Ablation electrode needle

Abstract

The present application relates to a kind of ablation electrode needle, it is related to the field of ablation technology.The ablation electrode needle of the present application, including first adjustable electrode component and second adjustable electrode component, the first adjustable electrode component includes first electrode and first insulating layer, the second adjustable electrode component includes second electrode and second insulating layer, the first insulating layer is located between the first electrode and the second electrode and coaxially with both settings, the second insulating layer is coaxially arranged on the outside of the second electrode;The first insulating layer and the second electrode are configured to be relatively movable, so that the first electrode and the second electrode can be used as the same electrode, or so that the first electrode and the second electrode are used as different electrodes respectively;Wherein, the working area of the first electrode and / or the working area of the second electrode is provided with energy guide structure.

Description

Technical Field

[0001] This invention relates to the field of ablation technology, and in particular to an ablation electrode needle. Background Technology

[0002] The pulsed / radiofrequency ablation electrode needle is inserted percutaneously or through an endoscopic channel under the guidance of imaging equipment into the lesion tissue requiring treatment. The energy source of the pulsed / radiofrequency device emits pulsed / radiofrequency energy signals of a certain frequency, which are transmitted to the ablation electrode needle to form a high-voltage / high-frequency electric field for treatment.

[0003] When generating a high-voltage / high-frequency electric field, the electrode needle can be used by pairing two electrodes at the tip (i.e., dual electrode needle) or by pairing a single electrode at the tip (i.e., single electrode needle) with the electrodes on the patient's body. However, existing electrode needles are all individually constructed and cannot switch between dual electrode needles and single electrode needles, thus limiting their flexibility. In addition, existing electrode needles have microscopic defects on their surface, which may cause uneven distribution of the pulsed electric field / radio frequency current on the electrode surface, leading to the risk of local hot spots. Summary of the Invention

[0004] The present invention provides an ablation electrode needle to solve at least one of the above-mentioned technical problems.

[0005] The ablation electrode needle of the present invention includes a first adjustable electrode assembly and a second adjustable electrode assembly. The first adjustable electrode assembly includes a first electrode and a first insulating layer. The second adjustable electrode assembly includes a second electrode and a second insulating layer. The first insulating layer is located between the first electrode and the second electrode and is coaxially disposed therewith. The second insulating layer is coaxially disposed outside the second electrode.

[0006] The first insulating layer and the second electrode are configured to be movable relative to each other, so that the first electrode and the second electrode can be used together as the same electrode, or the first electrode and the second electrode can be used as different electrodes respectively;

[0007] The working area of ​​the first electrode and / or the working area of ​​the second electrode are provided with an energy guiding structure, which is used to guide the pulse or radio frequency energy applied to each electrode.

[0008] In one embodiment, the energy guiding structure includes a groove structure located on the working area of ​​the first electrode and / or the working area of ​​the second electrode.

[0009] In one embodiment, the groove structure is an etching groove formed on the outer surface of the working area of ​​the first electrode and / or the outer surface of the working area of ​​the second electrode. The etching groove is configured to increase the surface area of ​​the first electrode and / or the surface area of ​​the second electrode so that the pulse electric field or radio frequency current is uniformly distributed on the surface of each electrode.

[0010] In one embodiment, the etching groove increases the surface area of ​​the first electrode by 20%-220% compared to its surface area before the etching groove was applied; and / or

[0011] The etching groove increases the surface area of ​​the second electrode by 20%-220% compared to its surface area before the etching groove was installed.

[0012] In one embodiment, the etching trench is constructed as one or more of the following:

[0013] An annular groove extending circumferentially along the first electrode or the second electrode;

[0014] A strip-shaped groove extending axially along the first electrode or the second electrode; and

[0015] A spiral groove extending spirally along the axial direction of the first electrode or the second electrode.

[0016] In one embodiment, when the first electrode and the first insulating layer are integrated, and the distance L2 between the far end of the second electrode and the far end of the first insulating layer is a first preset distance when they move relative to each other, the first electrode and the second electrode can be used together as the same electrode; or when the distance L2 between the far end of the second electrode and the far end of the first insulating layer is a second preset distance when they move relative to each other, the first electrode and the second electrode can be used as different electrodes.

[0017] In one embodiment, the first adjustable electrode assembly includes a first adjustment member connected to the proximal side of the first electrode or the proximal side of the first insulating layer, the first insulating layer being connected to the first electrode. The first adjustment member is configured to move the first insulating layer and the first electrode relative to the second electrode by a push-pull force or a rotational driving force; and / or

[0018] The second adjustable electrode assembly includes a second adjusting member located at the distal end of the first adjusting member. The first electrode and the first insulating layer pass through the second adjusting member. The second adjusting member is connected to the proximal end of the second electrode or the proximal end of the second insulating layer. The second adjusting member is configured to move the second insulating layer relative to the second electrode by a pushing or pulling force or by a rotational driving force to adjust the distance L3 between the distal end of the second electrode and the distal end of the second insulating layer.

[0019] In one embodiment, a handle is also included, wherein a movable locking part is provided on the handle;

[0020] When the second adjustable electrode assembly includes a second adjusting member, the second adjusting member includes:

[0021] A slider that is connected to the proximal side of the second electrode or the proximal side of the second insulating layer;

[0022] A positioning element is elastically connected to the slider, such that the positioning element can retract into the slider to unlock the movable locking part, or extend from the slider to lock the movable locking part;

[0023] A push button, located above the positioning member, moves to retract the positioning member into the slider to unlock it from the moving locking part.

[0024] In one embodiment, the movable locking part is configured as a locking groove on the outer surface of the handle or a rack on the inner surface of the handle;

[0025] When the movable locking part is constructed as a locking groove on the outer surface of the handle, the push button is provided with a pushing groove, and the upper end of the positioning member is movably located in the pushing groove. When the positioning member extends out of the slider, the positioning member engages in the locking groove to lock with it. The side walls on the pushing groove located on both sides of the positioning member are inclined relative to the positioning member. When the push button moves, the side walls cause the positioning member to retract into the slider to unlock with the movable locking part.

[0026] When the movable locking part is constructed as a rack on the inner surface of the handle, the push button is connected to the positioning member, and the positioning member has locking teeth. When the positioning member extends out of the slider, the locking teeth can engage with the rack to lock it. When the push button presses the positioning member back into the slider, the locking teeth separate from the rack, thereby unlocking the positioning member from the rack.

[0027] In one embodiment, when the second adjustable electrode assembly includes a second adjusting member, an insulating portion is provided on the portion of the second electrode located near the proximal end of the second adjusting member, and the outer diameter of the insulating portion is smaller than the inner diameter of the second insulating layer.

