Fully automatic biopsy needle having hemostatic function, and biopsy needle

Abstract

Disclosed in the present invention is a biopsy needle having a hemostasic function, the biopsy needle comprising: a sampling needle; a cutting needle assembly, which comprises a cutting needle and an inner insulation layer covering the outer circumference of the cutting needle, the cutting needle being fitted around the outer circumference of the sampling needle, and a distal end of the cutting needle being exposed from the inner insulation layer and forming a first electrode with a distal end of the sampling needle; a cannula assembly, which comprises a cannula and an outer insulation layer covering the outer circumference of the cannula, a distal end of the cannula being exposed from the outer insulation layer and forming a second electrode, wherein the cannula assembly is configured to be detachably connected to a handle of a biopsy needle by means of a cannula plug, so that the cannula is coaxially sleeved around the outer circumference of the cutting needle; and a proximal end of the sampling needle and a proximal end of the cannula plug are both electrically connected to a power supply device, so that after sample tissue is removed, the sampling needle and the cutting needle assembly are inserted into the cannula, and then the first electrode and the second electrode are energized to perform a hemostasis operation on a needle tract.

Description

A fully automated biopsy needle with hemostatic function and a biopsy needle Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a fully automated biopsy needle and biopsy needle with hemostasis function. Background Technology

[0002] Biopsy is a crucial method for tumor diagnosis, and with the continuous rise in tumor incidence, the demand for biopsy procedures is increasing year by year. Statistics show that the global market size for biopsy needles reached several billion US dollars in 2020, and it is expected to maintain rapid growth in the coming years. Biopsy procedures are often accompanied by bleeding, requiring the use of products with hemostatic functions to reduce the risk of bleeding. With the growth of the biopsy market, this invention also possesses significant technological advantages and market prospects.

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

[0004] Large size and complex operation: It requires connection to an external radio frequency or microwave host, which increases the difficulty and risk of surgical procedures.

[0005] High cost: Radiofrequency or microwave devices are expensive, increasing the cost of surgery.

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

[0007] The purpose of this invention is to provide a fully automated biopsy needle and biopsy needle with hemostasis function, which can perform needle tract hemostasis in a timely manner after tissue biopsy. It is simple to operate, low in cost, and highly safe. It does not require the use of expensive emergency medical resources, and can provide accurate diagnosis and treatment for tumor patients with high-risk bleeding, coagulation disorders, etc. It also does not excessively occupy emergency medical resources, thus promoting the healthy use of medical resources.

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

[0009] The sampling needle has a sampling groove at its distal end;

[0010] A cutting needle assembly includes a cutting needle and an inner insulating layer covering the outer periphery of the cutting needle. The distal end of the cutting needle is provided with a cutting edge that matches the sampling groove. The cutting needle is fitted around the outer periphery of the sampling needle. The distal end of the cutting needle is exposed in the inner insulating layer and forms a first electrode with the distal end of the sampling needle.

[0011] A cannula assembly includes a cannula, an outer insulating layer, and a cannula plug. The outer insulating layer covers the outer periphery of the cannula, and the distal end of the cannula is exposed on the outer insulating layer to form a second electrode. The cannula assembly is configured to be detachably connected to the handle of the biopsy needle via the cannula plug so that the cannula is coaxially fitted around the periphery of the cutting needle and is detachable.

[0012] The proximal end of the sampling needle and the proximal end of the cannula plug are electrically connected to the power supply device, so that after biopsy sampling, the cannula assembly can be disassembled from the handle so that the cannula assembly remains in the needle channel. After the sample tissue in the sampling slot is taken out, the sampling needle and cutting needle assembly are inserted into the cannula, and electrical energy is applied to use the first electrode and the second electrode to perform hemostasis on the needle channel.

[0013] Preferably, the biopsy needle further includes an adjustment block, which is slidably connected to the handle, and the distal end of the adjustment block is fixedly connected to the cannula plug. After the sampling needle and cutting needle assembly are inserted into the cannula, the biopsy needle is configured to include at least a sampling configuration and a hemostasis configuration.

[0014] In the sampling configuration, when the sampling needle and the cutting needle have completed the sampling state, the proximal end of the sampling groove extends out of the distal end of the cannula needle;

[0015] In the hemostasis configuration, the sampling needle and cutting needle maintain the sampling completed state, and the adjusting block and the cannula assembly adjust the preset distance to the distal end along the needle body length extension direction.

[0016] Preferably, the cross-section of the adjusting block matches the cross-section of the handle, and the inner walls of the adjusting block are provided with sliding buckles extending along the length direction on both sides. The outer surface of the handle is provided with a sliding groove that matches the sliding buckles. The adjusting block is configured to slide and connect with the sliding buckles and the sliding groove to realize the distance adjustment of the adjusting block along the length direction. After the adjusting block is adjusted to a predetermined position, the position is locked by a locking structure.

[0017] Preferably, the locking structure includes a plurality of locking holes penetrating the surface of the adjusting block and a spring-loaded locking button with one end fixed on the handle. The protrusion at the free end of the spring-loaded locking button engages with one of the locking holes to lock the axial relative positions of the first electrode and the second electrode.

