Hepatic artery radiofrequency ablation instrument, ablation system, ablation device and ablation method

Abstract

The invention discloses a hepatic artery radiofrequency ablation instrument, an ablation system, an ablation device and an ablation method.The hepatic artery radiofrequency ablation instrument is characterized in that an ablation instrument body is provided with multiple sets of data interfaces, and the data interfaces comprise a control interface, an electrode interface and a catheter interface; the ablation system comprises a control module, a stimulation ablation module, a detection processing module and a data storage module. The ablation method comprises the steps of evaluating an approach path and generating a preset treatment scheme; attaching a neutral electrode based on the attaching scheme, and placing an ablation catheter based on the approach path; detecting an impedance temperature parameter of the to-be-ablated position and a preset electrical parameter of radio frequency energy; the radial artery or femoral artery approach path can be selected according to the blood vessel condition, the radial artery approach path is short, the operation time and intraoperative and postoperative complications are effectively shortened, and the treatment time and the hospitalization cost are reduced; the nerve tissue can be accurately damaged to necrotize, energy is prevented from diffusing to the intima, the intima structure is ensured to be complete, and extra harm to a patient is effectively reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a hepatic artery radiofrequency ablation apparatus, a radiofrequency ablation system, and a radiofrequency ablation method. Background Art

[0002] Radiofrequency Ablation (RFA) of the hepatic artery is a minimally invasive interventional technology used to treat liver diseases (especially liver tumors). It mainly acts directly on tumor tissue through physical or chemical methods to cause necrosis and apoptosis, thereby achieving the purpose of treatment. The core principle of hepatic artery radiofrequency ablation is to use thermal energy to destroy tumor cells. The specific method is to use radiofrequency energy to rapidly increase the temperature of tumor tissue (usually >60°C), resulting in cell protein denaturation and coagulative necrosis. Among them, the specific location of hepatic artery radiofrequency ablation needs to be determined according to the location, size and blood supply of the tumor. The core step is to accurately puncture the ablation electrode into the tumor tissue through image guidance, and cover the entire range of the tumor and a small amount of normal liver tissue around it as much as possible (to ensure the ablation boundary).

[0003] The existing treatment plan for diseased tumor tissue is usually to insert the ablation catheter into the hepatic artery wall through the femoral artery intervention method and connect it to the radiofrequency ablation device. Then, low-level radiofrequency energy is transmitted to the adventitial nerves of the hepatic artery through the head electrode of the ablation catheter, causing the surrounding nerve tissue to heat up, thereby causing local nerve tissue to necrotize or degenerate, thereby affecting the sympathetic nerve signal transmission of the liver, regulating blood pressure, and thus lowering and controlling blood pressure. Due to the ablation through the femoral artery approach, the approach route is long, and a small amount of normal liver tissue will be destroyed during the treatment process, which will cause additional harm to the patient and more complications during or after the operation. The patient needs to be hospitalized for at least one day for observation after the operation, which consumes more treatment time and cost. Summary of the Invention

[0004] The purpose of the present invention is to solve the shortcomings of the prior art and to propose a hepatic artery radiofrequency ablation instrument, a radiofrequency ablation system and a radiofrequency ablation method.

[0005] To achieve the above objectives, in a first aspect, the present invention provides a hepatic artery radiofrequency ablation device, comprising an ablation device body:

[0006] The ablation instrument body is provided with multiple sets of data interfaces, including:

[0007] Control interface, used to connect the foot switch to complete the ablation procedure by stepping on it;

[0008] Electrode interface, used to connect the neutral electrode and conduct the current path from the preset ablation position to the ablation device;

[0009] The catheter interface is used to connect the ablation catheter and conduct the current flow path from the ablation device to the preset ablation position.

[0010] In some embodiments, the data interface further comprises:

[0011] Power supply interface, used to connect the power supply and control the power supply of the ablation instrument;

[0012] The burning interface is used to connect to the host computer to control the burning program code to complete the update or debugging process of the ablation instrument.

[0013] In a second aspect, the present invention further provides a radiofrequency ablation system, comprising the radiofrequency ablation apparatus described in the first aspect, and further comprising:

[0014] An ablation catheter is used to deliver radiofrequency ablation current to the treatment site through a preset path.

[0015] In some embodiments, the predetermined path is the radial artery and / or the femoral artery, and the treatment site is the hepatic artery.

[0016] In a third aspect, the present invention further provides a radiofrequency ablation device, comprising:

[0017] a control module, configured to obtain a stimulation signal to determine whether the location to be ablated on the inner wall of the hepatic artery has been reached, and to send an ablation signal to ablate the location to be ablated on the inner wall of the hepatic artery;

[0018] A stimulation and ablation module, configured to generate a stimulation control signal and an ablation control signal;

[0019] A detection and processing module is used to detect the preset electrical parameters of the radiofrequency energy and the impedance temperature parameters of the location to be ablated, and to process and feedback the detection results;

[0020] The data storage module is used to store preset ablation treatment plans and configure electrical parameters.

