Catheter system for treating chronic obstructive pulmonary disease through two-stage pulsed electric field ablation

Abstract

The invention discloses a catheter system for treating chronic obstructive pulmonary disease through two-stage pulsed electric field ablation, and the system comprises a two-stage electrode assembly which is used for guaranteeing that current only flows between specific electrodes; the handle regulation and control mechanism is used for dynamically adjusting the size of the electrode so as to adapt to different airway diameters; imaging probes, integrated OCT and / or ultrasound, for providing real-time airway wall structure and tissue condition monitoring. By means of the technical scheme, the problems that in the prior art, current flows through deep tissue in the ablation process of a single-stage system, and risks are caused due to incomplete electrode coverage can be effectively solved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a catheter system for bipolar pulsed electric field ablation therapy of COPD. Background Technology

[0002] In the field of interventional treatment for Chronic Obstructive Pulmonary Disease (COPD), electric field ablation technology, as an emerging non-thermal therapy, aims to relieve patient symptoms by ablating airway smooth muscle. However, existing electric field ablation catheter systems have significant technical limitations and potential risks, particularly the limitations of monopolar electrode design.

[0003] 1. Limitations and risks of single-stage electrode systems: In the electric field ablation treatment of COPD, the traditional monopolar electrode design causes current to flow between the electrode and ground, a current path that is often difficult to control precisely. In particular, when the electrode is close to sensitive organs such as the heart, spinal cord, and vagus nerve, there is a certain risk of current leakage. Existing studies have indicated that even in low-power applications, this undirected current flow can cause accidental damage to deep tissues, such as damage to the cardiac conduction system, irreversible electrical damage to the anterior horn cells of the spinal cord, and stimulation of the vagus nerve, leading to serious complications such as bradycardia or respiratory arrest.

[0004] Furthermore, the size and layout of single-stage electrodes are often unable to adapt to variations in airway diameter, especially within the broad range of 5-18 mm. This means that for different levels of airways, a single type of electrode may not be able to achieve comprehensive and effective coverage, thus affecting the thoroughness and safety of ablation.

[0005] 2. Challenges in Imaging and Control: Existing electric field ablation systems lack integrated imaging capabilities in their catheter designs, limiting the surgeon's field of vision and control precision during the procedure. While some systems incorporate parameter feedback mechanisms such as impedance monitoring, relying solely on impedance changes to guide ablation depth and extent remains uncertain in practical applications. Without real-time imaging monitoring, it is difficult for surgeons to intuitively determine whether electric field ablation has achieved its intended goal—precisely destroying the smooth muscle layer without damaging adjacent cartilage, mucosa, and other vital structures.

[0006] 3. Operational complexity and risks: Traditional electrode catheter handle designs do not adequately consider the ease of operation and safety for physicians. The lack of a precise adjustment mechanism for controlling electrode expansion and contraction can lead to poor adhesion between the electrode and the airway wall, or even unnecessary collisions during operation, increasing the risks and uncertainties of the treatment process.

[0007] In summary, existing electric field ablation catheter systems have significant shortcomings in electrode design, imaging integration, real-time control, and ease of handpiece operation. These limitations directly affect the safety and effectiveness of treatment, restricting the widespread application of electric field ablation technology in interventional treatment of COPD. Therefore, there is an urgent need for a novel electrode design and overall system integration solution to address these issues and improve the safety and precision of treatment. Summary of the Invention

[0008] The technical problem to be solved by the present invention is to provide a catheter system for the treatment of COPD by dual-stage pulsed electric field ablation, which can effectively solve the problems of current flowing through deep tissues and the risks caused by incomplete electrode coverage in the single-stage system during the ablation process in the prior art.

[0009] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is: a catheter system for dual-stage pulsed electric field ablation therapy of COPD, comprising: a dual-stage electrode assembly 1, used to ensure that the current flows only between specific electrodes; a handle adjustment mechanism 2, which realizes dynamic adjustment of electrode size to adapt to different airway diameters; and an imaging probe 3, which integrates OCT and / or ultrasound to provide real-time monitoring of airway wall structure and tissue status.

[0010] In one embodiment of this application, the dual-stage electrode assembly further includes positive and negative dual-network electrodes, wherein the spacing between the positive and negative networks is adjustable, specifically controlled by a fine thread mechanism in the handle adjustment mechanism to adapt to airways of different diameters.

[0011] In one embodiment of this application, the dual-stage electrode assembly further includes a small-pitch double-cage bar electrode, wherein the spacing between the cage bars of the electrode structure is smaller than that of a conventional design.

[0012] In one embodiment of this application, the bipolar electrode assembly adopts the form of a balloon electrode. The electrode is composed of a polyimide thin film magnetron sputtered metal layer. The internal inflatable balloon achieves isolation between the electrodes to prevent short circuits. The inflatable balloon is medical grade and has high biocompatibility and stability.

[0013] In one embodiment of this application, the handle control mechanism includes a high-precision encoder for real-time feedback of the push-pull wire displacement, ensuring precise real-time control during the electrode expansion and contraction process; the encoder can accurately detect displacement changes with a minimum unit of millimeters.

[0014] In one embodiment of this application, the handle control mechanism has an overload protection mechanism. When the tension exceeds a preset mechanical strength threshold, the retraction device is automatically triggered to prevent the electrode from being damaged or accidentally expanded. The threshold is, for example, 3 Newtons.

