Biopsy needle and biopsy sampling device

Abstract

The invention discloses a biopsy needle and a biopsy sampling device.The biopsy needle comprises an outer knife tube, a puncture head, an inner knife tube, an air valve assembly and a wire, the outer knife tube is provided with a first channel and a second channel, and the first channel and the second channel extend in the axial direction of the outer knife tube and are arranged side by side; the side wall of the first channel is provided with a sampling window communicated with the external environment, the outer knife tube is further provided with an air hole communicated with the first channel and the second channel, and the air hole is formed between the second end and the puncture head. The air valve assembly is arranged at the rear end of the outer knife tube and used for controlling connection or disconnection of the second channel and the external environment. And the energy transmission circuit is insulated from the outer knife tube, is electrically connected with the puncture head and is used for connecting the puncture head into the energy transmission circuit, so that at least part of energy transmitted by the energy transmission circuit can act on target tissue through an electrode pair formed by the puncture head and the outer knife tube. According to the technical scheme, bleeding in the operation is reduced, and the possibility that the cut tissue blocks the inner knife tube is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a biopsy needle and a biopsy sampling device. Background Art

[0002] A biopsy sampling device is used to take tissue samples from a patient's body for pathological examination, and is commonly used for biopsy sampling of parts such as the breast and thyroid.

[0003] There is a conventional biopsy sampling device, including a biopsy needle, a driving handle, and a suction assembly. The biopsy needle includes an outer cutter tube and an inner cutter tube sleeved inside the outer cutter tube. The front end of the outer cutter tube has a slender and sharp puncture head, and a sampling window is provided on the side wall of the outer cutter tube. After the puncture head penetrates into the tissue to reach the lesion site, the driving handle drives the inner cutter tube to axially move and circumferentially rotate, so that the inner cutter tube cuts the tissue at the sampling window, and then the suction assembly sucks out the cut tissue from the inside of the inner cutter tube to achieve the sampling operation.

[0004] However, when the puncture head of such a biopsy needle penetrates into the tissue, the puncture head often cuts the blood vessels in the tissue, resulting in more intraoperative bleeding, and the cut tissue is easily blocked inside the inner cutter tube. Summary of the Invention

[0005] The main object of the present invention is to propose a biopsy needle and a biopsy sampling device, aiming to reduce intraoperative bleeding and reduce the possibility of the cut tissue blocking the inner cutter tube.

[0006] To achieve the above object, the biopsy needle proposed by the present invention includes:

[0007] An outer cutter tube, provided with a first channel and a second channel, both the first channel and the second channel extend along the axial direction of the outer cutter tube and are arranged side by side, and a sampling window communicating with the external environment is provided on the side wall of the first channel;

[0008] A puncture head, provided at the front end of the outer cutter tube and insulated from the outer cutter tube; wherein, the sampling window has opposite first and second ends along the axial direction of the outer cutter tube, the first end is close to the puncture head, the second end is far from the puncture head, and the outer cutter tube is further provided with an air hole communicating the first channel and the second channel, and the air hole is provided between the second end and the puncture head;

[0009] An inner cutter tube, the inner cutter tube is partially disposed inside the first channel, and the inner cutter tube can reciprocate axially along the outer cutter tube to cut the tissue entering the first channel through the sampling window and close the sampling window, or open the sampling window;

[0010] The air valve assembly is provided at the rear end of the outer cutter tube and is used to control the communication or disconnection between the second channel and the external environment;

[0011] The wire is disposed within the second channel, is insulated from the outer cutter tube, and is electrically connected to the puncture head. It is used to connect the puncture head to the energy transmission circuit so that at least part of the energy transmitted by the energy transmission circuit can act on the target tissue through the electrode pair formed by the puncture head and the outer cutter tube.

[0012] In one embodiment, the biopsy needle further includes a support base. One end of the outer cutter tube passes through the support base, and the other end of the outer cutter tube extends outside the support base and is provided with the puncture head. Wherein, a conductive region and an insulating region are provided on the outer wall of the outer cutter tube, the sampling window is disposed in the insulating region, and part or all of the conductive region is used to form one electrode of the electrode pair.

[0013] In one embodiment, the conductive region includes a first sub-region and a second sub-region that are electrically connected. The first sub-region is disposed outside the support base, and the second sub-region is disposed inside the support base. The first sub-region is used to form one electrode of the electrode pair, and the second sub-region is in the energy transmission circuit.

[0014] In one embodiment, the biopsy needle further includes a first electrode. The first electrode passes through the support base, one end of the first electrode abuts against the second sub-region, and the other end of the first electrode is used to dock with the first docking electrode of the driving handle; and / or,

[0015] The surface area of the first sub-region is larger than the surface area of the puncture head.

[0016] In one embodiment, the biopsy needle further includes a second electrode. The second electrode passes through the support base, one end of the second electrode is used to dock with the second docking electrode of the driving handle, and the wire connects the other end of the second electrode and the puncture head; and / or,

[0017] An insulating layer is provided outside the outer cutter tube, and the insulating layer wraps around the outer wall of the outer cutter tube to form the insulating region.

[0018] In one embodiment, the inner diameter of the first channel is larger than the inner diameter of the second channel.

[0019] In one embodiment, the biopsy needle further includes an insulating structure. The insulating structure is disposed at the end of the second end of the outer cutter tube. The puncture head is fixed on the side of the insulating structure away from the outer cutter tube. The wire penetrates through the insulating structure, and one end of the wire is connected to the puncture head; or,

[0020] The puncture head includes a conductive needle tip and an insulating part integrally formed. The insulating part is connected to the end of the second end of the outer cutter tube. The conductive needle tip is arranged on the side of the insulating part facing away from the outer cutter tube. The wire penetrates through the insulating part, and one end of the wire is connected to the insulating part.

