Negative pressure suction rotary cutting biopsy needle and biopsy system

Abstract

The invention provides a negative pressure suction rotary cutting biopsy needle and a biopsy system.The biopsy needle comprises a far-end pipeline part and a near-end handheld part, the far-end pipeline part comprises a rotary cutting knife tube, and the near-end handheld part comprises a near-end shell and a rotary cutting knife tube transmission assembly; the rotary cutting knife tube is connected into the near-end shell through the rotary cutting knife tube transmission assembly, and the rotary cutting knife tube is made to rotate in the circumferential direction and move in the axial direction by driving the rotary cutting knife tube transmission assembly. The near end of the near-end shell is provided with a negative pressure connector used for being communicated with a negative pressure device, a connecting sleeve is arranged in the near-end shell, the near end of the connecting sleeve is communicated with the negative pressure connector in a sealed mode, the near end of the rotary cutting knife tube is inserted into the connecting sleeve from the far end of the connecting sleeve, and in addition, the near end of the rotary cutting knife tube is connected with the negative pressure connector in a sealed mode. The connecting sleeve and the rotary cutter pipe are in dynamic sealing through a dynamic sealing piece.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a negative pressure suction rotary cutting biopsy needle and a biopsy system. 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 structure, the rotary biopsy needle cannot currently be used with negative pressure suction to assist in sampling. Summary of the invention

[0007] To solve the above technical problems, an embodiment of the present invention provides a negative pressure suction biopsy needle, comprising a distal pipeline part and a proximal hand-held part, the distal pipeline part comprises a rotary cutter tube, the proximal hand-held part comprises a proximal shell and a rotary cutter tube transmission assembly, the rotary cutter tube is connected to the proximal shell through the rotary cutter tube transmission assembly, and the rotary cutter tube is driven to perform circumferential rotation and axial movement; a negative pressure interface for communicating with a negative pressure device is provided at the proximal end of the proximal shell, a connecting sleeve is provided in the proximal shell, the proximal end of the connecting sleeve is sealed and connected to the negative pressure interface, the proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and a dynamic seal is performed between the connecting sleeve and the rotary cutter tube through a dynamic seal.

[0008] Preferably, the dynamic seal is a sealing ring, the outer periphery of which is sealingly connected to the inner periphery of the connecting sleeve, or the sealing ring is fixed to the distal end face of the connecting sleeve; the proximal end of the rotary cutting knife tube is inserted into the sealing ring and dynamically sealed with the sealing ring.

[0009] Preferably, the sealing ring is a pan seal or a silicone seal.

[0010] Preferably, 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.

[0011] Preferably, the distal pipeline portion also includes an outer sheath and a puncture needle tube, the puncture needle tube is movably sleeved on the rotary cutting knife tube, and the outer sheath is movably sleeved on the puncture needle tube; before puncture, the distal end of the puncture needle tube is located in the outer sheath, and the distal end of the rotary cutting knife tube is located in the puncture needle tube; during puncture, the puncture needle tube and the rotary cutting knife tube pass through the distal end of the outer sheath together to puncture the tissue, and during the puncture process, the distal end of the rotary cutting knife tube is always located in the puncture needle tube; after the puncture is completed, the rotary cutting knife tube extends from the distal end of the puncture needle tube to perform rotary cutting sampling on the tissue.

[0012] Preferably, the outer sheath is also provided with an endoscope fixing part, and the endoscope fixing part includes a locking sleeve and a locking part. The locking sleeve includes an integrally arranged connecting part and a locking part, and the connecting part is used to be fixedly connected to the endoscope. The locking part is movably sleeved on the outer sheath and can slide axially on the outer sheath, and the locking part can be locked at any position of the outer sheath by the locking part.

[0013] Preferably, the connecting portion is a first Luer connector, the proximal end of the working channel of the endoscope is provided with a second Luer connector adapted to the first Luer connector, and the first Luer connector is cooperatively connected with the second Luer connector; the locking portion is provided with an external thread, and the locking piece is a locking cap, a threaded hole adapted to the external thread of the locking portion is provided in the locking cap, and the locking cap is tightened on the locking portion so that the locking portion is clamped and fixed to the outer sheath.

[0014] Preferably, the proximal handheld portion further comprises a puncture depth adjustment mechanism, the puncture depth adjustment mechanism comprises a sheath seat and a sheath seat locking member, the sheath seat is fixed to the proximal end of the outer sheath tube, and the proximal shell can move axially relative to the sheath seat;

[0015] During puncture, the proximal shell is pushed toward the distal end, so that the puncture needle tube and the rotary cutting knife tube pass through the distal end of the outer sheath tube and puncture the tissue. After the puncture is completed, the proximal shell is locked with the sheath seat through the sheath seat locking piece.

[0016] Preferably, the sheath seat is a sleeve structure, the distal end of the sheath seat is fixedly connected to the proximal end of the outer sheath tube, and the proximal movable outer sleeve of the sheath seat is on the proximal outer shell;

[0017] An external thread is provided on the proximal outer wall of the sheath seat, and the sheath seat locking piece is a locking cap. An internal threaded hole adapted to the external thread of the sheath seat is provided in the locking cap, and the sheath seat clamps the proximal outer shell by tightening the internal threaded hole of the locking cap onto the external thread of the sheath seat; or, a threaded hole is provided on one side wall of the sheath seat, and the sheath seat locking piece is a threaded fastener adapted to the threaded hole, one end of the threaded fastener passes through the threaded hole into the sheath seat, and the end of the threaded fastener is pressed against the proximal outer shell by tightening the threaded fastener.

[0018] Preferably, the proximal handheld portion further comprises a puncture needle tube adjusting mechanism, the puncture needle tube is installed in the proximal housing through the puncture needle tube adjusting mechanism, and the puncture needle tube is axially moved through the puncture needle tube adjusting mechanism.

[0019] Preferably, the puncture needle tube adjustment mechanism includes a puncture needle tube sleeve and an elastic locking structure, the puncture needle tube sleeve is located in the proximal shell and is fixedly sleeved on the puncture needle tube; the elastic locking structure is provided on at least one outer side of the puncture needle tube sleeve, and a puncture needle tube adjustment groove is axially opened on at least one side of the tube wall of the proximal shell, and the elastic locking structure passes through the puncture needle tube adjustment groove; the elastic locking structure includes an integrally arranged button and at least one limiting column, and a plurality of limiting grooves are spaced apart on at least one side of the groove wall of the puncture needle tube adjustment groove. In a natural state, the limiting column is located in the limiting groove, and by pressing the button, the limiting column is separated from the limiting groove to the proximal shell, so that the puncture needle tube can follow the button to move axially along the puncture needle tube adjustment groove.

[0020] Preferably, a mounting hole is axially provided at the center of the puncture needle tube sleeve, and the puncture needle tube passes through the mounting hole and is fixed to the mounting hole; a hollow area is provided at the proximal end of at least one side tube wall of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outer side of the hollow area, the elastic strip is axially arranged along the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, the elastic locking structure is fixed to the proximal end of the elastic strip, and the button is pressed, and the limit column follows the proximal end of the elastic strip to move toward the hollow area, so that the limit column disengages from the limit slot.

