Vascular intervention radio frequency pulse ablation operation system

Abstract

The invention relates to a vascular intervention radio-frequency pulse ablation operation system, and relates to the technical field of medical instruments. The vascular intervention radio frequency pulse ablation operation system comprises an outer sleeve, an inner tube, a guide wire and a pulse radio frequency generating element, the outer sleeve is arranged on the inner tube in a sliding and sleeving mode, and the guide wire penetrates through the inner tube in a sliding mode; an operating handle is fixedly arranged at one end of the outer sleeve; one end of the inner tube is sleeved with an elastic balloon capable of extending out of the other end of the outer sleeve, and the surface of the elastic balloon is coated with a silver paste electrode electrically connected with the pulse radio frequency generation element; a deflection guide head is arranged at the end, close to the elastic balloon, of the guide wire and can deflect and swing when encountering resistance. Through the design of the deflection guide head, the guide wire can deflect and swing when encountering resistance, the navigation capacity of the guide wire in a complex small blood vessel is improved, and the risk of damage to the inner wall of the blood vessel is reduced. The silver paste electrode coated on the surface of the elastic balloon realizes efficient and uniform ablation of plaques, and the treatment effect is improved.

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 instruments are inserted into the blood vessels through the artery, and special instruments are 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 plaque cutting methods can be used to remove the diseased tissue 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 conditions, and it is not efficient and thorough enough, and the treatment effect is not good. The method of using cutting 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 that escape 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 advancement 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: A vascular interventional radiofrequency pulse ablation surgical system, comprising an outer catheter, an inner tube, a guide wire, and a pulsed radiofrequency generating element. The outer catheter is slidably sleeved on the inner tube, and the guide wire slidably passes through the inner tube; One end of the outer catheter 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 catheter. The surface of the elastic balloon is coated with a silver paste electrode electrically connected to the pulsed radiofrequency generating element; an operating key connected to the other end of the inner tube and used to push the inner tube to move within the outer catheter is arranged on the operating handle; 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 and swing when encountering resistance.

[0008] During use, through the guiding action of the guide wire, the elastic balloon can quickly and accurately reach the lesion position. An external pressure device pressurizes the elastic balloon to make it expand and fill; after the elastic balloon expands, it fits against the inner wall of the vascular targeted stenosis lesion position. 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.

[0009] By adopting the above technical solution, the vascular interventional radiofrequency pulse ablation surgical system enables the guide wire to generate deflection and swing when encountering resistance through the design of the deflection guiding head, avoiding blood vessel damage caused by hard pushing, improving the navigation ability of the guide wire in complex and small blood vessels, making the advancement of the guide wire smoother, more accurate, and 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.

[0010] 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, 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.

[0011] By adopting the above technical solution, the design of the deflection guiding head enables the guide wire to flexibly generate deflection and swing when encountering resistance, avoiding damage to the inner wall of the blood vessel caused by hard 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 operation.

[0012] Optionally, the rod body is connected to the mounting seat by a compression spring, and a pressure feedback sensor abutted against the compression spring is arranged on the mounting seat; the cap body is made of a permanent magnet material capable of cooperating with a magnetic navigation system.

[0013] By adopting the above technical solution, the deflection guiding head can generate deflection 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 a complex blood vessel environment in real time during movement, improving the safety and accuracy of the operation; 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.

[0014] 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.

[0015] 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, contributing to more precise positioning and operation in a complex blood vessel path.

[0016] Optionally, an optical fiber controller is arranged in the operating handle, the pressure feedback sensor is an optical fiber sensor, and a reflecting mirror surface cooperating 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 operating handle.

[0017] 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 realized.

[0018] In this application, the optical fiber controller can also be combined with a pulse detection laser and a waveform acquisition device, which can realize precise monitoring and positioning of the position of the guide wire. The pulse detection laser emits pulsed laser light, which is conducted through the optical fiber to the cavity and forms scattering, and the waveform acquisition device receives the reflected pulsed laser light and analyzes its delay waveform, thereby determining the relative position of the guide wire and the cavity wall. This information is fed back to the optical fiber controller for adjusting the attitude of the guide wire and the next moving direction.

