Biopsy device

Abstract

The invention discloses a biopsy device, which relates to the technical field of medical instruments and comprises a biopsy needle, a driving handle, an energy source, a fluid component and a controller, the energy source is in circuit communication with at least one of the outer needle tube, the cutting tube and the puncture needle tip of the biopsy needle, so that at least one of the outer needle tube, the cutting tube and the puncture needle tip forms an electrode acting on target tissue; the controller can respond to mode selection operation of a user to control working modes of the biopsy device to be switched, and the working modes of the biopsy device comprise a sampling mode, a first ablation mode and a second ablation mode. According to the technical scheme, the problem that an existing biopsy device cannot change the acting range on tissue is solved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to biopsy devices. Background Technology

[0002] A biopsy needle is a medical device used for sampling and diagnosing lesions. It is widely used for biopsy of organs such as the thyroid, breast, lung, liver, and kidney to collect samples for pathological analysis.

[0003] A biopsy device includes a biopsy needle, a drive handle, and a fluid management component. The biopsy needle comprises an outer tube and a cutting tube fitted inside the outer tube. The front end of the outer tube has a slender and sharp puncture needle tip, and a sampling window is provided on the side wall of the outer tube. After the puncture needle tip is inserted into the tissue to reach the lesion site, the drive handle drives the cutting tube to move axially and rotate circumferentially, causing the cutting tube to cut off the tissue at the sampling window. Then, the fluid management component provides a pressure differential to expel the cut tissue from the inside of the cutting tube, thus completing the sampling operation. Some biopsy devices also integrate electrodes on the biopsy needle to achieve hemostasis or ablation of the tissue.

[0004] However, existing biopsy devices have a fixed range of action on tissue during tissue ablation and cannot change the range of action on the tissue. Summary of the Invention

[0005] The main objective of this invention is to provide a biopsy device that addresses the problem that existing biopsy devices cannot alter the extent of their effect on tissues.

[0006] To achieve the above objectives, the present invention provides a biopsy device comprising:

[0007] A biopsy needle includes an outer needle tube, a cutting tube, and a puncture needle tip. The puncture needle tip is located at the front end of the outer needle tube. The outer needle tube has a cutting tube movable cavity and a sampling window communicating with the cutting tube movable cavity. A drive handle, connected to the cutting tube, drives the cutting tube to rotate and translate relative to the sampling window within the cutting tube cavity, cutting the tissue sample received through the sampling window; An energy source is electrically connected to at least one of the external needle tube, the cutting tube, and the puncture needle tip so that at least one of the external needle tube, the cutting tube, and the puncture needle tip forms an electrode that acts on the target tissue; Fluid components, including gas source components and liquid source components; The controller is capable of switching the working modes of the biopsy device in response to a user's mode selection operation. The working modes of the biopsy device include a sampling mode, a first ablation mode, and a second ablation mode. When the biopsy device is in sampling mode, the controller blocks the connection between the liquid source component and the biopsy needle, and controls the gas source component to create a pressure difference between the movable cavity of the cutting tube and the inner cavity of the cutting tube. When the biopsy device is in the first ablation mode, the controller controls the energy source to connect with the electrode circuit and blocks the connection between the gas source assembly, the liquid source assembly and the biopsy needle. When the biopsy device is in the second ablation mode, the controller controls the energy source to connect with the electrode circuit, blocks the connection between the gas source assembly and the biopsy needle, and connects the liquid source assembly with the inner cavity of the cutting tube.

[0008] In one embodiment, the energy source is a radio frequency generator, and the radio frequency generator outputs a higher radio frequency current frequency in the first ablation mode than in the second ablation mode. or; The energy source includes a first radio frequency generator and a second radio frequency generator. The radio frequency current frequency output by the first radio frequency generator is higher than that output by the second radio frequency generator. When the biopsy device is in the first ablation mode, the electrode is connected to the first radio frequency generator. When the biopsy device is in the second ablation mode, the electrode is connected to the second radio frequency generator.

[0009] In one embodiment, the energy source has a first docking electrode and a second docking electrode, the first docking electrode being used to connect to the outer needle tube, and the second docking electrode being used to connect to the tip of the puncture needle.

[0010] In one embodiment, the gas source assembly includes a negative pressure generating assembly, and the fluid assembly further includes: The first pipeline assembly is used to connect the inner cavity of the negative pressure generating assembly and the cutting tube; A first valve assembly is disposed on the first pipeline assembly and is used to control the on / off state of the first pipeline assembly.

[0011] In one embodiment, the fluid assembly further includes: The second piping assembly connects to the movable chamber of the cutting tube and is also connected to the negative pressure generating assembly, the external environment, or the positive pressure generator; and A second valve assembly is provided on the second pipeline assembly and is used to control the on / off state of the second pipeline assembly; When the biopsy device is in the sampling mode, the first tubing assembly connects the inner cavity of the negative pressure generating assembly and the cutting tube, and the second tubing assembly connects the negative pressure generating assembly or the external environment or a positive pressure generator, so as to create a pressure difference between the first tubing assembly and the second tubing assembly.

[0012] In one embodiment, the fluid assembly further includes a third valve assembly disposed on the first pipeline assembly and on the pipe section between the first valve assembly and the cutting pipe. The third valve assembly is connected to the liquid source assembly and is used to selectively allow the cutting pipe to be in fluid communication with the negative pressure generating assembly or the liquid source assembly. When the biopsy device is in the second ablation mode, the controller controls the state of the third valve assembly to make the cutting tube and the liquid source assembly in fluid communication.

[0013] In one embodiment, the fluid assembly further includes: The second piping assembly connects the cutting tube's movable chamber to the negative pressure generating assembly; and A second valve assembly is provided on the second pipeline assembly and is used to control the on / off state of the second pipeline assembly; The biopsy device also includes a flushing mode. When the biopsy device is in the flushing mode, the controller controls the state of the third valve assembly to make the cutting tube and the liquid source assembly fluidly connected, and controls the state of the second valve assembly to make the second pipeline assembly connect the cutting tube movable chamber and the negative pressure generating assembly.

[0014] In one embodiment, the liquid source assembly includes: Liquid storage unit for containing a preset liquid; and The third piping assembly connects one of the interfaces of the liquid storage device and the third valve assembly; A liquid pump, located in the third pipeline assembly, is used to drive the preset liquid through the third valve assembly into the first pipeline assembly.

[0015] In one embodiment, the biopsy device also includes a drug delivery mode, and the fluid assembly further includes a syringe connected to the cutting tube via a first tubing assembly in the drug delivery mode.

[0016] In one embodiment, the outer needle tube has a first channel and a second channel arranged side by side, and the outer needle tube has an air hole connecting the first channel and the second channel. The first channel is the movable cavity of the cutting tube. When the biopsy device is in the sampling mode, the air pressure difference is the air pressure difference between the second channel and the inner cavity of the cutting tube. or; A gap is provided between the outer needle tube and the cutting tube, and the air pressure difference is the air pressure difference between the gap and the inner cavity of the cutting tube.

[0017] The biopsy device of this invention includes a biopsy needle, a drive handle, an energy source, a fluid assembly, and a controller, realizing functions such as tissue cutting and sampling, and ablation of lesions during the biopsy process. The biopsy device can be operated in sampling mode, and also in a first ablation mode or a second ablation mode. In the first ablation mode, the controller blocks the pathway between the gas source assembly, the liquid source assembly, and the biopsy needle, while connecting the energy source and the electrode circuit, enabling the electrode to have high-frequency energy output capability, achieving high-frequency ablation of the biopsy needle. The high-frequency ablation depth is deep, meeting the ablation needs of deeper surgical sites and larger tissue areas. In the second ablation mode, the controller blocks the connection between the gas source assembly and the biopsy needle, while connecting the energy source and the electrode circuit, ensuring ablation energy supply. Simultaneously, it connects the liquid source assembly to the inner cavity of the cutting tube, using the liquid source assembly to deliver the liquid medium to the outside of the sampling window, cooperating with the electrode to achieve low-temperature plasma ablation. The plasma ablation depth is relatively shallow, suitable for ablation operations on lesion boundaries and small lesions. The biopsy device integrates sampling, high-frequency ablation, and low-temperature plasma ablation modes. It allows for the completion of both tissue sampling and lesion ablation with a single instrument, eliminating the need to change ablation devices after sampling. This reduces the number of instrument changes, shortens the overall procedure time, and minimizes tissue damage caused by multiple instrument punctures. The first ablation mode is suitable for larger, deeper lesions, while the second ablation mode is suitable for smaller, shallower lesions or lesion boundaries. This allows the biopsy device to adjust the ablation depth and range, improving the accuracy of ablation treatment and avoiding unnecessary damage to surrounding healthy tissue. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the structure of a biopsy needle according to an embodiment of the biopsy device provided by the present invention; Figure 2 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 1 ; Figure 3 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 2 ; Figure 4 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 3 ; Figure 5 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 4 ; Figure 6 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 5 ; Figure 7 A partial structural schematic diagram of a biopsy needle according to an embodiment of the biopsy device provided by the present invention; Figure 8 This is a schematic diagram of the structure of an embodiment of the biopsy device provided by the present invention; Figure 9 A schematic diagram of the sampling mode of an embodiment of the biopsy device provided by the present invention. Figure 1 ; Figure 10 A schematic diagram of the sampling mode of an embodiment of the biopsy device provided by the present invention. Figure 2 ; Figure 11 This is a schematic diagram of the first ablation mode of an embodiment of the biopsy device provided by the present invention; Figure 12 This is a schematic diagram of the second ablation mode of an embodiment of the biopsy device provided by the present invention; Figure 13 This is a schematic diagram of the flushing mode of an embodiment of the biopsy device provided by the present invention; Figure 14 This is a schematic diagram of the drug delivery mode of an embodiment of the biopsy device provided by the present invention; Figure 15 A partial cross-sectional view of the biopsy needle according to another embodiment of the biopsy device provided by the present invention. Figure 1 ; Figure 16 for Figure 15 A magnified view of a section at point A in the middle; Figure 17 A partial cross-sectional view of the biopsy needle according to another embodiment of the biopsy device provided by the present invention. Figure 2 ; Figure 18 This is a schematic diagram of another embodiment of the biopsy device provided by the present invention.

