Electrode-adjustable pulse ablation device and control method

Abstract

The invention provides an electrode-adjustable pulse ablation device and a control method, and relates to the technical field of medical instruments, and the electrode-adjustable pulse ablation device comprises an ablation catheter module and a control module which are connected in sequence. The ablation catheter module comprises a catheter assembly and an electrode assembly, the catheter assembly comprises a catheter, a catheter flexible part and an electrode wire, the electrode assembly comprises an electrode, a mandrel and an electrode fixing head, and the control module comprises a shell structure set, a pulse input assembly, an electrode adjusting mechanism and an unfolding and contracting driving mechanism. The problems that in the prior art, a catheter is insufficient in flexibility, the electrode size is fixed, the adjusting function is deficient, and the mandrel pushing deviation is large are solved, and an accurate, safe and efficient technical solution is provided for bronchial interventional therapy of the chronic obstructive pulmonary disease.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an electrode-adjustable pulse ablation device and a control method. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) is a highly prevalent respiratory disease in my country, characterized by high morbidity, disability, and mortality. With the advancement of medical technology, interventional therapy has become an important approach to COPD treatment, with pulsed ablation technology attracting significant attention due to its precision and minimally invasive nature.

[0003] Pulse ablation technology uses high-frequency electrical pulses to generate an electric field in the target tissue, causing irreversible electroporation of the cell membrane, thereby achieving precise ablation of diseased tissue. This technology is relatively mature in the field of tumor treatment and offers advantages such as controllable ablation range, minimal damage to surrounding normal tissue, and rapid recovery time. However, current pulse ablation devices used for bronchial interventional treatment still have many technical deficiencies and limitations in actual clinical application.

[0004] Existing pulsed ablation catheters generally suffer from insufficient catheter flexibility. The excessive rigidity of the tip of traditional catheters makes it difficult to adapt to the complex and variable anatomy of the bronchi. This results in poor adhesion of the electrodes to the irregular bronchial wall, which in turn affects the uniform distribution of the ablation electric field and the therapeutic effect. As an important component of the respiratory system, the bronchi typically have an inner diameter ranging from 5-15 mm and are characterized by multiple branches and bends, placing higher demands on the catheter's flexibility and adaptability.

[0005] Another significant drawback of existing technologies is the fixed size of electrodes. The stent lengths of pulsed ablation catheters currently on the market are typically fixed and cannot be dynamically adjusted based on the bronchial diameters of different patients. Because the effective contact lengths of ablation stents of the same diameter and length vary significantly under bronchi of different diameters, fixed-size electrodes often result in fluctuations in the effective contact area exceeding 40%, severely impacting the consistency and predictability of the ablation effect. This one-size-fits-all design fails to meet the needs of individualized treatment and limits the technology's clinical application.

[0006] The lack of adjustment functionality further exacerbates the limitations of existing technologies. Traditional pulse ablation devices lack a mechanical feedback gear lock mechanism, making it impossible for operators to precisely control the electrode deployment, which can lead to the risk of overexpansion. In bronchial interventional treatment, accurate positioning and appropriate deployment of electrodes are crucial to ensuring treatment efficacy and avoiding complications. The lack of precise adjustment not only increases surgical difficulty but also increases medical risks.

[0007] Mandrel push deviation is a key technical issue affecting treatment accuracy. To enable the catheter to reach the distal small airways, existing catheters require the thinnest possible diameter, and the corresponding mandrel must also be thinner. However, thin mandrels are prone to significant deviation during the push process, typically exceeding 0.5mm. This lack of concentricity limits the expanded size of the electrode assembly, preventing optimal contact, thus prolonging the procedure and increasing patient pain.

[0008] Chinese patent CN117769398A discloses a system for applying energy to denervate the pulmonary artery, and discloses a technical solution for treating pulmonary hypertension by emitting ultrasonic energy in the pulmonary artery through an ultrasonic transducer. The system achieves the technical effects of accurately ablating the nerves around the pulmonary artery, stably positioning the transducer through an expandable anchor, and verifying the ablation effect by real-time monitoring of temperature and pressure changes. However, the system still has problems such as its application being limited to pulmonary artery vascular treatment, its inability to adapt to the complex anatomical structure of natural cavities such as bronchi, its lack of dynamic size adjustment function for bronchi of different diameters, and insufficient control over push accuracy.

[0009] Chinese patent CN119632657A discloses a multi-channel pulse ablation device, and discloses a technical solution for achieving simultaneous pulse ablation treatment with multiple flexible electrodes by accommodating at least two groups of ablation catheter assemblies through a multi-lumen tube. The solution has the technical effects of improving ablation efficiency, reducing operation time, achieving independent adjustment of electrode position through coarse adjustment and fine adjustment modes, and real-time monitoring of electrode position and morphology through an information collection device. However, there are still problems such as high complexity of the multi-channel system, high manufacturing cost, lack of specialized design for specific diseases such as COPD bronchial interventional treatment, and unresolved key technical issues such as push concentricity control and precise adaptation of electrode size.

