Radiofrequency ablation apparatus and radiofrequency ablation catheter

Abstract

Disclosed are a radiofrequency ablation apparatus and a radiofrequency ablation catheter. The apparatus comprises: a catheter body, a handle, a connection cable, and a connector which are sequentially connected from the distal end to the proximal end, wherein the catheter body is, from the distal end, sequentially provided with a rubber head, a heating section, and a main body catheter. The surface of the heating section is provided with an insulation outer sleeve with insulating and smoothing effects, and the heating section is internally provided with coils that are used for heating and are wound from alloy wires. The coils comprise a proximal end ablation coil and a distal end ablation coil. The ablation coils formed by winding different alloy wires are wound from the same start point or wound in an "end-to-end connection" manner; alloy wires with the same start point have opposite alloy wire winding directions, and alloy wires with "connected start and end points" have the same alloy wire winding direction. The radiofrequency ablation apparatus of the present disclosure can achieve radiofrequency closure of varicose veins at different diseased regions without the need to change instruments, avoiding the problem of uneven heating caused by uneven distribution of alloy wires between different coils and thereby preventing related surgical risks.

Description

Radiofrequency ablation device and radiofrequency ablation catheter

[0001] This application claims priority to the Chinese patent application with application number 202410375583X filed on March 29, 2024, and invention name “A radiofrequency ablation device and a radiofrequency ablation catheter”.

Technical field

[0002] The present invention relates to a medical device for interventional treatment, and in particular to a radiofrequency ablation device and a catheter for treating varicose veins. [Background Technology]

[0003] In recent years, radiofrequency therapy (RFT) has gained widespread application across multiple medical fields due to its unique advantages. RFT uses heat energy generated by high-frequency electromagnetic fields to precisely target tissue, causing it to shrink or coagulate, thereby achieving therapeutic effects. In the treatment of varicose veins, RFT can shrink diseased vein walls through thermal energy, thereby improving blood flow and reducing varicose veins.

[0004] However, despite the potential applications of radiofrequency therapy in varicose vein treatment, existing radiofrequency therapy technology still faces some challenges. For example, optimizing the design of treatment equipment to make it easier to operate and use, and improving treatment efficiency and patient comfort are issues that need to be addressed.

[0005] [Summary of the invention]

[0006] The present invention provides a radiofrequency ablation catheter, which can improve treatment efficiency.

[0007] The technical solutions of the present invention are as follows:

[0008] A radiofrequency ablation catheter, comprising:

[0009] Coil inner cannula, ablation coil;

[0010] The ablation coil includes a proximal ablation coil and a distal ablation coil, wherein the proximal ablation coil and the distal ablation coil are respectively located at the proximal end and the distal end of the coil inner sleeve;

[0011] The proximal ablation coil and the distal ablation coil are both formed by spirally winding alloy wire on the outer surface of the coil inner sleeve;

[0012] The proximal ablation coil and the distal ablation coil are formed by different alloy wires being wound from their respective starting points in opposite winding directions toward the proximal end and the distal end respectively, and the distance between the two starting points is 0-3mm, or the proximal ablation coil and the distal ablation coil are formed by different alloy wires being wound from their respective starting points in the same winding direction toward the proximal end, and the distance between the winding end point of the distal ablation coil and the winding starting point of the proximal ablation coil is 0-3mm.

[0013] In a preferred embodiment, the alloy wires wound on the outer surface of the inner sleeve of the coil are evenly distributed.

[0014] In a preferred embodiment, the two starting points are arranged on the same cross-section, or the starting point and the midpoint of the proximal ablation coil are arranged on the same cross-section, which is the cross-section of the coil inner sleeve. In a preferred embodiment, a first wire is further included, wherein a threading hole is provided on the surface of the coil inner sleeve near the winding end point of the proximal ablation coil. After the first wire is connected to the alloy wire of the proximal ablation coil, it enters the interior of the coil inner sleeve through the threading hole.

[0015] In a preferred embodiment, it also includes a second wire, and a threading hole is provided on the surface of the inner sleeve of the coil, near the winding end point of the distal ablation coil. The second wire is connected to the alloy wire of the distal ablation coil and then enters the inner sleeve of the coil through the threading hole.

[0016] In a preferred embodiment, the proximal ablation coil is formed by winding an alloy wire, and the distal ablation coil is formed by winding an alloy wire.

[0017] In a preferred embodiment, the proximal ablation coil is formed by winding two alloy wires, namely a first proximal ablation coil and a second proximal ablation coil.

[0018] In a preferred embodiment, a threading hole is provided on the surface of the coil inner sleeve at the end position of the alloy wire winding corresponding to the first proximal ablation coil and the second proximal ablation coil. The alloy wire is connected to the wire before entering the threading hole to prevent the connection point between the alloy wire and the wire from being located inside the coil inner sleeve.

[0019] In a preferred embodiment, at least two temperature measuring devices are provided on the proximal ablation coil.

