Radio frequency ablation guide wire

Abstract

The radiofrequency ablation guide wire comprises an inner guide wire assembly, an outer guide wire assembly arranged outside the inner guide wire assembly in a sleeving mode, an annular electrode array installed at the top end of the inner guide wire assembly and a control system connected with the inner guide wire assembly, and the inner guide wire assembly comprises an inner guide wire and an expandable anchoring device installed on the side wall of the inner guide wire; the internal guide wire comprises a guide wire front end, a guide wire middle section connected with the guide wire front end and a guide wire rear end connected with the guide wire middle section; the expandable anchoring device can be expanded and firmly fixed on myocardial tissue, the control system can control the annular electrode array to achieve ablation, the front end of a guide wire in the inner guide wire assembly is soft and used for making contact with the tissue, the middle section of the guide wire is used for supporting, the rear end of the guide wire is used for being held by a doctor, and work division is clear. Compared with the prior art, a better ablation effect can be achieved for some positions, and damage to tissue is reduced.

Description

Technical Field

[0001] The invention relates to a radio frequency ablation guide wire, in particular to a radio frequency ablation guide wire. Background Art

[0002] Radiofrequency ablation is a minimally invasive interventional treatment method used to treat certain types of arrhythmias (such as atrial fibrillation, supraventricular tachycardia, etc.). It delivers radiofrequency energy to specific locations within the heart through a catheter to destroy (ablate) abnormal tissue or pathways that cause arrhythmias. This technology involves the use of an electrode catheter that can be passed through the blood vessels to the heart and accurately positioned under the guidance of X-ray or other imaging technology.

[0003] The process of ablation treatment in the existing technology is: a guide wire and a catheter with a radiofrequency electrode are inserted and guided to the target area of ​​the heart through vascular puncture. After the abnormal tissue is accurately located with the help of a three-dimensional mapping system and electrophysiological examination, the electrode at the end of the catheter is close to the heart tissue, releasing radiofrequency energy to heat it locally, thereby destroying the abnormal tissue.

[0004] However, the anatomical structure between the left ventricular top (LVS) and the adjacent myocardium is complex, and the radiofrequency energy may not be effectively transmitted to the deep layer of the myocardium, resulting in incomplete ablation. Moreover, after some ablation operations, it is easy to cause greater damage to the patient's ablation site. Summary of the invention

[0005] The present invention overcomes the deficiencies of the prior art and provides a radiofrequency ablation guide wire.

[0006] To achieve the above-mentioned purpose, the technical solution adopted by the present invention is: a radiofrequency ablation guidewire, comprising: an inner guidewire assembly, an outer guidewire assembly sleeved outside the inner guidewire assembly, an annular electrode array installed on the top of the inner guidewire assembly, and a control system connected to the inner guidewire assembly;

[0007] The inner guidewire assembly comprises an inner guidewire and an expandable anchoring device mounted on the side wall of the inner guidewire;

[0008] The internal guide wire comprises a guide wire front end, a guide wire middle section connected to the guide wire front end, and a guide wire rear end connected to the guide wire middle section; the guide wire front end is a soft gradient section of 20mm-30mm, and the guide wire middle section is a rigid support section;

[0009] The annular electrode array includes a plurality of annular metal electrodes arranged around the tip of the catheter, and adjacent metal electrodes can be used to independently control the transmission of radio frequency energy, and each metal electrode is connected to a control system through a wire; adjacent metal electrodes are arranged at equal intervals;

[0010] The expandable anchoring device can be used to expand and be firmly fixed on the myocardial tissue.

[0011] In a preferred embodiment of the present invention, the control system includes a radio frequency generator and a high-precision control unit connected to the radio frequency generator; the radio frequency generator is connected to the annular electrode array through a precision wire to provide radio frequency energy; the high-precision control unit is connected to the expandable anchoring device, and the high-precision control unit is used to independently control the radio frequency energy transmission of each small electrode.

