Endoscopic forward negative-pressure suction biopsy needle and biopsy system

Abstract

The present invention provides an endoscopic forward negative-pressure suction rotary cutting biopsy needle and a biopsy system. The biopsy needle comprises a distal pipeline portion and a proximal handheld portion, wherein the proximal handheld portion comprises a proximal housing and a rotary cutter tube transmission assembly, the proximal end of a rotary cutter tube being mounted in the proximal housing by means of the rotary cutter tube transmission assembly. A proximal end wall of the proximal housing is provided with a negative pressure interface. The rotary cutter tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, wherein the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve which are located in the proximal housing, the mandrel assembly being fixedly sleeved on the rotary cutter tube, and the rotary shaft sleeve being sleeved on the mandrel assembly. The rotary shaft sleeve and the rotary cutter tube are dynamically sealed by means of a first dynamic sealing member. The proximal end of the rotary shaft sleeve is in fixed sealing communication with a rotary connecting tube, and the rotary connecting tube is further in dynamic sealing communication with the negative pressure interface by means of a second dynamic sealing member. The rotary shaft sleeve is driven to rotate, such that the rotary shaft sleeve drives the mandrel assembly to rotate, thereby driving the rotary cutter tube to rotate.

Description

An under-scope positive negative pressure suction biopsy needle and biopsy system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an under-scope positive negative pressure suction rotary cutting biopsy needle and biopsy system BACKGROUND

[0002] Biopsy is a group of medical diagnostic tests used to determine the structure and composition of tissues or cells. In a biopsy, a sample of cells or tissue is taken from an organ or other body part, and after being sent to the pathology department, it is made into standard pathological sections, and its morphological structure is observed under a microscope, and finally a clear pathological diagnosis can be given, so as to guide targeted treatment in clinic. 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 node 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 taken tissue is poor, thus causing problems of low sampling efficiency and poor sample quality.

[0005] The rotary cutting biopsy needle is different from the traditional biopsy needle, which has a rotary cutting knife tube. The rotary cutting knife tube is driven to rotate by a motor, and the rotary cutting mode replaces the traditional reciprocating puncture sampling, thereby improving the sampling efficiency and sample quality.

[0006] However, due to the structure of the rotary cutting biopsy needle, it cannot realize the sealing of the rotary cutting knife tube on the basis of meeting the normal rotation and forward and backward movement of the rotary cutting knife tube, and thus cannot realize the negative pressure suction of the rotary cutting knife tube.

[0007] SUMMARY

[0008] To solve the above technical problems, an embodiment of the present application provides an under-scope positive negative pressure suction rotary cutting biopsy needle, which comprises a distal end pipeline part and a proximal end handheld part. The distal end pipeline part comprises an outer sheath tube, a rotary cutting knife tube and a puncture needle which are sequentially movably sleeved from outside to inside. The proximal end handheld part comprises a proximal end shell and a rotary cutting knife tube transmission assembly. The proximal end of the rotary cutting knife tube is installed in the proximal end shell through the rotary cutting knife tube transmission assembly.

[0009] A negative pressure interface is formed on the proximal end wall of the proximal end shell, and the negative pressure interface is used for connecting a negative pressure device.

[0010] The rotary cutting knife tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism. The circumferential rotation transmission mechanism comprises a mandrel assembly and a rotation sleeve, the mandrel assembly is fixedly sleeved on the rotary cutting knife tube, the rotation sleeve is sleeved on the mandrel assembly and is in axial sliding connection with the mandrel assembly and in circumferential relative fixed connection; the rotation sleeve and the rotary cutting knife tube are dynamically sealed by a first dynamic sealing element; the proximal end of the rotation sleeve is fixedly and sealingly communicated with a threaded pipe, the threaded pipe is also dynamically sealed with the negative pressure interface by a second dynamic sealing element; the rotation sleeve is driven to rotate, so that the rotation sleeve drives the mandrel assembly to rotate, and in turn drives the rotary cutting knife tube to rotate.

[0011] The axial movement transmission mechanism comprises a screw sleeve and a transmission screw, the screw sleeve is rotationally arranged in the proximal end housing and is in threaded engagement with the transmission screw; the transmission screw is sleeved on the rotation sleeve and is in axial relative fixation and circumferential relative rotation connection with the mandrel assembly; the screw sleeve is driven to rotate, so that the rotational movement of the screw sleeve is converted into the axial movement of the transmission screw, and in turn the transmission screw drives the mandrel assembly and the rotary cutting knife tube to move axially.

[0012] Optionally, a rotation gear is fixedly connected to the rotation sleeve, and the rotation sleeve drives the rotation gear to rotate by a rotation driving motor.

[0013] Optionally, a stroke gear is fixedly connected to the screw sleeve, and the screw sleeve drives the stroke gear to rotate by a stroke driving motor.

[0014] Optionally, 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, and the motor handle is fixedly connected with the proximal end housing.

[0015] Optionally, the mandrel assembly comprises a fixed tube and an inner knife sleeve, the fixed tube is fixedly sleeved on the rotary cutting knife tube, the inner knife sleeve is fixedly sleeved on the fixed tube, the rotation sleeve is sleeved on the inner knife sleeve, and the rotation sleeve and the inner knife sleeve are in axial sliding connection and circumferential fixed connection by inserting an axial protrusion into an axial guide groove.

[0016] The inner knife sleeve and the transmission screw are in circumferential rotation connection and axial fixed connection by inserting an annular limiting clamping element provided in the circumferential direction into an annular limiting clamping groove.

[0017] Optionally, a guide rail is further provided on the inner wall of the proximal end housing, and the transmission screw is slidingly arranged on the guide rail.

[0018] Optionally, the proximal handheld part further comprises an endoscope fixing member and a distal shell, the endoscope fixing member comprises a sheath seat and a sheath seat locking member, the sheath seat movably sheaths the outer sheath tube; the sheath seat is provided with a second luer fitting which is adapted to a first luer fitting on the endoscope, the sheath seat is assembled and connected with the endoscope through the assembly of the first luer fitting and the second luer fitting, so as to realize the fixed connection with the endoscope.

[0019] The distal shell fixedly sheaths the proximal end of the outer sheath tube, the sheath seat is axially slidably connected with the distal end of the distal shell, and the sheath seat locking member can lock the distal shell; the proximal end of the distal shell is axially slidably connected with the distal end of the proximal shell.

[0020] Optionally, the proximal handheld part further comprises a puncture depth adjusting device, the puncture depth adjusting device comprises an adjusting sleeve and a sleeve locking member, in use, the puncture depth is first set by adjusting the position of the adjusting sleeve on the distal shell; then the adjusting sleeve is locked on the distal shell through the sleeve locking member; finally, the proximal shell is slid distally to realize puncture.

