Under-microscope positive negative pressure suction biopsy needle and biopsy system

Abstract

The invention provides an endoscopic positive negative pressure suction rotary-cut biopsy needle and a biopsy system.The biopsy needle comprises a far-end pipeline part and a near-end handheld part, the near-end handheld part comprises a near-end shell and a rotary-cut knife tube transmission assembly, and the near end of a rotary-cut knife tube is installed in the near-end shell through the rotary-cut knife tube transmission assembly; a negative pressure interface is formed in the near-end wall of the near-end shell; 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 rotating shaft sleeve which are located in the near-end shell, the rotary cutter tube is fixedly sleeved with the mandrel assembly, and the mandrel assembly is sleeved with the rotating shaft sleeve; the rotating shaft sleeve and the rotary cutter pipe are in dynamic sealing through a first dynamic sealing piece; the near end of the rotating shaft sleeve is fixedly and hermetically communicated with a rotating pipe; the rotating pipe is also hermetically communicated with the negative pressure interface through a second dynamic sealing piece; the rotating shaft sleeve is driven to rotate, so that the rotating shaft sleeve drives the mandrel assembly to rotate, and then the rotary cutter pipe is driven to rotate.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a positive negative pressure suction biopsy needle and a biopsy system under a microscope. Background Art

[0002] Biopsy is the abbreviation of "live tissue examination", also known as surgical pathology examination, which is a group of medical diagnostic test methods used to determine the structure and composition of tissues or cells. In a biopsy, cells or tissues are sampled from organs or other parts of the body and sent to the pathology department to make standard pathological sections. The changes in their morphological structure are observed under a microscope, and finally a clear pathological diagnosis can be given, thereby guiding clinical targeted treatment. Usually, if an abnormality is found through superficial examinations 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 the lung, peripulmonary tissues 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, while reducing the risk of heavy bleeding and improving the accuracy of sampling, and it is less invasive, simple to operate and relatively safe.

[0004] Traditional endoscopic ultrasonic biopsy needles require repeated punctures for sampling, and the integrity of the tissue removed is poor, resulting in low sampling efficiency and poor sample quality.

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

[0006] However, due to its structural reasons, the rotary cutting biopsy needle cannot achieve the sealing problem of the rotary cutting blade tube on the basis of satisfying the normal rotation and forward and backward movement of the rotary cutting blade tube, and thus cannot achieve negative pressure suction of the rotary cutting blade tube. Summary of the invention

[0007] In order to solve the above technical problems, an embodiment of the present invention provides a positive negative pressure suction rotary biopsy needle under a microscope, comprising a distal pipeline part and a proximal handheld part, wherein the distal pipeline part comprises an outer sheath tube, a rotary cutter tube and a puncture needle which are movably sleeved from the outside to the inside in sequence; the proximal handheld part comprises a proximal shell and a rotary cutter tube transmission assembly, and the proximal end of the rotary cutter tube is installed in the proximal shell through the rotary cutter tube transmission assembly;

[0008] A negative pressure interface is provided on the proximal end wall of the proximal shell, and the negative pressure interface is used to connect a negative pressure device;

[0009] The rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism includes a core shaft assembly and a rotating sleeve located in the proximal shell, the core shaft assembly is fixedly sleeved on the rotary cutter tube, the rotating sleeve is sleeved on the core shaft assembly, and is slidably connected to the core shaft assembly in the axial direction and relatively fixedly connected in the circumferential direction; the rotating sleeve and the rotary cutter tube are dynamically sealed by a first dynamic seal; the proximal end fixed seal of the rotating sleeve is connected to a rotating tube, and the rotating tube is also dynamically sealed and connected to the negative pressure interface through a second dynamic seal; the rotating sleeve is driven to rotate, so that the rotating sleeve drives the core shaft assembly to rotate, and then drives the rotary cutter tube to rotate;

[0010] The axial movement transmission mechanism includes a screw sleeve and a transmission screw, wherein the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the transmission screw sleeve is sleeved on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is relatively rotationally connected in the circumferential direction; the screw sleeve is driven to rotate so that the rotational motion of the screw sleeve is converted into axial movement of the transmission screw, and then the transmission screw drives the core shaft assembly and the rotary cutting knife tube to move axially.

[0011] Optionally, a rotating gear is fixedly connected to the rotating sleeve, and the rotating sleeve drives the rotating gear to perform rotational motion via a rotating driving motor.

[0012] Optionally, the screw sleeve is fixedly connected to the travel gear, and the screw sleeve drives the travel gear to rotate via a travel drive motor.

[0013] Optionally, the proximal handheld portion further includes a motor handle, the rotation drive motor and the stroke drive motor are both installed in the motor handle, and the motor handle is fixedly connected to the proximal housing.

[0014] Optionally, the mandrel assembly includes a fixed tube and an inner knife sleeve, the fixed tube fixedly sleeve is outerly mounted on the rotary cutter tube, the inner knife sleeve fixedly sleeve is outerly mounted on the fixed tube, the rotating sleeve is outerly mounted on the inner knife sleeve, and the rotating sleeve and the inner knife sleeve are connected by sliding in the axial direction and fixedly connected in the circumferential direction by inserting an axial protrusion into an axial guide groove;

[0015] The inner knife sleeve and the transmission screw are connected in a circumferential rotational direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.

[0016] Optionally, a guide rail is further provided on the inner wall of the proximal shell, and the transmission screw is slidably arranged on the guide rail.

[0017] Optionally, the proximal handheld portion further comprises an endoscope fixing part and a distal housing, the endoscope fixing part comprises a sheath seat and a sheath seat locking part, the sheath seat is movably sleeved on the outer sheath tube; the sheath seat is provided with a second Luer connector adapted to the first Luer connector on the endoscope, the sheath seat is assembled and connected with the second Luer connector through the first Luer connector, so as to realize a fixed connection with the endoscope;

[0018] The distal shell fixing sleeve is at the proximal end of the outer sheath tube, the sheath seat is axially slidably connected to the distal end of the distal sleeve, and can be locked with the distal shell by the sheath seat locking piece; the proximal end of the distal shell is axially slidably connected to the distal end of the proximal shell.