[0021] In a fourth aspect, the present invention further provides a radiofrequency ablation method, which is performed using the radiofrequency ablation device described in the third aspect, and the radiofrequency ablation method comprises:

[0022] S100, evaluating the access path based on the patient's hepatic artery medical image data and generating a preset treatment plan;

[0023] S200, running the ablation instrument's preset self-test process and debugging the corresponding data interface's preset working condition operating parameters;

[0024] S300, attaching the neutral electrode based on the attachment plan and placing the ablation catheter based on the access path;

[0025] S400, detecting the impedance temperature parameters of the location to be ablated and the preset electrical parameters of the radiofrequency energy, and determining whether a loop is formed along the current path;

[0026] S500, repeat the operation to perform hepatic artery radiofrequency ablation treatment.

[0027] In some embodiments, the S100 includes:

[0028] S110, importing the patient's hepatic artery image data, generating a hepatic artery vascular tree model, and marking the hepatic artery trunk, branches, and sympathetic nerve dense distribution areas;

[0029] S120, measuring radial artery-hepatic artery and femoral artery-hepatic artery pathway parameters, assessing vascular tortuosity and incorporating pathway solutions;

[0030] S130, marking the ablation points in the nerve-dense area of ​​the hepatic artery adventitia and generating a preset treatment plan.

[0031] In some embodiments, the S200 includes:

[0032] S210, connecting the power supply through the power supply interface and running the ablation device's preset self-test process;

[0033] S220, connecting the foot switch, neutral electrode, and ablation catheter through the data interface, and debugging the corresponding preset working condition operating parameters of the data interface;

[0034] S230, reading a preset treatment plan, and automatically configuring preset electrical parameters of radio frequency energy.

[0035] In some embodiments, the S300 includes:

[0036] S310, attaching the neutral electrode to the preset ablation point based on the attachment plan;

[0037] S320, puncture the radial artery or femoral artery to insert an arterial sheath and guiding catheter;

[0038] S330, hepatic artery angiography, the ablation catheter is sent into the preset ablation area of ​​the target blood vessel through the guide catheter.

[0039] In some embodiments, the S400 includes:

[0040] S410, operating the ablation device to perform wall adhesion detection, determine the wall adhesion status of the ablation electrode, and start radiofrequency energy output;

[0041] S420, detecting the impedance temperature parameters of the location to be ablated, and simultaneously monitoring and detecting the preset electrical parameters of the radio frequency energy to determine whether the current path forms a complete loop.

[0042] The present invention has the following beneficial effects:

[0043] 1. In the present invention, the radial artery or femoral artery access pathway can be freely selected according to the patient's vascular conditions. The radial artery access pathway is shorter, effectively reducing the operation time and intraoperative and postoperative complications, reducing treatment time and hospitalization costs.

[0044] 2. In the present invention, high-frequency alternating current is introduced into the ablation point of the tissue to be ablated through an ablation catheter, and then forms a loop through the neutral electrode on the body surface, causing a thermal effect in the tissue surrounding the ablation point. The thermal effect is concentrated in the adventitial nerve area of ​​the hepatic artery, which can accurately destroy the nerve tissue and cause necrosis, preventing energy from diffusing to the intima, thereby ensuring the integrity of the intima structure and effectively reducing additional damage to the patient.

[0045] 3. The present invention detects the impedance temperature parameters of the location to be ablated and the preset electrical parameters of the radiofrequency energy in real time to avoid poor electrode contact or abnormal tissue damage, ensure that the energy accurately matches the treatment needs, and realize the closed-loop management of "energy controllable-safe ablation", effectively improving the safety of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 Schematic diagram of the structure of the radiofrequency ablation device proposed in this invention Figure 1 ;

[0047] Figure 2 Schematic diagram of the structure of the radiofrequency ablation device proposed in this invention Figure 2 ;

[0048] Figure 3 This is a schematic diagram of the principle of the radiofrequency ablation system proposed in the present invention;

[0049] Figure 4 This is a schematic diagram of the principle of the radiofrequency ablation device proposed in the present invention;

[0050] Figure 5 Schematic diagram of the process of radiofrequency ablation method proposed in the present invention Figure 1 ;

[0051] Figure 6 Schematic diagram of the process of radiofrequency ablation method proposed in the present invention Figure 2 ;

[0052] Figure 7 Schematic diagram of the process of radiofrequency ablation method proposed in the present invention Figure 3 ;

[0053] Figure 8 Schematic diagram of the process of radiofrequency ablation method proposed in the present invention Figure 4 ;

[0054] Figure 9 Schematic diagram of the process of radiofrequency ablation method proposed in the present invention Figure 5 .

