Radiofrequency ablation combined electrode needle and ablation system

Abstract

The invention relates to a radiofrequency ablation combined electrode needle and an ablation system, and relates to the technical field of ablation. The radiofrequency ablation combined electrode needle comprises a main needle, a plurality of sub-needles and a handle assembly used for adjusting the main needle and the sub-needles, the main needle comprises a needle head assembly and a needle rod assembly, and the needle rod assembly comprises a first inner tube, a second inner tube and a needle rod which are sequentially and coaxially arranged from inside to outside; the far end of the second inner tube is fixedly connected with the near end of the needle head assembly, a guide groove is formed between the far end of the needle rod and the near end of the needle head assembly, and the needle rod can move relative to the needle head assembly to change the width of the guide groove.

Description

Technical Field

[0001] The present invention relates to the field of ablation technology, and particularly to a radiofrequency ablation composite electrode needle and an ablation system. Background Art

[0002] In the field of tumor radiofrequency ablation treatment, the existing ablation needles generally adopt a design scheme in which the sub-needles extend from the main needle. However, in order to ensure the smooth extension and retraction of the sub-needles, there are significant limitations in the extension length and extension angle of the sub-needles. At present, the maximum extension angle of the mainstream ablation needles on the market can only reach 180°. This angle limitation makes it difficult for the ablation needle to achieve a complete envelope of irregularly shaped lesions, and it is very easy to have ablation blind spots in clinical practice, thus leading to the risk of missed ablation.

[0003] To avoid the problem of missed ablation, the retraction ablation method is often used in clinical operations. This method requires multiple repetitions of the operation process of "retracting the needle → withdrawing the needle → extending the needle → ablation": after the first ablation is completed, the sub-needles are retracted, the ablation needle is withdrawn to a certain depth, and then the sub-needles are extended again for secondary ablation; if necessary, the ablation effect also needs to be evaluated by CT scan. If it is found that the lesion is not completely covered, a third or more retraction, withdrawal, extension, and ablation operations of the needle are required. This operation method of forming a target thermal damage range by superimposing multiple ablation areas axially through multiple punctures and ablations not only prolongs the operation time, increases the workload of medical staff, but also significantly reduces the intraoperative experience of patients, and at the same time increases the occurrence probability of complications such as infection during the operation. Summary of the Invention

[0004] The present invention provides a radiofrequency ablation composite electrode needle and an ablation system for solving at least one of the above technical problems.

[0005] The present invention provides a radiofrequency ablation composite electrode needle, which includes a main needle, a plurality of sub-needles, and a handle assembly for adjusting the main needle and each of the sub-needles. The main needle includes a needle head assembly and a needle rod assembly. The needle rod assembly includes a first inner tube, a second inner tube, and a needle rod that are coaxially arranged in sequence from inside to outside. The distal end of the second inner tube is fixedly connected to the proximal end of the needle head assembly. A guiding groove is formed between the distal end of the needle rod and the proximal end of the needle head assembly. The needle rod and the needle head assembly can move relative to each other to change the width of the guiding groove; Each of the sub-needles is arranged between the second inner tube and the needle rod. When the guiding groove is opened, each of the sub-needles can extend out from the guiding groove; Wherein, the extension length and extension diameter of each of the sub-needles can be adjusted. Each of the sub-needles has a pre-bending angle, and the maximum pre-bending angle of each of the sub-needles is 360°, so that the maximum extension angle of each of the sub-needles extending out from the guiding groove is 360°.

[0006] In one embodiment, each of the sub - needles includes a sub - needle outer rod, and the sub - needle outer rod is of an integral structure or a two - section structure. When the sub - needle outer rod is of a two - section structure, it includes: A front section of the sub - needle, which is used to extend out from the guiding groove; and A driving section of the sub - needle, which is connected to the front section of the sub - needle. The driving section of the sub - needle extends between the second inner tube and the needle rod and extends into the handle assembly; wherein, the diameter of the driving section of the sub - needle is less than or equal to the diameter of the front section of the sub - needle.

[0007] In one embodiment, the length of the front section of the sub - needle is from 10 mm to 120 mm; or the extended length of the sub - needle outer rod is from 0 mm to 100 mm.

[0008] In one embodiment, one or both of the front section of the sub - needle and the driving section of the sub - needle are of a hollow structure; or one or both of the front section of the sub - needle and the driving section of the sub - needle are of a solid structure.

[0009] In one embodiment, the width of the guiding groove is related to the bending deformation direction of each sub - needle. The smaller the width of the guiding groove, the greater the clamping force on each sub - needle when it extends out from the guiding groove, so that each sub - needle can bend and deform earlier.

[0010] In one embodiment, the needle rod assembly further includes an adjustable insulating tube located outside the needle rod. The adjustable insulating tube is configured to move relative to the needle rod according to the extended length and extended diameter of each sub - needle, so as to adjust the exposed length of the needle rod and / or the exposed length of the needle tip on the needle rod.

[0011] In one embodiment, the needle tip assembly includes a needle tip, and the needle tip includes: A needle handle; A puncture needle tip, which is located at the distal end of the needle handle; A needle tip inner cavity, which is arranged inside the needle handle and the puncture needle tip. The first inner tube and the second inner tube are respectively in fluid communication with the needle tip inner cavity; and A needle tip injection and aspiration channel, which is arranged on the needle handle and / or the puncture needle tip and is in fluid communication with the needle tip inner cavity; wherein, the diameter of the needle tip injection and aspiration channel is configured such that the medium circulation cooling and liquid injection can be realized synchronously.

[0012] In one embodiment, it further includes an aspiration and injection channel, and the aspiration and injection channel is configured as the guiding groove, or the aspiration and injection channel is configured as an aspiration and injection channel on the needle rod, and the aspiration and injection channel on the needle rod is in fluid communication with the space between the second inner tube and the needle rod.

[0013] In one embodiment, a linkage mechanism is provided in the handle assembly. The linkage mechanism includes a sub-needle extension switch respectively connected to each sub-needle and a guiding groove adjustment switch connected to the needle rod, and the sub-needle extension switch and the guiding groove adjustment switch are interlocked with each other.

[0014] The present invention also provides an ablation system, which includes an ablation main unit and the above-mentioned radiofrequency ablation composite electrode needle, and the ablation main unit is electrically connected to the radiofrequency ablation composite electrode needle through an electrical wire.

[0015] Compared with the prior art, the main advantages of the present invention are as follows: (1) The present invention innovatively designs that the maximum pre-bending angle of the sub-needles can reach 360°, so that the maximum exhibition angle of the sub-needles protruding from the guiding groove breaks through the traditional limit and also reaches 360°. When multiple sub-needles are all exhibited at the maximum exhibition angle, a spherical or quasi-spherical structure can be constructed. This unique structural design can form a spherical or quasi-spherical ablation thermal damage range matching it during the ablation treatment process. Compared with traditional ablation needles, it can more comprehensively and accurately envelop various irregularly shaped lesions, eliminating the hidden danger of missed ablation from the root cause. Based on this, the operation can be completed only by one puncture and ablation operation, which not only greatly shortens the operation time, significantly improves the operation efficiency, but also greatly improves the patient's intraoperative experience and reduces the risk of complications caused by multiple operations.

[0016] (2) The present invention break through to realize the flexible adjustment of the exposed length of the needle tip and / or the needle rod, that is, the working length of the main needle. Based on this, a plurality of adjustment modes are derived: the working length of the main needle can be adjusted alone, the exhibition length and exhibition angle of the sub-needles can be independently adjusted, and the working length of the main needle and the parameters (exhibition length, exhibition angle) of the sub-needles can be jointly adjusted. Especially in the joint adjustment mode, the working section of the main needle and the unfolded part of the sub-needles act synergistically, and a personalized combined thermal damage range can be accurately constructed according to the morphological characteristics of the tumor. Therefore, whether it is a tumor with a regular shape or a complex and changeable abnormal-shaped tumor, the embodiment scheme of the present invention can achieve high-precision conformal ablation through dynamic adjustment of parameters, thereby significantly improving the pertinence and effectiveness of radiofrequency ablation treatment and providing a more efficient and flexible solution for clinical tumor ablation treatment. Description of the Drawings

[0017] Hereinafter, the present invention will be described in more detail based on embodiments and with reference to the drawings.