[0020] Explanation of icon numbers: 100. Biopsy needle; 110. Handle; 111. Tissue collection groove; 120. Outer needle tube; 1201a. Cutting tube movable cavity; 1201b. First channel; 1202. Second channel; 1203. Sampling window; 1204. Vent; 121. Main tube body; 122. Side half tube body; 130. Puncture needle tip; 140. Cutting tube; 150. Conductive component; 151. First conductive element; 152. Second conductive element; 153. Cable; 154. Electrical connector; 160. Insulation structure; 171. Ejector rod; 1711. First fluid channel; 172. First tube connector; 181. Fluid component; 1811. Second fluid channel; 182. Second tube connector; 190. Needle tube mounting base; 210. Gas source assembly; 211. Negative pressure generating assembly; 212. Pressure relief valve; 213. Pressure monitoring assembly; 220. Liquid source assembly; 221. Liquid storage container; 222. Liquid pump; 223. Third pipeline assembly; 230. First pipeline assembly; 240. First valve assembly; 250. Second pipeline assembly; 260. Second valve assembly; 270. Third valve assembly; 280. Waste collection assembly; 300. Energy source; 400. Syringe.

[0021] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0023] It should be noted that if the embodiments of the present invention involve directional indicators (such as up, down, left, right, front, back, etc.), the directional indicators are only used to explain the relative positional relationship and movement of the components in a specific posture. If the specific posture changes, the directional indicators will also change accordingly.

[0024] In this invention, unless otherwise explicitly specified and limited, the terms "connection" and "fixed" should be interpreted broadly. For example, "fixed" can mean a fixed connection, a detachable connection, or an integral part; "connection" can mean a mechanical connection or an electrical connection, a direct connection or an indirect connection through an intermediate medium, or a connection within two components or an interaction between two components. Unless otherwise explicitly limited, those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0025] Furthermore, if the embodiments of this invention involve descriptions such as "first" or "second," these descriptions are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the meaning of "and / or" throughout the text includes three parallel solutions. Taking "A and / or B" as an example, it includes solution A, solution B, or a solution that simultaneously satisfies A and B. Furthermore, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0026] This invention proposes a biopsy needle.

[0027] Please see Figures 1 to 5 as well as Figure 8 , Figure 1 This is a schematic diagram of the structure of a biopsy needle according to an embodiment of the biopsy device provided by the present invention. Figure 2 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 1 , Figure 3 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 2 , Figure 4 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 3 , Figure 5 A partial cross-sectional view of the biopsy needle in an embodiment of the biopsy device provided by the present invention. Figure 4 , Figure 8 This is a schematic diagram of an embodiment of the biopsy device provided by the present invention.

[0028] In one embodiment of the present invention, the biopsy device includes: The biopsy needle 100 includes an outer needle tube 120, a cutting tube 140, and a puncture needle tip 130. The puncture needle tip 130 is located at the front end of the outer needle tube 120. The outer needle tube 120 has a cutting tube movable cavity 1201a and a sampling window 1203 communicating with the cutting tube movable cavity 1201a. A drive handle (not shown in the figure) is connected to the cutting tube 140 to drive the cutting tube 140 to rotate and translate relative to the sampling window 1203 within the cavity of the cutting tube 140, cutting the tissue sample received through the sampling window 1203; The energy source 300 is electrically connected to at least one of the external needle tube 120, the cutting tube 140, and the puncture needle tip 130 so that at least one of the external needle tube 120, the cutting tube 140, and the puncture needle tip 130 forms an electrode that acts on the target tissue. The fluid assembly includes a gas source assembly 210 and a liquid source assembly 220; The controller (not shown in the figure) is able to switch the working modes of the biopsy device in response to the user's mode selection operation. The working modes of the biopsy device include sampling mode, first ablation mode and second ablation mode. When the biopsy device is in sampling mode, the controller blocks the connection between the liquid source assembly 220 and the biopsy needle 100, and controls the gas source assembly 210 to create a pressure difference between the active cavity 1201a of the cutting tube and the inner cavity of the cutting tube 140. When the biopsy device is in the first ablation mode, the controller controls the energy source 300 to connect with the electrode circuit and blocks the connection between the gas source assembly 210, the liquid source assembly 220 and the biopsy needle 100. When the biopsy device is in the second ablation mode, the controller controls the energy source 300 to connect with the electrode circuit, blocks the connection between the gas source assembly 210 and the biopsy needle 100, and connects the liquid source assembly 220 with the inner cavity of the cutting tube 140.

[0029] Specifically, the puncture needle tip 130 is fixedly installed at the front end of the outer needle tube 120 to facilitate puncture into the target tissue. The outer needle tube 120 has a cutting tube movable cavity 1201a inside, and a sampling window 1203 is opened on the outer needle tube 120, communicating with the cutting tube movable cavity 1201a. The target tissue enters the cutting tube movable cavity 1201a through the sampling window 1203. A drive handle drives the connected cutting tube 140, which moves within the cutting tube movable cavity 1201a of the outer needle tube 120, simultaneously achieving a combined rotational and translational motion. After the target tissue enters the cutting tube movable cavity 1201a through the sampling window 1203, the cutting tube 140, through this combined motion, cuts and separates the tissue sample. The energy source 300 provides energy support for the ablation function of the biopsy device. It is electrically connected to at least one of the components—the external needle tube 120, the cutting tube 140, and the puncture needle tip 130—through a circuit connection. The component connected to the energy source 300 can act as an electrode to transfer energy to the target tissue, thereby achieving ablation treatment. The fluid assembly includes a gas source assembly 210 and a liquid source assembly 220. The core function of the gas source assembly 210 is to generate a pressure difference, allowing tissue to pass through the sampling window 1203 into the active cavity 1201a of the cutting tube, or to aspirate the excised tissue from the inner cavity of the cutting tube 140. The liquid source assembly 220 stores and delivers the liquid medium required for ablation, working in conjunction with the energy source 300 to achieve plasma ablation. The controller can receive and respond to the user's mode selection operation, switching the biopsy device to sampling mode, first ablation mode, or second ablation mode according to the user's instructions, thus completing the switching of the biopsy device's operating mode.