[0018] Preferably, the biopsy needle further includes an energy transmission socket, which is fixedly connected to the proximal end of the handle. The distal end of the energy transmission socket is a free end, and a spring-loaded 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. The two electrical connection terminals on the energy transmission socket are respectively electrically connected to the cannula needle plug and the proximal end of the sampling needle.

[0019] Preferably, the inner wall of the adjusting block is provided with a first wiring groove, and the inner wall of the energy transmission socket is provided with a second wiring groove that communicates with the first wiring groove. The wires connecting the sleeve needle plug and the energy transmission socket, and the sampling needle and the energy transmission socket, extend 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 via an electrical connector. The portable power supply device includes a lithium battery, a DC-DC module, an MCU controller, an H-bridge module, and a boost transformer. The lithium battery supplies power to the MCU controller through the DC-DC module. The lithium battery is electrically connected to the H-bridge module. The MCU controller outputs a drive signal to drive the H-bridge module to output current to the first electrode and the second electrode through the boost transformer for tissue hemostasis.

[0021] Preferably, the portable power supply device is detachably connected to the proximal end of the handle, the distal end of the portable power supply device is provided with a first magnetic absorbing piece inside, the proximal end of the handle is provided with a second magnetic absorbing piece inside, the distal end of the portable power supply device is provided with elastic arms with protruding locking points on both sides of the circumference, and the proximal end of the handle is provided with concave locking points that match the protruding locking points.

[0022] Preferably, the biopsy needle is configured such that, during hemostasis, the control system detects impedance in real time, and when the detected impedance meets a preset condition, the biopsy needle is retracted a preset distance to continue the hemostasis operation until the biopsy needle is completely withdrawn from the needle channel.

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

[0024] The sampling needle has a sampling groove at its distal end;

[0025] A cutting needle assembly includes a cutting needle and an inner insulating layer covering the outer periphery of the cutting needle. The distal end of the cutting needle is provided with a cutting edge that matches the sampling groove. The cutting needle is fitted around the outer periphery of the sampling needle. The distal end of the cutting needle is exposed in the inner insulating layer and forms a first electrode with the distal end of the sampling needle.

[0026] A cannula assembly includes a cannula, an outer insulating layer, and a cannula plug. The outer insulating layer covers the outer periphery of the cannula, and the distal end of the cannula is exposed on the outer insulating layer to form a second electrode. The cannula assembly is configured to be detachably connected to the handle of the biopsy needle via the cannula plug so that the cannula is coaxially fitted around the periphery of the cutting needle and is detachable.

[0027] The proximal end of the sampling needle and the proximal end of the cannula plug are electrically connected to the power supply device, so that after biopsy sampling, the cannula assembly can be disassembled from the handle so that the cannula assembly remains in the needle channel. After the sample tissue in the sampling slot is taken out, the sampling needle and cutting needle assembly are inserted into the cannula, and electrical energy is applied to use the first electrode and the second electrode to perform hemostasis on the needle channel.

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

[0029] 1. The technical solution of this invention uses a cannula assembly to both preserve the needle path and form two electrodes with the sampling needle and cutting needle for needle path ablation and hemostasis. Specifically, after the sampling and cutting needles have taken samples, they are withdrawn, while the cannula assembly remains in the needle path to preserve it. After the effectively sampled tissue is removed, the sampling needle and cutting needle are inserted back into the cannula, thus easily replicating the needle path punctured during sampling. Furthermore, the distal ends of the cutting needle and sampling needle form a first electrode, and the distal end of the cannula forms a second electrode. Applying a suitable current to the first and second electrodes enables tissue ablation and coagulation, preventing needle path bleeding.

[0030] 2. The present invention further includes an adjustment block. The adjustment block is detachably connected to the cannula assembly to allow the cannula assembly to remain in the needle channel after sampling. On the other hand, the adjustment block is slidably connected to the biopsy needle handle. Since the distal end of the biopsy needle has a long sampling groove, after sampling, the distal ends of the sampling needle and the cutting needle are a long distance from the distal end of the cannula. Furthermore, it is necessary to perform hemostasis and ablation on the site where the sampled tissue is obtained (e.g., tumor). Therefore, in this embodiment, the adjustment block and the handle are slidably connected. In the hemostasis configuration, the sampling needle and the cutting needle maintain the state after sampling and are inserted into the cannula to return to the original sampling needle channel. At this time, the cannula assembly is adjusted to a preset distance distally by the adjustment block. This enables effective ablation of the sampled tissue and reduces the distance between the first electrode and the second electrode, which is beneficial for achieving precise ablation and coagulation, avoiding excessive damage to the tissue or incomplete hemostasis. Attached Figure Description

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

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

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

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

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

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

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

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

[0039] Figure 9 is a schematic diagram of another variation of the loading method of the present invention;

[0040] Figure 10 is a schematic diagram of the fully automated biopsy needle with hemostasis function of the present invention for stimulation and sampling process;

[0041] Figure 11 is a schematic diagram of the overall structure of the fully automated biopsy needle with hemostasis function of the present invention (translation cannula and adjustment block);

[0042] Figure 12 is a schematic diagram of the adjustable distance block and energy transmission socket of the present invention;

[0043] Figure 13 is a schematic diagram of the state when biopsy sampling is completed according to the present invention;

[0044] Figure 14 is a schematic diagram of the state during ablation and hemostasis according to the present invention;

[0045] Figure 15 is a schematic diagram of the internal module composition of the portable power supply device of the present invention.

