Multipolar cauterization device

Abstract

A radiofrequency ablation device for delivering direct current, alternating current, and radiofrequency energy to a lesion is disclosed for use in treating pulmonary diseases. The radiofrequency ablation device can determine the effectiveness of ablation based on one or more of the following: the impedance drop, the impedance change rate, the change in the impedance change rate, or the change from a drop to an increase in impedance. The radiofrequency ablation device employs a step-by-step control method and dynamic smoothing to adjust the radiofrequency output power and control the ablation temperature, preventing a rapid rise in the temperature of the tissue to be ablated within a short period of time and ensuring a smooth change in the radiofrequency output power during the ablation process. It also has a unique protection mechanism to prevent repeated ablation. Before each ablation, the device measures the temperature of the area to be ablated and will not initiate ablation if the temperature exceeds 40°C to 60°C. A multipolar ablation device including the radiofrequency ablation device is also disclosed.

Description

Technical Field

[0001] The present invention relates to the field of minimally invasive medical devices, particularly radiofrequency ablation devices and multipolar ablation devices for transmitting energy within the trachea and bronchi.

Background Art

[0002] Chronic obstructive pulmonary disease is a progressive disease in which the airflow into and out of the lungs is restricted due to the obstruction of the airway, including asthma, emphysema, COPD, etc. Therefore, patients with chronic obstructive pulmonary disease experience dyspnea, as well as symptoms such as coughing, wheezing, shortness of breath, chest pain, and mucus production (asthma attacks), and require clinical treatment and therapy, consuming a lot of medical resources and risking hospitalization or life-threatening situations. The causes of chronic obstructive pulmonary disease include airway smooth muscle contraction, excessive mucus secretion from airway glands, hypertrophy due to airway wall smooth muscle inflammation, and changes in the anatomical structure of the peribronchial tissue.

[0003] Pathological proliferation and excessive and inappropriate contraction of airway smooth muscle within the airway wall of patients are one of the pathological mechanisms of chronic obstructive pulmonary disease. Therefore, reducing or removing pathologically proliferated airway smooth muscle is one of the options for treating chronic obstructive pulmonary disease.

[0004] Currently, the main methods for clinically treating chronic obstructive pulmonary diseases such as asthma, emphysema, and COPD are drug treatments such as octopamine, theophylline-based drugs, and hormones, as well as symptomatic treatments such as expectoration and anti-inflammation. However, not only is long-term medication required, but this type of disease cannot be cured. Some patients may still be unable to effectively control their condition even when using inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA).

[0005] Existing minimally invasive ablation techniques can reduce pathologically proliferated airway smooth muscle. During this treatment, a catheter is positioned within the airway, and the electrode array at the catheter's tip is expanded and brought into contact with the airway wall. The catheter is then moved to gradually deliver energy to multiple locations within the trachea, thereby removing the pathologically proliferated airway smooth muscle.

[0006] The safety and effectiveness of the ablation equipment used in bronchial radiofrequency ablation based on existing technologies are all flawed. For example, it is not possible to monitor or display the adhesion status of the ablation electrodes, a very large amount of radiofrequency energy is applied at the moment ablation begins, and there is a considerable overshoot in temperature after the set temperature is reached. The suddenly applied and / or suddenly changing radiofrequency energy irritates the patient's airway, and the temperature overshoot poses a threat to the patient's safety. In addition, during the treatment process of bronchial radiofrequency ablation, the temperature of the ablation electrodes is frequently and complexly disturbed due to changes in airflow caused by the patient's respiratory movements, electrode sliding due to the patient's chest cavity movements, and changes in adhesion due to the instability of the operator's grip strength. As a result, conventional proportional-integral control algorithms are prone to oscillations and overshoots, and it is difficult to adapt to these complex external disturbances, thus hindering the effectiveness of the ablation treatment.

[0007] In ideal bronchial radiofrequency ablation, it is essential to avoid repeating ablation on the same site. However, in actual clinical practice, operator negligence, errors, or the lack of prompting functions in the equipment used can lead to the catheter (electrode) not being moved after the first ablation is complete, or not being moved far enough. This can result in restarting ablation and repeating ablation on the same site, causing permanent and irreversible damage to airway tissue, and even leading to airway fistula. The present invention defines the logical relationship between impedance, output, and temperature, and before each ablation, measures the temperature of the site to be ablated. If the temperature of the site exceeds 40°C to 60°C, preferably above 45°C, the ablation is not started, and the control mechanism waits. This provides a protective mechanism in the radiofrequency ablation device of the present invention to prevent repeat ablation. [Overview of the Initiative] [Problems that the invention aims to solve]

[0008] The objective of the present invention is to provide a device that has the function of transmitting energy in the trachea and bronchi, which is safer and more effective than existing technologies, in order to address the shortcomings of existing technologies. [Means for solving the problem]

[0009] To achieve the above objectives, the present invention employs the following technical methods: A radiofrequency cautery device capable of generating and controlling DC current, AC current and radiofrequency energy, as well as collecting, processing and displaying temperature, impedance or tension signals, and determining the effectiveness of cautery based on changes in impedance or tension signals, wherein the change in impedance is one or more selected from impedance decrease value, impedance change rate, change in impedance change rate, or change from impedance decrease to increase.

[0010] Furthermore, the impedance drop value is 10Ω to 100Ω. 、 Or an impedance change rate of -1Ω / s to -50Ω / s 、 Alternatively, cauterization is effective when the impedance change shifts from decreasing to increasing. This indicates .

[0011] Furthermore, the impedance reduction value is 20Ω to 50Ω 、 Or an impedance change rate of -5Ω / s to -50Ω / s 、 Alternatively, cauterization is effective when the impedance change shifts from decreasing to increasing. This indicates .

[0012] Furthermore, the radiofrequency cautery device employs a stepwise control method through a closed-loop control system to control the cautery temperature by adjusting the radiofrequency output power. This stepwise control includes the following stages: (1) High-speed heating stage: lasting 0.5s to 2s from the start of cautery, with the endpoint temperature of the high-speed heating stage reaching 50% to 80%, preferably 65%, of the cautery temperature; (2) Low-speed heating stage: lasting 0.5s to 2s after the high-speed heating stage, with the endpoint temperature of the low-speed heating stage reaching 70% to 99%, preferably 90%, of the cautery temperature, or 0.1℃ to 10℃, preferably 2℃ lower than the cautery temperature; (3) Stability maintenance stage: after the low-speed heating stage, the temperature is stably maintained until cautery is stopped.

[0013] At each of the above stages, individual optimization is performed based on the actual treatment needs, taking into account the specific characteristics of the equipment. Throughout the entire cauterization treatment process, the radiofrequency output power starts from 0 and changes smoothly, increases sharply during the rapid heating phase, increases gradually during the slow heating phase, then gradually decreases, and continues to decrease slowly during the stabilization phase, gradually moving towards stability.