[0019] Optionally, the proximal handheld part also includes a puncture depth adjustment device, which includes an adjusting sleeve and a sleeve locking piece. The adjusting sleeve is movably mounted on the distal shell. When 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 by the sleeve locking piece; finally, the proximal shell is slid distally to achieve puncture.

[0020] Optionally, the distal shell is provided with a puncture depth scale.

[0021] Optionally, the inner ring of the rotating sleeve is provided with a first groove, and the first dynamic seal is fixedly installed in the first groove.

[0022] Optionally, a second groove is provided on the inner side of the proximal end wall of the proximal shell, the second groove is communicated with the negative pressure interface, and the second dynamic seal is fixedly installed in the second groove.

[0023] Optionally, the first dynamic seal and / or the second dynamic seal is a sealing ring.

[0024] Optionally, the sealing ring is a pan seal or a silicone sealing ring.

[0025] Optionally, the rotary cutting knife tube includes a distal metal tube, a metal wire spring tube, a proximal metal tube and a 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 to the distal end face of the metal wire spring tube; the polymer sealing tube at least has a sealing sleeve arranged on the metal wire spring tube and at the connection between the metal wire spring tube and the distal metal tube; the proximal metal tube is fixedly arranged at the proximal end of the polymer sealing tube.

[0026] Another embodiment of the present invention further provides a microscopic positive negative pressure suction biopsy system, comprising the biopsy needle and the negative pressure device described in the above embodiment, wherein the negative pressure device performs negative pressure suction on the tissue in the rotary cutting knife tube through the negative pressure interface.

[0027] Optionally, the biopsy system further includes 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.

[0028] Optionally, the biopsy system further includes a host, the host includes a main control module, and the main control module is electrically connected to the negative pressure device through a negative pressure drive module to control the negative pressure of the negative pressure device.

[0029] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:

[0030] Since the rotary cutter tube can rotate and move axially relative to the proximal housing, the present invention decomposes the sealing of the rotary cutter tube into axial sealing and rotary sealing. The specific implementation scheme of the axial sealing is: in the rotating sleeve, a first dynamic seal is formed between the rotating sleeve and the rotary cutter tube (since the axial movement speed of the rotary cutter tube is slow, the relative speed between it and the first dynamic seal is small, and the wear requirement for the first dynamic seal is low, which is conducive to the miniaturization of the first dynamic seal, so that the first dynamic seal can be placed in a narrow space in the rotating sleeve); the proximal end of the rotating sleeve is fixedly sealed and connected to a rotary tube. During sampling, no matter how the rotary cutter tube moves axially, the proximal end port of the rotary cutter tube is always located in the space between the distal end port of the rotary tube in the rotating sleeve and the first dynamic seal. Therefore, a sealed space is formed between the proximal end of the rotating sleeve and the first dynamic seal to accommodate the axial movement of the rotary cutter tube. The specific implementation scheme of the rotary seal is as follows: during sampling, since the rotary tube rotates synchronously with the rotating sleeve, relative rotation will occur between the rotary tube and the negative pressure interface. Based on this, the present invention performs dynamic sealing on the relative rotation between the rotary tube and the negative pressure interface, that is, the rotary tube is connected to the negative pressure interface through a second dynamic seal to achieve rotary sealing of the rotary cutter tube. Therefore, the present invention solves the sealing problem of the rotary cutter tube, and further achieves negative pressure suction of the rotary biopsy needle.

[0031] Furthermore, in the present invention, negative pressure suction can increase the sampling volume 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 continue to increase, and the friction resistance will affect the sample tissue from entering the deep cavity of the rotary cutter tube, resulting in the inability to increase the sample tissue obtained. The suction provided by the negative pressure can overcome the friction resistance, suck more sample tissue into the inner cavity of the rotary cutter, and increase the sampling volume.

[0032] Furthermore, the present invention can gradually increase the negative pressure value as the rotary cutting tube continues to move forward during the sampling process through the refined control of the negative pressure by the host, thereby avoiding excessively high negative pressure values ​​in the early stage and damaging the integrity of the tissue sample.

[0033] Furthermore, in the present invention, since the rotary cutter tube is a tubular structure with an annular blade at the distal end, after sampling is completed, the tissue at the blade edge needs to be pulled apart to complete the sampling. For some tissue structures that are difficult to pull apart, insufficient pulling force may occur, resulting in sampling failure. Negative pressure suction can increase the pulling force of the rotary cutter tube when retreating, ensuring that the tissue can be successfully pulled apart.

[0034] Furthermore, in the present invention, after sampling is completed, physiological saline is injected into the rotary cutter tube through the negative pressure interface, and the positive pressure provided by the injection of physiological saline is used to flush the tissue sample out of the rotary cutter tube, thereby avoiding sample destruction caused by ejection with a rigid needle.

[0035] Of course, any product implementing the present invention does not necessarily need to achieve all of the advantages described above at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0037] Figure 1 It is a structural schematic diagram of a negative pressure suction rotary biopsy needle provided in one embodiment of the present invention (with a motor handle installed);

[0038] Figure 2 is a schematic structural diagram of a distal pipeline portion provided by an embodiment of the present invention;

[0039] Figure 3 It is a structural schematic diagram of a rotary cutting blade tube provided by an embodiment of the present invention;

[0040] Figure 4 A schematic structural diagram of a rotary cutting blade tube with an inner cutting edge provided in one embodiment of the present invention;

[0041] Figure 5 A schematic structural diagram of a rotary cutting blade tube with an outer blade edge provided in one embodiment of the present invention;

[0042] Figure 6 1 is a schematic diagram of the structure of a negative pressure suction rotary biopsy needle provided in one embodiment of the present invention (without the motor handle installed);

[0043] Figure 7 is a cross-sectional view of a negative pressure suction rotary biopsy needle provided by an embodiment of the present invention;

[0044] Figure 8 It is a schematic diagram of the structure inside the distal end housing of a negative pressure suction biopsy needle provided by an embodiment of the present invention;

[0045] Fig. 9 It is a structural schematic diagram of a rotary cutting blade tube provided by an embodiment of the present invention moving axially to the farthest end;

[0046] Fig.10 It is a schematic structural diagram of a rotary cutter tube provided by an embodiment of the present invention moving axially to the most advanced end. DETAILED DESCRIPTION

[0047] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0048] The terms "first", "second", "third", "fourth", etc. (if any) in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so that the embodiments of the present invention described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are 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 positional relationships and do not represent a relationship of direct contact between the described objects.

