Negative pressure suction rotary cutting biopsy needle and biopsy system

Abstract

The present invention provides a negative pressure suction rotary cutting biopsy needle and a biopsy system. The biopsy needle comprises a distal pipeline portion and a proximal handheld portion. The distal pipeline portion comprises a rotary cutter tube, and the proximal handheld portion comprises a proximal housing and a rotary cutter tube transmission assembly. The rotary cutter tube is connected to the proximal housing by means of the rotary cutter tube transmission assembly, and by driving the rotary cutter tube transmission assembly, the rotary cutter tube rotates circumferentially and moves axially. The proximal end of the proximal housing is provided with a negative pressure interface configured to be in communication with a negative pressure apparatus, a connecting sleeve is arranged within the proximal housing, and the proximal end of the connecting sleeve is in sealing communication with the negative pressure interface. The proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and moreover, the connecting sleeve and the rotary cutter tube are dynamically sealed by means of a dynamic sealing member.

Description

Vacuum suction and rotation biopsy needle and biopsy system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and particularly relates to a vacuum suction and rotation biopsy needle and biopsy system. BACKGROUND

[0002] Biopsy is short for "biological examination of living tissue", also known as surgical pathology examination, which is 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 changes are observed under a microscope, and finally a clear pathological diagnosis can be given to guide targeted clinical 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 problems of low sampling efficiency and poor sample quality.

[0005] The rotation biopsy needle is different from the traditional biopsy needle, which has a rotary cutter tube driven by a motor to rotate, and replaces the traditional reciprocating puncture sampling with a rotary cutting method to improve the sampling efficiency and sample quality.

[0006] However, due to its structural reasons, the rotation biopsy needle cannot currently use negative pressure suction to assist sampling.

[0007] SUMMARY

[0008] To solve the above technical problems, an embodiment of the present application provides a negative pressure suction rotary biopsy needle, which comprises a distal pipeline part and a proximal handheld part, the distal pipeline part comprises a rotary cutter tube, the proximal handheld part comprises a proximal shell and a rotary cutter tube transmission assembly, the rotary cutter tube is connected in the proximal shell through the rotary cutter tube transmission assembly, and the rotary cutter tube is made to rotate circumferentially and move axially by driving the rotary cutter tube transmission assembly; a negative pressure interface for communicating with a negative pressure device is opened at the proximal end of the proximal shell, a connecting sleeve is arranged in the proximal shell, the proximal end of the connecting sleeve is in sealed communication with the negative pressure interface, the proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and dynamic sealing is performed between the connecting sleeve and the rotary cutter tube through a dynamic sealing element.

[0009] Preferably, the dynamic sealing element is a sealing ring, the outer periphery of the sealing ring is in sealed connection with the inner periphery of the connecting sleeve, or the sealing ring is fixed on the distal end face of the connecting sleeve; the proximal end of the rotary cutter tube is inserted into the sealing ring and dynamically sealed with the sealing ring.

[0010] Preferably, the sealing ring is a generic sealing ring or a silica gel sealing ring.

[0011] Preferably, the rotary cutter tube comprises a distal metal tube, a metal wire spring tube, a proximal metal tube and a high polymer sealing tube, the distal end of the distal metal tube is an annular blade, the proximal end face of the distal metal tube is fixedly connected with the distal end face of the metal wire spring tube; the high 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 metal tube; the proximal metal tube is fixedly sleeved on the proximal end of the high polymer sealing tube.

[0012] Preferably, the distal pipeline part further comprises an outer sheath tube and a puncture needle tube, the puncture needle tube movably sheaths the rotary cutter tube, and the outer sheath tube movably sheaths the puncture needle 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; when puncturing, the puncture needle tube and the rotary cutter tube are together punctured out of the distal end of the outer sheath tube to puncture tissue, and in the process of puncture, the distal end of the rotary cutter tube is always located in the puncture needle tube; after puncture, the rotary cutter tube is stretched out of the distal end of the puncture needle tube to rotate and sample the tissue.

[0013] Preferably, the outer sheath is further provided with an endoscope fixing member, the endoscope fixing member comprises a locking sleeve and a locking member, the locking 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 and can axially slide on the outer sheath, and the locking part can be locked at any position of the outer sheath by the locking member.

[0014] 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 provided with external threads, the locking member is a locking cap, the locking cap is internally 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 by screwing the locking cap on the locking part.

[0015] Preferably, the proximal end hand-held part further comprises a puncture depth adjusting mechanism, the puncture depth adjusting mechanism comprises a sheath seat and a sheath seat locking member, the sheath seat is fixed with the proximal end of the outer sheath, and the proximal end shell can axially move relative to the sheath seat.

[0016] During puncture, the proximal end shell is pushed to the distal end, so that the puncture needle tube and the rotary cutting knife tube are simultaneously taken out from the distal end of the outer sheath and puncture the tissue, and after puncture, the proximal end shell is locked with the sheath seat by the sheath seat locking member.

[0017] 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, and the proximal end of the sheath seat movably sleeves on the proximal end shell.

[0018] The proximal end of the sheath seat is provided with external threads, the sheath seat locking member is a locking cap, the locking cap is internally provided with an internal thread hole matched with the external threads of the sheath seat, the sheath seat clamps the proximal end shell by screwing the internal thread hole of the locking cap on the external threads of the sheath seat, or one side wall of the sheath seat is provided with a threaded hole, the sheath seat locking member is a threaded fastener matched with the threaded hole, one end of the threaded fastener passes through the threaded hole into the sheath seat, and the threaded fastener is abutted against the proximal end shell by screwing the threaded fastener.

[0019] Preferably, 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 by the puncture needle tube adjusting mechanism, and the puncture needle tube is axially moved by the puncture needle tube adjusting mechanism.

[0020] 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 sheathed on 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 key and at least one limiting column which are integrally arranged, and a plurality of limiting clamping grooves are arranged on at least one side of the tube wall of the puncture needle tube adjusting slot; in a natural state, the limiting column is located in the limiting clamping groove, the limiting column is separated from the limiting clamping groove into the proximal end shell by pressing the key, and then the puncture needle tube can move axially along the puncture needle tube adjusting slot following the key.

[0021] 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 of the tube wall of the puncture needle tube sleeve located at 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, 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 limiting column moves to the hollow area following the proximal end of the elastic pressing strip by pressing the key, so that the limiting column is separated from the limiting clamping groove.

[0022] Preferably, 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 by driving the circumferential rotation transmission mechanism, so that the rotary cutting knife tube cuts the tissue; the rotary cutting knife tube is driven to move axially by driving the axial movement transmission mechanism, so as to adjust the cutting depth of the rotary cutting knife tube.

[0023] Preferably, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve, the mandrel assembly is fixedly sheathed on the rotary cutting knife tube, the rotary shaft sleeve is sheathed on the mandrel assembly and is axially slidably connected with the mandrel assembly and is circumferentially relatively fixedly connected 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.