[0028] In one embodiment, the first insulating layer is sleeved on the outside of the first electrode layer, and the first insulating layer and the first electrode layer are movable relative to each other to adjust the distance L1 between the proximal end of the first insulating layer and the proximal end of the first electrode layer.

[0029] In one embodiment, a position sensor is also included, located outside or inside the handle of the ablation electrode needle, the position sensor calibrating the distance between the distal end of the handle and the target area using an absolute position calibration method or a relative position calibration method.

[0030] Compared with the prior art, the present invention has the following technical effects:

[0031] (1) On the one hand, the ablation electrode needle of the present invention has a flexible and adjustable mode: since the first insulating layer and the second electrode can move relative to each other, the first electrode and the second electrode can be used together as the same electrode, or the first electrode and the second electrode can be used as different electrodes respectively, thereby realizing the switching between single-electrode mode and dual-electrode mode. This allows for flexible adjustment of the ablation mode according to the surgical treatment plan, adapting to more clinical application scenarios. On the other hand, the ablation electrode needle of the present invention has a better and safer ablation effect: by setting an energy guiding structure in the working area of ​​the first electrode and / or the second electrode, the electrode surface area is effectively increased and the current density is reduced, making the distribution of the pulsed electric field / radio frequency current on the electrode surface more uniform. This helps to reduce the risk of bubble effect caused by excessive local heat, avoids tissue carbonization, and thus improves the safety and controllability of the ablation process.

[0032] (2) By forming etching grooves on the outer surface of the working area of ​​the first electrode and / or the outer surface of the working area of ​​the second electrode, the first electrode and / or the second electrode can obtain a large surface area with a small outer diameter, thereby reducing local current density and Joule heating, and thus reducing local hot spots and making the pulse electric field / radio frequency current uniformly distributed on the first electrode and the second electrode. Attached Figure Description

[0033] The invention will now be described in more detail with reference to embodiments and the accompanying drawings.

[0034] Figure 1 This is a front view of the ablation electrode needle in Embodiment 1 of the present invention, showing the state when the first electrode and the second electrode are used together as the same electrode;

[0035] Figure 2 This is a top view of the ablation electrode needle in Embodiment 1 of the present invention, showing the state when the first electrode and the second electrode are used together as the same electrode;

[0036] Figure 3 This is a cross-sectional view of the ablation electrode needle in Embodiment 1 of the present invention, showing the state when the first electrode and the second electrode are used together as the same electrode;

[0037] Figure 4A yes Figure 3 Enlarged view at point A;

[0038] Figure 4B yes Figure 3 Enlarged view at point II;

[0039] Figure 5 This is a front view of the ablation electrode needle in Embodiment 1 of the present invention, showing the state when the first electrode and the second electrode are used as different electrodes respectively;

[0040] Figure 6 This is a top view of the ablation electrode needle in Embodiment 1 of the present invention, showing the state when the first electrode and the second electrode are used as different electrodes;

[0041] Figure 7 yes Figure 5 Sectional view at FF;

[0042] Figure 8 yes Figure 6 Sectional view at EE;

[0043] Figure 9 yes Figure 8 Enlarged view at point I;

[0044] Figure 10A yes Figure 8 Enlarged view of the second adjusting element;

[0045] Figure 10B yes Figure 10A A magnified view of the slider;

[0046] Figure 11 yes Figure 8 Sectional view at AA;

[0047] Figure 12 yes Figure 8 Enlarged view at point B;

[0048] Figure 13 This is a top view of the ablation electrode needle in Embodiment 2 of the present invention;

[0049] Figure 14 This is a cross-sectional view of the ablation electrode needle in Embodiment 2 of the present invention;

[0050] Figure 15 yes Figure 13 Top view of the middle handle;

[0051] Figure 16 yes Figure 15 Sectional view at CC;

[0052] Figure 17 yes Figure 14 Sectional view at BB;

[0053] Figure 18 yes Figure 14 Front view of the push-pull torque;

[0054] Figure 19 yes Figure 14 Side view of the push-torque mechanism;

[0055] Figure 20 yes Figure 14 A three-dimensional structural diagram of the positioning component;

[0056] Figure 21 yes Figure 14 Side view of the center positioning component;

[0057] Figure 22 yes Figure 14 Top view of the middle slider;

[0058] Figure 23 yes Figure 22 Sectional view at DD;

[0059] Figure 24 This is a cross-sectional view of the ablation electrode needle in Embodiment 3 of the present invention;

[0060] Figure 25 yes Figure 24 Enlarged view at point H;

[0061] Figure 26 This is a cross-sectional view of the ablation electrode needle in Embodiment 4 of the present invention;

[0062] Figure 27 yes Figure 26 Enlarged view at point C;

[0063] Figure 28 yes Figure 26 Enlarged view at point F;

[0064] Figure 29 yes Figure 26 Enlarged view at point D;

[0065] Figure 30This is a schematic diagram of the structure of the first electrode in an embodiment of the present invention;

[0066] Figure 31 This is a schematic diagram of the structure of the second electrode in an embodiment of the present invention;

[0067] Figure 32 This is a schematic diagram of an embodiment of the present invention in which an energy guiding structure is provided on the first electrode or the second electrode, wherein an example of an etching groove being a strip groove is shown.

[0068] Figure 33 This is a schematic diagram of an energy guiding structure provided on the first or second electrode in an embodiment of the present invention, showing an example where the etching groove is an annular groove.

[0069] Figure 34 This is a schematic diagram of an embodiment of the present invention in which an energy guiding structure is provided on the first electrode or the second electrode, wherein an example of an etching groove being a spiral groove is shown.

[0070] Figure label:

[0071] 1. First electrode; 2. Second electrode; 3. First insulating layer; 4. Second insulating layer; 5. Position sensor; 6. Handle; 7. Second adjusting component; 8. Position indicator; 9. First adjusting component; 10. Connecting wire;

[0072] 61. Locking groove; 62. Scale layer; 63. Rack; 65. Moving groove;

[0073] 51. Transmitter; 52. Receiver;

[0074] 71. Push button; 72. Positioning component; 73. Spring; 74. Slider;

[0075] 711. Push groove; 7111. Side wall; 712. Connecting groove;

[0076] 721. Insert block; 722. Locking block; 743. Socket;

[0077] 741. Adhesive groove; 742. Slot; 761. Locking tooth;

[0078] 91. Adjusting nut; 92. Adjusting screw; 921. First limiting surface; 922. Second limiting surface;

[0079] 201. Energy guiding structure; 202. Conductive coating; 203. Etching tank;

[0080] 212. Insulation part; 213. Ablation electrode adapter; 214. Lamp board. Detailed Implementation

[0081] The invention will now be further described with reference to the accompanying drawings.