[0049] As described in the background art, due to its structural reasons, the existing rotary cutting biopsy needle cannot achieve the sealing problem of the rotary cutting blade tube while ensuring the normal rotation and forward and backward movement of the rotary cutting blade tube, and thus cannot achieve negative pressure suction of the rotary cutting blade tube.

[0050] In order to solve the above technical problems, the present invention provides a positive negative pressure suction rotary cutting biopsy needle under a microscope, comprising a distal pipeline part and a proximal handheld part, wherein the distal pipeline part comprises an outer sheath tube, a rotary cutting blade tube and a puncture needle which are movably sleeved from the outside to the inside in sequence; the proximal handheld part comprises a proximal shell and a rotary cutting blade tube transmission assembly, and the proximal end of the rotary cutting blade tube is installed in the proximal shell through the rotary cutting blade tube transmission assembly;

[0051] A negative pressure interface is provided on the proximal end wall of the proximal shell, and the negative pressure interface is used to connect a negative pressure device;

[0052] The rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism includes a core shaft assembly and a rotating sleeve located in the proximal shell, the core shaft assembly is fixedly sleeved on the rotary cutter tube, the rotating sleeve is sleeved on the core shaft assembly, and is slidably connected to the core shaft assembly in the axial direction and relatively fixedly connected in the circumferential direction; the rotating sleeve and the rotary cutter tube are dynamically sealed by a first dynamic seal; the proximal end fixed seal of the rotating sleeve is connected to a rotating tube, and the rotating tube is also dynamically sealed and connected to the negative pressure interface through a second dynamic seal; the rotating sleeve is driven to rotate, so that the rotating sleeve drives the core shaft assembly to rotate, and then drives the rotary cutter tube to rotate;

[0053] The axial movement transmission mechanism includes a screw sleeve and a transmission screw, wherein the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the transmission screw sleeve is sleeved on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is relatively rotationally connected in the circumferential direction; the screw sleeve is driven to rotate so that the rotational motion of the screw sleeve is converted into axial movement of the transmission screw, and then the transmission screw drives the core shaft assembly and the rotary cutting knife tube to move axially.

[0054] Since the rotary cutter tube can rotate and move axially relative to the proximal housing, the present invention decomposes the sealing of the rotary cutter tube into axial sealing and rotary sealing. The specific implementation scheme of the axial sealing is: in the rotating sleeve, a first dynamic seal is formed between the rotating sleeve and the rotary cutter tube (since the axial movement speed of the rotary cutter tube is slow, the relative speed between it and the first dynamic seal is small, and the wear requirement for the first dynamic seal is low, which is conducive to the miniaturization of the first dynamic seal, so that the first dynamic seal can be placed in a narrow space in the rotating sleeve); the proximal end of the rotating sleeve is fixedly sealed and connected to a rotary tube. During sampling, no matter how the rotary cutter tube moves axially, the proximal end port of the rotary cutter tube is always located in the space between the distal end port of the rotary tube in the rotating sleeve and the first dynamic seal. Therefore, a sealed space is formed between the proximal end of the rotating sleeve and the first dynamic seal to accommodate the axial movement of the rotary cutter tube. The specific implementation scheme of the rotary seal is as follows: during sampling, since the rotary tube rotates synchronously with the rotating sleeve, relative rotation will occur between the rotary tube and the negative pressure interface. Based on this, the present invention performs dynamic sealing on the relative rotation between the rotary tube and the negative pressure interface, that is, the rotary tube is dynamically sealed and connected to the negative pressure interface through a second dynamic seal, thereby realizing the rotary sealing of the rotary cutter tube. Therefore, the present invention solves the sealing problem of the rotary cutter tube, and further realizes the negative pressure suction of the rotary biopsy needle.

[0055] Moreover, negative pressure suction can increase the sampling volume 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 continue to increase. The friction resistance will affect the sample tissue from entering the deep cavity of the rotary cutter tube, resulting in the inability to increase the sample tissue obtained. The suction provided by the negative pressure can overcome the friction resistance, suck more sample tissue into the inner cavity of the rotary cutter, and increase the sampling volume.

[0056] At the same time, through the host's refined control of negative pressure, during the sampling process, as the rotary cutting knife tube continues to move forward, the negative pressure value can be gradually increased to avoid excessively high negative pressure values ​​in the early stage, which would damage the integrity of the tissue sample.

[0057] Since the rotary cutting tube is a tubular structure with a circular blade at the far end, after sampling, the tissue at the blade edge needs to be pulled apart to complete the sampling. For some tissue structures that are difficult to pull apart, the pulling force may be insufficient, resulting in sampling failure. Negative pressure suction can increase the pulling force of the rotary cutting tube when it retreats, ensuring that the tissue can be successfully pulled apart.

[0058] After the sampling is completed, normal saline is injected into the rotary cutter tube through the negative pressure interface. The positive pressure provided by the injection of normal saline is used to flush the tissue sample out of the rotary cutter tube, thereby avoiding sample damage caused by ejection with a rigid needle.

[0059] In order to make the above-mentioned purposes, features and beneficial effects of the present invention more obvious and understandable, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0060] Example 1

[0061] Please refer to Figures 1 to 10 An embodiment of the present invention provides an endoscopic positive negative pressure suction biopsy needle, comprising a distal pipeline portion 1 and a proximal handheld portion 2, wherein the distal pipeline portion 1 comprises an outer sheath tube 101, a rotary cutting blade tube 102 and a puncture needle 103 which are movably sleeved in sequence from outside to inside.

[0062] The outer sheath 101 serves as the outermost layer of the distal tubing portion 1 of the biopsy needle, and its inner cavity can completely accommodate the rotary cutting tube 102 and the puncture needle 103. Therefore, during the process of transporting the outer sheath 101 into the working channel of the endoscope, the puncture needle 103 or the rotary cutting tube 102 is prevented from damaging the endoscope.