[0020] In a preferred embodiment, an insulating outer sleeve is provided on the outer surface of the ablation coil, and the insulating outer sleeve is tightly attached to the surface of the ablation coil by high-temperature heat shrinkage.

[0021] The present invention also provides a radiofrequency ablation device, comprising the radiofrequency ablation catheter as described above.

[0022] In a preferred embodiment, it also includes an ablation start-stop button, a radiofrequency closure generator, and a temperature control controller; the radiofrequency ablation device includes multiple working modes; different working modes correspond to the working modes when one or more alloy wires are turned on and off.

[0023] The present invention also provides a radiofrequency ablation device, comprising a radiofrequency ablation catheter, an ablation start / stop button, a radiofrequency closure generator, and a temperature control controller; the radiofrequency ablation device comprises a first working mode and a second working mode;

[0024] In the first working mode, press the ablation start / stop button, and the radiofrequency sealing generator starts working, outputting high-frequency current to the proximal ablation coil and the distal ablation coil at the same time. The two coils generate heat under the action of the high-frequency current. At the same time, the first thermocouple, the second thermocouple, and the third thermocouple all monitor the temperature changes of the vascular tissue. The three thermocouples transmit the temperature signal to the temperature controller and control the radiofrequency sealing generator to control the current of the two coils respectively. The temperature value will also be displayed in real time on the radiofrequency sealing generator screen.

[0025] In the second working mode, press the ablation button and the RF closure generator starts working, while outputting high-frequency current to the distal ablation coil. The distal ablation coil generates heat under the action of the high-frequency current. At the same time, the third thermocouple monitors the temperature changes of the vascular tissue. The third thermocouple transmits the temperature signal to the temperature controller and controls the current of the distal coil by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0026] In a preferred embodiment, a third working mode is also included; in the third working mode, the ablation start-stop button is pressed, and the RF closure generator starts working and outputs high-frequency current to the proximal ablation coil. The proximal ablation coil generates heat under the action of the high-frequency current. At the same time, the first thermocouple and the second thermocouple monitor the changes in the temperature of the vascular tissue. The first thermocouple and the second thermocouple transmit the temperature signal to the temperature controller and control the current of the proximal coil by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0027] Compared with the prior art, the present invention has the following beneficial effects:

[0028] 1. In the radiofrequency ablation catheter of the present invention, different alloy wires are wound from the same starting point or in a "joined" manner. Alloy wires with the same starting point are wound in opposite directions, while alloy wires with the starting and ending points "joined" are wound in the same direction. This ensures that the alloy wires are evenly distributed on the inner sleeve of the coil at the junction of the ablation coils formed by different alloy wires. This can avoid the problem of uneven distribution of alloy wires between ablation coils formed by different alloy wires, which leads to uneven heating.

[0029] 2. In the radiofrequency ablation catheter of the present invention, the proximal and distal ablation coils are connected to the guide wires before entering the threading holes. This firstly prevents the alloy wires constituting the proximal and distal ablation coils from entering the coil inner sheath, which may cause the temperature of the coil inner sheath to be too high. Secondly, the connection points between the proximal and distal ablation coils and the guide wires are arranged outside the coil inner sheath, which can avoid the increased risk of fusing the connection points inside the tube and improve the reliability of the radiofrequency ablation catheter.

[0030] 3. The radiofrequency ablation catheter of the present invention evenly arranges multiple sets of temperature measuring devices on a longer radiofrequency ablation coil, avoiding inaccurate and insensitive temperature measurement of local coils far from the temperature measurement point. This can provide more accurate and comprehensive real-time feedback on the ablation process, ensuring a higher success rate and safety of the surgery.

[0031] 4. The radiofrequency ablation catheter of the present invention can achieve radiofrequency ablation of different lesion sites without changing the instrument by setting a distal ablation coil and a proximal ablation coil, wherein the distal ablation coil is used alone to treat communicating varicose veins, perforating varicose veins, tortuous lesions of superficial vein trunks and short segments at the end of ablation, and the distal ablation coil and the proximal ablation coil are used together to treat superficial varicose veins of the lower limbs. A single ablation coil or a combination of multiple ablation coils can meet the treatment of varicose veins in different sites.

Brief Description of the Drawings

[0032] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without inventive efforts. Among them:

[0033] FIG1 is a schematic diagram of the overall structure of a radiofrequency ablation catheter according to a first embodiment of the present invention;

[0034] FIG2 is a partial schematic diagram of a heating section of a radiofrequency ablation catheter according to a first embodiment of the present invention;

[0035] FIG3 is a partial schematic diagram of the connection portion between the inner sleeve of the coil and the main tube of the radiofrequency ablation catheter according to the first embodiment of the present invention;

[0036] FIG4 is a schematic diagram of a temperature measurement structure of a radiofrequency ablation catheter according to a first embodiment of the present invention;

[0037] FIG5 is a schematic diagram of the working principle of the radiofrequency ablation device according to the first embodiment of the present invention;

[0038] FIG6 is a partial schematic diagram of a heating section of a radiofrequency ablation catheter according to a second embodiment of the present invention;

