Electrode assembly for preventing needle passage bleeding and hemostatic instrument thereof

Abstract

The invention belongs to the technical field of medical instruments, and relates to an electrode assembly for preventing needle passage bleeding and a hemostasis instrument thereof. The electrode needle comprises an insulating needle head, an electrode I, an insulating part and an electrode II which are sequentially arranged from far to near; the polarity of the electrode I is opposite to that of the electrode II; the near end of the electrode II is wrapped with an outer insulating layer; the insulating tube is sleeved outside the electrode needle, the far end of the insulating tube is a cutting edge, and the side part of the insulating tube is provided with a coagulation cutting window; the control piece is connected with the insulating tube so as to control the insulating tube to rotate and / or move in the axial direction of the electrode needle; when the insulating tube is located at the farthest end, the single side of the first electrode and the single side of the second electrode are exposed through the coagulation cutting window, and the insulating needle head is exposed; when the insulating tube is located at the nearest end, the first electrode and the second electrode are completely exposed. The technical problem that needle passage bleeding is easily caused in the prior art is solved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to an electrode assembly for preventing needle tract bleeding and a hemostatic instrument thereof. Background Art

[0002] Electrosurgical hemostatic instruments are often used in surgical operations, such as electrosurgical knives, electrocoagulation forceps, ultrasonic scalpels, electrocoagulation forceps, etc. Currently, the hemostatic instruments on the market usually adopt two methods: "surface ablation" and "insertion ablation". Especially for the deep hemostatic instruments of "insertion ablation", most of them on the market do not have a cooling function at present, resulting in rapid drying and carbonization of tissues, and the phenomenon of "sticking to the knife" occurs. At this time, more time is required to clean the electrode.

[0003] In the field of ablation hemostasis of solid organs, such as in the clinical application of liver ablation, it is found that for the 'insertion ablation', even if the cooling function of the hemostatic electrode is increased, there is still a small probability of 'needle tract bleeding' during the insertion and extraction process. The so-called 'needle tract bleeding' means that after ablation, the tissue often adheres to the electrode to a certain extent. If the cooling effect on the electrode is weakened (such as too high main machine output power or too long electrode ablation time, etc.), the adhesion will be stronger; when the adhesion is relatively strong, if the 'needle is pulled out' forcefully, a piece of tissue will be pulled off, causing the originally coagulated part to bleed again. At this time, the operator can only repeat the operation or perform targeted hemostasis on the bleeding site. However, before performing secondary hemostasis, the operator often needs to clean the hemostatic electrode first and then perform the operation, which causes unnecessary trouble and wastes surgical time.

[0004] It is understood that there is no practical directional ablation hemostatic instrument on the market at present. This directional ablation function can avoid damage to important organs or blood vessels around the target tissue in clinical applications, and there is a certain demand. After retrieval, it is found that in Chinese Patent CN202421146551.4, a lateral ablation device with a puncture function, paragraphs

[0044] -

[0045] of its specification disclose that 'in one embodiment... a second window 201 is provided at one end of the outer sheath 200 close to the ablation electrode 101, and the first window 1031 can be completely externally exposed through the second window 201... the size of the first window 1031 is the same as the size of the second window 201. Specifically, the operator first externally exposes the puncture needle 102 in the first channel 202 of the outer sheath 200 to perform tissue puncture. When the puncture is completed, the outer sheath 200 needs to be moved to cover the puncture needle 102. At this time, if Figure 5As shown, when the puncture needle 102 is completely located within the first channel 202 of the outer sheath tube 200, the first window 1031 can be completely externally exposed through the second window 201, thereby enabling the ablation energy to be released from the first window 1031 and the second window 201. In this embodiment, the selection of the preset length of the ablation electrode 101 can also be achieved through the misaligned overlap of the first window 1031 and the second window 201 to adapt to lesion tissues of different sizes... The second window 201 can also be larger in area than the first window 1031. In this embodiment, it is only necessary to completely externally expose the first window 1031. Another Chinese patent CN202421146487.X, an ablation device for realizing directional release of ablation energy, also discloses in paragraphs