[0021] Preferably, the rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism. By driving the circumferential rotation transmission mechanism, the rotary cutter tube is driven to rotate so that the rotary cutter tube cuts the tissue; by driving the axial movement transmission mechanism, the rotary cutter tube is driven to move axially to adjust the cutting depth of the rotary cutter tube.

[0022] Preferably, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotating sleeve located in the proximal housing, the mandrel assembly is fixedly sleeved on the rotary cutter tube, the rotating sleeve is sleeved on the mandrel assembly, and is slidably connected to the mandrel assembly in the axial direction and relatively fixedly connected in the circumferential direction; a rotating gear is coaxially fixedly connected to the rotating sleeve, and the rotating gear is driven by a rotating drive motor, so that the rotating gear drives the rotating sleeve to rotate;

[0023] 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 threadedly meshed with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected with a stroke gear, and the stroke gear is driven by a stroke drive motor to perform rotational motion, and the stroke gear drives the screw sleeve to rotate, and the rotational motion of the screw sleeve is converted into axial movement of the transmission screw;

[0024] The transmission screw is sleeved on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is relatively rotatably connected in the circumferential direction.

[0025] Preferably, the mandrel assembly comprises a fixed tube and an inner knife sleeve, the fixed tube fixedly sleeve is outer-circuited on the rotary cutter tube, the inner knife sleeve fixedly sleeve is outer-circuited on the fixed tube, the rotating sleeve is outer-circuited 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;

[0026] 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.

[0027] Preferably, 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.

[0028] Preferably, the proximal handheld portion further comprises 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.

[0029] Another embodiment of the present invention provides a negative pressure suction biopsy system, comprising the negative pressure suction biopsy needle and a negative pressure device described in the above embodiment, wherein the negative pressure device performs negative pressure suction on the tissue in the rotary cutting blade tube through the negative pressure interface.

[0030] Preferably, the negative pressure suction rotary biopsy system further comprises 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.

[0031] Preferably, it also includes a three-way connector, which includes a first interface, a second interface and a third interface, the first interface is used to communicate with the negative pressure interface, the second interface is used to connect to the negative pressure device, and the third interface is used to connect to the syringe. An adjustment switch is provided in the three-way connector, and the first interface realizes path switching with the second interface and the third interface through the adjustment switch.

[0032] Preferably, the negative pressure suction excision biopsy system further comprises a host, wherein the host comprises a main control module, and the main control module is electrically connected to the negative pressure device via a negative pressure driving module to control the negative pressure of the negative pressure device.

[0033] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:

[0034] The present invention provides a negative pressure interface at the proximal end of the proximal shell of the biopsy needle, the negative pressure interface is sealed and connected with a connecting sleeve, the connecting sleeve is arranged in the proximal shell, the rotary cutting knife tube is inserted into the connecting sleeve, and a dynamic seal is performed with the connecting sleeve through a dynamic seal, thereby solving the sealing problem of the rotary cutting knife tube and realizing negative pressure suction of the rotary cutting biopsy needle.

[0035] Furthermore, negative pressure suction can increase the sampling volume of the rotary cutter tube. During sampling, as the amount of 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 frictional 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 frictional resistance, sucking more sample tissue into the inner cavity of the rotary cutter, and increasing the sampling volume.

[0036] Furthermore, through the refined control of the negative pressure by the host, during the sampling process, as the rotary cutting 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.

[0037] Furthermore, since the rotary cutter tube is a tubular structure with a circular blade at the distal 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 cutter tube when it is retreating, ensuring that the tissue can be successfully pulled apart.

[0038] Furthermore, after the 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 damage caused by ejection with a rigid needle.

[0039] Furthermore, in the present invention, the distal tubing portion includes an outer sheath, a puncture needle tube, and a rotary cutter tube from the outside to the inside. Before puncture, the distal end of the puncture needle tube is located inside the outer sheath, and the distal end of the rotary cutter tube is located inside the puncture needle tube; during puncture, the puncture needle tube and the rotary cutter tube are passed through the distal end of the outer sheath together to puncture the tissue, and during the puncture process, the distal end of the rotary cutter tube is always located inside the puncture needle tube; after the puncture is completed, the rotary cutter tube extends from the distal end of the puncture needle tube to sample by rotary cutting the tissue. Since the distal end of the rotary cutter tube is located inside the puncture needle tube during puncture, the rotary cutter tube can penetrate into the human tissue together with the puncture needle tube, ensuring the smoothness of the outer surface of the puncture needle tube, making it easier to puncture and break through.

[0040] Furthermore, in the present invention, the outer sheath serves as the outermost layer of the distal tubing portion of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube and the rotary cutting knife tube. Therefore, before puncture, the distal end of the puncture needle tube is placed in the outer sheath, and the distal end of the rotary cutting knife tube is placed in the puncture needle tube. During the process of transporting the outer sheath into the working channel of the endoscope, the puncture needle or the rotary cutting knife is prevented from damaging the endoscope.

[0041] Furthermore, in order to realize the flexible rotation of the rotary cutter tube, the rotary cutter tube realizes the flexible transmission of torque and speed through the rotary cutter flexible shaft of the wire spring tube. However, in the state without rigid support, the wire spring tube is very easy to shake, which affects the sampling effect. In the present invention, the puncture needle tube is sleeved on the outside of the rotary cutter tube, and the inner diameter of the puncture needle tube is slightly larger than the outer diameter of the rotary cutter tube. Therefore, the puncture needle tube can play a role similar to a sliding bearing. When the rotary cutter tube rotates, the rotary cutter tube rotates in the inner cavity of the puncture needle tube to prevent the rotary cutter tube from shaking, thereby providing rigid support for the rotary cutter tube and improving the stability of the rotary cutter tube during rotation.

[0042] Furthermore, conventional biopsy needles are usually fixed by a proximal housing and an endoscope, and are uniformly operated by an 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 conventional 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 directly fixes the outer sheath tube to the endoscope through the endoscope fixing piece 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.

[0043] 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

[0044] 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.

[0045] Figure 1 A schematic diagram of the structure of a rotary biopsy needle provided in one embodiment of the present invention;

[0046] Figure 2 A schematic diagram of the structure of a distal pipeline portion provided by an embodiment of the present invention;

[0047] Figure 3 A schematic diagram of the structure of a rotary biopsy needle before puncture provided by an embodiment of the present invention;

[0048] Figure 4 A schematic diagram of the structure of the rotary biopsy needle after puncture is completed provided by an embodiment of the present invention;

[0049] Figure 5 A schematic diagram of the structure of an endoscope fixing member provided by an embodiment of the present invention;

[0050] Figure 6 A schematic diagram of the structure of a puncture needle tube provided in one embodiment of the present invention;

[0051] Figure 7 An axial diagram of a puncture needle tube adjustment mechanism provided in one embodiment of the present invention;

[0052] Figure 8 An end view of a puncture needle tube adjustment mechanism provided in one embodiment of the present invention;

[0053] Fig. 9 A schematic structural diagram of a rotary cutting blade tube with an outer blade edge provided in one embodiment of the present invention;

[0054] Fig.10 A schematic structural diagram of a rotary cutting blade tube with an inner cutting edge provided in one embodiment of the present invention;

[0055] Fig.11 A schematic diagram of the structure of a rotary cutting blade tube provided in one embodiment of the present invention;

[0056] Fig.12 A schematic diagram of the structure of a rotary cutting blade tube transmission assembly provided in one embodiment of the present invention;

[0057] Fig.13 A schematic diagram of the positions of the outer sheath tube, the puncture needle tube and the rotary cutting knife tube before puncture provided in one embodiment of the present invention;

[0058] Fig.14 A schematic diagram of the positions of the outer sheath tube, the puncture needle tube and the rotary cutting knife tube during puncture provided by an embodiment of the present invention;

[0059] Fig.15 A schematic diagram of the positions of an outer sheath tube, a puncture needle tube and a rotary cutting knife tube during sampling provided in one embodiment of the present invention. DETAILED DESCRIPTION

[0060] 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.

