Rotary cutting biopsy needle

Abstract

The present invention provides a rotary cutting biopsy needle, comprising a distal tube portion, wherein the distal tube portion sequentially comprises, from outside to inside, an outer sheath tube, a puncture needle tube, and a rotary cutter tube. Before puncture, the distal end of the puncture needle tube is located in the outer sheath tube, and the distal end of the rotary cutter tube is located in the puncture needle tube. During puncture, the puncture needle tube and the rotary cutter tube emerge from the distal end of the outer sheath tube together to puncture the tissue, and in the puncture process, the distal end of the rotary cutter tube remains located in the puncture needle tube. After the puncture is completed, the rotary cutter tube extends out of the distal end of the puncture needle tube, and the tissue is sampled by means of rotary cutting. Since the distal end of the rotary cutter tube is located within the puncture needle tube during puncture, the rotary cutter tube may pierce human tissues together with the puncture needle tube, thereby ensuring the smoothness of the outer surface of the puncture needle tube and making puncture breakthrough easier.

Description

A rotational biopsy needle TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a rotational biopsy needle. BACKGROUND

[0002] Biopsy is short for "biological tissue examination", also known as surgical pathology examination, a group of medical diagnostic test methods for determining the structure and composition of tissues or cells. In biopsy, a sample of cells or tissues is taken from an organ or other body part, and after being sent to the pathology department, standard pathological sections are made, and the morphological structure is observed under a microscope, and finally a clear pathological diagnosis can be given to guide targeted treatment. Generally, if an abnormality is found through superficial examination, such as palpation or radiographic imaging, a biopsy can be performed to determine the nature of the suspected abnormality.

[0003] Endoscopic ultrasound-guided transbronchial needle aspiration biopsy is a minimally invasive examination technique for puncture biopsy of lung, peripulmonary tissue and lymph nodes under real-time ultrasound guidance. Its advantages are that it can avoid important parts such as large blood vessels and nerves as much as possible under real-time ultrasound monitoring, reduce the risk of massive bleeding, improve the accuracy of sampling, and is minimally invasive, simple to operate, and relatively safe.

[0004] Traditional endoscopic ultrasound biopsy needles need to be repeatedly punctured for sampling, and the integrity of the sampled tissue is poor, thus causing low sampling efficiency and poor sample quality. The rotational biopsy needle is different from the traditional biopsy needle, which has a rotary cutter head driven by a motor to rotate, replacing the traditional reciprocating puncture sampling with rotary cutting to improve sampling efficiency and sample quality.

[0005] Taking lung nodule sampling as an example, the rotational biopsy needle reaches the bronchus near the nodule through the endoscope, and then needs to puncture and break through the bronchial wall to reach the sampling position. The bronchial wall is relatively hard, and it is difficult to break through. Since the rotary cutter itself cannot break through the bronchial wall, a puncture needle is needed to guide the rotary cutter to achieve puncture breakthrough.

[0006] However, the puncture needle of the current rotational biopsy needle is a nickel-titanium wire (also known as a guide wire, which achieves the function of the puncture needle) located inside the rotary cutter. When puncturing and breaking through, the nickel-titanium wire can puncture the tissue wall, but the rotary cutter cannot puncture and is blocked outside the tissue wall, and cannot reach the sampling position, thus causing puncture failure.

[0007] SUMMARY

[0008] To solve the above technical problems, the present application provides a rotary biopsy needle, comprising a distal pipeline part, which comprises, from outside to inside, an outer sheath tube, a puncture needle tube and a rotary cutter tube, before puncture, the distal end of the puncture needle tube is located in the outer sheath tube, and the distal end of the rotary cutter tube is located in the puncture needle tube; during puncture, the puncture needle tube and the rotary cutter tube are pushed out from the distal end of the outer sheath tube to puncture the tissue, and during the puncture process, the distal end of the rotary cutter tube is always located in the puncture needle tube; after puncture, the rotary cutter tube is pushed out from the distal end of the puncture needle tube to sample the tissue.

[0009] Preferably, the outer sheath tube is further provided with an endoscope fixing part, the endoscope fixing part comprises a lock sleeve and a locking part, the lock sleeve comprises an integrated connecting part and a locking part, the connecting part is used for fixed connection with the endoscope, and the locking part is movably sleeved on the outer sheath tube and can axially slide on the outer sheath tube, and the locking part can be locked at any position of the outer sheath tube through the locking part.

[0010] Preferably, the connecting part is a first luer joint, the proximal end of the working channel of the endoscope is provided with a second luer joint matched with the first luer joint, and the first luer joint is connected with the second luer joint in a matched mode; the locking part is located at the proximal end of the intermediate connecting sleeve, the locking part is provided with external threads, and the locking part is a lock cap, the lock cap is provided with a threaded hole matched with the external threads of the locking part, and the locking part is clamped and fixed on the outer sheath tube by screwing the lock cap on the locking part.

[0011] Preferably, the proximal end hand-held part comprises a proximal end shell and a puncture depth adjusting mechanism, the puncture depth adjusting mechanism comprises a sheath seat and a sheath seat locking part, the sheath seat is fixed with the proximal end of the outer sheath tube, and the proximal end shell can axially move relative to the sheath seat.

[0012] The puncture needle tube and the rotary cutter tube are connected in the proximal end shell, during puncture, the puncture needle tube and the rotary cutter tube are pushed out from the distal end of the outer sheath tube to puncture the tissue by pushing the proximal end shell to the distal end, and after puncture, the proximal end shell is locked with the sheath seat through the sheath seat locking part.

[0013] Preferably, the sheath seat is a sleeve structure, the distal end of the sheath seat is fixedly connected with the proximal end of the outer sheath tube, and the proximal end of the sheath seat is movably sleeved on the proximal end shell.

[0014] The proximal end outer wall of the sheath seat is provided with external threads, and the sheath seat locking member is a lock cap, which is provided with an internal threaded hole matched with the external threads of the sheath seat. By screwing the internal threaded hole of the lock cap on the external threads of the sheath seat, the sheath seat clamps the proximal end shell; or, a side wall of the sheath seat is provided with a threaded hole, and the sheath seat locking member is a threaded fastener matched with the threaded hole. One end of the threaded fastener penetrates through the threaded hole into the sheath seat. By tightening the threaded fastener, the end of the threaded fastener abuts against the proximal end shell.

[0015] Preferably, the proximal end handheld part further comprises a puncture needle tube adjusting mechanism, the puncture needle tube is installed in the proximal end shell through the puncture needle tube adjusting mechanism, and the puncture needle tube is axially moved through the puncture needle tube adjusting mechanism.

