A vascular interventional radiofrequency pulse ablation surgical system

Abstract

This application relates to a vascular interventional radiofrequency pulse ablation surgical system, belonging to the technical field of medical devices. In this application, the vascular interventional radiofrequency pulse ablation surgical system includes an outer sheath, an inner tube, a guide wire, and a pulsed radiofrequency generating element. The outer sheath is slidably sleeved on the inner tube, and the guide wire slidably passes through the inner tube; an operating handle is fixedly provided at one end of the outer sheath; an elastic balloon capable of extending from the other end of the outer sheath is sleeved at one end of the inner tube, and a silver paste electrode electrically connected to the pulsed radiofrequency generating element is coated on the surface of the elastic balloon; a deflection guiding head is provided at one end of the guide wire close to the elastic balloon, and the deflection guiding head can generate deflection and swing when encountering resistance. In this application, the design of the deflection guiding head enables the guide wire to generate deflection and swing when encountering resistance, improving the navigation ability of the guide wire in complex and small blood vessels and reducing the risk of damage to the inner wall of the blood vessels. The silver paste electrode coated on the surface of the elastic balloon achieves efficient and uniform ablation of plaques, improving the treatment effect.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a vascular interventional radiofrequency pulse ablation surgical system. Background Art

[0002] Atherosclerosis is a common vascular disease, usually caused by the accumulation of fat, cholesterol, calcium, and other substances on the arterial wall to form atherosclerotic plaques. These plaques can gradually grow larger, obstruct blood flow, and may lead to serious health problems such as heart disease, stroke, and amputation.

[0003] Traditional treatment methods such as drug treatment and surgery have problems such as large trauma and slow recovery. With the continuous increase in the incidence of cardiovascular diseases, minimally invasive treatment technologies have gradually become the mainstream. Vascular interventional treatment is a relatively mature minimally invasive treatment method. Generally, an incision is made on the skin surface, and the instrument is inserted into the blood vessel through the artery, and a special instrument is used for blood vessel dilation to improve the situation of blood vessel stenosis. If there is an infarcted part, ablation drugs can be injected or the diseased tissue can be removed by using a plaque rotablation method for treatment. If the blood vessel stenosis is relatively severe, a stent can also be placed in the blood vessel to facilitate the dredging of local blood circulation, thereby treating vascular diseases. In traditional treatment methods, drug ablation can only target mild diseases, and it is not efficient and thorough enough, and the treatment effect is not good. The method of using rotablation may cause damage to the inner wall of the blood vessel, the surgical difficulty is relatively large, the risk is relatively high, and it is easy to produce small thrombi escaping distally to form embolisms, resulting in new problems.

[0004] Vascular interventional radiofrequency pulse ablation surgery is a modern new vascular interventional treatment technology that combines radiofrequency energy and balloon dilation technology and has received wide attention for its minimally invasive and efficient characteristics. It is mainly used for treating intravascular calcified plaques or stenotic lesions.

[0005] Medical devices used in vascular interventional radiofrequency pulse ablation surgery are all provided with guide wires for balloon and catheter guidance. The guide wire structure in related technologies is relatively simple. In complex and small blood vessels, the long-distance movement of the guide wire is very easy to damage the inner wall of the blood vessel, and it is difficult to ensure its smooth forward movement in curved blood vessels. In addition, the single-pole or multi-pole electrodes set in related technologies are difficult to perform stable, uniform, and efficient ablation treatment on plaques. Summary of the Invention

[0006] In order to improve the ablation effect of intravascular plaques and reduce the damage to the blood vessel wall, this application provides a vascular interventional radiofrequency pulse ablation surgical system.

[0007] The vascular interventional radiofrequency pulse ablation surgical system provided by this application adopts the following technical solutions:

[0008] A vascular interventional radiofrequency pulse ablation surgical system, comprising an outer sheath, an inner tube, a guide wire and a pulsed radiofrequency generating element, wherein the outer sheath is slidably sleeved on the inner tube, and the guide wire slidably passes through the inner tube;

[0009] One end of the outer sheath is fixedly provided with an operating handle; one end of the inner tube is sleeved with an elastic balloon that can extend from the other end of the outer sheath, and a silver paste electrode electrically connected to the pulsed radiofrequency generating element is coated on the surface of the elastic balloon; an operating key connected to the other end of the inner tube and used to push the inner tube to move within the outer sheath is arranged on the operating handle;

[0010] One end of the guide wire close to the elastic balloon is provided with a deflection guiding head, and the deflection guiding head can generate deflection swing when encountering resistance.