[0024] 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 to rotate by a stroke driving motor, the stroke gear drives the screw sleeve to rotate, and the rotation of the screw sleeve is converted into axial movement of the transmission screw.

[0025] The transmission screw sleeve is arranged on the rotating shaft sleeve and is axially fixedly connected with the mandrel assembly and is rotationally connected with the mandrel assembly.

[0026] Preferably, the mandrel assembly comprises a fixed tube and an inner cutter sleeve, the fixed tube is fixedly arranged on the rotary cutter tube, the inner cutter sleeve is fixedly arranged on the fixed tube, the rotating shaft sleeve is arranged on the inner cutter sleeve, and the rotating shaft sleeve and the inner cutter sleeve are axially slidably connected and circumferentially fixedly connected through axial protrusions inserted into axial guide grooves.

[0027] The inner cutter sleeve and the transmission screw are circumferentially rotationally connected and axially fixedly connected through annular limiting clamps inserted into annular limiting clamp grooves.

[0028] Preferably, 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.

[0029] Preferably, the proximal end handheld portion further comprises a motor handle, the rotation driving motor and the stroke driving motor are both arranged in the motor handle, and the motor handle is fixedly connected with the proximal end shell.

[0030] Another embodiment of the present application provides a negative pressure suction rotary cutting biopsy system comprising the negative pressure suction rotary cutting biopsy needle and the negative pressure device of the above-mentioned embodiments, and the negative pressure device performs negative pressure suction on the tissue in the rotary cutter tube through the negative pressure interface.

[0031] Preferably, the negative pressure suction rotary cutting biopsy system further comprises a syringe, after sampling is completed, the syringe injects physiological saline into the rotary cutter tube through the negative pressure interface to flush out the tissue sample in the rotary cutter tube.

[0032] Preferably, the system further comprises a three-way joint, the three-way joint comprises a first interface, a second interface and a third interface, the first interface is used for communication with the negative pressure interface, the second interface is used for connecting the negative pressure device, the third interface is used for connecting the syringe, the three-way joint is provided with an adjusting switch, and the first interface realizes switching of the passageway with the second interface and the third interface through the adjusting switch.

[0033] Preferably, the negative pressure suction rotary biopsy system further comprises a main machine, the main machine comprises a main control module, the main control module is electrically connected with the negative pressure device through a negative pressure driving module, and the negative pressure size of the negative pressure device is controlled.

[0034] Compared with the prior art, the technical scheme of the embodiment of the application has the following beneficial effects:

[0035] The negative pressure interface is in sealed communication with a connecting sleeve, the connecting sleeve is arranged in the proximal end shell, the rotary cutter tube is inserted into the connecting sleeve, and dynamic sealing is performed between the connecting sleeve and the rotary cutter tube through a dynamic sealing element, so that the sealing problem of the rotary cutter tube is solved, and negative pressure suction of the rotary biopsy needle is realized.

[0036] Further, the negative pressure suction can improve the sampling amount of the rotary cutter tube.

[0037] Further, through fine control of the negative pressure by the main machine, the negative pressure value can be gradually increased as the rotary cutter tube continuously advances during the sampling process, so that the negative pressure value in the early stage is prevented from being too high and the integrity of the tissue sample is prevented from being damaged.

[0038] Further, since the rotary cutter tube is a tubular structure and the distal end thereof is an annular blade, the tissue at the blade edge needs to be pulled off after sampling is completed.

[0039] Further, after sampling is completed, physiological saline is injected into the rotary cutter tube through the negative pressure interface, positive pressure is provided by the injected physiological saline, the tissue sample is flushed out of the rotary cutter tube, and damage to the sample caused by ejection of a rigid needle is avoided.

[0040] Further, in the present application, the distal pipeline part 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 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 cutter tube is always located in the puncture needle tube. After puncture, the rotary cutter tube extends from the distal end of the puncture needle tube to sample the tissue by rotary cutting. Since the distal end of the rotary cutter tube is located in the puncture needle tube during puncture, the rotary cutter tube can follow the puncture needle tube to penetrate into the human tissue, ensuring the smoothness of the outer surface of the puncture needle tube and making it easier to puncture.

[0041] Further, in the present application, the outer sheath tube is the outermost layer of the distal pipeline part of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube and the rotary cutter 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 cutter tube is placed in the puncture needle tube. During the transportation of the outer sheath tube into the working channel of the endoscope, the puncture needle or the rotary cutter is prevented from damaging the endoscope.

[0042] Further, in order to realize the flexible rotation of the rotary cutter tube, the rotary cutter tube realizes the flexible transmission of torque and rotation speed through the rotary soft shaft of the metal wire spring tube. However, without rigid support, the metal wire spring tube is prone to shaking, which affects the sampling effect. In the present application, the puncture needle tube is sleeved outside the rotary cutter tube, and the inner diameter of the puncture needle tube is slightly larger than the outer diameter of the rotary cutter tube. Therefore, the puncture needle tube can function as a sliding bearing. When the rotary cutter tube rotates, the rotary cutter tube rotates in the inner cavity of the puncture needle tube, avoiding shaking of the rotary cutter tube, thereby providing rigid support for the rotary cutter tube and improving the stability of the rotary cutter tube during rotation.

[0043] Further, the conventional biopsy needle is usually fixed by a proximal shell and an endoscope and is uniformly operated by an endoscope operator. However, the rotary biopsy needle has a motor, and the weight of the motor handle and the proximal shell after assembly is relatively large. If the conventional fixing method is adopted, the fixation of the proximal shell and the endoscope will greatly increase the difficulty of mirror operation and operation for the endoscope operator. In the present application, the endoscope is fixed directly with the outer sheath tube through the endoscope fixing part on the outer sheath tube, and the proximal shell and the motor handle are held and operated by another special operator. Therefore, the holding and operation of the endoscope are separated from the holding and operation of the proximal shell, which reduces the operation difficulty and increases the adjustment range of the intervention depth of the outer sheath tube.

[0044] Of course, any product implementing the present application does not necessarily need to achieve all the advantages described above. BRIEF DESCRIPTION OF DRAWINGS

[0045] In order to make the technical solutions in the embodiments of the present application or the prior art clearer, the accompanying drawings needed in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description only need to be some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort.