[0016] Preferably, the puncture needle tube adjusting mechanism comprises a puncture needle tube sleeve and an elastic clamping structure. The puncture needle tube sleeve is located in the proximal end shell and fixedly sheaths the puncture needle tube. At least one side of the puncture needle tube sleeve is provided with the elastic clamping structure. At least one side of the tube wall of the proximal end shell is axially provided with a puncture needle tube adjusting groove, and the elastic clamping structure penetrates through the puncture needle tube adjusting groove. The elastic clamping structure comprises an integral key and at least one limiting column. At least one side groove wall of the puncture needle tube adjusting groove is provided with a plurality of limiting clamping grooves at intervals. In a natural state, the limiting column is located in the limiting clamping groove. By pressing the key, the limiting column is separated from the limiting clamping groove into the proximal end shell, so that the puncture needle tube can be axially moved along the puncture needle tube adjusting groove following the key.

[0017] Preferably, the center of the puncture needle tube sleeve is axially provided with a mounting hole, the puncture needle tube penetrates through the mounting hole and is fixed with the mounting hole. The proximal end of at least one side tube wall of the puncture needle tube sleeve located in the mounting hole is provided with a hollow area. The outer side of the hollow area is provided with an elastic pressing strip. The elastic pressing strip is arranged along the axial direction of the puncture needle tube sleeve, and the distal end of the elastic pressing strip is fixedly connected with the puncture needle tube sleeve. The elastic clamping structure is fixed at the proximal end of the elastic pressing strip. By pressing the key, the limiting column moves to the hollow area following the proximal end of the elastic pressing strip, so that the limiting column is separated from the limiting clamping groove.

[0018] Preferably, the proximal end handheld part further comprises a rotary cutting knife tube transmission assembly. The rotary cutting knife tube is connected in the proximal end shell through the rotary cutting knife tube transmission assembly. By driving the rotary cutting knife tube transmission assembly, the rotary cutting knife tube is driven to rotate and cut the tissue.

[0019] Preferably, the rotary cutter tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism. The rotary cutter tube is driven to rotate by driving the circumferential rotation transmission mechanism, so that the rotary cutter tube cuts tissues. The rotary cutter tube is driven to move axially by driving the axial movement transmission mechanism, so that the cutting depth of the rotary cutter tube is adjusted.

[0020] Preferably, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotation sleeve. The mandrel assembly is fixedly sleeved on the rotary cutter tube. The rotation sleeve is sleeved on the mandrel assembly and is axially slidably connected with the mandrel assembly and circumferentially fixedly connected with the mandrel assembly. A rotation gear is coaxially fixedly connected with the rotation sleeve. The rotation gear is driven by a rotation driving motor, so that the rotation gear drives the rotation sleeve to rotate.

[0021] The axial movement transmission mechanism comprises a screw sleeve and a transmission screw. The screw sleeve is rotationally arranged in the proximal end shell and is in threaded engagement with the transmission screw. The screw sleeve is coaxially fixedly connected with a stroke gear. The stroke gear is driven by a stroke driving motor to rotate. The stroke gear drives the screw sleeve to rotate. The rotation of the screw sleeve is converted into the axial movement of the transmission screw.

[0022] The transmission screw is sleeved on the rotation sleeve and is axially fixedly connected with the mandrel assembly and circumferentially rotationally connected with the mandrel assembly.

[0023] Preferably, the mandrel assembly comprises a fixed tube and an inner cutter sleeve. The fixed tube is fixedly sleeved on the rotary cutter tube. The inner cutter sleeve is fixedly sleeved on the fixed tube. The rotation sleeve is sleeved on the inner cutter sleeve. The rotation sleeve and the inner cutter sleeve are axially slidably connected and circumferentially fixedly connected by inserting axial protrusions into axial guide grooves.

[0024] The inner cutter sleeve and the transmission screw are circumferentially rotationally connected and axially fixedly connected by inserting annular limiting clamping members into annular limiting clamping grooves.

[0025] Preferably, the inner wall of the proximal end shell is further provided with a guide rail. The transmission screw is slidably arranged on the guide rail.

[0026] Preferably, the proximal end hand-held part further comprises a motor handle. The rotation driving motor and the stroke driving motor are both mounted in the motor handle. The motor handle is fixedly connected with the proximal end shell.

[0027] Preferably, the rotary cutting knife tube comprises a distal end metal tube, a metal wire spring tube, a proximal end metal tube and a polymer sealing tube, the distal end of the distal end metal tube is a ring-shaped knife edge, the proximal end surface of the distal end metal tube is fixedly connected with the distal end surface of the metal wire spring tube; the polymer sealing tube is at least sealingly sleeved on the metal wire spring tube and the connection between the metal wire spring tube and the distal end metal tube; the proximal end metal tube is fixedly sleeved on the proximal end of the polymer sealing tube.

[0028] Compared with the prior art, the technical scheme of the embodiment of the application has the following beneficial effects:

[0029] 1. The rotary biopsy needle provided by the application comprises a distal end tube part, which comprises, from the outside to the inside, an outer sheath tube, a puncture needle tube and a rotary cutting knife tube; before puncture, the distal end of the puncture needle tube is located in the outer sheath tube, and the distal end of the rotary cutting knife tube is located in the puncture needle tube; during puncture, the puncture needle tube and the rotary cutting knife tube are punctured together from the distal end of the outer sheath tube to the tissue, and during the puncture process, the distal end of the rotary cutting knife tube is always located in the puncture needle tube; after puncture, the rotary cutting knife tube is extended from the distal end of the puncture needle tube to sample the tissue by rotary cutting. Since the distal end of the rotary cutting knife tube is located in the puncture needle tube during puncture, the rotary cutting knife tube can be punctured into the human tissue together with the puncture needle tube, thereby ensuring the smoothness of the outer surface of the puncture needle tube and facilitating puncture.

[0030] 2. In the application, the outer sheath tube is the outermost layer of the distal end tube part of the biopsy needle, and the inner cavity of the outer sheath tube can completely accommodate the puncture needle tube and the rotary cutting knife tube; therefore, before puncture, the distal end of the puncture needle tube is placed in the outer sheath tube, and the distal end of the rotary cutting knife tube is placed in the puncture needle tube; during the conveying of the outer sheath tube into the working channel of the endoscope, the puncture needle or the rotary cutting knife is prevented from damaging the endoscope.

[0031] 3. In order to realize the flexible rotation of the rotary cutting knife tube, the rotary cutting knife tube is connected with the rotary cutting soft shaft of the metal wire spring tube to realize the flexible transmission of torque and rotation speed; however, in the state without rigid support, the metal wire spring tube is prone to shaking, which affects the sampling effect. In the application, the puncture needle tube is sleeved outside the rotary cutting knife tube, and the inner diameter of the puncture needle tube is slightly larger than the outer diameter of the rotary cutting knife tube; therefore, the puncture needle tube can play a role similar to a sliding bearing, and when the rotary cutting knife tube rotates, the rotary cutting knife tube rotates in the inner cavity of the puncture needle tube, thereby preventing the rotary cutting knife tube from shaking and providing rigid support for the rotary cutting knife tube, and improving the stability of the rotary cutting knife tube during rotation.

