Electric pulse ablation system and device combined with endoscopic ultrasound real-time guidance

Abstract

The invention is suitable for the technical field of medical instruments and minimally invasive interventional therapy, and provides an electric pulse ablation system and device combined with endoscopic ultrasound real-time guidance. In the embodiment of the invention, for a lesion tissue area of the adrenal adenoma, the system firstly transmits ultrasonic waves through an endoscope ultrasonic probe, and generates a corresponding ultrasonic image after receiving reflection echoes of the lesion tissue; meanwhile, synchronously emitting low-intensity alternating current through the electrode needle to measure the conductivity of the tissue so as to obtain a conductivity distribution diagram of the lesion tissue; the ultrasonic image and the conductivity distribution diagram are fused to construct a three-dimensional adenoma model, the ablation path of the lesion tissue is simulated and predicted through the model, and finally pulse ablation is conducted according to the ablation path. Therefore, the accuracy and safety of electric pulse ablation during APA treatment are improved.

Description

Technical Field

[0001] This application relates to the technical fields of medical devices and minimally invasive interventional therapy, and in particular, to an electro-pulse ablation system and device combined with real-time endoscopic ultrasound guidance. Background Art

[0002] Primary aldosteronism (APA), as a common cause of secondary hypertension, the research on its treatment methods has always been an important topic in the medical field. The traditional treatment methods for APA mainly include laparoscopic or open surgery to remove adrenal adenomas. This surgical method can effectively treat APA to a certain extent, but there are also many drawbacks. First of all, the surgical trauma is relatively large, and the requirements for the patient's physical function are relatively high, which makes it difficult for some patients with poor physical conditions to tolerate. Secondly, the recovery period is relatively long, and the patient needs a long time to return to normal life and work, which not only brings physical pain to the patient, but also increases the patient's economic burden. Moreover, the risk of postoperative complications is relatively high, such as infection, bleeding, etc. These complications may affect the patient's prognosis and even endanger life.

[0003] In addition, some patients are unable to receive surgical treatment due to physical limitations and can only rely on antihypertensive drugs to control hypertension for a long time. However, the long-term use of antihypertensive drugs will not only bring economic burden to the patient, but also may cause adverse drug reactions, such as electrolyte disorders, liver and kidney function damage, etc., thus affecting the patient's quality of life.

[0004] With the continuous development of medical technology, radiofrequency ablation technology has gradually been applied to tumor treatment. Radiofrequency ablation technology coagulates and necroses tumor tissues through thermal effects to achieve the treatment purpose. However, there are some problems when this technology is applied to the treatment of APA. On the one hand, its thermal effect may damage surrounding healthy tissues, leading to unnecessary complications. On the other hand, for microadenomas, the radiofrequency ablation technology has insufficient precise positioning and selective ablation capabilities, making it difficult to ensure the treatment effect.

[0005] Electropulse ablation (irreversible electroporation), as an emerging non-thermal ablation technology, has received extensive attention in recent years. This technology destroys the cell membrane structure through high-voltage short-pulse electric fields, making the cells lose their activity, thereby achieving the treatment purpose. Compared with traditional thermal ablation technologies, electropulse ablation has the advantage of high tissue selectivity, can preserve blood vessels and nerve structures while destroying diseased tissues, and reduce the occurrence of complications. In addition, electropulse ablation also has the advantages of simple operation and short treatment time, providing new ideas and methods for the treatment of APA.

[0006] However, the current application of electro-pulse ablation in APA treatment has not been systematically studied, and its treatment effect and safety still need to be further verified. In addition, due to the complex anatomical structure of the adrenal gland, there is a lack of a real-time imaging guidance scheme adapted to the anatomical characteristics of the adrenal gland, which has limited the application of electro-pulse ablation in APA treatment. Summary of the Invention

[0007] In view of this, the present application provides an electro-pulse ablation system and device combined with real-time endoscopic ultrasound guidance to improve the accuracy and safety of electro-pulse ablation during APA treatment.