[0014] By employing a stepwise proportional-integral control algorithm, the device determines the differences in treatable areas of the bronchi and the degree of electrode adhesion. The bronchial radiofrequency ablation device controls the radiofrequency output power to bring the ablation electrode temperature to the set temperature within 3 seconds, and can keep the temperature overshoot after reaching the set temperature to 3°C, usually less than 0.5°C to 1.5°C. The temperature is stably maintained at the set temperature, with fluctuations of less than 1°C, usually less than 0.5°C. Throughout the ablation treatment process, the radiofrequency output power changes smoothly, and the radiofrequency energy is not suddenly applied or changed abruptly.

[0015] Furthermore, the radiofrequency cautery apparatus of the present invention performs a dynamic smoothing process on the temperature during the process of controlling the cautery temperature, which includes averaging, weighted averaging, or median averaging with respect to the sample temperature value. Based on the temperature value obtained by the dynamic smoothing process, the radiofrequency cautery apparatus is instructed to adjust the radiofrequency output power, thereby ensuring a smooth change in the radiofrequency output power during the cautery process.

[0016] The upper threshold of the dynamic smoothing process is 0.1°C / s to 20°C / s, preferably 5°C / s, and the lower threshold is -0.1°C / s to -20°C / s, preferably -5°C / s. If the rate of temperature change falls below the lower threshold, the time window for the smoothing process is extended; if the rate of temperature change exceeds the upper threshold, the time window for the smoothing process is shortened; and if the rate of temperature change is between the lower and upper thresholds, the time window for the smoothing process is kept constant.

[0017] Preferably, the dynamic range of the time window for the smoothing process is 0s to 10s, and more preferably 0s to 2.5s.

[0018] The dynamic temperature smoothing process described above can handle various complex disturbances. Throughout the entire cauterization treatment process, the radiofrequency output power changes smoothly, without sudden changes, and the temperature remains stable with minimal fluctuations. Even with frequent and severe disturbances, oscillations and overshoots do not occur. Furthermore, it effectively suppresses temperature overshoots that may be caused by disturbances, and even with severe and complex disturbances, the temperature overshoot does not exceed 3°C. This ensures the safety and effectiveness of the process in which cauterization energy eliminates pathological growths.

[0019] Furthermore, the radiofrequency cautery device of the present invention has a protective mechanism to prevent repeated cautery. Before each cautery procedure, the temperature of the area to be cautered is measured, and if the temperature of the area to be cautered exceeds 40°C to 60°C, preferably 45°C, the cautery procedure is not started.

[0020] Furthermore, the radiofrequency ablation device measures the impedance by continuously measuring a weak alternating current signal, and when outputting radio waves, calculates the impedance based on the voltage and current using Method 1, and / or directly measures the impedance without outputting radio waves using Method 2.

[0021] Furthermore, the radiofrequency ablation device has a radio wave energy transmission / feedback control mechanism. When the radio wave energy is output for 2 to 4 seconds, the tissue ablation temperature reaches the set temperature and is maintained for 6 to 8 seconds. If the tissue ablation temperature exceeds the over-temperature threshold, an over-temperature warning is issued, and the ablation system automatically interrupts the output of the radio wave energy. Preferably, the set temperature is 60°C to 70°C, and the over-temperature threshold is 1°C to 10°C higher than the set temperature.

[0022] More preferably, the set temperature is 65°C, and the over-temperature threshold is 3°C higher than the set temperature.

[0023] Furthermore, the radiofrequency ablation device adopts a multi-central controller, a temperature multiplexing circuit, and a voltage and current multiplexing circuit design.

[0024] Furthermore, the radiofrequency ablation device has a data transmission interface and can externally connect a computer to obtain each parameter information (such as temperature, impedance, output, time, whether the ablation is successful, etc.) in real time.

[0025] Furthermore, the radiofrequency ablation device has a touch panel for displaying the electrode state and the adhesion impedance value between the electrode and the tissue, and can control the emission energy of one or more electrodes by clicking on the touch panel.

[0026] Another object of the present invention is to provide a multi-polar ablation device including the radiofrequency ablation device, electrode module, guide catheter, handle, and connector described in the present invention.

[0027] Among them, there is at least one cavity in the guide catheter: The electrode module is installed at the front end of the guide catheter and is connected to the handle via wiring that penetrates the inside of the guide catheter. The electrode module includes one or more electrode groups and one or more detection devices, the electrode groups being capable of applying electrical energy, radiofrequency energy, laser energy, high-density focused ultrasound, or cryoablation, and the detection devices being used to measure temperature, impedance, or tension; The handle is connected to a connector and one or more electrode modules and includes one or more operating members, which are used to control the contraction, expansion, and energy release of the electrode group, and can also control the extension or retraction of the guide catheter by the electrode modules; The aforementioned connector is used to supply energy to the electrodes.

[0028] Furthermore, the radiofrequency ablation device can display the impedance or tension of the electrodes and indicate whether the electrode module is properly attached to the tracheal wall. If the impedance value after the electrodes of the bronchial radiofrequency ablation device are attached to the tissue is below a threshold, it indicates that the electrode module is properly attached to the tracheal wall.

[0029] Preferably, the impedance threshold is 500 ohms to 1000 ohms, and more preferably 900 ohms.

[0030] Furthermore, the method for determining whether the radiofrequency ablation device has good contact between the electrodes and the tracheal wall is such that the radiofrequency ablation device can measure the impedance of each electrode, and if the impedances match, the contact between the electrodes and the tracheal wall is good, and if the contact between any electrode and the tracheal wall is poor, the impedance is different from that of the other electrodes that have good contact.

[0031] Furthermore, the radiofrequency cautery device simultaneously uses two impedance measurement methods: Method 1, which calculates the impedance using voltage and current when a weak AC signal is continuously applied and the radio frequency is output; and Method 2, which measures the magnitude of the impedance without outputting a radio frequency.

[0032] Furthermore, the detection device includes a temperature detection device, an impedance detection device, and a tension detection device.

[0033] Furthermore, the electrode group includes one or more electrodes, each electrode connected to the handle through an independent electrode wire, and the electrode group unfolds in a basket, spiral, or balloon shape under the control of the operating member, and in the case of multiple electrode groups, the electrode groups are arranged sequentially in series, and the external dimensions of the unfolded electrode group increase as it approaches the handle, with the external dimensions being 1 to 20 mm.

[0034] Furthermore, the electrode module includes a traction wire, the ends of which are fixed to the traction wire, the traction wire passes through the guide catheter and is connected to a handle, the handle controls the contraction and expansion of the electrode group by pulling or releasing the traction wire.