[0055] Legend:

[0056] 1. Ablation instrument body; 11. Data interface; 111. Control interface; 112. Electrode interface; 113. Catheter interface; 114. Power supply interface; 115. Burning interface; 12. Power switch; 13. Equipotential terminal; 14. Volume controller; 2. Foot switch; 3. Neutral electrode; 4. Ablation catheter; 5. Power supply; 6. Host computer; 7. Control module; 8. Stimulation and ablation module; 9. Detection and processing module; 10. Data storage module. DETAILED DESCRIPTION

[0057] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0058] The embodiments of the present application provide a hepatic artery radiofrequency ablation instrument, ablation system, ablation device, and ablation method, which solve the problem that ablation in the prior art is performed via the femoral artery approach, the approach route is long, causing additional harm to the patient, and more complications during or after the operation, consuming more treatment time and treatment costs. The present application can select two access routes, radial artery or femoral artery, according to vascular conditions, and the radial artery approach route is shorter, effectively reducing the operation time and intraoperative and postoperative complications, reducing treatment time and hospitalization costs; it can accurately destroy nerve tissue to cause necrosis, avoid energy diffusion to the endothelium, and thus ensure the integrity of the endothelium structure, effectively reducing additional harm to the patient.

[0059] Please refer to the following examples for details:

[0060] Reference Figure 1-Figure 2 The present invention provides an embodiment of a hepatic artery radiofrequency ablation device, comprising an ablation device body 1, wherein the ablation device body 1 is provided with a plurality of data interfaces 11; wherein the data interfaces 11 include:

[0061] (1) Control interface 111, used to connect to the foot switch 2. Specifically, the foot switch 2 includes a pedal, a transmission connecting rod, a micro switch and a housing (as a prior art, it is not shown in this application). The pedal is made of high-strength engineering plastic material, which is sturdy and non-slip, can effectively withstand the pedaling force and ensure the safety of the user. When the pedal is stepped on, the force is transmitted through the transmission connecting rod, driving the micro switch to operate; the length and angle of the transmission connecting rod are precisely calculated to ensure that the pedaling action can be accurately and efficiently transmitted to the micro switch, achieving stable signal triggering.

[0062] For example, the foot switch 2 can utilize a mechanical trigger mechanism. The built-in microswitch has two sets of contacts: normally open and normally closed. Under normal conditions, the normally open contacts are open and the normally closed contacts are closed. Once the pedal is pressed, the transmission link causes the microswitch to change state, closing the normally open contacts and opening the normally closed contacts, thereby completing the on-off control of the circuit. As can be seen, the foot switch 2 can precisely control the on-off flow of current, thereby controlling operations such as starting, pausing, and power adjustment of the ablation device. This offers numerous advantages. In terms of operational convenience, it allows the surgeon to focus both hands on the surgical procedure. For example, during a hepatic artery radiofrequency ablation procedure, the surgeon can focus both hands on manipulating the ablation catheter 4 while easily controlling the ablation device through the foot switch 2, significantly improving surgical efficiency and accuracy. It also offers high safety: the housing has excellent insulation properties, effectively preventing the risk of electric shock. Furthermore, the structural design ensures that it is triggered only during normal pedaling, reducing the risk of misoperation. It is highly durable, with all components made of high-quality materials. The pedals, transmission connecting rods, etc. are treated with special technology, and have excellent wear and fatigue resistance. Even with frequent use, it can maintain stable and reliable performance, reducing surgical interruptions caused by equipment failures, and providing strong guarantees for the smooth progress of operations.

[0063] (2) Electrode interface 112, used to connect the neutral electrode 3, conducting the current path from the preset ablation position to the ablation device. Specifically, the neutral electrode 3 is connected to the surface electrode patch (for example, an area with abundant subcutaneous fat and less blood vessels such as the lower back or buttocks) through the cable, forming a complete current loop of "ablation device → ablation electrode → hepatic artery adventitial nerve tissue → neutral electrode 3 → ablation device".

[0064] For example, the electrode interface 112 can adopt a medical-grade waterproof and dustproof design, with a built-in high-precision impedance detection module, which monitors the contact state between the electrode sheet and the skin in real time through a bridge circuit (for example, when the contact area is less than 10 cm 2 Or when the contact resistance is greater than 100Ω, the module immediately triggers an audible and visual alarm and simultaneously sends an interrupt signal to the ablation device control module 7). It should be explained in detail that the electrode sheet can be made of flexible conductive silicone material, with micron-level bump structures evenly distributed on the surface to increase the contact area, and can be used with medical conductive gel to control the contact resistance below 50Ω; it is understandable that by dispersing the current density (for example, the current density is ≤0.1A / cm 2), avoiding the problem of local current concentration caused by poor contact in traditional monopolar circuits (such as high temperatures greater than 80°C), thereby effectively preventing skin burns; at the same time, real-time monitoring of loop impedance can ensure that radiofrequency energy (480kHz high-frequency current) is efficiently transmitted to the ablation electrode tip, and combined with power closed-loop control (for example, 2-20W adjustable), the adventitial nerve tissue of the hepatic artery is accurately heated to the preset treatment temperature range (for example, 60-80°C), while the temperature of the neutral electrode 3 contact area always remains in the preset contact temperature range (for example, <40°C), achieving safe and effective energy transfer.