[0012] In a preferred embodiment of the present invention, the diameter of the metal electrode is 0.5 mm-3.0 mm, the length of the metal electrode is 1.0 mm-5.0 mm, and the distance between adjacent metal electrodes is 1.0 mm-20.0 mm.

[0013] In a preferred embodiment of the present invention, the material of the annular electrode is platinum, platinum-iridium alloy, titanium alloy or stainless steel.

[0014] In a preferred embodiment of the present invention, an insulating layer is coated on the inner wall and the outer wall of the outer guide wire assembly.

[0015] In a preferred embodiment of the present invention, the insulating layer is polytetrafluoroethylene or polyimide.

[0016] In a preferred embodiment of the present invention, the expandable anchoring device includes an expansion sleeve installed on the side wall of the internal guide wire, an expansion medium channel connected to the expansion sleeve, and a control valve arranged on the expansion medium channel.

[0017] In a preferred embodiment of the present invention, the expansion sleeve has an unexpanded state and an expanded state. In the unexpanded state, the expansion sleeve fits tightly on the guide wire body to form an outer diameter of 1.5mm-2.5mm; in the expanded state, the expansion sleeve expands radially outward to fit tightly on the blood vessel wall or other biological tissues.

[0018] In a preferred embodiment of the present invention, the material of the inner guide wire assembly is nickel-titanium alloy.

[0019] The present invention solves the defects existing in the background technology and has the following beneficial effects:

[0020] (1) An inner guide wire assembly, an outer guide wire assembly sleeved on the outside of the inner guide wire assembly, an annular electrode array installed on the top of the inner guide wire assembly, and a control system connected to the inner guide wire assembly are provided. The inner guide wire assembly includes an inner guide wire and an expandable anchoring device installed on the side wall of the inner guide wire. The inner guide wire includes a guide wire front end, a guide wire middle section connected to the guide wire front end, and a guide wire rear end connected to the guide wire middle section. The expandable anchoring device can be used to expand and firmly fix on the myocardial tissue. The control system can control the annular electrode array to achieve ablation. The guide wire front end in the inner guide wire assembly is soft and used to contact the tissue, the guide wire middle section is used for support, and the guide wire rear end is used by the doctor to hold, with clear division of labor. Compared with the existing technology, better ablation effects can be achieved for some positions and damage to the tissue is reduced.

[0021] (2) An expandable anchoring device is provided, including an expansion sleeve installed on the side wall of the internal guide wire, an expansion medium channel connected to the expansion sleeve, and a control valve provided on the expansion medium channel. The expansion sleeve has an unexpanded state and an expanded state. In the unexpanded state, the expansion sleeve fits tightly on the guide wire body to form an outer diameter of 1.5mm-2.5mm; in the expanded state, the expansion sleeve expands radially outward to fit tightly on the blood vessel wall or other biological tissues; the introduction site is supported by the expandable anchoring device; compared with the prior art, the range of motion of the internal guide wire is increased, and after support, the contact between the ablation guide wire as a whole and the tissue surface is reduced, thereby reducing friction or discomfort caused by materials.

[0022] (3) By setting the diameter of the metal electrode to 0.5mm-3.0mm, the length of the metal electrode to 1.0mm-5.0mm, and the spacing between adjacent metal electrodes to 1.0mm-20.0mm; by setting the diameter of the metal electrode to 0.5mm-3.0mm and the length to 1.0mm-5.0mm, more precise control of the treatment area can be achieved, and by adjusting the diameter, length and spacing of the metal electrode, the radiofrequency ablation guidewire can adapt to treatment needs of different sizes, shapes and positions; compared with the existing technology, it helps doctors to more accurately locate the treatment site during surgery, reduce damage to healthy tissues, increase the flexibility and scope of application of the equipment, and enable more patients to benefit from radiofrequency ablation treatment.