[0021] Optionally, the distal shell is provided with a scale of puncture depth.

[0022] Optionally, the inner ring of the rotating shaft sleeve is provided with a first groove, and the first dynamic sealing member is fixedly installed in the first groove.

[0023] Optionally, the inner side of the proximal end wall of the proximal shell is provided with a second groove, the second groove is in communication with the negative pressure interface, and the second dynamic sealing member is fixedly installed in the second groove.

[0024] Optionally, the first dynamic sealing member and / or the second dynamic sealing member is a sealing ring.

[0025] Optionally, the sealing ring is a generic sealing ring or a silica gel sealing ring.

[0026] Optionally, the rotary cutting knife 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 at least sheathes 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 sheathed on the proximal end of the high polymer sealing tube.

[0027] Another embodiment of the present application also provides a below-the-scope positive-negative pressure suction biopsy system, comprising the biopsy needle and the negative pressure device in the above-mentioned embodiments, and the negative pressure device performs negative pressure suction on the tissue in the coring cutter tube through the negative pressure interface.

[0028] Optionally, the biopsy system further comprises a syringe, which injects physiological saline into the coring cutter tube through the negative pressure interface after sampling is completed, so as to flush the tissue sample in the coring cutter tube out.

[0029] Optionally, the biopsy system further comprises a host computer, and the host computer comprises a master control module, which is electrically connected with the negative pressure device through the negative pressure driving module and controls the negative pressure size of the negative pressure device.

[0030] Compared with the prior art, the technical scheme of the embodiment of the present application has the following beneficial effects:

[0031] Since the coring cutter tube rotates and moves axially relative to the proximal end shell, the present application decomposes the sealing of the coring cutter tube into axial sealing and rotary sealing, and the specific implementation scheme of the axial sealing is that: in the rotary shaft sleeve, the rotary shaft sleeve and the coring cutter tube are dynamically sealed through the first dynamic sealing element (since the axial movement speed of the coring cutter tube is relatively slow, the relative speed of the coring cutter tube and the first dynamic sealing element is small, the wear requirement of the first dynamic sealing element is low, which is conducive to the miniaturization of the first dynamic sealing element, so that the first dynamic sealing element can be placed in the narrow space in the rotary shaft sleeve); the proximal end sealing of the rotary shaft sleeve is in communication with a rotary joint pipe, and no matter how the coring cutter tube moves axially, the proximal end port of the coring cutter tube is always located in the space between the distal end port of the rotary joint pipe in the rotary shaft sleeve and the first dynamic sealing element, so that a sealing space is formed between the proximal end of the rotary shaft sleeve and the first dynamic sealing element to accommodate the axial movement of the coring cutter tube. The specific implementation scheme of the rotary sealing is that: during sampling, since the rotary joint pipe rotates synchronously with the rotary shaft sleeve, relative rotation occurs between the rotary joint pipe and the negative pressure interface, and based on this, the present application dynamically seals the relative rotation between the rotary joint pipe and the negative pressure interface, that is, the rotary joint pipe is dynamically sealed in communication with the negative pressure interface through the second dynamic sealing element, so as to realize the rotary sealing of the coring cutter tube. Thus, the present application solves the sealing problem of the coring cutter tube, and further realizes the negative pressure suction of the coring biopsy needle.

[0032] Further, in the present application, the negative pressure suction can improve the sampling amount of the coring cutter tube. During sampling, as the tissue in the inner cavity of the coring cutter tube increases, the friction between the tissue and the coring cutter tube will continuously increase, and the frictional resistance will affect the sample tissue to enter the deep part of the inner cavity of the coring cutter tube, so as to cause the sample tissue obtained to be unable to increase. However, the suction force provided by the negative pressure can overcome the frictional resistance and suck more sample tissue into the inner cavity of the coring cutter, so as to improve the sampling amount.

[0033] Further, the application can gradually increase the negative pressure value as the rotating cutter tube advances during the sampling process through the fine control of the host to the negative pressure, thereby avoiding high negative pressure values in the early stage that can damage the integrity of the tissue sample.

[0034] Further, in the application, the rotating cutter tube is in a tubular structure, and the distal end thereof is a ring-shaped blade. After sampling is completed, the tissue at the blade edge needs to be pulled off to complete the sampling. For some tissue structures that are difficult to pull off, the pulling force may be insufficient, resulting in sampling failure. Negative pressure suction can increase the pulling force of the rotating cutter tube when it is retracted, thereby ensuring that the tissue can be successfully pulled off.

[0035] Further, in the application, after sampling is completed, physiological saline is injected into the rotating cutter tube through the negative pressure interface to provide positive pressure, thereby flushing the tissue sample out of the rotating cutter tube, avoiding sample damage caused by the use of a rigid needle to eject.

[0036] Of course, implementing any product of the application does not necessarily need to achieve all the advantages described above. BRIEF DESCRIPTION OF DRAWINGS

[0037] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description only some embodiments of the application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0038] Fig. 1 is a structural schematic diagram of a negative pressure suction rotating cutter biopsy needle provided by an embodiment of the application (with a motor handle installed);

[0039] Fig. 2 is a structural schematic diagram of a distal end pipeline part provided by an embodiment of the application;

[0040] Fig. 3 is a structural schematic diagram of a rotating cutter tube provided by an embodiment of the application;

[0041] Fig. 4 is a structural schematic diagram of a rotating cutter tube with an inner blade edge provided by an embodiment of the application;

[0042] Fig. 5 is a structural schematic diagram of a rotating cutter tube with an outer blade edge provided by an embodiment of the application;

[0043] Fig. 6 is a structural schematic diagram of a negative pressure suction rotating cutter biopsy needle provided by an embodiment of the application (without a motor handle installed);

[0044] Fig. 7 is a sectional view of a negative pressure suction rotating cutter biopsy needle provided by an embodiment of the application;

[0045] Fig. 8 is a schematic diagram of the structure in the distal end shell of the negative pressure suction rotary biopsy needle according to an embodiment of the present application;

[0046] Fig. 9 is a schematic diagram of the structure of the rotary cutter tube moving axially to the farthest end according to an embodiment of the present application;

[0047] Fig. 10 is a schematic diagram of the structure of the rotary cutter tube moving axially to the nearest end according to an embodiment of the present application. DETAILED DESCRIPTION

[0048] 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 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.

[0049] The terms "first", "second", "third", "fourth" and the like (if any) in the specification and claims of the present application and the above-mentioned 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 that 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.