[0010] Furthermore, existing pulsed ablation devices generally lack intelligent treatment planning capabilities. During preoperative preparation, physicians often rely on experience and simple imaging data to estimate the required electrode size and treatment parameters. This highly subjective approach can easily lead to inappropriate treatment parameter selection, compromising treatment outcomes. Summary of the Invention

[0011] The purpose of the present invention is to provide an electrode-adjustable pulse ablation device and control method that achieves adaptive fitting, precise size adjustment and high-precision push control, thereby breaking through the limitations of the prior art in terms of flexibility, adaptability and accuracy.

[0012] To achieve the above object, the present invention is implemented through the following technical solutions: an electrode-adjustable pulse ablation device, comprising an ablation catheter module and a control module connected in sequence, the ablation catheter module comprising a catheter assembly and an electrode assembly connected in sequence, The catheter assembly includes a catheter, a catheter flexible component, and an electrode wire, wherein the electrode wire is arranged inside the catheter along the extension direction of the catheter, a catheter flexible component is provided on one side of the catheter, the electrode wire is electrically connected to the catheter flexible component, and the catheter flexible component is electrically connected to the electrode assembly; The electrode assembly includes an electrode, a core shaft and an electrode fixing head, wherein the core shaft is connected to the electrode along the interior of the catheter assembly, the electrode fixing head is fixedly disposed at the distal end of the electrode, and the catheter flexible component fixes the proximal end of the electrode to the catheter assembly; The control module includes a housing structure group, a pulse input component, an electrode adjustment mechanism and an expansion and contraction drive mechanism arranged inside the housing structure group. The housing structure group is provided with a slot, and the adjusting device of the electrode adjusting mechanism and the adjusting device of the expansion and contraction driving mechanism can slide along the slot respectively. The pulse input assembly is electrically connected to the electrode wire, and the pulse input assembly is connected to the pulse ablation device; The shell structure group includes an upper shell, a lower shell and a fixing seat; the core shaft is connected to the control module along the catheter assembly.

[0013] Furthermore: the catheter includes an inner catheter tube, an outer catheter tube and a sheath tube; The catheter inner tube is arranged inside the catheter outer tube, and the catheter outer tube is arranged inside the sheath tube and can be axially displaced along the sheath tube cavity.

[0014] Furthermore: a wire tube layer is provided between the outer tube of the catheter and the inner tube of the catheter, and the electrode wire is provided inside the wire tube layer.

[0015] Furthermore: a core shaft insulation tube is provided on the outer side of the core shaft.

[0016] Furthermore, the shell structure group further includes a catheter sheath and a wire sheath, and the catheter sheath and the wire sheath are fixedly arranged at both ends of the shell structure group by an upper shell and a lower shell.

[0017] Furthermore: the electrode adjustment mechanism includes a sheath fixing seat, an adjustment button and a sliding shaft, the sheath fixing seat is fixedly connected to the sheath, the adjustment button is axially connected to the sheath fixing seat, and the sheath fixing seat is slidingly connected to the sliding shaft.

[0018] Furthermore, a plurality of adjusting button slots are provided on one side of the slot where the electrode adjusting mechanism is located, and the adjusting button can be rotated along the axis of the sliding shaft and inserted into the adjusting button slot.

[0019] Furthermore: the expansion and contraction driving mechanism includes a push-pull button, a core shaft seat, a buffer member and a transmission shaft; The push-pull button is fixedly connected to the core shaft seat, the buffer is made of soft rubber material and embedded in the core shaft seat, the transmission shaft passes through the buffer and is fixed in a slot provided inside the outer shell structure group.

[0020] Furthermore: a stainless steel capillary is inlaid on the core shaft seat.

[0021] Furthermore: the flexible part of the catheter is made of nickel-titanium wire.

[0022] A control method for the electrode-adjustable pulse ablation device according to any one of the above items comprises the following steps: S1: Bronchial diameter D was obtained by preoperative CT three-dimensional reconstruction; S2: Determine the electrode length according to the bronchial diameter; S3: Adjust the electrode adjustment mechanism. When the electrode length reaches a certain value, it is locked. The system automatically checks the impedance value. When the impedance value is within the preset normal range, proceed to the next step. S4: controlling the electrode assembly to expand to a preset size through the expansion and contraction drive mechanism; S5: Start the pulse ablation device for treatment.