[0035] Furthermore, in situations where multiple electrode groups exist, a damage prevention structure is installed on the head of the electrode group furthest from the handle, and the electrode groups are connected to each other by support members.

[0036] Furthermore, a pressure sensor is installed on the tow wire.

[0037] Furthermore, the electrode module includes balloons placed between the electrodes, which penetrate the guide catheter via a balloon airway and are connected to a handle, which can be connected to an inspiratory device. When air is injected and the balloons inflate, they open the electrode group. In cases where multiple electrode groups exist, multiple balloons are arranged in series sequentially, and each balloon is connected to a handle via an independent balloon airway.

[0038] Furthermore, the guide catheter becomes harder as it approaches the handle, with a hardness distribution of 90A to 80D on the Shore hardness scale.

[0039] Furthermore, the operating member of the handle includes a control circuit board and control buttons, the control circuit is connected to electrode modules and control buttons, and the control buttons control different components in different electrode modules, respectively.

[0040] Furthermore, the electrode group can control the emission energy of one or more electrodes under the control of the handle operating member.

[0041] To achieve the objectives of the present invention, the present invention provides a multi-electrode cauterization device for the function of transmitting energy in the trachea and bronchi, the device mainly comprising a first electrode module, a second electrode module, a guide catheter, a handle, and a connector. The first and second electrode modules are arranged in a continuous axial direction in the guide catheter, the heads of the electrode modules are fitted with damage prevention structures and used to fix the first electrode module, the first and second electrode modules are connected by a support member, the near end of the first electrode module and the far end of the second electrode module are fixed on the support member, the far end of the traction wire is connected to the damage prevention structure of the head, the near end is fixed to the support member and enters the handle through the guide catheter. The near end of the second electrode module is fixed on the catheter. When the handle is controlled to contract the traction wire toward the near end, the first electrode module expands first, and at the same time the second electrode module expands synchronously. Due to the characteristics of the tracheal tube, the electrode modules are set so that the far end is small and the near end is large, with a diameter difference of approximately 1 to 5 mm.

[0042] Multiple electrodes, specifically the first, second, third, fourth, fifth, sixth, seventh, and eighth electrodes, are installed on the first and second electrode modules. The electrodes are made of stainless steel and have a certain degree of elasticity. Each electrode and its independent electrode wire is connected to a handle, which is connected to the bronchial radiofrequency ablation device via a connector. During use, each electrode can individually measure the adhesion impedance value between the electrode and the tissue through the circuit formed by the tracheal tissue and the control circuit board. If the electrodes are properly attached (measured impedance value is 500 ohms to 1000 ohms or less), the bronchial radiofrequency ablation device emits radiofrequency energy to ablate the lesion tissue. Temperature sensors are installed on both the first and second electrode modules, allowing for individual measurement of the temperature of the surrounding tissue of the electrode module.

[0043] Alternatively, a first balloon and a second balloon are installed below the first electrode module and the second electrode module, with a first balloon airway installed near the end of the first balloon and a second balloon airway installed near the end of the second balloon. The first and second balloons are separated from each other, and the first and second airways independently supply gas to the first and second balloons. When gas enters the balloons through the balloon airways, the first, second, third, fourth, fifth, sixth, seventh, and eighth electrodes are pressurized and expand, causing the electrode module to expand. The amount of gas entering is controlled by an external inhalation device, and the size of the electrode module expansion can be set by the amount of inhaled air. Furthermore, since the first and second electrode modules are controlled independently, it can accommodate the demands of various tracheal lesion sizes. The first, second, third, fourth, fifth, sixth, seventh, and eighth electrodes each have independent electrode wires, and during use, each electrode can individually measure the adhesion impedance value between the electrode and the tissue through the circuit formed by the tracheal tissue and the control circuit board. The electrode module and each electrode module are equipped with one temperature sensor, allowing for individual measurement of the temperature of the surrounding tissue of the electrode module.

[0044] Alternatively, by employing ring electrodes and arranging the first and second ring electrodes spirally on the first and second balloons, the outer dimensions of the first and second ring electrodes increase when gas is injected into the balloons. Independent electrode wires are installed on the first and second ring electrodes, and during use, each electrode can individually measure the adhesion impedance value between the electrode and the tissue through the circuit formed by the tracheal tissue and the control circuit board. One temperature sensor is installed on each ring electrode, allowing for individual measurement of the temperature of the tissue surrounding the electrode module.

[0045] In one preferred means of the present invention, an indicator is installed on the handle, which theoretically indicates that radiofrequency ablation may be performed if the impedance value after the electrode is attached to the tissue is 500 ohms to 1000 ohms or less. When the bronchial radiofrequency ablation device detects that the electrode attachment resistance is 500 ohms to 1000 ohms or less, the indicator turns green, indicating that ablation can be performed. When the bronchial radiofrequency ablation device detects that the electrode attachment resistance is 500 ohms to 1000 ohms or more, the indicator turns red, indicating that ablation cannot be performed.

[0046] In one preferred method of the present invention, a pressure sensor is installed within a portion of the traction wire, and both ends of the traction wire are connected to both ends of the pressure sensor. When the electrode module is pulled, the traction wire is subjected to force. The same tensile force received by the pressure sensor at this time is displayed after processing by a bronchial radiofrequency ablation device, and the degree of adhesion is determined. If the electrode is adhered to the tissue, the degree of adhesion between the electrode arm and the tissue can be determined by judging the tensile force of the traction.

[0047] In one preferred means of the present invention, the touch panel of the radiofrequency ablation device displays the electrode status and the adhesion impedance value between the electrode and the tissue, and allows the emission energy of one or more electrodes to be controlled by clicking the touch panel.

[0048] In one preferred means of the present invention, the guide catheter can be a guide tube, and the guide tube has an electrode module and a cavity capable of housing the electrode module, the electrode module can expand and contract freely within the guide tube, and liquid can pass through the guide tube cavity, so that anti-inflammatory agents, anesthetics, etc. can enter the lesion tissue to be cauterized by passing through the guide tube cavity, thereby alleviating the patient's pain and complications.

[0049] Another object of the present invention is to provide a method for determining the effectiveness of radiofrequency ablation, which involves applying electrical stimulation to the ablation site, measuring, collecting, and processing the impedance value of the ablation site, and determining the effectiveness of the ablation based on the change in impedance. The change in impedance is one or more selected from the following: a decrease in impedance, an impedance change rate, a change in the impedance change rate, or a change from a decrease to an increase in impedance.

[0050] Preferably, the impedance drop value is 10Ω to 100Ω, and more preferably 20Ω to 50Ω. 、 Alternatively, the impedance change rate is -1Ω / s to -50Ω / s, more preferably -5Ω / s to -50Ω / s. 、 Alternatively, cauterization is effective when the impedance change shifts from decreasing to increasing. This indicates .