[0050] As described in the background, the existing rotary biopsy needle 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 due to its structure, and thus cannot realize the negative pressure suction of the rotary cutter tube.

[0051] In order to solve the above technical problems, the present application provides an under-mirror positive negative pressure suction rotary biopsy needle, which comprises a distal end pipeline part and a proximal end handheld part. The distal end pipeline part comprises, from the outside to the inside, an outer sheath tube, a rotary cutter tube and a puncture needle which are movably sleeved in sequence. The proximal end handheld part comprises a proximal end shell and a rotary cutter tube transmission assembly. The proximal end of the rotary cutter tube is installed in the proximal end shell through the rotary cutter tube transmission assembly.

[0052] A negative pressure interface is formed on the proximal end wall of the proximal end shell, and the negative pressure interface is used to connect a negative pressure device.

[0053] The rotary cutting knife tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotation sleeve, the mandrel assembly is fixedly sleeved on the rotary cutting knife tube, the rotation sleeve is sleeved on the mandrel assembly and is in axial sliding connection with the mandrel assembly and in circumferential relative fixed connection; the rotation sleeve and the rotary cutting knife tube are dynamically sealed by a first dynamic sealing element; the proximal end of the rotation sleeve is fixedly and sealingly connected with a screw joint, and the screw joint is dynamically sealed with the negative pressure interface by a second dynamic sealing element; the rotation sleeve is driven to rotate, so that the rotation sleeve drives the mandrel assembly to rotate, and then drives the rotary cutting knife tube to rotate.

[0054] 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 transmission screw is sleeved on the rotation sleeve and is in axial relative fixation and circumferential relative rotation connection with the mandrel assembly; the screw sleeve is driven to rotate, so that the rotation movement of the screw sleeve is converted into the axial movement of the transmission screw, and then the transmission screw drives the mandrel assembly and the rotary cutting knife tube to move axially.

[0055] Since the rotary cutting knife tube moves rotationally and axially relative to the proximal end shell, the sealing of the rotary cutting knife tube is decomposed into axial sealing and rotational sealing in the application, the axial sealing is specifically implemented as follows: in the rotation sleeve, the rotation sleeve and the rotary cutting knife tube are dynamically sealed by a first dynamic sealing element (since the axial movement speed of the rotary cutting knife tube is relatively slow, the relative speed of the rotary cutting knife tube and the first dynamic sealing element is small, the wear requirement of the first dynamic sealing element is low, which is conducive to the miniaturization of the first dynamic sealing element, so that the first dynamic sealing element can be placed in a small space in the rotation sleeve); the proximal end of the rotation sleeve is fixedly and sealingly connected with a screw joint, and no matter how the rotary cutting knife tube moves axially, the proximal end port of the rotary cutting knife tube is always located in the space between the distal end port of the screw joint in the rotation sleeve and the first dynamic sealing element, so that a sealing space is formed between the proximal end of the rotation sleeve and the first dynamic sealing element to accommodate the axial movement of the rotary cutting knife tube. The rotational sealing is specifically implemented as follows: since the screw joint rotates synchronously with the rotation sleeve during sampling, the screw joint and the negative pressure interface will rotate relatively, based on which, the relative rotation between the screw joint and the negative pressure interface is dynamically sealed, that is, the screw joint is dynamically sealed with the negative pressure interface by a second dynamic sealing element, so as to realize the rotational sealing of the rotary cutting knife tube. Thus, the sealing problem of the rotary cutting knife tube is solved, and the negative pressure suction of the rotary biopsy needle is realized.

[0056] And the negative pressure suction can improve the sampling amount of the rotary cutter tube. During sampling, as the tissue in the inner cavity of the rotary cutter tube increases, the friction between the tissue and the rotary cutter tube will increase, and the frictional resistance will affect the sample tissue entering the deep part of the inner cavity of the rotary cutter tube, so that the obtained sample tissue cannot be increased. The suction force provided by the negative pressure can overcome the frictional resistance and suck more sample tissue into the inner cavity of the rotary cutter, thereby improving the sampling amount.

[0057] Meanwhile, through the fine control of the host to the negative pressure, the negative pressure value can be gradually increased during the sampling process as the rotary cutter tube continuously advances, so as to avoid that the negative pressure value is too high in the early stage and damages the integrity of the tissue sample.

[0058] Since the rotary cutter tube is a tubular structure, the distal end thereof is a ring-shaped blade, and after sampling is completed, the tissue at the blade edge needs to be pulled off to complete sampling. For some tissue structures that are difficult to pull off, the pulling force may be insufficient, resulting in sampling failure. The negative pressure suction can increase the pulling force of the rotary cutter tube when it is retracted, thereby ensuring that the tissue can be successfully pulled off.

[0059] After sampling is completed, physiological saline is injected into the rotary cutter tube through the negative pressure interface, and the tissue sample is flushed out of the rotary cutter tube by injecting the physiological saline to provide positive pressure, so as to avoid damage to the sample caused by the rigid needle.

[0060] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the technical solutions in the embodiments of the present application will be described clearly and completely in combination with 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. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0061] Embodiment 1

[0062] Please refer to FIGS. 1-10, an embodiment of the present application provides a mirror under positive negative pressure suction rotary biopsy needle, which comprises a distal end pipeline part 1 and a proximal end handheld part 2, the distal end pipeline part 1 comprises an outer sheath tube 101, a rotary cutter tube 102 and a puncture needle 103 which are successively sleeved from outside to inside.

[0063] The outer sheath tube 101 is the outermost layer of the distal end pipeline part 1 of the biopsy needle, and its inner cavity can completely accommodate the rotary cutter tube 102 and the puncture needle 103, so that the puncture needle 103 or the rotary cutter tube 102 is prevented from damaging the endoscope during the conveying of the outer sheath tube 101 into the working channel of the endoscope.

[0064] The material of the outer sheath tube 101 is not limited, and preferably is a smooth polymer material such as PTFE or PEEK, which prevents damage to the endoscope during passage through the working channel of the endoscope and ensures the delivery performance.

[0065] The single-side wall thickness of the outer sheath tube 101 is not limited and can be set according to actual use requirements. As an example, the single-side wall thickness of the outer sheath tube 101 is greater than 0.15 mm, so as to ensure that it has sufficient strength to support the rotary cutter tube 102, and the rotary cutter tube 102 can rotate at high speed inside.