[0015] In one embodiment of this application, the imaging probe integrates optical coherence tomography (OCT) and ultrasound. In a collaborative working mode, OCT dominates tissue structure identification, while ultrasound provides additional microbubble generation warnings, ensuring the safety and effectiveness of the ablation process.

[0016] In one embodiment of this application, the adaptive energy control model adjusts the depth and impedance weighting coefficients (k1, k2) according to the airway type. In large airways, the model focuses on depth monitoring (the depth weighting coefficient k1 is higher), while in small airways, it relies more on tissue impedance monitoring (the impedance weighting coefficient k2 is higher), thereby optimizing the ablation effect of airways of different sizes. The adaptive energy control model achieves precise real-time control through the following dynamic voltage adjustment formula:

[0017] Wherein, V is the ablation voltage adjusted in real time, V0 is the initial preset voltage, d is the ablation depth monitored in real time by OCT imaging, D_m is the smooth muscle layer thickness measured preoperatively by OCT, Z is the real-time tissue impedance, and Z0 is the initial tissue impedance; k1 and k2 are weighting coefficients, and their values ​​are adjusted according to the different types of large or small airways, as described above. The model ensures that the ablation depth reaches about 80% of the smooth muscle layer thickness through the depth compensation term k1 (1-d / (0.8D_m)), and dynamically responds to changes in tissue state (such as dehydration or carbonization) through the impedance compensation term k2 ((Z-Z0) / Z0), thereby maximizing the safety of treatment while ensuring ablation efficiency.

[0018] In one embodiment of this application, the bidirectional independent control mechanism of the dual-mesh electrode assembly achieves independent extension and retraction of the distal and proximal electrodes by separately controlling the push-pull wire of the distal electrode and the push-pull outer tube and wire of the proximal electrode. The handle design conforms to ergonomic principles, ensuring precise operation by the doctor.

[0019] In one embodiment of this application, in the nickel-titanium shape memory alloy cage bar electrode structure, the polarities of adjacent bars are opposite, and an inflatable balloon is built in. When the balloon inflation pressure is greater than a predetermined value, the electrodes are ensured to separate to avoid short circuits. The predetermined value is 0.3 MPa, and the near and far ends of the electrodes are insulated.

[0020] In one embodiment of this application, the surface of the insulating skeleton bar in the gold-plated cage electrode is magnetron sputtered with a thin film of metal such as gold, platinum-iridium alloy, or iridium to enhance conductivity. At the same time, the PI film provides sufficient insulation, making it suitable for the ablation process that conducts current.

[0021] In one embodiment of this application, the dual-net control structure of the handle, through a unique design, allows the user to control the extension and retraction of the far-end net and the near-end net respectively by rotating two independent knobs, avoiding possible confusion during operation and ensuring a more intuitive control experience.

[0022] In one embodiment of this application, the imaging system and ablation synergy algorithm can dynamically optimize pulse energy release based on OCT imaging data and ultrasound reflection signals, as well as measurement results from impedance sensors and EMG electrodes, to ensure accurate ablation depth and safe cessation before nerve / cartilage damage.

[0023] In one embodiment of this application, the dual-stage pulse generator can output nanosecond-microsecond dual-mode pulses, using biphase pulses to replace monophase pulses, eliminating charge accumulation, and adapting to the treatment needs of different levels of airways; the dual-mode pulses can automatically switch frequency and width according to tissue characteristics.

[0024] In one embodiment of this application, the system includes a safety monitoring module that can trigger an energy output interruption mechanism in advance by detecting EMG signals, electrode short circuits, and local temperature changes, thereby preventing nerve stimulation, electric shock injury, or tissue overheating damage that may occur during treatment.

[0025] In one embodiment of this application, during the ablation process, the system can dynamically adjust the ablation voltage based on a depth compensation term and an impedance compensation term; the depth compensation term ensures that the target depth is achieved, while the impedance compensation term dynamically responds to changes in tissue state, improving ablation efficiency and ensuring safety.

[0026] Compared with existing technologies, this invention has the following advantages: This dual-stage pulsed electric field ablation catheter system for COPD achieves personalized, safe, and efficient treatment for different airway sizes by precisely controlling the electrode spacing and diameter, combined with integrated OCT and ultrasound imaging technologies. Its dual-network electrode assembly's bidirectional independent control mechanism ensures the flexibility and precision of the surgical procedure. Furthermore, the adaptive energy control model and collaborative optimization algorithm enable intelligent adjustment of energy output based on real-time tissue conditions, effectively avoiding risks such as nerve stimulation, cartilage damage, and tissue overheating, significantly improving the safety and success rate of COPD treatment. In addition, the use of medical-grade materials and structural design not only enhances the system's biocompatibility but also greatly reduces the incidence of surgical complications, bringing a revolutionary breakthrough to clinical practice.

[0027] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the system of the present invention; Figure 2This is a schematic diagram of the structure of the balloon electrode of the present invention.

