Electrode assembly for preventing needle track bleeding and hemostatic device thereof

Abstract

The application belongs to the technical field of medical devices, and relates to an electrode assembly for preventing needle track bleeding and hemostatic devices thereof, comprising an electrode needle, an insulating tube and a control member; the electrode needle comprises, from far to near, an insulating needle head, an electrode one, an insulating member and an electrode two, the electrode one and the electrode two are opposite in polarity; the proximal end of the electrode two is wrapped with an outer insulating layer; the insulating tube is sleeved on the outside of the electrode needle, the distal end of the insulating tube is a cutting edge, and the side of the insulating tube is provided with a coagulation cutting window; the control member is connected with the insulating tube to control the rotation and / or axial movement of the insulating tube; when the insulating tube is located at the farthest end, the single side of the electrode one and the electrode two is exposed through the coagulation cutting window, and the insulating needle head is exposed; when the insulating tube is located at the nearest end, the electrode one and the electrode two are completely exposed. The application solves the technical problem that the prior art is prone to causing needle track bleeding.

Description

Technical Field

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

[0002] Electrosurgical hemostatic devices, such as electrosurgeries, electrocoagulation forceps, ultrasonic scalpels, and electrocoagulation tweezers, are frequently used in surgical procedures. Currently, hemostatic devices on the market typically offer either surface ablation or insertion ablation. Deep-seated hemostatic devices, particularly those for insertion ablation, often lack cooling capabilities, leading to rapid tissue drying and carbonization, resulting in "sticky blades" and requiring more time to clean the electrodes.

[0003] In the field of ablation and hemostasis of solid organs, such as in clinical liver ablation, it has been found that even with the addition of cooling capabilities to the hemostatic electrode during insertion and removal, there is still a small chance of "needle tract bleeding" during insertion and removal. This refers to the fact that after ablation, tissue often adheres to the electrode to a certain degree. If the cooling effect on the electrode is weakened (e.g., due to excessive power output from the host device or prolonged ablation), the adhesion becomes stronger. When this adhesion is strong, forcibly removing the needle can tear away a piece of tissue, causing renewed bleeding in the previously clotted area. In this case, the surgeon can only repeat the procedure or perform targeted hemostasis on the bleeding area. However, before performing secondary hemostasis, the surgeon often needs to clean the hemostatic electrode before continuing, which is unnecessary and wastes surgical time.

[0004] It is understood that there is no practical directional ablation hemostasis device on the market. 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 searching, it was found that Chinese patent CN202421146551.4 is a lateral ablation device with a puncture function. Its specification paragraphs

[0044] -

[0045] discloses that "In one embodiment... the outer sheath 200 is provided with a second window 201 at one end close to the ablation electrode 101, and the first window 1031 can be completely leaked through the second window 201... The size of the first window 1031 is consistent with the size of the second window 201. Specifically, the operator first performs tissue puncture by leaking the puncture needle 102 into the first channel 202 of the outer sheath 200. When the puncture is completed, the outer sheath 200 needs to be moved to cover the puncture needle 102. At this time, Figure 5As shown, when the puncture needle 102 is completely located within the first channel 202 of the outer sheath 200, the first window 1031 can be completely exposed to the outside 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 first window 1031 and the second window 201 can be staggered and overlapped to achieve the preset length of the ablation electrode 101 to accommodate lesions of different sizes. The second window 201 can also be larger than the first window 1031. In this embodiment, it is only necessary to ensure that the first window 1031 is completely exposed to the outside. ". Another Chinese patent CN202421146487.X is an ablation device that realizes the directional release of ablation energy. Its specification also discloses in paragraphs

[0045] to

[0048] that "an ablation window 201 is set at the position corresponding to the position of the first catheter 200 and the ablation electrode 203, so that 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 solution disclosed in the above patent has obvious defects and is not conducive to implementation and transformation, such as the following points: (1) The monopolar electrode needs to be negatively charged. The electrodes work together, resulting in a wide area of ​​the human body covered by energy, which is not only unsafe but also not conducive to precise 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. This method is not convenient because the tail of the electrode is connected to the cable plug and other components. (3) It is obvious that if the electrode with this structural design is used in the field of ablation of solid organs such as the liver, it is very easy to stick to the knife. The liver has many large blood vessels, and this electrode cannot effectively stop bleeding. It is also impossible to directly use the structure of the electrode itself to quickly eliminate the sticking phenomenon and the possible risk of secondary bleeding. It is not practical. Summary of the Invention

[0005] In view of this, an object of the present invention is to provide an electrode assembly and a hemostatic device thereof for preventing needle tract bleeding, so as to solve the technical problem of the prior art that needle tract bleeding is easily caused.