[0008] The first aspect of the present application provides an electro-pulse ablation system combined with real-time endoscopic ultrasound guidance, the system includes an ultrasonic real-time imaging module, a real-time navigation control module, and a pulse ablation module; The ultrasonic real-time imaging module is used to obtain real-time ultrasonic-conductivity dual-modal images of the target area through an endoscopic ultrasound probe and an electrode needle. The target area includes the lesion tissue and the surrounding area of the lesion tissue. The ultrasonic-conductivity dual-modal images include ultrasonic images and conductivity distribution maps; The real-time navigation control module is used to construct a three-dimensional adenoma model capable of predicting the electric field intensity distribution through the ultrasonic-conductivity dual-modal images, predict the ablation area of the target area through the three-dimensional adenoma model, and plan the ablation path according to the ablation area and the ultrasonic-conductivity dual-modal images; The pulse ablation module is used to generate pulse energy and emit the pulse energy to the lesion tissue for pulse ablation according to the ablation path.

[0009] Optionally, the endoscopic ultrasound probe includes an ultrasonic transducer, a mechanical rotation drive module, and an optical imaging module. Among them, the mechanical rotation drive module is used to drive the ultrasonic transducer to perform 360-degree rotation scanning, and the optical imaging module is used to provide real-time optical images; The obtaining of the real-time ultrasonic-conductivity dual-modal images of the target area through the endoscopic ultrasound probe and the electrode needle includes: Emitting ultrasonic waves through the ultrasonic transducer, receiving the reflected echoes of the target area, and processing the reflected echoes to obtain ultrasonic images; Emitting low-intensity alternating current through the electrode needle to measure the conductivity of the target area, and determining the conductivity distribution map through the conductivity.

[0010] Optionally, the electrode needle is a coaxial multi-pole electrode needle, which includes an ablation needle head, a retractable protective tube, a handle and a handle tail wire. The ablation needle head includes a needle head discharge electrode, a spacer insulating tube, and an annular electrode. A micro electromagnetic sensor is placed in the inner discharge hole of the needle head discharge electrode. The needle head discharge electrode and the annular electrode are connected to the handle tail wire through wires.

[0011] Optionally, spiral grooves are etched on the surface of the electrode needle, and a titanium nitride coating is applied on the surfaces of the needle head discharge electrode and the annular electrode.

[0012] Optionally, the system further includes a safety warning module; The safety warning module is used to trigger an audible and visual alarm when a sudden change in puncture resistance is detected by the force feedback sensor; And during the pulsed ablation of the diseased tissue by the pulsed ablation module, the electric field strength is detected. When the electric field strength reaches the threshold, the pulsed output of the pulsed ablation module is turned off.

[0013] In a second aspect of the present application, an electric pulse ablation device combined with real-time endoscopic ultrasound guidance is provided. The device includes: An ultrasound real-time imaging unit for obtaining real-time ultrasound-conductivity dual-modal images of a target area through an endoscopic ultrasound probe and an electrode needle. The target area includes a diseased tissue and the surrounding area of the diseased tissue. The ultrasound-conductivity dual-modal images include ultrasound images and conductivity distribution maps; A real-time navigation control unit for constructing a three-dimensional adenoma model capable of predicting the electric field strength distribution through the ultrasound-conductivity dual-modal images, predicting the ablation area of the target area through the three-dimensional adenoma model, and planning an ablation path according to the ablation area and the ultrasound-conductivity dual-modal images; A pulsed ablation unit for generating pulsed energy and emitting the pulsed energy to the diseased tissue for pulsed ablation according to the ablation path.