[0046] Explanation of reference numerals in the attached drawings: 001-First electrode; 002-Second electrode; 1-Sampling needle; 1001-Sampling groove; 2-Cutting needle; 3-Inner insulation layer; 4-Cannula needle; 5-Outer insulation layer; 6-Cannula needle plug; 7-Handle; 71-Slide groove; 72-Second magnetic chuck; 8-Adjusting block; 81-Slide buckle; 82-First wiring groove; 83-Locking hole; 84-Cannula needle socket; 9-Energy transmission socket; 91-Second wiring groove; 92-Spring arm locking button; 10-Power supply device; 101-First magnetic chuck; 11-Loading button No. 1; 111-First connecting hole; 112-First guide plate; 12-Loading button No. 2; 121-Second guide plate; 13-Sampling needle fixing slider; 13 1-Second elastic hook; 132-Second firing groove; 133-Elastic pad; 14-Cutting needle fixing slider; 141-First elastic hook; 15-Guide left shell; 151-Elastic plate limiting groove; 152-Guide limiting member guide groove; 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-Actuation switch; 211-Elastic plate; 212-Guide limiting member; 213-Linkage rod; 214-First firing groove. Detailed Implementation

[0047] The following specific examples illustrate the embodiments of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of the present invention, unless otherwise stated, "a plurality of" means two or more.

[0048] It should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0049] Biopsy is the gold standard for tumor pathological 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 of special sites such as the liver and kidneys, where the risk of bleeding is even higher and may even endanger the patient's life.

[0050] Biopsies are categorized into bone biopsies, tissue biopsies, and cytological biopsies. For solid tumors, tissue biopsies are generally used for pathological diagnosis. Solid tumors include those in the liver, lungs, kidneys, prostate, and thyroid, among others. The principle of a tissue biopsy typically involves using spring force to rapidly cut the tissue. A typical tissue biopsy needle consists of a core and a syringe. The core usually has a sampling groove (1001), while the syringe is primarily used for rapid tissue cutting, leaving the tissue in the sampling groove (1001). Biopsy needles are available in various sizes, ranging from large (7G, 9G, 12G) to smaller (16G, 18G, 20G), etc. Because of the mechanical cutting and puncture procedures, bleeding is the most frequent complication during biopsies. In normal circumstances, this bleeding can be easily stopped by clotting. However, in some special organs, special sites, or in some special patients, such as those with coagulation disorders, massive bleeding can easily occur. In such cases, biopsies cannot be performed normally. Clinically, there are some methods to address this type of bleeding, such as using radiofrequency or microwave to achieve needle tract hemostasis. However, this is considered emergency medical care, which is expensive and complex.

[0051] First Embodiment

[0052] Therefore, this embodiment provides a fully automated biopsy needle with hemostasis function, as shown in Figure 1, including:

[0053] Sampling needle 1, with a sampling groove 1001 at its distal end;

[0054] The cutting needle assembly includes a cutting needle 2 and an inner insulating layer 3 covering the outer periphery of the cutting needle 2. The distal end of the cutting needle 2 is provided with a cutting edge that cooperates with the sampling groove 1001. The cutting needle 2 is fitted around the outer periphery of the sampling needle 1. The distal end of the cutting needle 2 is exposed on the inner insulating layer 3 and forms a first electrode 001 with the distal end of the sampling needle 1.

[0055] The cannula assembly includes a cannula 4, an outer insulating layer 5, and a cannula plug 6. The outer insulating layer 5 covers the outer periphery of the cannula 4, and the distal end of the cannula 4 is exposed on the outer insulating layer 5 to form a second electrode 002. The cannula assembly is configured to be detachably connected to the handle 7 of the biopsy needle via the cannula plug 6 so that the cannula 4 is coaxially sleeved on the outer periphery of the cutting needle 2 and is detachable.

[0056] The proximal end of the sampling needle 1 and the proximal end of the cannula needle plug 6 are respectively electrically connected to the power supply device 10, so that after biopsy sampling, the cannula needle assembly and the handle 7 can be disassembled so that the cannula needle assembly is retained in the needle channel. 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 cannula needle 4, and electrical energy is applied to use the first electrode 001 and the second electrode 002 to perform hemostasis on the needle channel.

[0057] The technical solution of this embodiment uses a cannula assembly to preserve the needle path and to form two electrodes with the sampling needle 1 and the cutting needle 2 for needle path ablation and hemostasis. Specifically, after sampling by the sampling needle 1 and the cutting needle 2, the sampling needle 1 and the cutting needle 2 are withdrawn, while the cannula assembly remains in the needle path to preserve it. After the effectively sampled tissue is removed, the sampling needle 1 and the cutting needle 2 are inserted into the cannula 4, thus easily replicating the needle path punctured during sampling. Furthermore, 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 cannula 4 forms a second electrode 002. Applying a suitable current to the first electrode 001 and the second electrode 002 enables tissue ablation and coagulation, preventing needle path bleeding.

