Bipolar ablation device passing through human body cavity and operation method

Abstract

The invention provides a bipolar ablation device passing through a human body cavity and an operation method, and the device mainly comprises a needle core which is provided with a first ablation electrode; the needle tube is provided with a second ablation electrode; the needle core is arranged in the needle tube in a penetrating mode, the needle core and the needle tube can move synchronously, the needle core and the needle tube can move relatively, and the first ablation electrode can extend out of or be contained in the needle tube; when the first ablation electrode extends out of the needle tube, an adjustable preset distance is arranged between the first ablation electrode and the second ablation electrode, a puncture tip is arranged at the far end of the needle tube, and a smooth guide structure is arranged at the far end of the needle core, or the smooth guide structure is arranged at the far end of the needle tube, and the puncture tip is arranged at the far end of the needle core. By the adoption of the structure, the preset interval is adjusted to achieve adjustment of the ablation area so as to achieve coverage of a focus. Meanwhile, the smooth guide structure and the puncture tip are arranged on the needle core and the needle tube respectively, so that the puncture ablation capacity is achieved, and meanwhile the situation that in the conveying process, the puncture tip damages the blood vessels of the human body can be avoided.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a bipolar ablation device and an operation method through a human body cavity. 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 stronger electric fields causing permanent permeability of cell membranes and resulting 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] Among existing devices, since most bipolar ablation devices have two forms, one is that the lengths and positions of the two ablation electrodes are fixed, and the other is that the lengths and positions of the two electrodes are adjustable. For the device with the fixed form of the lengths and positions of the two ablation electrodes, the design of this device cannot be adjusted according to the size and shape of the tumor, resulting in over-ablation or under-ablation. Over-ablation is likely to damage normal tissues around the tumor, and under-ablation cannot complete the complete ablation of the tumor. For the second case, currently, related patent applications usually control the length of the exposed electrode by moving the outer sheath tube to solve the existing problems. Therefore, there must be a physical gap between the outer sheath tube and the electrode. On the one hand, it will cause conductive liquids such as human blood to fill the outer sheath tube, resulting in an error in the effective ablation length of the electrode; if the liquid reaches the handle part along the outer sheath tube, it may cause accidental injury to the operator. In addition, due to the gap between the outer sheath tube and the needle electrode, during the process of advancing the tissue, it may deform or turn outwards, reducing the puncture force and even causing tissue damage. Especially when the device is punctured through the human body cavity or in cooperation with channels of equipment 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 tube is prone to phenomena such as kinking and deformation.

[0005] 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 is required to push the blood vessel aside 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, since the position of the tumor changes constantly 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 withdrawal 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

[0006] The present invention provides a bipolar ablation device for human body cavities, which solves the problems in the above background technology that 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 piercing blood vessels or normal tissues can be avoided. The present invention also provides an operation method for the bipolar ablation device for human body cavities.

[0007] To achieve the above object, the present invention adopts the following technical solutions: A needle core, having a distal end and a proximal end, with a first insulating layer provided on the needle core, and the distal end of the needle core is exposed to form a first ablation electrode; A needle tube, which has 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 is exposed to form a second ablation electrode; The needle core is inserted into the needle tube, the needle core and the needle tube can move synchronously, and the needle core and the needle tube can move relative to each other. The first ablation electrode can extend out or be received in the needle tube; when the first ablation electrode extends out of the needle tube, an adjustable preset distance is provided between the first ablation electrode and the second ablation electrode; Wherein, 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 needle core, 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 needle core; An outer sheath tube, sleeved on the needle tube, the needle tube and the outer sheath tube can move relative to each other, and the distal ends of the needle tube and the needle core can be received or extended out of the outer sheath tube; It further includes a first push rod, a first sleeve tube, and a second sleeve tube that are connected in sequence. A first grip that can move relatively is sleeved on the first push rod. A first slider that can move relatively is provided on the first sleeve tube. A second grip that can move relatively is provided on the second sleeve tube. The proximal end of the outer sheath tube is connected to the first grip. The proximal end of the needle tube is connected to the first slider. The proximal end of the stylet is connected to the second grip. Wherein, the first push rod, the first sleeve tube, and the second sleeve tube are coaxially arranged; and A first wire and a second wire. The first wire and the second wire are arranged at one end of the second grip. One end of the first wire is electrically connected to the stylet. One end of the second wire is electrically connected to the needle tube. The other end of the first wire is provided with a first plug. The other end of the second wire is provided with a second plug.

