Radiofrequency ablation guide wire system for opening chronic complete occlusion of blood vessel

Abstract

The invention relates to the technical field of medical instruments, and discloses a radiofrequency ablation guide wire system for opening chronic complete occlusion of blood vessels. The system comprises a radio frequency guide wire, a monitoring device, a control device, a feedback device and a radio frequency generator. The radio frequency guide wire is provided with a movable electrode and a return electrode composed of a plurality of expandable and contractible return sub-electrodes. And the monitoring device monitors the current, impedance and temperature of each return sub-electrode in real time. The control device judges the electrode position relation according to the monitoring data and adjusts the radio frequency output. The feedback device provides sound, light or visually displayed position adjustment prompts. The system can further comprise a snare structure, a radiopaque marker, a hollow inner core and other functional components. The accuracy, the safety and the operation convenience of chronic complete occlusion interventional therapy are improved, the dependence on X-ray radiography is reduced, the operation process is simplified, and wide clinical application prospects are achieved.

Description

Technical Field

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

[0002] Chronic Total Occlusion (CTO) is a serious arterial vascular disease and one of the difficulties in current interventional treatment. CTO is usually defined as a lesion in which the coronary artery is completely occluded for more than 3 months. This lesion not only seriously affects the patient's quality of life, but may also lead to serious consequences such as myocardial ischemia, angina pectoris, and even myocardial infarction.

[0003] Traditional CTO interventional treatment mainly relies on doctors using thin guidewires to penetrate occluded tissue under image guidance.

[0004] However, this approach has several major problems:

[0005] First, precise positioning is difficult. In complex vascular structures, accurately locating the occlusion and precisely guiding the guidewire through the occluded tissue is an extremely challenging task. This often requires repeated use of X-ray angiography, increasing the risk of radiation exposure for patients and medical staff.

[0006] Moreover, the operation is risky. Due to the lack of accurate real-time feedback mechanism, it is difficult for the operator to determine the exact position and direction of the guidewire, which can easily cause serious complications such as vascular perforation and dissection.

[0007] Furthermore, the surgical efficiency is low. The traditional method requires frequent switching of different types of guide wires and repeated attempts to penetrate the occluded tissue, which greatly prolongs the operation time, increases the patient's pain and medical costs.

[0008] Furthermore, the success rate is unstable. The success rate of CTO interventional treatment is highly dependent on the operator's experience and skills. Even experienced doctors may face treatment failures.

[0009] In order 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 energy delivery range. However, the existing bipolar radiofrequency ablation system still has some limitations, such as:

[0010] Difficulty in electrode alignment: Traditional bipolar radiofrequency systems require precise alignment of the 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 angiography to confirm the position.

[0011] Lack of real-time feedback: It is difficult for the operator to understand the relative position of the electrodes and the ablation effect in real time, which increases the risk of the operation.

[0012] Insufficient system flexibility: Existing systems are difficult to adapt to vascular structures of different sizes and shapes, limiting their scope of application.

[0013] Complex operation: Many systems require the use of additional instruments (such as snares) to capture and retrieve the electrode, increasing the complexity and risk of the procedure.

[0014] Safety needs to be improved: there is a 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 treatment system that can overcome the above problems to improve the accuracy, safety and efficiency of treatment, while reducing dependence on X-ray angiography and reducing radiation exposure to patients and medical staff. This system should be able to provide real-time electrode position feedback, adapt to different vascular structures, simplify the operation process, and have an effective safety protection mechanism. The development of such a system will greatly promote the progress of CTO interventional treatment, improve the success rate of treatment, reduce the risk of complications, and ultimately benefit a large number of patients. Summary of the invention

[0016] The purpose of the present application is to provide a radiofrequency ablation guidewire system for opening chronic total occlusion of blood vessels, so as to solve the problems raised in the above-mentioned background technology.

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

[0018] A radio frequency guide wire, comprising an active electrode and a return electrode, wherein the return electrode is composed of a plurality of return sub-electrodes;

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

[0020] A control device, connected to the monitoring device for determining the relative position relationship between the active electrode and the return electrode according to the difference in currents passing through the multiple return sub-electrodes;

[0021] A feedback device, connected to the control device for communication, for providing a position adjustment prompt signal to the operator according to the control device's judgment result on the relative position relationship between the active electrode and the return electrode;

[0022] A radio frequency generator is electrically connected to the active electrode and the return sub-electrode and is used to provide radio frequency ablation energy.

[0023] In a preferred example, the monitoring device is also used to monitor the impedance and temperature between the active electrode and the return electrode, and the control device is also used to determine the distance between the electrode and the blood vessel wall 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, it also includes a snare structure for shrinking the return sub-electrode.

[0025] In a preferred example, the return sub-electrode is made of a memory alloy material.

[0026] In a preferred embodiment, the return electrode is also provided with a radiopaque marker to assist intraoperative angiographic positioning.

[0027] In a preferred embodiment, the radiofrequency guidewire includes a hollow inner core for injecting contrast agent or saline.

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

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

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

[0031] In a preferred embodiment, the return sub-electrode is capable of contracting to capture the active electrode.

[0032] The radiofrequency ablation guidewire system provided by the present invention significantly improves the accuracy, safety and convenience of interventional treatment of chronic total occlusion (CTO) through innovative electrode design and intelligent monitoring feedback mechanism, which is specifically reflected in the following aspects:

[0033] First, improve the accuracy and efficiency of electrode alignment: the return electrode is composed of multiple sub-electrodes distributed along the circumference. By real-time monitoring of the current difference of each sub-electrode, the system can accurately determine the offset of the active electrode relative to the center of the return electrode. Combined with the monitoring of inter-electrode impedance and temperature, the distance between the electrode and the blood vessel wall and the ablation effect can be fully evaluated. This design greatly improves the accuracy of electrode alignment and reduces the dependence on radiographic imaging, thereby shortening the operation time and reducing the radiation exposure of patients and doctors.