[0063] The present invention does not impose any restrictions on the material of the outer sheath 101, and preferably a smooth polymer material such as PTFE, PEEK, etc., is used to prevent damage to the endoscope during the process of passing through the working channel of the endoscope, thereby ensuring its delivery performance.

[0064] The present invention does not limit the thickness of the outer sheath tube 101 on one side, and can be set according to actual use requirements. As an embodiment, the thickness of the outer sheath tube 101 on one side is greater than 0.15 mm to ensure that it has sufficient strength to provide support for the rotary cutter tube 102 so that the rotary cutter tube 102 can rotate at high speed inside.

[0065] The rotary cutting blade tube 102 is a tubular structure, serving as the middle layer of the distal pipeline portion 1 of the biopsy needle, and is used to collect tissue samples. The distal end of the rotary cutting blade tube 102 is provided with an annular blade to ensure that the rotary cutting blade tube 102 can smoothly cut the tissue. The annular blade preferably adopts a flat-edge structure to ensure the integrity of the tissue after rotary cutting, so as not to be crushed and affect the pathological analysis.

[0066] As an example, please refer to Figure 4 The annular blade at the distal end of the rotary cutter tube 102 is an inner blade edge 1021 formed by removing the outer edges and corners of the distal end surface of the rotary cutter tube 102, and the inner blade edge 1021 is used for cutting high-density tissue.

[0067] As another example, please refer to Figure 5The annular blade at the distal end of the rotary cutter tube 102 is an outer blade edge 1021 ′ formed by removing the inner edges and corners of the distal end surface of the rotary cutter tube 102 , and the outer blade edge 1021 ′ is used for cutting low-density tissues.

[0068] In a specific implementation, please refer to Figure 3 The rotary cutter tube 102 includes a distal metal tube 1022, a wire spring tube 1023, a proximal metal tube 1025 and a polymer sealing tube 1024. The distal metal tube 1022 and the proximal metal tube 1025 are both metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1022 is an annular blade 1021. The distal metal tube 1022 is made of metal to ensure that the rotary cutter tube 102 can smoothly cut the tissue. The proximal metal tube 1025 is made of metal to facilitate its assembly and fixation. The wire spring tube 1023 is a hollow tube woven from metal wires. The metal wires are made of stainless steel or nickel-titanium structure. The 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 metal tube 1022 and the distal end of the metal wire spring tube 1023 are connected by end face welding to ensure that the outer diameter and inner diameter of the distal metal tube 1022 and the metal wire spring tube 1023 are substantially consistent.

[0069] On the outside of the rotary cutter tube 102, a layer of thin-walled polymer sealing tube 1024 is provided. The outer surface of the rotary cutter tube 102 is covered with the polymer sealing tube 1024. The polymer sealing tube 1024 is at least sealed on the metal wire spring tube 1023 and at the connection between the metal wire spring tube 1023 and the distal metal tube 1022. For example, a thin-walled heat shrink tube can be used, which is fixed to the outside of the rotary cutter tube 102 through a heat shrink process to achieve the sealing of the rotary cutter tube 102, so that the internal cavity can transmit negative pressure or positive pressure, and avoid leakage 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 cutter tube 102 and the puncture needle 103 during rotation, and avoid the wear of the braided metal wire of the rotary cutter tube 102.

[0070] The proximal metal tube 1025 is wrapped around the proximal outer side of the polymer sealing tube 1024, and the proximal metal tube 1025 and the polymer sealing tube 1024 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 cutter tube 102. In addition, the proximal metal tube 1025 is always connected to the first dynamic seal 208 in a dynamic sealing manner.

[0071] As an embodiment, the metal wire spring tube 1023, the polymer sealing tube 1024 and the proximal metal tube 1025 are flush at the proximal end surface.

[0072] In order to increase the adhesion strength of the tissue after cutting and avoid the tissue from falling off after cutting and sampling, the inner wall surface of the rotary cutting blade tube 102 is provided with a rough surface that increases the friction coefficient, such as a threaded surface.

[0073] In order to improve the effect of ultrasonic development, an ultrasonic reflection area is provided on the outer surface of the distal metal tube 1022. The ultrasonic reflection area is required to have an uneven texture. As for the texture shape of the ultrasonic reflection area, the present invention does not impose any specific restrictions. For example, the roughness of the outer surface of the distal metal tube 1022 can be increased by processes such as threading and dotting to improve the development effect of the rotary cutting knife tube 102 under ultrasound.

[0074] During sampling, the rotary cutter tube 102 can rotate while moving forward axially, and while cutting tissue, the cut tissue is stored in the inner cavity of the annular blade. After cutting, the rotary cutter tube 102 moves backward axially, and the tissue is broken by negative pressure and friction, completing sampling.

[0075] The puncture needle 103 is the innermost layer of the distal tubing part 1 of the biopsy needle, and it can be a nickel-titanium needle. The puncture needle 103 has a sharp tip, which can help the rotary cutter tube 102 to puncture, break through the tissue wall, and 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 edges and corners from 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 make room for the transmission of negative pressure.

[0076] The proximal handheld portion 2 includes a proximal housing 204 and a rotary cutter tube transmission assembly, and the proximal end of the rotary cutter tube 102 is installed in the proximal housing 204 through the rotary cutter tube transmission assembly.

[0077] A negative pressure interface 2041 is provided on the proximal end wall of the proximal housing 204. The negative pressure interface 2041 is used to connect a negative pressure device. The present invention does not limit the specific type of the negative pressure device, which may be a negative pressure suction syringe or a negative pressure pump.

[0078] The rotary cutter tube transmission assembly is installed in the proximal housing 204 , and the rotary cutter tube transmission assembly is connected to the rotary cutter tube 102 . The rotary cutter tube 102 is driven by the rotary cutter tube transmission assembly to perform rotary cutting on tissue.

[0079] Since the rotary cutter tube transmission assembly can not only drive the rotary cutter tube 102 to rotate and 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. Therefore, the rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, both of which are connected to 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.

