A misted saline regulated impedance lung nodule electric pulse ablation system and apparatus

Abstract

The application is suitable for the technical field of lung nodule treatment medical devices, and provides a lung nodule electric pulse ablation system and device for regulating impedance by atomized saline. In the embodiments provided in the application, for a lung nodule patient in need of pulse treatment, the atomized flow and atomized time are determined through an atomized regulation module, physiological saline is atomized into microdroplets of a preset particle size, the microdroplets are then injected into a lung ablation area through an ablation needle to fill the lung cavity, then a pulse energy generation module adjusts the characteristic impedance of an artificial line according to the impedance of the lung ablation area, generates a high-voltage pulse according to the characteristic impedance, and applies the high-voltage pulse to the lung ablation area filled with the cavity, and the load impedance characteristics are monitored in real time during the pulse treatment, so as to evaluate the ablation state. This solves the problems of ablation boundary ambiguity, high residual risk and destruction of electric field uniformity caused by high impedance areas in the cavity due to uneven lung impedance.

Description

Technical Field

[0001] This application relates to the field of medical device technology for the treatment of pulmonary nodules, and in particular to a system and device for pulmonary nodule electro-pulse ablation with impedance-controlled nebulized saline. Background Technology

[0002] Pulsed electric field ablation, as a non-thermal ablation technique, destroys tumor cells through irreversible electroporation. It offers advantages such as preserving the tumor microstructure (ECM) and protecting blood vessels and airways, and has been gradually applied to the treatment of pulmonary nodules. The core requirement for nanosecond pulse ablation is that the electric field intensity within the ablation area remains stable at 5-30 kV / cm, and the uniformity of the electric field distribution directly depends on the consistency of tissue impedance.

[0003] However, lung tissue possesses the following natural characteristics: 1. Extremely high impedance heterogeneity: Normal lung tissue contains a large amount of gas, and its impedance is as high as 10. 6 The impedance difference between different types of pulmonary nodules (solid / ground-glass), blood vessels, airways, and interstitium can reach 10 Ω·cm. 3 -10 5 times.

[0004] 2. The cavity structure of the lungs exacerbates the uneven impedance: The alveoli and bronchi in the lung tissue form a large number of natural cavities, and tissue displacement after puncture may also create new gaps.

[0005] These characteristics cause the pulsed electric field to preferentially propagate along low-impedance paths, resulting in "short circuits," "hot spots," or "blind zones," blurred ablation boundaries, high residual risk, and the formation of high-impedance regions in cavities, which block electric field propagation and further disrupt the uniformity of the electric field. Summary of the Invention

[0006] In view of this, this application provides a lung nodule electropulse ablation system and device with impedance-modulated saline to solve the problems of blurred ablation boundaries and high residual risk caused by uneven lung impedance, as well as the formation of high impedance regions in cavities that disrupt the uniformity of the electric field.

[0007] The first aspect of this application provides a lung nodule electropulse ablation system with impedance-regulated nebulized saline, the system comprising an ablation execution module, a nebulization regulation module, a pulse energy generation module, and an impedance monitoring module; The ablation execution module is used to inject microdroplets delivered by the ablation control module into the lung ablation area through an ablation needle containing atomization holes, and after the injection, to apply pulse energy to the lung ablation area through the pulse electric field action segment on the ablation needle; The nebulization control module is used to determine the nebulization flow rate and nebulization time according to the size and type of lung nodules in the lung ablation area. The physiological saline is nebulized into microdroplets of a preset particle size through the ultrasonic nebulization chip and the nebulization flow rate and nebulization time, and then the microdroplets are delivered to the ablation needle. The pulse energy generation module is used to generate high-voltage pulses through a control unit, a high-voltage power supply, and an artificial line. The control unit is used to determine the target pulse parameters, the high-voltage power supply is used to output DC high voltage, and the artificial line is used to adjust the characteristic impedance of the artificial line according to the load impedance of the lung ablation area. The impedance monitoring module is used to determine the impedance difference in the lung ablation area, and instruct the ablation execution module and the nebulization control module to start and stop injecting microdroplets into the lung ablation area based on the impedance difference. Furthermore, the load impedance characteristics of the lung ablation area are monitored in real time during pulse application, and the ablation status is evaluated through the load impedance characteristics. The ablation status includes the tissue contact status between the electrode and the lung ablation area, the ablation process, and the risk of abnormalities.

