Radio frequency catheter ablation assembly and radio frequency ablation system

Abstract

The invention discloses a radio frequency catheter ablation assembly and a radio frequency ablation system. The radio frequency ablation assembly comprises a handle and a radio frequency catheter connected with the handle. A radio frequency electrode is arranged on the radio frequency catheter in the length direction of the radio frequency catheter, a movable electrode slip sheet is electrically connected to the electrode, an electrode length adjusting assembly is arranged in the handle, the movable electrode slip sheet can move in the length direction of the radio frequency electrode under the action of the electrode length adjusting assembly, the length of the working end of the radio frequency electrode is adjusted, and the slip sheet is electrically connected with an external power source during use. The catheter radiofrequency ablation device effectively solves many technical problems of existing ultrasound-guided lower limb varicose vein catheter radiofrequency ablation, the length of an ablation catheter can be accurately adjusted, and length mismatching is avoided; a medicine injection function can be integrated, and the problem of lack or non-uniform injection is solved; the working end temperature can be flexibly adjusted, and the ablation problem is reduced; the blood vessel curve passing performance and the thrombus resistance are improved; the positioning difficulty is reduced, and the dependence on experience is reduced; uniform mixing of the hardening agent is realized; the spacer fluid injection operation is simplified, and the capacity difference influence is reduced.

Description

Technical Field

[0001] This invention belongs to the field of radiofrequency ablation equipment technology, and relates to a radiofrequency catheter ablation component and a radiofrequency ablation system. Background Technology

[0002] Ultrasound-guided catheter-based radiofrequency ablation for varicose veins in the lower extremities is a precise and minimally invasive technique for treating varicose veins. By using ultrasound for real-time localization and radiofrequency energy to close the diseased veins, it has become one of the preferred treatment options in international guidelines. Its core technical principle is: ultrasound guides the puncture and catheter positioning throughout the entire process, precisely inserting the radiofrequency ablation catheter into the lumen of the varicose vein. The working end of the radiofrequency catheter releases radiofrequency energy, reaching temperatures of 85-120℃, causing the collagen in the vein wall to denature, contract, and close. After closure, the diseased vein gradually undergoes fibrosis and absorption, allowing blood to return through healthy veins, eliminating abnormal venous pressure at its source. Furthermore, most tissues outside the fascial cavity require temperature adjustment (e.g., within the range of 85-100℃).

[0003] Ultrasound-guided radiofrequency ablation of varicose veins in the lower extremities offers numerous advantages over traditional treatments such as high ligation and stripping of the great saphenous vein, laser ablation, and sclerotherapy. Radiofrequency ablation catheters leave only 2-3mm incisions, eliminating the need for surgical incisions, removing the need for a stripper to pull on the vessel, avoiding long scars on the leg, achieving a high vascular closure rate, low recurrence rate, low pain level, no scarring, high aesthetic appeal, high safety, and few complications, demonstrating significant clinical significance and application value in venous ablation. However, several clinical limitations still exist in the practical application of radiofrequency ablation catheters. First, there is the issue of mismatched ablation catheter lengths. Due to the varying ablation requirements in different areas of the vein, it is necessary to achieve rapid and precise adjustment of the working length of the ablation catheter to reduce the number of ablation sessions and surgical time. Second, during lower extremity vein radiofrequency ablation electrode catheter surgery, it is necessary to simultaneously use ablation combined with sclerosing agents and other drug treatments to enhance the treatment effect on the target vessel and reduce complications such as inflammation. To reduce the inflammatory response of the vessel wall after ablation, it is necessary to inject anti-inflammatory drugs into the endothelium of the ablated vessel. However, some current ablation catheters do not have intravascular drug injection ports or drug injection tubes, or the drug injection port structure does not enable the uniform application of anti-inflammatory drugs to the perivascular intima of the ablated vessel, making it impossible to administer drugs through the side port of the radiofrequency ablation catheter or auxiliary catheter. In addition, the working end temperature of commonly used lower extremity vein radiofrequency ablation catheters is a single fixed value (such as 120 / 100 / 80℃). However, when the ablation temperature of the catheter electrode is too high, vapor explosion and carbonization are likely to occur; when the temperature is too low, uneven ablation and treatment failure may occur; under fixed power, the catheter cannot automatically compensate for displacement or poor contact, leading to problems such as discontinuous ablation foci and poor transmural penetration. When using a fixed-value mode, the lack of closed-loop control of tissue temperature is a fundamental defect of venous radiofrequency ablation catheters, resulting in a mismatch between energy output and tissue demand, causing a chain reaction of problems such as overheating, uneven ablation, and impedance loss of control; in addition, when the lower extremity venous radiofrequency ablation catheter passes through the bends of the blood vessel, it is necessary to ensure that the catheter can accurately conform to the vascular anatomy while maintaining stable energy delivery and tissue contact. Excessive friction of the catheter wall when passing through bends in a vein can damage the venous endothelium. Furthermore, once the ablation catheter enters the lower extremity veins, poor hydrophilicity or microdefects on the instrument surface can easily attract platelets and fibrinogen, initiating intrinsic coagulation. Excessive friction during catheter advancement can cause endothelial cell detachment, exposing collagen fibers, activating platelet adhesion and aggregation, leading to thrombus formation and compromising patient safety. Moreover, during lower extremity vein ablation, the saphenofemoral junction must be positioned 2cm below the vein to avoid deep vein injury. Ultrasound-guided catheter positioning requires a high level of operator experience; in tortuous veins, ultrasound-guided catheter positioning is difficult, often necessitating multiple adjustments. Traditional radiofrequency ablation relies on preset energy parameters and lacks tissue feedback mechanisms, affecting the actual effectiveness and efficiency of ablation.In addition, the preparation stage for lower extremity venous ablation requires the mixing and preparation of sclerosing agents, including polidocanol and carbon dioxide gas, which need to be thoroughly and evenly mixed. The operator needs to spend time and energy to mix them evenly. The efficacy and safety of the sclerosing agent are highly dependent on the uniformity of the mixture. Incomplete mixing can lead to a double problem of "excessive local concentration + insufficient local concentration", which directly affects the treatment effect and increases the risk of complications. At the same time, if the isolation fluid is missing or unevenly distributed in the area around the blood vessel during injection, the radiofrequency heat can be directly conducted to the skin, which can easily lead to epidermal redness, swelling and blisters. In severe cases, skin burns and necrosis may occur. In addition, if there is not enough isolation fluid to protect the saphenous nerve, the heat stimulation can cause nerve edema and damage, resulting in postoperative numbness, tingling and even long-term sensory abnormalities in the lower extremities. Meanwhile, the difference in the volume of the isolation fluid also affects the ablation effect of the vein. Too much local isolation fluid will dilute the radiofrequency energy, resulting in insufficient temperature of the target vein wall, failure to reach the target temperature, incomplete closure of the vein, and residual lumen, increasing the risk of postoperative recurrence. Too little isolation fluid will not be able to effectively wrap the vein, and the energy diffusion will result in an excessively large ablation area, which may damage adjacent normal blood vessels and tissues. Currently, the isolation fluid is injected using a single needle, which relies on the operator's experience to control the injection volume. The operation of mixing the isolation fluid is relatively cumbersome and laborious.

[0004] Based on the aforementioned clinical challenges in ultrasound-guided lower extremity venous ablation, there is an urgent need to develop a venous radiofrequency ablation catheter with a rapidly and precisely adjustable working end length. This catheter should also feature adjustable ablation temperature at the working end, intravenous drug injection, easy passage through tortuous veins with anti-thrombotic properties, LED marking of ablation location and indication of ablation effect, and be equipped with an innovative, fully automated sclerotherapy mixer and a multi-point, high-efficiency injection needle. This would provide a complete one-stop solution for lower extremity venous radiofrequency ablation, making ultrasound-guided lower extremity venous ablation safer, more effective, and more convenient, achieving precision medicine in varicose vein ablation. Summary of the Invention

[0005] To address the problems existing in the prior art, this invention provides a radiofrequency catheter ablation component and a radiofrequency ablation system, thereby solving the technical problems of existing ultrasound-guided radiofrequency ablation of varicose veins in the lower extremities, such as mismatched ablation catheter length requiring precise adjustment, lack of drug injection function or uneven injection, fixed working end temperature leading to many ablation problems, poor passage through vascular bends and antithrombotic properties, difficult positioning and reliance on experience, uneven mixing of sclerosing agents, and cumbersome operation of isolation fluid injection with effects affected by volume differences.

