Adjustable Curved Biopsy Needle and Biopsy System

Abstract

The present invention provides an adjustable bending biopsy needle and a biopsy system. The adjustable bending biopsy needle includes a sheath, a needle body and a traction member. The distal end of the sheath has an adjustable bending section, and the distal end of the traction member is connected to the adjustable bending section. The traction member moves axially along the sheath to drive the adjustable bending section to bend. The needle body is movably inserted into the sheath, and the distal end of the needle body is a hollow structure. By adjusting the adjustable bending section at the distal end of the sheath, the distal end of the sheath can be bent to different degrees, so that the distal end of the sheath can smoothly enter some small and curved human body cavities, and then the distal end of the needle body can enter these small and curved human body cavities along the distal end of the sheath to obtain biopsy tissue. Moreover, a bending orientation structure is provided on the bending following section at the distal end of the needle body so that the bending following section conforms to the adjustable bending section and bends in the same direction. The side where the tip is located and the side where the adjustable bending section is driven by the traction member to bend are on the same side relative to the axis of the needle body, which can prevent the tip from piercing the inner wall of the sheath.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an adjustable bending biopsy needle and a biopsy system. Background Art

[0002] Endoscopes such as bronchoscopes, gastroscopes, and colonoscopes can directly observe lesions in organs such as the lungs and gastrointestinal tract. Endoscopic examination is a commonly used clinical examination method. During the endoscopic examination, doctors often use a biopsy needle, which is short for a biopsy needle, to perform a biopsy: the biopsy needle reaches the patient's body through the working channel of the endoscope, and then a certain amount of diseased tissue is taken from the patient's body through puncture, aspiration, etc. of the biopsy needle for pathological examination, so as to make a clear histopathological diagnosis. This examination method is the most convenient and efficient way to obtain a pathological diagnosis of internal lesions in the human body. Therefore, biopsy needles are widely used in clinical endoscopic examinations.

[0003] Since imaging devices such as ultrasonic detectors or optical cameras are generally installed at the distal end of the endoscope, for some small human body cavities (such as some small bronchi in the lungs), the endoscope cannot enter, and the distal end of the existing biopsy needle usually does not have an adjustable bending function. After the distal end of the biopsy needle extends out of the working channel of the endoscope, it cannot enter the small and curved cavity for biopsy sampling. Summary of the Invention

[0004] The present invention provides an adjustable bending biopsy needle and a biopsy system including the adjustable bending biopsy needle, and the adjustable bending biopsy needle can smoothly enter a small and curved cavity for biopsy sampling.

[0005] The adjustable bending biopsy needle includes a sheath tube, a needle body, and a traction member. The distal end of the sheath tube has an adjustable bending section, the distal end of the traction member is connected to the adjustable bending section, and the traction member moves axially along the sheath tube to drive the adjustable bending section to bend; the needle body is movably inserted into the sheath tube so that the distal end of the needle body extends out of or retracts into the distal end of the sheath tube, and the distal end of the needle body is a hollow structure.

[0006] Wherein, the distal end of the needle body includes a needle tip and a bending following section provided on the proximal side of the needle tip; when the distal end of the needle body retracts into the distal end of the sheath tube, the bending following section of the needle body is correspondingly located in the adjustable bending section of the sheath tube; a bending orientation structure is provided on the bending following section so that the bending following section bends in the same direction as the adjustable bending section, and the side where the needle tip is located and the side where the adjustable bending section is driven by the traction member to bend are on the same side relative to the axis of the needle body.

[0007] Wherein, the bending orientation structure of the needle body includes a plurality of notches arranged at intervals along the axial direction of the needle body, and the opening of the notch faces the side where the needle tip is located.

[0008] Wherein, the cross-sectional shape of the notch along the axial direction is "U" shaped or "V" shaped.

[0009] Wherein, the needle body further includes a flexible reinforcement section provided on the proximal side of the bending-following section, and at least one flexible reinforcement structure is provided on the flexible reinforcement section to allow the flexible reinforcement section to bend in multiple directions.

[0010] Wherein, the flexible reinforcement structure includes a first notch and a second notch which are arranged alternately along the axial direction of the needle body, the opening direction of the first notch faces the side where the needle tip is located, and the opening direction of the second notch faces away from the side where the needle tip is located.

[0011] Wherein, the flexible reinforcement structure is a slit spiraling along the needle body.

[0012] Wherein, the flexible reinforcement structure includes a plurality of nearly annular gaps arranged at intervals along the axial direction of the needle body and engaging structures arranged at intervals in the circumferential direction of the nearly annular gaps.

[0013] Wherein, both the bending-following section and the flexible reinforcement section are coated with a flexible film.

[0014] Wherein, the traction member is embedded in the tube wall of the sheath tube.

[0015] Wherein, the sheath tube includes an inner tube, a reinforcing tube sleeved on the inner tube, and an outer tube sleeved on the reinforcing tube, and the traction member is located between the inner tube and the reinforcing tube.

[0016] Wherein, the inner tube is a flexible tube, the hardness of the outer tube is greater than that of the inner tube, and the hardness of the outer tube corresponding to the adjustable bending section is less than that of other parts of the outer tube.

[0017] Wherein, the adjustable bending biopsy needle further includes a sheath tube seat, the sheath tube seat includes a guide rod, a sliding member sliding axially along the guide rod, and a driving member for driving the sliding member to slide, the guide rod is fixed to the proximal end of the sheath tube, and the sliding member is connected to the proximal end of the traction member; the driving member drives the sliding member to slide relative to the guide rod to drive the traction member to drive the adjustable bending section to bend.

[0018] Wherein, the traction member includes a traction wire, the traction wire extends along the axial direction of the sheath tube, the distal end of the traction wire is connected to the adjustable bending section, the proximal end is connected to the sliding member of the sheath tube seat, and one side of the traction wire located on the sheath tube and the side where the needle tip is located are on the same side relative to the axis of the needle body, so that the side where the adjustable bending section is driven by the traction member to bend is the same as the side where the needle tip is located.

[0019] Wherein, the traction member further includes an anchoring ring, and the anchoring ring is fixed to the distal end of the traction wire and sleeved on the adjustable bending section, so that the traction wire is connected to the adjustable bending section.

[0020] Wherein, the sliding member is a slider, the slider is sleeved outside the guide rod, the guide rod is provided with guiding convex ribs, and the slider is provided with grooves adapted to the guiding convex ribs, and the guiding convex ribs are snapped into the grooves to slidably connect the slider to the guide rod.

