of electrode rings; it is used to discharge through the electrode head and the electrode ring to form a high-voltage pulse electric field required for ablation treatment; The needle advancing and withdrawing module is used to determine the advancing and withdrawing path of the ablation electrode needle according to the fused image, and to issue an alarm message when it is determined that the distance between the ablation electrode needle and a predetermined protective tissue reaches a threshold during the needle advancing and withdrawing operation.

2. The system according to claim 1, characterized in that The protected tissues include target tissues and organs manually or automatically outlined based on preoperative images.

3. The system according to claim 1, characterized in that Before the pulse electric field generating module performs pulse electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module, the method further includes: Conduct pulse electric field simulation to determine the simulated pulse electric field ablation area; The simulated pulse electric field ablation area is compared with the ablation range preset in the preoperative treatment plan. When the repetition rate of the preset ablation range and the simulated pulse electric field ablation area exceeds the preset value, the step of performing pulse electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module is executed.

4. The system according to claim 3, characterized in that The performing of pulse electric field simulation to determine the simulated pulse electric field ablation area includes: Through the equation and Determine the electric field strength E, where σ is conductivity, U is potential, the positive electrode boundary potential of U is a preset value U0, and the negative electrode boundary potential of U is grounded 0V; Let E(r,z,θ,τ)≥E threshold The area of ​​(τ) is determined as the simulated pulse electric field ablation area, where r, z, θ are radial, axial and tangential coordinates respectively, τ is the time parameter, and E threshold (τ) is the ablation threshold field strength.

5. A real-time monitoring device for ablation therapy based on a single-needle multipolar electrode needle, characterized in that: The device comprises: An ultrasound imaging unit is used to perform ultrasound imaging of the surrounding area of ​​the ablation electrode needle during the needle advancement and withdrawal operation and ablation treatment, and to generate real-time ultrasound images during the operation; An image fusion unit, used to fuse preoperative images with real-time intraoperative ultrasound images to generate a fused image; A needle advancement and withdrawal monitoring unit is used to locate the position and depth of the ablation electrode needle in real time according to the fused image when performing the needle advancement and withdrawal operation, and to issue an alarm message when determining that the distance between the ablation electrode needle and a predetermined protective tissue reaches a threshold; A treatment effect determination unit, used for setting a treatment cycle according to a preoperative ablation plan when performing pulsed electric field ablation treatment, wherein the treatment cycle includes a group of treatment pulses and a group of ultrasound imaging pulses, and the treatment pulses include a plurality of electronic pulses; The ablation range after the treatment cycle is determined by real-time ultrasound imaging, and the ablation range is compared with the ablation range preset in the preoperative planning. The therapeutic effect of the pulsed electric field is determined based on the comparison result, and the treatment parameters are adjusted or the pulsed electric field ablation treatment is terminated based on the treatment effect.

6. The device according to claim 5, characterized in that The protected tissues in the needle advancement and withdrawal monitoring unit include target tissues and organs manually or automatically outlined based on preoperative images.

7. The device according to claim 5, characterized in that The device also includes: A simulation calculation unit is used to perform pulse electric field simulation and determine a simulated pulse electric field ablation area before performing pulse electric field ablation treatment; The simulated pulse electric field ablation area is compared with the ablation range preset in the preoperative planning, and when the repetition rate of the preset ablation range and the simulated pulse electric field ablation area exceeds a preset value, the step of performing pulse electric field ablation treatment is executed.

8. The device according to claim 7, characterized in that The simulation calculation unit performs pulse electric field simulation to determine the simulated pulse electric field ablation area, including: Through the equation and Determine the electric field strength E, where σ is conductivity, U is potential, the positive electrode boundary potential of U is a preset value U0, and the negative electrode boundary potential of U is grounded 0V; Let E(r,z,θ,τ)≥E threshold The area of ​​(τ) is determined as the simulated pulse electric field ablation area, where r, z, θ are radial, axial and tangential coordinates respectively, τ is the time parameter, and E threshold (τ) is the ablation threshold field strength.

Images