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

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

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

[0037] Furthermore, the device design is optimized: the radiopaque marker on the return electrode helps with intraoperative positioning when necessary, while the hollow core design of the guidewire allows for injection of contrast agent or saline during surgery, improving operational flexibility.

[0038] In summary, the radiofrequency ablation guidewire system of the present invention integrates precise electrode control, intelligent feedback mechanism and flexible instrument design, which comprehensively improves the effectiveness and safety of CTO radiofrequency ablation treatment, simplifies the surgical operation process, and has broad clinical application prospects.

[0039] A large number of technical features are recorded in the specification of this application, which are distributed in various technical solutions. If all possible combinations of technical features of this application (i.e., technical solutions) are to be listed, the specification will be too long. In order to avoid this problem, the various technical features disclosed in the above-mentioned invention content of this application, the various technical features disclosed in the various embodiments and examples below, and the various technical features disclosed in the accompanying drawings can be freely combined with each other to form various new technical solutions (these technical solutions are all deemed to have been recorded in this specification), unless the combination of such technical features is technically infeasible. For example, in one example, feature A+B+C is disclosed, and in another example, feature A+B+D+E is disclosed, and features C and D are equivalent technical means that play the same role. Technically, only one can be used, and it is impossible to use them at the same time. Feature E can be combined with feature C technically. Then, the solution of A+B+C+D should not be deemed to have been recorded because it is technically infeasible, and the solution of A+B+C+E should be deemed to have been recorded. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0042] Figure 3 It 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 It is a schematic structural diagram of a return electrode of a radiofrequency ablation guidewire system for opening chronic total occlusion of a blood vessel according to the first embodiment of the present application.

[0044] Figure 5 It is a schematic structural diagram 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] Throughout the drawings, the same reference numerals are used to denote the same elements or structures, wherein:

[0046] 10: Active Electrode

[0047] 20: Return electrode

[0048] 30: RF generator

[0049] 40: Control device

[0050] 50: Monitoring device

[0051] 60: Feedback device

[0052] 70: Electrode wire

[0053] 80: Outer sheath

[0054] 90: Inner core

[0055] 100: snare rope DETAILED DESCRIPTION

[0056] In the following description, many technical details are provided to help readers better understand the present application. However, those skilled in the art can understand that the technical solution claimed in the present application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0057] Description of some concepts:

[0058] Chronic total occlusion (CTO): Long-term complete occlusion of the coronary artery leads to ischemia in the blood supply area of ​​the blood vessel, with clinical manifestations such as refractory angina pectoris and myocardial infarction.

[0059] Radiofrequency ablation: A method that uses the thermal effect of radiofrequency current to coagulate and necrotize diseased tissue. Compared with the use of mechanical force alone, radiofrequency ablation can soften diseased tissue and facilitate the penetration of the guidewire.

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

[0061] Return electrode 20: another electrode forming a radio frequency current loop, which is at a certain distance from the active electrode 10.

[0062] Bipolar electrode: It consists of two electrodes that are close to each other. The radio frequency current is confined between the two electrodes, which can achieve more precise control of the energy application range.

[0063] Monopolar electrode: There is only one electrode to which RF energy is applied, and the current is conducted through human tissue to a distant return electrode 20 pad.

[0064] Snare: A device used to capture foreign matter or the tip of a guidewire in a blood vessel, usually a ring-shaped structure with an adjustable diameter.

[0065] Angiography: Contrast agent is injected into the blood vessels to display the morphological structure of the blood vessels under X-rays, which is used for diagnosis and guidance of interventional surgery.

[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 locations on the patient's body surface.

[0067] Radiopaque marker band: A marker that presents a high-density image under radiation and is attached to the surface of surgical instruments for tracking during surgery.

[0068] Flexible electrodes: Electrodes made of flexible materials that can bend with the catheter to reduce irritation to the blood vessel wall.

[0069] Self-deployable structure: A device preformed into a specific shape, which is in a constrained state when restricted and can automatically return to its original shape after the constraint is released.

[0070] Memory alloy: A type of alloy material with shape memory effect, often used to manufacture medical devices with self-expanding properties.

[0071] Guidewire: A slender, flexible metal wire used to guide catheters and other instruments into tortuous and narrow cavities or lumens.

[0072] Occlusion: Deposition of lipids, calcification, fibrous tissue proliferation, etc. in the blood vessel lumen causes the lumen to narrow or even completely block, affecting blood flow.

[0073] The following is a brief description of some of the innovative features of this application:

[0074] After in-depth research, the inventor of this application proposed a radiofrequency ablation guidewire system to address the above technical issues, aiming to solve a series of technical challenges in the treatment of chronic total occlusion (CTO), especially in terms of accurate electrode positioning, operational safety, and reducing the dependence of surgery on imaging equipment. Specific innovations include:

[0075] 1. Multi-electrode configuration and dynamic adjustment: This application designs a composite return electrode 20 including multiple return sub-electrodes, which are arranged along the circumference of the guide wire and can be expanded and contracted. This structure can better control the distribution of radio frequency current density, thereby controlling the ablation area; and the expansion range 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 radio frequency 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-electrode in real time; the impedance between the return sub-electrode and the active electrode 10; the temperature of the active electrode 10 and / or the tip of the return sub-electrode. These parameters are the key to determine the electrode position, evaluate the ablation effect, and prevent excessive ablation. Based on these monitoring data, the control system can automatically adjust the output power of the RF 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 adopts an expandable / contractible flexible structure, so that the active electrode 10 can be safely captured and withdrawn after the 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 RF guidewire can be used as a normal guidewire to facilitate subsequent operations such as stent expansion.