[0030] The biopsy device in the technical solution of the present invention includes a biopsy needle 100, a drive handle, an energy source 300, a fluid component, and a controller, realizing functions such as tissue cutting and sampling and ablation of lesion tissue during the biopsy process. In sampling mode, the sharp puncture needle tip 130 and part of the outer needle tube 120 are inserted into the target tissue. When the biopsy needle 100 reaches the predetermined position, the cutting tube movable cavity 1201a generates negative pressure under the action of the air source component 210, so that the tissue outside the sampling window 1203 is sucked through the sampling window 1203 and enters the cutting tube movable cavity 1201a. The cutting tube 140 can make a combination of linear and rotational movements in the direction close to the puncture needle tip 130 to cut the tissue that has entered the cutting tube movable cavity 1201a. The cut tissue will be located in the cutting tube 140 at one end close to the puncture needle tip 130. After the cutting is completed, the cutting tube 140 moves backward in the direction away from the puncture needle tip 130 so that the cut tissue can be taken out from the cutting tube 140, or the air source component 210 generates negative pressure on both sides of the cut tissue so that the cut tissue leaves from the rear end of the cutting tube 140, thereby completing the entire cutting and sampling process. The biopsy device also includes two ablation modes: a first ablation mode and a second ablation mode. In the first ablation mode, the controller blocks the pathway between the gas source component 210, the liquid source component 220, and the biopsy needle 100, while connecting the energy source 300 to the electrode circuit. This enables the electrode to output high-frequency energy, achieving high-frequency ablation of the biopsy needle 100. The high-frequency ablation depth is deep, meeting the ablation needs of deeper surgical sites and larger tissue areas. In the second ablation mode, the controller blocks the connection between the gas source component 210 and the biopsy needle 100, while connecting the energy source 300 to the electrode circuit to ensure ablation energy supply. Simultaneously, it connects the liquid source component 220 to the inner cavity of the cutting tube 140, using the liquid source component 220 to deliver the liquid medium to the outside of the sampling window 1203. This, combined with the electrode, achieves low-temperature plasma ablation. The plasma ablation depth is relatively shallow, suitable for ablation operations on lesion boundaries and small lesions. The biopsy device integrates sampling, high-frequency ablation, and low-temperature plasma ablation modes. It allows for the completion of both tissue sampling and lesion ablation with a single instrument, eliminating the need to change ablation devices after sampling. This reduces the number of instrument changes, shortens the overall procedure time, and minimizes tissue damage caused by multiple instrument punctures. The first ablation mode is suitable for larger, deeper lesions, while the second ablation mode is suitable for smaller, shallower lesions or lesion boundaries. This allows the biopsy device to adjust the ablation depth and range, improving the accuracy of ablation treatment and avoiding unnecessary damage to surrounding healthy tissue.

[0031] In one embodiment, the energy source 300 is a radio frequency generator, and the radio frequency current frequency output by the radio frequency generator in the first ablation mode is higher than the radio frequency current frequency output in the second ablation mode. or; The energy source 300 includes a first radio frequency generator and a second radio frequency generator. The radio frequency current frequency output by the first radio frequency generator is higher than that output by the second radio frequency generator. When the biopsy device is in the first ablation mode, the electrode is connected to the first radio frequency generator. When the biopsy device is in the second ablation mode, the electrode is connected to the second radio frequency generator.

[0032] In an embodiment of the present invention, the energy source 300 employs a radio frequency (RF) generator with adjustable frequency, adapting to two ablation modes through frequency switching. The RF generator maintains an electrical connection with the electrodes (at least one of the external needle tube 120, the cutting tube 140, and the puncture needle tip 130). When the biopsy device switches to the first ablation mode, the RF generator outputs a higher frequency RF current to the electrodes to meet the high-frequency ablation requirements; when switching to the second ablation mode, the RF generator outputs a lower frequency RF current to the electrodes to meet the plasma ablation requirements. A single RF generator achieves mode adaptation through frequency adjustment, resulting in a simple structure, low cost, and facilitating the miniaturization of the biopsy device.

[0033] In an embodiment of the present invention, the energy source 300 includes two independent radio frequency (RF) generators: a first RF generator and a second RF generator. The output frequency of the first RF generator is higher than that of the second RF generator. The controller connects the electrode to the corresponding RF generator according to the switching requirements of the ablation mode. In the first ablation mode, the electrode is connected to the first RF generator to obtain a high-frequency RF current, adapting to the high-frequency ablation requirement. In the second ablation mode, the electrode is connected to the second RF generator to obtain a low-frequency RF current, adapting to the plasma ablation requirement. By providing current for the two ablation modes through two RF generators, frequent frequency tuning by the user is eliminated, which improves the stability of energy output and reduces the risk of errors in frequency tuning operations.

[0034] In one embodiment, the energy source 300 has a first docking electrode (not shown) and a second docking electrode (not shown), the first docking electrode being used to connect to the outer needle tube 120 and the second docking electrode being used to connect to the puncture needle tip 130.

[0035] In an embodiment of the present invention, the energy source 300 is provided with a first docking electrode and a second docking electrode. The first docking electrode is used to electrically connect with the outer needle tube 120 of the biopsy needle 100, and the second docking electrode is used to electrically connect with the puncture needle tip 130 of the biopsy needle 100. This allows the outer needle tube 120 and the puncture needle tip 130 to form a pair of electrodes that act on the target tissue. For example, the energy source 300 transmits energy to the outer needle tube 120 through the first docking electrode, the outer needle tube 120 releases energy to the surrounding tissue, and the energy returns to the energy source 300 through the puncture needle tip 130 and the second docking electrode, forming a current loop. During the energy transfer between the outer needle tube 120 and the puncture needle tip 130, tissue ablation is achieved. Conversely, the energy source 300 can also transmit energy to the puncture needle tip 130 through the second docking electrode, and the energy returns to the energy source 300 through the outer needle tube 120 and the first docking electrode, achieving the same result. The energy source 300 is equipped with a first docking electrode and a second docking electrode that are respectively connected to the outer needle tube 120 and the puncture needle tip 130, which improves the convenience of docking between the energy source 300 and the biopsy needle 100, facilitates disassembly and assembly during the transfer of the biopsy device, reduces the difficulty of disassembly and assembly, and helps to ensure the stability of energy transmission.

[0036] In one embodiment, the gas source assembly 210 includes a negative pressure generating assembly 211, and the fluid assembly further includes: The first pipeline assembly 230 is used to connect the inner cavity of the negative pressure generating assembly 211 and the cutting tube 140; The first valve assembly 240 is located in the first pipeline assembly 230 and is used to control the on / off state of the first pipeline assembly 230.

[0037] Reference Figure 8 and Figure 9 In an embodiment of the present invention, the gas source assembly 210 includes a negative pressure generating assembly 211, a pressure relief valve 212, and a pressure monitoring assembly 213. The pressure relief valve 212 is disposed on the side of the negative pressure generating assembly 211 facing the first pipeline assembly 230, and is used to restore the normal air pressure in the first pipeline assembly 230, thereby restoring the normal air pressure in the inner cavity of the cutting tube 140 and the cutting tube movement 1201a. The pressure monitoring assembly 213 includes a pressure sensor and a display module. The pressure sensor is disposed on the connecting pipeline between the negative pressure generating assembly 211 and the first pipeline assembly 230, and is used to directly or indirectly monitor the pressure in the first pipeline assembly 230, and display the pressure through the display module connected to the pressure sensor, so that the user can accurately know the air pressure in the first pipeline assembly 230, and thus know the air pressure in the inner cavity of the cutting tube 140 and the cutting tube movement 1201a.

[0038] Reference Figure 8In embodiments of the present invention, the fluid assembly further includes a first pipeline assembly 230 and a first valve assembly 240. A negative pressure generating assembly 211 provides a power source for negative pressure suction and can be a vacuum pump or an elastic airbag, etc. The first pipeline assembly 230 connects the negative pressure generating assembly 211 and the inner cavity of the cutting tube 140, enabling the negative pressure generating assembly 211 to draw air from the cutting tube 140 to control the air pressure within the cutting tube 140, thereby controlling the pressure difference between the inner cavity of the cutting tube 140 and the moving cavity 1201a of the cutting tube. The first valve assembly 240 is disposed on the first pipeline assembly 230 and is used to control the on / off state of the first pipeline assembly 230. The first valve assembly 240 can adopt various structural forms, such as a ball valve or a gate valve, and can be switched on / off manually, pneumatically, or electrically.

[0039] In one embodiment, the fluid assembly further includes: The second piping assembly 250 is connected to the cutting pipe movable chamber 1201a, and is also connected to the negative pressure generating assembly 211 or the external environment or a positive pressure generator; and The second valve assembly 260 is disposed on the second pipeline assembly 250 and is used to control the on / off state of the second pipeline assembly 250; When the biopsy device is in sampling mode, the first tubing assembly 230 is connected to the inner cavity of the negative pressure generating assembly 211 and the cutting tube 140, and the second tubing assembly 250 is connected to the negative pressure generating assembly 211 or the external environment or a positive pressure generator, so that a pressure difference is formed between the first tubing assembly 230 and the second tubing assembly 250.

