Monopolar adjustable ablation device and operation method

Abstract

The invention provides a monopole adjustable ablation device and an operation method, the device mainly comprises a needle core, the far end of which is provided with a first ablation electrode; a second insulating layer is arranged on the needle tube, and the far end of the needle tube is exposed to form a second ablation electrode; the needle core and the needle tube can move synchronously, and the needle core and the needle tube can move relatively; the delivery sheathing canal is movably arranged on the needle tube in a sleeving manner; the first push rod, the first sleeve and the second sleeve are coaxially and sequentially connected; the first push rod is provided with a first grip capable of linearly moving in a reciprocating mode, the first sleeve is provided with a first sliding block capable of linearly moving in a reciprocating mode, and the second sleeve is provided with a second grip capable of linearly moving in a reciprocating mode. One end of the conveying sheath tube is connected with the first grip, one end of the needle tube is connected with the first sliding block, and one end of the needle core is connected with the second grip. By the adoption of the structure, the effective ablation length can be increased by means of the needle core movably arranged in the needle tube in a penetrating mode, and therefore the effective ablation area is expanded to adapt to focuses of different sizes.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a monopolar adjustable ablation device and an operation method. Background Art

[0002] The application of pulsed electric field ablation technology in clinical practice is based on the electroporation effect of pulsed electric fields. Data shows that electroporation is divided into reversible electroporation and irreversible electroporation. Irreversible electroporation refers to the fact that stronger electric fields cause permanent permeability of cell membranes and result in cell death.

[0003] Based on the theory of reversible electroporation, clinicians use high-field electric pulses to make drugs that are not easily enter the lipid bilayer membrane enter cells more easily through small pores in the cell membrane, thereby improving the therapeutic effect. This method not only reduces the dosage of drugs, but also reduces certain toxic and side effects due to the reduced dosage of drugs taken. This therapy is called electrochemotherapy and is currently mainly applied to diseases such as cancer. Another medical application of reversible electroporation is to use electroporation to introduce genes into cells or tissues for gene therapy and DNA vaccine inoculation.

[0004] In existing devices, since the ablation area of most ablation devices is fixed and the structural design is single, several pain points are faced during the operation process. On the one hand, the length of the ablation electrode of the currently marketed products is fixed, and the single ablation range for tumors is not large. For larger tumors or tumors with irregular shapes, multiple ablations are required to completely cover them. Multiple ablations require multiple punctures of the human body, and normal tissues around may be damaged during the ablation process, causing unnecessary harm.

[0005] In currently publicly disclosed patent applications, to address the existing problems, the length of the ablation electrode is usually controlled by moving the outer sheath. Therefore, there must be a physical gap between the outer sheath and the electrode. On the one hand, it will cause conductive liquids such as human blood to fill the inner part of the outer sheath, resulting in an error in the effective ablation length of the electrode; if the liquid reaches the handle part along the outer sheath, it may cause accidental injury to the operator. In addition, due to the gap between the outer sheath and the needle electrode, during the process of advancing the tissue, it may deform or turn outward, reducing the puncture force and even causing tissue damage. Especially when the device is punctured through the human body cavity or in cooperation with equipment channels such as endoscopes and surgical robots, the ablation device catheter is long and the human body cavity is curved and variable. Therefore, it is difficult for the thrust at the handle end to be directly transmitted to the front end of the ablation electrode, and the outer sheath is prone to phenomena such as kinking and deformation.

[0006] On the other hand, due to the irregular distribution of human blood vessels, doctors need to avoid blood vessels during the operation to prevent the needle tip from piercing the blood vessels and causing bleeding. However, when it is impossible to avoid blood vessels after the puncture path is planned, a blunt needle needs to be used to push the blood vessel away first and then perform the puncture. Thus, minimally invasive treatment is achieved, the occurrence of complications is reduced, and the comfort of the patient is improved. At the same time, during the puncture process, due to the continuous change of the tumor position with breathing during human respiration, it is very difficult to insert the puncture needle into the designated position of the tumor at one time, and the operator needs to perform repeated needle insertion and retraction operations under CT. To solve this problem, the current clinical solution generally uses an ablation needle with a blunt tip and is equipped with a coaxial needle with a blade edge. This method can avoid the risk of blood vessel puncture, but it requires the ablation needle to be made thicker, which causes greater trauma to the human body and increases the difficulty for the operator. Summary of the Invention

[0007] The present invention provides a monopolar adjustable ablation device to solve the problems in the above-mentioned background technology, that is, the ablation area of existing medical devices is fixed and single, and cannot be adaptively adjusted according to the size of the lesion tissue. At the same time, when puncture is required, the problem of puncturing blood vessels or normal tissues can be avoided. Another aspect of the present invention also provides an operation method for the monopolar adjustable ablation device.

[0008] To achieve the above object, the present invention adopts the following technical solutions: A needle core, having a distal end and a proximal end, and a first ablation electrode is provided at the distal end of the needle core; A needle tube, having a distal end and a proximal end, a second insulating layer is provided on the needle tube, and the distal end of the needle tube is exposed to form a second ablation electrode; The needle core is movably inserted into the needle tube, the needle core is electrically connected to the needle tube, and the first ablation electrode can be extended or retracted into the needle tube; The needle core and the needle tube can move synchronously, and the needle core and the needle tube can move relatively; A delivery sheath tube is movably sleeved on the needle tube, the needle tube can move relative to the delivery sheath tube, and the distal ends of the needle core and the needle tube can be retracted or extended out of the delivery sheath tube; It further includes a first push rod, a first sleeve tube and a second sleeve tube connected in sequence, and the first push rod, the first sleeve tube and the second sleeve tube are coaxially arranged; A first grip is provided on the first push rod and can reciprocate linearly, a first slider is provided on the first sleeve tube and can reciprocate linearly, and a second grip is provided on the second sleeve tube and can reciprocate linearly; The proximal end of the delivery sheath tube is connected to the first grip, the proximal end of the needle tube is connected to the first slider, and the proximal end of the needle core is connected to the second grip; The first wire is disposed at one end of the second grip. One end of the first wire is electrically connected to the stylet or the needle tube, and the other end of the first wire is provided with a first plug.