[0019] By adopting the above technical solution, the fiber optic controller realizes the remote operation and autonomous navigation of the guide wire, helping doctors to complete surgeries in narrow channels; 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.

[0020] Optionally, an air flow channel communicating with the elastic balloon is provided inside the inner tube, and an air flow joint and an air flow pipe 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.

[0021] 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 the appropriate position and state, improving the flexibility and safety of the surgery. In addition, this design also helps to reduce the risk of blood vessel damage caused by improper manual operation.

[0022] 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 of 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.

[0023] 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.

[0024] Optionally, the vascular interventional radiofrequency pulse 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.

[0025] 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.

[0026] Optionally, a display screen for displaying the pressure and temperature data inside the elastic balloon is further provided on the operation handle, and the display screen is electrically connected to the fiber optic controller.

[0027] By adopting the above technical solutions, the real-time monitoring and display of the pressure and temperature inside the elastic balloon are realized. This not only helps doctors understand the state of the elastic balloon at any time during the operation to ensure the safety and accuracy of the operation, but also enables timely adjustment of the operation strategy to avoid blood vessel damage caused by excessive pressure or tissue thermal damage caused by out-of-control temperature, thereby improving the overall effect of the operation and the treatment experience of patients.

[0028] Optionally, the elastic balloon is made of a block polyetheramide resin material, and the guide wire is formed by a polyurethane tungsten mixed imaging material and a tungsten carbide material together, where the mass fractions of both the polyurethane tungsten mixed imaging material and the tungsten carbide material are 50%; a hydrophilic coating is coated on the outer surface of the guide wire.

[0029] By adopting the above technical solutions, the elastic balloon can withstand higher pressures, reducing the risk of elastic balloon rupture, and has better elasticity than traditional nylon materials, being suitable for complex vascular environments and having good biocompatibility; the above guide wire forms a thermoplastic polyurethane elastomer, having the characteristics of a wear-resistant and highly elastic plastic material, and at the same time having sufficient hardness and good chemical inertness. The guide wire with a hydrophilic coating shows significant lubricity, biocompatibility and maneuverability during interventional surgery, can effectively improve the safety and success rate of the operation, and at the same time reduce the pain of patients.

[0030] In summary, the present application includes at least one of the following beneficial technical effects: 1. In the present application, by setting a deflection guiding head on the guide wire, deflection and swing occur when encountering resistance, which can effectively avoid the guide wire from damaging the inner wall of the blood vessel in complex and small blood vessels, improving the safety and success rate of the operation.

[0031] 2. In the present application, a silver paste electrode is coated on the surface of the elastic balloon, realizing the efficient ablation of calcified plaques and the dilation of the blood vessel lumen, solving the deficiencies in traditional methods such as simple drug ablation or rotational ablation, and the electrode distribution is more uniform, enabling more efficient and reliable ablation, improving the treatment effect.

[0032] 3. In the present application, by setting a floating balloon on the guide wire, the guide wire can maintain a suspended state in the blood vessel, avoiding the guide wire from clinging to the blood vessel wall due to the action of gravity, thereby reducing mechanical damage to the inner wall of the blood vessel.

[0033] 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 surgical risk.

[0034] 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, being able to maintain stable electrical conductivity for a long time to ensure 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. Description of the Drawings

[0035] 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.

[0036] 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.

[0037] Figure 3 is a front structural schematic diagram of the vascular interventional radiofrequency pulse ablation surgical system in Embodiment 1 or Embodiment 3 of this application.

[0038] Figure 4 is Figure 3 a partial enlarged structural schematic diagram of the place A in

[0039] Figure 5 is a control diagram of the vascular interventional radiofrequency pulse ablation surgical system in this application.

[0040] Figure 6 is a three-dimensional structural schematic diagram of the vascular interventional radiofrequency pulse ablation surgical system in Embodiment 2 of this application.

[0041] Figure 7 is a three-dimensional structural schematic diagram of the vascular interventional radiofrequency pulse ablation surgical system after removing the outer sheath tube in Embodiment 2 of this application.