[0065] (3) A catheter interface 113, which is used to connect the ablation catheter 4 and conduct the current flow path of the ablation device to the preset ablation location. Specifically, a predetermined specification arterial sheath (e.g., 6Fr, i.e., inner diameter of approximately 2.0 mm, outer diameter of approximately 2.8 mm) can be used. This is designed for interventional treatment of small blood vessels such as the hepatic artery with a relatively small diameter (e.g., diameter of 4-8 mm), and is suitable for a spiral ablation catheter 4 (e.g., spiral inner diameter of 4-8 mm, pitch of 4-8 mm).

[0066] For example, a three-layer composite structure can be used inside the interface: the inner layer can be a medical-grade titanium alloy conductive shielding layer, which can effectively isolate the electromagnetic interference generated by the radio frequency current to ensure clear images during surgery; the middle layer can be a polytetrafluoroethylene insulation coating to prevent current leakage to the outer wall of the catheter; the outer layer can be a medical stainless steel shell, and the surface is passivated to improve biocompatibility. It should be explained in detail that through the impedance detection linkage mechanism, when the interface contact resistance reaches a preset value (for example, >50mΩ), an audible and visual alarm is automatically triggered to ensure the efficiency of radio frequency energy (for example, 480kHz high-frequency current) transmission, while avoiding local heat generation abnormalities caused by poor contact (for example, the safety mechanism is activated when the temperature is >85°C).

[0067] (4) Power supply interface 114, used to connect to power supply 5 and control the power supply of the ablation device. Specifically, power supply interface 114 can have a built-in overload protection fuse (rated current 10A) and EMI filter circuit to prevent power grid fluctuations from affecting the stability of the RF output. The ground terminal of the socket is directly connected to the metal casing of the device to ensure that the current is preferentially conducted to the ground in the event of leakage, reducing the risk of electric shock.

[0068] (5) Burning interface 115, used to connect to the host computer 6 to control the burning of program code to complete the update or debugging process of the ablation device. Specifically, various types of data interfaces 11 can be used. After connecting to the host computer 6 (such as a computer or mobile terminal), the ablation device control program can be upgraded through dedicated software (such as updating the 480kHz radio frequency output algorithm), preoperative simulation parameters (such as preset treatment plans) can be imported, or surgical data logs can be exported.

[0069] It should be noted that the ablation device body 1 is also provided with:

[0070] (6) Power switch 12, used to start or shut down the ablation instrument. Exemplarily, a double-position toggle switch (labeled "I / O") can be adopted, which triggers a device self-checking process (including temperature sensor calibration, impedance threshold test) when started, and cuts off power supply to all circuits when shut down.

[0071] (7) Equipotential terminal 13, used as a safety protection and test grounding equalization point. Exemplarily, the equipotential terminal 13 is connected to the hospital grounding system (or other devices) through a wire, so that the shells and metal parts of each ablation instrument are kept at the same potential (i.e. the potential difference is zero), thereby avoiding the conduction of electric current through the human body, eliminating the risk of electric shock from the source; and the equipotential terminal can guide the electromagnetic interference generated by the ablation instrument into the ground through grounding, while shielding external electromagnetic interference, ensuring stable circuit signals and improving treatment accuracy.

[0072] (8) Volume controller 14, used to control the volume of audible signals occurring in the process of radio frequency power transmission. Exemplarily, the volume controller 14 can adopt a knob-type stepless adjustment design, with a non-slip texture on the surface, which facilitates precise control by the operator when wearing sterile gloves, and further adjusts the volume of three types of audible signals in real time during the process of radio frequency power transmission: ① Power output dynamic prompt sound, with different frequency beeps corresponding to 2-20W power intervals (e.g. 500Hz short sound at 5W, 800Hz continuous sound at 10W); ② Safety threshold alarm sound (e.g. when the tissue temperature is <15℃ or >85℃, the impedance is <50Ω or >500Ω, a 1000Hz high-frequency continuous alarm is triggered); ③ Treatment time prompt sound, a gradually increasing prompt sound is emitted before the preset ablation time (e.g. 30-120s) is reached.

[0073] Referring to Figure 3 , the present application also provides an embodiment of a radio frequency ablation system, which comprises the radio frequency ablation instrument in the above embodiment, and further comprises: an ablation catheter 4 for delivering the radio frequency ablation current to the treatment site through a preset path; and the preset path is the radial artery and / or the femoral artery, and the treatment site is the hepatic artery.

