Fully automatic biopsy needle with hemostasis function and biopsy needle

Abstract

The present invention discloses a biopsy needle with a hemostatic function, comprising: a sampling needle; a cutting needle assembly, comprising a cutting needle and an inner insulating layer covering the outer periphery of the cutting needle, the cutting needle being sleeved on the outer periphery of the sampling needle, the distal end of the cutting needle being exposed from the inner insulating layer and forming a first electrode with the distal end of the sampling needle; a trocar assembly, comprising a trocar and an outer insulating layer, the outer insulating layer covering the outer periphery of the trocar, the distal end of the trocar being exposed from the outer insulating layer to form a second electrode, the trocar assembly being configured to be detachably connected to the handle of the biopsy needle through a trocar plug so that the trocar is coaxially sleeved on the outer periphery of the cutting needle; the proximal end of the sampling needle and the proximal end of the trocar plug are electrically connected to a power supply device respectively, so as to realize that after taking out the sample tissue, the sampling needle and the cutting needle assembly are inserted into the trocar, and the first electrode and the second electrode are passed with electric energy to perform a hemostatic operation on the needle track.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to a fully automatic biopsy needle with hemostasis function and a biopsy needle. Background Art

[0002] Biopsy is an important means of tumor diagnosis. With the increasing incidence of tumors, the demand for biopsy surgery is also increasing year by year. According to statistics, the global biopsy needle market size reached billions of dollars in 2020, and it is expected to maintain a rapid growth trend in the next few years. Biopsy surgery is often accompanied by bleeding, and it is necessary to use products with hemostatic function to reduce the risk of bleeding. With the growth of the biopsy market, the present invention also has significant technical advantages and market prospects.

[0003] There are already some ablation needle products with hemostatic function on the market, but most of them have the following shortcomings:

[0004] Bulky in size and complex to operate: It needs to be connected to an external radio frequency or microwave host, which increases the difficulty and risk of surgical operations.

[0005] High cost: The radio frequency or microwave main unit is expensive, which increases the cost of the operation.

[0006] Poor hemostatic effect: Some products have ablation hemostasis function, but they cannot accurately locate the biopsy needle track, resulting in poor hemostatic effect, or causing secondary puncture injury or bleeding (the needle tip is carbonized and adhered due to high temperature, and other tissues are torn during needle withdrawal, causing secondary bleeding). Summary of the invention

[0007] The purpose of the present invention is to provide a fully automatic biopsy needle and biopsy needle with hemostasis function, which can stop needle tract bleeding in time after completing tissue biopsy. It is simple to operate, low cost, and highly safe. It does not need to call on expensive rescue medical resources. It can provide accurate diagnosis and treatment for tumor patients with high-risk bleeding, coagulation disorders, etc., and does not need to excessively occupy rescue medical resources, thereby promoting the benign use of medical resources.

[0008] The technical solution provided by the present invention is: a fully automatic biopsy needle with hemostasis function, comprising:

[0009] A sampling needle, with a sampling slot disposed at the distal end;

[0010] A cutting needle assembly, comprising a cutting needle and an inner insulating layer covering the outer periphery of the cutting needle, wherein the distal end of the cutting needle is provided with a cutting edge matching the sampling groove, the cutting needle is sleeved on the outer periphery of the sampling needle, the distal end of the cutting needle is exposed from the inner insulating layer and forms a first electrode with the distal end of the sampling needle;

[0011] A trocar assembly, comprising a trocar, an outer insulating layer and a trocar plug, wherein the outer insulating layer covers the outer periphery of the trocar, the distal end of the trocar is exposed from the outer insulating layer to form a second electrode, and the trocar assembly is configured to be detachably connected to the handle of the biopsy needle through the trocar plug so that the trocar is coaxially sleeved on the outer periphery of the cutting needle and is detachable;

[0012] The proximal end of the sampling needle and the proximal end of the trocar plug are electrically connected to the power supply device respectively, so that the trocar assembly and the handle can be disassembled after biopsy sampling so that the trocar assembly can be retained in the needle track. After the sample tissue in the sampling groove is taken out, the sampling needle and the cutting needle assembly are inserted into the trocar, and the first electrode and the second electrode are used to stop bleeding on the needle track by supplying electric energy.

[0013] Preferably, the biopsy needle further comprises a distance adjusting block, the distance adjusting block is slidably connected to the handle, the distal end of the distance adjusting block is fixedly connected to the trocar plug, and after the sampling needle and the cutting needle assembly are inserted into the trocar, the biopsy needle is configured to at least include a sampling configuration and a hemostasis configuration;

[0014] In the sampling configuration, when the sampling needle and the cutting needle complete the sampling state, the proximal end of the sampling slot extends out of the distal end of the trocar;

[0015] In the hemostasis configuration, the sampling needle and the cutting needle maintain a sampling completion state, and the distance adjustment block and the trocar assembly are adjusted to a preset distance toward the distal end along the extension direction of the needle body length.

[0016] Preferably, the cross-section of the distance adjusting block matches the cross-section of the handle, and sliding buckles extending along the length direction are provided on both sides of the inner wall of the distance adjusting block, and a sliding groove matching the sliding buckle is provided on the outer surface of the handle. The distance adjusting block is configured to be slidably connected with the sliding groove through the sliding buckle to achieve distance adjustment of the distance adjusting block along the length direction, and the position is locked by a locking structure after the distance adjusting block is adjusted to a predetermined position.

[0017] Preferably, the locking structure includes a plurality of locking holes passing through the surface of the distance adjusting block and an elastic arm locking button fixed at one end on the handle, and a protrusion at the free end of the elastic arm locking button is engaged with one of the locking holes to achieve locking of the axial relative position of the first electrode and the second electrode.