[0042] In the figure: 10. Outer sheath tube; 11. First through hole; 20. Inner tube; 21. Second through hole; 22. Air flow channel; 30. Guide wire; 40. Operating handle; 41. First half shell; 42. Second half shell; 43. Installation cavity; 44. Strip-shaped hole; 50. Operating key; 60. Elastic balloon; 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; 80. Fiber optic controller; 90. Magnetic response coating; 100. Fiber optic connector; 110. Airflow switch; 120. Airflow pipeline; 130. Radio frequency generator; 140. Pulse radio frequency generating element; 150. Electrode connector; 160. Silver paste electrode; 170. Airflow connector; 180. Display screen; 190. Pressure sensor; 200. Temperature sensor; 210. Control switch; 220. Floating balloon; 230. Position signal transmission line. Detailed implementation manners

[0043] Next, in conjunction 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 and obtain other embodiments without creative labor, and these embodiments are also within the protection scope of the present invention. Embodiment 1

[0044] Referring to Figure 1 and Figure 2 as shown, a vascular interventional radiofrequency pulse ablation surgery system provided by an embodiment of the present application includes an outer catheter 10, an inner catheter 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 catheter 10 has a first through hole 11 along its axial direction. The first through hole 11 penetrates both ends of the outer catheter 10. One end of the outer catheter 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.

[0045] Referring to Figure 2 and Figure 3As shown, the length of the inner tube 20 is greater than that of the outer sleeve 10. The outer sleeve 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 sleeve 10. One end of the inner tube 20 extends out of the first through hole 11 of the outer sleeve 10 and extends into the installation cavity 43 inside the operating handle 40. A strip-shaped hole 44 is formed in 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 sleeve 10; an elastic balloon 60 is sleeved on the other end of the inner tube 20. The elastic balloon 60 is cylindrical and is coaxially arranged with the inner tube 20. The outer peripheries at both ends of the elastic balloon 60 are rounded to form a smooth surface transition; 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 sleeve 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 sleeve 10 through the operating key 50.

[0046] Referring to Figure 2 , Figure 3 and Figure 4 As shown, the inner tube 20 has a second through hole 21 along its axial direction inside. The second through hole 21 penetrates both ends of the inner tube 20. The guide wire 30 can slide through the second through hole 21 of the inner tube 20; a deflection guiding head 70 is provided at one end of the guide wire 30 close to the elastic balloon 60, and the deflection guiding head 70 can deflect and swing when encountering resistance. The design of the deflection guiding head 70 enables the guide wire 30 to deflect and swing flexibly when encountering resistance, avoiding damage to the inner wall of the blood vessel caused by hard pushing. Specifically, 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. The other end of the rod body 71 is connected to the installation seat 73, and a compression spring 74 is arranged between them. A pressure feedback sensor 75 that abuts against the compression spring 74 is also provided on 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 curved surface 722. The special structures of the rod body 71 and the cap body 72 not only enhance the stability of the guide wire 30 but also improve its flexibility and controllability in complex blood vessel paths. The design of the spherical curved surface 722 reduces the mechanical stimulation of the front end of the guide wire 30 to the blood vessel wall and reduces the surgical risk.

[0047] Referring to Figure 2 and Figure 3As shown, an optical fiber controller 80 is provided inside the operating handle 40. The pressure feedback sensor 75 is an optical fiber sensor, and a reflecting mirror surface 751 that cooperates 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. The application of optical fiber technology here mainly provides the magnitude of the resistance encountered by the force feedback deflector head 70 through the optical fiber sensor. It can use a fiber Bragg grating (FBG) sensor to detect the minute deformation at the end of the deflector head 70, thereby measuring the contact force.

[0048] In this embodiment, the optical fiber controller 80 can be used in combination with a pulse detection laser and a waveform acquisition device to achieve precise monitoring of the position of the guide wire 30. The pulse detection laser emits pulsed laser light, which is conducted through the optical fiber to the inside of 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 30. This information is fed back to the optical fiber controller 80 to adjust the attitude of the guide wire 30 and the direction of its next movement.

