Radiofrequency ablation composite electrode needle

Abstract

The application relates to a radio frequency ablation composite electrode needle and relates to the ablation technical field.The radio frequency ablation composite electrode needle comprises a main needle, a sub needle and a handle assembly, the main needle comprises a needle head and a needle rod assembly; the needle head comprises a needle handle, a puncture needle tip located at the far end of the needle handle and a needle head inner cavity arranged in the puncture needle tip and the inner side of the needle handle; the needle rod assembly comprises a needle rod, a second inner tube and a first inner tube arranged in sequence from outside to inside, the sub needle is arranged between the second inner tube and the needle rod, and the outer surface of the second inner tube and the inner surface of the needle rod define a sub needle outer cavity; the sub needle comprises a sub needle inner cavity; first, second and third liquid cavities are arranged in sequence in the handle assembly; wherein the first liquid cavity is in fluid communication with the sub needle outer cavity; the second liquid cavity is in fluid communication with the sub needle inner cavity; a liquid circulation channel is formed between the third liquid cavity, the first inner tube, the needle head inner cavity and the second inner tube.

Description

[0001] This application is a divisional application of Chinese Patent CN202510916499.9, filed on July 3, 2025, entitled "Radiofrequency Ablation Composite Electrode Needle and Ablation System". Technical Field

[0002] This invention relates to the field of ablation technology, and particularly to a radiofrequency ablation composite electrode needle. Background Technology

[0003] In the field of radiofrequency ablation therapy for tumors, existing ablation needles generally adopt a design where the daughter needle extends from the main needle. However, in order to ensure smooth extension and retraction of the daughter needle, there are significant limitations in the extension length and angle of the daughter needle. Currently, the maximum extension angle of mainstream ablation needles on the market can only reach 180°. This angle limitation makes it difficult for the ablation needle to achieve complete coverage of irregularly shaped lesions, which can easily lead to ablation blind spots in clinical practice, thus causing the risk of missed ablation.

[0004] To avoid missed ablation, the needle withdrawal ablation method is often used in clinical practice. This method requires repeating the "needle withdrawal → needle extension → ablation" procedure multiple times: after the first ablation, the needle is withdrawn, the ablation needle is pulled out to a certain depth, and then the needle is extended again for a second ablation; if necessary, a CT scan is used to evaluate the ablation effect. If it is found that the lesion is not completely covered, a third or even more needle withdrawal, needle extension, and ablation operations are required. This approach, which involves multiple punctures and ablations to superimpose multiple ablation areas axially to form the target thermal damage area, not only prolongs the operation time and increases the workload of medical staff, but also significantly reduces the patient's intraoperative experience and increases the incidence of complications such as infection during the operation. Summary of the Invention

[0005] This invention provides a radiofrequency ablation composite electrode needle to solve at least one of the above-mentioned technical problems.

[0006] This invention provides a radiofrequency ablation composite electrode needle, comprising a main needle, a sub-needle, and a handle assembly, wherein the main needle comprises a needle tip and a needle shaft assembly;

[0007] The needle includes a needle handle, a puncture needle tip located at the distal end of the needle handle, and a needle cavity disposed inside the puncture needle tip and the needle handle.

[0008] The needle bar assembly includes a needle bar, a second inner tube, and a first inner tube arranged sequentially from the outside to the inside. The sub-needle is disposed between the second inner tube and the needle bar. The outer surface of the second inner tube and the inner surface of the needle bar define the outer cavity of the sub-needle.

[0009] The sub-needle includes a sub-needle cavity;

[0010] The handle assembly is provided with a first liquid chamber, a second liquid chamber and a third liquid chamber in sequence;

[0011] The first liquid cavity is in fluid communication with the outer cavity of the sub-needle;

[0012] The second liquid chamber is in fluid communication with the inner cavity of the sub-needle;

[0013] A liquid circulation channel is formed between the third liquid chamber, the first inner tube, the needle inner cavity, and the second inner tube.

[0014] In one embodiment, the third liquid chamber includes a first inner tube cavity connecting chamber and a second inner tube cavity connecting chamber that are not interconnected.

[0015] The first inner tube includes a first inner tube outer rod, the interior of which forms a first inner tube cavity, and the first inner tube cavity is in fluid communication with the needle cavity and the connecting cavity of the first inner tube cavity respectively;

[0016] The second inner tube includes a second inner tube outer rod, the first inner tube outer rod is disposed in the second inner tube outer rod, the inner wall of the second inner tube outer rod and the outer wall of the first inner tube outer rod define the inner cavity of the second inner tube, and the inner cavity of the second inner tube is in fluid communication with the needle inner cavity and the connecting cavity of the inner cavity of the second inner tube respectively;

[0017] The fluid flows in opposite directions in the first inner tube cavity and the second inner tube cavity.

[0018] In one embodiment, the puncture needle tip and / or the needle handle are provided with a needle injection and aspiration channel, which is in fluid communication with the inner cavity of the needle, and the liquid in the inner cavity of the needle can be injected into the target area through the needle injection and aspiration channel.

[0019] In one embodiment, the needle cavity (103) is connected to a peristaltic pump, which operates to pump and circulate liquid into the needle cavity (103), and the injection volume of the needle injection channel (105) is... Q 1. Satisfies the following relationship

[0020] ;

[0021] in, Q 1 represents the total amount of injection fluid injected into the target area through each of the needle injection channels 105 from the inner cavity of the needle (103);

[0022] i The number of the needle injection channels (105);

[0023] k This refers to the pulse coefficient of the peristaltic pump's extrusion pressure.

[0024] Cd i For the first i The flow coefficient of the needle aspiration channel (105);

[0025] A i For the first i The cross-sectional area of ​​the orifice of each of the needle aspiration channels (105) (in units of...) m 2 );

[0026] The average pressure inside the needle cavity (103) is expressed in Pa.

[0027] ρ This refers to the density of the injected liquid.

[0028] In one embodiment, a needle bar injection channel is provided on the needle bar near the needle tip. The needle bar injection channel is in fluid communication with the outer cavity of the sub-needle, and the needle bar injection channel enables the medium in the inner cavity of the needle tip to flow to the target area.

[0029] In one embodiment, a guide groove is formed between the distal end of the needle bar and the proximal end of the needle handle. The outer cavity of the sub-needle is in fluid communication with the guide groove and the first liquid cavity, respectively. Fluid in the first liquid cavity can flow through the outer cavity of the sub-needle and through the guide groove to the target area.

[0030] In one embodiment, the needle bar assembly further includes an adjustable insulating tube located outside the needle bar, with its proximal end connected to a straight needle working end adjustment switch;

[0031] The proximal end of the needle bar or the proximal end of the second inner tube is connected to the guide groove adjustment switch;

[0032] The distal portion of the sub-needle is connected to the sub-needle deployment switch;

[0033] The radiofrequency ablation composite electrode needle includes multiple adjustment modes. When the radiofrequency ablation composite electrode needle is in the first adjustment mode of the multiple adjustment modes, the straight needle working end adjustment switch is operable, so that the adjustable insulating tube can move relative to the needle bar to adjust the working length of the main needle.

[0034] When the radiofrequency ablation composite electrode needle is in the second adjustment mode of the multi-mode adjustment, the sub-needle extension switch and the guide groove adjustment switch are operable, so that the parameters of the sub-needle are adjustable.

[0035] When the radiofrequency ablation composite electrode needle is in the third adjustment mode of the multi-mode adjustment, the straight needle working end adjustment switch, the sub-needle extension switch and the guide groove adjustment switch can operate in coordination, so that the working length of the main needle and the parameters of the sub-needle are adjustable.

[0036] In one embodiment, the pre-bending angle of the sub-needle is a maximum of 360°, so that the maximum display angle of the sub-needle is 360°.

[0037] In one embodiment, when the radiofrequency ablation composite electrode needle is in the third adjustment mode of the multi-mode adjustment, the extended length of the sub-needle is 1 / 2 of the pre-exposed length of the sub-needle, its extension angle is 180°-270°, and the exposed length of the needle bar is L1.

[0038] The extended length of the sub-needle is 3 / 4 of the pre-exposed length of the sub-needle, and its extended angle is 270°-360°. The exposed length of the needle bar is L2.

[0039] When the sub-needle is fully extended, its extension angle is 360°, and the exposed length of the needle bar is L3, where L3 < L2 < L1.

[0040] In one implementation, it further includes:

[0041] A temperature sensor is disposed in the inner cavity of the needle near the tip of the puncture needle;

[0042] A needle temperature sensor is disposed within the inner cavity of the needle; and

[0043] The electrical wire includes an electrical wire composite cable and an electrical wire connector for connection to the ablation host.

[0044] The electrical composite cable is connected to one or more of the temperature sensor, the sub-needle temperature sensor, the first inner tube, the second inner tube, and the sub-needle, and is used to transmit radio frequency energy, transmit temperature signals, and transmit and indicate switch light signals.

[0045] Compared with the prior art, the main advantages of the present invention are:

[0046] (1) The innovative design of this invention allows the maximum pre-bending angle of the sub-needle to reach 360°, breaking through traditional limitations to achieve the same maximum extension angle of 360° from the guide groove. When multiple sub-needles are extended at their maximum extension angle, a spherical or near-spherical structure can be constructed. This unique structural design can form a matching spherical or near-spherical ablation thermal damage range during ablation treatment. Compared with traditional ablation needles, it can more comprehensively and accurately encompass various irregularly shaped lesions, eliminating the risk of missed ablation from the root. Based on this, the surgery can be completed with only one puncture and ablation operation, which not only significantly shortens the operation time and greatly improves the efficiency of the operation, but also greatly improves the patient's intraoperative experience and reduces the risk of complications caused by multiple operations.

[0047] (2) This invention achieves a breakthrough in the flexible adjustment of the exposure length of the needle tip and / or needle shaft, i.e., the working length of the main needle. Based on this, a multi-mode adjustment is derived: the working length of the main needle can be adjusted independently, as can the extension length and extension angle of the sub-needle, and the working length of the main needle and the parameters (extension length, extension angle) of the sub-needle can be adjusted together. In particular, in the combined adjustment mode, the working section of the main needle and the extended part of the sub-needle work together to accurately construct a personalized combination of thermal damage range according to the morphological characteristics of the tumor. Therefore, whether it is a regularly shaped tumor or a complex and varied atypical tumor, the embodiments of this invention can achieve high-precision conformal ablation through dynamic adjustment of parameters, thereby significantly improving the targeting and effectiveness of radiofrequency ablation therapy and providing a more efficient and flexible solution for clinical tumor ablation therapy. Attached Figure Description

[0048] The invention will now be described in more detail with reference to embodiments and the accompanying drawings.

[0049] Figure 1A This is a schematic diagram of the structure of the radiofrequency ablation composite electrode needle in an embodiment of the present invention;

[0050] Figure 1B yes Figure 1A Schematic diagram of the middle handle shell;

[0051] Figure 2 This is a cross-sectional view of the distal portion of the radiofrequency ablation composite electrode needle in an embodiment of the present invention;

[0052] Figure 3A This is a cross-sectional view of the needle assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein the needle assembly does not have a column suction hole.

[0053] Figure 3B yes Figure 3A Schematic diagram of the middle guide groove;

[0054] Figure 3CThis is a cross-sectional view of the needle tip assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein a column suction hole is provided in the needle tip assembly;

[0055] Figure 4A , Figure 4B , Figure 4C and Figure 4D These are schematic diagrams of the puncture needle tip 101 of the radiofrequency ablation composite electrode needle in the embodiments of the present invention.