[0008] Optionally, the nebulization control module includes a micro booster pump and a flow regulating valve for adjusting the delivery flow rate of the physiological saline.

[0009] Optionally, the artificial line in the pulse energy generation module is composed of a coaxial cable, a spiral wire, or a distributed LC network, and has controllable inductance and capacitance parameters.

[0010] Optionally, the impedance monitoring module is also used to detect voltage or current, determine that the load impedance is abnormal when the waveform of the voltage or current is distorted, and instruct the nebulization control module and the ablation execution module to perform nebulization treatment on the lung ablation area.

[0011] A second aspect of this application provides a lung nodule electropulse ablation device with impedance-modulated saline nebulizer, the device comprising: The ablation device, including an ablation needle, an operating handle, and a connecting wire, is used to inject microdroplets into the lung ablation area and to apply pulsed energy to the lung ablation area. The nebulization device includes a saline storage tank, a miniature booster pump that provides stable pressure for nebulization, a flow regulating valve that adjusts the saline delivery flow rate, and a nebulization drive unit that atomizes liquid saline into microdroplets of a preset particle size. The pulse energy device includes a control unit for setting target pulse parameters, a high-voltage power supply for outputting DC high voltage, an artificial line for releasing pulse energy through a discharge circuit, a high-voltage switch, a high-frequency isolation transformer for achieving electrical isolation between the patient and the electrical system, and an output load interface for transmitting the pulse energy to the lung ablation area. Impedance monitoring equipment includes a high-voltage divider for sampling pulse voltage signals, a pulse current sensor for acquiring pulse current waveforms, an analog signal conditioning circuit for conditioning the voltage and current, a high-speed analog-to-digital converter for synchronously digitizing the voltage and current signals, and a main controller for determining the load impedance characteristics of the lung ablation area through the synchronously digitized voltage and current signals.

[0012] Optionally, the ablation needle consists of a hollow needle, an insulating layer, a fixed end, and an atomizing nozzle; The hollow needle is coaxially arranged with the insulating layer. The front end of the hollow needle is a pulsed electric field action section, the inside is an atomized saline injection channel, and the tail end is fixedly connected to the fixed end. The fixed end is internally insulated, connected to the pipeline of the atomizing device, and locked to the connecting wire by a thread; The atomizing nozzle is located at the far end of the insulating layer, penetrates the hollow needle, and has several atomizing holes.

[0013] Optionally, the diameter of the hollow needle is 0.8-1.5 mm, and the outer diameter of the insulating layer is 1-2 mm.

[0014] Optionally, the number of atomizing holes is 4-8, the hole diameter is 0.05-0.2mm, they are distributed in a circle, and the atomization angle is 30-60°.

[0015] Optionally, the saline storage tank has a capacity of 50-200ml and is equipped with a liquid level monitoring sensor.

[0016] Optionally, the primary winding of the high-frequency isolation transformer is connected to the discharge circuit, and the secondary winding is connected to the output port and connected to the ablation electrode of the lung ablation area.

[0017] In the embodiments provided in this application, for patients with pulmonary nodules requiring pulse therapy, the nebulization flow rate and nebulization time are first determined by the nebulization control module. Then, saline is nebulized into microdroplets of a preset particle size. These microdroplets are then injected into the pulmonary ablation area using an ablation needle to fill the pulmonary cavity. Subsequently, the pulse energy generation module adjusts the characteristic impedance of the artificial wire according to the impedance of the pulmonary ablation area, and then generates a high-voltage pulse based on this characteristic impedance. This pulse is applied to the pulmonary ablation area that has filled the cavity. Furthermore, the load impedance characteristics are monitored in real time during the pulse therapy to assess the ablation status. This solves the problems of blurred ablation boundaries and high residual risk caused by uneven pulmonary impedance, as well as the problem of high-impedance regions forming cavities disrupting the uniformity of the electric field. Attached Figure Description

