Varicosity ablation catheter, ablation monitoring system and ablation range measuring method

Abstract

The varicosity ablation catheter comprises a catheter body and further comprises a radiation assembly, a temperature measuring assembly, a connecting assembly and a control part, the radiation assembly is arranged on the catheter body and connected with a semi-rigid coaxial cable in the catheter body, and the temperature measuring assembly is arranged in the catheter body and close to the radiation assembly. The temperature measuring assembly measures the temperature inside and outside the radiation area of the radiation assembly and assists in judging the single ablation length. The catheter has the advantages that the three microwave tubes distributed on the catheter body at intervals form the three ablation radiation areas with the overlapped boundaries, the three radiation areas can be ablated at the same time during single ablation, the single ablation length is increased, and the ablation efficiency is improved; the ablation temperature in the ablation process is measured through the temperature measuring couple arranged in the radiation area in the ablation radiation area and the temperature measuring couple arranged outside the radiation area outside the ablation radiation area, the ablation effect is guaranteed, meanwhile, the control part can automatically generate a temperature rise curve graph according to the temperatures of different positions, and therefore the length of single-time ablation is automatically calculated.

Description

Technical Field

[0001] The present invention specifically relates to a varicose vein ablation catheter, an ablation monitoring system and an ablation range measurement method. Background Art

[0002] Varicose veins of the lower extremities are one of the most common diseases of the cardiovascular system, with an incidence rate of more than 15% in Chinese adults and 30%-40% in people over 50 years old. The main clinical manifestations are: dilation and tortuosity of the superficial veins of the lower extremities, heaviness and fatigue of the lower extremities, mild swelling of the ankles and nutritional changes in the skin of the foot and boot area: skin pigmentation, dermatitis, eczema, subcutaneous lipid sclerosis and ulcers. Some patients may develop superficial vein thrombosis. According to the CEAP clinical classification, surgical treatment is recommended for patients with simple varicose veins of greater or less than C2, symptomatic varicose veins, and clinical manifestations of moderate to severe chronic lower extremity venous insufficiency.

[0003] Common surgical methods include: high ligation and stripping of the greater / lesser saphenous vein, endovenous closure of the superficial vein and sclerotherapy. Among them, endovenous closure of the superficial vein can achieve the same clinical efficacy as traditional surgery, and has the advantages of short operation time, quick recovery, minimally invasive and beautiful appearance. It has become the current mainstream surgical method, accounting for more than 80% of varicose vein surgeries in tertiary hospitals.

[0004] The endovenous closure of superficial veins mainly includes three energy sources: radio frequency, microwave, and laser. The principle of microwave treatment is endogenous heating, which generates heat through molecular vibration and friction in the tissue, thereby causing damage to the vascular wall tissue, coagulation, closure, and ultimately fibrosis. Compared with laser and radio frequency, it has the advantages of high thermal efficiency, fast heating, uniform tissue heating, moderate thermal penetration, and controllable thermal coagulation range. At the same time, there is no ultrasonic interference, and the ablation effect is not affected by impedance.

[0005] The average length of the human great saphenous vein is 76.52 cm. The conventional surgical treatment area is from the vicinity of the knee joint to the groin, with a length ranging from 30 to 50 cm. At present, microwave ablation catheters all use a single microwave radiation antenna. The single ablation length varies with the thickness of the blood vessel, the action time, and the injection of surrounding swelling fluid. In the range of 1-1.5 cm, the actual ablation length cannot be confirmed. To avoid missed ablation, it is withdrawn every 1 cm. However, microwave thermal efficiency is high. After two ablations, carbonization will occur at the overlapping part, increasing the risk of local thermal damage and prolonging postoperative recovery time. If you want to accurately confirm the single ablation length, you need to use CT to shoot the ablation site after ablation to complete the determination of the single ablation length. This method is more cumbersome and inconvenient to use.

[0006] In addition, the efficiency of microwave ablation is 1cm / 4-6s, and the needle is withdrawn 30-50 times during the operation. Compared with the single-shot radiofrequency ablation efficiency of 7cm / 20s, the needle is withdrawn 6-7 times during the operation, the operation time is longer, and the operation is cumbersome.

[0007] Therefore, there is a need for a multi-point microwave ablation catheter with a temperature measurement function, which can improve surgical efficiency, measure ablation length, and reduce surgical complications while being used in the treatment of varicose veins of the lower limbs.

[0008] In the Chinese patent: CN202120733837.2, the name is: Microwave ablation catheter and microwave treatment equipment, which records that it includes a guide wire, a guide wire hole is provided in the microwave ablation catheter, the microwave ablation catheter is inserted into the varicose vein through the skin, the guide wire runs in the guide wire hole, extends the tortuous inner cavity of the varicose vein, and guides the microwave ablation catheter to the designated position.