[0006] The technical solutions provided by the present invention are as follows:

[0007] An electrode assembly for preventing needle tract bleeding comprises an electrode needle, an insulating tube, and a control member; the electrode needle comprises an insulating needle head, a first electrode, an insulating member, and a second electrode, arranged in sequence from distal to proximal, wherein the first electrode and the second electrode have opposite polarities; the proximal end of the second electrode is wrapped with an outer insulating layer; the insulating tube is sheathed over the electrode needle, its distal end being a cutting edge and its side being provided with a coagulation window; the control member is connected to the insulating tube to control the insulating tube to rotate and / or move in the axial direction of the electrode needle;

[0008] When the insulating tube is located at the most distal end, a single side of the electrode 1 and the electrode 2 is exposed through the coagulation window, and the insulating needle is exposed;

[0009] When the insulating tube is located at the most proximal end, the first electrode and the second electrode are completely exposed.

[0010] Furthermore, the cross section of the coagulation window is rectangular, and the axial length thereof is less than or equal to the sum of the axial lengths of the first electrode, the insulating member, and the second electrode.

[0011] Furthermore, the included angle of the coagulation window in the radial direction of the electrode needle is 10°-270°.

[0012] Furthermore, when the insulating tube is located at the farthest end, the cutting edge of the insulating tube is smoothly connected with the insulating needle.

[0013] Furthermore, the insulating member and the second electrode are sequentially sleeved on the first electrode, and the first electrode is wrapped with an inner insulating layer to isolate the second electrode.

[0014] Furthermore, the electrode 1 is provided with an outlet, and an inlet channel communicating with the outlet is provided inside the electrode.

[0015] Furthermore, a grid for balancing energy is provided in the middle of the coagulation window.

[0016] Furthermore, the electrode 1, the insulating member and the electrode 2 are coaxially arranged and have the same outer diameter, and the proximal end of the insulating needle is smoothly connected with the electrode 1.

[0017] The present invention also provides a hemostatic device, comprising a handle, a cable plug and an inlet tube, and also comprising the electrode assembly described above; 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 inlet tube.

[0018] Furthermore, a fixing block for fixing the electrode needle is provided in the handle; the control member is fixed to the outside of the insulating tube, and limiting steps are respectively provided at the distal and proximal ends of the control member, and the control member is clamped in the handle through the limiting steps.

[0019] Furthermore, the proximal ends of the electrode 1 and the electrode 2 extend into the interior of the handle, and both have exposed portions for connection to the cable plug via a wire.

[0020] Compared with the prior art, the main beneficial effects of the present invention are:

[0021] The main improvement of the present invention lies in the addition and improvement of the insulating tube. Different from the traditional simple insulating or guiding role, this small component with optimized structure is integrated into the electrode assembly, so that the hemostatic device has cutting, directional ablation and other functions. It not only solves the technical problem of needle tract bleeding, but is also suitable for "surface coagulation" and "insertion coagulation" at the same time, and does not affect the scope of use of the operator. After being converted into a product, the operator's acceptance will be higher. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work. The above and other purposes, features and advantages of the present invention will become clearer through the accompanying drawings. The same reference numerals indicate the same parts throughout the drawings. The present invention does not intentionally scale the drawings to the actual size, and the focus is on illustrating the main purpose of the present invention.

[0023] Figure 1 The overall appearance of the hemostatic device;

[0024] Figure 2 Schematic diagram of the electrode assembly in two states:

[0025] (a) The state diagram when the insulating tube is at the nearest end,

[0026] (b) The state diagram when the insulating tube is at the farthest end;

[0027] Figure 3 This is the exploded diagram of the overall structure of the electrode needle;

[0028] Figure 4 This is a diagram of the settings within the handle;

[0029] Figure 5 Schematic diagram comparing the effects of open ablation mode and directional ablation mode:

[0030] (a) Open ablation mode,

[0031] (b), directional ablation mode;

[0032] Figure 6 This is a schematic diagram of the structure after adding the grille;

[0033] Figure 7 Schematic diagram of the inlet channel.