[0009] In some embodiments, a puncture tip is provided at the distal end of the needle tube, a smooth guiding structure is provided at the distal end of the stylet, or a smooth guiding structure is provided at the distal end of the needle tube, and a puncture tip is provided at the distal end of the stylet.

[0010] In some embodiments, a first grip and a first push rod are further included. A part of the first push rod is inserted into the first grip, and the first push rod can make a reciprocating linear movement relative to the first grip. Both the stylet and the needle tube are connected to the first push rod so that the stylet and the needle tube move synchronously.

[0011] In some embodiments, a delivery sheath is sleeved on the needle tube. One end of the delivery sheath is connected to the first grip, and the stylet and the needle tube can be received in or protrude from the other end of the delivery sheath.

[0012] In some embodiments, a first limiting block capable of making a reciprocating linear movement is provided on the first grip. The first limiting block can be fixed in position relative to the first grip, and one end of the first push rod can abut against the first limiting block.

[0013] In some embodiments, a first threaded tube rotatably disposed relative to the first grip is further included. A first threaded hole adapted thereto is provided on the first limiting block, and the first limiting block is sleeved on the first threaded tube through the first threaded hole.

[0014] In some embodiments, a first limiting structure is provided between the first grip and the first limiting block to enable the first limiting block to make a reciprocating linear movement along the axial direction of the first threaded tube; The first limiting structure includes a first limiting groove provided on the first grip and a first limiting boss provided on the first limiting block, or a first limiting boss provided on the first grip and a first limiting groove provided on the first limiting block. The first limiting groove and the first limiting boss are adapted, and the limiting boss is snap-fitted into the first limiting groove.

[0015] In some embodiments, a first knob rotatably disposed on the first grip is further included. The first knob is connected to the first threaded tube to drive the first threaded tube to rotate relative to the first grip.

[0016] In some embodiments, a first annular groove is provided on the first knob, and a first annular boss is provided on the first grip, or a first annular boss is provided on the first knob, and a first annular groove is provided on the first grip. The first annular groove and the first annular boss are adapted, and the first annular boss is snap-fitted into the first annular groove.

[0017] In some embodiments, a first support plate is provided on the first grip, and a first support groove is provided on the first support plate. A part of the first threaded tube is rotatably disposed in the first support groove.

[0018] In some embodiments, a first fixed card slot is provided in the first grip, and is disposed at one end close to the first threaded tube. A first fixed card block is provided on the first fixed card slot, and one end of the delivery sheath tube passes through the first threaded tube and is connected to the first fixed card block.

[0019] In some embodiments, the first push rod includes a first abutting section and a first limiting section. The first abutting section is offset relative to the first limiting section. The first abutting section can abut against the first limiting block, and the first limiting section is used to limit the first push rod to perform reciprocating linear movement.

[0020] In some embodiments, the first limiting section is provided with a first limiting plane and a second limiting groove. A first baffle is provided on the first grip. The first limiting section can abut against the first baffle, and the first limiting plane abuts against the first baffle. A second limiting boss and a first locking knob are provided on the first grip. The second limiting boss is snap-fitted into the second limiting groove, and one end of the first locking knob can abut against the first limiting plane.

[0021] In some embodiments, a needle insertion depth scale line is provided on the first limiting block, and a first scale line is provided on the first grip. The needle insertion depth scale line can be aligned with the first scale line.

[0022] In some embodiments, a needle seat is provided in the first sleeve. One end of the needle tube is connected to the needle seat. A first connecting block is provided on the needle seat. A first slot adapted to the first sleeve is provided on the first sleeve. The first slot has a preset length. The first connecting block passes through the first slot and is connected to the first slider.

[0023] In some embodiments, a first limiting plate is provided at the connection between the first push rod and the first sleeve, and a second limiting plate is provided at the connection between the first sleeve and the second sleeve. The first slider can abut against the first limiting plate or the second limiting plate.

[0024] In some embodiments, a second scale marking line is provided on the first sleeve, a second locking knob is provided on the first slider, the side line of the first slider can be aligned with the second scale marking line, and one end of the second locking knob can abut against the first sleeve.

[0025] In some embodiments, a third scale marking line is provided on the second sleeve, a third locking knob is provided on the second grip, the side line of the second grip can be aligned with the third scale marking line, one end of the third locking knob can abut against the first sleeve, and the second grip can abut against the second limiting plate.

[0026] In some embodiments, it further includes a first wire disposed at one end of the second grip, one end of the first wire is connected to the needle core, and a first plug is disposed at the other end of the first wire.

[0027] In some embodiments, the present invention further provides an operation method for a monopolar adjustable ablation device, including the following steps: S1. Confirm the needle insertion depth, rotate the first knob to drive the first limiting block to a preset position to set the needle insertion depth, push the first push rod to drive the needle core and the needle tube to move synchronously until the first push rod abuts against the first limiting block, the needle core and the needle tube synchronously extend out of the delivery sheath, and fix the position of the first push rod; S2. According to the size, shape of the lesion and the initial needle insertion position, move the first slider to adjust the position of the needle tube, or move the second grip to adjust the position of the needle core, so that the needle core extends a certain length relative to the needle tube, and fix their relative positions; S3. Connect the power supply and perform the discharge operation.