[0014] Optionally, the endoscopic ultrasound probe includes an ultrasound transducer, a mechanical rotation drive module, and an optical imaging module. Among them, the mechanical rotation drive module is used to drive the ultrasound transducer to perform a 360-degree rotational scan, and the optical imaging module is used to provide real-time optical images; The obtaining of the real-time ultrasound-conductivity dual-modal images of the target area through the endoscopic ultrasound probe and the electrode needle in the ultrasound real-time imaging unit includes: Emitting ultrasonic waves through the ultrasound transducer, receiving the reflected echoes of the target area, and processing the reflected echoes to obtain ultrasound images; Measure the conductivity of the target area by emitting low-intensity alternating current through the electrode needle, and determine the conductivity distribution map based on the conductivity.

[0015] Optionally, the electrode needle in the ultrasonic real-time imaging unit is a coaxial multi-pole electrode needle, which includes an ablation needle head, a retractable protective tube, a handle, and a handle tail wire. The ablation needle head includes a needle head discharge electrode, a spaced insulating tube, and an annular electrode. A micro electromagnetic sensor is placed in the inner discharge hole of the needle head discharge electrode. The needle head discharge electrode and the annular electrode are connected to the handle tail wire through wires.

[0016] Optionally, spiral grooves are etched on the surface of the electrode needle, and titanium nitride coatings are applied on the surfaces of the needle head discharge electrode and the annular electrode.

[0017] Optionally, the device further includes: A safety warning module: used to trigger an audible and visual alarm when a sudden change in puncture resistance is detected by a force feedback sensor, and to detect the electric field intensity when the pulse ablation module performs pulse ablation on the diseased tissue. When the electric field intensity reaches the threshold, the pulse output of the pulse ablation module is turned off.

[0018] In the embodiment provided by the present application, for the diseased tissue area of an adrenal adenoma, the system first emits ultrasonic waves through an endoscopic ultrasound probe, generates a corresponding ultrasonic image after receiving the reflected echo of the diseased tissue; at the same time, synchronously measures the tissue conductivity by emitting low-intensity alternating current through the electrode needle to obtain the conductivity distribution map of the diseased tissue; then fuses the ultrasonic image and the conductivity distribution map to construct a three-dimensional adenoma model, simulates and predicts the ablation path of the diseased tissue through this model, and finally performs pulse ablation according to this ablation path. This improves the accuracy and safety of electric pulse ablation during APA treatment. Description of the Drawings

[0019] Figure 1 It is a system module diagram provided by an embodiment of the present application; Figure 2 It is a structure diagram of an ablation needle provided by an embodiment of the present application; Figure 3 It is a structure diagram of an ablation needle provided by an embodiment of the present application; Figure 4 It is a structure diagram of the device provided by an embodiment of the present application; Figure 5 It is a schematic internal structure diagram of a computer device provided by an embodiment of the present application. Detailed Embodiments

[0020] Exemplary embodiments will be described in detail herein, and examples thereof are shown in the accompanying drawings. When the following description refers to the accompanying drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present application. On the contrary, they are merely examples of devices and methods consistent with some aspects of the present application as detailed in the appended claims.

[0021] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit the present application. The singular forms "a", "the", and "said" used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0022] It should be understood that although the terms first, second, third, etc. may be used in this application to describe various information, such 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 "when" or "while" or "in response to determining".

[0023] The present application provides an electro-pulse ablation system combined with real-time endoscopic ultrasound guidance to improve the accuracy and safety of electro-pulse ablation during APA treatment.

[0024] The technical solutions of the present application will be described in detail below with specific embodiments. These several specific embodiments below can be combined with each other, and the same or similar concepts or processes may not be repeated in some embodiments.

[0025] As Figure 1 shown, it is a module diagram of an electro-pulse ablation system combined with real-time endoscopic ultrasound guidance provided by the present application. The implementation process and functional effects of each module will be described below.

[0026] 1. The real-time ultrasound imaging module. This module is used to obtain real-time ultrasound-conductivity dual-modal images of the target area through an endoscopic ultrasound probe and an electrode needle.