[0023] Further: in step S2, if D≤8mm, select the preset gear electrode, if D>8mm, calculate the electrode length according to the formula L=2.5D+5.

[0024] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention provides a flexible catheter component in the catheter assembly, so that the electrode assembly can passively adapt to the deflection of the bronchial axis, achieve parallel fit between the electrode and the central axis of the bronchus, and significantly improve the contact effect of the ablation electrode.

[0025] 2. The present invention realizes dynamic adjustment of the electrode length within the range of 20-50mm by setting an electrode adjustment mechanism. It can realize standard adjustment of 50mm, 40mm, 30mm and 20mm through four-speed precise positioning, and can realize stepless continuous adjustment in the unlocked state, effectively adapting to bronchi of different diameters, controlling the fluctuation of the effective contact area of ​​the ablation electrode within a reasonable range, and improving the ablation effect.

[0026] 3. The present invention significantly enhances the strength and pushing accuracy of the core shaft by inlaying a stainless steel capillary on the core shaft seat, and optimizes the pushing concentricity error from more than 0.5mm in traditional technology to less than 0.1mm, ensuring that the electrode assembly accurately reaches the predetermined position and achieves good contact, effectively shortening the operation time.

[0027] 4. The present invention uses an electrode length recommendation algorithm to automatically select a preset gear electrode when the bronchial diameter D is ≤ 8mm. When D is greater than 8mm, the electrode length is automatically calculated according to the formula L=2.5D+5. Combined with the system's automatic impedance value verification function, it ensures that the impedance value is within the normal range of 200-800Ω, realizing intelligent setting of personalized treatment parameters. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 A schematic diagram of an ablation catheter module of an electrode-adjustable pulse ablation device provided by the present invention; Figure 2 A schematic perspective view of a pulse ablation device with adjustable electrodes provided by the present invention; Figure 3 A schematic cross-sectional view of an ablation catheter in an electrode-adjustable pulse ablation device provided by the present invention; Figure 4 This is a schematic diagram of an exploded view of an electrode-adjustable pulse ablation device provided by the present invention; Figure 5 A schematic diagram of the structure of an electrode adjustment structure in an electrode-adjustable pulse ablation device provided by the present invention; Figure 6 A in the figure is a schematic diagram of an existing catheter without a flexible part of the catheter. Figure 6 B is a schematic diagram of the flexible part of the catheter added to the distal end of the catheter of the present invention; Figure 7 It is a schematic diagram of the structure of the electrode assembly in a contracted state; Figure 8 It is a schematic diagram of the structure of the electrode assembly in the expanded state; Figure 9 A flow chart of an ablation method of an electrode-adjustable pulse ablation device provided by the present invention; In the picture: 1. Ablation catheter module; 2. Control module; 11. Catheter assembly; 12. Electrode assembly; 1101. Sheath; 1102. Catheter outer tube; 1103. Catheter inner tube; 1105. Electrode wire; 1202. Electrode fixing head; 1203. Electrode; 1204. Core shaft; 1205. Core shaft insulation tube; 20. Shell structure group; 21. Electrode adjustment mechanism; 22. Deployment and retraction drive mechanism; 201. Upper shell; 202. Lower shell; 203. Catheter sheath; 204. Wire sheath; 205. Fixing seat; 2101. Sheath fixing seat; 2102. Adjusting button; 2103. Sliding shaft; 2201. Push-pull button; 2202. Core shaft seat; 2203. Transmission shaft; 2204. Buffer; 2301. Pulse wire; 2302. Pulse connector. DETAILED DESCRIPTION

[0029] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0030] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0031] Example 1 like Figure 1-9 As shown, this embodiment provides an electrode-adjustable pulse ablation device, which adopts a modular design and includes an ablation catheter module 1 and a control module 2 connected in sequence. The ablation catheter module 1 includes a catheter assembly 11 and an electrode assembly 12 connected in sequence.

[0032] The ablation catheter module 1 consists of a catheter assembly 11 and an electrode assembly 12. The catheter assembly 11 includes a catheter, a catheter flexible component, and an electrode wire 1105. The electrode wire 1105 is arranged inside the catheter along the extension direction of the catheter to ensure the stability of the electrical signal. A catheter flexible component is provided on one side of the catheter. The flexible component is made of a flexible material with biocompatibility. While maintaining a stable connection between the components, it has good flexibility and fatigue resistance. The electrode wire 1105 is electrically connected to the catheter flexible component, and the catheter flexible component is electrically connected to the electrode assembly 12 to form a complete circuit transmission path.