[0006] This invention is achieved through the following technical solution: A radiofrequency catheter ablation assembly includes a handle and a radiofrequency catheter connected to the handle; The radio frequency conduit is provided with radio frequency electrodes; the radio frequency electrodes are arranged along the length direction of the radio frequency conduit; and a movable electrode slider is electrically connected to the radio frequency electrodes. The handle is equipped with an electrode length adjustment component; the movable electrode slider can move along the length direction of the radio frequency electrode under the action of the electrode length adjustment component to adjust the length of the working end of the radio frequency electrode. In use, the movable electrode slider is electrically connected to an external power source.

[0007] Preferably, the electrode length adjustment assembly includes a rotation unit and a pulling unit; The rotating unit includes a drive shaft and a transmission shaft. The drive shaft is provided with a first drive shaft gear and a second drive shaft gear. The transmission shaft is provided with a first transmission shaft gear and a second driven shaft gear. The first drive shaft gear meshes with the first transmission shaft gear, and the second drive shaft gear meshes with the second driven shaft gear. One end of the drive shaft is provided with an adjustment knob, which is located outside the handle. The traction unit includes an electrode wire disposed on a movable electrode slider and a traction assembly disposed at the free end of the radio frequency conduit; the other end of the electrode wire is wound around a drive shaft; a traction wire is wound on the traction assembly, one free end of the traction wire is fixedly connected to the movable electrode slider, and the other free end is wound around the drive shaft, and the traction wire and the electrode wire are wound in opposite directions on the drive shaft.

[0008] Preferably, the number of teeth of the first gear of the drive shaft is greater than the number of teeth of the first gear of the transmission shaft, and the number of teeth of the second gear of the drive shaft is less than the number of teeth of the second gear of the driven shaft.

[0009] Preferably, a first indicator light is provided near the sliding plate of the movable electrode, and a second indicator light is provided near the end of the radio frequency electrode; the radio frequency ablation assembly also includes a control unit, which communicates with the first indicator light and the second indicator light.

[0010] Preferably, a plurality of thermocouples are provided near the radio frequency electrode; the plurality of thermocouples communicate with the control unit; in use, the plurality of thermocouples transmit the detected temperature to the control unit, the control unit compares the collected temperature with a preset temperature range value, if the difference between the collected temperature and the preset temperature exceeds a preset threshold range, the output power of the thermocouples is adjusted to adjust the ablation temperature, and after ablation is completed, the flashing frequency of the first indicator light and the second indicator light is controlled by the temperature feedback of the thermocouples.

[0011] Preferably, the handle has a drug injection channel inside, one free end of which extends to the tail of the handle and the other free end extends to the end of the radiofrequency catheter; the free end of the drug injection channel has an injection groove with a plurality of drug injection holes.

[0012] Preferably, the radio frequency electrode is provided with an insulating layer on the outside, and the insulating layer is provided with a friction-reducing, lubricating, and anti-coagulation coating material on the outside.

[0013] A radiofrequency ablation system includes the above-described radiofrequency catheter ablation assembly and an energy generating device electrically connected to the radiofrequency electrode; Preferably, the radiofrequency ablation system further includes a gas metering curing agent mixer; the gas metering curing agent mixer includes a mixing chamber, a mixing gas tank and several mixing solution injectors are connected to the mixing chamber; a motor and several mixing motion pistons are connected to the mixing chamber.

[0014] Preferably, the radiofrequency ablation system further includes a multi-point injection device for the isolating fluid; the multi-point injection device for the isolating fluid includes an injection needle, the free end of which is provided with several through holes. Compared with the prior art, the present invention has the following beneficial technical effects: This invention discloses a radiofrequency catheter ablation assembly, which includes a handle and a radiofrequency catheter. The radiofrequency catheter has radiofrequency electrodes arranged along its length, and these electrodes are electrically connected to movable electrode sliders. The handle is equipped with an electrode length adjustment component, which allows the movable electrode sliders to move along the length of the radiofrequency electrodes. This design allows doctors to precisely control the position of the movable electrode sliders by manipulating the electrode length adjustment component, based on the specific condition of the patient's varicose veins in the lower extremities, such as the length and direction of the affected veins. This allows for flexible adjustment of the length of the working end of the radiofrequency electrode. When the affected vein is long, the length of the working end of the electrode can be extended to ensure complete ablation; when the affected vein is short, the length of the working end of the electrode can be shortened to avoid unnecessary damage to surrounding normal tissues. Simultaneously, the movable electrode sliders are electrically connected to an external power source, ensuring the normal operation of the radiofrequency ablation procedure. Therefore, this invention achieves precise adjustment of the length of the working end of the radiofrequency electrode, effectively solving the problem of mismatched ablation catheter lengths.

[0015] Furthermore, the number of teeth on the first gear of the drive shaft is greater than the number of teeth on the first gear of the transmission shaft, effectively enabling rapid adjustment of the length of the working end of the radio frequency electrode; the number of teeth on the second gear of the drive shaft is less than the number of teeth on the second gear of the driven shaft, effectively enabling precise adjustment of the length of the working end of the radio frequency electrode.

[0016] Furthermore, a first indicator light is provided near the sliding plate of the movable electrode, and a second indicator light is provided near the end of the radio frequency electrode; the radio frequency ablation assembly also includes a control unit, which communicates with the first and second indicator lights to effectively realize intuitive confirmation of the radio frequency ablation position.

[0017] Furthermore, several thermocouples are positioned near the radio frequency electrode; these thermocouples communicate with the control unit; in use, the thermocouples transmit the detected temperature to the control unit, which compares the collected temperature with a preset temperature range. If the difference between the collected temperature and the preset temperature exceeds a preset threshold range, the output power of the thermocouples is adjusted to regulate the ablation temperature. After ablation is completed, the temperature feedback from the thermocouples controls the flashing frequency of the first and second indicator lights, effectively achieving precise temperature control during the radio frequency ablation process and precise control of the ablation end time.

[0018] Furthermore, the handle is equipped with a drug injection channel inside, with one free end of the drug injection channel extending to the tail of the handle and the other free end extending to the end of the radiofrequency catheter, effectively enabling rapid and convenient injection of the corresponding drugs before and after radiofrequency ablation.

[0019] Furthermore, the free end of the drug injection conduit is provided with a drug injection groove, and the drug injection groove is provided with a plurality of drug injection holes, so that the drug is more evenly dispersed.

[0020] Furthermore, the radiofrequency electrode is provided with an insulating layer on the outside, and the insulating layer is provided with a friction-reducing, lubricating, and anticoagulant coating material on the outside, which facilitates the passage of the radiofrequency catheter through the tortuous vein wall. At the same time, the anticoagulant coating technology on the outer surface of the radiofrequency catheter can reduce platelet adhesion rate and reduce the risk of thrombosis.

[0021] Furthermore, the present invention also discloses a radiofrequency ablation system, which further includes a gas metering sclerosing agent mixer, wherein the gas metering sclerosing agent mixer includes a mixing chamber, a mixing gas tank and several mixing solution injectors are connected to the mixing chamber; a motor and several mixing motion pistons are connected to the mixing chamber, thereby achieving efficient and thorough mixing of the sclerosing agent before the procedure.