[0058] Preferably, referring to Figures 1, 11, 12, 13, and 14, the biopsy needle further includes an adjusting block 8, which is slidably connected to the handle 7. The distal end of the adjusting block 8 is fixedly connected to the cannula needle plug 6. After the sampling needle 1 and the cutting needle assembly are inserted into the cannula needle 4, the biopsy needle is configured to include at least a sampling configuration and a hemostasis configuration.

[0059] In the sampling configuration, when the sampling needle 1 and the cutting needle 2 have completed the sampling state, the proximal end of the sampling groove 1001 extends out of the distal end of the cannula needle 4;

[0060] In the hemostasis configuration, the sampling needle 1 and the cutting needle 2 maintain the sampling completed state, and the adjusting block 8 and the cannula assembly adjust the preset distance to the distal end along the needle body length extension direction.

[0061] As a further preferred embodiment, the technical solution of this embodiment includes an adjusting block 8. The adjusting block 8 is detachably connected to the cannula assembly (the distal end of the adjusting block is provided with a cannula socket that matches the cannula plug for structural and electrical connection), allowing the cannula assembly to remain within the needle channel after sampling. Furthermore, the adjusting block 8 is slidably connected to the biopsy needle handle 7. Since the distal end of the sampling needle 1 of the biopsy needle has a relatively long sampling groove 1001, after sampling is completed, the distal ends of the sampling needle 1 and the cutting needle 2 are a considerable distance from the distal end of the cannula needle 4, and it is necessary to obtain the sample... For hemostasis and ablation of tissue sites (such as tumors), this embodiment sets the adjusting block 8 and the handle 7 as a sliding connection. 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 4 to return to the original sampling needle channel. At this time, the cannula assembly is adjusted to a preset distance distally by adjusting the adjusting block 8. On the one hand, it can effectively ablate the sampled tissue site. On the other hand, it reduces the distance between the first electrode 001 and the second electrode 002, which is beneficial to achieve precise ablation and coagulation, and avoids excessive damage to the tissue or incomplete hemostasis.

[0062] Preferably, referring to Figures 11 and 12, the cross-section of the adjusting block 8 matches the cross-section of the handle 7. The inner walls of the adjusting block 8 are provided with sliding buckles 81 extending along the length direction on both sides. The outer surface of the handle 7 is provided with a sliding groove 71 that matches the sliding buckles 81. The adjusting block 8 is configured to slide and connect with the sliding buckles 81 and the sliding groove 71 to realize the distance adjustment of the adjusting block 8 along the length direction. After the adjusting block 8 is adjusted to the predetermined position, the position is locked by a locking structure.

[0063] This embodiment discloses a connection structure between an adjusting block 8 and a handle 7. The adjusting block 8 has a sliding buckle 81 extending along its length, and the outer surface of the handle 7 has a groove 71 that mates with the sliding buckle 81. This adjustment mechanism allows for a smaller structure, preventing the radial dimension of the handle 7 from becoming excessively large, thus making it more portable and easier to operate. However, this invention is not limited to this axial sliding adjustment structure; any existing mechanism for axial adjustment of two components can be used. For example, the positions of the sliding buckle 81 and the groove 71 can be interchanged.

[0064] Preferably, referring to Figure 11, the locking structure includes a plurality of locking holes 83 penetrating the surface of the adjusting block 8 and a spring arm locking button 92 with one end fixed on the handle 7. The protrusion at the free end of the spring arm locking button 92 engages with one of the locking holes 83 to lock the axial relative positions of the first electrode 001 and the second electrode 002.

[0065] This embodiment provides a locking structure with multiple locking holes 83 on the surface of the adjusting block 8. These locking holes 83 provide various adjustment levels. A spring-loaded locking button 92, one end of which is fixed to the handle 7, engages with one of the locking holes 83, thereby achieving adjustment and fixation at different levels. This also allows for adjustment of the distance between the first electrode 001 and the second electrode 002, providing flexibility for coagulation operations. Of course, at least two locking holes 83 are provided, corresponding to the sampling configuration and the hemostasis configuration respectively. The locking structure of this embodiment achieves a smaller radial dimension, facilitating operation.

[0066] Preferably, referring to Figure 11, the biopsy needle further includes an energy transmission socket 9, which is fixedly connected to the proximal end of the handle 7. The distal end of the energy transmission socket 9 is a free end. A spring-loaded locking button 92 is provided on the free end of the energy transmission socket 9 to lock 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 respectively electrically connected to the cannula needle plug 6 and the proximal end of the sampling needle 1.