[0051] Another object of the present invention is to provide a method for controlling radio wave cautery temperature, employing a stepwise control method through a closed-loop control system to control the cautery temperature by adjusting the radio wave output power, the stepwise control including: (1) a high-speed heating stage: lasting 0.5s to 2s from the start of cautery, with the endpoint temperature of the high-speed heating stage reaching 50% to 80% of the cautery temperature; (2) a low-speed heating stage: lasting 0.5s to 2s after the high-speed heating stage, with the endpoint temperature of the low-speed heating stage reaching 70% to 99% of the cautery temperature, or 0.1℃ to 10℃ lower than the cautery temperature; and (3) a stable maintenance stage: after the low-speed heating stage, the temperature is stably maintained until cautery is stopped.

[0052] Preferably, the step-by-step control includes the following steps: (1) a high-speed heating step: lasting 1 second from the start of cauterization, with the endpoint temperature of the high-speed heating step reaching 65% of the cauterization temperature; (2) a low-speed heating step: lasting 1 second after the high-speed heating step, with the endpoint temperature of the low-speed heating step reaching 90% of the cauterization temperature, or 2°C lower than the cauterization temperature; and (3) a stable maintenance step: after the low-speed heating step, the temperature is stably maintained until the cauterization is stopped.

[0053] Another object of the present invention is to provide a method for removing noise from radiofrequency cautery temperature, which involves performing a dynamic smoothing process on the temperature during the process of controlling the cautery temperature, including averaging, weighted averaging, or median averaging with respect to the sample temperature value, and instructing the radiofrequency cautery unit to adjust the radiofrequency output power based on the temperature value obtained from the dynamic smoothing process, thereby ensuring a smooth change in the radiofrequency output power during the cautery process.

[0054] Preferably, the upper threshold for dynamic smoothing is 0.1°C / s to 20°C / s, more preferably 5°C / s, and the lower threshold is -0.1°C / s to -20°C / s, more preferably -5°C / s. If the rate of temperature change falls below the lower threshold, the time window for smoothing is extended; if the rate of temperature change exceeds the upper threshold, the time window for smoothing is shortened; and if the rate of temperature change is between the lower and upper thresholds, the time window for smoothing is kept constant.

[0055] As a preferred method of the above, when the rate of temperature change exceeds 1°C / s to 50°C / s, the dynamic range of the time window for the smoothing process is 0s to 10s. More preferably, when the rate of temperature change exceeds 20°C / s, the time window for the smoothing process is 2.5s.

[0056] Another object of the present invention is to provide a method for preventing repeated cauterization, in which the temperature of the area to be cauterized is measured each time before cauterization is performed, and if the temperature of the area to be cauterized is 40°C to 60°C, preferably above 45°C, the cauterization is not started.

[0057] The advantages of this invention are as follows: (1) The present invention precisely controls the generated and controlled DC current, AC current, and radio wave energy by defining the logical relationship between impedance, output, and temperature, and collects, processes, and displays temperature, impedance, or tension signals, and determines the effectiveness of cauterization based on changes in the impedance or tension signal. Among these, the change in impedance is one or more selected from the decrease in impedance, the rate of change in impedance, the change in the rate of change in impedance, or the change from decrease to increase in impedance. A closed-loop control system is used, and a stepwise control method is employed to control the cauterization temperature by adjusting the radio wave output power, and dynamic temperature smoothing is used to counteract various disturbances. This further guarantees the safety and effectiveness of the system, preventing situations such as cauterization failure or inability to cauterize, as well as situations such as overlapping cauterization or excessive cauterization.

[0058] (2) The present invention employs a stepwise proportional-integral control algorithm, and in all cases, regardless of the differences in the treatable sites of the bronchi and the degree of electrode adhesion, the bronchial radiofrequency ablation device controls the radiofrequency output power to bring the temperature of the ablation electrode to the ablation temperature within 3 seconds, and the temperature overshoot after reaching the ablation temperature can be kept to 3°C, usually less than 0.5°C to 1.5°C, and the temperature is stably maintained at the ablation temperature, so the fluctuation is less than 1°C, usually less than 0.5°C. Throughout the entire ablation treatment process, the radiofrequency output power changes smoothly, and the radiofrequency energy is not suddenly applied and / or changed abruptly.

[0059] (3) The present invention can handle various complex disturbances through dynamic temperature smoothing, and throughout the entire cauterization process, the radiofrequency output power changes smoothly without sudden changes in radiofrequency output power, the temperature is kept stable with small fluctuations, and even with frequent and severe disturbances, it does not cause vibrations or overshoots. Furthermore, it can effectively suppress temperature overshoots that may be caused by disturbances, and even with severe and complex disturbances, the temperature overshoot does not exceed 3°C.

[0060] (4) The radiofrequency ablation device of the present invention further has a protective mechanism to prevent repeated ablation. Before performing ablation, the temperature of the area to be ablated is measured each time, and if the temperature of the area to be ablated exceeds 40°C to 60°C, the ablation is not started. In this way, repeated ablation of the same area due to the operator's carelessness or error is easily and effectively prevented.

[0061] This invention provides a device that has the function of transmitting energy within the trachea and bronchi. By using this device to deliver direct current, alternating current, and radiofrequency energy to lesions, it is possible to remove pathologically proliferated bronchial smooth muscle, expand the diameter of the trachea at rest, reduce pathological contraction of the tracheal wall and respiratory resistance, and improve the regulatory adaptability of the trachea. It can be used in the non-pharmacological treatment of obstructive pulmonary diseases, for example, in patients with persistent asthma, emphysema, or COPD that cannot be effectively controlled even with the administration of drugs (corticosteroids and long-acting β2-agonists). [Brief explanation of the drawing]