[0023] (4) The annular electrode array includes several annular metal electrodes arranged around the tip of the catheter. Several metal electrodes can be used to independently control the transmission of radiofrequency energy. Each metal electrode is connected to the control system through a wire. By adjusting and controlling different metal electrodes, the ablation effect can be adjusted, making ablation more precise and improving efficiency. The independent control of the metal electrodes allows the radiofrequency energy to be more concentratedly transmitted to the target tissue, thereby improving the treatment efficiency. Shorter electrode length and appropriate spacing help reduce energy loss and ensure treatment effectiveness. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art are briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

[0025] Figure 1 is a cross-sectional structural diagram of a preferred embodiment of the present invention;

[0026] Figure 2 is a front view of a preferred embodiment of the present invention;

[0027] Figure numerals: 1. outer guide wire assembly; 2. inner guide wire assembly; 21. annular electrode array; 22. expandable anchoring device. DETAILED DESCRIPTION

[0028] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0029] In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention may also be implemented in other ways different from those described herein. Therefore, the protection scope of the present invention is not limited to the specific embodiments disclosed below.

[0030] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the scope of protection of the present application. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the invention, unless otherwise specified, "multiple" means two or more.

[0031] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood by specific circumstances.

[0032] like Figure 1 As shown, a radiofrequency ablation guidewire comprises: an inner guidewire assembly 2, an outer guidewire assembly 1 sleeved outside the inner guidewire assembly 2, a ring electrode array 21 installed on the top of the inner guidewire assembly 2, and a control system connected to the inner guidewire assembly 2;

[0033] The inner guidewire assembly 2 includes an inner guidewire and an expandable anchoring device 22 installed on the side wall of the inner guidewire;

[0034] The internal guide wire comprises a guide wire front end, a guide wire middle section connected to the guide wire front end, and a guide wire rear end connected to the guide wire middle section; the guide wire front end is a soft gradient section of 20mm-30mm, and the guide wire middle section is a rigid support section;

[0035] The annular electrode array 21 includes a plurality of annular metal electrodes arranged around the catheter tip, and adjacent metal electrodes can be used to independently control the transmission of radio frequency energy, and each metal electrode is connected to a control system via a wire;

[0036] The expandable anchoring device 22 can be used to expand and firmly fix on the myocardial tissue;

[0037] The control system includes a radio frequency generator and a high-precision control unit connected to the radio frequency generator; the radio frequency generator is connected to the annular electrode array 21 through a precision wire to provide radio frequency energy; the high-precision control unit is connected to the expandable anchoring device 22, and the high-precision control unit is used to independently control the radio frequency energy transmission of each small electrode.

[0038] Furthermore, the diameter of the metal electrode is 0.5mm-3.0mm, the length of the metal electrode is 1.0mm-5.0mm, the material of the annular electrode is platinum, platinum-iridium alloy, titanium alloy or stainless steel, etc.; the distance between adjacent metal electrodes is 1.0mm to 20.0mm.

[0039] Specifically, by adjusting the diameter, length and spacing of the metal electrodes, the radiofrequency ablation guidewire can adapt to treatment needs of different sizes, shapes and positions; compared with the existing technology, it helps doctors to more accurately locate the treatment site during surgery, reduce damage to healthy tissue, increase the flexibility and scope of application of the equipment, and enable more patients to benefit from radiofrequency ablation treatment.

[0040] More specifically, the annular electrode array 21 allows the doctor to fine-tune the different metal electrodes to achieve precise adjustment of the ablation effect. This precision is crucial to ensure that the treatment is only targeted at the target tissue, helping to reduce potential damage to surrounding healthy tissue.

[0041] By independently controlling each metal electrode, radiofrequency energy can be delivered to the target tissue more concentratedly, thereby improving overall treatment efficiency. This means that treatment time may be shortened while maintaining or improving treatment effects; the design of the annular electrode array 21 enables it to adapt to a variety of treatment needs. Different electrode configurations and energy delivery modes can be optimized for different medical conditions and patient characteristics.

[0042] Specifically, the annular electrode material is platinum, platinum-iridium alloy, titanium alloy or stainless steel, etc. These materials have good corrosion resistance and fatigue resistance, and can ensure the stability and reliability of the electrode during long-term use.