[0011] During use, under the guiding action of the guide wire, the elastic balloon quickly and accurately reaches the lesion position, and an external pressure device pressurizes the elastic balloon to make it expand; after the elastic balloon expands, it fits against the inner wall of the vascular targeted stenosis lesion position, and the pulsed radiofrequency energy acts on the lesion through the silver paste electrode, and the thermal effect generated by the pulsed radiofrequency current ablates the diseased tissue or abnormal lesion to achieve the treatment effect.

[0012] By adopting the above technical solution, in the vascular interventional radiofrequency pulse ablation surgical system, the design of the deflection guiding head enables the guide wire to generate deflection swing when encountering resistance, avoiding blood vessel damage caused by hard pushing, improving the navigation ability of the guide wire in complex and small blood vessels, making the guide wire push more smoothly and accurately, and being safer. The silver paste electrode coated on the surface of the elastic balloon is electrically connected to the pulsed radiofrequency generating element, and can effectively conduct radiofrequency energy when the elastic balloon contacts the lesion site, realizing efficient and uniform ablation of calcified plaques and improving the treatment effect. The overall system design conforms to ergonomics and is convenient to operate, enabling the elastic balloon and the silver paste electrode to be accurately positioned at the target position, reducing the operation time and complexity, and improving the ablation effect.

[0013] Optionally, the deflection guiding head includes a rod body and a cap body located at one end of the rod body. An installation seat is provided at the end of the guide wire, and the other end of the rod body is connected to the installation seat. One side of the cap body is a connection plane fixedly connected to the rod body, and the side of the cap body away from the rod body is a spherical curved surface.

[0014] By adopting the above technical solution, the design of the deflection guiding head enables the guide wire to flexibly deflect and swing when encountering resistance, avoiding damage to the inner wall of the blood vessel caused by rigid pushing. The special structures of the rod body and the cap body not only enhance the stability of the guide wire, but also improve its flexibility and controllability in complex blood vessel paths. The design of the spherical curved surface reduces the mechanical stimulation of the front end of the guide wire on the blood vessel wall and reduces the surgical risk. In short, this design significantly improves the safety and success rate of the surgery.

[0015] Optionally, the rod body and the mounting seat are connected by a compression spring, and a pressure feedback sensor that abuts against the compression spring is arranged on the mounting seat; the cap body is made of a permanent magnet material that can cooperate with the magnetic navigation system.

[0016] By adopting the above technical solution, the deflection guiding head can deflect and swing when encountering resistance, avoiding damage to the blood vessel wall; the arrangement of the compression spring and the pressure feedback sensor enables the guide wire to sense and adapt to the complex blood vessel environment in real time during movement, improving the safety and accuracy of the surgery; the cap body is made of a permanent magnet material and cooperates with the magnetic navigation system to achieve precise control and navigation of the guide wire.

[0017] Optionally, a floating balloon for suspending the guide wire in the blood of the blood vessel is arranged at a position near the deflection guiding head at the end of the guide wire.

[0018] By adopting the above technical solution, the floating balloon enables the guide wire to remain suspended in the blood vessel, avoiding the guide wire clinging to the blood vessel wall due to the action of gravity, thereby reducing mechanical damage to the inner wall of the blood vessel. In addition, the floating balloon can also increase the stability of the guide wire, helping to achieve more precise positioning and operation in complex blood vessel paths.

[0019] Optionally, an optical fiber controller is arranged in the operation handle, the pressure feedback sensor is an optical fiber sensor, and a reflecting mirror surface that cooperates with the optical fiber controller is arranged on the pressure feedback sensor; an optical fiber connector connected to the optical fiber controller is also arranged on the operation handle.

[0020] By adopting the above technical solution, the optical fiber sensor is used as the pressure feedback sensor to detect the change of the optical signal to measure the real-time pressure of the deflection guiding head at the front end of the guide wire. In this application, a periodic refractive index change is introduced into the optical fiber to form a grating. When the optical fiber is subjected to an external pressure, the period and reflection wavelength of the grating will change, and by monitoring the change of the reflection wavelength, high-sensitivity pressure measurement is achieved.

[0021] In this application, the fiber optic controller can also be combined with a pulsed detection laser and a waveform acquisition device to achieve precise monitoring and positioning of the guide wire. The pulsed detection laser emits pulsed laser light, which is transmitted through the optical fiber into the cavity and forms scattering. The waveform acquisition device receives the reflected pulsed laser light and analyzes its delay waveform to determine the relative position of the guide wire and the cavity wall. This information is fed back to the fiber optic controller to adjust the attitude and the next movement direction of the guide wire.

[0022] By adopting the above technical solution, the fiber optic controller realizes the remote operation and autonomous navigation of the guide wire, helping doctors complete surgeries in narrow cavities; by transmitting optical signals through the optical fiber, it realizes the precise positioning and real-time monitoring of the guide wire or surgical instruments, which can greatly improve the accuracy and safety of surgeries and reduce surgical risks.