[0027] In this module, the ultrasonic-conductivity dual-modal real-time image includes an ultrasonic image and a conductivity distribution map. The endoscopic ultrasonic probe is equipped with a high-frequency linear array transducer with an integrated frequency range of 12 - 20 MHz, which can obtain the fine structure of the adrenal adenoma and surrounding blood vessels in real time. The doctor inserts the endoscopic ultrasonic probe through the natural body cavity. The ultrasonic image obtained in real time by this high-frequency linear array transducer can display the target area, such as the anatomical structure information of the adrenal adenoma, including the size, shape, location of the adenoma and its relationship with the surrounding tissues. By measuring the conductivity characteristics of the tissue, a conductivity distribution map can be obtained, which reflects the electrical property differences of different tissues, such as the conductivity difference between adenoma tissue and normal tissue.

[0028] In another embodiment, the above endoscopic ultrasonic probe includes an ultrasonic transducer, a mechanical rotation drive module, and an optical imaging module. Among them, the mechanical rotation drive module is used to drive the ultrasonic transducer to perform a 360-degree rotational scan, and the optical imaging module is used to provide real-time optical images; The method of obtaining the ultrasonic-conductivity dual-modal real-time image of the target area by using the endoscopic ultrasonic probe and the electrode needle includes: Emitting ultrasonic waves through the ultrasonic transducer, receiving the reflected echoes of the target area, and processing the reflected echoes to obtain an ultrasonic image; Emitting low-intensity alternating current through the electrode needle to measure the conductivity of the target area, and determining the conductivity distribution map based on the conductivity.

[0029] In this embodiment, the mechanical rotation drive module drives the ultrasonic transducer to perform a 360-degree rotational scan, enabling the ultrasonic probe to obtain ultrasonic images of the surrounding tissues in all directions. Through the rotational scan, the mechanical drive module expands the coverage of ultrasonic imaging, ensuring that the lesion area and its surrounding structures can be completely imaged, providing more comprehensive diagnostic information for doctors.

[0030] The optical imaging module can provide high-resolution optical images in real time, intuitively showing the surface morphology and characteristics of the lesion area. Combined with the ultrasonic image, the optical image provides doctors with richer visual information, helping to more accurately judge the nature of the lesion. The optical imaging module can help doctors observe the situation of the operation area in real time, especially when inserting instruments or performing treatments, to avoid accidentally injuring blood vessels or other important structures and improve the safety of the operation.

[0031] In another embodiment, the above electrode needle is a coaxial multi-pole electrode needle, as Figure 2 shown. The main structure of this coaxial multi-pole electrode needle is the ablation needle tip 1, the retractable protective tube 2, the handle 3, and the tail wire 4. The ablation needle tip is as Figure 3As shown, it consists of a needle-shaped discharge electrode 1-1, a spaced insulating tube 1-2, an annular electrode 1-3, and a tube body main body 1-4. A micro electromagnetic sensor 1-5 is placed in the inner discharge hole of the needle-shaped discharge electrode 1-1. Both the needle-shaped discharge electrode 1-1 and the annular electrode 1-2 are connected to the handle tail wire 4 by wires. The diameter of the electrode needle can be φ0.8 - φ1.8mm, with 1 to 4 annular electrodes arranged coaxially inside, and the spacing can be adjusted within the range of 1 to 5mm, so as to adapt to adenomas of different sizes.

[0032] In this embodiment, a micro electromagnetic sensor is integrated at the tip of the needle, which can provide real-time feedback on the position (accuracy ±0.5mm) and angle. And the tip of the needle can be designed to be blunt to reduce the risk of blood vessel perforation.

[0033] In another embodiment, spiral grooves are etched on the surface of the electrode needle, and titanium nitride coatings are applied on the surfaces of the needle-shaped discharge electrode and the annular electrode.