[0066] The rotary cutter tube 102 is a tubular structure and is used as the middle layer of the distal end tube portion 1 of the biopsy needle for collecting tissue samples. The distal end of the rotary cutter tube 102 is provided with a ring-shaped blade, which ensures that the rotary cutter tube 102 can smoothly cut through tissue. The ring-shaped blade preferably has a flat mouth structure, which is used to ensure the integrity of the tissue after cutting, so as not to be shredded and affect pathological analysis.

[0067] As an example, referring to FIG. 4, the ring-shaped blade at the distal end of the rotary cutter tube 102 is an inner blade edge 1021 formed by removing the outer corners of the distal end face of the rotary cutter tube 102, and the inner blade edge 1021 is used for cutting high-density tissue.

[0068] As another example, referring to FIG. 5, the ring-shaped blade at the distal end of the rotary cutter tube 102 is an outer blade edge 1021' formed by removing the inner corners of the distal end face of the rotary cutter tube 102, and the outer blade edge 1021' is used for cutting low-density tissue.

[0069] In a specific embodiment, referring to FIG. 3, the rotary cutter tube 102 includes a distal end metal tube 1022, a metal wire spring tube 1023, a proximal end metal tube 1025, and a polymer sealing tube 1024. The distal end metal tube 1022 and the proximal end metal tube 1025 are both metal tubes, such as stainless steel tubes. The distal end of the distal end metal tube 1022 is a ring-shaped blade 1021, and the distal end metal tube 1022 is made of metal, which can ensure that the rotary cutter tube 102 can smoothly cut through tissue. The proximal end metal tube 1025 is also made of metal, which is used to facilitate assembly and fixation. The metal wire spring tube 1023 is a hollow tube woven by metal wires, and the metal wires are made of stainless steel or nickel-titanium structure. The metal wire spring tube 1023 can flexibly transmit the rotation speed and torque in a bent state and effectively reduce vibration. The proximal end of the distal end metal tube 1022 and the distal end of the metal wire spring tube 1023 are connected by end face welding technology, which ensures that the outer diameter and the inner diameter of the distal end metal tube 1022 and the metal wire spring tube 1023 are substantially the same.

[0070] On the outside of the rotary cutting knife tube 102, a thin-walled polymer sealing tube 1024 is arranged, the outer surface of the rotary cutting knife tube 102 is covered with the polymer sealing tube 1024, and the polymer sealing tube 1024 is at least sealed on the wire spring tube 1023 and the connection between the wire spring tube 1023 and the distal end metal tube 1022. For example, a thin-walled heat shrink tube can be used, which is fixed on the outside of the rotary cutting knife tube 102 through a heat shrink process, to realize sealing of the rotary cutting knife tube 102, so that the internal cavity can transmit negative pressure or positive pressure, and leakage is avoided at the welding position, the gap between the braided tubes, etc. At the same time, the thin-walled heat shrink tube can reduce the friction between the rotary cutting knife tube 102 and the puncture needle 103 during rotation, and avoid wear of the braided wire of the rotary cutting knife tube 102.

[0071] The proximal end metal tube 1025 is wrapped on the outside of the proximal end of the polymer sealing tube 1024, and can be fixed by bonding or other means. In this way, a sealed tube cavity with only two outlets can be formed inside the rotary cutting knife tube 102. Moreover, the proximal end metal tube 1025 is always in dynamic sealing connection with the first dynamic sealing member 208.

[0072] As an embodiment, the wire spring tube 1023, the polymer sealing tube 1024 and the proximal end metal tube 1025 are flush at the proximal end face.

[0073] In order to increase the adhesion of the cut tissue and avoid the tissue from falling off after the cutting and sampling are completed, the inner wall surface of the rotary cutting knife tube 102 is provided with a rough surface, such as a threaded surface, which increases the friction coefficient.

[0074] In order to improve the effect of ultrasonic imaging, the outer surface of the distal end metal tube 1022 is provided with an ultrasonic reflection area, which requires an uneven pattern. The shape of the pattern of the ultrasonic reflection area is not specifically limited in the present application. For example, the roughness of the outer surface of the distal end metal tube 1022 is increased by thread rolling, dotting, etc., to improve the imaging effect of the rotary cutting knife tube 102 under ultrasonic.

[0075] During sampling, the rotary cutting knife tube 102 can rotate and axially advance at the same time, cut the tissue and store the cut tissue in the inner cavity of the annular blade. After cutting is completed, the rotary cutting knife tube 102 axially retreats, and the tissue is pulled off by negative pressure and friction force, to complete sampling.

[0076] The puncture needle 103 is the innermost layer of the distal pipeline part 1 of the biopsy needle, which can be a nickel-titanium needle. The puncture needle 103 has a sharp tip, which can help the rotary cutter tube 102 to puncture and break through the wall of the tissue to reach the designated sampling position. The annular blade at the distal end of the rotary cutter tube 102 is an inner blade edge 1021 formed by removing the outer corners of the distal end face of the rotary cutter tube 102, so that it can easily break through the tracheal wall. After the breakthrough is completed, the puncture needle 103 is withdrawn from the rotary cutter tube 102 to provide space for the transmission of negative pressure.

[0077] The proximal hand-held part 2 includes a proximal shell 204 and a rotary cutter tube transmission assembly, the proximal end of the rotary cutter tube 102 being mounted in the proximal shell 204 through the rotary cutter tube transmission assembly.

[0078] A negative pressure interface 2041 is provided on the proximal end wall of the proximal shell 204, which is used to connect a negative pressure device. The specific type of negative pressure device is not limited in the present application, which can be a negative pressure suction needle cylinder or a negative pressure pump.

[0079] The rotary cutter tube transmission assembly is installed in the proximal shell 204, and is connected with the rotary cutter tube 102. The rotary cutter tube 102 is driven by the rotary cutter tube transmission assembly to perform rotary cutting on the tissue.

[0080] Since the rotary cutter tube transmission assembly can not only drive the rotary cutter tube 102 to rotate to cut the tissue, but also adjust the axial stroke of the rotary cutter tube 102 to adjust the cutting depth of the rotary cutter tube 102, the rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, both of which are connected with the rotary cutter tube 102. The circumferential rotation transmission mechanism drives the rotary cutter tube 102 to rotate, so that the rotary cutter tube 102 cuts the tissue. The axial movement transmission mechanism drives the rotary cutter tube 102 to move axially to adjust the axial stroke of the rotary cutter tube 102, thereby adjusting the cutting depth of the rotary cutter tube 102.