[0034] Reference numerals:

[0035] 1-electrode assembly, 2-handle, 3-cable plug, 4-inlet tube;

[0036] 11-electrode needle, 12-insulating tube, 13-control part;

[0037] 21-fixed block;

[0038] 31- wire;

[0039] 111 - insulated needle, 112 - electrode 1, 113 - insulating member, 114 - electrode 2, 115 - outer insulating layer, 116 - outlet, 117 - inlet channel, 118 - inner insulating layer;

[0040] 121- cutting edge, 122- cutting window;

[0041] 131-limiting step, 132-window positioning mark;

[0042] 1111-needle head; 1112-joint portion;

[0043] 1121-connecting pipe; 1122-exposed pipe;

[0044] 1221-Grille. DETAILED DESCRIPTION

[0045] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings herein can be arranged and designed in various different configurations.

[0046] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but rather merely represents selected embodiments of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort shall fall within the scope of protection of the present invention.

[0047] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0048] Fluid: The present invention mainly refers to physiological saline and the like.

[0049] Proximal end: refers to the end away from the puncture direction.

[0050] Distal: refers to the end in the direction of puncture.

[0051] Coagulation window: refers to the window that provides the release of electrocoagulation energy and can also serve as a window for removing tissue.

[0052] Example 1, with reference to Figure 1-5 As shown in Figures 7 and 8, an electrode assembly for preventing needle tract bleeding provided by the present invention comprises an electrode needle 11, an insulating tube 12, and a control member 13; the electrode needle 11 comprises an insulating needle head 111, an electrode 1 112, an insulating member 113, and an electrode 2 114, which are arranged in sequence from distal to proximal, and the electrode 1 112 and the electrode 2 114 have opposite polarities; the proximal end of the electrode 2 114 is wrapped with an outer insulating layer 115; the insulating tube 12 is sleeved outside the electrode needle 11, and its distal end is a cutting edge 121, and its side is provided with a coagulation window 122; the control member 13 is connected to the insulating tube 12 to control the insulating tube 12 to rotate and / or move in the axial direction of the electrode needle 11;

[0053] When the insulating tube 12 is at the most distal end, a single side of the electrode 1 112 and the electrode 2 114 (referring to the outer side corresponding to a partial angle of the electrode 1 112 / electrode 2 114 in the circumferential direction) is exposed through the coagulation window 122 (referring to the complete or partial exposure of the electrode 1 112 and the electrode 2 114 in the axial direction), and the insulating needle 111 is exposed;

[0054] When the insulating tube 12 is located at the nearest end, the first electrode 112 and the second electrode 114 are completely exposed.

[0055] Reference Attachment Figure 2-4 As shown, in order to implement the above solution, the following measures can be taken:

[0056] The electrode 1 112 is configured to include a connecting tube 1121 and an exposed tube 1122. The lengths of the exposed tube 1122 and the electrode 2 114 can be set to 1 cm, 1.5 cm, 2 cm, 2.5 cm, etc., depending on needs. The insulating member 113 only serves to isolate the electricity, and its size can be slightly shorter, such as 0.5 cm, 1 cm, etc., depending on needs. The shorter the insulating member 113, the stronger the energy near the two ends of the insulating member 113. The exposed tube 1122, insulating member 113, and electrode 2 114 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, which is approximately 0.5-1.8 mm. Generally, it is sufficient to ensure that the outer diameter of the connecting tube 1121 is at least 0.2 mm smaller than that of the exposed tube 1122. Of course, in some special cases, the above dimensions can also be changed. For example, after the target tissue is changed, the access channel to the surgical site is narrow, or the ablation accuracy requirements are increased, the required dimensions may be smaller. On the contrary, if the surgery is not limited by the access channel or ablation accuracy, the required dimensions may also be greater. 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 tissue. In this case, the connecting tube 1121 and the exposed tube 1122 can be solid connecting rods or hollow metal tubes. 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, it is necessary to seal the connection between the two when the connecting tube 1121 is connected to the exposed tube 1122, such as welding; if the connecting tube 1121 and the exposed tube 1122 are both solid, they can be directly welded; preferably, the insulating member 113 is an annular kit, the connecting tube 1121 and the exposed tube 1122 are coaxially arranged, and the connecting tube 1121 is wrapped with an inner insulating layer 118 to isolate the electrode 2 114, and the inner insulating layer 118 and the outer insulating layer 115 are preferably heat shrink tubes. The insulating part 113 and the second electrode 114 are mounted on the connecting tube 1121 covered with the inner insulating layer 118 to prevent the exposed tube 1122, the insulating part 113 and the second electrode 114 from being on the same axis due to shaking. It should also be ensured that the outer sides of the exposed tube 1122, the insulating part 113 and the second electrode 114 are flush. As much as possible, it should also be ensured that there is no gap at the connection between the exposed tube 1122, the insulating part 113 and the second electrode 114 to avoid excessive obstruction of the electrode needle 11 during the insertion into the tissue.

[0057] Further, the proximal end of the insulated needle 111 is smoothly connected with the electrode 112. That is, the connection between the insulated needle 111 and the electrode 112 is smooth, and no resistance is felt during insertion into the tissue. Specifically, the insulated needle 111 can be provided as a needle 1111 for puncturing and a connecting portion 1112 for connecting the electrode 112. Since the exposed tube 1122 is solid in the embodiment, a connecting rod (not shown) can be provided at the center of the distal end surface of the exposed tube 1122, and the connecting portion 1112 can be provided as a groove for the connecting rod to be inserted and then interference riveted.

[0058] The insulated tube 12 is a non-metal tube, which can be used as an insulation layer to prevent accidental injury. The material with certain strength, such as PEEK material, is selected to facilitate the provision of the blade 121 and the coagulation window 122. When the insulated tube 12 is located at the distal end, the blade 121 of the insulated tube 12 is smoothly connected with the insulated needle 111. That is, the connection between the blade 121 and the insulated needle 111 is smooth, and no resistance is felt during insertion into the tissue. The possible situation is that the tip of the insulated needle 111 is conical (or the tip can have edges, etc., refer to the accompanying drawings). Figure 2 The angle between the outer side of the blade 121 and the axial direction is half of the angle between the outer side of the tip of the insulated needle 111 (i.e., the distal end of the needle 1111) and the axial direction, or the distal end of the blade 121 is just located at the proximal end of the tip of the insulated needle 111, or both of the above conditions are met.

[0059] The coagulation window 122 has a rectangular cross-section, and its axial length is less than or equal to the sum of the axial lengths of electrode 1 112, insulating member 113, and electrode 2 114. The rectangular cross-section of the coagulation window 122 is only one preferred embodiment. Its directional ablation shape is more square and more conducive to resection after ablation. Other cross-sectional shapes, such as elliptical or circular, are not excluded. The angle of the coagulation window 122 in the radial direction of the electrode needle 11 is 10°-270°, preferably 10°, 15°, 20°, 30°, 45°, 60°, 90°, etc., to ensure a sufficiently large energy release window. The coagulation window 122 is a window with a "blade-like chamfer." The window is preferably entirely chamfered, or it may be chamfered on only two axial or radial sides. The coagulation window 122 not only serves as a window for directional ablation, but also allows for separation of tissue from the electrode without damaging the tissue. In order to assist in observing the direction and approximate position of the cutting window 122, a window positioning mark 132 can be added to the control member 13. The window positioning mark 132 can be set in various ways. For example, the window positioning mark 132 and the cutting window 122 can be set on the same straight line, can be marked with a single eye-catching color, or can be raised from the surface of the control member 13 and set to a ridge shape, which can both visually assist in determining the position of the cutting window 122 and tactilely assist in locating the direction of the cutting window 122. Other methods will not be repeated one by one, as long as they can achieve or basically achieve the same purpose.

[0060] Reference Attachment Figure 1 、 4 As shown, it is specifically applied to a hemostatic device, which includes a handle 2, a cable plug 3 and an inlet tube 4, and also includes the electrode assembly 1 mentioned 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 inlet tube 4.