[0040] Reference Figure 8 In embodiments of the present invention, the fluid assembly further includes a second pipeline assembly 250 and a second valve assembly 260. One end of the second pipeline assembly 250 is connected to the cutting tube movable chamber 1201a of the outer needle tube 120, and the other end is connected to the negative pressure generating assembly 211, the external environment, or a positive pressure generator. By selecting the connection object of the second pipeline assembly 250, the magnitude of the air pressure difference can be flexibly adjusted to adapt to different sampling requirements. The second valve assembly 260 is disposed on the second pipeline assembly 250 and is used to control the on / off state of the second pipeline assembly 250, thereby controlling the air pressure in the cutting tube movable chamber 1201a. The second valve assembly 260 can adopt various structural forms, such as ball valves, gate valves, etc., and can be switched on / off manually, pneumatically, or electrically.

[0041] Combination Figures 2 to 6 as well as Figure 8By setting the first valve assembly 240 and the second valve assembly 260, the first pipeline assembly 230 and the second pipeline assembly 250 can be controlled independently. This allows the air pressure inside the cutting tube 140 and the air pressure inside the cutting tube movable cavity 1201a to be controlled independently, thereby achieving different pressure differences between the inner cavity of the cutting tube 140 and the cutting tube movable cavity 1201a. This adapts to the different requirements of the sampling mode and improves the flexibility of the biopsy device in application. For example, after the biopsy needle 100 penetrates the target tissue, the negative pressure generating component 211 can reduce the air pressure inside the cutting tube 140 through the first tubing component 230, making the air pressure inside the cutting tube 140 less than the air pressure in the cutting tube movable cavity 1201a. At this time, the inner cavity of the cutting tube 140 is connected to the cutting tube movable cavity 1201a, thereby reducing the air pressure inside the cutting tube movable cavity 1201a, and thus drawing external tissue from the sampling window 1203 into the cutting tube movable cavity 1201a; the negative pressure generating component 211 can also directly reduce the air pressure inside the cutting tube movable cavity 1201a through the second tubing component 250. As the air pressure decreases, the external tissue is drawn into the active cavity 1201a of the cutting tube from the sampling window 1203. After the tissue is cut off by the cutting tube 140, the cut tissue is located at the front end of the inner cavity of the cutting tube 140. The negative pressure generating component 211 can reduce the air pressure in the inner cavity of the cutting tube 140. The active cavity 1201a of the cutting tube is connected to the external environment or a positive pressure generator, so that the air pressure on the side of the cut tissue facing the inner cavity of the cutting tube 140 is less than the air pressure on the side facing the active cavity 1201a of the cutting tube. As a result, the cut tissue moves backward along the inner cavity of the cutting tube 140 under the action of the air pressure difference and leaves from the rear end of the cutting tube 140.

[0042] Reference Figure 8 In an embodiment of the present invention, the fluid assembly further includes a waste collection assembly 280. The waste collection assembly 280 has an inlet and an outlet. The end of the first conduit assembly 230 away from the cutting tube 140 and the end of the second conduit assembly 250 away from the outer needle tube 120 are both connected to the inlet, and the outlet is connected to the negative pressure generating assembly 211. Waste (such as tissue debris, blood, etc.) sucked from the cutting tube's active cavity 1201a and the inner cavity of the cutting tube 140 through the first conduit assembly 230, as well as waste sucked from the cutting tube's active cavity 1201a through the second conduit assembly 250, are all collected at the inlet through their respective conduits and enter the waste collection assembly 280, realizing centralized collection and treatment of waste. The outlet of the waste collection assembly 280 is connected to the negative pressure generating assembly 211, ensuring that the negative pressure generated by the negative pressure generating assembly 211 can be transmitted to the waste collection assembly 280 through the outlet, and then transmitted to the first conduit assembly 230 and the second conduit assembly 250 through the inlet.

[0043] Specifically, the waste collection component 280 includes a cylinder and a cap that is fastened to the cylinder. The outlet and inlet are both located on the cap, away from the bottom of the cylinder. This allows the blood fragments and other waste collected by the first pipeline component 230 and the second pipeline component 250 to accumulate inside the cylinder without entering the negative pressure generating component 211 through the outlet, thereby reducing the risk of damage to the negative pressure generating component 211 and extending its service life.

[0044] In one embodiment, the fluid assembly further includes a third valve assembly 270, which is disposed on the first pipeline assembly 230 and on the pipe section between the first valve assembly 240 and the cutting pipe 140. The third valve assembly 270 is connected to the liquid source assembly 220 and is used to selectively make the cutting pipe 140 fluidly connected to the negative pressure generating assembly 211 or the liquid source assembly 220. When the biopsy device is in the second ablation mode, the controller controls the state of the third valve assembly 270 to make the cutting tube 140 and the liquid source assembly 220 fluidly connected.

[0045] Combination Figure 8 and Figure 12 In an embodiment of the present invention, the fluid assembly further includes a third valve assembly 270, which is installed on the first pipeline assembly 230 and is located in the pipe section between the first valve assembly 240 and the cutting pipe 140. It is a multi-way reversing valve structure, which on the one hand achieves fluid communication with the liquid source assembly 220, and on the other hand is connected in series in the gas source passage of the first pipeline assembly 230, selectively enabling the cutting pipe 140 to achieve fluid communication with either the negative pressure generating assembly 211 or the liquid source assembly 220, thereby realizing the switching of gas and liquid on the first pipeline assembly 230. For example, in sampling mode, the controller controls the first valve assembly 240 to open and the third valve assembly 270 to switch to the gas source assembly 210 passage, so that the negative pressure generating assembly 211 is connected to the inner cavity of the cutting tube 140 through the first pipeline assembly 230, and at the same time, the gas pressure is adjusted by the second pipeline assembly 250 to form a pressure difference; in the second ablation mode, the controller controls the first valve assembly 240 to close and the third valve assembly 270 to switch to the liquid source assembly 220 passage, so that the liquid source assembly 220 is injected with fluid through the first pipeline assembly 230 and the inner cavity of the cutting tube 140, which meets the liquid medium delivery requirements of plasma ablation. The reversing function of the third valve assembly 270 enables gas-liquid reuse of the first pipeline assembly 230. The first pipeline assembly 230 simultaneously achieves negative pressure transfer in the sampling mode and liquid medium delivery in the second ablation mode. This eliminates the need for an additional dedicated pipeline from the liquid source assembly 220 to the cutting tube 140, reducing the number of pipelines in the fluid assembly, simplifying the overall pipeline layout, reducing the structural complexity of the biopsy device, and minimizing the problem of pipeline entanglement during use. Specifically, in this embodiment, the third valve assembly 270 is a three-way valve.

[0046] In one embodiment, the fluid assembly further includes: The second piping assembly 250 connects the cutting pipe movable chamber 1201a and the negative pressure generating assembly 211; and The second valve assembly 260 is disposed on the second pipeline assembly 250 and is used to control the on / off state of the second pipeline assembly 250; The biopsy device also includes a flushing mode. When the biopsy device is in the flushing mode, the controller controls the state of the third valve assembly 270 to make the cutting tube 140 fluidly connected to the liquid source assembly 220, and controls the state of the second valve assembly 260 to make the second pipeline assembly 250 connected to the cutting tube active chamber 1201a and the negative pressure generating assembly 211.

[0047] Combination Figure 8 and Figure 13 In an embodiment of the present invention, the fluid assembly further includes a second conduit assembly 250 and a second valve assembly 260. One end of the second conduit assembly 250 is connected to the cutting tube movable chamber 1201a of the outer needle tube 120, and the other end is connected to the negative pressure generating assembly 211. The second valve assembly 260 is disposed on the second conduit assembly 250 and is used to control the on / off state of the second conduit assembly 250, thereby controlling the air pressure in the cutting tube movable chamber 1201a. The flushing mode involves injecting a cleaning liquid, such as saline, into the biopsy site through the liquid source assembly 220 to flush the insertion site of the biopsy needle 100, cleaning tissue fragments, blood, and other impurities generated during puncture, cutting, or ablation. This prevents impurities from affecting subsequent pathological test results or postoperative healing, and also reduces the risk of infection, improving the safety of the procedure. In addition, the irrigation mode is particularly suitable for cystic lesions because cystic lesions usually contain pus or impurities, making it difficult to directly perform high-frequency ablation or low-temperature plasma ablation. After the puncture needle tip 130 penetrates the cystic lesion, the irrigation mode can be used first. Cleaning liquid is injected into the cystic lesion through the liquid source component 220 for irrigation. The mixed liquid after cleaning is aspirated by the negative pressure generating component 211, effectively removing pus and impurities from the cystic lesion and creating favorable conditions for subsequent ablation treatment.

[0048] In one embodiment, the liquid source assembly 220 includes: Liquid storage component 221, for containing a preset liquid; and The third piping assembly 223 connects one of the interfaces of the liquid storage unit 221 and the third valve assembly 270; Liquid pump 222 is located in the third pipeline assembly 223 and is used to drive a preset liquid through the third valve assembly 270 into the first pipeline assembly 230.