[0081] Please refer to Fig. 8, the circumferential rotation transmission mechanism comprises a mandrel assembly 209 and a rotation sleeve 207, the mandrel assembly 209 is fixedly sleeved on the rotary cutter tube 102, the rotation sleeve 207 is sleeved on the mandrel assembly 209 and is in axial sliding connection and circumferential relative fixed connection with the mandrel assembly 209. The rotation sleeve 207 is driven to rotate, so that the rotation sleeve 207 drives the mandrel assembly 209 to rotate, and then drives the rotary cutter tube 102 to rotate. The driving device for driving the rotation sleeve 207 to rotate is not limited in the application, and can be pneumatic, hydraulic or electric. As an embodiment, the driving device adopts a rotary drive motor, specifically, a rotary gear 214 is coaxially and fixedly connected on the rotation sleeve 207, the rotary gear 214 is driven by the rotary drive motor, so that the rotation sleeve 207 drives the mandrel assembly 209 to rotate.

[0082] Since the rotation sleeve 207 and the mandrel assembly 209 in mutual sleeve connection are in axial sliding connection and circumferential relative fixed connection, which is a mature technical means in the mechanical field, the specific connection structure of the rotation sleeve 207 and the mandrel assembly 209 is not limited in the application.

[0083] As an embodiment, the mandrel assembly 209 comprises a fixed tube and an inner cutter sleeve, the fixed tube is fixedly sleeved on the rotary cutter tube 102, the inner cutter sleeve is fixedly sleeved on the fixed tube, the rotation sleeve 207 is sleeved on the inner cutter sleeve, and the rotation sleeve 207 and the inner cutter sleeve are in axial sliding connection and circumferential fixed connection through axial protrusions inserted into axial guide grooves.

[0084] In a specific implementation, the inner wall of the rotation sleeve 207 is provided with a plurality of protrusions in the circumferential direction, and the outer wall of the inner cutter sleeve is provided with a plurality of guide grooves matched with the protrusions in the circumferential direction. The protrusions are inserted into the guide grooves, so that the rotation sleeve 207 and the inner cutter sleeve are in axial sliding connection and circumferential fixed connection, that is, the rotation sleeve 207 and the inner cutter sleeve can slide relative to each other in the axial direction and rotate synchronously in the circumferential direction. Of course, the protrusions can also be arranged on the outer wall of the inner cutter sleeve, and the guide grooves can be arranged on the inner wall of the rotation sleeve 207. The embodiment does not make specific limitation on this.

[0085] In the application, the rotation sleeve 207 and the rotary cutter tube 102 are dynamically sealed by a first dynamic seal 208; the proximal end of the rotation sleeve 207 is fixedly and sealingly connected to a screw pipe 215, and the screw pipe 215 is also in dynamic sealing communication with the negative pressure interface 2041 through a second dynamic seal 206.

[0086] Since the rotary cutter tube 102 has rotational movement and axial movement relative to the proximal end housing 204, the present application decomposes the sealing of the rotary cutter tube 102 into axial sealing and rotational sealing:

[0087] The specific implementation scheme of the axial sealing is that, in the rotary sleeve 207, the rotary sleeve 207 and the rotary cutter tube 102 are dynamically sealed by the first dynamic seal 208; the proximal end of the rotary sleeve 207 is fixedly sealed in communication with a rotary joint pipe 215, and no matter how the rotary cutter tube 102 axially moves, the distal end port of the rotary cutter tube 102 is always located in the space 212 between the distal end port of the rotary joint pipe 215 in the rotary sleeve 207 and the first dynamic seal 208 during sampling, so that the sealed space 212 between the proximal end of the rotary sleeve 207 and the first dynamic seal 208 is formed to accommodate the axial movement of the rotary cutter tube 102. Please refer to FIG. 9, during sampling, the rotary cutter tube 102 rotates and axially advances, when the rotary cutter tube 102 axially moves to the farthest end, the rotary cutter tube 102 still dynamically seals the rotary sleeve 207 through the first dynamic seal 208, and the distal end port of the rotary cutter tube 102 is still located in the space 212' between the rotary joint pipe 215 in the rotary sleeve 207 and the first dynamic seal 208. Please refer to FIG. 10, after cutting is completed, the rotary cutter tube 102 axially retreats, when the rotary cutter tube 102 axially moves to the farthest end, the rotary cutter tube 102 still dynamically seals the rotary sleeve 207 through the first dynamic seal 208, and the distal end port of the rotary cutter tube 102 is still located in the space 212'' between the rotary joint pipe 215 in the rotary sleeve 207 and the first dynamic seal 208.

[0088] The specific implementation scheme of the rotational sealing is that, during sampling, since the rotary joint pipe 215 rotates synchronously with the rotary sleeve 207, relative rotation occurs between the rotary joint pipe 215 and the negative pressure interface 2041, based on this, the present application dynamically seals the relative rotation between the rotary joint pipe 215 and the negative pressure interface 2041, that is, the rotary joint pipe 215 dynamically seals and communicates with the negative pressure interface 2041 through the second dynamic seal 206, so as to realize the rotational sealing of the rotary cutter tube 102.

[0089] In order to facilitate assembly and fixation, the rotary joint pipe 215 adopts a metal pipe, such as a steel pipe. The rotary joint pipe 215 and the second dynamic seal 206 constitute the rotational sealing, and no leakage occurs at high rotation speed (>3000 RPM). The rotary joint pipe 215 has a surface roughness requirement, generally Ra<0.2.

[0090] Since the dynamic seal is a relatively mature technology in the field of mechanical fluid transmission, the specific structure of the first dynamic seal 208 and the second dynamic seal 206 is not limited.

[0091] As an embodiment, the first dynamic seal 208 and the second dynamic seal 206 are sealing rings, such as generic seal or silica gel sealing ring, etc.

[0092] The inner ring of the rotating shaft sleeve 207 is provided with a first groove, and the first dynamic seal 208 is fixedly installed in the first groove. The inner surface of the first dynamic seal 208 and the outer surface of the rotating cutter tube 102 should be as smooth as possible to reduce the friction resistance caused by sealing.

[0093] The inner side of the proximal end wall of the proximal end shell 204 is provided with a second groove, the second groove is in communication with the negative pressure interface 2041, and the second dynamic seal 206 is fixedly installed in the second groove. The inner surface of the second dynamic seal 206 and the outer surface of the rotating joint tube 215 should be as smooth as possible to reduce the friction resistance caused by sealing.

[0094] As an embodiment, the negative pressure interface 2041 is provided with a luer joint, which can be connected to a negative pressure suction needle cylinder or a negative pressure pump structure through the luer joint.