[0080] Please refer to Figure 8 , the circumferential rotation transmission mechanism includes a core shaft assembly 209 and a rotating sleeve 207 located in the proximal housing 204, the core shaft assembly 209 is fixedly sleeved on the rotary cutter tube 102, the rotating sleeve 207 is sleeved on the core shaft assembly 209, and is axially slidingly connected to the core shaft assembly 209, and relatively fixedly connected in the circumferential direction. The rotating sleeve 207 is driven to rotate, so that the rotating sleeve 207 drives the core shaft assembly 209 to rotate, and then drives the rotary cutter tube 102 to rotate. The present invention does not limit the driving device for driving the rotating sleeve 207 to rotate, which can be pneumatic, hydraulic or electric. As an embodiment, the driving device adopts a rotary drive motor. Specifically, the rotating sleeve 207 is coaxially fixedly connected to the rotating gear 214, and the rotating gear 214 is driven by the rotary drive motor, so that the rotating sleeve 207 drives the core shaft assembly 209 to rotate.

[0081] Since the rotating sleeve 207 and the core shaft assembly 209 that are sleeved with each other are slidably connected in the axial direction and relatively fixedly connected in the circumferential direction, it is a mature technical means in the mechanical field. Therefore, the present invention does not limit the specific connection structure of the rotating sleeve 207 and the core shaft assembly 209.

[0082] As an embodiment, the core shaft assembly 209 includes a fixed tube and an inner tool sleeve, the fixed outer sleeve of the fixed tube is on the rotary cutting tool tube 102, the fixed outer sleeve of the inner tool sleeve is on the fixed tube, and the rotating sleeve 207 is on the inner tool sleeve. The rotating sleeve 207 and the inner tool sleeve are connected by sliding in the axial direction and fixedly connected in the circumferential direction by inserting an axial protrusion into an axial guide groove.

[0083] In a specific implementation, the inner wall of the rotating sleeve 207 is provided with a plurality of protrusions at intervals along the circumferential direction, and these protrusions are all provided along the axial direction of the rotating sleeve 207; the outer wall of the inner knife sleeve is provided with a plurality of guide grooves adapted to the plurality of protrusions at intervals along the circumferential direction, and these guide grooves are all provided along the axial direction of the inner knife sleeve. By inserting a plurality of protrusions into a plurality of guide grooves, the rotating sleeve 207 is axially slidably connected to the inner knife sleeve and fixedly connected in the circumferential direction, that is, the rotating sleeve 207 and the inner knife sleeve shaft can slide relative to each other in the axial direction and rotate synchronously in the circumferential direction. Of course, the protrusions can also be provided on the outer wall of the inner knife sleeve, and the guide grooves can be provided on the inner wall of the rotating sleeve 207. This embodiment does not impose any specific restrictions on this.

[0084] In the present invention, the rotating sleeve 207 and the rotary cutter tube 102 are dynamically sealed via a first dynamic seal 208; the proximal fixed seal of the rotating sleeve 207 is connected to a rotary tube 215, and the rotary tube 215 is also dynamically sealed to the negative pressure interface 2041 via a second dynamic seal 206.

[0085] Since the rotary cutter tube 102 can rotate and move axially relative to the proximal housing 204, the present invention decomposes the sealing of the rotary cutter tube 102 into axial sealing and rotary sealing:

[0086] The specific implementation scheme of the axial seal is as follows: in the rotating sleeve 207, the rotating sleeve 207 and the rotary cutter tube 102 are dynamically sealed by the first dynamic seal 208; the proximal fixed seal of the rotating sleeve 207 is connected to a rotary tube 215. During sampling, no matter how the rotary cutter tube 102 moves axially, the distal end of the rotary cutter tube 102 is always located in the space 212 between the distal end of the rotary tube 215 in the rotating sleeve 207 and the first dynamic seal 208. Therefore, a sealed space 212 is formed between the proximal end of the rotating sleeve 207 and the first dynamic seal 208 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 moves axially. When the rotary cutter tube 102 moves axially to the farthest end, the rotary cutter tube 102 is still sealed with the rotating sleeve 207 through the first dynamic seal 208, and the distal end of the rotary cutter tube 102 is still located in the space 212' between the rotary tube 215 in the rotating sleeve 207 and the first dynamic seal 208. Please refer to Fig.10 After the cutting is completed, the rotary cutter tube 102 retreats axially. When the rotary cutter tube 102 moves axially to the farthest end, the rotary cutter tube 102 is still dynamically sealed with the rotating 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 tube 215 in the rotating sleeve 207 and the first dynamic seal 208.

[0087] The specific implementation scheme of the rotary seal is as follows: during sampling, since the rotary tube 215 rotates synchronously with the rotating sleeve 207, relative rotation will occur between the rotary tube 215 and the negative pressure interface 2041. Based on this, the present invention dynamically seals the relative rotation between the rotary tube 215 and the negative pressure interface 2041, that is, the rotary tube 215 is dynamically sealed and connected to the negative pressure interface 2041 through the second dynamic seal 206, thereby realizing the rotary seal of the rotary cutting knife tube 102.

[0088] In order to facilitate assembly and fixing, the rotary tube 215 is made of a metal tube, such as a steel tube. The rotary tube 215 and the second dynamic seal 206 form a rotary seal, and no leakage occurs at a high speed (>3000RPM). The rotary tube 215 has a surface roughness requirement, generally Ra<0.2.

[0089] Since dynamic seals are a relatively mature technology in the field of mechanical fluid transmission, the present invention does not limit the specific structures of the first dynamic seal 208 and the second dynamic seal 206 .

[0090] As an embodiment, the first dynamic seal 208 and the second dynamic seal 206 are sealing rings, such as a Variseal seal or a silicone seal.

[0091] The inner ring of the rotating 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 rotary cutter tube 102 should be as smooth as possible to reduce the friction resistance caused by the seal.

[0092] A second groove is provided on the inner side of the proximal end wall of the proximal housing 204, the second groove is communicated 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 screw tube 215 should be as smooth as possible to reduce the friction resistance caused by the seal.

[0093] As an embodiment, the negative pressure interface 2041 is provided with a Luer connector, which can be connected to a negative pressure suction syringe or a negative pressure pump structure through the Luer connector.