[0082] like Figures 1-34 As shown, the present invention provides an ablation electrode needle, including a first adjustable electrode assembly and a second adjustable electrode assembly, such as... Figure 1 , Figure 2 , Figure 3 and Figure 4A As shown, the first adjustable electrode assembly includes a first electrode 1 and a first insulating layer 3. The first electrode 1 and the first insulating layer 3 can be connected, for example, end-to-end (e.g., ...). Figure 4A and Figure 9 As shown, the proximal end of the first electrode 1 is connected to the proximal end of the first insulating layer 3, or they are connected in a nested manner (e.g., ...). Figure 24 and Figure 25 As shown, the first insulating layer 3 is coaxially sleeved on the outside of the first electrode 1.

[0083] The first electrode 1 is made of a metal material with certain strength, conductivity, and corrosion resistance (such as medical stainless steel 304 or 316, nickel-titanium alloy, etc.), so the first electrode 1 can be used as a radiofrequency ablation electrode. The first insulating layer 3 is an insulating tube made of a material with good insulating properties (such as PTFE, PI, PEEK, etc.), or the first insulating layer 3 can be an insulating tube coated with an insulating coating (such as PTFE, Parylene, TiO2, etc.), so it can provide insulation between the first electrode 1 and other components.

[0084] The second adjustable electrode includes a second electrode 2 and a second insulating layer 4, which is coaxially sleeved on the outside of the second electrode 2. The second electrode 2 can also be made of a metal material with sufficient strength, conductivity, and corrosion resistance (e.g., medical-grade stainless steel 304 or 316, nickel-titanium alloy, etc.), thus it can be used as a radiofrequency ablation electrode. The second insulating layer 4 can also be an insulating tube made of a material with good insulating properties (e.g., PTFE, PI, PEEK, etc.), or it can be an insulating tube coated with an insulating coating (e.g., PTFE, Parylene, TiO2, etc.), thus providing insulation between the second electrode 2 and other components.

[0085] The first insulating layer 3 is located between the first electrode 1 and the second electrode 2 and is coaxially arranged with them. The first insulating layer 3 and the second electrode 2 are configured to be movable relative to each other, so that the first electrode 1 and the second electrode 2 can be used together as the same electrode, or the first electrode 1 and the second electrode 2 can be used as different electrodes respectively.

[0086] like Figure 4AAs shown, the first insulating layer 3 and the second electrode 2 can move relative to each other, allowing the first electrode 1 and the second electrode 2 to be used together as the same electrode. For example, when the first insulating layer 3 and the second electrode 2 move relative to each other until the distance L2 between the distal end of the second electrode 2 and the distal end of the first insulating layer 3 is a first preset distance (e.g., 0mm-5mm), the distance between the distal end of the second electrode 2 and the distal end of the first insulating layer 3 is very small, meaning that the length of the first insulating layer 3 exposed to the second electrode 2 is very short, or even completely covered by the second electrode 2. At this time, there is essentially no insulating element between the first electrode 1 and the second electrode 2, so they can be used together as one electrode. That is, the ablation electrode needle is a single-electrode structure, which can be paired with other electrodes attached to the human body to perform pulse ablation / radiofrequency ablation.

[0087] like Figure 5 , Figure 6 , Figure 7 , Figure 8 , Figure 9 , Figure 10A and Figure 10B As shown, the first insulating layer 3 and the second electrode 2 are moved relative to each other until the distance L2 between the distal end of the second electrode 2 and the distal end of the first insulating layer 3 is a second preset distance (for example, it can be 5mm-20mm). At this time, the distance between the distal end of the second electrode 2 and the distal end of the first insulating layer 3 is large enough, that is, the length of the first insulating layer 3 exposed to the second electrode 2 is sufficient to achieve insulation between the first electrode 1 and the second electrode 2. Thus, the first electrode 1 and the second electrode 2 can be used as different electrodes respectively. That is, at this time, the ablation electrode needle is a dual electrode structure. One of the first electrode 1 and the second electrode 2 is used as the positive electrode of pulse ablation / radiofrequency ablation, and the other is used as the negative electrode to perform pulse ablation / radiofrequency ablation.

[0088] Therefore, by moving the first insulating layer 3 and the second electrode 2 relative to each other, the ablation needle can be flexibly switched between monopolar ablation mode and bipolar ablation mode, thereby flexibly adjusting its ablation mode according to the surgical treatment plan and adapting to more application scenarios.

[0089] Furthermore, such as Figure 30 and Figure 31 As shown, the working area of ​​the first electrode 1 and / or the working area of ​​the second electrode 2 are provided with an energy guiding structure 201, which is used to guide the pulse or radio frequency energy applied to each electrode, so that the pulse electric field or radio frequency current is uniformly distributed on the surface of each electrode.

[0090] The "working area" refers to the area on the first electrode 1 not covered by the first insulating layer 3 and the area on the second electrode 2 not covered by the second insulating layer 4. For example... Figure 9As shown, the length of the working area on the first electrode 1 not covered by the first insulating layer 3 is L1. The length of L1 can be 5mm-40mm (preferably 5mm-20mm), and this length can be a fixed length or adjusted by the relative movement of the first electrode 1 and the first insulating layer 3. The length of the working area on the second electrode 2 not covered by the second insulating layer 4 is L3. The length of L3 can be 5mm-40mm (preferably 5mm-20mm), and this length can be adjusted by the relative movement of the second electrode 2 and the second insulating layer 4.

[0091] Specifically, the energy guiding structure 201 includes a groove structure located on the outer surface of the working area of ​​the first electrode 1 and / or the outer surface of the working area of ​​the second electrode 2. The groove structure can be an etching groove 203 formed on the outer surface of the working area of ​​the first electrode 1 and / or the outer surface of the working area of ​​the second electrode 2. The etching groove 203 can be, for example, a recess or trench formed on the outer surface of the working area of ​​the first electrode 1 and / or the outer surface of the working area of ​​the second electrode 2 by means of laser etching, machining engraving or chemical etching.

[0092] By setting the etching groove 203, the current density of the first electrode 1 and the second electrode 2 can be dispersed, thereby reducing energy concentration and making the pulsed electric field / radio frequency current uniformly distributed on the first electrode 1 and the second electrode 2. This reduces the problem of excessive local heat on the first electrode 1 and the second electrode 2, which can cause bubble effects and lower the risk of local hot spots. In addition, the etching groove 203 can also increase the imaging under ultrasound, thereby improving the convenience of surgery.

[0093] In addition, the etching groove 203 also enhances the ablation effect because it provides a larger contact area, thereby improving energy transfer efficiency and expanding the ablation area.