[0021] Wherein, a fitting block is detachably connected to the sliding member, and the distal end of the traction member is fixed to the fitting block.

[0022] Wherein, the driving member is a rotating cylinder, the rotating cylinder is sleeved outside the guide rod and the sliding member and is rotatably connected to the guide rod, the inner surface of the rotating cylinder is provided with internal threads, the outer surface of the sliding member is provided with external threads adapted to the internal threads, and the rotating cylinder rotates to drive the sliding member to slide relative to the guide rod.

[0023] Wherein, a limiting convex rib is annularly arranged at the proximal end of the guide rod, and a clamping ring is detachably fixed on the guide rod, the clamping ring is arranged at an interval from the limiting convex rib, and the proximal end of the rotating cylinder is clamped between the limiting convex rib and the clamping ring.

[0024] Wherein, the adjustable bending biopsy needle further includes a handle, the handle includes a proximal handle and a distal handle, the distal handle is connected to the guide rod, the proximal handle includes a movable rod axially movably inserted into the distal handle, the proximal end of the needle body passes through the sheath tube and is fixed to the distal end of the movable rod, and the proximal handle moves relative to the distal handle, so that the movable rod drives the needle body to move in the sheath tube.

[0025] Wherein, the handle further includes a connecting belt, several clamping grooves are arranged at intervals on the movable rod, the proximal end of the connecting belt is clamped in any one of the clamping grooves, and the distal end is detachably connected to the distal handle.

[0026] Wherein, a first anti-rotation structure is arranged on the proximal handle, a second anti-rotation structure is arranged on the distal handle and is matched with the first anti-rotation structure, and the first anti-rotation structure and the second anti-rotation structure cooperate to limit the relative rotation of the proximal handle with respect to the distal handle.

[0027] Wherein, the adjustable bending biopsy needle further includes a liner core, the liner core includes a core body and a connecting member connected to the proximal end of the core body, the core body is movably inserted into the needle body, and the connecting member is detachably connected to the proximal handle.

[0028] The biopsy system includes an endoscope and the adjustable bending biopsy needle. The endoscope includes a working channel, and the sheath and the needle body of the adjustable bending biopsy needle are movably inserted into the working channel.

[0029] For the adjustable bending biopsy needle and the biopsy system provided by the present invention, an adjustable bending section is arranged at the distal end of the sheath, a traction member is arranged to drive the adjustable bending section to bend, the needle body is movably sleeved in the sheath, and by adjusting the adjustable bending section at the distal end of the sheath, the distal end of the sheath can be bent to different degrees, so that the distal end of the sheath can smoothly enter some small and curved human body cavities, and further the distal end of the needle body can enter these small and curved human body cavities along the distal end of the sheath to obtain biopsy tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] To more clearly illustrate the structural features and functions of the present invention, the following will be described in detail with reference to the drawings and specific embodiments.

[0031] Figure 1 is a three-dimensional structural schematic diagram of an adjustable bending biopsy needle according to an embodiment of the present invention;

[0032] Figure 2 is Figure 1 a schematic cross-sectional view of the adjustable bending biopsy needle shown along the axial direction;

[0033] Figure 3 is a three-dimensional structural schematic diagram of the needle body of an adjustable bending biopsy needle according to an embodiment of the present invention;

[0034] Figure 4 is a front view schematic diagram of the needle body of an adjustable bending biopsy needle according to another embodiment of the present invention;

[0035] Figure 5 is Figure 3 or Figure 4 a schematic diagram showing the distal end of the needle body of the adjustable bending biopsy needle following the bending of the sheath;

[0036] Figure 6 is a front view schematic diagram of the needle body of an adjustable bending biopsy needle according to another embodiment of the present invention;

[0037] Figure 7 is a front view schematic diagram of the needle body of an adjustable bending biopsy needle according to another embodiment of the present invention;

[0038] Figure 8 is Figure 7 an enlarged schematic diagram of the fitting structure on the needle body of the adjustable bending biopsy needle shown;

[0039] Figure 9a is a three-dimensional structural schematic diagram of a partial section of the flexible strengthening section on the needle body of an adjustable bending biopsy needle according to an embodiment of the present invention;

[0040] Figure 9b Schematic plan view of a partial section of a flexible reinforcement section on the needle body of an adjustable bending biopsy needle according to an embodiment of the present invention;

[0041] Figure 10 Enlarged schematic view of the engaging structure on the flexible reinforcement section shown in FIG. 9;

[0042] Figure 11 Schematic structural view of the sheath tube and the traction member of an adjustable bending biopsy needle according to an embodiment of the present invention;

[0043] Figure 12 Schematic connection view of the guide rod and the sliding member of an adjustable bending biopsy needle according to an embodiment of the present invention;

[0044] Figure 13 Is Figure 12 Schematic perspective view of the sliding member shown;

[0045] Figure 14 Schematic cross-sectional view of the sheath tube seat of an adjustable bending biopsy needle along the axial direction according to an embodiment of the present invention;

[0046] Figure 15 Schematic perspective view of the handle of an adjustable bending biopsy needle according to an embodiment of the present invention;

[0047] Figure 16 Is Figure 15 Exploded view of the handle shown;

[0048] Figure 17 Schematic structural view of the liner core of an adjustable bending biopsy needle according to an embodiment of the present invention;

[0049] Figure 18 Schematic view of the usage state of an adjustable bending biopsy system according to an embodiment of the present invention. Detailed implementation manners

[0050] 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. Among them, the accompanying drawings are only for illustrative purposes and represent only schematic diagrams and should not be construed as limiting the present invention.

[0051] In order to more clearly describe the structures of the adjustable bending biopsy needle and the biopsy system, the terms "proximal end" and "distal end" are defined herein as the commonly used terms in the field of interventional medicine. Specifically, the "distal end" represents the end far from the operator during the surgical operation, and the "proximal end" represents the end close to the operator during the surgical operation.

[0052] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the art. The terms used in the description of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention.