[0039] FIG7 is a partial schematic diagram of the heating section of the radiofrequency ablation catheter according to the third embodiment of the present invention. [Specific implementation method]

[0040] Example 1

[0041] As shown in Figure 1, the radiofrequency ablation device of this embodiment is provided with a rubber head 1, a heating section 2, a main tube 3, a stress relief tube 4, a handle 5, a guide wire port 6, a connecting cable 7, and a connector 8 in sequence from the distal end to the proximal end; wherein the rubber head 1, the heating section 2, and the main tube 3 are arranged in sequence from the distal end to the proximal end to form a radiofrequency ablation catheter. The stress relief tube 4 is sleeved on the proximal end of the main tube 3, and the distal outlet of the handle 5 is positioned and fixedly connected to the proximal end of the main tube 3 through the stress relief tube 4. The guide wire port 6 is located at the proximal end of the handle 5. One end of the connecting cable 7 is electrically connected to the heating section 2 at the handle 5, and the other end is electrically connected to the connector 8. The connector 8 is used to connect to an external device to provide radiofrequency current.

[0042] As shown in FIG. 2 , the heating section 2 includes a coil inner sleeve 10 , an ablation coil wound with alloy wire, and an insulating outer sleeve 9 .

[0043] Among them, the coil inner sleeve 10 is a single-lumen tube, and a coil formed by folding an alloy wire and winding it is provided on its surface; wherein, the alloy wire is folded at the winding starting point, and the folded alloy wire is wound in a spiral form along the surface of the coil inner sleeve 10.

[0044] The ablation coil includes two sections, namely the proximal ablation coil and the distal ablation coil. The width of the two sections depends on the treatment site. The width of the proximal ablation coil 2-1 is 0.3cm-8.0cm, and the width of the distal ablation coil 2-2 is 0.3cm-8.0cm.

[0045] In this embodiment, the proximal ablation coil 2-1 is formed by folding a single alloy wire in half and winding it, while the distal ablation coil 2-2 is formed by folding another single alloy wire in half and winding it. The alloy wire used to wind the distal ablation coil 2-2 is 300mm-2600mm long, while the alloy wire used to wind the proximal ablation coil 2-1 is 300mm-2600mm long. For coils formed from the same alloy wire, the spacing between the wires is 0-0.15mm, and the direction of this spacing aligns with the axial direction of the coil inner sleeve 10.

[0046] At the junction of the proximal ablation coil 2-1 and the distal ablation coil 2-2 formed by different alloy wires, there is often a large unwound gap or uneven distribution of alloy wires. The absence of alloy wires or uneven distribution of alloy wires will lead to poor heating effect in the area at the junction of the two coils, resulting in uneven heating when the proximal ablation coil and the distal ablation coil work at the same time, thereby reducing the treatment effect.

[0047] To solve this problem, the present application sets the distance between the winding starting point of the alloy wire of the proximal ablation coil 2-1 and the winding starting point of the alloy wire of the distal ablation coil 2-2 along the outer surface of the coil inner sleeve 10 to be between 0-3mm, and the two alloy wires are wound toward the proximal end and distal end respectively in opposite winding directions along the surface of the coil inner sleeve 10 from the starting point, so that the interval between the alloy wire at the junction of the two ablation coils and the adjacent alloy wires is the same as the interval between the alloy wires at the non-junction of the ablation coils, and "looks" like they are wound together by the same alloy wire. This setting ensures that the intervals between the alloy wires wound on the coil inner sleeve 10 are the same, the alloy wires distributed on the coil inner sleeve 10 are uniform, and the uniformity of the distribution of alloy wires at the junction of the ablation coils wound by different alloy wires ensures the independent control of each ablation coil while also ensuring the uniform temperature of the entire heating section, thereby improving the heating efficiency of the radio frequency ablation device during the ablation process.

[0048] Preferably, the starting point of the alloy wire of the proximal ablation coil 2-1 and the starting point of the alloy wire of the distal ablation coil 2-2 are arranged on the same cross-section, which is the cross-section of the coil inner sleeve 10 and passes through the starting point of the alloy wire. The distance between the two starting points on the cross-section is between 0-3 mm. The alloy wire forming the two ablation coils is then wound from the starting point along the surface of the coil inner sleeve 10 in opposite winding directions toward the proximal and distal ends, respectively. Furthermore, the distance between the two starting points is preferably 0 mm.

[0049] In actual operation, the applicant also found that the connection point between the alloy wire of the proximal ablation coil 2-1 or the distal ablation coil 2-2 and the wire 13 is set in the coil inner sleeve 10, and the alloy wire that generates heat will inevitably be partially located in the coil inner sleeve 10. During operation, the heat generated by the alloy wire in the coil inner sleeve 10 will inevitably cause the temperature in the coil inner sleeve 10 to further rise. If the connection point is set in the coil inner sleeve 10, the risk of melting or falling off of the connection point will increase, thereby increasing the risk of damage to the radiofrequency ablation catheter.

