A negative pressure suction and biopsy needle and biopsy system

Abstract

The application provides a negative pressure suction rotary biopsy needle and a biopsy system, wherein the biopsy needle comprises a distal pipeline part and a proximal handheld part, the distal pipeline part comprises a rotary cutter tube, the proximal handheld part comprises a proximal shell and a rotary cutter tube transmission assembly, the rotary cutter tube is connected in the proximal shell through the rotary cutter tube transmission assembly, the rotary cutter tube is driven to rotate circumferentially and move axially through the rotary cutter tube transmission assembly; a negative pressure interface for communicating with a negative pressure device is arranged at the proximal end of the proximal shell, a connecting sleeve is arranged in the proximal shell, the proximal end of the connecting sleeve is in sealed communication with the negative pressure interface, the proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and dynamic sealing is achieved between the connecting sleeve and the rotary cutter tube 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 biopsy needle and a biopsy system. Background Art

[0002] Biopsy, short for "live tissue examination," also known as surgical pathology, is a group of medical diagnostic tests used to determine the structure and composition of tissues or cells. During a biopsy, cells or tissues are sampled from an organ or other body part and sent to the pathology department. Standardized pathological sections are then made and observed under a microscope for changes in morphology and structure. Ultimately, a clear pathological diagnosis can be made, guiding targeted clinical treatment. Typically, if an abnormality is detected 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 technique for biopsy of the lungs, peripulmonary tissues, and lymph nodes under real-time ultrasound guidance. Its advantages include avoiding vital areas such as large blood vessels and nerves while minimizing the risk of major bleeding and improving sample collection accuracy. It is also minimally invasive, simple, and relatively safe.

[0004] Traditional ultrasonic endoscopic 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 sampling efficiency and sample quality.

[0006] However, due to its structural reasons, the rotary biopsy needle cannot currently be used to assist in sampling using negative pressure suction. Summary of the Invention

[0007] To solve the above technical problems, one 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 comprising a rotary cutter tube, the proximal hand-held part comprising a proximal shell and a rotary cutter tube transmission assembly, the rotary cutter tube being connected to the proximal shell through the rotary cutter tube transmission assembly, and the rotary cutter tube being 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 sealedly 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 by a dynamic seal.

[0008] Preferably, the dynamic seal is a sealing ring, the outer periphery of which is sealedly 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 varnish seal or a silicone seal ring.

[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, 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 is at least sealed 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 sleeved on 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 cutter 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 cutter tube is located in the puncture needle tube; during puncture, the puncture needle tube and the rotary cutter 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 cutter tube is always located in the puncture needle tube; after the puncture is completed, the rotary cutter tube extends from the distal end of the puncture needle tube to perform rotary cutting sampling on the tissue.

[0012] Preferably, 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 an integral connecting part and a locking part. The connecting part is used to be fixedly connected to the endoscope. The locking part is movably sleeved on the outer sheath tube and can slide axially on the outer sheath tube, and the locking part can be locked at any position of the outer sheath tube 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 and the second Luer connector are cooperatively connected; the locking portion 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 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 comprising a sheath seat and a sheath seat locking member, the sheath seat being fixed to the proximal end of the outer sheath tube, and the proximal end housing being axially movable relative to the sheath seat;

[0015] During puncture, the proximal shell is pushed distally so that the puncture needle tube and the rotary cutter 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 end of the sheath seat is movablely sheathed on the proximal end 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, and an internal threaded hole is provided in the locking cap that is adapted to the external thread of the sheath seat, and the sheath seat is clamped to the proximal 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 by tightening the threaded fastener, the end of the threaded fastener is pressed against the proximal shell.

[0018] Preferably, the proximal handheld portion further includes a puncture needle tube adjusting mechanism, through which the puncture needle tube is installed in the proximal housing, and the puncture needle tube is axially moved by 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 slots 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 slot, and by pressing the button, the limiting column is disengaged from the limiting slot to the proximal shell, thereby enabling the puncture needle tube to follow the button and move axially along the puncture needle tube adjustment groove.

[0020] Preferably, a mounting hole is provided in the axial direction 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 the tube wall of at least one side of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outside of the hollow area, and the elastic strip is arranged along the axial direction of the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, and the elastic locking structure is fixed to the proximal end of the elastic strip, and when the button is pressed, 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 includes 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 rotary 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, the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected to a travel gear, the travel gear is driven to rotate by a travel drive motor, the travel 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 externally mounted on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is connected to rotate relative to the core shaft assembly in the circumferential direction.