[0061] 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.

[0062] 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.

[0063] In order to solve the above technical problems, the present invention provides a negative pressure suction biopsy needle, comprising a distal pipeline part and a proximal hand-held part, the distal pipeline part comprises a rotary cutter tube, the proximal hand-held part comprises a proximal shell and a rotary cutter tube transmission assembly, the rotary cutter tube is connected to the proximal shell through the rotary cutter tube transmission assembly, and the rotary cutter tube is driven to perform circumferential rotation and axial movement; a negative pressure interface for communicating with a negative pressure device is provided at the proximal end of the proximal shell, a connecting sleeve is provided in the proximal shell, the proximal end of the connecting sleeve is sealed and connected to the negative pressure interface, the proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and a dynamic seal is performed between the connecting sleeve and the rotary cutter tube through a dynamic seal.

[0064] The present invention opens a negative pressure interface at the proximal end of the proximal shell, and the negative pressure interface is sealed and connected with a connecting sleeve. The connecting sleeve is arranged in the proximal shell, and the rotary cutting knife tube is inserted into the connecting sleeve and dynamically sealed with the connecting sleeve through a dynamic seal. Therefore, the sealing problem of the rotary cutting knife tube is solved, and negative pressure suction of the rotary cutting biopsy needle is realized.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] Example 1

[0071] Please refer to Figure 1 and Figure 2 The present invention provides a rotary cutting biopsy needle, comprising a distal pipeline part 1, wherein the distal pipeline part 1 comprises an outer sheath tube 101, a puncture needle tube 102 and a rotary cutting knife tube 103 from the outside to the inside, before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutting knife tube 103 is located in the puncture needle tube 102; during puncture, the puncture needle tube 102 and the rotary cutting knife tube 103 are passed through the distal end of the outer sheath tube 101 together to puncture the tissue, and during the puncture process, the distal end of the rotary cutting knife tube 103 is always located in the puncture needle tube 102; after the puncture is completed, the rotary cutting knife tube 103 extends from the distal end of the puncture needle tube 102 to collect samples by rotary cutting the tissue.

[0072] Since the distal end of the rotary cutter tube 103 is located inside the puncture needle tube 102 during puncture, the rotary cutter tube 103 can penetrate into the human tissue along with the puncture needle tube 102, thus ensuring the smoothness of the outer surface of the puncture needle tube and making puncture easier.

[0073] In the present invention, the outer sheath 101 serves as the outermost layer of the distal tubing portion of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube 102 and the rotary cutter tube 103. Therefore, before puncture, the distal end of the puncture needle tube 102 is placed in the outer sheath 101, and the distal end of the rotary cutter tube 103 is placed in the puncture needle tube 102. During the process of transporting the outer sheath 101 into the working channel of the endoscope, the puncture needle or the rotary cutter is prevented from damaging the endoscope.

[0074] As an embodiment, the rotary biopsy needle further comprises a proximal handheld portion, wherein the proximal handheld portion comprises a proximal housing 4 and a puncture depth adjustment mechanism 3, please refer to Figure 3 The puncture depth adjustment mechanism 3 includes a sheath seat 301 and a sheath seat locking piece 302. The sheath seat 301 is fixed to the proximal end of the outer sheath tube 101. The proximal shell 4 can move axially relative to the sheath seat 301. The sheath seat 301 can be locked with the proximal shell 4 through the sheath seat locking piece 302.

[0075] The puncture needle tube 102 and the rotary cutter tube 103 are respectively connected to the proximal housing 4. Before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102; during puncture, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal housing 4, and by pushing the proximal housing 4 to the distal end, the puncture needle tube 102 and the rotary cutter tube 103 pass through the distal end of the outer sheath tube 101 and puncture the tissue. Please refer to Figure 4 During the puncture process, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102, so the rotary cutter tube 103 can penetrate into the human tissue together with the puncture needle tube 103, ensuring the smoothness of the outer surface of the puncture needle tube 102, making it easier to puncture and break through.

[0076] 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.

[0077] Traditional biopsy needles are usually fixed by the proximal shell and the endoscope, and are operated uniformly by the endoscope operator. However, since the rotary biopsy needle has a motor, the motor handle and the proximal shell are heavy after assembly. If the traditional fixing method is used, the proximal shell and the endoscope will be fixed, which will greatly increase the difficulty of the endoscope operator to move the endoscope and operate.

[0078] In order to solve the above technical problems, the present invention directly fixes the outer sheath tube 101 to the endoscope through the endoscope fixing member 2 on the outer sheath tube 101, and the proximal housing and the motor handle are held and operated by another special operator. Therefore, the holding and operation of the endoscope are distinguished from the holding and operation of the proximal housing, which reduces the difficulty of operation and increases the adjustment range of the intervention depth of the outer sheath tube 101.

[0079] As an example, please refer to Figure 5 The endoscope fixing member 2 includes a locking member 202 and a locking sleeve 201. The locking sleeve 201 is provided with a connecting portion 2011 fixedly connected to the endoscope and a locking portion 2013 movably sleeved on the outer sheath tube 101. The locking portion 2013 can move axially relative to the outer sheath tube 101, and the locking portion 2013 is locked on the outer sheath tube 101 through the locking member 202.

[0080] This embodiment does not impose any specific restrictions on the fixed connection method between the connecting portion 2011 and the endoscope, such as threaded connection, clamping or other detachable fixed connection methods. At the same time, this embodiment does not impose any specific restrictions on the method in which the locking member 202 locks the locking portion 2013 on the outer sheath 101, such as nut locking, locking screw locking, etc.

[0081] As an embodiment, the connecting portion 2011 is a first Luer connector, and the proximal end of the working channel of the endoscope is provided with a second Luer connector adapted to the first Luer connector, and the first Luer connector is cooperatively connected with the second Luer connector.

[0082] In a specific embodiment, the connecting portion 2011 and the locking portion 2013 are coaxially fixedly connected via an intermediate connecting sleeve 2012, and both the connecting portion 2011 and the intermediate connecting sleeve 2012 are movably sleeved on the outer sheath 101, the connecting portion 2011 is located at the distal end of the intermediate connecting sleeve 2012, an internal threaded joint is provided on the connecting portion 2011, and an external threaded joint matching the internal threaded joint is provided at the proximal end of the working channel of the endoscope, and the internal threaded joint and the external threaded joint are fastened and connected via threads; the locking portion 2013 is located at the proximal end of the intermediate connecting sleeve 2012, an external thread is provided on the locking portion 2013, and the locking piece 202 is a first locking cap, a threaded hole matching the external thread of the locking portion 2013 is provided in the first locking cap, and the first locking cap is tightened on the locking portion 2013, so that the locking portion 2013 clamps the outer sheath 101.