[0021] In one embodiment, the biopsy needle further includes a support assembly. The rear end of the outer cutter tube penetrates through the support assembly. An air vent cavity is provided in the support assembly. The second channel communicates with the air vent cavity. The air valve assembly controls the air vent cavity to communicate with the external environment so that the second channel communicates with the external environment, and the air valve assembly controls the air vent cavity to be disconnected from the external environment so that the second channel is disconnected from the external environment.

[0022] In one embodiment, a gap is formed between the inner wall of the first channel and the inner cutter tube to form an air intake gap. The air intake gap communicates with the air vent cavity, so that the air valve assembly controls the air intake gap and the second channel to communicate with or be disconnected from the external environment synchronously.

[0023] The present invention also provides a biopsy sampling device, including:

[0024] The above-mentioned biopsy needle;

[0025] A driving handle, drivingly connected to the biopsy needle. The driving handle has a second docking electrode electrically connected to the wire and a first docking electrode electrically connected to the outer cutter tube; and

[0026] A high-frequency generator, used to generate high-frequency current, and electrically connected to the first docking electrode and the second docking electrode respectively.

[0027] The biopsy needle in the technical solution of the present invention includes an outer knife tube, an inner knife tube, a puncture head, a gas valve assembly, and a wire. The puncture head is arranged at the front end of the outer knife tube and is insulated from the outer knife tube. The wire is electrically connected to the puncture head. During the process of inserting into the tissue for sampling, the wire, the puncture head, and the outer knife tube are all located in the energy transmission circuit for transmitting energy. The puncture head and the outer knife tube form an electrode pair acting on the target tissue. When the current flows forward, the current is transmitted to the puncture head through the wire, then released from the puncture head to the target tissue, and after passing through the target tissue, it is received by the outer knife tube. When the current flows backward, the current is released to the target tissue through the outer knife tube, and after passing through the target tissue, it is received by the puncture head and then transmitted to the wire. During this current transmission process, heat concentration will occur at the puncture head, and the tissue cells around the puncture head will be dehydrated through the thermal effect, so that the puncture head has the function of electrocoagulation, accelerating the coagulation of the tissue around the puncture head, thereby reducing the bleeding volume during the biopsy sampling operation and improving the safety of the biopsy sampling operation. In addition, the reduction of the bleeding volume also provides a clearer surgical field of view for the user, which is beneficial for the user to judge the lesion site and excise the tissue, thereby shortening the time required for the operation. The outer knife tube is provided with a first channel and a second channel. The inner knife tube is arranged inside the first channel. Before the puncture head penetrates into the tissue, the inner knife tube is located on the side of the sampling window away from the puncture head, so that the sampling window is opened. After the puncture head penetrates into the tissue, the inner knife tube gradually closes the sampling window along the axis close to the puncture head. During the process of closing the sampling window, the front end of the inner knife tube cuts off the tissue located at the sampling window, so that the removed tissue enters the inside of the inner knife tube through the sampling window. The rear end of the inner knife tube is directly or indirectly connected to the suction assembly, and a negative pressure is created inside the inner knife tube to suck out the cut tissue from the inner knife tube. The sampling window has a first end close to the puncture head and a second end far from the puncture head along the axis of the outer knife tube. An air hole communicating the first channel and the second channel is also provided on the outer knife tube. When the inner knife tube cuts off the tissue, the gas valve assembly controls the second channel to communicate with the external environment, so that the air in the external environment enters the second channel, and then enters the front side of the inner knife tube through the air hole. Since the air hole is arranged between the second end of the sampling window and the puncture head, the air can easily enter the front side of the cut tissue close to the puncture head, and a negative pressure will be formed on the rear side of the cut tissue away from the puncture head under the action of the suction assembly, thereby increasing the air pressure difference between the front and rear sides of the cut tissue, making the cut tissue easier to be sucked out, thereby reducing the possibility of the cut tissue being blocked inside the inner knife tube, improving the sampling efficiency of the biopsy needle, and improving the safety of the biopsy sampling operation. Among them, the second channel is used to accommodate the wire, so that the outer knife tube plays a role in protecting the wire, and is also used to ventilate the air hole, realizing two functions through the same structure, and simplifying the structure of the biopsy needle. Description of the Drawings

[0028] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on the structures shown in these drawings.

[0029] Figure 1 Partial cross-section of a biopsy needle according to an embodiment of the present invention Figure 1 ;

[0030] Figure 2 Schematic diagram of the air flow path of a biopsy needle according to an embodiment of the present invention;

[0031] Figure 3 Partial cross-section of a biopsy needle according to an embodiment of the present invention Figure 2 ;

[0032] Figure 4 For Figure 3 Local enlarged view at position A in

[0033] Figure 5 Partial cross-section of a biopsy needle according to an embodiment of the present invention Figure 3 ;

[0034] Figure 6 For Figure 5 Local enlarged view at position B in

[0035] Figure 7 Structural schematic of the outer knife tube of the biopsy needle provided by the present invention Figure 1 ;

[0036] Figure 8 Structural schematic of the outer knife tube of the biopsy needle provided by the present invention Figure 2 ;

[0037] Figure 9 Structural schematic of the outer knife tube of the biopsy needle provided by the present invention Figure 3 ;

[0038] Figure 10 Partial cross-section of a biopsy sampling device according to an embodiment of the present invention Figure 4 ;

[0039] Figure 11 Partial cross-section of a biopsy sampling device according to an embodiment of the present invention Figure 5 ;

[0040] Figure 12 For Figure 11 Local enlarged view at position C in

[0041] Figure 13 is Figure 11 a partial enlarged view at position D in

[0042] Figure 14 a schematic structural view of the outer cutter tube of the biopsy needle provided by the present invention Figure 4 ;

[0043] Figure 15 is a schematic structural view of an embodiment of a biopsy sampling device provided by the present invention.