[0028] Compared with the prior art, the beneficial effects brought by the present invention are as follows: By providing a needle tube and a needle core, the needle core is movably inserted into the needle tube, a second ablation electrode is provided on the needle tube, a first ablation electrode is provided on the needle core, and in combination with a puncture tip provided on the needle tube and a smooth guiding structure provided on the needle core, it can meet the puncture conditions while avoiding damage to normal human tissues or blood vessels during the puncture process, reducing the operation difficulty of doctors. In addition, by electrically connecting the first ablation electrode on the needle core to the second ablation electrode on the needle tube to achieve the transmission of ablation energy, the second ablation electrode can expand the discharge range by means of the first ablation electrode provided on the needle core, thereby increasing the ablation area to meet the ablation requirements of different sizes of lesions.

[0029] The additional aspects and advantages of the present application will be partially given in the following description, and these will become apparent from the following description or be understood through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 Stereogram of a monopolar adjustable ablation device of the present invention; Figure 2 It is Figure 1 The enlarged view at position A in Figure 3 It is Figure 2 Another deformation embodiment of the structure in Figure 4 Schematic structural diagram of a partition groove opened in the syringe tube of the present invention; Figure 5 It is Figure 3 Schematic structural diagram of an insulating layer provided on the needle core of the deformed structure in Figure 6 Cross-sectional view of the first grip of a monopolar adjustable ablation device of the present invention; Figure 7 It is Figure 6 The enlarged view at position C in Figure 8 Exploded view of the first grip of the present invention; Figure 9 Schematic diagram of the first abutting section of the first push rod of the present invention abutting against one end of the first threaded tube; Figure 10 Schematic diagram of the internal structure of one of the shells of the first grip of the present invention; Figure 11 Cross-sectional view of the assembly of the first push rod and the first sleeve of the present invention; Figure 12 Stereogram of the assembly of the first sleeve, the second sleeve and the second grip of the present invention; Figure 13 Exploded view at the first sleeve of the present invention; Figure 14 Exploded view at the second grip of the present invention; Figure 15 Cross-sectional view at the second grip of the present invention; Figure 16 It is Figure 15 The enlarged view at position B in Figure 17 Cross-sectional view of the first knob of the present invention; Figure 18 Schematic diagram of the movement adjustment of the ablation device of the present invention. Detailed implementation manners

[0031] The present application will be further described in detail below in conjunction with specific drawings. In the description of this embodiment, unless otherwise specified, the orientation or positional relationship indicated by terms such as "left" and "right" is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the present application must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present application.

[0032] As Figure 1-2 shown, a unipolar adjustable ablation device provided by the present invention mainly includes a needle tube 600 and a needle core 700. Specifically, the needle tube 600 has a distal end and a proximal end. A second insulating layer 602 is provided on the needle tube 600. The distal end of the needle tube 600 is exposed, thereby forming a second ablation electrode 601 for releasing ablation energy. The distal end of the needle tube 600 is as Figure 2 shown on the left side. In this embodiment, in order to conform to the ablation of smaller-sized lesion tissues, the exposed length of the needle tube 600 is relatively small; in this embodiment, by means of hot melting and coating or gluing the second ablation electrode 601 and the second insulating layer 602, the second ablation electrode 601 and the second insulating layer 602 are made into an integral body. The rigidity and toughness of the needle tube 600 are increased through the insulating layer, and the pushing ability of the needle tube 600 is improved.

[0033] The needle core 700 has a distal end and a proximal end. The proximal end is the connection end, and the distal end is the discharge end. The needle core 700 is movably inserted into the needle tube 600. A first ablation electrode 701 is provided at the distal end of the needle core 700. The first ablation electrode 701 can be received or extended out of the needle tube 600. In this embodiment, the needle core 700 is a conductive rod-shaped structure. The length of the needle core 700 extending out of the needle tube is the length of the first ablation electrode 701, and it is also the effective discharge length increased for the second ablation electrode 601; in this embodiment, the ablation device is a unipolar ablation structure. Electrical connection is achieved by the contact between the needle core 700 and the needle tube 600, so as to transfer ablation energy. The external energy generator can be connected to the needle tube 600 or the needle core 700.

[0034] It should be particularly noted that the needle core 700 and the needle tube 600 can move synchronously, and the needle core 700 and the needle tube 600 can move relatively. For example, during actual operation, the needle tube 600 can move alone or the needle core 700 can move alone; among them, as Figure 2 shown, a puncture tip 6011 is provided at the distal end of the needle tube 600, and a smooth guiding structure 7011 is provided at the distal end of the needle core 700, or as Figure 3 and Figure 5As shown, a smooth guiding structure 7011 is provided at the distal end of the needle tube 600, and a puncture tip 6011 is provided at the distal end of the stylet 700. In this embodiment, the puncture tip 6011 has a cutting edge to enhance its puncture strength. The smooth guiding structure 7011 is a rounded corner structure, or a combined structure of an inclined surface and a rounded corner. Further, due to movement within the human body cavity, such as Figure 4 As shown, a plurality of evenly spaced partition grooves 6012 are formed on the surface of the needle tube 600 to ensure its flexibility and enable it to bend within the complete human body cavity. By providing the stylet 700, support force can also be provided during the puncture of the needle tube 600, enhancing the stiffness of the needle tube 600 to facilitate puncture.