[0009] As shown in the figure in patent CN202120733837.2, this patent is a traditional microwave ablation catheter, which has only one radiation head and does not have the ability to measure the ablation length. Summary of the invention

[0010] The first technical problem to be solved by the present invention is the low efficiency of conventional microwave catheter ablation mentioned in the background technology.

[0011] The second technical problem to be solved by the present invention is how to select the ablation range.

[0012] The third technical problem to be solved by the present invention is the problem of unclear single ablation length of the existing microwave catheter mentioned in the background technology.

[0013] In order to solve the first technical problem mentioned above, a varicose vein ablation catheter is proposed; it is achieved by the following technical scheme: a varicose vein ablation catheter, including a catheter body, one end of which is provided with an operating handle, characterized in that it also includes a radiation component, a temperature measuring component, a connecting component and a control unit, the radiation component is arranged on the catheter body through the connecting component, the radiation component is connected to the semi-rigid coaxial cable in the catheter body, the temperature measuring component is arranged in the catheter body, close to the radiation component, the temperature measuring component measures the temperature inside and outside the radiation area of ​​the radiation component respectively, the control unit connected to the radiation component and the temperature measuring component is connected to the computer end at the same time, the control unit controls the power of the radiation component and generates a temperature curve on the computer end according to the temperature measured by the temperature measuring component, and determines the length of a single ablation.

[0014] In a preferred embodiment of the technical solution of the present invention, the radiation component includes a microwave head, the microwave head forms a radiation zone on the catheter body, the microwave head includes a first microwave tube, a second microwave tube and a third microwave tube, the first microwave tube is arranged at the end of the catheter body to form a first radiation zone, the second microwave tube is connected to the first microwave tube through a connecting component, the two are spaced apart to form a second radiation zone, the third microwave tube is connected to the second microwave tube through a connecting component, the two are spaced apart to form a third radiation zone; The first radiation zone, the second radiation zone and the third radiation zone are spaced apart from each other, and the radiation ranges of the three overlap at the edges. The setting of multiple radiation zones enables the ablation catheter to ablate three areas at the same time, thereby increasing the length of a single ablation and improving the ablation efficiency.

[0015] Preferably, the temperature measuring component includes a temperature measuring couple inside the radiation zone and a temperature measuring couple outside the radiation zone. The temperature measuring couple inside the radiation zone is arranged in the radiation zone at the front of the catheter body, and the temperature measuring couple outside the radiation zone is arranged in the radiation zone at the rear end of the catheter body, outside the radiation area of ​​the microwave head at the rear end. The arrangement of the temperature measuring component is convenient for measuring the ablation temperature, and is convenient for judging the ablation effect and the length of a single ablation, and is easy to use.

[0016] Preferably, the temperature measuring couple in the radiation zone includes a first temperature measuring couple, a second temperature measuring couple and a third temperature measuring couple, wherein the first temperature measuring couple is arranged inside the catheter body, overlapping with the radiation edges of the first radiation zone and the second radiation zone, the second temperature measuring couple is arranged inside the catheter body, overlapping with the radiation edges of the second radiation zone and the third radiation zone, and the third temperature measuring couple is arranged inside the catheter body, near the middle of the radiation zone of the third radiation zone; The temperature measuring couple outside the radiation zone includes a fourth temperature measuring couple and a fifth temperature measuring couple. The fourth temperature measuring couple is arranged at the edge of the third radiation zone on the catheter body, and the fifth temperature measuring couple is arranged outside the third radiation zone. The distance between the fifth temperature measuring couple and the fourth temperature measuring couple is the same as the distance between the fourth temperature measuring couple and the third temperature measuring couple. The temperature measuring thermocouples are arranged at the overlapping edges of the two radiation zones to facilitate temperature monitoring of the ablation area and prevent incomplete ablation of the overlapping area. The fourth temperature measuring couple and the fifth temperature measuring couple are arranged at the end radiation zone to facilitate the cooperation with the third temperature measuring couple to jointly measure the temperature of the end radiation zone and outside the radiation zone, so as to facilitate the judgment of the single ablation distance by temperature.

[0017] Preferably, the connection assembly includes a connection socket, one end of the connection socket is provided with a connection groove, and the other end is provided with a connection head, the connection groove can be fixed with the end of the microwave head, and the connection head can be inserted into the catheter body. The setting of the connection assembly facilitates the connection of the microwave head with the catheter body.