[0094] Specifically, by setting etching trenches 203 in the working areas of the first electrode 1 and the second electrode 2, the surface area of ​​the first electrode 1 and the second electrode 2 can be increased. Since the electrode surface area (A) is inversely proportional to the current density (J) (J=I / A), increasing the surface area of ​​the first electrode 1 and the second electrode 2 can reduce the local current density and Joule heating, thereby reducing local hot spots and making the pulsed electric field / RF current uniformly distributed on the first electrode and the second electrode. However, if the surface area is increased too much, it will weaken the mechanical strength of the first electrode 1 and the second electrode 2, or cause excessive dispersion of the electric field, which may lead to incomplete ablation; conversely, if the surface area is increased too little, the suppression effect on local hot spots will be poor.

[0095] Therefore, the etching grooves 203 on the first electrode 1 and / or the second electrode 2 of the present invention are configured to ensure that the strength of the first electrode 1 and / or the second electrode 2 meets the usage requirements, and that the increase in the surface area of ​​the first electrode 1 and / or the second electrode 2 is within a certain range, so as to avoid the problem of incomplete ablation or insignificant effect in reducing local hot spots.

[0096] For example, the etching tank 203 increases the surface area of ​​the first electrode 1 by 20%-220% compared to its surface area before the etching tank 203 was provided. Preferably, the etching tank 203 increases the surface area of ​​the first electrode 1 by 50%-200% compared to its surface area before the etching tank 203 was provided. More preferably, the etching tank 203 increases the surface area of ​​the first electrode 1 by 50%-150% compared to its surface area before the etching tank 203 was provided. For example, it can be 60% or 104%.

[0097] Alternatively, the etching groove 203 increases the surface area of ​​the second electrode 2 by 20%-220% compared to its surface area before the etching groove 203 was provided. Preferably, the etching groove 203 increases the surface area of ​​the second electrode 2 by 50%-200% compared to its surface area before the etching groove 203 was provided. More preferably, the etching groove 203 increases the surface area of ​​the second electrode 2 by 50%-150% compared to its surface area before the etching groove 203 was provided, for example, it can be 62%, 75%, or 158%. Furthermore, since the second electrode 2 is sleeved outside the first electrode 1, the diameter of the first electrode 1 is smaller than the diameter of the second electrode 2. For example, the diameter of the first electrode 1 can be 1 mm or 1.8 mm. For the first electrode 1 with a diameter of 1 mm, the etching groove 203 increases the surface area of ​​the first electrode 1 by 20%-170% compared to its surface area before the etching groove 203 was provided. Because excessively large increases in surface area lead to increased machining difficulty and decreased mechanical strength of the first electrode 1, the aforementioned range ensures precise ablation, and excessive weakening of the electrode must be avoided. For a first electrode 1 with a diameter of 1.8 mm, the etching groove 203 increases the surface area of ​​the first electrode 1 by 30%-220% compared to its surface area before the etching groove 203 was applied. Larger diameters can accommodate deeper grooves or more complex textures (such as multi-level etching), thus allowing for a higher upper limit of surface area increase (220%), enabling a wider range of ablation, but requiring higher energy transfer efficiency.

[0098] When the diameter of the first electrode 1 is 1 mm, the diameter of the second electrode can be 1.8 mm. When the diameter of the first electrode 1 is 1.8 mm, the diameter of the second electrode can be a larger value.

[0099] The etching tank 203 of the second electrode 2 can be designed with a surface area increase of 30%-220%, which can make full use of the space advantage and ensure a balance between performance and safety.

[0100] The first electrode 1, the second electrode 2, and the etching tank 203 are all coated with a conductive coating (such as...). Figure 30 and Figure 31 As shown), for example, a conductive coating can be formed on its surface by means of plating (such as gold, silver or titanium nitride or other conductive coatings), which can compensate for the microscopic defects on the surface of each electrode, reduce the electrode impedance, improve the conductivity, and make the electric field distribution of each electrode more uniform.

[0101] Optionally, such as Figure 32 As shown, the etching groove 203 can be constructed as a strip-shaped groove extending along the axial direction of the first electrode 1 or the second electrode 2. The strip-shaped grooves are spaced apart in the circumferential direction of the first electrode 1 (e.g., they can be equally spaced, or they can be distributed according to a certain rule), and their length can be the same as the length of the working area of ​​the first electrode 1. Similarly, the strip-shaped grooves are spaced apart in the circumferential direction of the second electrode 2 (e.g., they can be equally spaced, or they can be distributed according to a certain rule), and their length can be the same as the length of the working area of ​​the second electrode 2.

[0102] The width of each strip groove (the circumferential dimension along the first electrode 1 / second electrode 2) can be 0.2mm-0.5mm, and its depth (the radial dimension along the first electrode 1 / second electrode 2) can be 0.1mm (or less than 0.1mm). The spacing between each strip groove can be 0.2mm-0.5mm. The length of the working area of ​​the first electrode 1 and the second electrode 2 can be 20mm or 40mm.

[0103] Optionally, such as Figure 33 As shown, the etching groove 203 can be constructed as annular grooves extending circumferentially along the first electrode 1 or the second electrode 2. The annular grooves are spaced apart along the axial direction of the first electrode 1 (e.g., they can be equally spaced, or they can be distributed according to a certain rule), and can be distributed across the entire working area of ​​the first electrode 1. The strip grooves are spaced apart along the circumferential direction of the second electrode 2 (e.g., they can be equally spaced, or they can be distributed according to a certain rule), and can be distributed across the entire working area of ​​the second electrode 2. The length of the working area of ​​the first electrode 1 and the second electrode 2 can be 20 mm or 40 mm.

[0104] The width of each annular groove (the dimension along the axial direction of the first electrode 1 / second electrode 2) can be 0.2mm-0.5mm, the groove depth (the dimension along the radial direction of the first electrode 1 / second electrode 2) can be 0.1mm (or less than 0.1mm), and the spacing between each strip groove can be 0.2mm-0.5mm.

[0105] Optionally, such as Figure 34As shown, the etching groove 203 can be constructed as a spiral groove extending helically along the axial direction of the first electrode 1 or the second electrode 2. The spiral groove can be distributed across the entire working area of ​​the first electrode 1 and the second electrode 2. The groove width (the dimension along the axial direction of the first electrode 1 / second electrode 2) can be 0.2mm-0.5mm, the groove depth (the dimension along the radial direction of the first electrode 1 / second electrode 2) can be 0.1mm (or less than 0.1mm), and the spiral pitch can be 0.2mm-0.5mm.

[0106] Alternatively, the etching groove 203 can also be constructed as a combination of two or more of the above-mentioned strip grooves, annular grooves and spiral grooves.

[0107] The following explanation uses an example where N annular grooves are provided on the first electrode 1. Table 1 below shows a comparison of the surface area of ​​the first electrode 1 with and without annular grooves, for different diameters and working area lengths.

[0108] Table 1 Comparison of surface areas with and without annular grooves.