[0032] 4. Traditional biopsy needles are typically fixed to the endoscope via a proximal sheath, and operated by a single endoscopist. However, because the rotary biopsy needle contains a motor, the combined weight of the motor handle and proximal sheath significantly increases the difficulty of maneuvering and operating the endoscope if the traditional fixing method is used. This invention directly fixes the outer sheath to the endoscope using an endoscope fixing component on the outer sheath. The proximal sheath and motor handle are then held and operated by a separate operator, allowing the physician to maneuver the endoscope and assist with sampling. This avoids the excessive weight of the motor handle and consumable handle, which would otherwise hinder operation. Therefore, the handling and operation of the endoscope are completely separated from those of the proximal sheath, reducing operational difficulty and increasing the adjustment range of the outer sheath's insertion depth.

[0033] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Attached Figure Description

[0034] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0035] Figure 1 is a schematic diagram of the structure of a rotary biopsy needle provided in an embodiment of the present invention;

[0036] Figure 2 is a schematic diagram of the structure of the remote pipeline section provided in an embodiment of the present invention;

[0037] Figure 3 is a schematic diagram of the structure of the rotary biopsy needle before puncture according to an embodiment of the present invention;

[0038] Figure 4 is a schematic diagram of the structure of a biopsy needle after puncture according to an embodiment of the present invention;

[0039] Figure 5 is a structural schematic diagram of an endoscope fixation component provided in an embodiment of the present invention;

[0040] Figure 6 is a schematic diagram of the structure of a puncture needle provided in an embodiment of the present invention;

[0041] Figure 7 is an axial view of the puncture needle adjustment mechanism provided in an embodiment of the present invention;

[0042] Figure 8 is an end view of the puncture needle adjustment mechanism provided in an embodiment of the present invention;

[0043] Figure 9 is a schematic diagram of the structure of a rotary cutting tube with an outer cutting edge provided in an embodiment of the present invention;

[0044] Fig. 10 is a schematic diagram of a structure of a rotary cutting needle tube with an inner blade according to an embodiment of the present application;

[0045] Fig. 11 is a schematic diagram of a structure of a rotary cutting needle tube according to an embodiment of the present application;

[0046] Fig. 12 is a schematic diagram of a structure of a rotary cutting needle tube transmission assembly according to an embodiment of the present application;

[0047] Fig. 13 is a schematic diagram of positions of an outer sheath tube, a puncture needle tube and a rotary cutting needle tube before puncture according to an embodiment of the present application;

[0048] Fig. 14 is a schematic diagram of positions of an outer sheath tube, a puncture needle tube and a rotary cutting needle tube during puncture according to an embodiment of the present application;

[0049] Fig. 15 is a schematic diagram of positions of an outer sheath tube, a puncture needle tube and a rotary cutting needle tube during sampling according to an embodiment of the present application. DETAILED DESCRIPTION

[0050] The technical solutions in the embodiments of the present application will be clearly and completely described in connection with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0051] The terms "first", "second", "third", "fourth" and the like (if any) in the description, claims, and drawings of the present application are used to distinguish similar objects, and do not necessarily indicate a particular order or a sequence. It should be understood that the data thus used can be interchanged under appropriate circumstances, so that the embodiments of the present application described herein can be implemented in other than the order illustrated or described herein. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion, for example, a process, method, system, product or device that includes a list of steps or units does not necessarily limit to those steps or units clearly listed, but can include other steps or units not clearly listed or inherent to such processes, methods, products or devices. The terms "on" and "above" and any variations thereof are intended to describe the positional relationship, and do not represent a direct contact relationship between the described objects.

[0052] As described in the background, the puncture needle of the current rotary cutting biopsy needle is a nickel-titanium wire (also known as a guide wire, which realizes the function of the puncture needle) located inside the rotary cutting knife. When the puncture breaks through, the nickel-titanium wire can puncture the tissue wall, but the rotary cutting knife cannot puncture and is blocked outside the tissue wall, and cannot reach the sampling position, thereby causing puncture failure.

[0053] In order to solve the above technical problems, referring to FIG. 1 and FIG. 2, the present application provides a rotary biopsy needle, comprising a distal pipeline part 1, which comprises, from outside to inside, an outer sheath tube 101, a puncture needle tube 102 and a rotary cutter tube 103, before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102; during puncture, the puncture needle tube 102 and the rotary cutter tube 103 are punctured together from the distal end of the outer sheath tube 101 to the tissue, and during the puncture process, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102; after puncture, the rotary cutter tube 103 is stretched out from the distal end of the puncture needle tube 102 to sample the tissue by rotary cutting.

[0054] Since the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102 during puncture, the rotary cutter tube 103 can follow the puncture needle tube 103 to penetrate into the human tissue, ensuring the smoothness of the outer surface of the puncture needle tube, and making it easier to puncture and break through.

[0055] In the present application, the outer sheath tube 101 is the outermost layer of the distal pipeline part of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube 102 and the rotary cutter tube 103, so that before puncture, the distal end of the puncture needle tube 102 is placed in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is placed in the puncture needle tube 102, and during the transportation of the outer sheath tube 101 into the working channel of the endoscope, the puncture needle or the rotary cutter is prevented from damaging the endoscope.

[0056] As an embodiment, the rotary biopsy needle further comprises a proximal hand-held part, which comprises a proximal shell 4 and a puncture depth adjusting mechanism 3, referring to FIG. 3, the puncture depth adjusting mechanism 3 comprises a sheath seat 301 and a sheath seat locking member 302, the sheath seat 301 is fixed with the proximal end of the outer sheath tube 101, the proximal shell 4 can move axially relative to the sheath seat 301, and the sheath seat 301 can be locked with the proximal shell 4 through the sheath seat locking member 302.

[0057] The puncture needle tube 102 and the rotary cutter tube 103 are connected in the proximal end shell 4 respectively. Before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102; when puncturing, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal end shell 4, and by pushing the proximal end shell 4 to the distal end, the puncture needle tube 102 and the rotary cutter tube 103 are taken out from the distal end of the outer sheath tube 101 and puncture the tissue, please refer to Fig. 4; during the puncture process, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102, so that the rotary cutter tube 103 can follow the puncture needle tube 102 to penetrate into the human tissue, and the smoothness of the outer surface of the puncture needle tube 102 is ensured, and the puncture is easier to break through.

[0058] The material of the outer sheath tube 101 is not limited in the application, and preferably smooth high molecular materials such as PTFE and PEEK are used to prevent damage to the endoscope during the process of passing through the working channel of the endoscope and to ensure the delivery performance.

[0059] The conventional biopsy needle is usually fixed by the proximal end shell and the endoscope and is uniformly operated by the endoscope operator. However, the rotary biopsy needle has a motor, and the weight of the motor handle and the proximal end shell is large after assembly, so that if the conventional fixing method is used, the fixing of the proximal end shell and the endoscope will greatly increase the difficulty of the endoscope operation and the operation difficulty of the endoscope operator.