[0045] -

[0048] of its specification that "an ablation window 201 is provided at a position corresponding to the ablation electrode 203 on the first catheter 200, so that a part of the ablation electrode 203 can be exposed through the ablation window 201 to realize the directional release of ablation energy through the ablation window 201, thereby achieving the purpose of precise ablation...". The solutions disclosed in the above patents have obvious defects and are not conducive to implementation and transformation. For example: (1) The monopolar electrode needs to cooperate with a negative electrode plate to work, resulting in a relatively wide area of the human body covered by energy, which is not only unsafe but also not conducive to precise ablation or directional ablation; (2) The position of the ablation window on the electrode is fixed. If the direction needs to be changed, the entire electrode can only be rotated to change the direction. Due to the interference of components such as cable plugs connected to the electrode tail, this method is not convenient; (3) Obviously, the electrode designed with this structure is very easy to stick to the knife when used in the ablation field of solid organs such as the liver. The liver has many large blood vessels. This electrode cannot effectively stop bleeding for them, nor can it directly use the structure of the electrode itself to quickly eliminate the phenomenon of sticking to the knife and the possible risk of secondary bleeding. It is not practical. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide an electrode assembly for preventing needle tract bleeding and its hemostasis instrument to solve the technical problem that the prior art is prone to needle tract bleeding.

[0006] The technical solution provided by the present invention is as follows: An electrode assembly for preventing needle tract bleeding, comprising an electrode needle, an insulating tube, and a control member; the electrode needle includes an insulating needle tip, electrode one, an insulating member, and electrode two arranged in sequence from far to near, and electrode one and electrode two have opposite polarities; the proximal end of electrode two is wrapped with an outer insulating layer; the insulating tube is sleeved outside the electrode needle, its distal end is a cutting edge, and its side is provided with a coagulation and cutting window; the control member is connected to the insulating tube to control the rotation of the insulating tube and / or its movement in the axial direction of the electrode needle; When the insulating tube is at the most distal end, a single side of electrode one and electrode two is exposed through the coagulation and cutting window, and the insulating needle tip is exposed; When the insulating tube is at the nearest end, the first electrode and the second electrode are completely exposed.

[0007] Furthermore, the cross-section of the coagulation cutting window is rectangular, and its axial length is less than or equal to the sum of the axial lengths of the first electrode, the insulating member, and the second electrode.

[0008] Furthermore, the included angle of the coagulation cutting window in the radial direction of the electrode needle is 10° - 270°.

[0009] Furthermore, when the insulating tube is at the farthest end, the cutting edge of the insulating tube is smoothly connected to the insulating needle tip.

[0010] Furthermore, the insulating member and the second electrode are sleeved on the first electrode in sequence, and an inner insulating layer is wrapped outside the first electrode to isolate the second electrode.

[0011] Furthermore, the first electrode is provided with an outflow port, and an inflow channel communicating with the outflow port is arranged inside it.

[0012] Furthermore, a grid for balancing energy is arranged in the middle of the coagulation cutting window.

[0013] Furthermore, the first electrode, the insulating member, and the second electrode are coaxially arranged and have the same outer diameter, and the proximal end of the insulating needle tip is smoothly connected to the first electrode.

[0014] The present invention also provides a hemostatic instrument, which includes a handle, a cable plug, and an inflow tube, and further includes the above-mentioned electrode assembly; the distal end of the handle is connected to the proximal end of the electrode assembly, and the proximal end of the handle is connected to the cable plug and the inflow tube.

[0015] Furthermore, a fixing block for fixing the electrode needle is arranged inside the handle; the control member is fixed outside the insulating tube, and limiting steps are respectively arranged at the distal end and the proximal end of the control member, and the control member is clamped in the handle through the limiting steps.

[0016] Furthermore, the proximal ends of the first electrode and the second electrode extend into the handle, and both have exposed parts to be connected to the cable plug through wires.