[0095] The axial movement transmission mechanism includes a screw sleeve 210 and a transmission screw 211, the screw sleeve 210 is rotationally arranged in the proximal end shell 204 and is in threaded engagement transmission with the transmission screw 211; the transmission screw 211 is sleeved on the rotating shaft sleeve 207, and is axially fixedly connected with the mandrel assembly 209 and is circumferentially rotationally connected with the mandrel assembly 209; the screw sleeve 210 is driven to rotate, so that the rotating movement of the screw sleeve 210 is converted into the axial movement of the transmission screw 211, and then the transmission screw 211 drives the mandrel assembly 209 and the rotating cutter tube 102 to move axially. The driving device for driving the screw sleeve 210 to rotate is not limited in the application, and can be pneumatic, hydraulic or electric. As an embodiment, the driving device adopts a stroke driving motor, specifically, the screw sleeve 210 is coaxially fixedly connected with a stroke gear 213, the stroke gear 213 is driven to rotate by a stroke driving motor, the stroke gear 213 drives the screw sleeve 210 to rotate, and the rotating movement of the screw sleeve 210 is converted into the axial movement of the transmission screw 211. The transmission screw 211 is sleeved on the rotating shaft sleeve 207, and is axially fixedly connected with the mandrel assembly 209 and is circumferentially rotationally connected with the mandrel assembly 209.

[0096] As an embodiment, the proximal end hand-held part 2 further includes a motor handle 205, the rotating drive motor and the stroke driving motor are both installed in the motor handle 205, and the motor handle 205 is fixedly connected with the proximal end shell 204. The rotating drive motor and the stroke driving motor directly control or control the rotating cutter gear and the stroke gear 213 through gear transmission respectively, so as to realize the rotation and forward and backward movement of the rotating cutter tube 102.

[0097] The screw sleeve 210 only rotates in the proximal shell 204 without axial movement. In order to limit the axial movement of the screw sleeve 210 in the proximal shell 204, positioning partitions are arranged on the proximal shell 204 at the proximal end and the distal end of the screw sleeve 210, so as to limit the screw sleeve 210 between the two positioning partitions and prevent axial movement.

[0098] In the embodiment, the transmission screw 211 is sleeved on the rotating shaft sleeve 207 and is fixedly connected with the mandrel assembly 209 in the axial direction and is relatively rotatably connected in the circumferential direction.

[0099] As an embodiment, the inner cutter sleeve and the transmission screw 211 are connected in the circumferential direction through the insertion of the annular limiting clamping piece into the annular limiting clamping slot, and are fixedly connected in the axial direction.

[0100] In a specific implementation, the outer side of the inner cutter sleeve is circumferentially provided with an annular limiting clamping slot, and the inner side of the transmission screw 211 is circumferentially provided with an annular limiting clamping piece matched with the annular limiting clamping slot. The circumferential rotational connection between the transmission screw 211 and the inner cutter sleeve is achieved by inserting the annular limiting clamping piece into the annular limiting clamping slot, and the axial fixed connection is achieved, that is, the inner cutter sleeve and the transmission screw 211 can rotate relative to each other, but cannot have relative displacement in the axial direction. Of course, the inner side of the transmission screw can be circumferentially provided with an annular limiting clamping slot, and the outer side of the inner cutter sleeve can be circumferentially provided with an annular limiting clamping piece matched with the annular limiting clamping slot, and the present embodiment does not make specific limitations in this regard.

[0101] The inner wall of the proximal shell 204 is axially provided with a guide rail, and the transmission screw 211 is slidingly arranged on the guide rail. By driving the screw sleeve 210 to rotate, the transmission screw 211 moves along the guide rail, so as to limit the axial movement distance of the transmission screw 211.

[0102] As an embodiment, the proximal handheld part 2 further comprises an endoscope fixing member 201 and a distal shell 203. The endoscope fixing member 201 comprises a sheath seat 2011 and a sheath seat locking member 2012. The sheath seat 2011 is movably sleeved on the outer sheath tube 101, so that the sheath seat 2011 can move axially on the outer sheath tube 101.

[0103] The sheath seat 2011 is provided with a second luer joint matched with a first luer joint on an endoscope. The sheath seat 2011 is assembled and connected with the second luer joint through the first luer joint, so as to realize the fixed connection with the endoscope.

[0104] The embodiment does not limit the specific connection form of the first luer joint and the second luer joint, which can be screw connection, clamping or other detachable fixed connection mode.

[0105] The distal shell 203 is a sleeve structure with both ends open, which is fixedly sleeved on the proximal end of the sheath tube 101. The distal shell 203 is located between the sheath seat 2011 and the proximal shell 204. The sheath seat 2011 is in axial sliding connection with the distal end of the distal shell 203 and can be locked with the distal shell 203 through the sheath seat lock 2012. The proximal end of the distal shell 203 is in axial sliding connection with the distal end of the proximal shell 204.

[0106] The fixed connection with the endoscope is realized by assembling and connecting the first luer joint on the endoscope and the second luer joint on the sheath seat 2011. After the sheath seat 2011 is fixed with the endoscope, the relative position of the sheath seat 2011 and the distal shell 203 is adjusted to adjust the relative position of the sheath tube 101 and the endoscope. After the adjustment is completed, the sheath seat 2012 and the distal shell 203 are locked to realize the fixation of the sheath tube 101 and the endoscope.

[0107] Since the technical scheme of adjusting and locking the two structures (the sheath seat 2011 and the distal shell 203) through the lock (the sheath seat lock 2012) belongs to a relatively mature technology in the mechanical field, the present application does not make specific limitations thereon. For example, the sheath seat lock 2012 can be a lock cap structure, the lock cap structure is provided with an internal thread, the sheath seat 2011 is provided with an external thread matched with the internal thread, and the sheath seat 2011 is locked on the distal shell 203 through the assembly of the internal thread and the external thread. When the lock cap structure is loosened, the sheath seat 2011 and the distal shell 203 are in an unlocked state and can be axially slid. Of course, the sheath seat lock 2012 of the present application is not limited to the lock cap structure, but can also be a threaded fastener. Specifically, one side wall of the sheath seat 2011 is provided with a threaded hole, the sheath seat lock 2012 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 2011, and the second end is located outside the sheath seat 2011. The threaded fastener is tightened by manually rotating the second end of the threaded fastener, so that the first end of the threaded fastener abuts against the distal shell 203, and the proximal shell 204 and the sheath seat 2011 are fixed. The threaded fastener can be a locking screw or the like.

[0108] The traditional biopsy needle is usually fixed by a proximal shell and an endoscope and is uniformly operated by an endoscope operator. However, the rotary cutting biopsy needle has a motor, and the weight of the motor handle and the proximal shell is large after assembly. If the traditional fixing method is used, the fixing of the proximal shell and the endoscope will greatly increase the difficulty of the endoscope operation and the operation difficulty of the endoscope operator. The endoscope is fixed by the endoscope fixing member on the outer sheath tube, the outer sheath tube is fixed with the endoscope, 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, the operation difficulty is reduced, and the adjustment range of the intervention depth of the outer sheath tube is increased.