[0078] 4. Reduced reliance on image navigation: Innovatively, radiopaque markers are added to the return electrode 20, which can assist in intraoperative image positioning when necessary. However, due to the high degree of automation and precise current monitoring capabilities of the system, the overall reliance 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 structural design: The return sub-electrode is made of memory alloy material, which improves the operability and durability of the electrode. The use of memory alloy enables the electrode to automatically expand to the ideal shape when it reaches the predetermined position, and reliably shrink when needed.

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

[0081] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below in conjunction with the accompanying drawings.

[0082] The first embodiment of the present application relates to a radiofrequency ablation guidewire system for opening chronic total occlusion of a blood vessel, and its structure is as follows: Figure 1 , Figure 4 and Figure 5 As shown, it includes: a radio frequency guide wire, a monitoring device 50, a control device 40, a feedback device 60, and a radio frequency generator 30. The details are as follows:

[0083] Radiofrequency guidewire:

[0084] The radio frequency guidewire includes an active electrode 10 that can be positioned at the proximal end of the vascular occlusion and a return electrode 20 that can be positioned at the distal end of the vascular occlusion. The return electrode 20 is composed of a plurality of return sub-electrodes uniformly arranged along the circumference of the radio frequency guidewire. The return sub-electrodes can be expanded relative to the radio frequency guidewire to expand the radial coverage range, and can be contracted to capture the active electrode 10, or contracted to capture and retract the active electrode 10 that has passed through the occlusion.

[0085] It should be noted that in some embodiments of the present application, the positions of the active electrode 10 and the return electrode 20 are not fixed. According to the specific clinical situation and surgical requirements, the active electrode 10 and the return electrode 20 can be interchanged. In other words, the active electrode 10 can be positioned at the proximal end of the vascular occlusion (i.e., the doctor's operating side) or at the distal end of the vascular occlusion; correspondingly, the return electrode 20 can be located at the distal end or proximal end of the occlusion.

[0086] Specifically, if Figure 2 As shown, the RF guidewire in this embodiment consists of two main parts: an active electrode 10 and a return electrode 20. The active electrode 10 is located at the distal end of the first guidewire and can be positioned at the proximal end of the vascular occlusion (i.e., the side where the doctor operates), and is the main point of application of RF energy. It directly contacts the occluded tissue to denature it, thereby opening the blockage. The return electrode 20 is located at the distal end of the second guidewire and can be positioned at the distal end of the vascular occlusion (i.e., the side that passes through the occlusion), serving as the return path of the RF current, and forming a loop with the active electrode 10, so that the RF current is concentrated between the active electrode 10 and the return electrode 20, achieving a precise ablation range.

[0087] It should be noted 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 vascular occlusion. 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 can be placed at the proximal end. This design enhances the operational flexibility of the system, allowing doctors to select the best electrode configuration according to the specific conditions and vascular anatomical structure of each patient, thereby improving the treatment effect and the success rate of the operation.

[0088] The return electrode 20 is composed of a plurality of sub-electrodes arranged circumferentially along the radio frequency guide wire. The advantages of this design are: first, it improves flexibility. When the guide wire bends and moves forward along the blood vessel, the sub-electrodes can be close to each other to ensure the pushability of the guide wire; second, the sub-electrodes can be expanded radially and laid radially in the blood vessel cavity, which expands the contact area with the occluded tissue and makes the radio frequency current distribution more uniform; third, it is easy to capture. After the radio frequency ablation causes the occlusion to degenerate and soften, the active electrode 10 can smoothly pass through the occlusion and reach the side of the return electrode 20. At this time, the expanded return sub-electrode can be retracted to reliably clamp the active electrode 10 that has passed through, and drag the guide wire out to complete the operation. This function can replace the traditional snare and simplify the operation.

[0089] The innovative structure of this radiofrequency guidewire takes into account the characteristics of stenosis and tortuosity of the vascular lumen, the requirements of radiofrequency ablation for electrode area and position, and the convenience of surgical operation. It integrates multiple functions such as positioning, ablation and capture, optimizes the operating procedures of chronic occlusion radiofrequency ablation surgery, and improves surgical efficiency and safety.

[0090] Monitoring device 50

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

[0092] Specifically, the monitoring device 50 is a key component of the radiofrequency ablation guidewire 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 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 is distributed among the sub-electrodes. By real-time monitoring of the current size of each sub-electrode, the monitoring device 50 can provide the following important information:

[0094] 1. Relative positions of the active electrode 10 and the return electrode 20:

[0095] When the active electrode 10 is facing the center of the return electrode 20, the radio frequency 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 greater than that of other sub-electrodes. By analyzing the relative magnitude of the current of each sub-electrode, the relative position of the active electrode 10 and the center of the return electrode 20 can be determined to ensure accurate alignment with the occluded area.

[0097] 2. Radiofrequency ablation effect:

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

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

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

[0101] In short, the monitoring device 50 can provide key information such as the positioning of the active electrode 10, electrode wall adhesion and ablation effect by real-time monitoring of the current of the return sub-electrode. This integrated monitoring mechanism is an important embodiment of the intelligence and precision of the system, providing an objective basis for surgical operations, improving the accuracy and safety of radiofrequency ablation, maximizing the treatment effect, and minimizing the risk of complications. It is an important advancement 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 position relationship between the active electrode 10 and the return electrode 20 according to the difference of the currents passing through the multiple return sub-electrodes.

