Radiofrequency ablation composite electrode needle and ablation system

Abstract

The present application relates to a kind of radiofrequency ablation composite electrode needle and ablation system, it is related to ablation technical field.The radiofrequency ablation composite electrode needle of the present application, including main needle, multiple sub-needle and handle assembly for adjusting the main needle and each the sub-needle, the main needle includes needle head assembly and needle stem assembly, the needle stem assembly includes first inner tube, second inner tube and needle stem sequentially coaxially arranged from inside to outside, the distal end of the second inner tube is fixedly connected with the proximal end of the needle head assembly, the distal end of the needle stem and the proximal end between the needle head assembly form guide slot, the needle stem can be moved relative to the needle head assembly to change the width of the guide slot.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of ablation technology, in particular to a radiofrequency ablation composite electrode needle and an ablation system. BACKGROUND

[0002] In the field of tumor radiofrequency ablation treatment, the existing ablation needles generally adopt the design scheme that the sub-needles are extended from the main needle. However, in order to ensure that the sub-needles can be smoothly extended and retracted, the extension length and the extension angle of the sub-needles are significantly limited, and the maximum extension angle of the mainstream ablation needle on the market can only reach 180°. This angle limitation makes it difficult for the ablation needle to achieve complete envelopment of irregularly shaped lesions, and in clinical practice, it is easy to cause ablation blind area, thereby causing the risk of missed ablation.

[0003] In order to avoid the problem of missed ablation, the method of withdrawing the needle is often used in clinical operation. This method needs to repeat the operation process of "retracting the needle→ withdrawing the needle→ extending the needle→ ablation" multiple times: after the first ablation is completed, the sub-needle is retracted, and the ablation needle is pulled out to a certain depth, and then the sub-needle is extended again for secondary ablation. If necessary, CT scanning is also needed to evaluate the ablation effect, and if it is found that the lesion is not completely covered, the operation of retracting, withdrawing, extending and ablation needs to be performed for the third time or more. This operation method of multiple punctures and ablations to form the target heat damage range by stacking multiple ablation areas in the axial direction not only prolongs the operation time and increases the work burden of medical staff, but also significantly reduces the patient's experience during the operation, and also increases the probability of complications such as infection during the operation. SUMMARY

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

[0005] The present application provides a radiofrequency ablation composite electrode needle, which comprises a main needle, a plurality of sub-needles and a handle assembly for adjusting the main needle and each sub-needle. The main needle comprises a needle head assembly and a needle shaft assembly. The needle shaft assembly comprises a first inner tube, a second inner tube and a needle shaft which are coaxially arranged from inside to outside. The distal end of the second inner tube is fixedly connected to the proximal end of the needle head assembly. A guide slot is formed between the distal end of the needle shaft and the proximal end of the needle head assembly. The needle shaft and the needle head assembly can move relative to each other to change the width of the guide slot.

[0006] Each sub-needle is arranged between the second inner tube and the needle shaft. When the guide slot is opened, each sub-needle can be extended from the guide slot.

[0007] Each sub-needle has a pre-bending angle, and the maximum pre-bending angle of each sub-needle is 360°, so that the maximum extension angle of each sub-needle extended from the guide slot is 360°.

[0008] In one embodiment, each of the sub-needles comprises a sub-needle outer rod, which is a one-piece structure or a two-segment structure,

[0009] When the sub-needle outer rod is a two-segment structure, it comprises:

[0010] a sub-needle front segment for unfolding from the guide slot; and

[0011] a sub-needle driving segment connected with the sub-needle front segment, the sub-needle driving segment extending between the second inner tube and the needle rod and into the handle assembly;

[0012] wherein the diameter of the sub-needle driving segment is less than or equal to the diameter of the sub-needle front segment.

[0013] In one embodiment, the length of the sub-needle front segment is 10-120 mm; or the unfolding length of the sub-needle outer rod is 0-100 mm.

[0014] In one embodiment, one or both of the sub-needle front segment and the sub-needle driving segment is a hollow structure; or one or both of the sub-needle front segment and the sub-needle driving segment is a solid structure.

[0015] In one embodiment, the width of the guide slot is related to the bending deformation direction of each of the sub-needles, the smaller the width of the guide slot, the greater the clamping force each of the sub-needles receives when unfolding from the guide slot, so that each of the sub-needles can be bent and deformed earlier.

[0016] In one embodiment, the needle rod assembly further comprises an adjustable insulation tube located outside the needle rod, the adjustable insulation tube is configured to move relative to the needle rod according to the unfolding length and the unfolding diameter of each of the sub-needles, so as to adjust the exposed length of the needle rod and / or the exposed length of the needle tip on the needle rod.

[0017] In one embodiment, the needle tip assembly comprises a needle tip, the needle tip comprises:

[0018] a needle handle;

[0019] a puncture needle tip located at the distal end of the needle handle;

[0020] a needle tip inner cavity arranged inside the needle handle and the puncture needle tip, the first inner tube and the second inner tube are respectively in fluid communication with the needle tip inner cavity; and

[0021] a needle tip infusion channel arranged on the needle handle and / or the puncture needle tip and in fluid communication with the needle tip inner cavity;

[0022] The diameter of the needle injection channel is configured to enable the medium circulation cooling and the liquid injection to be simultaneously achieved.

[0023] In an embodiment, an injection channel is further included, which is configured as the guide slot, or the injection channel is configured as a needle rod injection channel formed on the needle rod, and the needle rod injection channel is in fluid communication with the space between the second inner tube and the needle rod.

[0024] In an embodiment, a linkage mechanism is arranged in the handle assembly, which includes a sub-needle unfolding switch connected to each sub-needle and a guide slot adjusting switch connected to the needle rod, and the sub-needle unfolding switch and the guide slot adjusting switch are linked to each other.

[0025] The application also provides an ablation system, which includes an ablation host and the radiofrequency ablation composite electrode needle.

[0026] Compared with the prior art, the main advantages of the application are:

[0027] (1) The maximum pre-bending angle of the sub-needle can reach 360°, so that the maximum unfolding angle of the sub-needle from the guide slot breaks through the traditional limitation and also reaches 360°. When multiple sub-needles are unfolded at the maximum unfolding angle, a spherical or spherical-like structure can be constructed. This unique structural design can form a spherical or spherical-like ablation heat damage range during the ablation treatment process. Compared with the traditional ablation needle, it can more comprehensively and accurately envelope various irregularly shaped lesions, and eliminate the risk of missed ablation from the root. Based on this, the operation can be completed only by one-time puncture and ablation operation, which not only greatly shortens the operation time and significantly improves the operation efficiency, but also greatly improves the patient's experience during the operation and reduces the risk of complications caused by multiple operations.

[0028] (2) The application breaks through the flexible adjustment of the exposure length of the needle and / or the needle rod, i.e., the working length of the main needle. Based on this, multiple adjustment modes are derived: the working length of the main needle can be adjusted alone, the unfolding length and unfolding angle of the sub-needle can be adjusted independently, and the working length of the main needle and the parameters (unfolding length, unfolding angle) of the sub-needle can be jointly adjusted. Especially in the joint adjustment mode, the working section of the main needle and the unfolded part of the sub-needle work together to accurately construct a personalized combined heat damage range according to the morphological characteristics of the tumor. Therefore, whether the tumor is regular in shape or complex and variable in shape, the embodiment scheme of the application can achieve high-precision conformal ablation through dynamic adjustment of parameters, thereby significantly improving the pertinence and effectiveness of radiofrequency ablation treatment, and providing a more efficient and flexible solution for clinical tumor ablation treatment. BRIEF DESCRIPTION OF DRAWINGS

[0029] Hereinafter, the present invention will be described in more detail based on embodiments with reference to the accompanying drawings.

[0030] Figure 1A Schematic diagram of the structure of a radiofrequency ablation composite electrode needle in an embodiment of the present invention;

[0031] Figure 1B yes Figure 1A Schematic diagram of the structure of the middle handle shell;

[0032] Figure 2 is a cross-sectional view of the distal end portion of the radiofrequency ablation composite electrode needle in an embodiment of the present invention;

[0033] Figure 3A is a cross-sectional view of a needle assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein the needle assembly is not provided with a column suction hole;

[0034] Figure 3B yes Figure 3A Structural diagram of the middle guide groove;

[0035] Figure 3C is a cross-sectional view of a needle 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 assembly;

[0036] Figure 4A 、 Figure 4B 、 Figure 4C and Figure 4D They are schematic structural diagrams of the puncture needle tip 101 of the radiofrequency ablation composite electrode needle in an embodiment of the present invention;

[0037] Figure 5A 、 Figure 5B and Figure 5C They are cross-sectional views of a needle assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein: Figure 5A It shows that a temperature sensor is provided in the inner cavity of the needle near the puncture needle tip 101. Figure 5B It shows that the puncture needle tip 101 and the temperature sensor are set in the needle handle. Figure 5C It shows that a temperature sensor is provided in the inner cavity of the sub-needle;

[0038] Figure 5D yes Figure 5C Enlarged view at point A;

[0039] Figure 6A 、 Figure 6B and Figure 6C They are cross-sectional views of a needle assembly of a radiofrequency ablation composite electrode needle in one embodiment of the present invention, wherein: Figure 6A The guide slot is shown in a closed state;Figure 6B shows the guide slot in the open state; Figure 6C shows the guide slot in the open state and the sub-needle extended from the guide slot;

[0040] Figure 7 is a structural diagram of a sub-needle of a radiofrequency ablation composite electrode needle in an embodiment of the present application;

[0041] Figure 8A is Figure 7 an enlarged view at B;

[0042] Figure 8B is a structural diagram of a sub-needle in another embodiment of the present application;

[0043] Figure 9A , Figure 9B and Figure 9C and Figure 9D are respectively a sectional view of a needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present application, wherein, Figure 9A shows the state that the sub-needle is extended to 1 / 4 of the overall length of the sub-needle; Figure 9B shows the state that the sub-needle is extended to 2 / 4 of the overall length of the sub-needle; Figure 9C shows the state that the sub-needle is extended to 3 / 4 of the overall length of the sub-needle; Figure 9D shows the state that the sub-needle is fully extended;

[0044] Figure 10A is a sectional view of a needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present application, wherein the outer cavity of the sub-needle serves as a injection-suction channel;

[0045] Figure 10B is Figure 10A an enlarged view at C;

[0046] Figure 11A is a sectional view of a needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present application, wherein the injection-suction channel is arranged on the needle stem;

[0047] Figure 11B is Figure 11A an enlarged view at D;

[0048] Figure 12 is a sectional view of a needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present application, wherein the injection-suction channel is arranged on the needle head;

[0049] Figure 13A is a sectional view of a needle head assembly of a radiofrequency ablation composite electrode needle in one of the embodiments of the present application, wherein the inner cavity of the sub-needle serves as a injection-suction channel;

[0050] Figure 13Bis Figure 13A Enlarged view at E;