[0046] Fig. 1 is a structural schematic diagram of a rotary biopsy needle according to an embodiment of the present application;

[0047] Fig. 2 is a structural schematic diagram of a distal pipeline part according to an embodiment of the present application;

[0048] Fig. 3 is a structural schematic diagram of the rotary biopsy needle before puncture according to an embodiment of the present application;

[0049] Fig. 4 is a structural schematic diagram of the rotary biopsy needle after puncture according to an embodiment of the present application;

[0050] Fig. 5 is a structural schematic diagram of an endoscope fixing member according to an embodiment of the present application;

[0051] Fig. 6 is a structural schematic diagram of a puncture needle tube according to an embodiment of the present application;

[0052] Fig. 7 is an axial view of a puncture needle tube adjusting mechanism according to an embodiment of the present application;

[0053] Fig. 8 is an end view of the puncture needle tube adjusting mechanism according to an embodiment of the present application;

[0054] Fig. 9 is a structural schematic diagram of a rotary cutter tube with an outer blade edge according to an embodiment of the present application;

[0055] Fig. 10 is a structural schematic diagram of a rotary cutter tube with an inner blade edge according to an embodiment of the present application;

[0056] Fig. 11 is a structural schematic diagram of a rotary cutter tube according to an embodiment of the present application;

[0057] Fig. 12 is a structural schematic diagram of a rotary cutter tube transmission assembly according to an embodiment of the present application;

[0058] Fig. 13 is a position schematic diagram of an outer sheath tube, a puncture needle tube and a rotary cutter tube before puncture according to an embodiment of the present application;

[0059] Fig. 14 is a position schematic diagram of the outer sheath tube, the puncture needle tube and the rotary cutter tube during puncture according to an embodiment of the present application;

[0060] Fig. 15 is a position schematic diagram of the outer sheath tube, the puncture needle tube and the rotary cutter tube during sampling according to an embodiment of the present application. DETAILED DESCRIPTION

[0061] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. 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 the present application.

[0062] The terms "first", "second", "third", "fourth" and the like (if any) in the specification and claims of the present application and the above-described drawings are used to distinguish similar objects, and do not necessarily indicate a specific order or 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 an order other than those 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 including a series of steps or units does not necessarily have to be limited to those steps or units clearly listed, but can include other steps or units not clearly listed or inherent to these 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.

[0063] As described in the background, due to the structure of the existing rotary biopsy needle, it cannot realize the sealing of the rotary cutter tube on the basis of meeting the normal rotation and forward and backward movement of the rotary cutter tube, and thus cannot realize the negative pressure suction of the rotary cutter tube.

[0064] In order to solve the above technical problems, the present application provides a negative pressure suction rotary biopsy needle, which comprises a distal pipeline part and a proximal handheld part, the distal pipeline part comprises a rotary cutter tube, the proximal handheld part comprises a proximal shell and a rotary cutter tube transmission assembly, the rotary cutter tube is connected in the proximal shell through the rotary cutter tube transmission assembly, and the rotary cutter tube is driven to rotate circumferentially and move axially by driving the rotary cutter tube transmission assembly; a negative pressure interface for communicating with a negative pressure device is opened at the proximal end of the proximal shell, a connecting sleeve is arranged in the proximal shell, the proximal end of the connecting sleeve is in sealed communication with the negative pressure interface, the proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and dynamic sealing is performed between the connecting sleeve and the rotary cutter tube through a dynamic sealing element.

[0065] The present invention provides a negative pressure interface at the proximal end of the proximal shell, which is sealed and connected to a connecting sleeve. The connecting sleeve is located inside the proximal shell. The rotary cutting tube is inserted into the connecting sleeve and dynamically sealed with the connecting sleeve through a dynamic sealing element. Therefore, the sealing problem of the rotary cutting tube is solved, thereby realizing the negative pressure aspiration of the rotary cutting biopsy needle.

[0066] Furthermore, negative pressure suction can increase the sampling volume of the rotary cutter tube. During sampling, as the amount of tissue inside the rotary cutter tube increases, the friction between the tissue and the tube also increases. This frictional resistance can prevent the sample tissue from penetrating deeper into the tube, thus limiting the amount of sample tissue obtained. The suction provided by negative pressure can overcome this frictional resistance, drawing more sample tissue into the cutter's cavity and increasing the sampling volume.

[0067] Meanwhile, through the host's precise control of negative pressure, the negative pressure value can be gradually increased as the rotary cutting tube advances during the sampling process, avoiding excessively high negative pressure values ​​in the early stages that could damage the integrity of the tissue sample.

[0068] Because the rotary cutter tube has a tubular structure with a ring-shaped blade at its distal end, the tissue at the blade edge needs to be broken after sampling to complete the sampling. For some tissue structures that are difficult to break, insufficient breaking force may occur, leading to sampling failure. Negative pressure suction can increase the breaking force of the rotary cutter tube when it retracts, ensuring that the tissue can be successfully broken.

[0069] After sampling is completed, physiological saline is injected into the rotary cutter tube through the negative pressure interface. The injection of physiological saline provides positive pressure, which flushes the tissue sample out of the rotary cutter tube, avoiding sample damage caused by using a rigid needle to push it out.

[0070] To make the above-mentioned objectives, features, and beneficial effects of the present invention more apparent and understandable, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0071] Example 1

[0072] Please refer to Fig. 1 and Fig. 2, the present application provides a kind of rotary biopsy needle, including distal end pipeline portion 1, the distal end pipeline portion 1 from outside to inside includes sheath tube 101, puncture needle tube 102 and rotary cutter tube 103 in turn, before puncture, the distal end of the puncture needle tube 102 is located in the sheath tube 101, the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102;When puncturing, the puncture needle tube 102 is together with the rotary cutter tube 103 from the distal end of the sheath tube 101 and is punctured to tissue, and in the process of puncture, 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 from the distal end of the puncture needle tube 102, and is sampled by rotary tissue.

[0073] Since in puncture, the distal end of rotary cutter tube 103 is located in puncture needle tube 102, therefore, rotary cutter tube 103 can follow puncture needle tube 103 and be penetrated into human tissue, guarantee the smoothness of the outer surface of puncture needle tube, and more easily puncture breakthrough.

[0074] In the present application, sheath tube 101 as the outermost layer of the distal end pipeline portion of biopsy needle, its inner cavity can accommodate puncture needle tube 102 and rotary cutter tube 103 completely, therefore, before puncture, the distal end of puncture needle tube 102 is placed in sheath tube 101, and the distal end of rotary cutter tube 103 is placed in puncture needle tube 102, in the process of sheath tube 101 being transported into the working channel of endoscope, avoid puncture needle or rotary cutter from damaging endoscope.

[0075] As an embodiment, rotary biopsy needle also includes proximal end hand-held portion, and the proximal end hand-held portion includes proximal end shell 4 and puncture depth adjusting mechanism 3, please refer to Fig. 3, the puncture depth adjusting mechanism 3 includes sheath seat 301 and sheath seat locking piece 302, the sheath seat 301 is fixed with the proximal end of the sheath tube 101, the proximal end shell 4 can be axially moved relative to sheath seat 301, and the sheath seat 301 can be locked with the proximal end shell 4 by the sheath seat locking piece 302.