[0023] Optionally, an air flow channel communicating with the elastic balloon is provided in the inner tube, and an air flow joint and an air flow pipeline for communicating the air flow channel with the air flow joint are provided on the operation handle; an air flow switch for controlling the inflow and outflow of air in the elastic balloon is also provided on the operation handle.

[0024] By adopting the above technical solution, it is possible to conveniently inflate and deflate the elastic balloon, achieving precise control of the expansion and contraction of the balloon. Doctors can adjust the state of the elastic balloon at any time during the surgery to ensure that the elastic balloon performs radiofrequency ablation in a suitable position and state, improving the flexibility and safety of the surgery. In addition, this design also helps reduce the risk of vascular injury caused by improper manual operation.

[0025] Optionally, the elastic balloon is cylindrical, the elastic balloon is coaxially arranged with the inner tube, and smooth curved surfaces are formed by chamfering the outer peripheries at both ends of the elastic balloon; the silver paste electrodes are spirally distributed on the outer peripheral surface of the elastic balloon, or the silver paste electrodes are evenly spaced along the circumferential direction of the elastic balloon.

[0026] By adopting the above technical solution, it is possible to reduce the damage to blood vessels when the elastic balloon is filled; at the same time, it ensures that the electrodes have a sufficiently large coverage area and uniformity, thereby further improving the surgical ablation efficiency and ablation effect.

[0027] Optionally, the vascular intervention radiofrequency pulsed ablation surgical system further includes a radiofrequency generator, and an electrode connector for connecting the radiofrequency generator and the pulsed radiofrequency generating element is provided on the operation handle.

[0028] By adopting the above technical solution, the radiofrequency generator provides energy and ensures that the transmission of radiofrequency energy is more stable and controllable. It improves the efficiency and accuracy of radiofrequency ablation, avoids unnecessary tissue damage, and thus enhances the safety and success rate of the surgery.

[0029] Optionally, a display screen for displaying the pressure and temperature data inside the elastic balloon is further provided on the operating handle, and the display screen is electrically connected to the fiber optic controller.

[0030] By adopting the above technical solution, the real-time monitoring and display of the pressure and temperature inside the elastic balloon are realized, which not only helps the doctor to understand the state of the elastic balloon at any time during the operation, ensures the safety and accuracy of the operation, but also can timely adjust the operation strategy to avoid blood vessel damage caused by too high pressure or tissue thermal damage caused by out-of-control temperature, thereby improving the overall effect of the operation and the treatment experience of the patient.

[0031] Optionally, the elastic balloon is made of a block polyether amide resin material, and the guide wire is formed by a polyurethane tungsten mixed imaging material and a tungsten carbide material together, wherein the mass fractions of the polyurethane tungsten mixed imaging material and the tungsten carbide material are both 50%; a hydrophilic coating is coated on the outer surface of the guide wire.

[0032] By adopting the above technical solution, the elastic balloon can withstand higher pressure, reduce the risk of elastic balloon rupture, has better elasticity than traditional nylon materials, is suitable for complex vascular environments, and has good biocompatibility; the above guide wire forms a thermoplastic polyurethane elastomer, has the characteristics of wear-resistant and high-rebound plastic materials, and at the same time has sufficient hardness and good chemical inertness. The guide wire with a hydrophilic coating shows significant lubricity, biocompatibility and controllability during interventional surgery, can effectively improve the safety and success rate of the operation, and at the same time reduce the pain of the patient.

[0033] In summary, the present application includes at least one of the following beneficial technical effects:

[0034] 1. By providing a deflection guiding head on the guide wire in the present application, deflection and swing occur when encountering resistance, which can effectively avoid damage to the inner wall of the blood vessel by the guide wire in complex and small blood vessels, and improve the safety and success rate of the operation.

[0035] 2. In the present application, the surface of the elastic balloon is coated with a silver paste electrode, which realizes the efficient ablation of calcified plaques and the dilation of blood vessel lumen, solves the deficiencies in traditional methods such as simple drug ablation or rotational ablation, and the electrode distribution is more uniform, which can ablate more efficiently and reliably, and improves the treatment effect.

[0036] 3. By providing a floating balloon on the guide wire in the present application, the guide wire can be kept in a suspended state in the blood vessel, avoiding the guide wire sticking to the blood vessel wall due to the action of gravity, thereby reducing mechanical damage to the inner wall of the blood vessel.

[0037] 4. In the present application, the precise positioning and real-time monitoring of the guide wire and surgical instruments are realized, which can greatly improve the accuracy and safety of the operation and reduce the operation risk.