[0053] Please refer to Figure 1 and Figure 2 , the present invention provides an adjustable bending biopsy needle 100, and the adjustable bending biopsy needle 100 includes a sheath 10, a needle body 20 and a traction member 40. The distal end of the sheath 10 has an adjustable bending section 11, the distal end of the traction member 40 is connected to the adjustable bending section 11, and the traction member 40 moves axially along the sheath 10 to drive the adjustable bending section 11 to bend. The sheath 10 is a hollow tubular shape, the needle body 20 is movably inserted into the sheath 10 so that the distal end of the needle body 20 extends out of or retracts into the distal end of the sheath 10, and the distal end of the needle body 20 is a hollow structure, so that the distal end of the needle body 20 is more likely to be deformed and is convenient for biopsy operations. By adjusting the adjustable bending section 11 of the sheath 10 through the traction member 40, different degrees of bending can occur at the distal end of the sheath 10, so as to form different bending shapes according to the shapes of some small and curved human body cavities that the adjustable bending biopsy needle 100 needs to enter and perform biopsies on, so that the distal end of the sheath 10 can smoothly enter these small and curved human body cavities, and further enable the distal end of the needle body 20 to enter these small and curved human body cavities along the distal end of the sheath 10 to obtain biopsy tissues.

[0054] Furthermore, the adjustable bending biopsy needle 100 further includes a sheath base 30 and a handle 50. The sheath base 30 includes a guide rod 31, a sliding member 32 that moves axially along the guide rod 31, and a driving member 33 that drives the sliding member 32 to slide. The guide rod 31 is a hollow tubular shape, the proximal end of the sheath 10 is inserted into the guide rod 31 and fixedly connected to the guide rod 31. The hardness of the sheath 10 at the adjustable bending section 11 is smaller than that at other positions, so that the adjustable bending section 11 is easy to bend. Both ends of the traction member 40 are respectively connected to the adjustable bending section 11 and the sliding member 32, and the driving member 33 controls the sliding member 32 to slide axially relative to the guide rod 31 to drive the traction member 40 to drive the adjustable bending section 11 to bend. The proximal end of the needle body 20 movably installed in the sheath 10 is connected to the handle 50, and the handle 50 drives the needle body 20 to move in the sheath 10 along the extending direction of the sheath 10.

[0055] The adjustable bending biopsy needle 100 of the present invention can be used in combination with an endoscope. Specifically, taking a lung biopsy as an example, first, the endoscope is passed through the main bronchus into the part of the lung that needs to be biopsied, and then the sheath 10 and the needle body 20 of the adjustable bending biopsy needle 100 are sent into the lung along the working channel of the endoscope; when the position to be biopsied is in some small and curved bronchi, the endoscope cannot reach this position. At this time, the sheath 10 can be extended out of the working channel of the endoscope, and the bending degree of the adjustable bending section 11 at the distal end of the sheath 10 can be adjusted through the traction member 40 so that the distal end of the sheath 10 can conveniently enter the curved and small bronchi, and then the distal end of the needle body 20 is advanced along the distal end of the sheath 10 into the curved and small bronchi to reach the position to be biopsied, thereby enabling the biopsy operation to proceed smoothly.

[0056] Combined with Figure 2 With Figures 3 to 10 , the needle body 20 has a needle tip 21, and the tissue is punctured through the needle tip 21 to obtain biopsy tissue. In this embodiment, the needle tip 21 is formed by truncating the distal end of the needle body 20 with a plane intersecting the axis of the needle body 20, thereby forming a tip at the distal end of the needle body 20. It should be noted that the side where the needle tip 21 of the needle body 20 is located and the side where the adjustable bending section 11 is driven by the traction member 40 to bend are on the same side relative to the axis of the needle body 20. And, a bending following section S1 is provided on the proximal side of the needle tip 21 of the needle body 20. When the distal end of the needle body 20 is received into the distal end of the sheath 10, the bending following section S1 of the needle body 20 is correspondingly located within the adjustable bending section 11 of the sheath 10; a bending orientation structure is provided on the bending following section S1 to enable the bending following section S1 to bend in the same direction as the adjustable bending section 11, that is, to enable the bending following section S1 to bend towards the side where the needle tip 21 of the needle body 20 is located. Since the side where the needle tip 21 is located and the side where the adjustable bending section 11 of the sheath 10 is driven by the traction member 40 to bend are on the same side, and the bending following section S1 bends towards the side where the needle tip 21 is located, the bending direction of the bending following section S1 of the needle body 20 is the same as the bending direction of the adjustable bending section 11 of the sheath 10, which can avoid the risk of the needle tip 21 piercing the inner wall of the sheath 10 caused by the different bending directions of the distal end of the needle body 20 and the adjustable bending section 11 of the sheath 10. Specifically, in an embodiment of the present invention, the needle body 20 is made of a stainless steel tube material, and the bending orientation structure can be formed by laser, chemical etching, water jet or other suitable processes to cut the distal end of the needle body 20.

[0057] Please refer to Figures 3 to 5, in an embodiment of the present invention, the bending orientation structure of the upward bending following section S1 of the needle body 20 includes a plurality of notches 222 arranged at intervals along the axial direction of the needle body 20, and the openings of the notches 222 face the side where the needle tip 21 is located. Specifically, the bending following section S1 of the needle body 20 includes a first part 22a and a second part 22b connected to the first part 22a. The first part 22a and the second part 22b are obtained by cutting the bending following section S1 with a plurality of planes parallel to the axis of the bending following section S1 in a direction perpendicular to the axis of the bending following section S1. Among them, the axis of the bending following section S1 refers to the line connecting the center points of the cross-sections at each position of the bending following section S1, which is a virtual line, and the plane parallel to the axis is also a virtual plane. The first part 22a includes a plurality of first sections 221 arranged at intervals along the axial direction of the needle body 20, and the gap between two adjacent first sections 221 is the notch 222.

[0058] In this embodiment, the notch 222 is provided on the first part 22a, and the second part 22b is composed of the solid side wall of the distal end of the needle body 20 on the opposite side of the notch 222. Then, as Figure 5 shown, the ability of the first part 22a with notches to resist deformation is relatively weaker than that of the second part 22b to resist deformation. When the bending following section S1 is bent, it is easy to bend towards the opening direction of the notch 222, that is, the side where the needle tip 21 is located. Also, since the side where the needle tip 21 is located is on the same side as the side where the adjustable bending section 11 of the sheath tube 10 is bent driven by the traction member 40, when the adjustable bending section 11 is bent driven by the traction member 40, the bending following section S1 of the needle body 20 is easily bent in the same direction as the adjustable bending section 11 of the sheath tube 10, thereby avoiding the needle tip 21 from piercing the inner wall of the sheath tube 10.

[0059] Please refer to Figure 4 , in this embodiment, each of the first sections 221 includes an end face 2211, and the end faces 2211 of two adjacent first sections 221 are opposite to each other, and the opposite end faces 2211 are parallel, so that the cross-sectional shape of the notch 222 along the axial direction is "U" shaped.