[0017] Compared with the prior art, the main beneficial effects of the present invention are: The main improvement point of the present invention lies in adding and improving the insulating tube. Different from the traditional simple insulation function or guiding function, a small component with an optimized structure is integrated into the electrode assembly, so that the hemostatic instrument has functions such as self-cutting and directional ablation. It not only solves the technical problem of needle tract bleeding, but also is applicable to both "surface coagulation" and "insertion coagulation" at the same time, without affecting the use range of the operator, and the acceptance of the operator after being transformed into a product will be higher. Brief Description of the Drawings

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings. As shown in the drawings, the above-mentioned and other objects, features, and advantages of the present invention will become clearer. The same reference numerals indicate the same parts in all the drawings. The present invention does not deliberately draw the drawings in actual size and proportion, and the focus is on showing the gist of the present invention.

[0019] Figure 1 Overall external view of the hemostatic instrument; Figure 2 Schematic diagrams of the electrode assembly in two states: (a) State diagram when the insulating tube is at the nearest end, (b) State diagram when the insulating tube is at the farthest end; Figure 3 Exploded view of the overall structure of the electrode needle; Figure 4 Schematic diagram of the arrangement relationship inside the handle; Figure 5 Schematic diagram for comparing the effects of the open ablation mode and the directional ablation mode: (a) Open ablation mode, (b) Directional ablation mode; Figure 6 Schematic diagram of the structure after adding a grid; Figure 7 Schematic diagram of the inflow channel.

[0020] Reference Numerals: 1 - Electrode assembly, 2 - Handle, 3 - Cable plug, 4 - Inflow tube; 11 - Electrode needle, 12 - Insulating tube, 13 - Control member; 21 - Fixed block; 31 - Conducting wire; 111 - Insulating needle tip, 112 - Electrode one, 113 - Insulating member, 114 - Electrode two, 115 - Outer insulating layer, 116 - Outflow port, 117 - Inflow channel, 118 - Inner insulating layer; 121 - Cutting edge, 122 - Coagulation cutting window; 131 - Limiting step, 132 - Window positioning mark; 1111 - Needle tip; 1112 - Joint part; 1121 - Connecting tube; 1122 - Exposed tube; 1221 - Grille Detailed implementation mode

[0021] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. The components of the embodiments of the present invention described and illustrated herein can generally be arranged and designed in a variety of different configurations.

[0022] Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0023] It should be noted that like reference numerals and letters denote like items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0024] Fluid: This invention mainly refers to physiological saline, etc.

[0025] Proximal end: Refers to the end away from the puncture direction.

[0026] Distal end: Refers to the end in the puncture direction.

[0027] Coagulation cutting window: Refers to the window for releasing electrocoagulation energy and can also be used as the window for excising tissue.

[0028] Example 1, referring to the attached Figure 1-5 As shown in FIGS. 6 and 7, an electrode assembly for preventing bleeding of the needle track provided by the present invention includes an electrode needle 11, an insulating tube 12 and a control member 13; the electrode needle 11 includes an insulating needle head 111, an electrode 112, an insulating member 113 and an electrode 114 arranged in sequence from far to near, and the polarities of the electrode 112 and the electrode 114 are opposite; the proximal end of the electrode 114 is wrapped with an outer insulating layer 115; the insulating tube 12 is sleeved outside the electrode needle 11, the distal end thereof is a cutting edge 121, and a coagulation cutting window 122 is provided on the side thereof; the control member 13 is connected to the insulating tube 12 to control the rotation of the insulating tube 12 and / or its movement in the axial direction of the electrode needle 11; When the insulating tube 12 is at the most distal end, a single side of the electrode 112 and the electrode 114 (referring to the outer side corresponding to a partial angle in the circumferential direction of the electrode 112 / electrode 114) is exposed through the coagulation cutting window 122 (referring to all or part of the exposure in the axial direction of the electrode 112 and the electrode 114), and the insulating needle head 111 is exposed; When the insulating tube 12 is at the nearest end, the first electrode 112 and the second electrode 114 are completely exposed.