[0109]

[0110] Please combine Figure 33 For each annular groove, its surface area is (S2+S3+S4+S5), where S3 and S5 are the sidewalls of the annular groove, S4 is the inner wall of the annular groove, and S2 is the adjacent outer wall of the annular groove. Therefore, for the first electrode 1 with annular grooves, its surface area is (S2+S3+S4+S5)×N, where N is the number of annular grooves.

[0111] The surface area increase ratio is [(surface area S' of first electrode 1 - surface area S of first electrode 1) / surface area S of first electrode 1] × 100%.

[0112] As shown in Table 1, with the annular groove depth and the same working area length of the first electrode 1, the smaller the groove width and the groove spacing, the larger the increased surface area of ​​the first electrode 1. For example, when the diameter of the first electrode 1 is 1 mm, and the groove width and groove spacing are 0.15 mm and 0.1 mm respectively, the surface area of ​​the first electrode 1 with the annular groove is 60% larger than that without the annular groove. Therefore, it is more effective in uniformly distributing the pulsed electric field / radio frequency current on the first electrode 1, thereby achieving a better reduction in the risk of local hot spots.

[0113] Example 1

[0114] like Figure 4A and Figure 9As shown, the explanation will be based on the example of the proximal end of the first electrode 1 being connected to the proximal end of the first insulating layer 3. Figure 4A As shown, the first electrode 1 and the first insulating layer 3 move relative to the second electrode 2 until the distance L2 between the far end of the second electrode 2 and the far end of the first insulating layer 3 is a first preset distance. At this time, the first electrode 1 and the second electrode 2 can be used together as the same electrode.

[0115] like Figure 9 As shown, when the first electrode 1 and the first insulating layer 3 move relative to the second electrode 2 to a distance L2 between the far end of the second electrode 2 and the far end of the first insulating layer 3, the first electrode 1 and the second electrode 2 are used as different electrodes.

[0116] Furthermore, in this embodiment 1, the description focuses on the ability of the first insulating layer 3 to move relative to the second electrode 2. For example... Figure 4A and Figure 9 The first insulating layer 3 is movable relative to the second electrode 2 along with the first electrode 1, meaning the first insulating layer 3 can extend from the second electrode 2 (e.g., Figure 9 As shown), this increases the distance L2 between its distal end and the distal end of the second electrode 2, until it can act as an insulator between the first electrode 1 and the second electrode 2. Alternatively, the first insulating layer 3 can be retracted to the second electrode 2, reducing the distance L2 between its distal end and the distal end of the second electrode 2, or even reducing it to 0 (as shown). Figure 4A As shown in the figure, the first insulating layer 3 cannot provide insulation between the first electrode 1 and the second electrode 2.

[0117] In one specific embodiment, the first adjustable electrode assembly includes a first adjustment member 9 connected to the proximal side of the first electrode 1 or the proximal side of the first insulating layer 3, the first insulating layer 3 and the first electrode 1 being connected, and the first adjustment member 9 being configured to move the first insulating layer 3 and the first electrode 1 relative to the second electrode 2 by a pushing or pulling force or by a rotational driving force.

[0118] The following explanation will be based on the example of the first adjusting member 9 being constructed such that the first insulating layer 3 and the first electrode 1 move relative to the second electrode 2 by means of a rotational driving force.

[0119] like Figure 2 and Figure 3 As shown, the ablation electrode needle includes a handle 6, and a first adjusting member 9 includes an adjusting nut 91 and an adjusting screw 92. The adjusting nut 91 and the adjusting screw 92 are connected by threads. The adjusting nut 91 is partially located in the handle 6 and partially located outside the handle 6 to facilitate applying force. By applying force to the adjusting nut 91, it can be rotated relative to the handle 6 of the ablation electrode needle. The adjusting screw 92 is disposed in a moving groove 65 in the handle 6, and it can move within the moving groove 65.

[0120] Please combine Figure 4B The proximal end of the first electrode 1 extends to be fixedly connected to the adjusting screw 92. The rotational motion of the adjusting nut 91 is converted into the linear motion of the adjusting screw 92, thereby the adjusting screw 92 can drive the first electrode 1 and the first insulating layer 3 to move relative to the second electrode 2.

[0121] Furthermore, such as Figure 4B and Figure 12 As shown, the end of the adjusting screw 92 is provided with a limiting boss 920, which has a first limiting surface 921 and a second limiting surface 922 disposed opposite to each other. When the adjusting screw 92 moves in the moving groove 65 until the first limiting surface 921 abuts against the end of the adjusting nut 91 (e.g....), Figure 8 As shown in the diagram, this indicates that the adjusting screw 92 has moved by the maximum displacement, corresponding to the maximum value of the distance L2 between the distal end of the second electrode 2 and the distal end of the first insulating layer 3. Conversely, when the adjusting screw 92 moves in the moving groove 65 until the second limiting surface 922 on it abuts against the inner end face of the moving groove 65, this indicates that the adjusting screw 92 has moved by the maximum displacement in the opposite direction, corresponding to the minimum value of the distance L2 between the distal end of the second electrode 2 and the distal end of the first insulating layer 3.

[0122] In one specific embodiment, the second adjustable electrode assembly includes a second adjusting member 7 located at the distal end of the first adjusting member 9. The first electrode 1 and the first insulating layer 3 pass through the second adjusting member 7. The second adjusting member 7 is connected to the proximal end of the second electrode 2 or the proximal end of the second insulating layer 4. The second adjusting member 7 is configured to move the second insulating layer 4 relative to the second electrode 2 by a pushing or pulling force or by a rotational driving force to adjust the distance L3 between the distal end of the second electrode 2 and the distal end of the second insulating layer 4. Therefore, it can be understood that... Figure 1 The length L of the working area of ​​the first electrode 1 and the second electrode 2 shown is L = L1 + L2 + L3.

[0123] The following explanation will be based on the example of the second adjusting member 7 being constructed such that the second insulating layer 4 is moved relative to the second electrode 2 by a pushing or pulling force to adjust the distance L3 between the distal end of the second electrode 2 and the distal end of the second insulating layer 4.

[0124] like Figure 2 As shown, a movable locking part is provided on the handle 6. In this embodiment 1, the movable locking part is constructed as a locking groove 61 on the outer surface of the handle 6. The locking groove 61 is a groove provided at equal intervals along the handle 6.

[0125] like Figure 8 , Figure 9 and Figure 10AAs shown, the second adjusting member 7 includes a slider 74, a positioning member 72, and a push button 71. The slider 74 is connected to the proximal side of the second electrode 2 or the proximal side of the second insulating layer 4.