[0018] Preferably, the front end of the radiation component installed on the catheter body is covered with an outer sleeve, and the outer sleeve is disconnected near the microwave head on the radiation component, so that the microwave head used for microwave ablation is exposed to the outside. Such an arrangement prevents the outer sleeve from closing the microwave head and affecting the microwave ablation effect.

[0019] To solve the second technical problem mentioned above, the present invention also discloses an ablation monitoring system for a varicose vein ablation catheter, including a microwave ablation instrument and a temperature monitoring device. The microwave ablation instrument is configured to provide microwave energy to the microwave ablation catheter, and the temperature monitoring device displays a heating curve and adjusts the ablation power and ablation time according to the heating curve.

[0020] Preferably, the temperature monitoring device stores temperature information and corresponding ablation information, and the ablation information includes ablation power, time, and corresponding ablation long and short diameters. Such a setting enables timely adjustment of ablation power and ablation time according to the temperature rise curve and clinical data to prevent excessive ablation and thermal damage.

[0021] In order to solve the third technical problem mentioned above, the present invention also discloses a method for measuring the single ablation length of a varicose vein ablation catheter, which is characterized by comprising the following steps: Step 1: Catheterization: Under ultrasound guidance, the catheter body is inserted through the vascular sheath into the great saphenous vein, and anesthesia and swelling fluid are injected locally; Step 2: Setting ablation parameters: determining ablation power according to ablation position, and using a control unit to set ablation power and ablation duration; Step 3: Generating a temperature rise curve: The temperature measuring component feeds back the temperature values ​​of the five temperature measuring couples respectively, and generates a temperature rise curve of the five temperature measuring couples during the ablation process on the computer side; Step 4: Determine the single ablation length: Calculate the single ablation length according to the temperature measurement values ​​and temperature rise curve of the five temperature measuring couples fed back by the temperature measuring component according to the formula M=L1+L2+L3-LY+LX; Where: M is the total length of a single ablation; L1 is the length of the first radiation zone; L2 is the length of the second radiation zone; L3 is the length of the third radiation zone; LX is the length from the ablation end to the third radiation zone; LY is the total overlapping length of the radiation zone; Step 5: After a single ablation is completed, withdraw the needle according to the length of the single ablation and continue ablation until the ablation is completely completed.

[0022] Preferably, in the formula M=L1+L2+L3+LX-LY, the lengths of L1, L2, L3 and LY are fixed values, and the length of LX is automatically calculated according to the temperature rise curve. Such a setting facilitates the determination of the position of the ablation end according to the temperature value on the temperature curve, facilitates the automatic calculation of the single ablation length, is easy to use, and improves the ablation efficiency.

[0023] Compared with the prior art, the present invention has the following beneficial effects: The technical solution of the present invention utilizes three microwave tubes arranged at intervals on the catheter body to form three ablation radiation zones with overlapping boundaries. During a single ablation, the three radiation zones can be ablated simultaneously, thereby increasing the length of a single ablation and improving the ablation efficiency. In addition, the ablation temperature during the ablation process is measured using an in-radiation zone temperature measuring couple arranged in the ablation radiation zone and an out-radiation zone temperature measuring couple arranged outside the ablation radiation zone. While ensuring the ablation effect, a temperature rise curve can be automatically generated according to the temperatures at different positions, thereby automatically calculating the length of a single ablation. The invention is easy to use and solves the problems of low ablation efficiency and unclear single ablation length of existing microwave catheters mentioned in the background technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a three-dimensional schematic diagram of the present invention; Figure 2 This is a three-dimensional schematic diagram of the front ablation end of the present invention (excluding the outer sleeve); Figure 3 It is a partial cross-sectional view of the front end ablation end of the present invention; Figure 4 This is a schematic diagram of the radiation area distribution of the present invention; Figure 5 This is an exploded view of the front ablation end of the present invention; Figure 6 This is the ablation temperature table of different ablation times at 60W power of the present invention; Figure 7 This is a temperature rise curve diagram of the present invention at 60W power; Figure 8 The ablation process and ablation length calculation flow chart of the present invention; Explanation of the accompanying drawings: 1-catheter body, 11-semi-rigid coaxial cable, 12-microwave needle, 13-outer sleeve, 2-radiation component, 21-first microwave tube, 22-second microwave tube, 23-third microwave tube, 24-connector, 25-first radiation zone, 26-second radiation zone, 27-third radiation zone, 28-connecting tube, 3-temperature measuring component, 31-first temperature measuring couple, 32-second temperature measuring couple, 33-third temperature measuring couple, 34-fourth temperature measuring couple, 35-fifth temperature measuring couple, 4-connection component, 41-connection seat, 42-connection slot, 5-operating handle, 51-power interface. DETAILED DESCRIPTION