[0076] The puncture needle tube 102 and the rotary cutting knife tube 103 are connected to 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 cutting knife 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, the puncture needle tube 102 and the rotary cutting knife tube 103 are pushed to the distal end together 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 cutting knife tube 103 is always located in the puncture needle tube 102, so that the rotary cutting knife tube 103 can follow the puncture needle tube 103 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.

[0077] 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 conveying performance.

[0078] 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 cutting 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.

[0079] In order to solve the above technical problems, the endoscope fixing member 2 on the outer sheath tube 101 is used to directly fix the outer sheath tube 101 and the endoscope, and the proximal end shell and the motor handle are held and operated by another special operator. 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.

[0080] As an embodiment, please refer to Fig. 5, the endoscope fixing member 2 includes a locking member 202 and a locking sleeve 201, the locking 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 is locked on the outer sheath tube 101 by the locking member 202.

[0081] The fixed connection mode of the connecting part 2011 and the endoscope is not limited in this embodiment, for example, threaded connection, clamping or other detachable fixed connection modes can be used. Meanwhile, the mode of locking the locking part 2013 on the outer sheath tube 101 by the locking member 202 is not limited in this embodiment, for example, a nut can be used for locking, a locking screw can also be used for locking, etc.

[0082] 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 in a matched manner.

[0083] In a specific embodiment, the connecting part 2011 and the locking part 2013 are coaxially fixedly connected through an 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, an internal thread joint is formed on the connecting part 2011, 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 and the external thread joint are fastened and connected 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 part 2013 is provided with a first lock cap, a threaded hole matched with the external thread of the locking part 2013 is formed in the first lock cap, and the first lock cap is tightened on the locking part 2013, so that the locking part 2013 clamps the outer sheath 101.

[0084] 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 provided with a plurality of pressing strips which movably sleeve on the outer sheath 101, the first lock cap is designed into a tapered structure which is gradually narrowed 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.

[0085] During transportation, the endoscope is fixedly connected with the connecting part 2011, and the first lock cap is in a loosened state, so that 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 the locking part 2013 will be clamped with the outer sheath 101 by being locked and contracted with the first lock cap, so that the outer sheath 101 and the endoscope are fixed.

[0086] Since the locking part 2013 can move axially relative to the outer sheath 101, the endoscope fixing part 2 can be locked at any position of the outer sheath 101, thereby expanding the adjustment range of the intervention length of the outer sheath 101.

[0087] Since the technical scheme of adjusting and locking between two components by cooperating the locking piece 202 with the locking sleeve 201 belongs to the relatively mature technology in the mechanical field, therefore, any technical scheme of adjusting and locking between the outer sheath tube 101 and the endoscope by cooperating the locking piece 202 with the locking sleeve 201 is within the protection scope of the present application.

[0088] Similarly, since the sheath seat 301 and the sheath seat locking piece 302 of the puncture depth adjusting mechanism 3 are also the technical scheme of adjusting and locking between two components by cooperating, which belongs to the relatively mature technology in the mechanical field, therefore, the specific structure of the sheath seat 301 and the sheath seat locking piece 302 is not limited, any technical scheme of adjusting and locking between the outer sheath tube 101 and the proximal shell 4 by cooperating the sheath seat 301 with the sheath seat locking piece 302 is within the protection scope of the present application.

[0089] As an embodiment, the sheath seat 301 is a sleeve structure, the distal end of the sheath seat 301 is coaxially fixedly connected with the proximal end of the outer sheath tube 101, the proximal end of the sheath seat 301 movably sheaths on the proximal shell 4, the proximal outer wall of the sheath seat 301 is provided with external threads, the sheath seat locking piece 302 is a second lock cap, the second lock cap is provided with a threaded hole matched with the external threads of the sheath seat 301, and the second lock cap is screwed on the sheath seat 301 to make the sheath seat 301 clamp the proximal shell 4.

[0090] The proximal end of the sheath seat 301 can be an elastic member such as a silica gel structure, and the second lock cap can press the elastic member to improve the fixing effect. The proximal end of the sheath seat 301 is not limited to the elastic member, and a plurality of pressing strips can be arranged at intervals and movably sheathed on the proximal shell 4, the second lock cap is designed as a tapered structure gradually tapering from the distal end to the proximal end, and the second lock cap is screwed with the sheath seat 301 to make the plurality of pressing strips fold and clamp the proximal shell 4, thereby achieving the locking connection between the sheath seat 301 and the proximal shell 4.

[0091] 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, and the outer sheath tube 101 is delivered into the working channel of the endoscope. When the outer sheath tube 101 reaches the specified 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 shell 4 is quickly pushed to the distal end, the proximal shell 4 will drive the distal ends of the puncture needle tube 102 and the rotary cutter tube 103 to penetrate out of the outer sheath tube 101, and puncture the obstacle tissue such as the bronchial wall. After the puncture is completed, the second lock cap is locked.

[0092] In order to facilitate the operation of the proximal shell 4 by the hand, an annular protrusion 401 is arranged on the outside of the proximal shell 4, and the annular protrusion 401 is pushed to achieve the purpose of quickly pushing the proximal shell 4 to the distal end.

[0093] In order to identify the puncture depth, a puncture depth scale is arranged on the proximal shell 4.

[0094] 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 a 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 passes through the threaded hole into the sheath seat, and the second end is located outside the sheath seat 301. By manually tightening the second end of the threaded fastener, the first end of the threaded fastener is pressed against the proximal shell 4, and the proximal shell 4 is fixed with the sheath seat 301. The threaded fastener is a lock screw or the like.

[0095] The puncture needle tube 102 is an intermediate layer of the distal tube part of the biopsy needle, and is made of metal material, such as 304L, 316L, etc. The thickness of the puncture needle should be as low as possible, usually <0.1mm, to increase the inner cavity for accommodating the cutting knife tube. Please refer to FIG. 6, the puncture needle tube 102 has a needle tip 1021, through which the puncture breakthrough can be realized.

[0096] 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 working channel of the biopsy needle passing from the curved state of the endoscope.

[0097] 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, and 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 is increased by thread, dotting and other processes, and the imaging effect of the puncture needle tube 102 under ultrasonic is improved.

[0098] In the present application, the proximal handheld part 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.

[0099] As an embodiment, referring 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 end shell 4 and fixedly sheathed 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 end shell 4 is axially provided with a puncture needle tube adjusting slot, and the elastic clamping structure 601 penetrates the puncture needle tube adjusting slot; 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 slot at intervals; in a natural state, the limiting column 6012 is located in the limiting clamping groove, the button 6011 is pressed to make the limiting column 6012 separate from the limiting clamping groove to the proximal end shell 4, and then the puncture needle tube 102 can move along the button 6011 in the axial direction of the puncture needle tube adjusting slot.

