Radiofrequency ablation guidewire system for opening chronic total occlusions of blood vessels

Abstract

The application relates to the technical field of medical devices, and discloses a radiofrequency ablation guide wire system for opening a chronic total occlusion of a blood vessel. The system comprises a radiofrequency guide wire, a monitoring device, a control device, a feedback device and a radiofrequency generator. The radiofrequency guide wire has a movable electrode and a return electrode composed of a plurality of expandable and contractible return sub-electrodes. The monitoring device monitors the current, impedance and temperature of each return sub-electrode in real time. The control device judges the positional relationship of the electrodes and adjusts the radiofrequency output according to the monitoring data. The feedback device provides a position adjustment prompt in the form of sound, light or visual display. The system can further comprise functional components such as a snaring structure, a radio-opaque marker and a hollow inner core. The application improves the precision, safety and operation convenience of chronic total occlusion interventional treatment, reduces the dependence on X-ray contrast, simplifies the surgical procedure, and has a wide clinical application prospect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an interventional surgical device for treating chronic total occlusion (CTO) of blood vessels. BACKGROUND

[0002] Chronic Total Occlusion (CTO) is a serious arterial vascular disease and one of the current difficulties in interventional therapy. CTO is usually defined as a lesion with complete occlusion of the coronary artery for more than 3 months. Such lesions not only seriously affect the quality of life of patients, but also can lead to myocardial ischemia, angina pectoris, and even myocardial infarction and other serious consequences.

[0003] Traditional CTO interventional therapy mainly relies on the use of a long guide wire by a doctor under the guidance of imaging to penetrate the occluded tissue.

[0004] However, this method has the following main problems:

[0005] First, accurate positioning is difficult. In complex vascular structures, accurately positioning the occluded position and precisely guiding the guide wire through the occluded tissue is a highly challenging task. This often requires repeated use of X-ray contrast, increasing the risk of radiation exposure for patients and medical staff.

[0006] Moreover, the operation risk is high. Due to the lack of accurate real-time feedback mechanism, the operator has difficulty in judging the accurate position and direction of the guide wire, which can easily cause serious complications such as vascular perforation and dissection.

[0007] Further, the operation efficiency is low. The traditional method needs to frequently switch different types of guide wires and repeatedly try to penetrate the occluded tissue, which greatly prolongs the operation time and increases the pain and medical costs of patients.

[0008] Further, the success rate is unstable. The success rate of CTO interventional therapy is highly dependent on the experience and skill of the operator, even experienced doctors may face treatment failure.

[0009] To solve these problems, radiofrequency ablation technology has been introduced into the field of CTO treatment. Among them, bipolar radiofrequency ablation technology has attracted attention because it can better control the range of energy transmission. However, the existing bipolar radiofrequency ablation system still has some limitations, such as:

[0010] Electrode alignment difficulty: Traditional bipolar radiofrequency systems require precise alignment of electrodes located at both ends of the occlusion, which is difficult to operate in complex vascular structures and often requires frequent use of X-ray contrast to confirm the position.

[0011] Lack of real-time feedback: The operator has difficulty in real-time understanding of the relative position of the electrode and the ablation effect, increasing the risk of operation.

[0012] System flexibility is insufficient: Existing systems are difficult to adapt to different sizes and morphologies of vascular structures, limiting their application range.

[0013] Operation complexity: Many systems require the use of additional instruments (such as snares) to capture and retrieve electrodes, increasing the complexity and risk of surgery.

[0014] Safety needs to be improved: Lack of effective mechanisms to prevent excessive ablation or accidental damage to healthy vascular tissue.

[0015] Therefore, there is an urgent need for a new CTO interventional therapy system that can overcome the above problems, to improve the accuracy, safety and efficiency of treatment, while reducing the dependence on X-ray contrast and reducing radiation exposure to patients and medical staff. Such a system should be able to provide real-time electrode position feedback, adapt to different vascular structures, simplify the operation process, and have effective safety protection mechanisms. The development of such a system will greatly promote the progress of CTO interventional therapy, improve treatment success rate, reduce the risk of complications, and ultimately benefit the majority of patients. SUMMARY

[0016] The purpose of the present application is to provide a radiofrequency ablation guide wire system for opening chronic total occlusion of blood vessels to solve the problems raised in the background art.

[0017] The present application discloses a radiofrequency ablation guide wire system for opening chronic total occlusion of blood vessels, comprising:

[0018] A radiofrequency guide wire comprising a movable electrode and a return electrode composed of multiple return sub-electrodes;

[0019] A monitoring device electrically connected to the multiple return sub-electrodes for real-time monitoring of the current passing through each return sub-electrode;

[0020] A control device in communication with the monitoring device for determining the relative positional relationship between the movable electrode and the return electrode according to the current difference passing through the multiple return sub-electrodes;

[0021] A feedback device in communication with the control device for providing a position adjustment prompt signal to the operator according to the judgment result of the control device on the relative positional relationship between the movable electrode and the return electrode;

[0022] A radiofrequency generator electrically connected to the movable electrode and the return sub-electrodes for providing radiofrequency ablation energy.

[0023] In a preferred embodiment, the monitoring device is further configured to monitor impedance and temperature between the active electrode and the return electrode, and the control device is further configured to determine the distance between the electrodes and the ablation effect based on the monitoring results of the impedance and temperature between the active electrode and the return electrode, and adjust the output power of the radio frequency generator.

[0024] In a preferred embodiment, a snare structure is further included for retracting the return sub-electrodes.

[0025] In a preferred embodiment, the return sub-electrodes are made of a memory alloy material.

[0026] In a preferred embodiment, the return electrode is further provided with a radio-opaque marker for assisting intraoperative contrast positioning.

[0027] In a preferred embodiment, the radio frequency guide wire includes a hollow inner core for injecting contrast agent or saline.

[0028] In a preferred embodiment, the number of return sub-electrodes is 2-16.

[0029] In a preferred embodiment, the maximum diameter of the return sub-electrodes after expansion is 1-10 mm, and the return sub-electrodes can be expanded relative to the radio frequency guide wire to expand the radial coverage.

[0030] In a preferred embodiment, the feedback device further includes a display interface for visually displaying the relative position relationship between the active electrode and the return electrode.

[0031] In a preferred embodiment, the return sub-electrodes can be retracted to capture the active electrode.

[0032] The radio frequency ablation guide wire system provided by the present application significantly improves the precision, safety and operation convenience of chronic total occlusion (CTO) interventional therapy through innovative electrode design and intelligent monitoring feedback mechanism, which is embodied in the following aspects:

[0033] Firstly, the alignment accuracy and efficiency of the electrodes are improved: the return electrode is composed of multiple circumferentially distributed sub-electrodes, and by monitoring the current difference of each sub-electrode in real time, the system can accurately determine the offset of the active electrode relative to the center of the return electrode. Combined with the monitoring of the impedance and temperature between the electrodes, the distance between the electrodes and the ablation effect can be comprehensively evaluated. This design greatly improves the accuracy of electrode alignment, reduces the dependence on radiographic contrast, thereby shortening the operation time and reducing the radiation exposure of patients and doctors.

[0034] Further, intelligent operation feedback: the control system can provide real-time feedback such as sound and light to the operator based on monitoring data, guiding them to adjust the electrode position and optimize the operation process. The intuitive feedback makes the operation more accurate and convenient.

[0035] Further, integrated safety protection: the monitoring device can assess impedance and temperature changes in real time and automatically adjust or even stop the radiofrequency output when the electrode approaches the blood vessel wall, intravascular stent, or ablation temperature is too high, effectively preventing complications such as blood vessel perforation and improving surgical safety.