[0029] Explanation of reference numerals in the attached figures: 1. Bipolar electrode assembly; 2. Handle control mechanism; 3. Imaging probe. Detailed Implementation

[0030] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0031] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0032] like Figure 1 and Figure 2 As shown, the dual-stage pulsed electric field ablation catheter system includes: a dual-stage electrode assembly 1, which ensures that current flows only between specific electrodes; a handle adjustment mechanism 2, which enables dynamic adjustment of electrode size to adapt to different airway diameters; and an imaging probe 3, which integrates OCT and / or ultrasound to provide real-time monitoring of airway wall structure and tissue condition.

[0033] Furthermore, in this embodiment, the dual-stage electrode assembly 1 also includes a small-pitch double-cage bar electrode, the spacing between the cage bars of which is smaller than that of a conventional design.

[0034] In this embodiment, the small-pitch design allows the electrodes to fit more closely to the airway wall, enhancing the focusing effect of the current in the target smooth muscle layer, improving ablation efficiency, and reducing unnecessary tissue damage.

[0035] When the embodiments involve the coordinated operation of the handle control mechanism and the electrode structure, the linear relationship between the push-pull wire displacement ΔL and the electrode diameter D, D=D0+k·ΔL, ensures precise control of electrode expansion and retraction. The ergonomic design of the handle allows physicians to easily control the expansion and contraction of the dual-network electrodes, improving the ease and reliability of operation. By precisely adjusting the electrode diameter, the catheter can adapt to airways of different diameters, covering the treatment range from the large airways to branch airways, thereby enabling personalized and comprehensive treatment plans.

[0036] In this embodiment, the innovative design of the balloon electrode, dual-mesh electrode, gold-plated cage electrode, and fine-pitch dual-mesh electrode, combined with the imaging system and ablation synergy algorithm, jointly constructs a highly integrated and intelligent two-stage pulsed electric field ablation system. This system can dynamically adjust the energy release strategy based on real-time monitoring of tissue structure, impedance changes, and nerve signals, ensuring that the ablation depth accurately reaches the target threshold. Simultaneously, it intercepts potential nerve stimulation and tissue overheating risks in real time, significantly improving the safety and effectiveness of interventional treatment for COPD. Furthermore, the optimized handle design of this system streamlines the operation, making the entire treatment process more intuitive and efficient, providing physicians with a better control experience, and further solidifying the technology's position as a significant advancement in the field of COPD treatment.

[0037] Furthermore, in this embodiment, the bipolar electrode assembly 1 adopts the form of a balloon electrode. The electrode is composed of a polyimide (PI) thin film magnetron sputtered metal layer. The internal inflatable balloon achieves isolation between the electrodes to prevent short circuits. In particular, the inflatable balloon is medical grade and has high biocompatibility and stability.

[0038] In this embodiment, the bipolar electrode assembly 1 adopts the form of a balloon electrode, wherein the electrode is composed of a polyimide (PI) thin film magnetron sputtered metal layer. The internally inflated balloon isolates the electrodes, effectively preventing short circuits. The balloon is made of medical-grade materials, possessing high biocompatibility and stability, ensuring the safety of the treatment process and good contact with biological tissue. During ablation, when the balloon expands to the predetermined size, the electrode strips make full contact with the airway wall, allowing the pulsed electric field energy to be precisely transmitted to the target tissue. By adjusting the air pressure inside the balloon, the adhesion of the electrode strips is controlled, thereby optimizing the ablation effect. Furthermore, the isolation function of the balloon avoids unnecessary current leakage between the electrode strips, ensuring efficient energy utilization, reducing the impact on surrounding non-target tissues, and improving the overall safety and effectiveness of the treatment. When electrode retrieval is required, the gas inside the balloon is released, allowing the electrode strips to naturally detach from the airway wall, reducing mechanical damage to the airway wall and protecting the integrity of the airway. This design not only simplifies the surgical procedure, but also achieves precise treatment of tracheal smooth muscle by accurately controlling the ablation area, avoiding damage to sensitive tissues such as nerves and blood vessels, and greatly improving the accuracy of treatment and patient safety.

[0039] Furthermore, in this embodiment, the handle control mechanism 2 includes a high-precision encoder to provide real-time feedback on the push-pull wire displacement, ensuring precise real-time control during the electrode expansion and contraction process; in particular, the encoder is capable of accurately detecting displacement changes with a minimum unit of millimeters.

[0040] In this embodiment, the handle adjustment mechanism 2 integrates a high-precision encoder to provide real-time feedback on the displacement information of the push-pull wire, ensuring accurate and timely adjustment of the electrode diameter. Particularly noteworthy is the encoder's millimeter-level minimum displacement detection capability, which not only significantly enhances the system's operational sensitivity but also allows doctors higher control precision when fine-tuning electrode dimensions, thus better adapting to the needs of different airway diameters. During ablation, this precise real-time diameter control is crucial for achieving a tight fit between the electrode and the airway wall, ensuring effective transmission of pulsed electric field energy, while also reducing treatment risks caused by improper electrode size, improving the overall safety and effectiveness of the treatment. Furthermore, the encoder also assists the system in self-monitoring, promptly detecting and correcting any possible mechanical deviations, further enhancing the system's stability and reliability. Regarding the ergonomic design of the handle, this improvement also enhances the doctor's feel and confidence during operation, making the complex expansion and contraction of the bipolar electrode more intuitive and controllable, ultimately achieving high efficiency and patient safety in clinical applications.