[0035] By adopting the above combined structure, on the one hand, by providing the puncture tip 6011, the ablation puncture requirements are met. At the same time, by providing the smooth guiding structure 7011, when the ablation device is transmitted to the lesion site, the smooth guiding structure 7011 can prevent the normal human tissue from being punctured and damaged by the puncture tip 6011. Especially during the delivery process when blood vessels are relatively dense, the smooth guiding structure 7011 on the stylet 700 can push the blood vessels away, thus avoiding the blood vessels from being punctured and causing unnecessary damage, reducing the operation difficulty for doctors. On the other hand, by movably inserting the stylet 700 into the needle tube 600, since the stylet 700 is electrically connected to the needle tube 600, when the stylet 700 penetrates out of the needle tube 600, the length of the stylet 700 penetrating out of the needle tube 600 is the length of the first ablation electrode 701. The effective ablation length of the second ablation electrode 601 can be expanded by means of the relative length of the stylet 700 penetrating out of the needle tube 600, further enhancing the ablation area to meet the ablation requirements for larger lesion tissues.

[0036] In one embodiment, as Figure 6 shown, in order to achieve the synchronous movement of the stylet 700 and the needle tube 600, a first handle 200 and a first push rod 100 are further included. A part of the first push rod 100 is inserted into the first handle 200, and the first push rod 100 can make reciprocating linear movement relative to the first handle 200.

[0037] Further, a delivery sheath 500 is provided on the needle tube 600 to facilitate the delivery of the needle tube 600. The delivery sheath 500 has a distal end and a proximal end. The proximal end of the delivery sheath 500 is fixedly connected to the first handle 200. In the initial state, both the needle tube 600 and the stylet 700 are received within the delivery sheath 500. When the target position is reached, by pushing the first push rod 100, the needle tube 600 and the stylet 700 are pushed out of the other end of the delivery sheath 500 to puncture the lesion tissue. In this embodiment, the delivery sheath 500 is an insulating tube. For example, it is made of materials such as PTFE / PEBAX / PTFE and PI.

[0038] In one embodiment, as Figure 12 and13 As shown, at one end of the first push rod 100 located outside the first grip 200, there are also a first sleeve 300 and a second sleeve 400. One end of the first sleeve 300 is connected to the first limiting section 101 of the first push rod 100, and one end of the second sleeve 400 is connected to the other end of the first sleeve 300. It should be particularly noted that the first abutting section 102 of the first push rod 100, the first sleeve 300, and the second sleeve 400 are coaxially arranged; A first slider 301 is arranged on the first sleeve 300. The first slider 301 can make reciprocating linear movement along the axis direction of the first sleeve 300. One end of the syringe needle 600 is connected to the first slider 301; a second grip 401 is arranged on the second sleeve 400. The second grip 401 can make reciprocating linear movement along the axis direction of the second sleeve 400. One end of the plunger 700 is connected to the second grip 401. In this embodiment, the second grip 401 is divided into two detachably connected shells. A first clamping groove 4012 is arranged at one end of the second grip 401. A first clamping ring 40121 is arranged in the first clamping groove 4012. The first clamping ring 40121 is provided with a clamping boss with a guiding surface structure. The clamping boss can be clamped in the first clamping groove 4012, so as to fix the two shells.

[0039] By adopting the above structure, the synchronous movement of the syringe needle 600 and the plunger 700 is controlled, and at the same time, the independent movement of the syringe needle 600 and the plunger 700 is also realized.

[0040] Furthermore, in order to accurately control the needle insertion depth, a first limiting block 203 that can make reciprocating linear movement is arranged on the first grip 200. The first limiting block 203 can be fixed relative to the position of the first grip 200. One end of the first push rod 100 located inside the first grip 200 can abut against the first limiting block 203. By arranging the first limiting block 203, the accurate regulation of the puncture depth can be carried out before the operation, so as to avoid excessive puncture or insufficient puncture and unable to achieve the expected ablation effect.

[0041] In one embodiment, in order to facilitate the reciprocating linear movement of the first limiting block 203 on the first grip 200, it further includes a first threaded tube 202 rotatably arranged on the first grip 200. An external thread is arranged on the first threaded tube 202. A threaded hole adapted thereto is arranged on the first limiting block 203. The first limiting block 203 is sleeved on the first threaded tube 202 through thread fitting; further, a first limiting structure is arranged between the first grip 200 and the first limiting block 203. The first limiting structure is used to make the first limiting block 203 make reciprocating linear movement.

[0042] Specifically, as Figure 8As shown, the first limiting structure includes a first limiting boss disposed on the first limiting block 203 and a first limiting groove 204 disposed on the inner wall of the first grip 200. The first limiting groove 204 has a certain length to meet the needle insertion requirement of the syringe 600. The first limiting boss is slidably clamped in the first limiting groove 204. The length direction of the first limiting groove 204 is consistent with the axial direction of the first threaded tube 202. By rotating the first threaded tube 202, under the action of the first limiting structure, the first limiting block 203 makes a reciprocating linear movement on the first threaded tube 202.

[0043] Optionally, as another deformation mode of this embodiment, the first limiting groove 204 can be disposed on the first limiting block 203, and the first limiting boss can be disposed on the inner wall of the first grip 200, which can also achieve the above purpose.

[0044] Optionally, the first threaded tube 202 can also be set as a cylindrical sleeve, and the first limiting block 203 is movably sleeved thereon. A notch with a certain length is provided on the first grip 200. A part of the first limiting block 203 extends out of the first grip 200 through the notch to form a pushing structure, which can also achieve the reciprocating linear movement of the first limiting block 203.