[0036] Further, flexible and multifunctional electrode design: the return electrode can be expanded as needed to increase coverage, adapting to different sizes of blood vessels; it can also be retracted after passing through the occlusion, capturing and retracting the active electrode, simplifying the operation process. The use of memory alloy materials further optimizes the mechanical properties of the electrode.

[0037] Further, optimized instrument design: the radiopaque markers on the return electrode help with intraoperative positioning if necessary, and the hollow core design of the guide wire allows for the injection of contrast agent or saline during the operation, improving operational flexibility.

[0038] In summary, the radiofrequency ablation guide wire system of the present application integrates precise electrode control, intelligent feedback mechanisms, and flexible instrument design, significantly improving the effectiveness and safety of CTO radiofrequency ablation therapy, simplifying the operation process, and having broad clinical application prospects.

[0039] A large number of technical features are described in the specification of the present application, distributed among various technical solutions. If all possible combinations of technical features (i.e., technical solutions) of the present application are listed, the specification will be too long. To avoid this problem, each technical feature disclosed in the above summary of the invention, each technical feature disclosed in the following embodiments and examples, and each technical feature disclosed in the drawings can be freely combined with each other to form various new technical solutions (these technical solutions are considered to have been described in the specification), unless such a combination of technical features is technically infeasible. For example, features A+B+C are disclosed in one example, features A+B+D+E are disclosed in another example, features C and D are equivalent technical means that serve the same function, and can only be used together technically, and feature E can be combined with feature C technically. Therefore, the solution of A+B+C+D should not be considered to have been described because it is technically infeasible, and the solution of A+B+C+E should be considered to have been described. BRIEF DESCRIPTION OF DRAWINGS

[0040] Figure 1 is a structural schematic diagram of a radiofrequency ablation guide wire system for opening a blood vessel chronic total occlusion according to the first embodiment of the present application.

[0041] Figure 2 is a schematic diagram of the active electrode and the return electrode in the radiofrequency ablation guidewire system for opening chronic total occlusion of blood vessels according to the first embodiment of the present application.

[0042] Figure 3 is a schematic diagram of the working process of the radiofrequency ablation guidewire system for opening chronic total occlusion of blood vessels according to the first embodiment of the present application.

[0043] Figure 4 is a schematic diagram of the structure of the return electrode of the radiofrequency ablation guidewire system for opening chronic total occlusion of blood vessels according to the first embodiment of the present application.

[0044] Figure 5 is a schematic diagram of the structure of the return sub-electrode of the radiofrequency ablation guidewire system for opening chronic total occlusion of blood vessels according to the first embodiment of the present application.

[0045] In all the drawings, the same reference signs are used to represent the same elements or structures, wherein:

[0046] 10: active electrode

[0047] 20: return electrode

[0048] 30: radiofrequency generator

[0049] 40: control device

[0050] 50: monitoring device

[0051] 60: feedback device

[0052] 70: electrode lead wire

[0053] 80: outer sheath

[0054] 90: inner core

[0055] 100: snare cord DETAILED DESCRIPTION

[0056] In the following description, many technical details are presented in order to make the reader better understand the present application. However, it can be understood by those skilled in the art that the technical solutions claimed by the present application can be implemented even without these technical details and based on various changes and modifications of the following embodiments.

[0057] Explanation of some concepts:

[0058] Chronic total occlusion (CTO): long-term complete occlusion of coronary arteries, leading to ischemia in the blood supply area of the blood vessels, and clinically manifested as refractory angina pectoris, myocardial infarction, etc.

[0059] Radiofrequency ablation: a method of using the heat effect of radiofrequency current to make the lesion tissue coagulative necrosis. Compared with the use of mechanical force alone, radiofrequency ablation can make the lesion tissue soft, which is convenient for the wire to pass through.

[0060] Active electrode 10: refers to an electrode that can move relative to the catheter, directly contact the lesion tissue and apply radiofrequency energy.

[0061] Return electrode 20: the other electrode that constitutes the radiofrequency current loop, which is a certain distance away from the active electrode 10.

[0062] Bipolar electrode: composed of two electrodes close to each other, the radiofrequency current is limited between the two electrodes, which can achieve more precise control of the energy application range.

[0063] Monopolar electrode: only one electrode that applies radiofrequency energy, the current is conducted through the human tissue to the return electrode 20 pad far away.

[0064] Snare: a device used to capture foreign matter or the head end of the wire in the blood vessel, generally a ring structure with adjustable diameter.

[0065] Angiography: injection of contrast medium into the blood vessel to show the morphological structure of the blood vessel under X-ray, used for diagnosis and guidance of interventional operation.

[0066] Three-dimensional mapping system: a system that acquires and reconstructs the spatial position information of surgical instruments in the human body in real time by arranging detectors at different positions on the surface of the patient.

[0067] Radiopaque marker band: a marker that presents a high-density image under X-ray, attached to the surface of the surgical instrument, used for intraoperative tracing.

[0068] Flexible electrode: an electrode made of flexible material, which can bend with the catheter and reduce the stimulation to the blood vessel wall.

[0069] Self-expanding structure: a device pre-shaped into a specific shape, in a constrained state when limited, and automatically restored to the original shape after the constraint is removed.

[0070] Memory alloy: a kind of alloy material with shape memory effect, commonly used to manufacture medical instruments with self-expanding properties.

[0071] Guide wire: a long and flexible metal wire, used to guide the catheter and other instruments into the tortuous and narrow cavity or lumen.

[0072] Occlusion: deposition of lipid, calcification, fibrous tissue proliferation, etc. in the blood vessel lumen, which makes the lumen narrow or even completely blocked, affecting blood flow.

[0073] The following is a brief description of some of the innovations of the present application:

[0074] The inventors of the present application, after in-depth research, propose a radiofrequency ablation guide wire system to solve a series of technical challenges in the treatment of chronic total occlusion (CTO), especially in precise electrode positioning, operation safety, and reducing the dependence on imaging equipment. The specific innovations include:

[0075] 1. Multi-electrode configuration and dynamic adjustment: The present application designs a composite return electrode 20 containing multiple return sub-electrodes, which are arranged circumferentially along the guide wire and can be expanded and contracted. This structure can better control the distribution of radiofrequency current density, thereby controlling the ablation area; and the range of expansion of the return electrode 20 can be adjusted according to the size and shape of the occlusion, thereby improving the application efficiency and safety of radiofrequency energy.

[0076] 2. Real-time monitoring and intelligent feedback system: A highly advanced monitoring device 50 is introduced, which can monitor the current passing through the return sub-electrodes in real time; the impedance between the return sub-electrodes and the active electrode 10; the temperature of the active electrode 10 and / or the tip of the return sub-electrode, which are key parameters for judging electrode position, evaluating ablation effect, and preventing over-ablation. Based on these monitoring data, the control system can automatically adjust the output power of the radiofrequency generator 30, and guide the operator to make precise adjustments through sound, light signals or visual feedback.

[0077] 3. Adaptive electrode system: The design of the return electrode 20 uses a flexible structure that can expand / contract, allowing the active electrode 10 to be safely captured and withdrawn after treatment, simplifying the surgical process and reducing the need to use traditional snares. This design not only improves the safety of the operation, but also significantly simplifies the operation process. After ablation, the radiofrequency guide wire can be used as a normal guide wire, facilitating subsequent stent expansion and other operations.

[0078] 4. Reduce dependence on image navigation: Innovatively, radio-opaque markers are added to the return electrode 20, which can assist in intraoperative image positioning when necessary, but due to the high automation and precise current monitoring capabilities of the system, the overall dependence on contrast agents and X-ray exposure is greatly reduced, which is a significant improvement for the health of patients and operators.