[0029] Reference appendix Figure 2-4 As shown, to implement the above solution, the following measures can be specifically adopted: The first electrode 112 is set to have a structure including a connecting tube 1121 and an exposed tube 1122. The lengths of the exposed tube 1122 and the second electrode 114 can be set to dimensions such as 1 cm, 1.5 cm, 2 cm, 2.5 cm, etc., which are determined according to needs. The insulating member 113 only serves to isolate electricity, and its size can be slightly shorter, such as 0.5 cm, 1 cm, etc., which are determined according to needs. The shorter the insulating member 113, the stronger the energy near both ends of the insulating member 113 may be. The exposed tube 1122, the insulating member 113, and the second electrode 114 are coaxially arranged and have the same outer diameter, which is approximately 1 - 2 mm. The outer diameter of the connecting tube 1121 is smaller than that of the exposed tube 1122, approximately 0.5 - 1.8 mm. Generally, it is ensured that the outer diameter of the connecting tube 1121 is smaller than that of the exposed tube 1122 by more than 0.2 mm. Of course, in some special cases, the above dimensions can also be changed. For example, after changing the target tissue, when the access channel to the surgical site is narrow or the requirement for ablation accuracy is further improved, the size requirements may be smaller. On the contrary, if the surgery is not restricted by the access channel or ablation accuracy, the size requirements may be larger. In some cases, it may not be necessary to deliver physiological saline to the target site, such as in the case of surface ablation of avascular tissues. At this time, both the connecting tube 1121 and the exposed tube 1122 can be solid connecting rods or metal tubes with a hollow interior. Generally, since the diameters of the connecting tube 1121 and the exposed tube 1122 are different, if a metal tube with a hollow interior is selected, the connection between the two needs to be sealed when the connecting tube 1121 is connected to the exposed tube 1122, such as by welding. If both the connecting tube 1121 and the exposed tube 1122 are solid, direct welding can be used. Preferably, the insulating member 113 is an annular kit. The connecting tube 1121 and the exposed tube 1122 are coaxially arranged. The connecting tube 1121 is wrapped with an inner insulating layer 118 to isolate the second electrode 114. The inner insulating layer 118 and the outer insulating layer 115 are preferably heat shrinkable tubes. The insulating member 113 and the second electrode 114 are sleeved on the connecting tube 1121 wrapped with the inner insulating layer 118 to prevent the exposed tube 1122, the insulating member 113, and the second electrode 114 from being not on the same axis due to shaking, and it should also be ensured that the outer sides of the exposed tube 1122, the insulating member 113, and the second electrode 114 are flush. As much as possible, there should be no gap at the connection between the exposed tube 1122, the insulating member 113, and the second electrode 114 to avoid excessive obstruction during the insertion of the electrode needle 11 into the tissue.

[0030] Further, the proximal end of the insulating needle 111 is smoothly connected to the first electrode 112. That is, the connection between the insulating needle 111 and the first electrode 112 is smooth, and there will be no sense of retardation during the insertion into the tissue. Specifically, the insulating needle 111 can be set as the needle 1111 and the joint part 1112. The needle 1111 is used for puncturing, and the joint part 1112 is used for connecting the first electrode 112. Since a solid exposed tube 1122 can be used in this embodiment, a connecting rod (not shown in the drawings) can be provided at the center of the distal end face of the exposed tube 1122, and the joint part 1112 can be set as a groove for the connecting rod to be inserted and then press-fitted.

[0031] The insulating tube 12 is a non-metallic tube and can be used as an insulating layer to prevent accidental injury. At the same time, a material with a certain strength, such as PEEK material, is selected, which is beneficial to the setting of the cutting edge 121 and the coagulation cutting window 122. When the insulating tube 12 is located at the farthest end, the cutting edge 121 of the insulating tube 12 is smoothly connected to the insulating needle 111. That is, the connection between the cutting edge 121 and the insulating needle 111 is smooth, and there will be no sense of retardation during the insertion into the tissue. One possible situation is that the tip of the insulating needle 111 is conical (it can also be a tip with edges and corners, etc., refer to the attached Figure 2 drawing), the angle between the outer side of the cutting edge 121 and the axis is half of the outer side angle of the tip of the insulating needle 111 (that is, the distal end of the needle 1111), or the farthest end of the cutting edge 121 just lies at the nearest end of the tip of the insulating needle 111, or even both of the above situations are satisfied at the same time.