[0025] The following will be combined with the attached embodiment of the present invention Figure 1-8 , the technical solutions in the embodiments of the present invention are described in detail. Example

[0026] like Figure 1 , 2 As shown in 3, a varicose vein ablation catheter comprises a catheter body 1, a radiation component 2, a temperature measuring component 3 and a connecting component 4, wherein an operating handle 5 for easy hand-holding is provided at the end of the catheter body 1, the radiation component 2 for emitting ablation microwaves is arranged at the front end of the catheter body 1, the temperature measuring component 3 for temperature measurement is arranged in the catheter body 1, and the connecting component 4 is arranged on the catheter body 1 to connect the catheter body 1 and the radiation component 2.

[0027] The catheter body 1 is a hollow tube made of existing PEEK material. Its main function is to serve as the main body of the microwave ablation catheter. It also serves as a carrier for installing the radiation component and the temperature measurement component. An operating handle 5 is fixedly connected to one end of the catheter body 1, and the operator can operate it through the operating handle 5.

[0028] The main function of the radiation component 2 is to serve as a radiation antenna for generating microwaves of a frequency such as 915 MHz or 2450 MHz in order to achieve the purpose of ablation.

[0029] The main function of the temperature measuring component 3 is to measure the temperature of each radiation zone in the radiation component 2 and the temperature of the edge and outside of the last radiation zone, so as to facilitate real-time control of the ablation effect through the ablation temperature and assist in calculating the single ablation range.

[0030] The main function of the connecting component 4 is to connect the microwave tube in the radiation component 2 and the catheter body 1, so as to facilitate the fixation of the microwave tube.

[0031] The main function of the control unit is to adjust the ablation power of each microwave tube in the radiation component 2 and control the ablation time of each microwave tube. It is also used to receive the ablation temperature monitored by the temperature measurement component 3, generate a time-temperature table using the ablation temperature and ablation time, and use the time-temperature table to fit the temperature rise curve. Finally, the end point of a single ablation is determined according to the temperature rise curve, thereby calculating the single ablation length.

[0032] like Figure 2 , 3 As shown in Figures 4 and 5, the radiation component 2 includes a microwave head and a radiation area composed of the microwave head.

[0033] The microwave head includes a first microwave tube 21, a second microwave tube 22 and a third microwave tube 23. The first microwave tube 21, the second microwave tube 22 and the third microwave tube 23 are existing ablation electrodes, which are in a circular tube shape as a whole. The outer diameters of the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23 are the same as the outer diameter of the catheter body 1. The first microwave tube 21, the second microwave tube 22 and the third microwave tube 23 are composed of a semi-rigid coaxial cable 11 passed through the catheter body 1. The first microwave tube 21, the second microwave tube 22 and the third microwave tube 23 are powered by the semi-rigid coaxial cable 11 to generate microwaves, thereby achieving the purpose of ablation.

[0034] The semi-rigid coaxial cable 11 in this embodiment preferably adopts the model: SFT50-1 semi-steel coaxial RG407 metal microwave feeder. The semi-rigid coaxial cable 11 passes through the operating handle arranged at the end of the catheter body 1 and is connected to the first microwave tube 21 arranged at the front end of the catheter body 1. In order to facilitate the power supply of the semi-rigid coaxial cable 11, the end of the semi-rigid coaxial cable 11 is connected to the power interface 51 fixed on the operating handle 5.

[0035] In order to facilitate the connection and fixation of the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23, a circular boss is protruded outward on the circular end faces at both ends of the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23, and the boss is named a connector 24. The outer diameter of the connector 24 is the same as the inner diameter of the catheter body 1. The first microwave tube 21, the second microwave tube 22 and the third microwave tube 23 can be connected to the catheter body 1 through the connector 24 through the connecting assembly 4.

[0036] Regarding the position distribution and connection relationship of the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23, the first microwave tube 21 is located at the front end of the catheter body 1, and its radiation range is the first radiation zone 25. The second microwave tube 22 and the third microwave tube 23 are distributed at intervals, wherein the second microwave tube 22 is located between the first microwave tube 21 and the third microwave tube 23. The three are connected by a connecting component 4 and there is a distance between them. The radiation range of the second microwave tube 22 is the second radiation zone 26, and the radiation range of the third microwave tube 23 is the third radiation zone 27.

[0037] In order to ensure the radiation effect of the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23, so that the three can also achieve a stable ablation effect at the edge of the radiation zone, the radiation edges of the first radiation zone 25 and the second radiation zone 26, and the second radiation zone 26 and the third radiation zone 27 overlap, so that a stable ablation effect can be achieved at the radiation edge where the microwave is weaker.