[0018] Preferably, the biopsy needle also includes an energy transmission socket, which is fixedly connected to the proximal end of the handle, and the distal end of the energy transmission socket is a free end. A spring arm locking button for locking the axial relative position of the first electrode and the second electrode is provided on the free end of the energy transmission socket, and the two electrical connection ends on the energy transmission socket are electrically connected to the cannula needle plug and the proximal end of the sampling needle respectively.

[0019] Preferably, a first wiring groove is provided on the inner wall of the distance adjusting block, and a second wiring groove connected with the first wiring groove is provided on the inner wall of the energy transmission socket, and the wire connecting the cannula needle plug and the energy transmission socket, and the sampling needle and the energy transmission socket extends along the first wiring groove and / or the second wiring groove.

[0020] Preferably, it also includes a portable power supply device, which is electrically connected to the energy transmission socket through an electrical pin, and the portable power supply device includes a lithium battery, a DCDC module, an MCU controller, an H-bridge module and a step-up transformer. The lithium battery supplies power to the MCU controller through the DCDC module, and the lithium battery is electrically connected to the H-bridge module. The MCU controller outputs a driving signal to drive the H-bridge module to output current to the first electrode and the second electrode through the step-up transformer to perform tissue hemostasis.

[0021] Preferably, the portable power supply device is detachably connected to the proximal end of the handle, a first magnetic sheet is arranged inside the distal end of the portable power supply device, a second magnetic sheet is arranged inside the proximal end of the handle, elastic arms with convex clamping points are respectively arranged on both sides of the distal end of the portable power supply device, and a concave clamping point matching the convex clamping point is arranged on the proximal end of the handle.

[0022] Preferably, the biopsy needle is configured to control the control system to detect impedance in real time when performing a hemostasis operation, and when the detected impedance meets a preset condition, the biopsy needle is retracted a preset distance to continue to repeat the hemostasis operation until the biopsy needle is completely withdrawn from the needle track.

[0023] Based on the same concept, the present invention also provides a biopsy needle with hemostasis function, comprising:

[0024] A sampling needle, with a sampling slot disposed at the distal end;

[0025] A cutting needle assembly, comprising a cutting needle and an inner insulating layer covering the outer periphery of the cutting needle, wherein the distal end of the cutting needle is provided with a cutting edge matching the sampling groove, the cutting needle is sleeved on the outer periphery of the sampling needle, the distal end of the cutting needle is exposed from the inner insulating layer and forms a first electrode with the distal end of the sampling needle;

[0026] A trocar assembly, comprising a trocar, an outer insulating layer and a trocar plug, wherein the outer insulating layer covers the outer periphery of the trocar, the distal end of the trocar is exposed from the outer insulating layer to form a second electrode, and the trocar assembly is configured to be detachably connected to the handle of the biopsy needle through the trocar plug so that the trocar is coaxially sleeved on the outer periphery of the cutting needle and is detachable;

[0027] The proximal end of the sampling needle and the proximal end of the trocar plug are electrically connected to the power supply device respectively, so that the trocar assembly and the handle can be disassembled after biopsy sampling so that the trocar assembly can be retained in the needle track. After the sample tissue in the sampling groove is taken out, the sampling needle and the cutting needle assembly are inserted into the trocar, and the first electrode and the second electrode are used to stop bleeding on the needle track by supplying electric energy.

[0028] Compared with the prior art, the present invention has the following advantages:

[0029] 1. The technical solution of the present invention is to set up a trocar assembly, which is used to retain the needle track on the one hand, and to form two electrodes with the sampling needle and the cutting needle for needle track ablation and hemostasis on the other hand. Specifically, after the sampling needle and the cutting needle have completed sampling, the sampling needle and the cutting needle are pulled out, and the trocar assembly is retained in the needle track to retain the needle track. After the tissue obtained by effective sampling is removed, the sampling needle and the cutting needle are inserted into the trocar, so that the needle track punctured during sampling can be easily replicated. The distal end of the cutting needle and the distal end of the sampling needle form a first electrode, and the distal end of the trocar forms a second electrode. The first electrode and the second electrode are passed with an adaptive current to achieve tissue ablation and coagulation, and avoid needle track bleeding.

[0030] 2. The present invention further provides a distance adjustment block. On the one hand, the distance adjustment block is detachably connected to the trocar assembly so as to leave the trocar assembly in the needle channel after sampling. On the other hand, the distance adjustment block is slidably connected to the handle of the biopsy needle. Since a sampling groove with a long distance is provided at the distal end of the sampling needle of the biopsy needle, the distal ends of the sampling needle and the cutting needle are at a long distance from the distal end of the trocar after sampling is completed, and it is necessary to perform hemostasis and ablation on the site where the sampled tissue is obtained (such as a tumor, etc.). Therefore, in this embodiment, the distance adjustment block and the handle are set to be slidably connected. In the hemostasis configuration, the sampling needle and the cutting needle maintain the state when the sampling is completed and are inserted into the trocar to return to the original sampling needle channel. At this time, the trocar assembly is adjusted to the distal end by a preset distance through the distance adjustment block. On the one hand, effective ablation of the site of the sampled tissue can be achieved, and on the other hand, the distance between the first electrode and the second electrode is reduced, which is beneficial to achieve precise ablation and coagulation, and avoid excessive damage to the tissue or incomplete hemostasis. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic diagram of the overall structure of the fully automatic biopsy needle with hemostasis function of the present invention;

[0032] Figure 2 It is a cross-sectional view of the fully automatic biopsy needle with hemostasis function of the present invention;

[0033] Figure 3 This is a schematic diagram of the structure of the sampling needle fixing slider and the cutting needle fixing slider of the present invention;