[0079] 5. Optimized material and structure design: The return sub-electrodes are made of memory alloy material, improving the operability and durability of the electrodes. The use of memory alloy allows the electrodes to automatically expand to the ideal shape when reaching the predetermined position, and to reliably contract when needed.

[0080] Through these innovations, the radiofrequency ablation guidewire system of this invention has significant advantages in improving the efficiency, accuracy, and safety of interventional procedures for treating chronic total occlusion, while also significantly improving the convenience and flexibility of operation, providing patients with safer and more effective treatment options.

[0081] To make the objectives, technical solutions, and advantages of this application clearer, the embodiments of this application will be described in further detail below with reference to the accompanying drawings.

[0082] The first embodiment of this application relates to a radiofrequency ablation guidewire system for opening chronically total occlusion of blood vessels, the structure of which is as follows: Figure 1 , Figure 4 and Figure 5 As shown, it includes: an RF guide wire, a monitoring device 50, a control device 40, a feedback device 60, and an RF generator 30. Details are as follows:

[0083] RF guide wire:

[0084] The radiofrequency guidewire includes a movable electrode 10 that can be positioned to the proximal end of the vascular occlusion and a return electrode 20 that can be positioned to the distal end of the vascular occlusion. The return electrode 20 is composed of a plurality of return sub-electrodes that are uniformly arranged circumferentially along the radiofrequency guidewire. The return sub-electrodes can be deployed relative to the radiofrequency guidewire to expand the radial coverage area and can be contracted to capture the movable electrode 10, or contracted to capture and retract the movable electrode 10 that passes through the occlusion.

[0085] It should be noted that in some embodiments of this application, the positions of the active electrode 10 and the return electrode 20 are not fixed. Depending on the specific clinical situation and surgical requirements, the positions of the active electrode 10 and the return electrode 20 can be interchanged. That is, the active electrode 10 can be positioned either proximal to the occlusion (i.e., on the doctor's operating side) or distal to the occlusion; correspondingly, the return electrode 20 can be located either proximal to the occlusion.

[0086] Specifically, such as Figure 2 As shown, the radiofrequency guidewire in this embodiment consists of two main parts: a movable electrode 10 and a return electrode 20. The movable electrode 10 is located at the distal end of the first guidewire and can be positioned to the proximal end of the vascular occlusion (i.e., the side operated by the physician), serving as the primary point for applying radiofrequency energy. It directly contacts the occluded tissue, denaturing it and thus opening the blockage. The return electrode 20 is located at the distal end of the second guidewire and can be positioned to the distal end of the vascular occlusion (i.e., the side passing through the occlusion). It serves as the return path for the radiofrequency current, forming a loop with the movable electrode 10, allowing the radiofrequency current to be concentrated between the movable electrode 10 and the return electrode 20, achieving a precise ablation range.

[0087] It is particularly important to note that, as mentioned above, the positions of the active electrode 10 and the return electrode 20 are not fixed. The operator can flexibly choose to position the active electrode 10 at the proximal or distal end of the occlusion according to the actual occlusion of the blood vessel. This flexibility enables the system to better adapt to different types of occlusive lesions. For example, for some complex CTO lesions, radiofrequency ablation from the distal end may be more effective or safer. In this case, the active electrode 10 can be placed at the distal end and the return electrode 20 at the proximal end. This design enhances the operational flexibility of the system, allowing the doctor to choose the best electrode configuration according to the specific situation of each patient and the vascular anatomy, thereby improving treatment effectiveness and surgical success rate.

[0088] The return electrode 20 is composed of multiple sub-electrodes arranged circumferentially along the radiofrequency guide wire. The benefits of this design are as follows: first, it improves flexibility, as the sub-electrodes can move closer to each other when the guide wire bends along the blood vessel, ensuring the pushability of the guide wire; second, the sub-electrodes can expand radially and be laid out in a radial pattern in the blood vessel lumen, increasing the contact area with the occlusive tissue and making the radiofrequency current distribution more uniform; third, it facilitates capture, as the active electrode 10 can smoothly pass through the occlusion after the occlusion is softened by radiofrequency ablation to reach the side of the return electrode 20. At this time, the expanded return sub-electrodes can contract to reliably hold the active electrode 10 that has passed through and drag the guide wire out, completing the operation. This function can replace the traditional snare, simplifying the operation.

[0089] The innovative structure of this radiofrequency guide wire takes into account the characteristics of the narrow and tortuous blood vessel lumen, the requirements of radiofrequency ablation for electrode area and position, and the convenience of surgical operation, integrating multiple functions such as positioning, ablation, and capture, optimizing the operation process of radiofrequency ablation for chronic occlusion, and improving surgical efficiency and safety.

[0090] The monitoring device 50

[0091] The monitoring device 50 is electrically connected to the multiple return sub-electrodes for real-time monitoring of the current passing through each return sub-electrode.

[0092] Specifically, the monitoring device 50 is a key component of the radiofrequency ablation guide wire system, and its main function is to monitor the current passing through each return sub-electrode in real time. It is directly electrically connected to the multiple return sub-electrodes to ensure the accuracy and real-time nature of the monitoring data.

[0093] During radiofrequency ablation, radiofrequency current flows from the active electrode 10 to the return electrode 20, forming a loop. Since the return electrode 20 is composed of multiple sub-electrodes, the radiofrequency current will be distributed among the sub-electrodes. By monitoring the current of each sub-electrode in real time, the monitoring device 50 can provide the following important information:

[0094] 1. The relative position of the active electrode 10 and the return electrode 20:

[0095] When the active electrode 10 is directly opposite the center of the return electrode 20, the radiofrequency current should be evenly distributed to each sub-electrode, and their current readings should be similar.

[0096] If the active electrode 10 deviates from the center, the current of the sub-electrode closer to it will be significantly larger than that of the other sub-electrodes. By analyzing the relative size of the current of each sub-electrode, the relative position of the active electrode 10 to the center of the return electrode 20 can be determined, ensuring accurate alignment of the occluded area.

[0097] 2. Radiofrequency ablation effect:

[0098] During the ablation process, changes in the resistivity of the occluded tissue will cause changes in the current distribution. By dynamically monitoring the changes in current and impedance, the ablation effect can be evaluated, the radiofrequency output can be adjusted, and complications such as tissue carbonization can be avoided, ensuring safe and effective treatment. In addition, changes in current and impedance can also be used to assist in determining contact with the occlusion, preventing the electrode from contacting the stent in the blood vessel and the blood vessel wall.

[0099] 3. Real-time feedback and treatment optimization:

[0100] The real-time data feedback provided by the monitoring device 50 allows the medical team to quickly understand the conduction of radiofrequency energy in the occluded area and dynamically adjust the treatment strategy accordingly, optimizing the treatment effect.

[0101] In summary, the monitoring device 50 provides key information such as the positioning of the active electrode 10, electrode adhesion, and ablation effect by monitoring the current of the return sub-electrode in real time. This integrated monitoring mechanism is an important embodiment of the intelligence and precision of the system, providing objective evidence for surgical operation, improving the accuracy and safety of radiofrequency ablation, maximizing treatment effect, and minimizing the risk of complications, which is an important progress in modern interventional cardiology.

[0102] Control device 40

[0103] The control device 40 is in communication connection with the monitoring device 50, and is used to determine the relative positional relationship between the active electrode 10 and the return electrode 20 according to the current differences passed by the plurality of return sub-electrodes.