[0051] Figure 14A , Figure 14B and Figure 14C are respectively schematic diagrams of outward bending of sub-needles of a radiofrequency ablation composite electrode needle in an embodiment of the present application; wherein Figure 14A shows a state of outward bending of the sub-needles by 90°, Figure 14B shows a state of outward bending of the sub-needles by 180°, Figure 14C shows a state of outward bending of the sub-needles by 360°;

[0052] Figure 15A , Figure 15B and Figure 15C are respectively schematic diagrams of inward bending of sub-needles of a radiofrequency ablation composite electrode needle in an embodiment of the present application; wherein Figure 15A shows a state of inward bending of the sub-needles by 90°, Figure 15B shows a state of inward bending of the sub-needles by 180°, Figure 15C shows a state of inward bending of the sub-needles by 360°;

[0053] Figure 16 is a schematic diagram of a sub-needle structure of a radiofrequency ablation composite electrode needle in one of the embodiments of the present application;

[0054] Figure 17A is a schematic diagram of a sub-needle structure of a radiofrequency ablation composite electrode needle in one of the embodiments of the present application;

[0055] Figure 17B is Figure 17A Enlarged view at F;

[0056] Figure 18A and Figure 18B are respectively schematic diagrams of a needle head assembly of a radiofrequency ablation composite electrode needle in an embodiment of the present application; wherein Figure 18A shows a state in which the insulating tube completely covers the puncture needle tip 101, Figure 18B shows a state in which a part of the needle shaft is not covered by the insulating tube;

[0057] Figure 19A is a picture of an animal liver ablation experiment after using the radiofrequency ablation composite electrode needle of the present application;

[0058] Figure 19B is a picture of an animal liver ablation experiment after using an existing ablation needle;

[0059] Figure 20 is a curve diagram between the deployment diameter of the sub-needle when the sub-needle is completely deployed and the deployment length of the sub-needle when the sub-needle is deployed for the first time;

[0060] Figure 21Aand Figure 21B respectively are the state of the sub-needle after the first extension of the extension length of 5mm, the guide slot is in the minimum state and the half-closed state, and the sub-needle continues to extend to the fully extended state;

[0061] Figure 22A and Figure 22B respectively are the state of the sub-needle after the first extension of the extension length of 35mm, the guide slot is in the minimum state and the half-closed state, and the sub-needle continues to extend to the fully extended state;

[0062] Figure 23A is a schematic diagram of the ablation lesion when the extension length of the sub-needle 5 is 1 / 2 of the pre-extended length of the sub-needle 5 and the width of the guide slot 9 is 15mm;

[0063] Figure 23B is a schematic diagram of the ablation lesion when the extension length of the sub-needle 5 is 3 / 4 of the pre-extended length of the sub-needle 5 and the width of the guide slot 9 is 10mm;

[0064] Figure 23C is a schematic diagram of the ablation lesion when the sub-needle 5 is fully extended and the width of the guide slot 9 is 5mm;

[0065] Figure 24 is a schematic diagram of the linkage mechanism in the embodiment of the present application, wherein the handle shell is not shown;

[0066] Figure 25 is a schematic diagram of the gear mechanism in the embodiment of the present application;

[0067] Figure 26 is a schematic diagram of the cam mechanism in the embodiment of the present application;

[0068] Figure 27A shows the state of the linkage mechanism in the embodiment of the present application to close the guide slot and the sub-needle is not extended;

[0069] Figure 27B shows the state of the linkage mechanism in the embodiment of the present application to open the guide slot and the sub-needle is partially extended;

[0070] Figure 27C shows the state of the linkage mechanism in the embodiment of the present application to open the guide slot and the sub-needle is fully extended.

[0071] Reference signs:

[0072] 1, needle; 101, puncture needle tip; 102, needle handle; 103, needle lumen; 104, needle coating; 105, needle injection and suction channel;

[0073] 2, temperature sensor; 201, sensor probe; 202, temperature transmission line;

[0074] 3. First inner tube; 301. First inner tube outer rod; 302. First inner tube inner cavity;

[0075] 4. Second inner tube; 401. Second inner tube outer rod; 402. Second inner tube inner cavity;

[0076] 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 driving section;

[0077] 6. Needle rod; 601. Needle rod suction channel;

[0078] 7. Needle rod coating;

[0079] 8. Insulation tube;

[0080] 9. Guide slot;

[0081] 10. Handle assembly;

[0082] 11. Straight needle working end adjustment switch;

[0083] 12. Straight needle working end length pointer;

[0084] 13. Guide slot adjustment switch; 131. Cam; 132. Jack; 133. Spring; 134. First guide sleeve; 135. First connecting sleeve; 136. Connecting rod; 137. Second connecting sleeve; 138. Second guide sleeve;

[0085] 1311. Cam shaft; 1312. Cam tip; 1313. Flat part; 1314. Arc part;

[0086] 1321. Boss;

[0087] 1351. First connecting claw; 1352. Second connecting claw; 1353. First central connecting cylinder;

[0088] 1371. Third connecting claw; 1372. Fourth connecting claw; 1373. Second central connecting cylinder;

[0089] 61. Needle rod fixing seat; 62. Scale ring;

[0090] 14. Guide slot adjustment length pointer;

[0091] 15. Sub-needle extension switch; 151. Gear rack; 152. Gear; 153. Knob;

[0092] 1511. Sub-needle connecting slot; 1512. Arc-shaped recess; 1513. Vertical section; 1514. Horizontal section;

[0093] 16. Sub-needle extension length pointer;

[0094] 17. A first liquid pipe; 1701. a first liquid pipe body; 1702. a first liquid pipe joint;

[0095] 18. A second liquid pipe; 1801. a second liquid pipe body; 1802. a second liquid pipe joint;

[0096] 19. A third liquid pipe; 1901. a third liquid pipe body; 1902. a third liquid pipe joint;

[0097] 20. A fourth liquid pipe; 2001. a fourth liquid pipe body; 2002. a fourth liquid pipe joint;

[0098] 21. A first liquid cavity; 22. A second liquid cavity; 23. A third liquid cavity;

[0099] 2301. A first inner pipe inner cavity connecting cavity; 2302. A second inner pipe inner cavity connecting cavity;

[0100] 24. An electrical wire; 2402. An electrical wire composite cable; 2401. An electrical wire joint;

[0101] 25. A handle shell. DETAILED DESCRIPTION

[0102] The present application will be further described below with reference to the accompanying drawings.

[0103] As shown in Figure 1A , Figure 1B and Figure 2 , the present application provides a radiofrequency ablation composite electrode needle, which comprises a main needle, a sub-needle 5 located inside the main needle and capable of being deployed from inside the main needle, and a handle assembly 10 for adjusting the proximal side of the main needle and the sub-needle 5. The number of sub-needles 5 can be multiple, and multiple sub-needles 5 can be deployed from the main needle at the same time. Among them, the deployment length and the deployment diameter of each sub-needle 5 are both adjustable, and the working length of the main needle is also adjustable, and the sub-needle 5 and the main needle can be adjusted separately, so as to realize the adjustable single-needle ablation range; or the sub-needle 5 and the main needle can be adjusted together,

[0104] The main needle comprises a needle head assembly and a needle rod assembly. As shown in Figure 2 and Figure 3A , the needle head assembly comprises a needle head 1, and the needle head 1 comprises a needle handle 102 and a puncture needle tip 101 located at the distal end of the needle handle 102. The puncture needle tip 101 serves as a puncture component for puncturing the skin, tissue and treatment area in clinical treatment; it can also serve as part of the component for transmitting radiofrequency ablation energy signals to the tissue.

[0105] The shape of the puncture needle tip 101 can be a shape that facilitates puncture, for example, it can be a triangular shape as shown in Figure 4A , Figure 4Ba spearhead shape, Figure 4C a conical shape, or Figure 4D a semicircular shape, etc.

[0106] The length of the puncture needle tip 101 can be 2-10 mm, and different lengths of the puncture needle tip 101 can be selected according to different puncture sites. The outer diameter of the needle 1 (the needle handle 102) is 0.5-6 mm, and different diameters of the needle 1 can be selected according to different puncture sites.

[0107] The puncture needle tip 101 and the needle handle 102 can be fixedly connected by welding, mechanical connection, etc.; or the puncture needle tip 101 and the needle handle 102 can be formed by one-piece molding.

[0108] The puncture needle tip 101 and the needle handle 102 can be made of the same material, for example, both can be made of a conductive medical metal material, such as 304, 316, titanium alloy, platinum, iridium, etc. or alloy; or the puncture needle tip 101 and the needle handle 102 can be made of different materials, for example, the two can be different two kinds of materials in the above-mentioned conductive medical metal materials.

[0109] As shown in Figure 3A The needle 1 further includes a needle lumen 103 arranged inside the puncture needle tip 101 and the needle handle 102, and the needle lumen 103 is used for releasing and heat exchanging of the medium (cold medium or hot medium). The medium can be gas or liquid, etc., which can be selected according to the use scene.

[0110] In some embodiments, as shown in Figure 3A A needle coating 104 is arranged on the entire outer surface of the puncture needle tip 101 and the needle handle 102, and the needle coating 104 is used for preventing tissue adhesion during treatment; or the needle coating 104 can also be used as an electrode for conducting electricity during radiofrequency ablation.

[0111] 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.

[0112] The needle coating 104 can be made of PTFE, poly-p-xylylene, titanium nitride, etc. insulating or conductive temperature-resistant anti-adhesion material, which can be selected according to different uses.

[0113] In other embodiments, as shown in Figure 3C and Figure 12As shown, a needle injection and aspiration channel 105 is provided on the puncture needle tip 101 and / or the needle handle 102, and is in fluid communication with the needle lumen 103. The needle injection and aspiration channel 105 can be used for injecting liquids and aspirating fluids from human tissues; liquids include injectable anesthetics, saline, therapeutic drugs, and immunotherapies; and human tissue fluids include tissue blood, pathological tissue, and the like.

[0114] The needle injection and aspiration channels 105 may be one or more in number. If there are multiple needle injection and aspiration channels 105, they may be equally spaced along the axial direction of the puncture needle tip 101 (or needle handle 102), or equally spaced along the circumference of the puncture needle tip 101 (or needle handle 102). The spacing between the needle injection and aspiration channels 105 is 0.1 mm to 2 mm.

[0115] In addition, the spacing between the multiple needle injection and suction channels 105 may also be different.

[0116] like Figure 3C As shown, the needle injection and aspiration channel 105 can be a hole-like structure (injection and aspiration hole) extending radially through the wall of the puncture needle tip 101 (or needle shaft 102). The injection and aspiration hole can be circular, elliptical, or elongated. When there are multiple injection and aspiration holes, the diameters of each hole can be the same or different. For example, the diameter of each hole can gradually increase along the injection direction. The maximum diameter of a single injection and aspiration hole is 0.02 mm to 2 mm.