[0074] It is understandable that the ablation catheter 4 provided with the radiofrequency ablation device can freely select the radial artery or femoral artery access path according to the patient's vascular conditions, and accurately deliver the radiofrequency current to the hepatic artery treatment site. For example, taking the radial artery access path length of 15-25cm as an example, it is nearly 50% shorter than the 40-60cm of the femoral artery access, which can effectively reduce the catheter pushing resistance and vascular damage, effectively shorten the operation time, and effectively reduce the cost of catheter use due to the short path; at the same time, the high-frequency alternating current is introduced into the ablation point of the tissue to be ablated through the ablation catheter 4, and then forms a loop through the neutral electrode 3 on the body surface, so that the tissue around the ablation point produces a thermal effect, and is concentrated in the adventitial nerve area of ​​the hepatic artery, which can accurately destroy the nerve tissue to cause necrosis, avoid the ablation energy from diffusing to the endothelium, and thus ensure the structural integrity of the endothelium, effectively reducing additional damage to the patient. The access path is extremely minimally invasive, effectively reducing the incidence of intraoperative and postoperative complications, and supports the "day surgery" mode. The patient does not need to be hospitalized for observation after surgery and can be discharged on the same day. Compared with the femoral artery access with a hospital stay of at least 1 day, the hospitalization cost can be reduced by more than half.

[0075] Reference Figure 4 The present invention further provides an embodiment of a radiofrequency ablation device, comprising:

[0076] (1) A control module 7, configured to obtain a stimulation signal to determine whether the ablation location on the inner wall of the hepatic artery has been reached, and to send an ablation signal to ablate the ablation location on the inner wall of the hepatic artery. For example, the control module 7 includes a control display submodule and a configuration submodule; the control display submodule is configured to control the display panel to display electrical parameters such as actual power, preset power, tissue impedance, impedance change percentage, and tissue temperature during the ablation treatment process; and the configuration submodule is configured to obtain a stimulation signal to determine whether the ablation location on the inner wall of the hepatic artery has been reached, and to send an ablation signal to ablate the ablation location on the inner wall of the hepatic artery.

[0077] (2) Stimulation and ablation module 8, which is used to generate stimulation control signals and ablation control signals. Exemplarily, the stimulation and ablation module 8 includes a stimulation generation submodule and an ablation generation submodule; the stimulation generation submodule is used to generate an adjustable electrical stimulation signal, the parameter range of which includes voltage (e.g., 2-30V), pulse width (e.g., 0.1-10ms) and frequency (e.g., 10-30Hz), which is transmitted to the inner wall of the hepatic artery through the ablation catheter 4, and the signal output mode supports monopolar / bipolar switching, thereby adapting to the nerve positioning requirements of different blood vessel diameters; and the ablation generation submodule calculates the voltage RMS / current RMS in real time to generate impedance data through temperature-impedance closed-loop control, and dynamically adjusts the power output curve so that the thermal effect is precisely limited to the adventitial nerve layer of the hepatic artery.

[0078] (3) Detection and processing module 9, used to detect the preset electrical parameters of the radio frequency energy and the impedance temperature parameters of the location to be ablated, and process and feed back the detection results. Exemplarily, the detection and processing module 9 includes a signal detection submodule and a signal processing submodule; the signal detection submodule can collect the voltage / current root mean square of the RF energy and calculate the tissue impedance in real time, and obtain the temperature data of the treatment site through a thermocouple sensor to ensure dynamic capture of tissue parameter changes (for example, temperature 15-85°C, impedance 50-500Ω). When the range is exceeded, a hardware interrupt signal is triggered, providing real-time raw data to the signal processing submodule, which can effectively avoid problems such as poor electrode contact or abnormal tissue damage, ensure that the energy is accurately matched to the treatment needs, and thus achieve "energy controllable-safe ablation" closed-loop management, effectively improving surgical safety; the signal processing submodule filters, reduces noise, and performs logical operations on the detection data: ① Calculate the impedance change percentage (for example, ΔZ / Z×100%), and when the fluctuation exceeds 30%, determine that the electrode is well attached to the wall; ② Generate adjustment instructions based on the temperature-power mapping relationship (for example, the power is automatically reduced by 0.5W for every 1°C increase in temperature); ③ Feedback the processed data to the control module 7 through the data interface 11, driving the display panel to update the parameters in real time.

[0079] (4) A data storage module 10, used to store preset ablation treatment plans and configure electrical parameters.

[0080] It can be understood that the ablation device of the present application can use a microprocessor as the core control unit, and drive the ablation device through a pre-programmed algorithm to generate continuously adjustable precision radio frequency output in a preset frequency band (for example, the 480kHz frequency band). This frequency can cause the ions in the tissue to oscillate at high speed to generate heat and avoid neuromuscular stimulation; and the front panel of the ablation device is integrated with a dynamic display system to present in real time the actual power (for example, 2-20W), preset power parameters, tissue impedance (for example, calculated as voltage root mean square / current root mean square), impedance change percentage (for example, ΔZ / Z×100%) / tissue temperature (for example, collected in real time by a thermocouple sensor) and power output value (for example, through the average value of voltage root mean square*current root mean square), accurately reflecting the effective heat energy transmitted from the electrode tip to the nerve tissue.