[0100] In this embodiment, when the button 6011 is pressed, the limiting column 6012 separates from the limiting clamping groove, and the puncture needle tube 102 can move along the button 6011 in the axial direction of the puncture needle tube adjusting slot, 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 slot, and the puncture needle tube 102 is fixed.

[0101] In the present application, 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 rotary cutter tube 103 extends from the distal end of the puncture needle, and then the rotary cutter tube 103 starts to implement the rotary cutting. Of course, the mode of making the distal end of the rotary cutter tube 103 extend from the distal end of the puncture needle is not limited to withdrawing the puncture needle tube 102, but also can be directly extending the distal end of the rotary cutter tube 103 from the distal end of the puncture needle tube 102, as an embodiment, the distal end of the rotary cutter tube 103 is extended from the distal end of the puncture needle tube 102 through the driving of the rotary cutter tube transmission assembly 7.

[0102] 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 slot.

[0103] 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 shell 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 that the limiting columns 6012 are separated from the limiting clamping grooves, and then the button 6011 is pushed to adjust the position of the puncture needle tube 102.

[0104] 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 on at least one side of the mounting hole 6021 of the puncture needle tube sleeve 602 is provided with a hollow area 6022, the outer side 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, 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 at the proximal end of the elastic pressing strip 6013, and pressing the button 6011 makes the limiting column 6012 move with the proximal end of the elastic pressing strip 6013 to the hollow area 6022, so that the limiting column 6012 is separated from the limiting clamping groove.

[0105] The rotary cutting knife tube 103 is a tubular structure, which is the innermost layer of the distal end tube part of the biopsy needle. The distal end of the rotary cutting knife tube 103 is provided with a ring-shaped knife edge, which ensures that the rotary cutting knife tube 103 can smoothly cut the tissue. The ring-shaped knife edge preferably adopts a flat mouth structure, which is used to ensure the integrity of the tissue after rotary cutting, so as not to be twisted and mashed, and affect the pathological analysis.

[0106] As an embodiment, referring to FIG. 9, the ring-shaped knife edge at the distal end of the rotary cutting knife tube 103 is an outer blade knife edge 1031 formed by removing the inner corner of the distal end face of the rotary cutting knife tube 103. The outer blade knife edge 1031 is used for cutting low-density tissue.

[0107] As another embodiment, please refer to FIG. 10, the annular blade at the distal end of the rotary cutter tube 103 is an inner blade edge 1031' formed by removing the outer corner of the distal end face of the rotary cutter tube 103, which is used for cutting high-density tissues.

[0108] In a specific embodiment, please refer to FIG. 11, the rotary cutter 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 an annular blade. The distal metal tube 1032 is made of metal, which can ensure that the rotary cutter tube 103 can smoothly cut tissues. The proximal metal tube 1035 is made of metal, which is convenient for 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. The metal wire spring tube 1033 can flexibly transmit rotary speed and torque in a bent state and effectively reduce 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.

[0109] On the outside of the rotary cutter tube 103, there is a thin-walled high-molecular sealing tube 1034, such as a thin-walled heat shrink tube, which is fixed on the outside of the rotary cutter tube 103 by heat shrink process to realize the sealing of the rotary cutter tube 103, so that the internal cavity can transmit negative pressure or positive pressure to 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 rotary cutter tube and the puncture needle tube when rotating, and avoid the wear of the woven metal wires of the rotary cutter tube.

[0110] The proximal metal tube 1035 is wrapped on the proximal outside of the high-molecular sealing tube 1034, which can be fixed by bonding or other methods. In this way, a sealed tube cavity with only two outlets can be formed inside the rotary cutter tube.

[0111] As an embodiment, the metal wire spring tube 1033, the high-molecular sealing tube 1034, and the proximal metal tube 1035 are flush at the proximal end face.

[0112] In the field, in order to realize the flexible rotation of the rotary cutting knife tube 103, the torque and rotation speed of the rotary cutting knife tube 103 are realized by the flexible transmission of the rotary cutting soft shaft of the wire spring tube 1033, but the wire spring tube 1033 is very easy to vibrate in the state without rigid support, which affects the sampling effect. In the application, the puncture needle tube 102 is sleeved outside the rotary cutting knife tube 103, and the inner diameter of the puncture needle tube 102 is slightly larger than the outer diameter of the rotary cutting knife tube 103, so that the puncture needle tube 102 can play a role similar to a sliding bearing. When the rotary cutting knife tube 103 rotates, the rotary cutting knife tube 103 rotates in the inner cavity of the puncture needle tube 102, avoiding the vibration of the rotary cutting knife tube 103, thereby providing rigid support for the rotary cutting knife tube 103 and improving the stability of the rotary cutting knife tube 103 when rotating.

[0113] The outer surface of the rotary cutting knife tube 103 is covered with a high-molecular sealing tube 1034, and the high-molecular sealing tube 1034 is at least sleeved on the wire spring tube 1033 and the connection between the wire spring tube 1033 and the distal end metal tube 1032.

[0114] In order to reduce the friction between the rotary cutting knife tube 103 and the puncture needle tube 102 when rotating, and avoid the wear of the woven wire of the rotary cutting knife tube 103, the high-molecular sealing tube 1034 is a heat shrink tube formed by fixing a high-molecular tube material on the outer surface of the rotary cutting knife tube 103 through a heat shrink process. The heat shrink tube can also improve the torsional performance and sealing performance of the wire spring tube 1033 without losing the bending performance.

[0115] 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 cutting knife tube 103 is provided with a rough surface that increases the friction coefficient, such as a threaded surface.

[0116] 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 application does not make specific limitations, such as increasing the roughness of the outer surface of the distal end metal tube 1032 by threading, dotting and other processes, and improving the imaging effect of the rotary cutting knife tube 103 under ultrasonic.

[0117] In the application, referring to FIG. 3, the proximal end handheld part further comprises a rotary cutting knife tube transmission assembly 7, which is installed in the proximal end shell 4, and the rotary cutting knife tube transmission assembly 7 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 cut the tissue.

[0118] The rotation cutting knife tube transmission assembly 7 drives the rotation cutting knife tube 103 to rotate and cut tissues, and can adjust the axial stroke of the rotation cutting knife tube 103 to adjust the cutting depth of the rotation cutting knife tube 103, which is mature technology in the field, and thus the specific structure of the rotation cutting knife tube transmission assembly 7 is not limited.

[0119] The rotation cutting knife tube transmission assembly 7 can drive the rotation cutting knife tube 103 to rotate and cut tissues, and can adjust the axial stroke of the rotation cutting knife tube 103 to adjust the cutting depth of the rotation cutting knife tube 103, which is mature technology in the field, and thus the specific structure of the rotation cutting knife tube transmission assembly 7 is not limited.