[0060] Please refer to Figure 6 , in another embodiment of the present invention, each of the first sections 221 includes an end face 2211, and the end faces 2211 of two adjacent first sections 221 are opposite to each other, and the opposite end faces 2211 intersect, so that the cross-sectional shape of the notch 222 along the axial direction is "V" shaped.

[0061] Please refer to Figure 7, in another embodiment of the present invention, the bending orientation structure on the bending following section S1 of the needle body 20 further includes a fitting structure 224 in addition to the notch 222. The fitting structure 224 is connected to the notch 222. Specifically, the structure of the first portion 22a of the needle body 20 is the same as the structure shown in the embodiment of Figure 3 and Figure 4 . The second portion 22b includes a plurality of second sections 223 arranged along the axial direction of the needle body 20. Each of the second sections 223 corresponds to and is connected to the first section 221 one by one. The fitting structure 224 is disposed between two adjacent second sections 223 and connects the two adjacent second sections 223. In this embodiment, there are two fitting structures 224 between two adjacent second sections 223, and the two fitting structures 224 are respectively disposed on both sides of the first section 221 of the first portion 22a.

[0062] Please refer to Figure 8, for two adjacent second sections 223, each fitting structure 224 includes a first travel groove 2241 and a second travel groove 2242 which are spaced apart on one second section 223, and a first protrusion 2243 and a second protrusion 2244 which are spaced apart on the other second section 223. The first protrusion 2243 is closer to the first part 22a than the second protrusion 2244, and the first travel groove 2241 is closer to the first part 22a than the second travel groove 2242. The first protrusion 2243 is fitted in the first travel groove 2241, and the second protrusion 2244 is fitted in the second travel groove 2242. Specifically, the first protrusion 2243 and the second protrusion 2244 each include an opposite first outer wall and second outer wall and a top wall 2243c connecting the first outer wall and the second outer wall. The first travel groove 2241 and the second travel groove 2242 each include an opposite first inner wall and second inner wall and a bottom wall 2241c connecting the first inner wall and the second inner wall. The first outer wall, the second outer wall, the first inner wall, and the second inner wall are all arc-shaped surfaces. The first outer wall is in contact with and can rotate relative to the first inner wall, and the second outer wall is in contact with and can rotate relative to the second inner wall. In the natural state, there is a gap between the top wall 2243c of the first protrusion 2243 and the bottom wall 2241c of the first travel groove 2241, and the bottom wall 2241c of the second travel groove 2242 is in contact with the top wall 2243c of the second protrusion 2244. Coupled with the fact that the opening of the notch 222 faces the side where the needle tip 21 is located, the bending following section S1 is more likely to bend towards the side where the needle tip 21 is located, that is, the bending following section S1 of the needle body 20 is more likely to conform to the same-direction bending of the adjustable bending section 11 of the sheath tube 10, thereby preventing the needle tip 21 from piercing the inner wall of the sheath tube 10. When the bending following section S1 bends, the first protrusion 2243 rotates relative to the first travel groove 2241 and the top wall 2243c of the first protrusion 2243 gradually approaches the bottom wall 2241c of the first travel groove 2241, and the second protrusion 2244 rotates relative to the second travel groove 2242 and the top wall 2243c of the second protrusion 2244 gradually moves away from the bottom wall 2241c of the second travel groove 2242.

[0063] Please refer back to Figure 3 , Figure 4 , Figure 6 and Figure 7, the needle body 20 further includes a flexible reinforcement section S2 provided on the proximal side of the bending following section S1. At least one flexible reinforcement structure is provided on the flexible reinforcement section S2 to allow the flexible reinforcement section S2 to bend in multiple directions. By providing the flexible reinforcement section S2 that is easy to bend in multiple directions, the part of the needle body 20 located on the proximal side of the bending following section S1 can have excellent flexibility, and it can easily bend in various directions following the working channel of the bronchoscope or endoscope in the tortuous human tissue cavity, so that the needle body 20 can smoothly pass through the working channel of the bronchoscope or endoscope, so that the bending following section S1 and the needle tip 21 can approach the position to be biopsied. Specifically, the flexible reinforcement structure can be formed by cutting the needle body 20 through laser, chemical etching, water jet or other suitable processes.

[0064] As Figure 3 shown, in some embodiments of the present invention, the flexible reinforcement structure includes a first notch 231a and a second notch 231b arranged axially staggered along the needle body 20. The opening direction of the first notch 231a faces the side where the needle tip 21 is located, and the opening direction of the second notch 231b faces away from the side where the needle tip 21 is located, so that the flexible reinforcement section S2 can bend towards the side where the needle tip 21 is located and bend away from the side where the needle tip 21 is located.

[0065] Please refer back to Figure 4 , Figure 6 and Figure 7 , in some embodiments of the present invention, the flexible reinforcement structure is a slit 232 spiraling along the needle body 20. Through the slit 232 spiraling along the needle body 20, the flexible reinforcement section S2 is easy to bend in various directions. Specifically, the slit 232 spiraling along the needle body 20 is in a concave-convex undulating curve shape, so that the concave-convex parts of the needle body 20 on both sides of the slit 232 can be mutually engaged, and further, while ensuring that the flexible reinforcement section S2 can bend in various directions, it has a certain tensile strength. As Figure 7 shown, in some embodiments of the present invention, the slit 232 includes protruding portions 232a arranged at intervals, and a concave portion 232b is formed between adjacent protruding portions 232a. The protruding portion 232a can be arc-shaped or "T"-shaped. Preferably, the protruding portion 232a is "T"-shaped, and the concave portion 232b is also "T"-shaped accordingly, so that an engagement is formed between the protruding portion 232a and the concave portion 232b.