[0083] The locking part 2013 can be an elastic member such as a silicone structure, and the first locking cap can improve the fixing effect by squeezing the elastic member. The proximal end of the locking part 2013 can also be provided with a plurality of pressure strips at intervals, and the plurality of pressure strips are movably covered on the outer sheath tube 101, and the first locking cap is designed to be a tapered structure that gradually shrinks from the distal end to the proximal end. The first locking cap is tightened with the locking part 2013, so that the plurality of pressure strips are gathered and clamped on the outer sheath tube 101, thereby realizing the fixed connection between the outer sheath tube 101 and the endoscope.

[0084] During transportation, the endoscope is fixedly connected to the connecting portion 2011, and the first locking cap is in a loosened state. At this time, the endoscope can be moved arbitrarily to adjust the relative position of the outer sheath tube 101 and the endoscope. When the endoscope reaches the specified position, the adjustment is completed, and the first locking cap is locked. At this time, the locking portion 2013 will clamp the outer sheath tube 101 as the first locking cap is locked and contracted, thereby fixing the outer sheath tube 101 and the endoscope.

[0085] Since the locking portion 2013 can move axially relative to the outer sheath tube 101 , the endoscope fixture 2 can be locked at any position of the outer sheath tube 101 , thereby expanding the intervention length adjustment range of the outer sheath tube 101 .

[0086] Since the technical solution of adjusting and locking the two components by cooperating with the locking piece 202 and the locking sleeve 201 is a relatively mature technology in the mechanical field, all technical solutions of adjusting and locking the outer sheath 101 and the endoscope by cooperating with the locking piece 202 and the locking sleeve 201 are within the protection scope of the present invention.

[0087] Similarly, since the sheath seat 301 and the sheath seat locking piece 302 of the puncture depth adjustment mechanism 3 also cooperate to achieve a technical solution for adjusting and locking the two components, this technical solution belongs to a relatively mature technology in the mechanical field. Therefore, the present invention does not limit the specific structure of the sheath seat 301 and the sheath seat locking piece 302. Any technical solution that adjusts and locks the outer sheath tube 101 and the proximal shell 4 by cooperating with the sheath seat 301 and the sheath seat locking piece 302 is within the protection scope of the present invention.

[0088] As an embodiment, the sheath seat 301 is a sleeve structure, the distal end of the sheath seat 301 is coaxially fixedly connected with the proximal end of the outer sheath tube 101, and the proximal movable outer sleeve of the sheath seat 301 is on the proximal outer shell 4; the proximal outer wall of the sheath seat 301 is provided with an external thread, and the sheath seat locking piece 302 is a second locking cap, and the second locking cap is provided with a threaded hole adapted to the external thread of the sheath seat 301, and the sheath seat 301 is clamped to the proximal outer shell 4 by tightening the second locking cap on the sheath seat 301.

[0089] The proximal end of the sheath seat 301 can be an elastic member such as a silicone structure, and the second locking cap improves the fixing effect by squeezing the elastic member. The proximal end of the sheath seat 301 is not limited to the elastic member, and a plurality of beadings can be arranged at intervals, and the plurality of beadings are movably covered on the proximal shell 4. The second locking cap is designed to be a tapered structure that gradually shrinks from the distal end to the proximal end. The second locking cap is tightened with the sheath seat 301, so that the plurality of beadings are gathered and clamped on the proximal shell 4, thereby realizing the locking connection between the sheath seat 301 and the proximal shell 4.

[0090] In the initial state before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutting knife tube 103 is located in the puncture needle tube 102, and the outer sheath tube 101 is transported to the working channel of the endoscope. When the outer sheath tube 101 reaches the specified position and is fixed, puncture breakthrough can be performed. At this time, the puncture depth adjustment mechanism 3 is adjusted according to the puncture depth requirement. Specifically, the second locking cap is loosened, the sheath seat 301 is held, and the proximal shell 4 is quickly pushed to the distal end. The proximal shell 4 will drive the distal ends of the puncture needle tube 102 and the rotary cutting knife tube 103 to pass out of the outer sheath tube 101 and puncture the obstacle tissue such as the bronchial wall. After the puncture is completed, the second locking cap is locked.

[0091] When the proximal shell 4 is pushed quickly toward the distal end, in order to facilitate manual operation of the proximal shell 4, an annular protrusion 401 is provided on the outer side of the proximal shell 4. By pushing the annular protrusion 401, the purpose of pushing the proximal shell 4 quickly toward the distal end is achieved.

[0092] In order to identify the puncture depth, a puncture depth scale is provided on the proximal housing 4 .

[0093] Of course, the sheath seat locking member 302 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 sheath seat 301, and the sheath seat locking member 302 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, and the second end is located outside the sheath seat 301. 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 proximal housing 4, thereby fixing the proximal housing 4 to the sheath seat 301. The threaded fastener is a locking screw or other structure.

[0094] The puncture needle tube 102 is the middle layer of the distal tubing of the biopsy needle and is made of metal material, such as 304L, 316L and other stainless steel materials. The thickness of the puncture needle should be as low as possible, usually less than 0.1mm, to increase its inner cavity to accommodate the cutting knife tube. Please refer to Figure 6 The puncture needle tube 102 has a needle tip 1021, through which puncture breakthrough can be achieved.

[0095] The main body of the puncture needle tube 102 is provided with a hollow structure 1022, the purpose of which is to reduce the hardness of the local position of the puncture needle tube 102 without losing the puncture effect, and to improve the performance of the biopsy needle passing through the working channel of the endoscope in a bent state.

[0096] In order to improve the effect of ultrasonic imaging and facilitate observation of the position of the puncture needle tube 102, the puncture needle tube 102 is provided with a first ultrasonic reflection area on the outer surface near the needle tip 1021. The first ultrasonic reflection area is required to be an uneven texture. As for the texture shape of the first ultrasonic reflection area, the present invention does not make any specific restrictions. For example, the roughness of the outer surface of the puncture needle tube 102 is increased by processes such as threading and dotting to improve the imaging effect of the puncture needle tube 102 under ultrasound.

[0097] In the present invention, the proximal handheld part also includes a puncture needle tube adjustment mechanism 6, and the puncture needle tube 102 is installed in the proximal shell 4 through the puncture needle tube adjustment mechanism 6. The puncture needle tube 102 is axially moved by the puncture needle tube adjustment mechanism 6, that is, the puncture needle tube 102 can be moved toward the distal end or toward the proximal end through the puncture needle tube adjustment mechanism 6.

[0098] As an example, please refer to Figure 7 and Figure 8 The puncture needle tube adjustment mechanism 6 includes a puncture needle tube sleeve 602 and an elastic locking structure 601. The puncture needle tube sleeve 602 is located in the proximal shell 4 and is fixedly mounted on the proximal end of the puncture needle tube 102; at least one outer side of the puncture needle tube sleeve 602 is provided with the elastic locking structure 601, and at least one side of the tube wall of the proximal shell 4 is axially provided with a puncture needle tube adjustment groove, and the elastic locking structure 601 passes through the puncture needle tube adjustment groove; the elastic locking structure The structure 601 includes an integrally arranged button 6011 and at least one limiting column 6012. A plurality of limiting slots are arranged on at least one side wall of the puncture needle tube adjustment slot. In a natural state, the limiting column 6012 is located in the limiting slot. By pressing the button 6011, the limiting column 6012 is separated from the limiting slot to the proximal shell 4, thereby enabling the puncture needle tube 102 to follow the button 6011 and move axially along the puncture needle tube adjustment slot.