[0094] The axial movement transmission mechanism includes a screw sleeve 210 and a transmission screw 211. The screw sleeve 210 is rotatably arranged in the proximal housing 204 and is threadedly engaged with the transmission screw 211 for transmission; the transmission screw 211 is sleeved on the rotating sleeve 207 and is relatively fixed to the mandrel assembly 209 in the axial direction and is relatively rotatably connected in the circumferential direction; the screw sleeve 210 is driven to rotate so that the rotational 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 rotary cutter tube 102 to move axially. The present invention does not limit the driving device for driving the screw sleeve 210 to rotate, and it can be pneumatic, hydraulic or electric. As an embodiment, the driving device adopts a stroke drive motor. Specifically, the screw sleeve 210 is coaxially fixedly connected with a stroke gear 213. The stroke gear 213 is driven by the stroke drive motor to rotate. The stroke gear 213 drives the screw sleeve 210 to rotate, and the rotational 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 sleeve 207, and is relatively fixed to the core shaft assembly 209 in the axial direction and relatively rotationally connected in the circumferential direction.

[0095] As an embodiment, the proximal handheld portion 2 further includes a motor handle 205, in which the rotation drive motor and the stroke drive motor are both installed, and the motor handle 205 is fixedly connected to the proximal housing 204. The rotation drive motor and the stroke drive motor respectively directly control or control the peeling gear and the stroke gear 213 through gear transmission to realize the rotation and forward and backward movement of the peeling blade tube 102.

[0096] The screw sleeve 210 only performs rotational motion and does not perform axial movement in the proximal housing 204. In order to limit the axial movement of the screw sleeve 210 in the proximal housing 204, positioning baffles are provided at the proximal and distal ends of the screw sleeve 210 and the proximal housing 204, so as to limit the screw sleeve 210 between the two positioning baffles and prevent it from performing axial movement.

[0097] In this embodiment, the transmission screw 211 is sleeved on the rotating sleeve 207 and is relatively fixedly connected to the core shaft assembly 209 in the axial direction and relatively rotatably connected in the circumferential direction.

[0098] As an embodiment, the inner tool sleeve and the transmission screw 211 are connected in a circumferential rotational direction and fixedly connected in an axial direction by inserting a circumferentially arranged annular limiting clamp into an annular limiting clamping groove.

[0099] In a specific implementation, an annular limiting groove is provided on the outer circumference of the inner knife sleeve, and an annular limiting fixture matching the annular limiting groove is provided on the inner circumference of the transmission screw 211. The annular limiting fixture is inserted into the annular limiting groove to realize the circumferential rotation connection between the transmission screw 211 and the inner knife sleeve, and the axial fixed connection, that is, the inner knife sleeve and the transmission screw 211 can rotate relative to each other, but cannot produce relative displacement in the axial direction. Of course, the annular limiting groove can also be provided on the inner circumference of the transmission screw, and the annular limiting fixture matching the annular limiting groove can be provided on the outer circumference of the inner knife sleeve, and this embodiment does not impose specific restrictions on this.

[0100] A guide rail is axially provided on the inner wall of the proximal housing 204 , and the drive screw 211 is slidably arranged on the guide rail. By driving the screw sleeve 210 to rotate, the drive screw 211 moves along the guide rail, so as to limit the axial movement distance of the drive screw 211 .

[0101] In one embodiment, the proximal handheld portion 2 further includes an endoscope fixing member 201 and a distal shell 203, and the endoscope fixing member 201 includes a sheath seat 2011 and a sheath seat locking member 2012, and the sheath seat 2011 is movably mounted on the outer sheath tube 101, so that the sheath seat 2011 can move axially on the outer sheath tube 101.

[0102] The sheath seat 2011 is provided with a second Luer connector that is compatible with the first Luer connector on the endoscope. The sheath seat 2011 is assembled and connected with the second Luer connector through the first Luer connector to achieve a fixed connection with the endoscope.

[0103] This embodiment does not limit the specific connection form between the first Luer connector and the second Luer connector, which may be a threaded connection, a snap connection, or other detachable fixed connection methods.

[0104] The distal housing 203 is a sleeve-type structure with two ends open, and the distal housing 203 is fixedly sleeved on the proximal end of the outer sheath tube 101. The distal housing 203 is located between the sheath seat 2011 and the proximal housing 204. The sheath seat 2011 is axially slidably connected to the distal end of the distal housing 203, and can be locked with the distal housing 203 by the sheath seat locking piece 2012; the proximal end of the distal housing 203 is axially slidably connected to the distal end of the proximal housing 204.

[0105] The fixed connection with the endoscope is achieved by assembling and connecting the first Luer connector on the endoscope with the second Luer connector on the sheath seat 2011. After the sheath seat 2011 is fixed to the endoscope, the relative position of the outer sheath tube 101 and the endoscope is adjusted by adjusting the relative position of the sheath seat 2011 and the distal housing 203. After the adjustment is completed, the sheath seat locking piece 2012 is locked with the distal housing 203 to achieve the fixation of the outer sheath tube 101 and the endoscope.

[0106] Since the technical solution of adjusting and locking the two structures (sheath seat 2011 and distal housing 203) by means of a locking member (sheath seat locking member 2012) is a relatively mature technology in the mechanical field, the present invention does not impose specific restrictions on this. For example, the sheath seat locking member 2012 may be a locking cap structure, in which an internal thread is provided, and the sheath seat 2011 is provided with an external thread adapted to the internal thread, and the sheath seat 2011 is locked on the distal housing 203 by means of the matching assembly of the internal thread and the external thread. When the locking cap structure is loosened, the sheath seat 2011 and the distal housing 203 are in an unlocked state, and an axial sliding operation can be performed. Of course, the sheath seat locking member 2012 of the present invention is not limited to the locking cap structure, and can also be a threaded fastener. Specifically, a threaded hole is provided on one side wall of the sheath seat 2011, and the sheath seat locking member 2012 is a threaded fastener adapted to 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 tightening the second end of the threaded fastener, so that the first end of the threaded fastener abuts against the distal housing 203, thereby fixing the proximal housing 204 to the sheath seat 2011. The threaded fastener can be a locking screw or other structure.