[0041] Furthermore, in this embodiment, the handle control mechanism 2 has an overload protection mechanism. When the tension exceeds a preset mechanical strength threshold, the retraction device is automatically triggered to prevent the electrode from being damaged or accidentally expanded. Specifically, the threshold is, for example, 3 Newtons N.

[0042] In this embodiment, the handle control mechanism 2 integrates an overload protection design to ensure that when the external tension applied to the system exceeds 3 Newtons, the retraction mechanism is automatically activated, effectively preventing damage to the electrode assembly due to excessive tension or unexpected expansion. The core of this mechanism lies in the real-time monitoring of tension changes during operation using a precise force-sensing element. Once a force value exceeding the safe range is detected, the retraction device is immediately triggered, causing the electrode assembly to quickly return to its initial configuration, ensuring the safety of the treatment process and the integrity of the electrode structure. This design not only improves the reliability of the system but also greatly reduces potential operational risks, ensuring precise control and achieving ideal treatment results even in complex anatomical environments during interventional treatment. (End of paragraph)

[0043] Furthermore, in this embodiment, the optical coherence tomography (OCT) and ultrasound integrated in the imaging probe 3 can work in a collaborative mode, with OCT taking the lead in tissue structure identification and ultrasound providing additional microbubble generation warnings to ensure the safety and effectiveness of the ablation process.

[0044] In this embodiment, the catheter system for dual-stage pulsed electric field ablation therapy of COPD integrates a dual-mesh electrode, a small-pitch dual-cage bar electrode, and a small-pitch dual-mesh electrode structure. The dual-mesh electrode communicates through two positive and negative nickel-titanium mesh or cage-like components, ensuring that current flows only between the electrodes at the catheter tip, avoiding the risk of current damage to deep tissues. The small-pitch dual-cage bar electrode and the small-pitch dual-mesh electrode optimize the distance between electrodes, enhancing operational freedom while ensuring product safety. In the nickel-titanium cage bar electrode, several nickel-titanium bars are arranged in a cage-like pattern, with adjacent bars having opposite polarities. The built-in inflatable balloon prevents short circuits between electrodes while ensuring effective contact between the electrode and the airway wall. The gold-plated cage bar electrode includes several insulating skeleton bars and a gold-plated thin film distributed on them, improving the electrode's conductivity and durability. The annular electrode pairs arranged on the balloon electrode surface are achieved through magnetron sputtering of a gold layer combined with PI film adhesive or direct electroplating, enhancing the adhesion between the electrode and the balloon surface and avoiding the risk of electrode detachment during expansion.

[0045] In the design of the handle control mechanism 2, the push-pull wire displacement ΔL and the electrode diameter D satisfy a linear relationship, D=D0+k·ΔL, achieving precise control of the electrode size. In the dual-network expansion and contraction control structure, the opposite thread design of the distal and proximal knobs ensures that the dual networks expand or contract in opposite directions when both rotate in the same direction, avoiding operational confusion. Furthermore, the ergonomic design of the handle optimizes the operating experience, allowing doctors to easily operate the expansion and contraction of the dual networks with one hand, further improving the convenience and safety of the procedure. Through the integrated OCT and ultrasound imaging probe 3 working in tandem, with OCT primarily identifying tissue structures and ultrasound providing microbubble generation alerts, precise control and real-time monitoring of the ablation process are ensured, achieving efficient and safe interventional treatment for COPD.

[0046] Furthermore, in this embodiment, the adaptive energy control model adjusts the depth and impedance weighting coefficients (k1, k2) according to the airway type. In large airways, the model focuses on depth monitoring (the depth weighting coefficient k1 is higher), while in small airways, it relies more on tissue impedance monitoring (the impedance weighting coefficient k2 is higher), thereby optimizing the ablation effect of airways of different sizes. The adaptive energy control model achieves precise real-time control through the following dynamic voltage adjustment formula:

[0047] Wherein, V is the ablation voltage adjusted in real time, V0 is the initial preset voltage, d is the ablation depth monitored in real time by OCT imaging, D_m is the smooth muscle layer thickness measured preoperatively by OCT, Z is the real-time tissue impedance, and Z0 is the initial tissue impedance; k1 and k2 are weighting coefficients, and their values ​​are adjusted according to the different types of large or small airways, as described above. The model ensures that the ablation depth reaches about 80% of the smooth muscle layer thickness through the depth compensation term k1 (1-d / (0.8D_m)), and dynamically responds to changes in tissue state (such as dehydration or carbonization) through the impedance compensation term k2 ((Z-Z0) / Z0), thereby maximizing the safety of treatment while ensuring ablation efficiency.

[0048] This embodiment details the collaborative workflow of the adaptive energy control model, imaging system, and ablation synergy algorithm. The algorithm runs within the system's energy control and imaging system, specifically including the following steps: Step 1: Tissue Layer Identification (OCT-led) The system acquires real-time cross-sectional images of the airway wall using an OCT probe integrated into the distal end of the catheter (frame rate 20 frames / second). A trained U-Net convolutional neural network is used to automatically segment the images, accurately identifying the epithelial layer, smooth muscle layer, and cartilage layer, and calculating the ablation depth d and the total muscle layer thickness D_m in real time, providing key depth parameters for the voltage adjustment formula. Step 2: Ablation Endpoint Determination (Multimodal Fusion) The system processes multi-source information in parallel, including OCT structural data, impedance sensor signals, and photoacoustic signals. The ablation endpoint is triggered by one of the following conditions: 1. Structural compliance: Real-time ablation depth d ≥ 70% of smooth muscle layer thickness D_m.