[0099] In this embodiment, when the button 6011 is pressed, the limiting column 6012 is disengaged from the limiting slot, and the puncture needle tube 102 can follow the button 6011 and move arbitrarily along the puncture needle tube adjustment slot in its axial direction, thereby realizing the axial position adjustment of the puncture needle tube 102. After releasing the button, the button is reset under the action of elasticity, and the limiting column 6012 is inserted into the limiting slot of the puncture needle tube adjustment slot, thereby realizing the fixation of the puncture needle tube 102.

[0100] In the present invention, after the puncture is completed, the puncture needle tube 102 is withdrawn through the puncture needle tube adjustment mechanism 6, so that the distal end of the rotary cutter tube 103 extends from the distal end of the puncture needle, and the rotary cutter tube 103 starts to perform rotary cutting. Of course, the method of making the distal end of the rotary cutter tube 103 extend from the distal end of the puncture needle is not limited to withdrawing the puncture needle tube 102, and the distal end of the rotary cutter tube 103 can also be directly extended from the distal end of the puncture needle tube 102. As an embodiment, the distal end of the rotary cutter tube 103 is extended from the distal end of the puncture needle tube 102 by driving the rotary cutter tube transmission component 7.

[0101] In order to identify the retraction distance of the puncture needle tube 102, an adjustment scale is provided on the outside of the puncture needle tube adjustment groove.

[0102] In order to facilitate manual operation, it is preferred to respectively set an elastic retaining structure 601 on the two corresponding outer sides of the puncture needle tube sleeve 602, and the elastic retaining structure 601 is arranged along the radial direction of the puncture needle tube sleeve 602. A puncture needle tube adjustment groove is respectively provided along the axial direction on the two corresponding sides of the tube wall of the proximal shell 4, and the two elastic retaining structures 601 respectively penetrate a puncture needle tube adjustment groove. A plurality of limit slots are arranged at intervals on the groove walls on both sides of the puncture needle tube adjustment groove, and correspondingly, a limit column 6012 is respectively arranged on both sides of the button 6011, and the button 6011 and the limit columns 6012 on both sides thereof are arranged along the circumference of the puncture needle tube sleeve 602. In the natural state, the limit columns 6012 on both sides of the button 6011 are respectively located in a limit slot on the groove walls on both sides of the puncture needle tube adjustment groove. When it is necessary to press the button 6011, the operator presses the two buttons 6011 with two fingers at the same time to disengage the limit column 6012 from the limit slot, and then pushes the button 6011 to adjust the position of the puncture needle tube 102.

[0103] In one embodiment, a mounting hole 6021 is axially provided at the center of the puncture needle tube sleeve 602, and the puncture needle tube 102 passes through the mounting hole 6021 and is fixed to the mounting hole 6021; a hollow area 6022 is provided at the proximal end of at least one side tube wall of the puncture needle tube sleeve 602 located at the mounting hole 6021, and an elastic strip 6013 is provided on the outer side of the hollow area 6022, and the elastic strip 6013 is arranged along the axial direction of the puncture needle tube sleeve 602, and the distal end of the elastic strip 6013 is fixedly connected to the puncture needle tube sleeve 602, and the elastic locking structure 601 is fixed to the proximal end of the elastic strip 6013, and the button 6011 is pressed, and the limiting column 6012 follows the proximal end of the elastic strip 6013 to move toward the hollow area 6022, so that the limiting column 6012 disengages from the limiting slot.

[0104] The rotary cutter tube 103 is a tubular structure, which is the innermost layer of the distal pipeline part of the biopsy needle. The distal end of the rotary cutter tube 103 is provided with an annular blade to ensure that the rotary cutter tube 103 can smoothly cut the tissue. The annular blade preferably adopts a flat structure to ensure the integrity of the tissue after rotary cutting, so as not to be crushed and affect the pathological analysis.

[0105] As an example, please refer to Fig. 9 The annular blade at the distal end of the rotary cutter tube 103 is an outer blade edge 1031 formed by removing the inner edges and corners of the distal end surface of the rotary cutter tube 103, and the outer blade edge 1031 is used for cutting low-density tissue.

[0106] As another example, please refer to Fig.10 The annular blade at the distal end of the rotary cutter tube 103 is an inner blade edge 1031 ′ formed by removing the outer edges and corners from the distal end surface of the rotary cutter tube 103 . The inner blade edge 1031 ′ is used for cutting high-density tissues.

[0107] In a specific implementation, please refer to Fig.11 The rotary cutter tube 103 includes a distal metal tube 1032, a wire spring tube 1033, a proximal metal tube 1035 and a polymer sealing tube 1034. The distal metal tube 1032 and the proximal metal tube 1035 are both metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1032 is an annular blade. The distal metal tube 1032 is made of metal to ensure that the rotary cutter tube 103 can smoothly cut the tissue. The proximal metal tube 1035 is made of metal to facilitate its assembly and fixation. The wire spring tube 1033 is a hollow tube woven from metal wires. The metal wires are made of stainless steel or nickel-titanium structure. The wire spring tube 1033 can flexibly transmit the rotation speed and torque in a bent state and effectively reduce vibration. The proximal end of the distal metal tube 1032 and the distal end of the metal wire spring tube 1033 are connected by end face welding to ensure that the outer diameter and inner diameter of the distal metal tube 1032 and the metal wire spring tube 1033 are substantially consistent.

[0108] On the outside of the rotary cutter tube 103, a thin-walled polymer sealing tube 1034 is provided, such as a thin-walled heat shrink tube, which is fixed to the outside of the rotary cutter tube 103 through a heat shrink process to achieve sealing of the rotary cutter tube 103, so that the internal cavity can transmit negative pressure or positive pressure to avoid leakage at the welding position, the gap between the braided tubes, etc. At the same time, the thin-walled heat shrink tube can reduce the friction between the rotary cutter tube and the puncture needle tube during rotation, and avoid wear of the braided metal wire of the rotary cutter tube.

[0109] The proximal metal tube 1035 is wrapped around the proximal outer side of the polymer sealing tube 1034, and the proximal metal tube 1035 and the polymer sealing tube 1034 can be fixed by bonding or other methods. In this way, a sealed tube cavity with only two outlets can be formed inside the rotary cutter tube.

[0110] As an embodiment, the metal wire spring tube 1033, the polymer sealing tube 1034 and the proximal metal tube 1035 are flush at the proximal end surface.

[0111] In the art, in order to realize the flexible rotation of the rotary cutter tube 103, the rotary cutter tube 103 realizes the flexible transmission of torque and speed through the rotary cutter soft shaft of the wire spring tube 1033. However, in the state without rigid support, the wire spring tube 1033 is very easy to shake, which affects the sampling effect. In the present invention, the puncture needle tube 102 is sleeved on the outside of the rotary cutter tube 103, and the inner diameter of the puncture needle tube 102 is slightly larger than the outer diameter of the rotary cutter tube 103. Therefore, the puncture needle tube 102 can play a role similar to a sliding bearing. When the rotary cutter tube 103 rotates, the rotary cutter tube 103 rotates in the inner cavity of the puncture needle tube 102 to prevent the rotary cutter tube 103 from shaking, thereby providing rigid support for the rotary cutter tube 103 and improving the stability of the rotary cutter tube 103 when rotating.