[0056] Figure 5A , Figure 5B and Figure 5C These are cross-sectional views of the needle tip assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein... Figure 5A This shows that a temperature sensor is installed inside the needle cavity near the needle tip 101. Figure 5B The needle tip 101 and the needle handle are shown to have temperature sensors installed inside. Figure 5C The diagram shows a temperature sensor installed inside the sub-needle cavity;

[0057] Figure 5D yes Figure 5C Enlarged view at point A;

[0058] Figure 6A , Figure 6B and Figure 6C These are cross-sectional views of the needle tip assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein... Figure 6A This indicates that the guide slot is in the closed state; Figure 6B This indicates that the guide slot is in the open position; Figure 6C This shows the state where the guide slot is open and the sub-needle is extended from the guide slot;

[0059] Figure 7 This is a schematic diagram of the sub-needle of the radiofrequency ablation composite electrode needle in an embodiment of the present invention;

[0060] Figure 8A yes Figure 7 Enlarged view at point B;

[0061] Figure 8B This is a schematic diagram of the sub-needle structure in another embodiment of the present invention;

[0062] Figure 9A , Figure 9B and Figure 9C and Figure 9D These are cross-sectional views of the needle tip assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein... Figure 9A This shows a state where the length of the sub-needle is 1 / 4 of the total length of the sub-needle; Figure 9BThis shows a state where the length of the sub-needle is 2 / 4 of the total length of the sub-needle; Figure 9C This shows the state where the length of the sub-needle is 3 / 4 of the total length of the sub-needle; Figure 9D This shows the state in which all the sub-needles are displayed;

[0063] Figure 10A This is a cross-sectional view of the needle assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein the outer cavity of the sub-needle serves as an injection / absorption channel.

[0064] Figure 10B yes Figure 10A Enlarged view at point C;

[0065] Figure 11A This is a cross-sectional view of the needle tip assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein an injection / absorption channel is provided on the needle bar.

[0066] Figure 11B yes Figure 11A Enlarged view at point D;

[0067] Figure 12 This is a cross-sectional view of the needle tip assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein the needle tip is provided with an injection / absorption channel.

[0068] Figure 13A This is a cross-sectional view of the needle assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein the inner cavity of the sub-needle serves as an injection / absorption channel.

[0069] Figure 13B yes Figure 13A Enlarged view at point E;

[0070] Figure 14A , Figure 14B and Figure 14C These are schematic diagrams showing the outward bending of the sub-needle of the radiofrequency ablation composite electrode needle in an embodiment of the present invention; wherein, Figure 14A This shows the needle bent outwards at 90°. Figure 14B This shows the state where the needle is bent outwards by 180°. Figure 14C This shows the state where the sub-needle is bent outwards by 360°;

[0071] Figure 15A , Figure 15B and Figure 15C These are schematic diagrams showing the inward bending of the sub-needle of the radiofrequency ablation composite electrode needle in an embodiment of the present invention; wherein, Figure 15A This shows the needle bent inward at 90°. Figure 15B This shows the state where the needle is bent inward by 180°. Figure 15C This shows the state where the sub-needle is bent inward 360°;

[0072] Figure 16 This is a schematic diagram of the sub-needle structure of the radiofrequency ablation composite electrode needle in one embodiment of the present invention;

[0073] Figure 17A This is a schematic diagram of the sub-needle structure of the radiofrequency ablation composite electrode needle in one embodiment of the present invention;

[0074] Figure 17B yes Figure 17A Enlarged view at point F;

[0075] Figure 18A and Figure 18B These are schematic diagrams of the needle tip assembly of the radiofrequency ablation composite electrode needle in the embodiments of the present invention; wherein Figure 18A This shows the state where the insulating tube completely covers the tip of the puncture needle 101. Figure 18B This shows a portion of the needle bar that is not covered by the insulating tube;

[0076] Figure 19A These are images of animal livers after an ablation experiment using the radiofrequency ablation composite electrode needle of this invention;

[0077] Figure 19B These are images of animal livers after an ablation experiment using existing ablation needles;

[0078] Figure 20 It is a graph showing the relationship between the unfolded diameter of the sub-needle when it is fully displayed and the unfolded length of the sub-needle when it is first displayed.

[0079] Figure 21A and Figure 21B These are the states when the sub-needle is first displayed with an exhibition length of 5mm, the guide groove is in its minimum state and semi-closed state, and the sub-needle continues to be displayed until it is fully displayed.

[0080] Figure 22A and Figure 22B These are the states when the sub-needle is first displayed with an exhibition length of 35mm, the guide groove is in its minimum state and semi-closed state, and the sub-needle continues to be displayed until it is fully displayed.

[0081] Figure 23A A schematic diagram of the ablation of the lesion when the length of the sub-needle 5 is half of the pre-exhibition length of the sub-needle 5 and the width of the guide groove is 15mm.

[0082] Figure 23B A schematic diagram of the ablation of the lesion when the length of the sub-needle 5 is 3 / 4 of the pre-exhibition length of the sub-needle 5 and the width of the guide groove is 10mm.

[0083] Figure 23C The diagram shows the ablation of the lesion when all five needles are fully exposed and the width of the guide groove is 5mm.

[0084] Figure 24 This is a three-dimensional structural diagram of the linkage mechanism in an embodiment of the present invention, wherein the handle housing is not shown;

[0085] Figure 25 This is a three-dimensional structural diagram of the gear mechanism in an embodiment of the present invention;

[0086] Figure 26 This is a three-dimensional structural diagram of the cam mechanism in an embodiment of the present invention;

[0087] Figure 27A The embodiment of the present invention shows a state in which the linkage mechanism closes the guide groove and the sub-needle is not displayed;

[0088] Figure 27B This illustration shows an embodiment of the invention where the linkage mechanism causes the guide groove to open, exposing the sub-needle portion.

[0089] Figure 27C The illustration shows an embodiment of the invention where the linkage mechanism opens the guide groove, exposing all the sub-needles.

[0090] Figure label:

[0091] 1. Needle tip; 101. Puncture needle tip; 102. Needle handle; 103. Needle inner cavity; 104. Needle coating; 105. Needle injection / aspiration channel;

[0092] 2. Temperature sensor; 201. Sensor probe; 202. Temperature transmission line;

[0093] 3. First inner tube; 301. Outer rod of the first inner tube; 302. Inner cavity of the first inner tube;

[0094] 4. Second inner tube; 401. Outer rod of the second inner tube; 402. Inner cavity of the second inner tube;

[0095] 5. Sub-needle; 501. Sub-needle inner cavity; 502. Sub-needle outer rod; 503. Sub-needle outer cavity; 504. Sub-needle temperature sensor; 505. Sub-needle front section; 506. Sub-needle drive section;

[0096] 6. Needle bar; 601. Needle bar injection / absorption channel;

[0097] 7. Needle bar coating;

[0098] 8. Insulating tube;

[0099] 9. Guide groove;

[0100] 10. Handle assembly;

[0101] 11. Straight needle working end adjustment switch;

[0102] 12. Length pointer of the working end of the straight needle;

[0103] 13. Guide groove adjustment switch; 131. Cam; 132. Push rod; 133. Spring; 134. First guide sleeve; 135. First connecting sleeve; 136. Connecting rod; 137. Second connecting sleeve; 138. Second guide sleeve;

[0104] 1311. Camshaft; 1312. Cam tip; 1313. Flat section; 1314. Curved section;

[0105] 1321. Boss;

[0106] 1351. First connecting claw; 1352. Second connecting claw; 1353. First central connecting cylinder;

[0107] 1371. Third connecting claw; 1372. Fourth connecting claw; 1373. Second central connecting cylinder;

[0108] 61. Needle bar holder; 62. Scale ring;

[0109] 14. Guide groove adjustment length pointer;

[0110] 15. Sub-needle display switch; 151. Rack; 152. Gear; 153. Knob;

[0111] 1511. Sub-needle connecting groove; 1512. Arc-shaped recess; 1513. Vertical section; 1514. Horizontal section;

[0112] 16. The sub-needle displays the length pointer;

[0113] 17. First liquid pipe; 1701. First liquid pipe body; 1702. First liquid pipe connector;

[0114] 18. Second liquid pipe; 1801. Second liquid pipe body; 1802. Second liquid pipe connector;

[0115] 19. Third liquid pipe; 1901. Third liquid pipe body; 1902. Third liquid pipe connector;

[0116] 20. Fourth liquid pipe; 2001. Fourth liquid pipe body; 2002. Fourth liquid pipe connector;

[0117] 21. First liquid chamber; 22. Second liquid chamber; 23. Third liquid chamber;

[0118] 2301. First inner tube inner cavity connection cavity; 2302. Second inner tube inner cavity connection cavity;

[0119] 24. Electrical wire; 2402. Electrical wire composite cable; 2401. Electrical wire connector;

[0120] 25. Handle shell. Detailed Implementation

[0121] The invention will now be further described with reference to the accompanying drawings.

[0122] like Figure 1A , Figure 1B and Figure 2 As shown, this invention provides a radiofrequency ablation composite electrode needle, comprising a main needle, sub-needles 5 located inside the main needle and extendable from the main needle, and a handle assembly 10 for adjusting the proximal ends of the main needle and sub-needles 5. The number of sub-needles 5 can be multiple, and multiple sub-needles 5 can be simultaneously extended from the main needle. The extension length and extension diameter of each sub-needle 5 are adjustable, and the working length of the main needle is also adjustable. The sub-needles 5 and the main needle can be adjusted independently, thereby achieving adjustable single-needle ablation range; or the sub-needles 5 and the main needle can be adjusted together.

[0123] The main needle includes a needle tip assembly and a needle bar assembly. For example... Figure 2 and Figure 3A As shown, the needle assembly includes a needle 1, which includes a needle shank 102 and a puncture needle tip 101 located at the distal end of the needle shank 102. The puncture needle tip 101 serves as a puncture component for puncturing the skin, tissue, and treatment area in clinical treatment; it can also serve as part of a component that transmits radiofrequency ablation energy signals to the tissue.

[0124] The shape of the puncture needle tip 101 can be a shape that facilitates puncture, for example, it can be... Figure 4A The triangular shape shown Figure 4B The spear-shaped cone shown Figure 4C The cone shape shown or Figure 4D The shapes shown include semicircles.

[0125] The length of the puncture needle tip 101 can be 2mm-10mm, and different lengths of the puncture needle tip 101 can be selected according to different puncture sites. The outer diameter of the needle head 1 (needle handle 102) is 0.5mm-6mm, and different diameters of the needle head 1 can be selected according to different puncture sites.

[0126] The puncture needle tip 101 and the needle handle 102 can be fixedly connected by welding, mechanical connection or other means; or the puncture needle tip 101 and the needle handle 102 can be formed by integral molding.

[0127] The puncture needle tip 101 and the needle handle 102 can be made of the same material, for example, both can be made of conductive medical metal materials, such as 304, 316, titanium alloy, platinum, iridium and other metals or alloys; or the puncture needle tip 101 and the needle handle 102 can be made of different materials, for example, they can be two different materials among the above-mentioned conductive medical metal materials.

[0128] like Figure 3A As shown, the needle 1 also includes a needle cavity 103 disposed inside the puncture needle tip 101 and the needle handle 102. The needle cavity 103 is used for the release and heat exchange of the medium (cold medium or hot medium). The medium can be gas or liquid, etc., which can be selected according to the application scenario.