[0067] The technical solution of this embodiment uses an energy transmission socket 9. Two electrical connection terminals on the energy transmission socket 9 are electrically connected to the cannula needle plug 6 and the proximal end of the sampling needle 1, respectively. The energy transmission socket 9 is also electrically connected to the power supply device 10 via a pin. This connection method is simple and convenient, facilitating modular and standardized production. More preferably, the distal end of the energy transmission socket 9 is configured as a free end, allowing for the installation of a spring-loaded locking button 92 on the free end. This enables the energy transmission socket 9 to simultaneously perform energy transmission and mode adjustment (sampling / hemostasis) functions, further saving radial structural space on the operating handle 7 and improving product portability.

[0068] Preferably, referring to Figure 12, the inner wall of the 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 that communicates with the first wiring groove 82. The wires connecting the sleeve 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.

[0069] The technical solution of this embodiment provides a first wiring groove 82 on the inner wall of the adjusting block 8 and a second wiring groove 91 inside the energy transmission socket 9, which provides space for the wires to be connected by electricity, and the height of the wiring groove matches the wires to avoid jamming during the adjustment process.

[0070] Preferably, as shown in Figures 13, 14, and 15, the device also includes a portable power supply device 10. The portable power supply device 10 is electrically connected to the energy transmission socket 9 via an electrical connector. The portable power supply device 10 includes a lithium battery, a DC-DC module, an MCU controller, an H-bridge module, and a boost transformer. The lithium battery supplies power to the MCU controller through the DC-DC module. The lithium battery is electrically connected to the H-bridge module. The MCU controller outputs a drive signal to drive the H-bridge module to output current to the first electrode 001 and the second electrode 002 through the boost transformer for tissue hemostasis.

[0071] This embodiment discloses a portable power supply device 10. In the prior art, when encountering bleeding during biopsy, it is often necessary to call upon emergency medical resources and require an external radiofrequency ablation or microwave energy host 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 work well with the first electrode 001 and the second electrode 002 to perform tissue ablation and coagulation operations. Referring to Figure 15, it can be seen as a schematic diagram of the internal module composition of the portable power supply device 10.

[0072] Preferably, the portable power supply device 10 is detachably connected to the proximal end of the handle 7. The distal end of the portable power supply device 10 is provided with a first magnetic absorbing piece 101, and the proximal end of the handle 7 is provided with a second magnetic absorbing piece 72. The distal end of the portable power supply device 10 is provided with elastic arms with protruding locking points on both sides, and the proximal end of the handle 7 is provided with concave locking points that match the protruding locking points.

[0073] In this embodiment, the portable power supply device 10 adopts a modular and detachable form. This embodiment provides a convenient and quick connection structure to achieve rapid connection of the portable power supply device 10. Of course, this is only one connection method, and the main inventive concept of this invention does not limit the connection structure to only this one; any quick-disassembly structure in the prior art can be used.

[0074] Preferably, the biopsy needle is configured such that, during hemostasis, the control system detects impedance in real time, and when the detected impedance meets a preset condition, the biopsy needle is retracted a preset distance to continue the hemostasis operation until the biopsy needle is completely withdrawn from the needle channel.

[0075] The technical solution of this embodiment proposes that during the ablation hemostasis operation, 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 determined that the hemostasis and ablation of the tissue at that location have met the requirements, avoiding both over-ablation and damage to the tissue, and ensuring that the hemostasis purpose is not failed. At this point, the biopsy needle is retracted a certain distance to gradually achieve hemostasis along the needle path. Of course, in some solutions, since the distance between the first electrode 001 and the second electrode 002 has different adjustable levels, after hemostasis is achieved at one location, the needle is not completely removed from the ablation range, but is retracted by 1 / 2 (or other) of the ablation range for further ablation, thus achieving flexible operation of ablation hemostasis. Here, the ablation range refers to the distance between the first electrode 001 and the second electrode 002.

[0076] The fully automated biopsy excitation structure of the fully automated biopsy needle with hemostasis function of the present invention will be further described below.

[0077] As shown in Figures 1, 2, 3, and 4, the fully automated biopsy needle body includes a sampling needle 1, a cutting needle 2, and a cannula needle 4. The sampling needle 1 is fixedly connected to a sampling needle fixing slider 13, and the cutting needle 2 is fixedly connected to a cutting needle fixing slider 14. The sampling needle 1, cutting needle 2, and cannula needle 4 are coaxially sleeved, and an inner insulating layer 3 is coaxially sleeved on the outside of the cutting needle 2. The sampling needle fixing slider 13 is set in the space formed by the guide left shell 15 and the guide right shell 16. The guide left shell 15 and the guide right shell 16 are respectively provided with a first partition 17 that isolates the cutting needle fixing slider 14 and the sampling needle fixing slider 13. The first partition 17 has two functions: firstly, it acts as a partition and limiter. Another function is to facilitate the loading of the cutting needle fixing slider 14. Specifically, the bottom of the cutting needle fixing slider 14 is provided with a pair of first elastic hooks 141, and the center of the first partition 17 is provided with a first groove 171 that matches the first elastic hooks 141 of the cutting needle fixing slider 14. The biopsy needle also includes a first spring 18, which is disposed between the first partition 17 and the cutting needle fixing slider 14. When the cutting needle fixing slider 14 is pressed proximally to load the needle, the first spring 18 is compressed and deformed, and drives the cutting needle 2 to move proximally until the first elastic hooks 141 of the cutting needle fixing slider 14 pass through the first groove 171 and the needle is loaded into place.