[0112] The outer surface of the rotary cutter tube 103 is covered with a polymer sealing tube 1034 , and the polymer sealing tube 1034 is at least sealed on the metal wire spring tube 1033 and at the connection between the metal wire spring tube 1033 and the distal metal tube 1032 .

[0113] In order to reduce the friction between the rotary cutting blade tube 103 and the puncture needle tube 102 during rotation and avoid wear of the braided metal wire of the rotary cutting blade tube 103, the polymer sealing tube 1034 is a heat shrink tube formed by fixing the polymer tube on the outer surface of the rotary cutting blade tube 103 through a heat shrink process. The heat shrink tube can also improve the torsional performance and sealing performance of the metal wire spring tube 103 without losing the bending performance.

[0114] In order to increase the adhesion strength of tissue after cutting and avoid the tissue from falling off after cutting and sampling, the inner wall surface of the rotary cutting blade tube 103 is provided with a rough surface that increases the friction coefficient, such as a threaded surface.

[0115] In order to improve the effect of ultrasonic development, a second ultrasonic reflection area is provided on the outer surface of the distal metal tube 1032. The second ultrasonic reflection area is required to be an uneven texture. As for the texture shape of the second ultrasonic reflection area, the present invention does not make any specific restrictions. For example, the roughness of the outer surface of the distal metal tube 1032 can be increased by processes such as threading and dotting to improve the development effect of the rotary cutting tube 103 under ultrasound.

[0116] In the present invention, please refer to Figure 3 The proximal handheld part also includes a rotary cutter tube transmission assembly 7, which is installed in the proximal shell 4. The rotary cutter tube transmission assembly 7 is connected to the rotary cutter tube 103. The rotary cutter tube 103 is driven by the rotary cutter tube transmission assembly 7 to perform rotary cutting on the tissue.

[0117] By driving the rotary cutting blade tube transmission component 7, the rotary cutting blade tube transmission component 7 drives the rotary cutting blade tube 103 to perform rotary cutting, which is a mature technology in the field. Therefore, the present invention does not limit the specific structure of the rotary cutting blade tube transmission component 7. Any technical solution that can drive the rotary cutting blade tube transmission component 7 so that the rotary cutting blade tube transmission component 7 drives the rotary cutting blade tube 103 to perform rotary cutting is applicable to the present invention.

[0118] Since the rotary cutter tube transmission assembly 7 can not only drive the rotary cutter tube 103 to rotate and cut the tissue, but also adjust the axial stroke of the rotary cutter tube 103 to adjust the cutting depth of the rotary cutter tube 103. As an embodiment, the rotary cutter tube transmission assembly 7 includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, both of which are connected to the rotary cutter tube 103. The circumferential rotation transmission mechanism drives the rotary cutter tube 103 to rotate so that the rotary cutter tube 103 cuts the tissue; the axial movement transmission mechanism drives the rotary cutter tube 103 to move axially to adjust the axial stroke of the rotary cutter tube 103, thereby adjusting the cutting depth of the rotary cutter tube 103.

[0119] As an example, please refer to Fig.12 The circumferential rotation transmission mechanism includes a core shaft assembly and a rotating sleeve 702 located in the proximal shell 4. The core shaft assembly is fixedly sleeved on the rotary cutter tube 103. The rotating sleeve 702 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. A rotating gear 701 is coaxially fixedly connected to the rotating sleeve 702. The rotating gear 701 is driven by a rotating drive motor, so that the rotating gear 701 drives the rotating sleeve 702 to rotate.

[0120] Since the mutually sleeved rotating sleeve 702 and the core shaft assembly are slidably connected in the axial direction and relatively fixedly connected in the circumferential direction, it is a conventional technical means in the mechanical field. Therefore, the present invention does not limit the specific connection structure of the rotating sleeve 702 and the core shaft assembly.

[0121] As an embodiment, the core shaft assembly includes a fixed tube 708 and an inner knife sleeve 706, the fixed tube 708 is fixedly sleeved on the rotary cutting knife tube 103, the inner knife sleeve 706 is fixedly sleeved on the fixed tube 708, the rotating sleeve 702 is sleeved on the inner knife sleeve 706, and the rotating sleeve 702 and the inner knife sleeve 706 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.

[0122] In a specific implementation, the inner wall of the rotating sleeve 702 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 702; the outer wall of the inner knife sleeve 706 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 706. By inserting the plurality of protrusions into the plurality of guide grooves, the rotating sleeve 702 and the inner knife sleeve 706 are axially slidably connected and circumferentially fixedly connected, that is, the rotating sleeve 702 and the inner knife sleeve 706 can both 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 706, and the guide grooves can be provided on the inner wall of the rotating sleeve 702. This embodiment does not impose any specific restrictions on this.

[0123] The axial movement transmission mechanism includes a screw sleeve 703 and a transmission screw 704. The screw sleeve 703 is sleeved on the transmission screw 704 and is threadedly meshed with the transmission screw 704 for transmission. The screw sleeve 703 is coaxially fixedly connected with a stroke gear 709. The stroke gear 709 is driven by a stroke drive motor to rotate. The stroke gear 709 drives the screw sleeve 703 to rotate, and the rotational movement of the screw sleeve 703 is converted into axial movement of the transmission screw 704. The transmission screw 704 is sleeved on the rotating sleeve 702, and is relatively fixed to the core shaft assembly in the axial direction and relatively rotationally connected in the circumferential direction.

[0124] As an embodiment, the proximal handheld portion further includes a motor handle 5, the rotation drive motor and the stroke drive motor are both installed in the motor handle 5, and the motor handle 5 is fixedly connected to the proximal housing 4. The rotation drive motor and the stroke drive motor respectively directly control or control the rotation gear 701 and the stroke gear 709 through gear transmission to realize the rotation and forward and backward movement of the rotary cutting blade tube 103.

[0125] The screw sleeve 703 only performs rotational motion in the proximal housing 4, and does not perform axial movement. In order to limit the axial movement of the screw sleeve 703 in the proximal housing 4, positioning baffles are provided on the proximal housing 4 at the proximal and distal ends of the screw sleeve 703, with the purpose of limiting the screw sleeve 703 between the two positioning baffles to prevent it from performing axial movement.

[0126] In this embodiment, the transmission screw 704 is sleeved on the rotating sleeve 702 and is relatively fixedly connected to the core shaft assembly in the axial direction and relatively rotatably connected in the circumferential direction.

[0127] As an embodiment, the inner tool sleeve 706 and the transmission screw 704 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.

[0128] In a specific implementation, an annular limiting groove 7061 is provided on the outer circumference of the inner knife sleeve 706, and an annular limiting fixture 705 adapted to the annular limiting groove 7061 is provided on the inner circumference of the transmission screw 704. The annular limiting fixture 705 is inserted into the annular limiting groove 7061 to realize the circumferential rotation connection between the transmission screw 704 and the inner knife sleeve 706, and the axial fixed connection, that is, the inner knife sleeve 706 and the transmission screw 704 can rotate relative to each other, but cannot produce relative displacement in the axial direction. Of course, the inner circumference of the transmission screw 704 can also be provided with an annular limiting groove, and the outer circumference of the inner knife sleeve 706 can be provided with an annular limiting fixture adapted to the annular limiting groove. This embodiment does not impose specific restrictions on this.