[0038] 5. In this application, a silver paste electrode is used for radiofrequency pulse ablation. It has excellent electrical conductivity, can achieve efficient current transmission with low loss, and is not easily oxidized or corroded, so it can maintain stable electrical conductivity for a long time, ensuring the reliability and service life of the electrode. It also has good biocompatibility and will not cause irritation or damage to organisms. In addition, silver has antibacterial properties and can effectively inhibit the growth of bacteria, further improving the biological safety of the electrode. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 is a three-dimensional structural schematic diagram of the vascular interventional radiofrequency pulse ablation surgical system in Embodiment 1 or Embodiment 3 of this application.

[0040] Figure 2 is an exploded structural schematic diagram of the vascular interventional radiofrequency pulse ablation surgical system in Embodiment 1 or Embodiment 3 of this application.

[0041] Figure 3 is a front-view structural schematic diagram of the vascular interventional radiofrequency pulse ablation surgical system in Embodiment 1 or Embodiment 3 of this application.

[0042] Figure 4 is Figure 3 a partial enlarged structural schematic diagram of part A in

[0043] Figure 5 is a control diagram of the vascular interventional radiofrequency pulse ablation surgical system in this application.

[0044] Figure 6 is a three-dimensional structural schematic diagram of the vascular interventional radiofrequency pulse ablation surgical system in Embodiment 2 of this application.

[0045] Figure 7 is a three-dimensional structural schematic diagram of the vascular interventional radiofrequency pulse ablation surgical system in Embodiment 2 of this application after removing the outer sheath.

[0046] In the figure:

[0047] 10. Outer sheath; 11. First through hole;

[0048] 20. Inner tube; 21. Second through hole; 22. Air flow channel;

[0049] 30. Guide wire;

[0050] 40. Operating handle; 41. First half shell; 42. Second half shell; 43. Installation cavity; 44. Strip-shaped hole;

[0051] 50. Operating key;

[0052] 60. Elastic balloon;

[0053] 70. Deflection guide head; 71. Rod body; 72. Cap body; 721. Connection plane; 722. Spherical surface; 73. Mounting seat; 74. Pressure spring; 75. Pressure feedback sensor; 751. Reflective mirror surface;

[0054] 80. Optical fiber controller;

[0055] 90. Magnetoresponsive coating;

[0056] 100. Optical fiber connector;

[0057] 110. Airflow switch;

[0058] 120. Airflow pipeline;

[0059] 130. Radio frequency generator;

[0060] 140. Pulse radio frequency generating element;

[0061] 150. Electrode connector;

[0062] 160. Silver paste electrode;

[0063] 170. Airflow connector;

[0064] 180. Display screen;

[0065] 190. Pressure sensor;

[0066] 200. Temperature sensor;

[0067] 210. Control switch;

[0068] 220. Floating balloon;

[0069] 230. Position signal transmission line. Detailed implementation manners

[0070] Next, in combination with the attached Figure 1 - attached Figure 7 , the technical solutions in the embodiments of the present invention will be clearly and completely described. The described embodiments are only possible technical implementations of the present invention, not all possible implementations. Those skilled in the art can fully combine the embodiments of the present invention to obtain other embodiments without creative labor, and these embodiments are also within the protection scope of the present invention. Embodiment 1

[0071] Refer to Figure 1 and Figure 2As shown in the figure, a vascular interventional radiofrequency pulse ablation surgical system provided by an embodiment of the present application includes an outer sheath 10, an inner tube 20, a guide wire 30, and an operating handle 40. The operating handle 40 is elongated, and the outer peripheral surface of the operating handle 40 is an arc-shaped curved surface, and its shape is designed according to ergonomics, which is convenient for doctors to hold and operate. The operating handle 40 includes a first half-shell 41 and a second half-shell 42. The outer peripheries of the first half-shell 41 and the second half-shell 42 are buckled and fixedly connected together to form a complete operating handle structure. The inside of the outer sheath 10 has a first through hole 11 along its axial direction. The first through hole 11 penetrates through both ends of the outer sheath 10. One end of the outer sheath 10 is fixedly connected to the end of the operating handle 40. The inside of the operating handle 40 has an installation cavity 43, and the first through hole 11 is communicated with the installation cavity 43.