[0025] Preferably, the spindle assembly includes a fixed tube and an inner cutter sleeve, the fixed tube is fixedly sleeved on the rotary cutter tube, the inner cutter sleeve is fixedly sleeved on the fixed tube, the rotating sleeve is sleeved on the inner cutter sleeve, and the rotating sleeve and the inner cutter sleeve are connected by an axial protrusion inserted into an axial guide groove to achieve axial sliding connection and circumferential fixed connection;

[0026] The inner cutter sleeve and the transmission screw are connected in a circumferential rotation 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 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.

[0029] Another embodiment of the present invention provides a negative pressure suction rotary biopsy system, comprising the negative pressure suction rotary 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 cutter 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, a three-way connector is further included, 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 and rotary excision biopsy system further 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 drive 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, and the negative pressure interface is sealedly connected to 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.

[0035] Furthermore, negative pressure suction can increase the sample volume of the rotary cutter tube. During sampling, as the amount of tissue inside the rotary cutter tube increases, the friction between the tissue and the tube increases. This frictional resistance prevents the sample from entering deeper into the tube, preventing the sample from increasing. The suction provided by negative pressure overcomes this frictional resistance, drawing more sample tissue into the lumen of the rotary cutter tube and increasing the sample volume.

[0036] Furthermore, through the host's refined control of the negative pressure, the negative pressure value can be gradually increased during the sampling process as the rotary cutting tube continues to advance, avoiding excessively high negative pressure values ​​in the early stage that would damage the integrity of the tissue sample.

[0037] Furthermore, because the rotary cutter tube is tubular with a circular blade at its distal end, after sampling, the tissue at the cutting edge must be pulled apart to complete the sample. For some difficult-to-tear tissue structures, insufficient pulling force may result, leading to sampling failure. Negative pressure suction can increase the pulling force of the rotary cutter tube during its retreat, ensuring successful tissue severance.

[0038] Furthermore, after the sampling is completed, physiological saline is injected into the rotary cutter tube through the negative pressure interface. The injected physiological saline provides positive pressure to flush the tissue sample out of the rotary cutter tube, avoiding sample damage caused by using a rigid needle to push it out.

[0039] Furthermore, in the present invention, the distal tubing portion includes, from the outside to the inside, an outer sheath, a puncture needle, and a rotary cutter. Before puncture, the distal end of the puncture needle is located within the outer sheath, and the distal end of the rotary cutter is located within the puncture needle. During puncture, the puncture needle and rotary cutter together penetrate the tissue from the distal end of the outer sheath, and during the puncture process, the distal end of the rotary cutter remains within the puncture needle. After puncture, the rotary cutter extends from the distal end of the puncture needle to sample the tissue by rotary cutting. Because the distal end of the rotary cutter is located within the puncture needle during puncture, the rotary cutter can penetrate human tissue along with the puncture needle, ensuring the smoothness of the outer surface of the puncture needle and making puncture easier.

[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 cutter 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 cutter 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 cutter is prevented from damaging the endoscope.

[0041] Furthermore, to achieve flexible rotation of the rotary cutter tube, the rotary cutter tube uses a flexible rotary cutter shaft of a wire spring tube to achieve flexible transmission of torque and speed. However, without rigid support, the wire spring tube is very prone to shaking, affecting the sampling effect. In the present invention, the puncture needle tube is sheathed outside the rotary cutter tube. 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 act like a sliding bearing. When the rotary cutter tube rotates, the rotary cutter tube rotates within the inner cavity of the puncture needle tube, preventing 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 via a proximal housing and an endoscope, and are uniformly operated by an endoscope operator. However, since a rotary biopsy needle is provided with a motor, the motor handle and the proximal housing are relatively heavy after being assembled. If a conventional fixing method is adopted, the proximal housing and the endoscope are fixed, which will greatly increase the difficulty of moving the endoscope and the difficulty of operation for the endoscope operator. The present invention directly fixes the outer sheath to the endoscope via an endoscope fixing piece on the outer sheath, while the proximal housing and the motor handle are held and operated by another specialized 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 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. 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 any creative work.