[0066] Please refer to Figure 9a , Figure 9b and Figure 10, in some embodiments of the present invention, the flexible reinforcing section S2 includes a plurality of third sections 233 arranged along the axis of the needle body 20. A nearly annular gap 235 is formed between two adjacent third sections 233. And engaging structures 234 are arranged at intervals in the circumferential direction of the nearly annular gap 235. The nearly annular gap 235 and the engaging structures 234 constitute the flexible reinforcing structure. Two adjacent third sections 233 are connected by the engaging structures 234. Specifically, two engaging structures 234 are arranged at intervals and oppositely in the circumferential direction of each nearly annular gap 235, and the two engaging structures 234 are symmetrically arranged with respect to the plane where the axis of the needle body 20 is located. For two adjacent third sections 233, the engaging structure 234 includes a third travel groove 2341 and a fourth travel groove 2342 arranged at intervals on one third section 233, and a third protrusion 2343 and a fourth protrusion 2344 arranged at intervals on the other third section 233. The third protrusion 2343 is embedded in the third travel groove 2341, and the fourth protrusion 2344 is embedded in the fourth travel groove 2342. Specifically, the third protrusion 2343 and the fourth protrusion 2344 include opposite third outer walls and fourth outer walls and a top wall 2343c connecting the third outer wall and the fourth outer wall. The third travel groove 2341 and the fourth travel groove 2342 both include opposite third inner walls and fourth inner walls, and a bottom wall 2341c connecting the third inner wall and the fourth inner wall. The third outer wall, the fourth outer wall, the third inner wall, and the fourth inner wall are all arc-shaped surfaces. The third outer wall is in contact with and can rotate relative to the third inner wall, and the fourth outer wall is in contact with and can rotate relative to the fourth inner wall. There is a gap between the top wall 2343c of the third protrusion 2343 and the bottom wall 2341c of the third travel groove 2341, and there is also a gap between the bottom wall 2341c of the fourth travel groove 2342 and the top wall 2343c of the fourth protrusion 2344, so that when two adjacent third sections 233 are bent, they can be bent to both sides. Further, the positions of the engaging structures 234 on every two adjacent third sections 233 are different, so that the flexible reinforcing section S2 can be bent in all directions.

[0067] Further, the bending following section S1 and the flexible reinforcement section S2 are coated with a flexible film (not shown in the figure). The flexible film is made of a heat-shrinkable material and can withstand a pressure of at least 3 ATM. When a suction device such as a syringe is used to suck at the proximal end of the adjustable bending biopsy needle to enable a tissue sample to enter the needle body 20, the flexible film is coated outside the bending following section S1 and the flexible reinforcement section S2, which can avoid the formation of a pressure difference due to the presence of notches or gaps in the bending orientation structure and the flexible reinforcement structure, ensuring smooth suction so that the biopsy tissue enters the needle body 20. Moreover, the flexible film can also prevent the biopsy tissue obtained by suction from leaking out through the notches or gaps in the bending orientation structure and the flexible reinforcement structure. It can be understood that the flexible film can be coated on the outer surface of the entire needle body 20.

[0068] Please refer to Figure 11 , the sheath 10 includes an inner tube 10a, a reinforcement tube 10b sleeved on the inner tube 10a, and an outer tube 10c sleeved on the reinforcement tube 10b. The traction member 40 is disposed between the inner tube 10a and the reinforcement tube 10b. In this embodiment, the inner tube 10a is a flexible tube made of a flexible material such as PTFE material, which is easy to be flexibly bent; the reinforcement tube 10b is a metal braided mesh structure, which has a certain stiffness and can be bent in the axial direction, so as to provide support for the sheath 10, avoid the torsional deformation of the sheath 10 in the radial direction, and does not affect the bending of the adjustable bending section 11 of the sheath 10; the outer tube 10c is made of a material with a certain hardness such as PEBAX to achieve the protection of the sheath 10. Moreover, the hardness of the outer tube 10c corresponding to the adjustable bending section 11 is less than the hardness of other parts of the outer tube 10c, so as to avoid affecting the bending of the adjustable bending section 11 while realizing the protection of the sheath 10. Specifically, in this embodiment, the hardness of the material used for the part of the outer tube 10c corresponding to the adjustable bending section 11 is greater than the hardness of the material used for other parts of the outer tube 10c, so as to facilitate the bending of the adjustable bending section 11. Further, in this embodiment, the inner tube 10a, the reinforcement tube 10b, and the outer tube 10c are formed together by hot melt composite molding to form at least one delivery cavity that completely penetrates from the proximal end to the distal end. It can be understood that the inner tube 10a, the reinforcement tube 10b, and the outer tube 10c can also be made of other materials other than this embodiment.

[0069] Further, in this embodiment, the distal end of the sheath 10 is an arc-shaped end with a smooth surface, that is, a Tip head. A radiopaque imaging ring (not shown), such as a tantalum ring, etc., is provided on the proximal side of the Tip head, so that it can be accurately known whether the distal end of the sheath 10 reaches the designated position under an imaging device.

[0070] The traction member 40 is embedded in the tube wall of the sheath tube 10 and is arranged along the axial direction of the sheath tube 10. Specifically, in this embodiment, the traction member 40 is located between the inner tube 10a and the reinforcement tube 10b. The traction member 40 includes a traction wire 41. The distal end of the traction wire 41 is connected to the adjustable bending section 11, and the proximal end passes through the tube wall at the proximal end of the sheath tube 10 and is connected to the sliding member 32 in the sheath tube seat 30. When the sliding member 32 slides, it drives the traction wire 41 to move axially, so as to drive the adjustable bending section 11 to bend through the traction wire 41. It can be understood that in the present invention, the adjustable bending section 11 can be one section or multiple sections, and each section of the adjustable bending section 11 is connected to a traction wire 41. According to actual needs, all the traction wires 41 can be connected to the same sliding member to simultaneously control the bending of each adjustable bending section 11, or each traction wire 41 can be fixed to different sliding members respectively, and the sliding of each sliding member can be controlled respectively to control the bending of each adjustable bending section 11 respectively.

[0071] It should be noted that the side of the sheath tube 10 where the traction wire 41 is located and the side where the needle tip 21 is located are on the same side with respect to the axis of the needle body 20, so that when the traction wire 41 drives the adjustable bending section 11 on the sheath tube 10 to bend, the side where the adjustable bending section 11 is bent driven by the traction wire 41 is the same as the side where the needle tip 21 is located, thereby preventing the needle tip 21 from piercing the inner wall of the sheath tube 10.

[0072] An anchoring ring 42 is provided at the end of the traction wire 41 connected to the adjustable bending section 11. The anchoring ring 42 is a ring-shaped member and is sleeved on the adjustable bending section 11, that is, the distal end of the traction wire 41 is connected to the adjustable bending section 11 through the anchoring ring 42. In this embodiment, the anchoring ring 42 is sleeved on the inner tube 10a at the position corresponding to the adjustable bending section 11. Through the anchoring ring 42, the contact area between the traction member 40 and the adjustable bending section 11 is increased, so that the adjustable bending section 11 can be better driven to bend. The anchoring ring 42 can be made of metal material or polymer material. In this embodiment, the anchoring ring 42 is made of metal such as SUS304 stainless steel. The connection method between the traction wire 41 and the anchoring ring 42 includes but is not limited to bonding, welding, hot melting, knotting and other methods, which are not limited herein.