[0034] Through the design of spiral grooves, a regular geometric structure is formed. This structure can effectively reflect ultrasonic waves and generate stronger echo signals. The reflected ultrasonic wave signals form a sharp contrast with the signals of surrounding tissues, significantly improving the contrast of the electrode needle in ultrasonic images and making it easier to be identified.

[0035] Applying titanium nitride coatings on the surfaces of the needle-shaped discharge electrode and the annular electrode can ensure that the high conductivity and low interface impedance of the titanium nitride coatings can efficiently transfer electrical energy to the target tissue and improve the ablation effect.

[0036] 2. Real-time navigation control module. This module is used to construct a three-dimensional adenoma model capable of predicting the electric field intensity distribution through the ultrasonic-conductivity dual-modal real-time imaging, predict the ablation area of the target area through the three-dimensional adenoma model, and plan the ablation path according to the ablation area and the ultrasonic-conductivity dual-modal real-time imaging.

[0037] In this embodiment, the construction process of the three-dimensional adenoma model is as follows: 1) Preprocess the data, perform spatial registration on the ultrasonic image and conductivity data to ensure that they are aligned in the same coordinate system. Then filter the ultrasonic image and conductivity data to remove noise and improve the data quality.

[0038] 2) Use the ultrasonic image data to generate a three-dimensional structural model of the adenoma through a three-dimensional reconstruction algorithm. Based on the conductivity data, reconstruct the three-dimensional conductivity distribution model of the adenoma and its surrounding tissues. Then fuse the three-dimensional structural model reconstructed from the ultrasonic image with the conductivity distribution model to form a three-dimensional adenoma model containing structural information and electrical characteristics.

[0039] When performing conductivity field modeling, the mapping relationship between the grayscale value I(x) of the ultrasonic image and the conductivity σ(x) is , where λ ∈ [0, 1] is the fusion weight, is the image gradient feature, f ML () is a machine learning model, and σ meas (x) is the measured conductivity. Then, based on the Poisson equation the electric potential field is constructed , where σ(x) is the conductivity of the medium, which reflects the current conduction ability of the medium. In biological tissues, the conductivity of different tissues varies significantly. Jsrc(x) is the current source density, indicating the externally injected current distribution. Then, the electric potential gradient is calculated through the formula to determine the electric field strength E(x). The electric field strength E(x) is the negative gradient of the electric potential field , indicating the rate of change of the electric potential in space. Through the above calculation process, the prediction of the electric field strength distribution can be realized through the three-dimensional adenoma model.

[0040] After determining the electric field strength E(x), the ablation area is predicted through the formula , where H() is the step function, and E th is determined by the tissue type. For example, 300 V / m is often taken for liver tumors. Ω is the calculation domain of the ablation area, which is determined based on the discretization of the conductivity by the Galerkin method.

[0041] After determining the ablation area, the ablation path is further determined. The starting point of the path can be determined according to the access point of the treatment device (such as the entry position of the puncture needle or electrode). The end point or coverage area of the path is determined according to the position and range of the ablation target area. Then, according to the conductivity distribution, the area with higher conductivity is selected as the ablation path to improve the ablation efficiency. The ablation path can also be determined by the method of the cost function . In this formula, P is the set of paths, s is each path point on the path, κrisk(s) is the risk term, indicating the risk value of each point s on the path, which is determined by the distance to the surrounding dangerous structures. The closer the distance, the higher the risk. Curv(P) is the curvature penalty term, and the calculation formula is 2 . Through this method, the ablation path can be kept away from high-risk areas and the intraoperative injury risk can be reduced.

[0042] 3. Pulse ablation module. It is used to generate pulse energy and emit the pulse energy to the diseased tissue according to the ablation path for pulse ablation.

[0043] This module includes a pulse energy generation device and an energy transmission device. The pulse energy generation device can be composed of a high-voltage power supply, an energy storage element (such as a capacitor), and a pulse generator, and is capable of generating high-intensity electrical pulses. Parameters such as the voltage, frequency, and pulse width of the pulses can be adjusted according to the treatment requirements to ensure that the energy can effectively ablate the diseased tissue without causing excessive damage to the surrounding healthy tissue. The energy transmission device is the above-mentioned electrode needle, which performs pulsed ablation on the diseased tissue in combination with the above ablation path.