[0129] A guide rail 8 is axially provided on the inner wall of the proximal shell 4 , and the transmission screw 704 is slidably set on the guide rail 8 . By driving the screw sleeve 703 to rotate, the transmission screw 704 moves along the guide rail 8 , so as to limit the axial movement distance of the transmission screw 704 .

[0130] Please refer to Fig.12 The proximal surface of the proximal housing 4 is provided with a negative pressure interface 401 for communicating with the negative pressure device. A connecting sleeve 9 is provided inside the proximal housing 4. The proximal end of the connecting sleeve 9 is sealed and communicated with the negative pressure interface 401. The proximal end of the rotary cutter tube 103 is inserted into the connecting sleeve 9 from the distal end of the connecting sleeve 9. Moreover, the connecting sleeve 9 and the rotary cutter tube 103 are dynamically sealed by a dynamic seal 10. When the rotary cutter tube 103 is rotary cut forward, the rotary cutter tube 103 moves from the proximal end to the distal end. A portion of the rotary cutter tube 103 is always located in the connecting sleeve 9 of the rotary cutter tube 103 and contacts the dynamic seal 10 to form a dynamic seal.

[0131] In the initial position, the present invention does not limit the length of the rotary cutter tube 103 in the connecting sleeve 9. At the same time, when the rotary cutter tube 103 moves from the proximal end to the distal end to the maximum cutting depth, the length of the rotary cutter tube 103 in the connecting sleeve 9 is also not limited and can be set according to actual use requirements. In order to prevent the rotary cutter tube 103 from detaching from the connecting sleeve 9, as an embodiment, in the initial position, the size of the rotary cutter tube 103 in the connecting sleeve 9 is greater than 2 cm.

[0132] Since the dynamic seal 10 is a relatively mature technology in the field of mechanical fluid transmission, the present invention does not limit the specific structure of the dynamic seal 10 .

[0133] As an embodiment, the dynamic seal 10 is a sealing ring, such as a Variseal seal or a silicone seal.

[0134] In a specific embodiment, the outer periphery of the sealing ring is sealedly connected to the inner periphery of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and dynamically sealed with the sealing ring.

[0135] In another specific embodiment, the sealing ring is fixed on the distal end surface of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and dynamically sealed with the sealing ring. Please refer to Fig.12 .

[0136] The inner surface of the dynamic seal 10 and the outer surface of the rotary cutter tube 103 should be as smooth as possible to reduce the friction resistance caused by the seal.

[0137] The negative pressure interface 401 is connected to one end of the negative pressure pipeline through a Luer connector, and the other end of the negative pressure pipeline is connected to the negative pressure device. After the Luer connector is tightened, the negative pressure can be transmitted from the negative pressure device to the distal end of the rotary cutting blade tube 103.

[0138] In order to facilitate assembly and fixing, the connecting sleeve 9 is made of a metal pipe, such as a steel pipe.

[0139] Working principle of rotary biopsy needle:

[0140] Please refer to Fig.13 Before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutting knife tube 103 is located in the puncture needle tube 102, and the outer sheath tube 101 is transported into the working channel of the endoscope. When the outer sheath tube 101 reaches the specified position, the outer sheath tube 101 is fixed to the endoscope through the endoscope fixing member 2.

[0141] During puncture, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal shell 4, and by pushing the proximal shell 4 toward the distal end, the puncture needle tube 102 and the rotary cutting knife tube 103 pass through the distal end of the outer sheath tube 101 and puncture the tissue. Please refer to Fig.14 During the puncture process, the distal end of the rotary cutting blade tube 103 is always located in the puncture needle tube 102. After the puncture is completed, the sheath seat 301 and the proximal housing 4 are locked by the sheath seat locking member 302.

[0142] After the puncture is completed, the puncture needle tube 102 is withdrawn through the puncture needle tube adjustment mechanism 6, the distal end of the puncture needle tube 102 is withdrawn, and the rotary cutter tube 103 is left, so that the distal end of the rotary cutter tube 103 extends from the distal end of the puncture needle tube 102. At this time, the metal wire spring tube 1033 of the rotary cutter tube 103 is completely located in the puncture needle tube 102, and the distal end of the puncture needle tube 102 is located in front of the outer sheath tube 101 and between the proximal and distal ends of the distal metal tube 1032 of the rotary cutter tube 103. Please refer to Fig.15 The rotary cutting blade tube 103 is driven by the rotary cutting blade tube transmission assembly 7 to perform rotary cutting and sampling on the tissue.

[0143] Since the rotary cutter tube 103 is a tubular structure with a circular blade at its distal end, after sampling, the tissue at the blade edge needs to be pulled apart to complete the sampling. Therefore, during sampling, the negative pressure device performs negative pressure suction on the rotary cutter tube 103 through the negative pressure interface 401, and the negative pressure suction can increase the pulling force of the rotary cutter tube 103 when retreating, ensuring that the tissue can be successfully pulled apart.

[0144] After the sampling is completed, the syringe injects physiological saline into the rotary cutter tube 103 through the negative pressure interface 401 , and the injected physiological saline provides positive pressure to flush the tissue sample out of the rotary cutter tube 103 .

[0145] Example 2

[0146] This embodiment provides a negative pressure suction rotary biopsy system, 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 103 through the negative pressure interface 401 .

[0147] 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 103 through the negative pressure interface 401 to flush out the tissue sample in the rotary cutter tube 103 .

[0148] 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 401 .

[0149] As an embodiment, the negative pressure interface 401 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 401, 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 103 to achieve adsorption of the tissue; when the adjustment switch is in gear II, the syringe can flush out the tissue in the rotary cutter tube 103 for sampling to ensure the integrity of the tissue.

[0150] 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.

[0151] 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.

[0152] 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.

[0153] 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:

[0154] (1) In the initial stage, the negative pressure value is small, <10 KPa, so that the annular blade of the rotary cutter tube 103 can be close to the tissue, which is convenient for the annular blade of the rotary cutter tube 103 to cut and separate the tissue.

[0155] (2) During the sampling phase, the negative pressure value is gradually increased based on the rotary cutting depth of the rotary cutter tube 103. 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 103 is blocked and cannot penetrate deeper, resulting in the annular blade of the rotary cutter tube 103 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 103 moves deeper into the inner cavity, so that there is space at the far end of the rotary cutter tube 103 to accommodate more tissue, thereby increasing the sampling volume.

[0156] (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.

[0157] (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 tube 103 to flush out the sample tissue.

[0158] 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 negative pressure suction biopsy needle, characterized in that: The invention comprises a distal pipeline part and a proximal hand-held part, wherein the distal pipeline part comprises a rotary cutter tube, and the proximal hand-held part comprises a proximal shell and a rotary cutter tube transmission assembly, wherein the rotary cutter tube is connected to the proximal shell through the rotary cutter tube transmission assembly, and the rotary cutter tube is driven to perform circumferential rotation and axial movement; a negative pressure interface for communicating with a negative pressure device is provided at the proximal end of the proximal shell, a connecting sleeve is provided in the proximal shell, and the proximal end of the connecting sleeve is sealedly connected with the negative pressure interface, the proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and a dynamic seal is performed between the connecting sleeve and the rotary cutter tube through a dynamic seal.