[0050] In order to solve the above problems, as shown in Figure 2, the present invention opens small holes at the end points of the alloy wire winding on the surface of the coil inner sleeve 10, which are called circular threading holes 14. The two end points of the alloy wire of the proximal ablation coil 2-1 are respectively connected to different wires 13-1 through a connection point 12-1, and the two end points of the alloy wire of the distal ablation coil 2-2 are respectively connected to wires 13-2 through a connection point 2 12-2. The connection point 12-1 and the connection point 2 12-2 are both arranged on the outside of the coil inner sleeve 10; the wire 13-1 and the wire 2 13-2 are respectively connected to the proximal ablation coil 2-1 and the distal ablation coil 2-2 and then enter the inside of the coil inner sleeve 10 through the threading holes; through this arrangement, the alloy wire is prevented from entering the coil inner sleeve 10 to further increase the temperature inside the coil inner sleeve 10, and the connection point is arranged outside the coil inner sleeve 10, reducing the risk of damage to the connection point.

[0051] Specifically, the wire 13 is connected to the ablation coil by welding.

[0052] As shown in Figures 1-3, a guide wire tube 11 is also provided inside the coil inner sleeve 10. One end of the guide wire tube 11 passes through the distal opening of the coil inner sleeve 10, passes through the inner cavity of the main body tube 3 and the inner cavity of the handle 5, and the other end is inserted into the distal inner cavity of the guide wire port 6, and is connected to and communicated with the guide wire port 6.

[0053] Specifically, the alloy wire is made of 52 alloy (nickel-iron alloy) with a PI (polyimide) insulation coating, and has an outer diameter of 0.1-0.2 mm. Conductor 13 is made of copper wire with a PI (polyimide) or PA (nylon) insulation coating, and has an outer diameter of 0.1-0.15 mm. The inner diameter of the circular threading hole 14 in the coil inner sleeve 10 is 0.35-0.5 mm.

[0054] Both the proximal ablation coil 2-1 and the distal ablation coil 2-2 are provided with temperature measuring devices. For example, the temperature measuring devices can be provided on the unwound intervals provided on the distal ablation coil and the proximal ablation coil.

[0055] As shown in Figure 2 , the distal ablation coil 2-2 and the proximal ablation coil 2-1 should each have several unwound intervals with a width of 0.5mm-3.0mm. Temperature measuring devices are provided on the unwound intervals. In the present invention, two unwound intervals are preferably provided in the middle of the proximal ablation coil 2-1, evenly distributed along the length of the proximal ablation coil. An unwound interval is provided in the middle of the distal ablation coil 2-1, and the alloy wire runs along the axial direction of the RF ablation catheter on the surface of the unwound interval of each coil. The number of temperature measuring devices can be set based on the length of the ablation coil and the required temperature measurement sensitivity. For example, in this embodiment, the proximal ablation coil 2-1 is longer, and multiple temperature measuring devices can be provided in the proximal ablation coil 2-1. This can avoid inaccurate and insensitive temperature measurement in local coils farther from the temperature measurement point, providing more accurate and comprehensive real-time feedback on the ablation process, ensuring a higher success rate and safety of the procedure.

[0056] The distal ablation coil 2 - 2 or the proximal ablation coil 2 - 1 made of alloy wire is fixed to the inner sleeve 10 of the coil by gluing.

[0057] In this embodiment, the material of the coil inner sleeve 10 is preferably high-temperature resistant polyetheretherketone (PEEK) or polyimide (PI) material, specifically, for example, polyetheretherketone (PEEK); the length of the coil inner sleeve 10 is 5.0-15.0 cm, preferably 9.0-11.cm, the inner diameter of the coil inner sleeve 10 is 1.0-1.7 mm, and the outer diameter is 1.2-1.9 mm, preferably the inner diameter is 1.10-1.20 mm, and preferably the outer diameter is 1.30-1.40 mm.

[0058] In the embodiment shown in FIG2 , the insulating outer sleeve 9 is a single-lumen tube that can be heat-shrunk at high temperatures and adhered tightly to the surface of the coil wound by the alloy wire. The manufacturing material can be selected from one of FEP, PVDF, PTFE, and PET, and the thickness is 0.01-0.2 mm.

[0059] In addition, the arrangement of the temperature measuring devices of the distal ablation coil and the proximal ablation coil is shown in Figure 4. In this embodiment, each set of temperature measuring devices includes a temperature measuring ring 19 and a temperature sensor 20. The temperature measuring ring 19 is a "C-shaped" ring.

[0060] As shown in Figure 4, in this embodiment, the temperature measuring ring 19 is assembled in the middle position of the unwound interval of the coil. The cross-sectional opening of the temperature measuring ring 19 is located on both sides of the straight section of the alloy wire arranged along the axial direction of the radiofrequency ablation catheter and does not contact the alloy wire; the temperature measuring ring 19 is fixed to the surface of the inner sleeve 10 of the coil using glue.