[0060] In order to solve the above technical problems, the endoscope is fixed with the outer sheath tube 101 through the endoscope fixing member 2 on the outer sheath tube 101, and the proximal end shell and the motor handle are held and operated by another special operator, so that the doctor operates the endoscope and cooperates with sampling, the weight of the motor handle and the consumable handle is avoided to affect the operation. Therefore, the holding and operation of the endoscope and the holding and operation of the proximal end shell are separated, the operation difficulty is reduced, and the adjustment range of the intervention depth of the outer sheath tube 101 is increased.

[0061] As an embodiment, please refer to Fig. 5, the endoscope fixing member 2 includes a locking member 202 and a lock sleeve 201, the lock sleeve 201 is provided with a connecting part 2011 fixedly connected with the endoscope and a locking part 2013 movably sleeved on the outer sheath tube 101, the locking part 2013 can move axially relative to the outer sheath tube 101, and the locking part 2013 can be locked at any position of the outer sheath tube 101 by the locking member 202.

[0062] The embodiment does not make specific limitation on the fixed connection mode of the connecting part 2011 and the endoscope, such as threaded connection, clamping or other detachable fixed connection mode. Meanwhile, the embodiment does not make specific limitation on the mode of the locking part 2013 locked by the locking member 202 on the outer sheath 101, such as nut locking, locking screw locking and the like.

[0063] As an embodiment, the connecting part 2011 is a first luer joint, the proximal end of the working channel of the endoscope is provided with a second luer joint matched with the first luer joint, and the first luer joint is connected with the second luer joint.

[0064] In a specific embodiment, the connecting part 2011 and the locking part 2013 are coaxially fixedly connected through the intermediate connecting sleeve 2012, the connecting part 2011 and the intermediate connecting sleeve 2012 are movably sleeved on the outer sheath 101, the connecting part 2011 is located at the distal end of the intermediate connecting sleeve 2012, the connecting part 2011 is provided with an internal thread joint, the proximal end of the working channel of the endoscope is provided with an external thread joint matched with the internal thread joint, and the internal thread joint is fastened with the external thread joint through threads; the locking part 2013 is located at the proximal end of the intermediate connecting sleeve 2012, the locking part 2013 is provided with an external thread, the locking member 202 is a first lock cap, the first lock cap is internally provided with a threaded hole matched with the external thread of the locking part 2013, and the first lock cap is tightened on the locking part 2013, so that the locking part 2013 clamps the outer sheath 101.

[0065] The locking part 2013 can be an elastic member such as a silica gel structure, and the first lock cap can enhance the fixing effect by extruding the elastic member. The proximal end of the locking part 2013 can also be spaced apart from a plurality of pressing strips movably sleeved on the outer sheath 101, the first lock cap is designed into a tapered structure gradually tapering from the distal end to the proximal end, the first lock cap is tightened with the locking part 2013, so that the plurality of pressing strips are folded and clamp the outer sheath 101, and the fixed connection between the outer sheath 101 and the endoscope is achieved.

[0066] During delivery, the endoscope is fixedly connected with the connecting part 2011, the first lock cap is in a loosened state, and the endoscope can be moved arbitrarily to adjust the relative position between the outer sheath 101 and the endoscope. When the endoscope reaches the specified position, the adjustment is completed, the first lock cap is locked, and at this time, the locking part 2013 is locked and shrunk with the first lock cap to clamp the outer sheath 101, and the fixed connection between the outer sheath 101 and the endoscope is achieved.

[0067] Since the locking portion 2013 can move axially relative to the outer sheath 101, the endoscope fixing member 2 can be locked at any position of the outer sheath 101, thereby expanding the intervention length adjustment range of the outer sheath 101.

[0068] Since the technical scheme of adjusting and locking two components by the locking member 202 and the locking sleeve 201 belongs to a relatively mature technology in the mechanical field, any technical scheme of adjusting and locking the outer sheath 101 and the endoscope by the locking member 202 and the locking sleeve 201 is within the protection scope of the present application.

[0069] Similarly, since the sheath seat 301 and the sheath seat locking member 302 of the puncture depth adjustment mechanism 3 are also technical schemes of adjusting and locking two components by cooperation, the technical scheme belongs to a relatively mature technology in the mechanical field, and therefore, the present application does not limit the specific structure of the sheath seat 301 and the sheath seat locking member 302. Any technical scheme of adjusting and locking the outer sheath 101 and the proximal shell 4 by the cooperation of the sheath seat 301 and the sheath seat locking member 302 is within the protection scope of the present application.

[0070] As an embodiment, the sheath seat 301 is a sleeve structure, the distal end of the sheath seat 301 is fixedly connected coaxially with the proximal end of the outer sheath 101, and the proximal end of the sheath seat 301 movably sheaths the proximal shell 4; an outer thread is arranged on the proximal end outer wall of the sheath seat 301, the sheath seat locking member 302 is a second locking cap, a threaded hole adapted to the outer thread of the sheath seat 301 is arranged in the second locking cap, and the sheath seat 301 clamps the proximal shell 4 by screwing the second locking cap on the sheath seat 301.

[0071] The proximal end of the sheath seat 301 can be an elastic member such as a silica gel structure, and the second locking cap can enhance the fixing effect by extruding the elastic member. The proximal end of the sheath seat 301 is not limited to an elastic member, and a plurality of pressing strips can be arranged at intervals, the second locking cap is designed into a tapered structure gradually tapering from the distal end to the proximal end, and the second locking cap clamps the proximal shell 4 by screwing with the sheath seat 301, thereby achieving the locking connection between the sheath seat 301 and the proximal shell 4.

[0072] In the initial state before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102. The outer sheath tube 101 is delivered into the working channel of the endoscope. When the outer sheath tube 101 reaches the designated position and is fixed, puncture breakthrough can be performed. At this time, the puncture depth adjusting mechanism 3 is adjusted according to the requirement of puncture depth. Specifically, the second lock cap is loosened, the sheath seat 301 is held by hand, and the proximal end shell 4 is quickly pushed to the distal end. The proximal end shell 4 will drive the distal end of the puncture needle tube 102 and the rotary cutter tube 103 to penetrate out of the outer sheath tube 101 and puncture the barrier tissue such as the bronchial wall. After the puncture is completed, the second lock cap is locked.

[0073] When the proximal end shell 4 is quickly pushed to the distal end, in order to facilitate the hand to operate the proximal end shell 4, an annular protrusion 401 is arranged on the outside of the proximal end shell 4. By pushing the annular protrusion 401, the purpose of quickly pushing the proximal end shell 4 to the distal end is achieved.

[0074] In order to be able to identify the puncture depth, a puncture depth scale is arranged on the proximal end shell 4.