[0062] [Figure 1] This is a schematic diagram of the multi-electrode cauterization apparatus of Example 1. [Figure 2] This is a schematic diagram of the basket-shaped electrode module of Example 1 before expansion. [Figure 3] This is a schematic diagram 1 of the expanded basket-shaped electrode module of Example 1. [Figure 4] This is a schematic diagram 2 of the expanded basket-shaped electrode module of Example 1. [Figure 5] This is a partial cross-sectional view of the support member of Example 1. [Figure 6] This is a schematic diagram 1 of the balloon electrode module of Example 2. [Figure 7] This is a schematic diagram 2 of the balloon electrode module of Example 2. [Figure 8] This is a partial cross-section of the support member in Example 2. [Figure 9] This is a schematic diagram of the helical electrode module of Example 3. [Figure 10] This is a schematic diagram of the handle. [Figure 11] This is a cross-sectional view of the pressure sensor installation. [Figure 12] This is the touch panel for a radiofrequency ablation device. [Figure 13] This is an impedance measurement taken in the left lung lobe of a pig lung in the first case, due to differences in grip strength on a handle. [Figure 14] This is an impedance measurement taken in the right lobe of a pig lung in the first case, due to differences in grip strength on a handle. [Figure 15] This is an impedance measurement taken in the left lung lobe of a pig lung in the second case, due to differences in grip strength on the handle. [Figure 16] This is an impedance measurement taken in the right lobe of a pig lung in the second case, due to differences in grip strength on the handle. [Figure 17] This shows the relationship between the number of electrodes attached to isolated pig lungs and their impedance. [Figure 18] This shows the relationship between the number of saltwater electrodes attached and the impedance. [Figure 19] This is a measurement of the impedance of radiofrequency ablation. [Figure 20] This is a curve showing the change in tissue impedance during the cauterization process in animal experiments. [Figure 21] This curve shows the relationship between tissue temperature and radio frequency output power during a cauterization process that does not employ stepwise control or dynamic temperature smoothing. [Figure 22] This is a curve showing the relationship between tissue temperature and radio wave output power during the cauterization process when using stepwise control and dynamic temperature smoothing. [Figure 23] This is a record of an animal experiment where the tissue temperature exceeded the overheating threshold during the cauterization process, and the cauterization was stopped. [Modes for carrying out the invention]

[0063] The radiofrequency cautery device of the present invention generates and controls DC current, AC current, and radiofrequency energy, and can collect, process, and display temperature, impedance, or tension signals, and determines the effectiveness of cautery based on changes in the impedance or tension signal, wherein the change in impedance is one or more selected from the following: a decrease in impedance, an impedance change rate, a change in the impedance change rate, or a change from impedance decrease to impedance increase. Furthermore, the decrease in impedance is between 10Ω and 100Ω. 、 Or an impedance change rate of -1Ω / s to -50Ω / s 、 Alternatively, cauterization is effective when the impedance change shifts from decreasing to increasing. This indicates .

[0064] The radio frequency cautery device of the present invention employs a stepwise control method through a closed-loop control system to control the cautery temperature by adjusting the radio frequency output power. This stepwise control includes the following stages: (1) a high-speed heating stage: lasting 0.5s to 2s from the start of cautery, with the endpoint temperature reaching 50% to 80% of the cautery temperature; (2) a low-speed heating stage: lasting 0.5s to 2s after the high-speed heating stage, with the endpoint temperature reaching 70% to 99% of the cautery temperature, or 0.1°C to 10°C lower than the cautery temperature; and (3) a stable maintenance stage: after the low-speed heating stage, the temperature is stably maintained until the cautery is stopped.

[0065] Simultaneously, the radiofrequency cautery unit performs a dynamic smoothing process on the temperature during the process of controlling the cautery temperature, which includes averaging, weighted averaging, or median averaging the temperature with respect to the sample temperature value. Based on the temperature value obtained from the dynamic smoothing process, the radiofrequency cautery unit is instructed to adjust the radiofrequency output power, thereby ensuring a smooth change in the radiofrequency output power during the cautery process. The upper threshold of the dynamic smoothing process is 0.1°C / s to 20°C / s, and the lower threshold is -0.1°C / s to -20°C / s. If the rate of temperature change falls below the lower threshold, the time window for the smoothing process is extended; if the rate of temperature change exceeds the upper threshold, the time window for the smoothing process is shortened; and if the rate of temperature change is between the lower and upper thresholds, the time window for the smoothing process is kept constant. When the upper threshold of the dynamic smoothing process is 5°C / s and the lower threshold is -5°C / s, the dynamic range of the time window for the smoothing process is 0s to 10s, preferably 0s to 2.5s.

[0066] Furthermore, the radiofrequency cautery device has a protection mechanism to prevent repeated cautery. Before each cautery procedure, it measures the temperature of the area to be cautered, and if the temperature of the area exceeds 40°C to 60°C, it does not start the cautery procedure.

[0067] Furthermore, the radiofrequency ablation device has a radiofrequency energy transmission / feedback control mechanism. When radiofrequency energy is output for 2 to 4 seconds, the tissue ablation temperature reaches the set temperature and is maintained for 6 to 8 seconds. If the tissue ablation temperature exceeds the overtemperature threshold, an overtemperature warning is issued, and the ablation system automatically interrupts the output of radiofrequency energy. The set temperature is 60°C to 70°C, and the overtemperature threshold is 1°C to 10°C higher than the set temperature. Preferably, the set temperature is 65°C, and the overtemperature threshold is 3°C higher than the set temperature.

[0068] The objectives of the present invention can be achieved by employing the multi-electrode cauterization apparatus shown in the embodiments of the present invention. The following embodiments are merely preferred embodiments of the present invention and do not impose any limitations on the present invention. Simple modifications, equivalent changes, and modifications substantially made to the above embodiments based on the art and methods of the present invention all fall within the scope of the art and methods of the present invention. [Examples]

[0069] Example 1 The present invention relates to a device for the function of transmitting energy in the trachea and bronchi, and further to a multi-electrode cauterization device. As shown in Figure 1, the device mainly includes a first electrode module 2, a second electrode module 3, a guide catheter 6, a handle 17, and a connector 18. As shown in Figure 2, the first electrode module 2 and the second electrode module 3 are arranged continuously in the axial direction of the guide catheter 6. Damage prevention structures 1 are installed on the heads of the electrode modules and are used to fix the first electrode module 2. The first electrode module 2 and the second electrode module 3 are connected by a support member 4. The near end of the first electrode module 2 and the far end of the second electrode module 3 are fixed on the support member 4. The far end of the traction wire 5 is connected to the damage prevention structure 1 on the head, and the near end is fixed to the support member 4 (as shown in Figure 5), and enters the handle 17 through the guide catheter 6. The near end of the second electrode module 2 is fixed on the catheter 6. As shown in Figure 3, when the handle 17 controls the traction wire 5 to contract toward the near end, the first electrode module 2 expands first, and simultaneously the second electrode module 3 expands in sync. Due to the characteristics of the tracheal tube, the electrode modules are set so that the distal end is small and the near end is large, with a diameter difference of approximately 1 to 5 mm.

[0070] Multiple electrodes, specifically the first electrode 21, second electrode 22, third electrode 23, fourth electrode 24, fifth electrode 31, sixth electrode 32, seventh electrode 33, and eighth electrode 34, are installed on the first electrode module 2 and the second electrode module 3. The electrodes are made of stainless steel and have a certain degree of elasticity. Each electrode and its independent electrode wire is connected to a handle, which is connected to the bronchial radiofrequency ablation device via a connector 18. During use, each electrode can individually measure the adhesion impedance value between the electrode and the tissue through the circuit formed by the tracheal tissue and the control circuit board. If the electrodes are properly attached (measured impedance value is 500 ohms to 1000 ohms), the bronchial radiofrequency ablation device radiates radiofrequency energy to ablate the lesion tissue. One temperature sensor 201 and 202 are installed on the first electrode module 2 and the second electrode module 3, respectively, allowing for the individual measurement of the temperature of the surrounding tissue of the electrode module.