[0104] More specifically, the control device 40 is the core component of the radiofrequency ablation guide wire system, and its main function is to determine the relative positional relationship between the active electrode 10 and the return electrode 20 according to the data provided by the monitoring device 50, and to guide the surgical operation accordingly. The specific functions and working principles are as follows:

[0105] Communication connection. The control device 40 is in real-time communication connection with the monitoring device 50, ensuring that it can continuously receive current data from each return sub-electrode.

[0106] Data analysis. After receiving the current data transmitted by the monitoring device 50, the control device 40 performs the following analysis: a) Process the raw data, including possible normalization to eliminate system errors. b) Compare the current of each return sub-electrode and analyze the current difference. c) Calibration function: Due to the difference in actual tissue distribution, even if the active electrode 10 is directly opposite the center of the return electrode 20, there may still be differences in the current on each sub-electrode. In order to improve the accuracy of position judgment, the system integrates a calibration function. At the initial use, the operator can confirm the alignment of the active electrode 10 with the center of the return electrode 20 through imaging (such as X-ray fluoroscopy). At this time, the system records the current distribution of each sub-electrode as a reference value. This calibration process can eliminate the current distribution deviation caused by individual differences and tissue characteristics, making subsequent relative position judgment more accurate. The calibration value will be used as a reference benchmark for the system to make position judgments, significantly improving the adaptability and accuracy of the system in different patients and different vascular environments.

[0107] Position judgment. Based on the current difference analysis, the control device 40 judges the relative position of the active electrode 10 and the return electrode 20: a) When the current of each return sub-electrode is roughly equal, it indicates that the active electrode 10 may be directly opposite the center of the return electrode 20. b) If the current of some sub-electrodes is significantly higher than that of other sub-electrodes, it indicates that the active electrode 10 deviates from the center and is close to the sub-electrode with higher current. c) Through a pre-set algorithm, the current difference is converted into relative position information of the active electrode 10.

[0108] Real-time and accuracy. The judgment process of the control device 40 needs to be performed in real time to provide immediate feedback. At the same time, its algorithm needs to be strictly verified and optimized to ensure the accuracy of the judgment in complex vascular environments.

[0109] This position judgment method based on current difference enables the system to understand the relative position of the electrodes in real time without relying on additional imaging means, improving the accuracy and safety of the operation, while reducing the dependence on X-rays and reducing the risk of radiation exposure.

[0110] These functions of the control device 40 provide objective reference and guidance for surgical operation, and lay the foundation for the automation and intelligentization of future radiofrequency ablation surgery.

[0111] Feedback device 60

[0112] The feedback device 60 is in communication connection with the control device 40, and is used to provide the operator with position adjustment prompt signals of sound, light, touch or any combination thereof according to the judgment result of the control device 40 on the relative position relationship between the active electrode 10 and the return electrode 20.

[0113] More specifically, the feedback device 60 is a critical component of the radiofrequency ablation guidewire system, and its main function is to translate the results of the control device 40 into intuitive signals that the operator can understand. The specific functions and working principles are as follows:

[0114] Communication connection. The feedback device 60 is connected in real time with the control device 40, ensuring that it can receive the results of the control device 40's judgment of the relative position relationship between the active electrode 10 and the return electrode 20 in a timely manner.

[0115] Signal type. The feedback device 60 mainly provides position adjustment prompts to the operator through sound and light signals, for example, options: a) Sound signal: may include different tones, frequencies or patterns of sound. b) Light signal: may include different colors, brightness or flashing patterns of light. c) Tactile signal: may include different directions, frequencies, intensities of vibration.

[0116] Signal meaning. Different sound or light signals may represent different position relationships or adjustment suggestions, for example, options: a steady signal may indicate that the electrode position is ideal. A changing signal may indicate that adjustment is needed, and the way the signal changes may indicate the direction or amplitude of the adjustment.

[0117] Real-time and intuitive. The feedback device 60 translates the results of the control device 40 in a timely manner into simple and clear prompt signals, allowing the operator to quickly understand and respond in a complex surgical environment.

[0118] The benefits of this feedback mechanism are: improving the accuracy, safety and efficiency of the operation. By providing intuitive sound or light prompts, the operator can continuously obtain electrode position information without the need to frequently check the display screen or use X-ray imaging, thereby focusing more on the operation itself. This not only improves the efficiency of the operation, but also reduces the cognitive burden of the operator and the radiation exposure of the patient, representing an important progress in modern interventional therapy technology.

[0119] Radiofrequency generator 30

[0120] Radiofrequency generator 30, electrically connected to the active electrode 10 and return sub-electrode, for providing radiofrequency ablation energy. More specifically, the radiofrequency generator 30 is the core energy source of the radiofrequency ablation guidewire system, which is responsible for generating and providing high-frequency current required for radiofrequency ablation. The following is a detailed explanation of the functions and characteristics of the radiofrequency generator 30:

[0121] Electrical connection method:

[0122] The radiofrequency generator 30 establishes an electrical connection with the active electrode 10 and the return sub-electrode through cables. This connection ensures that the electrical current generated by the radiofrequency generator 30 is accurately and efficiently transmitted to the electrodes of the radiofrequency ablation guide wire, forming a complete circuit and providing the necessary energy for treatment.

[0123] Radiofrequency energy generation and control:

[0124] The main function of the radiofrequency generator 30 is to generate high-frequency alternating current required for radiofrequency ablation, usually with a frequency of 300 kHz to 1 MHz. The generator can accurately control the size, frequency and duration of the output energy to adapt to different treatment needs and tissue characteristics, ensuring that the ideal temperature is reached on the target tissue while minimizing the impact on surrounding healthy tissue.

[0125] Intelligent adjustment:

[0126] Modern radiofrequency generators 30 often have intelligent adjustment functions that can automatically optimize output power based on feedback information such as impedance and temperature obtained from the monitoring device 50. This real-time adjustment helps maintain optimal ablation results, improving the accuracy and safety of treatment.

[0127] Multifunctionality:

[0128] Advanced radiofrequency generators 30 may be equipped with multiple working modes such as constant power mode, temperature control mode and pulse mode to meet different clinical needs. This multifunctionality gives the radiofrequency ablation guide wire system greater flexibility and adaptability.

[0129] Safety protection mechanism:

[0130] To ensure patient safety, the radiofrequency generator 30 usually integrates multiple safety protection mechanisms such as overheat protection, impedance monitoring, fault detection and automatic shutdown functions. These mechanisms can effectively prevent accidental tissue damage and improve system reliability.

[0131] Human-computer interaction interface:

[0132] The radiofrequency generator 30 is usually equipped with a clear and intuitive user control panel and display screen. Operators can conveniently set radiofrequency parameters and monitor key indicators of the ablation process in real time through these interfaces, improving operational efficiency and accuracy.

[0133] In summary, the radiofrequency generator 30 is the core energy source of the radiofrequency ablation guide wire system, providing the necessary high-frequency current for radiofrequency ablation treatment through electrical connection with the active electrode 10 and the return sub-electrode. It integrates radiofrequency energy generation, intelligent control, multifunctional adaptation and safety protection, and is an important driving force for modern minimally invasive interventional therapy.

[0134] Optionally, the radiofrequency guide wire includes a hollow inner core 90 for injecting contrast agent or saline (see Figure 4 ), and also includes an electrode lead 70 and an outer sheath 80.

[0135] Specifically, the radiofrequency ablation guide wire can be optionally equipped with a hollow inner core 90 as a channel for delivering contrast agent or saline. This has the advantage of greatly enhancing the functionality, adaptability, and safety of the radiofrequency guide wire, making it a more comprehensive and efficient interventional treatment tool. The main advantages of the hollow inner core 90 are as follows:

[0136] Multifunctionality. The hollow inner core 90 enables the radiofrequency guide wire to integrate multiple functions such as radiofrequency ablation, contrast tracing, and flushing and cleaning, simplifying the surgical procedure and improving operational efficiency. The physician can flexibly use contrast agent and saline according to the surgical needs, enhancing the adaptability of radiofrequency ablation surgery.