[0044] Explanation of the reference numerals in the attached drawings:

[0045] 100. Outer cutter tube; 101. First channel; 102. Second channel; 103. Sampling window; 104. Air hole; 105. Air inlet gap; 106. Conductive area; 1061. First sub - area; 1062. Second sub - area; 107. Insulating area; 110. Tubular part; 120. Half - tube part;

[0046] 200. Inner cutter tube;

[0047] 300. Puncture head;

[0048] 400. Air valve assembly; 410. Sealing protrusion; 420. Compression sleeve; 430. Elastic member; 440. Sealing ring;

[0049] 500. Transmission seat;

[0050] 600. Support assembly; 601. Ventilation cavity; 610. Support seat; 620. Support sleeve;

[0051] 700. Conducting wire;

[0052] 810. First electrode; 820. Second electrode;

[0053] 900. Insulating structure;

[0054] 10. Driving handle; 11. First docking electrode; 12. Second docking electrode.

[0055] The realization, functional features and advantages of the purpose of the present invention will be further described with reference to the embodiments and the accompanying drawings. Detailed implementation manners

[0056] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the protection scope of the present invention.

[0057] It should be noted that if there are directional indications (such as up, down, left, right, front, back...) involved in the embodiments of the present invention, then such directional indications are only used to explain the relative positional relationship, movement conditions, etc. between components in a certain specific posture. If this specific posture changes, then the directional indications will also change accordingly.

[0058] In the present invention, unless otherwise clearly specified and defined, terms such as "connection" and "fixation" should be understood in a broad sense. For example, "fixation" can be a fixed connection, a detachable connection, or integrated; "connection" can be a mechanical connection, an electrical connection, can be directly connected, or can be indirectly connected through an intermediate medium, and can be the communication inside two components or the interaction relationship between two components. Unless otherwise clearly defined, for those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0059] In addition, if there are descriptions such as "first" and "second" involved in the embodiments of the present invention, then such "first" and "second" descriptions are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first" and "second" can explicitly or implicitly include at least one such feature. In addition, the meaning of "and / or" appearing throughout the text includes three parallel scenarios. Taking "A and / or B" as an example, it includes scenario A, scenario B, or the scenario where both A and B are satisfied simultaneously. In addition, the technical solutions between various embodiments can be combined with each other, but it must be based on the fact that those of ordinary skill in the art can implement it. When the combination of technical solutions results in contradictions or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the protection scope required by the present invention.

[0060] The present invention provides a biopsy needle.

[0061] Please refer to Figure 1 、 Figure 2 、 Figure 7 and Figures 9 to 11 , Figure 1 which is a cross-section of a partial structure of an embodiment of the biopsy needle provided by the present invention Figure 1 , Figure 2 which is a schematic diagram of the air flow path of an embodiment of the biopsy needle provided by the present invention, Figure 7 which is a schematic structure diagram of the outer knife tube of the biopsy needle provided by the present invention Figure 1 , Figure 9 which is a schematic structure diagram of the outer knife tube of the biopsy needle provided by the present invention Figure 3 , Figure 10 which is a cross-section of a partial structure of an embodiment of the biopsy sampling device provided by the present invention Figure 4 , Figure 11Cross-section of a partial structure of an embodiment of the biopsy sampling device provided by the present invention Figure 5 。

[0062] In an embodiment of the present invention, the biopsy needle includes:

[0063] An outer cutter tube 100 is provided with a first channel 101 and a second channel 102. Both the first channel 101 and the second channel 102 extend along the axial direction of the outer cutter tube 100 and are arranged side by side. A sampling window 103 communicating with the external environment is provided on the side wall of the first channel 101;

[0064] A puncture head 300 is provided at the front end of the outer cutter tube 100 and is insulated from the outer cutter tube 100. Among them, the sampling window 103 has opposite first and second ends along the axial direction of the outer cutter tube 100. The first end is close to the puncture head 300, and the second end is far from the puncture head 300. The outer cutter tube 100 is also provided with an air hole 104 communicating the first channel 101 and the second channel 102. The air hole 104 is provided between the second end and the puncture head 300;

[0065] An inner cutter tube 200 is partially inserted into the inside of the first channel 101, and the inner cutter tube 200 can reciprocate along the axial direction of the outer cutter tube 100 to cut the tissue entering the first channel 101 through the sampling window 103 and close the sampling window 103, or open the sampling window 103;

[0066] An air valve assembly 400 is provided at the rear end of the outer cutter tube 100 for controlling the communication or disconnection between the second channel 102 and the external environment;

[0067] A wire 700 is inserted into the second channel 102, is insulated from the outer cutter tube 100 and is electrically connected to the puncture head 300, and is used to connect the puncture head to an energy transmission circuit so that the energy transmitted by the energy transmission circuit can act on the target tissue at least partially through the electrode pair formed by the puncture head 300 and the outer cutter tube 100.

[0068] The biopsy needle in the technical solution of the present invention includes an outer cutter tube 100, an inner cutter tube 200, a puncture head 300, an air valve assembly 400 and a wire 700. The puncture head 300 is provided at the front end of the outer cutter tube 100 and is insulated from the outer cutter tube 100. The wire 700 is electrically connected to the puncture head 300. During the process of inserting and sampling tissue, the wire 700, the puncture head 300 and the outer cutter tube 100 are all located in the energy transmission circuit for transmitting current. The puncture head 300 and the outer cutter tube 100 form an electrode pair acting on the target tissue. When the high-frequency current flows forward, the high-frequency current is transmitted to the puncture head 300 through the wire 700, and then released from the puncture head 300 to the target tissue, and is received by the outer cutter tube 100 after passing through the target tissue; when the current flows reversely, the current is released to the target tissue through the outer cutter tube 100, and is received by the puncture head 300 after passing through the target tissue, and then transmitted to the wire 700.