[0018] Figure 1A is a schematic structural view of a radiofrequency ablation composite electrode needle in an embodiment of the present invention; Figure 1B is Figure 1A a schematic structural view of the handle housing in Figure 2 is a cross-sectional view of the distal portion of a radiofrequency ablation composite electrode needle in an embodiment of the present invention; Figure 3A is a cross-sectional view of the needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present invention, wherein no column suction holes are provided in the needle head assembly; Figure 3B is Figure 3A a schematic structural view of the guiding groove in Figure 3C is a cross-sectional view of the needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present invention, wherein column suction holes are provided in the needle head assembly; Figure 4A , Figure 4B , Figure 4C and Figure 4D are respectively schematic structural views of the puncture needle tip 101 of a radiofrequency ablation composite electrode needle in an embodiment of the present invention; Figure 5A , Figure 5B and Figure 5C are respectively cross-sectional views of the needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present invention, wherein, Figure 5A shows that a temperature sensor is provided near the puncture needle tip 101 in the needle lumen, Figure 5B shows that temperature sensors are provided in the puncture needle tip 101 and the needle handle, Figure 5C shows that a temperature sensor is provided in the lumen of the sub-needle; Figure 5D is) Figure 5C an enlarged view at A; Figure 6A , Figure 6B and Figure 6C are respectively cross-sectional views of the needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present invention, wherein, Figure 6A shows that the guiding groove is in a closed state; Figure 6B shows that the guiding groove is in an open state; Figure 6C shows that the guiding groove is in an open state and the sub-needle is in a state of being extended from the guiding groove; Figure 7 is a schematic structural view of the sub-needle of a radiofrequency ablation composite electrode needle in an embodiment of the present invention; Figure 8A is Figure 7 an enlarged view at B; Figure 8BIt is a schematic structural diagram of the sub-needle in another embodiment of the present invention; Figure 9A 、 Figure 9B and Figure 9C and Figure 9D are respectively cross-sectional views of the needle tip assembly of the radiofrequency ablation composite electrode needle in one of the embodiments of the present invention. Among them, Figure 9A shows the state where the extended length of the sub-needle is 1 / 4 of the overall length of the sub-needle; Figure 9B shows the state where the extended length of the sub-needle is 2 / 4 of the overall length of the sub-needle; Figure 9C shows the state where the extended length of the sub-needle is 3 / 4 of the overall length of the sub-needle; Figure 9D shows the state where the sub-needle is fully extended; Figure 10A is a cross-sectional view of the needle tip assembly of the radiofrequency ablation composite electrode needle in one of the embodiments of the present invention, where the outer cavity of the sub-needle serves as the injection and aspiration channel; Figure 10B is Figure 10A an enlarged view at C; Figure 11A is a cross-sectional view of the needle tip assembly of the radiofrequency ablation composite electrode needle in one of the embodiments of the present invention, where an injection and aspiration channel is provided on the needle shaft; Figure 11B is Figure 11A an enlarged view at D; Figure 12 is a cross-sectional view of the needle tip assembly of the radiofrequency ablation composite electrode needle in one of the embodiments of the present invention, where an injection and aspiration channel is provided on the needle tip; Figure 13A is a cross-sectional view of the needle tip assembly of the radiofrequency ablation composite electrode needle in one of the embodiments of the present invention, where the inner cavity of the sub-needle serves as the injection and aspiration channel; Figure 13B is Figure 13A an enlarged view at E; Figure 14A 、 Figure 14B [[ID=,49]]and Figure 14C are respectively schematic diagrams of the outward bending of the sub-needle of the radiofrequency ablation composite electrode needle in the embodiments of the present invention. Among them, Figure 14A shows the state where the sub-needle bends outward by 90°, Figure 14B shows the state where the sub-needle bends outward by 180°, Figure 14C shows the state where the sub-needle bends outward by 360°; Figure 15A 、 Figure 15B and Figure 15C are respectively schematic diagrams of the inward bending of the sub-needle of the radiofrequency ablation composite electrode needle in the embodiments of the present invention. Among them, Figure 15A shows the state where the sub-needle bends inward by 90°, Figure 15BShows the state where the sub-needle is bent inward by 180°, Figure 15C shows the state where the sub-needle is bent inward by 360°; Figure 16 is a schematic diagram of the sub-needle structure of the radiofrequency ablation composite electrode needle in one embodiment of the present invention; Figure 17A is a schematic diagram of the sub-needle structure of the radiofrequency ablation composite electrode needle in one embodiment of the present invention; Figure 17B is Figure 17A an enlarged view at F; Figure 18A and Figure 18B are respectively schematic diagrams of the needle head assembly of the radiofrequency ablation composite electrode needle in the embodiment of the present invention; where Figure 18A shows the state where the insulating tube completely covers the puncture needle tip 101, Figure 18B shows the state where a part of the needle rod is not covered by the insulating tube; Figure 19A is a picture after the ablation experiment of the radiofrequency ablation composite electrode needle of the present invention on an animal liver; Figure 19B is a picture after the ablation experiment of the existing ablation needle on an animal liver; Figure 20 is a curve graph between the unfolded diameter when the sub-needle is fully extended and the extended length when the sub-needle is first extended; Figure 21A and Figure 21B are respectively the states when the sub-needle continues to extend to the fully extended state when the guiding groove is in the minimum state and the semi-closed state after the extended length of the sub-needle is 5 mm for the first time; Figure 22A and Figure 22B are respectively the states when the sub-needle continues to extend to the fully extended state when the guiding groove is in the minimum state and the semi-closed state after the extended length of the sub-needle is 35 mm for the first time; Figure 23A is a schematic diagram of the ablation lesion when the extended length of the sub-needle 5 is 1 / 2 of the pre-extended length of the sub-needle 5 and the width of the guiding groove 9 is 15 mm; Figure 23B is a schematic diagram of the ablation lesion when the extended length of the sub-needle 5 is 3 / 4 of the pre-extended length of the sub-needle 5 and the width of the guiding groove 9 is 10 mm; Figure 23C is a schematic diagram of the ablation lesion when the sub-needle 5 is fully extended and the width of the guiding groove 9 is 5 mm; Figure 24 is a three-dimensional structure schematic diagram of the linkage mechanism in the embodiment of the present invention, where the handle shell is not shown; Figure 25It is a schematic three-dimensional structure diagram of a gear mechanism in an embodiment of the present invention; Figure 26 It is a schematic three-dimensional structure diagram of a cam mechanism in an embodiment of the present invention; Figure 27A It shows the state where the linkage mechanism in the embodiment of the present invention closes the guiding groove and the sub-needle is not extended; Figure 27B It shows the state where the linkage mechanism in the embodiment of the present invention opens the guiding groove and the sub-needle is partially extended; Figure 27C It shows the state where the linkage mechanism in the embodiment of the present invention opens the guiding groove and the sub-needle is fully extended.

[0019] Reference numerals: 1. Needle head; 101. Puncture tip; 102. Needle handle; 103. Inner cavity of the needle head; 104. Needle head coating; 105. Aspiration channel of the needle head; 2. Temperature sensor; 201. Sensor probe; 202. Temperature transmission line; 3. First inner tube; 301. Outer rod of the first inner tube; 302. Inner cavity of the first inner tube; 4. Second inner tube; 401. Outer rod of the second inner tube; 402. Inner cavity of the second inner tube; 5. Sub-needle; 501. Inner cavity of the sub-needle; 502. Outer rod of the sub-needle; 503. Outer cavity of the sub-needle; 504. Sub-needle temperature sensor; 505. Front section of the sub-needle; 506. Driving section of the sub-needle; 6. Needle rod; 601. Aspiration channel of the needle rod; 7. Needle rod coating; 8. Insulating tube; 9. Guiding groove; 10. Handle assembly; 11. Straight needle working end adjustment switch; 12. Straight needle working end length pointer; 13. Guiding groove adjustment switch; 131. Cam; 132. Ejector rod; 133. Spring; 134. First guide sleeve; 135. First connecting sleeve; 136. Link; 137. Second connecting sleeve; 138. Second guide sleeve; 1311. Camshaft; 1312. Cam tip; 1313. Flat part; 1314. Arc part; 1321. Boss; 1351. First connecting claw; 1352. Second connecting claw; 1353. First central connecting cylinder; 1371. Third connecting claw; 1372. Fourth connecting claw; 1373. Second central connecting cylinder; 61. Needle rod fixing seat; 62. Scale ring; 14. Guide groove adjustment length pointer; 15. Sub - needle extension switch; 151. Rack; 152. Gear; 153. Knob; 1511. Sub - needle connection groove; 1512. Arc recess; 1513. Vertical section; 1514. Horizontal section; 16. Sub - needle extension length pointer; 17. First liquid tube; 1701. First liquid tube body; 1702. First liquid tube joint; 18. Second liquid tube; 1801. Second liquid tube body; 1802. Second liquid tube joint; 19. Third liquid tube; 1901. Third liquid tube body; 1902. Third liquid tube joint; 20. Fourth liquid tube; 2001. Fourth liquid tube body; 2002. Fourth liquid tube joint; 21. First liquid cavity; 22. Second liquid cavity; 23. Third liquid cavity; 2301. First inner tube inner cavity connection cavity; 2302. Second inner tube inner cavity connection cavity; 24. Electrical wire; 2402. Electrical wire composite cable; 2401. Electrical wire joint; 25. Handle shell. Detailed implementation mode

[0020] The present invention will be further described below in conjunction with the accompanying drawings.

[0021] As Figure 1A 、 Figure 1B and Figure 2 shown, the present invention provides a radiofrequency ablation composite electrode needle, which includes a main needle, a sub - needle 5 located inside the main needle and capable of extending from the inside of the main needle, and a handle assembly 10 for adjusting the proximal sides of the main needle and the sub - needle 5. The number of sub - needles 5 can be multiple, and multiple sub - needles 5 can extend from the main needle simultaneously. Among them, the extension length and extension diameter of each sub - needle 5 can be adjusted, and the working length of the main needle can also be adjusted. The sub - needle 5 and the main needle can be adjusted separately, so as to realize the adjustable ablation range of a single needle; or the sub - needle 5 and the main needle can be adjusted together, The main needle includes a needle tip assembly and a needle rod assembly. As Figure 2 and Figure 3A shown, the needle tip assembly includes a needle tip 1, and the needle tip 1 includes a needle handle 102 and a puncture needle tip 101 located at the distal end of the needle handle 102. The puncture needle tip 101 is used as a puncture component for puncturing the skin, tissue and treatment area in clinical treatment; it can also be used as part of the component for transmitting radiofrequency ablation energy signals to the tissue.

[0022] The shape of the puncture needle tip 101 can be a shape convenient for puncture, for example, it can be Figure 4A shown as a triangular prism,Figure 4B the shown lanceolate shape, Figure 4C the shown conical shape or Figure 4D the shown semi-circular shape, etc.

[0023] The length of the puncture tip 101 can be 2mm - 10mm, and different lengths of the puncture tip 101 can be selected according to different puncture sites. The outer diameter of the needle 1 (the needle handle 102) is 0.5mm - 6mm, and needles 1 with different diameters can be selected according to different puncture sites.

[0024] The puncture tip 101 and the needle handle 102 can be fixedly connected by means such as welding and mechanical connection; or the puncture tip 101 and the needle handle 102 can be formed by an integral molding method.

[0025] The puncture tip 101 and the needle handle 102 can be made of the same material. For example, both can be made of a conductive medical metal material, such as made of metals or alloys such as 304, 316, titanium alloy, platinum, iridium, etc.; or the puncture tip 101 and the needle handle 102 can be made of different materials. For example, the two can be two different materials among the above-mentioned conductive medical metal materials.

[0026] As Figure 3A shown, the needle 1 further includes a needle inner cavity 103 provided inside the puncture tip 101 and the needle handle 102. The needle inner cavity 103 is used for the release and heat exchange of a medium (cold medium or hot medium). The medium can be a gas or a liquid, etc., and can be selected according to the usage scenario.

[0027] In some embodiments, as Figure 3A shown, a needle coating 104 is provided on the entire outer surface of the puncture tip 101 and the needle handle 102. The needle coating 104 is used to prevent tissue adhesion during the treatment process; or the needle coating 104 can also conduct electricity as an electrode during the radiofrequency ablation process.

[0028] Optionally, the needle coating 104 and the puncture tip 101 can be the same component, or the needle coating 104 and the needle handle 102 can also be the same component.

[0029] The needle coating 104 can be made of insulating or conductive temperature-resistant and anti-adhesive materials such as PTFE, parylene, titanium nitride, etc., and can be selected according to different uses.

[0030] In some other embodiments, as Figure 3C and Figure 12As shown, a needle injection and aspiration channel 105 is provided on the puncture needle tip 101 and / or the needle handle 102, and the needle injection and aspiration channel 105 is in fluid communication with the needle inner cavity 103. The needle injection and aspiration channel 105 can be used for liquid injection and aspiration of human tissue fluid; the liquid includes injection anesthetic drugs, normal saline, therapeutic drugs, immune drugs, etc.; the human tissue fluid includes tissue blood, pathological tissue, etc.

[0031] The number of the needle injection and aspiration channels 105 can be one or more. When the number of the needle injection and aspiration channels 105 is multiple, the multiple needle injection and aspiration channels 105 can be arranged at equal intervals along the axial direction of the puncture needle tip 101 (or the needle handle 102), or arranged at equal intervals along the circumferential direction of the puncture needle tip 101 (or the needle handle 102). The spacing between the needle injection and aspiration channels 105 is 0.1 mm - 2 mm.

[0032] In addition, the spacing between the multiple needle injection and aspiration channels 105 can also be different.

[0033] As Figure 3C shown, the needle injection and aspiration channel 105 can be a hole-like structure (injection and aspiration hole) that penetrates the wall thickness along the radial direction of the puncture needle tip 101 (or the needle handle 102). The injection and aspiration holes can be circular holes, oval holes, strip-shaped holes, etc. When there are multiple injection and aspiration holes, the diameters of the injection and aspiration holes can be the same or different. For example, along the liquid injection direction, the diameters of the injection and aspiration holes gradually increase. Among them, the maximum diameter of a single injection and aspiration hole is 0.02 mm - 2 mm.

[0034] If the aperture of the injection and aspiration hole is too small, the cooling medium in the needle inner cavity 103 can only achieve circulating cooling and there is no time for liquid injection. On the contrary, if the aperture of the injection and aspiration hole is too large, the circulating cooling of the cooling medium in the needle inner cavity 103 will be affected. Therefore, the present invention proposes to construct the diameter of the needle injection and aspiration channel 105 such that the medium circulating cooling and liquid injection can be achieved synchronously, that is, while the cooling medium (such as normal saline) in the needle inner cavity 103 exchanges heat in the needle inner cavity 103, it can also flow out from the needle inner cavity 103 through the needle injection and aspiration channel 105 into the tissue of the target area. Thus, while heat exchange is carried out, liquid can also be injected into the tissue, so as to reduce carbonization in the ablation area and improve the efficiency of radiofrequency ablation; at the same time, the liquid injected into the tissue is also conducive to conduction, so it is conducive to energy ablation.