[0049] 2. Impedance mutation: The real-time tissue impedance Z increases by more than 15% compared to the initial value Z0.

[0050] 3. Hemoglobin decay: Photoacoustic signals indicate a decrease in hemoglobin concentration exceeding 40%. When any of these conditions are met, the system immediately issues a command to stop energy release at the current location.

[0051] Step 3: Real-time Risk Interception (EMG + Ultrasound) This is the safety protection layer. The system continuously monitors the EMG signal. When the amplitude >10mV (indicating neural activation), energy output is paused within 200ms. Simultaneously, microbubble generation is detected via ultrasound (characterized by a high-echo signal >-40dB). Once detected, the power density is automatically limited and coolant perfusion is initiated to prevent tissue vaporization. The parameters (d, D_m, Z, Z0) obtained in the above steps are input in real-time into the voltage dynamic adjustment formula. In this process, the system's processor performs calculations and dynamically outputs the optimal ablation voltage V, thereby achieving closed-loop intelligent control of "imaging-guided ablation and ablation-verified imaging".

[0052] In this embodiment, the adaptive energy control model of the dual-stage pulsed electric field ablation system dynamically adjusts the weighting coefficients (k1, k2) of depth and impedance according to the airway type, achieving precise and safe ablation effects for airways of different sizes. Specifically, during the treatment of large airways (diameter greater than 10 mm), the model tends to monitor depth (a higher depth weighting coefficient k1) to ensure that the ablation depth reaches the airway epithelium and submucosa, targeting abnormal goblet cells and glands, while leaving connective tissue and cartilage undamaged. In the treatment of small airways (diameter between 4-9 mm), due to the confined space and the risk of heat accumulation, the model relies more heavily on tissue impedance monitoring (a higher impedance weighting coefficient k2), enabling rapid response to impedance changes and preventing over-ablation caused by tissue dehydration or carbonization, ensuring the safety and effectiveness of the treatment. Through this flexible weighting adjustment mechanism, the system can provide the optimal ablation plan under various airway conditions, ensuring both the thoroughness of the treatment and strict control of potential side effects, thus improving the accuracy of COPD interventional therapy and patient safety. Furthermore, the model possesses intelligent judgment capabilities, enabling it to take timely measures, such as pausing energy output or reducing voltage, when risks such as nerve stimulation or tissue overheating occur, further enhancing the safety and controllability of the treatment process. In summary, the adaptive energy control model in this embodiment, by comprehensively considering ablation depth and tissue impedance, achieves personalized and precise COPD treatment, and is the key to the system's efficient and safe ablation.

[0053] Furthermore, in this embodiment, the bidirectional independent control mechanism of the dual-mesh electrode assembly specifically achieves independent extension and retraction of the distal and proximal electrodes by separately controlling the push-pull wire of the distal electrode and the push-pull outer tube and wire of the proximal electrode. The handle design conforms to ergonomic principles, ensuring precise operation by the doctor.

[0054] In this embodiment, the bidirectional independent control mechanism of the dual-network electrode assembly is achieved through a cleverly designed handle adjustment mechanism 2. Specifically, the handle is equipped with a linear relationship adjustment device between the push-pull wire displacement ΔL and the electrode diameter D, i.e., D=D0+k·ΔL, ensuring precise changes in electrode size. The expansion and contraction control structure of the dual-network structure includes a distal knob and a proximal knob, which control the positive and negative electrodes at the distal end of the catheter, respectively, enabling independent extension and retraction of the electrodes. Particularly noteworthy is the ergonomic design of the handle, which, through the clever arrangement of the knob positions and the extension rod of the control wire, ensures that the surgeon can smoothly operate the expansion and contraction of the dual-network electrodes with one hand, avoiding operational confusion caused by improper layout of the control components. This design not only improves the ease and accuracy of operation during surgery but also significantly enhances the overall safety and reliability of the system by reducing accidental contact between electrodes. In practical applications, this independent and coordinated control mechanism can flexibly adjust the electrode coverage according to surgical needs, ensuring the personalization and efficiency of the ablation process. Of course, this control mechanism is also applicable to other electrode structures, such as small-pitch dual-mesh electrodes and small-pitch dual-cage bar electrodes, further expanding the system's application scope and therapeutic indications. Through the above design, this embodiment achieves precise control of the electrode components, improving the safety and effectiveness of pulsed electric field ablation therapy and providing clinicians with a more powerful support tool.

[0055] Furthermore, in this embodiment, in the nickel-titanium shape memory alloy cage bar electrode structure, the polarities of adjacent bars are opposite, and an inflatable balloon is built in. When the balloon inflation pressure is greater than a predetermined value, the electrodes are ensured to separate to avoid short circuits. In particular, the predetermined value is 0.3 MPa, and the near and far ends of the electrodes are insulated.