[0061] A fixing block 21 for fixing the electrode needle 11 is provided in the handle 2; the control member 13 is fixed to the outside of the insulating tube 12, and limiting steps 131 are respectively provided at the distal and proximal ends of the control member 13, and the control member 13 is clamped in the handle 2 through the limiting steps 131.

[0062] The proximal ends of the first and second electrodes 112 and 114 extend into the interior of the handle 2 and have exposed portions for connection to the cable plug 3 via a wire 31. The handle 2, the cable plug 3, the inlet pipe 4, etc. are configured in the prior art and will not be described in detail here.

[0063] The above-mentioned hemostatic device is connected to the corresponding host and can be used with a foot switch. The function of the foot switch is mainly to control the energy output mode and energy on and off of the hemostatic device. Even a manual switch can be set on the handle to replace the foot switch to reduce the objects in the surgical scene. This part is an existing mature technology and will not be elaborated here.

[0064] Reference Attachment Figure 1-5 As shown, the working mechanism and effects recommended by the present invention are as follows:

[0065] 1. Open ablation mode

[0066] The specific performance of this mode is "the electrode one 112 and the electrode two 114 are completely exposed, and the insulating tube 12 is located at the nearest end". In order to achieve the above performance, the operator only needs to move the control part 13 to the nearest end. When ablating the target tissue, both "surface ablation" and "insertion ablation" can be used. Taking "insertion ablation" as an example, the operator first finds the target tissue, moves the control part 13 to the nearest end, and inserts it into the target tissue (when encountering certain situations where it is inconvenient to use mechanical force for insertion, the operator can turn on the host to provide energy to assist puncture), and select the appropriate energy output mode to work. The difference from the prior art is that after the ablation is completed, the present invention can control the control part 13 to push the insulating tube 12 that comes with it to the farthest end so as to use the cutting edge 121 to directly cut off the adhesion between the ablated tissue and the electrode needle 11, which is convenient for pulling out the electrode needle 11 and avoids pulling the tissue in the process of pulling out the electrode needle 11, effectively preventing needle tract bleeding. Refer to the attached Figure 5 Since the electrical polarities of the electrode 1 112 and the electrode 2 114 are opposite when working, energy is only transferred between the electrode 1 112 and the electrode 2 114 , and the target tissue forms a roughly spindle-shaped ablation area after ablation is completed.

[0067] 2. Targeted ablation mode

[0068] This mode is specifically characterized by "a single side of electrode 112 and electrode 2 114 exposed through the coagulation window 122, the insulating needle 111 exposed, and the insulating tube 12 positioned at the distal end." To achieve this, the surgeon simply moves the control element 13 to its distal end. Ablation of target tissue can be performed using either "surface ablation" or "insertion ablation." Taking "insertion ablation" as an example, the surgeon first locates the target tissue, moves the control element 13 to its distal end, and inserts it into the target tissue. During this process, the surgeon manually supports the control element 13 to prevent the insulating tube 12 from returning to its proximal end during insertion (other embodiments may further incorporate corresponding mechanisms for improvement). The surgeon then selects the appropriate energy output mode. Unlike prior art techniques, the surgical method provided by the present invention does not require complex imaging functions, such as those directly added to the hemostatic device. Instead, it utilizes precise positioning with instruments such as CT scans, effectively reducing the production cost of hemostatic devices and the number of instruments used by the surgeon, significantly reducing human resources and improving surgical efficiency. Because electrosurgery for solid organs such as the liver can be performed by directly observing with the naked eye (open surgery) or under a microscope (microscopic surgery) or by touching or pressing with the hands or instruments to obtain the location of the target tissue. After obtaining the location of the target tissue, the directional ablation mode provided by the present invention can be used when it is necessary to avoid important organs or blood vessels around it. After the ablation is completed, the present invention can directly cut off the adhesion between the ablated tissue and the electrode needle 11 by pushing, pulling or rotating the control member 13 to utilize the coagulation window 122, which is convenient for pulling out the electrode needle 11 and can avoid pulling the tissue in the process of pulling out the electrode needle 11, effectively preventing the occurrence of needle tract bleeding. In addition, the operator usually adopts a pen-like grip method, and only the thumb and index finger need to cooperate to complete the rotation action on one hand. If pushing and pulling requires greater force, the other hand can be used. This not only saves other manpower, but also greatly improves the efficiency of the operation. Moreover, the present invention can change the direction of the coagulation window 122 by rotating the control member 13. The surgeon can change the coagulation direction at any time according to the actual situation. Similarly, it can be completed with one hand only by cooperating with the thumb and index finger, which not only saves other manpower but also greatly improves the efficiency of the operation. Figure 5 Since the electrical polarities of the electrode 1 112 and the electrode 2 114 are opposite when working, energy is only transferred between the electrode 1 112 and the electrode 2 114 , and the target tissue forms an ablation area with a roughly fan-shaped cross section after ablation is completed.