[0008] In some embodiments, a first limiting block that can perform reciprocating linear movement is provided on the first grip. The first limiting block can be fixed in position relative to the first grip. One end of the first push rod located inside the first grip can abut against the first limiting block.

[0009] In some embodiments, it further includes a first threaded tube that is rotatably arranged relative to the first grip. A first threaded hole adapted thereto is provided on the first limiting block. The first limiting block is sleeved on the first threaded tube through the first threaded hole.

[0010] 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 perform 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. The limiting boss is clamped in the first limiting groove.

[0011] In some embodiments, it further includes a first knob that is rotatably arranged on the first grip. The first knob is connected to the first threaded tube to drive the first threaded tube to rotate relative to the first grip.

[0012] In some embodiments, a first annular groove is provided on the first knob. A first annular boss is provided on the first grip, or a first annular boss is provided on the first knob. A first annular groove is provided on the first grip. The first annular groove and the first annular boss are adapted. The first annular boss is clamped in the first annular groove.

[0013] In some embodiments, 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 disposed in the first support groove.

[0014] In some embodiments, a first fixed card slot is provided in the first grip, the first fixed card slot 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 outer sheath tube passes through the first threaded tube and is connected to the first fixed card block.

[0015] 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.

[0016] 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, 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 clamped in the second limiting groove, and one end of the first locking knob can abut against the first limiting plane.

[0017] In some embodiments, a needle insertion depth scale line is provided on the first limiting block, a first scale line is provided on the first grip, and the needle insertion depth scale line can be aligned with the first scale line.

[0018] 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 thereto is provided on the first sleeve, the first slot has a preset length, and the first connecting block passes through the first slot and is connected to the first slider.

[0019] In some embodiments, a first limiting plate is provided at the connection between the first push rod and the first sleeve, a second limiting plate is provided at the connection between the first sleeve and the second sleeve, and the first slider can abut against the first limiting plate or the second limiting plate.

[0020] In some embodiments, a second scale 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 line, and one end of the second locking knob can abut against the first sleeve.

[0021] In some embodiments, the second sleeve is provided with a third scale marking, the second grip is provided with a third locking knob, the edge line of the second grip can be aligned with the third scale marking, one end of the third locking knob can abut against the first sleeve, and the second grip can abut against the second limiting plate.

[0022] In some embodiments, it further includes a first wire and a second wire disposed at one end of the second grip. One end of the first wire is electrically connected to the needle core, one end of the second wire passes through the second sleeve and is connected to the needle tube, the other end of the first wire is provided with a first plug, and the other end of the second wire is provided with a second plug.

[0023] In some embodiments, the present invention further provides an operation method of a bipolar ablation device, using a bipolar ablation device through a human body cavity as described in each of the above embodiments, including the following steps: S1. Confirm the needle insertion depth, rotate the first knob to drive the first limiting block to move to a preset position, push the first push rod and abut it against the first limiting block, the needle core and the needle tube synchronously extend out of the outer 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 as to adjust the preset distance between the first ablation electrode and the second ablation electrode, and fix the relative positions of the needle core and the needle tube; S3. Turn on the power supply and perform a discharge operation.

[0024] Compared with the prior art, the beneficial effects brought by the present invention are: 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, while meeting the puncture conditions, the puncture tip can be sent to the target position before puncture, avoiding damage to normal human tissues or blood vessels caused by the puncture tip and reducing the operation difficulty of doctors. By the relative movement of the needle core and the needle tube, an adjustable preset distance is formed between the needle core and the needle tube, so that the discharge range of the ablation device can be adjusted, thereby meeting the ablation of lesions of different sizes.

[0025] Additional aspects and advantages of the present application will be given in part in the following description, which will become apparent from the following description, or can be understood through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a perspective view of a bipolar ablation device through a human body cavity of the present invention; Figure 2 is Figure 1Enlarged view of part A in [the figure]; Figure 3 is Figure 2 Another variant embodiment of the structure in [the figure]; Figure 4 Schematic diagram of the structure of the present invention with a partition groove provided on the syringe; Figure 5 Cross-sectional view of the first grip of a bipolar ablation device through a human body cavity of the present invention; Figure 6 Cross-sectional view of the first knob of the present invention; Figure 7 is Figure 5 Enlarged view of part C in [the figure]; Figure 8 Exploded view of the first grip of the present invention; Figure 9 Schematic diagram of the abutment of the first abutting section of the first push rod and one end of the first threaded tube of the present invention; 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 is Figure 15 Enlarged view of part B in [the figure]; Figure 17 Schematic diagram of the energy generator; Figure 18 Schematic diagram of the movement adjustment of the ablation device of the present invention. Detailed Description of the Invention

[0027] The following further describes the present application in detail with reference to 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.