[0072] Referring to Figure 2 and Figure 3 As shown in the figure, the length of the inner tube 20 is greater than the length of the outer sheath 10. The outer sheath 10 is slidably sleeved on the inner tube 20, that is, the inner tube 20 is slidably inserted into the first through hole 11 of the outer sheath 10. One end of the inner tube 20 extends out of the first through hole 11 of the outer sheath 10 and extends into the installation cavity 43 inside the operating handle 40. A strip-shaped hole 44 is opened on the side of the operating handle 40. The length direction of the strip-shaped hole 44 is arranged along the length direction of the operating handle 40. An operating key 50 is fixedly connected to the end of the inner tube 20 extending into the operating handle 40. The operating key 50 passes through the strip-shaped hole 44 and extends out of the operating handle 40. When an operator holds the operating handle 40 and pushes the operating key 50, the inner tube 20 can be driven to move inside the outer sheath 10. An elastic balloon 60 is sleeved on the other end of the inner tube 20. The elastic balloon 60 is cylindrical, and the elastic balloon 60 is coaxially arranged with the inner tube 20. Smooth curved surface transitions are formed by rounding the outer peripheries at both ends of the elastic balloon 60. Scale values are provided on the elastic balloon 60. When the elastic balloon 60 is not inflated, it can contract into the first through hole 11 of the outer sheath 10 along with the inner tube 20. When it needs to be used at a predetermined position, the inner tube 20 and the elastic balloon 60 can be pushed out of the first through hole 11 of the outer sheath 10 through the operating key 50.

[0073] Referring to Figure 2 , Figure 3 and Figure 4As shown, the inner tube 20 has a second through hole 21 along its axial direction. The second through hole 21 extends through both ends of the inner tube 20, and the guide wire 30 can slide through the second through hole 21 of the inner tube 20. A deflection guide head 70 is provided at the end of the guide wire 30 near the elastic balloon 60. The deflection guide head 70 can deflect and swing when encountering resistance. The design of the deflection guide head 70 allows the guide wire 30 to flexibly deflect and swing when encountering resistance, avoiding damage to the inner wall of the blood vessel caused by rigid advancement. Specifically, the deflection guide head 70 includes a rod body 71 and a cap body 72 located at one end of the rod body 71. The end of the guide wire 30 is provided with a mounting seat 73. The other end of the rod body 71 is connected to the mounting seat 73 and a pressure spring 74 is provided between the two. The mounting seat 73 is also provided with a pressure feedback sensor 75 that abuts against the pressure spring 74. One side of the cap body 72 is a connecting plane 721 that is fixedly connected to the rod body 71, and the side of the cap body 72 away from the rod body 71 is a spherical surface 722. The special structure of the rod body 71 and the cap body 72 not only enhances the stability of the guide wire 30, but also improves its flexibility and controllability in complex vascular pathways. The design of the spherical surface 722 reduces the mechanical stimulation of the front end of the guide wire 30 on the blood vessel wall, thereby reducing surgical risks.

[0074] Reference Figure 2 and Figure 3 As shown, the operating handle 40 is equipped with a fiber optic controller 80. The pressure feedback sensor 75 is a fiber optic sensor with a reflective mirror 751 that mates with the fiber optic controller 80. The operating handle 40 is also equipped with a fiber optic connector 100 that connects to the fiber optic controller 80. The application of fiber optic technology here primarily uses the fiber optic sensor to provide force feedback on the resistance encountered by the deflection guide head 70. A fiber Bragg grating (FBG) sensor can be used to detect minute deformations at the end of the deflection guide head 70, thereby measuring contact force.

[0075] In this embodiment, the fiber optic controller 80 can be used in conjunction with a pulsed detection laser and a waveform collector to precisely monitor the position of the guidewire 30. The pulsed detection laser emits pulsed laser light, which is transmitted through the optical fiber into the cavity and scattered. The waveform collector receives the reflected pulsed laser light and analyzes its delayed waveform to determine the relative position of the guidewire 30. This information is fed back to the fiber optic controller 80, which is used to adjust the guidewire 30's posture and next movement direction.

[0076] Combine Figure 3 and Figure 4As shown, an air flow channel 22 communicating with the elastic balloon 60 is provided in the inner tube 20. The air flow channel 22 is located on one side of the second through hole and extends to the inside of the elastic balloon 60 and communicates with the elastic balloon 60 through a side opening. An air flow joint 170 and an air flow pipe 120 for communicating the air flow channel 22 with the air flow joint 170 are provided on the operation handle 40. An air flow switch 110 for controlling the air flow in and out of the elastic balloon 60 is also provided on the operation handle 40. This can facilitate the inflation and deflation of the elastic balloon 60 and achieve precise control of the expansion and contraction of the balloon. During the operation, the doctor can adjust the state of the elastic balloon 60 at any time to ensure that the elastic balloon 60 performs radiofrequency ablation in a proper position and state, improving the flexibility and safety of the operation. In addition, this design also helps to reduce the risk of vascular injury caused by improper manual operation.