[0022] Furthermore, the radiofrequency ablation system also includes a multi-point injection device for isolating fluid, which includes an injection needle with several through holes at the free end of the needle to achieve uniform distribution of the drug at the target site. Attached Figure Description

[0023] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1This is a schematic diagram of the structure of a radiofrequency catheter ablation assembly according to the present invention; Figure 2 This is a schematic diagram of the radiofrequency catheter in this invention; Figure 3 For the present invention Figure 2 A magnified view of a portion of point A in the middle; Figure 4 For the present invention Figure 2 A magnified view of a portion of point B in the middle; Figure 5 This is a schematic diagram illustrating the rapid reduction of the effective working length of the radio frequency electrode in one embodiment of the present invention; Figure 6 This is a schematic diagram illustrating the precise reduction of the effective working length of the radio frequency electrode in one embodiment of the present invention; Figure 7 This is a schematic diagram of the effective working length of the radio frequency electrode after adjustment in one embodiment of the present invention; Figure 8 This is a schematic diagram illustrating the rapid increase in the effective working length of the radio frequency electrode in one embodiment of the present invention; Figure 9 This is a schematic diagram of the temperature control principle in this invention; Figure 10 This is a schematic diagram of the fully automatic gas metering hardener mixer of the present invention; Figure 11 This is a schematic diagram illustrating the working principle of the fully automatic gas metering hardener mixer in this invention. Figure 12 This is a schematic diagram of the multi-point injection device for the isolation fluid in this invention; Figure 13 This is a schematic diagram illustrating the working principle of the multi-point fully automatic injector for isolating fluid in this invention. Figure 14 This is a schematic diagram illustrating the operation of mixing the isolation fluid and injecting it around blood vessels using the fully automated hardener mixing and multi-point injection needle of the present invention in Example 5. Figure 15 This is a schematic diagram of the operation of injecting a sclerosing agent or drug and performing radiofrequency ablation using the radiofrequency ablation component of the present invention in Example 5. Figure 16 This is a schematic diagram of the structure in Example 5 where the radiofrequency ablation component of the present invention is used to adjust the effective working length of the radiofrequency electrode; Figure 17 This is a schematic diagram of the structure used in Example 5 to adjust the working length of the radiofrequency electrode in this invention to complete conformal ablation treatment of blood vessels in all lesion areas.

[0025] The components include: 1. Starter; 2. Indicator light wire; 3. Handle; 4. First gear of the drive shaft; 5. Drive shaft; 6. Adjustment knob; 7. Drive shaft; 8. First gear of the drive shaft; 9. Electrode wire; 10. Radiofrequency conduit; 11. Marking line; 12. Radiofrequency electrode; 13. Traction wire; 14. Second gear of the driven shaft; 15. Locking spring; 16. Second gear of the drive shaft; 17. Thermocouple wire; 18. Drug injection tubing; 19. Injection tube connector; 20. Electrode connector; 21. Electrode cable; 22. Thermocouple; 23. First indicator light; 24. Moving electrode slider; 25. Insulating layer; 26. Drug injection slot; 27. Drug injection hole; 28. Traction assembly; 29. ​​Second indicator light; 30. Sliding component; 31. Radiofrequency ablation host. 101. Mixing gas tank; 102. Mixing gas pipe; 103. Gas tank valve; 104. Mixing gas pressure gauge; 105. Digital gas flow meter; 106. Gas flow adjustment button; 107. Inlet pipe; 108. Spare gas tank; 109. Mixing solution syringe 1; 1010. Mixing solution syringe 2; 1011. Mixing solution syringe 3; 1012. Mixed liquid inflow pipe; 1013. Mixing motion piston 1; 1014. Mixed liquid inflow channel; 1015. Mixing motion piston 2; 1016. Master cylinder piston; 1017. Deflecting crank; 1018. Motor; 1019. First mixed liquid outflow pipe; 1020. Mixed liquid outflow path selection control valve; 1021. Mixed liquid storage tank 1; 1022. Mixed liquid storage tank 2; 1023. Mixing chamber; 201. Isolation fluid injection bottle; 202. Isolation fluid inflow control valve; 203. Peristaltic pump; 204. Rotary pump head; 205. Power switch button; 206. Start button; 207. Speed ​​adjustment key; 208. Second mixture outflow pipe; 209. Injection needle; 2010. Through hole. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0027] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0028] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0029] In the description of the embodiments of the present invention, it should be noted that if terms such as "upper," "lower," "horizontal," or "inner" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of the invention is in use, they are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Furthermore, terms such as "first" and "second" are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0030] Furthermore, the use of the term "horizontal" does not imply that the component must be absolutely horizontal, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0031] In the description of the embodiments of the present invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in the present invention according to the specific circumstances.

[0032] The present invention will now be described in further detail with reference to the accompanying drawings: This invention provides a radiofrequency ablation system to address common clinical problems in current ultrasound-guided lower extremity vein ablation surgery: namely, poor matching between conventional fixed-length radiofrequency ablation catheters and the varying ablation needs of veins of different diameters and regions; the problem of fixed and uniform catheter ablation temperature values; issues with the injection of intravenous therapeutic drugs; the risk of damage to the vessel wall when the catheter passes through tortuous veins during the procedure; the lack of more convenient catheter positioning and ablation effectiveness indication; and the need for further improvement in the convenience and standardization of sclerotherapy preparation and isolation fluid injection.

[0033] Based on the above clinical problems in ultrasound-guided lower extremity vein ablation therapy, this invention discloses a venous radiofrequency ablation catheter with a rapidly and precisely adjustable working end length. It also features adjustable ablation temperature, intravascular sclerotherapy / drug injection, easy passage through tortuous veins with anti-thrombotic properties, LED position marking and ablation effect indication functions, and is equipped with a fully automatic sclerotherapy mixer and a multi-point injection needle structure for isolating fluid. Compared with conventional radiofrequency catheters, this radiofrequency ablation system has the following technical features: 1. The electrode connection at the working end of this venous radiofrequency ablation catheter is connected by a connecting wire with a sliding copper plate to form a circuit. By rotating the button roller, the sliding copper plate of the electrode connection can be moved along the catheter, achieving adjustment of the catheter length and thus enabling rapid adjustment of the working end length of the ablation catheter to adapt to lower extremity vascular lesions of different lengths. 2. The multi-gear switching adjustment mechanism at the handle allows the sliding copper electrode contact plate to slide along the catheter by rotating the scroll button. When the number of gears on the knob is greater than the number of gears on the rotating rod, rotating the knob will cause the rotating rod to rotate rapidly, moving the sliding copper electrode contact plate quickly at the working end of the catheter electrode, thus achieving rapid adjustment of the effective electrode length. When the adjustment knob position is switched, and the number of gears on the knob is less than the number of gears on the rotating rod, rotating the knob will cause the rotating rod to rotate precisely, moving the sliding copper electrode contact plate slowly at the working end of the catheter electrode, thus achieving precise adjustment of the effective electrode length. 3. By integrating multiple temperature sensors at various angles and positions at the working end of the radiofrequency ablation catheter, the temperature of the ablated vein wall and surrounding tissue is collected in real time, improving sensing sensitivity. The collected raw temperature signals are processed and sent to the system's main control module. After setting the target temperature, the main control module optimizes and adjusts the output power through algorithms, thereby achieving effective regulation of the catheter ablation temperature. 4. By adding a sclerosing agent / drug injection tubing within the radiofrequency ablation catheter and designing a porous, uniformly distributed sclerosing agent / drug injection outlet structure at the catheter tip, sclerosing agent can be injected into the ablated vein wall tissue along the venous radiofrequency ablation catheter, improving the effectiveness of radiofrequency ablation treatment. Simultaneously, the acquired raw temperature signal is preprocessed, such as filtered and amplified, before being sent to the system's main control module. 5. By improving the main material of the venous ablation catheter wall, a coating material with hydrophilic lubrication and anticoagulant properties is added to its outer wall. For example, the outer surface of the catheter with a super-lubricated surface treatment employs a multi-layer coating technology: a bottom layer of silane coupling agent to enhance adhesion, a middle layer of hydrophilic polyvinylpyrrolidone hydration layer, and an outer layer of PEG-modified layer to resist protein adsorption. Other materials include polytetrafluoroethylene, silicone resin, Preside hydrophilic coating, SurfLubri® hydrophilic coating, and MPC hydrophilic anticoagulant coating. It reduces frictional damage to the blood vessel wall, making it easier for the radiofrequency catheter to pass through the tortuous vein wall; at the same time, the anticoagulant coating technology on the outer surface of the catheter can reduce platelet adhesion rate and reduce the risk of thrombosis.6. High-penetration LED flashing lights are added to the tip of the ablation catheter and the tail of the electrode catheter. This improves the accuracy of the radiofrequency ablation catheter's positioning during the next ablation process after an effective ablation is achieved, avoiding excessive overlap in catheter positioning that could lead to repeated ablation or missed ablation of non-overlapping blood vessel sections. Furthermore, intelligent real-time thermocouples measure the blood vessel wall temperature. When the blood vessel wall temperature reaches the ablation value and remains there for a period of time, it indicates that the ablation of the blood vessel has been effective. The flashing frequency of the configured LED lights changes, indicating that the ablation of the venous segment is complete and the catheter can be moved to the next segment for ablation, effectively improving ablation efficiency and effectiveness. 7. By designing a fully automated sclerotherapy mixer and isolating fluid injection device for venous ablation, the sclerosing agent polidocanol and carbon dioxide gas can be thoroughly mixed, reducing the operator's pre-operative mixing steps for the sclerosing agent. Simultaneously, the "multi-point, quantitative, slow" injection needle structure allows the isolating fluid to more evenly cover the target vein, reducing thermal damage to tissues and skin, and improving the safety and efficiency of ablation.