[0073] The traction member 40 further includes a wire-wrapping tube (not labeled). The portion of the traction wire 41 located inside the sheath tube 10 is movably disposed inside the wire-wrapping tube to define the traction direction of the traction wire 41 through the wire-wrapping tube and protect the traction wire 41 through the wire-wrapping tube. In the present invention, the inner diameter of the wire-wrapping tube is slightly larger than the diameter of the traction wire 41 for the traction wire 41 to pass through, which can prevent the sheath tube from tightly holding the traction wire 41 when heat-melt shrinking, resulting in the inability of the traction wire 41 to smoothly slide axially and preventing the traction wire 41 from bending. The hardness of the portion of the wire-wrapping tube corresponding to the adjustable bending section 11 is less than the hardness of other portions of the wire-wrapping tube, that is, the portion of the wire-wrapping tube corresponding to the adjustable bending section 11 is relatively soft, so that the wire-wrapping tube does not affect the bending of the adjustable bending section 11. For example, the portion of the wire-wrapping tube embedded in the adjustable bending section 11 can be a PTFE thin tube, while other portions can be a PI thin tube or a stainless steel thin tube.

[0074] Please refer to Figure 2 and Figures 12 to 14 , the guide rod 31 is in a hollow tubular shape. The guide rod 31 includes a stroke section S3, and an opening 312 extending along the axial direction of the guide rod 31 is provided on the stroke section S3. The sliding member 32 is a slider, and the slider is sleeved outside the guide rod 31 and slides on the stroke section S3. In this embodiment, limiting ribs 313 are provided around both ends of the stroke section S3 to define the far and near limit positions that the sliding member 32 can slide to. And, guiding ribs 311 are provided on the stroke section S3 of the guide rod 31 along the axial direction of the guide rod 31, and grooves 321 adapted to the guiding ribs 311 are provided on the slider. The guiding ribs 311 are snapped into the grooves 321 to slidably connect the slider to the guide rod 31 and enable the slider to only slide axially. In this embodiment, there are two guiding ribs 311, which are respectively disposed on both sides of the opening 312, and two corresponding grooves 321 are provided, so that the sliding member 32 can slide more smoothly on the guide rod 31.

[0075] Further, please refer to Figure 13 and Figure 14 , a block 34 is detachably connected to the sliding member 32. One end of the block 34 is detachably fixed to the sliding member 32, and the other end extends into the opening 312 of the guide rod 31. The proximal end of the traction wire 41 passes through the wall of the proximal end of the sheath tube 10 and then passes through the opening 312 into the guide rod 31 and is fixed to the block 34.

[0076] Please refer back to Figure 1 , Figure 2 and Figure 12 and Figure 14, the driving member 33 is a rotating cylinder, the rotating cylinder is sleeved outside the guide rod 31 and the sliding member 32 and is rotatably connected to the guide rod 31, that is, the rotating cylinder can only rotate relative to the guide rod 31 and cannot move axially relative to the guide rod 31. Specifically, a snap ring 314 is detachably fixed on the guide rod 31, and the snap ring 314 is spaced from the limiting rib 313 at the proximal end of the guide rod 31. The proximal end of the rotating cylinder is clamped between the limiting rib 313 and the snap ring 314 to limit the axial movement of the rotating cylinder relative to the guide rod 31. An internal thread 331 is provided on the inner surface of the rotating cylinder, and an external thread 322 adapted to the internal thread 331 is provided on the outer surface of the sliding member 32. Rotating the rotating cylinder can drive the sliding member 32 to slide relative to the guide rod 31, and further drive the traction wire 41 to move, so as to drive the adjustable bending section 11 to bend or return to a straight state.

[0077] Please refer to Figure 1 , Figure 2 , Figure 15 and Figure 16 , the handle 50 includes a proximal handle 51 and a distal handle 52, and the distal end of the distal handle 52 is connected to the guide rod 31. In this embodiment, the distal end of the distal handle 52 is connected to the proximal end of the guide rod 31 through a Luer connector. The proximal handle 51 includes a movable rod 511 movably inserted into the distal handle 52 along the axial direction of the distal handle 52. The proximal end of the needle body 20 passes through the sheath 10 and the guide rod 31 and is fixed to the distal end of the movable rod 511. The proximal handle 51 moves relative to the distal handle 52, so that the movable rod 511 drives the needle body 20 to move in the sheath 10, so that the distal end of the needle body 20 extends out of or moves into the sheath 10. A plurality of card slots 512 are provided at intervals on the movable rod 511. A scale value is provided corresponding to one side of each card slot 512, and each scale value represents the length of the needle tip 21 extending out of the distal end of the sheath 10.

[0078] Further, a finger ring 521 is provided on the distal handle 52, and the finger is inserted into the finger ring 521 to facilitate the control of the distal handle 52. In this embodiment, two relatively arranged finger rings 521 are provided on the distal handle 52 for the index finger and middle finger of the operator to insert.

[0079] A finger ring 512 is also provided on the proximal handle 51, and the finger is inserted into the finger ring 512 to facilitate the control of the proximal handle 51. In this embodiment, a finger ring 512 is provided on the proximal handle 51 for the thumb of the operator to insert. When in use, the thumb is inserted into the finger ring 512, the index finger and middle finger are inserted into the finger ring 521, and the proximal handle 51 is controlled by the thumb to move relative to the distal handle 52, so that the needle body 20 moves relative to the sheath 10.

[0080] Further, the handle further includes a connecting belt 60. The proximal end of the connecting belt 60 is clamped in any one of the card slots 512, and the distal end is detachably connected to the distal handle 52. When the proximal handle 51 is pushed to move distally, the proximal end of the connecting belt 60 approaches its distal end. When the proximal end and the distal end of the connecting belt 60 are in contact, the proximal handle 51 stops. At this time, the length of the needle tip 21 extending from the distal end of the sheath tube 10 can be obtained through the scale value corresponding to the card slot 512 into which the proximal end of the connecting belt 60 is inserted. When it is necessary to adjust the length of the needle tip 21 extending from the distal end of the sheath tube 10, the proximal end of the connecting belt 60 can be changed to another card slot 512.