[0107] Traditional biopsy needles are usually fixed by the proximal housing and the endoscope, and are uniformly operated by the endoscope operator. However, since the rotary biopsy needle is equipped with a motor, the weight of the motor handle and the proximal housing after assembly is relatively large. If the traditional fixing method is adopted, the difficulty of moving the endoscope and the difficulty of operation of the endoscope operator will be greatly increased after the proximal housing and the endoscope are fixed. The present invention fixes the outer sheath tube to the endoscope through the endoscope fixing part on the outer sheath tube, and the proximal housing and the motor handle are held and operated by another special operator. Therefore, the hand-holding and operation of the endoscope are distinguished from the hand-holding and operation of the proximal housing, which reduces the difficulty of operation and increases the adjustment range of the outer sheath tube intervention depth.

[0108] The proximal handheld part 2 also includes a puncture depth adjustment device 202, which includes an adjustment sleeve 2021 and a sleeve locking piece 2022. The adjustment sleeve 2021 is movably mounted on the distal housing 203. When in use, the puncture depth is set by first adjusting the position of the adjustment sleeve 2021 on the distal housing 203; then the adjustment sleeve 2021 is locked on the distal housing 203 by the sleeve locking piece 2022; finally, the proximal housing 204 is slid distally to achieve puncture. When the distal end of the proximal housing 204 contacts the adjustment sleeve 2021, that is, the adjustment sleeve 2021 blocks the proximal housing 204 from continuing to slide distally, the puncture is completed.

[0109] Since the technical solution of adjusting and locking the two structures (adjusting sleeve 2021 and the inlet housing) by means of a locking member (sleeve locking member 2022) is a relatively mature technology in the mechanical field, the present invention does not impose any specific restrictions on this. For example, the sleeve locking member 2022 may be a locking cap structure, in which an internal thread is provided, and an external thread matching the internal thread is provided on the adjusting sleeve 2021. By means of the matching assembly of the internal thread and the external thread, the adjusting sleeve 2021 is locked on the distal housing 203. When the locking cap structure is loosened, the adjusting sleeve 2021 and the distal housing 203 are in an unlocked state, and an axial sliding operation can be performed. Of course, the sleeve locking member 2022 of the present invention is not limited to the lock cap structure, and can also be a threaded fastener. Specifically, a threaded hole is provided on one side wall of the adjusting sleeve 2021, and the sleeve locking member 2022 is a threaded fastener adapted to the threaded hole. The first end of the threaded fastener passes through the threaded hole into the adjusting sleeve 2021, and the second end is located outside the adjusting sleeve 2021. The threaded fastener is tightened by manually tightening the second end of the threaded fastener, so that the first end of the threaded fastener abuts against the distal housing 203, thereby fixing the proximal housing 204 and the adjusting sleeve 2021. The threaded fastener can be a locking screw or other structure.

[0110] Example 2

[0111] This embodiment provides a positive negative pressure suction biopsy system under a microscope, comprising the negative pressure suction rotary biopsy needle and the negative pressure device described in Example 1, wherein the negative pressure device performs negative pressure suction on the tissue in the rotary cutting blade tube 102 through the negative pressure interface 2041 .

[0112] As an embodiment, the biopsy system further includes a syringe. After the sampling is completed, the syringe injects physiological saline into the rotary cutter tube 102 through the negative pressure interface 2041 to flush out the tissue sample in the rotary cutter tube 102 .

[0113] The negative pressure device and the syringe may share a common interface, or may use separate interfaces to be connected to the negative pressure interface 2041 .

[0114] As an embodiment, the negative pressure interface 2041 is also connected to a three-way connector, which includes a first interface, a second interface and a third interface, wherein the first interface is used to communicate with the negative pressure interface 2041, the second interface is used to connect the negative pressure device, and the third interface is used to connect the syringe. The three-way connector is provided with an adjustment switch, and the first interface switches the passage with the second interface and the third interface through the adjustment switch. For example, when the adjustment 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 to achieve adsorption of tissue; when the adjustment switch is in gear II, the syringe can flush out the tissue in the rotary cutter tube 102 for sampling to ensure the integrity of the tissue.

[0115] This embodiment does not limit the specific type of the negative pressure device, such as a negative pressure suction syringe or a negative pressure pump. The following takes the negative pressure device as an example of a negative pressure pump to explain the method for adjusting the negative pressure.

[0116] In order to achieve the adjustment of the negative pressure, the biopsy system also includes a host, which includes a main control module. The main control module is electrically connected to the negative pressure pump through the negative pressure drive module. The main control module controls the output DAC analog signal and outputs an adjustable pressure drive signal. Since the driving voltage of the negative pressure pump is linearly related to the flow rate, the negative pressure can be adjusted by controlling the driving voltage of the negative pressure pump, that is, the flow rate of the negative pressure pump.

[0117] The host 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. The main control module adjusts the negative pressure value by adjusting the flow rate of the negative pressure pump based on the fed-back negative pressure value.

[0118] The main control module is also electrically connected to the rotary cutting drive motor and the stroke drive motor through the motor drive module. When sampling, the negative pressure is adjusted in three stages:

[0119] (1) In the initial stage, the negative pressure value is small, <10 KPa, so that the annular blade of the rotary cutter tube 102 can be close to the tissue, which is convenient for the annular blade of the rotary cutter tube 102 to cut and separate the tissue.

[0120] (2) During the sampling phase, the negative pressure value is gradually increased based on the rotary cutting depth of the rotary cutter tube 102. For example, if the rotary cut is screwed in 1mm, the negative pressure value can be increased by 1KPa. When the rotary cut 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 means that the inner cavity of the rotary cutter tube 102 is blocked and cannot penetrate deeper, resulting in the annular blade of the rotary cutter tube 102 being unable to 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 inner cavity of the rotary cutter tube 102 moves deeper into the inner cavity, so that there is space at the far end of the rotary cutter tube 102 to accommodate more tissue, thereby increasing the sampling volume.