[0120] As an embodiment, referring to FIG. 12, the circumferential rotation transmission mechanism includes a mandrel assembly and a rotation shaft sleeve 702 in the proximal end shell 4, the mandrel assembly is fixedly sleeved on the rotation cutting knife tube 103, the rotation shaft sleeve 702 is sleeved on the mandrel assembly and is in axial sliding connection and circumferential relative fixed connection with the mandrel assembly, the rotation gear 701 is coaxially and fixedly connected on the rotation shaft sleeve 702, the rotation gear 701 is driven by a rotation driving motor to drive the rotation shaft sleeve 702 to rotate.

[0121] The rotation shaft sleeve 702 and the mandrel assembly are in axial sliding connection and circumferential relative fixed connection, which is a conventional technical means in the mechanical field, and thus the specific connection structure of the rotation shaft sleeve 702 and the mandrel assembly is not limited.

[0122] As an embodiment, the mandrel assembly includes a fixed tube 708 and an inner knife sleeve 706, the fixed tube 708 is fixedly sleeved on the rotation cutting knife tube 103, the inner knife sleeve 706 is fixedly sleeved on the fixed tube 708, the rotation shaft sleeve 702 is sleeved on the inner knife sleeve 706, and the rotation shaft sleeve 702 and the inner knife sleeve 706 are in axial sliding connection and circumferential fixed connection through the axial protrusion inserted into the axial guide groove.

[0123] In a specific implementation, the inner wall of the rotating sleeve 702 is provided with a plurality of protrusions spaced in the circumferential direction, and the protrusions are arranged in the axial direction of the rotating sleeve 702. The outer wall of the inner cutter sleeve 706 is provided with a plurality of guide grooves spaced in the circumferential direction, and the guide grooves are arranged in the axial direction of the inner cutter sleeve 706. The rotating sleeve 702 and the inner cutter sleeve 706 are axially slidably connected, circumferentially fixedly connected, that is, the rotating sleeve 702 and the inner cutter sleeve 706 can relatively slide in the axial direction and synchronously rotate in the circumferential direction, by inserting the protrusions into the guide grooves. 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 rotating sleeve 702. This embodiment does not specifically limit this.

[0124] The axial movement transmission mechanism includes 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 rotation of the screw sleeve 703 is converted into the axial movement of the transmission screw 704. The transmission screw 704 is sleeved on the rotating sleeve 702 and is fixedly connected with the mandrel assembly in the axial direction and rotatably connected in the circumferential direction.

[0125] As an embodiment, the proximal hand-held part further includes a motor handle 5. The rotating 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 rotating drive motor and the stroke drive motor directly control or control the rotating gear 701 and the stroke gear 709 through gear transmission, respectively, to realize the rotation and forward and backward movement of the rotary cutter tube 103.

[0126] The screw sleeve 703 only rotates in the proximal shell 4 and does not move axially. 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. The purpose is to limit the screw sleeve 703 between the two positioning partition plates to prevent axial movement.

[0127] In this embodiment, the transmission screw 704 is sleeved on the rotating sleeve 702 and is fixedly connected with the mandrel assembly in the axial direction and rotatably connected in the circumferential direction.

[0128] As an embodiment, the inner cutter sleeve 706 and the transmission screw 704 are circumferentially rotatably connected and axially fixedly connected by inserting an annular limiting clamp arranged in the circumferential direction into an annular limiting clamp groove.

[0129] In a specific implementation, the outer side of the inner cutter sleeve 706 is circumferentially provided with an annular limiting clamping groove 7061, and the inner side of the transmission screw 704 is circumferentially provided with an annular limiting clamping piece 705 matched with the annular limiting clamping groove 7061. The annular limiting clamping piece 705 is inserted into the annular limiting clamping groove 7061 to achieve the circumferential rotation connection between the transmission screw 704 and the inner cutter sleeve 706, and the axial fixed connection, that is, the inner cutter sleeve 706 and the transmission screw 704 can rotate relative to each other, but cannot have relative displacement in the axial direction. Of course, the inner side of the transmission screw 704 can be circumferentially provided with an annular limiting clamping groove, and the outer side of the inner cutter sleeve 706 can be circumferentially provided with an annular limiting clamping piece matched with the annular limiting clamping groove. The present embodiment does not specifically limit this.

[0130] An inner wall of the proximal end shell 4 is axially provided with a guide rail 8, and the transmission screw 704 is slidingly arranged on the guide rail 8. By driving the rotation of the screw sleeve 703, the transmission screw 704 moves along the guide rail 8, so as to limit the axial movement distance of the transmission screw 704.

[0131] Please refer to FIG. 12. The proximal end face of the proximal end shell 4 is provided with a negative pressure interface 401 for communicating with a negative pressure device. The proximal end of a connecting sleeve 9 in the proximal end shell 4 is in sealed communication with the negative pressure interface 401. The proximal end of the rotary cutting knife tube 103 is inserted into the connecting sleeve 9 from the distal end of the connecting sleeve 9, and the connecting sleeve 9 and the rotary cutting knife tube 103 are dynamically sealed by a dynamic sealing piece 10. When the rotary cutting knife tube 103 rotates and advances, the rotary cutting knife tube 103 moves from the proximal end to the distal end. The rotary cutting knife tube 103 always has a part of the tube segment located in the connecting sleeve 9 of the rotary cutting knife tube 103 and in contact with the dynamic sealing piece 10, forming a dynamic seal.

[0132] In the initial position, the present application does not limit the length of the rotary cutting knife tube 103 located in the connecting sleeve 9, and when the rotary cutting knife tube 103 moves from the proximal end to the distal end to the maximum cutting depth, the length of the rotary cutting knife tube 103 located in the connecting sleeve 9 is also not limited, which can be set according to the actual use requirement. In order to prevent the rotary cutting knife tube 103 from being separated from the connecting sleeve 9, as an embodiment, the size of the rotary cutting knife tube 103 in the connecting sleeve 9 is greater than 2 cm in the initial position.

[0133] Since the dynamic sealing piece 10 is a relatively mature technology in the field of mechanical fluid transmission, the present application does not limit the specific structure of the dynamic sealing piece 10.

[0134] As an embodiment, the dynamic sealing piece 10 is a sealing ring, such as a generic sealing ring or a silica gel sealing ring.

[0135] In one embodiment, the outer periphery of the sealing ring is in sealing connection with the inner periphery of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and in dynamic sealing connection with the sealing ring.

[0136] In another embodiment, the sealing ring is fixed on the distal end face of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and in dynamic sealing connection with the sealing ring, as shown in FIG. 12.

[0137] The inner surface of the dynamic sealing member 10 and the outer surface of the rotary cutter tube 103 should be as smooth as possible to reduce the frictional resistance caused by the sealing.

[0138] The negative pressure interface 401 is connected to one end of a negative pressure pipeline through a luer joint, and the other end of the negative pressure pipeline is connected to a negative pressure device. After the luer joint is screwed, the negative pressure can be transmitted from the negative pressure device to the distal end of the rotary cutter tube 103.