[0044] So far, the Figure 1 functional descriptions of each module are completed.

[0045] In the embodiment of the present application, for the diseased tissue area of an adrenal adenoma, the system first emits ultrasonic waves through an endoscopic ultrasound probe, generates a corresponding ultrasonic image after receiving the reflected echo of the diseased tissue; at the same time, synchronously measures the tissue conductivity by emitting a low-intensity alternating current through the electrode needle to obtain the conductivity distribution map of the diseased tissue; then fuses the ultrasonic image and the conductivity distribution map to construct a three-dimensional adenoma model, simulates and predicts the ablation path of the diseased tissue through this model, and finally performs pulsed ablation according to this ablation path. This improves the accuracy and safety of electrical pulsed ablation during APA treatment.

[0046] In another embodiment, the above system further includes a safety warning module; The safety warning module is used to trigger an audible and visual alarm when a sudden change in puncture resistance is detected by a force feedback sensor; and detect the electric field strength when the pulsed ablation module performs pulsed ablation on the diseased tissue, and turn off the pulse output of the pulsed ablation module when the electric field strength reaches the threshold.

[0047] In this module, when the electrode needle touches a blood vessel or fibrotic tissue, the resistance is different from that of other tissues, and a sudden change in resistance will occur. The force feedback sensor can avoid the electrode needle from puncturing the blood vessel or fibrotic tissue by monitoring the sudden change in resistance. And, a safety threshold of the electric field strength is preset in this module, and the electric field strength is detected in real time during the ablation process to ensure that it is within the safe threshold range. When it exceeds this safety threshold, the pulse output is automatically cut off. Compared with the traditional puncture with a blood vessel injury rate of about 3% - 5%, this module can reduce the blood vessel injury rate to less than 1%.

[0048] As Figure 4 shown, the present application also provides an electrical pulsed ablation device combined with real-time endoscopic ultrasound guidance. The device includes: An ultrasonic real-time imaging unit 401 is configured to obtain real-time ultrasonic-conductivity dual-modal images of a target area through an endoscopic ultrasonic probe and an electrode needle. The target area includes a lesion tissue and the surrounding area of the lesion tissue. The ultrasonic-conductivity dual-modal images include ultrasonic images and conductivity distribution maps. A real-time navigation control unit 402 is configured to construct a three-dimensional adenoma model capable of predicting the electric field intensity distribution through the ultrasonic-conductivity dual-modal images, predict the ablation area of the target area through the three-dimensional adenoma model, and plan an ablation path according to the ablation area and the ultrasonic-conductivity dual-modal images. A pulsed ablation unit 403 is configured to generate pulsed energy and emit the pulsed energy to the lesion tissue according to the ablation path for pulsed ablation.

[0049] In another embodiment, the endoscopic ultrasonic probe includes an ultrasonic transducer, a mechanical rotation drive module, and an optical imaging module. The mechanical rotation drive module is configured to drive the ultrasonic transducer to perform a 360-degree rotational scan, and the optical imaging module is configured to provide real-time optical images. The obtaining of the ultrasonic-conductivity dual-modal real-time images of the target area through the endoscopic ultrasonic probe and the electrode needle in the ultrasonic real-time imaging unit includes: Emitting ultrasonic waves through the ultrasonic transducer, receiving the reflected echoes of the target area, and processing the reflected echoes to obtain ultrasonic images. Emitting low-intensity alternating current through the electrode needle to measure the conductivity of the target area, and determining the conductivity distribution map according to the conductivity.