[0034] Figure 4 It is a structural schematic diagram of the guide left shell and the excitation switch of the present invention;

[0035] Figure 5 A schematic diagram of a fully automatic biopsy needle with hemostasis function of the present invention (part of the handle housing is hidden);

[0036] Figure 6 It is a schematic diagram of the structure of No. 1 loading button and No. 2 loading button of the present invention;

[0037] Figure 7 A schematic diagram of a fully automatic biopsy needle with hemostasis function of the present invention (part of the handle housing is hidden);

[0038] Figure 8 A schematic diagram of a loading method variation of the present invention;

[0039] Fig. 9 It is a schematic diagram of another loading method change of the present invention;

[0040] Fig.10 It is a schematic diagram of the fully automatic biopsy needle excitation sampling process with hemostasis function of the present invention;

[0041] Fig.11 It is a schematic diagram of the overall structure of the fully automatic biopsy needle with hemostasis function of the present invention (translation trocar and distance adjustment block);

[0042] Fig.12 This is a schematic diagram of the distance adjustment block and the energy transmission socket of the present invention;

[0043] Fig.13 This is a schematic diagram of the state when the biopsy sampling of the present invention is completed;

[0044] Fig.14 This is a schematic diagram of the ablation hemostasis state of the present invention;

[0045] Fig.15 It is a schematic diagram of the internal modules of the portable power supply device of the present invention.

[0046] Description of reference numerals:

[0047] 001-first electrode; 002-second electrode; 1-sampling needle; 1001-sampling slot; 2-cutting needle; 3-inner insulation layer; 4-trocar; 5-outer insulation layer; 6-trocar plug; 7-handle; 71-slide; 72-second magnetic sheet; 8-distance adjustment block; 81-slide buckle; 82-first wiring slot; 83-locking hole; 84-trocar socket; 9-energy transmission socket; 91-second wiring slot; 92-elastic arm locking button; 10-power supply device; 101-first magnetic sheet; 11-No. 1 loading button; 111-first connecting hole; 112-first guide sheet; 12-No. 2 loading button; 121 -second guide plate; 13-sampling needle fixing slider; 131-second elastic hook; 132-second firing slot; 133-elastic gasket; 14-cutting needle fixing slider; 141-first elastic hook; 15-guide left shell; 151-elastic plate limiting slot; 152-guide limiting member guide slot; 153-lower slot; 16-guide right shell; 17-first partition; 171-first slot; 18-first spring; 19-second partition; 191 second slot; 20-second spring; 21-excitation switch; 211-elastic plate 211; 212-guide limiting member; 213-linking rod; 214-first firing slot. DETAILED DESCRIPTION

[0048] The following is an explanation of the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be understood that the orientation or position relationship indicated by the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc. is based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, the meaning of "multiple" is two or more.

[0049] It should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0050] Biopsy is the gold standard for tumor pathology diagnosis and is widely used in clinical practice. Traditional biopsy needles obtain tissue samples through mechanical cutting, but this method is prone to bleeding, especially for biopsies in special parts such as the liver and kidneys, where the risk of bleeding is higher and may even endanger the patient's life.

[0051] Biopsy is divided into: bone biopsy, tissue biopsy, cell biopsy. For solid tumors, tissue biopsy is generally used to diagnose pathological tissues, including liver, lung, kidney, prostate, thyroid, etc. The principle of tissue biopsy generally uses spring force to achieve rapid cutting of pathology. Generally, the tissue biopsy needle consists of a needle core and a needle tube. The needle core is generally provided with a sampling groove 1001. The needle tube mainly achieves rapid cutting of tissues, so that the tissue remains in the sampling groove 1001. Biopsy needles have various specifications, large ones are 7G, 9G, 12G, and small ones are 16G, 18G, 20G, etc. Because of the use of mechanical cutting and puncture operations, bleeding becomes the most frequent complication during the biopsy process. Of course, this kind of bleeding can be easily coagulated (hemostasis) under normal circumstances. However, in some special organs, special parts, or some special patients, such as those with coagulation disorders, heavy bleeding is prone to occur. In this scenario, the biopsy cannot be carried out normally. Of course, there are some clinical methods for analyzing this kind of bleeding, such as using radio frequency or microwaves to stop bleeding at the needle tract. Of course, this situation belongs to emergency medical treatment, which is expensive and complicated to operate.

[0052] First embodiment

[0053] To this end, this embodiment provides a fully automatic biopsy needle with a hemostatic function, see Figure 1 ,include:

[0054] The sampling needle 1 has a sampling slot 1001 at the distal end;

[0055] A cutting needle assembly, comprising a cutting needle 2 and an inner insulating layer 3 covering the outer periphery of the cutting needle 2, wherein the distal end of the cutting needle 2 is provided with a cutting edge matching the sampling groove 1001, the cutting needle 2 is sleeved on the outer periphery of the sampling needle 1, the distal end of the cutting needle 2 is exposed from the inner insulating layer 3 and forms a first electrode 001 with the distal end of the sampling needle 1;

[0056] A trocar assembly, comprising a trocar 4, an outer insulating layer 5 and a trocar plug 6, wherein the outer insulating layer 5 covers the outer periphery of the trocar 4, and the distal end of the trocar 4 is exposed from the outer insulating layer 5 to form a second electrode 002, and the trocar assembly is configured to be detachably connected to the handle 7 of the biopsy needle through the trocar plug 6 so that the trocar 4 is coaxially sleeved on the outer periphery of the cutting needle 2 and is detachable;

[0057] The proximal end of the sampling needle 1 and the proximal end of the trocar plug 6 are electrically connected to the power supply device 10 respectively, so that the trocar assembly and the handle 7 can be disassembled after biopsy sampling so that the trocar assembly can be retained in the needle track. After the sample tissue in the sampling groove 1001 is taken out, the sampling needle 1 and the cutting needle assembly are inserted into the trocar 4, and the first electrode 001 and the second electrode 002 are used to stop bleeding on the needle track by supplying electric energy.