[0034] Based on the clinical problems in ultrasound-guided lower extremity venous ablation treatment mentioned above, a venous radiofrequency ablation catheter with a rapidly and precisely adjustable working end length was developed. It also features adjustable working end electrode temperature, intravenous sclerotherapy / drug injection, easy passage through tortuous veins with anti-thrombotic properties, LED light marking of position and indication of ablation effect, and is equipped with a fully automated sclerotherapy mixer and a multi-point injection needle. This provides a complete, safer, and more effective one-stop solution for ultrasound-guided lower extremity venous radiofrequency ablation treatment. The technical solution of this invention is illustrated in the following embodiments: Example 1 This invention discloses a radiofrequency ablation system, which includes the radiofrequency ablation component of this invention and other supporting components; This radiofrequency ablation component enables rapid and precise adjustment of its working end length. In addition, multiple temperature sensors are integrated at various angles and positions at the working end of the radiofrequency catheter. Simultaneously, the output power is optimized and controlled through module algorithms, thereby achieving effective regulation of the catheter ablation temperature. High-penetration LED flashing lights are added to the top of the radiofrequency catheter and the tail of the radiofrequency electrode to improve ablation efficiency and effectiveness.

[0035] The aforementioned supporting components include a fully automated sclerotherapy mixer and a porous injection needle. This fully automated sclerotherapy mixer and porous injection needle are used to inject sclerosing agents and medications into the venous wall within the radiofrequency catheter, improving the efficacy of radiofrequency catheter ablation treatment and reducing complications. Furthermore, the main material design of the venous ablation catheter wall provides both friction-reducing and lubricating properties as well as anticoagulation, effectively reducing friction, preventing thrombosis, and improving the catheter's ability to navigate bends in tortuous blood vessels.

[0036] The radiofrequency ablation system of the present invention is applicable to radiofrequency ablation treatment of various types of varicose vein lesions of the lower extremities, and improves the safety, effectiveness and convenience of ultrasound-guided ablation treatment of varicose veins of the lower extremities.

[0037] Specifically, Figures 1-2 This is a schematic diagram of the structure of a radiofrequency catheter ablation assembly according to the present invention. The assembly includes a handle 3 and a radiofrequency catheter 10 connected to the handle 3. The radio frequency conduit 10 is provided with a radio frequency electrode 12; the radio frequency electrode 12 is arranged along the length direction of the radio frequency conduit 10; a movable electrode slider 24 is electrically connected to the radio frequency electrode 12; The handle 3 is equipped with an electrode length adjustment component inside; the movable electrode slider 24 is connected to the electrode length adjustment component, and the movable electrode slider 24 can move along the length direction of the radiofrequency electrode 12 under the action of the electrode length adjustment component to adjust the length of the working end of the radiofrequency electrode 12; and the radiofrequency electrode 12 is wrapped around the radiofrequency catheter 10, which is flexible and makes it easier to pass through tortuous blood vessels by holding the handle, avoiding the need for multiple insertions. In use, the movable electrode slider 24 is electrically connected to an external power source.

[0038] More specifically, such as Figure 1 As shown, the electrode length adjustment assembly includes a rotating unit and a pulling unit; the rotating unit includes a drive shaft 5 and a transmission shaft 7, the drive shaft 5 is provided with a first drive shaft gear 4 and a second drive shaft gear 16; the transmission shaft 7 is provided with a first transmission shaft gear 8 and a second driven shaft gear 14; the first drive shaft gear 4 meshes with the first transmission shaft gear 8, and the second drive shaft gear 16 meshes with the second driven shaft gear 14; one end of the drive shaft 5 is provided with an adjustment knob 6, which is located outside the handle 3; At the same time, such as Figures 1-3 As shown, the traction unit includes an electrode wire 9 disposed on the movable electrode slider 24 and a traction assembly 28 disposed at the free end of the radio frequency conduit 10; the other end of the electrode wire 9 is wound around the drive shaft 7 and then extends to the outside of the handle 3; a traction wire 13 is wound on the traction assembly 28, one free end of the traction wire 13 is fixedly connected to the movable electrode slider 24, and the other free end is wound around the drive shaft 7, with the traction wire 13 and the electrode wire 9 wound in opposite directions on the drive shaft 7. Preferably, the traction wire 13 is made of insulating material. The other end of the electrode wire 9 is connected to an external power source to realize the energizing and de-energizing process of the movable electrode slider 24 and the radio frequency electrode 12 connected to the circuit. More preferably, the traction assembly 28 can be a pulley.

[0039] Specifically, the traction wire 13 and the electrode wire 9 are wound in opposite directions on the drive shaft 7. When the traction wire 13 is wound on the drive shaft 7, the electrode wire 9 is unwound. At this time, the movable electrode slider 24 moves towards the top of the radio frequency electrode 12, shortening the length of the radio frequency electrode 12 connected to the electrical circuit, thus reducing the working length of the radio frequency electrode 12. Conversely, when the traction wire 13 is unwound on the drive shaft 7, the electrode wire 9 is wound on the drive shaft 7. At this time, the movable electrode slider 24 moves towards the tail end of the radio frequency electrode 12, lengthening the length of the radio frequency electrode 12 connected to the electrical circuit, thus increasing the working length of the radio frequency electrode 12. This achieves effective adjustment of the working length of the radio frequency electrode 12. Here, the tail end of the radio frequency electrode 12 refers to the end closer to the handle 3, while the top end of the radio frequency electrode 12 refers to the end farther from the handle 3. Therefore, the electrode wire 9 and the traction wire 13 can be wound around or unwound from the drive shaft 7 by rotating the adjustment knob 6, so that the position of the movable electrode slider 24 on the radio frequency electrode 12 can be moved along the length direction of the radio frequency conduit 10.

[0040] More preferably, the number of teeth of the first gear 4 on the drive shaft is greater than the number of teeth of the first gear 8 on the transmission shaft, and the number of teeth of the second gear 16 on the drive shaft is less than the number of teeth of the second gear 14 on the driven shaft. When the first gear 4 on the drive shaft meshes with the first gear 8 on the transmission shaft, the position of the movable electrode slider 24 is quickly adjusted. When the position is almost adjusted to the set position, the second gear 16 on the drive shaft meshes with the second gear 14 on the driven shaft, thereby achieving a slow and precise adjustment of the position of the movable electrode slider 24.

[0041] In addition, a locking spring 15 is provided at the other end of the drive shaft 5 to facilitate the switching of the position of the drive shaft 5.

[0042] In a preferred embodiment, the radio frequency electrode 12 is wound around the radio frequency conduit 10, and further, as shown in the following example... Figure 4 As shown, the movable electrode slider 24 is provided with a positive electrode and a negative electrode, both of which are electrically connected to the radio frequency electrode 12.