[0126] like Figure 10A An example is shown where the slider 74 is connected to the proximal side of the second insulating layer 4. The slider 74 has a socket 743, and the second insulating layer 4 is disposed in and connected to the socket 743 (e.g., by bonding, welding, etc.). Understandably, since the second insulating layer 4 is the outermost component, the second electrode 2, the first insulating layer 3, and the first electrode 1 inside it can pass through the socket 743 of the slider 74 (e.g., ...). Figure 10B (As shown).

[0127] The slider 74 is located in the handle 6 and can move within the handle 6, thereby causing the second insulating layer 4 to move relative to the second electrode 2. Alternatively, when the slider 74 is connected to the proximal side of the second electrode 2, the movement of the slider 74 within the handle 6 can cause the second electrode 2 to move relative to the second insulating layer 4.

[0128] like Figure 11 As shown, the positioning member 72 is elastically connected to the slider 74, so the positioning member 72 can retract into the slider 74 to unlock from the moving locking part, or extend from the slider 74 to lock with the moving locking part. Figure 11 As shown, the positioning member 72 includes a plug 721, and the slider 74 includes a slot 742. A spring 73 is provided between the plug 721 and the slot 742. When the positioning member 72 is pressed down, it compresses the spring 73 to contract, thereby retracting the positioning member 72 into the slider 74; conversely, the spring 73 extends, thereby extending the positioning member 72 out of the slider 74.

[0129] like Figure 11 As shown, a locking block 722 is provided at the upper end of the positioning member 72. When the positioning member 72 retracts into the slider 74, the locking block 722 on it separates from the locking groove 61 on the handle 6, thus unlocking the positioning member 72 from the handle 6. The slider 74 can then move the second insulating layer 4 relative to the second electrode 2 (or the second electrode 2 relative to the second insulating layer 4). Conversely, when the positioning member 72 extends from the slider 74, the locking block 722 on it inserts into the locking groove 61, thereby locking the positioning member 72 to the handle 6 and fixing the second insulating layer 4 and the second electrode 2 in their current positions.

[0130] Please combine Figure 11 and Figure 2 The locking block 722 on the positioning member 72 should be able to match the locking groove 61 on the handle 6.

[0131] Please continue reading Figure 11The push button 71 is located above the positioning member 72. Part of the push button 71 is located inside the handle 6, and part is located outside the handle 6, to facilitate the application of force. Figure 10A As shown, the push button is provided with a push groove 711, and the side walls 7111 on both sides of the positioning member 72 are inclined relative to the positioning member 72. The upper end of the positioning member 72 is movably located in the push groove 711.

[0132] When the positioning member 72 extends from the slider 74, it engages with the locking groove 61 to lock it in place. If it is necessary to adjust the relative position of the second insulating layer 4 and the second electrode 2, by pushing or pulling the push button 71, the inclined side wall 7111 will press the locking block 722 of the positioning member 72, causing the positioning member 72 to retract into the slider 74. The locking block 722 will then separate from the locking groove 61 on the handle 6, thus unlocking it. Continuing to push or pull the push button 71 will move the slider 74, and move the second insulating layer 4 relative to the second electrode 2 (or the second electrode 2 relative to the second insulating layer 4) until it reaches the desired position. At this point, the locking block 722 moves from the previous locking groove 61 to the next corresponding locking groove 61. Under the action of the spring 73, the positioning member 72 extends from the slider 74, allowing the locking block 722 to insert into the locking groove 61, thereby fixing it with the handle 6. This fixes the second insulating layer 4 and the second electrode 2 in the current position.

[0133] Therefore, it can be understood that the first adjusting member 9 of the present invention drives the first insulating layer 3 or the first electrode 1 to move by converting rotational motion into linear motion, and the second adjusting member 7 unlocks itself from the handle by pushing or pulling, thereby driving the second insulating layer 4 or the second electrode 2 to move. Therefore, it is understandable that the first adjusting member 9 can also be constructed with the same structure as the second adjusting member 7, that is, the first adjusting member 9 includes the aforementioned slider 74, positioning member 72, and push button 71, such that the slider 74 is connected to the first insulating layer 3 or the first electrode 1, thereby using the same driving principle as the second adjusting member 7 to drive the first insulating layer 3 or the first electrode 1 to move. Alternatively, the second adjusting member 7 can be constructed with the same structure as the first adjusting member 9, that is, the second adjusting member 7 includes the aforementioned adjusting nut 91 and adjusting screw 92, such that the second insulating layer 4 or the second electrode 2 is connected to the adjusting screw 92, thereby using the same driving principle as the first adjusting member 9 to drive the second insulating layer 4 or the second electrode 2 to move.

[0134] In other words, the movement of the first insulating layer 3 or the first electrode 1, and the movement of the second insulating layer 4 or the second electrode 2 are not limited to the adjustment by the first adjusting member 9 and the second adjusting member 7, and the adjusting members can be used interchangeably.

[0135] Furthermore, such as Figure 26 , Figure 27 , Figure 28 and Figure 29 As shown, when the relative position of the second electrode 2 and the second insulating layer 4 is adjusted by the second adjusting member 7, an insulating part 212 is provided on the part of the second electrode 2 located near the end of the second adjusting member 7, and the outer diameter of the insulating part 212 is smaller than the inner diameter of the second insulating layer 4.

[0136] Specifically, when the proximal end of the second electrode 2 is exposed to a shorter length outside the second insulating layer 4, for example, when the length of L3 is shorter, the proximal side of the slider 74 of the second adjusting member 7 (such as...) Figure 26 and Figure 29 As shown on the right, a portion of the second electrode 2 will be exposed in the handle 6, which poses a certain safety hazard. To address this issue, the second electrode 2 can be configured in a stepped shape, with an insulating portion 212 provided at the step, thereby insulating the portion of the second electrode 2 located near the second adjustment member 7 to ensure safety.

[0137] The insulating part 212 may be, for example, an insulating coating (such as PTFE, Parylene, TiO2, etc.) or an insulating sleeve (such as an insulating sleeve made of PTFE, PI, PEEK, etc.) provided on the part of the second electrode 2 located on the proximal side of the second adjusting member 7, with an outer diameter smaller than the inner diameter of the second insulating layer 4, so that the second insulating layer 4 and the second electrode 2 can move relative to each other.

[0138] like Figure 26 As shown, an ablation electrode adapter 213 is provided near the proximal end of the second electrode 2 (or the first electrode 1). The second electrode 2 (or the first electrode 1) can be connected to the connecting line 10 via the ablation electrode adapter 213, thereby transmitting the pulsed electric field / radio frequency current. The ablation electrode adapter 213 can adopt various suitable structures (such as... Figure 26 and Figure 24 (As shown) to achieve a safe connection between the electrode and the connecting line 10.

[0139] In addition, a light board 214 is provided at the near end of the handle 6, which can be a PCB board and is connected to various indicator lights on the handle 6.