[0121] (3) After the sampling is completed, the negative pressure pump provides a larger negative pressure value, such as >30KPa, so that the suction force of the negative pressure and the friction force are superimposed to completely separate the sample tissue.

[0122] (4) During the sample collection phase, the negative pressure is turned off, the three-way joint is adjusted, and physiological saline is injected into the inner cavity of the rotary cutting blade tube 102 to flush out the sample tissue.

[0123] Although the present invention is disclosed as above, the present invention 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 invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. A positive negative pressure suction biopsy needle under microscope, characterized in that: It includes a distal pipeline part and a proximal handheld part, wherein the distal pipeline part includes an outer sheath tube, a rotary cutter tube and a puncture needle which are movably sleeved from the outside to the inside in sequence; the proximal handheld part includes a proximal shell and a rotary cutter tube transmission assembly, and 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 provided on the proximal end wall of the proximal shell, and the negative pressure interface is used to connect a negative pressure device; The rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism includes a core shaft assembly and a rotating sleeve located in the proximal shell, the core shaft assembly is fixedly sleeved on the rotary cutter tube, the rotating sleeve is sleeved on the core shaft assembly, and is slidably connected to the core shaft assembly in the axial direction and relatively fixedly connected in the circumferential direction; the rotating sleeve and the rotary cutter tube are dynamically sealed by a first dynamic seal; the proximal end fixed seal of the rotating sleeve is connected to a rotating tube, and the rotating tube is also dynamically sealed and connected to the negative pressure interface through a second dynamic seal; the rotating sleeve is driven to rotate, so that the rotating sleeve drives the core shaft assembly to rotate, and then drives the rotary cutter tube to rotate; The axial movement transmission mechanism includes a screw sleeve and a transmission screw, wherein the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the transmission screw sleeve is sleeved on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is relatively rotationally connected in the circumferential direction; the screw sleeve is driven to rotate so that the rotational motion of the screw sleeve is converted into axial movement of the transmission screw, and then the transmission screw drives the core shaft assembly and the rotary cutting knife tube to move axially.

2. The biopsy needle according to claim 1, characterized in that: The rotating shaft sleeve is fixedly connected to a rotating gear, and the rotating shaft sleeve drives the rotating gear to perform a rotating motion through a rotating driving motor.

3. The biopsy needle according to claim 2, characterized in that: The screw sleeve is fixedly connected to the travel gear, and the screw sleeve drives the travel gear to rotate through a travel drive motor.

4. The biopsy needle according to claim 3, characterized in that: The proximal handheld part also includes a motor handle, the rotation drive motor and the stroke drive motor are both installed in the motor handle, and the motor handle is fixedly connected to the proximal housing.

5. The biopsy needle according to claim 1, characterized in that: The spindle assembly comprises a fixed tube and an inner knife sleeve, wherein the fixed tube is fixedly sleeved on the rotary cutter tube, the inner knife sleeve is fixedly sleeved on the fixed tube, and the rotating sleeve is sleeved on the inner knife sleeve. The rotating sleeve and the inner knife sleeve are connected by sliding in the axial direction and fixedly connected in the circumferential direction through an axial protrusion inserted into an axial guide groove. The inner knife sleeve and the transmission screw are connected in a circumferential rotational direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.

6. The biopsy needle according to claim 1, characterized in that: A guide rail is also provided on the inner wall of the proximal shell, and the transmission screw is slidably arranged on the guide rail.

7. The biopsy needle according to claim 1, characterized in that: The proximal handheld part also includes an endoscope fixing part and a distal shell, the endoscope fixing part includes a sheath seat and a sheath seat locking part, the sheath seat is movably sleeved on the outer sheath tube; the sheath seat is provided with a second Luer connector adapted to the first Luer connector on the endoscope, the sheath seat is assembled and connected with the second Luer connector through the first Luer connector, so as to realize fixed connection with the endoscope; The distal shell fixing sleeve is at the proximal end of the outer sheath tube, the sheath seat is axially slidably connected to the distal end of the distal sleeve, and can be locked with the distal shell by the sheath seat locking piece; the proximal end of the distal shell is axially slidably connected to the distal end of the proximal shell.

8. The biopsy needle according to claim 7, characterized in that: The proximal handheld part also includes a puncture depth adjustment device, which includes an adjustment sleeve and a sleeve locking piece. The adjustment sleeve is movably mounted on the distal shell. When in use, the puncture depth is first set by adjusting the position of the adjustment sleeve on the distal shell; then the adjustment sleeve is locked on the distal shell by the sleeve locking piece; finally, the proximal shell is slid distally to achieve puncture.

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

10. The biopsy needle according to claim 1, characterized in that: The inner ring of the rotating sleeve is provided with a first groove, and the first dynamic seal is fixedly installed in the first groove.

11. The biopsy needle according to claim 1, characterized in that: A second groove is provided on the inner side of the proximal end wall of the proximal shell, the second groove is communicated with the negative pressure interface, and the second dynamic seal is fixedly installed in the second groove.

12. The biopsy needle according to claim 1, characterized in that: The first dynamic seal and / or the second dynamic seal is a sealing ring.

13. The biopsy needle according to claim 12, characterized in that: The sealing ring is a pan seal or a silicone seal.

14. The negative pressure suction biopsy needle according to claim 1, characterized in that: The rotary cutting knife tube includes a distal metal tube, a metal wire spring tube, a proximal metal tube and a polymer sealing tube. The distal end of the distal metal tube is an annular blade, and the proximal end face of the distal metal tube is fixedly connected to the distal end face of the metal wire spring tube; the polymer sealing tube at least has a sealing sleeve arranged on the metal wire spring tube and at the connection between the metal wire spring tube and the distal metal tube; the proximal metal tube is fixedly arranged at the proximal end of the polymer sealing tube.

15. A positive negative pressure suction biopsy system under microscope, characterized in that: It comprises the biopsy needle and the negative pressure device as described in any one of claims 1 to 13, wherein 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 according to claim 15, characterized in that: It also includes a syringe. After the 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.

17. The biopsy system according to claim 15, characterized in that: It also includes a host, which includes a main control module. The main control module is electrically connected to the negative pressure device through a negative pressure driving module to control the negative pressure of the negative pressure device.

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