[0043] In addition, such as Figure 2 as well as Figure 4As shown, a first indicator light 23 is provided near the movable electrode slider 24. Preferably, the first indicator light 23 and the movable electrode slider 24 are simultaneously provided on the sliding member 30. The movable electrode slider 24 is electrically connected to the sliding member 30, and the sliding member 30 is also electrically connected to the radio frequency electrode 12, effectively keeping the positions of the first indicator light 23 and the movable electrode slider 24 synchronized, thus achieving effective indication of the position of the movable electrode slider 24. Simultaneously, a second indicator light 29, i.e., a top indicator light, is provided near the other end of the radio frequency electrode 12. Through the coordinated operation of the first indicator light 23 and the second indicator light 29, the length of the working segment of the radio frequency electrode 12 can be effectively displayed. Both the first indicator light 23 and the second indicator light 29 can be LED indicator lights, whose light can effectively penetrate the skin, allowing medical personnel to determine the location of radiofrequency ablation and the length of the working segment of the radio frequency electrode 12 with the naked eye. Indicator light wires 2 are electrically connected to the first indicator light 23 and the second indicator light 29, and the first indicator light 23 and the second indicator light 29 are connected to an external power supply device through the indicator light wires 2. In a specific embodiment, the movable electrode slider 24 is a copper sheet. In addition, the first indicator light 23 and the second indicator light 29 can also be adjusted according to the number of cycles required for ablation at different locations, such as some areas requiring 2 cycles and some areas requiring 3 cycles.

[0044] Furthermore, such as Figures 2-4 As shown, several thermocouples 22 are provided near the radio frequency electrode 12, and the thermocouples 22 are arranged along the length of the radio frequency conduit 10. The thermocouples 22 are electrically connected to thermocouple wires 17. The thermocouples 22 can transmit the detected temperature to the host computer control unit to accurately control the temperature of the ablation area. In addition, when the ablation is completed, the thermocouples 22 can feed back the results to the host computer control unit. The host computer control unit controls the flashing frequency of the first indicator light 23 and the second indicator light 29 to change, prompting medical staff to perform corresponding medical operations.

[0045] Meanwhile, for indicating the position of the radio frequency electrode 12, the radio frequency conduit 10 is provided with a plurality of marking lines 11, which are evenly spaced along the length of the radio frequency conduit 10.

[0046] Further preferred, such as Figures 1-4 As shown, the handle 3 has a drug injection channel 18 inside, one free end of which extends to the tail of the handle 1, and the other free end extends to the end of the radiofrequency catheter 10; additionally, as Figure 3 As shown, the free end of the drug injection conduit 18 is provided with a drug injection groove 26, which has a lotus-shaped structure and a plurality of drug injection holes 27, which are distributed in an umbrella shape. In addition, such as Figure 1 As shown, the handle 3 is provided with an injection tube connector 19 and an electrode cable 21 on its outside. The injection tube connector 19 is connected to the drug injection pipeline 18. The electrode cable 21 is electrically connected to the indicator light wire 2, the electrode wire 9 and the thermocouple wire 17 to realize the power supply and power de-energization of the first indicator light 23, the second indicator light 29, the radio frequency electrode 12 and the thermocouple 22. At the same time, the free end of the electrode cable 21 is provided with an electrode connector 20, making the use process more convenient.

[0047] Meanwhile, the handle 3 is provided with an activation element 1 on its exterior, which is used to control the power on and power off of the radio frequency electrode.

[0048] More specifically, the radiofrequency electrode 12 is externally provided with an insulating layer 25, and the insulating layer 25 is externally coated with a friction-reducing, lubricating, and anticoagulant coating material. This friction-reducing, lubricating, and anticoagulant coating comprises multiple layers: a bottom layer of silane coupling agent to enhance adhesion; a middle layer of hydrophilic polyvinylpyrrolidone hydration layer; and an outer layer of polyethylene glycol modification to resist protein adsorption. It also includes polytetrafluoroethylene, silicone resin, a Preside hydrophilic coating, a SurfLubri® hydrophilic coating, and a 2-methacryloyloxyethyl phosphocholine hydrophilic anticoagulant coating, reducing frictional damage to the blood vessel wall and facilitating the passage of the radiofrequency catheter 10 through tortuous vein walls. Simultaneously, the anticoagulant coating technology on the outer surface of the radiofrequency catheter 10 reduces platelet adhesion and the risk of thrombosis. The Preside hydrophilic coating is a hydrophilic medical device coating developed by Surmodics, characterized by low friction and low particle generation, designed to enhance distal access in neurovascular applications and improve the passage of challenging coronary arteries through lesions or chronic total occlusion. SurfLubri® hydrophilic coating is a patented product series of hydrophilic super-lubricating coating liquids independently developed by Jiangsu Baisaifei Biotechnology Co., Ltd., with hydrophilic polymers as the main component. This coating can form a firm and uniform micron-level coating on the surface of various medical catheters / guidewires through a photocuring process, and has excellent lubricity and durability. 2-Methacryloxyethylphosphocholine hydrophilic anticoagulant coating, also known as MPC hydrophilic anticoagulant coating, is a functional monomer with biomimetic properties. Its copolymer film exhibits optimized blood compatibility and hydrophilicity.

[0049] Figures 5-8This is a schematic diagram of the adjustment process of the working end length of the radiofrequency ablation component in this invention. In this invention, the radiofrequency ablation electrode for the venous catheter consists of a movable electrode slider 24, a radiofrequency electrode 12, and an external power supply forming an electrical circuit. By rotating the adjustment knob 6, the first gear 4 of the drive shaft meshes and rotates with the first gear 8 of the transmission shaft. The traction wire 13 and the electrode wire 9 pull the movable electrode slider 24 to move along the length direction of the radiofrequency electrode 12. By changing the position of the movable electrode slider 24, the winding energized length of the radiofrequency electrode 12 is changed, thereby realizing the adjustment of the effective working electrode length of the radiofrequency electrode 12, adapting to the different requirements of the effective ablation electrode length for different lesion areas during lower limb venous ablation.

[0050] Specifically, such as Figure 5 As shown, when the adjustment knob 6 is turned clockwise, the first gear 4 of the drive shaft meshes with the first gear 8 of the transmission shaft. The transmission shaft 7 rotates rapidly to wind the traction wire 13, and the electrode wire 9 is quickly unwound from the transmission shaft 7. The traction wire 13 drives the moving electrode slider 24 to move along the conduit electrode 12 to the far end through the traction component 28 at the top, that is, the effective working length of the radio frequency electrode 12 is reduced. like Figure 6 As shown, when the movable electrode slider 24 moves quickly to the appropriate position, pressing the adjustment knob 6 disengages the first gear 4 of the drive shaft from the first gear 8 of the transmission shaft, replacing it with the second gear 16 of the drive shaft meshing with the second gear 14 of the driven shaft. Continuing to rotate the adjustment knob 6 allows the transmission shaft 7 to slowly pull the traction wire 13, achieving precise and detailed adjustment of the length of the working end of the RF electrode 12. That is, by rotating the adjustment knob 6 clockwise, the length of the working end of the RF electrode 12 can be quickly and precisely reduced; after adjustment, the length of the working end of the RF electrode 12 is as follows... Figure 7 As shown in L.

[0051] like Figure 8 As shown, rotating the adjustment knob 6 counterclockwise engages the first gear 4 of the drive shaft with the first gear 8 of the transmission shaft. The transmission shaft 7 rotates rapidly to wind the electrode wire 9. The electrode wire 9, through the traction assembly 28, drives the moving electrode slider 24 to move along the radio frequency electrode 12 towards the proximal end, thus increasing the effective working length of the radio frequency electrode 12. When it reaches the appropriate position, pressing the adjustment knob 6 disengages the first gear 4 of the drive shaft from the first gear 8 of the transmission shaft, and the second gear 16 of the drive shaft engages with the second gear 14 of the driven shaft. Continuing to rotate the adjustment knob 6 counterclockwise allows the transmission shaft 7 to slowly rotate and wind the electrode wire 9, achieving precise and detailed adjustment of the working length of the radio frequency electrode 12. In other words, by rotating the adjustment knob 6 counterclockwise, the working length of the radio frequency electrode 12 can be rapidly and precisely increased.

[0052] This invention enables precise adjustment of the working length of the radiofrequency electrode 12 within a range of 10-80 mm in minimum 2.0 mm intervals via a movable electrode slider 24, allowing for faster, more accurate, and convenient adjustment of the venous catheter electrode length. Specifically, rotating the adjustment knob 6 clockwise or counterclockwise moves the traction wire 13 and electrode lead wire 9, causing the movable electrode slider 24 to move and effectively adjust the length of the working end of the radiofrequency electrode 12.