[0117] If the diameter of the injection and suction hole is too small, the cooling medium in the needle lumen 103 can only achieve circulation cooling without having time to inject liquid. Conversely, if the diameter of the injection and suction hole is too large, the circulation cooling of the cooling medium in the needle lumen 103 will be affected. Therefore, the present invention proposes to construct the diameter of the needle injection and suction channel 105 so that medium circulation cooling and liquid injection can be achieved simultaneously, that is, the cooling medium (such as saline) in the needle lumen 103 can simultaneously exchange heat within the needle lumen 103 and flow out of the needle lumen 103 through the needle injection and suction channel 105 to the tissue in the target area. Therefore, while heat exchange is being carried out, liquid can also be injected into the tissue, thereby reducing carbonization in the ablation area and improving the efficiency of radiofrequency ablation. At the same time, the liquid injected into the tissue is also conducive to electrical conductivity, which is conducive to energy ablation.

[0118] Specifically, when a peristaltic pump is used to pump liquid into the needle cavity 103 and circulate the liquid, the liquid injection volume is Q 1 satisfies the following relationship:

[0119] ;

[0120] in,Q 1 is the total amount of injection liquid injected from the needle lumen 103 through each needle injection and aspiration channel 105 (injection and aspiration hole), and its unit is m 3 / s or ml / min.

[0121] i The number of the needle injection and suction channels 105 is 105, and the sizes of the injection and suction holes can be the same or different.

[0122] k is the peristaltic pump extrusion pressure pulse coefficient, the pulse makes the instantaneous flow rate higher than the average flow rate, for example k It can be 1.0~2.0.

[0123] Cd i For the i The flow coefficient of the injection and suction holes. i When the opening of each injection and suction hole is a regular shape such as a circle, Cd i Can be 1; i When the opening of each injection and suction hole is irregular in shape, Cd i It can be 0.5~1.0 (rough orifice range).

[0124] A i For the i The cross-sectional area of ​​the injection and suction holes (unit: m 2 ). For example, if i Each injection hole is a circular hole. , d i For the i The diameter of the injection hole (diameter); if the i Each injection hole is a crack, and its cross section can be regarded as a rectangle, that is, A i = length of the long side of the cross section × length of the wide side of the cross section.

[0125] is the average pressure in the needle cavity 103, in Pa, The value range is 10 5 Pa ~10 6 Pa.

[0126] p The density of the injected liquid, for example, the injected liquid is regular injection water or physiological saline, p 1000 kg / m 3 .

[0127] Therefore, according to the above injection volume Q 1 and No. i Cross-sectional area of ​​the injection and suction holes A i The relationship between i The aperture (diameter) of each injection and suction hole enables medium circulation cooling and liquid injection to be achieved simultaneously.

[0128] The RF ablation composite electrode needle is equipped with a temperature measurement device, such as temperature sensor 2, which is used to monitor the temperature inside and outside the RF ablation composite electrode needle, or the temperature of the tissue being treated. Temperature sensor 2 can be a thermocouple, a thermistor (such as an NTC (negative temperature coefficient thermistor) or a PTC (positive temperature coefficient thermistor)), or a fiber optic sensor.

[0129] like Figure 2 As shown, the temperature sensor 2 includes a sensor probe 201 and a temperature transmission line 202 in communication with the sensor probe 201. The sensor probe 201 is used to contact the area where the temperature needs to be measured, thereby converting temperature change signals into impedance, current, voltage, phase change, and other signals. The temperature transmission line 202 is used to transmit these temperature change signals to the RF ablation host for digital processing, temperature control, and display.

[0130] The temperature measuring device can be located at different positions in the radiofrequency ablation composite electrode needle.

[0131] like Figure 5A As shown, the sensor probe 201 of the temperature sensor 2 is arranged in the needle lumen 103 in the needle 1 near the puncture needle tip 101. The temperature sensor 2 located in the needle lumen 103 can measure the temperature of the medium or the temperature of the normal tissue area contacted by the radiofrequency ablation composite electrode needle.

[0132] like Figure 5B As shown, the sensor probe 201 of the temperature sensor 2 extends from the needle inner 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 area of ​​the radiofrequency ablation composite electrode needle. Setting the temperature sensor 2 here can avoid the influence of the medium on the temperature measurement.

[0133] like Figure 5C and Figure 5D As shown, the temperature measuring device can also be provided on the sub-needle 5, such as the sub-needle temperature measuring device described below.

[0134] Please continue to see Figure 2The needle shaft assembly comprises an outermost adjustable insulating tube 8, a needle shaft 6 arranged inside the adjustable insulating tube 8 coaxially with the adjustable insulating tube 8, a second inner tube 4 arranged inside the needle shaft 6 coaxially with the needle shaft 6, and a first inner tube 3 arranged inside the second inner tube 4 coaxially with the second inner tube 4.

[0135] As shown in Figure 2 , Figure 3A and Figure 3C , the first inner tube 3 is the innermost tube, and the distal end of the first inner tube 3 extends into the needle lumen 103. The second inner tube 4 is arranged outside the first inner tube 3, and the distal end of the second inner tube 4 is fixedly connected to the proximal end of the needle handle 102. Therefore, the first inner tube 3 is in fluid communication with the needle lumen 103, and the second inner tube 4 is in fluid communication with the needle lumen 103. The medium conveyed in the first inner tube 3 can be released at the distal end of the first inner tube 3 and enter the needle lumen 103, and after heat exchange with the target area where the needle lumen 103 is located, the medium returns to the second inner tube 4 from the needle lumen 103.

[0136] The second inner tube 4 and the needle handle 102 can be fixed by welding, mechanical connection (such as riveting, threaded connection, etc.), or the second inner tube 4 and the needle handle 102 can be an integral structure. Therefore, the second inner tube 4 can also transmit radio frequency energy signals.

[0137] Please continue to refer to Figure 2 , the first inner tube 3 comprises a first inner tube outer rod 301, which is configured as a hollow structure, so that a first inner tube lumen 302 is formed inside the first inner tube outer rod 301, and the first inner tube lumen 302 is in fluid communication with the needle lumen 103, so that the medium conveyed in the first inner tube 3 is released through the first inner tube lumen 302 and enters the needle lumen 103.

[0138] Please continue to refer to Figure 2 , the second inner tube 4 has a similar structure to the first inner tube 3, and comprises a second inner tube outer rod 401, which is configured as a hollow structure, and the second inner tube outer rod 401 adjusts the first inner tube outer rod 301, so that the inner wall of the second inner tube outer rod 401 and the outer wall of the first inner tube outer rod 301 define a second inner tube lumen 402, and the second inner tube lumen 402 is in fluid communication with the needle lumen 103, so that the fluid after heat exchange in the needle lumen 103 can return to the second inner tube lumen 402 from the needle lumen 103.

[0139] Therefore, it can be seen that the medium channel in the radio frequency ablation composite electrode needle comprises the first inner tube lumen 302 and the second inner tube lumen 402, wherein the first inner tube lumen 302 serves as a medium inlet channel, and the second inner tube lumen 402 serves as a medium outlet channel, and the two form a heat exchange circulation inlet and outlet channel.

[0140] Please continue to refer to Figure 2 The sub-needle 5 is arranged between the second inner tube 4 and the needle rod 6. Specifically, the sub-needle 5 is located outside the second inner tube outer rod 401 and inside the needle rod 6, so that the liquid in the second inner tube lumen 402 can also cool the sub-needle 5.

[0141] As shown in Figure 2 , the temperature transmission line 202 of the temperature sensor 2 extends in the first inner tube 3, and the sensor probe 201 extends out of the first inner tube 3 and into the needle lumen 103. Therefore, the temperature sensor 2 can measure the temperature of the target area where the needle lumen 103 is located, thereby improving the accuracy of the measurement.

[0142] Please continue to refer to 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.

[0143] The first liquid cavity 21, the second liquid cavity 22 and the third liquid cavity 23 are sequentially arranged in the handle assembly 10. Among them, the third liquid cavity 23 includes a first inner tube lumen connecting cavity 2301 and a second inner tube lumen connecting cavity 2302 arranged in sequence, the first inner tube lumen connecting cavity 2301 and the second inner tube lumen connecting cavity 2302 are not connected, and the first inner tube lumen connecting cavity 2301 is closer to the puncture needle tip 101.

[0144] The proximal end of the first inner tube 3 extends out of the second inner tube 4 and into the first inner tube lumen connecting cavity 2301. Therefore, the first inner tube lumen 302 is in fluid communication with the first inner tube lumen connecting cavity 2301, and the medium in the first inner tube lumen connecting cavity 2301 can be transported into the needle lumen 103 through the first inner tube lumen 302. The proximal end of the second inner tube 4 extends into the second inner tube lumen connecting cavity 2302, so that the second inner tube lumen 402 is in fluid communication with the second inner tube lumen connecting cavity 2302, and the medium in the needle lumen 103 can return to the second inner tube lumen connecting cavity 2302 through the second inner tube lumen 402.

[0145] The first inner tube 3 is made of metal, for example, made of medical metal material (304, 316, titanium alloy, platinum, iridium, etc. Metal or alloy); or the first inner tube 3 can also be made of plastic, for example, made of PTFE, PEEK, PI, ceramic, glass fiber, etc. Material.

[0146] The second inner tube 4 is made of medical conductive material, for example, made of medical metal material (304, 316, titanium alloy, platinum, iridium, etc. Metal or alloy). The materials of the first inner tube 3 and the second inner tube 4 can be the same or different.

[0147] The needle shaft 6 is made of a medical conductive material, for example, a medical metal material (304, 316, titanium alloy, platinum, iridium, or other metal or alloy).

[0148] Please continue to refer to Figure 2 , and please refer to Figure 3B , the structure of the guide groove 9 is formed between the distal end of the needle shaft 6 (the end close to the puncture needle tip 101) and the proximal end of the needle handle 102 (the end away from the proximal puncture needle tip 101). Understandably, the guide groove 9 is the gap between the distal end of the needle shaft 6 and the proximal end of the needle handle 102.

[0149] As shown in Figure 6A , the distal end of the needle shaft 6 and the proximal end of the needle handle 102 abut each other, and the gap between them is 0, that is, the guide groove 9 is completely closed; as shown in Figure 6B , the distal end of the needle shaft 6 and the proximal end of the needle handle 102 have a certain distance, that is, the guide groove 9 is open. The gap between the distal end of the needle shaft 6 and the proximal end of the needle handle 102, that is, the width of the guide groove 9, is 0mm-10mm.

[0150] As shown in Figure 3B and Figure 6C , after the guide groove 9 is opened, the sub-needle 5 can be unfolded from the guide groove 9.

[0151] The inner diameter of the needle shaft 6 can be less than or equal to the outer diameter of the needle handle 102, so that the needle shaft 6 and the needle handle 102 can be relatively moved to the distal end of the needle shaft 6 and the proximal end of the needle handle 102 abut each other, so as to ensure that the guide groove 9 is completely closed, and the sub-needle 5 cannot be unfolded therefrom.

[0152] Please continue to refer to Figure 1B , the handle assembly 10 is provided with a guide groove adjusting switch 13, which is connected with the proximal end of the needle shaft 6 or the proximal end of the second inner tube 4. By operating the guide groove adjusting switch 13, the relative movement of the needle shaft 6 and the second inner tube 4 (and the needle handle 102) can be controlled, so as to adjust the distance between the distal end of the needle shaft 6 and the proximal end of the needle handle 102, that is, the width of the guide groove 9. For example, the guide groove adjusting switch 13 can be operated to control the movement of the needle shaft 6 relative to the needle handle 102, or the guide groove adjusting switch 13 can be operated to control the movement of the needle handle 102 relative to the needle shaft 6.