[0137] Precise contrast. By injecting contrast agent through the hollow inner core 90, real-time tracing of the radiofrequency guide wire and precise positioning of the ablation area can be achieved. Under the guidance of X-ray or other imaging equipment, the physician can better control the position of the guide wire, assess the ablation range and effect, which is particularly important for complex or delicate vascular operations.

[0138] Temperature control. During radiofrequency ablation, continuous perfusion of saline helps to cool the surface of the guide wire and the local tissue, control the ablation temperature, reduce the risk of thrombosis and thermal injury to the surrounding tissue, and improve the efficiency and safety of ablation.

[0139] Adjuvant therapy. The hollow inner core 90 provides a channel for local drug delivery, such as the delivery of anticoagulant drugs or other therapeutic drugs, enabling precise drug therapy. In the event of complications, it can also be used for emergency injection of therapeutic drugs, improving the ability to respond to surgery.

[0140] Optimized design. The hollow design ensures the strength of the guide wire while reducing the overall weight of the guide wire, enhancing the flexibility and maneuverability of the guide wire. The saline layer on the surface of the guide wire also prevents tissue adhesion, improving the smoothness of the operation.

[0141] In summary, the hollow inner core 90 design of the radiofrequency ablation guide wire integrates multiple therapeutic auxiliary functions, greatly expanding the application range and clinical effect of radiofrequency ablation technology. This innovative design reflects the progress of modern interventional treatment technology, providing more efficient, precise, and safe diagnosis and treatment options for physicians and patients. At the same time, the reasonable application of the hollow inner core 90 also puts higher requirements on the operation level and experience of the physician, requiring a comprehensive assessment of the patient's condition, surgical goals, and risk factors to achieve the best therapeutic effect.

[0142] Optionally, the number of return sub-electrodes is 2-16, preferably 3-8.

[0143] Specifically, the number of return sub-electrodes of the radiofrequency ablation guide wire is a key parameter affecting the ablation effect, safety and adaptability. The number of optional return sub-electrodes is 2-16, preferably 3-8, which has the following advantages:

[0144] Expanding the ablation range and uniform energy distribution. Multiple return sub-electrodes can form a larger electric field area, expand the range of single radiofrequency ablation, and improve the efficiency of the operation. At the same time, the reasonable layout of the return sub-electrodes helps the uniform distribution of radiofrequency energy in the target area, avoiding local overheating or incomplete ablation. The design of 3-8 electrodes balances the electrode density and mutual interference while ensuring good energy distribution.

[0145] Flexibility and adaptability. Different lesion conditions have different requirements for ablation range and accuracy. The design of 2-16 return sub-electrodes provides a wide range of selection space, and doctors can choose the appropriate number of electrodes according to the size, location and shape of the specific lesion, to achieve personalized precision treatment. This flexibility enhances the adaptability of radiofrequency ablation technology, enabling it to meet diverse clinical needs and vascular conditions.

[0146] Precise control and positioning. The number of return sub-electrodes also affects the accuracy of radiofrequency energy control. In complex or irregular lesion areas, multiple electrodes can more accurately adjust and position the output of radiofrequency energy. At the same time, more return sub-electrodes also mean more abundant spatial information, which helps to accurately determine the position of the active electrode 10 and improve the accuracy of the operation.

[0147] Safety considerations. The number of electrodes needs to consider the safety of the radiofrequency ablation process. Too many electrodes may increase the risk of energy accumulation and thermal damage, especially in narrow or curved blood vessels. The preferred design of 3-8 electrodes provides good ablation effect while reducing the incidence of complications, reflecting the emphasis on patient safety.

[0148] Economy and operability. The number of electrodes also needs to balance medical costs and operational convenience. More electrodes mean higher manufacturing costs and more complex operation procedures. The design of 2-16, especially 3-8 electrodes, balances the economy and operability while ensuring treatment effect, which is conducive to the popularization and efficient application of radiofrequency ablation technology.

[0149] In summary, the reasonable design of the number of return sub-electrodes of the radiofrequency ablation guide wire needs to balance multiple factors such as treatment effect, safety, adaptability, accuracy, and economy. The design of 2-16, especially 3-8 return sub-electrodes, achieves a good balance between these factors, representing the optimization direction of radiofrequency ablation technology. This flexible design also provides doctors with more choice space, enabling them to develop personalized treatment plans according to the specific circumstances of different patients, and comprehensively improve the efficacy and safety of radiofrequency ablation surgery.

[0150] Optionally, the maximum diameter of the return sub-electrode after deployment is 1-10 mm, preferably 1.5-5 mm.

[0151] Specifically, in the radiofrequency ablation guide wire system, the maximum diameter of the return sub-electrode after deployment is one of the key parameters affecting the ablation effect and safety. Optionally, the maximum diameter of the return sub-electrode after deployment is designed to be 1.5-5 mm, which has the following benefits:

[0152] Wide range of applications. The diameter range of 1.5-5 mm significantly expands the range of applications of the device, covering various sizes from small branch blood vessels to large main blood vessels. This enables the radiofrequency ablation guide wire system to cope with different types of blood vessel diseases in different parts, expanding its clinical application range.

[0153] High flexibility and personalized treatment. This wide range of adjustable diameters provides great operational flexibility, allowing the same device to be used for a variety of different vascular intervention surgeries, and doctors can customize personalized treatment plans according to the specific circumstances and vascular characteristics of each patient.

[0154] Accurate matching of lesion characteristics. Different types and degrees of vascular lesions have different requirements for electrode diameter. The diameter selection range of 1.5-5 mm provides doctors with more operational freedom, allowing them to accurately match the characteristics of the lesion and select the optimal electrode diameter, improving the targeting and effectiveness of treatment.

[0155] Adapt to complex vascular environments and vascular remodeling. The expanded diameter range enables the device to better adapt to various complex vascular lesions and post-vascular remodeling conditions, such as long segment occlusion, bifurcation lesions, irregularly shaped lesions, and abnormal vascular dilation, improving the applicability of radiofrequency ablation treatment.

[0156] Improve surgical efficiency and economic benefits. A larger diameter range may allow for more extensive one-time treatment in some cases, potentially reducing the number of surgeries and time. In addition, the versatility of the device may reduce the overall equipment investment of medical institutions, providing economic benefits.

[0157] In summary, the maximum diameter of the return sub-electrode after expansion is designed to be 1.5-5mm, which significantly enhances the applicability, flexibility and personalized treatment ability of the radiofrequency ablation guide wire system, enabling it to cope with a wider range of clinical needs. This design takes into account many factors such as vascular adaptability, lesion characteristics, wall attachment effect, energy transmission, blood flow influence, etc., while improving treatment effectiveness and surgical efficiency, safety and economic benefits are also considered.

[0158] Optionally, the return sub-electrode can be retracted to capture and retract the active electrode 10 through the occlusion.

[0159] Specifically, the return sub-electrode can be retracted to capture and retract the active electrode 10 through the occlusion, and its specific implementation can have many ways. The following examples illustrate several common implementation schemes in terms of mechanical structure design, driving and retraction mechanism, capture design, and feedback system, etc.:

[0160] 1. Mechanical retraction mechanism

[0161] The return sub-electrode can be designed to consist of multiple elastic metal wires or sheet structures, such as nickel-titanium alloy wires. These wires assume an expanded form in the natural state, forming an open or cage-like structure. When retraction is needed, by pulling the control wire connected to the return sub-electrode or pushing the sheath, the metal wires can be compressed and folded, forming a closed structure, thereby capturing the active electrode 10 therein.