[0035] Specifically, when a peristaltic pump is used to pump liquid into the needle inner cavity 103 and circulate, when injecting liquid through the needle injection and aspiration channel 105 of the needle inner cavity 103, the injection volume Q 1 satisfies the following relational expression: ; Among them, Q1 is the total amount of the injected liquid injected through each needle injection and suction channel 105 (injection and suction hole) of the needle inner cavity 103, and its unit is m 3 / s or ml / min.

[0036] i is the number of the needle injection and suction channels 105, and the sizes of the injection and suction holes can be the same or different.

[0037] k is the peristaltic pump extrusion pressure pulse coefficient. The pulse makes the instantaneous flow rate higher than the average flow rate. For example k can be 1.0 to 2.0.

[0038] Cd i is the i th flow coefficient of the injection and suction hole. Among them, when the orifice of the i th injection and suction hole is a regular shape such as a circle, Cd i can be 1; when the orifice of the i th injection and suction hole is an irregular shape, Cd i can be 0.5 to 1.0 (rough orifice range).

[0039] A i is the i th cross-sectional area of the orifice of the injection and suction hole (unit: m 2 ). For example, if the i th injection and suction hole is a circular hole, , d i is the i th aperture (diameter) of the injection and suction hole; if the i th injection and suction hole is a crack, its cross-section can be regarded as a rectangle, that is A i = the length of the long side of the cross-section × the length of the wide side of the cross-section.

[0040] is the average pressure in the needle inner cavity 103, and the unit is Pa, ranges from 10 5 Pa to 10 6 Pa.

[0041] ρ is the density of the injected liquid. For example, if the injected liquid is conventional injection water or physiological saline, ρ is 1000 kg / m 3 .

[0042] Therefore, according to the above-mentioned liquid injection volume Q 1 and the i orifice cross-sectional area of the A i first injection and aspiration hole, the aperture (diameter) of the i first injection and aspiration hole can be determined, so that the medium circulation cooling and liquid injection can be realized synchronously.

[0043] A temperature measuring device is provided in the radiofrequency ablation composite electrode needle, such as the temperature sensor 2. The temperature sensor 2 is used to monitor the temperature inside and outside the radiofrequency ablation composite electrode needle or the temperature of the tissue at the treatment site. The temperature sensor 2 can be one of a thermocouple, a thermistor (such as an NTC (negative temperature coefficient thermistor) or a PTC (positive temperature coefficient thermistor)), and an optical fiber sensor.

[0044] As Figure 2 shown, the temperature sensor 2 includes a sensor probe 201 and a temperature transmission line 202 communicatively connected to the sensor probe 201. Among them, the sensor probe 201 is used to contact the part where the temperature needs to be measured, so as to convert the temperature change signal into signals such as impedance, current voltage, and phase change. The temperature transmission line 202 is used to transmit the above-mentioned temperature change signal to the radiofrequency ablation host for digital processing, temperature regulation, and display.

[0045] The temperature measuring device can be located at different positions in the radiofrequency ablation composite electrode needle.

[0046] As Figure 5A shown, the sensor probe 201 of the temperature sensor 2 is disposed at a position close to the puncture tip 101 in the needle lumen 103 inside the needle 1. The temperature sensor 2 located in the needle lumen 103 can measure the temperature of the medium or the temperature of the normal tissue area contacted by the radiofrequency ablation composite electrode needle.

[0047] As Figure 5B shown, the sensor probe 201 of the temperature sensor 2 extends from the needle lumen 103 inside the needle 1 to the inside of the puncture tip 101. The temperature sensor 2 located inside the puncture tip 101 is used to measure the temperature of the heat exchange area of the radiofrequency ablation composite electrode needle. Setting the temperature sensor 2 here can avoid the influence of the medium on temperature measurement.

[0048] As Figure 5C and Figure 5D shown, the temperature measuring device can also be disposed on the sub-needle 5, such as the sub-needle temperature measuring device described below.

[0049] Please continue to refer to Figure 2, the needle rod assembly includes an adjustable insulating tube 8 located on the outermost layer, a needle rod 6 located inside the adjustable insulating tube 8 and arranged coaxially with the adjustable insulating tube 8, a second inner tube 4 arranged inside the needle rod 6 and coaxially with the needle rod 6, and a first inner tube 3 arranged inside the second inner tube 4 and coaxially with the second inner tube 4.

[0050] As Figure 2 , Figure 3A and Figure 3C shown, the first inner tube 3 is the innermost tube, and its distal end extends into the needle lumen 103. The second inner tube 4 is located outside the first inner tube 3, and its distal end extends to be fixedly connected to the proximal end of the needle handle 102. Therefore, the first inner tube 3 is in fluid communication with the needle lumen 103, and the second inner tube 4 is in fluid communication with the needle lumen 103. The medium conveyed in the first inner tube 3 can be released at the distal end of the first inner tube 3 and enter the needle lumen 103, and after heat exchange with the target area where the needle lumen 103 is located in the needle lumen 103, it returns to the second inner tube 4 from the needle lumen 103.

[0051] The second inner tube 4 and the needle handle 102 can be fixed by means such as welding, mechanical connection (such as riveting, threaded connection, etc.), or the second inner tube 4 and the needle handle 102 can be an integrally formed structure. Therefore, the second inner tube 4 can also transmit radio frequency energy signals.

[0052] Please continue to refer to Figure 2 , the first inner tube 3 includes a first inner tube outer rod 301, and the first inner tube outer rod 301 is configured to have a hollow structure inside, so a first inner tube lumen 302 is formed inside it. The first inner tube lumen 302 is in fluid communication with the needle lumen 103. Therefore, the medium conveyed in the first inner tube 3 is released through the first inner tube lumen 302 and enters the needle lumen 103.

[0053] Please continue to refer to Figure 2 , the second inner tube 4 is similar in structure to the first inner tube 3. It includes a second inner tube outer rod 401, and the second inner tube outer rod 401 is configured to have a hollow structure inside. The second inner tube outer rod 401 adjusts the first inner tube outer rod 301. Therefore, the inner wall of the second inner tube outer rod 401 and the outer wall of the first inner tube outer rod 301 define a second inner tube lumen 402. The second inner tube lumen 402 is in fluid communication with the needle lumen 103. Therefore, the fluid that has undergone heat exchange in the needle lumen 103 can return from the needle lumen 103 to the second inner tube lumen 402.

[0054] Therefore, it can be known that the medium channels in the radiofrequency ablation composite electrode needle include a first inner tube lumen 302 and a second inner tube lumen 402. Among them, the first inner tube lumen 302 serves as the medium inlet channel, and the second inner tube lumen 402 serves as the medium outlet channel, and the two form a heat exchange cycle inlet and outlet channel.

[0055] Please continue to refer to Figure 2 The sub-needle 5 is disposed between the second inner tube 4 and the needle rod 6. Specifically, the sub-needle 5 is located outside the outer rod 401 of the second inner tube and inside the needle rod 6. Therefore, the liquid in the inner cavity 402 of the second inner tube can also cool the sub-needle 5.

[0056] As Figure 2 shown, the temperature transmission line 202 of the temperature sensor 2 extends in the first inner tube 3, and the sensor probe 201 extends out of the first inner tube 3 and into the inner cavity 103 of the needle tip. Therefore, the temperature sensor 2 can measure the temperature of the target area where the inner cavity 103 of the needle tip is located, thereby improving the accuracy of the measurement.

[0057] Please continue to refer to[[ID=l1]] Figure 1A and Figure 1B , the proximal ends of the first inner tube 3 and the second inner tube 4 both extend into the handle assembly 10.

[0058] A first liquid cavity 21, a second liquid cavity 22, and a third liquid cavity 23 are sequentially arranged in the handle assembly 10. Among them, the third liquid cavity 23 includes a first inner tube inner cavity connection cavity 2301 and a second inner tube inner cavity connection cavity 2302 arranged in sequence. The first inner tube inner cavity connection cavity 2301 and the second inner tube inner cavity connection cavity 2302 are not connected, and the first inner tube inner cavity connection cavity 2301 is closer to the puncture needle tip 101.

[0059] The proximal end of the first inner tube 3 extends out of the second inner tube 4 and extends into the first inner tube inner cavity connection cavity 2301. Therefore, the first inner tube inner cavity 302 is in fluid communication with the first inner tube inner cavity connection cavity 2301, and the medium in the first inner tube inner cavity connection cavity 2301 can be transported into the inner cavity 103 of the needle tip through the first inner tube inner cavity 302. The proximal end of the second inner tube 4 extends into the second inner tube inner cavity connection cavity 2302. Therefore, the second inner tube inner cavity 402 is in fluid communication with the second inner tube inner cavity connection cavity 2302, and the medium in the inner cavity 103 of the needle tip can return to the second inner tube inner cavity connection cavity 2302 through the second inner tube inner cavity 402.

[0060] The first inner tube 3 is made of metal, such as made of medical metal materials (metals or alloys such as 304, 316, titanium alloy, platinum, iridium, etc.); or the first inner tube 3 can also be made of plastic, such as made of materials such as PTFE, PEEK, PI, ceramic, glass fiber, etc.

[0061] The second inner tube 4 is made of medical conductive materials, such as made of medical metal materials (metals or alloys such as 304, 316, titanium alloy, platinum, iridium, etc.). The materials of the first inner tube 3 and the second inner tube 4 can be the same or different.

[0062] The needle shaft 6 is made of a medical conductive material, for example, made of a medical metal material (such as metals or alloys like 304, 316, titanium alloy, platinum, iridium, etc.).

[0063] Please continue to refer to Figure 2 and, in combination with Figure 3B , a guiding groove 9 is formed between the distal end of the needle shaft 6 (the end close to the puncture tip 101) and the proximal end of the needle handle 102 (the end far from the near puncture tip 101). It can be understood that the guiding groove 9 is the gap between the distal end of the needle shaft 6 and the proximal end of the needle handle 102.

[0064] As Figure 6A shown, the distal end of the needle shaft 6 and the proximal end of the needle handle 102 are in mutual abutment, and the gap between them is 0, that is, the guiding groove 9 is completely closed; as Figure 6B shown in the figure, there is a certain distance between the distal end of the needle shaft 6 and the proximal end of the needle handle 102, that is, the guiding groove 9 is open. The gap between the distal end of the needle shaft 6 and the proximal end of the needle handle 102, that is, the width of the guiding groove 9, is 0 mm - 10 mm.

[0065] As Figure 3B and Figure 6C shown, after the guiding groove 9 is opened, the sub-needle 5 can be extended from the guiding groove 9.

[0066] The inner diameter of the needle shaft 6 can be less than or equal to the outer diameter of the needle handle 102, so the needle shaft 6 and the needle handle 102 can be relatively moved until the distal end of the needle shaft 6 abuts against the proximal end of the needle handle 102, thereby ensuring that the guiding groove 9 is completely closed and the sub-needle 5 cannot be extended from it.