[0053] Example 2 like Figure 9 As shown, multiple temperature sensors, namely thermocouples 22, are integrated at various angles and positions at the working end of the radiofrequency catheter 10 to collect the temperature of the ablation vein wall and surrounding tissue in real time, thereby improving sensing sensitivity. The collected raw temperature signals are processed and sent to the main control module of the system. After setting the target temperature, the main control module optimizes and adjusts the output power through algorithms, thereby achieving effective regulation of the catheter ablation temperature.

[0054] The temperature regulation process is as follows: The host system, which can be the main control module, sets the target temperature to 85~120°C. After locating the venous lesion site through the radiofrequency catheter 10, it collects temperature data. The temperature sensor, i.e., thermocouple 22, monitors the temperature of the ablated vascular tissue in real time and converts the signal into a temperature value. Then, the main control module compares the current temperature with the target temperature, calculates the difference, and optimizes the algorithm to adjust the power regulation value based on the temperature deviation. This results in power control, adjusting the output power of the radiofrequency generator. Simultaneously, it safely checks whether the temperature exceeds 120°C; if so, it immediately reduces the power. In other words, the intelligent control method involves the main control module comparing the calibrated actual temperature with the doctor's target temperature, typically 85~120°C. Based on this difference, the system employs an improved proportional-integral-derivative (PID) algorithm control strategy to automatically adjust the output power of the radiofrequency generator, ensuring that the temperature is quickly and stably maintained within the target range and avoiding fluctuations. In clinical practice, standardized configuration procedures, strict quality control, and optimized operating techniques are needed to avoid the risks of uneven mixing in order to improve the cure rate and safety of venous ablation.

[0055] Example 3 Figure 10This is a schematic diagram of the structure of the fully automatic gas metering hardener mixer of the present invention. The fully automatic gas metering hardener mixer includes a mixing tank 101, a mixing pipe 102, a tank valve 103, a mixing pressure gauge 104, a gas flow digital meter 105, a gas flow adjustment button 106, an inlet pipe 107, a spare tank 108, a first mixing solution syringe 109, a second mixing solution syringe 1010, a third mixing solution syringe 1011, a mixing liquid inflow pipe 1012, a first mixing movement piston 1013, a mixing liquid inflow channel 1014, a second mixing movement piston 1015, a main cylinder movement piston 1016, a deflection crank 1017, a motor 1018, a first mixing liquid outflow pipe 1019, a mixing liquid outflow path selection control valve 1020, a first mixing liquid storage tank 1021, a second mixing liquid storage tank 1022, and a mixing chamber 1023.

[0056] The mixing tank 101 is connected to the subsequent system via the mixing pipe 102, and the tank valve 103 controls the gas output. The mixing pressure gauge 104 displays the gas pressure, the digital gas flow meter 105 accurately measures the gas flow, and the gas flow adjustment button 106 adjusts the gas flow. The inlet pipe 107 introduces gas into the mixing area, and the backup gas tank 108 provides backup gas when the main tank is low. The mixing solution injector 109, mixing solution injector 1010, and mixing solution injector 1011 inject different types of reagents; the reagents enter the mixing cylinder via the mixing liquid inflow pipe 1012 and the mixing liquid inflow channel 1014. The first and second mixing pistons, 1013 and 1015, play a crucial role in the mixing process. The main cylinder piston, 1016, is driven by a motor, 1018, through a deflector crank, 1017, reciprocating within the mixing cylinder. This simultaneously drives the two mixing pistons, namely the first mixing piston 1013 and the second mixing piston 1015, to reciprocate. The first mixed liquid outlet pipe, 1019, is used to output the mixed solution. The mixed liquid outlet path selection control valve, 1020, controls the flow direction of the mixed liquid, directing it into either the first mixed liquid storage tank, 1021, or the second mixed liquid storage tank, 1022, thus enabling the classified storage of hardeners of different concentrations.

[0057] Figure 11This is a schematic diagram illustrating the working principle of the fully automatic gas metering hardener mixer of the present invention. During operation, firstly, the mixing gas tank valve 103 is opened, and the appropriate gas volume is set by adjusting the metering gauge using the gas flow adjustment button 106 according to the required amount of hardener. Then, based on the required amount, several types of agents are injected into the mixing channel using mixing solution syringe 109, mixing solution syringe 1010, and mixing solution syringe 1011. Next, the fully automatic hardener mixer is started. The motor 1018 rotates, driving the deflector crank 1017 to rotate, which in turn causes the connected main cylinder piston 1016 to reciprocate within the mixing cylinder. Simultaneously, it drives mixing pistons 1013 and 1015 to reciprocate. By controlling the motor speed, the uniform mixing of hardeners at different drug concentrations is ensured. After mixing, according to clinical needs, the flow path of the mixed solution is adjusted by the control valve 1020 to control the flow of different concentrations of sclerosing agent into the mixed solution storage tank 1021 or the mixed solution storage tank 2022, so as to achieve classified storage of sclerosing agents for different patients.

[0058] This mixer utilizes a mixing tank 101 to provide gas power, creating suitable conditions for sclerosing agent mixing by precisely controlling the gas flow rate and the injection volume of various agents. A motor 1018 drives a deflector crank 1017 to move a piston. The reciprocating motion of the piston generates pressure changes and fluid flow, ensuring thorough mixing of the injected agents and gas within the mixing cylinder. By controlling the motor speed, the mixing intensity and time can be adjusted to ensure uniform mixing of sclerosing agents at different drug concentrations. A mixed liquid outflow path selection control valve 1020 distributes different concentrations of mixed sclerosing agents into corresponding storage tanks according to clinical needs, achieving categorized storage to meet the usage needs of different patients. This fully automatic sclerosing agent mixer can uniformly mix polidocanol with a measured amount of carbon dioxide, achieving more convenient and uniform sclerosing agent preparation and reducing the surgeon's preoperative preparation and physical exertion.

[0059] Example 4 Figure 10 This is a schematic diagram of the structure of the isolation fluid multi-point injection device of the present invention. The isolation fluid multi-point injection device includes an isolation fluid injection bottle 201, an isolation fluid inflow control valve 202, a peristaltic pump 203, a rotary pump head 204, a power switch button 205, a start button 206, a speed adjustment key 207, a second mixed liquid outflow pipe 208, and an injection needle 209. The free end of the injection needle 209 is provided with several through holes 2010.

[0060] The device includes a separation fluid injection bottle 201 for holding the separation fluid; a separation fluid inflow control valve 202 for controlling the inflow of the separation fluid; a peristaltic pump 203, the core power component of the device, equipped with a rotary pump head 204, which uses rotational motion to deliver the liquid; a power switch button 205 for turning the device power on or off; a start button 206 for starting the peristaltic pump; a speed adjustment key 207 for adjusting the speed of the peristaltic pump, thereby controlling the delivery speed of the separation fluid; a second mixed liquid outflow pipe 208 for delivering the mixed separation fluid; and an injection needle 209 for injecting the separation fluid into the human body, which has a through hole 2010 to allow the separation fluid to flow out and distribute more evenly.

[0061] like Figure 13 As shown, the multi-point injection device for isolating fluid is used as follows: The pre-mixed isolating fluid is injected into the tissue surrounding the outer wall of the blood vessel. The flow path selection control valve is adjusted to open the pipeline for the appropriate concentration of isolating fluid. Next, the peristaltic pump power switch 205 is turned on, and the start button 206 is pressed to start the peristaltic pump. The pump speed is adjusted using the speed adjustment key 207 according to the injection volume of the isolating fluid. The peristaltic pump rotates, causing the isolating fluid to flow from the isolating fluid injection bottle 201 through the isolating fluid inflow control valve 202, and then through the second mixed fluid outflow pipeline 208 to the injection needle 209. Under ultrasound guidance, the multi-point injection needle is inserted into the area surrounding the diseased vein. Driven by the peristaltic pump, the mixed isolating fluid flows out at a uniform flow rate through the through-hole 2010, achieving the injection of the isolating fluid into the tissue surrounding the outer wall of the blood vessel.