[0069] For ease of understanding, by way of example, the energy transmission circuit transmits high-frequency current. During the transmission of this high-frequency current, heat concentration will occur at the puncture head 300. Through the thermal effect, the tissue cells around the puncture head 300 are dehydrated, so that the puncture head 300 has an electrocoagulation function, accelerating the blood coagulation of the tissue around the puncture head 300, thereby reducing the bleeding volume during the biopsy sampling operation and improving the safety of the biopsy sampling operation; in addition, the reduction in bleeding volume also provides a clearer surgical field of view for the user, which is conducive to the user's judgment of the lesion site and resection of the tissue, thereby shortening the time required for the operation. The outer cannula 100 is provided with a first channel 101 and a second channel 102. The inner cannula 200 is arranged inside the first channel 101. Before the puncture head 300 penetrates into the tissue, the inner cannula 200 is located on the side of the sampling window 103 away from the puncture head 300, so that the sampling window 103 is opened. After the puncture head 300 penetrates into the tissue, the inner cannula 200 gradually closes the sampling window 103 along the axis towards the puncture head 300. During the process of closing the sampling window 103, the front end of the inner cannula 200 cuts off the tissue located at the sampling window 103, so that the removed tissue enters the inside of the inner cannula 200 through the sampling window 103. The rear end of the inner cannula 200 is directly or indirectly connected to the suction assembly, and a negative pressure is created inside the inner cannula 200 to suck out the cut tissue from the inner cannula 200. The sampling window 103 has a first end close to the puncture head 300 and a second end far from the puncture head 300 along the axis of the outer cannula 100. An air hole 104 communicating the first channel 101 and the second channel 102 is also provided on the outer cannula 100. After the inner cannula 200 cuts off the tissue, the air valve assembly 400 controls the second channel 102 to communicate with the external environment, so that the air in the external environment enters the second channel 102, and then enters the front side of the inner cannula 200 through the air hole 104. Since the air hole 104 is provided between the second end of the sampling window 103 and the puncture head 300, the air can easily enter the front side of the cut tissue close to the puncture head 300, while a negative pressure will be formed on the rear side of the cut tissue away from the puncture head 300 under the action of the suction assembly, thereby increasing the air pressure difference between the front and rear sides of the cut tissue, making the cut tissue easier to be sucked out, thereby reducing the possibility of the cut tissue being blocked inside the inner cannula 200, improving the sampling efficiency of the biopsy needle, and improving the safety of the biopsy sampling operation. Among them, the second channel 102 is both used to accommodate the wire 700, so that the outer cannula 100 plays a role in protecting the wire 700, and is also used to ventilate the air hole 104, realizing two functions through the same structure, and simplifying the structure of the biopsy needle.

[0070] It is worth mentioning that the suction assembly is used to create a negative pressure inside the inner cannula 200 to suck the cut tissue, generally including a vacuum pump and related pipelines, valves, etc., and can adopt the existing technology.

[0071] In one embodiment, the biopsy needle further includes a support base 610. One end of the outer cutter tube 100 passes through the support base 610, and the other end of the outer cutter tube 100 extends outside the support base 610 and is provided with a puncture head 300. Wherein, a conductive region 106 and an insulating region 107 are provided on the outer wall of the outer cutter tube 100, and a sampling window 103 is arranged in the insulating region 107. Part or all of the conductive region 106 is used to form one electrode in the electrode pair.

[0072] Referring to Figure 11 , Figure 13 , Figure 7 and Figure 14 , in the embodiments of the present invention, the biopsy needle further includes a support base 610, and the support base 610 is used to fix and support the outer cutter tube 100. The inner cutter tube 200 moves axially and rotates in the first channel 101 of the outer cutter tube 100 to cut the tissue at the sampling window 103 to achieve the sampling function. Wherein, a conductive region 106 and an insulating region 107 are provided on the outer wall of the outer cutter tube 100. The high-frequency current returns to the conductive region 106 through the target tissue, so that the high-frequency current returns to the outer cutter tube 100. The sampling window 103 is arranged in the insulating region 107 to avoid the outer wall of the outer cutter tube 100 around the sampling window 103 from being conductive, thereby avoiding heat concentration around the sampling window 103 and affecting the sampling effect. Wherein, the outer cutter tube 100 can be made of a conductive material, and the insulating region 107 is formed by coating an insulating layer or pasting an insulating film on the outer peripheral wall, and the region without coating the insulating layer or pasting the insulating film is the conductive region 106; the outer cutter tube 100 can also be manufactured in sections with different materials and then spliced into shape, and the tube sections made of insulating materials form the insulating region 107, and the tube sections made of conductive materials form the conductive region 106.

[0073] In one embodiment, the conductive region 106 includes a first sub-region 1061 and a second sub-region 1062 that are electrically connected. The first sub-region 1061 is arranged outside the support base 610, and the second sub-region 1062 is arranged inside the support base 610. The first sub-region 1061 is used to form one electrode in the electrode pair, and the second sub-region 1062 is in the energy transmission circuit.

[0074] Referring to Figure 11 , Figure 13 and Figure 14, in an embodiment of the present invention, the conductive region 106 includes a first sub-region 1061 and a second sub-region 1062. When the puncture head 300 penetrates into the tissue, the first sub-region 1061 directly contacts the target tissue, so that the puncture head 300 and the first sub-region 1061 form an electrode pair acting on the target tissue. When the high-frequency current flows forward, the high-frequency current is transmitted to the puncture head 300 through the wire 700, then released from the puncture head 300 to the target tissue, and after passing through the target tissue, it is received by the first sub-region 1061 on the outer cutter tube 100; when the high-frequency current flows backward, the high-frequency current is released from the first sub-region 1061 on the outer cutter tube 100 to the target tissue, and after passing through the target tissue, it is received by the puncture head 300 and then transmitted to the wire 700. The first sub-region 1061 and the second sub-region 1062 are electrically connected, and the second sub-region 1062 is also located in the energy transmission circuit. In the case where the high-frequency current flows forward as described above, the high-frequency current received by the first sub-region 1061 will be transmitted to the second sub-region 1062; in the case where the high-frequency current flows backward as described above, the high-frequency current released by the first sub-region 1061 comes from the second sub-region 1062. The second sub-region 1062 is located in the support base 610, which is convenient for docking with the first electrode 810 of the biopsy needle or directly docking with the docking electrode on the drive handle 10, so as to realize the energy transfer between the biopsy needle and the drive handle 10.