[0033] Electrode assembly 12 includes electrode 1203, mandrel 1204, and electrode fixing head 1102. Mandrel 1204 connects to electrode 1203 along the interior of catheter assembly 11, serving as a support framework for electrode 1203 and ensuring stability during advancement and positioning. Electrode fixing head 1102 is fixed to the distal end of electrode 1203, providing protection against damage to the bronchial wall during catheter advancement. The flexible catheter component secures the proximal end of electrode 1203 to catheter assembly 11, ensuring a secure connection between the entire electrode assembly 12 and catheter assembly 11.

[0034] The control module 2 includes a shell structure group 20, a pulse input component, an electrode adjustment mechanism 21 and an expansion and contraction drive mechanism 22 arranged inside the shell structure group 20. The shell structure group 20 provides structural support and protection for the entire control system. A groove is provided on the shell structure group 20, and the adjustment device of the electrode adjustment mechanism 21 and the adjustment device of the expansion and contraction drive mechanism 22 can slide along the groove respectively to achieve the adjustment required in practice. The pulse input component is electrically connected to the electrode wire 1105, and the pulse input component is connected to the pulse ablation device to ensure the effective transmission of pulse energy. The shell structure group 20 includes an upper shell 201, a lower shell 202 and a fixing seat 205, and adopts an ergonomic design to facilitate doctor operation. The core shaft 1204 is connected to the control module 2 along the catheter assembly 11, and precise control of the electrode assembly 12 is achieved through the operation of the control module 2.

[0035] In a specific embodiment of this embodiment, the catheter includes an inner catheter tube 1103, an outer catheter tube 1102, and a sheath tube 1101. The inner catheter tube 1103 is disposed within the outer catheter tube 1102, forming a double-tube structure, which improves the overall strength and stability of the catheter. The outer catheter tube 1102 is disposed within the sheath tube 1101 and is capable of axial displacement within the lumen of the sheath tube 1101. This design allows the outer catheter tube 1102 to precisely move back and forth within the sheath tube 1101, enabling fine-tuning of the position of the electrode 1203. The sheath tube 1101, as the outermost protective structure, provides guidance and protection during catheter advancement.

[0036] In one embodiment of this invention, a wire tube layer is provided between the outer catheter tube 1102 and the inner catheter tube 1103, with the electrode wire 1105 disposed within the wire tube layer. The wire tube layer provides a dedicated channel for the electrode wire 1105, preventing interference between the wire and other components while facilitating wire maintenance and replacement. This layered design effectively improves the reliability and service life of the catheter and electrode wire 1105.

[0037] In one embodiment of this invention, a core shaft insulation tube 1205 is disposed outside the core shaft 1204. Made of medical-grade insulating material, the core shaft insulation tube 1205 isolates the core shaft 1204 from surrounding tissue, preventing accidental current leakage and improving treatment safety. It also protects the core shaft 1204 and extends its service life.

[0038] In one embodiment of this invention, the housing assembly 20 further includes a catheter sheath 203 and a wire sheath 204. The catheter sheath 203 and wire sheath 204 are fixedly mounted at both ends of the housing assembly 20 by an upper shell 201 and a lower shell 202. The catheter sheath 203 protects the connection of the catheter to the control module 2 from bending damage. The wire sheath 204 protects the electrode wire 1105 from bending damage at the housing. The provision of these two sheaths significantly improves the stability and durability of the entire device.

[0039] In one embodiment of the present invention, the electrode adjustment mechanism 21 includes a sheath holder 2101, an adjustment knob 2102, and a sliding shaft 2103. The sheath holder 2101 is fixedly connected to the sheath 1101, ensuring the stable position of the sheath 1101 during adjustment. The adjustment knob 2102 is axially connected to the sheath holder 2101, allowing the physician to precisely adjust the position of the sheath 1101 by pushing and pulling the adjustment knob 2102. The sheath holder 2101 is slidably connected to the sliding shaft 2103, which acts as a guide to ensure smooth and accurate adjustment.

[0040] In one embodiment of the present invention, a plurality of adjustment button slots are provided on one side of the slot where the electrode adjustment mechanism 21 is located. The adjustment button 2102 can be rotated along the axis of the sliding shaft 2103 and snapped into the adjustment button slot. In one embodiment, this design has a four-position locking function, and the electrode length can be precisely switched between four positions: 50mm, 40mm, 30mm, and 20mm. Through tactile feedback, the doctor can accurately sense the current position. When the position is unlocked, the electrode length can also be steplessly adjusted within the range of 20-50mm to meet the personalized treatment needs of different patients.

[0041] In a specific implementation of this embodiment, the expansion and contraction drive mechanism 22 includes a push-pull button 2201, a core shaft seat 2202, a buffer 2204 and a transmission shaft 2203. The push-pull button 2201 is fixedly connected to the core shaft seat 2202, and the doctor can control the forward and backward movement of the core shaft 1204 by operating the push-pull button 2201. The buffer 2204 is made of soft rubber material and embedded in the core shaft seat 2202, which plays a role in buffering and shock absorption, thereby preventing the impact during operation from causing damage to the electrode assembly 12. The transmission shaft 2203 passes through the buffer 2204 and fixes the transmission shaft 2203 in a slot provided inside the outer shell structure group 20 to ensure the stability of the transmission process.