[0038] In order to facilitate the guidance of the ablation catheter as a whole into the vein through the vascular sheath, a microwave needle 12 is provided at the front end of the first microwave tube 21 using the connecting component 4 , and the ablation catheter can enter the vein through the vascular sheath under the action of the microwave needle 12 .

[0039] The microwave needle 12 is a conical head as a whole. The microwave needle 12 is preferably made of PEEK material. A connector 24 protrudes perpendicularly from the end face of the microwave needle 12. The connector 24 can cooperate with the connecting component 4 to be fixedly connected.

[0040] The connecting component 4 includes a connecting card seat 41, which is a circular plastic tube made of PEEK material. The outer diameter of the connecting card seat 41 is the same as the outer diameter of the catheter body 1, and the inner diameter of the connecting card seat 41 is slightly smaller than the inner diameter of the catheter body 1. In order to facilitate connection, an annular groove is concave perpendicular to the end face on one end of the connecting card seat 41, and this groove is named as the outer connecting groove 42. The inner diameter of the connecting groove 42 is the same as the inner diameter of the connector 24. The two can be plugged together, and in order to improve the sealing of the connection, the two are coated with glue at the connection. At the same time, a boss with the same diameter as the connector 24 is convex on the end face of the other end of the connecting card seat 41. This end of the connecting card seat 41 can be inserted into the catheter body 1, and in order to improve the sealing of the connection, the two are coated with glue at the connection.

[0041] Definition: In this embodiment, one end of the catheter body 1 where the operating handle 5 is installed is the end, and the other end is the front end.

[0042] like Figure 3 , 4 As shown in FIG. 5 , the temperature measuring component 3 includes a first temperature measuring couple 31 , a second temperature measuring couple 32 , a third temperature measuring couple 33 , a fourth temperature measuring couple 34 and a fifth temperature measuring couple 35 .

[0043] The first temperature measuring couple 31, the second temperature measuring couple 32, the third temperature measuring couple 33, the fourth temperature measuring couple 34 and the fifth temperature measuring couple 35 are all annular temperature measuring couples, and in order to facilitate the wiring of the semi-rigid coaxial cable 11, the inner diameters of the first temperature measuring couple 31, the second temperature measuring couple 32, the third temperature measuring couple 33, the fourth temperature measuring couple 34 and the fifth temperature measuring couple 35 are larger than the outer diameter of the semi-rigid coaxial cable 11, and the semi-rigid coaxial cable 11 can pass through the inner diameter of the temperature measuring couple. In order to facilitate the power supply of the temperature measuring couple, the first temperature measuring couple 31, the second temperature measuring couple 32, the third temperature measuring couple 33, the fourth temperature measuring couple 34 and the fifth temperature measuring couple 35 are respectively connected to the power interface 51 at the operating handle 5 through wires (the wires are not drawn in the diagram).

[0044] In order to facilitate the installation of the temperature measuring couple, a connecting tube 28 is sleeved on the outside of the temperature measuring couple. The connecting tube 28 is a plastic tube made of PEEK material. The outer diameter and inner diameter of the connecting tube 28 are the same as the outer diameter and inner diameter of the catheter body 1. The annular boss at one end of the connecting seat 41 can be inserted into the connecting tube 28.

[0045] Regarding the functions of the first temperature measuring couple 31, the second temperature measuring couple 32, the third temperature measuring couple 33, the fourth temperature measuring couple 34 and the fifth temperature measuring couple 35, the first temperature measuring couple 31 is located at the overlap of the first radiation zone 25 and the second radiation zone 26, the second temperature measuring couple 32 is located at the overlap of the second radiation zone 26 and the third radiation zone 27, and the functions of the two are to monitor the temperature of the ablation area to prevent incomplete ablation in the overlapping area. The third temperature measuring couple 33 is close to the third microwave tube 23 and is located in the third radiation zone 27. The fifth temperature measuring couple 35 is located outside the third radiation zone 27, and the fourth temperature measuring couple 34 is located between the two. The temperature changes and temperature rise curves of the third temperature measuring couple 33, the fourth temperature measuring couple 34 and the fifth temperature measuring couple 35 can be used to determine the length of a single ablation. While ensuring complete ablation, the surgical efficiency can be effectively improved and the complications caused by local repeated ablation can be reduced.

[0046] In this embodiment, the connection and fixation of the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23 to the connecting holder 41 are all fixed by sealant, and no leakage will occur at the joints after fixation. The connection tube 28 and the connecting holder 41 and the connecting holder 41 and the first temperature measuring couple 31, the second temperature measuring couple 32, the third temperature measuring couple 33, the fourth temperature measuring couple 34 and the fifth temperature measuring couple 35 are also fixed by sealant, and no leakage will occur at the joints after fixation.