[0075] Of course, the sheath seat locking member 302 of the present application is not limited to the lock cap structure, but can also be a threaded fastener. Specifically, a threaded hole is arranged on one side wall of the sheath seat 301, the sheath seat locking member 302 is a threaded fastener matched with the threaded hole, the first end of the threaded fastener penetrates through the threaded hole into the sheath seat, and the second end is located on the outside of the sheath seat 301. By manually tightening the second end of the threaded fastener, the first end of the threaded fastener is abutted against the proximal end shell 4, so that the proximal end shell 4 is fixed with the sheath seat 301. The threaded fastener is a lock screw or the like structure.

[0076] The puncture needle tube 102 is an intermediate layer of the distal end tube part of the biopsy needle, which is made of metal material such as 304L, 316L stainless steel material. The thickness of the puncture needle should be as low as possible, usually <0.1mm, to increase its inner cavity for accommodating the rotary cutter tube. Please refer to FIG. 6, the puncture needle tube 102 has a needle tip 1021, through which puncture breakthrough can be achieved.

[0077] The main body of the puncture needle tube 102 is provided with a hollow structure 1022, which is used to reduce the hardness of the local position of the puncture needle tube 102 while not losing the puncture effect, and to improve the performance of the biopsy needle passing through the working channel of the endoscope in the curved state.

[0078] In order to improve the effect of ultrasonic imaging and facilitate the observation of the position of the puncture needle tube 102, the outer surface of the puncture needle tube 102 near the needle tip 1021 is provided with a first ultrasonic reflection area. The first ultrasonic reflection area requires uneven lines. The shape of the lines of the first ultrasonic reflection area is not limited in the present application. For example, the roughness of the outer surface of the puncture needle tube 102 can be increased by threading, dotting and other processes to improve the imaging effect of the puncture needle tube 102 under ultrasound.

[0079] In the present application, the proximal handheld portion further comprises a puncture needle tube adjusting mechanism 6, the puncture needle tube 102 is installed in the proximal shell 4 through the puncture needle tube adjusting mechanism 6, and the puncture needle tube 102 is axially moved through the puncture needle tube adjusting mechanism 6, that is, the puncture needle tube 102 can be moved to the distal end or to the proximal end through the puncture needle tube adjusting mechanism 6.

[0080] As an embodiment, please refer to FIG. 7 and FIG. 8, the puncture needle tube adjusting mechanism 6 comprises a puncture needle tube sleeve 602 and an elastic clamping structure 601, the puncture needle tube sleeve 602 is located in the proximal shell 4 and is fixedly sleeved on the proximal end of the puncture needle tube 102; at least one side of the puncture needle tube sleeve 602 is provided with the elastic clamping structure 601, at least one side of the tube wall of the proximal shell 4 is axially provided with a puncture needle tube adjusting groove, and the elastic clamping structure 601 penetrates the puncture needle tube adjusting groove; the elastic clamping structure 601 comprises a button 6011 and at least one limiting column 6012 which are integrally arranged, and a plurality of limiting clamping grooves are arranged on at least one side groove wall of the puncture needle tube adjusting groove; in the natural state, the limiting column 6012 is located in the limiting clamping groove, the limiting column 6012 is separated from the limiting clamping groove into the proximal shell 4 by pressing the button 6011, and then the puncture needle tube 102 can be axially moved along the puncture needle tube adjusting groove with the button 6011.

[0081] In this embodiment, when the button 6011 is pressed, the limiting column 6012 is separated from the limiting clamping groove, and the puncture needle tube 102 can be arbitrarily moved along the puncture needle tube adjusting groove in the axial direction of the button 6011, so as to realize the position adjustment of the puncture needle tube 102 in the axial direction. After the button is released, the button is reset under the action of elasticity, the limiting column 6012 is inserted into the limiting clamping groove of the puncture needle tube adjusting groove, and the fixation of the puncture needle tube 102 is realized.

[0082] As an embodiment, after the puncture is completed, the puncture needle tube 102 is withdrawn through the puncture needle tube adjusting mechanism 6, so that the distal end of the atherectomy cutter tube 103 extends out of the distal end of the puncture needle tube 102, and the atherectomy cutter tube 103 starts to perform atherectomy. Of course, the way to make the distal end of the atherectomy cutter tube 103 extend out of the distal end of the puncture needle tube 102 is not limited to withdrawing the puncture needle tube 102, but can also be directly extending the distal end of the atherectomy cutter tube 103 out of the distal end of the puncture needle tube 102. As an embodiment, the distal end of the atherectomy cutter tube 103 is extended out of the distal end of the puncture needle tube 102 by driving the atherectomy cutter tube transmission assembly 7.

[0083] In order to identify the distance of the withdrawal of the puncture needle tube 102, an adjusting scale is arranged on the outside of the puncture needle tube adjusting groove.

[0084] In order to facilitate manual operation, preferably, an elastic clamping structure 601 is arranged on each of the two corresponding outer sides of the puncture needle tube sleeve 602, and the elastic clamping structure 601 is arranged along the radial direction of the puncture needle tube sleeve 602. A puncture needle tube adjusting groove is formed in the tube wall of the proximal end housing 4 along the axial direction on each of the two corresponding sides, and the two elastic clamping structures 601 respectively penetrate the two puncture needle tube adjusting grooves. A plurality of limiting clamping grooves are arranged on the groove walls on both sides of the puncture needle tube adjusting groove. Correspondingly, a limiting column 6012 is arranged on each of the two sides of the button 6011, and the button 6011 and the limiting columns 6012 on both sides thereof are arranged along the circumferential direction of the puncture needle tube sleeve 602. In the natural state, the limiting columns 6012 on both sides of the button 6011 are respectively located in a limiting clamping groove on the groove wall on each side of the puncture needle tube adjusting groove. When the button 6011 needs to be pressed, the operator presses the two buttons 6011 with two fingers at the same time, so as to realize the disengagement of the limiting columns 6012 and the limiting clamping grooves, and then push the button 6011 to realize the position adjustment of the puncture needle tube 102.

[0085] In an embodiment, the center of the puncture needle tube sleeve 602 is provided with a mounting hole 6021 along the axial direction, the puncture needle tube 102 penetrates the mounting hole 6021 and is fixed with the mounting hole 6021; the proximal end of the tube wall of the puncture needle tube sleeve 602 on at least one side of the mounting hole 6021 is provided with a hollow area 6022, the outside of the hollow area 6022 is provided with an elastic pressing strip 6013, the elastic pressing strip 6013 is arranged along the axial direction of the puncture needle tube sleeve 602, and the distal end of the elastic pressing strip 6013 is fixedly connected with the puncture needle tube sleeve 602, the elastic clamping structure 601 is fixed on the proximal end of the elastic pressing strip 6013, pressing the button 6011, the limiting column 6012 moves with the proximal end of the elastic pressing strip 6013 to the hollow area 6022, so that the limiting column 6012 is disengaged from the limiting clamping groove.