[0109] The proximal holding part 2 further comprises a puncture depth adjustment device 202, which comprises an adjustment sleeve 2021 and a sleeve locking member 2022. The adjustment sleeve 2021 movably sheaths on the distal shell 203. In use, the puncture depth is set by adjusting the position of the adjustment sleeve 2021 on the distal shell 203. Then, the adjustment sleeve 2021 is locked on the distal shell 203 by the sleeve locking member 2022. Finally, the proximal shell 204 is slid to the distal end to realize puncture. Until the distal end of the proximal shell 204 contacts the adjustment sleeve 2021, that is, the adjustment sleeve 2021 blocks the proximal shell 204 from continuing to slide to the distal end. At this time, the puncture is completed.

[0110] Since the technical scheme of adjusting and locking the two structures (the adjustment sleeve 2021 and the proximal shell) by the locking member (the sleeve locking member 2022) belongs to a relatively mature technology in the mechanical field, the present application does not make specific limitations thereon. For example, the sleeve locking member 2022 can be a lock cap structure, the lock cap structure is provided with an internal thread, the adjustment sleeve 2021 is provided with an external thread matched with the internal thread, and the adjustment sleeve 2021 is locked on the distal shell 203 by the assembly of the internal thread and the external thread. When the lock cap structure is loosened, the adjustment sleeve 2021 and the distal shell 203 are in an unlocked state and can be axially slid. Of course, the sleeve locking member 2022 of the present application is not limited to the lock cap structure, but can also be a threaded fastener. Specifically, one side wall of the adjustment sleeve 2021 is provided with a threaded hole, the sleeve locking member 2022 is a threaded fastener matched with the threaded hole, the first end of the threaded fastener passes through the threaded hole into the adjustment sleeve 2021, and the second end is located outside the adjustment sleeve 2021. The second end of the threaded fastener is manually tightened to make the first end of the threaded fastener abut against the distal shell 203, so that the proximal shell 204 is fixed with the adjustment sleeve 2021. The threaded fastener can be a locking screw or the like.

[0111] Example 2

[0112] The embodiment provides a below-the-scope positive-negative pressure suction biopsy system, which comprises the negative pressure suction rotary biopsy needle and the negative pressure device in the embodiment 1, and the negative pressure device performs negative pressure suction on the tissue in the rotary cutter tube 102 through the negative pressure interface 2041.

[0113] As an embodiment, the biopsy system further comprises a syringe, which injects physiological saline into the rotary cutter tube 102 through the negative pressure interface 2041 after sampling is completed, so that the tissue sample in the rotary cutter tube 102 is flushed out.

[0114] The negative pressure device and the syringe can share one interface or use separate interfaces connected with the negative pressure interface 2041.

[0115] As an embodiment, the negative pressure interface 2041 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 2041, the second interface is used for connecting the negative pressure device, the third interface is used for connecting the syringe, and an adjusting switch is arranged in the three-way joint, and the first interface realizes switching of passages 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 102, so that the tissue is adsorbed; when the adjusting switch is in gear II, the syringe can flush out the tissue in the rotary cutter tube 102 for sampling, so as to ensure the integrity of the tissue.

[0116] 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.

[0117] In order to realize the adjustment of the negative pressure size, the biopsy system further comprises a host, and the host comprises a host control module, the host control module is electrically connected with the negative pressure pump through a negative pressure driving module, the host control module controls output of a DAC analog signal, and an adjustable pressure driving signal is output; since the driving voltage of the negative pressure pump is in linear relationship with the flow, the driving voltage of the negative pressure pump is controlled, and the flow size of the negative pressure pump can realize the adjustment of the negative pressure size.

[0118] The host further has a negative pressure sensor, which monitors the real-time negative pressure size of the negative pressure pump, feeds back an accurate negative pressure value to the host control module, and the host control module adjusts the negative pressure value by adjusting the flow size of the negative pressure pump based on the feedback negative pressure value.

[0119] The host control module is further electrically connected with a rotary driving motor and a stroke driving motor through a motor driving module. During sampling, the negative pressure is adjusted in three stages.

[0120] (1) Initial stage, the negative pressure value is small, <10KPa, so that the annular blade of the rotary cutter tube 102 can be close to the tissue, which facilitates the annular blade of the rotary cutter tube 102 to cut and separate the tissue.

[0121] (2) Sampling stage, based on the rotary cutting depth of the rotary cutter tube 102, the negative pressure value is gradually increased. For example, when rotating in 1mm, the negative pressure value is increased by 1KPa. When rotating in 20mm, the negative pressure value is increased to 30KPa. If the host machine finds that the torque of the rotary drive motor is obviously smaller (identified by the motor current), it means that the tissue in the lumen of the rotary cutter tube 102 is blocked and cannot be deepened, so that the annular blade of the rotary cutter tube 102 cannot cut and separate the tissue. At this time, the negative pressure pump is controlled to increase the negative pressure value, so that the tissue in the lumen of the rotary cutter tube 102 moves to the deep part of the lumen, so that there is space to accommodate more tissue at the distal end of the rotary cutter tube 102, thereby improving the sampling amount.

[0122] (3) Sampling end pull-off stage, after sampling, the negative pressure pump provides a larger negative pressure value, such as >30KPa, so that the suction force and friction force are superimposed to completely separate the sample tissue.

[0123] (4) Sample collection stage, close the negative pressure, adjust the three-way joint, inject normal saline in the lumen of the rotary cutter tube 102, and flush out the sample tissue.

[0124] Although the present application is disclosed as above, the present application is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present application, and therefore the protection scope of the present application should be subject to the range defined by the claims.