[0049] Combined with Figure 3 and Figure 4 As shown, an air flow channel 22 communicating with the elastic balloon 60 is provided inside 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 is connected to the elastic balloon 60 through a side opening. An air flow joint 170 and an air flow pipe 120 for connecting the air flow channel 22 and the air flow joint 170 are provided on the operating handle 40. An air flow switch 110 for controlling the inflow and outflow of air in the elastic balloon 60 is also provided on the operating handle 40. This enables convenient inflation and deflation of the elastic balloon 60 to 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 suitable position and state, improving the flexibility and safety of the operation. In addition, this design also helps to reduce the risk of blood vessel injury caused by improper manual operation.

[0050] Referring to Figure 4 and Figure 5As shown in the figure, 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, has a relatively large volume, and is independently arranged outside the operating handle 40. The pulsed radiofrequency generating element 140 can be arranged inside the operating handle 40 or inside the outer catheter 10 and the inner tube 20; an electrode connector 150 for connecting the radiofrequency generator 130 and the pulsed radiofrequency generating element 140 is arranged on the operating 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 arranged 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.

[0051] In this embodiment, a pressure sensor 190 and a temperature sensor 200 are arranged inside the elastic balloon 60, and a display screen 180 for displaying the pressure and temperature data inside the elastic balloon 60 is also arranged on the operating handle 40. The display screen 180 is electrically connected to the fiber optic controller 80. In this way, real-time monitoring and display of the pressure and temperature inside the elastic balloon 60 can be achieved, which not only helps the doctor to understand the state of the elastic balloon 60 at any time during the operation, ensures the safety and accuracy of the operation, but also can timely adjust the operation strategy to avoid vascular 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 patient's treatment experience.

[0052] The implementation principle is as follows: During use, the elastic balloon 60 quickly and accurately reaches the lesion position under the guiding action of the guide wire 30, and 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 target stenosis lesion position, and the pulsed radiofrequency energy acts on the lesion through the silver paste electrode 160, and the thermal effect generated by the pulsed radiofrequency current ablates the diseased tissue or abnormal lesion to achieve the treatment effect.

[0053] 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 and is convenient to operate, enabling the elastic balloon 60 and the silver paste electrode 160 to accurately locate to the target position, reducing the operation time and complexity, and improving the ablation effect.

[0054] In this embodiment, a 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 or 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 the organism. In addition, silver has antibacterial properties, can effectively inhibit the growth of bacteria, and further improve the biosafety of the electrode.

[0055] In this application, the elastic balloon 60 is made of a block polyetheramide resin material, and the guide wire 30 is formed by a polyurethane tungsten mixed imaging material and a tungsten carbide material together, where the mass fractions of the polyurethane tungsten mixed imaging material and the tungsten carbide material are both 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 guide wire 30 forms a thermoplastic polyurethane elastomer, has the characteristics of a wear-resistant and highly elastic plastic material, 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 maneuverability during interventional surgery, can effectively improve the safety and success rate of the surgery, and at the same time reduce the pain of patients. Example 2

[0056] Refer to Figure 6 and Figure 7 As shown, this embodiment is generally 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 guiding head 70 at the end of the guide wire 30, and 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, and each group of silver paste electrodes 160 is arranged along the length direction on the surface of the elastic balloon 60, and several groups of silver paste electrodes 160 are evenly spaced along the circumferential direction of the elastic balloon 60.

[0057] 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. Example 3

[0058] Reference Figure 1 、 Figure 2 and Figure 4 As shown, in this embodiment, 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 materials, such as Terfenol-D (Tb 0.3 Dy 0.7 Fe2), Galfenol (Fe-Ga alloy), ferrite (such as CoFe2O4), multiferroic material (such as BiFeO3), magnetoelectric composite material (such as Terfenol-D / PZT), etc. The magnetic response coating 90 is used in conjunction with an optical fiber sensor and an optical fiber controller 80. The magnetic response coating and the optical fiber sensor form an optical fiber magnetic field sensor. The entire system also includes a magnetic field generator, which forms 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 can reach 1000 ppm) under the action of the magnetic field, and the response speed is fast (microsecond level). By utilizing the time delay, phase change, or intensity change of light in the optical fiber, the optical signal is changed, and then the optical signal is transmitted to the optical fiber controller 80 for high-sensitivity magnetic field detection. After analyzing the magnetic field variables through data, 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 operation handle 40 to timely transmit the position information to the entire controller, and the position information can be displayed on the display screen 180 in real time for medical staff to refer to and operate.