[0129] In some implementations, such as Figure 3A As shown, a needle coating 104 is provided on the entire outer surface of the puncture needle tip 101 and the needle handle 102. The needle coating 104 is used to prevent tissue adhesion during treatment; or the needle coating 104 can also be used as an electrode to conduct electricity during the radiofrequency ablation process.

[0130] Optionally, the needle coating 104 and the puncture needle tip 101 can be the same component, or the needle coating 104 and the needle handle 102 can also be the same component.

[0131] The needle coating 104 can be made of insulating or conductive heat-resistant and non-stick materials such as PTFE, parylene, and titanium nitride, and can be selected according to different applications.

[0132] In other implementations, such as Figure 3C and Figure 12 As shown, a needle injection / aspiration channel 105 is provided on the needle tip 101 and / or needle handle 102, and the needle injection / aspiration channel 105 is in fluid communication with the inner cavity 103 of the needle. The needle injection / aspiration channel 105 can be used for injecting liquids and aspirating human tissue fluids; liquids include injecting anesthetic drugs, physiological saline, therapeutic drugs, and immunomodulatory drugs, etc.; human tissue fluids include tissue blood, pathological tissue, etc.

[0133] The needle aspiration channel 105 can be one or more. When there are multiple needle aspiration channels 105, they can be equally spaced along the axial direction of the puncture needle tip 101 (or needle handle 102), or equally spaced along the circumferential direction of the puncture needle tip 101 (or needle handle 102). The spacing between each needle aspiration channel 105 is 0.1mm-2mm.

[0134] In addition, the spacing between the multiple needle aspiration channels 105 can also be different.

[0135] like Figure 3CAs shown, the needle injection / aspiration channel 105 can be a perforated structure (injection / aspiration hole) that extends radially through the wall thickness of the needle tip 101 (or needle handle 102). The injection / aspiration hole can be circular, elliptical, elongated, etc. When there are multiple injection / aspiration holes, their diameters can be the same or different. For example, along the injection direction, the diameter of each injection / aspiration hole gradually increases. The maximum diameter of a single injection / aspiration hole is 0.02 mm to 2 mm.

[0136] If the aperture of the injection-aspiration orifice is too small, the cooling medium in the needle cavity 103 can only achieve circulating cooling but not enough for liquid injection. Conversely, if the aperture of the injection-aspiration orifice is too large, the circulating cooling of the cooling medium in the needle cavity 103 will be affected. Therefore, this invention proposes to construct the diameter of the needle injection-aspiration channel 105 so that the circulating cooling of the medium and the injection of liquid can be achieved simultaneously. That is, while the cooling medium (such as physiological saline) in the needle cavity 103 is exchanging heat within the needle cavity 103, it can also flow out from the needle cavity 103 through the needle injection-aspiration channel 105 into the tissue of the target area. Thus, while heat exchange is taking place, liquid can also be injected into the tissue, thereby reducing carbonization of the ablation area and improving the efficiency of radiofrequency ablation. At the same time, the liquid injected into the tissue is also beneficial for conductivity, thus facilitating energy ablation.

[0137] Specifically, when the peristaltic pump pumps liquid into the needle cavity 103 and circulates it, the liquid is injected through the needle injection / absorption channel 105 of the needle cavity 103, and the injection volume is... Q 1 satisfies the following relationship:

[0138] ;

[0139] in, Q 1 represents the total volume of injection fluid injected through the needle's internal cavity 103 via each needle injection / aspiration channel 105 (injection / aspiration port), expressed in m³. 3 / s or ml / min.

[0140] i The number of needle aspiration channels 105; the size of each aspiration hole can be the same or different.

[0141] k The peristaltic pump's compression pressure pulse coefficient refers to the pulse that causes the instantaneous flow rate to be higher than the average flow rate, for example... k It can be 1.0 to 2.0.

[0142] Cd i For the first i The flow coefficient of the injection orifice. Among them, the first... i When the orifice of each injection hole is a regular shape such as a circle, Cd iIt can be 1; the first i When the orifice of each injection hole is irregularly shaped, Cd i It can be 0.5~1.0 (roughness range).

[0143] A i For the first i The orifice cross-sectional area of ​​each injection hole (unit: m 2 For example, if the first i Each injection hole is circular. , d i For the first i The diameter of the first injection hole; if the first i Each injection hole is a crack, and its cross-section can be considered rectangular. A i =Length of the longer side of the cross section × Length of the wider side of the cross section.

[0144] This represents the average pressure within the needle's inner cavity 103, expressed in Pa. The value range is 10 5 Pa ~10 6 Pa.

[0145] ρ This refers to the density of the injected fluid, such as standard injectable water or saline solution. ρ For 1000 kg / m 3 .

[0146] Therefore, based on the above injection volume Q 1 and the i Cross-sectional area of ​​each injection hole A i The relationship between them can determine the first i The diameter of each injection hole allows for simultaneous cooling of the medium and injection of the liquid.

[0147] The radiofrequency ablation composite electrode needle is equipped with a temperature measuring device, such as temperature sensor 2. Temperature sensor 2 is used to monitor the internal and external temperature of the radiofrequency ablation composite electrode needle or the temperature of the tissue at the treatment site. Temperature sensor 2 can be one of the following: a thermocouple, a thermistor (such as an NTC (negative temperature coefficient thermistor) or a PTC (positive temperature coefficient thermistor)), or a fiber optic sensor.

[0148] like Figure 2As shown, the temperature sensor 2 includes a sensor probe 201 and a temperature transmission line 202 communicatively connected to the sensor probe 201. The sensor probe 201 is used to contact the part where the temperature needs to be measured, thereby converting the temperature change signal into signals such as impedance, current, voltage, and phase change. The temperature transmission line 202 is used to transmit the aforementioned temperature change signal to the radiofrequency ablation host for digital processing, temperature control, and display.

[0149] The temperature measuring device can be located at different positions within the radiofrequency ablation composite electrode needle.

[0150] like Figure 5A As shown, the sensor probe 201 of the temperature sensor 2 is located in the needle cavity 103 inside the needle 1, near the tip of the puncture needle 101. The temperature sensor 2, located in the needle cavity 103, can measure the temperature of the medium or the temperature of the normal tissue area contacted by the radiofrequency ablation composite electrode needle.

[0151] like Figure 5B As shown, the sensor probe 201 of the temperature sensor 2 extends from the needle cavity 103 inside the needle 1 to the inside of the puncture needle tip 101. The temperature sensor 2 located inside the puncture needle tip 101 is used to measure the temperature of the heat exchange zone of the radiofrequency ablation composite electrode needle. Setting the temperature sensor 2 here can avoid the influence of the medium on the temperature measurement.

[0152] like Figure 5C and Figure 5D As shown, the temperature measuring device can also be installed on the sub-needle 5, as described below for the sub-needle temperature measuring device.

[0153] Please continue reading Figure 2 The needle bar assembly includes an outermost adjustable insulating tube 8, a needle bar 6 located inside the adjustable insulating tube 8 and coaxially disposed with the adjustable insulating tube 8, a second inner tube 4 located inside the needle bar 6 and coaxially disposed with the needle bar 6, and a first inner tube 3 located inside the second inner tube 4 and coaxially disposed with the second inner tube 4.

[0154] like Figure 2 , Figure 3A and Figure 3C As shown, the first inner tube 3 is the innermost tube, with its distal end extending into the needle lumen 103. The second inner tube 4 is located outside the first inner tube 3, with its distal end extending to be fixedly connected to the proximal end of the needle handle 102. Therefore, the first inner tube 3 and the needle lumen 103 are in fluid communication, and the second inner tube 4 is also in fluid communication with the needle lumen 103. The medium transported in the first inner tube 3 can be released at its distal end and enter the needle lumen 103, where it undergoes heat exchange with the target area of ​​the needle lumen 103 before returning from the needle lumen 103 to the second inner tube 4.

[0155] The second inner tube 4 and the needle handle 102 can be fixed together by welding, mechanical connection (such as riveting, threaded connection, etc.), or the second inner tube 4 and the needle handle 102 can be a single molded structure. Therefore, the second inner tube 4 can also transmit radio frequency energy signals.

[0156] Please continue reading Figure 2 The first inner tube 3 includes a first inner tube outer rod 301. The first inner tube outer rod 301 is constructed with a hollow structure, thus forming a first inner tube cavity 302 inside. The first inner tube cavity 302 is in fluid communication with the needle cavity 103. Therefore, the medium transported in the first inner tube 3 is released through the first inner tube cavity 302 and enters the needle cavity 103.

[0157] Please continue reading Figure 2 The second inner tube 4 has a similar structure to the first inner tube 3. It includes a second inner tube outer rod 401, which is hollow 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 the inner cavity 402 of the second inner tube. The inner cavity 402 of the second inner tube is in fluid communication with the inner cavity 103 of the needle. Therefore, the fluid in the inner cavity 103 of the needle after heat exchange can return from the inner cavity 103 of the needle to the inner cavity 402 of the second inner tube.

[0158] Therefore, it can be known that the medium channel in the radiofrequency ablation composite electrode needle includes the first inner tube cavity 302 and the second inner tube cavity 402, wherein the first inner tube cavity 302 serves as the medium entry channel and the second inner tube cavity 402 serves as the medium outflow channel, and the two form a heat exchange circulation inflow and outflow channel.

[0159] Please continue reading Figure 2 The sub-needle 5 is positioned between the second inner tube 4 and the needle bar 6. Specifically, the sub-needle 5 is located outside the outer rod 401 of the second inner tube and inside the needle bar 6, so the liquid in the inner cavity 402 of the second inner tube can also cool the sub-needle 5.

[0160] like Figure 2 As shown, the temperature transmission line 202 of the temperature sensor 2 extends within the first inner tube 3, and the sensor probe 201 extends from the first inner tube 3 and into the needle cavity 103. Therefore, the temperature sensor 2 can measure the temperature of the target area where the needle cavity 103 is located, thereby improving the accuracy of the measurement.

[0161] Please continue reading 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.

[0162] The handle assembly 10 is provided with a first liquid chamber 21, a second liquid chamber 22, and a third liquid chamber 23 in sequence. The third liquid chamber 23 includes a first inner tube inner cavity connecting cavity 2301 and a second inner tube inner cavity connecting cavity 2302 in sequence. The first inner tube inner cavity connecting cavity 2301 and the second inner tube inner cavity connecting cavity 2302 are not connected. The first inner tube inner cavity connecting cavity 2301 is closer to the puncture needle tip 101.

[0163] The proximal end of the first inner tube 3 extends from the second inner tube 4 and into the connecting cavity 2301 of the first inner tube. Therefore, the inner cavity 302 of the first inner tube is in fluid communication with the connecting cavity 2301, and the medium in the connecting cavity 2301 can be delivered to the needle cavity 103 through the inner cavity 302. The proximal end of the second inner tube 4 extends into the connecting cavity 2302 of the second inner tube. Therefore, the inner cavity 402 of the second inner tube is in fluid communication with the connecting cavity 2302, and the medium in the needle cavity 103 can be returned to the connecting cavity 2302 through the inner cavity 402.

[0164] The first inner tube 3 is made of metal, such as medical metal materials (304, 316, titanium alloy, platinum, iridium and other metals or alloys); or the first inner tube 3 may be made of plastic, such as PTFE, PEEK, PI, ceramic, glass fiber and other materials.