[0162] 2. Shape memory alloy driving

[0163] By utilizing the properties of shape memory alloys (such as nickel-titanium alloy), active retraction of the return sub-electrode can be achieved. By controlling the phase transition temperature of the shape memory alloy (such as heating by electricity), the return sub-electrode can assume an expanded form at a predetermined low temperature state, and a closed form at a high temperature state. When capturing the active electrode 10 is needed, the return sub-electrode is heated to shrink and bind the active electrode 10 therein.

[0164] 3. Balloon expansion / retraction

[0165] The return sub-electrode can be designed as a flexible balloon structure. The balloon is connected to a charging / discharging pipeline inside, and by controlling the pressure inside the balloon, it can be inflated to expand and form an open structure, and deflated to shrink and form a closed structure. When capturing the active electrode 10 is needed, the balloon is deflated to shrink and wrap the active electrode 10 therein.

[0166] 4. Magnetic attraction

[0167] The principle of magnetic attraction can be used to capture and retract the active electrode 10 by the return sub-electrode. Magnetic materials, such as permanent magnets or electromagnets, are arranged on the return sub-electrode and the active electrode 10 respectively. When it is necessary to capture the active electrode 10, the magnetic field on the return sub-electrode is controlled (for example, a magnetic field is generated by energizing) to generate an attractive force with the magnetic material on the active electrode 10, thereby attracting the active electrode 10 to the return sub-electrode.

[0168] Optionally, the specific surgical procedure can be divided into the following steps:

[0169] Step 1: Initial state: The return sub-electrode is in an expanded state and located at the distal end of the occlusion. The active electrode 10 penetrates the occlusion from the proximal end.

[0170] Step 2: Penetration process: The active electrode 10 penetrates the occlusion step by step by radiofrequency energy. The return sub-electrode remains in an expanded state as a return path for radiofrequency energy.

[0171] Step 3: Penetration completion: When the active electrode 10 successfully penetrates the occlusion and enters the area covered by the return sub-electrode, the operator can observe this situation under X-ray guidance.

[0172] Step 4: Activation of capture: The operator activates the shrinkage mechanism of the return sub-electrode through the control device 40 on the handle.

[0173] Step 5: Shrinkage process: The return sub-electrode begins to shrink and gradually closes to form a cage-like structure. The impedance feedback sensor may detect an increase in resistance, prompting the operator to successfully capture the active electrode 10.

[0174] Step 6: Retraction operation: The operator slowly retracts the entire catheter system, bringing the captured active electrode 10 out of the blood vessel.

[0175] Step 7: Completion of the operation: After the catheter system is completely withdrawn, the occlusion has been opened, forming a new passage.

[0176] Regardless of the implementation, the function of the return sub-electrode shrinking to capture the active electrode 10 can significantly improve the ease of use, safety and reliability of the radiofrequency ablation guide wire system, simplify the surgical procedure, and provide a better operation experience for clinicians and safer and more effective treatment for patients.

[0177] Optionally, the radiofrequency ablation guide wire system for opening a chronic total occlusion of a blood vessel further comprises a snare structure (see Figure 5 , Figure 5 Snare rope 100 shown in

[0178] Specifically, in a radiofrequency ablation guidewire system, the snare structure used to collapse the return electrode can have various implementations. The following examples illustrate several common implementations:

[0179] 1. Push-pull snare structure

[0180] In this implementation, the snare structure is a cylindrical sleeve that is coaxial with the return electrode. One end of the sleeve is connected to the handle of the radiofrequency ablation guidewire, while the other end is located at the proximal end of the return electrode. The inner diameter of the sleeve is slightly larger than the outer diameter of the return electrode, allowing it to slide freely around the return electrode.

[0181] When it is necessary to collapse the return electrode, the operator pulls the control mechanism (such as a sliding button or knob) on the handle that is connected to the snare structure, causing the snare structure to move proximally. As the snare structure moves, its leading end gradually pushes against the return electrode, forcing it to collapse from the deployed state to a closed cage-like structure. When it is necessary to release the return electrode, the operator can push the control mechanism in the opposite direction, causing the snare structure to retreat distally, allowing the return electrode to return to the deployed state.

[0182] 2. Rope-pulling snare structure:

[0183] In this implementation, the snare structure is composed of multiple ropes or filaments that wrap around the return electrode. One end of these ropes is fixed to the proximal end of the return electrode, while the other end converges to the handle of the radiofrequency ablation guidewire, connected to the control mechanism.

[0184] When it is necessary to collapse the return electrode, the operator pulls the control mechanism on the handle, simultaneously pulling all the ropes. As the ropes tighten, they exert an inward compression force on the return electrode, forcing it to gradually collapse from the deployed state to a closed cage-like structure. Releasing the control mechanism releases the ropes, allowing the return electrode to return to the deployed state.

[0185] The advantage of the rope-pulling snare structure is that it is simple in structure and can achieve uniform distribution of the collapsing force.

[0186] 3. Hydraulic or pneumatic-driven snare structure:

[0187] This implementation uses the power of hydraulic or pneumatic pressure to drive the snare structure. The snare structure can be designed as an inflatable chamber that wraps around the return electrode. The chamber is connected to a hydraulic or pneumatic pump on the handle of the radiofrequency ablation guidewire through a pipeline.

[0188] When the return sub-electrode needs to be retracted, the operator activates the hydraulic or pneumatic pump to inject fluid or gas into the chamber of the snare structure. As the chamber expands, it exerts an inward compression force on the return sub-electrode, causing it to retract into a closed cage-like structure. Releasing the hydraulic or pneumatic pressure allows the chamber to return to its original state, allowing the return sub-electrode to expand again.

[0189] 4. Shape Memory Alloy Driven Snare Structure:

[0190] By utilizing the properties of shape memory alloys, an intelligent snare structure can be achieved. In this implementation, the snare structure is made of a shape memory alloy, such as Nitinol. Through special heat treatment, the snare structure is set to have a larger diameter at low temperatures and shrink to a smaller diameter at high temperatures.

[0191] When the return sub-electrode needs to be retracted, the snare structure is heated above the phase transition point by applying electricity (such as through the control button on the handle). As the temperature rises, the snare structure automatically retracts, compressing the return sub-electrode into a closed cage-like structure. Stopping heating allows the snare structure to cool and return to its original state, allowing the return sub-electrode to expand again.

[0192] This intelligent snare structure has the characteristics of shape memory and self-driving, and is easy to control. However, it requires precise control of the heating process, while ensuring the safety and biocompatibility of the shape memory alloy in the medical environment.

[0193] It should be noted that the above implementations are not independent of each other, and can be combined or optimized according to specific needs to achieve the best retraction control effect. For example, hydraulic drive can be combined with shape memory alloy to control the phase transition temperature of the shape memory alloy snare structure, achieving more precise and rapid retraction control.

[0194] Optionally, in radiofrequency ablation surgery, after the return sub-electrode successfully captures the active electrode 10, the operator needs to maintain the retracted state of the snare structure while slowly withdrawing the entire catheter system. This process may need to be performed under X-ray guidance to ensure that the snare structure and the return sub-electrode remain synchronized, avoiding slipping or instability. Once the catheter system is completely withdrawn from the blood vessel, the surgery can be successfully completed.