[0062] This multi-point injection device for the isolation fluid primarily relies on the working principle of the peristaltic pump 203 to deliver the isolation fluid. When the peristaltic pump is activated, the rotational motion of the pump head 204 alternately squeezes and releases the tubing, i.e., the pipe section delivering the isolation fluid, thereby generating a pumping effect and propelling the isolation fluid through the second mixed liquid outlet pipe 208. The speed of the peristaltic pump can be precisely controlled by adjusting the speed adjustment key 207, allowing for precise control of the flow rate and delivery volume of the isolation fluid. The through-hole 2010 design of the injection needle 209 allows the isolation fluid to flow evenly from multiple channels, distributing it around the outer wall of the blood vessel, surrounding tissues, and nerves, forming effective isolation protection. This prevents damage to surrounding tissues and nerves from the heat transferred by radiofrequency ablation, achieving more precise injection of the isolation fluid and better protective effects.

[0063] The porous needle structure of this invention ensures a more uniform distribution of the isolation fluid across the outer wall of the blood vessel and surrounding tissues and nerves, preventing heat damage from radiofrequency ablation. In other words, the multi-point fully automated isolation fluid injector for venous classification and quantification of this invention achieves a more thorough and uniform distribution of the injected isolation fluid around the blood vessel wall, more precise dosage, and better protection of nerves and normal tissues surrounding the blood vessel wall.

[0064] Example 5 Furthermore, the technical solution of the present invention will be described through this embodiment: The adjustable-length venous radiofrequency ablation catheter and its accessories of this invention are used to perform conformal ablation treatment on different areas of varicose veins in the lower extremities under ultrasound guidance.

[0065] Change requirement: The length of the intravenous radiofrequency catheter electrode is adjusted from 80mm to 16mm; Requirements for hardener preparation: To achieve a more uniform mixture of polydextrose and carbon dioxide, etc., and to prepare a more mixed and uniform hardener.

[0066] The process of using the hardener mixing injection and radiofrequency ablation component in this invention is as follows: 1. Hardener mixing, isolation fluid injection, and preparations before ablation. like Figure 14 As shown, under ultrasound guidance, the radiofrequency catheter 10 of the radiofrequency ablation component of this invention is inserted into the target area of ​​the blood vessel to be ablated. The gas cylinder valve 103 is opened, and the metering of the amount of carbon dioxide gas is adjusted according to the amount of sclerosing agent to be mixed. As needed, polidocanol or similar substances are injected into the mixing inflow channel 1014. The fully automatic sclerosing agent mixer is started; the motor 1018 drives the main cylinder piston 1016, the first mixing piston 1013, and the second mixing piston 1015 to reciprocate, achieving uniform mixing of the sclerosing agent. The uniformly mixed sclerosing agents of different concentrations are stored in the mixing reservoirs 1021 and 1022, respectively. Then, according to clinical needs, sclerosing agents of different concentrations can be injected into the blood vessel through the channel of the radiofrequency catheter 10.

[0067] When injecting the isolation fluid into the outer wall of the blood vessel to be ablated, open the isolation fluid inflow control valve 202, set the speed of the peristaltic pump 203 using the speed adjustment key 207, and start the peristaltic pump. Insert the injection needle 209 into the outer wall of the vein to inject the isolation fluid. Driven by the peristaltic pump, the isolation fluid flows out from the through-hole 2010 at the needle tip at a uniform flow rate, and is evenly and appropriately distributed on the outer wall of the blood vessel, around the tissue and nerves, preparing for radiofrequency catheter ablation.

[0068] 2. Perform ultrasound-guided radiofrequency catheter ablation for varicose veins. like Figure 15As shown, the radiofrequency electrode 12 is connected to the radiofrequency ablation host 31, the host is turned on, and parameters such as the target temperature, ablation power, and ablation time of the radiofrequency ablation catheter are set. Since the electrode length is not adjusted, the effective ablation length of the radiofrequency electrode 12 is at its maximum value of 80mm. The distribution of the isolation fluid injected around the radiofrequency electrode 12 is checked to be uniform and appropriate. The starter 1 on the handle 3 is activated to perform ablation treatment on the lower limb vein in the lesion area. The ablation process is observed in real-time using ultrasound. Simultaneously, the ablation area is determined by the first indicator light 23 and the second indicator light 29 on the radiofrequency electrode 12. When the first indicator light 23 and the second indicator light 29 begin to flash frequently, and the ultrasound echo increases, it is determined that the blood vessel in that area has been closed and ablated. Sclerosing agent or medication is injected through the drug injection port 27 at the tip of the radiofrequency catheter 10. Because the drug injection ports 27 are distributed in an umbrella shape, the drug distribution is more uniform, effectively improving the effectiveness of radiofrequency ablation and reducing complications.

[0069] 3. Adjustment of the working end length of radiofrequency conduit 10 like Figure 16 As shown, rotating the adjustment knob 6 on the top of the handle 3 clockwise during the rapid adjustment phase rotates the first gear 4 of the drive shaft, which meshes with the first gear 8 of the transmission shaft. The transmission shaft 7 rotates rapidly, causing the electrode wire 9 to quickly unwind from the transmission shaft 7 and the traction wire 13 to quickly wind around the transmission shaft 7. The traction wire 13 drives the moving electrode slider 24 to move along the radio frequency electrode 12 to the distal end through the traction assembly 28, thus reducing the effective working length of the radio frequency electrode 12. When the moving electrode slider 24 has moved to the appropriate position, press the adjustment knob. When knob 6 is turned, the first gear 4 of the drive shaft disengages from the first gear 8 of the transmission shaft, and the second gear 16 of the drive shaft meshes with the second gear 14 of the driven shaft. When the adjustment knob 6 is turned, the transmission shaft 7 rotates slowly, and the electrode wire 9 is slowly unwound from the transmission shaft 7, so that the traction wire 13 is slowly wound around the transmission shaft 7. The moving electrode slider 24 slides slowly, so as to achieve precise and detailed adjustment of the effective length of the working end of the radio frequency electrode 12. By rotating the adjustment knob 6 clockwise, the working length of the radio frequency electrode 12 can be quickly and accurately adjusted from 80mm to 16mm.

[0070] 4. After adjusting the length of the working end of the radiofrequency electrode, adjust the length of the working end of the radiofrequency electrode according to the actual ablation needs, and repeat the process to complete the ablation treatment of all diseased lower limb venous vascular areas.

[0071] After adjusting the working end length of radiofrequency electrode 12 to 16mm in the previous step, continue the ablation treatment of this segment of the diseased blood vessel. Simultaneously, refer to the above operating procedure, such as... Figure 17As shown, when the adjustment knob 6 is rotated counterclockwise, the moving electrode slider 24 moves proximally along the radiofrequency electrode 12, thus increasing the effective working length of the radiofrequency electrode 12. Continuing to move the radiofrequency electrode 12 to the working end to different vascular lesion areas, the effective working length of the radiofrequency electrode 12 is adjusted according to actual needs. Electrode stacking completes the closure and ablation treatment of all lesion areas.

[0072] This invention employs a rotary traction mechanism to move the sliding electrode 24 along the length of the working end of the radiofrequency catheter 10, enabling rapid and precise adjustment of the effective working length of the radiofrequency electrode 12. By integrating multiple thermocouples 22 at various angles and positions at the working end of the radiofrequency catheter 10 and feeding feedback to the host control module, effective adjustment of the catheter ablation temperature is achieved. Simultaneously, a multi-hole, uniformly distributed drug injection port 27 is designed at the tip of the radiofrequency catheter 10, enabling effective injection and distribution of sclerosing agents and drugs, improving the effectiveness of vascular closure while reducing complications such as inflammation. Furthermore, by adding hydrophilic lubricating and anticoagulant properties to the outer wall of the radiofrequency catheter 10... The coating material reduces frictional damage to the blood vessel wall and improves the performance of tortuous veins and anti-thrombotic properties. High-penetration LED flashing lights are added to the tip of the radiofrequency catheter 10 and the tail of the radiofrequency electrode 12 to improve the precise positioning of the ablation catheter. Changing the flashing frequency of the LED lights indicates the effectiveness of ablation, improving surgical efficiency. A fully automated sclerotherapy mixing device for vein ablation is designed to achieve better sclerotherapy preparation during preoperative procedures, while reducing the operator's steps. A further designed quantitative, multi-point fully automated injection needle structure allows for more uniform coverage of the target vein's surrounding tissues and nerves with the isolating fluid, improving ablation safety. The radiofrequency ablation components and supporting devices in this invention support one-stop minimally invasive interventional device diagnosis and treatment services for lower extremity varicose veins under ultrasound guidance via radiofrequency catheter, and provide a safer, more stable, and convenient new solution for varicose vein and various vascular closure ablation treatments.