[0049] Combination Figure 8 , Figure 12 and Figure 13In an embodiment of the present invention, the liquid source assembly 220 includes a liquid storage component 221, a third pipeline assembly 223, and a liquid pump 222. The liquid storage component 221 is a carrier for a preset liquid (such as the medium liquid required for the low-temperature plasma ablation mode, the debridement fluid required for the irrigation mode, and the drug solution required for the drug delivery mode). The third pipeline assembly 223 connects the liquid storage component 221 to one of the interfaces of the third valve assembly 270, ensuring that the liquid in the liquid storage component 221 can smoothly enter the first pipeline assembly 230 through the third pipeline assembly 223 and the third valve assembly 270, and then act on the target tissue along the cutting tube 140, the cutting tube movable cavity 1201a, and the sampling window 1203. The liquid pump 222 is used to provide power for the liquid transmission in the liquid storage component 221, avoiding liquid stagnation or transmission interruption due to insufficient power, thereby ensuring the reliability and safety of functions such as the low-temperature plasma ablation mode, the irrigation mode, and the drug delivery mode. The liquid pump 222 can be installed inside the liquid reservoir 221, directly contacting the preset liquid in the reservoir 221. Through its own suction or pushing action, the pump forces the liquid in the reservoir 221 into the third pipeline assembly 223, thereby driving the liquid to be delivered to the tissue. Alternatively, the liquid pump 222 can be installed on the third pipeline assembly 223 to drive the liquid, for example, by using a peristaltic pump to squeeze the pipeline and drive the liquid flow within the third pipeline assembly 223. It should be noted that when the liquid source assembly 220 is injecting liquid, the cutting tube 140 should be positioned between the sampling window 1203 and the tissue collection tank 111, so that the sampling window 1203 is open and the tissue collection tank 111 is closed, ensuring that the liquid flows from the sampling window 1203 to the target tissue without leaking from the tissue collection tank 111.

[0050] In one embodiment, the biopsy device also includes a drug delivery mode, and the fluid assembly further includes a syringe 400 connected to the cutting tube 140 via a first tubing assembly 230 in the drug delivery mode.

[0051] In embodiments of the present invention, the biopsy device also includes a drug delivery mode, whereby the liquid source component 220 can inject drugs, such as antibiotics, hemostatic agents, and anesthetics. Drug delivery can be achieved through the liquid source component 220, enabling necessary treatment of the patient during biopsy sampling or lesion tissue ablation surgery, thereby improving the safety of the procedure. (See reference...) Figure 14 Alternatively, the syringe 400 can be connected to the third valve assembly 270, or a fourth valve assembly (not shown in the figure) can be installed on a section of the first tubing assembly 230 between the biopsy needle 100 and the third valve assembly 270, with the syringe 400 connected to the fourth valve assembly. Both methods allow the syringe 400 to inject the drug solution into the first tubing assembly 230 to achieve the drug delivery function. The structure is simple, the operation is convenient, and the cost is low.

[0052] In one embodiment, the outer needle tube 120 is provided with a first channel 1201b and a second channel 1202 arranged side by side. The outer needle tube 120 is provided with an air hole 1204 connecting the first channel 1201b and the second channel 1202. The first channel 1201b is the active cavity 1201a of the cutting tube. When the biopsy device is in the sampling mode, the air pressure difference is the air pressure difference between the second channel 1202 and the inner cavity of the cutting tube 140.

[0053] Combination Figure 3 , Figure 4 and Figure 7In an embodiment of the present invention, the outer needle tube 120 has a first channel 1201b and a second channel 1202 arranged side by side inside. Both the first channel 1201b and the second channel 1202 extend along the axial direction of the outer needle tube 120. The first channel 1201b is the cutting tube movable cavity 1201a. The biopsy needle 100 also includes a handle 110, which has a tissue collection groove 111. The rear end of the outer needle tube 120 passes through the handle 110, and the first channel 1201b communicates with the external environment through the tissue collection groove 111, ensuring that the tissue cut by the cutting tube 140 can be smoothly removed through the tissue collection groove 111. The front end of the outer needle tube 120 extends away from the tissue collection groove 111 to the outside of the handle 110, and the front end of the outer needle tube 120 has a sampling window 1203 and an air hole 1204. 3. The first channel 1201b is connected to the external environment for the tissue to be sampled to enter the first channel 1201b; the vent 1204 connects the first channel 1201b and the second channel 1202 and is set opposite to the sampling window 1203. The second channel 1202 is connected to the negative pressure generating component 211, the external environment, or the positive pressure generator through the second pipeline assembly 250. The air pressure difference between the first channel 1201b and the inner cavity of the cutting tube 140 is actually equivalent to the air pressure difference between the second channel 1202 and the inner cavity of the cutting tube 140. Specifically, in this embodiment, when the biopsy device is in sampling mode, during the cutting tube 140's advance stage, under the action of the negative pressure generating component 211, the air pressure inside the second conduit component 250 decreases, causing the air pressure inside the second channel 1202 to decrease. The air pressure at the front end of the first channel 1201b, which is connected to the second channel 1202 via the air hole 1204, also decreases. This causes tissue outside the sampling window 1203 to be drawn into the first channel 1201b through the sampling window 1203. Furthermore, this also causes the air pressure inside the first channel 1201b in front of the cutting tube 140 to be slightly lower than the air pressure inside the cutting tube 140. This pressure difference promotes the forward rotary cutting action of the cutting tube 140 and reduces the forward jamming of the cutting tube 140. Issues with stagnation or pauses: During the retraction phase, the cut tissue is located at the front end of the inner cavity of the cutting tube 140. Under the action of the negative pressure generating component 211, the air pressure in the first pipeline component 230 decreases, causing the air pressure in the inner cavity of the cutting tube 140 to decrease. The air pressure in the second pipeline component 250 decreases, causing the air pressure in the second channel 1202 to decrease. Through the air hole 1204, the air pressure in the first channel 1201b decreases. Since the air hole 1204 is small, the air pressure in the first channel 1201b is slightly higher than the air pressure in the cutting tube 140. This allows the cut tissue to remain inside the front end of the cutting tube 140 under the action of the air pressure difference, preventing it from falling into the first channel 1201b during the retraction of the cutting tube 140.

[0054] In one embodiment, the biopsy needle 100 further includes a conductive component 150, which includes a first conductive element 151 and a second conductive element 152. The first conductive element 151 is disposed within the second channel 1202. The first conductive element 151 is insulated from the outer needle tube 120 and electrically connected to the puncture needle tip 130. The second conductive element 152 is electrically connected to the outer needle tube 120, so that the puncture needle tip 130 and the outer needle tube 120 form an electrode pair acting on the target tissue.

[0055] Reference Figures 3 to 5 as well as Figure 7 In an embodiment of the present invention, the conductive component 150 includes a first conductive element 151 and a second conductive element 152. The first conductive element 151 and the second conductive element 152 can be in various forms such as wires, circuit boards, or conductive metal rods. The first conductive element 151 is inserted into the second channel 1202 and is insulated from the outer needle tube 120. This can be achieved by wrapping the outer wall of the first conductive element 151 with an insulating coating, providing an insulating sleeve, or providing an insulating layer on the inner wall of the second channel 1202. The first conductive element 151 is electrically connected to the puncture needle tip 130, connecting the puncture needle tip 130 to the energy transmission circuit. The second conductive element 152 is electrically connected to the outer needle tube 120, connecting the outer needle tube 120 to the energy transmission circuit. This makes the puncture needle tip 130 and the outer needle tube 120 form an electrode pair acting on the target tissue. When the energy transmission circuit is turned on, the puncture needle tip 130 acts as one electrode, and the outer needle tube 120 acts as the other electrode. A current path is formed between the two electrodes. When the current transfers between the two electrodes, it passes through the surrounding tissue, achieving ablation, electrocoagulation, etc., of the surrounding tissue. The first conductive element 151 is disposed within the second channel 1202, while the cutting tube 140 moves within the first channel 1201b. This arrangement avoids interference between the first conductive element 151 and the moving cutting tube 140, reducing the risk of damage to both the cutting tube 140 and the first conductive element 151. Furthermore, the second channel 1202 serves both to mount the first conductive element 151 and to form a gas passage, achieving two functions within the same structure and improving the structural compactness of the biopsy needle 100.

[0056] In one embodiment, the biopsy needle 100 further includes an insulating structure 160, which is disposed at the end of the front end of the outer needle tube 120. A puncture needle tip 130 is fixed to the side of the insulating structure 160 facing away from the outer needle tube 120. One of the first conductive element 151 and the puncture needle tip 130 passes through the insulating structure 160 and connects to the other; or... The puncture needle tip 130 includes an integrally formed conductive needle tip and an insulating part. The insulating part is connected to the end of the front end of the outer needle tube 120. The conductive needle tip is located on the side of the insulating part away from the outer needle tube 120. The first conductive element 151 passes through the insulating part, and one end of the first conductive element 151 is connected to the conductive needle tip.