[0086] The tube 103 is a tubular structure, which is the innermost layer of the distal tube part of the biopsy needle. The distal end of the tube 103 is provided with a ring-shaped cutting edge, which ensures that the tube 103 can smoothly cut the tissue. The ring-shaped cutting edge is preferably provided with a flat mouth structure, which is used to ensure the integrity of the tissue after the cutting, so that the tissue is not disintegrated and the pathological analysis is not affected.

[0087] As an embodiment, referring to FIG. 9, the ring-shaped cutting edge at the distal end of the tube 103 is an outer blade cutting edge 1031 formed by removing the inner corner of the distal end face of the tube 103. The outer blade cutting edge 1031 is used for cutting low-density tissue.

[0088] As another embodiment, referring to FIG. 10, the ring-shaped cutting edge at the distal end of the tube 103 is an inner blade cutting edge 1031' formed by removing the outer corner of the distal end face of the tube 103. The inner blade cutting edge 1031' is used for cutting high-density tissue.

[0089] In a specific embodiment, referring to FIG. 11, the tube 103 includes a distal metal tube 1032, a metal wire spring tube 1033, a proximal metal tube 1035, and a high-molecular sealing tube 1034. The distal metal tube 1032 and the proximal metal tube 1035 are both metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1032 is a ring-shaped cutting edge. The distal metal tube 1032 is made of metal, which can ensure that the tube 103 can smoothly cut the tissue. The proximal metal tube 1035 is also made of metal, which is used to facilitate its assembly and fixation. The metal wire spring tube 1033 is a hollow tube woven by metal wires. The metal wires are made of stainless steel or nickel-titanium structure. In the bent state, the metal wire spring tube 1033 can flexibly transmit the rotation speed and torque, and effectively reduce the vibration. The proximal end of the distal metal tube 1032 and the distal end of the metal wire spring tube 1033 are connected by end face welding process, which ensures that the outer diameter and the inner diameter of the distal metal tube 1032 and the metal wire spring tube 1033 are basically consistent.

[0090] On the outside of the tube 103, a thin-walled high-molecular sealing tube 1034 is provided, which can be a thin-walled heat shrink tube. The thin-walled heat shrink tube is fixed on the outside of the tube 103 by heat shrink process, which realizes the sealing of the tube 103, so that the internal cavity can transmit negative pressure or positive pressure, and avoid leakage at the welding position, the gap between the woven tubes, etc. At the same time, the thin-walled heat shrink tube can reduce the friction between the tube 103 and the puncture needle tube during rotation, and avoid the abrasion of the woven metal wires of the tube 103.

[0091] The proximal metal tube 1035 is wrapped on the proximal outside of the high-molecular sealing tube 1034, and the fixation of the proximal metal tube 1035 and the high-molecular sealing tube 1034 can be completed by bonding or other methods. In this way, a sealed tube cavity with only two outlets can be formed in the inside of the tube 103.

[0092] As an embodiment, the metal wire spring tube 1033, the polymer sealing tube 1034 and the proximal end metal tube 1035 are flush at the proximal end surface.

[0093] In the art, in order to realize the flexible rotation of the rotary cutter tube 103, the rotary cutter tube 103 realizes the flexible transmission of torque and rotation speed through the rotary cutter soft shaft of the metal wire spring tube 103, but in the state without rigid support, the metal wire spring tube 103 is very easy to vibrate, which affects the sampling effect. In the present application, the puncture needle tube 102 is sleeved outside the rotary cutter tube 103, and the inner diameter of the puncture needle tube 102 is slightly larger than the outer diameter of the rotary cutter tube 103, so that the puncture needle tube 102 can play a role similar to a sliding bearing. When the rotary cutter tube 103 rotates, the rotary cutter tube 103 rotates in the inner cavity of the puncture needle tube 102, avoiding the vibration of the rotary cutter tube 103, thereby providing rigid support for the rotary cutter tube 103 and improving the stability of the rotary cutter tube 103 when rotating.

[0094] The outer surface of the rotary cutter tube 103 is covered with a polymer sealing tube 1034, and the polymer sealing tube 1034 is at least sealingly sleeved on the metal wire spring tube 1033 and the connection between the metal wire spring tube 1033 and the distal end metal tube 1032.

[0095] In order to reduce the friction between the rotary cutter tube 103 and the puncture needle tube 102 when rotating, and avoid the wear of the woven metal wire of the rotary cutter tube 103, the polymer sealing tube 1034 is a heat shrink tube formed by fixing a polymer tube material on the outer surface of the rotary cutter tube 103 through a heat shrink process. The heat shrink tube can also improve the torsional performance and sealing performance of the metal wire spring tube 1033 without losing the bending performance.

[0096] In order to increase the adhesion of the cut tissue and avoid the shedding of the cut and sampled tissue, the inner wall surface of the rotary cutter tube 103 is provided with a rough surface that increases the friction coefficient, such as a threaded surface.

[0097] In order to improve the effect of ultrasonic imaging, the outer surface of the distal end metal tube 1032 is provided with a second ultrasonic reflection area, which requires an uneven pattern. As for the pattern shape of the second ultrasonic reflection area, the present application does not make specific limitation, such as increasing the roughness of the outer surface of the distal end metal tube 1032 through thread, dotting and other processes to improve the imaging effect of the rotary cutter tube 103 under ultrasonic.

[0098] In the present application, please refer to Fig. 3, the proximal handheld part further comprises a rotary cutting knife tube transmission assembly 7, which is installed in the proximal shell 4, and is connected with the rotary cutting knife tube 103. The rotary cutting knife tube 103 is driven by the rotary cutting knife tube transmission assembly 7 to perform rotary cutting on the tissue.

[0099] By driving the rotary cutting knife tube transmission assembly 7, the rotary cutting knife tube transmission assembly 7 drives the rotary cutting knife tube 103 to perform rotary cutting, which is a mature technology in the field. Therefore, the present application does not limit the specific structure of the rotary cutting knife tube transmission assembly 7. Any technical solution that can drive the rotary cutting knife tube transmission assembly 7 to drive the rotary cutting knife tube 103 to perform rotary cutting is applicable to the present application.

[0100] Since the rotary cutting knife tube transmission assembly 7 can drive the rotary cutting knife tube 103 to rotate and perform rotary cutting on the tissue, and can also adjust the axial stroke of the rotary cutting knife tube 103 to adjust the cutting depth of the rotary cutting knife tube 103. As an embodiment, the rotary cutting knife tube transmission assembly 7 comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, both of which are connected with the rotary cutting knife tube 103. The circumferential rotation transmission mechanism drives the rotary cutting knife tube 103 to rotate to make the rotary cutting knife tube 103 cut the tissue. The axial movement transmission mechanism drives the rotary cutting knife tube 103 to move axially to adjust the axial stroke of the rotary cutting knife tube 103, thereby adjusting the cutting depth of the rotary cutting knife tube 103.