[0028] As Figure 1-2As shown in the figure, a bipolar ablation device through a human body cavity 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, so as to form a second ablation electrode 601 for releasing ablation energy. The distal end of the needle tube 600 is as shown in the left side of Figure 2 In this embodiment, the human body cavity is, for example, a cavity such as a human airway, intestine, esophagus or blood vessel. In this embodiment, the ablation device needs to enter the human body cavity with the aid of an endoscope. The endoscope is provided with a working channel. The needle tube 600 and the needle core 700 are accommodated in an outer sheath tube 500 and move to the target position in the working channel through the outer sheath tube 500. The endoscope is a prior art and will not be elaborated here. In this embodiment, by means of hot melt 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 one 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.

[0029] The needle core 700 has a distal end and a proximal end. Its distal end and proximal end are in the same direction as those of the needle tube 600. The needle core 700 movably penetrates through 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 accommodated in or extend out of the needle tube 600. Specifically, a first insulating layer 702 is provided on the needle core 700 to make the needle core 700 and the needle tube 600 electrically insulated. The distal end of the needle core 700 is exposed to form the first ablation electrode 701, as shown in Figure 17 As shown in the figure, it is a schematic diagram of the positive and negative electrode sockets of an external energy generator. For example, when the second ablation electrode 601 is connected to the positive input terminal of the external energy generator and the first ablation electrode 701 is connected to the negative output terminal of the external energy generator; conversely, the same purpose can be achieved by connecting in the opposite way. In this embodiment, the needle core 700 needs to extend out of the needle tube 600 to a certain length so that a preset distance is left between the second ablation electrode 601 and the first ablation electrode 701, thereby avoiding electrical contact between the second ablation electrode 601 and the first ablation electrode 701. The size of the preset distance between the second ablation electrode 601 and the first ablation electrode 701 is adjusted according to the size of the tumor tissue, so as to achieve one-time complete ablation of a larger tumor tissue, avoid repeated puncture ablation, reduce the difficulty of surgical operation, and improve the ablation efficiency.

[0030] 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 shown in Figure 2 In the figure, 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 shown inFigure 3 As 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 603 are formed on the surface of the needle tube 600 to ensure its flexibility and enable it to bend within the 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 for easier puncture. In addition, by providing the partition grooves 603, it is also possible to facilitate the operator to identify the position of the needle tube under CT, achieving a visualization effect for easier operation by the operator.

[0031] 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 aside, thus avoiding the blood vessels being punctured and causing unnecessary damage, reducing the operation difficulty for doctors.

[0032] In one embodiment, as Figure 5 As shown, to achieve the synchronous movement of the stylet 700 and the needle tube 600, a first grip 200 and a first push rod 100 are further included. A part of the first push rod 100 is inserted into the first grip 200, and the first push rod 100 can perform reciprocating linear movement relative to the first grip 200. As Figure 15 As shown, the stylet 700 is connected to the second grip 401, the needle tube 600 is connected to the first slider 301, and the first slider 301 and the second grip 401 can be fixed relative to the position of the first push rod 100. By relatively moving between the first push rod 100 and the first grip 200, the synchronous movement of the stylet 700 and the needle tube 600 is achieved.

[0033] Furthermore, as Figure 1 As shown, an outer sheath tube 500 is provided on the needle tube 600 to facilitate the delivery of the needle tube 600. The outer sheath tube 500 is an insulating tube, such as made of materials like PTFE / pebax / ptfe and PI. One end of the outer sheath tube 500 is fixedly connected to the first grip 200. In the initial state, both the needle tube 600 and the stylet 700 are received within the outer sheath tube 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 from the other end of the outer sheath tube 500 for puncturing the lesion tissue.

[0034] Further, in order to accurately control the needle insertion depth, as Figure 5 shown, a first limiting block 203 capable of 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 in the first grip 200 can abut against the first limiting block 203. By arranging the first limiting block 203, accurate regulation of the puncture depth can be carried out before the operation to avoid excessive puncture or incomplete puncture, and the expected ablation effect cannot be achieved.