[0069] Because of the structural features of the present application, in the above two modes, the insulated needle 111 can damage the tissue or blood vessels, and even cause bleeding, especially in the directional ablation mode, more careful use of the "insertion of blood clotting" is required. Therefore, it is more recommended to gradually approach the target tissue through the "insertion of blood clotting" and then cut the ablated part to expose the target tissue as much as possible, and then perform directional ablation through the "surface blood clotting" mode. In order to reduce the risk of puncture injury caused by the insulated needle 111, the size of the needle 1111 of the insulated needle 111 can be as short as possible.

[0070] Embodiment 2, refer to the attached Figure 2 、 3 , 7, the main difference between this embodiment and the above-mentioned embodiments is:

[0071] In this embodiment, the connecting pipe 1121 is set to be hollow inside to serve as a fluid passage (i.e. inflow or backflow), and this embodiment is mainly used as a physiological saline inflow passage 117. The exposed pipe 1122 of the electrode one 112 is provided with an outflow port 116, which is generally multiple, uniformly distributed or regularly arranged on the exposed pipe 1122. The connecting pipe 1121 extends into the exposed pipe 1122 and can further be provided with an outflow port 116 at the part located inside the exposed pipe 1122, both of which are coaxially arranged, and the connecting pipe 1121 has a gap from the farthest end of the exposed pipe 1122.

[0072] To optimize the structure, at this time the insulated needle 111 can be provided with a needle 1111 and a connecting part 1112, the needle 1111 is used for puncture, and the connecting part 1112 is used for connecting the electrode one 112. Because the hollow connecting pipe 1121 and the exposed pipe 1122 are used in this embodiment, the connecting part 1112 can be set as a pipe for interference riveting after the connecting pipe 1121 is inserted, and the length of the connecting part 1112 is the same as the length of the gap, so as to ensure that there is no gap as much as possible after the insulated needle 111 and the electrode one 112 are assembled.

[0073] Embodiment 3, refer to the attached Figure 6 The main difference between this embodiment and the above-mentioned embodiments is:

[0074] This embodiment improves the structure of the coagulation window 122. Specifically, a grille 1221 is provided in the middle of the coagulation window 122. The grille 1221 has shielding strips and gaps. The overall length of the grille 1221 can be set to 0.5 cm, 1.5 cm, 2 cm, 2.5 cm, or other sizes as needed. The grille 1221 divides the coagulation window 122 into two parts, and the grille 1221 at least shields the portion of the first electrode 112 or the second electrode 114 adjacent to the insulating member 113. It can even shield the portions of both the first electrode 112 and the second electrode 114 adjacent to the insulating member 113. Whether or not the insulating member 113 is shielded is irrelevant.

[0075] The above embodiments all have the following problems: no matter whether the open ablation mode or the directional ablation mode is adopted, no matter whether it is "surface ablation" or "insertion ablation", the electrode 1 112 and the electrode 2 114 are close to the insulating part 113 and relatively far away from the two ends of the insulating part 113, and their energy is stronger in the working state. At the same gear and the same time, the degree of ablation of the target tissue is higher. If the host energy output gear is higher and the ablation time is shorter, it may happen that the ablation effect of the target tissue corresponding to the two ends of the electrode 1 112 and the electrode 2 114 is obviously poor, while the target tissue corresponding to the area close to the insulating part 113 is better. It will show a thin and brittle ablation effect. Even if the target tissue adhering to electrode 1 12 and electrode 2 114 is first removed using the coagulation window 122, it is still easy to bleed again after being pulled out. 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 surgeon, although the manufacturer can provide the recommended working time for each gear, it is still impossible for the surgeon to be familiar with the use of the equipment if he has not used it many times in clinical practice. Therefore, in order to control consistent surgical quality, it is more dependent on surgical experience, which is more difficult.