[0101] As an embodiment, please refer to Fig. 12, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve 702 located in the proximal shell 4. The mandrel assembly is fixedly sleeved on the rotary cutting knife tube 103. The rotary shaft sleeve 702 is sleeved on the mandrel assembly and is axially slidably connected with the mandrel assembly while being circumferentially fixedly connected with the mandrel assembly. The rotary shaft sleeve 702 is coaxially fixedly connected with a rotary gear 701. The rotary gear 701 is driven by a rotary drive motor to make the rotary gear 701 drive the rotary shaft sleeve 702 to rotate.

[0102] Since the rotary shaft sleeve 702 and the mandrel assembly are axially slidably connected and circumferentially relatively fixedly connected by being sleeved with each other, which is a conventional technical means in the mechanical field. Therefore, the present application does not limit the specific connection structure of the rotary shaft sleeve 702 and the mandrel assembly.

[0103] As an embodiment, the mandrel assembly comprises a fixed tube 708 and an inner cutter sleeve 706, the fixed tube 708 is fixedly sleeved on the rotary cutter tube 103, the inner cutter sleeve 706 is fixedly sleeved on the fixed tube 708, the rotary sleeve 702 is sleeved on the inner cutter sleeve 706, the rotary sleeve 702 and the inner cutter sleeve 706 are axially slidably connected and circumferentially fixedly connected through the axial protrusions inserted into the axial guide grooves.

[0104] In a specific implementation, the inner wall of the rotary sleeve 702 is circumferentially spaced with a plurality of protrusions, and the protrusions are arranged along the axial direction of the rotary sleeve 702; the outer wall of the inner cutter sleeve 706 is circumferentially spaced with a plurality of guide grooves matched with the protrusions, and the guide grooves are arranged along the axial direction of the inner cutter sleeve 706. By inserting the protrusions into the guide grooves, the rotary sleeve 702 and the inner cutter sleeve 706 are axially slidably connected and circumferentially fixedly connected, that is, the rotary sleeve 702 and the inner cutter sleeve 706 can axially slide relative to each other and synchronously rotate in the circumferential direction. Of course, the protrusions can also be arranged on the outer wall of the inner cutter sleeve 706, and the guide grooves can be arranged on the inner wall of the rotary sleeve 702. This embodiment does not specifically limit this.

[0105] The axial movement transmission mechanism comprises a screw sleeve 703 and a transmission screw 704, the screw sleeve 703 is sleeved on the transmission screw 704 and is in threaded engagement with the transmission screw 704 for transmission; the screw sleeve 703 is coaxially fixedly connected with a stroke gear 709, the stroke gear 709 is driven to rotate by a stroke drive motor, the stroke gear 709 drives the screw sleeve 703 to rotate, and the rotary motion of the screw sleeve 703 is converted into the axial movement of the transmission screw 704. The transmission screw 704 is sleeved on the rotary sleeve 702, and the mandrel assembly is axially fixed relative to the transmission screw 704 and circumferentially rotatably connected relative to the transmission screw 704.

[0106] As an embodiment, the proximal hand-held part further comprises a motor handle 5, the rotary drive motor and the stroke drive motor are both mounted in the motor handle 5, and the motor handle 5 is fixedly connected with the proximal shell 4. The rotary drive motor and the stroke drive motor directly control or control the rotary gear 701 and the stroke gear 709 through gear transmission to realize the rotation and forward and backward movement of the rotary cutter tube 103.

[0107] The screw sleeve 703 only rotates in the proximal shell 4 and does not axially move. In order to limit the axial movement of the screw sleeve 703 in the proximal shell 4, a positioning partition plate is arranged on the proximal shell 4 at the proximal end and the distal end of the screw sleeve 703, and the purpose is to limit the screw sleeve 703 between the two positioning partition plates to prevent axial movement.

[0108] In the embodiment, the transmission screw 704 is sleeved on the rotating shaft sleeve 702 and is fixedly connected with the mandrel assembly in the axial direction and is relatively rotatably connected in the circumferential direction.

[0109] As an embodiment, the inner cutter sleeve 706 is circumferentially rotatably connected with the transmission screw 704 through the annular limiting clamping member inserted into the annular limiting clamping slot.

[0110] In a specific implementation, the outer side of the inner cutter sleeve 706 is circumferentially provided with the annular limiting clamping slot 7061, and the inner side of the transmission screw 704 is circumferentially provided with the annular limiting clamping member 705 matched with the annular limiting clamping slot 7061. The annular limiting clamping member 705 is inserted into the annular limiting clamping slot 7061 to achieve the circumferential rotational connection and axial fixed connection between the transmission screw 704 and the inner cutter sleeve 706, that is, the inner cutter sleeve 706 can rotate relative to the transmission screw 704, but cannot be relatively displaced in the axial direction. Of course, the inner side of the transmission screw 704 can be circumferentially provided with the annular limiting clamping slot, and the outer side of the inner cutter sleeve 706 can be circumferentially provided with the annular limiting clamping member matched with the annular limiting clamping slot. The embodiment does not specifically limit this.

[0111] The inner wall of the proximal shell 4 is axially provided with a guide rail 8, and the transmission screw 704 is slidingly arranged on the guide rail 8. The transmission screw 704 is driven to move along the guide rail 8 by rotating the screw sleeve 703, so as to limit the axial movement distance of the transmission screw 704.

[0112] Working principle of the rotary biopsy needle:

[0113] Please refer to FIG. 13. Before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102. The outer sheath tube 101 is delivered into the working channel of the endoscope. When the outer sheath tube 101 reaches the designated position, the outer sheath tube 101 is fixed by the endoscope fixing member 2 and the endoscope.

[0114] During puncture, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal shell 4. By pushing the proximal shell 4 to the distal end, the puncture needle tube 102 and the rotary cutter tube 103 are together penetrated out of the distal end of the outer sheath tube 101 and puncture the tissue. Please refer to FIG. 14. During puncture, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102. After puncture, the sheath seat 301 and the proximal shell 4 are locked by the sheath seat locking member 302.

[0115] After the puncture is completed, the puncture needle tube 102 is withdrawn through the puncture needle tube adjusting mechanism 6, the distal end of the puncture needle tube 102 is withdrawn, the rotary cutter tube 103 is left in place, so that the distal end of the rotary cutter tube 103 protrudes from the distal end of the puncture needle tube 102, at this time, the wire spring tube 1033 of the rotary cutter tube 103 is completely located in the puncture needle tube 102, the distal end of the puncture needle tube 102 is located in front of the outer sheath tube 101, and is located between the proximal end and the distal end of the distal metal tube 1032 of the rotary cutter tube 103, please refer to FIG. 15. The rotary cutter tube 103 is driven by the rotary cutter tube transmission assembly 7 to perform rotary cutting sampling on the tissue.