[0077] Referring to Figure 4 and Figure 5 As shown, the vascular interventional radiofrequency pulse ablation surgery system in this embodiment further includes a radiofrequency generator 130 and a pulsed radiofrequency generating element 140. The radiofrequency generator 130 is used to provide energy, is relatively large in volume, and is independently provided outside the operation handle 40. The pulsed radiofrequency generating element 140 can be provided inside the operation handle 40 or inside the outer sheath 10 and the inner tube 20. An electrode joint 150 for connecting the radiofrequency generator 130 and the pulsed radiofrequency generating element 140 is provided on the operation handle 40. The surface of the elastic balloon 60 is coated with a silver paste electrode 160 electrically connected to the pulsed radiofrequency generating element 140. The silver paste electrode 160 is spirally distributed on the outer peripheral surface of the elastic balloon 60. The silver paste electrode 160 disposed on the outer surface of the elastic balloon 60 has a sufficiently large coverage area and ensures uniformity, thereby improving the surgical ablation efficiency and ablation effect.

[0078] In this embodiment, a pressure sensor 190 and a temperature sensor 200 are provided in the elastic balloon 60. A display screen 180 for displaying the pressure and temperature data inside the elastic balloon 60 is also provided on the operation handle 40. The display screen 180 is electrically connected to the fiber optic controller 80. This can realize the real-time monitoring and display of the pressure and temperature inside the elastic balloon 60, which not only helps the doctor to understand the state of the elastic balloon 60 at any time during the operation to ensure the safety and accuracy of the operation, but also can timely adjust the operation strategy to avoid vascular injury caused by excessive pressure or tissue thermal injury caused by temperature out of control, thereby improving the overall effect of the operation and the treatment experience of the patient.

[0079] The implementation principle is as follows: During use, under the guiding action of the guide wire 30, the elastic balloon 60 can quickly and accurately reach the lesion site. An external pressure device pressurizes the elastic balloon 60 to make it expand and fill; after the elastic balloon 60 expands, it fits against the inner wall of the vascular targeted stenosis lesion site, and pulsed radiofrequency energy acts on the lesion through the silver paste electrode 160. The thermal effect generated by the pulsed radiofrequency current ablates the diseased tissue or abnormal lesion to achieve the treatment effect.

[0080] In this embodiment, through the design of the deflection guiding head 70, the guide wire 30 can deflect and swing when encountering resistance, avoiding vascular damage caused by hard pushing, improving the navigation ability of the guide wire 30 in complex and small blood vessels, making the advancement of the guide wire 30 smoother, more accurate, and safer. The silver paste electrode 160 coated on the surface of the elastic balloon 60 is electrically connected to the pulsed radiofrequency generating element 140, and can effectively conduct radiofrequency energy when the elastic balloon 60 contacts the lesion site, achieving efficient and uniform ablation of calcified plaques and improving the treatment effect. The overall system design conforms to ergonomics, is convenient to operate, enables the elastic balloon 60 and the silver paste electrode 160 to accurately locate to the target position, reduces the operation time and complexity, and improves the ablation effect.

[0081] In this embodiment, the silver paste electrode 160 is used for radiofrequency pulse ablation. It has excellent electrical conductivity, can achieve efficient current transmission with low loss; is not easily oxidized and corroded, can maintain stable electrical conductivity for a long time, ensuring the reliability and service life of the electrode; it also has good biocompatibility and will not cause irritation or damage to organisms. In addition, silver also has antibacterial properties, can effectively inhibit the growth of bacteria, and further improves the biological safety of the electrode.

[0082] In this application, the elastic balloon 60 is made of a block polyether amide resin material, and the guide wire 30 is formed by a polyurethane tungsten mixed imaging material and tungsten carbide material together, and the mass fractions of both the polyurethane tungsten mixed imaging material and the tungsten carbide material are 50%; in this way, the elastic balloon 60 can withstand higher pressures, reduce the risk of rupture of the elastic balloon 60, and has better elasticity than traditional nylon materials, is suitable for complex vascular environments, and has good biocompatibility; the above-mentioned guide wire 30 forms a thermoplastic polyurethane elastomer, has the characteristics of wear-resistant and high-rebound plastic materials, and at the same time has sufficient hardness and good chemical inertness. The outer surface of the guide wire 30 is coated with a hydrophilic coating. The hydrophilic coating is composed of hydrophilic polymers such as polyacrylate and polyurethane, and is attached to the surface of the guide wire 30 by chemical bonding or physical adsorption. Cross-linking agents and photoinitiators can also be added to enhance the adhesion and stability of the coating. The guide wire 30 with a hydrophilic coating shows significant lubricity, biocompatibility and controllability during interventional surgery, can effectively improve the safety and success rate of the surgery, and at the same time reduce the pain of patients. Embodiment 2

[0083] Referring to Figure 6 and Figure 7 As shown, this embodiment is substantially the same as Embodiment 1. The difference is that in this embodiment, a floating balloon 220 for suspending the guide wire 30 in the blood of the blood vessel is provided at a position near the deflection guide head 70 at the end of the guide wire 30. A control switch 210 for controlling the inflow and outflow of air in the floating balloon 220 is also provided on the operation handle 40 for inflating and deflating the floating balloon 220. In addition, there are several groups of silver paste electrodes 160 in this embodiment. Each group of silver paste electrodes 160 is in a long strip shape. Each group of silver paste electrodes 160 is arranged on the surface of the elastic balloon 60 along its length direction. The several groups of silver paste electrodes 160 are evenly spaced along the circumferential direction of the elastic balloon 60.