[0018] Figure 1 A system block diagram provided for embodiments of this application; Figure 2 This is a schematic diagram of the ablation needle structure provided in the embodiments of this application; Figure 3 This is a structural diagram of the atomizing device provided in an embodiment of this application; Figure 4 This is a schematic diagram of another ablation needle structure provided in an embodiment of this application; Figure 5 This is a schematic diagram of the spray range of atomized brine provided in an embodiment of this application; Figure 6 This is a schematic diagram of the internal structure of a computer device provided in an embodiment of this application. Detailed Implementation

[0019] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this application. Rather, they are merely examples of apparatuses and methods consistent with some aspects of this application as detailed in the appended claims.

[0020] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0021] It should be understood that although the terms first, second, third, etc., may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."

[0022] This application provides a lung nodule electropulse ablation system and device with impedance-modulated saline solution to solve the problems of blurred ablation boundaries and high residual risk caused by uneven lung impedance, as well as the formation of high-impedance regions in cavities that disrupt the uniformity of the electric field.

[0023] The technical solutions of this application will be described in detail below with specific embodiments. These specific embodiments can be combined with each other, and the same or similar concepts or processes may not be described again in some embodiments.

[0024] like Figure 1 The diagram shown is a system block diagram of a lung nodule electro-pulse ablation system with impedance-controlled nebulized saline provided in this application. The functions and implementation processes of each module are described below: Module 1, Ablation Execution Module. This module is used to inject microdroplets delivered by the atomization control module into the lung ablation area through an ablation needle containing atomization orifices, and after injection, apply pulse energy to the lung ablation area through the pulsed electric field segment on the ablation needle.

[0025] This module requires filling uneven cavities in the lung ablation area and then performing ablation treatment. Existing saline perfusion techniques are unsuitable for lung applications because the saline perfusion structure of current pulsed electric field ablation catheters is primarily used for cooling and preventing crusting in solid tissues such as the heart. Using a liquid perfusion method, it is difficult to penetrate the alveolar spaces and tiny cavities in the lungs, making it impossible to achieve uniform impedance control. Furthermore, liquid perfusion easily leads to local fluid accumulation, increasing the risk of pneumothorax and pulmonary edema, making it unsuitable for air-containing organs like the lungs. Therefore, this module uses microdroplets of a preset particle size generated by saline atomization for perfusion, thus avoiding the aforementioned risks.

[0026] In scenarios where multiple treatment goals need to be achieved, the most common approach is to use a step-by-step single-needle method or a double-needle synergistic method.

[0027] Stepwise single-needle method: This method typically uses a single needle to complete the procedure in steps. First, under image guidance, the puncture needle is inserted into the cavity area and filling material is injected. Then, the needle core is withdrawn or a coaxial cannula is used, and an ablation needle (microwave / radiofrequency) is introduced to reach the target point for treatment through the same path.

[0028] The dual-needle synergistic method uses two independent needles. One needle is specifically used for continuous injection of filler material, while the other ablation needle is responsible for energy ablation. The two needles work together to dynamically adjust the filling area during ablation, making it suitable for high-risk areas or large lesions.

[0029] Of these two methods, the double-needle synergistic method requires two punctures, significantly increasing the risk of bleeding. While the stepwise single-needle method only requires one puncture, the instrument needs to be changed after perfusion, which may lead to displacement.

[0030] This module integrates the atomizing nozzle onto the ablation needle and insulates the nozzle surface to prevent electrical connection with the electrodes. This allows the ablation needle to simultaneously include a pulsed electric field application section and an atomizing nozzle, enabling microdroplet injection and ablation treatment through a single needle. This method eliminates the need to replace the needle core, thus avoiding instrument misalignment issues.

[0031] Module 2, Nebulization Control Module. This module is used to determine the nebulization flow rate and nebulization time based on the size and type of lung nodules in the lung ablation area. Using an ultrasonic nebulization chip and the specified nebulization flow rate and time, physiological saline is atomized into microdroplets of a preset particle size, which are then delivered to the ablation needle.