[0078] As shown in Figures 1, 2, 3, and 4, the bottom of the sampling needle fixing slider 13 is provided with a pair of second elastic hooks 131. The guide left shell 15 and guide right shell 16 are respectively provided with second partitions 19. The center of the second partition 19 is provided with a second groove 191 that matches the second elastic hooks 131 of the sampling needle fixing slider 13. The biopsy needle also includes a second spring 20, which is disposed between the second partition 19 and the sampling needle fixing slider 13. When the sampling needle fixing slider 13 is pressed proximally, the second spring 20 is compressed and deformed, and drives the sampling needle 13 to move forward. Move towards 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 position. Here, the left and right sides of the sampling needle fixing slider 13 are provided with I-shaped elastic pads 133, which play a buffering role. Here, the sampling needle fixing slider 13 and the cutting needle fixing slider 14 have the same function 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).

[0079] As shown in Figures 2, 4, 5, and 7, the fully automated biopsy needle includes an activation switch 21. The main body of the activation switch 21 is located near the cavity formed by the left guide shell 15 and the right guide shell 16. The inner diameter of the cavity where the activation switch 21 is placed is larger than the inner diameter of the inner diameter of the sampling needle fixing slider 13 and the cutting needle fixing slider 14, so that the linkage rod 213 of the activation switch 21 can extend out of the left guide shell 15. The biopsy needle includes a handle 7 housing and a push button. The handle 7 housing is sleeved on the outside of the left and right guide shells, and the push button is located in the push button groove of the handle 7 housing, and the push button is engaged with the linkage rod 213. The activation switch 21 includes an elastic sheet 211, a guide limiting 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. The guide left shell 15 has a limiting groove on its outside to limit the offset of the linkage rod 213. The inner cavity where the activation switch 21 is placed has a guide limiting member guide groove 152. The guide limiting member 212 is disposed in the guide limiting member guide groove 152 to ensure that the guide limiting member 212 moves up and down in the guide limiting member guide groove 152 with its stroke limited. The inner cavity where the activation switch 21 is placed has an elastic sheet limiting groove 151. The elastic sheet 211 is disposed in the elastic sheet limiting groove 151. The elastic sheet 211 and the guide limiting member 212 are connected in the middle and separated at their free ends. The two ends of the elastic sheet 211 abut against the inwardly extending inner buckling abutment surface at the connection between the guide limiting member guide groove 152 and the elastic sheet limiting groove 151. The guide limiter 212 has a first firing groove 214 at its far end, which is used to compress the second elastic hook 131 of the sampling needle fixing slider 13 when firing. The top of the sampling needle fixing slider 13 has a second firing groove 132, which is used to compress the first elastic hook 141 of the cutting needle fixing slider 14 when firing.

[0080] As shown in Figures 6 and 7, the biopsy needle also includes a loading button 11 and a loading button 2. The loading buttons 11 and 2 are shaped and connected. The loading button 11 has a first connecting hole 111, which is matched and fixedly connected with the cutting needle button (loading button 11) connector. The loading button 11 has a first guide plate 112 inwardly. The first guide plate 112 is matched and slidably connected with the first guide groove at the upper outer end of the guide left shell 15 to ensure axial limiting movement. The loading button 2 also has a second connecting hole, which is matched and fixedly connected with the sampling needle 1 button (loading button 2) connector. The bottom of the loading button 2 has symmetrically provided second guide plates 121. The second guide plates 121 are matched and slidably connected with the second guide groove at the lower end of the guide left shell 15 and the third guide groove at the lower outer end of the guide right shell 16 to ensure vertical movement. At the same time, the second guide plates 121 clamp the guide left shell 15 and the guide right shell 16.

[0081] There are two ways to load the gun:

[0082] Method 1: As shown in Figure 8, the cutting needle 2 and the sampling needle 1 are loaded in stages. Pressing the loading button 11 moves the cutting needle fixing slider 14 and the cutting needle 2 to 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 loading of the cutting needle 2 is completed. Pressing the loading button 2 12 moves the sampling needle fixing slider 13 and the sampling needle 1 to the downward, 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 loading of the sampling needle 1 is completed. At this time, the loading of the biopsy needle in stages is completed.

[0083] Method 2: As shown in Figure 9, the cutting needle 2 and the sampling needle 1 are loaded simultaneously. The loading button 11 and the loading button 2 are connected in shape. Pressing the loading button 2 causes the loading button 11 to move synchronously, which in turn causes the cutting needle fixing slider 14 to move the cutting needle 2 downward, 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. Simultaneously, the sampling needle fixing slider 13 moves the sampling needle 1 downward, 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 needles are loaded simultaneously.