[0042] In one embodiment of this invention, a stainless steel capillary is embedded in the mandrel seat 2202. This significantly enhances the strength and pushing accuracy of the mandrel 1204, keeping the pushing concentricity error within 0.1 mm, a significant improvement over the 0.5 mm deviation of conventional technology. Furthermore, the stainless steel capillary also extends the lifespan of the mandrel 1204, improving the stability of the device and making it more durable.

[0043] In one embodiment of this invention, the flexible component of the catheter is made of nickel-titanium wire. Nickel-titanium wire has excellent elasticity and shape memory properties, and can return to its original shape after undergoing large deformation. It is very suitable for medical devices that require repeated bending, allowing the electrode 1203 to achieve good contact with the bronchial wall while maintaining sufficient strength to support the normal operation of the electrode 1203.

[0044] In one embodiment of this invention, the pulse input assembly includes a pulse lead 2301 and a pulse connector 2302. The electrode lead 1105 connects to the pulse lead 2301, establishing an electrical connection between the device's internal circuitry and the external pulse ablation device. The pulse connector 2302 connects to the pulse ablation device and utilizes a standardized interface design to ensure compatibility with pulse ablation devices from different manufacturers. The connector offers excellent electrical performance and mechanical strength, capable of withstanding frequent plugging and unplugging.

[0045] Example 2 This embodiment provides a control method for an electrode-adjustable pulse ablation device, which fully utilizes the intelligent functions of the device and implements personalized treatment planning based on preoperative images. The control method includes the following steps: Step S1: Obtain bronchial diameter D through preoperative CT 3D reconstruction. Before surgery, high-resolution CT scans are used to obtain 3D images of the patient's bronchi. 3D reconstruction is performed using specialized medical imaging software to accurately measure the bronchial diameter at the target treatment site. This step provides an accurate anatomical basis for subsequent treatment parameter setting.

[0046] Step S2: Determine electrode length based on bronchial diameter. Based on the bronchial diameter data obtained in step S1, the system automatically calculates or the physician manually selects the appropriate electrode length. This step accounts for individual bronchial variations and ensures that the electrode length matches the patient's anatomy.

[0047] Step S3: Adjust the electrode adjustment mechanism. When the electrode length reaches the specified value, it locks. The system automatically verifies the impedance value. When the impedance value is within the preset normal range, the next step is taken. The doctor adjusts the electrode to the length determined in step S2 by operating the electrode adjustment mechanism on the control module and secures the electrode position using the rotation lock function. The system's built-in impedance detection function automatically measures the current electrode impedance value, with the normal range typically set between 200-800Ω. Only when the impedance value is within the normal range will the system allow the next step to be taken. This design effectively ensures the safety of treatment.

[0048] Step S4: The electrode assembly is deployed to the preset size using the deployment and contraction drive mechanism. After confirming that the electrode length and impedance are normal, the physician operates the deployment and contraction drive mechanism to deploy the electrode assembly to the preset size at the target site. The deployment process should be performed slowly to ensure adequate contact between the electrode and the bronchial wall while avoiding damage to the bronchus caused by over-deployment.

[0049] Step S5: Activate the pulse ablation device for treatment. After completing all the aforementioned preparations, activate the external pulse ablation device and begin the formal ablation treatment. During treatment, the patient's vital signs and treatment response must be closely monitored to ensure the safety and effectiveness of the treatment.

[0050] In a specific implementation of this embodiment, in step S2, if D ≤ 8 mm, the preset gear electrode is selected; if D > 8 mm, the electrode length is calculated according to the formula L = 2.5D + 5. This judgment standard is based on a large amount of clinical data. When the bronchial diameter is less than or equal to 8 mm, an electrode with a length of 20 mm is usually selected. This length can provide sufficient treatment coverage in small-diameter bronchi. When the bronchial diameter is greater than 8 mm, the required electrode length is calculated using the formula L = 2.5D + 5. This formula reflects the relationship between the bronchial diameter and the optimal electrode length, ensuring that the best treatment effect can be obtained in bronchi of different diameters in practice.

[0051] Example 3 This embodiment demonstrates the specific operation process and effect verification of the electrode-adjustable pulse ablation device in actual clinical application.