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

[0105] Communication connection: The control device 40 and the monitoring device 50 are connected via real-time communication to ensure that the current data of each return sub-electrode can be continuously received.

[0106] Data analysis. After the control device 40 receives the current data transmitted by the monitoring device 50, it performs the following analysis: a) Processing the raw data, including possible normalization processing to eliminate system errors. b) Comparing the current size of each return sub-electrode and analyzing the current difference. c) Calibration function: Due to differences in actual tissue distribution, even if the active electrode 10 is facing 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. During initial use, the operator can confirm the alignment of the active electrode 10 with the center of the return electrode 20 through imaging methods (such as X-ray fluoroscopy). At this time, the system will record 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 the subsequent relative position judgment more accurate. The calibration value will serve 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 determination. Based on the current difference analysis, the control device 40 determines the relative position of the active electrode 10 and the return electrode 20: a) When the currents of the return sub-electrodes are approximately equal, it indicates that the active electrode 10 may be facing the center of the return electrode 20. b) If the currents of some sub-electrodes are significantly higher than those of other sub-electrodes, it indicates that the active electrode 10 is off-center and close to the sub-electrode with higher current. c) The current difference is converted into relative position information of the active electrode 10 through a preset algorithm.

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

[0109] This position determination method based on current differences enables the system to understand the relative position of electrodes in real time without relying on additional imaging methods, improving the accuracy and safety of surgery while reducing 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 operations, and lay the foundation for the automation and intelligence of future radiofrequency ablation surgeries.

[0111] Feedback device 60

[0112] The feedback device 60 is connected to the control device 40 for communication, and is used to provide the operator with a position adjustment prompt signal 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 key component of the radiofrequency ablation guidewire system, and its main function is to convert the judgment result of the control device 40 into a prompt signal that the operator can intuitively understand. The specific functions and working principles are as follows:

[0114] Communication connection: The feedback device 60 is connected to the control device 40 through real-time communication, ensuring that the control device 40 can receive the judgment result 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, optional: a) sound signal: may include sounds of different tones, frequencies or patterns. b) light signal: may include lights of different colors, brightness or flashing patterns. c) tactile signal: may include vibrations of different directions, frequencies and intensities.

[0116] Signal meaning. Different sound or light signals may represent different positional relationships or adjustment suggestions, for example, optional: a continuous stable 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 magnitude of the adjustment.

[0117] Real-time and intuitive. The feedback device 60 timely converts the judgment result of the control device 40 into a simple and clear prompt signal, so that the operator can quickly understand and respond in a complex surgical environment.

[0118] The benefit of this feedback mechanism is to improve the accuracy, safety and efficiency of the surgery. By providing intuitive sound or light prompts, the operator can continuously obtain electrode position information without frequently checking the display screen or using X-ray imaging, so that he can focus more on the surgical operation itself. This can not only improve surgical efficiency, but also reduce the operator's cognitive burden and the patient's radiation exposure, representing an important advancement in modern interventional treatment technology.

[0119] RF generator 30

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

[0121] Electrical connection:

[0122] The radio frequency generator 30 is electrically connected to the active electrode 10 and the return sub-electrode through a cable. This connection ensures that the current generated by the radio frequency generator 30 can be accurately and efficiently transmitted to the electrode of the radio frequency ablation guide wire, forming a complete circuit and providing the necessary energy for treatment.

[0123] RF Energy Generation and Control:

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

[0125] Intelligent adjustment:

[0126] Modern RF generators 30 often have intelligent adjustment functions, which can automatically optimize the output power according to feedback information such as impedance and temperature obtained from the monitoring device 50. This real-time adjustment helps to maintain the best ablation effect and improve the accuracy and safety of treatment.

[0127] Versatility:

[0128] The advanced RF generator 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 versatility gives the RF ablation guidewire system greater flexibility and adaptability.

[0129] Security protection mechanism:

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

[0131] Human-computer interaction interface:

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

[0133] In summary, the RF generator 30 is the core energy source of the RF ablation guidewire system, and provides the necessary high-frequency current for RF ablation treatment through electrical connection with the active electrode 10 and the return sub-electrode. It integrates multiple key technologies such as RF energy generation, intelligent control, multi-functional adaptation and safety protection, and is an important driving force for modern minimally invasive interventional treatment.

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

[0135] Specifically, the radiofrequency ablation guidewire can be equipped with a hollow inner core 90 as a channel for delivering contrast agent or saline. The advantage of this is that it greatly enhances the functionality, adaptability and safety of the radiofrequency guidewire, 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 guidewire to integrate multiple functions such as radiofrequency ablation, contrast tracing, flushing and cleaning, simplifying the surgical process and improving the operating efficiency. Doctors can flexibly use contrast agents and saline according to surgical needs, which enhances the adaptability of radiofrequency ablation surgery.

[0137] Precise angiography. By injecting contrast agent through the hollow inner core 90, real-time tracking of the radiofrequency guidewire and precise positioning of the ablation area can be achieved. Under the guidance of X-ray or other imaging equipment, doctors can better control the position of the guidewire and evaluate 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 cool the guidewire surface and local tissue, controls the ablation temperature, reduces the risk of thrombosis and thermal damage to surrounding tissues, and improves ablation efficiency and safety.

[0139] Auxiliary treatment. The hollow inner core 90 provides a channel for local drug delivery, such as delivering anticoagulants or other therapeutic drugs, to achieve precise drug treatment. In the event of complications, it can also be used for emergency injection of therapeutic drugs to improve surgical response capabilities.