[0139] In order to facilitate assembly and fixation, the connecting sleeve 9 is made of a metal tube, such as a steel tube.

[0140] Working principle of the rotary biopsy needle:

[0141] As shown in 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 to the endoscope through the endoscope fixing member 2.

[0142] During puncture, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal housing 4, and by pushing the proximal housing 4 distally, the puncture needle tube 102 and the rotary cutter tube 103 are simultaneously pushed out from the distal end of the outer sheath tube 101 and puncture the tissue, as shown in 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 housing 4 are locked by the sheath seat locking member 302.

[0143] After puncture, the puncture needle tube 102 is withdrawn by the puncture needle tube adjusting mechanism 6, the distal end of the puncture needle tube 102 is withdrawn, and 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 metal 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, as shown in FIG. 15. The rotary cutter tube 103 is driven by the rotary cutter tube transmission assembly 7 to perform rotary cutting and sampling on the tissue.

[0144] Since the rotary cutter tube 103 is a tubular structure, its distal end is a ring-shaped blade, and after sampling is completed, the tissue at the blade edge needs to be pulled off to complete the sampling. Therefore, during sampling, the negative pressure device performs negative pressure suction on the rotary cutter tube 103 through the negative pressure interface 401, and the negative pressure suction can increase the pulling-off force of the rotary cutter tube 103 when it is retracted, thereby ensuring that the tissue can be successfully pulled off.

[0145] After sampling is completed, the syringe injects physiological saline into the rotary cutter tube 103 through the negative pressure interface 401, and the positive pressure provided by the injection of physiological saline can flush the tissue sample out of the rotary cutter tube 103.

[0146] Embodiment 2

[0147] The embodiment provides a negative pressure suction rotary cutting biopsy system, which comprises the negative pressure suction rotary cutting biopsy needle and the negative pressure device of embodiment 1, and the negative pressure device performs negative pressure suction on the tissue in the rotary cutter tube 103 through the negative pressure interface 401.

[0148] As an embodiment, the biopsy system further comprises a syringe, which injects physiological saline into the rotary cutter tube 103 through the negative pressure interface 401 after sampling is completed, so as to flush the tissue sample in the rotary cutter tube 103 out.

[0149] The negative pressure device and the syringe can share one interface or use separate interfaces connected with the negative pressure interface 401.

[0150] As an embodiment, the negative pressure interface 401 is further connected with a three-way joint, the three-way joint comprises a first interface, a second interface and a third interface, the first interface is used for communication with the negative pressure interface 401, the second interface is used for connecting the negative pressure device, and the third interface is used for connecting the syringe, an adjusting switch is arranged in the three-way joint, and the first interface realizes switching of the passageway with the second interface and the third interface through the adjusting switch. For example, when the adjusting switch is in gear I, the negative pressure suction of the negative pressure device can be transmitted to the distal end of the rotary cutter tube 103, so as to realize adsorption of the tissue; when the adjusting switch is in gear II, the syringe can flush the tissue in the rotary cutter tube 103 out for sampling, so as to ensure the integrity of the tissue.

[0151] The embodiment does not limit the specific type of the negative pressure device, which can be a negative pressure suction needle cylinder or a negative pressure pump. The following takes the negative pressure device as a negative pressure pump as an example to describe the adjusting method of the negative pressure size.

[0152] To adjust the negative pressure, the biopsy system also includes a host unit, which includes a main control module. The main control module is electrically connected to the negative pressure pump through a negative pressure drive module. The main control module controls the output of a DAC analog signal and outputs an adjustable pressure drive signal. Since the drive voltage of the negative pressure pump is linearly related to the flow rate, the negative pressure can be adjusted by controlling the drive voltage of the negative pressure pump, i.e., by controlling the flow rate of the negative pressure pump.

[0153] The main unit also has a negative pressure sensor to monitor the real-time negative pressure of the negative pressure pump and feed back the precise negative pressure value to the main control module. Based on the feedback negative pressure value, the main control module adjusts the negative pressure value by adjusting the flow rate of the negative pressure pump.

[0154] The main control module is also electrically connected to the rotary cutting drive motor and the stroke drive motor via the motor drive module. During sampling, the negative pressure is adjusted in three stages:

[0155] (1) In the initial stage, the negative pressure value is small, <10KPa, so that the annular blade of the rotary cutting tube 103 can be close to the tissue, which facilitates the annular blade of the rotary cutting tube 103 to cut and separate the tissue.

[0156] (2) During the sampling stage, the negative pressure value is gradually increased based on the cutting depth of the rotary cutting tube 103. For example, if the tube is screwed in 1mm, the negative pressure value can be increased by 1KPa. When the tube is screwed in 20mm, the negative pressure value increases to 30KPa. If the host finds that the torque of the rotary drive motor is significantly reduced (identified by the motor current), it indicates that the tissue inside the rotary cutting tube 103 is blocked and cannot penetrate deeply, causing the annular blade of the rotary cutting tube 103 to be unable to cut and separate the tissue. At this time, the negative pressure pump is controlled to increase the negative pressure value, allowing the tissue inside the rotary cutting tube 103 to move deeper into the inner cavity, so that there is space at the far end of the rotary cutting tube 103 to accommodate more tissue and increase the sampling volume.

[0157] (3) Sampling end and breakage stage: After sampling, the negative pressure pump provides a large negative pressure value, such as >30KPa, so that the sample tissue is completely separated by the superposition of the suction force and friction force of the negative pressure.

[0158] (4) During the sample collection stage, turn off the negative pressure, adjust the three-way connector, and inject physiological saline into the inner cavity of the rotary cutter tube 103 to flush out the sample tissue.

[0159] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the invention; therefore, the scope of protection of the present invention should be determined by the scope defined in the claims.

Claims

1. A negative pressure suction, rotary-cut biopsy needle, comprising: The application relates to a rotary cutting device, which comprises a distal pipeline part and a proximal handheld part, the distal pipeline part comprises a rotary cutting tube, the proximal handheld part comprises a proximal shell and a rotary cutting tube transmission assembly, the rotary cutting tube is connected in the proximal shell through the rotary cutting tube transmission assembly, the rotary cutting tube is driven to rotate and move axially by driving the rotary cutting tube transmission assembly; a negative pressure interface for communicating with a negative pressure device is arranged on the proximal end of the proximal shell, a connecting sleeve is arranged in the proximal shell, the proximal end of the connecting sleeve is in sealed communication with the negative pressure interface, the proximal end of the rotary cutting tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and dynamic sealing is realized between the connecting sleeve and the rotary cutting tube through a dynamic sealing element.

2. The negative pressure suction trephine biopsy needle according to claim 1, characterized in that The dynamic sealing element is a sealing ring, the outer periphery of the sealing ring is in sealed connection with the inner periphery of the connecting sleeve, or the sealing ring is fixed on the distal end face of the connecting sleeve; the proximal end of the rotary cutting tube is inserted into the sealing ring and dynamically sealed with the sealing ring.