[0058] The technical solution of this embodiment is to set up a trocar assembly to retain the needle track on the one hand, and to form two electrodes with the sampling needle 1 and the cutting needle 2 for needle track ablation and hemostasis on the other hand. Specifically, after the sampling needle 1 and the cutting needle 2 have completed sampling, the sampling needle 1 and the cutting needle 2 are pulled out, and the trocar assembly is retained in the needle track to retain the needle track. After the tissue obtained by effective sampling is removed, the sampling needle 1 and the cutting needle 2 are inserted into the trocar 4, so that the needle track punctured during sampling can be easily replicated. In addition, the distal end of the cutting needle 2 forms a first electrode 001 with the distal end of the sampling needle 1, and the distal end of the trocar 4 forms a second electrode 002. The first electrode 001 and the second electrode 002 are passed with an adaptive current so that tissue ablation and coagulation can be achieved to avoid needle track bleeding.

[0059] Preferably, see Figure 1 , Fig.11 , Fig.12 , Fig.13 , Fig.14 The biopsy needle further comprises a distance adjusting block 8, the distance adjusting block 8 is slidably connected to the handle 7, the distal end of the distance adjusting block 8 is fixedly connected to the trocar plug 6, and after the sampling needle 1 and the cutting needle assembly are inserted into the trocar 4, the biopsy needle is at least configured to include a sampling configuration and a hemostasis configuration;

[0060] In the sampling configuration, when the sampling needle 1 and the cutting needle 2 complete the sampling state, the proximal end of the sampling slot 1001 extends out of the distal end of the trocar 4;

[0061] In the hemostasis configuration, the sampling needle 1 and the cutting needle 2 maintain a sampling completion state, and the distance adjustment block 8 and the trocar assembly are adjusted to a preset distance toward the distal end along the extension direction of the needle body.

[0062] The technical solution of this embodiment is a further preferred solution, and a distance adjusting block 8 is provided. On the one hand, the distance adjusting block 8 is detachably connected to the trocar assembly (a trocar socket matching the trocar plug is provided at the far end of the distance adjusting block to achieve structural and electrical connection), so as to achieve the trocar assembly being left in the needle channel after sampling. On the other hand, the distance adjusting block 8 is slidably connected to the biopsy needle handle 7. Since a long sampling groove 1001 is provided at the far end of the sampling needle 1 of the biopsy needle, after the sampling is completed, the far ends of the sampling needle 1 and the cutting needle 2 are at a long distance from the far end of the trocar 4, and it is necessary to obtain the sampling. In order to perform hemostasis and ablation on tissue parts (such as tumors, etc.), the distance adjusting block 8 and the handle 7 are set to be slidably connected in this embodiment. In the hemostasis configuration, the sampling needle 1 and the cutting needle 2 maintain the state when the sampling is completed and are inserted into the cannula needle 4 to return to the original sampling needle channel. At this time, the cannula needle assembly is adjusted to the preset distance toward the distal end through the distance adjusting block 8. On the one hand, it can realize effective ablation of the sampled tissue part, and on the other hand, it can reduce the distance between the first electrode 001 and the second electrode 002, which is beneficial to realize accurate ablation and coagulation, and avoid excessive damage to the tissue or incomplete hemostasis.

[0063] Preferably, continue to see Fig.11 , Fig.12 The cross section of the distance adjusting block 8 matches the cross section of the handle 7, and the inner walls of the distance adjusting block 8 are provided with sliders 81 extending along the length direction on both sides, and the outer surface of the handle 7 is provided with a slide groove 71 matching the slider 81. The distance adjusting block 8 is configured to be slidably connected with the slide groove 71 through the slider 81 to achieve distance adjustment of the distance adjusting block 8 along the length direction, and the position is locked by a locking structure after the distance adjusting block 8 is adjusted to a predetermined position.

[0064] The technical solution of this embodiment discloses a connection structure between a distance adjusting block 8 and a handle 7. A sliding buckle 81 extending in the length direction is provided on the distance adjusting block 8, and a sliding groove 71 matching with the sliding buckle 81 is provided on the outer surface of the handle 7. The use of such an adjustment mechanism can obtain a smaller structure so that the radial dimension of the operating handle 7 is not too large, which is more portable and easy to operate. However, the present invention is not limited to this axial sliding adjustment structure, and any mechanism in the prior art for realizing axial adjustment of two components can be used. For example, the positions of the sliding buckle 81 and the sliding groove 71 are interchanged.

[0065] Preferably, continue to see Fig.11 The locking structure includes a plurality of locking holes 83 penetrating the surface of the distance adjusting block 8 and an elastic arm locking button 92 fixed at one end on the handle 7, and the protrusion at the free end of the elastic arm locking button 92 is engaged with one of the locking holes 83 to achieve the locking of the axial relative positions of the first electrode 001 and the second electrode 002.

[0066] This embodiment provides a locking structure, and a plurality of locking holes 83 are set on the surface of the distance adjustment block 8. The plurality of locking holes 83 are used to provide a variety of adjustment gears. The free end protrusion of the elastic arm locking button 92 fixedly set on the handle 7 is engaged with one of the locking holes 83 to achieve the adjustment and fixation of different gears, thereby achieving the adjustment of the distance between the first electrode 001 and the second electrode 002, providing flexibility for the coagulation operation. Of course, at least two locking holes 83 are set, corresponding to the sampling configuration and the hemostasis configuration respectively. The locking structure of this embodiment can obtain a smaller radial size, which is convenient for operation.