[0052] In the bronchial adaptation process, the detailed anatomical information of the patient's bronchi is first obtained through preoperative CT three-dimensional reconstruction, including key parameters such as the diameter, length, and branch angle of the bronchi at all levels. For a patient with a bronchial diameter of 6mm, the system automatically selects gear 4 according to the preset rules, corresponding to a 20mm electrode length. The doctor pushes the adjustment knob on the control module to the target gear, hears a clear mechanical feedback sound, and rotates 15° to lock it. At this time, the system automatically performs impedance value calibration, displaying an impedance value of 350Ω, which is within the normal range of 200-800Ω, confirming that the system is working properly.

[0053] For another patient with a bronchial diameter of 12mm, the system calculated the required electrode length using the formula L = 2.5 × 12 + 5 = 35mm. Since this length is within the stepless adjustment range of 20-50mm, the physician unlocked the adjustment knob and continuously adjusted it to precisely 35mm. Throughout the adjustment process, the stainless steel capillary embedded in mandrel holder 2202 ensured a concentricity error of less than 0.1mm, significantly superior to the 0.5mm deviation of conventional technology.

[0054] During electrode deployment, once the electrode reaches the target position, the expansion and contraction drive mechanism slowly pushes the core shaft, and the electrode begins to deploy within the bronchus. The highly flexible materials used in the catheter's flexible components, such as nickel-titanium wire, enable the electrode to passively adapt to deflections of the bronchial axis, achieving parallel alignment with the central axis of the bronchus. The entire deployment process is smooth and seamless, significantly enhancing contact force against the bronchial wall.

[0055] During treatment, the pulse input assembly ensures stable transmission of pulse energy. The electrode lead is connected to the pulse lead via the catheter's flexible component, and then to the external pulse ablation device via the pulse connector 2302. The impedance of the entire circuit transmission path is stable, ensuring effective transmission of pulse energy. After treatment is complete, the electrode is smoothly retracted and safely withdrawn by reversing the expansion and contraction drive mechanism.

[0056] Example 4 This example provides an alternative solution for bronchi with diameters greater than 10 mm. In this example, the electrode length is fixed at 50 mm, and the contact pressure is directly controlled by a push-pull knob, simplifying the operation process. This design is particularly suitable for treatment sites with larger diameters, such as mainstem bronchi.

[0057] In this embodiment, the control device and ablation catheter utilize a sheath-free connection, reducing system complexity. Due to the larger diameter of the target bronchus, the flexibility requirements for the catheter are relatively low, allowing for a relatively simplified structural design. In this configuration, the electrode adjustment mechanism primarily controls electrode deployment and contact pressure, eliminating the need for complex length adjustments.

[0058] The stainless steel capillary embedded in the mandrel seat ensures that the concentricity error of the push rod is controlled within 0.1mm. This precision control is also crucial for the treatment of large-diameter bronchi, ensuring that the electrode is accurately deployed at the predetermined position.

[0059] In the flexible part of the catheter, the nickel-titanium wire material used provides sufficient flexibility to enable the 50mm long electrode to fit well in large-diameter bronchus, allowing the electrode to adapt to the natural curvature of the bronchus and ensuring that the entire length of the electrode can maintain effective contact with the bronchial wall.

[0060] The control method in this embodiment is relatively simplified, primarily comprising four steps: electrode positioning, deployment, treatment, and retraction. Since the electrode length is fixed, length adjustment is eliminated, but impedance testing is still required to confirm proper system operation. The monitoring and control mechanisms during treatment are essentially the same as those in the previous embodiment, ensuring both safe and effective treatment.

[0061] The detailed description of the above embodiments demonstrates that the electrode-adjustable pulse ablation device of the present invention offers significant advantages, including structural innovation, precise control, and strong adaptability. It can provide a safe and effective technical solution for interventional bronchial treatment of COPD. While the differences between the various embodiments primarily lie in the specific structural configurations and control strategies, all adhere to the same design principles and technical approaches, demonstrating the versatility and flexibility of the present invention's technical solutions.

[0062] The working principle of the present invention is as follows: The electrode-adjustable pulse ablation device of the present invention achieves full-process optimization of bronchial interventional treatment through modular design.

[0063] First, a high-resolution CT scan is used to obtain detailed anatomical information of the patient's bronchi. Professional medical imaging software is then used to perform a three-dimensional reconstruction and measure the diameter of the bronchus at the target treatment site. The system's built-in algorithm uses this measurement to calculate the optimal electrode length: when the bronchial diameter D is ≤ 8mm, the system automatically selects a preset 20mm electrode length. When the bronchial diameter D is greater than 8mm, the required electrode length is calculated using the formula L = 2.5D + 5, ensuring that the electrode size precisely matches the patient's individual anatomy.