[0061] The glue is preferably UV glue or Loctite 4011 glue. The material of the temperature measuring ring can be selected from one of platinum-iridium alloy, platinum, gold, and stainless steel; the inner diameter of the temperature measuring ring ranges from 1.3 to 2.0 mm, the outer diameter ranges from 1.4 to 2.1 mm, and the width ranges from 0.5 to 2.5 mm.

[0062] Continuing to refer to Figure 4, a circular threading hole 18 is opened on the surface of the coil inner sleeve 10 at the gap position between the temperature measuring ring 19 and the distal end of the alloy wire (the threading hole 18 can also be set on the side of the temperature measuring ring 19 close to the proximal end of the alloy wire as needed). The aperture size of the threading hole 18 is 0.15mm-0.3mm. The extension line of the temperature sensor 20 is inserted into the inner cavity of the coil inner sleeve 10 from the circular threading hole 18. The extension line is subsequently connected to the connector 8 through the inner cavity of the main tube 3, the handle 5, and the connecting cable 7 (please refer to Figure 1); the head end of the temperature sensor 20 is set at the center of the surface of the temperature measuring ring 19 and is fixed with UV glue or Loctite 4011 glue.

[0063] In this embodiment, the temperature sensor 20 is a thermocouple.

[0064] As shown in Figure 2, after the coil is wound and the temperature measuring device is installed, an insulating outer sleeve 9 is placed on the outermost layer of the entire heating section 2, keeping the distal end of the insulating outer sleeve 9 flush with the distal end opening of the coil inner sleeve 10. A heat shrink machine is used to heat shrink the insulating outer sleeve 9 to completely wrap the heating section 2. The heat shrinking temperature is 200-260°C. Specifically, the material of the insulating outer sleeve 9 can be FEP (fluorinated ethylene propylene copolymer), which is transparent in color, has a wall thickness of 0.09-0.11mm, a length of 10cm-15cm, an expanded inner diameter greater than 1.9mm, and a restored inner diameter less than 1.3mm.

[0065] In the present embodiment, guide wire tube 11 is shaped as single lumen tubular. Guide wire tube 11, when installed, penetrates one end of guide wire tube 11 from the distal opening of sleeve tube 10 in coil, penetrates the inner cavity of sleeve tube 10, main body pipe 3 and handle 5 in coil successively, and the far-end of guide wire tube 11 exposes the distal opening 1.0-5.0mm of sleeve tube 10 in coil, preferably 2.0-3.0mm, the near-end of guide wire tube 11 inserts the distal inner cavity of guide wire port 6, and insertion length is 0.3-1.0cm, and glue is used to bond and fix interface. Specifically, the material of guide wire tube 11 can be PI (polyimide), and internal diameter is 0.5-0.7mm, and external diameter is 0.6-0.8mm.Glue is preferably UV glue or Loctite 4011 glue.

[0066] As shown in Figure 2, the adhesive tip 1 is located at the distal end of the RF ablation catheter. Its function is to make the catheter tip smoother, ensuring that the movement of the catheter during surgery does not damage the blood vessels. The adhesive tip 1 is made of epoxy resin glue or UV glue. Specifically, the glue is applied layer by layer to the outer surface of the guidewire tube 11 and cured to form the adhesive tip 1. The shape of the adhesive tip 1 should be essentially spherical, with an outer diameter of 1.5-2.33mm, preferably 1.7-2.1mm. The glue is preferably UV glue or Loctite 4011 glue.

[0067] After the alloy wires forming the proximal ablation coil 2-1 and the distal ablation coil 2-2 are wound, they are connected to the guide wire 13. Referring to Figure 3, all guide wires 13 and the extension wires of the temperature sensor 20 are inserted into the inner lumen of the main tube 3. Glue is applied to the proximal 5-10 mm length of the coil inner sleeve 10. The glued portion of the coil inner sleeve 10 is then inserted into the inner lumen of the main tube 3 to bond the coil inner sleeve 10 and the main tube 3 together. The main tube 3 is a multi-layer single-lumen braided tube, with an outer layer made of Pebax 7233 or PA12, a middle layer of 304 stainless steel mesh, and an inner layer made of Pebax 7233 or PA12. The PA12 material used has a Shore hardness of 77D. The inner diameter of the main tube 3 is 1.20-1.80 mm, and the outer diameter is 1.65-2.25 mm.

[0068] Please refer to Figure 1. The stress relief tube 4 is put on the proximal end of the main tube 3. The proximal opening of the main tube 3 has a wire 13 and an extension wire of the temperature sensor 20. Use soldering to solder all the wires 13 and the extension wires of the temperature sensor 20 to the circuit board inside the handle 5. Solder one end of the connecting cable 7 to the circuit board and the other end of the connecting cable 7 to the connector 8. Use Loctite 4011 glue to bond and fix the proximal end of the main tube 3 to the distal outlet of the handle 5. At the same time, use Loctite 4011 glue to bond and fix the proximal end of the stress relief tube 4 and the distal outlet of the handle 5.