[0165] The second inner tube 4 is made of medical conductive material, such as medical metallic materials (304, 316, titanium alloy, platinum, iridium, etc.). The first inner tube 3 and the second inner tube 4 can be made of the same or different materials.

[0166] The needle shaft 6 is made of medical conductive materials, such as medical metal materials (304, 316, titanium alloy, platinum, iridium and other metals or alloys).

[0167] Please continue reading Figure 2 And please combine Figure 3B The guide groove 9 is formed between the distal end of the needle bar 6 (the end near the puncture needle tip 101) and the proximal end of the needle handle 102 (the end away from the puncture needle tip 101). Understandably, the guide groove 9 is the gap between the distal end of the needle bar 6 and the proximal end of the needle handle 102.

[0168] like Figure 6A As shown, the distal end of the needle bar 6 and the proximal end of the needle handle 102 abut against each other, with a gap of 0, meaning the guide groove 9 is completely closed; Figure 6BAs shown in the figure, there is a certain distance between the distal end of the needle bar 6 and the proximal end of the needle handle 102, i.e., the guide groove 9 is open. The gap between the distal end of the needle bar 6 and the proximal end of the needle handle 102, i.e., the width of the guide groove 9, is 0mm-10mm.

[0169] like Figure 3B and Figure 6C As shown, after the guide groove 9 is opened, the sub-needle 5 can be displayed from the guide groove 9.

[0170] The inner diameter of the needle bar 6 can be less than or equal to the outer diameter of the needle handle 102. Therefore, the needle bar 6 and the needle handle 102 can move relative to each other until the distal end of the needle bar 6 and the proximal end of the needle handle 102 abut against each other, thereby ensuring that the guide groove 9 is completely closed and the sub-needle 5 cannot be exposed from it.

[0171] Please continue reading Figure 1B The handle assembly 10 includes a guide groove adjustment switch 13, which is connected to the proximal end of the needle bar 6 or the proximal end of the second inner tube 4. By operating the guide groove adjustment switch 13, the relative movement of the needle bar 6 and the second inner tube 4 (and the needle handle 102) can be controlled, thereby adjusting the distance between the distal end of the needle bar 6 and the proximal end of the needle handle 102, thus adjusting the width of the guide groove 9. For example, the guide groove adjustment switch 13 can be operated to control the movement of the needle bar 6 relative to the needle handle 102, or the guide groove adjustment switch 13 can be operated to control the movement of the needle handle 102 relative to the needle bar 6.

[0172] In one implementation, such as Figure 11A and Figure 11B As shown, the radiofrequency ablation composite electrode needle also includes an injection-aspiration channel, which is constructed as a needle bar injection-aspiration channel 601 opened on the needle bar 6 near the needle tip 1. The needle bar injection-aspiration channel 601 is in fluid communication with the space between the second inner tube 4 and the needle bar 6 (i.e., the outer cavity 503 of the sub-needle).

[0173] The needle bar injection and aspiration channel 601 can be used for injecting liquids and aspirating fluids from human tissues; liquids include anesthetic drugs, saline, therapeutic drugs, and immunosuppressive drugs; human tissue fluids include tissue blood and pathological tissues.

[0174] The number of needle bar injection channels 601 can be one or more. When there are multiple needle bar injection channels 601, the multiple needle bar injection channels 601 can be arranged at equal intervals along the axial direction of the needle bar 6, or at equal intervals along the circumference of the needle bar 6. The spacing between each needle injection channel 105 is 0.1mm-2mm.

[0175] In addition, the spacing between the multiple needle bar injection channels 601 can also be different.

[0176] like Figure 11BAs shown, the needle bar injection channel 601 can be an injection hole that penetrates the wall thickness of the needle bar 6 radially. The injection hole can be a circular hole, an elliptical hole, an elongated hole, etc. When there are multiple injection holes, the diameters of each injection hole can be the same or different. For example, along the injection direction, the diameters of each injection hole gradually increase. The maximum diameter of a single injection hole is 0.02mm-2mm.

[0177] When liquid is injected through the needle rod injection channel 601 in the space between the second inner tube 4 and the needle rod 6 (i.e., the outer cavity 503 of the sub-needle), the injection volume is... Q 2 satisfies the following relationship:

[0178] ;

[0179] in, Q 2 represents the total volume of injection fluid injected through each injection port (needle shaft injection channel 601) into the outer cavity 503 of the needle, expressed in cubic meters (m³). 3 / s or ml / min.

[0180] i The number of injection channels 601 on the needle bar; the size of each injection hole can be the same or different.

[0181] Cd i For the first i The flow coefficient of the injection orifice. Among them, the first... i When the orifice of each injection hole is a regular shape such as a circle, Cd i It can be 1; the first i When the orifice of each injection hole is irregularly shaped, Cd i It can be 0.5~1.0 (roughness range).

[0182] A i For the first i The orifice cross-sectional area of ​​each injection hole (unit: m 2 For example, if the first i Each injection hole is circular. , d i For the first i The diameter of the first injection hole; if the first i Each injection hole is a crack, and its cross-section can be considered rectangular. A i =Length of the longer side of the cross section × Length of the wider side of the cross section.

[0183] The pressure difference across the needle bar injection channel 601 (unit: Pa).

[0184] It can be based on the internal pressure P 注内 With respect to the external atmospheric pressure P 组织 The difference is calculated to obtain:

[0185] ΔP=P 注内 -P 组织 When the external atmospheric pressure P 组织 When the pressure is standard atmosphere, the above formula can be simplified to ∆P = P 注内 .

[0186] Please continue reading Figure 2 An adjustable insulating tube 8 is coaxially disposed on the outside of the needle bar 6. The distal end of the adjustable insulating tube 8 is close to the puncture needle 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.

[0187] The adjustable insulating tube 8 provides both heat insulation and electrical insulation, allowing heat and energy exchange to occur on the portions of the needle tip 1 and needle bar 6 not covered by the adjustable insulating tube 8. The adjustable insulating tube 8 can move relative to the needle bar 6, thereby adjusting the exposed length of the needle tip 1 and / or needle bar 6 (i.e., the length of the portions of the needle tip 1 and needle bar 6 not covered by the adjustable insulating tube 8), thus adjusting the working length of the main needle. Figure 1A and Figure 1B As shown, the handle assembly 10 is equipped with a straight needle working end adjustment switch 11, which 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 closer to or further away from the puncture needle tip 101 (e.g., ...). Figure 18A and Figure 18B (as shown), to change the length of its covering needle 1 and needle bar 6.

[0188] like Figure 18A As shown, the adjustable insulating tube 8 moves towards the tip of the puncture needle 101 until it completely covers the tip of the puncture needle 101, at which point the adjustable insulating tube 8 reaches its maximum coverage area. Figure 18B As shown, the adjustable insulating tube 8 moves away from the puncture needle tip 101, so that the needle tip 1 is completely exposed outside the adjustable insulating tube 8, and a portion of the needle shaft 6 is exposed outside the adjustable insulating tube 8.

[0189] The exposed length of needle 1 and needle bar 6 can be indicated by the straight needle working end length pointer 12. The exposed length of needle 1 and / or needle bar 6 can be adjusted from 0mm to 100mm.

[0190] The adjustable insulating tube 8 can be made of plastic with insulating medium, such as PTFE, PEEK, PI, ceramic, glass fiber, etc.; or it can be made of metal material that has been insulated, such as medical metal material (304, 316, titanium alloy, platinum, iridium, etc. or alloys).

[0191] The needle shaft 6 is also provided with a needle shaft coating 7, which is used to prevent tissue adhesion during treatment. For example, the needle shaft coating 7 can be provided on the entire outer surface of the needle shaft 6, or it can be provided only on the outer surface of the end near the needle tip 1.

[0192] The needle bar coating 7 and the needle bar 6 can also be the same component.

[0193] The needle bar coating 7 can be made of insulating or conductive heat-resistant and non-stick materials such as PTFE and titanium nitride. The needle bar coating 7 can be selected according to different applications.

[0194] The surface of the needle shaft 6 is also provided with a scale layer to facilitate clinical confirmation of puncture depth.

[0195] The number of sub-needles 5 can be multiple; please refer to the following: Figure 2 The distal portions of multiple sub-needles 5 are coaxially disposed between the second inner tube 4 and the needle bar 6, and there is a certain gap between the outer wall of the second inner tube 4 and the inner wall of the needle bar 6 to facilitate the extension and sliding of the sub-needles 5.

[0196] The proximal portions of multiple sub-needles 5 extend as a whole into the handle assembly 10. For example... Figure 1A As shown, the distal end of each sub-needle 5 is connected to the sub-needle deployment switch 15 in the handle assembly 10. By operating the sub-needle deployment switch 15, when the guide groove 9 is opened, each sub-needle 5 can be deployed from the guide groove 9.

[0197] Specifically, such as Figure 7 and Figure 8A As shown, the needle 5 includes a needle outer rod 502 and a needle outer cavity 503. Please refer to... Figure 6A and Figure 6B Before the needle 5 unfolds, a portion of the outer rod 502 of the needle is located within 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 needle is the remaining gap after the outer rod 502 fills the aforementioned cavity. Figure 6C As shown, when the guide groove 9 is opened, the outer rod 502 of the sub-needle can be extended by operating the sub-needle extension switch 15.

[0198] Optionally, such as Figure 8A As shown, the outer rod 502 of the needle has a hollow structure, forming an inner cavity 501. Therefore, the inner cavity 501 can also serve as an injection / aspiration channel. Please refer to... Figure 13A and Figure 13B After the sub-needle 5 is displayed, liquid can be injected and human tissue fluid can be aspirated through the inner cavity 501 of the sub-needle.

[0199] Please continue reading Figure 1A The first liquid chamber 21 is closer to the puncture needle tip 101 than the third liquid chamber 23. The sub-needle 5 extends beyond the first liquid chamber 21 beyond the handle assembly 10, and the second inner tube 4 and needle bar 6 extend into the first liquid chamber 21; the space between the second inner tube 4 and the needle bar 6, i.e., the sub-needle outer cavity 503, is in fluid communication with the first liquid chamber 21. When the sub-needle 5 is extended, as... Figure 10A and Figure 10B As shown, the fluid in the first liquid chamber 21 can be injected through the outer cavity 503 of the sub-needle and via the guide groove 9, or the fluid in human tissue can be aspirated through the guide groove 9 and returned to the first liquid chamber 21 via the outer cavity 503 of the sub-needle.

[0200] Please continue reading 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, therefore 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 extended, as... Figure 13A and Figure 13B As shown, the fluid in the second liquid chamber 22 can be injected through the inner cavity 501 of the sub-needle, or the fluid in human tissue can be aspirated through the inner cavity 501 of the sub-needle and returned to the second liquid chamber 22.

[0201] Optionally, such as Figure 8B As shown, the outer rod 502 of the sub-needle is a solid structure.

[0202] As described above, the injection channel can also be constructed as a guide groove 9, that is, liquid can be injected through the guide groove 9, and the amount of liquid injected by the guide groove 9... Q g Satisfy the following expression:

[0203] ;

[0204] Q g The volume of liquid injected into guide tank 9, in cubic meters (m³). 3 / s or ml / min.

[0205] C v The velocity coefficient is used because the liquid flows through the outer cavity 503 of the needle and experiences friction against its inner wall, which can... C v Setting it to 0.5~1 makes the inner wall of the outer cavity 503 of the sub-needle smoother. C vThe value can be as large as possible, for example, reaching a maximum value of 1.