[0045] In one embodiment, in order to facilitate the control of the first limiting block 203, a first knob 201 is disposed at one end of the first grip 200 close to the delivery sheath 500. The first knob 201 is connected to the first threaded tube 202, and the first knob 201 is rotatably disposed relative to the first grip 200. By rotating the first knob 201, the first threaded tube 202 is driven to rotate, and thus the reciprocating movement of the first limiting block 203 is realized. In this embodiment, for the convenience of assembly, the first knob 201 and the first threaded tube 202 are detachably arranged, such as Figure 6 and Figure 8 As shown, they are fixed by threaded connection and cooperation. Optionally, they can also be fixed by clamping. Optionally, the first knob 201 and the first threaded tube 202 can be integrally arranged. At the same time, since the first grip 200 is set as two detachably connected shells, by setting the first knob 201, the structure of the first grip 200 formed by the two shells can be further strengthened.

[0046] Specifically, as Figure 6 、 Figure 8 and Figure 17As shown in the figure, a first annular groove 2012 is provided on the first knob 201, and a first annular boss 211 is provided on the first grip 200. The first annular boss 211 is adapted to the first annular groove 2012, and the first annular boss 211 is snap-fitted into the first annular groove 2012. The plane formed by the contour of the first annular boss 211 is perpendicular to the axial direction of the first threaded tube 202. Optionally, the first annular boss 211 can also be provided on the first knob 201, and the first annular groove can be provided on the first grip 200, which can also achieve the rotational setting of the first knob 201 relative to the first grip 200.

[0047] Further, a first connecting thread 2011 is provided on the first knob 201, and the first connecting thread 2011 is connected to an external instrument. In this embodiment, the external instrument is an endoscope, and it is movably connected to the forceps port of the endoscope through the first connecting thread 2011. The connection effect is the same as that of a luer connector. The luer connector is a prior art and will not be elaborated here.

[0048] In one embodiment, in order to support the first threaded tube 202, a first support plate 212 is provided inside the first grip 200, as Figure 8 and Figure 9 shown in the figure. A first support groove is provided on the first support plate 212, and the first support groove is adapted to a part of the structure of the first threaded tube 202. A part of the first threaded tube 202 is rotatably provided in the first support groove.

[0049] In one embodiment, in order to facilitate the fixation of the delivery sheath 500, a first fixing card slot 208 is provided in the first grip 200, and a first fixing block 207 is provided in the first fixing card slot 208. The first fixing card slot 208 is provided at one end close to the first threaded tube 202. One end of the delivery sheath 500 passes through the first threaded tube 202 and is fixedly connected to the first fixing block 207, so as to realize the fixed connection of the delivery sheath 500 relative to the first grip 200. By setting this structure, the delivery sheath 500 can pass through the first threaded tube 202, thereby further strengthening the support structure of the first threaded tube 202.

[0050] In one embodiment, as Figure 11As shown, since the first threaded tube 202 needs to occupy a certain space and the first limiting block 203 is sleeved on the first threaded tube 202, in order to facilitate the abutment between the first push rod 100 and the first limiting block 203 and prevent movement interference between the first push rod 100 and the first threaded tube 202, the first push rod 100 is provided with a first abutting section 102 and a first limiting section 101. The first abutting section 102 is offset relative to the first limiting section 101. The first abutting section 102 is used to abut against the first limiting block 203, and the first limiting section 101 is used for the first push rod 100 to perform reciprocating linear movement along its own axis direction.

[0051] Specifically, as Figure 13 shown, in order to ensure the stability of the abutting structure, the first abutting section 102 is an arc-shaped plate structure with a continuous structure. The radian range of the arc-shaped plate is not greater than 180 degrees. A certain gap should be left between the first abutting section 102 and the first support plate 212 to facilitate the first abutting section 102 to smoothly push and abut against the first limiting block 203. The length of the arc-shaped plate structure of the first abutting section 102 can cover the thread length of the first threaded tube 202 to facilitate reaching the maximum needle insertion depth of the syringe 600. By setting the first abutting section 102 with an arc-shaped plate structure, movement interference between the first abutting section 102 and the first threaded tube 202 can be avoided, and the abutting strength between the first push rod 100 and the first limiting block 203 can be further strengthened. To ensure that the first push rod only makes linear movement, as Figure 10 and Figure 11 shown, a second limiting groove 1011 is provided on the first limiting section 101, and a second limiting boss 206 is provided on the first grip 200. The length direction of the second limiting boss 206 is consistent with the axis direction of the first push rod 100, and the second limiting boss 206 is clamped in the second limiting groove 1011; on this basis, a first limiting plane is also provided on the first limiting section 101, as Figure 7 and Figure 12 shown, a first baffle 205 is provided on the first grip 200, and the first baffle 205 abuts against the first limiting plane, thereby limiting the first push rod 100 in the vertical direction and preventing the first push rod 100 from swinging up and down. The vertical direction is the up and down direction of the Figure 6 shown direction. At the initial position, as Figure 7As shown, the first abutting section 102 of the first push rod 100 abuts against the first baffle 205. At this time, the needle insertion depth is 0. Further, a first locking knob 210 is provided on the first grip 200. The first locking knob 210 is rotationally arranged on the first grip 200 through thread fit. One end of the first locking knob 210 can abut against the first limiting plane. When the first locking knob 210 abuts against the first limiting plane, the position of the first push rod 100 is fixed at this time. When the first locking knob 210 disengages from the first limiting plane, the first push rod 100 can move.

[0052] Optionally, the second limiting boss 206 can also be arranged on the first limiting section 101 of the first push rod 100, and the second limiting groove 1011 can be arranged on the inner wall of the first grip 200, which can also achieve the above effects.