[0075] In one embodiment, the biopsy needle further includes a first electrode 810. The first electrode 810 penetrates through the support base 610, one end of the first electrode 810 abuts against the second sub-region 1062, and the other end of the first electrode 810 is used for docking with the first docking electrode 11 of the drive handle 10; and / or,

[0076] The surface area of the first sub-region 1061 is larger than the surface area of the puncture head 300.

[0077] Referring to Figure 11 、 Figure 13 and Figure 14 , in an embodiment of the present invention, the biopsy needle further includes a first electrode 810. One end of the first electrode 810 abuts against the second sub-region 1062, and the other end of the first electrode 810 is docked with the first docking electrode 11 of the drive handle 10. Energy transfer is carried out between the outer cutter tube 100 and the drive handle 10 through the first electrode 810. Setting the first electrode 810 facilitates docking with the first docking electrode 11 of the drive handle 10, and the docking is convenient. Specifically in this embodiment, the first electrode 810 adopts a two-way spring contact, and both ends of the first electrode 810 can elastically expand and contract to ensure the tightness of the docking between the first electrode 810 and the outer cutter tube 100 and the first docking electrode 11.

[0078] In an embodiment of the present invention, the surface area of the first sub-region 1061 is larger than the surface area of the puncture head 300. The surface area of the first sub-region 1061 is relatively large, and the surface area of the puncture head 300 is relatively small, such that the high-frequency current in the circuit is most concentrated at the puncture head 300, and heat concentration is most likely to occur at the puncture head 300, thereby improving the electrocoagulation effect of the puncture head 300, further reducing surgical bleeding, and at the same time, heat concentration is not likely to occur on the outer wall of the outer cannula 100, avoiding scalding the surrounding tissues of the outer cannula 100 punctured into the tissue.

[0079] In one embodiment, the biopsy needle further includes a second electrode 820. The second electrode 820 is disposed through the support base 610. One end of the second electrode 820 is used to dock with the second docking electrode 12 of the driving handle 10, and the wire 700 connects the other end of the second electrode 820 and the puncture head 300; and / or,

[0080] An insulating layer is provided outside the outer cannula 100. The insulating layer wraps the outer wall of the outer cannula 100 to form an insulating region 107.

[0081] Referring to Figures 11 to 12 , in an embodiment of the present invention, the biopsy needle further includes a second electrode 820. The second electrode 820 docks with the second docking electrode 12 on the driving handle 10. The wire 700 connects the second electrode 820 and the puncture head 300, and energy transfer is performed between the wire 700 and the driving handle 10 through the second electrode 820. Since the biopsy needle is generally for single use and the driving handle 10 can be reused, the biopsy needle and the driving handle 10 are generally detachably connected. The provision of the second electrode 820 facilitates docking with the second docking electrode 12 of the driving handle 10, reducing disassembly and assembly operations, and the structures of the second electrode 820 and the wire 700 are relatively simple, facilitating inspection, replacement, and maintenance. Specifically in this embodiment, the second electrode 820 adopts a one-way spring contact, and the end docking with the second docking electrode 12 can be elastically telescoped to ensure the tightness of the docking between the second electrode 820 and the second docking electrode 12.

[0082] In an embodiment of the present invention, the outer cannula 100 is integrally made of a conductive material, and an insulating layer formed of an insulating material is coated on the outer wall of the outer cannula 100. The region provided with the insulating layer is the insulating region 107. The structure is simple and easy to manufacture, which is beneficial to reducing production costs. Among them, the insulating layer can be a coating formed by spraying or a film-like material pasted on, and the insulating material can be polyimide, polytetrafluoroethylene, etc.

[0083] In one embodiment, the inner diameter of the first channel 101 is larger than the inner diameter of the second channel 102.

[0084] Referring to Figures 7 to 8, in an embodiment of the present invention, the inner diameter of the first channel 101 is larger than that of the second channel 102, which facilitates the setting of the inner cutter tube 200 for tissue rotary cutting in the first channel 101 with a larger inner diameter. The second channel 102 only needs to accommodate the wire 700 and ventilate the air holes 104. Therefore, the inner diameter of the second channel 102 is set smaller, which is beneficial to reducing the outer diameter of the entire outer cutter tube 100, thereby reducing the size of the wound caused to the tissue and improving the safety of the operation.

[0085] In one embodiment, the biopsy needle further includes an insulating structure 900. The insulating structure 900 is provided at the end of the second end of the outer cutter tube 100. The puncture head 300 is fixed to the side of the insulating structure 900 away from the outer cutter tube 100. The wire 700 penetrates through the insulating structure 900, and one end of the wire 700 is connected to the puncture head 300; or,

[0086] The puncture head 300 includes an integrally formed conductive needle tip and an insulating part. The insulating part is connected to the end of the second end of the outer cutter tube 100. The conductive needle tip is provided on the side of the insulating part away from the outer cutter tube 100. The wire 700 penetrates through the insulating part, and one end of the wire 700 is connected to the insulating part.