Claims

1. An under-mirror forward negative pressure suction rotary cutting biopsy needle, characterized in that, The device comprises a distal pipeline part and a proximal handheld part, the distal pipeline part comprises, from outside to inside, an outer sheath tube, a rotary cutter tube and a puncture needle which are sleeved in sequence, the proximal handheld part comprises a proximal shell and a rotary cutter tube transmission assembly, the proximal end of the rotary cutter tube is installed in the proximal shell through the rotary cutter tube transmission assembly; A negative pressure interface is arranged on the proximal end wall of the proximal shell, and the negative pressure interface is used for connecting a negative pressure device; The rotary cutter tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve which are located in the proximal shell, the mandrel assembly is fixedly sleeved on the rotary cutter tube, the rotary shaft sleeve is sleeved on the mandrel assembly and is axially slidably connected with the mandrel assembly and is circumferentially fixedly connected with the mandrel assembly, the rotary shaft sleeve and the rotary cutter tube are dynamically sealed through a first dynamic sealing element, the proximal end of the rotary shaft sleeve is fixedly and sealingly connected with a rotary joint pipe, the rotary joint pipe is also dynamically sealed with the negative pressure interface through a second dynamic sealing element, the rotary shaft sleeve is driven to rotate, so that the rotary shaft sleeve drives the mandrel assembly to rotate, and then drives the rotary cutter tube to rotate; The axial movement transmission mechanism comprises a screw sleeve and a transmission screw, the screw sleeve is rotationally arranged in the proximal shell and is in threaded engagement with the transmission screw, the transmission screw is sleeved on the rotary shaft sleeve and is axially fixedly connected with the mandrel assembly and is circumferentially rotationally connected with the mandrel assembly, the screw sleeve is driven to rotate, so that the rotary motion of the screw sleeve is converted into the axial movement of the transmission screw, and then the transmission screw drives the mandrel assembly and the rotary cutter tube to move axially.

2. The biopsy needle of claim 1, wherein, A rotary gear is fixedly connected to the rotary shaft sleeve, and the rotary shaft sleeve drives the rotary gear to rotate through a rotary drive motor.

3. The biopsy needle of claim 2, wherein, A stroke gear is fixedly connected to the screw sleeve, and the screw sleeve drives the stroke gear to rotate through a stroke drive motor.

4. The biopsy needle of claim 3, wherein, The proximal handheld part further comprises a motor handle, the rotary drive motor and the stroke drive motor are both arranged in the motor handle, and the motor handle is fixedly connected with the proximal shell.

5. The biopsy needle of claim 1, wherein, 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 rotary shaft sleeve is sleeved on the inner cutter sleeve, and the rotary shaft sleeve and the inner cutter sleeve are axially slidably connected and circumferentially fixedly connected through the protrusions and the guide grooves; The inner cutter sleeve and the transmission screw are circumferentially rotationally connected and axially fixedly connected through the annular limiting clamping members and the annular limiting clamping grooves.

6. The biopsy needle of claim 1, wherein, A guide rail is further arranged on the inner wall of the proximal shell, and the transmission screw is slidably arranged on the guide rail.

7. The biopsy needle of claim 1, wherein, The proximal handheld part further comprises an endoscope fixing member and a distal shell, the endoscope fixing member comprises a sheath seat and a sheath seat locking member, the sheath seat movably sheaths the outer sheath tube; the sheath seat is provided with a second luer fitting which is adapted to a first luer fitting on the endoscope, the sheath seat is assembled and connected with the first luer fitting and the second luer fitting, so as to realize fixed connection with the endoscope; The distal shell fixedly sheaths the proximal end of the outer sheath tube, the sheath seat is axially slidably connected with the distal end of the distal shell, and the sheath seat locking member can lock the distal shell; the proximal end of the distal shell is axially slidably connected with the distal end of the proximal shell.

8. The biopsy needle of claim 7, wherein, The proximal handheld part further comprises a puncture depth adjusting device, the puncture depth adjusting device comprises an adjusting sleeve and a sleeve locking member, in use, the puncture depth is set by adjusting the position of the adjusting sleeve on the distal shell; then the adjusting sleeve is locked on the distal shell by the sleeve locking member; finally, the proximal shell is slid distally to realize puncture.

9. The negative pressure suction trephine biopsy needle according to claim 8, characterized in that The distal shell is provided with a scale of puncture depth.

10. The biopsy needle of claim 1, wherein, The inner ring of the rotating shaft sleeve is provided with a first groove, and the first dynamic sealing member is fixedly installed in the first groove.

11. The biopsy needle of claim 1, wherein, The inner side of the proximal end wall of the proximal shell is provided with a second groove, the second groove is in communication with the negative pressure interface, and the second dynamic sealing member is fixedly installed in the second groove.

12. The biopsy needle of claim 1, wherein, The first dynamic sealing member and / or the second dynamic sealing member is a sealing ring.

13. The biopsy needle of claim 12, wherein, The sealing ring is a generic sealing ring or a silica gel sealing ring.

14. The negative pressure suction trephine biopsy needle according to claim 1, wherein, The rotary cutting knife 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 at least sheaths 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 sheathed on the proximal end of the high polymer sealing tube.

15. An under-scope positive suction pressure biopsy system, comprising: The biopsy needle and a negative pressure device are provided, the negative pressure device performs negative pressure suction on the tissue in the rotary cutting knife tube through the negative pressure interface.

16. The biopsy system of claim 15, wherein, An injector is further provided, after sampling is completed, the injector injects physiological saline into the rotary cutting knife tube through the negative pressure interface, so as to flush out the tissue sample in the rotary cutting knife tube.

17. The biopsy system of claim 15, wherein, A host is further provided, the host comprises a host control module, the host control module is electrically connected with the negative pressure device through a negative pressure driving module, and controls the negative pressure size of the negative pressure device. The proximal handheld part further comprises a puncture depth adjusting device, the puncture depth adjusting device comprises an adjusting sleeve and a sleeve locking member, in use, the puncture depth is set by adjusting the position of the adjusting sleeve on the distal shell; then the adjusting sleeve is locked on the distal shell by the sleeve locking member; finally, the proximal shell is slid distally to realize puncture. The distal shell is provided with a scale of puncture depth. The inner ring of the rotating shaft sleeve is provided with a first groove, and the first dynamic sealing member is fixedly installed in the first groove. The inner side of the proximal end wall of the proximal shell is provided with a second groove, the second groove is in communication with the negative pressure interface, and the second dynamic sealing member is fixedly installed in the second groove. The first dynamic sealing member and / or the second dynamic sealing member is a sealing ring. The sealing ring is a generic sealing ring or a silica gel sealing ring. The rotary cutting knife 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 at least sheaths 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 sheathed on the proximal end of the high polymer sealing tube. The biopsy needle and a negative pressure device are provided, the negative pressure device performs negative pressure suction on the tissue in the rotary cutting knife tube through the negative pressure interface. An injector is further provided, after sampling is completed, the injector injects physiological saline into the rotary cutting knife tube through the negative pressure interface, so as to flush out the tissue sample in the rotary cutting knife tube. A host is further provided, the host comprises a host control module, the host control module is electrically connected with the negative pressure device through a negative pressure driving module, and controls the negative pressure size of the negative pressure device.

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