[0140] Optimized design. The hollow design reduces the overall weight of the guidewire while ensuring its strength, and enhances its flexibility and maneuverability. The saline layer on the surface of the guidewire can also prevent tissue adhesion and improve the smoothness of the surgery.

[0141] In summary, the hollow core 90 design of the radiofrequency ablation guidewire integrates a variety of treatment auxiliary functions, greatly expanding the application scope and clinical effect of radiofrequency ablation technology. This innovative design reflects the progress of modern interventional treatment technology and provides doctors and patients with more efficient, accurate and safe diagnosis and treatment solutions. At the same time, the rational application of the hollow core 90 also puts higher requirements on the doctor's operation level and experience, and requires a comprehensive assessment of the patient's condition, surgical goals and risk factors to achieve the best treatment effect.

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

[0143] Specifically, the number of return sub-electrodes of the radiofrequency ablation guidewire is a key parameter that affects the ablation effect, safety and adaptability. The optional number of return sub-electrodes is 2-16, preferably 3-8, and the advantages of doing so are:

[0144] Expand the ablation range and evenly distribute energy. Multiple return sub-electrodes can form a larger electric field area, expand the range of a single radiofrequency ablation, and improve surgical efficiency. At the same time, the reasonable layout of the return sub-electrodes helps to evenly distribute the radiofrequency energy in the target area, avoiding local overheating or incomplete ablation. The design of 3-8 electrodes not only ensures good energy distribution, but also takes into account the balance between electrode density and mutual interference.

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

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

[0147] Safety considerations. The number of electrodes must take into account 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 effects while reducing the incidence of complications, reflecting the importance of patient safety.

[0148] Economy and operability. The number of electrodes must also balance medical costs and ease of operation. More electrodes mean higher manufacturing costs and more complicated operation procedures. The design of 2-16, especially 3-8 electrodes, takes into account economy and operability while ensuring the 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 for radiofrequency ablation guidewires requires a balance between treatment effect, safety, adaptability, accuracy, and economy. The design of 2-16, especially 3-8 return sub-electrodes, has achieved a good balance between these factors and represents the optimization direction of radiofrequency ablation technology. This flexible design also provides doctors with more options, and can formulate personalized treatment plans according to the specific conditions of different patients, comprehensively improving the efficacy and safety of radiofrequency ablation surgery.

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

[0151] Specifically, in the radiofrequency ablation guidewire system, the maximum diameter of the return sub-electrode after expansion is one of the key parameters affecting the ablation effect and safety. Optionally, the maximum diameter of the return sub-electrode after expansion is designed to be 1.5-5mm. The advantages of this are:

[0152] Wide range of applications. The diameter range of 1.5-5mm significantly expands the scope of application of the device, covering a variety of sizes from small branch vessels to large trunk vessels. This enables the radiofrequency ablation guidewire system to cope with different locations and types of vascular diseases, 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 interventional procedures, and doctors can customize personalized treatment plans based on each patient's specific situation and vascular characteristics.

[0154] Accurately match the characteristics of the lesion. Different types and degrees of vascular lesions have different requirements for electrode diameter. The diameter selection range of 1.5-5mm provides doctors with more operational freedom, which can accurately match the characteristics of the lesion, select the optimal electrode diameter, and improve the pertinence 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 conditions after vascular remodeling, such as long-segment occlusions, bifurcation lesions, irregularly shaped lesions, and abnormal vascular dilation, improving the applicability of radiofrequency ablation treatment.

[0156] Improved surgical efficiency and economic benefits. A wider diameter range may allow for a wider range of treatments to be performed in some cases, potentially reducing the number and duration of surgeries. 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 guidewire system, enabling it to meet a wider range of clinical needs. This design fully considers factors such as vascular adaptability, lesion characteristics, wall adhesion effect, energy transfer, and blood flow influence, while improving treatment effects and surgical efficiency, taking into account safety and economic benefits.

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

[0159] Specifically, the return sub-electrode can be contracted to capture and withdraw the active electrode 10 that has passed through the occlusion, and there are many specific implementation methods. The following examples illustrate several common implementation schemes in combination with mechanical structure design, drive and contraction mechanism, capture design, and feedback system:

[0160] 1. Mechanical contraction mechanism

[0161] The return sub-electrode can be designed to be composed of a plurality of elastic metal wires or sheet structures, such as nickel-titanium alloy wires. These metal wires are unfolded in a natural state, forming an open or cage-like structure. When it is necessary to shrink, by pulling the control wire connected to the return sub-electrode or pushing the sheath tube, the metal wires can be compressed and gathered to form a closed structure, thereby capturing the active electrode 10 therein.

[0162] 2. Shape memory alloy drive

[0163] By utilizing the characteristics of shape memory alloys (such as nickel-titanium alloys), the active contraction of the return sub-electrode can be achieved. By controlling the phase change temperature of the shape memory alloy (for example, heating by electricity), the return sub-electrode can be made to present an unfolded shape at a preset low temperature state, and contract to a closed shape at a high temperature state. When the active electrode 10 needs to be captured, the return sub-electrode is heated to contract and the active electrode 10 is bound therein.

[0164] 3. Airbag expansion / contraction

[0165] The return sub-electrode can be designed as a flexible airbag structure. The airbag is connected to an inflation / deflation pipeline. By controlling the pressure in the airbag, it can be expanded and unfolded when inflated to form an open structure; and contracted when deflated to form a closed structure. When the active electrode 10 needs to be captured, the airbag is deflated to shrink and wrap the active electrode 10 therein.