[0056] In this embodiment, the nickel-titanium shape memory alloy cage electrode employs a design where adjacent bars have opposite polarities and incorporates an inflatable balloon to prevent electrode short circuits and ensure the safety and effectiveness of the treatment. When the balloon's inflation pressure exceeds the set 0.3 MPa, its expansion will cause the electrodes to separate, avoiding the risk of short circuits caused by electrode contact. Furthermore, both the proximal and distal ends of the electrode are insulated, further enhancing electrical isolation and improving system reliability. Through these designs, even in complex physiological environments during ablation, current control during treatment can be effectively ensured, preventing unnecessary tissue damage and improving the safety margin and operational precision of interventional treatment for COPD.

[0057] Furthermore, in this embodiment, the surface of the insulating skeleton bar in the gold-plated cage electrode is magnetron sputtered with metal thin films such as gold, platinum-iridium alloy, and iridium gold to enhance conductivity while providing sufficient insulation through the PI film, making it suitable for the ablation process of conducting current.

[0058] In this embodiment, the gold-plated electrode employs a technique involving magnetron sputtering of thin films of metals such as gold, platinum-iridium alloy, and iridium onto the surface of several insulating skeleton strips. This design not only enhances the electrode's conductivity, ensuring efficient current transmission during ablation, but also effectively isolates the risk of short circuits between adjacent electrodes through the insulation provided by the PI film, guaranteeing treatment safety even in complex airway environments. During implementation, the gold plating layer on the electrode is uniform in thickness and tightly bonded to the insulating skeleton strips, improving the electrode's durability. Furthermore, the application of magnetron sputtering technology ensures the purity and consistency of the gold plating layer, further enhancing the stability of electrode performance. The effectiveness of this technique lies in a more controllable ablation process and safer operation, representing a new breakthrough in interventional treatment of COPD. Of course, the specific material and thickness of the gold plating layer can be adjusted within a certain range according to different airway sizes and lesion conditions to meet the needs of different patients and improve the overall success rate of treatment.

[0059] Furthermore, in this embodiment, the dual-net control structure of the handle, through a unique design, allows the user to control the extension and retraction of the far-end net and the near-end net respectively by rotating two independent knobs, avoiding possible confusion during operation and ensuring a more intuitive control experience.

[0060] In this embodiment, the dual-network control structure of the handle employs an innovative design, allowing the surgeon to independently control the extension and retraction of the distal and proximal networks by rotating two knobs. The key to this design lies in extending the control knob and corresponding moving rod of the distal network, allowing the extended portion to pass through a special slot on the proximal knob and reach its proximal position. This layout ensures that even though the distal network control knob is physically located proximally on the handle, it still effectively controls the extension and retraction of the distal network, while the proximal knob handles the corresponding movements of the proximal network. This arrangement avoids operational confusion that can occur with conventional layouts, simplifies the process of adjusting electrode size during surgery, and thus improves the surgeon's operational efficiency and precision. Furthermore, the ergonomic design of the handle takes into account the surgeon's need for single-handed operation, making the control of dual-network expansion and contraction more comfortable and convenient, thereby enhancing the practicality and safety of the entire ablation system. This dual-network control structure not only improves the intuitiveness and accuracy of operation, but also ensures that doctors can more freely adjust the equipment during surgery through the optimized handle design, thereby reducing the difficulty of operation and improving the success rate of surgery and the treatment effect for patients.

[0061] Furthermore, in this embodiment, the imaging system and ablation synergy algorithm can dynamically optimize pulse energy release based on OCT imaging data and ultrasound reflection signals, as well as the measurement results of impedance sensors and EMG electrodes, to ensure accurate ablation depth and safe cessation before nerve / cartilage damage.

[0062] In this embodiment, the imaging system and ablation synergy algorithm dynamically optimize pulse energy release based on OCT imaging data, ultrasound reflection signals, and measurement results from impedance sensors and EMG electrodes. This ensures precise ablation depth and safe cessation before nerve / cartilage damage. Specifically, the system comprehensively utilizes high-resolution tissue tomography images from OCT, real-time bubble and vessel detection from ultrasound signals, tissue type and necrosis degree identification from impedance sensors, and nerve stimulation warning information from EMG electrodes to intelligently adjust pulse energy during the ablation process. This not only improves the accuracy of ablation, allowing the ablation depth to reach the airway epithelium and submucosa, targeting abnormal goblet cells and glands without damaging connective tissue and cartilage, but also enables immediate response to any potential risks, such as nerve stimulation or tissue overheating, by pausing or reducing energy output, effectively protecting surrounding important structures from damage. In this way, the system achieves a balance between safety and efficiency during ablation, significantly improving the safety and success rate of the procedure.

[0063] Furthermore, in this embodiment, the dual-stage pulse generator can output nanosecond-microsecond dual-mode pulses, using biphasic pulses to replace monophasic pulses, eliminating charge accumulation, and adapting to the treatment needs of different levels of airways; specifically, the dual-mode pulses can automatically switch frequency and width according to tissue characteristics.

[0064] In this embodiment, the dual-stage pulse generator is capable of outputting nanosecond to microsecond dual-mode pulses. By using biphasic pulses instead of monophasic pulses, the problem of charge accumulation is effectively solved, ensuring the precise release of electric field energy during treatment. This design not only adapts to the treatment needs of different levels from the large to the small airways but also introduces an adaptive mechanism that automatically adjusts the frequency and pulse width based on real-time monitored tissue characteristics to achieve the best ablation effect. By precisely controlling the pulse parameters, the system can minimize the impact on surrounding healthy tissues while ensuring treatment effectiveness, improving the safety and success rate of the procedure. Of course, in other embodiments, the dual-stage pulse generator can further optimize the pulse sequence to achieve more refined energy management, ensuring stable treatment efficacy under various complex conditions and providing COPD patients with more personalized and efficient treatment options.