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

[0046] Figure 2 A schematic structural diagram 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 provided in one embodiment of the present invention after puncture is completed;

[0049] Figure 5 A schematic structural diagram of an endoscope fixing member provided in one embodiment of the present invention;

[0050] Figure 6 A schematic structural diagram 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] Figure 9 A schematic structural diagram of a rotary cutting blade tube with an outer cutting edge provided by one embodiment of the present invention;

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

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

[0056] Figure 12 A schematic structural diagram of a rotary cutter tube transmission assembly provided in one embodiment of the present invention;

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

[0058] Figure 14 A schematic diagram showing the positions of the outer sheath, puncture needle, and rotary cutting blade during puncture according to one embodiment of the present invention;

[0059] Figure 15 This is a schematic diagram of the positions of the outer sheath tube, puncture needle tube and rotary cutting knife tube during sampling provided by one embodiment of the present invention. DETAILED DESCRIPTION

[0060] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 making creative efforts are within the scope of protection of the present invention.

[0061] The terms "first", "second", "third", "fourth", etc. (if any) in the description 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 numbers used in this way are interchangeable where appropriate, so that the embodiments of the 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 biopsy needle cannot achieve the sealing problem of the rotary cutter tube while ensuring the normal rotation and forward and backward movement of the rotary cutter tube, and thus cannot achieve negative pressure suction of the rotary cutter 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 includes a rotary cutter tube, the proximal hand-held part includes 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 by the rotary cutter tube transmission assembly to make the rotary cutter tube rotate circumferentially and move axially; the proximal end of the proximal shell is provided with a negative pressure interface for communicating with a negative pressure device, 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 the connecting sleeve and the rotary cutter tube are dynamically sealed by a dynamic seal.

[0064] The present invention provides a negative pressure interface at the proximal end of the proximal shell, which is sealed and connected to a connecting sleeve. The connecting sleeve is 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] Furthermore, negative pressure suction can increase the sample volume of the rotary cutter tube. During sampling, as the amount of tissue inside the rotary cutter tube increases, the friction between the tissue and the tube increases. This frictional resistance prevents the sample from entering deeper into the tube, preventing the sample from increasing. The suction provided by negative pressure overcomes this frictional resistance, drawing more sample tissue into the lumen of the rotary cutter tube and increasing the sample volume.

[0066] At the same time, through the host's refined control of negative pressure, the negative pressure value can be gradually increased during the sampling process as the rotary cutting tube continues to move forward, avoiding excessively high negative pressure values ​​in the early stage and destroying the integrity of the tissue sample.

[0067] Because the rotary cutting blade is tubular with a circular blade at its distal end, the tissue must be pulled apart at the blade edge after sampling. For some difficult-to-tear tissue structures, insufficient pulling force may result, leading to sampling failure. Negative pressure suction increases the pulling force during the retreat of the rotary cutting blade, ensuring successful tissue severance.

[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 flushes the tissue sample out of the rotary cutter tube, avoiding sample damage caused by the use of a rigid needle.

[0069] To make the above-mentioned objects, features, and beneficial effects of the present invention more clearly understood, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying 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 making creative efforts shall fall 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 biopsy needle, comprising a distal pipeline part 1, which comprises an outer sheath 101, a puncture needle tube 102 and a rotary cutter 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 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102; during puncture, the puncture needle tube 102 and the rotary cutter tube 103 pass through the distal end of the outer sheath 101 together to puncture the tissue, and during the puncture process, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102; after the puncture is completed, the rotary cutter 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 the human tissue together with the puncture needle tube 102, 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, which comprises a proximal housing 4 and a puncture depth adjustment mechanism 3, see 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 toward the distal end, the puncture needle tube 102 and the rotary cutter tube 103 are passed 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 inside the puncture needle tube 102. Therefore, the rotary cutter tube 103 can penetrate the human tissue together with the puncture needle tube 103, ensuring the smoothness of the outer surface of the puncture needle tube 102 and 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 passage through the working channel of the endoscope and ensure its delivery performance.

[0077] Traditional biopsy needles are typically secured to the endoscope via a proximal housing and operated by the endoscope operator. However, because rotary biopsy needles incorporate a motor, the motor handle and proximal housing are relatively heavy when assembled. Using traditional securing methods, securing the proximal housing to the endoscope significantly increases the difficulty for the endoscope operator in manipulating the needle and operating the needle.