[0071] Example 2 Figures 6-8 show a second embodiment of the device, in which a first balloon 11 and a second balloon 12 are installed below a first electrode module 2 and a second electrode module 3, respectively. A first balloon airway 15 is installed near the end of the first balloon 11, and a second balloon airway 16 is installed near the end of the second balloon 12. The first balloon 11 and the second balloon 12 are separated from each other, and the first airway 15 and the second airway 16 independently supply gas to the first balloon 11 and the second balloon 12. When gas enters the balloon through the balloon airway, the first electrode 71, second electrode 72, third electrode 73, fourth electrode 74, fifth electrode 81, sixth electrode 82, seventh electrode 83, and eighth electrode 84 are subjected to pressure and expand, causing the electrode module to expand. The amount of gas entering is controlled by an external intake system, and the size of the electrode module expansion can be set according to the intake volume. Furthermore, since the first electrode module 2 and the second electrode module 3 are controlled independently, it can accommodate the demands of various tracheal lesion sizes.

[0072] The first electrode 71, second electrode 72, third electrode 73, fourth electrode 74, fifth electrode 81, sixth electrode 82, seventh electrode 83, and eighth electrode 84 each have independent electrode wires, and during use, each electrode can individually measure the adhesion impedance value between the electrode and the tissue through the circuit formed by the tracheal tissue and the control circuit board. One temperature sensor 201 and one temperature sensor 202 are installed on the first electrode module 2 and the second electrode module 3, respectively, and the temperature of the surrounding tissue of the electrode module can be measured individually.

[0073] Example 3 Figure 9 shows a third embodiment in which the first ring electrode 1 and the second ring electrode 2 are spirally arranged on the first balloon 11 and the second balloon 12, respectively. When gas is injected into the balloons, the outer shapes of the first ring electrode 1 and the second ring electrode 2 increase. Independent electrode wires are installed on the first ring electrode 1 and the second ring electrode 2, and during use, each electrode can individually measure the adhesion impedance value between the electrode and the tissue through the circuit formed by the tracheal tissue and the control circuit board. One temperature sensor 201 and one temperature sensor 202 are installed on the ring electrode 1 and the ring electrode 2, respectively, and the temperature of the surrounding tissue of the electrode module can be individually detected.

[0074] As shown in Figure 10, an indicator 19 is installed on the handle 17. Theoretically, radiofrequency ablation can be performed if the impedance value after the electrode is attached to the tissue is 500 ohms to 1000 ohms or less. When the bronchial radiofrequency ablation device detects that the electrode attachment resistance is 500 ohms to 1000 ohms or less, the indicator turns green, indicating that ablation can be performed. When the bronchial radiofrequency ablation device detects that the electrode attachment resistance is 500 ohms to 1000 ohms or more, the indicator turns red, indicating that ablation cannot be performed.

[0075] As shown in Figure 11, a pressure sensor 20 is installed within a portion of the traction wire 5, and the two ends of the traction wire are connected to both ends of the pressure sensor. When the electrode module is pulled, the traction wire 5 receives force, and the same tensile force received by the pressure sensor 20 at this time is displayed after processing by the bronchial radiofrequency ablation device, and the degree of adhesion is determined. When the electrode adheres to the tissue, the degree of adhesion between the electrode arm and the tissue can be determined by judging the tensile force of the traction.

[0076] As shown in Figure 12, the touch panel of the radiofrequency ablation device displays the electrode status and the adhesion impedance value between the electrode and the tissue, and allows the emission energy of one or more electrodes to be controlled by clicking the touch panel.

[0077] The guide catheter 6 may be a guide tube, which has a cavity capable of accommodating electrode modules 2 and 3. The electrode modules can expand and contract freely within the guide tube, and liquid can pass through the guide tube cavity. This allows anti-inflammatory agents, anesthetics, etc., to enter the lesion tissue to be cauterized through the guide tube cavity, thereby alleviating the patient's pain and complications.

[0078] Example 4: Consideration of the relationship between impedance, number of electrodes, and tension in the multi-electrode cautery apparatus of the present invention. Through tissue separation studies, we simulate the clinical application of multipolar cautery devices and observe impedance measurements of the cautery catheter under different bronchial locations, handle grip strength, and electrode placement counts.

[0079] Test environment: Temperature: 15℃~20℃, Humidity: 55%RH~60%RH.

[0080] Test tissue: Two fresh, isolated pig lungs.

[0081] Test principle: Immerse isolated pig lungs in saline solution, connect a cauterization catheter to a radiofrequency ablation device, and manipulate the catheter. Observe and record the impedance reading of the radiofrequency ablation device under different conditions, including different bronchial locations, handle grip strength, and number of electrodes attached.

[0082] Test sites: left upper lobe → left lower lobe → right upper lobe → right lower lobe.

[0083] 1. Consideration of the relationship between differences in electrode tension and impedance. Impedance measurements were observed and recorded at various bronchial sites, with the catheter handle loosened and fully gripped. The results are shown in Tables 1-4 and Figures 13-16. The results indicate a correlation between electrode tension and impedance measurements.

[0084] [Table 1]

[0085] [Table 2]

[0086] [Table 3]

[0087] [Table 4]

[0088] 2. Consideration of the relationship between the number of electrodes attached and impedance. Different numbers of electrodes were attached to the bronchi, and impedance measurements were observed and recorded. The results are shown in Table 5 and Figure 17. Different numbers of electrodes were immersed in saline solution, and impedance measurements were observed and recorded (eliminating the effect of adhesion pressure). The results are shown in Table 6 and Figure 18. From the results, it is clear that the effect of different numbers of electrodes on impedance measurements is significant; the more electrodes attached, the smaller the impedance measurement, and the number of electrodes can be determined based on the impedance measurement.

[0089] [Table 5]

[0090] [Table 6]

[0091] 3. Consideration of the effect of radiofrequency ablation on impedance. Radio waves were emitted, and impedance measurements were observed and recorded. The results are shown in Table 7 and Figure 19. The results show that radiofrequency ablation causes a decrease in impedance measurements, and the effectiveness of ablation can be judged based on the change in impedance or tension signal. The change in impedance is one or more selected from the following: the decrease in impedance, the rate of change in impedance, the change in the rate of change in impedance, or the change from a decrease to an increase in impedance.