[0206] A g The cross-sectional area of ​​the opening of guide groove 9 (unit: m 2 ).

[0207] P This represents the absolute pressure inside the radiofrequency ablation composite electrode needle, measured in Pa.

[0208] ρ This refers to the density of the injected fluid, such as standard injectable water or saline solution. ρ 1000 kg / m 3 .

[0209] Furthermore, such as Figure 5C and Figure 5D As shown, a sub-needle temperature measuring device, such as a sub-needle temperature sensor 504, is provided inside the sub-needle cavity 501. The sub-needle temperature sensor 504 can be used to monitor the temperature of the tissue at the edge of the treatment thermal ablation area, accurately obtain the spatial temperature of the treatment area, and can work in conjunction with the temperature sensor 2 inside the puncture needle tip 101 assembly 1 for temperature monitoring and control; or the sub-needle temperature sensor 504 can also independently monitor and control the temperature of the treatment area, thereby achieving precise ablation and real-time efficacy evaluation.

[0210] The sub-needle temperature sensor 504 can be the same as the temperature sensor 2 described above, such as a thermocouple, NTC, PTC, fiber optic sensor, etc.

[0211] After the sub-needle 5 is exhibited, the outer rod 502 of the sub-needle can also be used as part of the component that transmits radiofrequency ablation energy signals to the tissue, and work in conjunction with the needle tip 1 and / or the needle rod 6 to form the ablation damage range required for treatment.

[0212] After the sub-needle 5 is displayed, the outer shaft 502 of the sub-needle needs to be inserted into the tissue of the treatment area. Therefore, the distal end of the outer shaft 502 can be a shape suitable for puncture, such as a triangular, spear-shaped, or conical shape (e.g., Figure 8A and Figure 8B (As shown).

[0213] The number of needle outer rods 502 can be multiple, for example, from 1 to 20; the extended length of each needle outer rod 502 can be from 0mm to 100mm. The diameter of a single needle outer rod 502 is 0.1mm to 2mm.

[0214] The outer rod 502 of the sub-needle is made of medical conductive material, such as medical metal material (304, 316, titanium alloy, platinum, iridium and other metals or alloys).

[0215] In one alternative configuration, sub-needle 5 is a multi-segment structure. For example, sub-needle 5 is a two-segment structure.

[0216] Specifically, such as Figure 17A and Figure 17B As shown, the sub-needle 5 includes a sub-needle outer rod 502, which includes a sub-needle front section 505 and a sub-needle drive section 506. The proximal end of the sub-needle front section 505 is connected to the sub-needle drive section 506. The sub-needle front section 505 is closer to the puncture needle tip 101 and is the part of the sub-needle 5 used for deployment.

[0217] When this two-section structure is adopted, the front section 505 of the needle for display only extends to connect with the needle drive section 506, and does not need to extend into the handle assembly 10; the proximal end of the needle drive section 506, the proximal end of the needle bar 6, and the proximal end of the second inner tube 4 extend into the handle assembly 10.

[0218] The front section 505 of the needle and the driving section 506 of the needle can be fixedly connected by welding (laser welding, tin soldering, high frequency welding, etc.), bonding and mechanical connection.

[0219] Understandably, the front section 505 of the sub-needle can also be composed of multiple tube segments spliced ​​together, and the driving section 506 of the sub-needle can also be composed of multiple tube segments spliced ​​together.

[0220] The length of the front section of the needle 505 is 10mm-120mm.

[0221] like Figure 17B As shown, the diameter of the front section 505 of the sub-needle is larger than the diameter of the sub-needle driving section 506. Since the sub-needle driving section 506 does not need to be displayed, it can be a common tubular structure, and its diameter can be smaller than that of the front section 505 of the sub-needle.

[0222] In one optional way, such as Figure 16 As shown, the sub-needle 5 is a one-piece structure, meaning the outer rod 502 of the sub-needle is also a one-piece structure. In other words, the proximal end of the outer rod 502 of the sub-needle extends all the way into the handle assembly 10.

[0223] When the outer rod 502 of the needle is hollow, one or both of the front section 505 of the needle and the driving section 506 of the needle can be hollow; when the outer rod 502 of the needle is solid, one or both of the front section 505 of the needle and the driving section 506 of the needle can be solid.

[0224] For example, the front section 505 of the needle is hollow, and the outer rod 502 of the needle is also hollow. That is, the inner cavity 501 of the needle includes the internal space of the front section 505 and the internal space of the outer rod 502. Alternatively, the front section 505 of the needle is hollow, and the outer rod 502 of the needle is solid. That is, the inner cavity 501 of the needle includes the internal space of the front section 505. In this case, the inner cavity 501 of the needle can be fluidly connected with the outer cavity 503 of the needle. Therefore, the medium in the first liquid chamber 21 can be injected through the guide groove 9 or the inner cavity 501 of the needle, or human tissue fluid can be aspirated through the guide groove 9 or the inner cavity 501 of the needle and returned to the first liquid chamber 21 through the outer cavity 503 of the needle.

[0225] like Figure 9A , Figure 9B , Figure 9C and Figure 9D As shown, after the guide groove 9 is displayed on the sub-needle 5, its extended length and angle can be adjusted.

[0226] like Figure 9A As shown, the extension length of the sub-needle 5 is adjusted by the sub-needle extension switch 15 so that the extension length of the sub-needle 5 is 1 / 4 of the pre-extension length of the sub-needle 5; as Figure 9B As shown, the extension length of the sub-needle 5 is adjusted by the sub-needle extension switch 15 so that the extension length of the sub-needle 5 is 2 / 4 of the pre-extension length of the sub-needle 5; as Figure 9C As shown, the extension length of the sub-needle 5 is adjusted by the sub-needle extension switch 15 so that the extension length of the sub-needle 5 is 3 / 4 of the pre-extension length of the sub-needle 5; as Figure 9D As shown, the length of the sub-needle 5 is adjusted by the sub-needle display switch 15 so that the sub-needle 5 is fully displayed.

[0227] It should be noted that the pre-exhibited length of the sub-needle 5 is the maximum length that the sub-needle 5 can be exhibited from the guide slot 9.

[0228] The extended length of the sub-needle 5 (sub-needle outer rod 502) is 0mm-100mm, that is, the maximum extended length (pre-exhibition length) of the sub-needle outer rod 502 from the guide groove 9 is 120mm. Therefore, after the sub-needle outer rod 502 is extended, it can form an area with a diameter of 0mm-70mm.

[0229] The extension angle of the needle 5 (outer rod of the needle 502) is 0°-360°, that is, the maximum extension angle of the outer rod of the needle 502 from the guide groove 9 is 360°. In other words, the extension angle of the outer rod of the needle 502 can be adjusted arbitrarily within the range of 360°.

[0230] Therefore, compared to existing ablation needles, the sub-needles of the radiofrequency ablation composite electrode needle of the present invention have no angle limitations when displayed, overcoming the technical difficulty that the display angle of existing ablation needles can only reach 180°. Thus, the radiofrequency ablation composite electrode needle of the present invention can achieve complete coverage of irregularly shaped lesions, avoiding ablation blind spots in clinical practice and thus avoiding the risk of missed ablation. Furthermore, because the display 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 near-spherical structure can be constructed. Therefore, based on the characteristic that this structure can more comprehensively and accurately cover various irregularly shaped lesions, the radiofrequency ablation composite electrode needle of the present invention does not require the complex and difficult operation process of multiple needle withdrawals, retractions, extensions, and ablation in the prior art. Instead, it only requires a single puncture and ablation operation, which not only significantly shortens the operation time and improves the efficiency of the operation, but also greatly improves the patient's intraoperative experience and reduces the risk of complications caused by multiple operations.

[0231] To achieve a maximum display angle of 360° for the sub-needle 5, the sub-needle 5 (sub-needle outer rod 502) has a pre-bending angle, with each sub-needle 5 having a maximum pre-bending angle of 360°. The pre-bending angle refers to the bending angle of the sub-needle 5 before it is installed into the second inner tube 4 and needle rod 6. In other words, before installation into the second inner tube 4 and needle rod 6, the sub-needle 5 is pre-bent 360°, forming a circle, and then extended when installed into the second inner tube 4 and needle rod 6. Therefore, when the guide groove 9 opens and the sub-needle 5 is displayed from it, due to its shape memory characteristic, it will return to its pre-bent state, achieving a 360° display angle.

[0232] Therefore, it is understandable that when multiple sub-needles 5 (sub-needle outer rod 502) are all extended at their maximum extension angle, a spherical or near-spherical (ellipsoidal, such as...) shape can be formed. Figure 23C (as shown) structure, such as Figure 9D As shown. Since the outer rod 502 of the needle extends from the guide groove 9 and bends outward or inward, when the extension angle of the outer rod 502 of the needle is 360°, the puncture tip of the outer rod 502 of the needle reaches the guide groove 9 or the vicinity of the guide groove 9.

[0233] Understandably, when the above-mentioned spherical structure is used for ablation, the resulting thermal damage range is spherical or quasi-spherical (almost spherical), thus it can more completely encapsulate the lesion and avoid the risk of missed ablation.

[0234] It should be noted that the angle of the unfolded sub-needle 5 refers to the central angle of the arc formed after the sub-needle 5 is unfolded.

[0235] The display length and display angle of the sub-needle 5 (sub-needle outer rod 502) are positively correlated, such as... Figure 9A As shown, the length of the sub-needle 5 is 1 / 4 of its pre-exhibited length, and its exhibit angle is 90°; Figure 9B As shown, the length of the sub-needle 5 is 2 / 4 of its pre-exhibited length, and its exhibit angle is 180°; Figure 9C As shown, the length of the sub-needle 5 is 3 / 4 of its pre-exhibited length, and its exhibit angle is 270°. Figure 9D As shown, all of the sub-needles 5 are displayed at an angle of 360°.

[0236] The length of the sub-needle 5 can be indicated by the sub-needle length pointer 16.

[0237] Before the needle 5 is displayed, the width of the guide groove 9 can be adjusted to a suitable width. During the display of the needle 5, the width of the guide groove 9 can remain unchanged; or during the display of the needle 5, the width of the guide groove 9 can be adjusted at any time to control the direction and timing of the bending deformation of the needle 5.

[0238] like Figure 19A The image shown is an image of an isolated porcine liver after an ablation experiment using the radiofrequency ablation composite electrode needle of the present invention. It illustrates the ablation thermogram after a single puncture and ablation. It can be seen that the ablation thermogram is predominantly spherical or ellipsoidal, thus allowing for more complete lesion coverage, avoiding the risk of missed ablation, resulting in better ablation effects, and enabling the procedure to be completed in a single ablation session.

[0239] However, the bending angle of existing ablation needles is limited, and they cannot be adjusted arbitrarily within a 360° range, resulting in irregular shapes of the ablation area, tending towards a teardrop shape. For example... Figure 19B As shown, existing ablation needles produce ablation thermograms that are predominantly triangular or teardrop-shaped, exhibiting incomplete lesion coverage and potentially leading to missed ablation. To avoid this, the conventional clinical approach is needle withdrawal ablation, where the needle is withdrawn after one ablation, then withdrawn to a certain depth before being extended for another ablation. If a CT scan reveals incomplete lesion coverage, a third withdrawal, extension, and re-ablation may be required, or even more procedures. This method results in prolonged surgery time and a poor patient experience. Therefore, the existing ablation needles utilize multiple punctures and ablations to create an axially oriented, triangular or teardrop-shaped coverage area, resulting in an approximately spherical or ellipsoidal ablation thermal damage zone.