[0087] Refer to Figure 12 , in an embodiment of the present invention, an insulating structure 900 is further provided between the outer cutter tube 100 and the puncture head 300. By providing the insulating structure 900 to separate the puncture head 300 and the outer cutter tube 100, it is ensured that current cannot be directly transmitted between the puncture head 300 and the outer cutter tube 100, and it is ensured that the current flows along a predetermined path, thereby improving the electrocoagulation effect of the puncture head 300. In another embodiment, the puncture head 300 includes an integrally formed conductive needle tip and an insulating part. The wire 700 connects the second electrode 820 and the conductive needle tip, and the insulating part separates the conductive needle tip and the outer cutter tube 100, ensuring that current cannot be directly transmitted between the conductive needle tip and the outer cutter tube 100, and ensuring that the current flows along a predetermined path, thereby improving the electrocoagulation effect of the puncture head 300.

[0088] In one embodiment, there are multiple air holes 104, and the multiple air holes 104 are arranged at intervals along the axial direction of the outer cutter tube 100; and / or,

[0089] There is at least one air hole 104 between the first end of the sampling window 103 and the puncture head 300; and / or,

[0090] The air hole 104 and the sampling window 103 are arranged on opposite sides of the inner cutter tube 200.

[0091] Refer to Figure 1, in an embodiment of the present invention, a plurality of air holes 104 are provided along the axial direction of the outer cutter tube 100. By introducing air into the front side of the cut tissue through the plurality of air holes 104, the possibility of biopsy needle blockage is further reduced, and the sampling efficiency is improved. Specifically, the plurality of air holes 104 are arranged at equal intervals along the axial direction of the outer cutter tube 100, with uniform air intake, which is convenient for processing. Among them, the plurality of air holes 104 can have the same diameter or different diameters. For example, the diameters of the plurality of air holes 104 can gradually increase in the direction close to the puncture head 300, so as to ensure that as much air as possible enters the front side of the cut tissue.

[0092] Refer to Figure 1 , in an embodiment of the present invention, at least one air hole 104 is provided between the first end of the sampling window 103 and the puncture head 300, that is, at least one air hole 104 is provided between the sampling window 103 and the puncture head 300, ensuring that air can enter the front side of the cut tissue, thereby ensuring the formation of a pressure difference on the front and back sides of the cut tissue, further reducing the possibility of biopsy needle blockage, and improving the sampling efficiency.

[0093] In an embodiment of the present invention, the air hole 104 and the sampling window 103 are arranged on opposite sides of the inner cutter tube 200, so that the distance between the air hole 104 and the sampling window 103 is relatively far, reducing the influence of the air hole 104 and the sampling window 103 on the strength of the outer cutter tube 100, reducing the possibility of damage or deformation of the outer cutter tube 100, and thus extending the service life of the biopsy needle.

[0094] In one embodiment, the outer cutter tube 100 includes:

[0095] a tubular portion 110, provided with a first channel 101, a sampling window 103, and air holes 104; and

[0096] a semi-tube portion 120, connected to the outer wall of the tubular portion 110, and the outer wall of the tubular portion 110 and the semi-tube portion 120 jointly enclose a second channel 102.

[0097] Refer to Figure 8 , in an embodiment of the present invention, the outer cutter tube 100 includes a tubular portion 110 and a semi-tube portion 120. The tubular portion 110 is internally hollow to form a first channel 101, and the semi-tube portion 120 is buckled on the outer wall of the tubular portion 110, so that the outer wall of the tubular portion 110 and the semi-tube portion 120 enclose a second channel 102, making the outer cutter tube 100 with a double-channel structure easy to process, reducing the manufacturing difficulty and cost; in addition, the outer walls of the tubular portion 110 and the semi-tube portion 120 are relatively smooth, avoiding accidental injuries after penetrating into the tissue, and improving the safety of the operation. Among them, the cross-section of the semi-tube portion 120 is an incomplete circle, such as three-quarters circle, four-fifths circle, etc., not specifically referring to a semi-circular cross-section.

[0098] In one embodiment, the biopsy needle also includes a support assembly 600, the rear end of the outer knife tube 100 is inserted into the support assembly 600, a ventilation cavity 601 is provided in the support assembly 600, the second channel 102 is connected to the ventilation cavity 601, the air valve assembly 400 controls the ventilation cavity 601 to be connected to the external environment so that the second channel 102 is connected to the external environment, and the air valve assembly 400 controls the ventilation cavity 601 to be disconnected from the external environment so that the second channel 102 is disconnected from the external environment.

[0099] Reference Figures 3 to 6 In an embodiment of the present invention, the biopsy needle also includes a support assembly 600. The support assembly 600 has a ventilation cavity 601. The ventilation cavity 601 is connected to the second channel 102. The second channel 102 is connected to the external environment by controlling the ventilation cavity 601 to open, and the second channel 102 is disconnected from the external environment by controlling the ventilation cavity 601 to close. The structure is simple and it is easy to connect and disconnect the second channel 102 with the external environment. Specifically in this embodiment, the support assembly 600 includes a support seat 610 and a support sleeve 620. The rear end of the outer knife tube 100 is inserted into the support seat 610. The support sleeve 620 is sleeved on the outside of the inner knife tube 200 at intervals. The air valve assembly 400 includes a pressing sleeve 420, an elastic member 430, a sealing ring 440, and a sealing protrusion 410 protruding from the outer wall of the support sleeve 620. The ventilation cavity 601 is formed between the inner wall of the support sleeve 620 and the outer wall of the inner knife tube 200. The pressing sleeve 420 can be axially movably sleeved on the support sleeve 6 20 and there is a gap with the outer wall of the support sleeve 620, the sealing ring 440 is arranged between the pressing sleeve 420 and the support sleeve 620 and moves with the pressing sleeve 420, the elastic member 430 drives the connecting pressing sleeve 420, when the elastic member 430 is in a natural state, the sealing ring 440 abuts against the sealing protrusion 410, so that the ventilation cavity 601 is separated from the external environment, when the elastic member 430 is deformed by force, the pressing sleeve 420 drives the sealing ring 440 to be staggered with the sealing protrusion 410, so that the ventilation cavity 601 is connected with the external environment.