[0053] Similarly, in order to enable the second grip 401 to make a reciprocating linear movement relative to the second sleeve 400, a fourth limiting groove 403 is arranged on the second sleeve 400, and a fourth limiting boss 4014 is arranged on the second grip 401. The fourth limiting boss 4014 is clamped in the fourth limiting groove 403. The fourth limiting groove 403 has a preset length to satisfy the reciprocating linear movement of the second grip 401 relative to the second sleeve 400.

[0054] Further, as Figure 8 and Figure 9 shown, in order to fix the first threaded pipe 202, a circular fixing plate 2021 can also be arranged at one end of the first threaded pipe 202. The circular fixing plate 2021 is coaxially arranged with the first threaded pipe 202. An annular supporting surface is arranged on the first abutting section 102. The inner diameter of the annular supporting surface is the same as the outer diameter of the circular fixing plate 2021. In the initial state, the circular fixing plate 2021 abuts against the annular supporting surface. It should be particularly noted that the outer diameter of the circular fixing plate 2021 is larger than the outer diameter of the threaded section of the first threaded pipe 202, so as to ensure that there is a gap between the first threaded pipe 202 and the annular supporting surface, so that the first abutting section 102 can smoothly advance and abut against the first limiting block 203.

[0055] Further, in order to accurately measure the needle insertion depth, a first scale marking 209 is arranged on the first grip 200, and a needle insertion depth marking is arranged on the first limiting block 203. In the initial position, the needle insertion depth marking is aligned with the 0 scale line of the first scale marking 209. When the needle insertion depth marking is aligned with a certain numerical scale line of the first scale marking 209, it indicates the needle insertion depth of the syringe needle.

[0056] Further, as Figure 13As shown, a needle base 303 is provided inside the first sleeve 300. The outer shape of the needle base 303 is adapted to the internal structure of the first sleeve 300, so that the needle base 303 can move linearly inside the first sleeve 300. One end of the needle tube 600 is connected to the needle base 303. A first connecting block 3031 is arranged on the needle base 303. The first connecting block 3031 protrudes relative to the needle base 303. A first notch 302 is formed on the side of the first sleeve 300. The first notch 302 has a preset length, so as to meet the adjustment of the moving distance of the needle tube 600. The first connecting block 3031 extends out of the first notch 302 and is connected to the first slider 301. In this embodiment, a first connecting groove 3011 adapted to the first connecting block 3031 is arranged on the first slider 301. The first connecting block 3031 is partially clamped in the first connecting groove 3011, and the two are fixed by means of glue bonding, clamping, etc. In this embodiment, the number of the first notches 302 is two, and the number of the first connecting blocks 3031 is two. It can be known that the number of the first notches 302 and the first connecting blocks 3031 is not limited by the present invention, and only the connection between the first slider 301 and the needle base 303 is required.

[0057] In one embodiment, in order to limit the first slider 301, a first limiting plate 304 is arranged at the connection between the first sleeve 300 and the first push rod 100, and a second limiting plate 402 is arranged at the connection between the first sleeve 300 and the second sleeve 400. The first slider 301 can abut against the first limiting plate 304 or the second limiting plate 402, so as to prevent the first slider 301 from moving beyond the limit.

[0058] In this embodiment, for the convenience of assembly, the first sleeve 300 and the first push rod 100 are integrally formed. The first limiting plate 304 is arranged on the first sleeve 300. The second sleeve 400 is detachably connected to the first sleeve 300. In this embodiment, a threaded fit is adopted for fixation, so the second limiting plate 402 is arranged on the second sleeve 400, which is convenient for opening a threaded hole at the second limiting plate 402, and an adapted external thread is arranged at the other end of the first sleeve 300.

[0059] Optionally, the first sleeve 300 and the second sleeve 400 can also be connected in a snap form. The first push rod 100 and the first sleeve 300 can also be arranged in a split structure, which is consistent with the connection structure between the first sleeve 300 and the second sleeve 400.

[0060] Furthermore, in order to facilitate the precise control of the moving distance of the needle tube 600, such as Figure 12As shown, a second scale marking 306 is provided on the first sleeve 300. The edge line of the first slider 301 can be aligned with the second scale marking 306. The number at which the edge line of the first slider 301 is aligned with the second scale marking 306 is the moving distance of the syringe 600 in this embodiment. To facilitate fixing the relative position of the syringe 600, a second locking knob 305 is provided on the first slider 301. The second locking knob 305 is arranged on the first slider 301 through a threaded fit. One end of the second locking knob 305 can abut against or disengage from the first sleeve 300. In this embodiment, a planar structure is provided on the first sleeve 300 to facilitate the abutting and fixing of the second locking knob 305.

[0061] In one embodiment, as Figure 14 shown, a third scale marking 404 is provided on the second sleeve 400. The edge line of the second grip 401 can be aligned with the third scale marking 404. A third locking knob 4013 is provided on the second grip 401. The third scale marking 404 and the third locking knob 4013 are the same as the foregoing principle and will not be elaborated here. The second grip 401 can abut against the second limiting plate 402 so that the second limiting plate 402 can limit the second grip 401. In this embodiment, a card slot is provided on the second grip 401, and a first card holder 4015 is provided on the card slot. The first card holder 4015 is detachably arranged in the card slot, and one end of the needle core 700 is connected to the first card holder 4015, so as to realize the second grip 401 driving the needle core 700 to move.