[0047] In this embodiment, regarding the assembly relationship between the radiation component 2 and the temperature measuring component 3: when connected, a connection base 41 is fixed to each of the two ends of the first microwave tube 21 by glue, and a microwave needle 12 is connected to the connection base 41 at the front end by glue, and a connection tube 28 is fixed to the connection base 41 at the other end by glue at the connection head 24, and a first temperature measuring couple 31 is fixed to the inner wall of the connection tube 28 and placed in the center, and a connection base 41 is fixed to the other end of the connection tube 28, and a second microwave tube 22 is fixed to the other end of the connection base 41, and a connection base 41 is fixed to the other end of the second microwave tube 22, and a connection base 41 is fixed to the other end of the connection base 41. A connecting tube 28 is fixed at the other end, and a second temperature measuring couple 32 is fixed in the center of the inner wall of the connecting tube 28. A connecting socket 41 is fixed at the other end of the connecting tube 28, and a third microwave tube 23 is fixed at the other end of the connecting socket 41. A connecting socket 41 is fixed at the other end of the third microwave tube 23, and the other end of the connecting socket 41 is inserted into the front port of the catheter body 1 and fixed with glue. The third temperature measuring couple 33 is fixed in the catheter body 1 at the connecting socket 41 with glue, and a fourth temperature measuring couple 34 is fixed at a distance of 1 cm from the third temperature measuring couple 33, and a fifth temperature measuring couple 35 is fixed at a distance of 1 cm from the fourth temperature measuring couple 34.

[0048] In order to ensure the smoothness of the device as a whole and facilitate the device to enter the vein through the vascular sheath, an outer sleeve 13 is sleeved on the outside of the front end of the catheter body 1. The outer sleeve 13 cannot be removed after being fixed. The outer sleeve 13 is sleeved on the outside of the radiation component 2 and the connecting component 4. The outer sleeve 13 is a circular tube. In this embodiment, it is preferably made of polytetrafluoroethylene material. In order to prevent the outer sleeve 13 from affecting the microwave head for microwave ablation, the outer sleeve 13 is given way at the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23, that is, the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23 are exposed to the outside.

[0049] The control unit includes a control board. The main function of the control board is to receive signals and control the ablation power and ablation time. It can be directly used with existing devices. The power interface 51 on the operating handle 5 and the various temperature measuring couples in the temperature measuring component 3 are connected to the control board, and the control board is connected to the computer end. The ablation power and ablation time of the first microwave tube 21, the second microwave tube 22 and the third microwave tube 23 can be adjusted respectively through the operation keys on the computer end. The control unit is a device used in conjunction with the ablation catheter. Unlike the ablation catheter, the control unit is not a disposable device and can be used continuously.

[0050] The present invention also provides an ablation monitoring system for a varicose vein microwave ablation catheter, comprising a microwave ablation instrument as an energy source, configured to provide microwave energy to the microwave ablation catheter; and a temperature monitoring device, which may be coupled to the microwave ablation instrument or may be an independent microprocessor, for receiving and storing temperature information of the temperature measuring component and displaying a temperature rise curve, such as Figure 6 and 7 As shown, in addition to displaying the heating curve, it can also be used to display power, time and other information known in the art, and adjust the ablation power and ablation time according to the heating curve.

[0051] In the present invention, the temperature monitoring device also stores temperature information and corresponding ablation information. Because there are multiple radiation zones in the ablation catheter, the temperature rise rate is too fast due to the overlapping effect of the thermal field, and the ablation long diameter and short diameter will rapidly increase in a short period of time. For the safety of ablation, ablation information including ablation power, time and corresponding ablation long diameter and short diameter size can be stored in the microprocessor before ablation. Before ablation, the patient's information is input into the microprocessor, and the ablation long diameter and short diameter size information can be automatically recommended based on the stored information. Then, the ablation power and ablation time are recommended based on the ablation long diameter and short diameter size information to prevent excessive ablation and thermal damage.