[0067] Please continue to refer to Figure 1B , a guiding groove adjusting switch 13 is provided in the handle assembly 10, which is connected to the proximal end of the needle shaft 6 or the proximal end of the second inner tube 4. By operating the guiding groove adjusting switch 13, the relative movement of the needle shaft 6 and the second inner tube 4 (and the needle handle 102) can be controlled, so as to adjust the distance between the distal end of the needle shaft 6 and the proximal end of the needle handle 102, that is, the width of the guiding groove 9 can be adjusted. For example, the guiding groove adjusting switch 13 can be operated to control the movement of the needle shaft 6 relative to the needle handle 102, or the guiding groove adjusting switch 13 can be operated to control the movement of the needle handle 102 relative to the needle shaft 6.

[0068] In one embodiment, as Figure 11A and Figure 11B shown, the radiofrequency ablation composite electrode needle further includes a suction and injection channel, and the suction and injection channel is configured as a needle shaft suction and injection channel 601 opened on the needle shaft 6 near the needle tip 1. The needle shaft suction and injection channel 601 is in fluid communication with the space between the second inner tube 4 and the needle shaft 6 (that is, the outer cavity 503 of the sub-needle).

[0069] The needle rod injection and suction channel 601 can be used for the injection of liquids and the suction of human tissue fluids; the liquids include injection anesthetic drugs, physiological saline, therapeutic drugs, and immune drugs, etc.; the human tissue fluids include tissue blood, pathological tissues, etc.

[0070] The number of the needle rod injection and suction channels 601 can be one or more. When the number of the needle rod injection and suction channels 601 is multiple, the multiple needle rod injection and suction channels 601 can be arranged at equal intervals along the axial direction of the needle rod 6, or arranged at equal intervals along the circumferential direction of the needle rod 6. The distance between each needle head injection and suction channel 105 is 0.1 mm - 2 mm.

[0071] In addition, the distances between the multiple needle rod injection and suction channels 601 can also be different.

[0072] Such as Figure 11B As shown, the needle rod injection and suction channel 601 can be an injection and suction hole that penetrates the wall thickness of the needle rod 6 along the radial direction. The injection and suction hole can be a circular hole, an oval hole, a long strip hole, etc. When there are multiple injection and suction holes, the diameters of each injection and suction hole can be the same or different. For example, along the liquid injection direction, the diameters of each injection and suction hole gradually increase. Among them, the maximum diameter of a single injection and suction hole is 0.02 mm - 2 mm.

[0073] When injecting liquid through the space (i.e., the outer cavity 503 of the sub-needle) between the second inner tube 4 and the needle rod 6 via the needle rod injection and suction channel 601, the injection liquid volume Q 2 satisfies the following relational expression: ; Among them, Q 2 is the total amount of the injection liquid injected through each injection and suction hole (the needle rod injection and suction channel 601) of the outer cavity 503 of the sub-needle, and the unit is m 3 / s or ml / min.

[0074] i is the number of the needle rod injection and suction channels 601, and the sizes of each injection and suction hole can be the same or different.

[0075] Cd i is the i th flow coefficient of the injection and suction hole. Among them, when the orifice of the i th injection and suction hole is a regular shape such as a circle, Cd i can be 1; when the orifice of the i th injection and suction hole is an irregular shape, Cd i can be 0.5 - 1.0 (rough orifice range).

[0076] A i is the orifice cross-sectional area of the i th injection and suction hole (the unit ism 2 ). For example, if the i th aspiration hole is a circular hole, , d i is the aperture diameter (diameter) of the i th aspiration hole; if the i th aspiration hole is a crack, its cross-section can be regarded as a rectangle, that is, A i = length of the long side of the cross-section × length of the wide side of the cross-section.

[0077] is the pressure difference (unit: Pa ) between both sides of the aspiration channel 601 of the anchor rod.

[0078] It can be obtained by calculating the difference between the internal pressure P 注内 and the external atmospheric pressure P 组织 , that is: ΔP = P 注内 -P 组织 . When the external atmospheric pressure P 组织 is the standard atmospheric pressure, the above formula can be simplified to ∆𝑃 = P 注内 .

[0079] Please continue to refer to Figure 2 , an adjustable insulating tube 8 is coaxially arranged outside the anchor rod 6. The distal end of the adjustable insulating tube 8 is close to the puncture tip 101, and its proximal end extends into the handle assembly 10 and is connected to the straight needle working end adjustment switch 11 in the handle assembly 10.

[0080] The adjustable insulating tube 8 can play the roles of heat insulation and insulation. Therefore, the parts of the needle head 1 and the anchor rod 6 that are not covered by the adjustable insulating tube 8 can perform heat and energy exchange. The adjustable insulating tube 8 can move relative to the anchor rod 6, so as to adjust the exposed length of the needle head 1 and / or the anchor rod 6 (that is, the length of the parts of the needle head 1 and the anchor rod 6 that are not covered by the adjustable insulating tube 8), that is, the working length of the main needle can be adjusted. As Figure 1A and Figure 1B shown, a straight needle working end adjustment switch 11 is arranged in the handle assembly 10, and it is connected to the proximal end of the adjustable insulating tube 8. By operating the straight needle working end adjustment switch 11, the adjustable insulating tube 8 is moved in the direction close to or away from the puncture tip 101 (as Figure 18A and Figure 18B shown), so as to change the length of its coverage of the needle head 1 and the anchor rod 6.

[0081] As Figure 18AAs shown, the adjustable insulating tube 8 moves towards the direction of the puncture needle tip 101 until it completely covers the puncture needle tip 101. At this time, it corresponds to the maximum coverage range of the adjustable insulating tube 8. As Figure 18B shown, the adjustable insulating tube 8 moves away from the puncture needle tip 101, so that the needle 1 is completely exposed outside the adjustable insulating tube 8, and a part of the needle rod 6 is exposed outside the adjustable insulating tube 8.

[0082] The exposed lengths of the needle 1 and the needle rod 6 can be indicated by the straight needle working end length pointer 12. The adjustable range of the exposed lengths of the needle 1 and / or the needle rod 6 is 0 mm - 100 mm.

[0083] The adjustable insulating tube 8 can be made of insulating plastic, such as made of materials such as PTFE, PEEK, PI, ceramics, glass fiber, etc.; it can also be made of metal materials with insulation treatment, such as made of medical metal materials (metals or alloys such as 304, 316, titanium alloy, platinum, iridium, etc.).

[0084] A needle rod coating 7 is also provided on the needle rod 6. The needle rod coating 7 is used to prevent tissue adhesion during the treatment process. For example, the needle rod coating 7 can be provided on the entire outer surface of the needle rod 6, or the needle rod coating 7 can be provided only on the outer surface of one end close to the needle 1.

[0085] The needle rod coating 7 and the needle rod 6 can also be the same component.

[0086] The needle rod coating 7 can be made of insulating or conductive temperature-resistant anti-adhesion materials such as PTFE and titanium nitride. The needle rod coating 7 can be selected according to different uses.

[0087] A scale layer is also provided on the surface of the needle rod 6 to facilitate the confirmation of the clinical puncture depth.

[0088] The number of the sub-needles 5 can be multiple. Please continue to refer to Figure 2 wherein, the distal parts of the multiple sub-needles 5 are coaxially arranged between the second inner tube 4 and the needle rod 6, and there is a certain gap between the outer wall of the second inner tube 4 and the inner wall of the needle rod 6 to facilitate the extension and sliding of the sub-needles 5.

[0089] The proximal parts of the multiple sub-needles 5 extend into the handle assembly 10 as a whole. As Figure 1A shown, the distal parts of the respective sub-needles 5 are connected to the sub-needle exhibition switch 15 in the handle assembly 10. By operating the sub-needle exhibition switch 15, when the guiding groove 9 is opened, the respective sub-needles 5 can be made to exhibit from the guiding groove 9 respectively.

[0090] Specifically, as Figure 7 and Figure 8A shown, the sub-needle 5 includes a sub-needle outer rod 502 and a sub-needle outer cavity 503. Please combineFigure 6A and Figure 6B Before the sub-needle 5 is deployed, a part of the outer rod 502 of the sub-needle is located in the cavity between the outer surface of the second inner tube 4 and the inner surface of the needle rod 6. Therefore, the outer cavity 503 of the sub-needle is the remaining gap part after the outer rod 502 of the sub-needle fills the above cavity. As Figure 6C shown, when the guiding groove 9 is opened, the outer rod 502 of the sub-needle can be deployed by operating the sub-needle deployment switch 15.

[0091] Optionally, as Figure 8A shown, the outer rod 502 of the sub-needle is a hollow structure, and an inner cavity 501 of the sub-needle is formed inside it. Therefore, the inner cavity 501 of the sub-needle can also be used as an injection and aspiration channel. Please refer to Figure 13A and Figure 13B . After the sub-needle 5 is deployed, liquid can be injected through the inner cavity 501 of the sub-needle and body tissue liquid can be aspirated.

[0092] Please continue to refer to Figure 1A , the first liquid cavity 21 is closer to the puncture tip 101 than the third liquid cavity 23. The sub-needle 5 extends beyond the first liquid cavity 21 of the handle assembly 10, and the second inner tube 4 and the needle rod 6 extend into the first liquid cavity 21; the space between the second inner tube 4 and the needle rod 6, that is, the outer cavity 503 of the sub-needle is in fluid communication with the first liquid cavity 21. When the sub-needle 5 is deployed, as Figure 10A and Figure 10B shown, the fluid in the first liquid cavity 21 can be injected through the outer cavity 503 of the sub-needle and via the guiding groove 9, or body tissue liquid can be aspirated through the guiding groove 9 and returned to the first liquid cavity 21 via the outer cavity 503 of the sub-needle.

[0093] Please continue to refer to Figure 1A , the second liquid cavity 22 is located between the third liquid cavity 23 and the first liquid cavity 21. The sub-needle 5 extends into the second liquid cavity 22, so the inner cavity 501 of the sub-needle 5 is in fluid communication with the second liquid cavity 22. When the sub-needle 5 is deployed, as Figure 13A and Figure 13B shown, the fluid in the second liquid cavity 22 can be injected through the inner cavity 501 of the sub-needle, or body tissue liquid can be aspirated through the inner cavity 501 of the sub-needle and returned to the second liquid cavity 22.

[0094] Optionally, as Figure 8B shown, the outer rod 502 of the sub-needle is a solid structure.

[0095] As described above, the injection and aspiration channel can also be configured as the guiding groove 9, that is, liquid can be injected through the guiding groove 9, and the amount of liquid injected through the guiding groove 9 Q g satisfies the following expression: ; Qg The amount of liquid injected into the guiding groove 9, in units of m 3 / s or ml / min.

[0096] C v is the velocity coefficient. Since there is friction between the liquid and the inner wall when the liquid flows in the outer cavity 503 of the sub-needle, C v can be set to 0.5 to 1. The smoother the inner wall of the outer cavity 503 of the sub-needle, C v the larger can be, for example, reaching the maximum value of 1.

[0097] A g is the opening cross-sectional area of the guiding groove 9 (in units of m 2 ).

[0098] P is the absolute pressure inside the radiofrequency ablation composite electrode needle, in units of Pa.

[0099] ρ is the density of the injected liquid. For example, if the injected liquid is conventional injection water or physiological saline, ρ is 1000 kg / m 3 .

[0100] Furthermore, as shown in Figure 5C and Figure 5D , a sub-needle temperature measuring device is provided in the inner cavity 501 of the sub-needle. For example, it can be a sub-needle temperature sensor 504. The sub-needle temperature sensor 504 can be used to monitor the temperature of the tissue at the edge of the thermal ablation treatment area, accurately obtain the spatial temperature of the treatment area, and can cooperate with the temperature sensor 2 in the puncture tip 101 assembly 1 for temperature monitoring and control; or the sub-needle temperature sensor 504 can also be used alone for temperature monitoring and control of the treatment area, so as to achieve precise ablation and real-time efficacy evaluation.