[0065] Furthermore, in this embodiment, the system includes a safety monitoring module that can detect EMG signals, electrode short circuits, and local temperature changes to trigger an energy output interruption mechanism in advance, preventing nerve stimulation, electric shock injury, or tissue overheating damage that may occur during treatment.

[0066] Furthermore, the security monitoring module includes a triple protection mechanism, with the specific trigger thresholds and response actions as follows: 1. Neurostimulation protection: Continuously monitor electromyography (EMG) signals. When the amplitude is >10mV, the system will pause energy output within 200ms.

[0067] 2. Electrode short circuit protection: Real-time monitoring of inter-electrode impedance. When the impedance value suddenly drops by more than 50%, the energy output is immediately cut off and the electrode retraction mechanism is triggered.

[0068] 3. Overheat protection: Local temperature is monitored by a temperature sensor. When the temperature rise is >42℃, energy cutoff and electrode retraction are also performed.

[0069] In this embodiment, the system integrates a safety monitoring module. This module monitors EMG signals, electrode short-circuit conditions, and local temperature changes to identify potential risks during treatment and immediately trigger an energy output interruption mechanism. Specifically, the EMG signal monitors nerve stimulation. If the EMG amplitude exceeds 10mV, it indicates that the nerve is affected by current, and the safety system will pause energy output within 200ms to prevent nerve damage. For electrode short-circuit issues, the system uses impedance detection. When the impedance suddenly drops by more than 50%, it indicates that contact may have occurred between the electrodes. In this case, the energy supply will be immediately cut off, and the electrodes will retract to prevent damage caused by a short circuit. Local temperature monitoring ensures that the tissue temperature does not exceed the safe threshold of 42°C during treatment. If it does, energy output will also be interrupted, and the electrodes will retract. Through these three protection mechanisms, the system significantly reduces the risks of nerve stimulation, electric shock injury, and tissue overheating, improving the safety and reliability of the treatment process. Of course, in other embodiments not shown, the safety system can further expand the monitoring scope, such as adding real-time monitoring of electrocardiogram (ECG), to comprehensively ensure patient safety.

[0070] Furthermore, in this embodiment, during the ablation process, the system can dynamically adjust the ablation voltage based on the depth compensation term and the impedance compensation term; the depth compensation term ensures that the target depth is achieved, while the impedance compensation term dynamically responds to changes in tissue state, improving ablation efficiency and ensuring safety.

[0071] In this embodiment, the dual-stage pulsed electric field ablation system dynamically adjusts voltage parameters during the ablation process through integrated depth compensation and impedance compensation to achieve precise tissue ablation. The depth compensation, based on optical coherence tomography (OCT), ensures the ablation depth reaches 70% of the target smooth muscle layer thickness. This mechanism effectively controls the ablation depth, avoiding the risk of tissue damage from over-ablation. The impedance compensation, through real-time monitoring of tissue impedance, dynamically adjusts the voltage to compensate for energy loss due to tissue dehydration or impedance changes, ensuring the efficiency and safety of the ablation process. In small airways, when tissue carbonization begins, causing a sharp increase in impedance, but the ablation depth is still insufficient, the impedance compensation takes the lead, rapidly increasing the voltage to avoid ineffective ablation. Combined with the precise control of the depth compensation, this results in efficient and safe ablation of specific tissues. Furthermore, the system incorporates a triple protection mechanism to monitor and interrupt potential nerve stimulation, electrode short circuits, and tissue overheating risks in real time, ensuring patient safety during treatment. The combined application of these technologies has not only improved the accuracy and efficiency of interventional treatment for COPD, but also greatly reduced the incidence of complications, bringing patients a safer and more effective treatment experience.

[0072] It is obvious to those skilled in the art that the modules or steps of the present invention described above can be implemented using general-purpose computing devices. They can be centralized on a single computing device or distributed across a network of multiple computing devices. They can be implemented using computer-executable program code, and thus can be stored in a storage device for execution by a computing device. In some cases, the steps shown or described can be performed in a different order than those described herein, or they can be fabricated as separate integrated circuit modules, or multiple modules or steps can be fabricated as a single integrated circuit module. Thus, the present invention is not limited to any particular combination of hardware and software.

[0073] The above description is merely a preferred embodiment of the present invention and does not constitute any limitation on the present invention. Any simple modifications, alterations, or equivalent structural changes made to the above embodiments based on the technical essence of the present invention shall still fall within the protection scope of the present invention.

Claims

1. A catheter system for dual-stage pulsed electric field ablation therapy of COPD, characterized in that, Comprise: A two-stage electrode assembly (1) for ensuring the current flow only between specific electrodes; A handle control mechanism (2) for realizing the dynamic adjustment of the electrode size to adapt to different airway diameters; An imaging probe (3) integrated with OCT and / or ultrasound for providing real-time airway wall structure and tissue state monitoring.