[0153] In one embodiment, as shown in Figure 11A and Figure 11B , the radiofrequency ablation composite electrode needle further comprises an injection and suction channel, which is configured as a needle shaft injection and suction channel 601 opened on the needle shaft 6 close to the needle head 1. The needle shaft injection and suction channel 601 is in fluid communication with the space (i.e. the sub-needle outer cavity 503) between the second inner tube 4 and the needle shaft 6.

[0154] The needle rod injection and suction channel 601 can be used for injecting liquids and aspirating human tissue liquids; liquids include injectable anesthetics, physiological saline, therapeutic drugs, and immune drugs, etc.; human tissue liquids include tissue blood, pathological tissue, etc.

[0155] The needle bar injection and suction channels 601 may be one or more in number. When there are multiple needle bar injection and suction channels 601, the multiple needle bar injection and suction channels 601 may be evenly spaced along the axial direction of the needle bar 6, or evenly spaced along the circumference of the needle bar 6. The spacing between the needle head injection and suction channels 105 is 0.1 mm to 2 mm.

[0156] In addition, the spacing between the multiple needle rod injection and suction channels 601 may also be different.

[0157] like Figure 11B As shown, the needle shaft injection and aspiration channel 601 can be an injection and aspiration hole extending radially through the wall of the needle shaft 6. The injection and aspiration hole can be circular, elliptical, or elongated. When there are multiple injection and aspiration holes, the diameters of the holes can be the same or different. For example, the diameters of the holes can gradually increase along the injection direction. The maximum diameter of a single injection and aspiration hole is 0.02 mm to 2 mm.

[0158] When the space between the second inner tube 4 and the needle rod 6 (i.e., the outer cavity 503 of the needle) is filled with liquid through the needle rod injection and suction channel 601, the injection volume is Q 2 satisfies the following relationship:

[0159] ;

[0160] in, Q 2 is the total amount of injection liquid injected from the needle outer cavity 503 through each injection and suction hole (needle rod injection and suction channel 601), the unit is m 3 / s or ml / min.

[0161] i The number of needle bar injection and suction channels 601, the sizes of the injection and suction holes can be the same or different.

[0162] Cd i For the i The flow coefficient of the injection and suction holes. i When the opening of each injection and suction hole is a regular shape such as a circle, Cd i Can be 1; i When the opening of each injection and suction hole is irregular in shape, Cd i It can be 0.5~1.0 (rough orifice range).

[0163] A i For thei The cross-sectional area of ​​the injection and suction holes (unit: m 2 ). For example, if i The injection hole is a circular hole. , d i For the i The diameter of the injection hole (diameter); if the i Each injection hole is a crack, and its cross section can be regarded as a rectangle, that is, A i =The length of the long side of the cross section × the length of the wide side of the cross section.

[0164] is the pressure difference on both sides of the needle bar injection and suction channel 601 (unit: Pa ).

[0165] According to the pressure P in the pipe 注内 and the external atmospheric pressure P 组织 The difference is calculated, that is:

[0166] AP = P 注内 -P 组织 , when the external atmospheric pressure P 组织 When the pressure is standard atmospheric pressure, the above formula can be simplified to ∆𝑃=P 注内 .

[0167] Please continue to see Figure 2 An adjustable insulating tube 8 is coaxially provided on the outside of the needle rod 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.

[0168] The adjustable insulating tube 8 can provide thermal insulation and insulation, so the parts of the needle 1 and the needle rod 6 not covered by the adjustable insulating tube 8 can exchange heat and energy. The adjustable insulating tube 8 can be moved relative to the needle rod 6 to adjust the exposed length of the needle 1 and / or the needle rod 6 (i.e., the length of the parts of the needle 1 and the needle rod 6 not covered by the adjustable insulating tube 8), that is, the working length of the main needle can be adjusted. Figure 1A and Figure 1B As shown, the handle assembly 10 is provided 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 toward or away from the puncture needle tip 101 (as shown in FIG. Figure 18A and Figure 18B as shown), to change the length of the needle 1 and the needle rod 6 it covers.

[0169] like Figure 18AAs shown, the adjustable insulation tube 8 moves towards the direction of the puncture needle tip 101 until it completely covers the puncture needle tip 101, which corresponds to the maximum coverage range of the adjustable insulation tube 8. As shown, Figure 18B As shown, the adjustable insulation tube 8 moves away from the puncture needle tip 101, so that the needle 1 is completely exposed outside the adjustable insulation tube 8, and a part of the needle shaft 6 is exposed outside the adjustable insulation tube 8.

[0170] The exposed length of the needle 1 and the needle shaft 6 can be indicated by the straight needle working end length pointer 12, and the adjustable range of the exposed length of the needle 1 and / or the needle shaft 6 is 0mm-100mm.

[0171] The adjustable insulation tube 8 can be made of plastic of insulating medium, such as PTFE, PEEK, PI, ceramic, glass fiber, etc.; or can be made of insulating metal material, such as medical metal material (304, 316, titanium alloy, platinum, iridium, etc. Metal or alloy).

[0172] 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 only on the outer surface near the end of the needle 1.

[0173] The needle shaft coating 7 and the needle shaft 6 can also be the same component.

[0174] The needle shaft coating 7 can be made of PTFE, titanium nitride, etc. Insulating or conductive temperature-resistant anti-adhesion material, and the needle shaft coating 7 can be selected according to different purposes.

[0175] The surface of the needle shaft 6 is also provided with a scale layer to facilitate clinical puncture depth confirmation.

[0176] The number of sub-needles 5 can be multiple, please continue to refer to Figure 2 The distal end part of the plurality of sub-needles 5 is coaxially arranged between the second inner tube 4 and the needle shaft 6, and has a certain gap between the outer wall of the second inner tube 4 and the inner wall of the needle shaft 6, to facilitate the extension and sliding of the sub-needles 5.

[0177] The proximal end part of the plurality of sub-needles 5 extends into the handle assembly 10 as a whole. As shown, Figure 1A As shown, the distal end part of each sub-needle 5 is connected with the sub-needle extension switch 15 in the handle assembly 10. By operating the sub-needle extension switch 15, each sub-needle 5 can be extended from the guide slot 9 when the guide slot 9 is opened.

[0178] Specifically, as shown in Figure 7 and Figure 8A The sub-needle 5 includes a sub-needle outer shaft 502 and a sub-needle outer cavity 503. Please refer toFigure 6A and Figure 6B Before the needle 5 is deployed, a portion of the needle outer shaft 502 is located in the cavity between the outer surface of the second inner tube 4 and the inner surface of the needle shaft 6. Thus, the needle outer cavity 503 is the gap portion remaining after the needle outer shaft 502 fills the cavity. As shown in Figure 6C When the guide slot 9 is opened, the needle outer shaft 502 can be deployed by operating the needle deployment switch 15.

[0179] Optionally, as shown in Figure 8A , the needle outer shaft 502 is hollow, and the needle inner cavity 501 is formed inside the needle outer shaft 502. Thus, the needle inner cavity 501 can also serve as the injection and aspiration channel. Please refer to Figure 13A and Figure 13B After the needle 5 is deployed, the needle inner cavity 501 can be used for injecting liquid and aspirating human tissue liquid.

[0180] Please continue to refer to Figure 1A , the first liquid chamber 21 is closer to the needle tip 101 than the third liquid chamber 23. The needle 5 extends beyond the handle assembly 10 to the first liquid chamber 21, and the second inner tube 4 and the needle shaft 6 extend into the first liquid chamber 21; the space between the second inner tube 4 and the needle shaft 6, i.e. the needle outer cavity 503, is in fluid communication with the first liquid chamber 21. When the needle 5 is deployed, as shown in Figure 10A and Figure 10B , the liquid in the first liquid chamber 21 can be injected through the needle outer cavity 503 and via the guide slot 9, or human tissue liquid can be aspirated through the guide slot 9 and returned to the first liquid chamber 21 via the needle outer cavity 503.

[0181] Please continue to refer to Figure 1A , the second liquid chamber 22 is located between the third liquid chamber 23 and the first liquid chamber 21. The needle 5 extends into the second liquid chamber 22, so the needle inner cavity 501 of the needle 5 is in fluid communication with the second liquid chamber 22. When the needle 5 is deployed, as shown in Figure 13A and Figure 13B , the liquid in the second liquid chamber 22 can be injected through the needle inner cavity 501, or human tissue liquid can be aspirated through the needle inner cavity 501 and returned to the second liquid chamber 22.

[0182] Optionally, as shown in Figure 8B , the needle outer shaft 502 is solid.

[0183] As mentioned above, the injection and aspiration channel can also be configured as the guide slot 9, i.e. liquid can be injected through the guide slot 9, and the amount of liquid injected through the guide slot 9 Q g satisfies the following expression:

[0184] ;

[0185] Q g The amount of liquid injected into the guide groove 9, in m 3 / s or ml / min.

[0186] C v The speed coefficient, because the liquid flowing in the sub-needle outer cavity 503 will have friction with its inner wall, can be C v Set to 0.5-1, the smoother the inner wall of the sub-needle outer cavity 503, C v The larger the can be, for example, up to a maximum of 1.

[0187] A g The opening cross-sectional area of the guide groove 9 (in m 2 ).

[0188] P The absolute pressure inside the radiofrequency ablation composite electrode needle, in Pa.

[0189] p The density of the injected liquid, for example, the injected liquid is conventional injection water or normal saline, p 1000 kg / m 3 .

[0190] Further, as shown in Figure 5C and Figure 5D , the sub-needle inner cavity 501 is provided with a sub-needle temperature measuring device, which can be a sub-needle temperature sensor 504. The sub-needle temperature sensor 504 can be used to monitor the temperature of the tissue at the edge of the treatment thermal ablation area, accurately obtain the temperature of the treatment area space, and can cooperate with the temperature sensor 2 in the puncture needle tip 101 assembly 1 for temperature monitoring and control; or the sub-needle temperature sensor 504 can also be used alone for temperature monitoring and control of the treatment area, so as to realize precise ablation and real-time efficacy evaluation.

[0191] The sub-needle temperature sensor 504 can be the same as the temperature sensor 2 described above, for example, it can be a temperature measuring thermocouple, NTC, PTC, optical fiber sensor, etc.

[0192] After the sub-needle 5 is deployed, the sub-needle outer rod 502 can also be part of the component for transmitting radiofrequency ablation energy signals to the tissue, and cooperate with the needle 1 and / or needle rod 6 to form the required ablation damage range for treatment.

[0193] After the sub-needle 5 is deployed, the sub-needle outer rod 502 needs to puncture into the tissue of the treatment area. Therefore, the distal end of the sub-needle outer rod 502 can be shaped to be suitable for puncture, for example, it can be shaped as a triangular prism, a spear cone, a cone, etc. (as shown in Figure 8A and Figure 8B ).