[0101] The sub-needle temperature sensor 504 can be the same as the temperature sensor 2 described above. For example, it can be a thermocouple, NTC, PTC, fiber optic sensor, etc.

[0102] After the sub-needle 5 is extended, the outer rod 502 of the sub-needle can also be part of a component that transmits the radiofrequency ablation energy signal to the tissue, and cooperate with the needle tip 1 and / or the needle shaft 6 to form the ablation damage range required for treatment.

[0103] After the sub-needle 5 is extended, the outer rod 502 of the sub-needle needs to penetrate into the tissue of the treatment area. Therefore, the distal end of the outer rod 502 of the sub-needle can be in a shape suitable for puncture, such as a triangular prism shape, a spear cone shape, a conical shape, etc. (asFigure 8A and Figure 8B as shown).

[0104] The number of the outer sub-needle rods 502 can be multiple, for example, it can be 1 - 20; the length extended by each outer sub-needle rod 502 can be 0 mm - 100 mm. The diameter of a single outer sub-needle rod 502 is 0.1 mm - 2 mm.

[0105] The outer sub-needle rod 502 is made of a medical conductive material, for example, it is made of a medical metal material (such as metals or alloys like 304, 316, titanium alloy, platinum, iridium, etc.).

[0106] In an alternative manner, the sub-needle 5 is of a multi-segment structure. For example, the sub-needle 5 is of a two-segment structure.

[0107] Specifically, as Figure 17A and Figure 17B shown, the sub-needle 5 includes an outer sub-needle rod 502, and the outer sub-needle rod 502 includes a front sub-needle segment 505 and a driving sub-needle segment 506. The proximal end of the front sub-needle segment 505 is connected to the driving sub-needle segment 506. The front sub-needle segment 505 is closer to the puncture tip 101, and it is the part of the sub-needle 5 for deployment.

[0108] When adopting such a two-segment structure, the front sub-needle segment 505 for deployment only needs to extend to be connected to the driving sub-needle segment 506, and there is no need to extend it into the handle assembly 10; the proximal ends of the driving sub-needle segment 506, the needle rod 6, and the second inner tube 4 extend into the handle assembly 10.

[0109] The front sub-needle segment 505 and the driving sub-needle segment 506 can be fixedly connected by means such as welding (laser welding, soldering, high-frequency welding, etc.), bonding, and mechanical connection.

[0110] It can be understood that the front sub-needle segment 505 can also be formed by splicing multiple pipe segments, and the driving sub-needle segment 506 can also be formed by splicing multiple pipe segments.

[0111] The length of the front sub-needle segment 505 is 10 mm - 120 mm.

[0112] As Figure 17B shown, the diameter of the front sub-needle segment 505 is larger than that of the driving sub-needle segment 506. Since the driving sub-needle segment 506 does not need to be deployed, it can be of a common tubular structure, so its diameter can be smaller than that of the front sub-needle segment 505.

[0113] In an alternative manner, as Figure 16 shown, the sub-needle 5 is of an integral structure, that is, the outer sub-needle rod 502 is of an integral structure. That is to say, the proximal end of the outer sub-needle rod 502 extends all the way into the handle assembly 10.

[0114] When the sub-needle outer rod 502 is of a hollow structure, one or both of the front section 505 and the driving section 506 of the sub-needle can be of a hollow structure; when the sub-needle outer rod 502 is of a solid structure, one or both of the front section 505 and the driving section 506 of the sub-needle can be of a solid structure.

[0115] For example, if the front section 505 of the sub-needle is of a hollow structure and the sub-needle outer rod 502 is also of a hollow structure, that is, the inner cavity 501 of the sub-needle includes the internal space of the front section 505 of the sub-needle and the internal space of the sub-needle outer rod 502. Or the front section 505 of the sub-needle is of a hollow structure and the sub-needle outer rod 502 is of a solid structure, that is, the inner cavity 501 of the sub-needle includes the internal space of the front section 505 of the sub-needle. At this time, the inner cavity 501 of the sub-needle can be in fluid communication with the outer cavity 503 of the sub-needle. Therefore, the medium in the first liquid chamber 21 can be injected via the guiding groove 9 or the inner cavity 501 of the sub-needle, or the body tissue fluid can be aspirated through the guiding groove 9 or the inner cavity 501 of the sub-needle and returned to the first liquid chamber 21 via the outer cavity 503 of the sub-needle.

[0116] Such as Figure 9A 、 Figure 9B 、 Figure 9C and Figure 9D As shown in

[0117] Such as Figure 9A shown, the extended length of the sub-needle 5 is adjusted by the sub-needle extension switch 15 so that the extended length of the sub-needle 5 is 1 / 4 of the pre-extended length of the sub-needle 5; as Figure 9B shown, the extended length of the sub-needle 5 is adjusted by the sub-needle extension switch 15 so that the extended length of the sub-needle 5 is 2 / 4 of the pre-extended length of the sub-needle 5; as Figure 9C shown, the extended length of the sub-needle 5 is adjusted by the sub-needle extension switch 15 so that the extended length of the sub-needle 5 is 3 / 4 of the pre-extended length of the sub-needle 5; as Figure 9D shown, the extended length of the sub-needle 5 is adjusted by the sub-needle extension switch 15 so that the sub-needle 5 is fully extended.

[0118] It should be noted that the pre-extended length of the sub-needle 5 is the maximum length that the sub-needle 5 can extend from the guiding groove 9.

[0119] The extended length of the sub-needle 5 (sub-needle outer rod 502) is 0 mm - 100 mm, that is, the maximum length (pre-extended length) of the sub-needle outer rod 502 extending from the guiding groove 9 is 120 mm. Therefore, after the sub-needle outer rod 502 is extended, a region with a diameter of 0 mm - 70 mm can be formed.

[0120] The extended angle of the sub-needle 5 (sub-needle outer rod 502) is 0° - 360°, that is, the maximum extended angle of the sub-needle outer rod 502 extending from the guiding groove 9 is 360°, which means that the extended angle of the sub-needle outer rod 502 can be adjusted arbitrarily within the range of 360°.

[0121] Therefore, compared with existing ablation needles, the sub-needles of the radiofrequency ablation composite electrode needle of the present invention have no angle limitation during exhibition, breaking through the technical problem that the exhibition angle of existing ablation needles can only reach 180°. Thus, the radiofrequency ablation composite electrode needle of the present invention can achieve complete envelope for irregularly shaped lesions, avoiding ablation blind spots in clinical practice and thus avoiding the risk of missed ablation. Further, since the exhibition angle of the sub-needles of the radiofrequency ablation composite electrode needle of the present invention breaks through the traditional 180° limitation and can reach 360°, a spherical or quasi-spherical structure can be constructed. Therefore, based on the characteristics of this structure that can more comprehensively and accurately envelope various irregularly shaped lesions, the radiofrequency ablation composite electrode needle of the present invention does not need to adopt the complex and difficult operation process of multiple needle retraction → needle withdrawal → needle exhibition → ablation in the prior art, but only needs one puncture and ablation operation to complete, which not only greatly shortens the operation time, significantly improves the operation efficiency, but also can greatly improve the intraoperative experience of patients and reduce the risk of complications caused by multiple operations.

[0122] In order to achieve a maximum exhibition angle of 360° for the sub-needle 5, the sub-needle 5 (sub-needle outer rod 502) has a pre-bending angle, and the maximum pre-bending angle of each sub-needle 5 is 360°. The pre-bending angle refers to the bending angle that the sub-needle 5 has before being installed into the second inner tube 4 and the needle rod 6. That is to say, before the sub-needle 5 is installed into the second inner tube 4 and the needle rod 6, it is pre-bent by 360°, that is, bent into a circle, and when it is installed into the second inner tube 4 and the needle rod 6, it is extended. Therefore, when the guiding groove 9 is opened and it is exhibited from the guiding groove 9, due to the characteristic of the sub-needle 5 to remember its shape, it will return to the pre-bent state, that is, a 360° exhibition angle is achieved.

[0123] Therefore, it can be understood that when multiple sub-needles 5 (sub-needle outer rods 502) are all exhibited at the maximum exhibition angle, a spherical or quasi-spherical (ellipsoidal, as Figure 23C shown) structure can be formed, as Figure 9D shown. Since the sub-needle outer rod 502 is exhibited from the guiding groove 9 and bends outward or inward, when the exhibition angle of the sub-needle outer rod 502 is 360°, the puncture tip corresponding to the sub-needle outer rod 502 reaches the guiding groove 9 or the vicinity of the guiding groove 9.

[0124] It can be understood that when the above quasi-spherical structure is used for ablation, the formed thermal damage range is spherical or quasi-spherical (almost spherical), so it can more completely envelope the lesion and avoid the risk of missed ablation.

[0125] It should be noted that the exhibition angle of the sub-needle 5 refers to the central angle of the arc formed after the sub-needle 5 is exhibited.

[0126] The extended length and extended angle of the sub-needle 5 (outer rod 502 of the sub-needle) are positively correlated. As ​ shown, the extended length of the sub-needle 5 is 1 / 4 of the pre-extended length of the sub-needle 5, and its extended angle is 90°; as ​ shown, the extended length of the sub-needle 5 is 2 / 4 of the pre-extended length of the sub-needle 5, and its extended angle is 180°; as ​ shown, the extended length of the sub-needle 5 is 3 / 4 of the pre-extended length of the sub-needle 5, and its extended angle is 270°. As ​ shown, for the entire sub-needle 5, its extended angle is 360°.

[0127] The extended length of the sub-needle 5 can be indicated by the sub-needle extended length pointer 16.

[0128] Before the sub-needle 5 is extended, the width of the guiding groove 9 can be adjusted to a suitable width. During the extension of the sub-needle 5, the width of the guiding groove 9 can remain unchanged; or during the extension of the sub-needle 5, the width of the guiding groove 9 can be adjusted at any time to control the direction and timing of the bending deformation of the sub-needle 5.

[0129] As ​ shown, it is a picture after the ablation experiment of the radiofrequency ablation composite electrode needle of the present invention on an ex vivo porcine liver, which shows the ablation thermal map after one puncture and ablation. It can be seen that the ablation thermal map is spherical or ellipsoidal, so it can envelop the lesion more completely, avoid the risk of missed ablation, has a better ablation effect, and the operation can be completed with one ablation.

[0130] However, the bending angle of the sub-needle in the existing ablation needle is limited and cannot be adjusted arbitrarily within 360°, resulting in an irregular ablation area shape, tending to be water-drop-shaped. As ​ shown, the ablation thermal map of the existing ablation needle is triangular or water-drop-shaped, and there is a phenomenon of incomplete enveloping of the lesion, which may cause the risk of missed ablation. To avoid the problem of missed ablation, the conventional clinical measure is the retraction needle ablation method, that is, retracting the needle after one ablation; pulling out the needle to a certain depth and then expanding it again for ablation. After CT scanning, if it is found that the lesion is not completely covered, a third retraction, withdrawal, expansion and ablation or even more operations are required. This method has a long operation time and a poor intraoperative experience for the patient. Therefore, the above operations of the existing ablation needle are to form an ablation thermal damage range approximately spherical or ellipsoidal by covering with multiple triangles or water-drop shapes axially through multiple punctures and ablations.