[0069] Specifically, for example, the stress relief tube 4 is made of silicone rubber, is shaped like a cylinder with a cavity, and has a length of 3-10 cm; the handle 5 is made of PC+ABS resin and is made using injection molding technology, and its shape can be the shape of a conventional interventional instrument handle; the connector 8 is a standard part, for example, the REDEL 12-pin plastic connector of Remo (Shanghai) Trading Co., Ltd. can be used.

[0070] As shown in FIG5 , the present invention further discloses a radiofrequency ablation device including an ablation start / stop button, a radiofrequency closing generator, and a temperature controller, wherein the radiofrequency ablation device includes a first working mode and a second working mode.

[0071] The first and third working modes are suitable for the treatment of superficial varicose veins in the lower limbs, and the second working mode is suitable for the treatment of communicating varicose veins, perforating varicose veins, tortuous lesions of the superficial vein trunk and short segments of the ablation terminal.

[0072] In the first working mode, press the ablation button and the RF closure generator starts working, and outputs high-frequency current to the proximal ablation coil and the distal ablation coil at the same time. The two coils generate heat under the action of the high-frequency current. At the same time, the first thermocouple, the second thermocouple and the third thermocouple all monitor the changes in the temperature of the vascular tissue. The three thermocouples transmit the temperature signal to the temperature controller and control the current of the two coils respectively by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0073] In the second working mode, press the ablation button and the RF closure generator starts working, while outputting high-frequency current to the distal ablation coil. The distal ablation coil generates heat under the action of the high-frequency current. At the same time, the third thermocouple monitors the temperature changes of the vascular tissue. The third thermocouple transmits the temperature signal to the temperature controller and controls the current of the distal coil by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0074] The radiofrequency ablation device also includes a third working mode. In the third working mode, when the ablation start-stop button is pressed, the radiofrequency closure generator starts working and outputs high-frequency current to the proximal ablation coil. The proximal ablation coil generates heat under the action of the high-frequency current. At the same time, the first thermocouple and the second thermocouple monitor the changes in the temperature of the vascular tissue. The first thermocouple and the second thermocouple transmit the temperature signal to the temperature controller and control the current of the proximal coil by controlling the radiofrequency closure generator. The temperature value will also be displayed in real time on the radiofrequency closure generator screen.

[0075] Example 2

[0076] In this embodiment, other structures are basically the same as those in the first embodiment, except that the proximal ablation coil 2-1 and the distal ablation coil 2-2 are wound in an "end-to-end" manner.

[0077] Specifically, referring to FIG6 , the proximal ablation coil 2-1 and the distal ablation coil 2-2 are formed using the same winding direction. The alloy wire of the proximal ablation coil 2-1 is spirally wound from the second starting point 15-1 along the surface of the coil inner sleeve 10 from the distal end to the proximal end. The alloy wire of the distal ablation coil 2-2 is spirally wound from the third starting point 15-2 along the surface of the coil inner sleeve 10 from the distal end to the proximal end. The proximal ablation coil 2-1 and the distal ablation coil 2-2 have the same winding direction along the surface of the coil inner sleeve 10, and the winding end point of the distal ablation coil 2-2 is near the second starting point 15-1. Two threading holes 14 are provided on the surface of the coil inner sleeve 10 at the corresponding end points of the alloy wire winding of the second proximal ablation coil 2-12. Before entering the threading holes 14, the alloy wire is connected to the guide wire 13-2 to prevent the connection point 12-2 from being located inside the coil inner sleeve 10.

[0078] The distance between the winding starting point of the alloy wire of the proximal ablation coil 2-1 and the midpoint of the line connecting the two winding end points of the alloy wire of the distal ablation coil 2-2 is set at 0-3mm. This distance is the distance along the outer surface of the coil inner sleeve 10. The two alloy wires are wound from their respective starting points along the surface of the coil inner sleeve 10 in the same winding direction from the distal end to the proximal end, so that the interval between the alloy wires at the junction of the two ablation coils and the adjacent ablation coil alloy wires is the same as the interval between the alloy wires at the non-junction of the ablation coils, and "looks" like a wound alloy wire. This setting ensures that the intervals between the alloy wires wound on the coil inner sleeve 10 are the same, the alloy wires distributed on the coil inner sleeve 10 are uniform, and the uniformity of the distribution of alloy wires at the junction of the ablation coils wound by different alloy wires ensures the independent control of each ablation coil while also ensuring the uniform temperature of the entire heating section, thereby improving the heating efficiency of the radio frequency ablation device during the ablation process.

[0079] Example 3

[0080] In this embodiment, other structures are basically the same as those in the first embodiment, except that:

[0081] To accommodate different locations and lengths of venous ablation areas, the proximal ablation coil 2-1 and the distal ablation coil 2-2 can also be wound with multiple alloy wires. It should be understood that when the ablation coils are composed of different alloy wires, each alloy wire can independently control the on / off of the current.