[0081] During the RF energy delivery process, the ablation device achieves safety control through a dual closed-loop feedback mechanism: based on the measured temperature (thermocouple accuracy ±0.5°C) and impedance data of the treatment site, when the system is in the ready state, if the temperature is <15°C or >85°C, and the impedance is <50Ω or >500Ω, the RF output is automatically locked; when the system is in the output state, the above parameters exceeding the threshold will trigger the power output to be forced to shut down, avoiding the spread of thermal damage or circuit abnormalities. The power control mode allows users to adjust the power (in steps of 0.5W) and ablation time (adjustable from 30-120s) according to the characteristics of the lesion. Combined with the resistive thermal effect of the 480kHz high-frequency current, a precise thermal field (60-80°C) is formed in the adventitial nerve area of ​​the hepatic artery, achieving the treatment goal of nerve necrosis without damaging the endothelium.

[0082] In addition, the ablation device adopts a lightweight design (weight ≤ 2kg) to adapt to the space requirements of interventional surgery. Its hands-free foot switch 2 interface supports one-handed operation during surgery, allowing the surgeon to focus on catheter positioning and image guidance, improving surgical efficiency and safety.

[0083] Reference Figure 5-Figure 9 The present invention further provides an embodiment of a radiofrequency ablation method, which is performed by the radiofrequency ablation device in the above embodiment. The radiofrequency ablation method includes:

[0084] S100, evaluating the access path based on the patient's hepatic artery medical image data and generating a preset treatment plan;

[0085] S200, running the ablation instrument preset self-test process, debugging the corresponding data interface 11 preset working condition operating parameters;

[0086] S300, attaching the neutral electrode 3 based on the attachment plan, and placing the ablation catheter 4 based on the access path;

[0087] S400, detecting the impedance temperature parameters of the location to be ablated and the preset electrical parameters of the radiofrequency energy, and determining whether a loop is formed along the current path;

[0088] S500, repeat the operation to perform hepatic artery radiofrequency ablation treatment.

[0089] For example, first connect the power supply 5 to the power supply interface 114 on the rear panel of the ablation instrument body 1 through a cable, turn on the power supply 5 switch to the "I" position, and the ablation instrument automatically starts the self-test process of temperature detection and impedance monitoring, and enters the standby mode after confirming that it is normal; then stick the neutral electrodes 3 one by one on the fleshy part of the patient's lower back or buttocks, and connect them to the electrode interface 112 on the front panel of the ablation instrument through a cable to form a current loop, and at the same time connect the ablation catheter 4 to the catheter interface 113 on the front panel of the ablation instrument through a cable; according to the preoperative hepatic artery imaging assessment (CTA / MRA), select the radial artery or femoral artery approach, and during puncture A 6Fr arterial sheath and guiding catheter are then inserted, and the spiral segment ablation catheter 4 is delivered into the target vessel under the guidance of hepatic artery angiography. The temperature and impedance are then confirmed to be valid through the thermocouple sensor and impedance algorithm, and the ablation device is operated to perform wall adhesion detection and start high-frequency radiofrequency energy. After the ablation is completed, the ablation site is changed, and the wall adhesion detection and ablation operation are repeated. After all ablation targets are completed, the catheter is withdrawn, and standard nursing procedures are used to stop bleeding at the puncture site. During the entire process, the temperature, impedance and power parameters are monitored in real time through the front panel of the ablation device. When the safety threshold is exceeded, the output is automatically cut off to ensure the closed-loop management of "energy controllable-safe ablation".

[0090] Please continue reading Figure 6 In this example, S100 includes:

[0091] S110, importing the patient's hepatic artery image data, generating a hepatic artery vascular tree model, and marking the hepatic artery trunk, branches, and sympathetic nerve dense distribution areas;

[0092] S120, measuring radial artery-hepatic artery and femoral artery-hepatic artery pathway parameters, assessing vascular tortuosity and incorporating pathway solutions;

[0093] S130, marking the ablation points in the nerve-dense area of ​​the hepatic artery adventitia and generating a preset treatment plan.