[0062] Furthermore, as Figure 14 and Figure 15 shown, a first wire 4011 is further included. The first wire 4011 can also be fixedly connected to the first card holder 4015. The first wire 4011 is electrically connected to the needle core 700, so as to realize the ablation energy of the external energy generator being transmitted to the first ablation electrode 701 through the needle core 700. To facilitate the plugging and unplugging with the external energy generator, a first plug 40111 is provided at one end of the first wire 4011, and conduction with the external energy generator is achieved by plugging and unplugging the first plug 40111.

[0063] Optionally, the first wire 4011 can also be electrically connected to the syringe 600, and the above purpose can also be achieved.

[0064] Furthermore, as Figure 15 and Figure 16As shown in the figure, a third limiting groove 405 is provided on the first sleeve 300, and a matching third limiting boss 4016 is provided on the inner wall of the second grip 401. The third limiting boss 4016 can be clamped in the third limiting groove 405, so as to realize the limitation between the second grip 401 and the first sleeve 300. By providing the third limiting groove 405 and the third limiting boss 4016, it is possible to prevent the second grip 401 from moving beyond the limit relative to the second sleeve 400.

[0065] In one embodiment, the present invention further provides an operation method of a monopolar adjustable ablation device, which is applied to a monopolar adjustable ablation device in each of the above embodiments, and includes the following steps: S1. Confirm the needle insertion depth. As Figure 2 shown, the needle core 700 and the needle tube 600 move synchronously and extend out of the delivery sheath 500 to a preset position; the specific process is as follows: As Figure 6 shown, rotate the first knob 201 to drive the first threaded tube 202 to rotate. At this time, under the action of the first threaded tube 202, the first limiting block 203 moves linearly. When it moves to the preset position, at this time, unlock the first locking knob 210, push the first push rod 100, and the first push rod 100 moves linearly relative to the first grip 200, driving the needle tube 600 and the needle core 700 to move synchronously and extend out of the delivery sheath 500. As Figure 18 shown, this is the moving direction of A1. When the first abutting section 102 of the first push rod 100 abuts against the first limiting block 203, at this time, lock the first knob 201, and the adjustment of the needle insertion depth is completed.

[0066] S2. According to the size, shape of the lesion and the initial needle insertion position, adjust the relative length of the needle core 700 extending out of the needle tube 600 and fix the relative position; as Figure 18 shown by the moving directions of A2 and A3 in When puncturing into the lesion tissue, if only the needle tube 600 is retracted, that is, in the right direction as shown in Figure 12 and Figure 15 shown, unlock the second locking knob 305, retract the first slider 301, drive the needle tube 600 to retract. At this time, the needle core 700 leaks out relative to the needle tube 600. According to the size of the lesion tissue, adjust the relative length of the needle core 700 extending out of the needle tube 600 to ensure that the pulsed electric field can cover the lesion tissue. When the required discharge length is adjusted, at this time, lock the second locking knob 305. In this embodiment, the distal part of the needle core 700 is an exposed metal structure, which constitutes the first ablation electrode 701. The needle core 700 is electrically connected in contact with the needle tube 600. At this time, the length of the needle core 700 extending out relative to the needle tube 600 is the increased effective ablation length of the second ablation electrode 601.

[0067] It can also be, for example, only the forward movement of the needle core 700, that is Figure 15 in the left direction shown. At this time, the third locking knob 4013 is unlocked, and by moving the second grip 401 to the left in the direction shown Figure 15 , the needle core 700 is driven to extend out of the needle tube 600 and adjusted to the required discharge length, and then the third locking knob 4013 is locked.

[0068] If the lesion tissue is very large, the needle core 700 and the needle tube 600 can also be moved and adjusted. Just repeat the above steps for moving and adjusting the needle core 700 and the needle tube 600.

[0069] After the above operations are completed, both the second ablation electrode 601 and the first ablation electrode 701 are within the lesion tissue and their positions are fixed relative to the lesion tissue. At this time, the discharge operation is performed. In this embodiment, the lesion tissue is a tumor.

[0070] It should be noted that when the needle tube has a puncture tip 6011, during the puncture process, when a blood vessel is encountered, the needle core 700 is extended. Since the head end of the needle core 700 has a rounded and smooth guiding structure 7011, it can push the blood vessel aside. After the blood vessel is pushed aside, the needle tube 600 is pushed to continue puncturing along the path of the needle core 700. When the distal end of the needle tube 600 is a rounded and smooth guiding structure 7011, during the needle insertion, the blood vessel will not be directly damaged. When reaching the tumor position, since the softness and hardness of tumors vary, softer tumors can be directly penetrated. When a harder tumor is encountered, the needle core 700 can be extended. After the puncture tip 6011 provided on the needle core 700 punctures the tumor, the needle tube 600 is pushed to advance along the path of the needle core 700.

[0071] The above are only the preferred embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made. These improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A monopolar adjustable ablation device, characterized in that, Comprising: A stylet having a distal end and a proximal end, with a first ablation electrode provided at the distal end of the stylet; A needle tube having a distal end and a proximal end, with a second insulating layer provided on the needle tube, and the distal end of the needle tube being exposed to form a second ablation electrode; The stylet is movably disposed within the needle tube, the stylet is electrically connected to the needle tube, and the first ablation electrode can extend out of or be received within the needle tube; The stylet and the needle tube can move synchronously, and the stylet and the needle tube can also move relative to each other; A delivery sheath is movably sleeved on the needle tube, the needle tube can move relative to the delivery sheath, and the distal ends of the stylet and the needle tube can be received within or extend out of the delivery sheath; It further includes a first push rod, a first sleeve, and a second sleeve connected in sequence, and the first push rod, the first sleeve, and the second sleeve are coaxially arranged; The first push rod is provided with a first grip that can reciprocate linearly, the first sleeve is provided with a first slider that can reciprocate linearly, and the second sleeve is provided with a second grip that can reciprocate linearly; The proximal end of the delivery sheath is connected to the first grip, the proximal end of the needle tube is connected to the first slider, and the proximal end of the stylet is connected to the second grip; A first wire is disposed at one end of the second grip, one end of the first wire is electrically connected to the stylet or the needle tube, and the other end of the first wire is provided with a first plug.