[0032] This module can be pre-built with a collaborative control algorithm for nebulization and pulse parameters. This algorithm automatically matches the optimal nebulization flow rate and nebulization time based on the size and type of lung nodules in the patient's lung ablation area. Lung nodules can be automatically segmented based on preoperative 3D CT images, quantifying key parameters such as their maximum diameter, volume, and proportion of solid components. Then, the built-in algorithm model, based on these parameters and a pre-set database containing the permeability and diffusion range of the drug solution at different tissue densities, calculates the minimum nebulization flow rate and optimal nebulization duration required to ensure complete perfusion of microdroplets into the cavities of the lung nodules. Nebulization is then performed according to this flow rate and duration, and the generated microdroplets are perfused into the cavities and gaps in the lung ablation area through the ablation needle. The size of these microdroplets can be pre-set; in this module, it can be set to 5-50 μm. The operating frequency of the ultrasonic nebulization chip can be set to 1.7-2.4 MHz.

[0033] In another embodiment, the nebulization control module includes a miniature booster pump and a flow regulating valve for regulating the delivery flow rate of the physiological saline.

[0034] In this embodiment, the micro booster pump can be set to a working pressure of 0.1-0.5 MPa and a flow rate adjustment range of 0.1-1 ml / min, providing a stable pressure source for atomization. The flow regulating valve can be electromagnetically controlled to precisely adjust the brine delivery flow rate with an adjustment accuracy of 0.01 ml / min.

[0035] Module 3, Pulse Energy Generation Module. This module is used to generate high-voltage pulses via a control unit, a high-voltage power supply, and an artificial wire.

[0036] The control unit is used to set the target pulse parameters, including voltage amplitude, pulse width, and pulse count. These parameters can be determined based on preoperative 3D CT images. Under the command of the control unit, the high-voltage power supply outputs a DC high voltage to charge the artificial thread. Once the artificial thread is charged to the preset voltage, the control unit triggers the high-voltage switch to close, allowing the artificial thread to rapidly release stored energy into the lung ablation area through the discharge circuit, forming a high-voltage pulse with a steep leading edge and narrow pulse width. This high-voltage switch can be a solid-state semiconductor switch (such as an IGBT or MOSFET array) or a gas spark gap switch to achieve nanosecond-precise timing control.

[0037] In this module, the characteristic impedance of the artificial thread and the load impedance of the lung ablation area together determine the waveform characteristics of the output pulse, including rise time, pulse width, and oscillation characteristics. By matching the characteristic impedance of the artificial thread with the typical lung tissue load impedance (usually 50-200 Ω), pulse reflection can be effectively suppressed, obtaining an optimized waveform with approximately rectangular or unipolar exponential decay, thereby improving electroporation efficiency and reducing off-target thermal damage.

[0038] In another embodiment, the artificial line may be composed of a coaxial cable, a spiral wire, or a distributed LC network, and has controllable inductance and capacitance parameters for shaping the output pulse.

[0039] In another embodiment, this module also includes a high-frequency isolation transformer. Its primary winding is connected to the discharge circuit, and its secondary winding is connected to the output port and to the in vivo ablation electrode. This isolation transformer not only achieves electrical isolation between the patient and the high-voltage source, ensuring operational safety, but also efficiently transfers the steep pulse energy from the primary side to the secondary side load via magnetic coupling.

[0040] This system, through the coordinated operation of the aforementioned modules, can apply high-intensity, short-duration high-voltage pulses to pulmonary nodule lesions while ensuring the electrical safety of the patient. This induces irreversible electroporation of the tumor cell membrane, achieving non-thermal, precise, and minimally invasive ablation that preserves blood vessels and bronchial structures. It is particularly suitable for the treatment of small pulmonary nodules adjacent to important anatomical structures.

[0041] Module 4, Impedance Monitoring Module. This module is used to determine the impedance difference in the lung ablation area and, based on the impedance difference, instruct the ablation execution module and the nebulization control module to start and stop injecting microdroplets into the lung ablation area. Furthermore, the load impedance characteristics of the lung ablation area are monitored in real time during pulse application, and the ablation status is evaluated through the load impedance characteristics. The ablation status includes the tissue contact status between the electrode and the lung ablation area, the ablation process, and the risk of abnormalities.