[0100] In one embodiment, the inner wall of the first channel 101 and the inner knife tube 200 have a gap to form an air intake gap 105, and the air intake gap 105 is connected to the ventilation cavity 601, so that the air valve assembly 400 controls the air intake gap 105 and the second channel 102 to be synchronously connected or disconnected with the external environment.

[0101] Reference Figures 2 to 6, in an embodiment of the present invention, there is a gap between the inner wall of the first channel 101 and the outer wall of the inner cutter tube 200 to form an air intake gap 105. The air in the air intake gap 105 can enter the interior of the inner cutter tube 200 from the front end of the inner cutter tube 200, thereby increasing the air pressure difference between the front and back sides of the cut tissue and further reducing the possibility of biopsy needle blockage. Both the air intake gap 105 and the second channel 102 are communicated with the ventilation cavity 601. When the ventilation cavity 601 is communicated with the external environment, the air intake gap 105 and the second channel 102 are simultaneously communicated with the external environment; when the ventilation cavity 601 is disconnected from the external environment, the air intake gap 105 and the second channel 102 are simultaneously disconnected from the external environment. The on-off of the two air paths of the air intake gap 105 and the second channel 102 is realized through an air valve assembly 400, which simplifies the components of the biopsy needle and also reduces the operation steps of the user.

[0102] In one embodiment, the biopsy needle further includes a transmission seat 500, and the transmission seat 500 is sleeved outside the inner cutter tube 200 and axially moves synchronously with the inner cutter tube 200;

[0103] Wherein, the inner cutter tube 200 closes the sampling window 103, drives the transmission seat 500 to drive the air valve assembly 400, so that the air valve assembly 400 controls the communication between the ventilation cavity 601 and the external environment;

[0104] The inner cutter tube 200 opens the sampling window 103, drives the transmission seat 500 away from the air valve assembly 400, so that the air valve assembly 400 controls the disconnection between the ventilation cavity 601 and the external environment.

[0105] Refer to Figures 2 to 6 , in an embodiment of the present invention, the biopsy needle further includes a transmission seat 500 sleeved outside the inner cutter tube 200. The transmission seat 500 axially moves synchronously with the inner cutter tube 200, so that when the user controls the inner cutter tube 200 to cut the sampled tissue, the on-off of the air valve assembly 400 is controlled through the transmission seat 500, which simplifies the structure of the biopsy needle and reduces the operation steps of the user. Specifically, when the inner cutter tube 200 opens the sampling window 103, that is, when the inner cutter tube 200 does not rotate forward to cut the tissue, as Figure 5 and Figure 6 shown, the transmission seat 500 is away from the air valve assembly 400, the elastic member 430 of the air valve assembly 400 is in a natural state or a slightly deformed state, and the sealing ring 440 in the pressing sleeve 420 abuts against the sealing protrusion 410 on the support sleeve 620, so that the ventilation cavity 601 is separated from the external environment, thereby preventing the air in the external environment from entering the ventilation cavity 601; when the inner cutter tube 200 moves in the direction of closing the sampling window 103, that is, when the inner cutter tube 200 rotates forward to cut the tissue, as Figure 3 and Figure 4As shown, the inner cutter tube 200 drives the transmission seat 500 to approach the air valve assembly 400 until the inner cutter tube 200 cuts off the tissue to seal the sampling window 103. The transmission seat 500 contacts the pressing sleeve 420 of the air valve assembly 400, driving the pressing sleeve 420 to compress the elastic member 430. The sealing ring 440 in the pressing sleeve 420 is offset from the sealing protrusion 410 on the support sleeve 620, so that the ventilation cavity 601 is communicated with the external environment. Thus, air passes through the ventilation cavity 601 from the external environment. A part of the air enters the second channel 102 and then enters the front side of the cut-off tissue through the air holes 104, and another part of the air enters the intake gap 105 and then enters the front side of the cut-off tissue through the front end of the inner cutter tube 200, increasing the air pressure difference between the front and back sides of the cut-off tissue, thereby reducing the possibility of biopsy needle blockage.

[0106] See Figure 13 , the first electrode 810 and the second electrode 820 are both hermetically connected to the support seat 610 and are arranged on the same side of the outer periphery of the inner cutter tube 200. A notch is provided at the rear end of the outer cutter tube 100, and the first electrode 810 and the second electrode 820 are both arranged at the notch. That is, in the axial direction, the first electrode 810 and the second electrode 820 are arranged at the connection position of the support sleeve 620 and the outer cutter tube. This way of concentrating the first electrode 810 and the second electrode 820 on the support seat 610, a single part, is convenient for processing, helps reduce the processing cost, and the air valve assembly 400 will not be adversely affected by the setting of the electrodes on its own sealing, with high reliability.

[0107] Refer to Figure 15 , the present invention also proposes a biopsy sampling device, including:

[0108] The above-mentioned biopsy needle;

[0109] A driving handle 10, drivingly connected to the biopsy needle. The driving handle 10 has a second docking electrode 12 electrically connected to the wire 700 and a first docking electrode 11 electrically connected to the outer cutter tube 100; and

[0110] A high-frequency generator, used to generate high-frequency current, electrically connected to the first docking electrode 11 and the second docking electrode 12 respectively.