[0078] To solve the above technical problems, the present invention directly fixes the outer sheath 101 to the endoscope through the endoscope fixing member 2 on the outer sheath 101, and the proximal housing and motor handle are held and operated by another dedicated 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 insertion depth of the outer sheath 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. 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 manner in which the connection portion 2011 is fixedly connected to the endoscope, and for example, a threaded connection, a clamping connection, or other detachable fixed connection methods may be used. Furthermore, this embodiment does not impose any specific restrictions on the manner in which the locking member 202 locks the locking portion 2013 to the outer sheath 101, and for example, a nut or a locking screw may be used for locking.

[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 and the second Luer connector are cooperatively connected.

[0082] In a specific embodiment, the connecting portion 2011 and the locking portion 2013 are coaxially fixedly connected through an intermediate connecting sleeve 2012, and the connecting portion 2011 and the intermediate connecting sleeve 2012 are both movably sleeved on the outer sheath 101, and the connecting portion 2011 is located at the distal end of the intermediate connecting sleeve 2012, and an internal threaded joint is provided on the connecting portion 2011, and an external threaded joint adapted to 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 by threads; the locking portion 2013 is located at the proximal end of the intermediate connecting sleeve 2012, and an external thread is provided on the locking portion 2013, and the locking piece 202 is a first locking cap, and a threaded hole adapted to 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 portion 2013 may be an elastic member such as a silicone structure, and the first locking cap squeezes the elastic member to enhance the fixing effect. A plurality of pressure strips may be spaced apart at the proximal end of the locking portion 2013, and the pressure strips are movably positioned over the outer sheath 101. The first locking cap is designed to have a tapered structure that gradually tapers from the distal end to the proximal end. When the first locking cap is tightened with the locking portion 2013, the pressure strips are contracted and clamped to the outer sheath 101, thereby achieving a fixed connection between the outer sheath 101 and the endoscope.

[0084] During transport, 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 designated position, the adjustment is completed and the first locking cap is locked. At this time, the locking portion 2013 will contract as the first locking cap is locked to clamp the outer sheath tube 101, thereby fixing the outer sheath tube 101 and the endoscope.

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

[0086] Since the technical solution of adjusting and locking the two components by cooperating with the locking sleeve 201 through the locking member 202 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 sleeve 201 through the locking member 202 are within the scope of protection 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 are also a technical solution for adjusting and locking the two components through cooperation, this technical solution is 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 for adjusting and locking the outer sheath tube 101 and the proximal shell 4 through 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 to the proximal end of the outer sheath tube 101, and the proximal movable outer sleeve of the sheath seat 301 is on the proximal 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. By tightening the second locking cap on the sheath seat 301, the sheath seat 301 clamps the proximal shell 4.

[0089] The proximal end of the sheath seat 301 can be an elastic member, such as a silicone structure, and the second locking cap squeezes the elastic member to enhance the fixation effect. The proximal end of the sheath seat 301 is not limited to an elastic member. A plurality of beadings can also be provided at intervals. These beadings are movably mounted on the proximal housing 4. The second locking cap is designed to have a tapered structure that gradually tapers from the distal end to the proximal end. When the second locking cap is tightened with the sheath seat 301, the beadings are contracted and clamped to the proximal housing 4, achieving a locked connection between the sheath seat 301 and the proximal housing 4.

[0090] In the initial state before puncture, the distal end of the puncture needle tube 102 is located inside the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located inside 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 designated position and is fixed, puncture breakthrough can be performed. At this time, the puncture depth adjustment mechanism 3 is adjusted according to the required puncture depth. Specifically, the second locking cap is loosened, the sheath seat 301 is held, and the proximal shell 4 is quickly pushed toward the distal end. The proximal shell 4 will drive the distal ends of the puncture needle tube 102 and the rotary cutter tube 103 to pass out of the outer sheath tube 101 and puncture obstructive tissue such as the bronchial wall. After the puncture is completed, the second locking cap is locked.

[0091] When the proximal housing 4 is pushed quickly toward the distal end, an annular protrusion 401 is provided on the outer side of the proximal housing 4 to facilitate manual operation of the proximal housing 4. By pushing the annular protrusion 401, the proximal housing 4 can be pushed quickly toward the distal end.

[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 a locking 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 structure such as a locking screw.

[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. 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 puncture needle tube 102 at a local position without sacrificing the puncture effect, thereby improving the performance of the biopsy needle passing through the working channel of the endoscope in a bent state.