[0092] [Table 7]

[0093] Example 5: Consideration of the cauterization effectiveness of the multi-electrode cauterization apparatus of the present invention By employing animal experiments, the cauterization effectiveness of the multi-electrode cauterization apparatus of the present invention was investigated. By defining the logical relationship between impedance, output, and temperature, the generated and controlled DC current, AC current, and radio wave energy are precisely controlled, and temperature and impedance signals are collected, processed, and displayed. The effectiveness of cauterization is determined based on the change in the impedance signal, and the impedance drop value is 10Ω to 100Ω. 、 Or an impedance change rate of -1Ω / s to -50Ω / s 、 Alternatively, cauterization is effective when the impedance change shifts from decreasing to increasing. This indicates .

[0094] The specific steps are as follows: The electrodes of the multi-electrode cauterization apparatus of the present invention are inserted into the planned test site in the canine lung, and the data interface of the multi-electrode cauterization apparatus is connected to a computer. Cauterization is performed by operating the multi-electrode cauterization apparatus, and temperature, output, and impedance data during the test process are displayed and recorded on the computer. The entire test process is observed using a bronchoscope.

[0095] The results are shown in Figure 20, which is the tissue impedance change curve during the cauterization process in animal experiments. The horizontal axis represents time, the left vertical axis represents tissue temperature and radio wave output power, and the right vertical axis represents tissue impedance. As shown in the figure, when cauterization begins, the tissue impedance starts to decrease, and the rate of decrease in tissue impedance gradually slows down and then gradually begins to increase. This indicates that cauterization using the multi-electrode cauterization apparatus of the present invention is effective.

[0096] Example 6: Consideration of the safety and temperature noise reduction capabilities of the multi-electrode cautery apparatus of the present invention. The present invention relates to a device for the function of transmitting energy in the trachea and bronchi, and the device employs a stepwise proportional-integral control algorithm to perform dynamic smoothing processing with respect to temperature. From 0s to 1s after the start of cauterization is a rapid heating stage, in which the radio wave output power rapidly increases from 0 to 10W or more, and the tissue temperature begins to rise rapidly. From 1s to 2s is a slow heating stage, in which the radio wave output power increases slowly and then gradually decreases, and the rate of increase in tissue temperature begins to slow down. From 2s until the end of cauterization is a stable maintenance stage, in which the radio wave output power decreases slowly and maintains the tissue temperature while making small adjustments.

[0097] The dynamic range of the temperature dynamic smoothing time window is 0s to 2.5s. Each time the rate of temperature change exceeds 5°C / s, the smoothing time window is shortened by 0.01s. Each time the rate of temperature change falls below -5°C / s, the smoothing time window is extended by 0.01s. If the rate of temperature change is between -5°C / s and 5°C / s, the smoothing time window remains unchanged. Dynamic temperature smoothing is achieved by averaging the temperatures within the smoothing time window.

[0098] The procedure for the animal experiment is the same as in Example 5.

[0099] The results are shown in Figures 21 and 22. Figure 21 shows the curves of tissue temperature and radiofrequency output power during the cauterization process in animal experiments where stepwise control and dynamic temperature smoothing were not employed. Figure 22 shows the curves of tissue temperature and radiofrequency output power during the cauterization process when stepwise control and dynamic temperature smoothing were employed, with the horizontal axis representing time, the left vertical axis representing tissue temperature, and the right vertical axis representing radiofrequency output power. As shown in the figures, the radiofrequency output power rises sharply within 1 second from the start of cauterization, rises gradually within 2 seconds and then begins to decline, and after 2 seconds it declines gradually and adjusts in small increments. Within 1 second from the start of cauterization, the tissue temperature begins to rise sharply, the temperature rise becomes gradual within 2 seconds, and the cauterization temperature is reached and maintained within 3 seconds. This device controls the radiofrequency output power to bring the cauterization electrode temperature to the cauterization temperature within 3 seconds, and keeps the temperature overshoot after reaching the cauterization temperature to less than 1°C. Because it stably maintains the tissue temperature at the cauterization temperature, fluctuations are less than 1°C, and throughout the entire cauterization process, the radiofrequency output power changes smoothly, so there is no sudden application or / or sudden change in radiofrequency energy. Without stepped control and dynamic temperature smoothing, there would be significant fluctuations in tissue temperature and a considerable temperature overshoot. With stepped control and dynamic temperature smoothing, the tissue temperature is stably maintained and the temperature overshoot is small.

[0100] These results show that the present invention effectively utilizes a closed-loop control system and employs a stepwise control method to adjust the radio wave output power and control the cauterization temperature, while also using dynamic temperature smoothing to counteract various disturbances. This further guarantees the safety and effectiveness of the system, preventing situations such as cauterization errors or failure to cauterize, as well as situations such as repeated cauterization or excessive cauterization.

[0101] Example 7: Consideration of the safety control capability of the radiofrequency cautery apparatus of the present invention The radiofrequency ablation apparatus of the present invention has a radiofrequency energy transmission / feedback control mechanism. When radiofrequency energy is output for 2 to 4 seconds, the tissue ablation temperature reaches the set temperature of 60°C to 70°C and is maintained for 6 to 8 seconds. If the tissue ablation temperature exceeds the overtemperature threshold (1 to 10°C higher than the set temperature), an overtemperature warning is issued and the ablation system automatically stops outputting radiofrequency energy.

[0102] The procedure for the animal experiment is the same as in Example 5.

[0103] As shown in Figure 23, this figure records the time at which the tissue temperature exceeded the overheat threshold during the ablation process in animal experiments, resulting in the ablation being stopped. The horizontal axis represents time, the left vertical axis represents tissue temperature, and the right vertical axis represents radio frequency output power. As shown in the figure, when the tissue temperature exceeds 68°C, the radio frequency output power rapidly decreases to 0, and the ablation is stopped.

Claims

1. A system for generating and controlling direct current, alternating current, and radio wave energy. A system for collecting, processing, and displaying tissue temperature and electrode-tissue adhesion impedance to determine if cauterization is effective by detecting changes in impedance, and A closed-loop control system for controlling the cauterization temperature by adjusting the radio wave output power using a step-by-step control method. It has, The aforementioned change in impedance is characterized by a decrease in impedance of 10Ω to 100Ω, a rate of change in impedance of -1Ω / s to -50Ω / s, or a change in impedance from decreasing to increasing. The aforementioned step-by-step control method is characterized by including the following steps: (1) a high-speed heating step: which lasts for 0.5 s to 2 s from the start of cauterization, and at the end of the high-speed heating step, the tissue temperature reaches 65% to 80% of the cauterization temperature; (2) a low-speed heating step: which lasts for 0.5 s to 2 s after the high-speed heating step, and at the end of the low-speed heating step, the tissue temperature is higher than the tissue temperature at the end of the high-speed heating step, and reaches 70% to 99% of the cauterization temperature, or 0.1°C to 10°C lower than the cauterization temperature; and (3) a stable maintenance step: which lasts for 0.5 s to 2 s after the low-speed heating step, and maintains the tissue temperature stably at the cauterization temperature until the cauterization is stopped. This radiofrequency ablation device transmits energy within the trachea and bronchi.