[0240] Therefore, it can be seen that the present invention achieves controllable ablation range by controlling the width of the guide groove 9 (i.e., the opening size of the guide groove 9), the outward angle of the outer rod 502 of the sub-needle, and the extended length of the sub-needle 5. 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 sphere, thus achieving a more precise ablation range and less damage to normal tissue.

[0241] Specifically, the width of the guide groove 9 is related to the bending deformation direction of the sub-needle 5. The smaller the width of the guide groove 9, the greater the clamping force that the sub-needle 5 experiences when it emerges from the guide groove 9, enabling the sub-needle 5 to achieve bending deformation earlier.

[0242] Optionally, such as Figure 14A , Figure 14B and Figure 14C As shown, after the sub-needle 5 extends the guide groove 9, its bending direction can be outward, that is, towards the direction away from the puncture needle tip 101. Therefore, the ablation area formed after the sub-needle 5 is extended is behind the puncture needle tip 101.

[0243] Optionally, such as Figure 15A , Figure 15B and Figure 15C As shown, after the sub-needle 5 extends the guide groove 9, its bending direction can be inward, that is, towards the direction close to the puncture needle tip 101. Therefore, the ablation area formed after the sub-needle 5 is extended can cover the puncture needle tip 101.

[0244] Furthermore, when the sub-needle 5 is displayed, one way to control the diameter of the displayed sub-needle 5 is as follows: the first display length of the sub-needle 5. L x Then, the width of the guide groove 9 is reduced, and the sub-needle 5 is fully extended. For example, the width of the guide groove 9 is reduced by changing the distance between the distal end of the needle bar 6 and the proximal end of the needle handle 102 by moving the needle bar 6.

[0245] The diameter of the sub-needle 5 when fully displayed D y The first exhibition length of the needle 5 L x The following relation is satisfied:

[0246] D y = a + b×L x ;

[0247] in, a , b All are coefficients. a The value range is 23.15-28.35; b The value range is 0.13-0.17. a , b All of these are empirical coefficients obtained from experiments.

[0248] like Figure 20 As shown, the unfolded diameter of the sub-needle 5 when fully extended is illustrated. D yThe first exhibition length of the needle 5 L x The curve graph. Figure 20 In the figure, the horizontal axis represents the length of the sub-needle 5 when it is first displayed (unit: mm); the vertical axis represents the diameter of the sub-needle 5 when it is fully displayed (unit: mm). Figure 20 The blue curve at the bottom center represents the unfolding diameter when the width of the guide groove 9 is reduced to its minimum (i.e., the minimum state of the guide groove 9) after the first unfolding length of the sub-needle 5, and the sub-needle 5 continues to be unfolded until it is fully unfolded; the red curve at the top represents the unfolding diameter when the width of the guide groove 9 is reduced by 1 / 2 (i.e., the semi-closed state of the guide groove 9) after the first unfolding length of the sub-needle 5, and the sub-needle 5 continues to be unfolded until it is fully unfolded.

[0249] It should be noted that the minimum state of the guide groove 9 corresponds to the state in which the two ends of the guide groove 9 completely clamp the sub-needle 5.

[0250] according to Figure 20 It can be seen that when the guide groove 9 is in a semi-closed state, the sub-needle 5 continues to be displayed until it is fully displayed, resulting in a larger unfolding diameter.

[0251] like Figure 21A As shown, the first display length of sub-needle 5 is illustrated. L x After 5mm, when the width of the guide groove 9 is reduced to its minimum (the minimum state of the guide groove 9), the sub-needle 5 continues to be displayed until it is fully displayed; as shown. Figure 21B As shown, the first display length of sub-needle 5 is shown. L x After 5mm, when the width of the guide groove 9 is reduced to 1 / 2 of its total width (guide groove 9 in a semi-closed state), the sub-needle 5 continues to be displayed until it is fully displayed. According to... Figure 21A and Figure 21B It can be seen that when the guide groove 9 is adjusted to the minimum state, the exhibited sub-needle 5 continues to be exhibited with a smaller diameter, but the shape of the sub-needle 5 is fuller and the sub-needle 5 is more densely enveloped.

[0252] like Figure 22A As shown, the first display length of sub-needle 5 is illustrated. L x After 35mm, when the opening size of the guide groove 9 is reduced to its minimum (the minimum state of the guide groove 9), the sub-needle 5 continues to be displayed until it is fully displayed; as shown. Figure 22B As shown, the first display length of sub-needle 5 is illustrated. L xAfter 35mm, when the opening size of the guide groove 9 decreases by 1 / 2 (guide groove 9 is in a semi-closed state), the sub-needle 5 continues to be displayed until it is fully displayed. According to... Figure 22A and Figure 22B It can be seen that even if the exhibition length of the first exhibition is increased... L x Then, when the guide groove 9 is adjusted to the minimum state, the sub-needle 5 is displayed again, resulting in a smaller display diameter, but the shape of the sub-needle 5 is fuller and the sub-needle 5 is more densely enveloped.

[0253] Understandably, if the sub-needle 5 (sub-needle outer rod 502) is not exposed, and the exposure length of the needle tip 1 and / or needle rod 6 is adjusted only, the single-needle ablation range can be adjusted. If the sub-needle 5 (sub-needle outer rod 502) is also exposed, a dual-form structure can be achieved by arbitrarily combining different exposure lengths of the needle tip 1 and / or needle rod 6 with different display lengths (angles) of the sub-needle outer rod 502.

[0254] Therefore, the radiofrequency ablation composite electrode needle of the present invention includes multiple adjustment modes. The first adjustment mode is to adjust the working length of the main needle alone; the second adjustment mode is to adjust the parameters of the sub-needle independently, such as the extension length and extension angle of the sub-needle; and the third adjustment mode is to adjust the working length of the main needle and the parameters of the sub-needle together.

[0255] When the radiofrequency ablation composite electrode needle is in the first adjustment mode, the straight needle working end adjustment switch 11 can be operated, so the adjustable insulating tube 8 can move relative to the needle bar 6, making the length of the part of the needle head 1 and the needle bar 6 not covered by the adjustable insulating tube 8 adjustable, that is, the working length of the main needle is adjustable.

[0256] When the radiofrequency ablation composite electrode needle is in the second adjustment mode, the sub-needle extension switch 15 and the guide groove adjustment switch 13 are operable, so the extension length and extension angle of the sub-needle are adjustable, that is, the parameters of the sub-needle are adjustable.

[0257] 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 guide groove adjustment switch 13 can operate in tandem, thus the working length of the main needle and the parameters of the sub-needle are adjustable. Therefore, the working section of the main needle and the extended portion of the sub-needle work together to ablate, achieving the effect of precisely constructing a personalized combined thermal damage range based on the morphological characteristics of the tumor.

[0258] Therefore, whether it is a regularly shaped tumor or a complex and varied atypical 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 targeting and effectiveness of radiofrequency ablation treatment and providing a more efficient and flexible solution for clinical tumor ablation treatment.

[0259] The working length of the main needle and the unfolded portion of the sub-needle together form the combined thermal damage area. Therefore, the ablation morphology can be switched according to treatment needs to achieve any combination of ablation thermal damage areas. This facilitates the control of the ablation thermal damage area and enables precise three-dimensional shape control. The aforementioned dual-morphology structure can adapt to ablation treatment of tumors of different shapes, sizes, and dimensions, thus providing more flexible clinical application effects.

[0260] For example, the adjustable insulating tube 8 is configured to move relative to the needle bar 6 according to the extended length and extended diameter of each of the said sub-needles 5, thereby adjusting the exposed length (working length of the main needle) of the needle tip 1 and / or the needle bar 6. Figure 23A The diagram shows the ablation of the lesion when the width of the guide groove 9 is adjusted to 15mm, the extension length of the sub-needle 5 is adjusted to 1 / 2 of the pre-extension length of the sub-needle 5, and the exposure length of the needle bar 6 is adjusted to L1. At this time, the thermal damage range formed by each sub-needle 5 and the main needle is egg-shaped. Figure 23B The diagram shows the ablation of the lesion when the width of the guide groove 9 is adjusted to 10 mm, the extension length of the sub-needle 5 is adjusted to 3 / 4 of the pre-extension length of the sub-needle 5, and the exposure length of the needle bar 6 is adjusted to L2 (L2 is less than L1). At this time, the thermal damage range formed by each sub-needle 5 is an irregular ellipsoid. Figure 23C The diagram shows the ablation of the lesion when the width of the guide groove 9 is adjusted to 5mm, the extension length of the sub-needle 5 is adjusted to be fully extended, and the exposure length of the needle bar 6 is adjusted to L3 (L3 is less than L2). At this time, the thermal damage range formed by each sub-needle 5 is a relatively regular ellipsoid, and it is very close to a sphere.

[0261] like Figure 23A As shown, the extended length of the sub-needle 5 is half of its pre-exposed length, and its extended angle is between 180° and 270°. The exposed length of the needle bar 6 is L1. Figure 23B As shown, in Figure 23A Based on this, the extended length of the sub-needle 5 increases to 3 / 4 of the pre-exposed length, and its extended angle also increases accordingly, between 270° and 360°. At this point, the exposed length of the needle bar 6 can be reduced accordingly, for example, from L1 to L2 (L2 is less than L1); Figure 23C As shown, in Figure 23B Based on this, the length of the needle 5 is further increased to be fully exposed, and its exposure angle is also increased to the maximum bending angle, i.e., 360°. At this time, the exposed length of the needle bar 6 can be further reduced, for example, from L2 to L3 (L3 is less than L2).

[0262] In the above-described scheme for adjusting the extended length and angle of the sub-needle 5 and the exposed length of the needle bar 6, the two ends of the sub-needle 5 are respectively located on both sides of the exposed area of ​​the needle bar 6 (or can be considered to be in contact with both sides of the exposed area of ​​the needle bar 6), that is... Figure 23C As shown, the thermal damage range in this state is a relatively regular ellipsoid, and its thermal ablation range is more comprehensive and the effect is better.

[0263] Please continue reading Figure 1A and Figure 1B The handle assembly 10 includes a handle housing 25, which supports the various components within the handle assembly 10 and provides a gripping function for clinical operations. The handle housing 25 is equipped with the straight needle working end adjustment switch 11, the straight needle working end length pointer 12, the guide groove adjustment switch 13, the sub-needle deployment switch 15, and the sub-needle deployment length pointer 16, as described above.

[0264] The straight needle working end adjustment switch 11 and the adjustable insulating tube 8 are connected 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 tip 1 and / or needle bar 6, and the length value is displayed by the straight needle working end length pointer 12.

[0265] The straight needle working end adjustment switch 11 can adopt a push structure, a knob structure, or a dial structure. By pushing, rotating, or toggling the drive structure, the adjustable insulating tube 8 can move axially relative to the needle tip 1 and the needle bar 6. More specifically, the straight needle working end adjustment switch 11 can be one or a combination of gear and rack structure, worm gear structure, or ball screw structure.

[0266] The straight needle working end length pointer 12 can be a separate pointer indicator structure or an indicator structure integrated with the straight needle working end adjustment switch 11.