[0084] The implementation principle is as follows: The floating balloon 220 enables the guide wire 30 to maintain a suspended state in the blood vessel, avoiding the guide wire 30 clinging to the blood vessel wall due to the action of gravity, thereby reducing mechanical damage to the inner wall of the blood vessel. In addition, the floating balloon 220 can also increase the stability of the guide wire 30, helping to achieve more accurate positioning and operation in complex blood vessel paths. Embodiment 3

[0085] Referring to Figure 1 、 Figure 2 and Figure 4 As shown, a magnetic response coating 90 is provided on the outer peripheral surface of one end of the inner tube 20 where the deflection guide head 70 is installed. The magnetic response coating 90 can be made of magnetostrictive material, for example, it can be Terfenol-D (Tb 0.3 Dy 0.7Fe2), Galfenol (Fe-Ga alloy), ferrites (such as CoFe2O4), multiferroic materials (such as BiFeO3), magnetoelectric composite materials (such as Terfenol-D / PZT), etc. The magnetic response coating 90 is used in conjunction with the fiber optic sensor and the fiber optic controller 80. The magnetic response coating and the fiber optic sensor form a fiber optic magnetic field sensor. The entire system also includes a magnetic field generator that creates a stable magnetic field environment. When the inner tube 20 moves within the magnetic field environment, the magnetic response coating 90 will deform due to the change in the magnetic field. In this embodiment, the magnetic response coating 90 undergoes significant deformation (strain up to 1000 ppm) under the action of the magnetic field, with a fast response speed (microsecond level). By utilizing the time delay, phase change, or intensity change of light in the optical fiber, which in turn causes a change in the optical signal, and then transmitting the optical signal to the fiber optic controller 80 for high-sensitivity magnetic field detection. Through data analysis of the magnetic field variables, the precise positioning of the inner tube 20 is achieved, and it can also be used to detect the bending shape of the end of the inner tube 20. A position signal transmission line 230 is provided on the operating handle 40 to promptly transmit the position information to the entire controller and can display the position information on the display screen 180 in real time for medical staff to reference and control.

[0086] The technical solution in this embodiment can be used in combination with the technical solution in Embodiment 1 to achieve dual positioning and a more precise positioning effect. Embodiment 4

[0087] In this embodiment, the cap body 72 is made of a permanent magnet material that can cooperate with the magnetic navigation system, or a magnetic conductive material coating is applied to the cap body 72. The magnetic navigation system controls the position of the deflection guide head 70 through the change in the magnetic field. The magnetic field of the magnetic navigation system is provided by two hemispherical magnets located on both sides of the patient respectively, with a magnetic field strength between 0.08 and 0.1 T and a magnetic field range of a sphere with a diameter of 15 to 20 cm. Each magnet is controlled by a computer system through a motor to change the deflection vector of the magnetic field. The cap body 72 made of a permanent magnet material or the cap body 72 with a magnetic conductive material coating is affected by the changing magnetic field and rotates the angle along with the direction of the resultant magnetic field vector; at the same time, the operator controls the advancement and retreat of the guide wire 30 and the inner tube 20, and its positioning precision can reach 1 mm.

[0088] The technical solution in this embodiment can be used in combination with the technical solution in Embodiment 1 or / and Embodiment 3. In this embodiment, through the fiber optic controller 80 and the magnetic navigation system, the remote operation and autonomous navigation of the guide wire 30 can be realized, helping doctors complete surgeries in narrow channels; by transmitting optical signals through optical fibers, the precise positioning and real-time monitoring of the guide wire 30 or surgical instruments can be achieved, which can greatly improve the accuracy and safety of surgeries and reduce surgical risks.

[0089] Through precise positioning, and then using an external magnetic field to guide the precise movement of the guide wire 30, ensuring that the guide wire 30 accurately reaches the target position. And this technical solution can achieve remote control, reduce the need for manual operation by doctors, and at the same time reduce the trauma to patients. In this embodiment, the combination of fiber optic positioning and magnetic navigation improves the performance of the overall system.

[0090] The embodiments of this specific implementation manner are all preferred embodiments of this application, and do not limit the protection scope of this application accordingly. The same components are represented by the same reference numerals. Therefore, all equivalent changes made according to the structure, shape, and principle of this application should be covered within the protection scope of this application.