3. The negative pressure suction trephine biopsy needle according to claim 2, characterized in that The sealing ring is a universal sealing ring or a silica gel sealing ring.

4. The negative pressure suction trephine biopsy needle according to claim 1, characterized in that The rotary cutting tube comprises a distal metal tube, a metal wire spring tube, a proximal metal tube and a high polymer sealing tube, the distal end of the distal metal tube is an annular blade, the proximal end face of the distal metal tube is fixedly connected with the distal end face of the metal wire spring tube; the high polymer sealing tube is arranged at least on the metal wire spring tube and the connection position of the metal wire spring tube and the distal metal tube; the proximal metal tube is fixedly arranged on the proximal end of the high polymer sealing tube.

5. The negative pressure suction trephine biopsy needle according to claim 1, wherein, The distal pipeline part further comprises an outer sheath tube and a puncture needle tube, the puncture needle tube is movably sleeved on the rotary cutting tube, and the outer sheath tube is movably sleeved on the puncture needle 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 tube is located in the puncture needle tube; during puncture, the puncture needle tube and the rotary cutting tube are simultaneously taken out from the distal end of the outer sheath tube to puncture tissues, and the distal end of the rotary cutting tube is always located in the puncture needle tube during the puncture process; after puncture, the rotary cutting tube is taken out from the distal end of the puncture needle tube to rotate and sample tissues.

6. The negative pressure suction trephine biopsy needle according to claim 5, characterized in that An endoscope fixing element is further arranged on the outer sheath tube, the endoscope fixing element comprises a lock sleeve and a locking element, 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 element.

7. The negative pressure suction trephine biopsy needle according to claim 6, characterized in that 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 matched and connected with the second luer joint; an outer thread is arranged on the locking part, the locking element is a lock cap, a threaded hole matched with the outer thread of the locking part is arranged in the lock cap, and the lock cap is screwed on the locking part to clamp and fix the locking part on the outer sheath tube.

8. The negative pressure suction trephine biopsy needle according to claim 5, characterized in that The proximal handheld part further comprises a puncture depth adjusting mechanism, which comprises a sheath seat and a sheath seat locking member, the sheath seat is fixed with the proximal end of the outer sheath, and the proximal end shell can be axially moved relative to the sheath seat; During puncture, the proximal shell is pushed to the distal end, so that the puncture needle tube and the atherectomy cutter tube are simultaneously taken out from the distal end of the outer sheath and puncture the tissue, and after puncture, the proximal shell is locked with the sheath seat through the sheath seat locking member.

9. The negative pressure suction trephine biopsy needle according to claim 8, characterized in that 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, and the proximal end of the sheath seat movably sheaths the proximal end shell; The proximal end of the sheath seat is provided with an external thread, the sheath seat locking member is a lock cap, the lock cap is provided with an internal thread hole matched with the external thread of the sheath seat, the internal thread hole of the lock cap is screwed on the external thread of the sheath seat, so that the sheath seat clamps the proximal end shell; or, one side wall of the sheath seat is provided with a threaded hole, 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, and the threaded fastener is tightened, so that the end of the threaded fastener abuts against the proximal end shell.

10. The negative pressure suction trephine biopsy needle according to claim 8, wherein, The proximal 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.

11. The negative pressure suction trephine biopsy needle according to claim 10, characterized in that 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 a key and at least one limiting column arranged integrally, a plurality of limiting clamping grooves are arranged at intervals on at least one side groove wall of the puncture needle tube adjusting groove, in a natural state, the limiting column is located in the limiting clamping groove, the key is pressed to make the limiting column separate from the limiting clamping groove into the proximal end shell, and then the puncture needle tube can be axially moved along the puncture needle tube adjusting groove following the key.

12. The negative pressure suction trephine biopsy needle according to claim 11, characterized in that 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 along 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 key 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.

13. The negative pressure suction trephine biopsy needle according to claim 11, wherein, The rotating cutter tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism. The circumferential rotation transmission mechanism drives the rotating cutter tube to rotate, so that the rotating cutter tube cuts the tissue. The axial movement transmission mechanism drives the rotating cutter tube to move axially, so as to adjust the cutting depth of the rotating cutter tube.

14. The negative pressure suction trephine biopsy needle according to claim 13, characterized in that The circumferential rotation transmission mechanism comprises a mandrel assembly and a rotating sleeve in the proximal end shell. The mandrel assembly is fixedly sleeved on the rotating cutter tube. The rotating sleeve is sleeved on the mandrel assembly and is axially slidably connected with the mandrel assembly and circumferentially fixedly connected with the mandrel assembly. The rotating sleeve is coaxially fixedly connected with a rotating gear. The rotating gear is driven by a rotating drive motor, so that the rotating gear drives the rotating 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 with the transmission screw. The screw sleeve is coaxially fixedly connected with a stroke gear. The stroke gear is driven by a stroke drive 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. The transmission screw is sleeved on the rotating sleeve and is axially fixedly connected with the mandrel assembly and circumferentially rotationally connected with the mandrel assembly.

15. The negative pressure suction trephine biopsy needle according to claim 14, characterized in that The mandrel assembly comprises a fixed tube and an inner cutter sleeve. The fixed tube is fixedly sleeved on the rotating cutter tube. The inner cutter sleeve is fixedly sleeved on the fixed tube. The rotating sleeve is sleeved on the inner cutter sleeve. The rotating sleeve and the inner cutter sleeve are axially slidably connected and circumferentially fixedly connected through the axial protrusions inserted into the axial guide grooves. The inner cutter sleeve and the transmission screw are circumferentially rotationally connected and axially fixedly connected through the annular limiting clamps inserted into the annular limiting clamp grooves.

16. The negative pressure suction trephine biopsy needle according to claim 14, wherein, 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.

17. The negative pressure suction trephine biopsy needle according to claim 14, wherein, The proximal end handheld portion further comprises a motor handle. The rotating drive motor and the stroke drive motor are both mounted in the motor handle. The motor handle is fixedly connected with the proximal end shell.

18. A vacuum assisted suction biopsy system, comprising: The negative pressure suction rotating cutter biopsy needle and the negative pressure device are connected through the negative pressure interface. The negative pressure device is used to suck the tissue in the rotating cutter tube.

19. The negative pressure suction trephination biopsy system according to claim 18, wherein, The syringe is used to inject physiological saline into the rotating cutter tube through the negative pressure interface after the sampling is completed, so as to flush out the tissue sample in the rotating cutter tube.

20. The negative pressure suction trephination biopsy system according to claim 18, wherein, The main machine comprises a main control module. The main control module is electrically connected with the negative pressure device through a negative pressure drive module, so as to control the negative pressure of the negative pressure device.

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