2. The negative pressure suction biopsy needle according to claim 1, characterized in that: The dynamic seal is a sealing ring, the outer periphery of which is sealingly connected to the inner periphery of the connecting sleeve, or the sealing ring is fixed to the distal end face of the connecting sleeve; the proximal end of the rotary cutter tube is inserted into the sealing ring and dynamically sealed with the sealing ring.

3. The negative pressure suction biopsy needle according to claim 2, characterized in that: The sealing ring is a pan seal or a silicone seal.

4. 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.

5. The negative pressure suction biopsy needle according to claim 1, characterized in that: The distal pipeline part also includes an outer sheath tube and a puncture needle tube, the puncture needle tube is movably sleeved on the rotary cutting knife tube, and the outer sheath tube is movably sleeved on the puncture needle tube; before puncture, the distal end of the puncture needle tube is located in the outer sheath tube, and the distal end of the rotary cutting knife tube is located in the puncture needle tube; during puncture, the puncture needle tube and the rotary cutting knife tube are penetrated from the distal end of the outer sheath tube together to puncture the tissue, and during the puncture process, the distal end of the rotary cutting knife tube is always located in the puncture needle tube; after the puncture is completed, the rotary cutting knife tube extends from the distal end of the puncture needle tube to perform rotary cutting sampling on the tissue.

6. The negative pressure suction biopsy needle according to claim 5, characterized in that: An endoscope fixing part is also provided on the outer sheath tube, and the endoscope fixing part includes a locking sleeve and a locking part. The locking sleeve includes a connecting part and a locking part which are integrally arranged. The connecting part is used for fixed connection with the endoscope. The locking part is movably sleeved on the outer sheath tube and can slide axially on the outer sheath tube. The locking part can be locked at any position of the outer sheath tube through the locking part.

7. The negative pressure suction biopsy needle according to claim 6, characterized in that: The connecting part is a first Luer connector, and the proximal end of the working channel of the endoscope is provided with a second Luer connector adapted to the first Luer connector, and the first Luer connector is cooperatively connected with the second Luer connector; the locking part is provided with an external thread, and the locking piece is a locking cap, and a threaded hole adapted to the external thread of the locking part is provided in the locking cap, and the locking cap is tightened on the locking part so that the locking part is clamped and fixed on the outer sheath.

8. The negative pressure suction biopsy needle according to claim 5, characterized in that: The proximal handheld part further comprises a puncture depth adjustment mechanism, the puncture depth adjustment mechanism comprises a sheath seat and a sheath seat locking piece, the sheath seat is fixed to the proximal end of the outer sheath tube, and the proximal shell can move axially relative to the sheath seat; During puncture, the proximal shell is pushed toward the distal end, so that the puncture needle tube and the rotary cutting knife tube pass through the distal end of the outer sheath tube and puncture the tissue. After the puncture is completed, the proximal shell is locked with the sheath seat through the sheath seat locking piece.

9. The negative pressure suction biopsy needle according to claim 8, characterized in that: The sheath seat is a sleeve structure, the distal end of the sheath seat is fixedly connected to the proximal end of the outer sheath tube, and the proximal movable outer sleeve of the sheath seat is on the proximal outer shell; An external thread is provided on the proximal outer wall of the sheath seat, and the sheath seat locking piece is a locking cap. An internal threaded hole adapted to the external thread of the sheath seat is provided in the locking cap, and the sheath seat clamps the proximal outer shell by tightening the internal threaded hole of the locking cap onto the external thread of the sheath seat; or, a threaded hole is provided on one side wall of the sheath seat, and the sheath seat locking piece is a threaded fastener adapted to the threaded hole, one end of the threaded fastener passes through the threaded hole into the sheath seat, and the end of the threaded fastener is pressed against the proximal outer shell by tightening the threaded fastener.

10. The negative pressure suction biopsy needle according to claim 8, characterized in that: The proximal handheld part also includes a puncture needle tube adjustment mechanism, through which the puncture needle tube is installed in the proximal shell, and the puncture needle tube is axially moved by the puncture needle tube adjustment mechanism.

11. The negative pressure suction biopsy needle according to claim 10, characterized in that: The puncture needle tube adjustment mechanism includes a puncture needle tube sleeve and an elastic locking structure, wherein the puncture needle tube sleeve is located in the proximal shell and is fixedly sleeved on the puncture needle tube; the elastic locking structure is provided on at least one outer side of the puncture needle tube sleeve, and a puncture needle tube adjustment groove is axially opened on at least one side of the tube wall of the proximal shell, and the elastic locking structure passes through the puncture needle tube adjustment groove; the elastic locking structure includes an integrally arranged button and at least one limiting column, and a plurality of limiting grooves are spaced apart on at least one side of the groove wall of the puncture needle tube adjustment groove. In a natural state, the limiting column is located in the limiting groove, and by pressing the button, the limiting column is separated from the limiting groove to the proximal shell, so that the puncture needle tube can follow the button to move axially along the puncture needle tube adjustment groove.

12. The negative pressure suction biopsy needle according to claim 11, characterized in that: A mounting hole is axially provided at the center of the puncture needle tube sleeve, and the puncture needle tube passes through the mounting hole and is fixed to the mounting hole; a hollow area is provided at the proximal end of at least one side tube wall of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outer side of the hollow area, the elastic strip is axially arranged along the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, the elastic locking structure is fixed to the proximal end of the elastic strip, and the button is pressed, and the limit column follows the proximal end of the elastic strip to move toward the hollow area, so that the limit column disengages from the limit slot.

13. The negative pressure suction biopsy needle according to claim 11, characterized in that: The rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism. The rotary cutter tube is driven to rotate by driving the circumferential rotation transmission mechanism, so that the rotary cutter tube cuts the tissue; and the rotary cutter tube is driven to move axially by driving the axial movement transmission mechanism to adjust the cutting depth of the rotary cutter tube.

14. The negative pressure suction biopsy needle according to claim 13, characterized in that: The circumferential rotation transmission mechanism comprises a core shaft assembly and a rotating sleeve located in the proximal housing, 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; a rotating gear is coaxially fixedly connected to the rotating sleeve, and the rotating gear is driven by a rotating drive motor, so that the rotating gear drives the rotating sleeve to rotate; The axial movement transmission mechanism includes a screw sleeve and a transmission screw, wherein the screw sleeve is rotatably arranged in the proximal housing and is threadedly meshed with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected with a stroke gear, and the stroke gear is driven by a stroke drive motor to perform rotational motion, and the stroke gear drives the screw sleeve to rotate, and the rotational motion of the screw sleeve is converted into axial movement of the transmission screw; The transmission screw is sleeved on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is relatively rotatably connected in the circumferential direction.

15. The negative pressure suction biopsy needle according to claim 14, 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.

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

17. The negative pressure suction biopsy needle according to claim 14, 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.

18. A negative pressure suction biopsy system, characterized in that: It comprises the negative pressure suction rotary biopsy needle and the negative pressure device as described in any one of claims 1 to 17, wherein the negative pressure device performs negative pressure suction on the tissue in the rotary cutting blade tube through the negative pressure interface.

19. The negative pressure aspiration biopsy system according to claim 18, 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.

20. The negative pressure aspiration biopsy system according to claim 18, 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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