[0082] In this embodiment, taking the example of a proximal ablation coil composed of two alloy wires and a distal ablation coil composed of one alloy wire, the proximal ablation coil includes a first proximal ablation coil 2-11 and a second proximal ablation coil 2-12. The two alloy wires form the first proximal ablation coil 2-11 and the second proximal ablation coil 2-12 respectively. The first proximal ablation coil 2-11 is formed by winding an alloy wire around the outer surface of the coil inner sleeve 10, and the second proximal ablation coil 2-12 is formed by winding another alloy wire around the outer surface of the coil inner sleeve 10; the winding method of the second proximal ablation coil 2-12 and the distal ablation coil 2-2 adopts the winding method in embodiment one, and the winding method of the first proximal ablation coil 2-11 and the second proximal ablation coil 2-12 adopts the winding method in embodiment two.

[0083] In this embodiment, the radiofrequency ablation device includes seven working modes, namely the first, second, third, fourth, fifth, sixth, and seventh working modes. Different working modes are working modes for controlling the on and off of one or more alloy wires. Specifically:

[0084] In the first working mode, press the ablation button and the RF closure generator starts working, and outputs high-frequency current to the first proximal ablation coil 2-11. The first proximal ablation coil 2-11 generates heat under the action of the high-frequency current. The first thermocouple monitors the temperature change of the vascular tissue, and transmits the temperature signal to the temperature controller and controls the current of the first proximal ablation coil 2-11 by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0085] In the second working mode, press the ablation button and the RF closure generator starts working, and outputs high-frequency current to the second proximal ablation coil 2-12. The second proximal ablation coil 2-12 generates heat under the action of the high-frequency current. At the same time, the second thermocouple monitors the temperature change of the vascular tissue. The second thermocouple transmits the temperature signal to the temperature controller and controls the current of the second proximal ablation coil 2-12 by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0086] In the third working mode, press the ablation button and the RF closure generator starts working, and outputs high-frequency current to the distal ablation coil 2-2. The distal ablation coil 2-2 generates heat under the action of the high-frequency current. At the same time, the third thermocouple monitors the temperature change of the vascular tissue. The third thermocouple transmits the temperature signal to the temperature controller and controls the current of the distal coil by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0087] In the fourth working mode, press the ablation button and the radiofrequency closure generator starts working, and at the same time outputs high-frequency current to the first proximal ablation coil 2-11 and the second proximal ablation coil 2-12. The two coils generate heat under the action of the high-frequency current. The first thermocouple and the second thermocouple monitor the changes in the temperature of the vascular tissue, and transmit the temperature signal to the temperature controller and control the current of the two ablation coils by controlling the radiofrequency closure generator. The temperature value will also be displayed in real time on the radiofrequency closure generator screen.

[0088] In the fifth working mode, press the ablation button and the RF closure generator starts working, and outputs high-frequency current to the second proximal ablation coil 2-12 and the distal ablation coil 2-2. The two coils generate heat under the action of the high-frequency current. At the same time, the second thermocouple and the third thermocouple monitor the changes in the temperature of the vascular tissue, and transmit the temperature signal to the temperature controller and control the current of the two ablation coils respectively by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0089] In the sixth working mode, press the ablation button and the RF closure generator starts working, and outputs high-frequency current to the first proximal ablation coil 2-11 and the distal ablation coil 2-2. The two coils generate heat under the action of the high-frequency current. At the same time, the first thermocouple and the third thermocouple monitor the changes in the temperature of the vascular tissue, and transmit the temperature signal to the temperature controller and control the current of the two ablation coils respectively by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

[0090] In the seventh working mode, press the ablation button and the RF closure generator starts working, and outputs high-frequency current to the first proximal ablation coil 2-11, the second proximal ablation coil 2-12 and the distal ablation coil 2-2. The three coils generate heat under the action of high-frequency current. At the same time, the first thermocouple, the second thermocouple and the third thermocouple all monitor the changes in the temperature of the vascular tissue, and transmit the temperature signal to the temperature controller and control the RF closure generator to control the current of the three ablation coils respectively. The temperature value will also be displayed in real time on the RF closure generator screen.

[0091] In other embodiments, the first proximal ablation coil 2-11, the second proximal ablation coil 2-12, and the distal ablation coil 2-2 can be formed in any combination of "head-to-head connection", "head-to-tail connection", and "tail-to-tail connection", as long as the alloy wire wrapped around the inner sleeve 10 of the coil is evenly distributed. The head represents the starting point of the winding, and the tail represents the end point of the winding.

[0092] Finally, it should be noted that the above embodiments and implementation methods are intended only to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the above embodiments and implementation methods, those skilled in the art should understand that they may modify the technical solutions described in the above embodiments and implementation methods, or replace some or all of the technical features therein with equivalents. Such modifications or replacements do not deviate from the essence of the corresponding technical solutions within the scope of the embodiments and implementation methods of the present invention. The present invention is limited only by the claims and their full scope and equivalents.