[0094] For example, after importing the patient's hepatic artery CTA / MRA and other preoperative imaging data, a hepatic artery vascular tree model is generated through a three-dimensional reconstruction algorithm, and the hepatic artery trunk, branches at all levels, and the sympathetic nerve dense distribution area (adventitial area) determined based on anatomical characteristics are automatically identified and labeled; then the path parameters of the radial artery-hepatic artery and femoral artery-hepatic artery are measured, including vascular diameter, tortuosity angle, and degree of stenosis (for example, if the radial artery diameter is ≥2mm and the tortuosity is <30°, the radial artery approach is recommended to shorten the surgical path and reduce catheter loss; if the blood If the catheter conditions are complex or there is severe tortuosity, the femoral artery approach is selected to ensure the stability of catheter pushing); then, multiple ablation targets are marked in the nerve-dense area of ​​the hepatic artery adventitia (for example, the distance between adjacent targets is ≥4mm), and a preset treatment plan is generated (for example, 480kHz high-frequency radiofrequency energy is used, the power is set to 2-10W, the ablation time is 30-60s, and the temperature threshold is ≤60℃). At the same time, impedance monitoring (for example, a safe range of 150-280Ω) and a temperature closed-loop control mechanism are integrated to ensure that the thermal effect acts precisely on the nerve tissue without damaging the endothelium.

[0095] Please continue reading Figure 7 In this example, S200 includes:

[0096] S210, connecting the power supply 5 via the power supply interface 114, and running the ablation device's preset self-test process;

[0097] S220, connecting the foot switch 2, the neutral electrode 3 and the ablation catheter 4 through the data interface 11, and debugging the operating parameters of the corresponding preset working conditions of the data interface 11;

[0098] S230, reading a preset treatment plan, and automatically configuring preset electrical parameters of radio frequency energy.

[0099] For example, the power supply 5 is connected to the power supply interface 114 on the rear panel of the ablation instrument body 1 through a cable, the power supply 5 switch is turned on to the "I" position, and the preset self-test process of the ablation instrument is triggered - the system automatically calibrates the thermocouple temperature sensor and tests the impedance threshold, and enters the standby mode after confirming that it is correct; then the hands-free foot switch 2 is connected to the control interface 111, and the linear relationship between the pedaling stroke and the power output is debugged; then the neutral electrodes 3 are pasted one by one on the fleshy part of the patient's lower back or buttocks, and connected to the electrode interface 1 on the front panel of the ablation instrument through a cable. 12 forms a current loop, and at the same time, the ablation catheter 4 is connected to the catheter interface 113 on the front panel of the ablation instrument through a cable; based on the preoperative hepatic artery imaging assessment (CTA / MRA), the radial artery or femoral artery access is selected, and a 6Fr arterial sheath and a guide catheter are inserted after puncture, and the spiral segment ablation catheter 4 is sent into the target blood vessel under the guidance of hepatic artery angiography; then the preset treatment plan generated before the operation is read from the data storage module 10, the electrical parameters of the high-frequency radio frequency are automatically configured, and the impedance closed-loop control is activated at the same time to complete the safety verification and automatic loading of the treatment parameters.

[0100] Please continue reading Figure 8 In this example, S300 includes:

[0101] S310, attaching the neutral electrode 3 to the preset ablation point based on the attachment plan;

[0102] S320, puncture the radial artery or femoral artery to insert an arterial sheath and guiding catheter;

[0103] S330, hepatic artery angiography: the ablation catheter 4 is sent into the preset ablation area of ​​the target blood vessel via the guiding catheter.

[0104] For example, according to the attachment scheme planned before the operation, the neutral electrodes 3 are attached one by one to the patient's lower back or buttocks and other fleshy parts with rich subcutaneous fat. When attaching, it is necessary to ensure that the electrode is in close contact with the skin, and the contact resistance is monitored in real time to ensure that the current circuit is unobstructed and avoid local current concentration causing skin burns; then, according to the vascular conditions evaluated before the operation, the radial artery or femoral artery access is selected. During the puncture process, the position of the puncture point needs to be confirmed by angiography to ensure smooth blood flow after the sheath is inserted, providing a stable pathway for the subsequent delivery of the ablation catheter 4; then, under the guidance of angiography, the arterial sheath and the guiding catheter guide the spiral segment ablation catheter 4 into the preset ablation area of ​​the hepatic artery target vessel; the ring electrode at the catheter tip needs to be precisely attached to the nerve-dense area of ​​the hepatic artery adventitia. After confirming that the catheter position is correct through contrast agent development, the ablation instrument is operated to perform wall adhesion detection to prepare for the subsequent precise application of radiofrequency energy to the target area.

[0105] Please continue reading Figure 9 In this example, S400 includes:

[0106] S410, operating the ablation device to perform wall adhesion detection, determine the wall adhesion status of the ablation electrode, and start radiofrequency energy output;

[0107] S420, detecting the impedance temperature parameters of the location to be ablated, and simultaneously monitoring and detecting the preset electrical parameters of the radio frequency energy to determine whether the current path forms a complete loop.