[0043] More specifically, the insulating portion of the electrode is made of polytetrafluoroethylene (PTFE), polyimide (PI) or other high-performance polymer materials, which have excellent electrical insulation and chemical stability, can prevent radio frequency energy leakage and protect surrounding tissues from damage.

[0044] like Figure 2 As shown, the expandable anchoring device 22 includes an expansion sleeve installed on the side wall of the internal guide wire, an expansion medium channel connected to the expansion sleeve, and a control valve arranged on the expansion medium channel.

[0045] Specifically, the expansion sleeve has an unexpanded state and an expanded state. In the unexpanded state, the expansion sleeve fits tightly on the guide wire body to form an outer diameter of 1.5mm-2.5mm; in the expanded state, the expansion sleeve expands radially outward to fit tightly on the blood vessel wall or other biological tissues.

[0046] More specifically, the expansion sleeve is sleeved on the guide wire body and is made of elastic material, such as medical grade silicone, polyurethane, etc.

[0047] Specifically, the expansion medium channel is arranged inside the expansion sleeve or connected thereto, and is used to inject the expansion medium (such as saline, contrast agent, etc.) into the expansion sleeve to drive the expansion sleeve to change from an unexpanded state to an expanded state. One end of the expansion medium channel is connected to the inside of the expansion sleeve, and the other end is connected to an external injection device.

[0048] The control valve is arranged on the expansion medium passage to control the injection and release of the expansion medium. The control valve can be designed to be operated manually or automatically to ensure that the expansion and contraction of the expansion casing can be quickly and accurately controlled when necessary.

[0049] In detail, before the radiofrequency ablation surgery, the expandable anchoring device 22 of the radiofrequency ablation guidewire is inserted into the target blood vessel or tissue. Then, the expansion medium is injected into the expansion medium channel through an external injection device, so that the expansion sleeve is changed from an unexpanded state to an expanded state, and fits tightly on the blood vessel wall or other biological tissue. At this time, the retractable support component provides additional support force to prevent the expansion sleeve from being damaged due to excessive expansion. Next, the position of the guidewire body and the radiofrequency ablation electrode is adjusted by the position adjustment mechanism to achieve the optimal treatment position. Finally, the radiofrequency ablation device is started to transfer radiofrequency energy to the target tissue to achieve ablation treatment.

[0050] The outer guidewire assembly 1 is tubular; it is wrapped around the outside of the inner guidewire assembly 2 to provide it with an additional protective barrier. The tubular structure can ensure that the guidewire maintains sufficient strength and stability when passing through a narrow space such as a blood vessel.

[0051] An insulating layer, such as polytetrafluoroethylene (PTFE) or polyimide (PI), may be coated on the inner wall or the outer wall (or both) of the outer guide wire assembly 1. The main function of the insulating layer is to prevent the leakage of radio frequency energy and protect the surrounding tissue from damage. The thickness and uniformity of the insulating layer are critical to the performance of the guide wire and need to be precisely controlled to ensure the best effect.

[0052] Furthermore, in order to improve the passability of the guide wire in the blood vessel and reduce friction, a lubricating layer can be added to the surface of the outer guide wire assembly 1. The lubricating layer can be a hydrophilic or hydrophobic coating, depending on the required performance characteristics.

[0053] For example, a hydrophilic coating can attract water molecules to form a smooth "gel-like" surface, thereby reducing friction between the guidewire and the vessel wall.

[0054] Radioactive markers or contrast agents may be added to specific locations of the outer guidewire assembly 1 so as to more clearly show the location of the guidewire under X-ray or other imaging techniques.

[0055] This helps the doctor to more accurately locate and operate the guide wire during the operation, thereby improving the safety and success rate of the operation. Although the outer guide wire assembly 1 mainly provides protection and support, it can also be designed to have a certain degree of flexibility.