[0032] The cross-section of the coagulation cutting window 122 is rectangular, and its axial length is less than or equal to the sum of the axial lengths of the first electrode 112, the insulating member 113, and the second electrode 114. The coagulation cutting window 122 having a rectangular cross-section is only one of the preferred shapes. Its shape for directional ablation is more square, which is more conducive to resection after ablation. The possibility of using other cross-sectional shapes such as ellipse and circle is not excluded. The included angle of the coagulation cutting window 122 in the radial direction of the electrode needle 11 is 10° - 270°, preferably 10°, 15°, 20°, 30°, 45°, 60°, 90°, etc., in order to ensure a large enough energy release window. The coagulation cutting window 122 is a window with a "blade-shaped chamfer". It is preferred that the entire window is provided with a "blade-shaped chamfer", or only two sides in the axial or radial direction can be provided with a "blade-shaped chamfer". The coagulation cutting window 122 can not only be used as a window for directional ablation, but also peel off tissues from the electrode without damaging the tissues. In order to assist in observing the orientation and approximate position of the coagulation cutting window 122, a window positioning mark 132 can be added to the control member 13. The setting method of the window positioning mark 132 can be diverse. For example, the window positioning mark 132 and the coagulation cutting window 122 can be arranged on the same straight line, can be marked with a single eye-catching color, or can be protruded from the surface of the control member 13 and set as a convex rib shape, which can visually assist in determining the position of the coagulation cutting window 122 and also tactilely assist in positioning the orientation of the coagulation cutting window 122. Other methods will not be elaborated one by one, as long as the same or basically the same purpose can be achieved.

[0033] Refer to the attached Figure 1 、 4 As shown, specifically applied to a hemostatic instrument, the hemostatic instrument includes a handle 2, a cable plug 3, and an inflow tube 4, and also includes the electrode assembly 1 described above; the distal end of the handle 2 is connected to the proximal end of the electrode assembly 1, and the proximal end of the handle 2 is connected to the cable plug 3 and the inflow tube 4.

[0034] A fixing block 21 for fixing the electrode needle 11 is provided inside the handle 2; the control member 13 is fixed outside the insulating tube 12, and limit steps 131 are respectively provided at the distal end and the proximal end of the control member 13, and the control member 13 is clamped in the handle 2 through the limit steps 131.

[0035] The proximal ends of the first electrode 112 and the second electrode 114 extend into the handle 2, and both have exposed parts to connect to the cable plug 3 through a wire 31. The settings of the handle 2, the cable plug 3, the inflow tube 4, etc. are prior arts and will not be elaborated here.

[0036] The above-mentioned hemostatic instrument can be used by being connected to the corresponding host and equipped with a foot switch. The main function of the foot switch is to control the energy output mode and energy on / off of the hemostatic instrument. Even a manual switch that replaces the foot switch can be set on the handle to reduce the objects in the surgical scene. This part is mature existing technology and will not be elaborated further.