[0131] Therefore, it can be known that the present invention controls the width of the guiding groove 9 (i.e., the opening size of the guiding groove 9), as well as the angle of outward turning of the outer sub-needle rod 502 and the extended length of the sub-needle 5, so as to achieve the purpose of controllable ablation range. By combining the exposed length of the needle tip 1 and / or the needle rod 6, the ablation thermal damage range formed by the present invention is also closer to a spherical shape, thereby having a more accurate ablation range and a lower effect of normal tissue damage.

[0132] Specifically, the width of the guiding groove 9 is related to the bending deformation direction of the sub-needle 5. The smaller the width of the guiding groove 9, the greater the clamping force on the sub-needle 5 when it extends from the guiding groove 9, so that the sub-needle 5 can achieve bending deformation earlier.

[0133] Optionally, as ​ 、 ​ and ​ shown, after the sub-needle 5 extends out of the guiding groove 9, its bending direction can be outward bending, that is, bending away from the puncture needle tip 101. Therefore, the ablation area formed after the sub-needle 5 extends is behind the puncture needle tip 101.

[0134] Optionally, as ​ 、 ​ and ​ shown, after the sub-needle 5 extends out of the guiding groove 9, its bending direction can be inward bending, that is, bending towards the puncture needle tip 101. Therefore, the ablation area formed after the sub-needle 5 extends can cover the puncture needle tip 101.

[0135] Furthermore, when the sub-needle 5 extends, a way to control the extended diameter size of the sub-needle 5 is: the extended length L x of the first extension of the sub-needle 5, then reduce the width of the guiding groove 9 and continue to extend the sub-needle 5 until the sub-needle 5 is completely extended. For example, by moving the needle rod 6 to change the distance between the distal end of the needle rod 6 and the proximal end of the needle handle 102, so as to reduce the width of the guiding groove 9.

[0136] The unfolded diameter D y when the sub-needle 5 is completely extended L x and the extended length D y = a + ​ x ; wherein, a 、 b are both coefficients, a the value range of bThe value range is 0.13 - 0.17. a and b are both empirical coefficients obtained from experiments.

[0137] As ​ shown, it shows the expansion diameter when the sub - needle 5 is fully extended. D y and the extension length when the sub - needle 5 is first extended. L x of the curve graph. ​ In it, the abscissa is the extension length when the sub - needle 5 is first extended (unit: mm); the ordinate is the expansion diameter when the sub - needle 5 is fully extended (unit: mm). ​ In it, the lower blue curve is the expansion diameter corresponding to when, after the extension length when the sub - needle 5 is first extended, the width of the guiding groove 9 is reduced to the minimum (i.e., the minimum state of the guiding groove 9) and the sub - needle 5 is continuously extended until it is fully extended; the upper red curve is the expansion diameter corresponding to when, after the extension length when the sub - needle 5 is first extended, the width of the guiding groove 9 is reduced by 1 / 2 (i.e., the semi - closed state of the guiding groove 9) and the sub - needle 5 is continuously extended until it is fully extended.

[0138] It should be noted that the minimum state of the guiding groove 9 corresponds to the state where the two ends of the guiding groove 9 fully clamp the sub - needle 5.

[0139] According to ​ it can be known that when the guiding groove 9 is in the semi - closed state and the sub - needle 5 is continuously extended until it is fully extended, the obtained expansion diameter is larger.

[0140] As ​ shown, it shows the extension length when the sub - needle 5 is first extended. L x After it is 5 mm, when the width of the guiding groove 9 is reduced to the minimum (the minimum state of the guiding groove 9), the state when the sub - needle 5 is continuously extended until it is fully extended; as ​ shown, it shows the extension length when the sub - needle 5 is first extended. L x After it is 5 mm, when the width of the guiding groove 9 is reduced by 1 / 2 of the total width of the guiding groove 9 (the semi - closed state of the guiding groove 9), the state when the sub - needle 5 is continuously extended until it is fully extended. According to ​ and ​ it can be known that when the guiding groove 9 is adjusted to the minimum state and the sub - needle 5 is continuously extended, the obtained exhibition diameter is smaller, but the shape of the sub - needle 5 is fuller and the sub - needle 5 is more densely enveloped.

[0141] As ​ shown, it shows the extension length when the sub - needle 5 is first extended. L xAfter reaching 35 mm, when the opening size of the guiding groove 9 is reduced to the minimum (the minimum state of the guiding groove 9), the sub-needle 5 is continuously extended until the sub-needle 5 is completely extended; as ​ shown, the extended length of the first extension of the sub-needle 5 is shown L x After reaching 35 mm, when the opening size of the guiding groove 9 is reduced by 1 / 2 (the semi-closed state of the guiding groove 9), the sub-needle 5 is continuously extended until the sub-needle 5 is completely extended. According to ​ and ​ it can be seen that even if the extended length of the first extension is increased L x after that, when the guiding groove 9 is adjusted to the minimum state and the sub-needle 5 is continuously extended, a smaller extended diameter can be obtained, but the shape of the sub-needle 5 is more plump and the sub-needles 5 are more densely enveloped.

[0142] It can be understood that if the sub-needle 5 (the outer rod 502 of the sub-needle) is not extended, and only by adjusting the exposed length of the needle tip 1 and / or the needle rod 6, the effect of adjustable ablation range of a single needle can be achieved. If the sub-needle 5 (the outer rod 502 of the sub-needle) is also extended, by any combination of different exposed lengths of the needle tip 1 and / or the needle rod 6 and different extended lengths (angles) of the outer rod 502 of the sub-needle, a dual-morphology structure can be achieved.

[0143] Therefore, the radiofrequency ablation composite electrode needle of the present invention includes a multi-mode adjustment. The first adjustment mode is to separately adjust the working length of the main needle; the second adjustment mode is to independently adjust the parameters of the sub-needle, such as the extended length and extended angle of the sub-needle; the third adjustment mode is to jointly adjust the working length of the main needle and the parameters of the sub-needle.

[0144] Among them, when the radiofrequency ablation composite electrode needle is in the first adjustment mode, the straight needle working end adjustment switch 11 is operable. Therefore, the adjustable insulating tube 8 can move relative to the needle rod 6, so that the lengths of the parts of the adjustment needle tip 1 and the needle rod 6 that are not covered by the adjustable insulating tube 8 are adjustable, that is, the working length of the main needle is adjustable.

[0145] When the radiofrequency ablation composite electrode needle is in the second adjustment mode, the sub-needle extension switch 15 and the guiding groove adjustment switch 13 are operable. Therefore, the extended length and extended angle of the sub-needle are adjustable, that is, the parameters of the sub-needle are adjustable.

[0146] When the radiofrequency ablation composite electrode needle is in the third adjustment mode, the straight needle working end adjustment switch 11, the sub-needle extension switch 15 and the guiding groove adjustment switch 13 can cooperate. Therefore, the working length of the main needle is adjustable and the parameters of the sub-needle are adjustable. Thus, the working section of the main needle and the extended part of the sub-needle cooperate to perform ablation, and the effect of accurately constructing a personalized combined thermal damage range according to the morphological characteristics of the tumor can be achieved.

[0147] Therefore, whether it is a tumor with a regular shape or a complex and variable abnormal-shaped tumor, the radiofrequency ablation composite electrode needle of the present invention can achieve high-precision conformal ablation through dynamic adjustment of parameters, thereby significantly improving the pertinence and effectiveness of radiofrequency ablation treatment and providing a more efficient and flexible solution for clinical tumor ablation treatment.

[0148] Among them, the working length of the main needle and the deployed part of the sub-needles together form a combined thermal damage range. Therefore, the ablation morphology can be switched according to the treatment requirements to achieve any combination of ablation thermal damage ranges, thereby making it more convenient to control the ablation thermal damage range and achieving precise shaping in three-dimensional space. The above dual-morphology structure can adapt to the ablation treatment of tumors with different shapes, sizes, and dimensions, thus having a more flexible clinical application effect.

[0149] For example, the adjustable insulating tube 8 is configured to be able to move relative to the needle rod 6 according to the deployed length and deployed diameter of each sub-needle 5, so as to adjust the exposed length of the needle tip 1 and / or the needle rod 6 (the working length of the main needle). ​ The schematic diagram of the ablation lesion is shown when the width of the guiding groove 9 is adjusted to 15 mm, the deployed length of the sub-needle 5 is adjusted to 1 / 2 of the pre-deployed length of the sub-needle 5, and the exposed length of the needle rod 6 is adjusted to L1. At this time, the thermal damage range formed by each sub-needle 5 and the main needle together is in the shape of an egg; ​ The schematic diagram of the ablation lesion is shown when the width of the guiding groove 9 is adjusted to 10 mm, the deployed length of the sub-needle 5 is adjusted to 3 / 4 of the pre-deployed length of the sub-needle 5, and the exposed length of the needle rod 6 is adjusted to L2 (L2 is less than L1). At this time, the thermal damage range formed by each sub-needle 5 is in the shape of an irregular ellipsoid; ​ The schematic diagram of the ablation lesion is shown when the width of the guiding groove 9 is adjusted to 5 mm, the deployed length of the sub-needle 5 is adjusted to full deployment, and the exposed length of the needle rod 6 is adjusted to L3 (L3 is less than L2). At this time, the thermal damage range formed by each sub-needle 5 is in a relatively regular ellipsoidal shape and is already very close to a spherical shape.

[0150] As ​ shown, the deployed length of the sub-needle 5 is 1 / 2 of the pre-deployed length of the sub-needle 5, its deployed angle is between 180° and 270°, and the exposed length of the needle rod 6 is L1; as ​ shown, on the basis of ​ , the deployed length of the sub-needle 5 increases to 3 / 4 of the pre-deployed length, and its deployed angle also increases accordingly, between 270° and 360°. At this time, the exposed length of the needle rod 6 can be reduced accordingly, for example, from L1 to L2 (L2 is less than L1); as ​ shown, on the basis of ​On the basis of this, the exposed length of the sub-needle 5 is further increased to fully extended, and its extended angle is correspondingly increased to the maximum bending angle, i.e. 360°. At this time, the exposed length of the needle rod 6 can be further reduced accordingly, for example, from L2 to L3 (L3 is less than L2).

[0151] In the above scheme for adjusting the extended length and extended angle of the sub-needle 5 and the exposed length of the needle rod 6, the two ends of the sub-needle 5 are respectively located on both sides of the exposed area of the needle rod 6 (or can be considered to be in contact with both sides of the exposed area of the needle rod 6), that is, ​ In the state shown, the thermal damage range in this state is a relatively regular ellipsoid, and the thermal ablation range is more comprehensive and the effect is better.

[0152] Please continue to see ​ and ​ The handle assembly 10 includes a handle housing 25, which supports the various components within the handle assembly 10 and functions as a grip for clinical operation. The handle housing 25 houses the aforementioned straight needle working end adjustment switch 11, straight needle working end length pointer 12, guide slot adjustment switch 13, sub-needle extension switch 15, and sub-needle extension length pointer 16.

[0153] The straight needle working end adjustment switch 11 is connected to the adjustable insulating tube 8 at the radially extending end toward the handle assembly 10. The straight needle working end adjustment switch 11 is used to move the insulating tube 8 to adjust the exposed length of the needle head 1 and / or needle shaft 6, and the length value is displayed by the straight needle working end length pointer 12.