[0057] Reference Figure 3and Figure 4 In an embodiment of the present invention, an insulating structure 160 is provided between the outer needle tube 120 and the puncture needle tip 130. The insulating structure 160 is made of insulating materials such as plastic or ceramic. A portion of the first conductive element 151 passes through the insulating structure 160 and connects to the puncture needle tip 130, or a portion of the puncture needle tip 130 passes through the insulating structure 160 and connects to the first conductive element 151. By providing the insulating structure 160 to separate the puncture needle tip 130 and the outer needle tube 120, it is ensured that current cannot be directly transmitted between the puncture needle tip 130 and the outer needle tube 120, ensuring that the current flows along a predetermined path, thereby improving the ablation and electrocoagulation effect of the biopsy needle 100.

[0058] In an embodiment of the present invention, the puncture needle tip 130 includes an integrally formed conductive needle tip and an insulating portion. A first conductive element 151 connects to the conductive needle tip, and the insulating portion separates the conductive needle tip from the outer needle tube 120. By providing an integrally formed insulating portion on the conductive needle tip to separate it from the outer needle tube 120, it is ensured that current cannot be directly transmitted between the puncture needle tip 130 and the outer needle tube 120, ensuring that the current flows along a predetermined path, thereby improving the ablation and electrocoagulation effect of the biopsy needle 100, and also ensuring the stability of the conductive needle tip installation and reducing the risk of the conductive needle tip falling off.

[0059] In one embodiment, the biopsy needle 100 further includes an ejection structure that extends into the interior of the cutting tube 140 and is used to eject the tissue cut out in the cutting tube 140 into the tissue collection groove 111 during the retraction of the cutting tube 140.

[0060] In an embodiment of the present invention, the biopsy needle 100 further includes an ejection structure, which is disposed inside the cutting tube 140. When the cutting tube 140, carrying the excised tissue, moves away from the puncture needle tip 130 to the vicinity of the tissue collection groove 111, the ejection structure is responsible for ejecting the excised tissue from the cutting tube 140, thereby facilitating the user to remove the excised tissue from the tissue collection groove 111. Furthermore, it helps reduce tissue residue within the cutting tube 140, ensuring the accuracy of the sample pathological diagnosis. The ejection structure can be configured as a movable type, ejecting the excised tissue from the cutting tube 140 by moving towards the puncture needle tip 130; or it can be configured as a fixed type, where the extruded tissue is ejected by moving the cutting tube 140 away from the puncture needle tip 130.

[0061] In one embodiment, the ejection structure includes an ejection rod 171 fixedly disposed on the handle 110. The ejection rod 171 is provided with a first fluid channel 1711 that is in fluid communication with the cutting tube 140, and a first pipe connector 172 is connected to the rear end of the ejection rod 171.

[0062] Combination Figure 1 , Figure 2 and Figure 5In an embodiment of the present invention, the ejection structure includes an ejection rod 171. One end of the ejection rod 171 is fixed to the handle 110, and the other end of the ejection rod 171 can penetrate into the interior of the cutting tube 140. The position of the ejection rod 171 is fixed. As the cutting tube 140 moves away from the puncture needle tip 130, the ejection structure contacts and abuts against the cut tissue, causing the cut tissue to leave the cutting tube 140. The structure is simple and easy to implement. Figure 2 , Figure 5 , Figure 6 and Figure 8 The ejector rod 171 is provided with a first fluid channel 1711 that is in fluid communication with the cutting tube 140. The rear end of the ejector rod 171 is connected to a first pipe connector 172, which is used to connect to the gas source assembly 210 or the liquid source assembly 220, so that the ejector rod 171 can flow liquid or gas, thereby improving the structural compactness of the biopsy needle 100. When the first pipe connector 172 is connected to the gas source assembly 210, air can be drawn from inside the cutting tube 140 through the first fluid channel 1711 and the first pipe connector 172, thereby creating a negative pressure environment inside the cutting tube 140. When the first connector 172 is connected to the liquid source assembly 220, the liquid can sequentially enter the cutting tube 140 through the first connector 172 and the first fluid channel 1711, and then enter the first channel 1201b of the outer needle tube 120. It can then reach the surrounding tissue through the sampling window 1203 to inject liquid into the biopsy site, thereby enabling drug delivery to the biopsy site, or to irrigate and clean cystic lesions, or to provide plasma medium for plasma ablation, etc.

[0063] In one embodiment, the outer needle tube 120 includes a main tube 121 and a side tube 122. The inner wall of the main tube 121 forms a first channel 1201b. The side tube 122 is arranged parallel to the outside of the main tube 121, and the inner wall of the side tube 122 and the outer wall of the main tube 121 form a second channel 1202. The handle 110 is also provided with a fluid component 181. The fluid component 181 is provided with a second fluid channel 1811 that is in fluid communication with the second channel 1202. The rear end of the fluid component 181 is connected to a second pipe connector 182.

[0064] Reference Figure 7 In an embodiment of the present invention, the outer needle tube 120 includes a main tube 121 and a side tube 122. The main tube 121 is hollow and has a first channel 1201b. The side tube 122 has an incomplete annular cross-section. The side tube 122 is fastened to the outer wall of the main tube 121 and then welded and fixed. A second channel 1202 is formed between the inner wall of the side tube 122 and the outer wall of the main tube 121, which reduces the processing and manufacturing difficulty of the outer needle tube 120. Figure 2 , Figure 5 , Figure 6 and Figure 8The handle 110 is also provided with a fluid component 181. The fluid component 181 is provided with a second fluid channel 1811 that is in fluid communication with the second channel 1202. The rear end of the fluid component 181 is connected to a second pipe connector 182, which is used to connect to the second pipeline assembly 250, so that the fluid component 181 can flow liquid or gas.

[0065] In one embodiment, the handle 110 is further provided with a needle mounting seat 190, the rear end of the outer needle tube 120 passes through the needle mounting seat 190, the main body 121 is provided with a protrusion extending backward beyond the side half tube, the needle mounting seat 190 is provided with a wire hole and a vent hole, the vent hole is opened on the outside of the protrusion, the second channel 1202 is connected to the second fluid channel 1811 through the vent hole, the first conductive element 151 is the first wire, the second conductive element 152 is the second wire, both the first wire and the second wire pass through the wire hole, the second wire is connected to the protrusion and the connection part is located at the position corresponding to the vent hole.

[0066] Reference Figures 3 to 5 as well as Figure 7 In the embodiments of the present invention, both the first conductive element 151 and the second conductive element 152 are in the form of wires. The manufacturing process of wires is mature, the cost is low, and the connection flexibility is high. One end of the first wire passes through the second channel 1202 of the outer needle tube 120 and is insulated from the outer needle tube 120. The other end passes through the wire hole on the needle tube mounting base 190 and is used to directly or indirectly connect to the energy source 300 to realize the circuit connection from the energy source 300 to the puncture needle tip 130. One end of the second wire is used to connect to the outer needle tube 120, and the other end passes through the wire hole on the needle tube mounting base 190 to directly or indirectly connect to the energy source 300 to realize the circuit connection from the energy source 300 to the outer needle tube 120. In other words, the entire biopsy device forms two energy transmission paths: one is the energy source 300, the second lead wire, and the outer needle tube 120; the other is the energy source 300, the first lead wire, and the puncture needle tip 130. When the puncture needle tip 130 and part of the outer needle tube 120 penetrate the tissue, the two energy transmission paths form a complete closed loop through the tissue surrounding the puncture needle tip 130 and the outer needle tube 120, thus allowing current to act on the tissue surrounding the puncture needle tip 130 and the outer needle tube 120. The rear end of the main tube 121 has an extension, and the second lead wire connects to the extension. The connection point corresponds to the vent hole position of the needle tube mounting base 190, facilitating observation of the connection point. Furthermore, at this time, the second conductive component 152 does not extend into the second channel 1202, reducing the influence of the conductive component 150 on the airflow within the second channel 1202.

[0067] In one embodiment, the biopsy needle 100 is further provided with an energy transmission interface (not shown in the figure) for connecting to an energy source 300. The first conductive element 151 is electrically connected to the puncture needle tip 130 and the energy transmission interface, respectively, and the second conductive element 152 is electrically connected to the outer needle tube 120 and the energy transmission interface, respectively.