[0073] This invention adjusts the knob 6 to engage and rotate the first gear 4, second gear 16, first gear 8, and second gear 14 of the drive shaft, causing the traction wire 13 and electrode wire 9 to be wound or unwound on the drive shaft 7. This changes the energized length of the radiofrequency electrode 12 winding, thereby adjusting the effective working electrode length of the catheter. Simultaneously, by designing the number of teeth on the first gear 4, second gear 16, first gear 8, and second gear 14 of the drive shaft, the rotational speed of the drive shaft 7 is adjusted, enabling rapid and precise adjustment of the working end length of the radiofrequency electrode 12. Furthermore, this invention integrates multiple temperature sensors at various angles and positions at the working end of the radiofrequency catheter 10 to collect real-time temperature data of the ablated vein wall and surrounding tissue. The main control module optimizes and controls the output power through algorithms, thereby achieving effective regulation of the catheter ablation temperature. The automatic adjustment of the radiofrequency generator's output power ensures that the temperature is maintained rapidly and stably within the target range, achieving safer and more effective temperature regulation. Furthermore, this invention adds a sclerosing agent and drug injection tubing (drug injection channel 18) within the radiofrequency ablation catheter, and designs a porous, uniformly distributed sclerosing agent and drug injection outlet structure at the tip. This allows for more uniform injection of the sclerosing agent into the blood vessel lumen along the venous radiofrequency ablation catheter, achieving safer and more effective ablation treatment. Simultaneously, after ablation, medication is injected into the venous wall tissue along the catheter, reducing postoperative complications such as venous wall inflammation. Moreover, this invention modifies the main material of the venous ablation catheter wall, adding a coating material with hydrophilic lubrication and anticoagulant properties to its outer wall, reducing frictional damage to the blood vessel wall and facilitating the passage of the radiofrequency catheter through tortuous vein walls. Simultaneously, the anticoagulant coating technology on the outer surface of the catheter reduces platelet adhesion and decreases... The invention reduces the risk of thrombosis. Furthermore, it adds high-penetration LED flashing lights to the tip of the radiofrequency catheter 10 and the tail of the radiofrequency electrode 12, improving the precise positioning of the catheter after ablation and preventing overlapping or missed ablation. It uses intelligent real-time thermocouples to measure blood vessel wall temperature, and changes in the flashing frequency of the LED lights indicate the progress of ablation, effectively improving ablation efficiency and effectiveness. The invention also features a fully automated sclerosing agent mixer to achieve thorough and uniform mixing of podocarboxylic acid and a measured amount of carbon dioxide gas. Different concentrations of sclerosing agents can be stored separately in different mixing tanks. An adjustable-speed peristaltic pump allows for the quantitative injection of the sclerosing agent. The design of a dotted, multi-hole needle structure ensures more uniform distribution of the mixed sclerosing agent on the outer wall of the blood vessel, surrounding tissues, and nerves, enhancing the safety and efficiency of ablation.

[0074] The radiofrequency ablation system of this invention provides one-stop instrument support for ultrasound-guided lower extremity vein ablation treatment, enabling more precise, safe, and convenient ablation treatment. It shows great clinical application potential in closed ablation treatment of various vascular cavities.

[0075] The above are merely preferred embodiments of the present invention and are not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A radiofrequency catheter ablation assembly, characterized in that, Includes a handle (3) and a radio frequency conduit (10) connected to the handle (3); The radio frequency conduit (10) is provided with a radio frequency electrode (12); the radio frequency electrode (12) is arranged along the length direction of the radio frequency conduit (10); a movable electrode slider (24) is electrically connected to the radio frequency electrode (12). The handle (3) is equipped with an electrode length adjustment component inside; the movable electrode slider (24) can move along the length direction of the radio frequency electrode (12) under the action of the electrode length adjustment component to adjust the length of the working end of the radio frequency electrode (12); In use, the movable electrode slider (24) is electrically connected to an external power source.

2. The radiofrequency catheter ablation assembly according to claim 1, characterized in that, The electrode length adjustment assembly includes a rotation unit and a pulling unit; The rotating unit includes a drive shaft (5) and a transmission shaft (7). The drive shaft (5) is provided with a first drive shaft gear (4) and a second drive shaft gear (16). The transmission shaft (7) is provided with a first transmission shaft gear (8) and a second driven shaft gear (14). The first drive shaft gear (4) meshes with the first transmission shaft gear (8), and the second drive shaft gear (16) meshes with the second driven shaft gear (14). One end of the drive shaft (5) is provided with an adjustment knob (6), which is located outside the handle (3). The traction unit includes an electrode wire (9) disposed on a movable electrode slide (24) and a traction assembly (28) disposed at the free end of the radio frequency conduit (10); the other end of the electrode wire (9) is wound around a drive shaft (7); a traction wire (13) is wound on the traction assembly (28), one free end of the traction wire (13) is fixedly connected to the movable electrode slide (24), and the other free end is wound around the drive shaft (7), and the traction wire (13) and the electrode wire (9) are wound in opposite directions on the drive shaft (7).

3. The radiofrequency catheter ablation assembly according to claim 2, characterized in that, The number of teeth of the first gear (4) of the drive shaft is greater than the number of teeth of the first gear (8) of the transmission shaft, and the number of teeth of the second gear (16) of the drive shaft is less than the number of teeth of the second gear (14) of the driven shaft.

4. The radiofrequency catheter ablation assembly according to claim 1, characterized in that, A first indicator light (23) is provided near the movable electrode slider (24), and a second indicator light (29) is provided near the end of the radio frequency electrode (12); the radio frequency ablation assembly also includes a control unit, which communicates with the first indicator light (23) and the second indicator light (29).

5. A radiofrequency catheter ablation assembly according to claim 4, characterized in that, Several thermocouples (22) are provided near the radio frequency electrode (12); the thermocouples (22) communicate with the control unit; in use, the thermocouples (22) transmit the detected temperature to the control unit, the control unit compares the collected temperature with the preset temperature range value, if the difference between the collected temperature and the preset temperature exceeds the preset threshold range, the output power of the thermocouples (22) is adjusted to adjust the ablation temperature, and after the ablation is completed, the temperature feedback of the thermocouples (22) controls the flashing frequency of the first indicator light (23) and the second indicator light (29).

6. The radiofrequency catheter ablation assembly according to claim 1, characterized in that, The handle (3) is provided with a drug injection tube (18) inside. One free end of the drug injection tube (18) extends to the tail of the handle (1) and the other free end extends to the end of the radiofrequency catheter (10). The free end of the drug injection tube (18) is provided with a drug injection groove (26) and a plurality of drug injection holes (27) are provided on the drug injection groove (26).

7. The radiofrequency catheter ablation assembly according to claim 1, characterized in that, The radio frequency electrode (12) is provided with an insulating layer (25) on the outside, and the insulating layer (25) is provided with a friction-reducing, lubricating and anti-coagulation coating material.

8. A radiofrequency ablation system, characterized in that, It includes a radiofrequency catheter ablation assembly as described in any one of claims 1 to 7 and an energy generating device electrically connected to the radiofrequency electrode (12).

9. A radiofrequency ablation system according to claim 8, characterized in that, The radiofrequency ablation system also includes a gas metering curing agent mixer; the gas metering curing agent mixer includes a mixing chamber (1023), on which a mixing gas tank (101) and several mixing solution injectors are connected; on which a motor (1018) and several mixing motion pistons are connected.

10. A radiofrequency ablation system according to claim 8, characterized in that, The radiofrequency ablation system also includes a multi-point injection device for isolating fluid; the multi-point injection device for isolating fluid includes an injection needle (209), and the free end of the injection needle (209) is provided with several through holes (2010).

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