[0154] The straight needle working end adjustment switch 11 can employ a push mechanism, a knob mechanism, or a dial mechanism. By pushing, rotating, or toggling the drive mechanism, the adjustable insulating tube 8 can be axially moved relative to the needle head 1 and needle shaft 6. More specifically, the straight needle working end adjustment switch 11 can employ one or a combination of a rack and pinion mechanism, a worm gear mechanism, or a ball screw mechanism.

[0155] The straight needle working end length pointer 12 can be a separate pointer indicating structure, or can be an indicating structure integrated with the straight needle working end adjusting switch 11 .

[0156] The guide groove adjustment switch 13, the first fluid chamber 21, and the needle rod 6 are connected at the radially extending end of the handle assembly 10. The guide groove adjustment switch 13 allows the needle rod 6 to move axially relative to the needle handle 102 to adjust the size of the guide groove 9 opening. Corresponding guide groove adjustment length indicators 14 are provided on one or both sides of the guide groove adjustment switch 13 to indicate the size of the guide groove 9 opening.

[0157] The guide slot adjustment switch 13 can be a push mechanism, a knob mechanism, or a dial mechanism. By pushing, rotating, or toggling the drive mechanism, the needle rod 6 can be axially moved relative to the needle head 1. More specifically, the guide slot adjustment switch 13 can be a rack and pinion mechanism, a worm gear mechanism, or a ball screw mechanism, or a combination thereof.

[0158] The straight needle working end length pointer 12 can be a separate pointer indicating structure.

[0159] The needle extension switch 15, the second liquid chamber 22, and the needle 5 are connected at the radially extending end toward the handle assembly 10. The needle extension switch 15 is used to control the extension length and angle of the needle outer rod 502 of the needle 5, and the needle extension length pointer 16 indicates the extension length and angle of the needle 5.

[0160] The needle extension switch 15 can be a push mechanism, a knob mechanism, or a dial mechanism. By pushing, rotating, or toggling the drive mechanism, the needle 5 can be axially moved relative to the needle head 1. More specifically, the needle extension switch 15 can be a rack and pinion mechanism, a worm gear mechanism, or a ball screw mechanism, or a combination thereof.

[0161] The sub-hand length pointer 16 can be a separate pointer indicating structure, or it can be an indicating structure integrated with the sub-hand length switch 15.

[0162] Furthermore, the sub-needle extension switch 15 and the guide slot adjustment switch 13 are connected by a linkage mechanism, which enables the guide slot adjustment switch 13 to operate simultaneously to open the guide slot 9 when the sub-needle extension switch 15 is operated to extend the sub-needle; and the guide slot adjustment switch 13 to operate simultaneously to close the guide slot 9 when the sub-needle extension switch 15 is operated to retract the sub-needle.

[0163] In a specific embodiment, ​ 、 ​ 、 ​ 、 ​ and ​ As shown, the linkage mechanism is constructed as a composite mechanism of a gear rack and a cam. Specifically, the linkage mechanism includes a guide slot adjustment switch 13 constructed as a cam mechanism and a sub-needle display switch 15 constructed as a gear rack mechanism, and the two are linked to each other.

[0164] Specifically, if ​ As shown, the sub-needle display switch 15 includes a rack 151, a gear 152 meshing with the rack 151, and a knob 153 connected to the gear 152, wherein the knob 153 is located on the handle housing 25 (please refer to ​ By rotating the knob 153, the gear 152 can be driven to rotate, thereby causing the rack 151 and the gear 152 to move relative to each other.

[0165] As ​ shown, the rack 151 is configured as an L-shaped structure, which includes a vertical section 1513 and a horizontal section 1514 perpendicular to the vertical section 1513. Teeth are provided at the lower end of the horizontal section 1514, which mesh with the gear 152.

[0166] A sub-needle connecting groove 1511 is provided on the vertical section 1513, and the sub-needle 5 is fixedly arranged in the sub-needle connecting groove 1511. Therefore, when the rack 151 moves, it can drive the sub-needle 5 to move, so that the sub-needle 5 is extended or retracted.

[0167] Furthermore, an arc-shaped recess 1512 is provided at the end of the upper surface of the horizontal section 1514 away from the vertical section 1513, which is used to cooperate with the cam mechanism.

[0168] Specifically, as ​ shown, the guide groove adjustment switch 13 includes a cam 131, and the cam 131 is rotatably arranged in the handle housing 25 through a camshaft 1311 (please refer to ​ ).

[0169] As ​ shown, the cam 131 includes a cam tip 1312, an arc-shaped portion 1314 coaxially arranged with the camshaft 1311, and a flat portion 1313 connected to the cam tip 1312 and the arc-shaped portion 1314 respectively. The cam tip 1312 is eccentrically arranged with respect to the camshaft 1311. The arc-shaped recess 1512 on the rack 151 coincides with the cam tip 1312 of the cam 131. Therefore, when the cam tip 1312 of the cam 131 is located in the arc-shaped recess 1512 and contacts the inner wall of the arc-shaped recess 1512 (as ​ shown), if the rack 151 moves at this time (for example, the rack 151 moves to the ​ right as shown), the rack 151 will cause the cam 131 to rotate (for example, the cam 131 rotates counterclockwise).

[0170] Furthermore, the guide groove adjustment switch 13 further includes a push rod 132, which is located on one side of the cam tip 1312 of the cam 131. As ​ shown, when the cam tip 1312 of the cam 131 is located in the arc-shaped recess 1512 and contacts the inner wall of the arc-shaped recess 1512, that is, when the cam 131 is in a vertical state, the flat portion 1313 of the cam 131 contacts the end of the push rod 132 (as ​ shown).

[0171] As ​ shown, the push rod 132 extends into the first guide sleeve 134 and is fixedly connected to the first guide sleeve 134, and the first guide sleeve 134 is arranged in the handle housing 25.

[0172] Further, the guide groove adjustment switch 13 further includes a first connecting sleeve 135 and a spring 133. The first connecting sleeve 135 is sleeved on the ejector rod 132 and fixedly connected to the boss 1321 on the ejector rod 132. The spring 133 is sleeved on the ejector rod 132, and the spring 133 is located between the first connecting sleeve 135 and the first guide sleeve 134. The two ends of the spring 133 respectively abut against the side of the first connecting sleeve 135 away from the cam 131 and the first guide sleeve 134. Therefore, it can be understood that when the ejector rod 132 moves under the action of a thrust force, the ejector rod 132 can push the first connecting sleeve 135 to move together, and the movement of the first connecting sleeve 135 will compress the spring 133; conversely, when the force on the ejector rod 132 is removed, the spring 133 will apply a force in the direction opposite to the above-mentioned thrust force to the first connecting sleeve 135 under the action of its restoring force, so that the first connecting sleeve 135 and the ejector rod 132 move in opposite directions and can be restored to the initial state.

[0173] As ​ and ​ shown, the first connecting sleeve 135 is configured as a star-shaped connecting sleeve, which includes a first central connecting cylinder 1353 and a plurality of connecting claws radially diverging along the circumferential direction of the first central connecting cylinder 1353. The first central connecting cylinder 1353 is sleeved on the ejector rod 132, and the end of the first central connecting cylinder 1353 is fixedly connected to the boss 1321 on the ejector rod 132. The first connecting claw 1351 among the plurality of connecting claws is fixedly connected to the connecting rod 136, and the second connecting claw 1352 among the plurality of connecting claws is for the second inner tube 4 (and the sub-needle 5 inside it) to pass through.

[0174] The connecting rod 136 is a rod-shaped member extending parallel to the second inner tube 4, and it extends to be fixedly connected to the second connecting sleeve 137 in the handle housing 25. Among them, the second connecting sleeve 137 is disposed opposite to the first connecting sleeve 135, and the second connecting sleeve 137 is closer to the proximal end of the handle housing 25 than the first connecting sleeve 135 (i.e., ​ the lower end shown).

[0175] As ​ shown, the second connecting sleeve 137 can adopt the same structure as the first connecting sleeve 135. That is, the second connecting sleeve 137 is also configured as a star-shaped connecting sleeve, which includes a second central connecting cylinder 1373 and a plurality of connecting claws radially diverging along the circumferential direction of the second central connecting cylinder 1373. Among them, the third connecting claw 1371 among the plurality of connecting claws of the second connecting sleeve 137 is fixedly connected to the other end of the connecting rod 136, and the fourth connecting claw 1372 among the plurality of connecting claws of the second connecting sleeve 137 is fixedly connected to the proximal end of the second inner tube 4.

[0176] As ​As shown, the first connecting sleeve 135 and the second connecting sleeve 137 are arranged oppositely, and are respectively located on both sides of the sub-needle connecting groove 1511 of the rack 151. The connecting rod 136 extends between the first connecting claw 1351 and the third connecting claw 1371, and both ends of the connecting rod 136 are fixedly connected to the first connecting claw 1351 and the third connecting claw 1371 respectively. The second inner tube 4 and the sub-needle 5 pass through the second connecting claw 1352 together, and the sub-needle 5 is fixedly connected to the sub-needle connecting groove 1511. The second inner tube 4 continues to extend beyond the sub-needle connecting groove 1511 until it extends to be fixedly connected to the fourth connecting claw 1372. The second connecting sleeve 137 is fixedly connected to the second guiding sleeve 138, and the second guiding sleeve 138 is movably arranged in the handle housing 25. Therefore, when the second connecting sleeve 137 moves, the second guiding sleeve 138 can guide the movement of the second connecting sleeve 137.

[0177] As described above, when the ejector rod 132 moves under the action of a thrust force, the ejector rod 132 can push the first connecting sleeve 135 to move together, and the movement of the first connecting sleeve 135 will drive the connecting rod 136, the second connecting sleeve 137 and the second inner tube 4 to move together.

[0178] Specifically, as ​ shown, at this time, the guiding groove 9 is closed and the sub-needle 5 is in the state of not being exhibited. At this time, the cam tip 1312 of the cam 131 cooperates with the arc-shaped recess 1512 on the rack 151, the cam 131 is in a vertical state, and the flat part 1313 of the cam 131 contacts the ejector rod 132.

[0179] When the knob 153 is rotated, the rack 151 and the gear 152 move relative to each other. For example, the rack 151 moves to the right ( ​ shown); the movement of the rack 151 will cause the cam 131 to rotate counterclockwise, as ​ shown. After the cam 131 rotates counterclockwise to the horizontal state, its cam tip 1312 contacts the ejector rod 132. Since the distance between the cam tip 1312 and the camshaft 1311 is greater than the distance between the flat part 1313 and the camshaft 1311, the distance between the cam 131 and the ejector rod 132 becomes smaller due to the rotation of the cam 131. Therefore, the cam 131 will push the ejector rod 132 to move in the direction away from the cam 131. The movement of the ejector rod 132 will cause the first connecting sleeve 135 to move, and the movement of the first connecting sleeve 135 will drive the connecting rod 136, then drive the second connecting sleeve 137, and finally drive the second inner tube 4 to move; as described above, the second inner tube 4 is connected to the needle handle 102. Therefore, the second inner tube 4 will move together with the needle handle 102, and the needle rod 6 is fixed in the needle rod fixing seat 61 in the handle housing 25 (as ​ shown). Therefore, the needle handle 102 will move relative to the needle rod 6, so that the guiding groove 9 can be opened, thereby realizing the exhibition of the sub-needle 5 while opening the guiding groove 9.

[0180] Understandably, the moving direction of the above-mentioned sub-needle 5 is the same as that of the second inner tube 4 and the needle handle 102. That is to say, in this embodiment, the guiding groove 9 is opened by the movement of the needle handle 102 relative to the needle rod 6.