[0042] Because of the large impedance difference in the lung ablation area, nebulization adjustment is required before ablation treatment, and the impedance difference is monitored in real time during nebulization until it is lower than the preset threshold before ablation treatment is performed.

[0043] In this module, a high-voltage voltage signal can be safely sampled from the high-voltage pulse circuit using a high-voltage divider. The pulse current waveform is then non-invasively acquired via a pulse current sensor connected in series with a discharge circuit. The acquired voltage and current analog signals are then filtered, amplified, and level-shifted by the analog signal conditioning circuit before being synchronously input to a high-speed analog-to-digital converter (ADC). This high-speed ADC synchronously digitizes the voltage and current signals to determine the voltage and current values ​​of the lung ablation area. Finally, the impedance value can be calculated using the impedance calculation formula Z = V / I, where Z is the impedance value, V is the voltage value, and I is the current value.

[0044] After determining the impedance at various locations within the lung ablation area, the impedance difference can be identified. If the impedance difference is greater than a preset value, nebulization control is initiated, instructing the ablation execution module and the nebulization control module to begin injecting microdroplets into the lung ablation area. After nebulization control is completed, the impedance difference is determined again. If the impedance difference is less than the preset value, ablation treatment is performed.

[0045] It should be noted that during the nebulization adjustment process, the impedance difference can be monitored in real time. If the impedance difference is less than the preset value at a certain moment, the nebulization adjustment can be stopped immediately and ablation treatment can be performed even if the nebulization time has not been reached.

[0046] In another embodiment, the impedance monitoring module is also used to detect voltage or current, determine an abnormal load impedance when the waveform of the voltage or current is distorted, and instruct the nebulization control module and the ablation execution module to perform nebulization treatment on the lung ablation area.

[0047] This embodiment can determine impedance anomalies by analyzing voltage or current waveforms, achieving near-instantaneous response and extremely low computational load. Traditional impedance measurement requires sending signals and calculating the voltage-to-current ratio to obtain specific values. This process involves analog-to-digital conversion and complex mathematical operations, introducing millisecond-level delays. Waveform-based judgment, however, falls under analog domain or edge-triggered detection, capturing waveform abrupt changes caused by tissue carbonization, vaporization, or poor electrode contact within microseconds, thereby immediately interrupting or adjusting energy output. This "feature-based" strategy not only significantly shortens the system's closed-loop control time, more effectively preventing excessive tissue damage or equipment failure, but also frees up the main controller's computing power, allowing it to focus on other complex collaborative algorithms.

[0048] This concludes the process. Figure 1 Descriptions of each module shown.

[0049] In the above embodiments, for patients with pulmonary nodules requiring pulse therapy, the nebulization flow rate and nebulization time are first determined by the nebulization control module. Then, saline is nebulized into microdroplets of a preset particle size. These microdroplets are then injected into the pulmonary ablation area using an ablation needle to fill the pulmonary cavity. Subsequently, the pulse energy generation module adjusts the characteristic impedance of the artificial wire according to the impedance of the pulmonary ablation area, and then generates a high-voltage pulse based on this characteristic impedance. This pulse is applied to the pulmonary ablation area that has filled the cavity. Furthermore, the load impedance characteristics are monitored in real time during the pulse therapy to assess the ablation status. This solves the problems of blurred ablation boundaries and high residual risk caused by uneven pulmonary impedance, as well as the problem of high-impedance regions forming cavities disrupting the uniformity of the electric field.