[0056] The material of the inner guide wire assembly 2 is nickel-titanium alloy; specifically, the inner guide wire assembly 2 is made of high-strength, high-elasticity stainless steel alloy or nickel-titanium alloy to ensure the flexibility and stability of the guide wire. The diameter and length of the inner core are customized according to clinical needs to meet the requirements of use in different surgical scenarios; an insulating layer, such as polytetrafluoroethylene (PTFE) or polyimide (PI), is wrapped around the outside of the inner core to prevent radio frequency energy leakage and protect surrounding tissues from damage. The thickness and uniformity of the insulating layer are crucial to the performance of the guide wire.

[0057] Specifically, the front end of the guidewire is designed with a ring electrode, which is composed of multiple independent small electrodes, each of which can independently control the transmission of radiofrequency energy. The material of the ring electrode is platinum-iridium alloy or titanium alloy, which has good conductivity and biocompatibility; an expandable anchor is connected to the back of the ring electrode to fix the guidewire to the myocardial tissue during the ablation process. The expandable anchor is composed of multiple bendable metal sheets, which have a central axis at the front end. The expansion and contraction of the metal sheets are achieved by controlling the tightness of the central axis.

[0058] It should be noted that for thinner myocardial tissue, the spacing between the ring electrodes may need to be appropriately reduced to ensure that the radiofrequency energy can fully cover the entire myocardial layer and achieve a good ablation effect; for thicker myocardial tissue or complex anatomical structures (such as myocardial bridges, ventricular aneurysms, etc.), the spacing between the ring electrodes may need to be appropriately increased to avoid unnecessary damage to the surrounding tissues and ensure that the radiofrequency energy can penetrate deep into the myocardium for ablation.

[0059] The spacing between the ring electrodes also affects the size and shape of the ablation zone. A smaller spacing may produce a narrower ablation zone, while a larger spacing may produce a wider ablation zone.

[0060] The transmission efficiency of radiofrequency energy is also affected by the spacing between the annular electrodes. If the spacing is too large, the radiofrequency energy may be attenuated or leaked during transmission, thereby reducing the ablation effect.

[0061] Example 1

[0062] The front end of the guide wire is 20 mm, the diameter of the ring electrode is 1.3 mm, the length of the metal electrode is 3.0 mm, and the material of the ring electrode is stainless steel; the distance between adjacent metal electrodes is 10.0 mm.

[0063] Comparative Example 1

[0064] The front end of the guide wire is 20 mm, the diameter of the annular electrode is 1.3 mm, the length of the metal electrode is 3.0 mm, and the material of the annular electrode is platinum; the distance between adjacent metal electrodes is 10.0 mm.

[0065] Comparative Example 2

[0066] The front end of the guide wire is 20 mm, the diameter of the annular electrode is 1.3 mm, the length of the metal electrode is 3.0 mm, and the material of the annular electrode is platinum-iridium alloy; the distance between adjacent metal electrodes is 10.0 mm.

[0067] Comparative Example 3

[0068] The front end of the guide wire is 20 mm, the diameter of the annular electrode is 1.3 mm, the length of the metal electrode is 3.0 mm, and the material of the annular electrode is titanium alloy; the distance between adjacent metal electrodes is 10.0 mm.

[0069] Comparative Example 4

[0070] The front end of the guide wire is 20 mm, the diameter of the annular electrode is 1.3 mm, the length of the metal electrode is 3.0 mm, and the material of the annular electrode is stainless steel, etc.; the distance between adjacent metal electrodes is 1.0 mm.

[0071] Comparative Example 5

[0072] The front end of the guide wire is 20 mm, the diameter of the annular electrode is 1.3 mm, the length of the metal electrode is 3.0 mm, and the material of the annular electrode is stainless steel, etc.; the distance between adjacent metal electrodes is 5.0 mm.

[0073] Comparative Example 6

[0074] The front end of the guide wire is 20 mm, the diameter of the annular electrode is 1.3 mm, the length of the metal electrode is 3.0 mm, and the material of the annular electrode is stainless steel, etc.; the distance between adjacent metal electrodes is 15.0 mm.