[0195] In summary, the snare structure for retracting the return sub-electrode can be one of the key components of the radiofrequency ablation guide wire system. Through clever mechanical design and the application of intelligent materials, the snare structure can achieve precise control of the return sub-electrode, ensuring reliable capture and safe withdrawal of the active electrode 10. With the continuous progress of technology, the design and implementation of the snare structure are constantly optimized, providing more security, effectiveness and convenience for radiofrequency ablation surgery.

[0196] Optionally, the return sub-electrode is made of a memory alloy material.

[0197] Specifically, the use of memory alloy material to manufacture the return sub-electrode is an innovative design in the radiofrequency ablation guide wire system. Memory alloy, especially Nitinol, has unique shape memory effect and super-elasticity, enabling the electrode to achieve complex mechanical functions such as automatic expansion and contraction, enhancing the flexibility, controllability and treatment efficiency of the entire system. At the same time, memory alloy also has good biocompatibility, corrosion resistance and fatigue resistance, and is particularly suitable for making implantable medical devices.

[0198] The working principle of the memory alloy electrode is as follows: in the manufacturing process, the memory alloy material is processed into a specific shape (such as a ring or a cage), and is subjected to special heat treatment, so that it "remembers" the preset expanded shape. At room temperature, the electrode can be deformed to a contracted state, facilitating delivery to the target site in the body through a catheter. Once it reaches the treatment site, the electrode can automatically recover to the expanded shape remembered at body temperature or under specific activation conditions (such as heating, stress unloading), achieving controllable electrode expansion to establish good contact with the surrounding tissue.

[0199] According to the driving and control mechanism, the return sub-electrode driven by memory alloy can be divided into the following implementation ways:

[0200] 1. Thermal activation shape memory effect: using temperature change to cause phase change of memory alloy, realizing automatic expansion and contraction of the electrode.

[0201] 2. Stress-induced martensitic phase change: using stress loading / unloading to cause phase change of memory alloy, realizing quasi-instantaneous expansion and contraction of the electrode.

[0202] 3. Compound driving mode: combining thermal activation and stress-induced, realizing multi-step control and fine adjustment of electrode expansion and contraction.

[0203] In addition to the above ways, novel driving mechanisms such as magnetic field driving and current driving can also be explored.

[0204] The benefits of using memory alloy material for the return sub-electrode are as follows: first, the operation process of the radiofrequency ablation guide wire system is simplified, reducing the difficulty and risk of surgery. Further, dynamic control of electrode shape and function is achieved, improving the accuracy and effectiveness of ablation therapy. Further, it has good tissue compatibility and mechanical stability, meeting the safety requirements of clinical application.

[0205] Optionally, the monitoring device 50 is also used to monitor the impedance and temperature between the active electrode 10 and the return electrode 20, and the control device 40 is also used to determine the distance between the electrode and the blood vessel wall and the ablation effect according to the monitoring results of the impedance and temperature between the active electrode 10 and the return electrode 20, and adjust the output power of the radio frequency generator 30.

[0206] Specifically, the benefits of doing so are: 1. Safety improvement: By monitoring impedance and temperature in real time, prevent excessive ablation and blood vessel injury. 2. Precise control: Real-time adjustment of radio frequency output, optimize ablation effect. 3. Increased automation: Reduce human intervention, improve the consistency and reliability of the operation.

[0207] The specific implementation mode is exemplarily explained below.

[0208] First, in terms of hardware settings, the system installs micro temperature sensors such as thermocouples on the active electrode 10 and the return electrode 20 to achieve accurate temperature monitoring. At the same time, impedance measurement circuit is integrated in the radio frequency generator 30 to measure the impedance change between electrodes in real time.

[0209] During the monitoring process, the system uses high-frequency sampling technology. Temperature monitoring is sampled about 10 times per second, with an accuracy of ±0.5℃; while the frequency of impedance monitoring is higher, up to 100 times per second, with an accuracy of about ±1Ω. This high frequency and high accuracy monitoring ensures the real-time and accuracy of the data.

[0210] In the data processing stage, the control device 40 receives and analyzes the data from temperature and impedance monitoring in real time. In order to improve the reliability of the data, the system uses methods such as sliding window algorithm to smooth the original data, effectively reducing the influence of noise.

[0211] The judgment logic of the system is divided into two main aspects. First, the distance between the electrode and the blood vessel wall is determined by the impedance value: low impedance (such as <100Ω) may indicate that the electrode is in contact with blood, while high impedance (such as >300Ω) may mean that the electrode is close to the blood vessel wall. Second, the system determines the ablation effect by temperature change: rapid temperature rise indicates the start of ablation, and stable temperature in the target range (such as 60-65℃) indicates good ablation effect. In addition, the change pattern of impedance can also reflect the change of tissue state.

[0212] Based on these judgments, the system can dynamically adjust the radio frequency power. It will adjust the output power in real time according to the changes of temperature and impedance, and set safety thresholds. When the temperature is too high or the impedance is abnormal, the system will automatically reduce the power or stop output to ensure the safety of treatment.

[0213] Finally, in terms of safety measures and feedback display, the system sets an alarm threshold. Once the parameters exceed the preset range, the system will immediately stop the radiofrequency output and trigger an alarm. At the same time, the system also provides real-time display functions, including temperature, impedance curve and current power, and uses color coding to intuitively indicate the ablation status, facilitating the operator to monitor the treatment process in real time.

[0214] Through this comprehensive and precise monitoring and control mechanism, the radiofrequency ablation guide wire system can ensure patient safety to the maximum extent while ensuring treatment effectiveness.

[0215] Optionally, the return electrode 20 is also provided with a radio-opaque marker for assisting intraoperative angiographic positioning.

[0216] Specifically, the benefits of doing so are: 1. Improved visualization: clearly showing the position of the return electrode 20 under X-ray fluoroscopy. 2. Precise positioning: helping doctors accurately determine the position of the return electrode 20 relative to the blood vessels and lesion site. 3. Reduce radiation exposure: by improving positioning accuracy, the number of X-ray imaging needed can be reduced. 4. Improve surgical efficiency: fast positioning can shorten the operation time.

[0217] The specific implementation mode is exemplarily explained below.

[0218] Material selection: Use high-atomic-number metal materials such as platinum, gold, tungsten, tantalum or barium sulfate. These materials exhibit high contrast under X-ray.

[0219] Marker design: a) Ring marker: thin ring markers are placed at the proximal and distal ends of the return electrode 20. b) Dot marker: small dot markers are evenly distributed on the return electrode 20. c) Line marker: thin lines are placed along the long axis of the return electrode 20.

[0220] Manufacturing process: a) Embedded: embed the marker material in the reserved slot. b) Plating: add markers at specific locations by electroplating or vacuum deposition. c) Composite material: directly mix the marker material into the base material during the manufacturing process.

[0221] Marker layout: Considering the expandability of the return electrode 20 and the visibility at different angles, markers may need to be placed on multiple planes.

[0222] Safety considerations: Ensure that the marker material is firmly combined with the electrode substrate, choose materials with good biocompatibility, and the marker design should not affect the performance of the electrode.

[0223] The design of the radio-opaque marker can significantly improve the operation precision and safety of the radiofrequency ablation guidewire system in complex vascular intervention surgery. It provides an additional visual reference for doctors, helps to optimize treatment strategies, and improves the success rate of surgery, and has a broad application prospect in minimally invasive interventions such as percutaneous coronary radiofrequency ablation.

[0224] Optionally, the feedback device 60 further comprises a display interface for visualizing the relative position relationship between the active electrode 10 and the return electrode 20.

[0225] Specifically, in the radiofrequency ablation guidewire system, in order to further improve the accuracy and safety of the operation, a display interface can be integrated into the feedback device 60 to visualize the relative position relationship between the active electrode 10 and the return electrode 20 in real time. This design can provide intuitive and real-time spatial navigation information for doctors, helping them better control the movement trajectory of the electrode and the ablation process.