[0067] Preferably, continue to see Fig.11 The biopsy needle also includes an energy transmission socket 9, which is fixedly connected to the proximal end of the handle 7, and the distal end of the energy transmission socket 9 is a free end. The free end of the energy transmission socket 9 is provided with an elastic arm locking button 92 for locking the axial relative position of the first electrode 001 and the second electrode 002. The two electrical connection ends on the energy transmission socket 9 are electrically connected to the trocar plug 6 and the proximal end of the sampling needle 1 respectively.

[0068] The technical solution of this embodiment is to set an energy transmission socket 9, and the two electrical connection ends on the energy transmission socket 9 are respectively electrically connected to the trocar plug 6 and the proximal end of the sampling needle 1, and the energy transmission socket 9 is electrically connected to the power supply device 10 through the plug pin. The connection method is simple and convenient, which is convenient for componentization, modularization, and standardized production. More preferably, the distal end of the energy transmission socket 9 is configured as a free end, so that a spring arm locking button 92 can be set on the free end, so that the energy transmission socket 9 has the functions of energy transmission and mode adjustment (sampling / hemostasis) at the same time, further saving the radial structural space of the operating handle 7, which is conducive to the portability of the product.

[0069] Preferably, see Fig.12 The inner wall of the distance adjusting block 8 is provided with a first wiring groove 82, and the inner wall of the energy transmission socket 9 is provided with a second wiring groove 91 connected with the first wiring groove 82. The wires connecting the cannula needle plug 6 and the energy transmission socket 9, and the sampling needle 1 and the energy transmission socket 9 extend along the first wiring groove 82 and / or the second wiring groove 91.

[0070] The technical solution of this embodiment sets a first wiring groove 82 on the inner wall of the distance adjustment block 8, and sets a second wiring groove 91 inside the energy transmission socket 9, reserving an accommodation space for the electrically connected wires, and the wiring groove is highly matched with the wires to avoid jamming during the adjustment process.

[0071] Preferably, see Fig.13 , Fig.14 , Fig.15 , also includes a portable power supply device 10, the portable power supply device 10 is electrically connected to the energy transmission socket 9 through an electrical pin, the portable power supply device 10 includes a lithium battery, a DCDC module, an MCU controller, an H-bridge module and a step-up transformer, the lithium battery supplies power to the MCU controller through the DCDC module, the lithium battery is electrically connected to the H-bridge module, the MCU controller outputs a driving signal to drive the H-bridge module to output current to the first electrode 001 and the second electrode 002 through the step-up transformer to perform tissue hemostasis.

[0072] The technical solution of this embodiment discloses a portable power supply device 10. In the prior art, when encountering a biopsy bleeding situation, it is often necessary to call for rescue medical resources, and an external radiofrequency ablation or microwave energy host is required to provide energy for ablation and hemostasis. However, the portable power supply device 10 provided in this embodiment is only used for ablation and coagulation of the needle tract, and does not need to reach the energy level of tissue ablation to necrosis. Therefore, the portable power supply device 10 of this embodiment can cooperate well with the first electrode 001 and the second electrode 002 to perform tissue ablation and coagulation operations. See Fig.15 , which is a schematic diagram of the internal module composition of the portable power supply device 10.

[0073] Preferably, the portable power supply device 10 is detachably connected to the proximal end of the handle 7, a first magnetic sheet 101 is provided inside the distal end of the portable power supply device 10, a second magnetic sheet 72 is provided inside the proximal end of the handle 7, elastic arms with convex clamping points are respectively provided on both sides of the distal end of the portable power supply device 10, and a concave clamping point matching the convex clamping point is provided on the proximal end of the handle 7.

[0074] In this embodiment, the portable power supply device 10 is in a modular and detachable form, and this embodiment provides a convenient and quick connection structure to achieve quick connection of the portable power supply device 10. Of course, this is only one of the connection methods, and the main inventive concept of the present invention is not limited to this connection structure, and any quick-detachable structure in the prior art can be used.

[0075] Preferably, the biopsy needle is configured to control the control system to detect impedance in real time when performing a hemostasis operation, and when the detected impedance meets a preset condition, the biopsy needle is retracted a preset distance to continue to repeat the hemostasis operation until the biopsy needle is completely withdrawn from the needle track.

[0076] The technical solution of this embodiment proposes that during the operation of ablation hemostasis, the control system (or MCU controller) calculates the impedance in real time based on the collected voltage, current and other data. When the impedance meets the preset conditions, it can be judged that the hemostatic ablation of the tissue at this time has met the requirements, and neither excessive ablation damages the tissue nor fails to achieve the purpose of hemostatic ablation. At this time, the biopsy needle is retracted a certain distance, so as to gradually stop the bleeding of the needle track. Of course, in some schemes, since the distance between the first electrode 001 and the second electrode 002 has different gear adjustments, when the hemostasis of a part is achieved, it does not completely leave the interval, but retreats 1 / 2 (or other) ablation interval to perform ablation, so as to achieve flexible operation of ablation hemostasis. The ablation interval here refers to the distance between the first electrode 001 and the second electrode 002.

[0077] The fully automatic biopsy excitation structure of the fully automatic biopsy needle with hemostasis function of the present invention is further described below.