[0081] Further, a first anti-rotation structure is provided on the proximal handle 51, and a second anti-rotation structure cooperating with the first anti-rotation structure is provided on the distal handle 52. The first anti-rotation structure and the second anti-rotation structure cooperate to limit the rotation of the proximal handle 51 relative to the distal handle 52, thereby avoiding the rotation of the needle body 20 relative to the sheath tube 10, and further ensuring that the side where the needle tip 21 is located and the side where the adjustable bending section 11 of the sheath tube 10 is bent driven by the traction wire are always on the same side relative to the axis of the needle body 20, avoiding the needle tip 21 from piercing the inner wall of the sheath tube 10. In this embodiment, the movable rod 511 includes two oppositely arranged arc surfaces 511a and a flat surface 511b located between the two arc surfaces 511a. The distal end of the connecting belt 60 fixed to the distal handle 52 has an opening, and the shape of the opening is the same as the cross-section of the movable rod 511, that is, the peripheral wall of the opening includes a flat wall that fits the flat surface 511b and an arc wall that fits the arc surface 511a. The movable rod 511 passes through the opening and is installed in the distal handle 52. Since the shape of the opening is the same as the cross-section of the movable rod 511, and the opening is non-circular, the movable rod 511 cannot rotate after being inserted into the opening, thereby restricting the rotation of the proximal handle 51 relative to the distal handle 52. That is, the flat surface 511b of the movable rod 511 is the first anti-rotation structure, and the flat wall of the opening is the second anti-rotation structure. It can be understood that in other embodiments of the present invention, the inner wall of the distal handle 52 can be set to the same shape as the outer wall of the movable rod 511, thereby restricting the rotation of the proximal handle 51 relative to the distal handle 52, that is, the flat surface of the inner wall of the distal handle 52 is the second anti-rotation structure; or, a groove extending axially is provided on the inner wall of the distal handle 52, and a convex rib cooperating with the groove is provided on the movable rod. The convex rib is movably adapted to the groove, thereby restricting the rotation of the proximal handle 51 relative to the distal handle 52, that is, the convex rib on the proximal handle 51 is the first anti-rotation structure, and the groove on the inner wall of the distal handle 52 is the second anti-rotation structure.

[0082] Please refer to Figure 2 and Figure 17 The adjustable bending biopsy needle 100 further includes a liner core 70. The liner core 70 includes a core body 71 and a connecting member 72 connected to the proximal end of the core body 71. The core body 71 is movably disposed within the needle body 20, and the connecting member 72 is detachably connected to the handle 50. The core body 71 is made of a filamentous material with relatively strong flexibility and certain hardness. By inserting the core body 71 into the needle body 20, the needle body 20 is supported to prevent the needle body 20 from breaking. In this embodiment, the connecting member 72 is a Luer connector, and the connecting member 72 and the core body 71 are fixedly bonded by a medical-grade glue. The core body 71 passes through the proximal handle 51 and the distal handle 52 and enters the needle body 20, and the connecting member 72 is detachably fixed to the proximal end of the proximal handle 51.

[0083] Please refer to Figure 18 The present invention further provides a biopsy system 200. The biopsy system 200 includes an endoscope 110 and the adjustable bending biopsy needle 100. The endoscope includes a working channel, and the sheath 10 and the needle body 20 of the adjustable bending biopsy needle 100 are movably disposed within the working channel. The endoscope 400 includes, but is not limited to, various types of bronchoscopes, gastroscopes, colonoscopes, etc., and an ultrasonic detector or / and an optical camera are provided at its distal end.

[0084] Taking the endoscope 110 as a bronchoscope as an example, the use process of the biopsy system 200 of the present application includes the steps:

[0085] Insert the liner core 70 into the needle body 20, fix the connecting member 72 of the liner core 70 to the proximal end of the proximal handle 51, then insert the needle body 20 into the sheath 10, and connect the distal handle 52 to the sheath base 30;

[0086] Feed the assembled adjustable bending biopsy needle 100 into the body along the working channel of the bronchoscope 110. At this time, the bending following section S1 and the needle tip 21 of the adjustable bending biopsy needle 100 are received within the adjustable bending section 11 at the distal end of the sheath 10;

[0087] When encountering a small bronchial lumen that cannot be reached by the distal end of the bronchoscope, rotate the driving member 33 of the sheath base 30 to adjust the adjustable bending section 11 at the distal end of the sheath 10 to an appropriate angle and shape, so that the distal end of the sheath 10 enters the small bronchial lumen where biopsy is to be performed;

[0088] Push the proximal handle 51 to move it distally relative to the distal handle 52, so that the needle tip 21 of the needle body 20 or the needle tip 21 and a part of the bending following section S1 extend out from the distal end of the sheath 10 and penetrate into the tissue within the small bronchial lumen where biopsy is to be performed;

[0089] Remove the lining core 70, connect a suction device, such as a syringe, to the proximal end of the proximal handle 51. By pulling the syringe piston, the tissue sample is drawn into the needle body 20. Then, pull the proximal handle 51 to move it proximally relative to the distal handle 52, so as to bend the tip following section S1 of the needle body 20 and retract it into the sheath 10. Then, take out the adjustable bending biopsy needle 100;

[0090] Squeeze out the biopsy tissue and hand it over to the examiner for inspection.

[0091] In the present invention, by adjusting the adjustable bending section 11 of the sheath 10, the distal end of the sheath 10 can be bent to different degrees, so that the distal end of the sheath 10 can smoothly enter some small and curved human body cavities, and then the distal end of the needle body 20 can enter these small and curved cavities along the distal end of the sheath 10 to obtain biopsy tissue. Moreover, a bending orientation structure is provided on the tip following section S1 at the distal end of the needle body 20, so that the tip following section S1 bends in the same direction as the adjustable bending section 11. The side where the tip 21 is located and the side where the adjustable bending section 11 is bent driven by the traction member 40 are on the same side relative to the axis of the needle body 20, which can prevent the tip 21 from piercing the inner wall of the sheath 10. At the same time, the flexible strengthening section S2 is provided on the needle body 20, so that the needle body 20 can adaptively bend in all directions in the tortuous human tissue cavity following the working channel of the bronchoscope or endoscope, so that the needle body 20 can smoothly pass through the working channel of the bronchoscope or endoscope.

[0092] The above is the preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art of the present technology, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention.