[0194] The number of sub-needle outer rods 502 can be multiple, for example, it can be 1-20; the length of each sub-needle outer rod 502 deployed can be 0mm-100mm. The diameter of a single sub-needle outer rod 502 is 0.1mm-2mm.

[0195] The sub-needle outer rod 502 is made of a medical conductive material, for example, it is made of a medical metal material (304, 316, titanium alloy, platinum, iridium, etc. metal or alloy).

[0196] In an optional manner, the sub-needle 5 is a multi-segment structure. For example, the sub-needle 5 is a two-segment structure.

[0197] Specifically, as shown in Figure 17A and Figure 17B , the sub-needle 5 includes a sub-needle outer rod 502, the sub-needle outer rod 502 includes a sub-needle front segment 505 and a sub-needle driving segment 506, and the proximal end of the sub-needle front segment 505 is connected to the sub-needle driving segment 506. The sub-needle front segment 505 is closer to the puncture needle tip 101, and it is the part of the sub-needle 5 used for deployment.

[0198] When this two-segment structure is adopted, the sub-needle front segment 505 used for deployment only needs to extend to the connection with the sub-needle driving segment 506, and does not need to extend into the handle assembly 10; the proximal end of the sub-needle driving segment 506, the proximal end of the needle rod 6, and the proximal end of the second inner tube 4 extend into the handle assembly 10.

[0199] The sub-needle front segment 505 and the sub-needle driving segment 506 can be fixedly connected by welding (laser welding, soldering, high-frequency welding, etc.), bonding, mechanical connection, etc.

[0200] It can be understood that the sub-needle front segment 505 can also be composed of multiple tube segments, and the sub-needle driving segment 506 can also be composed of multiple tube segments.

[0201] The length of the sub-needle front segment 505 is 10mm-120mm.

[0202] As shown in Figure 17B , the diameter of the sub-needle front segment 505 is greater than the diameter of the sub-needle driving segment 506, and the sub-needle driving segment 506 does not need to be deployed, so it can be a normal tubular structure, so its diameter can be smaller than the diameter of the sub-needle front segment 505.

[0203] In an optional manner, as shown in Figure 16As shown, the sub-needle 5 is of an integral structure, i.e. the sub-needle outer rod 502 is of an integral structure. That is, the proximal end of the sub-needle outer rod 502 extends into the handle assembly 10.

[0204] When the sub-needle outer rod 502 is of a hollow structure, one or both of the sub-needle front section 505 and the sub-needle driving section 506 can be of a hollow structure; when the sub-needle outer rod 502 is of a solid structure, one or both of the sub-needle front section 505 and the sub-needle driving section 506 can be of a solid structure.

[0205] For example, when the sub-needle front section 505 is of a hollow structure, the sub-needle outer rod 502 is also of a hollow structure, i.e. the sub-needle inner cavity 501 comprises the internal space of the sub-needle front section 505 and the internal space of the sub-needle outer rod 502. Alternatively, when the sub-needle front section 505 is of a hollow structure, the sub-needle outer rod 502 is of a solid structure, i.e. the sub-needle inner cavity 501 comprises the internal space of the sub-needle front section 505, in which case the sub-needle inner cavity 501 can be in fluid communication with the sub-needle outer cavity 503, so that the medium in the first liquid chamber 21 can be injected via the guide groove 9 or the sub-needle inner cavity 501, or alternatively, the human tissue fluid can be aspirated via the guide groove 9 or the sub-needle inner cavity 501 and returned to the first liquid chamber 21 via the sub-needle outer cavity 503.

[0206] As shown in FIGS. 1-3, the sub-needle 5 is in a retracted state. Figure 9A , Figure 9B , Figure 9C and Figure 9D As shown, the length and angle of the sub-needle 5 can be adjusted after the sub-needle 5 is deployed out of the guide groove 9.

[0207] As shown in FIG. 4, the length of the sub-needle 5 is adjusted by the sub-needle deployment switch 15, so that the deployed length of the sub-needle 5 is 1 / 4 of the pre-deployed length of the sub-needle 5. Figure 9A As shown in FIG. 5, the length of the sub-needle 5 is adjusted by the sub-needle deployment switch 15, so that the deployed length of the sub-needle 5 is 2 / 4 of the pre-deployed length of the sub-needle 5. Figure 9B As shown in FIG. 6, the length of the sub-needle 5 is adjusted by the sub-needle deployment switch 15, so that the deployed length of the sub-needle 5 is 3 / 4 of the pre-deployed length of the sub-needle 5. Figure 9C As shown in FIG. 7, the length of the sub-needle 5 is adjusted by the sub-needle deployment switch 15, so that the sub-needle 5 is fully deployed. Figure 9D It should be noted that the pre-deployed length of the sub-needle 5 is the maximum length that the sub-needle 5 can be deployed out of the guide groove 9.

[0208] The deployed length of the sub-needle 5 (sub-needle outer rod 502) is 0mm-100mm, i.e. the maximum length (pre-deployed length) of the sub-needle outer rod 502 deployed out of the guide groove 9 is 120mm. Therefore, the sub-needle outer rod 502 can form a region with a diameter of 0mm-70mm after being deployed.

[0209]

[0210] ​The unfolding angle of the sub-needle 5 (the sub-needle outer rod 502) is 0°-360°, that is, the maximum unfolding angle of the sub-needle outer rod 502 from the guide groove 9 is 360°, that is, the unfolding angle of the sub-needle outer rod 502 can be adjusted within the range of 360°.

[0211] Therefore, compared with the existing ablation needle, the sub-needle of the radiofrequency ablation composite electrode needle of the present application has no angle limitation when unfolded, breaking through the technical difficulty that the unfolding angle of the existing ablation needle can only reach 180°, so that the radiofrequency ablation composite electrode needle of the present application can realize complete enveloping for irregularly shaped lesions, avoid the ablation blind area in clinical practice, and thus avoid the risk of missed ablation. Further, since the unfolding angle of the sub-needle of the radiofrequency ablation composite electrode needle of the present application breaks through the limitation of 180° of the traditional one and can reach 360°, a spherical or spherical-like structure can be constructed. Therefore, based on the characteristics that such a structure can more completely and accurately envelop lesions of various irregular shapes, the radiofrequency ablation composite electrode needle of the present application does not need to adopt the complex and difficult operation process of multiple needle retraction→needle withdrawal→needle unfolding→ablation in the prior art, but only needs one-time puncture and ablation operation, which not only greatly shortens the operation time and significantly improves the operation efficiency, but also greatly improves the patient's experience during the operation and reduces the risk of complications caused by multiple operations.

[0212] In order to realize that the unfolding angle of the sub-needle 5 is maximum 360°, the sub-needle 5 (the sub-needle outer rod 502) has a pre-bending angle, and the pre-bending angle of each sub-needle 5 is maximum 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 the needle rod 6. That is, before the sub-needle 5 is installed into the second inner tube 4 and the needle rod 6, it has been pre-bent by 360°, that is, bent into a circular shape, and when it is installed into the second inner tube 4 and the needle rod 6, it is stretched. Therefore, when the guide groove 9 is opened and the sub-needle 5 is unfolded from the guide groove 9, due to the memory shape characteristic of the sub-needle 5, it will return to the pre-bending state, that is, realize the unfolding angle of 360°.

[0213] Therefore, it can be understood that when the plurality of sub-needles 5 (sub-needle outer rods 502) are all unfolded at the maximum unfolding angle, a spherical or spherical-like (ellipsoidal, such as Figure 23C as shown) structure can be formed, as shown in Figure 9D Since the sub-needle outer rod 502 is unfolded from the guide groove 9 and bent outward or inward, when the unfolding angle of the sub-needle outer rod 502 is 360°, the puncture tip of the sub-needle outer rod 502 reaches the guide groove 9 or the vicinity of the guide groove 9.

[0214] It can be understood that when ablation is performed using the above-mentioned spherical-like structure, the heat damage range formed thereby is spherical or spherical-like (almost spherical), so that the lesion can be more completely enveloped and the risk of missed ablation can be avoided.

[0215] It should be noted that the unfolding angle of the sub-needle 5 refers to the central angle of the circular arc formed after the sub-needle 5 is unfolded.

[0216] The unfolding length of the sub-needle 5 (the outer rod 502 of the sub-needle) is positively correlated with the unfolding angle, as shown in the following table. Figure 9A As shown in the table, the unfolding length of the sub-needle 5 is 1 / 4 of the pre-unfolding length of the sub-needle 5, and the unfolding angle is 90°; as shown in the table, the unfolding length of the sub-needle 5 is 2 / 4 of the pre-unfolding length of the sub-needle 5, and the unfolding angle is 180°; as shown in the table, the unfolding length of the sub-needle 5 is 3 / 4 of the pre-unfolding length of the sub-needle 5, and the unfolding angle is 270°; as shown in the table, the sub-needle 5 is fully unfolded, and the unfolding angle is 360°. Figure 9B Figure 9C Figure 9D

[0217] The unfolding length of the sub-needle 5 can be indicated by the sub-needle unfolding length pointer 16.

[0218] Before the sub-needle 5 is unfolded, the width of the guide groove 9 can be adjusted to a suitable width, and during the unfolding process of the sub-needle 5, the width of the guide groove 9 can remain unchanged; or during the unfolding process of the sub-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 sub-needle 5.

[0219] As shown in the following table, the present application is a radiofrequency ablation composite electrode needle for ablation experiments on pig livers in vitro, and the ablation heat map after one-time puncture and ablation is shown. As can be seen, the ablation heat map is spherical or ellipsoidal, so it can completely envelope the lesion, avoid the risk of incomplete ablation, and achieve better ablation effect, and the ablation can be completed in one operation. Figure 19A However, the bending angle of the sub-needle in the existing ablation needle is limited and cannot be adjusted arbitrarily within 360°, resulting in an irregular ablation area shape that tends to be droplet-shaped. As shown in the following table, the ablation heat map of the existing ablation needle is triangular or droplet-shaped, and there is a phenomenon of incomplete envelope of the lesion, which may pose a risk of incomplete ablation. In order to avoid the problem of incomplete ablation, the conventional clinical measure is the needle withdrawal ablation method, that is, the needle is withdrawn after ablation; the needle is pulled out to a certain depth and then unfolded again for ablation, and if it is found that the lesion is not completely covered after CT scanning, the needle needs to be withdrawn, unfolded and ablated again or even more times, which is a long operation time and poor patient experience during the operation. Therefore, the above operation of the existing ablation needle is performed by multiple punctures and ablations, and multiple triangular or droplet-shaped shapes are used in the axial direction to form an ablation heat damage range that is approximately spherical or ellipsoidal.

[0220] Figure 19B

[0221] ​​​​​Therefore, it is known that the ablation range size is controllable by controlling the width of the guide groove 9 (i.e. the opening size of the guide groove 9) and the angle of the outward turning of the outer rod 502 of the sub-needle 5 and the unfolding length of the sub-needle 5. By combining the exposure length of the needle head 1 and / or the needle rod 6, the ablation heat damage range formed by the present application is also closer to a spherical shape, thereby having a more precise ablation range and a lower normal tissue damage effect.