2. The monopolar adjustable ablation device according to claim 1, characterized in that, A puncture tip is provided at the distal end of the needle tube, a smooth guiding structure is provided at the distal end of the stylet, or a smooth guiding structure is provided at the distal end of the needle tube, and a puncture tip is provided at the distal end of the stylet.

3. The monopolar adjustable ablation device according to claim 1, characterized in that, The first grip is provided with a first limiting block that can reciprocate linearly, the first limiting block can be fixed in position relative to the first grip, and one end of the first push rod can abut against the first limiting block.

4. The monopolar adjustable ablation device according to claim 3, characterized in that, It further includes a first threaded tube rotatably disposed relative to the first grip, the first limiting block is provided with a matching first threaded hole, and the first limiting block is sleeved on the first threaded tube through the first threaded hole.

5. The monopolar adjustable ablation device according to claim 4, characterized in that, A first limiting structure is provided between the first grip and the first limiting block to enable the first limiting block to reciprocate linearly along the axis of the first threaded tube; The first limiting structure includes a first limiting groove provided on the first grip and a first limiting boss provided on the first limiting block, or a first limiting boss provided on the first grip and a first limiting groove provided on the first limiting block, the first limiting groove and the first limiting boss are matched, and the limiting boss is clamped within the first limiting groove.

6. The monopolar adjustable ablation device according to claim 4, characterized in that, It further includes a first knob rotatably disposed on the first grip, and the first knob is connected to the first threaded tube to drive the first threaded tube to rotate relative to the first grip.

7. The monopolar adjustable ablation device according to claim 6, characterized in that, The first knob is provided with a first annular groove, the first grip is provided with a first annular boss, or the first knob is provided with a first annular boss, the first grip is provided with a first annular groove, the first annular groove and the first annular boss are matched, and the first annular boss is clamped within the first annular groove.

8. The monopolar adjustable ablation device according to claim 4, characterized in that, A first support plate is provided on the first grip, a first support groove is provided on the first support plate, and a part of the first threaded tube is rotatably arranged in the first support groove.

9. The monopolar adjustable ablation device according to claim 8, characterized in that, A first fixed card slot is provided in the first grip, which is arranged at one end close to the first threaded tube. A first fixed card block is provided on the first fixed card slot, and one end of the delivery sheath tube passes through the first threaded tube and is connected to the first fixed card block.

10. The monopolar adjustable ablation device according to claim 4, characterized in that, The first push rod includes a first abutting section and a first limiting section. The first abutting section is offset relative to the first limiting section. The first abutting section can abut against the first limiting block, and the first limiting section is used to limit the first push rod to perform reciprocating linear movement.

11. The monopolar adjustable ablation device according to claim 10, characterized in that, The first limiting section is provided with a first limiting plane and a second limiting groove. A first baffle is arranged on the first grip. The first limiting section can abut against the first baffle, and the first limiting plane abuts against the first baffle. A second limiting boss and a first locking knob are arranged on the first grip. The second limiting boss is clamped in the second limiting groove, and one end of the first locking knob can abut against the first limiting plane.

12. The monopolar adjustable ablation device according to claim 3, characterized in that, The first limiting block is provided with a needle insertion depth scale line, and the first grip is provided with a first scale line. The needle insertion depth scale line can be aligned with the first scale line.

13. The monopolar adjustable ablation device according to claim 1, characterized in that, A needle seat is arranged in the first sleeve. One end of the needle tube is connected to the needle seat. A first connecting block is arranged on the needle seat. A first slot adapted to it is arranged on the first sleeve. The first slot has a preset length. The first connecting block passes through the first slot and is connected to the first slider.

14. A monopolar adjustable ablation device according to claim 1, characterized in that, A first limiting plate is arranged at the connection between the first push rod and the first sleeve. A second limiting plate is arranged at the connection between the first sleeve and the second sleeve. The first slider can abut against the first limiting plate or the second limiting plate.

15. A monopolar adjustable ablation device according to claim 1, characterized in that, A second scale line is arranged on the first sleeve. A second locking knob is arranged on the first slider. The side line of the first slider can be aligned with the second scale line. One end of the second locking knob can abut against the first sleeve.

16. A monopolar adjustable ablation device according to claim 14, characterized in that, The second sleeve is provided with a third scale line. A third locking knob is arranged on the second grip. The side line of the second grip can be aligned with the third scale line. One end of the third locking knob can abut against the first sleeve. The second grip can abut against the second limiting plate.

17. An operation method of a monopolar adjustable ablation device, characterized in that, It includes the following steps: S1. Confirm the needle insertion depth. Rotate the first knob to drive the first limiting block to a preset position, set the needle insertion depth, push the first push rod to drive the needle core and the needle tube to move synchronously until the first push rod abuts against the first limiting block, the needle core and the needle tube synchronously extend out of the delivery sheath tube, and fix the position of the first push rod; S2. According to the size, shape of the lesion and the initial needle insertion position, move the first slider to adjust the position of the needle tube, or move the second grip to adjust the position of the needle core, so that the needle core extends out of the needle tube by a certain length, and fix their relative positions; S3. Turn on the power supply and perform a discharge operation.

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