[0050] In another embodiment, the electrode needle in the ultrasonic real-time imaging unit is a coaxial multi-pole electrode needle. The coaxial multi-pole electrode needle includes an ablation needle head, a retractable protection tube, a handle, and a handle tail wire. The ablation needle head includes a needle head discharge electrode, a spaced insulation tube, and an annular electrode. A micro electromagnetic sensor is placed in the inner discharge hole of the needle head discharge electrode. The needle head discharge electrode and the annular electrode are connected to the handle tail wire through wires.

[0051] In another embodiment, spiral grooves are etched on the surface of the electrode needle, and titanium nitride coatings are coated on the surfaces of the needle head discharge electrode and the annular electrode.

[0052] In another embodiment, the device further includes: A safety warning unit 404 is configured to trigger an audible and visual alarm when a sudden change in puncture resistance is detected through a force feedback sensor, and detect the electric field intensity when the pulsed ablation module performs pulsed ablation on the lesion tissue, and stop pulsed output when the electric field intensity reaches a threshold value.

[0053] In the above embodiments of the present invention, an electro-pulse ablation system combined with real-time endoscopic ultrasound guidance is provided, and based on this system, an electro-pulse ablation device combined with real-time endoscopic ultrasound guidance is provided. Through the above system and device, the accuracy and safety of electro-pulse ablation during APA treatment can be improved.

[0054] This embodiment also discloses a computer device, as Figure 5 shown, the computer device includes a processor and a memory. At least one instruction is stored in the memory, and the at least one instruction is loaded and executed by the processor to implement the method on the electro-pulse ablation system combined with real-time endoscopic ultrasound guidance described in any one of the above.

[0055] In addition, in the embodiments of the electro-pulse ablation device combined with real-time endoscopic ultrasound guidance in the above examples, the logical division of each program module is only for illustration. In actual applications, according to needs, for example, considering the configuration requirements of the corresponding hardware or the convenience of software implementation, the above functions can be assigned to different program modules to complete, that is, the internal structure of the electro-pulse ablation device combined with real-time endoscopic ultrasound guidance is divided into different program modules to complete all or part of the functions described above.

[0056] The above are only the preferred embodiments of the present application and are not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present application shall be included in the scope of protection of the present application.

Claims

1. An electro-pulse ablation system combined with real-time endoscopic ultrasound guidance, characterized in that, The system includes an ultrasonic real-time imaging module, a real-time navigation control module, and a pulsed ablation module; The ultrasonic real-time imaging module is used to obtain real-time ultrasonic-electrical conductivity dual-modal images of a target area through an endoscopic ultrasonic probe and an electrode needle. The target area includes a lesion tissue and the surrounding area of the lesion tissue. The ultrasonic-electrical conductivity dual-modal images include ultrasonic images and electrical conductivity distribution maps; The real-time navigation control module is used to construct a three-dimensional adenoma model capable of predicting the electric field intensity distribution through the ultrasonic-electrical conductivity dual-modal images, predict the ablation area of the target area through the three-dimensional adenoma model, and plan an ablation path according to the ablation area and the ultrasonic-electrical conductivity dual-modal images; The pulsed ablation module is used to generate pulsed energy and emit the pulsed energy to the lesion tissue according to the ablation path for pulsed ablation.

2. The system according to claim 1, wherein The endoscopic ultrasonic probe includes an ultrasonic transducer, a mechanical rotation drive module, and an optical imaging module. Among them, the mechanical rotation drive module is used to drive the ultrasonic transducer to perform a 360-degree rotation scan, and the optical imaging module is used to provide real-time optical images; The obtaining of the ultrasonic-electrical conductivity dual-modal real-time images of the target area through the endoscopic ultrasonic probe and the electrode needle includes: Emitting ultrasonic waves through the ultrasonic transducer, receiving the reflected echoes of the target area, and processing the reflected echoes to obtain ultrasonic images; Emitting low-intensity alternating current through the electrode needle to measure the electrical conductivity of the target area, and determining the electrical conductivity distribution map through the electrical conductivity.