[0222] Specifically, the width of the guide groove 9 is related to the bending deformation direction of the sub-needle 5, and the smaller the width of the guide groove 9, the greater the clamping force that the sub-needle 5 receives when unfolding from the guide groove 9, so that the sub-needle 5 can realize bending deformation as soon as possible.

[0223] Optionally, as shown in Figure 14A 、 Figure 14B and Figure 14C , the bending direction of the sub-needle 5 after unfolding the guide groove 9 can be outward bending, i.e. bending towards the direction away from the puncture needle tip 101. Therefore, the ablation area formed after the sub-needle 5 unfolds is behind the puncture needle tip 101.

[0224] Optionally, as shown in Figure 15A 、 Figure 15B and Figure 15C , the bending direction of the sub-needle 5 after unfolding the guide groove 9 can be inward bending, i.e. bending towards the direction close to the puncture needle tip 101. Therefore, the ablation area formed after the sub-needle 5 unfolds can cover the puncture needle tip 101.

[0225] Further, when the sub-needle 5 unfolds, one way to control the diameter size of the sub-needle 5 is that the unfolding length of the sub-needle 5 when unfolded for the first time L x is reduced, and then the sub-needle 5 is continuously unfolded until the sub-needle 5 is completely unfolded. For example, the distance between the distal end of the needle rod 6 and the proximal end of the handle 102 is changed by moving the needle rod 6, so as to reduce the width of the guide groove 9.

[0226] The unfolding diameter of the sub-needle 5 when completely unfolded D y is L x satisfies the following relationship:

[0227] D y = a + b x L x ;

[0228] wherein, a 、 b are coefficients, a the value range of is 23.15-28.35;b The value range is 0.13-0.17. a 、 b These are empirical coefficients obtained from experiments.

[0229] like Figure 20 As shown, it shows the diameter of the sub-needle 5 when it is fully unfolded D y The length of the first display with needle 5 L x Graph of the curve. Figure 20 In the figure, the horizontal axis is the length of the sub-needle 5 when it is first extended (unit: mm); the vertical axis is the expanded diameter of the sub-needle 5 when it is fully extended (unit: mm). Figure 20 The blue curve in the lower middle section represents the expanded diameter when, after the needle 5 is extended for the first time, the width of the guide groove 9 is reduced to the minimum (i.e., the minimum state of the guide groove 9) and the needle 5 continues to be extended until the needle 5 is fully extended; the red curve above represents the expanded diameter when, after the needle 5 is extended for the first time, the width of the guide groove 9 is reduced by 1 / 2 (i.e., the semi-closed state of the guide groove 9) and the needle 5 continues to be extended until the needle 5 is fully extended.

[0230] It should be noted that the minimum state of the guide groove 9 corresponds to a state where both ends of the guide groove 9 completely clamp the sub-needle 5 .

[0231] according to Figure 20 It can be seen that when the guide groove 9 is in the semi-closed state, the sub-needle 5 continues to be extended until it is fully extended, and the obtained extended diameter is larger.

[0232] like Figure 21A As shown, it shows the length of the sub-needle 5 when it is first displayed. L x After the width of the guide groove 9 is reduced to 5mm, the guide groove 9 is reduced to the minimum (the minimum state of the guide groove 9), and the needle 5 is continued to be extended until the needle 5 is fully extended; Figure 21B As shown, it shows the length of the sub-needle 5 when it is first displayed. L x After the width of the guide groove 9 is reduced to 5mm, the width of the guide groove 9 is reduced to 1 / 2 of the total width of the guide groove 9 (the guide groove 9 is in a semi-closed state), and the needle 5 is continued to be extended until the needle 5 is fully extended. Figure 21A and Figure 21B It can be seen that when the guide groove 9 is adjusted to the minimum state, the sub-needle 5 continues to be extended to obtain a smaller extended diameter, but the shape of the sub-needle 5 is fuller and the sub-needle 5 is more densely enclosed.

[0233] like Figure 22A As shown, it shows the length of the sub-needle 5 when it is first displayed. L xWhen the opening size of the guide groove 9 is reduced to the minimum (the minimum state of the guide groove 9) after 35mm, the sub-needle 5 is continuously extended until the state when the sub-needle 5 is fully extended; as shown in FIG. 8, the extension length of the first extension of the sub-needle 5 is shown. Figure 22B L x When the opening size of the guide groove 9 is reduced by 1 / 2 (the half-closed state of the guide groove 9) after 35mm, the sub-needle 5 is continuously extended until the state when the sub-needle 5 is fully extended. According to the above and Figure 22A Figure 22B L x After that, the guide groove 9 is also adjusted to the minimum state, and the sub-needle 5 is continuously extended to obtain a smaller extension diameter, but the shape of the sub-needle 5 is more full, and the sub-needle 5 is more densely enveloped.

[0234] It can be understood that if the sub-needle 5 (the sub-needle outer rod 502) is not extended, but only the exposure length of the needle head 1 and / or the needle rod 6 is adjusted, the effect of adjustable single-needle ablation range can be achieved. If the sub-needle 5 (the sub-needle outer rod 502) is also extended, by combining different exposure lengths of the needle head 1 and / or the needle rod 6 with different extension lengths (angles) of the sub-needle outer rod 502, a double-morphology structure can be achieved.

[0235] Therefore, the radiofrequency ablation composite electrode needle of the present application 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 independently adjust the parameters of the sub-needle, such as the extension length and the extension angle of the sub-needle. The third adjustment mode is to jointly adjust the working length of the main needle and the parameters of the sub-needle.

[0236] When the radiofrequency ablation composite electrode needle is in the first adjustment mode, the straight-needle working-end adjustment switch 11 is operable, and therefore the adjustable insulating tube 8 can move relative to the needle rod 6, so that the length of the part of the needle head 1 and the needle rod 6 that is not covered by the adjustable insulating tube 8 is adjustable, i.e., the working length of the main needle is adjustable.

[0237] 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 that the extension length and the extension angle of the sub-needle are adjustable, i.e., the parameters of the sub-needle are adjustable.

[0238] When the radiofrequency ablation composite electrode needle is in the third adjustment mode, the straight-needle working-end adjustment switch 11 and the sub-needle extension switch 15 and the guide groove adjustment switch 13 are cooperatively operable, so that the working length of the main needle is adjustable and the parameters of the sub-needle are adjustable. Therefore, the working section of the main needle and the extended part of the sub-needle cooperatively perform ablation, i.e., the effect of accurately constructing a personalized combined thermal damage range according to the morphological characteristics of a tumor can be achieved.

[0239] ​​​Therefore, whether it is a tumor with regular shape or a complex and changeable heteromorphic 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.

[0240] The working length of the main needle and the expanded portion of the sub-needles together form a combined thermal damage range. This allows switching ablation patterns based on treatment needs to achieve any combination of ablation thermal damage ranges. This facilitates regulation of the ablation thermal damage range and enables precise three-dimensional shape control. This dual-pattern structure accommodates ablation treatment of tumors of varying shapes, sizes, and dimensions, providing greater clinical flexibility.

[0241] For example, the adjustable insulating tube 8 is constructed to be able to move relative to the needle rod 6 according to the exposed length and exposed diameter of each sub-needle 5, thereby adjusting the exposed length of the needle head 1 and / or the needle rod 6 (the working length of the main needle). Figure 23A A schematic diagram of ablation lesions is shown when the width of the guide slot 9 is adjusted to 15 mm, the extended length of the sub-needle 5 is adjusted to 1 / 2 of the pre-extended length of the sub-needle 5, and the exposed length of the needle shaft 6 is adjusted to L1. At this point, the thermal lesion formed by the sub-needles 5 and the main needle is egg-shaped. Figure 23B The diagram shows a schematic diagram of an ablation lesion when the width of the guide groove 9 is adjusted to 10 mm, the extended length of the needle 5 is adjusted to 3 / 4 of the pre-extended length of the needle 5, and the exposed length of the needle shaft 6 is adjusted to L2 (L2 is less than L1). In this case, the thermal damage range formed by each needle 5 is an irregular ellipsoid. Figure 23C The diagram shows a schematic diagram of the ablation lesion when the width of the guide groove 9 is adjusted to 5 mm, the extended length of the sub-needle 5 is adjusted to be fully extended, and the exposed length of the needle rod 6 is adjusted to L3 (L3 is less than L2). At this time, the thermal damage range formed by each sub-needle 5 is a relatively regular ellipsoid, and is very close to a sphere.

[0242] like Figure 23A As shown, the length of the needle 5 is 1 / 2 of the pre-exhibited length of the needle 5, the exposure angle is between 180°-270°, and the exposed length of the needle rod 6 is L1; Figure 23B As shown, in Figure 23A On the basis of the pre-extension length of the needle 5, the extension length is increased to 3 / 4 of the pre-extension length, and the extension angle is also increased accordingly, between 270° and 360°. At this time, the exposed length of the needle rod 6 can be reduced accordingly, for example, from L1 to L2 (L2 is less than L1); Figure 23C As shown, in Figure 23BOn the basis of the above, the length of the sub-needle 5 is further increased to full deployment, and the deployment angle is also correspondingly increased to the maximum bending angle, i.e. 360°, at which time the exposed length of the needle shaft 6 can be correspondingly further reduced, for example from L2 to L3 (L3 is less than L2).

[0243] In the above scheme of adjusting the deployment length, deployment angle of the sub-needle 5 and the exposed length of the needle shaft 6, the two ends of the sub-needle 5 are respectively located on (or can be considered to be in contact with) the two sides of the exposed area of the needle shaft 6, i.e. Figure 23C In the state shown, the thermal damage range of this state is a relatively regular ellipsoidal shape, and the thermal ablation range is more comprehensive and effective.

[0244] Please continue to refer to Figure 1A and Figure 1B The handle assembly 10 includes a handle shell 25 for supporting various components within the handle assembly 10 and for clinical operation gripping functions. The handle shell 25 is provided 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 described above.

[0245] The straight needle working end adjustment switch 11 and the adjustable insulating tube 8 are connected at the radially extending end of the handle assembly 10. The straight needle working end adjustment switch 11 is used to move the insulating tube 8 to adjust the exposed length of the needle head 1 and / or the needle shaft 6, and the length value is displayed through the straight needle working end length pointer 12.

[0246] The straight needle working end adjustment switch 11 can adopt a push structure, a knob structure or a dial structure. By pushing, rotating or dialing the driving structure, the adjustable insulating tube 8 can be axially moved relative to the needle head 1 and the needle shaft 6. More specifically, the straight needle working end adjustment switch 11 can be one or a combination of gear and rack structure, worm and gear structure or ball screw structure.

[0247] The straight needle working end length pointer 12 can be a separate pointer indicating structure or an indicating structure integrated with the straight needle working end adjustment switch 11.

[0248] The guide groove adjustment switch 13, the first liquid cavity 21 and the needle shaft 6 are connected at the radially extending end of the handle assembly 10. The guide groove adjustment switch 13 can axially move the needle shaft 6 relative to the needle handle 102 to adjust the size of the opening of the guide groove 9. One side or both sides of the guide groove adjustment switch 13 is provided with a corresponding guide groove adjustment length pointer 14 to display the size of the opening of the guide groove 9.