[0075] Comparative Example 7

[0076] The front end of the guide wire is 20 mm, the diameter of the annular electrode is 1.3 mm, the length of the metal electrode is 3.0 mm, and the material of the annular electrode is stainless steel, etc.; the distance between adjacent metal electrodes is 20.0 mm.

[0077] Experimental Example 1

[0078] The annular electrodes were installed on the RF ablation guide wire, and the RF generator power was set to 50W and the frequency was set to 460kHz; the guide wire was inserted into a biosimulation gel similar to the simulated left ventricular apex (LVS) myocardial tissue to ensure that the annular electrodes were in good contact with the target tissue. The data of Example 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3 were brought in, the RF generator was started, and the current, voltage, temperature and other parameters during the ablation process were recorded once every 10 hours, for a total of 6 times (i.e., 60 hours of ablation), and the tissue morphology after ablation, i.e., the ablation range, depth and other parameters were recorded;

[0079]

[0080]

[0081] The post-ablation effect is shown by the average ablation diameter and average ablation depth, as shown in Table 2 ;

[0082] Material Average ablation diameter Average ablation depth platinum 10.5 3.2 Platinum-iridium alloy 11.2 3.5 Titanium Alloy 9.8 2.9 Stainless steel 12.8 4.5

[0083] like Figure 2 As shown in the figure, the average ablation diameter of stainless steel is 11.8mm and the depth is 3.7mm, which has the largest ablation range among all materials, followed by platinum-iridium alloy and platinum. The ablation range of titanium alloy is the smallest. The good thermal conductivity and high resistivity of stainless steel enable it to more effectively convert electrical energy into thermal energy during radiofrequency ablation, thereby producing a larger ablation area in the target tissue. The reason for this difference is that under the action of the electric field, the free electrons of elements such as iron, chromium, and nickel in stainless steel will accelerate their movement and collide with molecules in the surrounding tissues, causing the molecular vibration to intensify, thereby generating heat. When this heat accumulates to a certain extent, it will cause the protein in the tissue cells to denature and coagulate, thereby achieving the purpose of ablation, and the ablation effect is more intense.

[0084] like Figure 1 As shown in the figure, stainless steel has the highest post-ablation current and post-ablation voltage, followed by platinum-iridium alloy, then platinum, and finally titanium alloy. This shows that stainless steel has good conductivity, and the current and voltage changes are small, followed by platinum-iridium alloy, then platinum, and finally titanium alloy. The reason is that under the action of the electric field, the free electrons in stainless steel can more easily pass through the lattice structure inside the material, thereby realizing smooth transmission of current. This good conductivity makes it possible to more effectively convert electrical energy into heat energy during radiofrequency ablation, thereby improving the ablation efficiency.

[0085] In summary, stainless steel exhibits high ablation efficiency and good electrical conductivity during radiofrequency ablation, which is mainly due to its good thermal conductivity, resistivity and chemical stability. At the molecular level, the energy transfer and conversion efficiency of the elements in stainless steel under the action of the electric field is high, making the ablation effect more significant. Stainless steel can be used as one of the preferred materials for the ring electrode in the radiofrequency ablation guidewire.

[0086] Experimental Example 2

[0087] The experimental environment was set to a constant temperature and humidity state to ensure the stability of environmental factors during the experiment; the annular electrode was installed on the radiofrequency ablation guidewire and ensured to be firmly fixed; a vernier caliper was used to accurately measure and adjust the spacing between the electrodes to 10 mm, and the measurement data was recorded;

[0088] Pour the myocardial tissue simulation gel into an experimental container, which is a cylindrical culture dish with a diameter of 100 mm and a height of 50 mm. The myocardial tissue simulation gel contains water, collagen, fibrin, cell culture medium and other ingredients;

[0089] Use a vernier caliper to measure the thickness and diameter of the gel and record the measurement data. (Use a vernier caliper to measure vertically at the center of the container to ensure measurement accuracy. The gel thickness is 20 mm and the gel diameter is 95 mm.