[0076] The addition of the grid 1221 in this embodiment effectively reduces the effect of the energy. This is achieved by utilizing the gaps in the grid 1221 to transmit energy, reducing the area over which the energy is applied, thereby weakening the effect on the tissue and balancing the energy across the entire coagulation window 122. It is worth noting that energy spreads somewhat when applied to tissue. Therefore, with the addition of the grid 1221, since the entire grid 1221 is relatively small, the target tissue obscured by the grid 1221 will not be affected and thus prevented from ablation.

[0077] Furthermore, the edges of the grille 1221 can still be configured as "blade-like chamfers" with a cutting effect to better maintain the function of the cutting window 122. However, the potential clogging of the grille 1221 needs to be taken into consideration. Therefore, the gaps in the grille 1221 need to be sufficiently large, such as with a minimum width of 1.5mm, 2mm, 2.5mm, or greater, to facilitate sufficient energy transmission and avoid clogging that makes cleaning inconvenient. The width of the shielding strips of the grille 1221 itself can be set based on the size of the gaps, and can also be slightly wider or narrower than the gaps.

[0078] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. An electrode assembly (1) for preventing needle tract bleeding, characterized in that: It comprises an electrode needle (11), an insulating tube (12) and a control member (13); the electrode needle (11) comprises an insulating needle head (111), an electrode 1 (112), an insulating member (113) and an electrode 2 (114) arranged in sequence from far to near, and the polarities of the electrode 1 (112) and the electrode 2 (114) are opposite; the proximal end of the electrode 2 (114) is wrapped with an outer insulating layer (115); the insulating tube (12) is sleeved outside the electrode needle (11), the distal end of which is a cutting edge (121), and the side of which is provided with a coagulation window (122); the control member (13) is connected to the insulating tube (12) to control the insulating tube (12) to rotate and / or move in the axial direction of the electrode needle (11); When the insulating tube (12) is located at the farthest end, a single side of the electrode 1 (112) and the electrode 2 (114) is exposed through the coagulation window (122), and the insulating needle (111) is exposed; When the insulating tube (12) is located at the nearest end, the first electrode (112) and the second electrode (114) are completely exposed; The cross section of the coagulation window (122) is rectangular, and its axial length is equal to the sum of the axial lengths of the electrode (112), the insulating member (113) and the electrode (114); 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 (111) is smoothly connected to the electrode one (112).

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

3. The electrode assembly (1) for preventing needle tract bleeding according to claim 1, characterized in that: 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).

4. The electrode assembly (1) for preventing needle tract bleeding according to claim 1, characterized in that: The insulating member (113) and the second electrode (114) are sequentially sleeved on the first electrode (112), and the first electrode (112) is wrapped with an inner insulating layer (118) to isolate the second electrode (114).

5. The electrode assembly (1) for preventing needle tract bleeding according to claim 4, characterized in that: The electrode 1 (112) is provided with an outlet (116), and an inlet channel (117) communicating with the outlet (116) is provided inside the electrode.

6. The electrode assembly (1) for preventing needle tract bleeding according to claim 1, characterized in that: A grid (1221) for balancing energy is provided in the middle of the coagulation window (122).

7. A hemostatic device comprising a handle (2), a cable plug (3) and an inlet tube (4), characterized in that: It also includes an electrode assembly (1) according to any one of claims 1 to 6; 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 inlet pipe (4).

8. A hemostatic device according to claim 7, characterized in that: A fixing block (21) for fixing the electrode needle (11) is provided in the handle (2); the control member (13) is fixed to the outside of the insulating tube (12), and limiting steps (131) are provided at the distal end and the proximal end of the control member (13), respectively, and the control member (13) is clamped in the handle (2) via the limiting steps (131).

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