[0037] Refer to the appendix Figure 1-5 As shown, the recommended working mechanism and effects of the present invention are as follows: 1. Open ablation mode The specific manifestation of this mode is that "the first electrode 112 and the second electrode 114 are completely exposed, and the insulating tube 12 is at the proximal end". To achieve the above manifestation, the operator only needs to move the control member 13 to the proximal end. For the ablation of the target tissue, either "surface ablation" or "insertion ablation" can be used. Taking "insertion ablation" as an example, the operator first finds the target tissue, moves the control member 13 to the proximal end, inserts the target tissue (when it is inconvenient to insert using mechanical force in some cases, the operator can turn on the energy provided by the host to assist in puncture), and selects a suitable energy output mode to work. Different from the prior art, after ablation, the present invention can push the self - contained insulating tube 12 to the distal end by controlling the control member 13 to directly cut off the adhesion between the ablated tissue and the electrode needle 11 with the cutting edge 121. This is not only convenient for pulling out the electrode needle 11 but also can avoid pulling the tissue during the process of pulling out the electrode needle 11, effectively preventing the occurrence of needle - track bleeding. Refer to the appendix Figure 5 Since the electrode polarities of the first electrode 112 and the second electrode 114 are opposite during operation, the energy is only transmitted between the first electrode 112 and the second electrode 114, and the target tissue forms an ablation area approximately in a spindle shape after ablation.

[0038] 2. Directional ablation mode The specific manifestation of this mode is that "one side of the first electrode 112 and the second electrode 114 is exposed through the coagulation and cutting window 122, the insulating needle 111 is exposed, and the insulating tube 12 is located at the farthest end". To achieve the above manifestation, the operator only needs to move the control member 13 to the farthest end. The ablation of the target tissue can be carried out by either "surface ablation" or "insertion ablation". Taking "insertion ablation" as an example, the operator first finds the target tissue, moves the control member 13 to the farthest end and inserts it into the target tissue. During this process, the hand needs to hold against the control member 13 to prevent the insulating tube 12 from returning to the nearest end during the insertion process (in other embodiments, corresponding mechanisms can be further added for improvement), and then select a suitable energy output mode to work. Different from the prior art, the surgical method provided by the present invention does not require the aid of complex imaging functions, such as directly adding imaging function components to the hemostatic instrument and accurately positioning with instruments such as CT, which can effectively reduce the production cost of the hemostatic instrument, and at the same time effectively reduce the number of instruments used by the operator, greatly reducing human resources and improving the surgical efficiency. Because for electro-surgical operations on solid organs such as the liver, the position of the target tissue can be directly observed with the naked eye (open surgery) or under endoscopic imaging (endoscopic surgery), or obtained through behaviors such as touching and pressing with the hand or instrument. After obtaining the position of the target tissue, in the case of needing to avoid surrounding important organs or blood vessels, the directional ablation mode provided by the present invention can be adopted. After ablation, the present invention can cut the adhesion between the ablated tissue and the electrode needle 11 directly through the coagulation and cutting window 122 by pushing, pulling or rotating the control member 13, which is convenient for pulling out the electrode needle 11 and can avoid pulling the tissue during the process of pulling out the electrode needle 11, effectively preventing the occurrence of bleeding in the needle track. In addition, the operator usually adopts a pen-holding grip, and only the cooperation of the thumb and index finger is required to complete the rotation action with one hand. If greater force is required for pushing and pulling, the cooperation of the other hand can be used, which not only saves other human resources but also greatly improves the surgical efficiency. Moreover, the present invention can change the orientation of the coagulation and cutting window 122 by rotating the control member 13, and the operator can change the coagulation and cutting orientation at any time according to the actual situation, which also only requires the cooperation of the thumb and index finger to complete with one hand, not only saving other human resources but also greatly improving the surgical efficiency. Refer to the appendix Figure 5 , since the electrode polarities of the first electrode 112 and the second electrode 114 are opposite during operation, therefore, the energy is only transmitted between the first electrode 112 and the second electrode 114, and the target tissue forms an ablation area with a cross-section approximately in the shape of a fan after ablation is completed.

[0039] Due to the structural characteristics of the present invention, in the above two modes, the insulated needle 111 may damage tissues or blood vessels, or even cause bleeding. Especially in the directional ablation mode, the method of "inserting coagulation" needs to be used more cautiously. Therefore, it is more recommended to gradually penetrate and approach the target tissue by the method of "inserting coagulation", then expose the target tissue as much as possible by cutting the ablated part, and then perform directional ablation by the method of "surface coagulation". In order to reduce the risk of accidental injury caused by the puncture of the insulated needle 111, the size of the needle tip 1111 of the insulated needle 111 can be made as short as possible.