2. The radiofrequency cautery apparatus according to claim 1, characterized in that the impedance change is such that the impedance decrease is between 20Ω and 50Ω, the impedance change rate is between -5Ω / s and -50Ω / s, or the impedance change is from decreasing to increasing.

3. The radiofrequency ablation device according to claim 1, characterized in that the step-by-step control method includes the following steps: (1) a high-speed heating step: which lasts for 1 second from the start of ablation, and at the end of the high-speed heating step the tissue temperature reaches 65% of the ablation temperature; (2) a low-speed heating step: which lasts for 1 second after the high-speed heating step, and at the end of the low-speed heating step the tissue temperature reaches 90% of the ablation temperature, or 2°C lower than the ablation temperature; and (3) a stable maintenance step: which, after the low-speed heating step, stably maintains the tissue temperature at the ablation temperature until the ablation is stopped.

4. The radio frequency cautery apparatus according to claim 1, characterized in that, in the process of controlling the cautery temperature, the radio frequency cautery apparatus performs a dynamic smoothing process, which includes averaging, weighted averaging, or median averaging of the tissue temperature values ​​with respect to the tissue temperature collected by the tissue temperature collection, processing, and display system, and instructs the radio frequency cautery apparatus to adjust the radio frequency output power based on the temperature value obtained by the dynamic smoothing process, thereby ensuring a smooth change in the radio frequency output power during the cautery process.

5. The radio wave cautery device according to claim 1, characterized in that it uses method 1, which involves continuously applying a weak AC signal to detect impedance and then calculating impedance by voltage and current when outputting radio waves, and / or method 2, which involves directly detecting impedance without outputting radio waves.

6. The radiofrequency cautery apparatus according to claim 1, characterized by having a data transmission interface that can be connected to an external computer.

7. The radiofrequency ablation device according to claim 1, characterized in that it has a touch panel that displays the electrode status of a cauterization catheter connected to the radiofrequency ablation device and the adhesion impedance value between the electrode and the tissue, and that allows the emission energy of one or more electrodes to be controlled by clicking.

8. A multipolar cautery device for transmitting energy in the trachea and bronchi, comprising a radiofrequency ablation device according to any one of claims 1 to 7, an electrode module, a guide catheter, a handle, and a connector, The guide catheter contains at least one cavity, The electrode module is installed at the front end of the guide catheter and is connected to the handle by electrode wires that pass through the inside of the guide catheter. The electrode module includes one or more electrode groups and one or more detection devices. The electrode groups can apply electrical energy, radio wave energy, laser energy, high-density focused ultrasound, or cryoablation to the tissue to be ablated. The detection devices are used to measure tissue temperature and electrode-tissue adhesion impedance. The handle is connected to a connector and one or more electrode modules and includes one or more operating members, which are used to control the contraction, expansion and energy release of the electrode modules, and can also control the extension of the electrode modules from or retraction into the guide catheter. The aforementioned connector is used to provide energy to the electrodes. The DC current, AC current, and radio wave energy generation and control system of the radio wave cautery unit transmits energy to the electrode module. The tissue temperature and electrode-tissue adhesion impedance measured by the detection device are transmitted to the tissue temperature and electrode-tissue adhesion impedance collection, processing, and display system. Characterized by, Multipolar cauterization device.

9. The multi-pole cauterization apparatus according to claim 8, characterized in that the detection device includes a temperature detection device, an impedance detection device, and an electrode tension detection device.

10. The multi-electrode cautery apparatus according to claim 9, characterized in that the electrode group includes one or more electrodes, each electrode is connected to a handle through an independent electrode wire, the electrode group unfolds in a basket shape, spiral shape or balloon shape under the control of an operating member, and in the case where there are multiple electrode groups, the electrode groups are arranged sequentially in series, and as the electrode group approaches the handle, the external dimensions after unfolding increase, and the external dimensions are 1 to 20 mm.

11. The multi-electrode cauterization apparatus according to claim 10, characterized in that the electrode module further includes a traction wire, both ends of the electrode are fixed on the traction wire, the traction wire passes through a guide catheter and is connected to a handle, and the handle controls the contraction and expansion of the electrode group by pulling or releasing the traction wire.

12. The multi-electrode cautery apparatus according to claim 11, characterized in that, in a situation in which multiple electrode groups exist, a damage prevention structure is installed at the head end of the electrode group furthest from the handle, and the electrode groups are connected to each other by a support member.

13. The multi-pole cauterization apparatus according to claim 11, characterized in that a pressure sensor is installed on the traction wire.

14. The multi-electrode cauterization apparatus according to claim 10, characterized in that the electrode module further includes a balloon, the balloon is placed between electrodes, is connected to a handle through a balloon airway that penetrates a guide catheter, is connected to an inspiratory device via the handle, the electrode group can be deployed by inflating the balloon with air, and in the case where there are multiple electrode groups, the multiple balloons are arranged in series in sequence, and the multiple balloons are each connected to a handle via independent balloon airways.

15. The multipolar cautery apparatus according to claim 8, characterized in that the guide catheter becomes harder closer to the handle, and its hardness distribution is Shore hardness 90A to 80D.

16. The multi-electrode cautery apparatus according to claim 8, wherein the operating member of the handle includes a control circuit board and control buttons, the control circuit board is connected to electrode modules and control buttons, and the control buttons control different members in different electrode modules, respectively.

17. The multi-electrode cauterization apparatus according to claim 10, characterized in that the electrode group can control the energy release of one or more electrodes under the control of a handle operating member.

18. The multi-electrode cautery apparatus according to claim 8, characterized in that the radiofrequency cautery apparatus can display the impedance of the electrodes and can indicate whether or not the electrode module is properly attached to the tracheal wall, and if the impedance value after the electrodes of the bronchial radiofrequency cautery apparatus have adhered to the tissue is below a threshold, it indicates that the electrode module is properly attached to the tracheal wall.

19. The multi-electrode cautery apparatus according to claim 18, characterized in that the threshold is 500 Ω to 1000 Ω.

20. The multi-pole cauterization apparatus according to claim 19, characterized in that the threshold value is 900 Ω.

21. The multi-electrode cautery apparatus according to claim 8, characterized in that it has a system for displaying the impedances of each electrode to indicate that when the impedances of each electrode match, the contact between the electrode and the tracheal wall is good, and if the contact between any electrode and the tracheal wall is poor, the impedance of that electrode is different from that of the other electrodes that have good contact.

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