3. The system according to claim 1 or 2, characterized in that, The electrode needle is a coaxial multi-pole electrode needle. The coaxial multi-pole electrode needle includes an ablation needle head, a retractable protection tube, a handle, and a handle tail wire. The ablation needle head includes a needle head discharge electrode, a spaced insulation tube, and an annular electrode. A micro electromagnetic sensor is placed in the inner discharge hole of the needle head discharge electrode. The needle head discharge electrode and the annular electrode are connected to the handle tail wire through wires.

4. The system according to claim 3, characterized in that Spiral grooves are etched on the surface of the electrode needle, and titanium nitride coatings are coated on the surfaces of the needle head discharge electrode and the annular electrode.

5. The system according to claim 1, characterized in that, The system further includes a safety warning module; The safety warning module is used to trigger an audible and visual alarm when a sudden change in puncture resistance is detected by a force feedback sensor; And detect the electric field intensity when the pulsed ablation module performs pulsed ablation on the lesion tissue, and turn off the pulsed output of the pulsed ablation module when the electric field intensity reaches a threshold value.

6. An electro-pulse ablation device combined with real-time endoscopic ultrasound guidance, characterized in that, The device includes; An ultrasonic real-time imaging unit, which is used to obtain real-time ultrasonic-electrical conductivity dual-modal images of a target area through an endoscopic ultrasonic probe and an electrode needle. The target area includes a lesion tissue and the surrounding area of the lesion tissue. The ultrasonic-electrical conductivity dual-modal images include ultrasonic images and electrical conductivity distribution maps; A real-time navigation control unit, which is used to construct a three-dimensional adenoma model capable of predicting the electric field intensity distribution through the ultrasonic-electrical conductivity dual-modal images, predict the ablation area of the target area through the three-dimensional adenoma model, and plan an ablation path according to the ablation area and the ultrasonic-electrical conductivity dual-modal images; A pulse ablation unit for generating pulse energy and emitting the pulse energy to the diseased tissue along the ablation path for pulse ablation.

7. The device according to claim 6, characterized in that, The endoscopic ultrasound probe includes an ultrasonic transducer, a mechanical rotation drive module, and an optical imaging module. Among them, the mechanical rotation drive module is used to drive the ultrasonic transducer to perform a 360-degree rotational scan, and the optical imaging module is used to provide real-time optical images. The ultrasonic real-time imaging unit obtains real-time ultrasound-conductivity dual-modal images of the target area through the endoscopic ultrasound probe and the electrode needle, including: Emitting ultrasonic waves through the ultrasonic transducer, receiving the reflected echoes of the target area, and processing the reflected echoes to obtain ultrasonic images. Emitting low-intensity alternating current through the electrode needle to measure the conductivity of the target area, and determining the conductivity distribution map based on the conductivity.

8. The device according to claim 6 or 7, characterized in that, The electrode needle in the ultrasonic real-time imaging unit is a coaxial multi-pole electrode needle. The coaxial multi-pole electrode needle includes an ablation needle tip, a retractable protective tube, a handle, and a handle tail wire. The ablation needle tip includes a needle tip discharge electrode, a spaced insulating tube, and an annular electrode. A micro electromagnetic sensor is placed in the inner discharge hole of the needle tip discharge electrode. The needle tip discharge electrode and the annular electrode are connected to the handle tail wire through wires.

9. The device according to claim 8, characterized in that, Spiral grooves are etched on the surface of the electrode needle, and titanium nitride coatings are coated on the surfaces of the needle tip discharge electrode and the annular electrode.

10. The device according to claim 6, characterized in that, The device further includes: A safety warning unit for triggering an audible and visual alarm when a sudden change in puncture resistance is detected by a force feedback sensor, and detecting the electric field intensity when the pulse ablation module performs pulse ablation on the diseased tissue. When the electric field intensity reaches the threshold, the pulse output is stopped.

Images