[0108] For example, the ablation instrument is first operated to perform wall adhesion detection through the impedance fluctuation method. A low-power detection signal needs to be sent, and the percentage of tissue impedance change is calculated in real time. When the fluctuation amplitude exceeds the preset value, it is determined that the ablation electrode is well adhered to the wall of the dense nerve area of ​​the hepatic artery adventitia; after confirming the adhesion to the wall, the high-frequency radio frequency energy output is started by the foot switch 2, and the power is automatically loaded according to the preset plan. At the same time, the actual power, preset power and impedance parameters are dynamically displayed on the front panel of the ablation instrument to ensure that the energy acts accurately on the target area; then the temperature of the position to be ablated is collected in real time through the thermocouple sensor, and the voltage root mean square / current root mean square is calculated synchronously to judge the integrity of the current loop. When the loop impedance fluctuation exceeds the safe range, an audible and visual alarm is issued and the radio frequency energy is cut off to avoid local thermal damage caused by poor contact, thereby realizing the closed-loop management of "energy controllable-safe ablation".

[0109] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A hepatic artery radiofrequency ablation device, comprising an ablation device body, characterized in that: The ablation instrument body is provided with multiple sets of data interfaces, including: Control interface, used to connect the foot switch to complete the ablation procedure by stepping on it; Electrode interface, used to connect the neutral electrode and conduct the current path from the preset ablation position to the ablation device; The catheter interface is used to connect the ablation catheter and conduct the current flow path from the ablation device to the preset ablation position.

2. The radiofrequency ablation apparatus according to claim 1, characterized in that: The data interface also includes: Power supply interface, used to connect the power supply and control the power supply of the ablation instrument; The burning interface is used to connect to the host computer to control the burning program code to complete the update or debugging process of the ablation instrument.

3. A radiofrequency ablation system, characterized in that: The radiofrequency ablation apparatus according to any one of claims 1 to 2, further comprising: An ablation catheter is used to deliver radiofrequency ablation current to the treatment site through a preset path.

4. The radiofrequency ablation system according to claim 3, characterized in that The preset path is the radial artery and / or femoral artery, and the treatment site is the hepatic artery.

5. A radiofrequency ablation device, characterized in that: include: a control module, configured to obtain a stimulation signal to determine whether the location to be ablated on the inner wall of the hepatic artery has been reached, and to send an ablation signal to ablate the location to be ablated on the inner wall of the hepatic artery; A stimulation and ablation module, configured to generate a stimulation control signal and an ablation control signal; A detection and processing module is used to detect the preset electrical parameters of the radiofrequency energy and the impedance temperature parameters of the location to be ablated, and to process and feedback the detection results; The data storage module is used to store preset ablation treatment plans and configure electrical parameters.

6. A radiofrequency ablation method, characterized in that: The radiofrequency ablation method is performed by the radiofrequency ablation device described in claim 5, and the radiofrequency ablation method includes: S100, evaluating the access path based on the patient's hepatic artery medical image data and generating a preset treatment plan; S200, running the ablation instrument's preset self-test process and debugging the corresponding data interface's preset working condition operating parameters; S300, attaching the neutral electrode based on the attachment plan and placing the ablation catheter based on the access path; S400, detecting the impedance temperature parameters of the location to be ablated and the preset electrical parameters of the radiofrequency energy, and determining whether a loop is formed along the current path; S500, repeat the operation to perform hepatic artery radiofrequency ablation treatment.

7. The radiofrequency ablation method according to claim 6, characterized in that: The S100 includes: S110, importing the patient's hepatic artery image data, generating a hepatic artery vascular tree model, and marking the hepatic artery trunk, branches, and sympathetic nerve dense distribution areas; S120, measuring radial artery-hepatic artery and femoral artery-hepatic artery pathway parameters, assessing vascular tortuosity and incorporating pathway solutions; S130, marking the ablation points in the nerve-dense area of ​​the hepatic artery adventitia and generating a preset treatment plan.

8. The radiofrequency ablation method according to claim 6, characterized in that: The S200 includes: S210, connecting the power supply through the power supply interface and running the ablation device's preset self-test process; S220, connecting the foot switch, neutral electrode, and ablation catheter through the data interface, and debugging the corresponding preset working condition operating parameters of the data interface; S230, reading a preset treatment plan, and automatically configuring preset electrical parameters of radio frequency energy.

9. The radiofrequency ablation method according to claim 6, characterized in that: The S300 includes: S310, attaching the neutral electrode to the preset ablation point based on the attachment plan; S320, puncture the radial artery or femoral artery to insert an arterial sheath and guiding catheter; S330, hepatic artery angiography, the ablation catheter is sent into the preset ablation area of ​​the target blood vessel through the guide catheter.

10. The radiofrequency ablation method according to claim 6, characterized in that: The S400 includes: S410, operating the ablation device to perform wall adhesion detection, determine the wall adhesion status of the ablation electrode, and start radiofrequency energy output; S420, detecting the impedance temperature parameters of the location to be ablated, and simultaneously monitoring and detecting the preset electrical parameters of the radio frequency energy to determine whether the current path forms a complete loop.

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