[0096] To enhance ultrasound imaging and facilitate visualization of the position of the puncture needle 102, a first ultrasound-reflecting region is provided on the outer surface of the puncture needle 102 near its needle tip 1021. The first ultrasound-reflecting region is required to have an uneven texture. The present invention does not impose any specific restrictions on the shape of the texture in the first ultrasound-reflecting region. For example, the outer surface of the puncture needle 102 may be roughened by processes such as threading or dotting to enhance ultrasound imaging of the puncture needle 102.

[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 spaced apart 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 disengaged 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 post 6012 disengages from the limiting slot, and the puncture needle tube 102 can follow the button 6011 and move freely in the axial direction along the puncture needle tube adjustment slot, thereby adjusting the axial position of the puncture needle tube 102. When the button is released, the button returns to its original position under the action of elasticity, and the limiting post 6012 inserts into the limiting slot of the puncture needle tube adjustment slot, thereby fixing the puncture needle tube 102.

[0100] In the present invention, after puncture is completed, the puncture needle tube 102 is retracted 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 begins to perform rotary cutting. Of course, the method for extending the distal end of the rotary cutter tube 103 from the distal end of the puncture needle is not limited to withdrawing the puncture needle tube 102. 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 assembly 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] To facilitate manual operation, it is preferred that an elastic retaining structure 601 is provided on each of the two corresponding outer sides of the puncture needle tube sleeve 602, and the elastic retaining structure 601 is provided along the radial direction of the puncture needle tube sleeve 602. A puncture needle tube adjustment groove is provided along the axial direction on each of the two corresponding sides of the tube wall of the proximal housing 4, and the two elastic retaining structures 601 respectively penetrate a puncture needle tube adjustment groove. A plurality of limit slots are provided on the groove walls on both sides of the puncture needle tube adjustment groove, and correspondingly, a limit post 6012 is provided on each side of the button 6011. The button 6011 and the limit posts 6012 on both sides thereof are provided along the circumference of the puncture needle tube sleeve 602. In the natural state, the limit posts 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 the tube wall of at least one side of the mounting hole 6021 of the puncture needle tube sleeve 602, and an elastic pressure strip 6013 is provided on the outside of the hollow area 6022. The elastic pressure strip 6013 is arranged along the axial direction of the puncture needle tube sleeve 602, and the distal end of the elastic pressure 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 pressure strip 6013. When the button 6011 is pressed, the limiting column 6012 follows the proximal end of the elastic pressure strip 6013 to move toward the hollow area 6022, so that the limiting column 6012 disengages from the limiting slot.

[0104] The rotary cutting blade 103 is a tubular structure that forms the innermost layer of the distal tubing of the biopsy needle. The distal end of the rotary cutting blade 103 includes an annular blade that ensures smooth tissue incision. The annular blade preferably has a flat edge to ensure the integrity of the tissue after rotary cutting, preventing it from being crushed and affecting pathological analysis.

[0105] As an example, please refer to Figure 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 corners of the distal end surface of the rotary cutter tube 103 . The outer blade edge 1031 is used for cutting low-density tissue.

[0106] As another example, please refer to Figure 10 The annular blade at the distal end of the rotary cutter tube 103 is an inner blade edge 1031 ′ formed by removing 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 tissue.

[0107] In a specific embodiment, please refer to Figure 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. Both the distal metal tube 1032 and the proximal metal tube 1035 are metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1032 is an annular blade. The metal structure of the distal metal tube 1032 ensures that the rotary cutter tube 1033 can smoothly cut tissue. The metal structure of the proximal metal tube 1035 facilitates assembly and fixation. The wire spring tube 1033 is a hollow tube woven from stainless steel or nickel-titanium wire. When bent, the wire spring tube 1033 can flexibly transmit rotational speed and torque, effectively reducing vibration. The proximal end of the distal metal tube 1032 and the distal end of the 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 wire spring tube 1033 are substantially consistent.

[0108] A thin-walled polymer sealing tube 1034, such as a thin-walled heat-shrink tubing, is attached to the outside of the rotary cutter tube 103 via a heat-shrink process. This seals the rotary cutter tube 103, allowing the internal cavity to transmit negative or positive pressure, preventing leakage at welds and gaps between braided tubes. Furthermore, the thin-walled heat-shrink tubing reduces friction between the rotary cutter tube and the puncture needle during rotation, preventing wear of the braided 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 can be fixed to the proximal metal tube 1035 and the polymer sealing tube 1034 by bonding or other means. 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 achieve flexible rotation of the rotary cutter tube 103, the rotary cutter tube 103 uses a flexible rotary cutter shaft of a wire spring tube 1033 to achieve flexible transmission of torque and speed. However, without rigid support, the wire spring tube 1033 is very prone to shaking, affecting the sampling effect. In the present invention, the puncture needle tube 102 is sheathed outside the rotary cutter tube 103. 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 within the inner cavity of the puncture needle tube 102, preventing 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 during rotation.