[0068] In an embodiment of the present invention, the biopsy needle 100 is connected to the energy source 300 via an energy transmission interface. The energy transmission interface serves as a common energy input terminal and simultaneously provides energy input to two independent conductive paths. The first conductive element 151 and the second conductive element 152 independently conduct energy, acting on the puncture needle tip 130 and the outer needle tube 120 respectively, without interference between the two conductive paths. The dedicated energy transmission interface standardizes the connection method between the external energy source 300 and the biopsy needle 100, facilitating rapid adaptation and connection between the biopsy needle 100 and the energy source 300, simplifying the preoperative assembly process of surgical equipment, and improving the convenience of clinical operation.

[0069] In one embodiment, the energy transmission interface is directly disposed on the handle 110; or, The conductive component 150 includes a connected cable 153 and an electrical connector 154. The portions of the first conductive element 151 and the second conductive element 152 extending out of the handle 110 are integrated into the cable 153, and the energy transmission interface is located in the electrical connector 154.

[0070] In an embodiment of the present invention, the energy transmission interface is directly integrated into the handle 110 of the biopsy needle 100. The handle 110 serves as the core component for handheld operation of the biopsy needle 100, and the energy transmission interface is directly integrated therein. The first conductive element 151 and the second conductive element 152 can directly complete the electrical connection with the energy transmission interface inside the handle 110, without needing to extend outside the handle 110. This simplifies the overall structure of the biopsy needle 100, reduces the number of parts, and helps to lower manufacturing costs.

[0071] Reference Figure 2In an embodiment of the present invention, the conductive component 150 includes a cable 153 and an electrical connector 154 electrically connected to each other. The portions of the first conductive element 151 and the second conductive element 152 extending out of the handle 110 are integrated inside the cable 153, which provides neatness and protection for the portions of the two conductive elements extending out of the handle 110. An energy transmission interface is located on the electrical connector 154. An external energy source 300 connects to the energy transmission interface on the electrical connector 154, and then transmits energy to the puncture needle tip 130 and the outer needle tube 120 via the cable 153 and the first and second conductive elements 151 and 152 integrated within the cable 153. The energy transmission interface is located on a separate electrical connector 154, facilitating compatibility with more specifications and types of external energy sources 300, thus expanding the compatibility range of the energy source 300. Furthermore, it facilitates replacement when the electrical connector 154 or the cable 153 is damaged, eliminating the need to disassemble the entire biopsy needle 100, reducing maintenance difficulty.

[0072] In summary, the biopsy device provided in this embodiment integrates multiple functions such as biopsy sampling, high-frequency ablation, electrocautery, electrocoagulation, plasma ablation, irrigation and debridement, and drug administration. This enriches the application scope and applicable scenarios of the biopsy needle 100 in actual clinical operations, reduces the complex steps and time consumption caused by frequent changes of different devices during the operation, and thus improves the efficiency of the operation.

[0073] The steps for using the sampling mode include: refer to Figure 1 The cutting tube 140 is located at the rear end of the first channel 1201b, opening the sampling window 1203 and the tissue collection groove 111; (Refer to...) Figure 4 The puncture needle tip 130 and part of the external needle tube 120 penetrate the tissue, covering the sampling window 1203; the first valve assembly 240 is closed, the third valve assembly 270 is closed, and the second valve assembly 260 is opened; combined with Figure 3 , Figure 5 , Figure 6 and Figure 9 The negative pressure generating component 211 draws air, causing the air near the sampling window 1203 to be drawn in sequence through the air hole 1204, the second channel 1202, the second fluid channel 1811 of the fluid component 181, the second pipeline assembly 250, and the waste collection assembly 280 by the negative pressure generating component 211. Figure 9 As indicated by the middle arrow, a negative pressure is formed near the sampling window 1203 in the first channel 1201b, allowing tissue to enter the sampling window 1203; the cutting tube 140 rotates and advances towards the tip of the puncture needle 130, cutting off the tissue within the sampling window 1203, and sealing the sampling window 1203 and the tissue collection groove 111. At this time, the cut tissue is located inside the cutting tube 140; the cutting tube 140 moves backward, and simultaneously, the first valve assembly 240 opens, the negative pressure generating assembly 211 draws air, combined with... Figure 3 , Figure 5 , Figure 6 and Figure 10 The air inside the cutting tube 140 is sequentially drawn out by the negative pressure generating component 211 through the first fluid channel 1711 of the ejector rod 171, the first pipeline assembly 230, and the waste collection assembly 280. Figure 10 As indicated by the middle arrow, a negative pressure is created within the cutting tube 140 to reduce the risk of tissue falling into the first channel 1201b during the backward movement of the cutting tube 140. The cutting tube 140 continues to move backward to the vicinity of the tissue collection groove 111, where the ejector rod 171 pushes the tissue out of the cutting tube 140, allowing it to exit through the tissue collection groove 111, thus ending the sampling process. Furthermore, debris and blood generated during tissue cutting can sequentially enter the waste collection assembly 280 through the vent 1204, the second channel 1202, the second fluid channel 1811, and the second tubing assembly 250, or sequentially through the cutting tube 140, the first fluid channel 1711, and the first tubing assembly 230.

[0074] Reference Figure 11 The first ablation mode (high-frequency ablation mode) is generally used after the puncture needle tip 130 is inserted into the lesion tissue. The steps include: inserting the puncture needle tip 130 and part of the outer needle tube 120 into the lesion tissue; turning on the energy source 300, and a high-frequency current flows between the puncture needle tip 130 and the outer needle tube 120 to ablate the lesion tissue.

[0075] Electrosurgical resection is generally used during the insertion of the puncture needle tip into the lesion tissue at a depth of 130°.

[0076] The electrocoagulation function is generally used after biopsy sampling is completed. The steps include: inserting the puncture needle tip 130 and part of the external needle tube 120 into the wound after sampling; turning on the energy source 300, and an electric current flows between the puncture needle tip 130 and the external needle tube 120, so that the tissue coagulates and stops bleeding through the thermal effect.

[0077] The second ablation mode (low-temperature plasma ablation mode) is generally used after the puncture needle tip penetrates 130 mm into the lesion tissue, combined with... Figures 4 to 6 as well as Figure 12 The procedure includes: inserting the puncture needle tip 130 and part of the external needle tube 120 into the lesion tissue, with the tissue covering the sampling window 1203; refer to Figure 12 The first valve assembly 240 is closed, the second valve assembly 260 is closed, and the third valve assembly 270 is opened, connecting the third pipeline assembly 223 and the first pipeline assembly 230; the liquid pump 222 is turned on, and the liquid in the reservoir 221 flows sequentially through the third pipeline assembly 223, part of the first pipeline assembly 230, the first fluid channel 1711 of the ejector rod 171, the cutting tube 140, and the first channel 1201b of the external needle tube 120 towards the outside of the sampling window 1203, as shown. Figure 12 As shown by the middle arrow; when the energy source 300 is turned on, current flows between the puncture needle tip 130 and the outer needle tube 120. The liquid generates plasma under the action of the current, which ablates the lesion tissue.

[0078] The irrigation mode can be used after biopsy sampling, high-frequency ablation, or plasma ablation. For some cystic lesions, it can be used before high-frequency ablation or plasma ablation. Combined with... Figures 4 to 6 as well as Figure 13 The steps for using the flushing mode include: inserting the puncture needle tip 130 and part of the external needle tube 120 into the lesion tissue, covering the sampling window 1203; inserting the front end of the cutting tube 140 into the first channel 1201b, and sleeved the rear end on the ejector rod 171; closing the first valve assembly 240 and opening the third valve assembly 270 to connect the first tubing assembly 230 and the third tubing assembly 223; turning on the liquid pump 222, and the liquid in the reservoir 221 flows sequentially through the third tubing assembly 223, part of the first tubing assembly 230, the first fluid channel 1711 of the ejector rod 171, the cutting tube 140, and the first channel 1201b of the external needle tube 120 towards the outside of the sampling window 1203, such as... Figure 13 As indicated by the middle arrow, the biopsy wound and lesion tissue are flushed; at the same time, the second valve assembly 260 opens, and under the action of the negative pressure generating assembly 211, the mixture of cleaning liquid, blood, tissue debris and other liquid near the sampling window 1203 passes through the vent 1204, the second channel 1202, the second fluid channel 1811 and the second pipeline assembly 250, leaving the biopsy needle 100 and entering the waste collection assembly 280, thus realizing the flushing function.