[0140] It should be noted that, Figure 26 This is only to illustrate the specific arrangement of the portion of the second electrode 2 located near the proximal end of the second adjusting member 7. Since the first electrode 1 and the first insulating layer 3 are located inside the second electrode 2, therefore... Figure 26 The first electrode 1 and the first insulating layer 3 are not shown in the diagram.

[0141] In addition, such as Figure 2 and Figure 3 As shown, a scale layer 62 is provided on the outer surface of the handle 6. Figure 2 As shown, the scale on the scale layer 62 located on the side of each locking groove 61 can indicate the movement of the second adjustment member 7, thereby indicating the relative position between the second insulating layer 4 and the second electrode 2.

[0142] Similarly, as Figure 3 As shown, the adjusting screw 92 is also connected to the position indicator 8, which can be in the form of a pointer or similar structure, and can extend from the inside of the handle 6. When the adjusting screw 92 moves, the position indicator 8 moves along with it. The scale on the scale layer where the position indicator 8 is located indicates the movement of the second adjusting member 7, thereby indicating the relative position between the first insulating layer 3 (and the first electrode 1) and the second electrode 2.

[0143] In addition, a position sensor 5 can be installed inside or outside the upper handle 6, such as Figure 5 As shown, the position sensor 5 is located inside the handle 6; Figure 26 As shown, the position sensor 5 is located outside the handle 6. The position sensor 5 can be, for example, a time-of-flight (Tof) sensor. The position sensor 5 is used to determine the distance between the handle 6 and the target area (e.g., the patient's skin surface), thereby achieving precise control of the puncture depth. It can monitor the positional changes of each electrode in real time during the procedure and promptly alert the operator, further improving the safety of the surgery.

[0144] Specifically, the position sensor 5 has a transmitter 51 and a receiver 52. The transmitter 51 transmits a signal that is reflected in a target area (e.g., the patient's skin surface) and received by the receiver 52, thereby obtaining the distance between the handle 6 and the target area (e.g., the patient's skin surface).

[0145] The position sensor 5 can be calibrated using either absolute or relative position calibration to determine the distance between the distal end of the handle 6 and the target area. In absolute position calibration, the patient's skin surface or a pre-defined marked location is used as the absolute zero point, and the position sensor 5 displays the real-time depth values ​​of the first electrode 1 and the second electrode 2 penetrating the patient's tissue. For example, an initial position marker can be set at the tip or proximal position of the first electrode 1. When the tip of the first electrode 1 touches the patient's skin surface or penetrates to a pre-defined marked location, this becomes the reference point for the absolute position, and subsequent adjustments are measured against this reference point.

[0146] The relative position calibration method involves calibrating the change in position of the first electrode 1 and the second electrode 2. For example, after the first electrode 1 and the second electrode 2 enter a certain position in the patient's tissue, that position can be used as a reference point. Subsequent adjustments are all relative to this reference point. Tissue deeper than this reference point can be represented by positive values, while tissue farther from the patient can be represented by negative values, and vice versa. The advantage of this calibration method is that the reference point can be set at any time according to the actual situation.

[0147] Therefore, the position sensor 5 can monitor the position changes of each electrode in real time. If a deviation occurs, it can be fed back in time, so as to adjust its position in time to ensure the safety and effectiveness of ablation.

[0148] Example 2

[0149] like Figures 13-23 As shown, based on the above embodiment 1, a modified embodiment 2 is provided.

[0150] like Figure 13 and Figure 14 As shown, the difference between this embodiment 2 and the above embodiment 1 is that the movable locking part in this embodiment 2 is constructed as a rack 63 on the inner surface of the handle 6, and therefore the structure of the second adjusting member 7 is adjusted accordingly.

[0151] Specifically, such as Figure 15 and Figure 16 As shown, a rack 63 is provided on the inner surface of the handle 6, and the rack 63 extends along the extension direction of the handle 6.

[0152] like Figure 17 As shown, the second adjusting member 7 still includes the slider 74, positioning member 72, and push button 71 as described in Embodiment 1. The difference is that, as... Figure 18 and Figure 19 As shown, the push button 71 has a connecting groove 712, which is connected to the locking block 722 on the positioning member 72. And as... Figure 20 and Figure 21 As shown, the positioning member 72 is provided with locking teeth 761, which can mesh with the teeth on the rack.

[0153] like Figure 22 and Figure 23 As shown, the slider 74 is the same as in Embodiment 1 above, and it is provided with a socket 743 and a slot 742 to facilitate the connection between the second insulating layer 4 (or the second electrode 2) and the insertion block 721 of the positioning member 72. Figure 17 As shown, a spring 73 is also connected between the insert 721 and the slot 742.

[0154] Therefore, during adjustment, by pressing down the push button 71, the positioning member 72 can be pressed down into the retractable slider 74, thereby separating the locking teeth 761 from the rack 63 and unlocking the positioning member 72 from the rack 63. Thus, when the push button 71 is pushed or pulled, the second insulating layer 4 can be moved relative to the second electrode 2 (or the second electrode 2 relative to the second insulating layer 4). After moving to the desired position, the push button 71 is released, and the positioning member 72 extends out of the slider 74 under the action of the spring 73. The locking teeth 761 on it mesh with the corresponding teeth on the rack 63 to lock it, thereby keeping the second insulating layer 4 and the second electrode 2 in the current position.

[0155] Therefore, it can be seen that the difference between the second adjusting member 7 in this embodiment 2 and the one in embodiment 1 is that the locking of the second adjusting member 7 and the handle 6 in this embodiment 2 is achieved by the meshing of the rack and the locking teeth, while the locking of the second adjusting member 7 and the handle 6 in embodiment 1 is achieved by the mutual insertion of the locking block 722 and the locking groove 61. Therefore, the positioning member 72 in this embodiment 2 needs to be separated from the rack 63 by the downward pressure of the push button 71, while the positioning member 72 in embodiment 1 does not require the downward pressure of the push button 71, and the locking block 722 is separated from the locking groove 61 by its inclined side wall 7111 when the push button 71 moves.

[0156] Understandably, the first adjusting member 9 in the above embodiment 1 can also adopt the structural form of the second adjusting member 7 described in this embodiment 2.

[0157] The similarities between this embodiment 2 and the above embodiment 1 will not be repeated.

[0158] Example 3

[0159] like Figure 24 and Figure 25 As shown, based on the above embodiments 1 and 2, a modified embodiment 3 is provided.

[0160] like Figure 24 and Figure 25 As shown, the difference between this embodiment 3 and embodiments 1 and 2 is that the first insulating layer 3 is sleeved on the outside of the first electrode 1 layer, and the first insulating layer 3 and the first electrode 1 layer can move relative to each other, thereby adjusting the distance L1 between the proximal end of the first insulating layer 3 and the proximal end of the first electrode 1 layer. That is, L1 is a fixed value in embodiment 1, while L1 is an adjustable distance in this embodiment 3, thus the length of the first electrode 1 exposed to the first insulating layer 3 can be changed.