[0084] Biopsy stimulation sampling:

[0085] As shown in Figure 10, after loading, push the handle 7, which has a push button on its outer shell or a button on the bottom of the biopsy unit (activation switch 21), to move the guide limiter 212 to the far end. The first firing groove 214 abuts against the second elastic hook 131. As the first firing groove 214 continues to squeeze the second elastic hook 131, the second elastic hook 131 is compressed and disengaged from the second slot 191. The compressed second spring 20 releases the hook, thus activating the sampling needle 1. At the moment the activation ends, the sampling needle fixing slider 13 strikes the cutting needle fixing slider 14, causing the second firing groove 132 to strike the first elastic hook 141 on the cutting needle fixing slider 14. During the instantaneous impact, the first elastic hook 141 is compressed and disengaged from the first slot 171. The compressed first spring 18 releases the hook, thus activating the cutting needle 2. Thus, the biopsy activation sampling is completed.

[0086] Second Embodiment

[0087] The same concept also provides a biopsy needle with hemostatic function, comprising:

[0088] Sampling needle 1, with a sampling groove 1001 at its distal end;

[0089] The cutting needle assembly includes a cutting needle 2 and an inner insulating layer 3 covering the outer periphery of the cutting needle 2. The distal end of the cutting needle 2 is provided with a cutting edge that cooperates with the sampling groove 1001. The cutting needle 2 is fitted around the outer periphery of the sampling needle 1. The distal end of the cutting needle 2 is exposed on the inner insulating layer 3 and forms a first electrode 001 with the distal end of the sampling needle 1.

[0090] The cannula assembly includes a cannula 4, an outer insulating layer 5, and a cannula plug 6. The outer insulating layer 5 covers the outer periphery of the cannula 4, and the distal end of the cannula 4 is exposed on the outer insulating layer 5 to form a second electrode 002. The cannula assembly is configured to be detachably connected to the handle 7 of the biopsy needle via the cannula plug 6 so that the cannula 4 is coaxially sleeved on the outer periphery of the cutting needle 2 and is detachable.

[0091] The proximal end of the sampling needle 1 and the proximal end of the cannula needle plug 84 are respectively electrically connected to the power supply device 10, so that after biopsy sampling, the cannula needle assembly and the handle 7 can be disassembled so that the cannula needle assembly is retained in the needle channel. 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 cannula needle 4, and electrical energy is applied to use the first electrode 001 and the second electrode 002 to perform hemostasis on the needle channel.

[0092] The technical solution of this embodiment uses a cannula assembly to preserve the needle path and to form two electrodes with the sampling needle 1 and the cutting needle 2 for needle path ablation and hemostasis. Specifically, after sampling by the sampling needle 1 and the cutting needle 2, the sampling needle 1 and the cutting needle 2 are withdrawn, while the cannula assembly remains in the needle path to preserve it. After the effectively sampled tissue is removed, the sampling needle 1 and the cutting needle 2 are inserted into the cannula 4, thus easily replicating the needle path punctured during sampling. Furthermore, 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 cannula 4 forms a second electrode 002. Applying a suitable current to the first electrode 001 and the second electrode 002 enables tissue ablation and coagulation, preventing needle path bleeding. The biopsy needle in this embodiment is not necessarily a fully automatic biopsy needle; it can be a semi-automatic biopsy needle, or even a manual biopsy needle.

[0093] This invention eliminates the need for separate biopsy and ablation procedures (or two separate products), and eliminates the need to connect a radiofrequency or microwave host during hemostasis. We integrate the functions required for biopsy and hemostasis from a bulky radiofrequency (microwave) host into a disposable consumable, truly enabling biopsy and hemostasis to be completed in one procedure during outpatient surgery. This significantly reduces surgical time and costs while greatly improving surgical safety. This invention can be used for various tissue biopsies, especially for biopsies with high bleeding risks, such as those for liver cancer and kidney cancer, and has broad application prospects.

[0094] Furthermore, in the description of this application, "proximal" and "distal" are commonly used terms in the medical field. Specifically, "proximal" refers to the end closer to the operator, "proximal face" refers to the end face closer to the operator, "distal" refers to the end farther from the operator, and "distal face" refers to the end face farther from the operator.

[0095] The embodiments of the present invention have been described in detail above with reference to 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 shall still fall within the protection scope of the present invention.

Claims

1. A fully automated biopsy needle with hemostatic function, characterized in that, include: The sampling needle has a sampling groove at its distal end; A cutting needle assembly includes a cutting needle and an inner insulating layer covering the outer periphery of the cutting needle. The distal end of the cutting needle is provided with a cutting edge that matches the sampling groove. The cutting needle is fitted around the outer periphery of the sampling needle. The distal end of the cutting needle is exposed in the inner insulating layer and forms a first electrode with the distal end of the sampling needle. A cannula assembly includes a cannula, an outer insulating layer, and a cannula plug. The outer insulating layer covers the outer periphery of the cannula, and the distal end of the cannula is exposed on the outer insulating layer to form a second electrode. The cannula assembly is configured to be detachably connected to the handle of the biopsy needle via the cannula plug so that the cannula is coaxially fitted around the periphery of the cutting needle and is detachable. The proximal end of the sampling needle and the proximal end of the cannula plug are electrically connected to the power supply device, so that after biopsy sampling, the cannula assembly can be disassembled from the handle so that the cannula assembly remains in the needle channel. After the sample tissue in the sampling slot is taken out, the sampling needle and cutting needle assembly are inserted into the cannula, and electrical energy is applied to use the first electrode and the second electrode to perform hemostasis on the needle channel.