[0059] The technical solution in this embodiment can be used in combination with the technical solution in Embodiment 1 to achieve dual positioning and obtain a more precise positioning effect. Embodiment 4

[0060] 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 of 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, and its magnetic field strength is between 0.08 and 0.1 T, and the magnetic field range is 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 turns the angle along with the direction of the combined 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.

[0061] The technical solution in this embodiment can be used in combination with the technical solutions in Embodiment 1 or / and Embodiment 3. In this embodiment, the remote operation and autonomous navigation of the guide wire 30 can be realized through the optical fiber controller 80 and the magnetic navigation system, helping doctors to 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.

[0062] Through precise positioning, the precise movement of the guide wire 30 is guided by using an external magnetic field to ensure that the guide wire 30 accurately reaches the target position. And this technical solution can realize remote control, reduce the need for doctors' manual operations, and at the same time reduce the trauma to patients. In this embodiment, the combination of optical fiber positioning and magnetic navigation improves the performance of the overall system.

[0063] 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 denoted 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 sleeve (10), an inner tube (20), a guide wire (30) and a pulsed radiofrequency generating element (140), wherein the outer sleeve (10) is slidably mounted on the inner tube (20), and the guide wire (30) slides through the inner tube (20); It is characterized in that An operating handle (40) is fixedly provided at one end of the outer sleeve (10); an elastic balloon (60) is sleeved on one end of the inner tube (20) and can be extended from the other end of the outer sleeve (10); a silver paste electrode (160) is coated on the surface of the elastic balloon (60) and is electrically connected to the pulsed radio frequency generating element (140); an operating key (50) connected to the other end of the inner tube (20) and used to push the inner tube (20) to move inside the outer sleeve (10) is provided on the operating handle (40); A deflection guide head (70) is provided at one end of the guide wire (30) close to the elastic balloon (60), and the deflection guide head (70) can generate deflection and swing when encountering resistance; the deflection guide head (70) comprises a rod body (71) and a cap body (72) located at one end of the rod body (71); a mounting seat (73) is provided at the end of the guide wire (30); the other end of the rod body (71) is connected to the mounting seat (73); one side of the cap body (72) is a connecting 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 curved surface (722); the rod body (71) and the mounting seat (73) are connected via a pressure spring (74); and a pressure feedback sensor (75) is provided on the mounting seat (73) and abuts against the pressure spring (74).

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

3. The vascular interventional 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 vessel is provided at a position of the end of the guide wire (30) close to the deflection guide head (70).

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

5. The vascular interventional radiofrequency pulse ablation surgical system according to claim 4, characterized in that: A magnetic response coating (90) matching with the magnetic field generator is arranged on the outer peripheral surface of one end of the inner tube (20) on which the deflection guide head (70) is mounted, and the magnetic response coating (90) is made of magnetostrictive material.

6. The vascular interventional radiofrequency pulse ablation surgical system according to claim 1 or 2, characterized in that: An air flow channel (22) connected to the elastic balloon (60) is provided in the inner tube (20); an air flow connector (170) and an air flow duct (120) for connecting the air flow channel (22) and the air flow connector (170) are provided on the operating handle (40); and an air flow switch (110) for controlling the air flow in and out of the elastic balloon (60) is also provided on the operating 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 in shape, the elastic balloon (60) is coaxially arranged with the inner tube (20), and the outer peripheries of both ends of the elastic balloon (60) are chamfered to form a smooth curved surface transition; the silver paste electrodes (160) are distributed in a spiral shape on the outer peripheral surface of the elastic balloon (60), or the silver paste electrodes (160) are evenly spaced along the circumference of the elastic balloon (60).

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

9. The vascular interventional radiofrequency pulse ablation surgery system according to claim 4, characterized in that: The operating handle (40) is also provided with a display screen (180) for displaying the pressure and temperature data inside the elastic balloon (60), 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 segmented polyetheramide resin material, and the guide wire (30) is formed by a polyurethane mixed tungsten developing material and a tungsten carbide material, wherein the mass fractions of the polyurethane mixed tungsten developing material and the tungsten carbide material are both 50%; the outer surface of the guide wire (30) is coated with a hydrophilic coating.

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