[0249] The guide slot adjusting switch 13 can be in a push structure, a knob structure or a dial structure. By pushing, rotating or dialing the driving structure, the needle rod 6 can be axially moved relative to the needle head 1. More specifically, the guide slot adjusting switch 13 can be one or a combination of a rack and pinion structure, a worm gear structure or a ball screw structure.

[0250] The straight needle working end length pointer 12 can be a separate pointer indicating structure.

[0251] The sub-needle extension switch 15, the second liquid cavity 22 and the sub-needle 5 are connected at the radially extended end of the handle assembly 10. The sub-needle extension switch 15 is used to control the length and angle of the sub-needle outer rod 502 of the sub-needle 5 extending out, and the length and angle of the sub-needle 5 extending out are indicated by the sub-needle extension length pointer 16.

[0252] The sub-needle extension switch 15 can be in a push structure, a knob structure or a dial structure. By pushing, rotating or dialing the driving structure, the sub-needle 5 can be axially moved relative to the needle head 1. More specifically, the sub-needle extension switch 15 can be one or a combination of a rack and pinion structure, a worm gear structure or a ball screw structure.

[0253] The sub-needle extension length pointer 16 can be a separate pointer indicating structure, or a combined indicating structure with the sub-needle extension switch 15.

[0254] Further, the sub-needle extension switch 15 and the guide slot adjusting switch 13 are connected through a linkage mechanism, which enables the sub-needle extension switch 15 to operate the sub-needle to extend out while the guide slot adjusting switch 13 simultaneously operates to open the guide slot 9, and enables the sub-needle extension switch 15 to operate the sub-needle to retract while the guide slot adjusting switch 13 simultaneously operates to close the guide slot 9.

[0255] In a specific embodiment, as shown in Figure 24 , Figure 25 , Figure 27A , Figure 27B and Figure 27C , the linkage mechanism is configured as a combination of a rack and pinion and a cam. Specifically, the linkage mechanism includes the guide slot adjusting switch 13 configured as a cam mechanism and the sub-needle extension switch 15 configured as a rack and pinion mechanism, which are linked to each other.

[0256] Specifically, as shown in Figure 24 , the sub-needle extension switch 15 includes a rack 151, a pinion 152 engaged with the rack 151, and a knob 153 connected to the pinion 152, wherein the knob 153 is located outside the handle shell 25 (please refer to Figure 1A ). By rotating the knob 153, the pinion 152 can be driven to rotate, thereby causing the rack 151 to move relative to the pinion 152.

[0257] As shown in Figure 25 , the rack 151 is configured as an L-shaped structure, which includes a vertical segment 1513 and a horizontal segment 1514 perpendicular to the vertical segment 1513. The lower end of the horizontal segment 1514 is provided with a tooth, which is engaged with the gear 152.

[0258] The vertical segment 1513 is provided with a sub-needle connecting groove 1511, and the sub-needle 5 is fixedly arranged in the sub-needle connecting groove 1511, so that the rack 151 can drive the sub-needle 5 to move when the rack 151 moves, thereby causing the sub-needle 5 to be deployed or retracted.

[0259] Further, the horizontal segment 1514 is provided with an arc-shaped recess 1512 at the end of the upper surface away from the vertical segment 1513, which is used to cooperate with the cam mechanism.

[0260] Specifically, as shown in Figure 24 , the guide slot adjusting switch 13 includes a cam 131, which is rotatably arranged in the handle shell 25 (please refer to Figure 1A ) through a cam shaft 1311.

[0261] As shown in Figure 26 , the cam 131 includes a cam tip 1312, an arc-shaped portion 1314 coaxially arranged with the cam shaft 1311, and a flat portion 1313 connected with the cam tip 1312 and the arc-shaped portion 1314 respectively. The cam tip 1312 is eccentrically arranged with the cam shaft 1311. The arc-shaped recess 1512 on the rack 151 is in line with the cam tip 1312 of the cam 131, so when the cam tip 1312 of the cam 131 is located in the arc-shaped recess 1512 and in contact with the inner wall of the arc-shaped recess 1512 (as shown in Figure 27A ), if the rack 151 moves (for example, the rack 151 moves to the right as shown in Figure 27A ), the rack 151 will cause the cam 131 to rotate (for example, the cam 131 rotates counterclockwise).

[0262] Further, the guide slot adjusting switch 13 further includes a top rod 132, which is located on one side of the cam tip 1312 of the cam 131, as shown in Figure 25 , when the cam tip 1312 of the cam 131 is located in the arc-shaped recess 1512 and in contact with the inner wall of the arc-shaped recess 1512, that is, the cam 131 is in a vertical state, the flat portion 1313 of the cam 131 is in contact with the end of the top rod 132 (as shown in Figure 27A ).

[0263] As shown in Figure 24 , the top rod 132 extends into the first guide sleeve 134 and is fixedly connected with the first guide sleeve 134, and the first guide sleeve 134 is arranged in the handle shell 25.

[0264] Further, the guide slot adjusting switch 13 further comprises a first connecting sleeve 135 and a spring 133. The first connecting sleeve 135 is sleeved on the top rod 132 and fixedly connected with the boss 1321 on the top rod 132. The spring 133 is sleeved on the top rod 132 and 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 top rod 132 is moved by a pushing force, the top 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 top rod 132 is removed, the spring 133 will exert a force on the first connecting sleeve 135 in the opposite direction of the above-mentioned pushing force under the action of its restoring force, so as to make the first connecting sleeve 135 and the top rod 132 move in the opposite direction, i.e. to recover to the initial state.

[0265] As shown in Figure 24 and Figure 25 , the first connecting sleeve 135 is configured as a star-shaped connecting sleeve, which comprises a first central connecting cylinder 1353 and a plurality of connecting claws radially diverging 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 with the boss 1321 on the top rod 132. A first connecting claw 1351 in the plurality of connecting claws is fixedly connected with the connecting rod 136, and a second connecting claw 1352 in the plurality of connecting claws is used for the second inner tube 4 (and the sub-needle 5 inside it) to pass through.

[0266] The connecting rod 136 is a rod-shaped member extending parallel to the second inner tube 4, which extends to be fixedly connected with a second connecting sleeve 137 in the handle shell 25. Among them, the second connecting sleeve 137 is oppositely arranged with the first connecting sleeve 135, and the second connecting sleeve 137 is closer to the proximal end of the handle shell 25 (i.e. the lower end shown in Figure 1A ).

[0267] As shown in Figure 24 , the second connecting sleeve 137 can adopt the same structure as the first connecting sleeve 135. That is, the second connecting sleeve 137 is also configured as a star-shaped connecting sleeve, which comprises a second central connecting cylinder 1373 and a plurality of connecting claws radially diverging along the circumference of the second central connecting cylinder 1373. Among them, a third connecting claw 1371 in the plurality of connecting claws of the second connecting sleeve 137 is fixedly connected with the other end of the connecting rod 136, and a fourth connecting claw 1372 in the plurality of connecting claws of the second connecting sleeve 137 is fixedly connected with the proximal end of the second inner tube 4.

[0268] As shown in Figure 24As shown, the first connecting sleeve 135 and the second connecting sleeve 137 are arranged opposite each other, and are respectively located on either side of the sub-needle connecting groove 1511 of the rack 151. The connecting rod 136 extends between the first connecting claw 1351 and the third connecting claw 1371, and the two ends of the connecting rod 136 are fixedly connected to the first connecting claw 1351 and the third connecting claw 1371, respectively. The second inner tube 4 and the sub-needle 5 pass through the second connecting claw 1352 together, and the sub-needle 5 is fixedly connected to the sub-needle connecting groove 1511. The second inner tube 4 continues to extend beyond the sub-needle connecting groove 1511 until it extends to be fixedly connected to the fourth connecting claw 1372. The second connecting sleeve 137 is fixedly connected to the second guide sleeve 138, which is movably arranged in the handle housing 25. Therefore, when the second connecting sleeve 137 moves, the second guide sleeve 138 can guide the movement of the second connecting sleeve 137.

[0269] As described above, when the push rod 132 is moved by the thrust, 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.

[0270] Specifically, if Figure 27A As shown, at this time, the guide groove 9 is closed and the sub-needle 5 is in the unstretched state. At this time, the cam tip 1312 of the cam 131 cooperates with the arc-shaped recess 1512 on the rack 151, the cam 131 is in a vertical state, and the flat portion 1313 of the cam 131 contacts the push rod 132.

[0271] When the knob 153 is rotated, the rack 151 and the gear 152 move relative to each other, for example, the rack 151 moves to the right ( Figure 27A As shown); the movement of the rack 151 causes the cam 131 to rotate counterclockwise, as shown Figure 27B As shown. After the cam 131 rotates counterclockwise to a horizontal state, its cam tip 1312 contacts the push rod 132. Since the distance between the cam tip 1312 and the cam shaft 1311 is greater than the distance between the flat portion 1313 and the cam shaft 1311, the distance between the cam 131 and the push rod 132 becomes smaller due to the rotation of the cam 131, so the cam 131 will push the push rod 132 to move in a direction away from the cam 131, and the movement of the push rod 132 will prompt the first connecting sleeve 135 to move, and the movement of the first connecting sleeve 135 will drive the connecting rod 136, and then drive the second connecting sleeve 137, and finally drive the second inner tube 4 to move; as mentioned above, the second inner tube 4 is connected to the needle handle 102, so the second inner tube 4 will move together with the needle handle 102, and the needle bar 6 is fixed to the needle bar fixing seat 61 (as shown in the figure) in the handle shell 25. Figure 24 As shown in the figure, the needle handle 102 will move relative to the needle rod 6, so that the guide groove 9 can be opened, thereby realizing the simultaneous opening of the guide groove 9 while exhibiting the sub-needle 5.

[0272] It can be appreciated that the moving direction of the sub-needle 5 is the same as the moving direction of the second inner tube 4 and the handle 102. That is, in this embodiment, the opening of the guide slot 9 is achieved by the movement of the handle 102 relative to the needle bar 6.

[0273] Further, after the cam 131 rotates counterclockwise to the horizontal state, it passes the arc-shaped recess 1512 on the rack 151, and the flat part 1313 of the cam 131 is in contact with the upper end surface of the horizontal segment 1514 of the rack 151, as shown in Figure 25 and Figure 27B .

[0274] When the guide slot 9 is opened, the knob 153 can be continuously rotated, so that the rack 151 is continuously moved, as shown in Figure 27B and Figure 27C , during the continuous movement of the rack 151, the cam 131 moves on the upper end surface of the rack 151 in its horizontal state. When the cam 131 moves to the position where it is in contact with the vertical segment 1513 of the rack 151, it stops moving.