Claims

1. A radiofrequency ablation catheter, characterized in that: include: Coil inner cannula, ablation coil; The ablation coil includes a proximal ablation coil and a distal ablation coil, wherein the proximal ablation coil and the distal ablation coil are respectively located at the proximal end and the distal end of the coil inner sleeve; The proximal ablation coil and the distal ablation coil are both formed by spirally winding alloy wire on the outer surface of the coil inner sleeve; The proximal ablation coil and the distal ablation coil are formed by different alloy wires being wound from their respective starting points in opposite winding directions toward the proximal end and the distal end respectively, and the distance between the two starting points is 0-3mm; or the proximal ablation coil and the distal ablation coil are formed by different alloy wires being wound from their respective starting points in the same winding direction toward the proximal end, and the distance between the midpoint of the line connecting the two winding end points of the distal ablation coil and the winding starting point of the proximal ablation coil is 0-3mm.

2. The radiofrequency ablation catheter according to claim 1, wherein: The alloy wires wound on the outer surface of the inner sleeve of the coil are evenly distributed.

3. The radiofrequency ablation catheter according to claim 1, characterized in that: The two starting points are arranged on the same cross section, or the starting point and the midpoint of the proximal ablation coil are arranged on the same cross section, and the cross section is the cross section of the inner sleeve of the coil.

4. The radiofrequency ablation catheter according to claim 1, wherein: It also includes a wire 1, which has a threading hole on the surface of the coil inner sleeve near the winding end point of the proximal ablation coil. The wire 1 is connected to the alloy wire of the proximal ablation coil and then enters the interior of the coil inner sleeve through the threading hole.

5. The radiofrequency ablation catheter according to claim 1, characterized in that: It also includes a second wire, which has a threading hole on the surface of the coil inner sleeve near the winding end point of the distal ablation coil. The second wire is connected to the alloy wire of the distal ablation coil and then enters the interior of the coil inner sleeve through the threading hole.

6. The radiofrequency ablation catheter according to claim 1, characterized in that: The proximal ablation coil is formed by winding an alloy wire, and the distal ablation coil is formed by winding an alloy wire.

7. The radiofrequency ablation catheter according to claim 1, characterized in that: The proximal ablation coil is formed by winding two alloy wires, and the two alloy wires respectively form a first proximal ablation coil and a second proximal ablation coil.

8. The radiofrequency ablation catheter according to claim 7, characterized in that: A threading hole is provided on the surface of the coil inner sleeve at the end position of the alloy wire winding corresponding to the first proximal ablation coil and the second proximal ablation coil. The alloy wire is connected to the wire before entering the threading hole to prevent the connection point between the alloy wire and the wire from being located inside the coil inner sleeve.

9. The radiofrequency ablation catheter according to claim 1, characterized in that: At least two temperature measuring devices are provided on the proximal ablation coil.

10. The radiofrequency ablation catheter according to claim 1, characterized in that: An insulating outer sleeve is provided on the outer surface of the ablation coil, and the insulating outer sleeve is tightly attached to the surface of the ablation coil by high-temperature heat shrinkage.

11. A radiofrequency ablation device, characterized in that: The invention comprises the radiofrequency ablation catheter according to any one of claims 1 to 10.

12. The radiofrequency ablation device according to claim 11, wherein: It also includes an ablation start and stop button, a radiofrequency closure generator, and a temperature control controller; the radiofrequency ablation device includes multiple working modes; different working modes correspond to the working modes when one or more alloy wires are turned on and off.

13. A radiofrequency ablation device, characterized in that: The invention comprises the radiofrequency ablation catheter as claimed in claim 6, an ablation start / stop button, a radiofrequency closure generator, and a temperature control controller; the radiofrequency ablation device comprises a first working mode and a second working mode; In the first working mode, press the ablation start / stop button, and the radiofrequency sealing generator starts working, outputting high-frequency current to the proximal ablation coil and the distal ablation coil at the same time. The two coils generate heat under the action of the high-frequency current. At the same time, the first thermocouple, the second thermocouple, and the third thermocouple all monitor the temperature changes of the vascular tissue. The three thermocouples transmit the temperature signal to the temperature controller and control the radiofrequency sealing generator to control the current of the two coils respectively. The temperature value will also be displayed in real time on the radiofrequency sealing generator screen. In the second working mode, press the ablation button and the RF closure generator starts working, while outputting high-frequency current to the distal ablation coil. The distal ablation coil generates heat under the action of the high-frequency current. At the same time, the third thermocouple monitors the temperature changes of the vascular tissue. The third thermocouple transmits the temperature signal to the temperature controller and controls the current of the distal coil by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

14. The radiofrequency ablation device according to claim 13, wherein: Also includes a third working mode; In the third working mode, press the ablation start and stop button, the RF closure generator starts working, and outputs high-frequency current to the proximal ablation coil. The proximal ablation coil generates heat under the action of the high-frequency current. At the same time, the first thermocouple and the second thermocouple monitor the changes in the temperature of the vascular tissue. The first thermocouple and the second thermocouple transmit the temperature signal to the temperature controller and control the current of the proximal coil by controlling the RF closure generator. The temperature value will also be displayed in real time on the RF closure generator screen.

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