[0035] In one embodiment, in order to facilitate the reciprocating linear movement of the first limiting block 203 on the first grip 200, a first threaded tube 202 rotatably arranged on the first grip 200 is further included. An external thread is arranged on the first threaded tube 202, and 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, and the first limiting structure is used to make the first limiting block 203 perform reciprocating linear movement.

[0036] Specifically, as Figure 8 shown, the first limiting structure includes a first limiting boss arranged on the first limiting block 203 and a first limiting groove 204 arranged on the inner wall of the first grip 200. The first limiting groove 204 is set to have a certain length to meet the needle insertion requirement of the needle tube 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 performs reciprocating linear movement on the first threaded tube 202.

[0037] Optionally, as another deformation mode of this embodiment, the first limiting groove 204 can be arranged on the first limiting block 203, and the first limiting boss can be arranged on the inner wall of the first grip 200, and the above purpose can also be achieved.

[0038] 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 arranged on the first grip 200, and a part of the first limiting block 203 extends out of the first grip 200 through the notch to form a pushing structure, and the reciprocating linear movement of the first limiting block 203 can also be realized.

[0039] In one embodiment, to facilitate the control of the first limiting block 203, a first knob 201 is provided at one end of the first grip 200 close to the outer sheath tube 500. The first knob 201 is connected to the first threaded tube 202, and the first knob 201 is rotatably arranged relative to the first grip 200. By rotating the first knob 201, the first threaded tube 202 is driven to rotate, thereby realizing the reciprocating movement of the first limiting block 203. In this embodiment, for the convenience of assembly, the first knob 201 and the first threaded tube 202 are detachably arranged, such as Figure 5 , Figure 6 and Figure 8 shown, fixed by threaded connection and cooperation. Optionally, it can also be fixed by snap connection. Optionally, the first knob 201 and the first threaded tube 202 can also be integrally arranged. At the same time, since the first grip 200 is arranged 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. Further, a first internal thread 2011 for connecting to an external instrument is also provided on the first knob 201, and its connection principle is similar to the connection principle and structure of a Luer connector, which will not be elaborated here.

[0040] Specifically, as Figure 6 and Figure 8 shown, 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 realize the rotatable arrangement of the first knob 201 relative to the first grip 200.

[0041] In one embodiment, 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, a first support groove is provided on the first support plate 212. The first support groove is adapted to a part of the structure of the first threaded tube 202, and a part of the first threaded tube 202 is rotatably arranged in the first support groove.

[0042] In one embodiment, as Figure 8 and Figure 9As shown in the figure, for the convenience of fixing the outer sheath tube 500, a first fixing card slot 208 is provided in the first grip 200, and a first fixing block 207 is arranged in the first fixing card slot 208. The first fixing card slot 208 is arranged at one end close to the first threaded tube 202. One end of the outer sheath tube 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 outer sheath tube 500 relative to the first grip 200. By setting this structure, the outer sheath tube 500 passes through the first threaded tube 202, thereby further strengthening the support structure of the first threaded tube 202.

[0043] In one embodiment, as Figure 11 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, for the convenience of the first push rod 100 and the first limiting block 203 to abut and there is no movement interference between the first push rod 100 and the first threaded tube 202, the first push rod 100 is set as 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 make reciprocating linear movement along its own axis direction.

[0044] Specifically, as Figure 13 shown, to ensure the stability of the abutting structure, the first abutting section 102 is an arc plate structure of a continuous structure. The radian range of the arc plate is not more 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 plate structure of the first abutting section 102 can cover the thread length of the first threaded tube 202 to facilitate the maximum needle insertion depth of the needle tube 600. By setting the first abutting section 102 of the arc 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 arranged on the first limiting section 101, and a second limiting boss 206 is arranged 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. The second limiting boss 206 is clamped in the second limiting groove 1011; on this basis, a first limiting plane is also arranged on the first limiting section 101, as Figure 7 and Figure 11As shown, a first baffle 205 is provided on the first grip 200. 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 Figure 6 up and down direction of the direction shown. In the initial position, as Figure 7 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 a threaded 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.

[0045] Optionally, the second limiting boss 206 can also be provided on the first limiting section 101 of the first push rod 100, and the second limiting groove 1011 can be provided on the inner wall of the first grip 200, which can also achieve the above effects.