[0112] The outer surface of the rotary cutter tube 103 is covered with a polymer sealing tube 1034 . 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 cutter tube 103 and the puncture needle tube 102 during rotation and avoid wear of the braided metal wire of the rotary cutter tube 103, the polymer sealing tube 1034 is a heat shrink tube formed by fixing a polymer tube to the outer surface of the rotary cutter tube 103 through a heat shrink process. The heat shrink tube can also improve the torsional performance and sealing performance of the metal wire spring tube 103 without losing the bending performance.

[0114] In order to increase the adhesion strength of the tissue after cutting and prevent 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 imaging, 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 impose any specific restrictions. For example, the roughness of the outer surface of the distal metal tube 1032 can be increased through processes such as threading and dotting to improve the imaging effect of the rotary cutting tube 103 under ultrasound.

[0116] In this 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 peeling blade tube transmission assembly 7, the peeling blade tube transmission assembly 7 drives the peeling blade tube 103 to perform peeling, which is a mature technology in this field. Therefore, the present invention does not limit the specific structure of the peeling blade tube transmission assembly 7. Any technical solution that can drive the peeling blade tube transmission assembly 7 to drive the peeling blade tube 103 to perform peeling is applicable to the present invention.

[0118] The rotary cutter tube transmission assembly 7 can both drive the rotary cutter tube 103 to rotate and cut tissue, and can also adjust the axial stroke of the rotary cutter tube 103 to adjust the cutting depth of the rotary cutter tube 103. In one 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, causing the rotary cutter tube 103 to cut tissue; the axial movement transmission mechanism drives the rotary cutter tube 103 to move axially, thereby adjusting the axial stroke of the rotary cutter tube 103 and, in turn, the cutting depth of the rotary cutter tube 103.

[0119] As an example, please refer to Figure 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, and 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, and the rotating gear 701 is driven by a rotary 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 outer-circuited on the rotary cutting knife tube 103, the inner knife sleeve 706 is fixedly outer-circuited on the fixed tube 708, the rotating sleeve 702 is outer-circuited 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 one specific implementation, the inner wall of the rotating sleeve 702 is provided with a plurality of protrusions spaced circumferentially, each of which is arranged axially along the rotating sleeve 702. The outer wall of the inner blade sleeve 706 is provided with a plurality of guide grooves spaced circumferentially, each of which is adapted to mate with the protrusions. These guide grooves are also arranged axially along the inner blade sleeve 706. By inserting the protrusions into the guide grooves, the rotating sleeve 702 and the inner blade sleeve 706 are both axially slidably connected and circumferentially fixedly connected. This allows the rotating sleeve 702 and the inner blade sleeve 706 to both slide relative to each other axially and rotate synchronously circumferentially. Alternatively, the protrusions may be provided on the outer wall of the inner blade sleeve 706, and the guide grooves may be provided on the inner wall of the rotating sleeve 702. This embodiment does not impose any specific limitations on this.

[0123] The axial movement transmission mechanism includes a screw sleeve 703 and a transmission screw 704. The screw sleeve 703 is mounted on the transmission screw 704 and is threadedly engaged with the transmission screw 704 for transmission. The screw sleeve 703 is coaxially fixedly connected to a travel gear 709. The travel gear 709 is driven by a travel drive motor to rotate. The travel 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 mounted on the rotating sleeve 702 and is relatively fixed to the core shaft assembly in the axial direction and is connected to the core shaft assembly for relative rotation in the circumferential direction.

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

[0125] The screw sleeve 703 only rotates within the proximal housing 4 and does not move axially. To limit axial movement of the screw sleeve 703 within the proximal housing 4, positioning baffles are provided at the proximal and distal ends of the screw sleeve 703 and the proximal housing 4. The purpose is to confine the screw sleeve 703 between the two positioning baffles to prevent it from moving axially.

[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 knife 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 groove.