[0226] Working principle:

[0227] Reference Figure 3 First, the distal end of the radiofrequency guidewire (including the return electrode 20) is placed in the blood vessel and advanced to the distal end of the occlusion, and the return sub-electrode is automatically deployed in the blood vessel lumen to cover the cross section of the blood vessel. At the same time, the active electrode 10 is located at the proximal end of the guidewire and placed at the proximal end of the occlusion.

[0228] Then, the radiofrequency generator 30 is turned on to apply radiofrequency energy to the occluded tissue. At the same time, the monitoring device 50 starts to monitor the current, impedance and temperature of each return sub-electrode in real time.

[0229] Next, the control device 40 judges the offset of the active electrode 10 relative to the return electrode 20 according to the monitoring data: if the currents of each return sub-electrode are basically consistent, it indicates that the active electrode 10 is located at the center of the return electrode 20; if the current of a certain sub-electrode is significantly higher than that of the other electrodes, it indicates that the active electrode 10 is biased to the side of that sub-electrode.

[0230] At the same time, the changes of the inter-electrode impedance and temperature are monitored to evaluate the distance between the electrode and the blood vessel wall and the ablation effect: high impedance indicates that the electrode is close to the blood vessel wall; rapid reduction of impedance indicates that the active electrode 10 is close to the metal stent or the return electrode 20; high temperature indicates that the tissue is carbonized and scabbed.

[0231] According to the above judgment, the control device 40 can automatically adjust the radiofrequency power to avoid excessive ablation, and provide visual cues such as sound, light, image, etc. to the operator through the feedback device 60 to guide them to adjust the electrode position and keep it in the center of the occlusion.

[0232] Under the synergistic effect of radiofrequency ablation and guidewire advancement, the active electrode 10 gradually penetrates the occlusion. After penetration, the control device 40 instructs the return sub-electrodes to contract, ensnare and retract the active electrode 10, completing the operation.

[0233] Throughout the process, if necessary, contrast agent can be injected through the hollow core 90 of the radiofrequency guidewire, combined with the radiopaque markers on the return electrode 20, to confirm the position of the guidewire under X-ray, guiding the operation.

[0234] Technical effects:

[0235] The radiofrequency ablation guidewire system provided by the above embodiment significantly improves the precision, safety and operational convenience of chronic total occlusion (CTO) interventional therapy through innovative electrode design and intelligent monitoring feedback mechanism, which is embodied in the following aspects:

[0236] Firstly, improve the accuracy and efficiency of electrode alignment: the return electrode 20 is composed of multiple sub-electrodes uniformly distributed in the radial direction. By monitoring the current difference of each sub-electrode in real time, the system can accurately judge the offset of the active electrode 10 relative to the center of the return electrode 20. Combined with the monitoring of electrode impedance and temperature, the distance between the electrode and the blood vessel wall and the ablation effect can be comprehensively evaluated. This design greatly improves the accuracy of electrode alignment, reduces the dependence on radiographic contrast, thereby shortening the operation time and reducing the radiation exposure of patients and doctors.

[0237] Further, intelligent operation feedback: the control system can provide real-time feedback such as sound and light to the operator according to the monitoring data, guiding them to adjust the electrode position and optimize the operation process. The intuitive feedback makes the operation more precise and convenient.

[0238] Further, integrated safety protection: the monitoring device 50 can evaluate impedance and temperature changes in real time, automatically adjust or even stop radiofrequency output when the electrode approaches the blood vessel wall or the temperature is too high, effectively preventing complications such as blood vessel perforation and improving the safety of the operation.

[0239] Further, flexible and multifunctional electrode design: the return electrode 20 can be expanded as needed to increase the coverage area, adapting to different sizes of blood vessels; it can also contract after penetrating the occlusion to capture and retract the active electrode 10, simplifying the operation process. The use of memory alloy material further optimizes the mechanical properties of the electrode.

[0240] Further, optimized instrument design: the radiopaque markers on the return electrode 20 help with intraoperative positioning if necessary, while the hollow core 90 of the guidewire design allows for the injection of contrast agent or saline during the operation, improving the flexibility of the operation.

[0241] In summary, the RF ablation guidewire system of the above embodiments integrates precise electrode control, intelligent feedback mechanism and flexible device design, which comprehensively improves the effectiveness and safety of CTO RF ablation treatment, simplifies the operation process, and has a broad clinical application prospect.

[0242] It should be noted that the relational terms herein, such as first and second, are used solely to distinguish one from another entity or action, without necessarily requiring or implying any actual relationship or order between such entities or actions. Moreover, the terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises... a" does not, without more constraints, exclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element. The application file contains at least one expression of a "means or step for" performing an identified function or step. It is believed that the claim format using means-plus-function clauses is an inducement to infringe. The clauses recite a means for performing a function and are intended to cover the structure described herein that performs the function and its equivalents. The term "and / or" includes any and all combinations of one or more of the associated listed items. Expressions such as "at least one of," when preceding a list of elements, modify the entire list of elements and do not modify the elements individually.

[0243] All documents mentioned in this application are believed to be incorporated in their entirety by reference herein, to the same extent as if the documents were specifically and individually indicated to be incorporated by reference. Moreover, it should be understood that various modifications and changes can be made to the application disclosed herein without departing from the scope thereof, it is therefore desired that such modifications and changes be considered as falling within the scope of the application as claimed.

Claims

1. A radiofrequency ablation guidewire system for opening chronically total occlusion of blood vessels, characterized in that, The application relates to a radiofrequency guide wire for ablation of a blood vessel occlusion, comprising: a radiofrequency guide wire, comprising a movable electrode positioned at one end of the occlusion and a return electrode positioned at the other end of the occlusion, wherein the return electrode is composed of multiple return sub-electrodes; a monitoring device electrically connected to the multiple return sub-electrodes, for monitoring the current passing through each return sub-electrode in real time; a control device in communication with the monitoring device, for judging the relative position relationship between the movable electrode and the return electrode according to the current difference passing through the multiple return sub-electrodes; a feedback device in communication with the control device, for providing a position adjustment prompt signal to an operator according to the judgment result of the control device on the relative position relationship between the movable electrode and the return electrode; a radiofrequency generator electrically connected to the movable electrode and the return sub-electrodes, for providing radiofrequency ablation energy.

2. The system of claim 1, wherein, The monitoring device is also used for monitoring the impedance and temperature between the movable electrode and the return electrode, and the control device is also used for judging the distance between the electrodes and the blood vessel wall and the ablation effect according to the monitoring result of the impedance and temperature between the movable electrode and the return electrode, and adjusting the output power of the radiofrequency generator.

3. The system of claim 1, wherein, The application further comprises a snare structure for retracting the return sub-electrodes.

4. The system of claim 1, wherein, The return sub-electrodes are made of a memory alloy material.

5. The system of claim 1, wherein, The return electrode is further provided with a radio-opaque marker for assisting in intraoperative contrast positioning.

6. The system of claim 1, wherein, The radiofrequency guide wire comprises a hollow inner core for injection of contrast agent or physiological saline.

7. The system of claim 1, wherein, The number of the return sub-electrodes is 2-16.

8. The system of claim 1, wherein, The return sub-electrodes can be unfolded relative to the radiofrequency guide wire to expand the radial coverage.

9. The system of claim 1, wherein, The feedback device further comprises a display interface for visually displaying the relative position relationship between the movable electrode and the return electrode.

10. The system of claim 1, wherein, The return sub-electrodes can be retracted to capture the movable electrode.

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