[0046] 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 provided on the second sleeve 400, and a fourth limiting boss 4014 is provided on the second grip 401. The fourth limiting boss 4014 is clamped in the fourth limiting groove 403. The fourth limiting groove 403 is provided with a preset length to satisfy the reciprocating linear movement of the second grip 401 relative to the second sleeve 400.

[0047] Further, as Figure 8 and Figure 9 shown, in order to fix the first threaded tube 202, a circular fixing plate 2021 can also be provided at one end of the first threaded tube 202. The circular fixing plate 2021 is coaxially arranged with the first threaded tube 202. An annular supporting surface is provided 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 tube 202, so as to ensure that there is a gap between the first threaded tube 202 and the annular supporting surface, so that the first abutting section 102 can smoothly advance and abut against the first limiting block 203.

[0048] Further, in order to accurately control the needle insertion depth, a first scale marking 209 is provided on the first grip 200, and a needle insertion depth marking is provided on the first limiting block 203. At 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 tube.

[0049] In one embodiment, as Figure 12 and 13 shown, at one end of the first push rod 100 located outside the first grip 200, a first sleeve 300 and a second sleeve 400 are further provided. 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 provided on the first sleeve 300. The first slider 301 can make a reciprocating linear movement along the axis direction of the first sleeve 300. One end of the syringe tube 600 is connected to the first slider 301; a second grip 401 is provided on the second sleeve 400. The second grip 401 can make a reciprocating linear movement along the axis direction of the second sleeve 400. One end of the needle core 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 40172 is provided at one end of the second grip 401, and a first clamping ring 40171 is provided in the first clamping groove 40172. The first clamping ring 40171 is provided with a clamping boss with a guiding surface structure, and the clamping boss can be clamped in the first clamping groove 40172, so as to fix the two shells.

[0050] By adopting the above structure, the synchronous movement of the syringe tube 600 and the needle core 700 is controlled, and at the same time, the separate movement of the syringe tube 600 and the needle core 700 is realized.

[0051] Further, as Figure 13As shown in the figure, a needle holder 303 is provided inside the first sleeve 300. The outer shape of the needle holder 303 is adapted to the internal structure of the first sleeve 300, so that the needle holder 303 can move linearly inside the first sleeve 300. One end of the needle tube 600 is connected to the needle holder 303. A first connecting block 3031 is provided on the needle holder 303. The first connecting block 3031 protrudes relative to the needle holder 303. A first notch 302 is formed on the side of the first sleeve 300. The first notch 302 has a preset length 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 provided 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 holder 303 is required.

[0052] In one embodiment, in order to limit the first slider 301, a first limiting plate 304 is provided at the connection between the first sleeve 300 and the first push rod 100, and a second limiting plate 402 is provided 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.

[0053] 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 provided on the first sleeve 300. The second sleeve 400 is detachably connected to the first sleeve 300. In this embodiment, a threaded fit is used for fixation, so the second limiting plate 402 is provided on the second sleeve 400 to facilitate the opening of a threaded hole at the second limiting plate 402, and an adapted external thread is provided at the other end of the first sleeve 300.

[0054] Optionally, the first sleeve 300 and the second sleeve 400 can also be connected in a snap - fit form. The first push rod 100 and the first sleeve 300 can also be provided in a split structure, which is consistent with the connection structure between the first sleeve 300 and the second sleeve 400.

[0055] Further, in order to facilitate the precise control of the moving distance of the needle tube 600, 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.

[0056] 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.

[0057] Further, as Figure 1 and Figure 14 as well as Figure 15 shown, it further includes a first wire 4011 and a second wire 4012, and the first wire 4011 and the second wire 4012 are insulated from each other. Specifically, in this embodiment, a part of the first wire 4011 and the second wire 4012 are coated together to facilitate the fixed connection with the first card holder 4015. The first wire 4011 is electrically connected to the needle core 700, and the second wire 4012 is connected to the syringe 600. Specifically, as Figure 15 shown, a suitable through hole is provided on the second sleeve 400. One end of the second wire 4012 passes through the through hole and enters the first sleeve 300, then passes through the cavity of the first sleeve 300 and is fixedly arranged on the first slider 301, and then is electrically connected to the syringe 600. Further, as Figure 1As shown, a first plug 40111 is provided on the first wire 4011, and a second plug 40121 is provided on the second wire 4012. Both the first plug 40111 and the second plug 40121 are connected to an energy generator. For example, when the first plug 40111 is inserted into the input end of the energy generator, the second plug 40121 is inserted into the output end of the energy generator; when the first plug 40111 is inserted into the output end of the energy generator, the second plug 40121 is inserted into the input end of the energy generator.