[0161] The movement between the first insulating layer 3 and the first electrode 1 can adopt the structural form of the first adjusting member 9 or the second adjusting member 7 described in Embodiment 1 above, or it can also adopt the structural form of the second adjusting member 7 described in Embodiment 2 above.

[0162] In other words, in this embodiment 3, the first insulating layer 3 and the first electrode 1 can move relative to each other, the second electrode 2 and the first insulating layer 3 can move relative to each other, and the second insulating layer 4 and the second electrode 2 can move relative to each other. That is, L1, L2 and L3 in the above embodiment 1 are all adjustable.

[0163] In the above embodiments, "proximal end" or "proximal side" is the side closer to the tip of the first electrode 1 (i.e., the patient side); "distal end" or "distal side" is the side away from the tip of the first electrode 1 (i.e., the operator side holding the handle 6).

[0164] Although the invention has been described with reference to preferred embodiments, various modifications can be made and components can be replaced with equivalents without departing from the scope of the invention. In particular, the technical features mentioned in the various embodiments can be combined in any manner as long as there is no structural conflict. The invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. An ablation electrode needle, characterized in that, The first adjustable electrode assembly comprises a first electrode and a first insulation layer, and the second adjustable electrode assembly comprises a second electrode and a second insulation layer, the first insulation layer is coaxially arranged between the first electrode and the second electrode, and the second insulation layer is coaxially arranged outside the second electrode; The first insulation layer and the second electrode are configured to be relatively movable, so that the first electrode and the second electrode can be used as the same electrode together, or the first electrode and the second electrode can be used as different electrodes respectively; The working area of the first electrode and / or the working area of the second electrode is provided with an energy guiding structure for guiding the pulse or radio frequency energy applied to each electrode; The length of the working area of the first electrode and / or the working area of the second electrode is adjustable; When the first electrode and the first insulation layer are relatively moved to the second electrode to a distance L2 between the distal end of the second electrode and the distal end of the first insulation layer is a first preset distance, the first electrode and the second electrode can be used as the same electrode together; or when the first electrode and the first insulation layer are relatively moved to the second electrode to a distance L2 between the distal end of the second electrode and the distal end of the first insulation layer is a second preset distance, the first electrode and the second electrode can be used as different electrodes respectively.

2. The ablation electrode needle of claim 1, wherein, The energy guiding structure comprises a groove structure on the working area of the first electrode and / or the working area of the second electrode.

3. The ablation electrode needle of claim 2, wherein, The groove structure is an etching groove formed on the outer surface of the working area of the first electrode and / or the working area of the second electrode, and the etching groove is configured to increase the surface area of the first electrode and / or the surface area of the second electrode to make the pulse electric field or radio frequency current uniformly distributed on the surface of each electrode.

4. The ablation electrode needle of claim 3, wherein, The etching groove increases the surface area of the first electrode by 20%-220% compared with the surface area before the etching groove is arranged on the first electrode; and / or The etching groove increases the surface area of the second electrode by 20%-220% compared with the surface area before the etching groove is arranged on the second electrode.

5. The ablation electrode needle of claim 3, wherein, The etching groove is configured as one or more of the following: A ring-shaped groove extending along the circumference of the first electrode or the second electrode; A strip-shaped groove extending along the axial direction of the first electrode or the second electrode; and A spiral groove extending along the axial direction of the first electrode or the second electrode in a spiral manner. The first adjustable electrode assembly comprises a first adjusting member connected to the proximal end side of the first electrode or the proximal end side of the first insulation layer, the first insulation layer and the first electrode are connected, and the first adjusting member is configured to move the first insulation layer and the first electrode relative to the second electrode by pushing and pulling force or by rotating driving force; and / or 6. The ablation electrode needle of claim 5, wherein, ​ The second adjustable electrode assembly comprises a second adjusting member, which is located on the distal side of the first adjusting member, the first electrode and the first insulating layer penetrating through the second adjusting member, the second adjusting member being connected with the proximal side of the second electrode or the proximal side of the second insulating layer, and the second adjusting member being configured to move the second insulating layer relative to the second electrode by a pushing and pulling force or by a rotating driving force to adjust the distance L3 between the distal end of the second electrode and the distal end of the second insulating layer.

7. The ablation electrode needle of claim 1, wherein, Further comprising a handle, and a movement locking portion is arranged on the handle; When the second adjustable electrode assembly comprises a second adjusting member, the second adjusting member comprises: a sliding block connected with the proximal side of the second electrode or the proximal side of the second insulating layer; a positioning member elastically connected with the sliding block, so that the positioning member can retract into the sliding block to unlock the movement locking portion or extend from the sliding block to lock the movement locking portion; a push button located above the positioning member, and the push button is configured to make the positioning member retract into the sliding block to unlock the movement locking portion when the push button is moved.

8. The ablation electrode needle of claim 7, wherein, The movement locking portion is configured as a locking groove on the outer surface of the handle or a rack on the inner surface of the handle; When the movement locking portion is configured as a locking groove on the outer surface of the handle, a pushing groove is arranged on the push button, and the upper end of the positioning member is movably located in the pushing groove, wherein when the positioning member extends from the sliding block, the positioning member is engaged in the locking groove to be locked; the side walls respectively located on both sides of the positioning member on the pushing groove are inclined relative to the positioning member, and when the push button is moved, the side walls make the positioning member retract into the sliding block to unlock the movement locking portion; When the movement locking portion is configured as a rack on the inner surface of the handle, the push button is connected with the positioning member, and a locking tooth is arranged on the positioning member, wherein when the positioning member extends from the sliding block, the locking tooth can be engaged with the rack to be locked; when the push button is pressed to make the positioning member retract into the sliding block, the locking tooth is separated from the rack to unlock the positioning member from the rack.

9. The ablation electrode needle of claim 1, wherein, When the second adjustable electrode assembly comprises a second adjusting member, an insulating portion is arranged on the part of the second electrode located on the proximal side of the second adjusting member, and the outer diameter of the insulating portion is smaller than the inner diameter of the second insulating layer.

10. The ablation electrode needle of claims 1 or 2, wherein, The first insulating layer is sleeved on the outside of the first electrode layer, and the first insulating layer and the first electrode layer can move relative to each other to adjust the distance L1 between the proximal end of the first insulating layer and the proximal end of the first electrode layer.

11. The ablation electrode needle of claims 1 or 2, wherein, Further comprising a position sensor located on the outside or inside of the handle of the ablation electrode needle, and the position sensor is configured to calibrate the distance between the distal end of the handle and the target region in an absolute position calibration mode or a relative position calibration mode.

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