[0052] like Figure 6 , 7 As shown in FIG8 , a single ablation length measurement method for a varicose vein ablation catheter specifically includes the following steps: Step 1: Catheterization: Under ultrasound guidance, the catheter body 1 is inserted through the vascular sheath to puncture the great saphenous vein, and anesthesia swelling fluid is locally injected; Step 2: Setting ablation parameters: determining ablation power according to ablation position, and using a control unit to set ablation power and ablation duration; Step 3, generating a temperature rise curve: the temperature measuring component feeds back the temperature measurement values ​​of the five temperature measuring couples respectively, and generates a temperature rise curve diagram of the five temperature measuring couples during the ablation process on the computer side, naming the temperature monitored by the first temperature measuring couple 31 as T1, the temperature monitored by the second temperature measuring couple 32 as T2, the temperature monitored by the third temperature measuring couple 33 as T3, the temperature monitored by the fourth temperature measuring couple 34 as T4, and the temperature monitored by the fifth temperature measuring couple 35 as T5; Step 4: Determine the single ablation length: Calculate the single ablation length according to the temperature measurement values ​​and temperature rise curve of the five temperature measuring couples fed back by the temperature measuring component according to the formula M=L1+L2+L3-LY+LX; Where: M is the total length of a single ablation; L1 is the length of the first radiation zone 25; L2 is the length of the second radiation zone 26; L3 is the length of the third radiation zone 27; LX is the distance between the ablation end and the third radiation zone 27; LY is the total overlapping length of the radiation zone; Step 5: After a single ablation is completed, withdraw the needle according to the length of the single ablation and continue ablation until the ablation is completely completed.

[0053] In step 2, the preferred ablation power is 60 W, the ablation time for ablation of the thicker starting area is usually 11 s, and the ablation time for ablation of the slightly thinner trunk is usually 6 s.

[0054] In the present embodiment, regarding the calculation of the single ablation length in step four, the present embodiment preferably has a single microwave tube ablation length of 2.5 cm, that is, L1, L2 and L3 are all 2.5 cm, and the overlapping area of ​​two adjacent microwave tubes is 0.5 cm. Therefore, the total length of the three ablation areas is 2.5+2.5+2.5-0.5-0.5=6.5 cm. The values ​​of L1, L2, L3 and LY can be preset in the control unit. The total overlapping length of the radiation area is 0.5+0.5=1 cm. LX is the length of the ablation end from the third radiation area 27 automatically calculated by the control unit. The calculation method is based on the temperature rise curve diagram. According to the total temperature difference between the third temperature measuring couple 33 and the fifth temperature measuring couple 35 and the distance between the third temperature measuring couple 33 and the fifth temperature measuring couple 35, the curvature of the temperature rise curve is used to obtain an accurate value.

[0055] In this embodiment, preferably, the distance between the fourth temperature measuring couple 34 and the third temperature measuring couple 33 is 1 cm, and the distance between the fifth temperature measuring couple 35 and the fourth temperature measuring couple 34 is 1 cm.

[0056] The calculation process of a single ablation length in this embodiment is as follows: taking an ablation power of 60 W and an ablation time of 11 s as an example, for example, LX calculated by the control unit is 1.5 cm, and the formula M=L1+L2+L3-LY+LX is substituted for calculation, and the single ablation length M is 2.5+2.5+2.5-1+1.5=8 cm. Therefore, the single ablation length is 8 cm. After a single ablation is completed, the tube is withdrawn 8 cm according to the length of the single ablation when ablation is continued, and subsequent ablation is performed.

[0057] The above embodiments are only for illustrating the technical idea of ​​the present invention, and cannot be used to limit the protection scope of the present invention. Any changes made on the basis of the technical solution in accordance with the technical idea proposed by the present invention shall fall within the protection scope of the present invention.

Claims

1. A varicose vein ablation catheter, comprising a catheter body (1), one end of the catheter body (1) being provided with an operating handle (5), characterized in that: The catheter also comprises a radiation component (2), a temperature measuring component (3), a connection component (4) and a control unit. The radiation component (2) is arranged on the catheter body (1) through the connection component (4). The radiation component (2) is connected to a semi-rigid coaxial cable (11) in the catheter body (1). The temperature measuring component (3) is arranged in the catheter body (1) close to the radiation component (2). The temperature measuring component (3) measures the temperature inside and outside the radiation area of ​​the radiation component (2). The control unit connected to the radiation component (2) and the temperature measuring component (3) is also connected to a computer terminal. The control unit controls the power of the radiation component (2) and generates a temperature curve on the computer terminal according to the temperature measured by the temperature measuring component (3) to determine the length of a single ablation.

2. The varicose vein ablation catheter according to claim 1, characterized in that: The radiation component (2) comprises a microwave head, wherein the microwave head forms a radiation zone on the catheter body (1), and the microwave head comprises a first microwave tube (21), a second microwave tube (22) and a third microwave tube (23); the first microwave tube (21) is arranged at the end of the catheter body (1) to form a first radiation zone (25); the second microwave tube (22) is connected to the first microwave tube (21) via a connecting component (4), and the two are spaced apart to form a second radiation zone (26); the third microwave tube (23) is connected to the second microwave tube (22) via a connecting component (4), and the two are spaced apart to form a third radiation zone (27); The first radiation zone (25), the second radiation zone (26) and the third radiation zone (27) are spaced apart from each other, and the radiation ranges of the three overlap at the edges.