[0058] Optionally, a conductive metal sleeve can also be provided inside the second sleeve 400. The second wire 4012 is electrically connected to the metal sleeve. A metal conductive rod is fixedly provided on the first slider 301. The metal conductive rod is of a rigid structure. One end of the metal conductive rod is electrically connected to the needle tube 600, and the other end of the metal conductive rod is movably inserted into the metal sleeve. A part of the metal conductive rod is arranged coaxially with the metal sleeve, so as to ensure good sliding electrical connection therebetween. The length of the metal conductive rod should be such that when the first slider 301 slides to Figure 15 the left extreme position in

[0059] Furthermore, as shown in Figure 15 and Figure 16 , a third limiting groove 405 is provided on the second sleeve 400, 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 snapped into the third limiting groove 405, so as to realize the limitation between the second grip 401 and the second sleeve 400. At this time, the second grip 401 has reached the extreme position and cannot move further in the right direction as shown in Figure 15 , thus preventing the operator from over-sliding the second grip 401 relative to the second sleeve 400.

[0060] In one embodiment, the present invention further provides an operation method for a bipolar ablation device, using a bipolar ablation device through a human body cavity in any of the above embodiments, including the following steps: S1. Confirm the needle insertion depth, and the needle core 700 and the needle tube 600 move synchronously and extend out of the outer sheath tube 500 to a preset position; the specific process is as follows: 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, unlock the first locking knob 210 at this time, and push the first push rod 100. 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 outer sheath tube 500, as shown in Figure 18As shown, it 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, lock the first locking knob 210 at this time, and the adjustment of the needle insertion depth is completed.

[0061] S2. According to the size, shape of the lesion and the initial needle insertion position, adjust the preset distance between the second ablation electrode 601 and the first ablation electrode 701 and fix the relative position; as Figure 18 the moving directions of A2 and A3 in, the specific process is as follows: When puncturing into the lesion tissue, if only the syringe 600 is moved backward, that is, as Figure 15 shown in the right direction, unlock the second locking knob 305, move the first slider 301 backward, drive the syringe 600 to move backward. At this time, the needle core 700 leaks out relative to the syringe 600. According to the size of the lesion tissue, adjust the preset distance between the second ablation electrode 601 and the first ablation electrode 701 to ensure that the pulsed electric field can cover the lesion tissue. When the required preset distance is adjusted, lock the second locking knob 305 at this time.

[0062] It can also be, for example, if only the needle core 700 is moved forward, that is, as Figure 15 shown in the left direction, unlock the third locking knob 4013 at this time, and by moving the second grip 401 to the left in the Figure 15 shown direction, drive the needle core 700 to extend out of the syringe 600 and adjust to the required preset distance, and then lock the third locking knob 4013.

[0063] If the lesion tissue is very large, the needle core 700 and the syringe 600 can also be moved and adjusted. Repeat the above moving and adjusting steps of the needle core 700 and the syringe 600.

[0064] After the above operations are completed, both the second ablation electrode and the first ablation electrode are in the lesion tissue, and their positions are fixed relative to the lesion tissue. At this time, the discharging operation is performed. In this embodiment, the lesion tissue is a tumor.

[0065] It should be noted that when puncturing into the human body, if the syringe 600 has a puncture tip 6011, when encountering a blood vessel during the puncture process, extend the needle core 700. Since the distal end of the needle core 700 has a round and smooth guiding structure 7011, the blood vessel is pushed open. After the blood vessel is pushed open, push the syringe 600 to continue puncturing along the path of the needle core 700. If the distal end of the syringe 600 is a round and smooth guiding structure 7011, when inserting the needle, the blood vessel will not be directly damaged. When reaching the tumor position, since the softness and hardness of the tumor vary, a softer tumor can be directly penetrated. When encountering a harder tumor, the needle core 700 can be extended. After the puncture tip 6011 at the distal end of the needle core 700 punctures the tumor, push the syringe 600 to advance along the path of the needle core 700.

[0066] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the protection scope of the present invention.