[0064] The ablation catheter module 1 is introduced into the patient's body through a natural cavity or percutaneous puncture. The catheter assembly 11 utilizes a three-layer nested structure, with an inner catheter tube 1103 positioned within an outer catheter tube 1102, which in turn is positioned within a sheath 1101. This design enables precise axial displacement of the outer catheter tube 1102 within the lumen of the sheath 1101. The flexible components of the catheter enable the electrode 1203 to maintain good tracking within the complex curvature of the bronchus, passively adapting to deflections of the bronchial axis.

[0065] The operator makes adjustments through the electrode adjustment mechanism 21 on the control module 2. The sheath holder 2101 is fixedly connected to the sheath 1101, and the adjustment button 2102 is axially connected to the sheath holder 2101. When the operator pushes the adjustment button 2102, the sheath holder 2101 slides along the sliding shaft 2103, driving the entire sheath 1101 to move. The multiple adjustment button slots provided in the electrode adjustment mechanism 21 realize a four-speed precise positioning function. The adjustment button 2102 can be rotated along the axis of the sliding shaft 2103 and snapped into the corresponding adjustment button slot, providing the operator with clear tactile confirmation through mechanical feedback. When stepless adjustment is required, the operator can push the adjustment button 2102 to make continuous adjustments within the range of 20-50mm.

[0066] At the beginning of treatment, the operator pushes the push-pull button 2201 of the expansion and contraction drive mechanism 22 to expand the electrode 1203. The push-pull button 2201 is fixedly connected to the core shaft seat 2202. The stainless steel capillary embedded in the core shaft seat 2202 enhances the strength and pushing accuracy of the core shaft 1204, and can control the pushing concentricity error within 0.1mm. The buffer 2204 is made of soft rubber material and embedded in the core shaft seat 2202. It plays a buffering and shock-absorbing role during the transmission process to prevent sudden impact from causing damage to the electrode assembly 12. The transmission shaft 2203 passes through the buffer 2204 and is fixed in the slot of the outer shell structure group 20 to ensure the stability of the transmission system. When the core shaft 1204 pushes the electrode 1203 forward, the electrode fixing head 1102 first contacts the bronchial wall, playing a protective and guiding role. Then the electrode assembly 12 is gradually expanded under the support of the flexible part of the catheter, forming a good fitting contact with the bronchial wall.

[0067] During the treatment process, the pulse input assembly ensures the stable transmission of treatment energy. The electrode wire 1105 is arranged inside the catheter along the extension direction of the catheter, and is protected and guided by the wire tube layer between the catheter outer tube 1102 and the catheter inner tube 1103. The electrode wire 1105 is electrically connected to the flexible part of the catheter, and the flexible part of the catheter is electrically connected to the electrode assembly 12 to form a complete circuit transmission path. The pulse wire 2301 is connected to the electrode wire 1105, and the pulse connector 2302 is connected to the external pulse ablation device to ensure that the pulse electrical signal is accurately transmitted to the electrode assembly 12. The built-in impedance detection function of the pulse ablation device continuously monitors the circuit status. The normal impedance value range is set at 200-800Ω. When an impedance abnormality is detected, the device automatically alarms and stops treatment to ensure patient safety.

[0068] During the ablation process, electrode assembly 12 generates a high-intensity pulsed electric field within the bronchus, causing irreversible electroporation of the target tissue cell membranes, leading to cell death and achieving precise ablation of the diseased tissue. Due to the excellent contact of electrode 1203 with the bronchial wall, the ablation electric field is evenly distributed, and the treatment effect is controllable. The core shaft insulation tube 1205, located outside the core shaft 1204, ensures isolation from the surrounding tissue, preventing accidental current leakage and improving treatment safety.

[0069] After treatment is complete, electrode 1203 is retracted by reversing the expansion / contraction drive mechanism 22. The operator reverses the push / pull knob 2201, causing core shaft 1204 to retract, and electrode assembly 12 to retract smoothly under the guidance of the flexible catheter component. The shape memory properties of the nickel-titanium wire material in the flexible catheter component ensure that electrode 1203 returns to its original retracted state, preventing additional damage to the bronchus during withdrawal. The entire withdrawal process is smooth and controllable, minimizing patient discomfort.

[0070] The operating principle of this invention fully embodies the concept of precision medicine. Through intelligent preoperative planning, precise mechanical control, stable energy transmission, and a safe monitoring mechanism, it provides a complete technical solution for COPD bronchial interventional treatment. The coordinated cooperation between various modules ensures the accuracy and safety of the entire process from electrode positioning to treatment completion, significantly improving treatment effectiveness and patient experience.

[0071] The above embodiments are intended only to illustrate the technical concepts and features of the present invention. Their purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. They are not intended to limit the scope of protection of the present invention. Any equivalent changes or modifications made in accordance with the spirit of the present invention are intended to be covered by the scope of protection of the present invention.