[0078] like Figure 1 , Figure 2 , Figure 3 , Figure 4 The needle body of the fully automatic biopsy needle includes a sampling needle 1, a cutting needle 2 and a trocar 4. The sampling needle 1 is fixedly connected to the sampling needle fixed slider 13, and the cutting needle 2 is fixedly connected to the cutting needle fixed slider 14. The sampling needle 1, the cutting needle 2 and the trocar 4 are coaxially sleeved, and the outer coaxial sleeve of the cutting needle 2 is provided with an inner insulating layer 3; the sampling needle fixed slider 13 is arranged in the space formed by the guide left shell 15 and the guide right shell 16, and the guide left shell 15 and the guide right shell 16 are correspondingly provided with a first partition 17 for isolating the cutting needle fixed slider 14 and the sampling needle fixed slider 13. The first partition 17 has two functions. On the one hand, it plays a role of partition and limit, and on the other hand, it plays a role of partition and limit. The function is to facilitate the loading of the cutting needle fixing slider 14. Specifically, a pair of first elastic hooks 141 are provided at the bottom of the cutting needle fixing slider 14. A first card slot 171 matching the first elastic hook 141 of the cutting needle fixing slider 14 is provided at the center of the first partition 17. The biopsy needle also includes a first spring 18, which is arranged between the first partition 17 and the cutting needle fixing slider 14. When the cutting needle fixing slider 14 is pressed toward the proximal end to load the cutting needle, the first spring 18 is compressed and deformed, and drives the cutting needle 2 to move toward the proximal end until the first elastic hook 141 of the cutting needle fixing slider 14 passes through the first card slot 171 and the cutting needle is loaded into place.

[0079] like Figure 1 , Figure 2 , Figure 3 , Figure 4A pair of second elastic hooks 131 are provided at the bottom of the sampling needle fixing slider 13, and a second partition 19 is provided corresponding to the left guide shell 15 and the right guide shell 16. A second card slot 191 matching the second elastic hook 131 of the sampling needle fixing slider 13 is provided at the center of the second partition 19. The biopsy needle also includes a second spring 20, which is arranged between the second partition 19 and the sampling needle fixing slider 13. When the sampling needle fixing slider 13 is pressed toward the proximal end and loaded, the second spring 20 is compressed and deformed, and drives the sampling needle 1 to move toward the proximal end. Until the second elastic hook 131 of the sampling needle fixing slider 13 passes through the second slot 191 and is loaded into place, here, the left and right sides of the sampling needle fixing slider 13 are provided with I-shaped elastic gaskets 133 to play a buffering role; here, the sampling needle fixing slider 13 and the cutting needle fixing slider 14 play the same role and are basically the same in structure. The sampling needle fixing slider 13 is provided with a connecting piece for connecting the sampling needle button (No. 2 loading button 12), and the cutting needle fixing slider 14 is provided with a connecting piece for connecting the cutting needle button (No. 1 loading button 11).

[0080] like Figure 2 , Figure 4 , Figure 5 , Figure 7The fully automatic biopsy needle includes an excitation switch 21, the main body of which is arranged at the proximal end of the cavity formed by the guide left shell 15 and the guide right shell 16, and the inner cavity diameter of the excitation switch 21 is larger than the inner cavity diameter of the sampling needle fixed slider 13 and the cutting needle fixed slider 14, so that the linkage rod 213 of the excitation switch 21 can be extended out of the guide left shell 15. The biopsy needle includes a handle 7 shell and a push button, the handle 7 shell is sleeved on the outside of the guide left and right shells, the push button is arranged in the push button groove of the handle 7 shell, and the push button is clamped with the linkage rod 213. The excitation switch 21 includes an elastic sheet 211, a guide limit member 212 and a linkage rod 213. The linkage rod 213 extends from the lower slot 153 of the guide left shell 15 to at least the upper edge of the upper opening. A limit slot is provided on the outside of the guide left shell 15 to limit the displacement of the linkage rod 213. The inner cavity where the excitation switch 21 is placed is provided with a guide slot 152 for the guide limit member. The guide limit member 212 is arranged in the guide slot 152 for the guide limit member to ensure that the guide limit member 212 moves up and down in the guide slot 152 for the guide limit member and the stroke is limited. The inner cavity where the excitation switch 21 is placed is provided with an elastic sheet limit slot 151. The elastic sheet 211 is arranged in the elastic sheet limit slot 151. The middle parts of the elastic sheet 211 and the guide limit member 212 are connected and the free ends are separated from each other. The two ends of the elastic sheet 211 abut against the inner buckle abutting surface extending inwardly at the connection between the guide slot 152 for the guide limit member and the elastic sheet limit slot 151. A first firing groove 214 is provided at the distal end of the guide limiter 212 for compressing the second elastic hook 131 of the sampling needle fixing slider 13 when firing. A second firing groove 132 is provided at the top of the sampling needle fixing slider 13 for compressing the first elastic hook 141 of the cutting needle fixing slider 14 when firing.

[0081] like Figure 6 , Figure 7 The biopsy needle also includes a No. 1 loading button 11 and a No. 2 loading button 12, which are matched in shape and connected. The No. 1 loading button 11 is provided with a first connecting hole 111, which is matched and fixedly connected with the cutting needle button (No. 1 loading button 11) connecting piece. The No. 1 loading button 11 is provided with a first guide piece 112 inwardly, and the first guide piece 112 is matched and slidably connected with a first guide groove provided at the outer upper end of the guide left shell 15 to ensure axial limited movement; the No. 2 loading button 12 is also provided with a second connecting hole, which is matched and fixedly connected with the sampling needle 1 button (No. 2 loading button 12) connecting piece, and the No. 2 loading button 12 is symmetrically provided with a second guide piece 121 at the bottom, and the second guide piece 121 is matched and slidably connected with the second guide groove provided at the lower end of the guide left shell 15 and the third guide groove provided at the outer lower end of the guide right shell 16 respectively, to ensure up and down movement, and at the same time, the second guide piece 121 clamps the guide left shell 15 and the guide right shell 16.