[0166] 4. Magnetic attraction

[0167] By using the principle of magnetic attraction, the return sub-electrode can capture and withdraw the active electrode 10. Magnetic materials, such as permanent magnets or electromagnets, are respectively provided on the return sub-electrode and the active electrode 10. When the active electrode 10 needs to be captured, the magnetic field on the return sub-electrode is controlled (for example, a magnetic field is generated by powering on) so that it generates an attractive force with the magnetic material on the active electrode 10, and the active electrode 10 is adsorbed onto the return sub-electrode.

[0168] Optional, the specific surgical process can be divided into the following steps:

[0169] Step 1: Initial state: The return sub-electrode is in the expanded state and is 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 gradually penetrates the occlusion through the radio frequency energy. The return sub-electrode remains in the expanded state, serving as a return path for the radio frequency energy.

[0171] Step 3: Penetration completed: When the active electrode 10 successfully passes through the occlusion and enters the area covered by the return sub-electrode, the operator will observe this under X-ray guidance.

[0172] Step 4: Activate capture: The operator activates the retraction mechanism of the return sub-electrode via the control device 40 on the handle.

[0173] Step 5: Contraction process: The returning sub-electrode begins to contract 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: Withdrawal operation: The operator slowly withdraws the entire catheter system, driving the captured active electrode 10 out of the blood vessel.

[0175] Step 7: The operation is completed: After the catheter system is completely withdrawn, the blockage has been opened and a new pathway has been formed.

[0176] Regardless of the implementation method used, the function of the return sub-electrode to contract and capture the active electrode 10 can significantly improve the usability, safety and reliability of the radiofrequency ablation guidewire system, simplify the surgical process, provide clinicians with a better operating experience, and bring safer and more effective treatment to patients.

[0177] Optionally, the radiofrequency ablation guidewire system for opening chronic total occlusion of a blood vessel further comprises a snare structure for contracting the return sub-electrode (see Figure 5 , Figure 5 A snare rope 100 is shown in FIG.

[0178] Specifically, in the radiofrequency ablation guidewire system, the snare structure for retracting the return sub-electrode can be implemented in a variety of ways. The following examples illustrate several common implementation schemes:

[0179] 1. Push-pull trap structure

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

[0181] When the return sub-electrode needs to be retracted, the operator pulls the control mechanism (such as a sliding button or a knob) connected to the snare structure on the handle to move the snare structure toward the proximal end. As the snare structure moves, its front end gradually pushes the return sub-electrode, forcing it to retract from the expanded state to a closed cage-like structure. When the return sub-electrode needs to be released, the operator can push the control mechanism in the opposite direction to make the snare structure retract toward the distal end, allowing the return sub-electrode to return to the expanded state.

[0182] 2. Rope traction snare structure:

[0183] In this implementation, the snare structure is composed of a plurality of ropes or filaments surrounding the return sub-electrode, one end of these ropes is fixed to the proximal end of the return sub-electrode, and the other end is gathered to the handle of the radiofrequency ablation guide wire and connected to the control mechanism.

[0184] When the return sub-electrode needs to be retracted, the operator pulls the control mechanism on the handle and pulls all the ropes at the same time. As the ropes tighten, they exert an inward compressive force on the return sub-electrode, forcing it to gradually retract from the expanded state to a closed cage-like structure. Releasing the control mechanism releases the ropes, allowing the return sub-electrode to return to the expanded state.

[0185] The advantage of the rope-traction snare structure is that it has a simple structure and can achieve uniform contraction force distribution.

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

[0187] This implementation utilizes hydraulic or pneumatic force to drive the snare structure. The snare structure can be designed as an expandable chamber surrounding the return sub-electrode. The chamber is connected to a hydraulic or pneumatic pump on the RF ablation guidewire handle through a pipeline.

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

[0189] 4. Shape memory alloy driven snare structure:

[0190] By utilizing the characteristics of shape memory alloys, an intelligent snare structure can be realized. In this implementation, the snare structure is made of shape memory alloys, 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 electrically heated (e.g., through a control button on the handle) to raise its temperature above the phase transition point. As the temperature rises, the snare structure automatically shrinks, compressing the return sub-electrode into a closed cage-like structure. Stopping the heating will cool the snare structure and restore it to its original state, allowing the return sub-electrode to re-expand.

[0192] This intelligent snare structure has the characteristics of shape memory and self-actuation and is easy to control. However, the heating process needs to be precisely controlled while ensuring the safety and biocompatibility of shape memory alloys in medical environments.

[0193] It should be noted that the above implementation methods are not independent of each other and can be combined or optimized according to specific needs to achieve the best contraction control effect. For example, hydraulic drive can be combined with shape memory alloy, and the phase change temperature of the shape memory alloy snare structure can be controlled by hydraulic pressure to achieve more accurate and rapid contraction control.

[0194] Optionally, during the radiofrequency ablation procedure, after the return sub-electrode successfully captures the active electrode 10, the operator needs to maintain the contraction 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 to avoid slippage or instability. Once the catheter system is completely withdrawn from the blood vessel, the procedure can be successfully completed.

[0195] In conclusion, the snare structure used to retract the return sub-electrode can be used as one of the key components of the radiofrequency ablation guidewire system. Through the ingenious mechanical design and the application of intelligent materials, the snare structure can achieve precise control of the return sub-electrode, ensuring the reliable capture and safe withdrawal of the active electrode 10. With the continuous advancement of technology, the design and implementation of the snare structure are also being continuously optimized, providing more guarantees for the safety, effectiveness and convenience of radiofrequency ablation surgery.