[0181] Furthermore, after the cam 131 rotates counterclockwise to the horizontal state, it crosses the arc-shaped recess 1512 on the rack 151, and the flat portion 1313 of the cam 131 contacts the upper end surface of the horizontal section 1514 of the rack 151, as ​ and ​ shown.

[0182] After the guiding groove 9 is opened, the knob 153 can be continuously rotated to make the rack 151 continue to move, as ​ and ​ shown. During the continuous movement of the rack 151, the cam 131 moves on the upper end surface of the rack 151 in its horizontal state. When the cam 131 moves to contact the vertical section 1513 of the rack 151, its movement stops.

[0183] Furthermore, as described above, since the movement of the ejector rod 132 will cause the first connecting sleeve 135 to move, and the movement of the first connecting sleeve 135 will compress the spring 133. Therefore, when the guiding groove 9 is opened, the spring 133 is in a compressed state. Therefore, when retracting the sub-needle 5, the rack 151 rotates in the opposite direction (clockwise). When the rack 151 moves until the cam tip 1312 cooperates with the arc-shaped recess 1512 again, the cam 131 rotates back to the vertical state again. Then the spring 133 has a tendency to recover. Therefore, under the action of the restoring force of the spring 133, the first connecting sleeve 135 moves in the direction close to the cam 131. Thus, the first connecting sleeve 135 drives the connecting rod 136, then drives the second connecting sleeve 137, and finally drives the second inner tube 4 to move in the opposite direction, so that the guiding groove 9 can be closed, thereby realizing the closing of the guiding groove 9 while retracting the sub-needle 5.

[0184] As ​As shown, the first inner tube lumen connection chamber 2301 of the third liquid chamber 23 is in fluid communication with the first liquid tube 17, and the second inner tube lumen connection chamber 2302 of the third liquid chamber 23 is in fluid communication with the second liquid tube 18. Therefore, a liquid circulation channel is formed among the first liquid tube 17, the first inner tube lumen connection chamber 2301, the first inner tube 3 (the first inner tube lumen 302), the needle lumen 103, the second inner tube 4 (the second inner tube lumen 402), the second inner tube lumen connection chamber 2302, and the second liquid tube 18. That is, the liquid can enter from the first liquid tube 17, flow into the needle lumen 103 through the first inner tube lumen connection chamber 2301 and the first inner tube 3 (the first inner tube lumen 302), and flow out from the second inner tube lumen connection chamber 2302 and the second liquid tube 18; or enter from the second liquid tube 18 and flow out from the first liquid tube 17.

[0185] As ​ shown, the first liquid tube 17 includes a first liquid tube body 1701 and a first liquid tube joint 1702. One end of the first liquid tube body 1701 is connected to the first inner tube lumen connection chamber 2301, which can restrict the injection and suction liquid from entering or flowing out of the first inner tube lumen 302 of the first inner tube 3; the other end of the first liquid tube body 1701 is connected to the first liquid tube joint 1702, and the first liquid tube joint 1702 can be connected to an external injection and suction liquid component.

[0186] As ​ shown, the second liquid tube 18 includes a second liquid tube body 1801 and a second liquid tube joint 1802. One end of the second liquid tube body 1801 is connected to the second inner tube lumen connection chamber 2302, which can restrict the injection and suction liquid from entering or flowing out of the injection and suction liquid channel formed between the outer rod 301 of the first inner tube 3 and the second inner tube lumen 402 of the second inner tube 4; the other end of the second liquid tube body 1801 is connected to the second liquid tube joint 1802, and the second liquid tube joint 1802 is used to connect to an external injection and suction liquid component.

[0187] As ​ shown, the third liquid tube 19 is connected to the first liquid chamber 21, and the first liquid chamber 21 forms an injection and suction passage with the needle rod 6 and the sub-needle outer cavity 503. The third liquid tube 19 includes a third liquid tube body 1901 and a third liquid tube joint 1902. One end of the third liquid tube body 1901 is connected to the first liquid chamber 21, which can restrict the injection and suction liquid from entering or flowing out of the injection and suction liquid channel formed between the outer surface of the needle rod 6 and the outer surface of the sub-needle driving section 506 of the sub-needle 5; the other end of the third liquid tube body 1901 is connected to the third liquid tube joint 1902, and the third liquid tube joint 1902 is used to connect to an external injection and suction liquid component.

[0188] As ​As shown, the fourth liquid tube 20 is connected to the second liquid chamber 22, and the second liquid chamber 22 is connected to the injection and suction passage of the sub-needle formed by the second inner tube 4 and the sub-needle 5. The fourth liquid tube 20 includes a fourth liquid tube body 2001 and a fourth liquid tube joint 2002. One end of the fourth liquid tube body 2001 is connected to the second liquid chamber 22, which can restrict the injection and suction liquid from entering or flowing out of the injection and suction liquid passage formed between the inner surface of the sub-needle driving section 506 of the sub-needle 5 and the second outer rod 401 of the second inner tube 4; the other end of the fourth liquid tube body 2001 is connected to the fourth liquid tube joint 2002, and the fourth liquid tube body 2001 is used to connect with an external injection and suction liquid component.

[0189] The first liquid tube body 1701, the second liquid tube body 1801, the third liquid tube body 1901, and the fourth liquid tube body 2001 can all be made of plastic, such as made of materials such as PVC, TPU, PTFE, PEEK, PI, etc.

[0190] The first liquid chamber 21, the second liquid chamber 22, and the third liquid chamber 23 can all be made of metal or plastic. They can be formed in the handle housing 25 by means of machining, injection molding with a mold, or die casting with a mold.

[0191] As ​ shown, the electrical wire 24 includes an electrical wire composite cable 2402 and an electrical wire joint 2401. The electrical wire composite cable 2402 extends into the handle housing 25 and is connected to one or more of the temperature sensor 2, the sub-needle temperature sensor 504, the first inner tube 3, the second inner tube 4, and the sub-needle 5, and is used for transmitting radio frequency energy, transmitting temperature signals, transmitting and indicating switch light signals, etc. The electrical wire joint 2401 is connected to the end of the electrical wire composite cable 2402 and is used for connection with the ablation system.

[0192] The present invention also provides an ablation system, including the radio frequency ablation composite electrode needle described above and an ablation host. The electrical wire 24 is respectively connected to the radio frequency ablation composite electrode needle and the ablation host, so as to realize transmitting radio frequency energy, transmitting temperature signals, transmitting and indicating switch light signals, etc.

[0193] Although the present invention has been described with reference to the preferred embodiments, various improvements can be made to it and components therein can be replaced with equivalents without departing from the scope of the present invention. In particular, as long as there is no structural conflict, the various technical features mentioned in each embodiment can be combined in any way. The present invention is not limited to the specific embodiments disclosed in the text, but includes all technical solutions falling within the scope of the claims.

Claims

1. A radiofrequency ablation composite electrode needle, characterized in that, It includes a main needle, a plurality of sub - needles (5), and a handle assembly (10) for adjusting the main needle and the sub - needles (5). The main needle includes a needle - tip assembly and a needle - rod assembly. The needle - rod assembly includes a first inner tube (3), a second inner tube (4), and a needle rod (6) which are coaxially arranged from inside to outside. The distal end of the second inner tube (4) is fixedly connected to the proximal end of the needle - tip assembly. A guiding groove (9) is formed between the distal end of the needle rod (6) and the proximal end of the needle - tip assembly. The needle rod (6) and the needle - tip assembly can move relative to each other to adjust the width of the guiding groove (9). Each of the sub - needles (5) is arranged between the second inner tube (4) and the needle rod (6). When the guiding groove (9) is opened, each of the sub - needles (5) can be extended from the guiding groove (9). Among them, the extended length and the extended diameter of each of the sub - needles (5) can be adjusted. Each of the sub - needles (5) has a pre - bending angle, and the maximum pre - bending angle of each of the sub - needles (5) is 360°, so that the maximum extended angle of each of the sub - needles (5) extended from the guiding groove (9) is 360°.

2. The radiofrequency ablation composite electrode needle according to claim 1, characterized in that, Each of the sub - needles (5) includes a sub - needle outer rod (502), and the sub - needle outer rod (502) is of an integral or two - section structure. The two - section structure includes: A sub - needle front section (505) for extending from the guiding groove (9); and A sub - needle driving section (506) connected to the sub - needle front section (505), which extends between the second inner tube (4) and the needle rod (6) and is connected to the handle assembly (10). Among them, the diameter of the sub - needle driving section (506) is less than or equal to the diameter of the sub - needle front section (505).

3. The radiofrequency ablation composite electrode needle according to claim 2, characterized in that, The length of the sub - needle front section (505) is 10 mm - 120 mm; or The extended length of the sub - needle outer rod (502) is 0 mm - 100 mm.

4. The radiofrequency ablation composite electrode needle according to claim 2 or 3, characterized in that, One or both of the sub - needle front section (505) and the sub - needle driving section (506) are of a hollow structure; or One or both of the sub - needle front section (505) and the sub - needle driving section (506) are of a solid structure.

5. The radiofrequency ablation composite electrode needle according to any one of claims 1-3, characterized in that, The width of the guiding groove (9) affects the bending deformation direction of each of the sub - needles (5). The smaller the width of the guiding groove (9), the greater the clamping force on each of the sub - needles (5) when extended, so that each of the sub - needles (5) can be bent and deformed earlier.

6. The radiofrequency ablation composite electrode needle according to any one of claims 1-3, characterized in that, The needle - rod assembly further includes an adjustable insulating tube (8) located outside the needle rod (6). The adjustable insulating tube (8) is configured to move relative to the needle rod (6) according to the extended length and the extended diameter of each of the sub - needles (5), so as to adjust the exposed length of the needle rod (6) and / or the exposed length of the needle tip (1) on the needle rod (6).

7. The radiofrequency ablation composite electrode needle according to any one of claims 1-3, characterized in that The needle - tip assembly includes a needle tip (1), and the needle tip (1) includes: A needle handle (102); A puncture needle tip (101) located at the distal end of the needle handle (102). The inner cavity of the needle (103) is disposed inside the needle handle (102) and the puncturing needle tip (101), and the first inner tube (3) and the second inner tube (4) are respectively in fluid communication with the inner cavity of the needle (103); and The needle aspiration channel (105) is disposed on the needle handle (102) and / or the puncturing needle tip (101) and is in fluid communication with the inner cavity of the needle (103); Wherein, the diameter of the needle aspiration channel (105) is configured such that the medium circulation cooling and the liquid injection can be realized synchronously.

8. The radiofrequency ablation composite electrode needle according to any one of claims 1-3, characterized in that, It further includes an aspiration channel, the aspiration channel is configured as the guiding groove (9), or the aspiration channel is configured as a needle-bar aspiration channel (601) opened on the needle bar (6), and the needle-bar aspiration channel (601) is in fluid communication with the space between the second inner tube (4) and the needle bar (6).

9. The radiofrequency ablation composite electrode needle according to any one of claims 1-3, characterized in that, A linkage mechanism is disposed in the handle assembly (10), the linkage mechanism includes a sub-needle deployment switch (15) respectively connected to each sub-needle (5) and a guiding groove adjustment switch (13) connected to the needle bar (6), and the sub-needle deployment switch (15) and the guiding groove adjustment switch (13) are interlocked with each other.

10. An ablation system, characterized in that, It includes an ablation host and the radiofrequency ablation composite electrode needle according to any one of claims 1-9, and the ablation host is electrically connected to the radiofrequency ablation composite electrode needle through an electrical wire.

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