Claims

1. A vascular interventional radiofrequency pulse ablation surgical system, comprising an outer catheter (10), an inner catheter (20), a guide wire (30), and a radiofrequency pulse generating element (140). The outer catheter (10) is slidably sleeved on the inner catheter (20), and the guide wire (30) slidably passes through the inner catheter (20). It is characterized in that, One end of the outer catheter (10) is fixedly provided with an operating handle (40); one end of the inner catheter (20) is sleeved with an elastic balloon (60) that can extend from the other end of the outer catheter (10). A silver paste electrode (160) electrically connected to the radiofrequency pulse generating element (140) is coated on the surface of the elastic balloon (60); an operating key (50) connected to the other end of the inner catheter (20) and used to push the inner catheter (20) to move within the outer catheter (10) is provided on the operating handle (40). One end of the guide wire (30) close to the elastic balloon (60) is provided with a deflection guiding head (70), and the deflection guiding head (70) can generate deflection and swing when encountering resistance. The deflection guiding head (70) includes a rod body (71) and a cap body (72) located at one end of the rod body (71). An installation seat (73) is provided at the end of the guide wire (30), and the other end of the rod body (71) is connected to the installation seat (73). One side of the cap body (72) is a connection plane (721) fixedly connected to the rod body (71), and the side of the cap body (72) away from the rod body (71) is a spherical surface (722); the rod body (71) and the installation seat (73) are connected by a compression spring (74), and a pressure feedback sensor (75) abutted against the compression spring (74) is provided on the installation seat (73).

2. The vascular interventional radiofrequency pulse ablation surgery system according to claim 1, wherein The cap body (72) is made of a permanent magnet material that can cooperate with a magnetic navigation system, or a magnetic conductive material coating is coated on the cap body (72) so that the magnetic navigation system can control the position of the deflection guiding head (70) through the change of the magnetic field.

3. The vascular intervention radiofrequency pulse ablation surgical system according to claim 1 or 2, characterized in that A floating balloon (220) for suspending the guide wire (30) in the blood of the blood vessel is provided at a position of the end of the guide wire (30) close to the deflection guiding head (70).

4. The vascular interventional radiofrequency pulse ablation surgical system according to claim 1 or 2, characterized in that An optical fiber controller (80) is provided in the operating handle (40). The pressure feedback sensor (75) is an optical fiber sensor, and a reflecting mirror surface (751) cooperating with the optical fiber controller (80) is provided on the pressure feedback sensor (75); an optical fiber connector (100) connected to the optical fiber controller (80) is also provided on the operating handle (40).

5. The vascular interventional radiofrequency pulse ablation surgery system according to claim 4, wherein A magnetic response coating (90) cooperating with a magnetic field generator is provided on the outer peripheral surface of one end of the inner catheter (20) where the deflection guiding head (70) is installed. The magnetic response coating (90) is made of a magnetostrictive material.

6. The vascular intervention radiofrequency pulse ablation surgery system according to claim 1 or 2, characterized in that An air flow channel (22) communicating with the elastic balloon (60) is provided in the inner tube (20). An air flow joint (170) and an air flow pipe (120) for communicating the air flow channel (22) with the air flow joint (170) are provided on the operation handle (40); An air flow switch (110) for controlling the air flow in and out of the elastic balloon (60) is also provided on the operation handle (40).

7. The vascular interventional radiofrequency pulse ablation surgical system according to claim 1 or 2, characterized in that, The elastic balloon (60) is cylindrical, the elastic balloon (60) is coaxially arranged with the inner tube (20), and smooth curved surface transitions are formed by chamfering the outer circumferences of both ends of the elastic balloon (60); The silver paste electrodes (160) are spirally distributed on the outer circumferential surface of the elastic balloon (60), or the silver paste electrodes (160) are evenly spaced along the circumferential direction of the elastic balloon (60).

8. The vascular intervention radiofrequency pulse ablation surgical system according to claim 1 or 2, characterized in that, The vascular interventional radiofrequency pulse ablation surgical system further includes a radiofrequency generator (130). An electrode connector (150) for connecting the radiofrequency generator (130) and the pulsed radiofrequency generating element (140) is provided on the operation handle (40).

9. The vascular interventional radiofrequency pulse ablation surgical system according to claim 4, characterized in that, A display screen (180) for displaying the pressure and temperature data in the elastic balloon (60) is also provided on the operation handle (40), and the display screen (180) is electrically connected to the optical fiber controller (80).

10. The vascular interventional radiofrequency pulse ablation surgical system according to claim 1 or 2, characterized in that, The elastic balloon (60) is made of a block polyether amide resin material. The guide wire (30) is formed by a polyurethane tungsten-developing material and a tungsten carbide material together, and the mass fractions of the polyurethane tungsten-developing material and the tungsten carbide material are both 50%; A hydrophilic coating is coated on the outer surface of the guide wire (30).

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