[0128] In one specific implementation, an annular limiting groove 7061 is provided on the outer circumference of the inner blade sleeve 706, and an annular limiting clamp 705 is provided on the inner circumference of the drive screw 704, which is adapted to the annular limiting groove 7061. The annular limiting clamp 705 is inserted into the annular limiting groove 7061 to achieve a circumferential rotational connection between the drive screw 704 and the inner blade sleeve 706, and an axially fixed connection, that is, the inner blade sleeve 706 and the drive screw 704 can rotate relative to each other but cannot produce relative displacement in the axial direction. Of course, the annular limiting groove can also be provided on the inner circumference of the drive screw 704, and the annular limiting clamp adapted to the annular limiting groove is provided on the outer circumference of the inner blade sleeve 706. This embodiment does not impose specific limitations 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 Figure 12 The proximal end surface of the proximal housing 4 is provided with a negative pressure interface 401 for communicating with a negative pressure device. A connecting sleeve 9 is provided within the proximal housing 4. The proximal end of the connecting sleeve 9 is in sealed communication 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. A dynamic seal 10 is formed between the connecting sleeve 9 and the rotary cutter tube 103. When the rotary cutter tube 103 moves forward, it moves from the proximal end to the distal end. A portion of the rotary cutter tube 103 is always located within the connecting sleeve 9 of the rotary cutter tube 103 and contacts the dynamic seal 10, forming a dynamic seal.

[0131] In the initial position, the present invention does not impose a limit on the length of the rotary cutter tube 103 within the connecting sleeve 9. Furthermore, 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 within the connecting sleeve 9 is also not limited and can be set according to actual usage requirements. To prevent the rotary cutter tube 103 from escaping from the connecting sleeve 9, as an example, in the initial position, the rotary cutter tube 103 is greater than 2 cm within the connecting sleeve 9.

[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 ring.

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

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

[0138] In order to facilitate assembly and fixation, 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 Figure 13 Before puncture, the distal end of the puncture needle tube 102 is located inside the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located inside the puncture needle tube 102. The outer sheath tube 101 is transported into the working channel of the endoscope. When the outer sheath tube 101 reaches the designated position, the outer sheath tube 101 is fixed to the endoscope through the endoscope fixing member 2.

[0141] During puncture, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal shell 4. By pushing the proximal shell 4 toward 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 14 During the puncture process, the distal end of the rotary cutter 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 Figure 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 an annular blade at its distal end, after sampling, the tissue at the blade edge needs to be severed to complete the sampling. Therefore, during sampling, the negative pressure device applies negative pressure suction to the rotary cutter tube 103 through the negative pressure interface 401. The negative pressure suction can increase the breaking force of the rotary cutter tube 103 during retreat, ensuring that the tissue can be successfully severed.

[0144] After the sampling is completed, the syringe injects physiological saline into the rotary cutter tube 103 through the negative pressure interface 401 . 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. The negative pressure device performs negative pressure suction on the tissue in the rotary cutter tube 103 through the negative pressure interface 401 .

[0147] As an embodiment, the biopsy system further includes a syringe. After 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 connected to the negative pressure interface 401 .

[0149] As an embodiment, the negative pressure interface 401 is further connected to 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 401, the second interface is used to connect to the negative pressure device, and the third interface is used to connect to the syringe. The three-way connector is provided with an adjustment switch, and the adjustment switch switches the first interface's access to the second and third interfaces. For example, when the adjustment switch is in position I, the negative pressure suction of the negative pressure device can be transmitted to the distal end of the rotary cutter tube 103, achieving tissue absorption; when the adjustment switch is in position II, the syringe can flush and sample the tissue within the rotary cutter tube 103 to ensure tissue integrity.

[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 to illustrate the method for adjusting the negative pressure.

[0151] In order to adjust 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 based on the feedback negative pressure value by adjusting the flow rate of the negative pressure pump.

[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, making it easier 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 cutting depth of the rotary cutter tube 103. For example, when the rotary cutter tube 103 is screwed in 1 mm, the negative pressure value can be increased by 1 KPa. When the rotary cutter tube 103 is screwed in 20 mm, the negative pressure value is increased to 30 KPa. 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 distal 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 sample tissue is completely separated by the superposition of the suction force of the negative pressure and the friction force.

[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 scope of protection of the present invention should be based on the scope defined by the claims.