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

[0197] Specifically, the use of memory alloy materials to manufacture return sub-electrodes is an innovative design in the radiofrequency ablation guidewire system. Memory alloys, especially nickel-titanium alloys (Nitinol), have unique shape memory effects and superelasticity, which enable the electrodes to achieve complex mechanical functions such as automatic expansion and contraction, enhancing the flexibility, controllability and therapeutic efficacy of the entire system. At the same time, memory alloys also have good biocompatibility, corrosion resistance and fatigue resistance, and are particularly suitable for the manufacture of implantable medical devices.

[0198] The working principle of the memory alloy electrode is as follows: During the manufacturing process, the memory alloy material is processed into a specific shape (such as a ring or cage) and undergoes a special heat treatment to make it "memorize" the preset expanded shape. At room temperature, the electrode can be deformed to a contracted state, which is convenient for delivery to the target location in the body through a catheter. Once it reaches the treatment site, the electrode can automatically return to the memorized expanded shape at body temperature or specific activation conditions (such as heating, stress unloading), achieving controllable electrode expansion to establish good contact with surrounding tissues.

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

[0200] 1. Thermally activated shape memory effect: The temperature change is used to cause the memory alloy to change phase, thus realizing the automatic expansion and contraction of the electrode.

[0201] 2. Stress-induced martensitic phase transformation: Utilize stress loading / unloading to induce phase transformation of memory alloy and realize quasi-instant expansion and contraction of electrodes.

[0202] 3. Composite driving mode: Combining thermal activation and stress induction to achieve multi-step control and fine adjustment of electrode expansion and contraction.

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

[0204] The benefits of using a return sub-electrode made of memory alloy are: first, it simplifies the operation process of the radiofrequency ablation guidewire system, reducing the difficulty and risk of surgery. Furthermore, it realizes the dynamic control of the electrode shape and function, improving the accuracy and effectiveness of ablation treatment. Furthermore, it has good tissue compatibility and mechanical stability, meeting the safety requirements of clinical applications.

[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. Improved safety: Real-time monitoring of impedance and temperature can prevent excessive ablation and vascular damage. 2. Precise control: Real-time adjustment of RF output to optimize ablation effects. 3. Improved automation: Reduced human intervention, improved consistency and reliability of surgery.

[0207] The specific implementation method is described below by way of example.

[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, an impedance measurement circuit is integrated in the RF generator 30 to measure the impedance change between the 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°C; while impedance monitoring is performed at a higher frequency of 100 times per second with an accuracy of about ±1Ω. This high-frequency, high-precision 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 the temperature and impedance monitoring in real time. In order to improve the reliability of the data, the system uses a sliding window algorithm and other methods to smooth the raw data, effectively reducing the impact 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 judged by the impedance value: low impedance (such as <100Ω) may mean that the electrode is in contact with the blood, while high impedance (such as >300Ω) may mean that the electrode is close to the blood vessel wall. Secondly, the system judges the ablation effect by temperature changes: a rapid rise in temperature indicates the start of ablation, and a stable temperature in the target range (such as 60-65°C) indicates a good ablation effect. In addition, the change pattern of impedance can also reflect changes in tissue state.

[0212] Based on these judgments, the system can dynamically adjust the RF power. It adjusts the output power in real time according to changes in temperature and impedance, and sets safety thresholds. When the temperature is too high or the impedance is abnormal, the system automatically reduces the power or stops the output to ensure the safety of treatment.

[0213] Finally, in terms of safety measures and feedback display, the system sets alarm thresholds. Once the parameters exceed the preset range, the system will immediately stop the RF 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, making it easier for the operator to monitor the treatment process in real time.

[0214] Through this comprehensive and precise monitoring and control mechanism, the radiofrequency ablation guidewire system can ensure the treatment effect while maximizing patient safety.

[0215] Optionally, the return electrode 20 is also provided with a radiopaque marker to assist in intraoperative angiography positioning.

[0216] Specifically, the benefits of doing so are: 1. Improved visualization: The position of the return electrode 20 is clearly displayed under X-ray fluoroscopy. 2. Accurate positioning: Helps doctors accurately determine the position of the return electrode 20 relative to the blood vessel and the lesion. 3. Reduced radiation exposure: By improving positioning accuracy, the number of X-ray imaging required may be reduced. 4. Improved surgical efficiency: Rapid positioning can shorten surgical time.

[0217] The specific implementation method is described below by way of example.

[0218] Material selection: Use metal materials with high atomic numbers, such as platinum, gold, tungsten, tantalum or barium sulfate. These materials show high contrast under X-rays.

[0219] Marking design: a) Ring marking: thin ring markings are set at the proximal and distal ends of the return electrode 20. b) Dot marking: small dot markings are evenly distributed on the return electrode 20. c) Line marking: a thin line is set along the long axis direction of the return electrode 20.

[0220] Manufacturing process: a) Embedded: The marking material is embedded in the reserved slot. b) Plated: The marking is added at a specific location by electroplating or vacuum deposition. c) Composite: The marking material is directly mixed into the base material during the manufacturing process.

[0221] Marking layout: Considering the deployability of the return electrode 20 and the visibility at different angles, it may be necessary to place markings on multiple planes.

[0222] Safety considerations: ensure that the marking material is firmly bonded to the electrode matrix, select materials with good biocompatibility, and the marking design does not affect the performance of the electrode.

[0223] This radiopaque marker design can significantly improve the operating accuracy and safety of the radiofrequency ablation guidewire system in complex vascular interventional procedures. It provides doctors with additional visual references, helps optimize treatment strategies, improves surgical success rates, and has broad application prospects in minimally invasive interventional treatments such as percutaneous coronary radiofrequency ablation.