2. The fully automated biopsy needle with hemostasis function as described in claim 1, characterized in that, The biopsy needle also includes an adjustment block, which is slidably connected to the handle. The distal end of the adjustment block is fixedly connected to the cannula plug. After the sampling needle and cutting needle assembly are inserted into the cannula, the biopsy needle is configured to include at least a sampling configuration and a hemostasis configuration. In the sampling configuration, when the sampling needle and the cutting needle have completed the sampling state, the proximal end of the sampling groove extends out of the distal end of the cannula needle; In the hemostasis configuration, the sampling needle and cutting needle maintain the sampling completed state, and the adjusting block and the cannula assembly adjust the preset distance to the distal end along the needle body length extension direction.

3. The fully automated biopsy needle with hemostasis function as described in claim 2, characterized in that, The cross-section of the adjusting block matches the cross-section of the handle. The inner walls of the adjusting block are provided with sliding buckles extending along the length direction on both sides. The outer surface of the handle is provided with a sliding groove that matches the sliding buckles. The adjusting block is configured to slide and connect with the sliding buckles and the sliding groove to realize the distance adjustment of the adjusting block along the length direction. After the adjusting block is adjusted to the predetermined position, the position is locked by a locking structure.

4. The fully automated biopsy needle with hemostasis function as described in claim 3, characterized in that, The locking structure includes multiple locking holes penetrating the surface of the adjusting block and a spring-loaded locking button with one end fixed on the handle. The protrusion at the free end of the spring-loaded locking button engages with one of the locking holes to lock the axial relative positions of the first electrode and the second electrode.

5. The fully automated biopsy needle with hemostasis function as described in claim 2, characterized in that, The biopsy needle also includes an energy transmission socket, which is fixedly connected to the proximal end of the handle. The distal end of the energy transmission socket is a free end. A spring-loaded 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. The two electrical connection terminals on the energy transmission socket are respectively electrically connected to the cannula needle plug and the proximal end of the sampling needle.

6. The fully automated biopsy needle with hemostasis function as described in claim 5, characterized in that, The inner wall of the adjusting block is provided with a first wiring groove, and the inner wall of the energy transmission socket is provided with a second wiring groove that communicates with the first wiring groove. The wires connecting the sleeve needle plug and the energy transmission socket, and the sampling needle and the energy transmission socket extend along the first wiring groove and / or the second wiring groove.

7. The fully automated biopsy needle with hemostasis function as described in claim 5, characterized in that, It also includes a portable power supply device, which is electrically connected to the energy transmission socket via an electrical connector. The portable power supply device includes a lithium battery, a DC-DC module, an MCU controller, an H-bridge module, and a boost transformer. The lithium battery supplies power to the MCU controller through the DC-DC module. The lithium battery is electrically connected to the H-bridge module. The MCU controller outputs a drive signal to drive the H-bridge module to output current to the first electrode and the second electrode through the boost transformer for tissue hemostasis.

8. The fully automated biopsy needle with hemostasis function as described in claim 7, characterized in that, The portable power supply device is detachably connected to the proximal end of the handle. The distal end of the portable power supply device is provided with a first magnetic absorbing piece, and the proximal end of the handle is provided with a second magnetic absorbing piece. The distal end of the portable power supply device is provided with elastic arms with protruding locking points on both sides of the circumference, and the proximal end of the handle is provided with concave locking points that match the protruding locking points.

9. The fully automated biopsy needle with hemostasis function as described in claim 1, characterized in that, The biopsy needle is configured such that, during hemostasis, the control system detects impedance in real time. When the detected impedance meets a preset condition, the biopsy needle is retracted a preset distance to continue the hemostasis operation until the biopsy needle is completely withdrawn from the needle channel.

10. A biopsy needle with hemostatic function, characterized in that, include: The sampling needle has a sampling groove at its distal end; A cutting needle assembly includes a cutting needle and an inner insulating layer covering the outer periphery of the cutting needle. The distal end of the cutting needle is provided with a cutting edge that matches the sampling groove. The cutting needle is fitted around the outer periphery of the sampling needle. The distal end of the cutting needle is exposed in the inner insulating layer and forms a first electrode with the distal end of the sampling needle. A cannula assembly includes a cannula, an outer insulating layer, and a cannula plug. The outer insulating layer covers the outer periphery of the cannula, and the distal end of the cannula is exposed on the outer insulating layer to form a second electrode. The cannula assembly is configured to be detachably connected to the handle of the biopsy needle via the cannula plug so that the cannula is coaxially fitted around the periphery of the cutting needle and is detachable. The proximal end of the sampling needle and the proximal end of the cannula plug are electrically connected to the power supply device, so that after biopsy sampling, the cannula assembly can be disassembled from the handle so that the cannula assembly remains in the needle channel. After the sample tissue in the sampling slot is taken out, the sampling needle and cutting needle assembly are inserted into the cannula, and electrical energy is applied to use the first electrode and the second electrode to perform hemostasis on the needle channel.

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