[0050] This application also provides a lung nodule electropulse ablation device with impedance-modulated saline nebulizer, the device comprising: The ablation device, including an ablation needle, operating handle, and connecting cable, is used to inject microdroplets into the lung ablation area and to apply pulsed energy to the lung ablation area, specifically as follows: Figure 2 As shown, the ablation needle (1-1), the operating handle (1-2), and the connecting wire (1-3) are shown. The nebulization device includes a saline storage tank, a miniature booster pump that provides stable pressure for nebulization, a flow control valve that regulates the saline delivery flow rate, and a nebulization drive unit that atomizes liquid saline into microdroplets of a preset particle size. The structure is as follows: Figure 3 As shown; The pulse energy device includes a control unit for setting target pulse parameters, a high-voltage power supply for outputting DC high voltage, an artificial line for releasing pulse energy through a discharge circuit, a high-voltage switch, a high-frequency isolation transformer for achieving electrical isolation between the patient and the electrical system, and an output load interface for transmitting the pulse energy to the lung ablation area. Impedance monitoring equipment includes a high-voltage divider for sampling pulse voltage signals, a pulse current sensor for acquiring pulse current waveforms, an analog signal conditioning circuit for conditioning the voltage and current, a high-speed analog-to-digital converter for synchronously digitizing the voltage and current signals, and a main controller for determining the load impedance characteristics of the lung ablation area through the synchronously digitized voltage and current signals.

[0051] In another embodiment, the ablation needle consists of a hollow needle, an insulating layer, a fixed end, and an atomizing nozzle; The hollow needle is coaxially arranged with the insulating layer. The front end of the hollow needle is a pulsed electric field action section, the inside is an atomized saline injection channel, and the tail end is fixedly connected to the fixed end. The fixed end is internally insulated, connected to the pipeline of the atomizing device, and locked to the connecting wire by a thread; The atomizing nozzle is located at the far end of the insulating layer, penetrates the hollow needle, and has several atomizing holes.

[0052] like Figure 4 As shown, the ablation needle (1-1) consists of a hollow needle (1-1-1), an insulating layer (1-1-2), a fixed end (1-1-3), and an atomizing nozzle (1-1-4). The hollow needle (1-1-1) and the insulating layer (1-1-2) are coaxially arranged. The front end is a pulse electric field action section (without insulation and exposed part). The hollow needle (1-1-1) has an atomized saline injection channel inside. The tail end is fixedly connected to the fixed end (1-1-3). The fixed end (1-1-3) is connected to the atomization control module (2) pipeline through a Luer connector. The fixed end (1-1-3) is internally insulated. The external threaded connector is locked to the connecting line (1-3) through a threaded locking connection.

[0053] In another embodiment, the diameter of the hollow needle is 0.8-1.5 mm, and the outer diameter of the insulating layer is 1-2 mm.

[0054] In another embodiment, the number of atomizing holes is 4-8, with a diameter of 0.05-0.2 mm, arranged circumferentially, and the atomization angle is 30-60°. The nozzle surface is insulated to prevent electrical connection with the electrodes, and the structure is as follows. Figure 5 As shown.

[0055] The beneficial effects of this equipment are as follows: 1. Integrated atomization-ablation design: An atomized saline injection channel is integrated inside the ablation needle. The atomization range is precisely positioned according to the electrode assembly, realizing integrated operation of "atomization impedance regulation - pulse ablation". This solves the problems of separate impedance regulation and ablation in existing equipment and cumbersome operation. The atomizing nozzle adopts a circumferentially distributed micropore design, which can atomize saline into 5-50μm microdroplets. This can accurately fill the tiny cavities in the lungs and avoid the accumulation of liquid caused by liquid perfusion, adapting to the gas-containing environment of the lungs.

[0056] 2. Impedance closed-loop feedback control system: It integrates an impedance monitoring and feedback module to collect tissue impedance data in real time and dynamically adjust the flow rate and time parameters of the nebulized saline to achieve precise and uniform impedance control, ensuring that the pulse electric field is always in a uniform distribution state, thus solving the problem of electric field distortion caused by the impedance heterogeneity of lung tissue; a preset impedance uniformity threshold (≤20%) provides quantitative assurance for the ablation effect.

[0057] 3. Multi-parameter collaborative control logic: The control terminal has a built-in collaborative control algorithm for nebulization parameters and pulse parameters, which can automatically match the optimal nebulization flow rate, nebulization time and pulse electric field parameters according to the size (0.5-3cm) and type (solid / ground glass) of the lung nodule, improving the ease of operation and adapting to the needs of different clinical scenarios.