[0082] There are two ways to load the gun:

[0083] Method 1: If Figure 8 , the cutting needle 2 and the sampling needle 1 are loaded in batches, and the No. 1 loading button 11 is pressed to drive the cutting needle fixing slider 14 to move the cutting needle 2 toward the proximal end, compressing the first spring 18. When the first elastic hook 141 of the cutting needle fixing slider 14 passes through the first slot 171, the cutting needle 2 is loaded; the No. 2 loading button 12 is pressed to drive the sampling needle fixing slider 13 to move the sampling needle 1 downward in a linked manner, compressing the second spring 20. When the second elastic hook 131 of the sampling needle fixing slider 13 passes through the second slot 191, the sampling needle 1 is loaded. At this time, the biopsy needle is loaded in batches;

[0084] Method 2: If Fig. 9 , the cutting needle 2 and the sampling needle 1 are loaded at the same time, the loading button No. 1 11 and the loading button No. 2 12 are matched in shape and connected, and the loading button No. 2 12 is pressed, and the loading button No. 2 12 synchronously drives the loading button No. 1 11 to move, and drives the cutting needle fixing slider 14 to move downward in conjunction with the cutting needle 2, compressing the first spring 18, and when the first elastic hook 141 of the cutting needle fixing slider 14 passes through the first slot 171, the loading of the cutting needle 2 is completed; synchronously, the sampling needle fixing slider 13 moves downward in conjunction with the sampling needle 1, compressing the second spring 20, and when the second elastic hook 131 of the sampling needle fixing slider 13 passes through the second slot 191, the loading of the sampling needle 1 is completed. At this time, the loading of the biopsy needles is completed at the same time.

[0085] Biopsy stimulation sampling:

[0086] like Fig.10 After loading is completed, the push button or the button (activation switch 21) at the bottom of the biopsy is pushed on the outer shell of the handle 7, driving the guide limiter 212 to move toward the distal end, and the first firing slot 214 abuts against the second elastic hook 131. As the first firing slot 214 continues to squeeze the second elastic hook 131, the second elastic hook 131 is compressed and disengaged from the second slot 191, and the compressed second spring 20 is released to realize the activation of the sampling needle 1; at the moment of excitation completion, the sampling needle fixed slider 13 hits the cutting needle fixed slider 14, so that the second firing slot 132 hits the first elastic hook 141 on the cutting needle fixed slider 14. During the instantaneous collision, the first elastic hook 141 is compressed and disengaged from the first slot 171, and the compressed first spring 18 is released to realize the activation of the cutting needle 2. At this point, the biopsy activation sampling is completed.

[0087] Second embodiment

[0088] The present invention also provides a biopsy needle with hemostasis function, comprising:

[0089] The sampling needle 1 has a sampling slot 1001 at the distal end;

[0090] A cutting needle assembly, comprising a cutting needle 2 and an inner insulating layer 3 covering the outer periphery of the cutting needle 2, wherein the distal end of the cutting needle 2 is provided with a cutting edge matching the sampling groove 1001, the cutting needle 2 is sleeved on the outer periphery of the sampling needle 1, the distal end of the cutting needle 2 is exposed from the inner insulating layer 3 and forms a first electrode 001 with the distal end of the sampling needle 1;

[0091] A trocar assembly, comprising a trocar 4, an outer insulating layer 5 and a trocar plug 6, wherein the outer insulating layer 5 covers the outer periphery of the trocar 4, and the distal end of the trocar 4 is exposed from the outer insulating layer 5 to form a second electrode 002, and the trocar assembly is configured to be detachably connected to the handle 7 of the biopsy needle through the trocar plug 6 so that the trocar 4 is coaxially sleeved on the outer periphery of the cutting needle 2 and is detachable;

[0092] The proximal end of the sampling needle 1 and the proximal end of the trocar plug 84 are electrically connected to the power supply device 10 respectively, so that the trocar assembly and the handle 7 can be disassembled after biopsy sampling so that the trocar assembly can be retained in the needle track. After the sample tissue in the sampling groove 1001 is taken out, the sampling needle 1 and the cutting needle assembly are inserted into the trocar 4, and the first electrode 001 and the second electrode 002 are used to stop bleeding on the needle track by supplying electric energy.

[0093] The technical solution of this embodiment is to set up a trocar assembly, which is used to retain the needle track on the one hand, and to form two electrodes with the sampling needle 1 and the cutting needle 2 for needle track ablation and hemostasis on the other hand. Specifically, after the sampling needle 1 and the cutting needle 2 have completed sampling, the sampling needle 1 and the cutting needle 2 are pulled out, and the trocar assembly is retained in the needle track to retain the needle track. After the tissue obtained by effective sampling is removed, the sampling needle 1 and the cutting needle 2 are inserted into the trocar 4, so that the needle track punctured during sampling can be easily replicated. And the distal end of the cutting needle 2 and the distal end of the sampling needle 1 form a first electrode 001, and the distal end of the trocar 4 forms a second electrode 002. The first electrode 001 and the second electrode 002 are passed with an adaptive current so that tissue ablation and coagulation can be achieved to avoid needle track bleeding. The biopsy needle of this embodiment is not necessarily a fully automatic biopsy needle, it can be a semi-automatic biopsy needle, or even a manual biopsy needle.

[0094] The present invention does not need to perform biopsy and ablation surgery twice (or two products), and does not need to connect to a radio frequency or microwave host during the hemostasis process. We integrate the functions required for biopsy and hemostasis of the huge radio frequency (microwave) host into disposable consumables, truly realizing the one-time operation of biopsy and hemostasis during outpatient surgery, greatly reducing the operation time and cost, and greatly improving the safety of the operation. The present invention can be used for various tissue biopsies, especially for biopsy operations with a higher risk of bleeding, such as liver cancer, kidney cancer and other tumor biopsies, and has broad application prospects.