2. The dual-stage pulsed electric field ablation catheter system for treating COPD according to claim 1, wherein, The two-stage electrode assembly (1) further comprises positive and negative double mesh electrodes, wherein the distance between the positive and negative meshes is adjustable, specifically controlled by the fine threaded mechanism in the handle control mechanism (2) to adapt to airways of different diameters.

3. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 2, wherein, The two-stage electrode assembly (1) also includes a small-distance double-cage electrode, whose cage distance is smaller than that of the conventional design.

4. The dual-stage pulsed electric field ablation catheter system for treating COPD of claim 3, wherein, The two-stage electrode assembly (1) adopts a balloon electrode form, which is composed of a polyimide (PI) film with a metal layer formed by magnetron sputtering. The balloon is inflated internally to isolate the electrodes and prevent short circuits. In particular, the inflatable balloon is of medical grade, with high biocompatibility and stability.

5. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 4, wherein, The handle control mechanism (2) contains a high-precision encoder to provide real-time feedback on the displacement of the push-pull wire, ensuring accurate real-time control during electrode expansion and contraction. In particular, the encoder can accurately detect displacement changes with a minimum unit of millimeters.

6. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 5, wherein, The handle control mechanism (2) has an overload protection mechanism that automatically triggers a retraction device when the tension exceeds a pre-set mechanical strength threshold, preventing the electrode from being damaged or expanding unexpectedly. Specifically, the threshold is, for example, 3 Newtons (N).

7. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 1, wherein, The imaging probe (3) integrates optical coherence tomography and ultrasound, which can work in a cooperative mode, with OCT leading the identification of tissue structure and ultrasound providing additional micro-bubble generation warnings to ensure the safety and effectiveness of the ablation process.

8. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 7, wherein, The adaptive energy control model adjusts the depth and impedance weight coefficients according to the airway type. In large airways, the model focuses on depth monitoring, while in small airways, it relies more on tissue impedance monitoring to optimize ablation effectiveness in different-sized airways. The adaptive energy control model achieves precise real-time control through the following voltage dynamic adjustment formula: ； Where V is the real-time adjusted ablation voltage, V0 is the initial preset voltage, d is the real-time monitored ablation depth by OCT imaging, D_m is the smooth muscle layer thickness measured by OCT preoperatively, Z is the real-time tissue impedance, Z0 is the initial tissue impedance; k1 and k2 are weight coefficients, whose values are adjusted according to the type of large or small airways as previously described. The model ensures that the ablation depth reaches about 80% of the smooth muscle layer thickness through the depth compensation term k1(1-d / (0.8D_m)), and dynamically responds to changes in tissue state (such as dehydration or carbonization) through the impedance compensation term k2((Z-Z0) / Z0), thereby ensuring ablation efficiency while maximizing treatment safety.

9. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 8, wherein, The bidirectional independent control mechanism of the double-net electrode assembly, specifically by respectively controlling the distal electrode push-pull wire and the proximal electrode push-pull outer tube and lead wire, realizes the independent extension and contraction of the distal and proximal electrodes, and the handle design conforms to the principle of ergonomics, ensuring accurate operation by the doctor.

10. The dual-stage pulsed electric field ablation catheter system for treating COPD of claim 9, wherein, In the nickel-titanium memory alloy cage electrode structure, the polarities of adjacent strips are opposite, and an inflatable balloon is built in, which ensures electrode separation and avoids short circuit when the balloon inflation pressure is greater than a predetermined value; in particular, the predetermined value is 0.3 MPa, and the proximal and distal ends of the electrode are both insulated.

11. The dual-stage pulsed electric field ablation catheter system for treating COPD of claim 10, wherein, The surface of the insulated skeleton strip in the cage strip gold-plated electrode is magnetron sputtered with a metal film of gold, platinum-iridium alloy, iridium gold, etc., to enhance the conductivity while providing sufficient insulation through the PI film, suitable for the ablation process of conducting current.

12. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 1, wherein, The double-net control structure of the handle allows users to control the extension and contraction of the distal net and the proximal net through two independent knobs, avoiding possible confusion during operation and ensuring a more intuitive control experience.

13. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 1, wherein, The imaging system and ablation coordination algorithm can dynamically optimize pulse energy release based on the OCT imaging data and the ultrasonic reflection signal, as well as the measurement results of the impedance sensor and the EMG electrode, ensuring accurate ablation depth and safe stop before nerve / cartilage damage.

14. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 1, wherein, The dual-stage pulse generator can output nanosecond-microsecond dual-mode pulses, using dual-phase pulses instead of single-phase pulses to eliminate charge accumulation and adapt to the treatment needs of different levels of airways; specifically, the dual-mode pulses can automatically switch frequency and width according to the tissue characteristics.

15. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 14, wherein, The system includes a safety monitoring module that can detect the EMG signal, electrode short circuit condition, and local temperature change to trigger an energy output interruption mechanism in advance, preventing possible nerve stimulation, electric shock injury, or tissue overheating damage during treatment.

16. The dual stage pulsed electric field ablation catheter system for treating COPD of claim 1, wherein, During ablation, the system can dynamically adjust the ablation voltage based on a depth compensation term and an impedance compensation term; the depth compensation term ensures that the target depth is achieved, and the impedance compensation term dynamically responds to changes in tissue state, improving ablation efficiency and ensuring safety.

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