[0058] The following is a detailed explanation using a specific example of lung ablation treatment: 1. Perform preoperative preparation and instrument assembly.

[0059] Instrument selection and inspection: Determine the size of the lung nodule (e.g., 1.5cm solid nodule) and puncture path based on the preoperative CT images, and select a suitable ablation needle (0.1mm nebulizer nozzle orifice diameter, 45° nebulization angle); connect the ablation needle and nebulization tubing; inspect the steep pulse therapy equipment to confirm the status of nebulization control function, pulse generation function, and impedance monitoring feedback function, and ensure there are no tubing leaks or cable damage.

[0060] Filling with saline solution: Inject 100ml of sterile saline solution into the saline storage tank, start the micro booster pump to purge the pipeline, and ensure that there are no air bubbles left in the nebulization channel.

[0061] Preset parameters: Input patient information and nodule parameters, select the corresponding personalized plan. The preset parameters are as follows: nebulization flow rate 0.3ml / min, nebulization time 30s, impedance uniformity threshold 15%, pulse voltage 20kV, pulse width 300ns, number of pulse groups 200.

[0062] 2. Surgical procedure Puncture localization: According to the preoperative plan, determine the puncture point, puncture angle and depth under CT guidance; hold the operating handle and insert the ablation needle percutaneously into the lung. Determine the puncture depth according to the scale markings on the ablation needle assembly. CT scan to determine whether the ablation needle has reached the designated position. Repeat the operation until all ablation needles are in place (2-6 sets of ablation needles are arranged according to the size of the tumor).

[0063] Initial impedance monitoring: The impedance data of the lung ablation area is collected through the impedance monitoring module to determine the impedance difference. If the impedance difference is 45% (greater than the preset threshold of 15%), the nebulization control process is started.

[0064] Nebulization impedance control: The nebulization control module is automatically activated, and the micro booster pump delivers physiological saline at a pressure of 0.3MPa. After nebulization, it is sprayed onto the ablation area at a 45° angle through the ablation needle nozzle. The impedance monitoring module provides real-time feedback data. When the impedance difference drops to 12% (meeting the standard) after 25 seconds of nebulization, the control terminal automatically stops nebulization.

[0065] Pulse ablation therapy: Ablation is initiated after the impedance reaches the target. A pulsed electric field is generated according to preset parameters and released through the ablation execution module. The ablation is completed after 400 pulses are released continuously. During the ablation process, the impedance monitoring module continuously monitors the impedance. If the impedance fluctuation exceeds 5%, the infusion of saline solution is automatically started (5s) to maintain impedance stability.

[0066] Postoperative management: After ablation, activate the nebulization control module and nebulize the needle tract at a flow rate of 0.2 ml / min for 10 seconds; close all modules, slowly withdraw the ablation needle assembly, and apply pressure to the puncture site for hemostasis and bandage.

[0067] The above embodiments of the present invention provide a lung nodule electro-pulse ablation system with impedance-modulated saline solution, and based on this system, a lung nodule electro-pulse ablation device with impedance-modulated saline solution. Through the above system and device, not only are the problems of blurred ablation boundaries and high residual risk caused by uneven lung impedance solved, but the problem of high-impedance regions forming in cavities disrupting the uniformity of the electric field can also be solved.

[0068] This embodiment also discloses a computer device, such as... Figure 6 As shown, the computer device includes a processor and a memory, the memory storing at least one instruction, which is loaded and executed by the processor to implement the method on the pulmonary nodule electropulse ablation system with nebulized saline-modulated impedance as described above.