[0275] Further, as mentioned above, the movement of the top rod 132 will cause the first connecting sleeve 135 to move, and the movement of the first connecting sleeve 135 will compress the spring 133. Therefore, when the guide slot 9 is opened, the spring 133 is in a compressed state. Therefore, when the sub-needle 5 is retracted, the rack 151 is rotated in the reverse direction (clockwise), and when the rack 151 moves to the position where the cam tip 1312 is again matched with the arc-shaped recess 1512, the cam 131 rotates back to the vertical state again, and the spring 133 has a restoring tendency, so that under the action of the restoring force of the spring 133, the first connecting sleeve 135 moves in the direction close to the cam 131, so that the first connecting sleeve 135 drives the connecting rod 136, and then drives the second connecting sleeve 137, and finally drives the second inner tube 4 to move in the reverse direction, so that the guide slot 9 can be closed, thereby achieving the retraction of the sub-needle 5 while closing the guide slot 9.

[0276] As shown in Figure 1AAs shown, the first inner tube lumen connecting cavity 2301 of the third liquid cavity 23 is in fluid communication with the first liquid tube 17, and the second inner tube lumen connecting cavity 2302 of the third liquid cavity 23 is in fluid communication with the second liquid tube 18. Thus, a liquid circulation channel is formed between the first liquid tube 17, the first inner tube lumen connecting cavity 2301, the first inner tube 3 (the first inner tube lumen 302), the needle lumen 103, the second inner tube 4 (the second inner tube lumen 402), the second inner tube lumen connecting cavity 2302, and the second liquid tube 18. That is, liquid can enter from the first liquid tube 17, flow into the needle lumen 103 through the first inner tube lumen connecting cavity 2301 and the first inner tube 3 (the first inner tube lumen 302), and flow out from the second liquid tube 18; or enter from the second liquid tube 18 and flow out from the first liquid tube 17.

[0277] As shown in FIG. 1, the first liquid tube 17 is connected to the first inner tube lumen connecting cavity 2301 of the third liquid cavity 23. Figure 1A As shown, the first liquid tube 17 includes a first liquid tube body 1701 and a first liquid tube joint 1702. One end of the first liquid tube body 1701 is connected to the first inner tube lumen connecting cavity 2301, which can restrict the injection liquid from entering or flowing out of the first inner tube lumen 302 of the first inner tube 3. The other end of the first liquid tube body 1701 is connected to the first liquid tube joint 1702, which can be connected to an external injection liquid component.

[0278] As shown in FIG. 1, the second liquid tube 18 is connected to the second inner tube lumen connecting cavity 2302 of the third liquid cavity 23. Figure 1A As shown, the second liquid tube 18 includes a second liquid tube body 1801 and a second liquid tube joint 1802. One end of the second liquid tube body 1801 is connected to the second inner tube lumen connecting cavity 2302, which can restrict the injection liquid from entering or flowing out of the injection liquid channel formed between the first inner tube outer rod 301 of the first inner tube 3 and the second inner tube lumen 402 of the second inner tube 4. The other end of the second liquid tube body 1801 is connected to the second liquid tube joint 1802, which is used to connect to an external injection liquid component.

[0279] As shown in FIG. 1, the third liquid tube 19 is connected to the first liquid cavity 21. Figure 1A As shown, the third liquid tube 19 is connected to the first liquid cavity 21, and the first liquid cavity 21 forms an injection channel with the needle rod 6 and the sub-needle outer cavity 503. The third liquid tube 19 includes a third liquid tube body 1901 and a third liquid tube joint 1902. One end of the third liquid tube body 1901 is connected to the first liquid cavity 21, which can restrict the injection liquid from entering or flowing out of the injection liquid channel formed between the outer surface of the needle rod 6 and the outer surface of the sub-needle driving section 506 of the sub-needle 5. The other end of the third liquid tube body 1901 is connected to the third liquid tube joint 1902, which is used to connect to an external injection liquid component.

[0280] As shown in FIG. 1, the third liquid tube 19 is connected to the first liquid cavity 21. Figure 1AAs shown, the fourth liquid pipe 20 is connected with the second liquid cavity 22, and the second liquid cavity 22 is connected with the sub-needle injection liquid passage formed by the second inner pipe 4 and the sub-needle 5. The fourth liquid pipe 20 comprises a fourth liquid pipe body 2001 and a fourth liquid pipe joint 2002. One end of the fourth liquid pipe body 2001 is connected with the second liquid cavity 22, and can constrain the injection liquid to enter or flow out of the injection liquid passage formed between the inner surface of the sub-needle driving section 506 of the sub-needle 5 and the second inner pipe outer rod 401 of the second inner pipe 4. The other end of the fourth liquid pipe body 2001 is connected with the fourth liquid pipe joint 2002, and the fourth liquid pipe body 2001 is used for connecting with an external injection liquid component.

[0281] The first liquid pipe body 1701, the second liquid pipe body 1801, the third liquid pipe body 1901 and the fourth liquid pipe body 2001 can be made of plastic, such as PVC, TPU, PTFE, PEEK, PI and the like.

[0282] The first liquid cavity 21, the second liquid cavity 22 and the third liquid cavity 23 can be made of metal or plastic. They can be formed in the handle shell 25 by machining, mold injection molding or mold die casting and the like.

[0283] As shown, Figure 1A The electrical wire 24 comprises an electrical wire composite cable 2402 and an electrical wire joint 2401. The electrical wire composite cable 2402 extends into the handle shell 25 and is connected with one or more of the temperature sensor 2, the sub-needle temperature sensor 504, the first inner pipe 3, the second inner pipe 4 and the sub-needle 5, for transmitting radio frequency energy, transmitting temperature signals, transmitting and indicating switch light signals and the like. The electrical wire joint 2401 is connected with the end of the electrical wire composite cable 2402, for connecting with an ablation system.

[0284] The application further provides an ablation system, comprising the radio frequency ablation composite electrode needle and an ablation host machine as described above. The electrical wire 24 is connected with the radio frequency ablation composite electrode needle and the ablation host machine respectively, so as to realize the transmission of radio frequency energy, the transmission of temperature signals, the transmission and indication of switch light signals and the like.

[0285] Although the application has been described with reference to the preferred embodiments thereof, various changes in form and details can be made therein without departing from the scope of the application. In particular, the technical features mentioned in each of the embodiments can be combined in any manner as long as there is no structural conflict. The application 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, The main needle, a plurality of sub-needles (5), and a handle assembly (10) for adjusting the main needle and the sub-needles (5), the main needle comprising a needle head assembly and a needle shaft assembly, the needle shaft assembly comprising a first inner tube (3), a second inner tube (4), and a needle shaft (6) coaxially arranged from inside to outside, the distal end of the second inner tube (4) is fixedly connected to the proximal end of the needle head assembly, the distal end of the needle shaft (6) and the proximal end of the needle head assembly form a guide slot (9), the needle shaft (6) and the needle head assembly can move relatively to adjust the width of the guide slot (9); each of the sub-needles (5) is arranged between the second inner tube (4) and the needle shaft (6), and each of the sub-needles (5) can be unfolded from the guide slot (9) when the guide slot (9) is opened; wherein the unfolding length and the unfolding diameter of each of the sub-needles (5) are adjustable, each of the sub-needles (5) has a pre-bending angle, and the pre-bending angle of each of the sub-needles (5) is at most 360°, so that the maximum unfolding angle of each of the sub-needles (5) unfolded from the guide slot (9) is 360°; each of the sub-needles (5) has a memory shape characteristic, each of the sub-needles (5) is pre-bent into a circular shape before installation, and each of the sub-needles (5) can recover to the pre-bent state when unfolded from the guide slot (9); The first time each of the sub-needles (5) is deployed has a deployment length L x Afterwards, the width of the guide slot (9) is reduced and the deployment of each of the sub-needles (5) is continued until each of the sub-needles (5) is fully deployed. the diameter of the deployment of each of said sub-needles (5) when fully deployed D y the length of the first deployment of each of said sub-needles (5) L x satisfies the following relation: D y = a + b x L x ； wherein, a , b are coefficients, a has a value range of 23.15-28.35; b has a value range of 0.13-0.

17.

2. The radiofrequency ablation composite electrode needle of claim 1, wherein, each of the sub-needles (5) comprises a sub-needle outer shaft (502), the sub-needle outer shaft (502) is a one-piece structure or a two-segment structure, the two-segment structure comprises: a sub-needle front segment (505) for unfolding from the guide slot (9); and a sub-needle driving segment (506) connected to the sub-needle front segment (505), which extends between the second inner tube (4) and the needle shaft (6) and is connected to the handle assembly (10); wherein the diameter of the sub-needle driving segment (506) is less than or equal to the diameter of the sub-needle front segment (505).

3. The radiofrequency ablation composite electrode needle of claim 2, wherein, the length of the sub-needle front segment (505) is 10mm-120mm; or the unfolding length of the sub-needle outer shaft (502) is 0mm-100mm.

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

5. The radiofrequency ablation composite electrode needle of any one of claims 1-3, wherein, The width of the guide slot (9) affects the bending deformation direction of each of the sub-needles (5), the smaller the width of the guide slot (9), the greater the clamping force each of the sub-needles (5) receives when unfolded, so that each of the sub-needles (5) can be bent and deformed earlier.

6. The radiofrequency ablation composite electrode needle of any one of claims 1-3, wherein, The needle shaft assembly further comprises an adjustable insulating tube (8) located outside the needle shaft (6), the adjustable insulating tube (8) is configured to move relative to the needle shaft (6) according to the unfolding length and the unfolding diameter of each of the sub-needles (5), thereby adjusting the exposed length of the needle shaft (6) and / or the exposed length of the needle head (1) on the needle shaft (6).

7. The radiofrequency ablation composite electrode needle of any one of claims 1-3, wherein, The needle head assembly comprises a needle head (1), the needle head (1) comprises: a needle handle (102); a puncture needle tip (101) located at the distal end of the needle handle (102); A needle inner cavity (103) is arranged inside the needle handle (102) and the puncture needle tip (101), and the first inner tube (3) and the second inner tube (4) are respectively in fluid communication with the needle inner cavity (103); and A needle injection and suction channel (105) is arranged on the needle handle (102) and / or the puncture needle tip (101) and is in fluid communication with the needle inner cavity (103); The diameter of the needle injection and suction channel (105) is configured to enable the medium circulating cooling and the liquid injection to be simultaneously achieved.

8. The radiofrequency ablation composite electrode needle of any one of claims 1-3, wherein, The injection and suction channel is configured as the guide groove (9), or the injection and suction channel is configured as a needle rod injection and suction channel (601) arranged on the needle rod (6), and the needle rod injection and suction channel (601) is in fluid communication with the space between the second inner tube (4) and the needle rod (6).

9. The radiofrequency ablation composite electrode needle of any one of claims 1-3, wherein, A linkage mechanism is arranged in the handle assembly (10), and the linkage mechanism includes a sub-needle unfolding switch (15) connected with each sub-needle (5) and a guide groove adjusting switch (13) connected with the needle rod (6), and the sub-needle unfolding switch (15) and the guide groove adjusting switch (13) are interlinked.

10. An ablation system, characterized by, The radiofrequency ablation composite electrode needle according to any one of claims 1-9, and an ablation host connected with the radiofrequency ablation composite electrode needle through an electrical wire.

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