Claims

1. A negative pressure suction biopsy needle, characterized in that: The rotary cutter tube comprises a distal pipeline portion and a proximal handheld portion, wherein the distal pipeline portion comprises a rotary cutter tube, and the proximal handheld portion 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 by the rotary cutter tube transmission assembly to make the rotary cutter tube rotate circumferentially and move axially. 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 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 by a dynamic seal. The dynamic seal is a sealing ring, the outer periphery of which is sealedly connected to the inner periphery of the connecting sleeve, or the sealing ring is fixed to the distal end surface 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; 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 is at least sealed 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 sleeved on the proximal end of the polymer sealing tube.

2. The negative pressure suction biopsy needle according to claim 1, characterized in that: The sealing ring is a varnish seal or a silicone seal ring.

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

4. The negative pressure suction biopsy needle according to claim 3, 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 an integral connecting part and a locking part. The connecting part is used to be fixedly connected to 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.

5. The negative pressure suction biopsy needle according to claim 4, 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 and the second Luer connector are cooperatively connected; 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.

6. The negative pressure suction biopsy needle according to claim 3, characterized in that: The proximal handheld portion further comprises a puncture depth adjustment mechanism, the puncture depth adjustment mechanism comprising a sheath seat and a sheath seat locking member, the sheath seat being fixed to the proximal end of the outer sheath tube, and the proximal end housing being axially movable relative to the sheath seat; During puncture, the proximal shell is pushed distally so that the puncture needle tube and the rotary cutter 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.

7. The negative pressure suction biopsy needle according to claim 6, 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 end movable sleeve of the sheath seat is on the proximal end 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, and an internal threaded hole is provided in the locking cap that is adapted to the external thread of the sheath seat, and the sheath seat is clamped to the proximal 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 by tightening the threaded fastener, the end of the threaded fastener is pressed against the proximal shell.

8. The negative pressure suction biopsy needle according to claim 6, characterized in that: The proximal handheld portion further comprises a puncture needle tube adjusting mechanism, through which the puncture needle tube is installed in the proximal housing, and the puncture needle tube is axially moved by the puncture needle tube adjusting mechanism.

9. The negative pressure suction biopsy needle according to claim 8, 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 slots are spaced apart on at least one side groove wall of the puncture needle tube adjustment groove. In a natural state, the limiting column is located in the limiting slot, and by pressing the button, the limiting column is disengaged from the limiting slot to the proximal shell, thereby enabling the puncture needle tube to follow the button and move axially along the puncture needle tube adjustment slot.

10. The negative pressure suction biopsy needle according to claim 9, 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 the tube wall of at least one side of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outside of the hollow area, and the elastic strip is arranged along the axial direction of the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, and the elastic locking structure is fixed to the proximal end of the elastic strip, and when the button is pressed, 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.

11. The negative pressure suction biopsy needle according to claim 9, characterized in that: 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, so as to adjust the cutting depth of the rotary cutter tube.

12. The negative pressure suction biopsy needle according to claim 11, characterized in that: The circumferential rotation transmission mechanism includes 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 rotary 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, the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected to a travel gear, the travel gear is driven to rotate by a travel drive motor, the travel 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 externally mounted on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is connected to rotate relative to the core shaft assembly in the circumferential direction.

13. The negative pressure suction biopsy needle according to claim 12, characterized in that: The core shaft assembly includes a fixed tube and an inner knife sleeve, the fixed tube is fixedly outer-circuited on the rotary cutter tube, the inner knife sleeve is fixedly 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 in an axial sliding manner by inserting an axial protrusion into an axial guide groove, and are fixedly connected in the circumferential direction; The inner cutter sleeve and the transmission screw are connected in a circumferential rotation direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.

14. The negative pressure suction biopsy needle according to claim 12, characterized in that: 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.

15. The negative pressure suction biopsy needle according to claim 12, characterized in that: The proximal handheld portion further comprises a motor handle, in which both the rotation drive motor and the stroke drive motor are mounted, and the motor handle is fixedly connected to the proximal housing.

16. A negative pressure suction biopsy system, characterized in that: It comprises the negative pressure suction rotary biopsy needle and the negative pressure device according to any one of claims 1 to 15, wherein the negative pressure device performs negative pressure suction on the tissue in the rotary cutting blade tube through the negative pressure interface.

17. The negative pressure aspiration biopsy system according to claim 16, 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.

18. The negative pressure aspiration biopsy system according to claim 16, 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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