[0079] Combination Figures 4 to 6 as well as Figure 14 The steps for using the drug delivery mode include: closing the first valve assembly 240, closing the second valve assembly 260, and opening the third valve assembly 270; injecting the drug solution into the third valve assembly 270 using the syringe 400; the drug solution flows sequentially through a portion of the first tubing assembly 230, the first fluid channel 1711 of the ejector rod 171, the cutting tube 140, and the first channel 1201b of the external needle tube 120 towards the outside of the sampling window 1203, as shown below. Figure 14 As indicated by the middle arrow, the drug delivery mode is implemented. Switching between the low-temperature plasma ablation mode, the injection flushing mode, and the drug delivery mode also includes the disassembly and assembly steps of the syringe 400, the third tubing assembly 223, and the third valve assembly 270.

[0080] In another embodiment, a gap is provided between the outer needle tube 120 and the cutting tube 140, and the air pressure difference is the air pressure difference between the gap and the inner cavity of the cutting tube 140.

[0081] Combination Figures 15 to 18In another embodiment of the invention, the outer needle tube 120 has a single channel and is connected to the external environment through a vent on the handle 110, and the gap between the outer needle tube 120 and the cutting tube 140 forms a pressure difference. Specifically, in sampling mode, before the cutting tube 140 cuts the tissue, the sampling window 1203 is opened, and the cutting tube 140 is connected to the collection chamber of the tissue collector at the rear end. The negative pressure generating component 211 reduces the internal pressure of the collection chamber through the first pipeline component 230, thereby reducing the internal air pressure of the cutting tube 140 and reducing the internal pressure of the cutting tube movable chamber 1201a of the outer needle tube 120. The tissue outside the sampling window 1203 is drawn into the cutting tube movable chamber 1201a of the outer needle tube 120 through the sampling window 1203, which facilitates the cutting tube 140 to cut the tissue. Then, the cutting tube 140 moves towards the direction close to the puncture needle tip 130 to cut off the tissue. At the same time, the cutting tube 140 closes the sampling window 1203. Under the action of negative pressure, the cut tissue moves through the interior of the cutting tube 140 to the collection chamber of the tissue collector, which facilitates the subsequent sample retrieval. The steps in the first ablation mode include: inserting the puncture needle tip 130 and part of the external needle tube 120 into the lesion tissue; turning on the energy source 300, and transmitting energy from the energy output interface of the energy source 300 to the energy input interface of the biopsy handle 200, the energy input electrode of the biopsy needle 100, and finally to the puncture needle tip 130 and the external needle tube 120, so that a high-frequency current flows between the puncture needle tip 130 and the external needle tube 120 to ablate the lesion tissue. The steps for using the second ablation mode include: the puncture needle tip 130 and part of the external needle tube 120 are inserted into the lesion tissue, covering the sampling window 111; the plasma ablation medium in the reservoir 221 flows sequentially through the third tubing assembly 223, the inner cavity of the cutting tube 140, and the external needle tube 120 outwards from the sampling window 111; the energy source 300 is turned on, and energy is sequentially transferred from the energy output interface of the energy source 300 to the energy input interface of the biopsy handle 200, the energy input electrode of the biopsy needle 100, and finally to the puncture needle tip 130 and the external needle tube 120. Current flows between the puncture needle tip 130 and the external needle tube 120, and the plasma ablation medium generates plasma under the action of the current, ablating the lesion tissue.

[0082] The above description is merely an exemplary embodiment of the present invention and does not limit the scope of protection of the present invention. Any equivalent structural transformations made based on the inventive concept and the contents of the present invention specification and drawings, or direct / indirect applications in other related technical fields, are included within the scope of protection of the present invention.

Claims

1. A biopsy device, characterized in that, include: A biopsy needle includes an outer needle tube, a cutting tube, and a puncture needle tip. The puncture needle tip is located at the front end of the outer needle tube. The outer needle tube has a cutting tube movable cavity and a sampling window communicating with the cutting tube movable cavity. A drive handle, connected to the cutting tube, drives the cutting tube to rotate and translate relative to the sampling window within the cutting tube cavity, cutting the tissue sample received through the sampling window; An energy source is electrically connected to at least one of the external needle tube, the cutting tube, and the puncture needle tip so that at least one of the external needle tube, the cutting tube, and the puncture needle tip forms an electrode that acts on the target tissue; Fluid components, including gas source components and liquid source components; The controller is capable of switching the working modes of the biopsy device in response to a user's mode selection operation. The working modes of the biopsy device include a sampling mode, a first ablation mode, and a second ablation mode. When the biopsy device is in sampling mode, the controller blocks the connection between the liquid source component and the biopsy needle, and controls the gas source component to create a pressure difference between the movable cavity of the cutting tube and the inner cavity of the cutting tube. When the biopsy device is in the first ablation mode, the controller controls the energy source to connect with the electrode circuit and blocks the connection between the gas source assembly, the liquid source assembly and the biopsy needle. When the biopsy device is in the second ablation mode, the controller controls the energy source to connect with the electrode circuit, blocks the connection between the gas source assembly and the biopsy needle, and connects the liquid source assembly with the inner cavity of the cutting tube.

2. The biopsy device as described in claim 1, characterized in that, The energy source is a radio frequency generator, and the radio frequency generator outputs a higher radio frequency current in the first ablation mode than in the second ablation mode. or; The energy source includes a first radio frequency generator and a second radio frequency generator. The radio frequency current frequency output by the first radio frequency generator is higher than that output by the second radio frequency generator. When the biopsy device is in the first ablation mode, the electrode is connected to the first radio frequency generator. When the biopsy device is in the second ablation mode, the electrode is connected to the second radio frequency generator.

3. The biopsy device as described in claim 1, characterized in that, The energy source has a first docking electrode and a second docking electrode. The first docking electrode is used to connect with the outer needle tube, and the second docking electrode is used to connect with the puncture needle tip.

4. The biopsy device as described in claim 1, characterized in that, The gas source assembly includes a negative pressure generating assembly, and the fluid assembly further includes: The first pipeline assembly is used to connect the inner cavity of the negative pressure generating assembly and the cutting tube; A first valve assembly is disposed on the first pipeline assembly and is used to control the on / off state of the first pipeline assembly.

5. The biopsy device as described in claim 4, characterized in that, The fluid assembly also includes: The second piping assembly connects to the movable chamber of the cutting tube and is also connected to the negative pressure generating assembly, the external environment, or the positive pressure generator; and A second valve assembly is provided on the second pipeline assembly and is used to control the on / off state of the second pipeline assembly; When the biopsy device is in the sampling mode, the first tubing assembly connects the inner cavity of the negative pressure generating assembly and the cutting tube, and the second tubing assembly connects the negative pressure generating assembly or the external environment or a positive pressure generator, so as to create a pressure difference between the first tubing assembly and the second tubing assembly.

6. The biopsy device as described in claim 4, characterized in that, The fluid assembly further includes a third valve assembly, which is disposed on the first pipeline assembly and on the pipe section between the first valve assembly and the cutting pipe. The third valve assembly is connected to the liquid source assembly and is used to selectively make the cutting pipe fluidly connected to the negative pressure generating assembly or the liquid source assembly. When the biopsy device is in the second ablation mode, the controller controls the state of the third valve assembly to make the cutting tube and the liquid source assembly in fluid communication.

7. The biopsy device as described in claim 6, characterized in that, The fluid assembly also includes: The second piping assembly connects the movable chamber of the cutting tube and the negative pressure generating assembly; and A second valve assembly is provided on the second pipeline assembly and is used to control the on / off state of the second pipeline assembly; The biopsy device also includes a flushing mode. When the biopsy device is in the flushing mode, the controller controls the state of the third valve assembly to make the cutting tube and the liquid source assembly fluidly connected, and controls the state of the second valve assembly to make the second pipeline assembly connect the cutting tube movable chamber and the negative pressure generating assembly.

8. The biopsy device as claimed in claim 7, characterized in that, The liquid source component includes: Liquid storage unit for containing a preset liquid; and The third piping assembly connects one of the interfaces of the liquid storage device and the third valve assembly; A liquid pump, located in the third pipeline assembly, is used to drive the preset liquid through the third valve assembly into the first pipeline assembly.

9. The biopsy device as claimed in claim 6, characterized in that, The biopsy device also includes a drug delivery mode, and the fluid assembly further includes a syringe connected to the cutting tube via a first tubing assembly in the drug delivery mode.

10. The biopsy device according to any one of claims 1-9, characterized in that, The outer needle tube has a first channel and a second channel arranged side by side. The outer needle tube has an air hole that connects the first channel and the second channel. The first channel is the movable cavity of the cutting tube. When the biopsy device is in the sampling mode, the air pressure difference is the air pressure difference between the second channel and the inner cavity of the cutting tube. or; A gap is provided between the outer needle tube and the cutting tube, and the air pressure difference is the air pressure difference between the gap and the inner cavity of the cutting tube.

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