Claims

1. A bipolar ablation device for passing through a human body cavity, characterized in that, Comprising: A stylet having a distal end and a proximal end, with a first insulating layer provided on the stylet, and the distal end of the stylet being exposed to form a first ablation electrode; 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 inserted into the needle tube, the stylet and the needle tube can move synchronously, and the stylet and the needle tube can move relative to each other. The first ablation electrode can extend out or be retracted into the needle tube; when the first ablation electrode extends out of the needle tube, an adjustable preset distance is provided between the first ablation electrode and the second ablation electrode; Wherein, 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; An outer sheath tube is sleeved on the needle tube, the needle tube and the outer sheath tube can move relative to each other, and the distal ends of the needle tube and the stylet can be retracted into or extend out of the outer sheath tube; It further includes a first push rod, a first sleeve tube and a second sleeve tube connected in sequence. A relatively movable first grip is sleeved on the first push rod. A relatively movable first slider is provided on the first sleeve tube. A relatively movable second grip is provided on the second sleeve tube. The proximal end of the outer sheath tube is connected to the first grip. The proximal end of the needle tube is connected to the first slider. The proximal end of the stylet is connected to the second grip. Wherein, the first push rod, the first sleeve tube and the second sleeve tube are coaxially arranged; And a first wire and a second wire. The first wire and the second wire are arranged at one end of the second grip. One end of the first wire is electrically connected to the stylet. One end of the second wire is electrically connected to the needle tube. The other end of the first wire is provided with a first plug. The other end of the second wire is provided with a second plug.

2. The bipolar ablation device for passing through a human body cavity according to claim 1, characterized in that, 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. One end of the first push rod located inside the first grip can abut against the first limiting block.

3. The bipolar ablation device for passing through a human body cavity according to claim 2, characterized in that, It further includes a first threaded tube rotatably arranged relative to the first grip. A matching first threaded hole is provided on the first limiting block. The first limiting block is sleeved on the first threaded tube through the first threaded hole.

4. The bipolar ablation device for passing through a human body cavity according to claim 3, 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 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 matched, and the limiting boss is clamped in the first limiting groove.

5. The bipolar ablation device for passing through a human body cavity according to claim 3, characterized in that, It further includes a first knob rotatably arranged on the first grip. The first knob is connected to the first threaded tube to drive the first threaded tube to rotate relative to the first grip.

6. The bipolar ablation device for passing through a human body cavity according to claim 5, characterized in that, The first knob is provided with a first annular groove, and the first grip is provided with a first annular boss, or the first knob is provided with a first annular boss, and the first grip is provided with a first annular groove. The first annular groove and the first annular boss are adapted, and the first annular boss is clamped in the first annular groove.

7. The bipolar ablation device for passing through a human body cavity according to claim 3, characterized in that, The first grip is provided with a first support plate, and the first support plate is provided with a first support groove. A part of the first threaded tube is rotatably arranged in the first support groove.

8. The bipolar ablation device for passing through a human body cavity according to claim 3, characterized in that, A first fixed card slot is arranged in the first grip, and the first fixed card slot is arranged at one end close to the first threaded tube. A first fixed card block is arranged on the first fixed card slot, and one end of the outer sheath tube passes through the first threaded tube and is connected to the first fixed card block.

9. The bipolar ablation device for passing through a human body cavity according to claim 2, 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.

10. The bipolar ablation device for passing through a human body cavity according to claim 9, 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.

11. The bipolar ablation device for passing through a human body cavity according to claim 2, 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.

12. The bipolar ablation device for passing through a human body cavity 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. The needle seat is provided with a first connecting block. The first sleeve is provided with a matching first notch. The first notch has a preset length. The first connecting block passes through the first notch and is connected to the first slider.

13. The bipolar ablation device for passing through a human body cavity 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.

14. A bipolar ablation device through a human body cavity according to claim 1, characterized in that, The first sleeve is provided with a second scale line. The first slider is provided with a second locking knob. 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.

15. A bipolar ablation device through a human body cavity according to claim 13, characterized in that, The second sleeve is provided with a third scale line. The second grip is provided with a third locking knob. 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.

16. An operation method of a bipolar ablation device through a human body cavity, characterized in that, Using a bipolar ablation device through a human body cavity according to any one of claims 1-15, comprising the following steps: S1. Confirm the needle insertion depth, rotate the first knob to drive the first limiting block to move to a preset position, push the first push rod and abut it against the first limiting block. The needle core and the needle tube extend out of the outer sheath tube synchronously, 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 as to adjust the preset distance between the first ablation electrode and the second ablation electrode, and fix the relative positions of the needle core and the needle tube; S3. Connect the power supply and perform the discharge operation.

Images