[0095] In addition, in the description of this application, the "proximal end" and "distal end" of "proximal end" are commonly used terms in the medical field. Specifically, the "proximal end" is the end close to the operator, the "proximal end surface" is the end surface close to the operator, the "distal end" is the end away from the operator, and the "distal end surface" is the end surface away from the operator.

[0096] The embodiments of the present invention are described in detail above in conjunction with the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they still fall within the protection scope of the present invention.

Claims

1. A biopsy needle with hemostatic function, characterized in that: include: A sampling needle, with a sampling slot disposed at the distal end; A cutting needle assembly, comprising a cutting needle and an inner insulating layer covering the outer periphery of the cutting needle, wherein the distal end of the cutting needle is provided with a cutting edge matching the sampling groove, the cutting needle is sleeved on the outer periphery of the sampling needle, the distal end of the cutting needle is exposed from the inner insulating layer and forms a first electrode with the distal end of the sampling needle; A trocar assembly, comprising a trocar, an outer insulating layer and a trocar plug, wherein the outer insulating layer covers the outer periphery of the trocar, the distal end of the trocar is exposed from the outer insulating layer to form a second electrode, and the trocar assembly is configured to be detachably connected to the handle of the biopsy needle through the trocar plug so that the trocar is coaxially sleeved on the outer periphery of the cutting needle and is detachable; The proximal end of the sampling needle and the proximal end of the trocar plug are electrically connected to the power supply device respectively, so that the trocar assembly and the handle are disassembled after biopsy sampling so that the trocar assembly is retained in the needle track, and after the sample tissue in the sampling groove is taken out, the sampling needle and the cutting needle assembly are inserted into the trocar, and the first electrode and the second electrode are used to stop bleeding on the needle track by passing electrical energy; The biopsy needle further comprises a distance adjusting block, the distance adjusting block is slidably connected to the handle, the distal end of the distance adjusting block is fixedly connected to the trocar plug, and after the sampling needle and the cutting needle assembly are inserted into the trocar, the biopsy needle is configured to at least include a sampling configuration and a hemostasis configuration; In the sampling configuration, when the sampling needle and the cutting needle complete the sampling state, the proximal end of the sampling slot extends out of the distal end of the trocar; In the hemostasis configuration, the sampling needle and the cutting needle maintain a sampling completion state, and the distance adjustment block and the trocar assembly are adjusted to a preset distance toward the distal end along the extension direction of the needle body length.

2. The biopsy needle with hemostasis function according to claim 1, characterized in that: The cross section of the distance adjusting block matches the cross section of the handle, and sliding buckles extending along the length direction are provided on both sides of the inner wall of the distance adjusting block. The outer surface of the handle is provided with a sliding groove matching the sliding buckle. The distance adjusting block is configured to be slidably connected with the sliding groove through the sliding buckle to achieve distance adjustment of the distance adjusting block along the length direction, and the position is locked by a locking structure after the distance adjusting block is adjusted to a predetermined position.

3. The biopsy needle with hemostasis function as claimed in claim 2, characterized in that: The locking structure includes a plurality of locking holes penetrating the surface of the distance adjusting block and an elastic arm locking button fixedly arranged on the handle at one end, and a protrusion at the free end of the elastic arm locking button is engaged with one of the locking holes to achieve locking of the axial relative positions of the first electrode and the second electrode.

4. The biopsy needle with hemostasis function according to claim 1, characterized in that: The biopsy needle also includes an energy transmission socket, which is fixedly connected to the proximal end of the handle, and the distal end of the energy transmission socket is a free end. A spring arm locking button for locking the axial relative position of the first electrode and the second electrode is provided on the free end of the energy transmission socket, and the two electrical connection ends on the energy transmission socket are electrically connected to the trocar plug and the proximal end of the sampling needle respectively.

5. The biopsy needle with hemostasis function according to claim 4, characterized in that: The inner wall of the distance adjusting block is provided with a first wiring groove, the inner wall of the energy transmission socket is provided with a second wiring groove connected with the first wiring groove, and the wire connecting the cannula needle plug and the energy transmission socket, and the sampling needle and the energy transmission socket extends along the first wiring groove and / or the second wiring groove.

6. The biopsy needle with hemostasis function according to claim 4, characterized in that: It also includes a portable power supply device, which is electrically connected to the energy transmission socket through an electrical pin. The portable power supply device includes a lithium battery, a DCDC module, an MCU controller, an H-bridge module and a step-up transformer. The lithium battery supplies power to the MCU controller through the DCDC module. The lithium battery is electrically connected to the H-bridge module. The MCU controller outputs a driving signal to drive the H-bridge module to output current to the first electrode and the second electrode through the step-up transformer to perform tissue hemostasis.

7. The biopsy needle with hemostasis function according to claim 6, characterized in that: The portable power supply device is detachably connected to the proximal end of the handle, a first magnetic sheet is arranged inside the distal end of the portable power supply device, a second magnetic sheet is arranged inside the proximal end of the handle, elastic arms with convex clamping points are arranged on both sides of the distal end of the portable power supply device, and concave clamping points matching the convex clamping points are arranged on the proximal end of the handle.

8. The biopsy needle with hemostasis function according to claim 1, characterized in that: The biopsy needle is configured to control the control system to detect impedance in real time when performing a hemostasis operation, and when the detected impedance meets a preset condition, the biopsy needle is retracted a preset distance to continue to repeat the hemostasis operation until the biopsy needle completely exits the needle tract.

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