[0069] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A lung nodule electro-pulse ablation system with impedance-modulated nebulized saline, characterized in that, The system includes an ablation execution module, an atomization control module, a pulse energy generation module, and an impedance monitoring module; The ablation execution module is used to inject microdroplets delivered by the ablation control module into the lung ablation area through an ablation needle containing atomization holes, and after the injection, to apply pulse energy to the lung ablation area through the pulse electric field action segment on the ablation needle; The nebulization control module is used to determine the nebulization flow rate and nebulization time according to the size and type of lung nodules in the lung ablation area. The physiological saline is nebulized into microdroplets of a preset particle size through the ultrasonic nebulization chip and the nebulization flow rate and nebulization time, and then the microdroplets are delivered to the ablation needle. The pulse energy generation module is used to generate high-voltage pulses through a control unit, a high-voltage power supply, and an artificial line. The control unit is used to determine the target pulse parameters, the high-voltage power supply is used to output DC high voltage, and the artificial line is used to adjust the characteristic impedance of the artificial line according to the load impedance of the lung ablation area. The impedance monitoring module is used to determine the impedance difference in the lung ablation area, and instruct the ablation execution module and the nebulization control module to start and stop injecting microdroplets into the lung ablation area based on the impedance difference. Furthermore, the load impedance characteristics of the lung ablation area are monitored in real time during pulse application, and the ablation status is evaluated through the load impedance characteristics. The ablation status includes the tissue contact status between the electrode and the lung ablation area, the ablation process, and the risk of abnormalities.

2. The system according to claim 1, characterized in that, The atomization control module includes a miniature booster pump and a flow regulating valve, used to regulate the delivery flow rate of the physiological saline.

3. In the system according to claim 1, the artificial line in the pulse energy generation module is composed of a coaxial cable, a spiral wire, or a distributed LC network, and has controllable inductance and capacitance parameters.

4. The system according to claim 1, characterized in that, The impedance monitoring module is also used to detect voltage or current, determine abnormal load impedance when the waveform of the voltage or current is distorted, and instruct the nebulization control module and the ablation execution module to perform nebulization treatment on the lung ablation area.

5. A lung nodule electro-pulse ablation device with impedance-controlled nebulized saline, characterized in that, The device includes: The ablation device, including an ablation needle, an operating handle, and a connecting wire, is used to inject microdroplets into the lung ablation area and to apply pulsed energy to the lung ablation area. The nebulization device includes a saline storage tank, a miniature booster pump that provides stable pressure for nebulization, a flow regulating valve that adjusts the saline delivery flow rate, and a nebulization drive unit that atomizes liquid saline into microdroplets of a preset particle size. The pulse energy device includes a control unit for setting target pulse parameters, a high-voltage power supply for outputting DC high voltage, an artificial line for releasing pulse energy through a discharge circuit, a high-voltage switch, a high-frequency isolation transformer for achieving electrical isolation between the patient and the electrical system, and an output load interface for transmitting the pulse energy to the lung ablation area. Impedance monitoring equipment includes a high-voltage divider for sampling pulse voltage signals, a pulse current sensor for acquiring pulse current waveforms, an analog signal conditioning circuit for conditioning the voltage and current, a high-speed analog-to-digital converter for synchronously digitizing the voltage and current signals, and a main controller for determining the load impedance characteristics of the lung ablation area through the synchronously digitized voltage and current signals.

6. The device according to claim 5, characterized in that, The ablation needle consists of a hollow needle, an insulating layer, a fixed end, and an atomizing nozzle; The hollow needle is coaxially arranged with the insulating layer. The front end of the hollow needle is a pulsed electric field action section, the inside is an atomized saline injection channel, and the tail end is fixedly connected to the fixed end. The fixed end is internally insulated, connected to the pipeline of the atomizing device, and locked to the connecting wire by a thread; The atomizing nozzle is located at the far end of the insulating layer, penetrates the hollow needle, and has several atomizing holes.

7. The device according to claim 6, characterized in that, The hollow needle has a diameter of 0.8-1.5 mm, and the outer diameter of the insulating layer is 1-2 mm.

8. The device according to claim 6, characterized in that, The number of atomizing holes is 4-8, the hole diameter is 0.05-0.2mm, they are distributed in a circle, and the atomization angle is 30-60°.

9. The device according to claim 5, characterized in that, The saline storage tank has a capacity of 50-200ml and is equipped with a liquid level monitoring sensor.

10. The device according to claim 5, characterized in that, The primary winding of the high-frequency isolation transformer is connected to the discharge circuit, and the secondary winding is connected to the output port and to the ablation electrode of the lung ablation area.

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