[0090] The radiofrequency generator was set to 50 W power and 460 kHz frequency, and the ablation time was set to 60 h;

[0091] The data of Example 1, Comparative Example 4, Comparative Example 5, Comparative Example 6 and Comparative Example 7 are introduced, and the radiofrequency ablation guide wire is inserted into the biological simulation tissue to ensure that the electrode is in full contact with the gel, and the radiofrequency generator is started to start the ablation process. During the ablation process, a data recorder is used to record data such as current, voltage and temperature, and a camera is used to record morphological changes during the ablation process. After the ablation is completed, a vernier caliper and an electronic scale are used to measure the ablation range (diameter and depth) and the affected range of the surrounding tissue;

[0092] All measurements were recorded and photos of the post-ablation morphology were taken;

[0093] In order to verify the stability and significance of the experimental results, the above experimental steps need to be repeated multiple times (e.g., 3 times), using new biomimetic tissue samples in each experiment, and recording all measurement data, as shown in Table 3;

[0094]

[0095]

[0096] According to Table 3, the ablation range and depth of Comparative Example 4 are the largest, but the tissue damage is the most serious. As the spacing increases, the ablation range and depth of Comparative Examples 5, 6, and 7 also decrease. In the three groups of experiments in Example 1, the electric field strength is moderate at a spacing of 10 mm, which can generate enough heat energy to destroy the target tissue without causing excessive damage to the surrounding tissue. This shows that the molecular vibration and heat energy generated under this electric field strength are moderate, so that the ablation range and depth are moderate, achieving a balance between the ablation effect and the damage to the surrounding tissue. In Comparative Example 4, due to the excessively high electric field strength, the chemical bonds between the molecules of the local tissue are broken, and a large amount of heat energy is generated, thereby causing extensive tissue damage. The excessively high electric field strength not only destroys the target tissue, but also significantly affects the surrounding tissue, causing significant damage. In Comparative Examples 5, 6, and 7, this is because the weakening of the electric field strength leads to a reduction in the heat energy generated between the molecules, thereby reducing the range and depth of ablation. This trend is positive in reducing damage to surrounding tissues, but the ablation effect may not be enough to meet expectations.

[0097] From the current and voltage data, we can see that as the spacing increases, the electric field strength weakens, so the initial current and voltage also decrease accordingly. At a spacing of 10 mm, the electric field distribution is relatively stable, resulting in little difference in the initial current and voltage. This stability is conducive to the control and prediction of the ablation process. The current and voltage after ablation: Similarly, at a spacing of 10 mm, the current and voltage after ablation also remain relatively stable, indicating that the electric field distribution during the ablation process has not changed significantly, which is conducive to the stability and repeatability of the ablation effect.

[0098] The temperature data also show that as the spacing increases, the maximum temperature gradually decreases. At a spacing of 10 mm, the maximum temperature is moderate, which can destroy the target tissue without causing overheating and damage to the surrounding tissue. This temperature control is crucial to protect the surrounding tissue and maintain a balance between the ablation effect.

[0099] In summary, at a spacing of 10 mm, the electric field strength is moderate, and the vibration and heat energy generated between molecules are also moderate. This moderate electric field strength can ensure that the molecules in the target tissue are subjected to sufficient energy shock during the ablation process, thereby destroying their chemical bonds and causing tissue necrosis. At the same time, due to the moderate electric field strength, the molecules in the surrounding tissues are subjected to less energy shock, and therefore less damage. In addition, the electric field distribution at a spacing of 10 mm is relatively stable, which is conducive to the control and prediction of the ablation process, thereby improving the significance and stability of the ablation effect. The 10 mm spacing shows the best performance in terms of ablation effect, surrounding tissue damage, current and voltage stability, and temperature control.