[0116] Although the present application is disclosed as above, the present application is not limited to this. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present application, therefore the protection scope of the present application should be limited by the scope defined by the claims.

Claims

1. A rotary cutting biopsy needle comprising: The outer sheath tube is further provided with an endoscope fixing member, the endoscope fixing member comprises a lock sleeve and a locking member, the lock sleeve comprises an integrated connecting part and locking part, the connecting part is used for fixed connection with the endoscope, and the locking part is movably sleeved on the outer sheath tube and can axially slide on the outer sheath tube, and the locking part can be locked at any position of the outer sheath tube by the locking member.

2. The rotary cutting biopsy needle of claim 1 wherein, The connecting part is a first luer joint, the proximal end of the working channel of the endoscope is provided with a second luer joint matched with the first luer joint, and the first luer joint is connected with the second luer joint in a matched mode; the locking part is provided with an external thread, the locking member is a lock cap, the lock cap is internally provided with a threaded hole matched with the external thread of the locking part, and the locking part is clamped and fixed on the outer sheath tube by screwing the lock cap on the locking part.

3. The rotary cutting biopsy needle of claim 2 wherein, The proximal end hand-held part further comprises a puncture needle tube adjusting mechanism, the puncture needle tube is installed in the proximal end shell through the puncture needle tube adjusting mechanism, and the puncture needle tube is axially moved through the puncture needle tube adjusting mechanism.

4. The rotary cutting biopsy needle of claim 1 wherein, ​ ​ 5. The rotary cutting biopsy needle of claim 4 wherein, ​ ​ ​ 6. The rotary cutting biopsy needle of claim 4 wherein, ​ 7. The rotary cutting biopsy needle of claim 6 wherein, The puncture needle tube adjusting mechanism comprises a puncture needle tube sleeve and an elastic clamping structure, the puncture needle tube sleeve is located in the proximal end shell and fixedly sheaths the puncture needle tube, at least one side of the puncture needle tube sleeve is provided with the elastic clamping structure, at least one side of the tube wall of the proximal end shell is axially provided with a puncture needle tube adjusting slot, and the elastic clamping structure penetrates through the puncture needle tube adjusting slot; the elastic clamping structure comprises a button and at least one limiting column which are integrally arranged, and a plurality of limiting clamping grooves are arranged on at least one side groove wall of the puncture needle tube adjusting slot; in a natural state, the limiting column is located in the limiting clamping groove, the button is pressed to make the limiting column separate from the limiting clamping groove to the proximal end shell, and then the puncture needle tube can move along the puncture needle tube adjusting slot in the axial direction following the button.

8. The rotary cutting biopsy needle of claim 7 wherein, A mounting hole is axially arranged in the center of the puncture needle tube sleeve, the puncture needle tube penetrates through the mounting hole and is fixed with the mounting hole, the proximal end of at least one side tube wall of the puncture needle tube sleeve located in the mounting hole is provided with a hollow area, the outer side of the hollow area is provided with an elastic pressing strip, the elastic pressing strip is arranged in the axial direction of the puncture needle tube sleeve, the distal end of the elastic pressing strip is fixedly connected with the puncture needle tube sleeve, and the elastic clamping structure is fixed at the proximal end of the elastic pressing strip; the button is pressed, the limiting column moves to the hollow area following the proximal end of the elastic pressing strip, and the limiting column separates from the limiting clamping groove.

9. The rotary cutting biopsy needle of claim 4 wherein, The proximal end hand-held part further comprises a rotary cutting knife tube transmission assembly, the rotary cutting knife tube is connected in the proximal end shell through the rotary cutting knife tube transmission assembly, and the rotary cutting knife tube is driven to rotate and cut tissues by driving the rotary cutting knife tube transmission assembly.

10. The rotary cutting biopsy needle of claim 9 wherein, The rotary cutting knife tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the rotary cutting knife tube is driven to rotate and cut tissues by driving the circumferential rotation transmission mechanism; the rotary cutting knife tube is driven to move axially to adjust the cutting depth of the rotary cutting knife tube by driving the axial movement transmission mechanism.

11. The rotary cutting biopsy needle of claim 10 wherein, The circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve which are located in the proximal end shell, the mandrel assembly is fixedly sheathed on the rotary cutting knife tube, the rotary shaft sleeve is sheathed on the mandrel assembly and is in axial sliding connection and circumferential relative fixed connection with the mandrel assembly; a rotary gear is coaxially and fixedly connected on the rotary shaft sleeve, the rotary gear is driven by a rotary drive motor, so that the rotary gear drives the rotary shaft sleeve to rotate; The axial movement transmission mechanism comprises a screw sleeve and a transmission screw, the screw sleeve is rotationally arranged in the proximal end shell and is in threaded engagement transmission with the transmission screw; the screw sleeve is coaxially and fixedly connected with a stroke gear, the stroke gear is driven to rotate by a stroke drive motor, the stroke gear drives the screw sleeve to rotate, and the rotary motion of the screw sleeve is converted into the axial movement of the transmission screw; The transmission screw sleeve is sleeved on the rotating shaft sleeve and is axially fixed and circumferentially rotatably connected with the mandrel assembly.

12. The rotary cutting biopsy needle of claim 11 wherein, The mandrel assembly comprises a fixed tube and an inner cutter sleeve, the fixed tube is fixed on the rotary cutter tube, the inner cutter sleeve is fixed on the fixed tube, the rotating shaft sleeve is sleeved on the inner cutter sleeve, and the rotating shaft sleeve and the inner cutter sleeve are axially slidably connected through the axial protrusion inserted into the axial guide groove and circumferentially fixedly connected. The inner cutter sleeve and the transmission screw are circumferentially rotatably connected through the annular limiting clamping piece inserted into the annular limiting clamping groove and axially fixedly connected.

13. The rotary cutting biopsy needle of claim 12 wherein, The inner wall of the proximal end shell is further provided with a guide rail, and the transmission screw is slidably arranged on the guide rail.

14. The rotary cutting biopsy needle of claim 11 wherein, The proximal end handheld part further comprises a motor handle, the rotary drive motor and the stroke drive motor are both mounted in the motor handle, and the motor handle is fixedly connected with the proximal end shell.

15. The rotary cutting biopsy needle of claim 1 wherein, The rotary cutter tube comprises a distal end metal tube, a metal wire spring tube, a proximal end metal tube and a high polymer sealing tube, the distal end of the distal end metal tube is an annular blade, the proximal end surface of the distal end metal tube is fixedly connected with the distal end surface of the metal wire spring tube, the high polymer sealing tube is at least sleeved on the metal wire spring tube and the connection between the metal wire spring tube and the distal end metal tube, and the proximal end metal tube is fixedly sleeved on the proximal end of the high polymer sealing tube.

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