Claims

1. An electrode-adjustable pulse ablation device, comprising an ablation catheter module and a control module connected in sequence, wherein the ablation catheter module comprises a catheter assembly and an electrode assembly connected in sequence, characterized in that: The catheter assembly includes a catheter, a catheter flexible component, and an electrode wire, wherein the electrode wire is arranged inside the catheter along the extension direction of the catheter, a catheter flexible component is provided on one side of the catheter, the electrode wire is electrically connected to the catheter flexible component, and the catheter flexible component is electrically connected to the electrode assembly; The electrode assembly includes an electrode, a core shaft and an electrode fixing head, wherein the core shaft is connected to the electrode along the interior of the catheter assembly, the electrode fixing head is fixedly disposed at the distal end of the electrode, and the catheter flexible component fixes the proximal end of the electrode to the catheter assembly; The control module includes a housing structure group, a pulse input component, an electrode adjustment mechanism and an expansion and contraction drive mechanism arranged inside the housing structure group. The housing structure group is provided with a slot, and the adjusting device of the electrode adjusting mechanism and the adjusting device of the expansion and contraction driving mechanism can slide along the slot respectively. The pulse input assembly is electrically connected to the electrode wire, and the pulse input assembly is connected to the pulse ablation device; The shell structure group includes an upper shell, a lower shell and a fixing seat; the core shaft is connected to the control module along the catheter assembly.

2. The electrode-adjustable pulse ablation device according to claim 1, characterized in that: The catheter comprises an inner catheter tube, an outer catheter tube and a sheath tube; The catheter inner tube is arranged inside the catheter outer tube, and the catheter outer tube is arranged inside the sheath tube and can be axially displaced along the sheath tube cavity.

3. The electrode-adjustable pulse ablation device according to claim 2, characterized in that: A wire tube layer is provided between the outer tube of the catheter and the inner tube of the catheter, and the electrode wire is provided inside the wire tube layer.

4. The electrode-adjustable pulse ablation device according to claim 1, characterized in that: A core shaft insulating tube is provided on the outer side of the core shaft.

5. The electrode-adjustable pulse ablation device according to claim 1, characterized in that: The shell structure group further includes a catheter sheath and a wire sheath, and the catheter sheath and the wire sheath are fixedly arranged at two ends of the shell structure group by an upper shell and a lower shell.

6. The electrode-adjustable pulse ablation device according to claim 2, characterized in that: The electrode adjustment mechanism includes a sheath fixing seat, an adjustment button and a sliding shaft. The sheath fixing seat is fixedly connected to the sheath, the adjustment button is axially connected to the sheath fixing seat, and the sheath fixing seat is slidably connected to the sliding shaft.

7. The electrode-adjustable pulse ablation device according to claim 6, characterized in that: A plurality of adjusting button slots are provided on one side of the slot where the electrode adjusting mechanism is located. The adjusting buttons can be rotated along the axis of the sliding shaft and inserted into the adjusting button slots.

8. The electrode-adjustable pulse ablation device according to claim 1, characterized in that: The expansion and contraction driving mechanism includes a push-pull button, a core shaft seat, a buffer member and a transmission shaft; The push-pull button is fixedly connected to the core shaft seat, the buffer is made of soft rubber material and embedded in the core shaft seat, the transmission shaft passes through the buffer and is fixed in a slot provided inside the outer shell structure group.

9. The electrode-adjustable pulse ablation device according to claim 8, characterized in that: The core shaft seat is inlaid with a stainless steel capillary.

10. The electrode-adjustable pulse ablation device according to claim 1, characterized in that: The flexible part of the catheter is made of nickel titanium wire.

11. The electrode-adjustable pulse ablation device according to claim 1, characterized in that: The pulse input component includes a pulse wire and a pulse connector. The electrode wire is connected to the pulse wire, and the pulse connector is connected to a pulse ablation device.

12. A control method for the electrode-adjustable pulse ablation device according to any one of claims 1 to 11, characterized in that: The following steps are involved: S1: Bronchial diameter D was obtained by preoperative CT three-dimensional reconstruction; S2: Determine the electrode length according to the bronchial diameter; S3: Adjust the electrode adjustment mechanism. When the electrode length reaches a certain value, it is locked. The system automatically checks the impedance value. When the impedance value is within the preset normal range, proceed to the next step. S4: controlling the electrode assembly to expand to a preset size through the expansion and contraction drive mechanism; S5: Start the pulse ablation device for treatment.

13. The control method of the electrode-adjustable pulse ablation device according to claim 12, characterized in that: In step S2, if D≤8mm, select the preset gear electrode; if D>8mm, calculate the electrode length according to the formula L=2.5D+5.

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