[0111] The specific structure of the biopsy needle refers to the above-mentioned embodiments. Since this biopsy sampling device adopts all the technical solutions of the above-mentioned embodiments, it has at least all the beneficial effects brought by the technical solutions of the above-mentioned embodiments, which will not be elaborated one by one here. Among them, the complete energy transmission loop includes a high-frequency generator, a first docking electrode 11 and a second docking electrode 12 on the driving handle 10, a first electrode 810, an outer cutter tube 100, a puncture head 300, a wire 700, a second electrode 820 on the biopsy needle, and the target tissue. Taking the forward flow of the high-frequency current as an example, during sampling, the high-frequency current generated by the high-frequency generator is transmitted to the second docking electrode 12 of the driving handle 10, then transmitted from the second docking electrode 12 to the second electrode 820 of the biopsy needle, and then transmitted through the wire 700 to the puncture head 300. The puncture head 300 releases the high-frequency current to the surrounding tissue to achieve the electrocoagulation function and reduce surgical bleeding. Then the high-frequency current passes through the tissue and returns to the first sub-region 1061 on the outer cutter tube 100, and then is transmitted through the tube body of the outer cutter tube 100 to the second sub-region 1062, and then is transmitted through the first electrode 810 to the first docking electrode 11 of the driving handle 10, and finally is transmitted back to the high-frequency generator by the first docking electrode 11 to form a complete current loop.

[0112] The above description is only an exemplary embodiment of the present invention, and does not limit the patent scope of the present invention. Any equivalent structural transformation made under the technical concept of the present invention by using the content of the specification and drawings of the present invention, or directly / indirectly applied in other related technical fields, is included in the patent protection scope of the present invention.

Claims

1. A biopsy needle, characterized in that, include: The outer knife tube is provided with a first channel and a second channel, the first channel and the second channel both extend along the axial direction of the outer knife tube and are arranged side by side, and the side wall of the first channel is provided with a sampling window communicating with the external environment; A puncture head is arranged at the front end of the outer knife tube and is insulated from the outer knife tube; wherein the sampling window has a first end and a second end opposite to each other along the axial direction of the outer knife tube, the first end is close to the puncture head, and the second end is far away from the puncture head, and the outer knife tube is further provided with an air hole connecting the first channel and the second channel, and the air hole is arranged between the second end and the puncture head; An inner knife tube, wherein the inner knife tube is partially disposed inside the first channel, and the inner knife tube can reciprocate along the axial direction of the outer knife tube to cut the tissue entering the first channel through the sampling window and close the sampling window, or open the sampling window; An air valve assembly, disposed at the rear end of the outer knife tube, for controlling whether the second channel is connected to or disconnected from the external environment; A wire is inserted into the second channel, insulated from the outer blade tube and electrically connected to the puncture head, and is used to connect the puncture head to an energy transmission circuit so that the energy transmitted by the energy transmission circuit can at least partially act on the target tissue through the electrode pair formed by the puncture head and the outer blade tube.

2. The biopsy needle according to claim 1, wherein The biopsy needle also includes a support seat, one end of the outer knife tube is inserted into the support seat, and the other end of the outer knife tube extends to the outside of the support seat and is provided with the puncture head, wherein the outer wall of the outer knife tube is provided with a conductive area and an insulating area, the sampling window is provided in the insulating area, and part or all of the conductive area is used to constitute an electrode in the electrode pair.

3. The biopsy needle according to claim 2, characterized in that, The conductive area includes a first sub-area and a second sub-area that are electrically connected, the first sub-area is arranged outside the support base, the second sub-area is arranged inside the support base, the first sub-area is used to constitute an electrode in the electrode pair, and the second sub-area is in the energy transmission circuit.

4. The biopsy needle according to claim 3, wherein The biopsy needle further includes a first electrode, which is inserted into the support seat, one end of the first electrode abuts against the second sub-region, and the other end of the first electrode is used for docking with a first docking electrode of a driving handle; and / or, The surface area of ​​the first sub-region is greater than the surface area of ​​the puncture head.

5. The biopsy needle according to claim 2, characterized in that, The biopsy needle further comprises a second electrode, the second electrode is inserted into the support seat, one end of the second electrode is used for docking with the second docking electrode of the driving handle, and the other end of the wire connects the second electrode and the puncture head; and / or, An insulating layer is arranged outside the outer knife tube, and the insulating layer is wrapped around the outer wall of the outer knife tube to form the insulating area.

6. The biopsy needle according to claim 1, wherein, The inner diameter of the first channel is greater than the inner diameter of the second channel.

7. The biopsy needle according to any one of claims 1 to 6, characterized in that, The biopsy needle further comprises an insulating structure, the insulating structure is arranged at the end of the second end of the outer blade tube, the puncture head is fixed to a side of the insulating structure away from the outer blade tube, the wire passes through the insulating structure, and one end of the wire is connected to the puncture head; or, The puncture head includes an integrally formed conductive needle tip and an insulating portion, the insulating portion is connected to the end of the second end of the outer blade tube, the conductive needle tip is arranged on a side of the insulating portion away from the outer blade tube, the wire passes through the insulating portion, and one end of the wire is connected to the insulating portion.

8. The biopsy needle according to claim 1, wherein The biopsy needle also includes a support assembly, the rear end of the outer knife tube is inserted into the support assembly, a ventilation cavity is provided in the support assembly, the second channel is connected to the ventilation cavity, the air valve assembly controls the ventilation cavity to be connected to the external environment so that the second channel is connected to the external environment, and the air valve assembly controls the ventilation cavity to be disconnected from the external environment so that the second channel is disconnected from the external environment.

9. The biopsy needle according to claim 8, wherein The inner wall of the first channel and the inner knife tube have a gap to form an air intake gap, and the air intake gap is connected to the ventilation cavity, so that the air valve assembly controls the air intake gap and the second channel to be connected or disconnected with the external environment synchronously.

10. A biopsy sampling device, characterized in that, include: A biopsy needle as claimed in any one of claims 1 to 9; A driving handle, drivingly connected to the biopsy needle, wherein the driving handle has a second docking electrode electrically connected to the guide wire and a first docking electrode electrically connected to the outer knife tube; as well as The high-frequency generator is used to generate high-frequency current and is electrically connected to the first butt-jointed electrode and the second butt-jointed electrode respectively.

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