[0267] The guide groove adjustment switch 13, the first liquid chamber 21, and the needle bar 6 are connected at the radially extending end of the handle assembly 10. The guide groove adjustment switch 13 allows the needle bar 6 to move axially relative to the needle handle 102 to adjust the size of the guide groove 9 opening. A corresponding guide groove adjustment length pointer 14 is provided on one or both sides of the guide groove adjustment switch 13 to indicate the size of the guide groove 9 opening.

[0268] The guide groove adjustment switch 13 can adopt a push structure, a knob structure, or a dial structure. By pushing, rotating, or toggling the drive structure, the needle bar 6 can move axially relative to the needle head 1. More specifically, the guide groove adjustment switch 13 can be one or a combination of gear and rack structure, worm gear structure, or ball screw structure.

[0269] The straight needle working end length pointer 12 can be a separate pointer indicator structure.

[0270] The sub-needle extension switch 15, the second liquid chamber 22, and the sub-needle 5 are connected at the radially extending end toward the handle assembly 10. The sub-needle extension switch 15 is used to control the extension length and angle of the sub-needle outer rod 502 of the sub-needle 5, and the extension length and angle of the sub-needle 5 are indicated by the sub-needle extension length pointer 16.

[0271] The sub-needle extension switch 15 can employ a push mechanism, a knob mechanism, or a dial mechanism. By pushing, rotating, or toggling the drive mechanism, the sub-needle 5 can move axially relative to the needle head 1. More specifically, the sub-needle extension switch 15 can be one or a combination of gear and rack mechanisms, worm gear mechanisms, or ball screw mechanisms.

[0272] The sub-needle display length pointer 16 can be a separate pointer indicator structure, or it can be an indicator structure integrated with the sub-needle display switch 15.

[0273] Furthermore, the sub-needle display switch 15 and the guide slot adjustment switch 13 are connected by a linkage mechanism. The linkage mechanism enables the guide slot adjustment switch 13 to be operated simultaneously to open the guide slot 9 when the sub-needle display switch 15 is operated to display the sub-needle; and the guide slot adjustment switch 13 to be operated simultaneously to close the guide slot 9 when the sub-needle display switch 15 is operated to retract the sub-needle.

[0274] In one specific implementation, such as Figure 24 , Figure 25 , Figure 27A , Figure 27B and Figure 27C As shown, the linkage mechanism is a composite mechanism of gear rack and cam. Specifically, the linkage mechanism includes a guide groove adjusting switch 13, which is configured as a cam mechanism, and a pin extension switch 15, which is configured as a gear rack mechanism, and the two are linked together.

[0275] Specifically, such as Figure 24 As shown, the pin-mounted switch 15 includes a rack 151, a gear 152 meshing with the rack 151, and a knob 153 connected to the gear 152. The knob 153 is located in the handle housing 25 (please refer to...). Figure 1A The outside of the rack 151. By rotating the knob 153, the gear 152 can be rotated, thereby causing the rack 151 to move relative to the gear 152.

[0276] like Figure 25 As shown, the rack 151 has an L-shaped structure, including a vertical section 1513 and a horizontal section 1514 perpendicular to the vertical section 1513. The lower end of the horizontal section 1514 has teeth that mesh with the gear 152. The vertical section 1513 has a pin connecting groove 1511, in which the pin 5 is fixedly installed. Therefore, when the rack 151 moves, it can drive the pin 5 to move, thereby extending or retracting the pin 5.

[0277] Furthermore, an arc-shaped recess 1512 is provided on the upper surface end of the horizontal segment 1514 away from the vertical segment 1513, which is used to cooperate with the cam mechanism.

[0278] Specifically, such as Figure 24 As shown, the guide groove adjustment switch 13 includes a cam 131, which is rotatably mounted on the handle housing 25 via a camshaft 1311 (please refer to...). Figure 1A )middle.

[0279] like Figure 26 As shown, the cam 131 includes a cam tip 1312, an arcuate portion 1314 coaxially disposed with the cam shaft 1311, and a flat portion 1313 connected to the cam tip 1312 and the arcuate portion 1314 respectively. The cam tip 1312 is eccentrically disposed with respect to the cam shaft 1311. The arcuate recess 1512 on the rack 151 matches the cam tip 1312 of the cam 131. Therefore, when the cam tip 1312 of the cam 131 is located in the arcuate recess 1512 and contacts the inner wall of the arcuate recess 1512 (e.g., ... Figure 27A As shown), if the rack 151 moves at this time (for example, the rack 151 moves towards...), Figure 27A If the movement is as shown on the right), then the rack 151 will cause the cam 131 to rotate (for example, the cam 131 rotates counterclockwise).

[0280] Furthermore, the guide slot adjustment switch 13 also includes a push rod 132, which is located on one side of the cam tip 1312 of the cam 131, such as... Figure 25 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 part 1313 of the cam 131 contacts the end of the push rod 132 (as shown). Figure 27A (As shown).

[0281] like Figure 24 As shown, the push rod 132 extends into the first guide sleeve 134 and is fixedly connected to the first guide sleeve 134, which is disposed in the handle housing 25.

[0282] Furthermore, the guide groove adjustment switch 13 also includes a first connecting sleeve 135 and a spring 133. The first connecting sleeve 135 is sleeved on the push rod 132 and is fixedly connected to the boss 1321 on the push rod 132. The spring 133 is sleeved on the push rod 132 and is located between the first connecting sleeve 135 and the first guide sleeve 134. The two ends of the spring 133 abut against the side of the first connecting sleeve 135 away from the cam 131 and the first guide sleeve 134, respectively. Therefore, it can be understood that when the push rod 132 is pushed and moves, the push 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 push rod 132 is removed, the spring 133 will apply a force in the opposite direction to the above-mentioned pushing force to the first connecting sleeve 135 under the action of its restoring force, so that the first connecting sleeve 135 and the push rod 132 move in opposite directions, thus returning to the initial state.

[0283] like Figure 24 and Figure 25 As shown, the first connecting sleeve 135 is constructed as a star-shaped connecting sleeve, which includes a first central connecting cylinder 1353 and a plurality of connecting claws radiating radially along the circumference of the first central connecting cylinder 1353. The first central connecting cylinder 1353 is sleeved on the top rod 132, and the end of the first central connecting cylinder 1353 is fixedly connected to the boss 1321 on the top rod 132. The first connecting claw 1351 of the plurality of connecting claws is fixedly connected to the connecting rod 136, and the second connecting claw 1352 of the plurality of connecting claws is used for the second inner tube 4 (and the sub-needle 5 inside it) to pass through.

[0284] The connecting rod 136 is a rod-shaped member extending parallel to the second inner tube 4, extending to be fixedly connected to the second connecting sleeve 137 in the handle housing 25. 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. Figure 1A (As shown at the lower end).

[0285] like Figure 24 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 constructed as a star-shaped connecting sleeve, which includes a second central connecting cylinder 1373 and a plurality of connecting claws that radiate radially along the circumference of the second central connecting cylinder 1373. Among the plurality of connecting claws of the second connecting sleeve 137, the third connecting claw 1371 is fixedly connected to the other end of the connecting rod 136, and the fourth connecting claw 1372 is fixedly connected to the proximal end of the second inner tube 4.

[0286] like Figure 24As shown, the first connecting sleeve 135 and the second connecting sleeve 137 are arranged opposite to each other, located on both sides of the pin connecting groove 1511 of the rack 151. A connecting rod 136 extends between the first connecting claw 1351 and the third connecting claw 1371, with both ends of the connecting rod 136 fixedly connected to the first connecting claw 1351 and the third connecting claw 1371, respectively. The second inner tube 4 and the pin 5 pass through the second connecting claw 1352 together, and the pin 5 is fixedly connected to the pin connecting groove 1511. The second inner tube 4 continues to extend beyond the pin connecting groove 1511 until it is fixedly connected to the fourth connecting claw 1372. The second connecting sleeve 137 is fixedly connected to the second guide sleeve 138, which is movably disposed within the handle housing 25. Therefore, when the second connecting sleeve 137 moves, the second guide sleeve 138 guides the movement of the second connecting sleeve 137.

[0287] As described above, when the push rod 132 is pushed and moves, the push 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.

[0288] Specifically, such as Figure 27A As shown, the guide groove 9 is closed and the sub-needle 5 is not exposed. At this time, the cam tip 1312 of the cam 131 engages 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 push rod 132.

[0289] When knob 153 is rotated, rack 151 and gear 152 move relative to each other; for example, rack 151 moves to the right. Figure 27A (As shown); the movement of rack 151 will cause cam 131 to rotate counterclockwise, as shown. Figure 27B As shown. After cam 131 rotates counterclockwise to a horizontal position, its cam tip 1312 contacts push rod 132. Since the distance between cam tip 1312 and camshaft 1311 is greater than the distance between flat portion 1313 and camshaft 1311, the distance between cam 131 and push rod 132 decreases due to the rotation of cam 131. Therefore, cam 131 pushes push rod 132 to move away from cam 131. The movement of push rod 132 causes the first connecting sleeve 135 to move, and the movement of the first connecting sleeve 135 drives connecting rod 136, then drives second connecting sleeve 137, and finally drives second inner tube 4 to move. As mentioned above, second inner tube 4 is connected to needle handle 102, so second inner tube 4 moves together with needle handle 102. Needle bar 6 is fixed in needle bar fixing seat 61 in handle housing 25 (e.g. Figure 24 As shown in the diagram, the needle handle 102 will move relative to the needle bar 6, thereby opening the guide groove 9 and thus opening the guide groove 9 while displaying the sub-needle 5.

[0290] Understandably, the movement direction of the sub-needle 5 is the same as that of the second inner tube 4 and the needle handle 102. That is, in this embodiment, the opening of the guide groove 9 is achieved by the movement of the needle handle 102 relative to the needle bar 6.

[0291] Furthermore, after the cam 131 rotates counterclockwise to a horizontal position, it passes over the arc-shaped recess 1512 on the rack 151, and the flat portion 1313 of the cam 131 contacts the upper end face of the horizontal section 1514 of the rack 151, as shown. Figure 25 and Figure 27B As shown.

[0292] After the guide groove 9 is opened, the knob 153 can be rotated to allow the rack 151 to continue moving, as shown below. Figure 27B and Figure 27C As shown, during the continued movement of rack 151, cam 131 moves horizontally on the upper surface of rack 151. When cam 131 moves to contact the vertical segment 1513 of rack 151, its movement stops.

[0293] Furthermore, as described above, the movement of the push rod 132 causes the first connecting sleeve 135 to move, and the movement of the first connecting sleeve 135 compresses the spring 133. Therefore, when the guide groove 9 is open, the spring 133 is in a compressed state. Therefore, when the sub-needle 5 is retracted, the rack 151 rotates in the opposite direction (clockwise). When the rack 151 moves to the point where the cam tip 1312 engages with the arc-shaped recess 1512 again, the cam 131 rotates back to the vertical state, and 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 closer to the cam 131, thereby driving the connecting rod 136, then the second connecting sleeve 137, and finally the second inner tube 4 to move in the opposite direction, so that the guide groove 9 can be closed, thereby realizing the closure of the guide groove 9 while retracting the sub-needle 5.