[0100] When the present invention is used, under the guidance of echocardiography, the doctor inserts the radiofrequency ablation guidewire through the blood vessels to near the top of the left ventricle. The position and depth of the guidewire should be adjusted according to the real-time monitoring of the echocardiogram. When the guidewire reaches the predetermined position, the doctor injects the expansion medium (such as saline) in the expansion sleeve to make it expand radially outward rapidly and evenly, and fit closely to the myocardial wall at the top of the left ventricle. The degree of expansion of the expansion sleeve should be adjusted according to the patient's specific situation and surgical needs to ensure that it provides a stable anchoring effect. After confirming that the guidewire and electrode are in the correct position, the doctor starts the control system to send radiofrequency current to the electrode. During the treatment process, the doctor should regularly monitor the effect of radiofrequency ablation and make adjustments as needed.

[0101] The above is based on the ideal embodiment of the present invention. Through the above description, relevant personnel can make various changes and modifications without departing from the technical concept of the present invention. The technical scope of the present invention is not limited to the content in the specification, and the technical scope must be determined according to the scope of the claims.

Claims

1. A radiofrequency ablation guidewire, characterized in that: include: An inner guide wire assembly (2), an outer guide wire assembly (1) sleeved on the outside of the inner guide wire assembly (2), an annular electrode array (21) mounted on the top of the inner guide wire assembly (2), and a control system connected to the inner guide wire assembly (2); The inner guide wire assembly (2) comprises an inner guide wire and an expandable anchoring device (22) installed on the side wall of the inner guide wire; The internal guide wire comprises a guide wire front end, a guide wire middle section connected to the guide wire front end, and a guide wire rear end connected to the guide wire middle section; the guide wire front end is a soft gradient section of 20mm-30mm, and the guide wire middle section is a rigid support section; The annular electrode array (21) comprises a plurality of annular metal electrodes arranged around the tip of the catheter, adjacent metal electrodes can be used to independently control the transmission of radio frequency energy, and each metal electrode is connected to a control system via a wire; The expandable anchoring device (22) can be used to expand and be firmly fixed on the myocardial tissue.

2. A radiofrequency ablation guidewire according to claim 1, characterized in that: The control system comprises a radio frequency generator and a high-precision control unit connected to the radio frequency generator; the radio frequency generator is connected to the annular electrode array (21) via a precision wire to provide radio frequency energy; the high-precision control unit is connected to the expandable anchoring device (22), and the high-precision control unit is used to independently control the radio frequency energy transmission of each small electrode.

3. The radiofrequency ablation guidewire according to claim 1, characterized in that: The diameter of the metal electrode is 0.5 mm-3.0 mm, the length of the metal electrode is 1.0 mm-5.0 mm, and the distance between adjacent metal electrodes is 1.0 mm-20.0 mm.

4. The radiofrequency ablation guidewire according to claim 1, characterized in that: The material of the annular electrode is, for example, platinum, platinum-iridium alloy, titanium alloy or stainless steel.

5. The radiofrequency ablation guidewire according to claim 1, characterized in that: An insulating layer is coated on the inner wall and the outer wall of the outer guide wire assembly (1).

6. A radiofrequency ablation guidewire according to claim 5, characterized in that: The insulating layer is polytetrafluoroethylene or polyimide.

7. The radiofrequency ablation guidewire according to claim 1, characterized in that: The expandable anchoring device (22) comprises an expansion sleeve installed on the side wall of the internal guide wire, an expansion medium channel connected to the expansion sleeve, and a control valve arranged on the expansion medium channel.

8. The radiofrequency ablation guidewire according to claim 7, characterized in that: The expansion sleeve has an unexpanded state and an expanded state. In the unexpanded state, the expansion sleeve fits tightly on the guide wire body to form an outer diameter of 1.5mm-2.5mm; in the expanded state, the expansion sleeve expands radially outward to fit tightly on the blood vessel wall or other biological tissues.

9. The radiofrequency ablation guidewire according to claim 1, characterized in that: The material of the inner guide wire assembly (2) is nickel-titanium alloy.

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