3. The varicose vein ablation catheter according to claim 1, characterized in that: The temperature measuring assembly (3) comprises a temperature measuring couple inside the radiation zone and a temperature measuring couple outside the radiation zone. The temperature measuring couple inside the radiation zone is arranged in the radiation zone at the front of the catheter body (1), and the temperature measuring couple outside the radiation zone is arranged in the radiation zone at the rear end of the catheter body (1), outside the radiation area of ​​the microwave head at the rear end.

4. The varicose vein ablation catheter according to claim 3, characterized in that: The temperature measuring couple in the radiation zone comprises a first temperature measuring couple (31), a second temperature measuring couple (32) and a third temperature measuring couple (33), wherein the first temperature measuring couple (31) is arranged inside the catheter body (1) at a location where the radiation edges of the first radiation zone (25) and the second radiation zone (26) overlap, the second temperature measuring couple (32) is arranged inside the catheter body (1) at a location where the radiation edges of the second radiation zone (26) and the third radiation zone (27) overlap, and the third temperature measuring couple (33) is arranged inside the catheter body (1) at a location where the radiation edges of the third radiation zone (27) overlap; The temperature measuring couple outside the radiation zone comprises a fourth temperature measuring couple (34) and a fifth temperature measuring couple (35); the fourth temperature measuring couple (34) is arranged at the edge of the third radiation zone (27) on the catheter body (1); the fifth temperature measuring couple (35) is arranged outside the third radiation zone (27); and the distance between the fifth temperature measuring couple (35) and the fourth temperature measuring couple (34) is the same as the distance between the fourth temperature measuring couple (34) and the third temperature measuring couple (33).

5. The varicose vein ablation catheter according to claim 1, characterized in that: The connection assembly (4) comprises a connection card seat (41), one end of the connection card seat (41) is provided with a connection groove (42), and the other end is provided with a connection head (24), the connection groove (42) can be matched and fixed with the end of the microwave head, and the connection head (24) can be inserted into the catheter body (1).

6. The varicose vein ablation catheter according to claim 1, characterized in that: An outer sleeve (13) is sleeved on the front end of the catheter body (1) on which the radiation component (2) is mounted. The outer sleeve 13 is disconnected near the microwave head on the radiation component (2), so that the microwave head used for microwave ablation is exposed to the outside.

7. An ablation monitoring system for a varicose vein ablation catheter according to any one of claims 1 to 6, characterized in that: It includes a microwave ablation device and a temperature monitoring device. The microwave ablation device is configured to provide microwave energy to the microwave ablation catheter. The temperature monitoring device displays a temperature rise curve and adjusts the ablation power and ablation time according to the temperature rise curve.

8. The ablation monitoring system for a varicose vein ablation catheter according to claim 7, characterized in that: The temperature monitoring device also stores temperature information and corresponding ablation information, wherein the ablation information includes ablation power, time, and corresponding ablation long diameter and short diameter sizes.

9. The method for measuring the ablation range of a varicose vein ablation catheter according to claim 7, characterized in that: The steps include: Step 1: Catheterization: Under ultrasound guidance, the catheter body (1) is inserted through the vascular sheath into the great saphenous vein, and anesthesia and tumescent fluid are locally injected; Step 2: Setting ablation parameters: determining ablation power according to ablation position, and using a control unit to set ablation power and ablation duration; Step 3: Generating a temperature rise curve: The temperature measuring component feeds back the temperature values ​​of the five temperature measuring couples respectively, and generates a temperature rise curve of the five temperature measuring couples during the ablation process on the computer side; Step 4: Determine the single ablation length: Calculate the single ablation length according to the temperature measurement values ​​and temperature rise curve of the five temperature measuring couples fed back by the temperature measuring component according to the formula M=L1+L2+L3-LY+LX; Where: M is the total length of a single ablation; L1 is the length of the first radiation zone (25); L2 is the length of the second radiation zone (26); L3 is the length of the third radiation zone (27); LX is the length from the ablation end to the third radiation zone (27); LY is the total overlapping length of the radiation zone; Step 5: After a single ablation is completed, withdraw the needle according to the length of the single ablation and continue ablation until the ablation is completely completed.

10. The method for measuring the single ablation length of a varicose vein ablation catheter according to claim 9, characterized in that: In the formula M=L1+L2+L3+LX-LY, the lengths of L1, L2, L3 and LY are fixed values, and the length of LX is automatically calculated according to the temperature rise curve.

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