[0040] Example 2, refer to the appendix Figure 2 、 3 As shown in FIGS. In this embodiment, the connecting pipe 1121 is provided with a hollow interior to serve as a fluid passage (i.e., inflow or return flow), and this embodiment is mainly used as the inflow channel 117 for physiological saline. The exposed pipe 1122 of the first electrode 112 is provided with an outflow port 116, and generally there are a plurality of the outflow ports 116, which are evenly distributed or arranged regularly on the exposed pipe 1122. The connecting pipe 1121 extends into the interior of the exposed pipe 1122, and outflow ports 116 can be further provided on the part located inside the exposed pipe 1122. The two are coaxially arranged, and there is a gap between the most distal end of the connecting pipe 1121 and the exposed pipe 1122.

[0041] To optimize the structure, at this time, the insulated needle 111 can be set as the needle tip 1111 and the joint part 1112. The needle tip 1111 is used for puncture, and the joint part 1112 is used to connect the first electrode 112. Since the hollow connecting pipe 1121 and the exposed pipe 1122 are adopted in this embodiment, the joint part 1112 can be set as a pipe into which the connecting pipe 1121 is inserted for interference riveting. The length of the joint part 1112 is the same as the length of this gap to ensure that there is as little gap as possible after the insulated needle 111 and the first electrode 112 are assembled.

[0042] Example 3, refer to the appendix Figure 6 As shown in FIGS. In this embodiment, the structure of the coagulation cutting window 122 is improved. Specifically, in this embodiment, a grid 1221 is provided in the middle of the coagulation cutting window 122. The grid 1221 has blocking strips and gaps. The overall length of the grid 1221 can be set as needed to dimensions such as 0.5 cm, 1.5 cm, 2 cm, 2.5 cm, etc. That is, the grid 1221 divides the coagulation cutting window 122 into two parts, and the grid 1221 blocks at least a part of the electrode 112 or the electrode 114 close to the insulating part 113, and even blocks a part of both the electrode 112 and the electrode 114 close to the insulating part 113 at the same time. As for the insulating part 113, it doesn't matter whether it is blocked as a whole or not.

[0043] The following problems exist in the above embodiments: Whether using the open ablation mode or the directional ablation mode, whether it is "surface ablation" or "insertion ablation", at the two ends of the electrode 112 and the electrode 114 close to the insulating part 113 and relatively far from the insulating part 113, the energy in the working state is stronger. At the same gear and the same time, the ablation degree of the target tissue is higher. For example, if the energy output gear of the main unit is relatively high and the ablation time is relatively short, it may occur that the ablation effect of the target tissue corresponding to the two ends of the electrode 112 and the electrode 114 is significantly poor, while the ablation effect of the target tissue corresponding to the area close to the insulating part 113 will show a thin and brittle ablation effect. Even if the target tissue adhered to the electrode 112 and the electrode 114 is first removed using the coagulation cutting window 122 and then pulled out, secondary bleeding is still likely to occur. To improve this situation, it is necessary to appropriately extend the working time to make the ablation more thorough, especially to control the ablation effect of the target tissue corresponding to the area close to the insulating part 113. For the operator, although the manufacturer can provide the recommended working time for each gear, if the operator has not used it clinically many times, it is still impossible to be familiar with the use of the device. Therefore, to control the consistent surgical quality, it is more dependent on surgical experience, and the difficulty is relatively high.

[0044] However, adding the grid 1221 in this embodiment can effectively weaken the effect of energy. That is, the grid 1221 uses the gaps to transfer energy, and weakens the effect on the tissue by reducing the area of energy action, so as to achieve the purpose of balancing the energy of the entire coagulation cutting window 122. It is worth mentioning that when energy acts on the tissue, there will be a certain spread. Therefore, after adding the grid 1221, since the entire grid 1221 itself is relatively small, the target tissue blocked by the grid 1221 will not be affected and unable to be ablated.