Claims

1. An adjustable bending biopsy needle, characterized in that, It includes a sheath tube, a needle body and a traction member. The distal end of the sheath tube has an adjustable bending section, and the distal end of the traction member is connected to the adjustable bending section. The traction member moves axially along the sheath tube to drive the adjustable bending section to bend; the needle body is movably inserted into the sheath tube so that the distal end of the needle body extends out of or retracts into the distal end of the sheath tube, and the distal end of the needle body is a hollow structure; Wherein, the needle body includes a flexible reinforcement section, and at least one flexible reinforcement structure is provided on the flexible reinforcement section to allow the flexible reinforcement section to bend in multiple directions. Among them, the flexible reinforcement structure includes a plurality of nearly annular gaps arranged at intervals along the axial direction of the needle body and engaging structures arranged at intervals in the circumferential direction of the nearly annular gaps; Wherein, the distal end of the needle body includes a needle tip and a bending following section provided on the proximal side of the needle tip; when the distal end of the needle body retracts into the distal end of the sheath tube, the bending following section of the needle body is correspondingly located within the adjustable bending section of the sheath tube; a bending orientation structure is provided on the bending following section to enable the bending following section to bend in the same direction as the adjustable bending section, and the side where the needle tip is located and the side where the adjustable bending section is driven by the traction member to bend are on the same side relative to the axis of the needle body; Wherein, the adjustable biopsy needle further includes a sheath tube seat, and the sheath tube seat includes a guide rod, a sliding member that slides axially along the guide rod, and a driving member that drives the sliding member to slide. The guide rod is fixed to the proximal end of the sheath tube, and the sliding member is connected to the proximal end of the traction member; the driving member drives the sliding member to slide relative to the guide rod to drive the traction member to drive the adjustable bending section to bend; Wherein, the adjustable biopsy needle further includes a handle, and the handle includes a proximal handle and a distal handle. The distal handle is connected to the guide rod. The proximal handle includes a movable rod that is axially movably inserted into the distal handle. The proximal end of the needle body passes through the sheath tube and is fixed to the distal end of the movable rod. The proximal handle moves relative to the distal handle to enable the movable rod to drive the needle body to move within the sheath tube; Wherein, the handle further includes a connecting band. A plurality of card slots are arranged at intervals on the movable rod. The proximal end of the connecting band is clamped in any one of the card slots, and the distal end is detachably connected to the distal handle. Among them, when the proximal handle moves distally, the proximal end of the connecting band approaches the distal end of the connecting band. When the proximal end of the connecting band fits with the distal end of the connecting band, the proximal handle stops.

2. The adjustable bending biopsy needle according to claim 1, wherein The bending orientation structure of the needle body includes a plurality of notches arranged at intervals along the axial direction of the needle body, and the openings of the notches face the side where the needle tip is located.

3. The adjustable bending biopsy needle according to claim 2, wherein The cross-sectional shape of the notch along the axial direction is in the shape of "U" or "V".

4. The adjustable bending biopsy needle according to claim 1, wherein The flexible reinforcement section is arranged on the proximal side of the bending following section.

5. The adjustable bending biopsy needle according to claim 4, wherein The flexible reinforcement structure includes a first notch and a second notch arranged alternately along the axial direction of the needle body. The opening direction of the first notch faces the side where the needle tip is located, and the opening direction of the second notch faces away from the side where the needle tip is located.

6. The adjustable bending biopsy needle according to claim 4, wherein, The flexible reinforcement structure is a slit spiraling along the needle body.

7. The adjustable bending biopsy needle according to any one of claims 2-6, characterized in that Both the bending adjustment following section and the flexible reinforcement section are coated with flexible films.

8. The adjustable bending biopsy needle according to claim 1, wherein, The traction member is embedded in the tube wall of the sheath tube.

9. The adjustable bending biopsy needle according to claim 8, wherein The sheath tube includes an inner tube, a reinforcement tube sleeved on the inner tube, and an outer tube sleeved on the reinforcement tube. The traction member is located between the inner tube and the reinforcement tube.

10. The adjustable bending biopsy needle according to claim 9, wherein The inner tube is a flexible tube. The hardness of the outer tube is greater than that of the inner tube, and the hardness of the outer tube corresponding to the adjustable bending section is less than that of other parts of the outer tube.

11. The adjustable bending biopsy needle according to claim 1, wherein The traction member includes a traction wire. The traction wire extends along the axial direction of the sheath tube. The distal end of the traction wire is connected to the adjustable bending section, and the proximal end is connected to the sliding member of the sheath tube base. And the side of the traction wire on the sheath tube and the side where the needle tip is located are on the same side with respect to the axis of the needle body, so that the side where the adjustable bending section is bent driven by the traction member is the same as the side where the needle tip is located.

12. The adjustable bending biopsy needle according to claim 11, wherein, The traction member further includes an anchoring ring. The anchoring ring is fixed to the distal end of the traction wire and sleeved on the adjustable bending section to connect the traction wire to the adjustable bending section.

13. The adjustable bending biopsy needle according to claim 1, wherein, The sliding member is a slider. The slider is sleeved outside the guide rod. The guide rod is provided with guiding convex ribs, and the slider is provided with grooves adapted to the guiding convex ribs. The guiding convex ribs are engaged in the grooves to slidably connect the slider to the guide rod.

14. The adjustable bending biopsy needle according to claim 13, characterized in that, A fitting block is detachably connected to the sliding member, and the proximal end of the traction member is fixed to the fitting block.

15. The adjustable bending biopsy needle according to claim 1, wherein, The driving member is a rotating cylinder. The rotating cylinder is sleeved outside the guide rod and the sliding member and is rotatably connected to the guide rod. The inner surface of the rotating cylinder is provided with internal threads, and the outer surface of the sliding member is provided with external threads adapted to the internal threads. The rotating cylinder rotates to drive the sliding member to slide relative to the guide rod.

16. The adjustable bending biopsy needle according to claim 15, wherein A limiting convex rib is annularly provided at the proximal end of the guide rod, and a clamping ring is detachably fixed on the guide rod. The clamping ring is spaced from the limiting convex rib. The proximal end of the rotating cylinder is clamped between the limiting convex rib and the clamping ring.

17. The adjustable bending biopsy needle according to claim 1, wherein The proximal handle is provided with a first anti-rotation structure, and the distal handle is provided with a second anti-rotation structure cooperating with the first anti-rotation structure. The first anti-rotation structure and the second anti-rotation structure cooperate to limit the relative rotation of the proximal handle with respect to the distal handle.

18. The adjustable bending biopsy needle according to claim 1, wherein, The adjustable bending biopsy needle further includes a liner core. The liner core includes a core body and a connecting member connected to the proximal end of the core body. The core body movably passes through the needle body, and the connecting member is detachably connected to the proximal handle.

19. A biopsy system, characterized in that, An endoscope and the adjustable bending biopsy needle according to any one of claims 1-18 are included. The endoscope includes a working channel, and the sheath tube and the needle body of the adjustable bending biopsy needle movably pass through the working channel.

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