[0294] like Figure 1AAs shown, the first inner tube cavity connecting cavity 2301 of the third liquid chamber 23 is in fluid communication with the first liquid tube 17, and the second inner tube cavity connecting cavity 2302 of the third liquid chamber 23 is in fluid communication with the second liquid tube 18. Therefore, a liquid circulation channel is formed between the first liquid tube 17, the first inner tube cavity connecting cavity 2301, the first inner tube 3 (first inner tube cavity 302), the needle cavity 103, the second inner tube 4 (second inner tube cavity 402), the second inner tube cavity connecting cavity 2302, and the second liquid tube 18. That is, liquid can enter from the first liquid tube 17, flow into the needle cavity 103 through the first inner tube cavity connecting cavity 2301 and the first inner tube 3 (first inner tube cavity 302), and flow out from the second inner tube cavity connecting cavity 2302 and the second liquid tube 18; or it can enter from the second liquid tube 18 and flow out from the first liquid tube 17.

[0295] like Figure 1A As shown, the first liquid tube 17 includes a first liquid tube body 1701 and a first liquid tube connector 1702. One end of the first liquid tube body 1701 is connected to the inner cavity 2301 of the first inner tube, which can constrain the liquid to enter or flow out of the inner cavity 302 of the first inner tube 3. The other end of the first liquid tube body 1701 is connected to the first liquid tube connector 1702, which can be connected to an external liquid injection component.

[0296] like Figure 1A As shown, the second liquid tube 18 includes a second liquid tube body 1801 and a second liquid tube connector 1802. One end of the second liquid tube body 1801 is connected to the inner cavity 2302 of the second inner tube, which can restrict the liquid to enter or flow out of the liquid injection channel formed between the outer rod 301 of the first inner tube 3 and the inner cavity 402 of the second inner tube 4. The other end of the second liquid tube body 1801 is connected to the second liquid tube connector 1802, which is used to connect with an external liquid injection component.

[0297] like Figure 1A As shown, the third liquid tube 19 is connected to the first liquid chamber 21, and the first liquid chamber 21, together with the needle rod 6 and the outer cavity 503 of the sub-needle, forms an injection / absorption passage. The third liquid tube 19 includes a third liquid tube body 1901 and a third liquid tube connector 1902. One end of the third liquid tube body 1901 is connected to the first liquid chamber 21, which can constrain the injection / absorption liquid to enter or flow out of the injection / absorption liquid passage formed between the outer surface of the needle rod 6 and the outer surface of the sub-needle drive section 506 of the sub-needle 5. The other end of the third liquid tube body 1901 is connected to the third liquid tube connector 1902, which is used to connect to an external injection / absorption component.

[0298] like Figure 1AAs shown, the fourth liquid tube 20 is connected to the second liquid chamber 22, and the second liquid chamber 22 is connected to the needle injection passage formed by the second inner tube 4 and the needle 5. The fourth liquid tube 20 includes a fourth liquid tube body 2001 and a fourth liquid tube connector 2002. One end of the fourth liquid tube body 2001 is connected to the second liquid chamber 22, which can constrain the injection liquid from entering the injection passage formed between the inner surface of the needle drive section 506 of the needle 5 and the outer rod 401 of the second inner tube of the second inner tube 4, or from flowing out of the injection passage. The other end of the fourth liquid tube body 2001 is connected to the fourth liquid tube connector 2002, and the fourth liquid tube body 2001 is used to connect to an external injection component.

[0299] 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 PVC, TPU, PTFE, PEEK, PI, etc.

[0300] The first liquid cavity 21, the second liquid cavity 22, and the third liquid cavity 23 can all be made of metal or plastic. They can be formed inside the handle shell 25 by machining, injection molding, or die casting.

[0301] like Figure 1A As shown, the electrical wire 24 includes an electrical wire composite cable 2402 and an electrical wire connector 2401. The electrical wire composite cable 2402 extends into the handle housing 25 and is connected to one or more of the following: temperature sensor 2, sub-needle temperature sensor 504, first inner tube 3, second inner tube 4, and sub-needle 5. It is used to transmit radio frequency energy, transmit temperature signals, and transmit and indicate switch signals, etc. The electrical wire connector 2401 is connected to the end of the electrical wire composite cable 2402 for connection to the ablation system.

[0302] The present invention also provides an ablation system, including the radiofrequency ablation composite electrode needle described above and an ablation host, wherein the electrical wire 24 is connected to the ablation host, thereby realizing the transmission of radiofrequency energy, the transmission of temperature signals, and the transmission and indication of switch light signals, etc.

[0303] Although the invention has been described with reference to preferred embodiments, various modifications can be made and components can be replaced with equivalents without departing from the scope of the invention. In particular, the technical features mentioned in the various embodiments can be combined in any manner as long as there is no structural conflict. The invention is not limited to the specific embodiments disclosed herein, 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 sub-needle (5) and a handle assembly (10), wherein the main needle includes a needle tip (1) and a needle bar assembly; The needle (1) includes a needle handle (102), a puncture needle tip (101) located at the distal end of the needle handle (102), and a needle inner cavity (103) disposed inside the puncture needle tip (101) and the needle handle (102). The needle bar assembly includes a needle bar (6), a second inner tube (4) and a first inner tube (3) arranged sequentially from the outside to the inside. The sub-needle (5) is disposed between the second inner tube (4) and the needle bar (6). The outer surface of the second inner tube (4) and the inner surface of the needle bar (6) define the sub-needle outer cavity (503). The sub-needle (5) includes a sub-needle cavity (501); The handle assembly (10) is provided with a first liquid chamber (21), a second liquid chamber (22) and a third liquid chamber (23) in sequence. The first liquid cavity (21) is in fluid communication with the outer cavity (503) of the sub-needle; The second liquid cavity (22) is in fluid communication with the inner cavity (501) of the sub-needle; A liquid circulation channel is formed between the third liquid chamber (23), the first inner tube (3), the needle inner cavity (103), and the second inner tube (4); The puncture needle tip (101) and / or the needle handle (102) are provided with a needle injection and aspiration channel (105), the needle injection and aspiration channel (105) is in fluid communication with the needle inner cavity (103), and the liquid in the needle inner cavity (103) can be injected into the target area through the needle injection and aspiration channel (105); The needle cavity (103) is connected to a peristaltic pump, which operates to pump liquid into the needle cavity (103) and circulate it. The injection volume of the needle injection channel (105) is... Q 1 satisfies the following relationship: ； in, Q 1 represents the total amount of injection fluid injected into the target area through each of the needle injection channels (105) from the inner cavity of the needle (103); i The number of the needle injection channels (105); k This refers to the pulse coefficient of the peristaltic pump's extrusion pressure. Cd i For the first i The flow coefficient of the needle aspiration channel (105); A i For the first i The cross-sectional area of ​​the orifice of each needle injection channel (105), in units of m 2 ; The average pressure inside the needle cavity (103) is expressed in Pa. ρ The density of the injected liquid; According to the injection volume Q 1 and the i Cross-sectional area of ​​each injection hole A i The relationship between the two, to determine the first i The aperture of each injection hole allows for simultaneous cooling of the medium circulation and liquid injection.

2. The radiofrequency ablation composite electrode needle according to claim 1, characterized in that, The third liquid chamber (23) includes a first inner tube inner cavity connecting chamber (2301) and a second inner tube inner cavity connecting chamber (2302) that are not interconnected. The first inner tube (3) includes a first inner tube outer rod (301), and the interior of the first inner tube outer rod (301) forms a first inner tube cavity (302). The first inner tube cavity (302) is in fluid communication with the needle cavity (103) and the first inner tube cavity connecting cavity (2301), respectively. The second inner tube (4) includes a second inner tube outer rod (401), and the first inner tube outer rod (301) is disposed in the second inner tube outer rod (401). The inner wall of the second inner tube outer rod (401) and the outer wall of the first inner tube outer rod (301) define the inner cavity (402) of the second inner tube. The inner cavity (402) of the second inner tube is in fluid communication with the needle inner cavity (103) and the connecting cavity (2302) of the inner cavity of the second inner tube, respectively. The fluid flows in opposite directions in the first inner tube cavity (302) and the second inner tube cavity (402).

3. The radiofrequency ablation composite electrode needle according to claim 1 or 2, characterized in that, A needle bar injection channel (601) is provided on the needle bar (6) near the needle tip (1). The needle bar injection channel (601) is in fluid communication with the outer cavity (503) of the sub-needle. The needle bar injection channel (601) enables the medium in the outer cavity (503) of the sub-needle to flow to the target area.

4. The radiofrequency ablation composite electrode needle according to claim 1 or 2, characterized in that, A guide groove (9) is formed between the distal end of the needle bar (6) and the proximal end of the needle handle (102). The outer cavity (503) of the sub-needle is in fluid communication with the guide groove (9) and the first liquid cavity (21), respectively. The fluid in the first liquid cavity (21) flows through the outer cavity (503) of the sub-needle and through the guide groove (9) to the target area.

5. The radiofrequency ablation composite electrode needle according to claim 1 or 2, characterized in that, The needle bar assembly also includes an adjustable insulating tube (8) located outside the needle bar (6), with its proximal end connected to the straight needle working end adjustment switch (11); The proximal end of the needle bar (6) or the proximal end of the second inner tube (4) is connected to the guide groove adjustment switch (13); The distal portion of the sub-needle (5) is connected to the sub-needle display switch (15); The radiofrequency ablation composite electrode needle includes multiple adjustment modes. When the radiofrequency ablation composite electrode needle is in the first adjustment mode of the multiple adjustment modes, the straight needle working end adjustment switch (11) is operable, so that the adjustable insulating tube (8) can move relative to the needle bar (6) to adjust the working length of the main needle. When the radiofrequency ablation composite electrode needle is in the second adjustment mode of the multi-mode adjustment, the sub-needle extension switch (15) and the guide groove adjustment switch (13) are operable, so that the parameters of the sub-needle (5) are adjustable. When the radiofrequency ablation composite electrode needle is in the third adjustment mode of the multi-mode adjustment, the straight needle working end adjustment switch (11), the sub-needle extension switch (15) and the guide groove adjustment switch (13) can operate in coordination, so that the working length of the main needle is adjustable and the parameters of the sub-needle are adjustable.

6. The radiofrequency ablation composite electrode needle according to claim 5, characterized in that, The maximum pre-bending angle of the sub-needle (5) is 360°, so that the maximum display angle of the sub-needle (5) is 360°.

7. The radiofrequency ablation composite electrode needle according to claim 5, characterized in that, When the radiofrequency ablation composite electrode needle is in the third adjustment mode of the multi-adjustment mode, the extended length of the sub-needle (5) is 1 / 2 of the pre-exposed length of the sub-needle (5), its extended angle is 180°-270°, and the exposed length of the needle bar (6) is L1. The extended length of the sub-needle (5) is 3 / 4 of the pre-exposed length of the sub-needle (5), and its extended angle is 270°-360°. The exposed length of the needle bar (6) is L2. When the sub-needle (5) is fully extended, its extension angle is 360°, and the exposed length of the needle bar (6) is L3, where L3 < L2 < L1.

8. The radiofrequency ablation composite electrode needle according to claim 1 or 2, characterized in that, Also includes: A temperature sensor (2) is disposed in the inner cavity (103) of the needle near the tip (101) of the puncture needle; Sub-needle temperature sensor (504), which is disposed in the inner cavity (501) of the sub-needle; and Electrical wire (24), the electrical wire (24) includes an electrical wire composite cable (2402) and an electrical wire connector (2401) for connection to the ablation host. The electrical wire composite cable (2402) 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) for transmitting radio frequency energy, transmitting temperature signals, and transmitting and indicating switch light signals.

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