[0045] Further, the edge of the grille 1221 can still be set to a "blade-shaped chamfer" with a cutting effect to better maintain the function of the coagulation cutting window 122. However, it is necessary to consider the possible clogging drawbacks brought by the grille 1221 here. Therefore, the gaps of the grille 1221 need to be set to be large enough, such as setting the minimum width of the gaps to 1.5 mm, 2 mm, 2.5 mm or more, so as to transfer sufficient energy and avoid clogging and inconvenient cleaning. The width of the shielding strips of the grille 1221 itself can be set with reference to the size of the gaps, or can be slightly wider or slightly narrower than the gaps.

[0046] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. An electrode assembly (1) for preventing bleeding of the needle track, characterized in that, It includes an electrode needle (11), an insulating tube (12) and a control member (13); the electrode needle (11) includes an insulating needle tip (111), an electrode one (112), an insulating member (113) and an electrode two (114) arranged in sequence from far to near, and the polarities of the electrode one (112) and the electrode two (114) are opposite; the proximal end of the electrode two (114) is wrapped with an outer insulating layer (115); the insulating tube (12) is sleeved outside the electrode needle (11), its distal end is a cutting edge (121), and a coagulation cutting window (122) is provided on its side; the control member (13) is connected to the insulating tube (12) to control the rotation of the insulating tube (12) and / or its movement in the axial direction of the electrode needle (11); When the insulating tube (12) is at the farthest end, a single side of the electrode one (112) and the electrode two (114) is exposed through the coagulation cutting window (122), and the insulating needle tip (111) is exposed; When the insulating tube (12) is at the nearest end, the electrode one (112) and the electrode two (114) are completely exposed.

2. The electrode assembly (1) for preventing bleeding of the needle track according to claim 1, characterized in that, The cross-section of the coagulation cutting window (122) is rectangular, and its axial length is less than or equal to the sum of the axial lengths of the electrode one (112), the insulating member (113) and the electrode two (114).

3. An electrode assembly (1) for preventing bleeding of a needle track according to claim 1, characterized in that, The included angle of the coagulation cutting window (122) in the radial direction of the electrode needle (11) is 10°-270°.

4. An electrode assembly (1) for preventing bleeding of a needle track according to claim 1, characterized in that, When the insulating tube (12) is at the farthest end, the cutting edge (121) of the insulating tube (12) is smoothly connected to the insulating needle tip (111).

5. The electrode assembly (1) for preventing bleeding of the needle track according to claim 1, characterized in that, The insulating member (113) and the electrode two (114) are sequentially sleeved on the electrode one (112), and an inner insulating layer (118) is wrapped outside the electrode one (112) to isolate the electrode two (114).

6. An electrode assembly (1) for preventing bleeding of a needle track according to claim 5, characterized in that, The electrode one (112) is provided with an outflow port (116), and an inflow channel (117) communicating with the outflow port (116) is arranged inside it.

7. An electrode assembly (1) for preventing bleeding of a needle track according to claim 1, characterized in that, A grid (1221) for balancing energy is arranged in the middle of the coagulation cutting window (122).

8. An electrode assembly (1) for preventing bleeding of a needle track according to any one of claims 1-7, characterized in that, The electrode one (112), the insulating member (113) and the electrode two (114) are coaxially arranged and have the same outer diameter, and the proximal end of the insulating needle tip (111) is smoothly connected to the electrode one (112).

9. A hemostatic instrument, comprising a handle (2), a cable plug (3) and an inflow tube (4), characterized in that, It further includes the electrode assembly (1) according to any one of claims 1-8; the distal end of the handle (2) is connected to the proximal end of the electrode assembly (1), and the proximal end of the handle (2) is connected to the cable plug (3) and the inflow tube (4).

10. A hemostatic instrument according to claim 9, characterized in that, A fixing block (21) for fixing the electrode needle (11) is arranged inside the handle (2); the control member (13) is fixed outside the insulating tube (12), and limiting steps (131) are respectively arranged at the distal end and the proximal end of the control member (13), and the control member (13) is clamped in the handle (2) through the limiting steps (131).

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