[0224] Optionally, the feedback device 60 further includes a display interface for visually displaying 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 in 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 doctors with intuitive and real-time spatial navigation information to help 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 into the blood vessel and pushed to the distal end of the occlusion, and the return sub-electrode automatically unfolds in the blood vessel cavity 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 is placed at the proximal end of the occlusion.

[0228] Then, the radio frequency generator 30 is turned on to apply radio frequency 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 determines the offset of the active electrode 10 relative to the return electrode 20 based on the monitoring data: if the currents of the return sub-electrodes are basically the same, it means 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 other electrodes, it indicates that the active electrode 10 is biased toward the side of the sub-electrode.

[0230] At the same time, the impedance and temperature changes between the electrodes are monitored to evaluate the distance between the electrode and the blood vessel wall and the ablation effect: too high impedance indicates that the electrode is close to the blood vessel wall; a rapid decrease in impedance indicates that the active electrode 10 is close to the metal stent or the return electrode 20; and too high temperature indicates tissue carbonization and scab.

[0231] Based on the above judgment, the control device 40 can automatically adjust the radio frequency power to avoid excessive ablation; and provide the operator with intuitive prompts such as sound, light, and images through the feedback device 60 to guide the operator to adjust the electrode position and keep it in the occlusion center.

[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-electrode to contract, snare and withdraw the active electrode 10, and complete the operation.

[0233] During the whole process, contrast agent can be injected through the hollow inner core 90 of the radiofrequency guidewire when necessary, and the position of the guidewire can be confirmed under X-rays in combination with the radiopaque marker on the return electrode 20 to guide the surgical operation.

[0234] Technical effects:

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

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

[0237] Furthermore, intelligent operation feedback: the control system can provide the operator with real-time feedback such as sound and light based on the monitoring data, guiding him to adjust the electrode position and optimize the surgical process. The intuitive feedback method makes the operation more accurate and convenient.

[0238] Furthermore, integrated safety protection: the monitoring device 50 can evaluate impedance and temperature changes in real time, and automatically adjust or even stop the radio frequency output when the electrode is close to the blood vessel wall or the temperature is too high, effectively preventing complications such as blood vessel perforation and improving surgical safety.

[0239] Furthermore, the electrode design is flexible and multifunctional: the return electrode 20 can be expanded as needed to increase the coverage and adapt to blood vessels of different sizes; it can also be retracted after passing through the occlusion, capturing and withdrawing the active electrode 10, simplifying the surgical process. The use of memory alloy material further optimizes the mechanical properties of the electrode.

[0240] Furthermore, the device design is optimized: the radiopaque marker on the return electrode 20 helps with intraoperative positioning when necessary, and the hollow inner core 90 design of the guidewire allows for injection of contrast agent or saline during surgery, thereby improving operational flexibility.

[0241] In summary, the radiofrequency ablation guidewire system of the above-mentioned embodiment integrates precise electrode control, intelligent feedback mechanism and flexible instrument design, which comprehensively improves the effectiveness and safety of CTO radiofrequency ablation treatment, simplifies the surgical operation process, and has broad clinical application prospects.

[0242] It should be noted that in the application documents of this patent, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "including one" do not exclude the existence of other identical elements in the process, method, article or device including the elements. In the application documents of this patent, if it is mentioned that an action is performed according to an element, it means that the action is performed at least according to the element, which includes two situations: performing the action only according to the element, and performing the action according to the element and other elements. Expressions such as multiple, multiple, and multiple include 2, 2 times, 2 kinds, and more than 2, more than 2 times, and more than 2 kinds.

[0243] All documents mentioned in this application are considered to be included in the disclosure of this application as a whole, so that they can be used as the basis for modification when necessary. In addition, it should be understood that after reading the above disclosure of this application, those skilled in the art can make various changes or modifications to this application, and these equivalent forms also fall within the scope of protection claimed in this application.

Claims

1. A radiofrequency ablation guidewire system for opening chronic total occlusion of blood vessels, characterized in that: include: A radio frequency guide wire, comprising an active electrode and a return electrode, wherein the return electrode is composed of a plurality of return sub-electrodes; A monitoring device, electrically connected to the plurality of return sub-electrodes, for real-time monitoring of the current passing through each return sub-electrode; A control device, connected in communication with the monitoring device, for determining a relative positional relationship between the active electrode and the return electrode according to a difference in currents passing through the plurality of return sub-electrodes; A feedback device, connected to the control device for communication, for providing a position adjustment prompt signal to the operator according to the control device's judgment result on the relative position relationship between the active electrode and the return electrode; A radio frequency generator is electrically connected to the active electrode and the return sub-electrode and is used to provide radio frequency ablation energy.

2. The system according to claim 1, characterized in that The monitoring device is also used to monitor the impedance and temperature between the active electrode and the return electrode. The control device is also used to determine the distance between the electrode and the blood vessel wall 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.

3. The system according to claim 1, characterized in that Also included is a snare structure for contracting the return sub-electrode.

4. The system according to claim 1, characterized in that The return sub-electrode is made of memory alloy material.

5. The system according to claim 1, wherein: The return electrode is also provided with a radiopaque marker to assist in intraoperative angiography positioning.

6. The system according to claim 1, characterized in that The radiofrequency guide wire comprises a hollow inner core for injecting contrast agent or physiological saline.

7. The system according to claim 1, characterized in that The number of the return sub-electrodes is 2-16.

8. The system of claim 1, wherein: The return sub-electrode can be deployed relative to the radio frequency guide wire to expand the radial coverage.

9. The system according to claim 1, characterized in that The feedback device also includes a display interface for visually displaying the relative position relationship between the active electrode and the return electrode.

10. The system according to claim 1, wherein: The return sub-electrode is capable of contracting to capture the active electrode.

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